The New Gastroenterologist

Introduction

The field of cancer immunotherapy has exploded in recent years, with new therapies showing promising results for effective treatment of various cancer types. Immune checkpoint inhibitors (ICI) work by blocking checkpoint proteins that prevent breakdown of tumor cells by T-lymphocytes. Checkpoint proteins exist to prevent autoimmunity and destruction of healthy cells, but may allow tumor cells to grow unchallenged. Three checkpoint proteins – cytotoxic T-lymphocyte protein–4 (CTLA-4), programmed cell-death protein–1 (PD-1), and programmed cell-death protein ligand–1 (PDL-1) – are therapeutic targets for current ICIs.¹

ICIs are used to treat various cancer types (e.g., lung, renal-cell, and Hodgkin’s lymphoma). Immune-related adverse events (irAE) are frequently seen with ICI use, ranging from 15% to 90%, and can occur at any point during, or even after, treatment.²Although ICIs are known to cause multisystem adverse reactions, this review will discuss the spectrum of these reactions in the gastrointestinal and hepatopancreaticobiliary realms.

Immune checkpoint inhibitor–related gastrointestinal adverse reactions

GI adverse reactions are the second most common irAE, occurring in about 35%-50% of all reported irAEs.³ Anti-CTLA-4 medications have the highest association with GI irAE. The most common GI symptoms are diarrhea, abdominal pain, urgency, and nausea/vomiting. GI involvement can occur along the entirety of the GI tract – from the oral cavity to the colorectum. These are usually seen within 6-8 weeks of starting treatment, but can occur as early as 1 week after initiation or as late as 12 months after the last dose.² Although colitis is the most common area of luminal inflammation, aphthous ulcers, esophagitis, gastritis, and enteritis can be seen. Anti-CTLA-4 antibodies have the highest associated rate of diarrhea (33%-50%) and colitis (7%-22%) of all ICIs.⁴ Computed tomography (CT) may show colonic wall thickening or fat stranding, indicating inflammation. Endoscopically, the colon can appear grossly normal or demonstrate erythema, erosions, ulcerations, and/or loss of vascular pattern.⁵ Inflammation can be patchy or continuous. Typical histology shows increased lamina propria cellularity, neutrophilic infiltration (intraepithelial or crypt abscesses), and increased crypt apoptosis.⁶

The liver, pancreas, gallbladder, and biliary tract can also be affected by irAE. The liver is most commonly involved (i.e. 5% of irAE), manifesting as asymptomatic liver chemistry elevation, particularly aminotransferases. This can progress to acute symptomatic hepatitis with jaundice, fever, or malaise, and rarely to fulminant hepatitis. ICI-associated hepatitis appears histologically similar to autoimmune hepatitis, with pan-lobular hepatitis and infiltrating CD8+ T lymphocytes seen on liver biopsy.⁷ Less commonly, pancreatic toxicity can occur (<2% of irAE), seen with anti-CTLA-4 therapy.⁸ While this typically results in asymptomatic lipase or amylase elevations (2.7%), acute pancreatitis (AP) can occur(1.9%). ICI-associated AP presents with classic symptoms and imaging changes, but can also manifest with exocrine or endocrine pancreatic insufficiency. An increase in rates of acute acalculous cholecystitis has been reported in patients receiving ICIs compared to patients receiving non-ICI chemotherapy.⁹ There are also rare reports of ICI-associated secondary sclerosing cholangitis.
 

Management

Evaluation and management of GI irAEs are guided by severity, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading classification (Table 1).¹⁰

A thorough history of GI and systemic symptoms should be obtained and compared to baseline bowel habits. Patients with mild symptoms should undergo studies to assess alternate etiologies for their symptoms. Bacterial stool cultures and testing for C. difficile should be performed. Erythrocyte sedimentation rate, C-reactive protein, fecal lactoferrin, and calprotectin can help assess the degree of intestinal inflammation and can be used to risk-stratify or assess treatment response. CT scans can assess for colitis and associated complications, including abdominal abscess, toxic megacolon, and bowel perforation.

Patients unresponsive to initial treatment for grade I irAE, with hematochezia, or with at least grade 2 diarrhea, should undergo GI consultation and endoscopic evaluation. Flexible sigmoidoscopy is the test of choice, as 95% of patients will have left-sided colonic inflammation.¹¹ Patients with at least grade 3 diarrhea should be hospitalized for treatment. In cases of failed methylprednisolone and when infliximab is ineffective or contraindicated, vedolizumab is suggested, although evidence is limited.¹²

Patients responsive to systemic corticosteroids (complete resolution or improvement to grade 1) can continue a tapered regimen over 4-6 weeks. There is conflicting evidence on the effect that corticosteroids have on ICI-related antitumor response rates. While some studies report no change in antitumor response rates or survival, others report reduced overall survival.¹³ Regardless, given its unfavorable side-effect profile, steroids should be used only for short periods of time.

PD-1 and PD-L1 antibodies can be restarted after symptoms have resolved or improved to grade 1, having finished the corticosteroid taper. CTLA-4 antibodies should be discontinued permanently in the setting of grade 3 toxicity. All ICIs should be discontinued permanently in grade 4 toxicity.

Conclusions

Therapy with ICI is a rapidly expanding and changing field. Side effects of ICIs can affect nearly every organ system, and thus management should involve a multidisciplinary team of oncologists, pathologists, radiologists, pharmacists, and other specialists. Given that GI adverse effects are the second most commonly affected system, all gastroenterologists and hepatologists should be knowledgeable about the spectrum of GI adverse events, as well as with the respective clinical presentations, diagnostics, and management of these events.

Dr. Kwon is with the division of gastroenterology and hepatology, University of California Irvine, Orange. Dr. Kröner is with the division of advanced endoscopy, Riverside Health System, Newport News, Va. The authors certify that they have no financial arrangements (e.g., consultancies, stock ownership, equity interests, patent-licensing arrangements, research support, honoraria, etc.) with a company whose product figures prominently in this manuscript or with a company making a competing product. Funding: None.

References

1. Webster RM. The immune checkpoint inhibitors: where are we now? Nature Reviews: Drug Discovery. 2014;13(12):883.

2. Thompson JA et al. NCCN guidelines insights: Management of immunotherapy-related toxicities, version 1.2020: Featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2020;18(3):230-41.

3. Bertrand A et al. Immune related adverse events associated with anti-CTLA-4 antibodies: Systematic review and meta-analysis. BMC Med. 2015 Sep 4;13:211.

4. Gupta A et al. Systematic review: Colitis associated with anti‐CTLA‐4 therapy. Aliment Pharmacol Ther. 2015;42(4):406-17.

5. Verschuren EC et al. Clinical, endoscopic, and histologic characteristics of ipilimumab-associated colitis. Clin Gastroenterol Hepatol. 2016;14(6):836-42.

6. Foppen MHG et al. Immune checkpoint inhibition–related colitis: Symptoms, endoscopic features, histology and response to management. ESMO Open. 2018;3(1):e000278.

7. Sanjeevaiah A et al. Approach and management of checkpoint inhibitor–related immune hepatitis. J Gastrointest Oncol. 2018;9(1):220.

8. Abu-Sbeih H et al. Clinical characteristics and outcomes of immune checkpoint inhibitor–induced pancreatic injury. J Immunother Cancer. 2019 Feb 6;7(1):31.

9. Abu-Sbeih H et al. Case series of cancer patients who developed cholecystitis related to immune checkpoint inhibitor treatment. J Immunother Cancer. 2019 May 3;7(1):118.

10. Thompson JA et al. Management of immunotherapy-related toxicities, version 1.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2019;17(3):255-89.

11. Marthey L et al. Cancer immunotherapy with anti-CTLA-4 monoclonal antibodies induces an inflammatory bowel disease. J Crohns Colitis. 2016;10(4):395-401.

12. Abu-Sbeih H et al. Outcomes of vedolizumab therapy in patients with immune checkpoint inhibitor–induced colitis: A multicenter study. J Immunother Cancer. 2018 Dec 5;6(1):142.

13. Das S and Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019 Nov 15;7(1):306.

14. Reddy HG et al. Immune checkpoint inhibitor–associated colitis and hepatitis. Clin Transl Gastroenterol. 2018 Sep 19;9(9):180.

15. Reynolds K et al. Diagnosis and management of hepatitis in patients on checkpoint blockade. Oncologist. 2018;23(9):991-7.

Introduction

The field of cancer immunotherapy has exploded in recent years, with new therapies showing promising results for effective treatment of various cancer types. Immune checkpoint inhibitors (ICI) work by blocking checkpoint proteins that prevent breakdown of tumor cells by T-lymphocytes. Checkpoint proteins exist to prevent autoimmunity and destruction of healthy cells, but may allow tumor cells to grow unchallenged. Three checkpoint proteins – cytotoxic T-lymphocyte protein–4 (CTLA-4), programmed cell-death protein–1 (PD-1), and programmed cell-death protein ligand–1 (PDL-1) – are therapeutic targets for current ICIs.¹

ICIs are used to treat various cancer types (e.g., lung, renal-cell, and Hodgkin’s lymphoma). Immune-related adverse events (irAE) are frequently seen with ICI use, ranging from 15% to 90%, and can occur at any point during, or even after, treatment.²Although ICIs are known to cause multisystem adverse reactions, this review will discuss the spectrum of these reactions in the gastrointestinal and hepatopancreaticobiliary realms.

Immune checkpoint inhibitor–related gastrointestinal adverse reactions

GI adverse reactions are the second most common irAE, occurring in about 35%-50% of all reported irAEs.³ Anti-CTLA-4 medications have the highest association with GI irAE. The most common GI symptoms are diarrhea, abdominal pain, urgency, and nausea/vomiting. GI involvement can occur along the entirety of the GI tract – from the oral cavity to the colorectum. These are usually seen within 6-8 weeks of starting treatment, but can occur as early as 1 week after initiation or as late as 12 months after the last dose.² Although colitis is the most common area of luminal inflammation, aphthous ulcers, esophagitis, gastritis, and enteritis can be seen. Anti-CTLA-4 antibodies have the highest associated rate of diarrhea (33%-50%) and colitis (7%-22%) of all ICIs.⁴ Computed tomography (CT) may show colonic wall thickening or fat stranding, indicating inflammation. Endoscopically, the colon can appear grossly normal or demonstrate erythema, erosions, ulcerations, and/or loss of vascular pattern.⁵ Inflammation can be patchy or continuous. Typical histology shows increased lamina propria cellularity, neutrophilic infiltration (intraepithelial or crypt abscesses), and increased crypt apoptosis.⁶

The liver, pancreas, gallbladder, and biliary tract can also be affected by irAE. The liver is most commonly involved (i.e. 5% of irAE), manifesting as asymptomatic liver chemistry elevation, particularly aminotransferases. This can progress to acute symptomatic hepatitis with jaundice, fever, or malaise, and rarely to fulminant hepatitis. ICI-associated hepatitis appears histologically similar to autoimmune hepatitis, with pan-lobular hepatitis and infiltrating CD8+ T lymphocytes seen on liver biopsy.⁷ Less commonly, pancreatic toxicity can occur (<2% of irAE), seen with anti-CTLA-4 therapy.⁸ While this typically results in asymptomatic lipase or amylase elevations (2.7%), acute pancreatitis (AP) can occur(1.9%). ICI-associated AP presents with classic symptoms and imaging changes, but can also manifest with exocrine or endocrine pancreatic insufficiency. An increase in rates of acute acalculous cholecystitis has been reported in patients receiving ICIs compared to patients receiving non-ICI chemotherapy.⁹ There are also rare reports of ICI-associated secondary sclerosing cholangitis.
 

Management

Evaluation and management of GI irAEs are guided by severity, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading classification (Table 1).¹⁰

A thorough history of GI and systemic symptoms should be obtained and compared to baseline bowel habits. Patients with mild symptoms should undergo studies to assess alternate etiologies for their symptoms. Bacterial stool cultures and testing for C. difficile should be performed. Erythrocyte sedimentation rate, C-reactive protein, fecal lactoferrin, and calprotectin can help assess the degree of intestinal inflammation and can be used to risk-stratify or assess treatment response. CT scans can assess for colitis and associated complications, including abdominal abscess, toxic megacolon, and bowel perforation.

Patients unresponsive to initial treatment for grade I irAE, with hematochezia, or with at least grade 2 diarrhea, should undergo GI consultation and endoscopic evaluation. Flexible sigmoidoscopy is the test of choice, as 95% of patients will have left-sided colonic inflammation.¹¹ Patients with at least grade 3 diarrhea should be hospitalized for treatment. In cases of failed methylprednisolone and when infliximab is ineffective or contraindicated, vedolizumab is suggested, although evidence is limited.¹²

Patients responsive to systemic corticosteroids (complete resolution or improvement to grade 1) can continue a tapered regimen over 4-6 weeks. There is conflicting evidence on the effect that corticosteroids have on ICI-related antitumor response rates. While some studies report no change in antitumor response rates or survival, others report reduced overall survival.¹³ Regardless, given its unfavorable side-effect profile, steroids should be used only for short periods of time.

PD-1 and PD-L1 antibodies can be restarted after symptoms have resolved or improved to grade 1, having finished the corticosteroid taper. CTLA-4 antibodies should be discontinued permanently in the setting of grade 3 toxicity. All ICIs should be discontinued permanently in grade 4 toxicity.

Conclusions

Therapy with ICI is a rapidly expanding and changing field. Side effects of ICIs can affect nearly every organ system, and thus management should involve a multidisciplinary team of oncologists, pathologists, radiologists, pharmacists, and other specialists. Given that GI adverse effects are the second most commonly affected system, all gastroenterologists and hepatologists should be knowledgeable about the spectrum of GI adverse events, as well as with the respective clinical presentations, diagnostics, and management of these events.

Dr. Kwon is with the division of gastroenterology and hepatology, University of California Irvine, Orange. Dr. Kröner is with the division of advanced endoscopy, Riverside Health System, Newport News, Va. The authors certify that they have no financial arrangements (e.g., consultancies, stock ownership, equity interests, patent-licensing arrangements, research support, honoraria, etc.) with a company whose product figures prominently in this manuscript or with a company making a competing product. Funding: None.

References

1. Webster RM. The immune checkpoint inhibitors: where are we now? Nature Reviews: Drug Discovery. 2014;13(12):883.

2. Thompson JA et al. NCCN guidelines insights: Management of immunotherapy-related toxicities, version 1.2020: Featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2020;18(3):230-41.

3. Bertrand A et al. Immune related adverse events associated with anti-CTLA-4 antibodies: Systematic review and meta-analysis. BMC Med. 2015 Sep 4;13:211.

4. Gupta A et al. Systematic review: Colitis associated with anti‐CTLA‐4 therapy. Aliment Pharmacol Ther. 2015;42(4):406-17.

5. Verschuren EC et al. Clinical, endoscopic, and histologic characteristics of ipilimumab-associated colitis. Clin Gastroenterol Hepatol. 2016;14(6):836-42.

6. Foppen MHG et al. Immune checkpoint inhibition–related colitis: Symptoms, endoscopic features, histology and response to management. ESMO Open. 2018;3(1):e000278.

7. Sanjeevaiah A et al. Approach and management of checkpoint inhibitor–related immune hepatitis. J Gastrointest Oncol. 2018;9(1):220.

8. Abu-Sbeih H et al. Clinical characteristics and outcomes of immune checkpoint inhibitor–induced pancreatic injury. J Immunother Cancer. 2019 Feb 6;7(1):31.

9. Abu-Sbeih H et al. Case series of cancer patients who developed cholecystitis related to immune checkpoint inhibitor treatment. J Immunother Cancer. 2019 May 3;7(1):118.

10. Thompson JA et al. Management of immunotherapy-related toxicities, version 1.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2019;17(3):255-89.

11. Marthey L et al. Cancer immunotherapy with anti-CTLA-4 monoclonal antibodies induces an inflammatory bowel disease. J Crohns Colitis. 2016;10(4):395-401.

12. Abu-Sbeih H et al. Outcomes of vedolizumab therapy in patients with immune checkpoint inhibitor–induced colitis: A multicenter study. J Immunother Cancer. 2018 Dec 5;6(1):142.

13. Das S and Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019 Nov 15;7(1):306.

14. Reddy HG et al. Immune checkpoint inhibitor–associated colitis and hepatitis. Clin Transl Gastroenterol. 2018 Sep 19;9(9):180.

15. Reynolds K et al. Diagnosis and management of hepatitis in patients on checkpoint blockade. Oncologist. 2018;23(9):991-7.

Introduction

The field of cancer immunotherapy has exploded in recent years, with new therapies showing promising results for effective treatment of various cancer types. Immune checkpoint inhibitors (ICI) work by blocking checkpoint proteins that prevent breakdown of tumor cells by T-lymphocytes. Checkpoint proteins exist to prevent autoimmunity and destruction of healthy cells, but may allow tumor cells to grow unchallenged. Three checkpoint proteins – cytotoxic T-lymphocyte protein–4 (CTLA-4), programmed cell-death protein–1 (PD-1), and programmed cell-death protein ligand–1 (PDL-1) – are therapeutic targets for current ICIs.¹

ICIs are used to treat various cancer types (e.g., lung, renal-cell, and Hodgkin’s lymphoma). Immune-related adverse events (irAE) are frequently seen with ICI use, ranging from 15% to 90%, and can occur at any point during, or even after, treatment.²Although ICIs are known to cause multisystem adverse reactions, this review will discuss the spectrum of these reactions in the gastrointestinal and hepatopancreaticobiliary realms.

Immune checkpoint inhibitor–related gastrointestinal adverse reactions

GI adverse reactions are the second most common irAE, occurring in about 35%-50% of all reported irAEs.³ Anti-CTLA-4 medications have the highest association with GI irAE. The most common GI symptoms are diarrhea, abdominal pain, urgency, and nausea/vomiting. GI involvement can occur along the entirety of the GI tract – from the oral cavity to the colorectum. These are usually seen within 6-8 weeks of starting treatment, but can occur as early as 1 week after initiation or as late as 12 months after the last dose.² Although colitis is the most common area of luminal inflammation, aphthous ulcers, esophagitis, gastritis, and enteritis can be seen. Anti-CTLA-4 antibodies have the highest associated rate of diarrhea (33%-50%) and colitis (7%-22%) of all ICIs.⁴ Computed tomography (CT) may show colonic wall thickening or fat stranding, indicating inflammation. Endoscopically, the colon can appear grossly normal or demonstrate erythema, erosions, ulcerations, and/or loss of vascular pattern.⁵ Inflammation can be patchy or continuous. Typical histology shows increased lamina propria cellularity, neutrophilic infiltration (intraepithelial or crypt abscesses), and increased crypt apoptosis.⁶

The liver, pancreas, gallbladder, and biliary tract can also be affected by irAE. The liver is most commonly involved (i.e. 5% of irAE), manifesting as asymptomatic liver chemistry elevation, particularly aminotransferases. This can progress to acute symptomatic hepatitis with jaundice, fever, or malaise, and rarely to fulminant hepatitis. ICI-associated hepatitis appears histologically similar to autoimmune hepatitis, with pan-lobular hepatitis and infiltrating CD8+ T lymphocytes seen on liver biopsy.⁷ Less commonly, pancreatic toxicity can occur (<2% of irAE), seen with anti-CTLA-4 therapy.⁸ While this typically results in asymptomatic lipase or amylase elevations (2.7%), acute pancreatitis (AP) can occur(1.9%). ICI-associated AP presents with classic symptoms and imaging changes, but can also manifest with exocrine or endocrine pancreatic insufficiency. An increase in rates of acute acalculous cholecystitis has been reported in patients receiving ICIs compared to patients receiving non-ICI chemotherapy.⁹ There are also rare reports of ICI-associated secondary sclerosing cholangitis.
 

Management

Evaluation and management of GI irAEs are guided by severity, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading classification (Table 1).¹⁰

A thorough history of GI and systemic symptoms should be obtained and compared to baseline bowel habits. Patients with mild symptoms should undergo studies to assess alternate etiologies for their symptoms. Bacterial stool cultures and testing for C. difficile should be performed. Erythrocyte sedimentation rate, C-reactive protein, fecal lactoferrin, and calprotectin can help assess the degree of intestinal inflammation and can be used to risk-stratify or assess treatment response. CT scans can assess for colitis and associated complications, including abdominal abscess, toxic megacolon, and bowel perforation.

Patients unresponsive to initial treatment for grade I irAE, with hematochezia, or with at least grade 2 diarrhea, should undergo GI consultation and endoscopic evaluation. Flexible sigmoidoscopy is the test of choice, as 95% of patients will have left-sided colonic inflammation.¹¹ Patients with at least grade 3 diarrhea should be hospitalized for treatment. In cases of failed methylprednisolone and when infliximab is ineffective or contraindicated, vedolizumab is suggested, although evidence is limited.¹²

Patients responsive to systemic corticosteroids (complete resolution or improvement to grade 1) can continue a tapered regimen over 4-6 weeks. There is conflicting evidence on the effect that corticosteroids have on ICI-related antitumor response rates. While some studies report no change in antitumor response rates or survival, others report reduced overall survival.¹³ Regardless, given its unfavorable side-effect profile, steroids should be used only for short periods of time.

PD-1 and PD-L1 antibodies can be restarted after symptoms have resolved or improved to grade 1, having finished the corticosteroid taper. CTLA-4 antibodies should be discontinued permanently in the setting of grade 3 toxicity. All ICIs should be discontinued permanently in grade 4 toxicity.

Conclusions

Therapy with ICI is a rapidly expanding and changing field. Side effects of ICIs can affect nearly every organ system, and thus management should involve a multidisciplinary team of oncologists, pathologists, radiologists, pharmacists, and other specialists. Given that GI adverse effects are the second most commonly affected system, all gastroenterologists and hepatologists should be knowledgeable about the spectrum of GI adverse events, as well as with the respective clinical presentations, diagnostics, and management of these events.

Dr. Kwon is with the division of gastroenterology and hepatology, University of California Irvine, Orange. Dr. Kröner is with the division of advanced endoscopy, Riverside Health System, Newport News, Va. The authors certify that they have no financial arrangements (e.g., consultancies, stock ownership, equity interests, patent-licensing arrangements, research support, honoraria, etc.) with a company whose product figures prominently in this manuscript or with a company making a competing product. Funding: None.

References

1. Webster RM. The immune checkpoint inhibitors: where are we now? Nature Reviews: Drug Discovery. 2014;13(12):883.

2. Thompson JA et al. NCCN guidelines insights: Management of immunotherapy-related toxicities, version 1.2020: Featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2020;18(3):230-41.

3. Bertrand A et al. Immune related adverse events associated with anti-CTLA-4 antibodies: Systematic review and meta-analysis. BMC Med. 2015 Sep 4;13:211.

4. Gupta A et al. Systematic review: Colitis associated with anti‐CTLA‐4 therapy. Aliment Pharmacol Ther. 2015;42(4):406-17.

5. Verschuren EC et al. Clinical, endoscopic, and histologic characteristics of ipilimumab-associated colitis. Clin Gastroenterol Hepatol. 2016;14(6):836-42.

6. Foppen MHG et al. Immune checkpoint inhibition–related colitis: Symptoms, endoscopic features, histology and response to management. ESMO Open. 2018;3(1):e000278.

7. Sanjeevaiah A et al. Approach and management of checkpoint inhibitor–related immune hepatitis. J Gastrointest Oncol. 2018;9(1):220.

8. Abu-Sbeih H et al. Clinical characteristics and outcomes of immune checkpoint inhibitor–induced pancreatic injury. J Immunother Cancer. 2019 Feb 6;7(1):31.

9. Abu-Sbeih H et al. Case series of cancer patients who developed cholecystitis related to immune checkpoint inhibitor treatment. J Immunother Cancer. 2019 May 3;7(1):118.

10. Thompson JA et al. Management of immunotherapy-related toxicities, version 1.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2019;17(3):255-89.

11. Marthey L et al. Cancer immunotherapy with anti-CTLA-4 monoclonal antibodies induces an inflammatory bowel disease. J Crohns Colitis. 2016;10(4):395-401.

12. Abu-Sbeih H et al. Outcomes of vedolizumab therapy in patients with immune checkpoint inhibitor–induced colitis: A multicenter study. J Immunother Cancer. 2018 Dec 5;6(1):142.

13. Das S and Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019 Nov 15;7(1):306.

14. Reddy HG et al. Immune checkpoint inhibitor–associated colitis and hepatitis. Clin Transl Gastroenterol. 2018 Sep 19;9(9):180.

15. Reynolds K et al. Diagnosis and management of hepatitis in patients on checkpoint blockade. Oncologist. 2018;23(9):991-7.

It was my dream from an early age to become a physician. Even as a child I was fascinated by medical procedures and interventions. As I pursued my medical degree, I became increasingly interested in a career where I could integrate patient care and the latest innovations in technology.

Training in gastroenterology has provided me an exciting mix of patient care and procedures, with medical devices and technologies that are constantly evolving. As I began my career, I joined Dayton Gastroenterology, a private practice affiliated with GI fellowship at Wright State University, Fairborn, Ohio, because the practice provided an opportunity to care for patients, train GI fellows, and provide employment opportunities to the community I serve.

After spending so many years to become an expert in medicine and then training in gastroenterology, it might have seemed daunting to go back to school to get an education in another field. But we all know the medical environment is constantly changing – in the last decade dramatically so, in technology as well as in how groups are organizing themselves in response to health care consolidation and other external forces. Developing expertise in both medicine and business can prepare physicians to be better advocates and leaders as health care continues to change.
 

The importance of understanding the business of health care

Consolidation in health care has increasingly impacted private practices, with more primary care and specialty physicians being employed by hospitals. In some areas of the country, this has affected the flow of patient referrals to independent GI practices, and these practices must now adapt to continue serving their communities. This is being amplified by the increasing demands for patient services coupled with staffing issues and reimbursement cuts.

These challenges have resulted in some smaller practices joining local hospitals systems. Others have come together to form larger groups or managed services organizations (MSO), and some have partnered with private equity firms to compete in response to these market forces.

During our training and education in medical school, we aren’t taught how to run a successful practice. We aren’t taught how to bring together different industry partners, collaborators, and payers or how to build patient-centric practice models. But sometimes the best method of learning is by doing, and my experiences during the merger of Dayton Gastroenterology with One GI, a physician-focused MSO with practices in six states, was invaluable.

That merger process taught me a lot about how companies are valued, the nuances in determining deal flow, networking, human capital, and everything else involved in how a transaction takes place. I developed a greater understanding about how to develop and build successful large practices, with improved employee satisfaction, company culture, and great patient experience.
 

Developing a positive practice culture

It was during the process of partnering with One GI and during the pandemic that I decided to pursue my desire to get a formal business education, and I’m glad I did. The executive MBA program at the Kellogg School of Management at Northwestern University allowed me to gain an in-depth understanding of various aspects of business, finance, accounting, marketing, leadership, governance, organizational transformation, negotiations, and so much more, all while continuing to work full time as a gastroenterologist in private practice.

We met for classes in-person each month over the course of four days. There were also live and recorded virtual sessions in between each monthly class. The program was rigorous, but worth it. Connecting with leaders from different industries and learning from exceptional professors alongside these professionals was an invaluable experience.

Two of the most vital things I learned were the importance of team building and development of a company culture that will sustain an organization over the long term. I learned management strategies to empower employees, governance best practices, and how to align the interests of internal and external stakeholders.

Anyone can buy a practice, and anyone can merge their practice into a larger entity, but it is critical to understand the components of a successful integration. Culture eats strategy for breakfast. You can have the best minds, develop the best processes, but if there is not a strong culture with the alignment of physicians, staff, and practice management, even the best strategies can easily fail.

What to look for in joining a practice

As physicians, we all want to be the best at what we do. It’s important to be intentional about what you value and how you would like to shape your career. When considering which practice you might join, there are several things to consider, such as the location, medical needs of the community, and services offered by the practice. Equally important is understanding how the practice is managed.

Does the practice promote growth opportunities for its physicians and staff? Are there governance structures and processes in place to empower and retain talented staff? What values does the practice portray? Is there a buy-in or buy-out when becoming a partner in the practice, and are there equity opportunities? These are just some of many questions early-career physicians should ask.
 

My MBA helped me become a better leader

A physician understands the needs of delivering exceptional medical care, the challenges involved, and the resources required. Increasing the depth and breadth of our knowledge is power. Good people make good organizations, but great people make great organizations. Those of us who are on the front lines are the best advocates for our patients and other frontline workers. We can become powerful advocates and leaders when we better understand how business trends and other external forces affect our ability to care for the patients in the future.

Pursuing a business education provides a strong foundation for physician leaders who have strong analytical intuition and focus on patient-centric practice models. If you are considering a career in private practice and are interested in practice management or growing a practice, an MBA or similar educational programs will provide an understanding of finance, accounting, and other business-related fields that can enable physicians to become agile and empathic leaders.
 

Dr. Appalaneni is a practicing gastroenterologist at Dayton Gastroenterology in Ohio. She is Executive Vice President of Clinical Innovation at One GI, a physician-led managed services organization. Dr. Appalaneni has no conflicts to declare.

It was my dream from an early age to become a physician. Even as a child I was fascinated by medical procedures and interventions. As I pursued my medical degree, I became increasingly interested in a career where I could integrate patient care and the latest innovations in technology.

Training in gastroenterology has provided me an exciting mix of patient care and procedures, with medical devices and technologies that are constantly evolving. As I began my career, I joined Dayton Gastroenterology, a private practice affiliated with GI fellowship at Wright State University, Fairborn, Ohio, because the practice provided an opportunity to care for patients, train GI fellows, and provide employment opportunities to the community I serve.

After spending so many years to become an expert in medicine and then training in gastroenterology, it might have seemed daunting to go back to school to get an education in another field. But we all know the medical environment is constantly changing – in the last decade dramatically so, in technology as well as in how groups are organizing themselves in response to health care consolidation and other external forces. Developing expertise in both medicine and business can prepare physicians to be better advocates and leaders as health care continues to change.
 

The importance of understanding the business of health care

Consolidation in health care has increasingly impacted private practices, with more primary care and specialty physicians being employed by hospitals. In some areas of the country, this has affected the flow of patient referrals to independent GI practices, and these practices must now adapt to continue serving their communities. This is being amplified by the increasing demands for patient services coupled with staffing issues and reimbursement cuts.

These challenges have resulted in some smaller practices joining local hospitals systems. Others have come together to form larger groups or managed services organizations (MSO), and some have partnered with private equity firms to compete in response to these market forces.

During our training and education in medical school, we aren’t taught how to run a successful practice. We aren’t taught how to bring together different industry partners, collaborators, and payers or how to build patient-centric practice models. But sometimes the best method of learning is by doing, and my experiences during the merger of Dayton Gastroenterology with One GI, a physician-focused MSO with practices in six states, was invaluable.

That merger process taught me a lot about how companies are valued, the nuances in determining deal flow, networking, human capital, and everything else involved in how a transaction takes place. I developed a greater understanding about how to develop and build successful large practices, with improved employee satisfaction, company culture, and great patient experience.
 

Developing a positive practice culture

It was during the process of partnering with One GI and during the pandemic that I decided to pursue my desire to get a formal business education, and I’m glad I did. The executive MBA program at the Kellogg School of Management at Northwestern University allowed me to gain an in-depth understanding of various aspects of business, finance, accounting, marketing, leadership, governance, organizational transformation, negotiations, and so much more, all while continuing to work full time as a gastroenterologist in private practice.

We met for classes in-person each month over the course of four days. There were also live and recorded virtual sessions in between each monthly class. The program was rigorous, but worth it. Connecting with leaders from different industries and learning from exceptional professors alongside these professionals was an invaluable experience.

Two of the most vital things I learned were the importance of team building and development of a company culture that will sustain an organization over the long term. I learned management strategies to empower employees, governance best practices, and how to align the interests of internal and external stakeholders.

Anyone can buy a practice, and anyone can merge their practice into a larger entity, but it is critical to understand the components of a successful integration. Culture eats strategy for breakfast. You can have the best minds, develop the best processes, but if there is not a strong culture with the alignment of physicians, staff, and practice management, even the best strategies can easily fail.

What to look for in joining a practice

As physicians, we all want to be the best at what we do. It’s important to be intentional about what you value and how you would like to shape your career. When considering which practice you might join, there are several things to consider, such as the location, medical needs of the community, and services offered by the practice. Equally important is understanding how the practice is managed.

Does the practice promote growth opportunities for its physicians and staff? Are there governance structures and processes in place to empower and retain talented staff? What values does the practice portray? Is there a buy-in or buy-out when becoming a partner in the practice, and are there equity opportunities? These are just some of many questions early-career physicians should ask.
 

My MBA helped me become a better leader

A physician understands the needs of delivering exceptional medical care, the challenges involved, and the resources required. Increasing the depth and breadth of our knowledge is power. Good people make good organizations, but great people make great organizations. Those of us who are on the front lines are the best advocates for our patients and other frontline workers. We can become powerful advocates and leaders when we better understand how business trends and other external forces affect our ability to care for the patients in the future.

Pursuing a business education provides a strong foundation for physician leaders who have strong analytical intuition and focus on patient-centric practice models. If you are considering a career in private practice and are interested in practice management or growing a practice, an MBA or similar educational programs will provide an understanding of finance, accounting, and other business-related fields that can enable physicians to become agile and empathic leaders.
 

Dr. Appalaneni is a practicing gastroenterologist at Dayton Gastroenterology in Ohio. She is Executive Vice President of Clinical Innovation at One GI, a physician-led managed services organization. Dr. Appalaneni has no conflicts to declare.

It was my dream from an early age to become a physician. Even as a child I was fascinated by medical procedures and interventions. As I pursued my medical degree, I became increasingly interested in a career where I could integrate patient care and the latest innovations in technology.

Training in gastroenterology has provided me an exciting mix of patient care and procedures, with medical devices and technologies that are constantly evolving. As I began my career, I joined Dayton Gastroenterology, a private practice affiliated with GI fellowship at Wright State University, Fairborn, Ohio, because the practice provided an opportunity to care for patients, train GI fellows, and provide employment opportunities to the community I serve.

After spending so many years to become an expert in medicine and then training in gastroenterology, it might have seemed daunting to go back to school to get an education in another field. But we all know the medical environment is constantly changing – in the last decade dramatically so, in technology as well as in how groups are organizing themselves in response to health care consolidation and other external forces. Developing expertise in both medicine and business can prepare physicians to be better advocates and leaders as health care continues to change.
 

The importance of understanding the business of health care

Consolidation in health care has increasingly impacted private practices, with more primary care and specialty physicians being employed by hospitals. In some areas of the country, this has affected the flow of patient referrals to independent GI practices, and these practices must now adapt to continue serving their communities. This is being amplified by the increasing demands for patient services coupled with staffing issues and reimbursement cuts.

These challenges have resulted in some smaller practices joining local hospitals systems. Others have come together to form larger groups or managed services organizations (MSO), and some have partnered with private equity firms to compete in response to these market forces.

During our training and education in medical school, we aren’t taught how to run a successful practice. We aren’t taught how to bring together different industry partners, collaborators, and payers or how to build patient-centric practice models. But sometimes the best method of learning is by doing, and my experiences during the merger of Dayton Gastroenterology with One GI, a physician-focused MSO with practices in six states, was invaluable.

That merger process taught me a lot about how companies are valued, the nuances in determining deal flow, networking, human capital, and everything else involved in how a transaction takes place. I developed a greater understanding about how to develop and build successful large practices, with improved employee satisfaction, company culture, and great patient experience.
 

Developing a positive practice culture

It was during the process of partnering with One GI and during the pandemic that I decided to pursue my desire to get a formal business education, and I’m glad I did. The executive MBA program at the Kellogg School of Management at Northwestern University allowed me to gain an in-depth understanding of various aspects of business, finance, accounting, marketing, leadership, governance, organizational transformation, negotiations, and so much more, all while continuing to work full time as a gastroenterologist in private practice.

We met for classes in-person each month over the course of four days. There were also live and recorded virtual sessions in between each monthly class. The program was rigorous, but worth it. Connecting with leaders from different industries and learning from exceptional professors alongside these professionals was an invaluable experience.

Two of the most vital things I learned were the importance of team building and development of a company culture that will sustain an organization over the long term. I learned management strategies to empower employees, governance best practices, and how to align the interests of internal and external stakeholders.

Anyone can buy a practice, and anyone can merge their practice into a larger entity, but it is critical to understand the components of a successful integration. Culture eats strategy for breakfast. You can have the best minds, develop the best processes, but if there is not a strong culture with the alignment of physicians, staff, and practice management, even the best strategies can easily fail.

What to look for in joining a practice

As physicians, we all want to be the best at what we do. It’s important to be intentional about what you value and how you would like to shape your career. When considering which practice you might join, there are several things to consider, such as the location, medical needs of the community, and services offered by the practice. Equally important is understanding how the practice is managed.

Does the practice promote growth opportunities for its physicians and staff? Are there governance structures and processes in place to empower and retain talented staff? What values does the practice portray? Is there a buy-in or buy-out when becoming a partner in the practice, and are there equity opportunities? These are just some of many questions early-career physicians should ask.
 

My MBA helped me become a better leader

A physician understands the needs of delivering exceptional medical care, the challenges involved, and the resources required. Increasing the depth and breadth of our knowledge is power. Good people make good organizations, but great people make great organizations. Those of us who are on the front lines are the best advocates for our patients and other frontline workers. We can become powerful advocates and leaders when we better understand how business trends and other external forces affect our ability to care for the patients in the future.

Pursuing a business education provides a strong foundation for physician leaders who have strong analytical intuition and focus on patient-centric practice models. If you are considering a career in private practice and are interested in practice management or growing a practice, an MBA or similar educational programs will provide an understanding of finance, accounting, and other business-related fields that can enable physicians to become agile and empathic leaders.
 

Dr. Appalaneni is a practicing gastroenterologist at Dayton Gastroenterology in Ohio. She is Executive Vice President of Clinical Innovation at One GI, a physician-led managed services organization. Dr. Appalaneni has no conflicts to declare.

AGA members advocate for GI during Alliance of Specialty Medicine fly-in

In December, six AGA members joined more than 100 specialty doctors organized by the Alliance of Specialty Medicine, a coalition that represents specialty physicians, to meet with House and Senate offices and discuss pressing policy priorities.

Members spoke on behalf of GI and stressed the need for Congress to act immediately on the upcoming Medicare cuts, and discussed step therapy protocols, prior authorization reform, and the role of artificial intelligence in the specialty.

Courtesy AGA

Our members represented GI well throughout the day’s meetings!

AGA PAC Board Member and Congressional Advocate Dr. Sadeea Abbasi spoke to House Leader Kevin McCarthy (R-CA) about challenges specialty doctors are facing and petitioned for Congress to mitigate the nearly 10 percent Medicare payment cuts before the end of the 117th Congress.

Additionally, AGA Government Affairs Committee Chair Dr. Rotonya Carr engaged with several members of Congress on issues impacting specialty care and discussed the future of AI in medicine with Rep. Mariannette Miller-Meeks (R-IA), who is an ophthalmologist.

Thank you to all our members who spoke on behalf of GI! We appreciate our AGA leaders who took time to participate!

• Sadeea Abbasi, MD, PhD
• Dawn B. Beaulieu, MD, AGAF
• Brent Burnette, MD
• Rotonya M. Carr, MD, FACP
• Peter S. Margolis, MD, AGAF
• Suzette Rivera MacMurray, MD

Learn how AGA is advocating for you. Visit gastro.org/advocacy.

AGA workshops champion women in GI

At AGA, we’re committed to supporting, empowering, and amplifying women in GI. As part of our ongoing efforts, we were thrilled to host nearly 250 women at four Women in GI regional workshops this fall. These workshops provided women across the country with opportunities to develop their personal and professional networks, participate in leadership development seminars, receive career mentoring, and engage in various wellness practices.

Following the conclusion of the regional workshops, we hosted the AGA Women’s Leadership Collaboration Conference at the AGA national office in Bethesda, Md.

Courtesy AGA

During the two-day conference, 22 delegates discussed workplace experiences, reported on their region’s workshop, and participated in strategy development exercises to further gender equity in GI, which included identifying tactics and ideas for action.

This unique event brought together delegates from each regional workshop, including 2023 Dr. Maria Leo-Lieber scholarship winners Alyssa Parian and Alexandra Livanos, who attended the Northeast workshop. It was a great time of collaboration and connection with the AGA #WomenInGI community!

Thank you to everyone who participated and made the events a success. We look forward to uplifting all women in GI and identifying ways to support the community in the coming year.

AGA thanks Johnson & Johnson Health Care Systems, Inc. for their support of this program.


 

Help move innovation forward at the 2023 AGA Tech Summit

Innovative technologies for endoscopy, advanced imaging, and bariatric care are a few of the topics that will headline the 2023 AGA Tech Summit, March 9-10, 2023, at the Grand Hyatt San Francisco. Registration is now open. Visit techsummit.gastro.org to secure your spot.

The Tech Summit is where GI innovators, clinicians, medical device companies, venture capitalists and regulatory agencies meet to foster the development and adoption of GI technologies. It is the perfect venue for:

• All innovators, entrepreneurs and clinicians who want to build their professional networks in the GI space.
• Early-stage GI companies who want to showcase their technologies and find new ideas for further innovations that will improve patient care.
• GI fellows who want an exclusive and immersive behind-the-scenes look into the MedTech world.

Learn more by visiting techsummit.gastro.org.

AGA members advocate for GI during Alliance of Specialty Medicine fly-in

In December, six AGA members joined more than 100 specialty doctors organized by the Alliance of Specialty Medicine, a coalition that represents specialty physicians, to meet with House and Senate offices and discuss pressing policy priorities.

Members spoke on behalf of GI and stressed the need for Congress to act immediately on the upcoming Medicare cuts, and discussed step therapy protocols, prior authorization reform, and the role of artificial intelligence in the specialty.

Courtesy AGA

Our members represented GI well throughout the day’s meetings!

AGA PAC Board Member and Congressional Advocate Dr. Sadeea Abbasi spoke to House Leader Kevin McCarthy (R-CA) about challenges specialty doctors are facing and petitioned for Congress to mitigate the nearly 10 percent Medicare payment cuts before the end of the 117th Congress.

Additionally, AGA Government Affairs Committee Chair Dr. Rotonya Carr engaged with several members of Congress on issues impacting specialty care and discussed the future of AI in medicine with Rep. Mariannette Miller-Meeks (R-IA), who is an ophthalmologist.

Thank you to all our members who spoke on behalf of GI! We appreciate our AGA leaders who took time to participate!

• Sadeea Abbasi, MD, PhD
• Dawn B. Beaulieu, MD, AGAF
• Brent Burnette, MD
• Rotonya M. Carr, MD, FACP
• Peter S. Margolis, MD, AGAF
• Suzette Rivera MacMurray, MD

Learn how AGA is advocating for you. Visit gastro.org/advocacy.

AGA workshops champion women in GI

At AGA, we’re committed to supporting, empowering, and amplifying women in GI. As part of our ongoing efforts, we were thrilled to host nearly 250 women at four Women in GI regional workshops this fall. These workshops provided women across the country with opportunities to develop their personal and professional networks, participate in leadership development seminars, receive career mentoring, and engage in various wellness practices.

Following the conclusion of the regional workshops, we hosted the AGA Women’s Leadership Collaboration Conference at the AGA national office in Bethesda, Md.

Courtesy AGA

During the two-day conference, 22 delegates discussed workplace experiences, reported on their region’s workshop, and participated in strategy development exercises to further gender equity in GI, which included identifying tactics and ideas for action.

This unique event brought together delegates from each regional workshop, including 2023 Dr. Maria Leo-Lieber scholarship winners Alyssa Parian and Alexandra Livanos, who attended the Northeast workshop. It was a great time of collaboration and connection with the AGA #WomenInGI community!

Thank you to everyone who participated and made the events a success. We look forward to uplifting all women in GI and identifying ways to support the community in the coming year.

AGA thanks Johnson & Johnson Health Care Systems, Inc. for their support of this program.


 

Help move innovation forward at the 2023 AGA Tech Summit

Innovative technologies for endoscopy, advanced imaging, and bariatric care are a few of the topics that will headline the 2023 AGA Tech Summit, March 9-10, 2023, at the Grand Hyatt San Francisco. Registration is now open. Visit techsummit.gastro.org to secure your spot.

The Tech Summit is where GI innovators, clinicians, medical device companies, venture capitalists and regulatory agencies meet to foster the development and adoption of GI technologies. It is the perfect venue for:

• All innovators, entrepreneurs and clinicians who want to build their professional networks in the GI space.
• Early-stage GI companies who want to showcase their technologies and find new ideas for further innovations that will improve patient care.
• GI fellows who want an exclusive and immersive behind-the-scenes look into the MedTech world.

Learn more by visiting techsummit.gastro.org.

AGA members advocate for GI during Alliance of Specialty Medicine fly-in

In December, six AGA members joined more than 100 specialty doctors organized by the Alliance of Specialty Medicine, a coalition that represents specialty physicians, to meet with House and Senate offices and discuss pressing policy priorities.

Members spoke on behalf of GI and stressed the need for Congress to act immediately on the upcoming Medicare cuts, and discussed step therapy protocols, prior authorization reform, and the role of artificial intelligence in the specialty.

Courtesy AGA

Our members represented GI well throughout the day’s meetings!

AGA PAC Board Member and Congressional Advocate Dr. Sadeea Abbasi spoke to House Leader Kevin McCarthy (R-CA) about challenges specialty doctors are facing and petitioned for Congress to mitigate the nearly 10 percent Medicare payment cuts before the end of the 117th Congress.

Additionally, AGA Government Affairs Committee Chair Dr. Rotonya Carr engaged with several members of Congress on issues impacting specialty care and discussed the future of AI in medicine with Rep. Mariannette Miller-Meeks (R-IA), who is an ophthalmologist.

Thank you to all our members who spoke on behalf of GI! We appreciate our AGA leaders who took time to participate!

• Sadeea Abbasi, MD, PhD
• Dawn B. Beaulieu, MD, AGAF
• Brent Burnette, MD
• Rotonya M. Carr, MD, FACP
• Peter S. Margolis, MD, AGAF
• Suzette Rivera MacMurray, MD

Learn how AGA is advocating for you. Visit gastro.org/advocacy.

AGA workshops champion women in GI

At AGA, we’re committed to supporting, empowering, and amplifying women in GI. As part of our ongoing efforts, we were thrilled to host nearly 250 women at four Women in GI regional workshops this fall. These workshops provided women across the country with opportunities to develop their personal and professional networks, participate in leadership development seminars, receive career mentoring, and engage in various wellness practices.

Following the conclusion of the regional workshops, we hosted the AGA Women’s Leadership Collaboration Conference at the AGA national office in Bethesda, Md.

Courtesy AGA

During the two-day conference, 22 delegates discussed workplace experiences, reported on their region’s workshop, and participated in strategy development exercises to further gender equity in GI, which included identifying tactics and ideas for action.

This unique event brought together delegates from each regional workshop, including 2023 Dr. Maria Leo-Lieber scholarship winners Alyssa Parian and Alexandra Livanos, who attended the Northeast workshop. It was a great time of collaboration and connection with the AGA #WomenInGI community!

Thank you to everyone who participated and made the events a success. We look forward to uplifting all women in GI and identifying ways to support the community in the coming year.

AGA thanks Johnson & Johnson Health Care Systems, Inc. for their support of this program.


 

Help move innovation forward at the 2023 AGA Tech Summit

Innovative technologies for endoscopy, advanced imaging, and bariatric care are a few of the topics that will headline the 2023 AGA Tech Summit, March 9-10, 2023, at the Grand Hyatt San Francisco. Registration is now open. Visit techsummit.gastro.org to secure your spot.

The Tech Summit is where GI innovators, clinicians, medical device companies, venture capitalists and regulatory agencies meet to foster the development and adoption of GI technologies. It is the perfect venue for:

• All innovators, entrepreneurs and clinicians who want to build their professional networks in the GI space.
• Early-stage GI companies who want to showcase their technologies and find new ideas for further innovations that will improve patient care.
• GI fellows who want an exclusive and immersive behind-the-scenes look into the MedTech world.

Learn more by visiting techsummit.gastro.org.

The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.

We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.¹ Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.² What value might gastroenterologists gain from the use of telehealth going forward? Data are emerging that virtual care can reduce expensive and unnecessary emergency room visits, help effectively manage chronic disease, address disparities in care, and increase access to specialty care.³ For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
 

As GI demand outpaces supply, it’s time to consider alternative channels of care

The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.⁴ On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.⁵ Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.⁶ And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.⁷

Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.⁸ Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
 

The case for virtual GI care

Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.⁹

In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.¹⁰

Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,¹¹ and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.¹²

Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
 

Financial implications

Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.

The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.¹³ With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.¹⁴

While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.

Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
 

Overcoming obstacles

Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.

In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).

Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
 

The ultimate aim: Better patient outcomes

Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.¹⁵ Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.

Change can be hard, but it will come

The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.

The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.

As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
 

Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).

References

1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.

2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.

3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.

4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.

5. See id.

6. See id.

7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.

8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).

9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.

10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.

11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.

12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.

13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.

14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.

15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.

The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.

We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.¹ Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.² What value might gastroenterologists gain from the use of telehealth going forward? Data are emerging that virtual care can reduce expensive and unnecessary emergency room visits, help effectively manage chronic disease, address disparities in care, and increase access to specialty care.³ For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
 

As GI demand outpaces supply, it’s time to consider alternative channels of care

The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.⁴ On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.⁵ Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.⁶ And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.⁷

Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.⁸ Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
 

The case for virtual GI care

Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.⁹

In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.¹⁰

Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,¹¹ and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.¹²

Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
 

Financial implications

Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.

The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.¹³ With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.¹⁴

While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.

Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
 

Overcoming obstacles

Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.

In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).

Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
 

The ultimate aim: Better patient outcomes

Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.¹⁵ Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.

Change can be hard, but it will come

The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.

The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.

As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
 

Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).

References

1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.

2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.

3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.

4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.

5. See id.

6. See id.

7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.

8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).

9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.

10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.

11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.

12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.

13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.

14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.

15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.

The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.

We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.¹ Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.² What value might gastroenterologists gain from the use of telehealth going forward? Data are emerging that virtual care can reduce expensive and unnecessary emergency room visits, help effectively manage chronic disease, address disparities in care, and increase access to specialty care.³ For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
 

As GI demand outpaces supply, it’s time to consider alternative channels of care

The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.⁴ On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.⁵ Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.⁶ And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.⁷

Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.⁸ Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
 

The case for virtual GI care

Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.⁹

In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.¹⁰

Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,¹¹ and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.¹²

Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
 

Financial implications

Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.

The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.¹³ With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.¹⁴

While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.

Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
 

Overcoming obstacles

Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.

In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).

Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
 

The ultimate aim: Better patient outcomes

Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.¹⁵ Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.

Change can be hard, but it will come

The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.

The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.

As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
 

Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).

References

1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.

2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.

3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.

4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.

5. See id.

6. See id.

7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.

8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).

9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.

10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.

11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.

12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.

13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.

14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.

15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.

Dear colleagues,

This November issue of The New Gastroenterologist marks my official transition as the new Editor in Chief! I am humbled with this opportunity to be a part of such a unique publication and have received immense support from Dr. Vijaya Rao, the TNG staff, as well as my mentors and colleagues. With its foundation built by Dr. Bryson Katona and then taken to the next level by Dr. Rao, TNG has grown over the years, and I hope that I can continue to extend its reach to more trainees and early faculty.

In this issue’s In Focus, Dr. Wenfei Wang and Dr. Neil Sengupta (both from University of Chicago) review the management of antithrombotic medications in elective endoscopic procedures and emphasize individualizing the approach while providing guideline recommendations on how to navigate the gastrointestinal bleeding risk and cardiovascular disease in this day and age.

With endoscopic bariatric therapy and antiobesity medications burgeoning within gastroenterology, Dr. Singrid Young (New York University), Dr. Cameron Zenger (New York University), Dr. Erik Holzwanger (Harvard Medical School in Boston), and Dr. Violeta Popov (New York University) review how their multidisciplinary approach has made their endoscopic bariatric program successful in treating patients struggling with obesity. In our Ethics section, Dr. David Ney (Thomas Jefferson University Hospital, Philadelphia) and Dr. Jason Karlawish (University of Pennsylvania, Philadelphia) delve into patient capacity, particularly when consenting for procedures.

Being involved with national society committees may seem daunting to a lot of trainees and early faculty, but Dr. Peter S. Liang (New York University Langone Health) and Dr. Stephanie D. Pointer (Tristar Hendersonville Medical Center in Tennessee) describe their journeys to becoming AGA committee chairs as early-career physicians. While you ponder whether to join a committee, it may be a good time to learn new ways to increase your financial portfolio through passive income, detailed by Dr. Latifat Alli-Akintade (Kaiser Permanente South Sacramento Medical Center in California).

Last but not least, I am excited to introduce a personal favorite in this newsletter – a piece on females supporting female gastroenterologists in career development and more. Dr. Tonya Adams outlines action items on how to create a culture that fosters professional and leadership development among females, using the Gastro Health Women’s Network as an example of how this network has succeeded in cultivating such an environment.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with an interesting historical fact: William Beaumont, the father of Gastroenterology, published the first findings on the digestive system after performing experiments on Alexis St. Martin when he developed a large gastrocutaneous fistula from an abdominal gunshot wound.



Yours truly,

Judy A. Trieu, MD, MPH
Editor in Chief
Advanced Endoscopy Fellow, University of North Carolina at Chapel Hill, Division of Gastroenterology & Hepatology
 

Dear colleagues,

This November issue of The New Gastroenterologist marks my official transition as the new Editor in Chief! I am humbled with this opportunity to be a part of such a unique publication and have received immense support from Dr. Vijaya Rao, the TNG staff, as well as my mentors and colleagues. With its foundation built by Dr. Bryson Katona and then taken to the next level by Dr. Rao, TNG has grown over the years, and I hope that I can continue to extend its reach to more trainees and early faculty.

In this issue’s In Focus, Dr. Wenfei Wang and Dr. Neil Sengupta (both from University of Chicago) review the management of antithrombotic medications in elective endoscopic procedures and emphasize individualizing the approach while providing guideline recommendations on how to navigate the gastrointestinal bleeding risk and cardiovascular disease in this day and age.

With endoscopic bariatric therapy and antiobesity medications burgeoning within gastroenterology, Dr. Singrid Young (New York University), Dr. Cameron Zenger (New York University), Dr. Erik Holzwanger (Harvard Medical School in Boston), and Dr. Violeta Popov (New York University) review how their multidisciplinary approach has made their endoscopic bariatric program successful in treating patients struggling with obesity. In our Ethics section, Dr. David Ney (Thomas Jefferson University Hospital, Philadelphia) and Dr. Jason Karlawish (University of Pennsylvania, Philadelphia) delve into patient capacity, particularly when consenting for procedures.

Being involved with national society committees may seem daunting to a lot of trainees and early faculty, but Dr. Peter S. Liang (New York University Langone Health) and Dr. Stephanie D. Pointer (Tristar Hendersonville Medical Center in Tennessee) describe their journeys to becoming AGA committee chairs as early-career physicians. While you ponder whether to join a committee, it may be a good time to learn new ways to increase your financial portfolio through passive income, detailed by Dr. Latifat Alli-Akintade (Kaiser Permanente South Sacramento Medical Center in California).

Last but not least, I am excited to introduce a personal favorite in this newsletter – a piece on females supporting female gastroenterologists in career development and more. Dr. Tonya Adams outlines action items on how to create a culture that fosters professional and leadership development among females, using the Gastro Health Women’s Network as an example of how this network has succeeded in cultivating such an environment.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with an interesting historical fact: William Beaumont, the father of Gastroenterology, published the first findings on the digestive system after performing experiments on Alexis St. Martin when he developed a large gastrocutaneous fistula from an abdominal gunshot wound.



Yours truly,

Judy A. Trieu, MD, MPH
Editor in Chief
Advanced Endoscopy Fellow, University of North Carolina at Chapel Hill, Division of Gastroenterology & Hepatology
 

Dear colleagues,

This November issue of The New Gastroenterologist marks my official transition as the new Editor in Chief! I am humbled with this opportunity to be a part of such a unique publication and have received immense support from Dr. Vijaya Rao, the TNG staff, as well as my mentors and colleagues. With its foundation built by Dr. Bryson Katona and then taken to the next level by Dr. Rao, TNG has grown over the years, and I hope that I can continue to extend its reach to more trainees and early faculty.

In this issue’s In Focus, Dr. Wenfei Wang and Dr. Neil Sengupta (both from University of Chicago) review the management of antithrombotic medications in elective endoscopic procedures and emphasize individualizing the approach while providing guideline recommendations on how to navigate the gastrointestinal bleeding risk and cardiovascular disease in this day and age.

With endoscopic bariatric therapy and antiobesity medications burgeoning within gastroenterology, Dr. Singrid Young (New York University), Dr. Cameron Zenger (New York University), Dr. Erik Holzwanger (Harvard Medical School in Boston), and Dr. Violeta Popov (New York University) review how their multidisciplinary approach has made their endoscopic bariatric program successful in treating patients struggling with obesity. In our Ethics section, Dr. David Ney (Thomas Jefferson University Hospital, Philadelphia) and Dr. Jason Karlawish (University of Pennsylvania, Philadelphia) delve into patient capacity, particularly when consenting for procedures.

Being involved with national society committees may seem daunting to a lot of trainees and early faculty, but Dr. Peter S. Liang (New York University Langone Health) and Dr. Stephanie D. Pointer (Tristar Hendersonville Medical Center in Tennessee) describe their journeys to becoming AGA committee chairs as early-career physicians. While you ponder whether to join a committee, it may be a good time to learn new ways to increase your financial portfolio through passive income, detailed by Dr. Latifat Alli-Akintade (Kaiser Permanente South Sacramento Medical Center in California).

Last but not least, I am excited to introduce a personal favorite in this newsletter – a piece on females supporting female gastroenterologists in career development and more. Dr. Tonya Adams outlines action items on how to create a culture that fosters professional and leadership development among females, using the Gastro Health Women’s Network as an example of how this network has succeeded in cultivating such an environment.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with an interesting historical fact: William Beaumont, the father of Gastroenterology, published the first findings on the digestive system after performing experiments on Alexis St. Martin when he developed a large gastrocutaneous fistula from an abdominal gunshot wound.



Yours truly,

Judy A. Trieu, MD, MPH
Editor in Chief
Advanced Endoscopy Fellow, University of North Carolina at Chapel Hill, Division of Gastroenterology & Hepatology
 

Antithrombotic therapy is increasingly used to either reduce the risk of or treat thromboembolic episodes in patients with various medical conditions such as ischemic and valvular heart disease, atrial fibrillation (AF), cerebrovascular disease, peripheral arterial disease, venous thromboembolism (VTE) and hypercoagulable diseases. Antithrombotics include medications classified as anticoagulants or antiplatelets. Anticoagulants work by interfering with the native clotting cascade and consist of four main classes: vitamin K antagonists (VKA), heparin derivatives, direct factor Xa inhibitors, and direct thrombin inhibitors. Direct oral anticoagulants (DOACs) refer to dabigatran (a direct thrombin inhibitor) and the factor Xa inhibitors (apixaban, rivaroxaban, and edoxaban).

Antiplatelets, on the other hand, work by decreasing platelet aggregation and thus preventing thrombus formation; they include P2Y12 receptor inhibitors, protease-activated receptor-1 inhibitors, glycoprotein IIb/IIIa receptor inhibitors, acetylsalicylic acid (ASA), and nonsteroidal anti-inflammatory drugs. All of these agents may directly cause or increase the risk of gastrointestinal (GI) bleeding from luminal sources such as ulcers or diverticula, as well as after endoscopic interventions such as polypectomy. However, there is also a risk of thromboembolic consequences if some of these agents are withheld. Thus, the management of patients receiving antithrombotic agents and undergoing GI endoscopy represents an important clinical challenge and something that every GI physician has to deal with routinely.

The goal of this review is to discuss the optimal strategy for managing antithrombotics in patients undergoing elective endoscopy based on current available evidence and published clinical guidelines.^1-4 Much of our discussion will review recommendations from the recently published joint American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines on management of anticoagulants and antiplatelets in the periendoscopic period by Abraham et al.⁴

Factors that guide decision-making

The two most vital factors to consider prior to performing endoscopic procedures in patients receiving antithrombotic therapy are to assess the risk of bleeding associated with the procedure and to assess the risk of thromboembolism associated with the underlying medical condition for which the antithrombotic agents are being used. In addition, it is also important to keep in mind the individual characteristics of the antithrombotic agent(s) used when making these decisions.

Estimating procedure-related bleeding risk

Various endoscopic procedures have different risks of associated bleeding. Although guidelines from GI societies may differ when classifying procedures into low or high risk, it is important to know that most of the original data on postprocedural bleeding risks are from studies conducted in patients who are not on complex antithrombotic regimens and thus may not accurately reflect the bleeding risk of patients using newer antithrombotic therapies.^1,4-7

Traditionally, some of the common low-risk procedures have included diagnostic EGD and colonoscopy with or without biopsy, ERCP without sphincterotomy, biliary stent placement, and push or balloon-assisted enteroscopy. On the other hand, endoscopic procedures associated with interventions are known to have higher bleeding risk, and other procedural factors can influence this risk as well.⁸ For example, polypectomy, one of the most common interventions during endoscopy, is associated with bleeding risk ranging from 0.3% to 10% depending on multiple factors including polyp size, location, morphology (nonpolypoid, sessile, pedunculated), resection technique (cold or hot forceps, cold or hot snare), and type of cautery used.⁹ For some procedures, such as routine screening colonoscopy, however, the preprocedure estimate of bleeding risk can be uncertain because it is unclear if a high risk intervention (e.g., polypectomy of large polyp) will be necessary. For example, in the most recent ACG/CAG guidelines, colonoscopy with polypectomy < 1cm is considered a low/moderate risk bleeding procedure, whereas polypectomy > 1cm is considered high risk for bleeding.⁴ In these situations, the management of antithrombotic medications may depend on the individual patient’s risk of thrombosis and the specific antithrombotic agent. In the example of a patient undergoing colonoscopy while on antithrombotic medications, the bleeding risk associated with polypectomy can potentially be reduced by procedural techniques such as preferential use of cold snare polypectomy. Further high-quality data on the optimal procedural technique to reduce postpolypectomy bleeding in patients on antithrombotic medications is needed to help guide management.
 

Estimating thromboembolic risk

The risk of thromboembolic events in patients who are withholding their antithrombotic therapy for an endoscopic procedure depends on their underlying condition and individual characteristics. In patients who are on antithrombotic therapy for stroke prevention in non-valvular AF, the risk of cerebral thromboembolism in these patients is predictable using the CHA₂DS₂Vasc index.¹⁰ This scoring index includes heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischemic attack (TIA), vascular disease, age 65-74 years, and sex categories.

Patients with previous VTE on anticoagulation or those who have mechanical heart valves may have different risk factors for thromboembolic episodes. Among patients with VTE, time from initial VTE, history of recurrent VTE with antithrombotic interruption, and presence of underlying thrombophilia are most predictive of future thromboembolic risk. And for patients with mechanical heart valves, presence of a mitral valve prosthesis, and the presence or absence of associated heart failure and AF determine the annual risk of thromboembolic events. Bioprosthetic valves are generally considered low risk.

In patients with coronary artery disease (CAD), high thrombosis risk scenarios with holding antiplatelets include patients within 3 months of an acute coronary syndrome (ACS) event, within 6 months of a drug-eluting stent (DES) placement, or within 1 month of a bare metal coronary stent (BMS) placement. In addition, patients with ACS that occurred within the past 12 months of DES placement or within 2 months of BMS placement are also considered high risk.^11,12 Even beyond these periods, certain patients may still be at high risk of stent occlusion. In particular, patients with a prior history of stent occlusion, ACS or ST elevation myocardial infection, prior multivessel percutaneous coronary intervention, diabetes, renal failure, or diffuse CAD are at higher risk of stent occlusion or ACS events with alteration of antithrombotic therapy.¹³ Thus, modification of antithrombotic regimens in these patients should be cautiously approached.
 

Management of antithrombotics prior to elective endoscopy

In patients who need elective endoscopic procedures, if the indication for antithrombotic therapy is short-term, the procedure is probably best delayed until after that period.¹³ For patients on long-term or lifelong antithrombotic treatment, the decision to temporarily hold the treatment for endoscopy should occur after a discussion with the patient and all of the involved providers. In some high-risk patients, these agents cannot be interrupted; therefore, clinicians must carefully weigh the risks and benefits of the procedure before proceeding with endoscopy. For patients who are known to be undergoing an elective endoscopic procedure, antithrombotic medications may or may not need to be held prior to the procedure depending on the type of therapy. For example, according to the recent ACG/CAG guidelines, warfarin should be continued, whereas DOACs should be temporarily stopped for patients who are undergoing elective/planned endoscopic GI procedures.

Unfractionated heparin (UFH) administered as a continuous intravenous infusion can generally be held 3-4 hours before the procedure, given its short half-life. Low molecular weight heparin (LMWH), including enoxaparin and dalteparin, should be stopped 24 hours prior to the procedure.^2,14 Fondaparinux is a synthetic X-a inhibitor that requires discontinuation at least 36 hours preceding a high risk procedure. For patients on warfarin who are undergoing elective endoscopic procedures that are low risk for inducing bleeding, warfarin can be continued, as opposed to temporarily interrupted, although the dose should be omitted the morning of the procedure.⁴ For those who are undergoing high-risk endoscopic procedures (including colonoscopy with possible polypectomy > 1 cm), 5 days of temporary interruption without periprocedural bridging is appropriate in most patients. This is contrary to previous guidelines, which had recommended bridging for patients with a CHA2DS2Vasc score ≥ 2. Recent impactful randomized trials (BRIDGE and PERIOP-2) have called into question the benefit of periprocedural bridging with LMWH. Avoiding bridging anticoagulation was generally found to be similar to bridging in regard to prevention of thromboembolic complications, but importantly was associated with a decreased risk of major bleeding.^15,16 Of note, periprocedural bridging may still be appropriate in a small subset of patients, including those with mechanical valves, AF with CHADS2 score > 5, and previous thromboembolism during temporary interruption of VKAs. The decision to bridge or not should ideally be made in a multidisciplinary fashion.^15-20

Data are lacking on the ideal strategy for periendoscopic DOAC management. As mentioned above, for patients on DOACs who are undergoing elective endoscopic GI procedures, temporarily interrupting DOACs rather than continuing them is recommended. Currently, there are no randomized controlled trials addressing the management of DOACs in the periendoscopic period. However, based on five cohort studies, the ideal duration of DOAC interruption before endoscopic procedures may be between 1 and 2 days, excluding the day of the procedure.^21-25 This strategy allows for a short preprocedural duration of DOAC interruption and likely provides a balance between bleeding and thromboembolism risk. Importantly, there are no reliable laboratory assays to assess the anticoagulant effect of DOACs, and an individual patient’s degree of renal dysfunction may impact how long the DOAC should be held. In general, the anti-Xa drugs should be held for 1-2 days if the creatinine clearance (CrCl) is ≥ 60 mL/min, for 3 days if the CrCl is between 30 mL/min and 59 mL/min, and for 4 days if the CrCl is less than 30 mL/min.²⁶ For edoxaban, the recommendation is to hold at least 24 hours before high-risk procedures. The recommendation for stopping dabigatran is 2-3 days before a high-risk procedure in patients with CrCl more than 80 mL/min, 3-4 days prior if between 30 and 49 mL/min, and 4-6 days prior if less than 30 mL/min respectively.²⁷

In regard to antiplatelet management, ASA and the P2Y₁₂ receptor inhibitors (e.g. clopidogrel, prasugrel, and ticagrelor) are the most commonly utilized antiplatelets in patients undergoing endoscopic procedures. For patients who are on ASA monotherapy, whether 81 mg or 325 mg daily, for secondary cardiovascular prevention, no interruption of ASA therapy is necessary for elective procedures. The benefit of ASA for secondary cardiovascular prevention and the possible reduction in thrombotic events seen in RCTs of nonendoscopic surgical procedures is well known. However, there may be certain exceptions in which aspirin should be temporarily held. For example, short-term interruption of ASA could be considered in high risk procedures such as biliary or pancreatic sphincterotomy, ampullectomy, and peroral endoscopic myotomy. For patients on single antiplatelet therapy with a P2Y₁₂ receptor inhibitor who are undergoing elective endoscopic GI procedures, the recent CAG/ACG guidelines did not provide a clear recommendation for or against temporary interruption of the P2Y₁₂ receptor inhibitor. Although interruption of a P2Y₁₂ receptor inhibitor should theoretically decrease a patient’s risk of bleeding, the available evidence reported a nonsignificant increased bleeding risk in patients who stop a P2Y₁₂ receptor inhibitor for an elective endoscopic procedure compared with those who continue the medication.^28,29 Therefore, until further data are available, for patients on P2Y₁₂ receptor monotherapy, a reasonable strategy would be to temporarily hold therapy prior to high risk endoscopic procedures, assuming the patients are not at high cardiovascular risk. Clopidogrel and prasugrel have to be stopped 5-7 days prior to allow normal platelet aggregation to resume as opposed to ticagrelor, a reversible P2Y₁₂ receptor inhibitor that can be stopped 3-5 days prior.³⁰

Lastly, for patients who are on dual antiplatelet therapy (DAPT) for secondary prevention, continuation of ASA and temporary interruption of the P2Y₁₂ receptor inhibitor is recommended while undergoing elective endoscopy. Studies have shown that those who discontinued both had a much higher incidence of stent thrombosis compared with those who remained on aspirin alone.^4,28,31

Resumption of antithrombotic therapy after endoscopy

In general, antithrombotic therapy should be resumed upon completion of the procedure unless there remains a persistent risk of major bleeding.^1,14 This consensus is based on studies available on warfarin and heparin products, with minimal literature available regarding the resumption of DOACs. The benefits of immediate re-initiation of antithrombotic therapy for the prevention of thromboembolic events should be weighed against the risk of hemorrhage associated with the specific agent, the time to onset of the medication, and procedure-specific circumstances. For the small subset of patients on warfarin with a high risk of thromboembolism (e.g., mechanical heart valve), bridging with LMWH should be started at the earliest possible time when there is no risk of major bleeding and continued until the international normalized ratio (INR) reaches a therapeutic level with warfarin. For patients at a lower risk of thromboembolism, warfarin should be restarted within 24 hours of the procedure. In addition, because of the shorter duration of DOACs, if treatment with these agents cannot resume within 24 hours of a high-risk procedure, bridge therapy should be considered with UFH or LMWH in patients with a high risk of thrombosis.¹⁸ In patients receiving DOACs for stroke prophylaxis in AF, the DOACS can be safely resumed 1 day after low-risk procedures and 2-3 days after high-risk procedures without the need for bridging.²⁵ All antiplatelet agents should be resumed as soon as hemostasis is achieved.

Conclusion

Antithrombotic therapy is increasingly used given the aging population, widespread burden of cardiovascular comorbidities, and expanding indications for classes of medications such as direct oral anticoagulants. Given the association with antithrombotic medications and gastrointestinal bleeding, it is essential for gastroenterologists to understand the importance, necessity, and timing when holding these medications for endoscopic procedures. Even with the practice guidelines available today to help clinicians navigate certain situations, each patient’s antithrombotic management may be different, and communication with the prescribing physicians and including patients in the decision-making process is essential before planned procedures.

Dr. Wang is a gastroenterology fellow at the University of Chicago. Dr. Sengupta is an associate professor at the University of Chicago. They reported no funding or conflicts of interest.

References

1. ASGE Standards of Practice Committee, Acosta RD et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016;83(1):3-16.

2. Veitch AM et al. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016;48(4):c1. doi: 10.1055/s-0042-122686.

3. Chan FKL et al. Management of patients on antithrombotic agents undergoing emergency and elective endoscopy: Joint Asian Pacific Association of Gastroenterology (APAGE) and Asian Pacific Society for Digestive Endoscopy (APSDE) practice guidelines. Gut. 2018;67(3):405-17.

4. Abraham NS et al. American College of Gastroenterology – Canadian Association of Gastroenterology clinical practice guideline: Management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period. Am J Gastroenterol. 2022;117(4):542-58.

5. Boustière C et al. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2011;43(5):445-61.

6. Fujimoto K et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. Dig Endosc. 2014;26(1):1-14.

7. Wilke T et al. Patient preferences for oral anticoagulation therapy in atrial fibrillation: A systematic literature review. Patient 2017;10(1):17-37.

8. Gerson LB et al. Adverse events associated with anticoagulation therapy in the periendoscopic period. Gastrointest Endosc. 2010 Jun;71(7):1211-17.e2.

9. Horiuchi A et al. Removal of small colorectal polyps in anticoagulated patients: A prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc 2014;79(3):417-23.

10. Lip GYH et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The euro heart survey on atrial fibrillation. Chest. 2010;137(2):263-72.

11. 2012 Writing Committee Members, Jneid H et al. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction (Updating the 2007 guideline and replacing the 2011 focused update): A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2012;126(7):875-910.

12. Douketis JD et al. Perioperative management of antithrombotic therapy: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-e350S.

13. Becker RC et al. Management of platelet-directed pharmacotherapy in patients with atherosclerotic coronary artery disease undergoing elective endoscopic gastrointestinal procedures. J Am Coll Cardiol. 2009;54(24):2261-76.

14. Kwok A and Faigel DO. Management of anticoagulation before and after gastrointestinal endoscopy. Am J Gastroenterol. 2009;104(12):3085-97; quiz 3098.

15. Douketis JD et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373(9):823-33.

16. Kovacs MJ et al. Postoperative low molecular weight heparin bridging treatment for patients at high risk of arterial thromboembolism (PERIOP2): Double blind randomised controlled trial. BMJ 2021;373:n1205.

17. Tafur A and Douketis J. Perioperative management of anticoagulant and antiplatelet therapy. Heart 2018;104(17):1461-7.

18. Kato M et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment: 2017 appendix on anticoagulants including direct oral anticoagulants. Dig Endosc. 2018;30(4):433-40.

19. Inoue T et al. Clinical features of postpolypectomy bleeding associated with heparin bridge therapy. Dig Endosc. 2014;26(2):243-9.

20. Takeuchi Y et al. Continuous anticoagulation and cold snare polypectomy versus heparin bridging and hot snare polypectomy in patients on anticoagulants with subcentimeter polyps: A randomized controlled trial. Ann Intern Med. 2019;171(4):229-37.

21. Ara N et al. Prospective analysis of risk for bleeding after endoscopic biopsy without cessation of antithrombotics in Japan. Dig Endosc. 2015;27(4):458-64.

22. Yanagisawa N et al. Postpolypectomy bleeding and thromboembolism risks associated with warfarin vs. direct oral anticoagulants. World J Gastroenterol. 2018;24(14):1540-9.

23. Arimoto J et al. Safety of cold snare polypectomy in patients receiving treatment with antithrombotic agents. Dig Dis Sci. 2019;64(11):3247-55.

24. Heublein V et al. Gastrointestinal endoscopy in patients receiving novel direct oral anticoagulants: Results from the prospective Dresden NOAC registry. J Gastroenterol. 2018;53(2):236-46.

25. Douketis JD et al. Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant. JAMA Intern Med. 2019;179(11):1469-78.

26. Dubois V et al. Perioperative management of patients on direct oral anticoagulants. Thromb J. 2017;15:14.

27. Weitz JI et al. Periprocedural management and approach to bleeding in patients taking dabigatran. Circulation. 2012 Nov 13;126(20):2428-32.

28. Chan FKL et al. Risk of postpolypectomy bleeding with uninterrupted clopidogrel therapy in an industry-independent, double-blind, randomized trial. Gastroenterology. 2019;156(4):918-25.

29. Watanabe K et al. Effect of antiplatelet agent number, types, and pre-endoscopic management on postpolypectomy bleeding: Validation of endoscopy guidelines. Surg Endosc. 2021;35(1):317-25.

30. Gurbel PA et al. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: The ONSET/OFFSET study. Circulation. 2009;120(25):2577-85.

31. Eisenberg MJ et al. Safety of short-term discontinuation of antiplatelet therapy in patients with drug-eluting stents. Circulation. 2009;119(12):1634-42.
 

Antithrombotic therapy is increasingly used to either reduce the risk of or treat thromboembolic episodes in patients with various medical conditions such as ischemic and valvular heart disease, atrial fibrillation (AF), cerebrovascular disease, peripheral arterial disease, venous thromboembolism (VTE) and hypercoagulable diseases. Antithrombotics include medications classified as anticoagulants or antiplatelets. Anticoagulants work by interfering with the native clotting cascade and consist of four main classes: vitamin K antagonists (VKA), heparin derivatives, direct factor Xa inhibitors, and direct thrombin inhibitors. Direct oral anticoagulants (DOACs) refer to dabigatran (a direct thrombin inhibitor) and the factor Xa inhibitors (apixaban, rivaroxaban, and edoxaban).

Antiplatelets, on the other hand, work by decreasing platelet aggregation and thus preventing thrombus formation; they include P2Y12 receptor inhibitors, protease-activated receptor-1 inhibitors, glycoprotein IIb/IIIa receptor inhibitors, acetylsalicylic acid (ASA), and nonsteroidal anti-inflammatory drugs. All of these agents may directly cause or increase the risk of gastrointestinal (GI) bleeding from luminal sources such as ulcers or diverticula, as well as after endoscopic interventions such as polypectomy. However, there is also a risk of thromboembolic consequences if some of these agents are withheld. Thus, the management of patients receiving antithrombotic agents and undergoing GI endoscopy represents an important clinical challenge and something that every GI physician has to deal with routinely.

The goal of this review is to discuss the optimal strategy for managing antithrombotics in patients undergoing elective endoscopy based on current available evidence and published clinical guidelines.^1-4 Much of our discussion will review recommendations from the recently published joint American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines on management of anticoagulants and antiplatelets in the periendoscopic period by Abraham et al.⁴

Factors that guide decision-making

The two most vital factors to consider prior to performing endoscopic procedures in patients receiving antithrombotic therapy are to assess the risk of bleeding associated with the procedure and to assess the risk of thromboembolism associated with the underlying medical condition for which the antithrombotic agents are being used. In addition, it is also important to keep in mind the individual characteristics of the antithrombotic agent(s) used when making these decisions.

Estimating procedure-related bleeding risk

Various endoscopic procedures have different risks of associated bleeding. Although guidelines from GI societies may differ when classifying procedures into low or high risk, it is important to know that most of the original data on postprocedural bleeding risks are from studies conducted in patients who are not on complex antithrombotic regimens and thus may not accurately reflect the bleeding risk of patients using newer antithrombotic therapies.^1,4-7

Traditionally, some of the common low-risk procedures have included diagnostic EGD and colonoscopy with or without biopsy, ERCP without sphincterotomy, biliary stent placement, and push or balloon-assisted enteroscopy. On the other hand, endoscopic procedures associated with interventions are known to have higher bleeding risk, and other procedural factors can influence this risk as well.⁸ For example, polypectomy, one of the most common interventions during endoscopy, is associated with bleeding risk ranging from 0.3% to 10% depending on multiple factors including polyp size, location, morphology (nonpolypoid, sessile, pedunculated), resection technique (cold or hot forceps, cold or hot snare), and type of cautery used.⁹ For some procedures, such as routine screening colonoscopy, however, the preprocedure estimate of bleeding risk can be uncertain because it is unclear if a high risk intervention (e.g., polypectomy of large polyp) will be necessary. For example, in the most recent ACG/CAG guidelines, colonoscopy with polypectomy < 1cm is considered a low/moderate risk bleeding procedure, whereas polypectomy > 1cm is considered high risk for bleeding.⁴ In these situations, the management of antithrombotic medications may depend on the individual patient’s risk of thrombosis and the specific antithrombotic agent. In the example of a patient undergoing colonoscopy while on antithrombotic medications, the bleeding risk associated with polypectomy can potentially be reduced by procedural techniques such as preferential use of cold snare polypectomy. Further high-quality data on the optimal procedural technique to reduce postpolypectomy bleeding in patients on antithrombotic medications is needed to help guide management.
 

Estimating thromboembolic risk

The risk of thromboembolic events in patients who are withholding their antithrombotic therapy for an endoscopic procedure depends on their underlying condition and individual characteristics. In patients who are on antithrombotic therapy for stroke prevention in non-valvular AF, the risk of cerebral thromboembolism in these patients is predictable using the CHA₂DS₂Vasc index.¹⁰ This scoring index includes heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischemic attack (TIA), vascular disease, age 65-74 years, and sex categories.

Patients with previous VTE on anticoagulation or those who have mechanical heart valves may have different risk factors for thromboembolic episodes. Among patients with VTE, time from initial VTE, history of recurrent VTE with antithrombotic interruption, and presence of underlying thrombophilia are most predictive of future thromboembolic risk. And for patients with mechanical heart valves, presence of a mitral valve prosthesis, and the presence or absence of associated heart failure and AF determine the annual risk of thromboembolic events. Bioprosthetic valves are generally considered low risk.

In patients with coronary artery disease (CAD), high thrombosis risk scenarios with holding antiplatelets include patients within 3 months of an acute coronary syndrome (ACS) event, within 6 months of a drug-eluting stent (DES) placement, or within 1 month of a bare metal coronary stent (BMS) placement. In addition, patients with ACS that occurred within the past 12 months of DES placement or within 2 months of BMS placement are also considered high risk.^11,12 Even beyond these periods, certain patients may still be at high risk of stent occlusion. In particular, patients with a prior history of stent occlusion, ACS or ST elevation myocardial infection, prior multivessel percutaneous coronary intervention, diabetes, renal failure, or diffuse CAD are at higher risk of stent occlusion or ACS events with alteration of antithrombotic therapy.¹³ Thus, modification of antithrombotic regimens in these patients should be cautiously approached.
 

Management of antithrombotics prior to elective endoscopy

In patients who need elective endoscopic procedures, if the indication for antithrombotic therapy is short-term, the procedure is probably best delayed until after that period.¹³ For patients on long-term or lifelong antithrombotic treatment, the decision to temporarily hold the treatment for endoscopy should occur after a discussion with the patient and all of the involved providers. In some high-risk patients, these agents cannot be interrupted; therefore, clinicians must carefully weigh the risks and benefits of the procedure before proceeding with endoscopy. For patients who are known to be undergoing an elective endoscopic procedure, antithrombotic medications may or may not need to be held prior to the procedure depending on the type of therapy. For example, according to the recent ACG/CAG guidelines, warfarin should be continued, whereas DOACs should be temporarily stopped for patients who are undergoing elective/planned endoscopic GI procedures.

Unfractionated heparin (UFH) administered as a continuous intravenous infusion can generally be held 3-4 hours before the procedure, given its short half-life. Low molecular weight heparin (LMWH), including enoxaparin and dalteparin, should be stopped 24 hours prior to the procedure.^2,14 Fondaparinux is a synthetic X-a inhibitor that requires discontinuation at least 36 hours preceding a high risk procedure. For patients on warfarin who are undergoing elective endoscopic procedures that are low risk for inducing bleeding, warfarin can be continued, as opposed to temporarily interrupted, although the dose should be omitted the morning of the procedure.⁴ For those who are undergoing high-risk endoscopic procedures (including colonoscopy with possible polypectomy > 1 cm), 5 days of temporary interruption without periprocedural bridging is appropriate in most patients. This is contrary to previous guidelines, which had recommended bridging for patients with a CHA2DS2Vasc score ≥ 2. Recent impactful randomized trials (BRIDGE and PERIOP-2) have called into question the benefit of periprocedural bridging with LMWH. Avoiding bridging anticoagulation was generally found to be similar to bridging in regard to prevention of thromboembolic complications, but importantly was associated with a decreased risk of major bleeding.^15,16 Of note, periprocedural bridging may still be appropriate in a small subset of patients, including those with mechanical valves, AF with CHADS2 score > 5, and previous thromboembolism during temporary interruption of VKAs. The decision to bridge or not should ideally be made in a multidisciplinary fashion.^15-20

Data are lacking on the ideal strategy for periendoscopic DOAC management. As mentioned above, for patients on DOACs who are undergoing elective endoscopic GI procedures, temporarily interrupting DOACs rather than continuing them is recommended. Currently, there are no randomized controlled trials addressing the management of DOACs in the periendoscopic period. However, based on five cohort studies, the ideal duration of DOAC interruption before endoscopic procedures may be between 1 and 2 days, excluding the day of the procedure.^21-25 This strategy allows for a short preprocedural duration of DOAC interruption and likely provides a balance between bleeding and thromboembolism risk. Importantly, there are no reliable laboratory assays to assess the anticoagulant effect of DOACs, and an individual patient’s degree of renal dysfunction may impact how long the DOAC should be held. In general, the anti-Xa drugs should be held for 1-2 days if the creatinine clearance (CrCl) is ≥ 60 mL/min, for 3 days if the CrCl is between 30 mL/min and 59 mL/min, and for 4 days if the CrCl is less than 30 mL/min.²⁶ For edoxaban, the recommendation is to hold at least 24 hours before high-risk procedures. The recommendation for stopping dabigatran is 2-3 days before a high-risk procedure in patients with CrCl more than 80 mL/min, 3-4 days prior if between 30 and 49 mL/min, and 4-6 days prior if less than 30 mL/min respectively.²⁷

In regard to antiplatelet management, ASA and the P2Y₁₂ receptor inhibitors (e.g. clopidogrel, prasugrel, and ticagrelor) are the most commonly utilized antiplatelets in patients undergoing endoscopic procedures. For patients who are on ASA monotherapy, whether 81 mg or 325 mg daily, for secondary cardiovascular prevention, no interruption of ASA therapy is necessary for elective procedures. The benefit of ASA for secondary cardiovascular prevention and the possible reduction in thrombotic events seen in RCTs of nonendoscopic surgical procedures is well known. However, there may be certain exceptions in which aspirin should be temporarily held. For example, short-term interruption of ASA could be considered in high risk procedures such as biliary or pancreatic sphincterotomy, ampullectomy, and peroral endoscopic myotomy. For patients on single antiplatelet therapy with a P2Y₁₂ receptor inhibitor who are undergoing elective endoscopic GI procedures, the recent CAG/ACG guidelines did not provide a clear recommendation for or against temporary interruption of the P2Y₁₂ receptor inhibitor. Although interruption of a P2Y₁₂ receptor inhibitor should theoretically decrease a patient’s risk of bleeding, the available evidence reported a nonsignificant increased bleeding risk in patients who stop a P2Y₁₂ receptor inhibitor for an elective endoscopic procedure compared with those who continue the medication.^28,29 Therefore, until further data are available, for patients on P2Y₁₂ receptor monotherapy, a reasonable strategy would be to temporarily hold therapy prior to high risk endoscopic procedures, assuming the patients are not at high cardiovascular risk. Clopidogrel and prasugrel have to be stopped 5-7 days prior to allow normal platelet aggregation to resume as opposed to ticagrelor, a reversible P2Y₁₂ receptor inhibitor that can be stopped 3-5 days prior.³⁰

Lastly, for patients who are on dual antiplatelet therapy (DAPT) for secondary prevention, continuation of ASA and temporary interruption of the P2Y₁₂ receptor inhibitor is recommended while undergoing elective endoscopy. Studies have shown that those who discontinued both had a much higher incidence of stent thrombosis compared with those who remained on aspirin alone.^4,28,31

Resumption of antithrombotic therapy after endoscopy

In general, antithrombotic therapy should be resumed upon completion of the procedure unless there remains a persistent risk of major bleeding.^1,14 This consensus is based on studies available on warfarin and heparin products, with minimal literature available regarding the resumption of DOACs. The benefits of immediate re-initiation of antithrombotic therapy for the prevention of thromboembolic events should be weighed against the risk of hemorrhage associated with the specific agent, the time to onset of the medication, and procedure-specific circumstances. For the small subset of patients on warfarin with a high risk of thromboembolism (e.g., mechanical heart valve), bridging with LMWH should be started at the earliest possible time when there is no risk of major bleeding and continued until the international normalized ratio (INR) reaches a therapeutic level with warfarin. For patients at a lower risk of thromboembolism, warfarin should be restarted within 24 hours of the procedure. In addition, because of the shorter duration of DOACs, if treatment with these agents cannot resume within 24 hours of a high-risk procedure, bridge therapy should be considered with UFH or LMWH in patients with a high risk of thrombosis.¹⁸ In patients receiving DOACs for stroke prophylaxis in AF, the DOACS can be safely resumed 1 day after low-risk procedures and 2-3 days after high-risk procedures without the need for bridging.²⁵ All antiplatelet agents should be resumed as soon as hemostasis is achieved.

Conclusion

Antithrombotic therapy is increasingly used given the aging population, widespread burden of cardiovascular comorbidities, and expanding indications for classes of medications such as direct oral anticoagulants. Given the association with antithrombotic medications and gastrointestinal bleeding, it is essential for gastroenterologists to understand the importance, necessity, and timing when holding these medications for endoscopic procedures. Even with the practice guidelines available today to help clinicians navigate certain situations, each patient’s antithrombotic management may be different, and communication with the prescribing physicians and including patients in the decision-making process is essential before planned procedures.

Dr. Wang is a gastroenterology fellow at the University of Chicago. Dr. Sengupta is an associate professor at the University of Chicago. They reported no funding or conflicts of interest.

References

1. ASGE Standards of Practice Committee, Acosta RD et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016;83(1):3-16.

2. Veitch AM et al. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016;48(4):c1. doi: 10.1055/s-0042-122686.

3. Chan FKL et al. Management of patients on antithrombotic agents undergoing emergency and elective endoscopy: Joint Asian Pacific Association of Gastroenterology (APAGE) and Asian Pacific Society for Digestive Endoscopy (APSDE) practice guidelines. Gut. 2018;67(3):405-17.

4. Abraham NS et al. American College of Gastroenterology – Canadian Association of Gastroenterology clinical practice guideline: Management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period. Am J Gastroenterol. 2022;117(4):542-58.

5. Boustière C et al. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2011;43(5):445-61.

6. Fujimoto K et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. Dig Endosc. 2014;26(1):1-14.

7. Wilke T et al. Patient preferences for oral anticoagulation therapy in atrial fibrillation: A systematic literature review. Patient 2017;10(1):17-37.

8. Gerson LB et al. Adverse events associated with anticoagulation therapy in the periendoscopic period. Gastrointest Endosc. 2010 Jun;71(7):1211-17.e2.

9. Horiuchi A et al. Removal of small colorectal polyps in anticoagulated patients: A prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc 2014;79(3):417-23.

10. Lip GYH et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The euro heart survey on atrial fibrillation. Chest. 2010;137(2):263-72.

11. 2012 Writing Committee Members, Jneid H et al. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction (Updating the 2007 guideline and replacing the 2011 focused update): A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2012;126(7):875-910.

12. Douketis JD et al. Perioperative management of antithrombotic therapy: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-e350S.

13. Becker RC et al. Management of platelet-directed pharmacotherapy in patients with atherosclerotic coronary artery disease undergoing elective endoscopic gastrointestinal procedures. J Am Coll Cardiol. 2009;54(24):2261-76.

14. Kwok A and Faigel DO. Management of anticoagulation before and after gastrointestinal endoscopy. Am J Gastroenterol. 2009;104(12):3085-97; quiz 3098.

15. Douketis JD et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373(9):823-33.

16. Kovacs MJ et al. Postoperative low molecular weight heparin bridging treatment for patients at high risk of arterial thromboembolism (PERIOP2): Double blind randomised controlled trial. BMJ 2021;373:n1205.

17. Tafur A and Douketis J. Perioperative management of anticoagulant and antiplatelet therapy. Heart 2018;104(17):1461-7.

18. Kato M et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment: 2017 appendix on anticoagulants including direct oral anticoagulants. Dig Endosc. 2018;30(4):433-40.

19. Inoue T et al. Clinical features of postpolypectomy bleeding associated with heparin bridge therapy. Dig Endosc. 2014;26(2):243-9.

20. Takeuchi Y et al. Continuous anticoagulation and cold snare polypectomy versus heparin bridging and hot snare polypectomy in patients on anticoagulants with subcentimeter polyps: A randomized controlled trial. Ann Intern Med. 2019;171(4):229-37.

21. Ara N et al. Prospective analysis of risk for bleeding after endoscopic biopsy without cessation of antithrombotics in Japan. Dig Endosc. 2015;27(4):458-64.

22. Yanagisawa N et al. Postpolypectomy bleeding and thromboembolism risks associated with warfarin vs. direct oral anticoagulants. World J Gastroenterol. 2018;24(14):1540-9.

23. Arimoto J et al. Safety of cold snare polypectomy in patients receiving treatment with antithrombotic agents. Dig Dis Sci. 2019;64(11):3247-55.

24. Heublein V et al. Gastrointestinal endoscopy in patients receiving novel direct oral anticoagulants: Results from the prospective Dresden NOAC registry. J Gastroenterol. 2018;53(2):236-46.

25. Douketis JD et al. Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant. JAMA Intern Med. 2019;179(11):1469-78.

26. Dubois V et al. Perioperative management of patients on direct oral anticoagulants. Thromb J. 2017;15:14.

27. Weitz JI et al. Periprocedural management and approach to bleeding in patients taking dabigatran. Circulation. 2012 Nov 13;126(20):2428-32.

28. Chan FKL et al. Risk of postpolypectomy bleeding with uninterrupted clopidogrel therapy in an industry-independent, double-blind, randomized trial. Gastroenterology. 2019;156(4):918-25.

29. Watanabe K et al. Effect of antiplatelet agent number, types, and pre-endoscopic management on postpolypectomy bleeding: Validation of endoscopy guidelines. Surg Endosc. 2021;35(1):317-25.

30. Gurbel PA et al. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: The ONSET/OFFSET study. Circulation. 2009;120(25):2577-85.

31. Eisenberg MJ et al. Safety of short-term discontinuation of antiplatelet therapy in patients with drug-eluting stents. Circulation. 2009;119(12):1634-42.
 

Antithrombotic therapy is increasingly used to either reduce the risk of or treat thromboembolic episodes in patients with various medical conditions such as ischemic and valvular heart disease, atrial fibrillation (AF), cerebrovascular disease, peripheral arterial disease, venous thromboembolism (VTE) and hypercoagulable diseases. Antithrombotics include medications classified as anticoagulants or antiplatelets. Anticoagulants work by interfering with the native clotting cascade and consist of four main classes: vitamin K antagonists (VKA), heparin derivatives, direct factor Xa inhibitors, and direct thrombin inhibitors. Direct oral anticoagulants (DOACs) refer to dabigatran (a direct thrombin inhibitor) and the factor Xa inhibitors (apixaban, rivaroxaban, and edoxaban).

Antiplatelets, on the other hand, work by decreasing platelet aggregation and thus preventing thrombus formation; they include P2Y12 receptor inhibitors, protease-activated receptor-1 inhibitors, glycoprotein IIb/IIIa receptor inhibitors, acetylsalicylic acid (ASA), and nonsteroidal anti-inflammatory drugs. All of these agents may directly cause or increase the risk of gastrointestinal (GI) bleeding from luminal sources such as ulcers or diverticula, as well as after endoscopic interventions such as polypectomy. However, there is also a risk of thromboembolic consequences if some of these agents are withheld. Thus, the management of patients receiving antithrombotic agents and undergoing GI endoscopy represents an important clinical challenge and something that every GI physician has to deal with routinely.

The goal of this review is to discuss the optimal strategy for managing antithrombotics in patients undergoing elective endoscopy based on current available evidence and published clinical guidelines.^1-4 Much of our discussion will review recommendations from the recently published joint American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines on management of anticoagulants and antiplatelets in the periendoscopic period by Abraham et al.⁴

Factors that guide decision-making

The two most vital factors to consider prior to performing endoscopic procedures in patients receiving antithrombotic therapy are to assess the risk of bleeding associated with the procedure and to assess the risk of thromboembolism associated with the underlying medical condition for which the antithrombotic agents are being used. In addition, it is also important to keep in mind the individual characteristics of the antithrombotic agent(s) used when making these decisions.

Estimating procedure-related bleeding risk

Various endoscopic procedures have different risks of associated bleeding. Although guidelines from GI societies may differ when classifying procedures into low or high risk, it is important to know that most of the original data on postprocedural bleeding risks are from studies conducted in patients who are not on complex antithrombotic regimens and thus may not accurately reflect the bleeding risk of patients using newer antithrombotic therapies.^1,4-7

Traditionally, some of the common low-risk procedures have included diagnostic EGD and colonoscopy with or without biopsy, ERCP without sphincterotomy, biliary stent placement, and push or balloon-assisted enteroscopy. On the other hand, endoscopic procedures associated with interventions are known to have higher bleeding risk, and other procedural factors can influence this risk as well.⁸ For example, polypectomy, one of the most common interventions during endoscopy, is associated with bleeding risk ranging from 0.3% to 10% depending on multiple factors including polyp size, location, morphology (nonpolypoid, sessile, pedunculated), resection technique (cold or hot forceps, cold or hot snare), and type of cautery used.⁹ For some procedures, such as routine screening colonoscopy, however, the preprocedure estimate of bleeding risk can be uncertain because it is unclear if a high risk intervention (e.g., polypectomy of large polyp) will be necessary. For example, in the most recent ACG/CAG guidelines, colonoscopy with polypectomy < 1cm is considered a low/moderate risk bleeding procedure, whereas polypectomy > 1cm is considered high risk for bleeding.⁴ In these situations, the management of antithrombotic medications may depend on the individual patient’s risk of thrombosis and the specific antithrombotic agent. In the example of a patient undergoing colonoscopy while on antithrombotic medications, the bleeding risk associated with polypectomy can potentially be reduced by procedural techniques such as preferential use of cold snare polypectomy. Further high-quality data on the optimal procedural technique to reduce postpolypectomy bleeding in patients on antithrombotic medications is needed to help guide management.
 

Estimating thromboembolic risk

The risk of thromboembolic events in patients who are withholding their antithrombotic therapy for an endoscopic procedure depends on their underlying condition and individual characteristics. In patients who are on antithrombotic therapy for stroke prevention in non-valvular AF, the risk of cerebral thromboembolism in these patients is predictable using the CHA₂DS₂Vasc index.¹⁰ This scoring index includes heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischemic attack (TIA), vascular disease, age 65-74 years, and sex categories.

Patients with previous VTE on anticoagulation or those who have mechanical heart valves may have different risk factors for thromboembolic episodes. Among patients with VTE, time from initial VTE, history of recurrent VTE with antithrombotic interruption, and presence of underlying thrombophilia are most predictive of future thromboembolic risk. And for patients with mechanical heart valves, presence of a mitral valve prosthesis, and the presence or absence of associated heart failure and AF determine the annual risk of thromboembolic events. Bioprosthetic valves are generally considered low risk.

In patients with coronary artery disease (CAD), high thrombosis risk scenarios with holding antiplatelets include patients within 3 months of an acute coronary syndrome (ACS) event, within 6 months of a drug-eluting stent (DES) placement, or within 1 month of a bare metal coronary stent (BMS) placement. In addition, patients with ACS that occurred within the past 12 months of DES placement or within 2 months of BMS placement are also considered high risk.^11,12 Even beyond these periods, certain patients may still be at high risk of stent occlusion. In particular, patients with a prior history of stent occlusion, ACS or ST elevation myocardial infection, prior multivessel percutaneous coronary intervention, diabetes, renal failure, or diffuse CAD are at higher risk of stent occlusion or ACS events with alteration of antithrombotic therapy.¹³ Thus, modification of antithrombotic regimens in these patients should be cautiously approached.
 

Management of antithrombotics prior to elective endoscopy

In patients who need elective endoscopic procedures, if the indication for antithrombotic therapy is short-term, the procedure is probably best delayed until after that period.¹³ For patients on long-term or lifelong antithrombotic treatment, the decision to temporarily hold the treatment for endoscopy should occur after a discussion with the patient and all of the involved providers. In some high-risk patients, these agents cannot be interrupted; therefore, clinicians must carefully weigh the risks and benefits of the procedure before proceeding with endoscopy. For patients who are known to be undergoing an elective endoscopic procedure, antithrombotic medications may or may not need to be held prior to the procedure depending on the type of therapy. For example, according to the recent ACG/CAG guidelines, warfarin should be continued, whereas DOACs should be temporarily stopped for patients who are undergoing elective/planned endoscopic GI procedures.

Unfractionated heparin (UFH) administered as a continuous intravenous infusion can generally be held 3-4 hours before the procedure, given its short half-life. Low molecular weight heparin (LMWH), including enoxaparin and dalteparin, should be stopped 24 hours prior to the procedure.^2,14 Fondaparinux is a synthetic X-a inhibitor that requires discontinuation at least 36 hours preceding a high risk procedure. For patients on warfarin who are undergoing elective endoscopic procedures that are low risk for inducing bleeding, warfarin can be continued, as opposed to temporarily interrupted, although the dose should be omitted the morning of the procedure.⁴ For those who are undergoing high-risk endoscopic procedures (including colonoscopy with possible polypectomy > 1 cm), 5 days of temporary interruption without periprocedural bridging is appropriate in most patients. This is contrary to previous guidelines, which had recommended bridging for patients with a CHA2DS2Vasc score ≥ 2. Recent impactful randomized trials (BRIDGE and PERIOP-2) have called into question the benefit of periprocedural bridging with LMWH. Avoiding bridging anticoagulation was generally found to be similar to bridging in regard to prevention of thromboembolic complications, but importantly was associated with a decreased risk of major bleeding.^15,16 Of note, periprocedural bridging may still be appropriate in a small subset of patients, including those with mechanical valves, AF with CHADS2 score > 5, and previous thromboembolism during temporary interruption of VKAs. The decision to bridge or not should ideally be made in a multidisciplinary fashion.^15-20

Data are lacking on the ideal strategy for periendoscopic DOAC management. As mentioned above, for patients on DOACs who are undergoing elective endoscopic GI procedures, temporarily interrupting DOACs rather than continuing them is recommended. Currently, there are no randomized controlled trials addressing the management of DOACs in the periendoscopic period. However, based on five cohort studies, the ideal duration of DOAC interruption before endoscopic procedures may be between 1 and 2 days, excluding the day of the procedure.^21-25 This strategy allows for a short preprocedural duration of DOAC interruption and likely provides a balance between bleeding and thromboembolism risk. Importantly, there are no reliable laboratory assays to assess the anticoagulant effect of DOACs, and an individual patient’s degree of renal dysfunction may impact how long the DOAC should be held. In general, the anti-Xa drugs should be held for 1-2 days if the creatinine clearance (CrCl) is ≥ 60 mL/min, for 3 days if the CrCl is between 30 mL/min and 59 mL/min, and for 4 days if the CrCl is less than 30 mL/min.²⁶ For edoxaban, the recommendation is to hold at least 24 hours before high-risk procedures. The recommendation for stopping dabigatran is 2-3 days before a high-risk procedure in patients with CrCl more than 80 mL/min, 3-4 days prior if between 30 and 49 mL/min, and 4-6 days prior if less than 30 mL/min respectively.²⁷

In regard to antiplatelet management, ASA and the P2Y₁₂ receptor inhibitors (e.g. clopidogrel, prasugrel, and ticagrelor) are the most commonly utilized antiplatelets in patients undergoing endoscopic procedures. For patients who are on ASA monotherapy, whether 81 mg or 325 mg daily, for secondary cardiovascular prevention, no interruption of ASA therapy is necessary for elective procedures. The benefit of ASA for secondary cardiovascular prevention and the possible reduction in thrombotic events seen in RCTs of nonendoscopic surgical procedures is well known. However, there may be certain exceptions in which aspirin should be temporarily held. For example, short-term interruption of ASA could be considered in high risk procedures such as biliary or pancreatic sphincterotomy, ampullectomy, and peroral endoscopic myotomy. For patients on single antiplatelet therapy with a P2Y₁₂ receptor inhibitor who are undergoing elective endoscopic GI procedures, the recent CAG/ACG guidelines did not provide a clear recommendation for or against temporary interruption of the P2Y₁₂ receptor inhibitor. Although interruption of a P2Y₁₂ receptor inhibitor should theoretically decrease a patient’s risk of bleeding, the available evidence reported a nonsignificant increased bleeding risk in patients who stop a P2Y₁₂ receptor inhibitor for an elective endoscopic procedure compared with those who continue the medication.^28,29 Therefore, until further data are available, for patients on P2Y₁₂ receptor monotherapy, a reasonable strategy would be to temporarily hold therapy prior to high risk endoscopic procedures, assuming the patients are not at high cardiovascular risk. Clopidogrel and prasugrel have to be stopped 5-7 days prior to allow normal platelet aggregation to resume as opposed to ticagrelor, a reversible P2Y₁₂ receptor inhibitor that can be stopped 3-5 days prior.³⁰

Lastly, for patients who are on dual antiplatelet therapy (DAPT) for secondary prevention, continuation of ASA and temporary interruption of the P2Y₁₂ receptor inhibitor is recommended while undergoing elective endoscopy. Studies have shown that those who discontinued both had a much higher incidence of stent thrombosis compared with those who remained on aspirin alone.^4,28,31

Resumption of antithrombotic therapy after endoscopy

In general, antithrombotic therapy should be resumed upon completion of the procedure unless there remains a persistent risk of major bleeding.^1,14 This consensus is based on studies available on warfarin and heparin products, with minimal literature available regarding the resumption of DOACs. The benefits of immediate re-initiation of antithrombotic therapy for the prevention of thromboembolic events should be weighed against the risk of hemorrhage associated with the specific agent, the time to onset of the medication, and procedure-specific circumstances. For the small subset of patients on warfarin with a high risk of thromboembolism (e.g., mechanical heart valve), bridging with LMWH should be started at the earliest possible time when there is no risk of major bleeding and continued until the international normalized ratio (INR) reaches a therapeutic level with warfarin. For patients at a lower risk of thromboembolism, warfarin should be restarted within 24 hours of the procedure. In addition, because of the shorter duration of DOACs, if treatment with these agents cannot resume within 24 hours of a high-risk procedure, bridge therapy should be considered with UFH or LMWH in patients with a high risk of thrombosis.¹⁸ In patients receiving DOACs for stroke prophylaxis in AF, the DOACS can be safely resumed 1 day after low-risk procedures and 2-3 days after high-risk procedures without the need for bridging.²⁵ All antiplatelet agents should be resumed as soon as hemostasis is achieved.

Conclusion

Antithrombotic therapy is increasingly used given the aging population, widespread burden of cardiovascular comorbidities, and expanding indications for classes of medications such as direct oral anticoagulants. Given the association with antithrombotic medications and gastrointestinal bleeding, it is essential for gastroenterologists to understand the importance, necessity, and timing when holding these medications for endoscopic procedures. Even with the practice guidelines available today to help clinicians navigate certain situations, each patient’s antithrombotic management may be different, and communication with the prescribing physicians and including patients in the decision-making process is essential before planned procedures.

Dr. Wang is a gastroenterology fellow at the University of Chicago. Dr. Sengupta is an associate professor at the University of Chicago. They reported no funding or conflicts of interest.

References

1. ASGE Standards of Practice Committee, Acosta RD et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc. 2016;83(1):3-16.

2. Veitch AM et al. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016;48(4):c1. doi: 10.1055/s-0042-122686.

3. Chan FKL et al. Management of patients on antithrombotic agents undergoing emergency and elective endoscopy: Joint Asian Pacific Association of Gastroenterology (APAGE) and Asian Pacific Society for Digestive Endoscopy (APSDE) practice guidelines. Gut. 2018;67(3):405-17.

4. Abraham NS et al. American College of Gastroenterology – Canadian Association of Gastroenterology clinical practice guideline: Management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period. Am J Gastroenterol. 2022;117(4):542-58.

5. Boustière C et al. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2011;43(5):445-61.

6. Fujimoto K et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. Dig Endosc. 2014;26(1):1-14.

7. Wilke T et al. Patient preferences for oral anticoagulation therapy in atrial fibrillation: A systematic literature review. Patient 2017;10(1):17-37.

8. Gerson LB et al. Adverse events associated with anticoagulation therapy in the periendoscopic period. Gastrointest Endosc. 2010 Jun;71(7):1211-17.e2.

9. Horiuchi A et al. Removal of small colorectal polyps in anticoagulated patients: A prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc 2014;79(3):417-23.

10. Lip GYH et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The euro heart survey on atrial fibrillation. Chest. 2010;137(2):263-72.

11. 2012 Writing Committee Members, Jneid H et al. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction (Updating the 2007 guideline and replacing the 2011 focused update): A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2012;126(7):875-910.

12. Douketis JD et al. Perioperative management of antithrombotic therapy: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-e350S.

13. Becker RC et al. Management of platelet-directed pharmacotherapy in patients with atherosclerotic coronary artery disease undergoing elective endoscopic gastrointestinal procedures. J Am Coll Cardiol. 2009;54(24):2261-76.

14. Kwok A and Faigel DO. Management of anticoagulation before and after gastrointestinal endoscopy. Am J Gastroenterol. 2009;104(12):3085-97; quiz 3098.

15. Douketis JD et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373(9):823-33.

16. Kovacs MJ et al. Postoperative low molecular weight heparin bridging treatment for patients at high risk of arterial thromboembolism (PERIOP2): Double blind randomised controlled trial. BMJ 2021;373:n1205.

17. Tafur A and Douketis J. Perioperative management of anticoagulant and antiplatelet therapy. Heart 2018;104(17):1461-7.

18. Kato M et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment: 2017 appendix on anticoagulants including direct oral anticoagulants. Dig Endosc. 2018;30(4):433-40.

19. Inoue T et al. Clinical features of postpolypectomy bleeding associated with heparin bridge therapy. Dig Endosc. 2014;26(2):243-9.

20. Takeuchi Y et al. Continuous anticoagulation and cold snare polypectomy versus heparin bridging and hot snare polypectomy in patients on anticoagulants with subcentimeter polyps: A randomized controlled trial. Ann Intern Med. 2019;171(4):229-37.

21. Ara N et al. Prospective analysis of risk for bleeding after endoscopic biopsy without cessation of antithrombotics in Japan. Dig Endosc. 2015;27(4):458-64.

22. Yanagisawa N et al. Postpolypectomy bleeding and thromboembolism risks associated with warfarin vs. direct oral anticoagulants. World J Gastroenterol. 2018;24(14):1540-9.

23. Arimoto J et al. Safety of cold snare polypectomy in patients receiving treatment with antithrombotic agents. Dig Dis Sci. 2019;64(11):3247-55.

24. Heublein V et al. Gastrointestinal endoscopy in patients receiving novel direct oral anticoagulants: Results from the prospective Dresden NOAC registry. J Gastroenterol. 2018;53(2):236-46.

25. Douketis JD et al. Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant. JAMA Intern Med. 2019;179(11):1469-78.

26. Dubois V et al. Perioperative management of patients on direct oral anticoagulants. Thromb J. 2017;15:14.

27. Weitz JI et al. Periprocedural management and approach to bleeding in patients taking dabigatran. Circulation. 2012 Nov 13;126(20):2428-32.

28. Chan FKL et al. Risk of postpolypectomy bleeding with uninterrupted clopidogrel therapy in an industry-independent, double-blind, randomized trial. Gastroenterology. 2019;156(4):918-25.

29. Watanabe K et al. Effect of antiplatelet agent number, types, and pre-endoscopic management on postpolypectomy bleeding: Validation of endoscopy guidelines. Surg Endosc. 2021;35(1):317-25.

30. Gurbel PA et al. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: The ONSET/OFFSET study. Circulation. 2009;120(25):2577-85.

31. Eisenberg MJ et al. Safety of short-term discontinuation of antiplatelet therapy in patients with drug-eluting stents. Circulation. 2009;119(12):1634-42.
 

Vaccine recommendations for your patients with IBD

It’s cold and flu season – are your patients with inflammatory bowel disease (IBD) properly informed about increased risk of infections?

It is especially important for patients with IBD to receive the flu vaccine every year. With IBD, you can only get the shot (and not the spray in the nose).

The AGA GI Patient Center provides additional recommendations about vaccines in adults with IBD. Talk to your patients with IBD about what vaccines are needed for their treatment regimen, age and sex.

Review vaccines and vaccine-preventable diseases the patient had when first diagnosed with IBD, no matter the age and continue discussing vaccines during regular health care visits.

Give patients vaccine(s) for infections they are not immune as soon as possible.

Make sure patients are up to date or receive any live vaccines prior to starting some immunosuppressive treatments, such as biologics.
 

Help drive HCV testing, treatment, and eradication

AGA has been working with the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention to help drive the national priority for hepatitis C virus (HCV) testing, treatment and eradication.

Updates to QPP measure 400

In July 2022, CMS contacted AGA to modify measure 400 – to update the coverage for one-time screening for HCV to include a referral for treatment for patients with positive antibodies. CMS also advised that confirmation of eradication is a priority and we have started working with the CDC to modify AGA’s sustained virologic response measure for future consideration in the Quality Payment Program.

The modifications to measure 400 have been drafted and given the substantial changes to the measure specification, the measure needs to be retested and submitted to the National Quality Forum for consideration by the Measures Application Partnership. The CMS contractor for this project, Mathematica, will be leading this testing initiative and selected test sites will qualify for up to $2,000 to participate.

Additionally, there will be a second phase of testing to use deidentified patient-level data to assess the measure’s validity and reliability, which will be contracted separately. Our hope is that testing sites recruited for the first phase of testing will stay on through the second phase.

Participants in the second phase of testing are expected to have at least 2 years of patient data available containing data elements needed to calculate the measure. Ideally, each of the participating clinicians at the prospective testing sites would see at least 40 confirmed HCV-positive cases annually.

Vaccine recommendations for your patients with IBD

It’s cold and flu season – are your patients with inflammatory bowel disease (IBD) properly informed about increased risk of infections?

It is especially important for patients with IBD to receive the flu vaccine every year. With IBD, you can only get the shot (and not the spray in the nose).

The AGA GI Patient Center provides additional recommendations about vaccines in adults with IBD. Talk to your patients with IBD about what vaccines are needed for their treatment regimen, age and sex.

Review vaccines and vaccine-preventable diseases the patient had when first diagnosed with IBD, no matter the age and continue discussing vaccines during regular health care visits.

Give patients vaccine(s) for infections they are not immune as soon as possible.

Make sure patients are up to date or receive any live vaccines prior to starting some immunosuppressive treatments, such as biologics.
 

Help drive HCV testing, treatment, and eradication

AGA has been working with the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention to help drive the national priority for hepatitis C virus (HCV) testing, treatment and eradication.

Updates to QPP measure 400

In July 2022, CMS contacted AGA to modify measure 400 – to update the coverage for one-time screening for HCV to include a referral for treatment for patients with positive antibodies. CMS also advised that confirmation of eradication is a priority and we have started working with the CDC to modify AGA’s sustained virologic response measure for future consideration in the Quality Payment Program.

The modifications to measure 400 have been drafted and given the substantial changes to the measure specification, the measure needs to be retested and submitted to the National Quality Forum for consideration by the Measures Application Partnership. The CMS contractor for this project, Mathematica, will be leading this testing initiative and selected test sites will qualify for up to $2,000 to participate.

Additionally, there will be a second phase of testing to use deidentified patient-level data to assess the measure’s validity and reliability, which will be contracted separately. Our hope is that testing sites recruited for the first phase of testing will stay on through the second phase.

Participants in the second phase of testing are expected to have at least 2 years of patient data available containing data elements needed to calculate the measure. Ideally, each of the participating clinicians at the prospective testing sites would see at least 40 confirmed HCV-positive cases annually.

Vaccine recommendations for your patients with IBD

It’s cold and flu season – are your patients with inflammatory bowel disease (IBD) properly informed about increased risk of infections?

It is especially important for patients with IBD to receive the flu vaccine every year. With IBD, you can only get the shot (and not the spray in the nose).

The AGA GI Patient Center provides additional recommendations about vaccines in adults with IBD. Talk to your patients with IBD about what vaccines are needed for their treatment regimen, age and sex.

Review vaccines and vaccine-preventable diseases the patient had when first diagnosed with IBD, no matter the age and continue discussing vaccines during regular health care visits.

Give patients vaccine(s) for infections they are not immune as soon as possible.

Make sure patients are up to date or receive any live vaccines prior to starting some immunosuppressive treatments, such as biologics.
 

Help drive HCV testing, treatment, and eradication

AGA has been working with the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention to help drive the national priority for hepatitis C virus (HCV) testing, treatment and eradication.

Updates to QPP measure 400

In July 2022, CMS contacted AGA to modify measure 400 – to update the coverage for one-time screening for HCV to include a referral for treatment for patients with positive antibodies. CMS also advised that confirmation of eradication is a priority and we have started working with the CDC to modify AGA’s sustained virologic response measure for future consideration in the Quality Payment Program.

The modifications to measure 400 have been drafted and given the substantial changes to the measure specification, the measure needs to be retested and submitted to the National Quality Forum for consideration by the Measures Application Partnership. The CMS contractor for this project, Mathematica, will be leading this testing initiative and selected test sites will qualify for up to $2,000 to participate.

Additionally, there will be a second phase of testing to use deidentified patient-level data to assess the measure’s validity and reliability, which will be contracted separately. Our hope is that testing sites recruited for the first phase of testing will stay on through the second phase.

Participants in the second phase of testing are expected to have at least 2 years of patient data available containing data elements needed to calculate the measure. Ideally, each of the participating clinicians at the prospective testing sites would see at least 40 confirmed HCV-positive cases annually.

When I was in fellowship in the late 1990s, it was rare to see women at many of the big gastroenterology conferences. And in terms of presentations, there was maybe one session led by or for women at lunchtime. These conferences were the only events I had ever been to where the line for the men’s room was longer than the line for the women’s room.

Over the years, the lines for the women’s room have gotten longer, and the sessions led by female gastroenterologists have grown exponentially. However, women are still underrepresented in our field. Two out of five GI fellows are women, but women constitute less than 18% of practicing gastroenterologists. And the number of women in leadership positions is even lower.
 

Women in medicine face many challenges

According to a report in JAMA Network Open, women have lower starting salaries more than 90% of the time, which can create income disparities in earning potential throughout our entire careers.

Other studies suggest that female physicians also spend more time with patients and answering messages from patients and colleagues as well. This extra time, although it is done in small increments, adds up quickly and could suggest the pay gap between women and men is wider than we think.

Of course, female physicians still spend more time parenting children and doing household labor. A study found that female physicians spent 8.5 hours more per week on activities that support the family and household.

We’ve been discussing equity for women in medicine, and in the workplace, for decades. But events over the past several years – such as the killing of George Floyd and the formation of the #MeToo movement in response to workplace sexual harassment – have accelerated a paradigm shift in how organizations are focusing on diversity, equity, and inclusion (DEI) and creating cultures that support leadership development for women.

The Gastro Health Women’s Network

In 2020, the leadership of Gastro Health reiterated its commitment to fight discrimination and support equity by sending out a company-wide correspondence that encouraged us to be good stewards within our communities during these turbulent times.

This led to the development of the Gastro Health DEI Council and the Gastro Health Women’s Network, led by Dr. Asma Khapra and based on the framework developed by Dr. Dawn Sears. The programs developed by Dr. Sears are focused on facilitating authentic and supportive relationships, and they helped us create a network for women focused on recruitment, mentorship and retention, networking and social events, and leadership development.

Our network started with a meet & greet, inviting all women in Gastro Health to join a virtual call and get to know each other in an informal setting. This was a great way to introduce people to each other in our natural elements. It was wonderful to see how people are when they are at home and not working.
 

Recruiting female gastroenterologists

Even though about half of gastroenterology fellows choose independent GI, most fellowship programs don’t educate students about private practice careers or promote that path. In addition, a lot of the national GI conferences are geared toward the academic experience.

It’s incumbent on those of us in private practice to educate students about the benefits and challenges we face as members of independent GI groups, and Gastro Health set out to hold networking and recruitment events at different national conferences with GI fellows and residents.

We’re also working to develop partnerships with fellowship programs. This past year, we’ve held several educational dinners for fellows and residents. Most recently, Dr. Khapra and others took a road trip to New York for dinners with fellows from Mount Sinai, Westchester Medical Center, and the Albert Einstein College of Medicine.

While it was beneficial for Gastro Health to provide information about life as private practice gastroenterologists, it was also helpful for us to hear how the GI leaders of tomorrow are navigating their career choices and what is impacting their decisions about the future.
 

Mentorship and retention are vital to practice sustainability

Once you’ve recruited physicians to join your practice, how do you ensure their success? Many practices are rightly concerned about their long-term sustainability and are exploring ways to help early-career physicians maintain the clinical skills they need to treat patients and learn the business skills they need to succeed in private practice.

Sometimes it’s as simple as reaching out to new associates on the first day to let them know you’re glad they’ve joined the practice and to let them know you’re available if they need anything. But there’s also growing recognition that implementing a formal mentorship program can help people feel included and supported.

The Women’s Network worked to pair its members with Gastro Health partners as mentors, and we’ve learned some things along the way. Initially, we tried to pair people with similar lifestyles and interests. What we found is that while this sometimes works, we may have overcomplicated the process. We learned that sometimes people would prefer mentors who have backgrounds that are different from their own. We were reminded that mentorship has many faces, and letting those relationships develop naturally can sometimes be more effective.
 

Networking and social events deter isolation and keep people engaged

Private practice can be different from working within a hospital because oftentimes your colleagues are working in different offices or facilities. In the case of our organization, those offices may be in different states hundreds of miles away. Within a hospital, there might be more potential to interact with your colleagues, whether in clinical conferences or through a chance encounter in the cafeteria.

In private practice, you may need to be more intentional about creating opportunities for people to network and get to know each other outside of work. This year, we developed an email and WhatsApp group so that women throughout the network can connect with each other. We have used it to disseminate information about upcoming events, fellowship opportunities with the national GI societies, interesting articles, and anything important that we think other women within Gastro Health would like to know.

In March, Gastro Health sponsored five women to attend the Scrubs & Heels Summit, which was developed by Dr. Anita Afzali and Dr. Aline Charabaty to create opportunities for women in GI at different stages of their GI careers and help them succeed and achieve their professional goals. There were 2 days of educational talks, but it also included plenty of events for our colleagues to get to know each other and network with other amazing female GI leaders from across the nation.


 

Where’s the boardroom?

A recent study found that the percentage of women on the boards of the 1,000 largest public companies in America is a little more than 28%, even though research shows that S&P 500 companies headquartered in California with 30% or more women on their boards had 29% higher revenue.

We’re working to develop opportunities for women to be in leadership positions, within our practices and on the national stage in terms of representation, within our national GI societies. It’s very exciting that we have women in leadership within AGA and ASGE, and that Dr. Latha Alaparthi has made increasing the focus on leadership and pipeline development one of her main priorities as the president and board chair of the Digestive Health Physicians Association (DHPA).

Another way private practices can support women who are leaders is by making recommendations for committees within our national societies and by recognizing that time spent developing presentations and speaking at national conferences is beneficial to the practice in terms of thought leadership, branding, and recruitment of the next generation of practice leaders.

While we have a long way to go, we’re also making strides in the board room at the practice level. I’m the first woman, and notably a woman of color, to join the Gastro Health board of directors under the guidance of support of CEO Joseph Garcia. Dr. Aja McCutchen, who serves as the chair of the DHPA Diversity, Equity, and Inclusion committee, is similarly the first woman and woman of color on the board of directors for United Digestive in Atlanta.


 

What to look for in joining a practice

When determining which practice you might join, ask how committed the leadership of the organization is to supporting career development for women. Does the practice have a network, a committee or other internal group that supports female physicians? What steps does the practice leadership take to support women who are interested in executive opportunities?

If the practice does have an internal organization, how does it measure progress? For example, we’ve implemented focus groups to measure what is working and where we face the most challenges. Gastro Health partnered with a consultant to hold three confidential sessions with 10 women at a time. This will allow for us to collect depersonalized data that can be compiled into a report for the Gastro Health Board and leadership.

If you’re a woman who is considering a career in independent GI, seek out women in private practice and ask about their experiences. Ask about their path and what opportunities they sought out when starting their careers. They may know of some great opportunities that are available to build your leadership skills.

By creating a network for women, Gastro Health is hoping to make it easier to develop relationships and create productive partnerships. We are certain that working to address the specific challenges that female physicians face in their careers will strengthen our group, and ultimately independent gastroenterology overall.

Dr. Adams is a practicing gastroenterologist and partner at Gastro Health Fairfax in Virginia and serves on the Digestive Health Physicians Association’s Diversity, Equity, and Inclusion Committee. Dr. Adams has no conflicts to declare.

When I was in fellowship in the late 1990s, it was rare to see women at many of the big gastroenterology conferences. And in terms of presentations, there was maybe one session led by or for women at lunchtime. These conferences were the only events I had ever been to where the line for the men’s room was longer than the line for the women’s room.

Over the years, the lines for the women’s room have gotten longer, and the sessions led by female gastroenterologists have grown exponentially. However, women are still underrepresented in our field. Two out of five GI fellows are women, but women constitute less than 18% of practicing gastroenterologists. And the number of women in leadership positions is even lower.
 

Women in medicine face many challenges

According to a report in JAMA Network Open, women have lower starting salaries more than 90% of the time, which can create income disparities in earning potential throughout our entire careers.

Other studies suggest that female physicians also spend more time with patients and answering messages from patients and colleagues as well. This extra time, although it is done in small increments, adds up quickly and could suggest the pay gap between women and men is wider than we think.

Of course, female physicians still spend more time parenting children and doing household labor. A study found that female physicians spent 8.5 hours more per week on activities that support the family and household.

We’ve been discussing equity for women in medicine, and in the workplace, for decades. But events over the past several years – such as the killing of George Floyd and the formation of the #MeToo movement in response to workplace sexual harassment – have accelerated a paradigm shift in how organizations are focusing on diversity, equity, and inclusion (DEI) and creating cultures that support leadership development for women.

The Gastro Health Women’s Network

In 2020, the leadership of Gastro Health reiterated its commitment to fight discrimination and support equity by sending out a company-wide correspondence that encouraged us to be good stewards within our communities during these turbulent times.

This led to the development of the Gastro Health DEI Council and the Gastro Health Women’s Network, led by Dr. Asma Khapra and based on the framework developed by Dr. Dawn Sears. The programs developed by Dr. Sears are focused on facilitating authentic and supportive relationships, and they helped us create a network for women focused on recruitment, mentorship and retention, networking and social events, and leadership development.

Our network started with a meet & greet, inviting all women in Gastro Health to join a virtual call and get to know each other in an informal setting. This was a great way to introduce people to each other in our natural elements. It was wonderful to see how people are when they are at home and not working.
 

Recruiting female gastroenterologists

Even though about half of gastroenterology fellows choose independent GI, most fellowship programs don’t educate students about private practice careers or promote that path. In addition, a lot of the national GI conferences are geared toward the academic experience.

It’s incumbent on those of us in private practice to educate students about the benefits and challenges we face as members of independent GI groups, and Gastro Health set out to hold networking and recruitment events at different national conferences with GI fellows and residents.

We’re also working to develop partnerships with fellowship programs. This past year, we’ve held several educational dinners for fellows and residents. Most recently, Dr. Khapra and others took a road trip to New York for dinners with fellows from Mount Sinai, Westchester Medical Center, and the Albert Einstein College of Medicine.

While it was beneficial for Gastro Health to provide information about life as private practice gastroenterologists, it was also helpful for us to hear how the GI leaders of tomorrow are navigating their career choices and what is impacting their decisions about the future.
 

Mentorship and retention are vital to practice sustainability

Once you’ve recruited physicians to join your practice, how do you ensure their success? Many practices are rightly concerned about their long-term sustainability and are exploring ways to help early-career physicians maintain the clinical skills they need to treat patients and learn the business skills they need to succeed in private practice.

Sometimes it’s as simple as reaching out to new associates on the first day to let them know you’re glad they’ve joined the practice and to let them know you’re available if they need anything. But there’s also growing recognition that implementing a formal mentorship program can help people feel included and supported.

The Women’s Network worked to pair its members with Gastro Health partners as mentors, and we’ve learned some things along the way. Initially, we tried to pair people with similar lifestyles and interests. What we found is that while this sometimes works, we may have overcomplicated the process. We learned that sometimes people would prefer mentors who have backgrounds that are different from their own. We were reminded that mentorship has many faces, and letting those relationships develop naturally can sometimes be more effective.
 

Networking and social events deter isolation and keep people engaged

Private practice can be different from working within a hospital because oftentimes your colleagues are working in different offices or facilities. In the case of our organization, those offices may be in different states hundreds of miles away. Within a hospital, there might be more potential to interact with your colleagues, whether in clinical conferences or through a chance encounter in the cafeteria.

In private practice, you may need to be more intentional about creating opportunities for people to network and get to know each other outside of work. This year, we developed an email and WhatsApp group so that women throughout the network can connect with each other. We have used it to disseminate information about upcoming events, fellowship opportunities with the national GI societies, interesting articles, and anything important that we think other women within Gastro Health would like to know.

In March, Gastro Health sponsored five women to attend the Scrubs & Heels Summit, which was developed by Dr. Anita Afzali and Dr. Aline Charabaty to create opportunities for women in GI at different stages of their GI careers and help them succeed and achieve their professional goals. There were 2 days of educational talks, but it also included plenty of events for our colleagues to get to know each other and network with other amazing female GI leaders from across the nation.


 

Where’s the boardroom?

A recent study found that the percentage of women on the boards of the 1,000 largest public companies in America is a little more than 28%, even though research shows that S&P 500 companies headquartered in California with 30% or more women on their boards had 29% higher revenue.

We’re working to develop opportunities for women to be in leadership positions, within our practices and on the national stage in terms of representation, within our national GI societies. It’s very exciting that we have women in leadership within AGA and ASGE, and that Dr. Latha Alaparthi has made increasing the focus on leadership and pipeline development one of her main priorities as the president and board chair of the Digestive Health Physicians Association (DHPA).

Another way private practices can support women who are leaders is by making recommendations for committees within our national societies and by recognizing that time spent developing presentations and speaking at national conferences is beneficial to the practice in terms of thought leadership, branding, and recruitment of the next generation of practice leaders.

While we have a long way to go, we’re also making strides in the board room at the practice level. I’m the first woman, and notably a woman of color, to join the Gastro Health board of directors under the guidance of support of CEO Joseph Garcia. Dr. Aja McCutchen, who serves as the chair of the DHPA Diversity, Equity, and Inclusion committee, is similarly the first woman and woman of color on the board of directors for United Digestive in Atlanta.


 

What to look for in joining a practice

When determining which practice you might join, ask how committed the leadership of the organization is to supporting career development for women. Does the practice have a network, a committee or other internal group that supports female physicians? What steps does the practice leadership take to support women who are interested in executive opportunities?

If the practice does have an internal organization, how does it measure progress? For example, we’ve implemented focus groups to measure what is working and where we face the most challenges. Gastro Health partnered with a consultant to hold three confidential sessions with 10 women at a time. This will allow for us to collect depersonalized data that can be compiled into a report for the Gastro Health Board and leadership.

If you’re a woman who is considering a career in independent GI, seek out women in private practice and ask about their experiences. Ask about their path and what opportunities they sought out when starting their careers. They may know of some great opportunities that are available to build your leadership skills.

By creating a network for women, Gastro Health is hoping to make it easier to develop relationships and create productive partnerships. We are certain that working to address the specific challenges that female physicians face in their careers will strengthen our group, and ultimately independent gastroenterology overall.

Dr. Adams is a practicing gastroenterologist and partner at Gastro Health Fairfax in Virginia and serves on the Digestive Health Physicians Association’s Diversity, Equity, and Inclusion Committee. Dr. Adams has no conflicts to declare.

When I was in fellowship in the late 1990s, it was rare to see women at many of the big gastroenterology conferences. And in terms of presentations, there was maybe one session led by or for women at lunchtime. These conferences were the only events I had ever been to where the line for the men’s room was longer than the line for the women’s room.

Over the years, the lines for the women’s room have gotten longer, and the sessions led by female gastroenterologists have grown exponentially. However, women are still underrepresented in our field. Two out of five GI fellows are women, but women constitute less than 18% of practicing gastroenterologists. And the number of women in leadership positions is even lower.
 

Women in medicine face many challenges

According to a report in JAMA Network Open, women have lower starting salaries more than 90% of the time, which can create income disparities in earning potential throughout our entire careers.

Other studies suggest that female physicians also spend more time with patients and answering messages from patients and colleagues as well. This extra time, although it is done in small increments, adds up quickly and could suggest the pay gap between women and men is wider than we think.

Of course, female physicians still spend more time parenting children and doing household labor. A study found that female physicians spent 8.5 hours more per week on activities that support the family and household.

We’ve been discussing equity for women in medicine, and in the workplace, for decades. But events over the past several years – such as the killing of George Floyd and the formation of the #MeToo movement in response to workplace sexual harassment – have accelerated a paradigm shift in how organizations are focusing on diversity, equity, and inclusion (DEI) and creating cultures that support leadership development for women.

The Gastro Health Women’s Network

In 2020, the leadership of Gastro Health reiterated its commitment to fight discrimination and support equity by sending out a company-wide correspondence that encouraged us to be good stewards within our communities during these turbulent times.

This led to the development of the Gastro Health DEI Council and the Gastro Health Women’s Network, led by Dr. Asma Khapra and based on the framework developed by Dr. Dawn Sears. The programs developed by Dr. Sears are focused on facilitating authentic and supportive relationships, and they helped us create a network for women focused on recruitment, mentorship and retention, networking and social events, and leadership development.

Our network started with a meet & greet, inviting all women in Gastro Health to join a virtual call and get to know each other in an informal setting. This was a great way to introduce people to each other in our natural elements. It was wonderful to see how people are when they are at home and not working.
 

Recruiting female gastroenterologists

Even though about half of gastroenterology fellows choose independent GI, most fellowship programs don’t educate students about private practice careers or promote that path. In addition, a lot of the national GI conferences are geared toward the academic experience.

It’s incumbent on those of us in private practice to educate students about the benefits and challenges we face as members of independent GI groups, and Gastro Health set out to hold networking and recruitment events at different national conferences with GI fellows and residents.

We’re also working to develop partnerships with fellowship programs. This past year, we’ve held several educational dinners for fellows and residents. Most recently, Dr. Khapra and others took a road trip to New York for dinners with fellows from Mount Sinai, Westchester Medical Center, and the Albert Einstein College of Medicine.

While it was beneficial for Gastro Health to provide information about life as private practice gastroenterologists, it was also helpful for us to hear how the GI leaders of tomorrow are navigating their career choices and what is impacting their decisions about the future.
 

Mentorship and retention are vital to practice sustainability

Once you’ve recruited physicians to join your practice, how do you ensure their success? Many practices are rightly concerned about their long-term sustainability and are exploring ways to help early-career physicians maintain the clinical skills they need to treat patients and learn the business skills they need to succeed in private practice.

Sometimes it’s as simple as reaching out to new associates on the first day to let them know you’re glad they’ve joined the practice and to let them know you’re available if they need anything. But there’s also growing recognition that implementing a formal mentorship program can help people feel included and supported.

The Women’s Network worked to pair its members with Gastro Health partners as mentors, and we’ve learned some things along the way. Initially, we tried to pair people with similar lifestyles and interests. What we found is that while this sometimes works, we may have overcomplicated the process. We learned that sometimes people would prefer mentors who have backgrounds that are different from their own. We were reminded that mentorship has many faces, and letting those relationships develop naturally can sometimes be more effective.
 

Networking and social events deter isolation and keep people engaged

Private practice can be different from working within a hospital because oftentimes your colleagues are working in different offices or facilities. In the case of our organization, those offices may be in different states hundreds of miles away. Within a hospital, there might be more potential to interact with your colleagues, whether in clinical conferences or through a chance encounter in the cafeteria.

In private practice, you may need to be more intentional about creating opportunities for people to network and get to know each other outside of work. This year, we developed an email and WhatsApp group so that women throughout the network can connect with each other. We have used it to disseminate information about upcoming events, fellowship opportunities with the national GI societies, interesting articles, and anything important that we think other women within Gastro Health would like to know.

In March, Gastro Health sponsored five women to attend the Scrubs & Heels Summit, which was developed by Dr. Anita Afzali and Dr. Aline Charabaty to create opportunities for women in GI at different stages of their GI careers and help them succeed and achieve their professional goals. There were 2 days of educational talks, but it also included plenty of events for our colleagues to get to know each other and network with other amazing female GI leaders from across the nation.


 

Where’s the boardroom?

A recent study found that the percentage of women on the boards of the 1,000 largest public companies in America is a little more than 28%, even though research shows that S&P 500 companies headquartered in California with 30% or more women on their boards had 29% higher revenue.

We’re working to develop opportunities for women to be in leadership positions, within our practices and on the national stage in terms of representation, within our national GI societies. It’s very exciting that we have women in leadership within AGA and ASGE, and that Dr. Latha Alaparthi has made increasing the focus on leadership and pipeline development one of her main priorities as the president and board chair of the Digestive Health Physicians Association (DHPA).

Another way private practices can support women who are leaders is by making recommendations for committees within our national societies and by recognizing that time spent developing presentations and speaking at national conferences is beneficial to the practice in terms of thought leadership, branding, and recruitment of the next generation of practice leaders.

While we have a long way to go, we’re also making strides in the board room at the practice level. I’m the first woman, and notably a woman of color, to join the Gastro Health board of directors under the guidance of support of CEO Joseph Garcia. Dr. Aja McCutchen, who serves as the chair of the DHPA Diversity, Equity, and Inclusion committee, is similarly the first woman and woman of color on the board of directors for United Digestive in Atlanta.


 

What to look for in joining a practice

When determining which practice you might join, ask how committed the leadership of the organization is to supporting career development for women. Does the practice have a network, a committee or other internal group that supports female physicians? What steps does the practice leadership take to support women who are interested in executive opportunities?

If the practice does have an internal organization, how does it measure progress? For example, we’ve implemented focus groups to measure what is working and where we face the most challenges. Gastro Health partnered with a consultant to hold three confidential sessions with 10 women at a time. This will allow for us to collect depersonalized data that can be compiled into a report for the Gastro Health Board and leadership.

If you’re a woman who is considering a career in independent GI, seek out women in private practice and ask about their experiences. Ask about their path and what opportunities they sought out when starting their careers. They may know of some great opportunities that are available to build your leadership skills.

By creating a network for women, Gastro Health is hoping to make it easier to develop relationships and create productive partnerships. We are certain that working to address the specific challenges that female physicians face in their careers will strengthen our group, and ultimately independent gastroenterology overall.

Dr. Adams is a practicing gastroenterologist and partner at Gastro Health Fairfax in Virginia and serves on the Digestive Health Physicians Association’s Diversity, Equity, and Inclusion Committee. Dr. Adams has no conflicts to declare.

Gastroenterology

August 2022
Johnson-Laghi KA, Mattar MC. Integrating cognitive apprenticeship into gastroenterology clinical training. Gastroenterology. 2022 Aug;163(2):364-7. doi: 10.1053/j.gastro.2022.06.013.

Wood LD et al. Pancreatic cancer: Pathogenesis, screening, diagnosis, and treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056.

Calderwood AH and Robertson DJ. Stopping surveillance in gastrointestinal conditions: Thoughts on the scope of the problem and potential solutions. Gastroenterology. 2022 Aug;163(2):345-9. doi: 10.1053/j.gastro.2022.04.009.
 

September 2022
Donnangelo LL et al. Disclosure and reflection after an adverse event: Tips for training and practice. Gastroenterology. 2022 Sep;163(3):568-71. doi: 10.1053/j.gastro.2022.07.003.

Chey WD et al. Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe: Randomized clinical trial. Gastroenterology. 2022 Sep;163(3):608-19. doi: 10.1053/j.gastro.2022.05.055.

Bushyhead D and Quigley EMM. Small intestinal bacterial overgrowth-pathophysiology and its implications for definition and management. Gastroenterology. 2022 Sep;163(3):593-607. doi: 10.1053/j.gastro.2022.04.002.

Long MT et al. AGA Clinical practice update: Diagnosis and management of nonalcoholic fatty liver disease in lean individuals: Expert review. Gastroenterology. 2022 Sep;163(3):764-74.e1. doi: 10.1053/j.gastro.2022.06.023.
 

CGH

August 2022
Lennon AM and Vege SS. Pancreatic cyst surveillance. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1663-7.e1. doi: 10.1016/j.cgh.2022.03.002.

Crockett SD et al. Large Polyp Study Group Consortium. Clip closure does not reduce risk of bleeding after resection of large serrated polyps: Results from a randomized trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-17--65.e4. doi: 10.1016/j.cgh.2021.12.036.

Martin P et al. Treatment algorithm for managing chronic hepatitis b virus infection in the United States: 2021 update. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1766-75. doi: 10.1016/j.cgh.2021.07.036.
 

September 2022
Pawlak KM et al. How to train the next generation to provide high-quality peer-reviews. Clin Gastroenterol Hepatol. 2022 Sep;20(9):1902-6. doi: 10.1016/j.cgh.2022.05.018.

Choung RS et al. Collagenous gastritis: Characteristics and response to topical budesonide. Clin Gastroenterol Hepatol. 2022 Sep;20(9):1977-85.e1. doi: 10.1016/j.cgh.2021.11.033.

Basnayake C et al. Long-term outcome of multidisciplinary versus standard gastroenterologist care for functional gastrointestinal disorders: A randomized trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-11.e9. doi: 10.1016/j.cgh.2021.12.005.

Deutsch-Link S et al. Alcohol-associated liver disease mortality increased from 2017 to 2020 and accelerated during the COVID-19 pandemic. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2142-4.e2. doi: 10.1016/j.cgh.2022.03.017.
 

TIGE

Nakamatsu, Dai et al. Safety of cold snare polypectomy for small colorectal polyps in patients receiving antithrombotic therapy. Tech Innov Gastrointest Endosc. 2022 Apr 8;24[3]:246-53. doi: 10.1016/j.tige.2022.03.008.

Gastro Hep Advances

Brindusa Truta et al. Outcomes of continuation vs. discontinuation of adalimumab therapy during third trimester of pregnancy in inflammatory bowel disease. Gastro Hep Advances. 2022 Jan 1;1[5]:785-91. doi: 10.1016/j.gastha.2022.04.009.

Gastroenterology

August 2022
Johnson-Laghi KA, Mattar MC. Integrating cognitive apprenticeship into gastroenterology clinical training. Gastroenterology. 2022 Aug;163(2):364-7. doi: 10.1053/j.gastro.2022.06.013.

Wood LD et al. Pancreatic cancer: Pathogenesis, screening, diagnosis, and treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056.

Calderwood AH and Robertson DJ. Stopping surveillance in gastrointestinal conditions: Thoughts on the scope of the problem and potential solutions. Gastroenterology. 2022 Aug;163(2):345-9. doi: 10.1053/j.gastro.2022.04.009.
 

September 2022
Donnangelo LL et al. Disclosure and reflection after an adverse event: Tips for training and practice. Gastroenterology. 2022 Sep;163(3):568-71. doi: 10.1053/j.gastro.2022.07.003.

Chey WD et al. Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe: Randomized clinical trial. Gastroenterology. 2022 Sep;163(3):608-19. doi: 10.1053/j.gastro.2022.05.055.

Bushyhead D and Quigley EMM. Small intestinal bacterial overgrowth-pathophysiology and its implications for definition and management. Gastroenterology. 2022 Sep;163(3):593-607. doi: 10.1053/j.gastro.2022.04.002.

Long MT et al. AGA Clinical practice update: Diagnosis and management of nonalcoholic fatty liver disease in lean individuals: Expert review. Gastroenterology. 2022 Sep;163(3):764-74.e1. doi: 10.1053/j.gastro.2022.06.023.
 

CGH

August 2022
Lennon AM and Vege SS. Pancreatic cyst surveillance. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1663-7.e1. doi: 10.1016/j.cgh.2022.03.002.

Crockett SD et al. Large Polyp Study Group Consortium. Clip closure does not reduce risk of bleeding after resection of large serrated polyps: Results from a randomized trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-17--65.e4. doi: 10.1016/j.cgh.2021.12.036.

Martin P et al. Treatment algorithm for managing chronic hepatitis b virus infection in the United States: 2021 update. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1766-75. doi: 10.1016/j.cgh.2021.07.036.
 

September 2022
Pawlak KM et al. How to train the next generation to provide high-quality peer-reviews. Clin Gastroenterol Hepatol. 2022 Sep;20(9):1902-6. doi: 10.1016/j.cgh.2022.05.018.

Choung RS et al. Collagenous gastritis: Characteristics and response to topical budesonide. Clin Gastroenterol Hepatol. 2022 Sep;20(9):1977-85.e1. doi: 10.1016/j.cgh.2021.11.033.

Basnayake C et al. Long-term outcome of multidisciplinary versus standard gastroenterologist care for functional gastrointestinal disorders: A randomized trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-11.e9. doi: 10.1016/j.cgh.2021.12.005.

Deutsch-Link S et al. Alcohol-associated liver disease mortality increased from 2017 to 2020 and accelerated during the COVID-19 pandemic. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2142-4.e2. doi: 10.1016/j.cgh.2022.03.017.
 

TIGE

Nakamatsu, Dai et al. Safety of cold snare polypectomy for small colorectal polyps in patients receiving antithrombotic therapy. Tech Innov Gastrointest Endosc. 2022 Apr 8;24[3]:246-53. doi: 10.1016/j.tige.2022.03.008.

Gastro Hep Advances

Brindusa Truta et al. Outcomes of continuation vs. discontinuation of adalimumab therapy during third trimester of pregnancy in inflammatory bowel disease. Gastro Hep Advances. 2022 Jan 1;1[5]:785-91. doi: 10.1016/j.gastha.2022.04.009.

Gastroenterology

August 2022
Johnson-Laghi KA, Mattar MC. Integrating cognitive apprenticeship into gastroenterology clinical training. Gastroenterology. 2022 Aug;163(2):364-7. doi: 10.1053/j.gastro.2022.06.013.

Wood LD et al. Pancreatic cancer: Pathogenesis, screening, diagnosis, and treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056.

Calderwood AH and Robertson DJ. Stopping surveillance in gastrointestinal conditions: Thoughts on the scope of the problem and potential solutions. Gastroenterology. 2022 Aug;163(2):345-9. doi: 10.1053/j.gastro.2022.04.009.
 

September 2022
Donnangelo LL et al. Disclosure and reflection after an adverse event: Tips for training and practice. Gastroenterology. 2022 Sep;163(3):568-71. doi: 10.1053/j.gastro.2022.07.003.

Chey WD et al. Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe: Randomized clinical trial. Gastroenterology. 2022 Sep;163(3):608-19. doi: 10.1053/j.gastro.2022.05.055.

Bushyhead D and Quigley EMM. Small intestinal bacterial overgrowth-pathophysiology and its implications for definition and management. Gastroenterology. 2022 Sep;163(3):593-607. doi: 10.1053/j.gastro.2022.04.002.

Long MT et al. AGA Clinical practice update: Diagnosis and management of nonalcoholic fatty liver disease in lean individuals: Expert review. Gastroenterology. 2022 Sep;163(3):764-74.e1. doi: 10.1053/j.gastro.2022.06.023.
 

CGH

August 2022
Lennon AM and Vege SS. Pancreatic cyst surveillance. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1663-7.e1. doi: 10.1016/j.cgh.2022.03.002.

Crockett SD et al. Large Polyp Study Group Consortium. Clip closure does not reduce risk of bleeding after resection of large serrated polyps: Results from a randomized trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-17--65.e4. doi: 10.1016/j.cgh.2021.12.036.

Martin P et al. Treatment algorithm for managing chronic hepatitis b virus infection in the United States: 2021 update. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1766-75. doi: 10.1016/j.cgh.2021.07.036.
 

September 2022
Pawlak KM et al. How to train the next generation to provide high-quality peer-reviews. Clin Gastroenterol Hepatol. 2022 Sep;20(9):1902-6. doi: 10.1016/j.cgh.2022.05.018.

Choung RS et al. Collagenous gastritis: Characteristics and response to topical budesonide. Clin Gastroenterol Hepatol. 2022 Sep;20(9):1977-85.e1. doi: 10.1016/j.cgh.2021.11.033.

Basnayake C et al. Long-term outcome of multidisciplinary versus standard gastroenterologist care for functional gastrointestinal disorders: A randomized trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-11.e9. doi: 10.1016/j.cgh.2021.12.005.

Deutsch-Link S et al. Alcohol-associated liver disease mortality increased from 2017 to 2020 and accelerated during the COVID-19 pandemic. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2142-4.e2. doi: 10.1016/j.cgh.2022.03.017.
 

TIGE

Nakamatsu, Dai et al. Safety of cold snare polypectomy for small colorectal polyps in patients receiving antithrombotic therapy. Tech Innov Gastrointest Endosc. 2022 Apr 8;24[3]:246-53. doi: 10.1016/j.tige.2022.03.008.

Gastro Hep Advances

Brindusa Truta et al. Outcomes of continuation vs. discontinuation of adalimumab therapy during third trimester of pregnancy in inflammatory bowel disease. Gastro Hep Advances. 2022 Jan 1;1[5]:785-91. doi: 10.1016/j.gastha.2022.04.009.

Obesity currently affects more than 40% of the U.S. population. It is the second-leading preventable cause of mortality behind smoking with an estimated 300,000 deaths per year.^1,2 Weight loss can reduce the risk of metabolic comorbidities such as diabetes, heart disease, and stroke. However, 5%-10% total body weight loss (TBWL) is required for risk reduction.³ Sustained weight loss involves dietary alterations and physical activity, although it is difficult to maintain long term with lifestyle changes alone. Less than 10% of Americans with a BMI greater than 30 kg/m² will achieve 5% TBWL each year, and nearly 80% of people will regain the weight within 5 years, a phenomenon known as “weight cycling.”^4,5 Not only can these weight fluctuations make future weight-loss efforts more difficult, but they can also negatively impact cardiometabolic health in the long term.⁵ Thus, additional therapies are typically needed in conjunction with lifestyle interventions to treat obesity.

Current guidelines recommend bariatric surgery for patients unable to achieve or maintain weight loss through lifestyle changes.⁶ Surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy lead to improvements in morbidity and mortality from metabolic diseases but are often only approved for select patients with a BMI of at least 40 or at least 35 with obesity-related comorbidities.⁷ These restrictions exclude patients at lower BMIs who may have early metabolic disease. Furthermore, only a small proportion of eligible patients are referred or willing to undergo surgery because of access issues, socioeconomic barriers, and concerns about adverse events.^8,9 Endoscopic bariatric therapy and antiobesity medications (AOMs) have blossomed because of the need for other less-invasive options to stimulate weight loss.
 

Minimally invasive and noninvasive therapies in obesity

Endoscopic bariatric and metabolic therapies

Endoscopic bariatric and metabolic therapies (EBMTs) are used for the treatment of obesity in patients with a BMI of 30 kg/m², a cohort that may be ineligible for bariatric surgery.^10,11 EBMTs involve three categories: space-occupying devices (intragastric balloons [IGBs], transpyloric shuttle [TPS]), aspiration therapy, and gastric remodeling (endoscopic sleeve gastroplasty [ESG]).^21,13 Presently, TPS and aspiration therapy are not commercially available in the United States. There are three types of IGB approved by the Food and Drug Administration, and Apollo ESGTM recently received de novo marketing authorization for the treatment of obesity. TBWL with EBMTs is promising at 12 months post procedure. Ranges include 7%-12% TBWL for IGBs and 15%-19% for ESG, with low rates of serious adverse events (AEs).^13-18 Weight loss often reaches or exceeds the 10% TBWL needed to improve or completely reverse metabolic complications.

Obesity pharmacotherapy

Multiple professional societies support the use of obesity pharmacotherapy as an effective adjunct to lifestyle interventions.¹⁹ AOMs are classified as peripherally-acting to prevent nutrition absorption (e.g. orlistat), centrally acting to suppress appetite and/or cravings (e.g., phentermine/topiramate or naltrexone/bupropion), or incretin mimetics such as glucagonlike peptide–1 agonists (e.g., liraglutide, semaglutide).²⁰ With the exception of orlistat, most agents have some effects on the hypothalamus to suppress appetite.²¹ Obesity medications tend to lead to a minimum weight loss of 3-10 kg after 12 months of treatment, and newer medications have even greater efficacy.²² Despite these results, discontinuation rates of the popular GLP-1 agonists can be as high as 47.7% and 70.1% at 12 and 24 months, respectively, because of the high cost of medications, gastrointestinal side effects, and poor tolerance.^23,24

An ongoing challenge for patients is maintaining weight loss following cessation of pharmacotherapy when weight loss goals have been achieved. In this context, the combination of obesity pharmacotherapy and EBMTs can be utilized for long-term weight loss and weight maintenance given the chronic, relapsing, and complex nature of obesity.²⁵

Advantages of less-invasive therapies in obesity management

The advantages of both pharmacologic and endoscopic weight-loss therapies are numerous. Pharmacotherapies are noninvasive, and their multiple mechanisms allow for combined use to synergistically promote weight reduction.^26,27 Medications can be used in both the short- and long-term management of obesity, allowing for flexibility in use for patients pending fluctuations in weight. Furthermore, medications can improve markers of cardiovascular health including total cholesterol, LDL cholesterol, blood pressure, and glycemic control.²⁸

As minimally invasive therapies, EBMTs have less morbidity and mortality, compared with bariatric surgeries.²⁹ The most common side effects of IGBs or ESG include abdominal pain, nausea, and worsening of acid reflux symptoms, which can be medically managed unlike some of the AEs associated with surgery, such as bowel obstruction, anastomotic dehiscence, fistulization, and postoperative infections.³⁰ Long-term AEs from surgery also include malabsorption, nutritional deficiencies, cholelithiasis, and anastomotic stenosis.³¹ Even with improvement in surgical techniques, the rate of perioperative and postoperative mortality in Roux-en-Y gastric bypass is estimated to be 0.4% and 0.7%, respectively, compared with only 0.08% with IGBs.^30,32

In addition, EBMTs are also more cost effective than surgery, as they are often same-day outpatient procedures, leading to decreased length of stay (LOS) for patients. In ongoing research conducted by Sharaiha and colleagues, it was found that patients undergoing ESG had an average LOS of only 0.13 days, compared with 3.09 days for laparoscopic sleeve gastrectomy and 1.68 for laparoscopic gastric banding. The cost for ESG was approximately $12,000, compared with $15,000-$22,000 for laparoscopic bariatric surgeries.³³ With their availability to patients with lower BMIs and their less-invasive nature, EBMTs and pharmacotherapy can be utilized on the spectrum of obesity care as bridge therapies both before and after surgery.

Our clinical approach

In 2015, the first Veterans Affairs hospital-based endoscopic bariatric program was established at the VA New York Harbor Healthcare System utilizing IGBs and weight loss pharmacotherapy in conjunction with the VA MOVE! Program to treat obesity and metabolic comorbidities in veterans. Since then, EBMTs have expanded to include ESG and novel medications. Our treatment algorithm accounts for the chronic nature of obesity, the risk of weight regain after any intervention, and the need for longitudinal patient care.

Patients undergo work-up by a multidisciplinary team (MD team) with a nutritionist, psychologist, primary care physician, gastroenterologist, and endocrinologist to determine the optimal treatment plan (Fig. 1).²⁹

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Patients are required to attend multiple information sessions, where all weight-loss methods are presented, including surgery, bariatric endoscopy, and pharmacotherapy. Other specialists also help manage comorbid conditions. Prior to selecting an initial intervention, patients undergo intensive lifestyle and behavioral therapy (Fig. 2 and 3). Depending on the selected therapy, initial treatment lasts between 3 and 12 months with ongoing support from the MD team.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

If patients do not achieve their targeted weight loss after initial treatment, a new strategy is selected. This includes a different EBMT such as ESG, alternate pharmacotherapy, or surgery until the weight and health goals of the patient are achieved and sustained (Fig. 3). From the start, patients are informed that our program is a long-term intervention and that active participation in the MOVE! Program, as well as follow-up with the MD team are keys to success. EBMTs and medications are presented as effective tools that only work to enhance the effects of lifestyle changes.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Our multidisciplinary approach provides flexibility for patients to trial different options depending on their progress. Research on long-term outcomes with weight loss and metabolic parameters is ongoing, though early results are promising. Thus far, we have observed that patients undergoing a combination therapy of EBMTs and AOMs have greater weight loss than patients on a single therapeutic approach with either EBMT or AOMs alone.³⁴ Racial and socioeconomic disparities in referrals to bariatric surgery are yet another barrier for patients to access weight reduction and improvement in cardiovascular health.³⁵ EBMTs and pharmacotherapy are no longer just on the horizon; they are here as accessible, effective, and long-term treatments for all patients with obesity. More expansive insurance coverage is needed for EBMTs and AOMs in order to prevent progression of obesity-related comorbidities, reduce high costs, and ensure more equitable access to these effective therapies.
 

Dr. Young and Dr. Zenger are resident physicians in the department of internal medicine at New York University. Dr. Holzwanger is an advanced endoscopy fellow in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. Dr. Popov is director of bariatric endoscopy at VA New York Harbor Healthcare System, and assistant professor of medicine at New York University. Dr. Popov reported relationships with Obalon, Microtech, and Spatz, but the remaining authors reported no competing interests.

References

1. Ward ZJ et al. N Engl J Med. 2019;381(25):2440-50.

2. Stein CJ and Colditz GA. J Clin Endocrinol Metab. 2004;89(6):2522-5.

3. Ryan DH and Yockey SR. Curr Obes Rep. 2017;6(2):187-94.

4. Fildes A et al. Am J Public Health. 2015;105(9):e54-9.

5. Rhee E-J. J Obes Metab Syndr. 2017;26(4):237-42.

6. American College of Cardiology/American Heart Association Task Force on Practice Guidelines OEP. Obesity (Silver Spring). 2014;22 Suppl 2:S5-39.

7. Adams TD et al. N Engl J Med. 2018;378(1):93-6.

8. Wharton S et al. Clin Obes. 2016;6(2):154-60.

9. Iuzzolino E and Kim Y. Obes Res Clin Pract. 2020;14(4):310-20.

10. Goyal D, Watson RR. Endoscopic Bariatric Therapies. Curr Gastroenterol Rep. 2016;18(6):26.

11. Ali MR et al. Surg Obes Relat Dis. 2016;12(3):462-467.

12. Turkeltaub JA, Edmundowicz SA. Curr Treat Options Gastroenterol. 2019;17(2):187-201.
 

13. Reja D et al. Transl Gastroenterol Hepatol. 2022;7:21.

14. Force ABET et al. Gastrointest Endosc. 2015;82(3):425-38e5.

15. Thompson CC et al. Am J Gastroenterol. 2017;112(3):447-57.

16. Nystrom M et al. Obes Surg. 2018;28(7):1860-8.

17. Abu Dayyeh BK et al. Surg Obes Relat Dis. 2019;15(8):1423-4.

18. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2017;15(4):504-10.

19. Apovian CM et al. J Clin Endocrinol Metab. 2015;100(2):342-62.

20. Son JW and Kim S. Diabetes Metab J. 2020;44(6):802-18.

21. Holst JJ. Int J Obes (Lond). Int J Obes (Lond). 2013;37(9):1161-8.

22. Joo JK and Lee KS. J Menopausal Med. 2014;20(3):90-6.

23. Weiss T et al. Patient Prefer Adherence. 2020;14:2337-45.

24. Sikirica MV et al. Diabetes Metab Syndr Obes. 2017;10:403-12.

25. Kahan S et al. Tech Innov Gastrointest Endosc. 2020;22(3):154-8.

26. Bhat SP and Sharma A. Curr Drug Targets. 2017;18(8):983-93.

27. Pendse J et al. Obesity (Silver Spring). 2021;29(2):308-16.

28. Rucker D et al. BMJ. 2007;335(7631):1194-9.

29. Jirapinyo P and Thompson CC. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

30. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81(5):1073-86.

31. Schulman AR and Thompson CC. Am J Gastroenterol. 2017;112(11):1640-55.

32. Ma IT and Madura JA, 2nd. Gastroenterol Hepatol (NY). 2015;11(8):526-35.

33. Sharaiha RZ. Endoscopic sleeve gastroplasty as a nonsurgical weight loss alternative. Digestive Disease Week, oral presentation. 2017.

34. Young S et al. Long-term efficacy of a multidisciplinary minimally invasive approach to weight management compared to single endoscopic therapy: A cohort study. P0865. American College of Gastroenterology Meeting, Abstract P0865. 2021.

35. Johnson-Mann C et al. Surg Obes Relat Dis. 2019;15(4):615-20.
 

Obesity currently affects more than 40% of the U.S. population. It is the second-leading preventable cause of mortality behind smoking with an estimated 300,000 deaths per year.^1,2 Weight loss can reduce the risk of metabolic comorbidities such as diabetes, heart disease, and stroke. However, 5%-10% total body weight loss (TBWL) is required for risk reduction.³ Sustained weight loss involves dietary alterations and physical activity, although it is difficult to maintain long term with lifestyle changes alone. Less than 10% of Americans with a BMI greater than 30 kg/m² will achieve 5% TBWL each year, and nearly 80% of people will regain the weight within 5 years, a phenomenon known as “weight cycling.”^4,5 Not only can these weight fluctuations make future weight-loss efforts more difficult, but they can also negatively impact cardiometabolic health in the long term.⁵ Thus, additional therapies are typically needed in conjunction with lifestyle interventions to treat obesity.

Current guidelines recommend bariatric surgery for patients unable to achieve or maintain weight loss through lifestyle changes.⁶ Surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy lead to improvements in morbidity and mortality from metabolic diseases but are often only approved for select patients with a BMI of at least 40 or at least 35 with obesity-related comorbidities.⁷ These restrictions exclude patients at lower BMIs who may have early metabolic disease. Furthermore, only a small proportion of eligible patients are referred or willing to undergo surgery because of access issues, socioeconomic barriers, and concerns about adverse events.^8,9 Endoscopic bariatric therapy and antiobesity medications (AOMs) have blossomed because of the need for other less-invasive options to stimulate weight loss.
 

Minimally invasive and noninvasive therapies in obesity

Endoscopic bariatric and metabolic therapies

Endoscopic bariatric and metabolic therapies (EBMTs) are used for the treatment of obesity in patients with a BMI of 30 kg/m², a cohort that may be ineligible for bariatric surgery.^10,11 EBMTs involve three categories: space-occupying devices (intragastric balloons [IGBs], transpyloric shuttle [TPS]), aspiration therapy, and gastric remodeling (endoscopic sleeve gastroplasty [ESG]).^21,13 Presently, TPS and aspiration therapy are not commercially available in the United States. There are three types of IGB approved by the Food and Drug Administration, and Apollo ESGTM recently received de novo marketing authorization for the treatment of obesity. TBWL with EBMTs is promising at 12 months post procedure. Ranges include 7%-12% TBWL for IGBs and 15%-19% for ESG, with low rates of serious adverse events (AEs).^13-18 Weight loss often reaches or exceeds the 10% TBWL needed to improve or completely reverse metabolic complications.

Obesity pharmacotherapy

Multiple professional societies support the use of obesity pharmacotherapy as an effective adjunct to lifestyle interventions.¹⁹ AOMs are classified as peripherally-acting to prevent nutrition absorption (e.g. orlistat), centrally acting to suppress appetite and/or cravings (e.g., phentermine/topiramate or naltrexone/bupropion), or incretin mimetics such as glucagonlike peptide–1 agonists (e.g., liraglutide, semaglutide).²⁰ With the exception of orlistat, most agents have some effects on the hypothalamus to suppress appetite.²¹ Obesity medications tend to lead to a minimum weight loss of 3-10 kg after 12 months of treatment, and newer medications have even greater efficacy.²² Despite these results, discontinuation rates of the popular GLP-1 agonists can be as high as 47.7% and 70.1% at 12 and 24 months, respectively, because of the high cost of medications, gastrointestinal side effects, and poor tolerance.^23,24

An ongoing challenge for patients is maintaining weight loss following cessation of pharmacotherapy when weight loss goals have been achieved. In this context, the combination of obesity pharmacotherapy and EBMTs can be utilized for long-term weight loss and weight maintenance given the chronic, relapsing, and complex nature of obesity.²⁵

Advantages of less-invasive therapies in obesity management

The advantages of both pharmacologic and endoscopic weight-loss therapies are numerous. Pharmacotherapies are noninvasive, and their multiple mechanisms allow for combined use to synergistically promote weight reduction.^26,27 Medications can be used in both the short- and long-term management of obesity, allowing for flexibility in use for patients pending fluctuations in weight. Furthermore, medications can improve markers of cardiovascular health including total cholesterol, LDL cholesterol, blood pressure, and glycemic control.²⁸

As minimally invasive therapies, EBMTs have less morbidity and mortality, compared with bariatric surgeries.²⁹ The most common side effects of IGBs or ESG include abdominal pain, nausea, and worsening of acid reflux symptoms, which can be medically managed unlike some of the AEs associated with surgery, such as bowel obstruction, anastomotic dehiscence, fistulization, and postoperative infections.³⁰ Long-term AEs from surgery also include malabsorption, nutritional deficiencies, cholelithiasis, and anastomotic stenosis.³¹ Even with improvement in surgical techniques, the rate of perioperative and postoperative mortality in Roux-en-Y gastric bypass is estimated to be 0.4% and 0.7%, respectively, compared with only 0.08% with IGBs.^30,32

In addition, EBMTs are also more cost effective than surgery, as they are often same-day outpatient procedures, leading to decreased length of stay (LOS) for patients. In ongoing research conducted by Sharaiha and colleagues, it was found that patients undergoing ESG had an average LOS of only 0.13 days, compared with 3.09 days for laparoscopic sleeve gastrectomy and 1.68 for laparoscopic gastric banding. The cost for ESG was approximately $12,000, compared with $15,000-$22,000 for laparoscopic bariatric surgeries.³³ With their availability to patients with lower BMIs and their less-invasive nature, EBMTs and pharmacotherapy can be utilized on the spectrum of obesity care as bridge therapies both before and after surgery.

Our clinical approach

In 2015, the first Veterans Affairs hospital-based endoscopic bariatric program was established at the VA New York Harbor Healthcare System utilizing IGBs and weight loss pharmacotherapy in conjunction with the VA MOVE! Program to treat obesity and metabolic comorbidities in veterans. Since then, EBMTs have expanded to include ESG and novel medications. Our treatment algorithm accounts for the chronic nature of obesity, the risk of weight regain after any intervention, and the need for longitudinal patient care.

Patients undergo work-up by a multidisciplinary team (MD team) with a nutritionist, psychologist, primary care physician, gastroenterologist, and endocrinologist to determine the optimal treatment plan (Fig. 1).²⁹

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Patients are required to attend multiple information sessions, where all weight-loss methods are presented, including surgery, bariatric endoscopy, and pharmacotherapy. Other specialists also help manage comorbid conditions. Prior to selecting an initial intervention, patients undergo intensive lifestyle and behavioral therapy (Fig. 2 and 3). Depending on the selected therapy, initial treatment lasts between 3 and 12 months with ongoing support from the MD team.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

If patients do not achieve their targeted weight loss after initial treatment, a new strategy is selected. This includes a different EBMT such as ESG, alternate pharmacotherapy, or surgery until the weight and health goals of the patient are achieved and sustained (Fig. 3). From the start, patients are informed that our program is a long-term intervention and that active participation in the MOVE! Program, as well as follow-up with the MD team are keys to success. EBMTs and medications are presented as effective tools that only work to enhance the effects of lifestyle changes.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Our multidisciplinary approach provides flexibility for patients to trial different options depending on their progress. Research on long-term outcomes with weight loss and metabolic parameters is ongoing, though early results are promising. Thus far, we have observed that patients undergoing a combination therapy of EBMTs and AOMs have greater weight loss than patients on a single therapeutic approach with either EBMT or AOMs alone.³⁴ Racial and socioeconomic disparities in referrals to bariatric surgery are yet another barrier for patients to access weight reduction and improvement in cardiovascular health.³⁵ EBMTs and pharmacotherapy are no longer just on the horizon; they are here as accessible, effective, and long-term treatments for all patients with obesity. More expansive insurance coverage is needed for EBMTs and AOMs in order to prevent progression of obesity-related comorbidities, reduce high costs, and ensure more equitable access to these effective therapies.
 

Dr. Young and Dr. Zenger are resident physicians in the department of internal medicine at New York University. Dr. Holzwanger is an advanced endoscopy fellow in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. Dr. Popov is director of bariatric endoscopy at VA New York Harbor Healthcare System, and assistant professor of medicine at New York University. Dr. Popov reported relationships with Obalon, Microtech, and Spatz, but the remaining authors reported no competing interests.

References

1. Ward ZJ et al. N Engl J Med. 2019;381(25):2440-50.

2. Stein CJ and Colditz GA. J Clin Endocrinol Metab. 2004;89(6):2522-5.

3. Ryan DH and Yockey SR. Curr Obes Rep. 2017;6(2):187-94.

4. Fildes A et al. Am J Public Health. 2015;105(9):e54-9.

5. Rhee E-J. J Obes Metab Syndr. 2017;26(4):237-42.

6. American College of Cardiology/American Heart Association Task Force on Practice Guidelines OEP. Obesity (Silver Spring). 2014;22 Suppl 2:S5-39.

7. Adams TD et al. N Engl J Med. 2018;378(1):93-6.

8. Wharton S et al. Clin Obes. 2016;6(2):154-60.

9. Iuzzolino E and Kim Y. Obes Res Clin Pract. 2020;14(4):310-20.

10. Goyal D, Watson RR. Endoscopic Bariatric Therapies. Curr Gastroenterol Rep. 2016;18(6):26.

11. Ali MR et al. Surg Obes Relat Dis. 2016;12(3):462-467.

12. Turkeltaub JA, Edmundowicz SA. Curr Treat Options Gastroenterol. 2019;17(2):187-201.
 

13. Reja D et al. Transl Gastroenterol Hepatol. 2022;7:21.

14. Force ABET et al. Gastrointest Endosc. 2015;82(3):425-38e5.

15. Thompson CC et al. Am J Gastroenterol. 2017;112(3):447-57.

16. Nystrom M et al. Obes Surg. 2018;28(7):1860-8.

17. Abu Dayyeh BK et al. Surg Obes Relat Dis. 2019;15(8):1423-4.

18. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2017;15(4):504-10.

19. Apovian CM et al. J Clin Endocrinol Metab. 2015;100(2):342-62.

20. Son JW and Kim S. Diabetes Metab J. 2020;44(6):802-18.

21. Holst JJ. Int J Obes (Lond). Int J Obes (Lond). 2013;37(9):1161-8.

22. Joo JK and Lee KS. J Menopausal Med. 2014;20(3):90-6.

23. Weiss T et al. Patient Prefer Adherence. 2020;14:2337-45.

24. Sikirica MV et al. Diabetes Metab Syndr Obes. 2017;10:403-12.

25. Kahan S et al. Tech Innov Gastrointest Endosc. 2020;22(3):154-8.

26. Bhat SP and Sharma A. Curr Drug Targets. 2017;18(8):983-93.

27. Pendse J et al. Obesity (Silver Spring). 2021;29(2):308-16.

28. Rucker D et al. BMJ. 2007;335(7631):1194-9.

29. Jirapinyo P and Thompson CC. Clin Gastroenterol Hepatol. 2017;15(5):619-30.

30. Abu Dayyeh BK et al. Gastrointest Endosc. 2015;81(5):1073-86.

31. Schulman AR and Thompson CC. Am J Gastroenterol. 2017;112(11):1640-55.

32. Ma IT and Madura JA, 2nd. Gastroenterol Hepatol (NY). 2015;11(8):526-35.

33. Sharaiha RZ. Endoscopic sleeve gastroplasty as a nonsurgical weight loss alternative. Digestive Disease Week, oral presentation. 2017.

34. Young S et al. Long-term efficacy of a multidisciplinary minimally invasive approach to weight management compared to single endoscopic therapy: A cohort study. P0865. American College of Gastroenterology Meeting, Abstract P0865. 2021.

35. Johnson-Mann C et al. Surg Obes Relat Dis. 2019;15(4):615-20.
 

Obesity currently affects more than 40% of the U.S. population. It is the second-leading preventable cause of mortality behind smoking with an estimated 300,000 deaths per year.^1,2 Weight loss can reduce the risk of metabolic comorbidities such as diabetes, heart disease, and stroke. However, 5%-10% total body weight loss (TBWL) is required for risk reduction.³ Sustained weight loss involves dietary alterations and physical activity, although it is difficult to maintain long term with lifestyle changes alone. Less than 10% of Americans with a BMI greater than 30 kg/m² will achieve 5% TBWL each year, and nearly 80% of people will regain the weight within 5 years, a phenomenon known as “weight cycling.”^4,5 Not only can these weight fluctuations make future weight-loss efforts more difficult, but they can also negatively impact cardiometabolic health in the long term.⁵ Thus, additional therapies are typically needed in conjunction with lifestyle interventions to treat obesity.

Current guidelines recommend bariatric surgery for patients unable to achieve or maintain weight loss through lifestyle changes.⁶ Surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy lead to improvements in morbidity and mortality from metabolic diseases but are often only approved for select patients with a BMI of at least 40 or at least 35 with obesity-related comorbidities.⁷ These restrictions exclude patients at lower BMIs who may have early metabolic disease. Furthermore, only a small proportion of eligible patients are referred or willing to undergo surgery because of access issues, socioeconomic barriers, and concerns about adverse events.^8,9 Endoscopic bariatric therapy and antiobesity medications (AOMs) have blossomed because of the need for other less-invasive options to stimulate weight loss.
 

Minimally invasive and noninvasive therapies in obesity

Endoscopic bariatric and metabolic therapies

Endoscopic bariatric and metabolic therapies (EBMTs) are used for the treatment of obesity in patients with a BMI of 30 kg/m², a cohort that may be ineligible for bariatric surgery.^10,11 EBMTs involve three categories: space-occupying devices (intragastric balloons [IGBs], transpyloric shuttle [TPS]), aspiration therapy, and gastric remodeling (endoscopic sleeve gastroplasty [ESG]).^21,13 Presently, TPS and aspiration therapy are not commercially available in the United States. There are three types of IGB approved by the Food and Drug Administration, and Apollo ESGTM recently received de novo marketing authorization for the treatment of obesity. TBWL with EBMTs is promising at 12 months post procedure. Ranges include 7%-12% TBWL for IGBs and 15%-19% for ESG, with low rates of serious adverse events (AEs).^13-18 Weight loss often reaches or exceeds the 10% TBWL needed to improve or completely reverse metabolic complications.

Obesity pharmacotherapy

Multiple professional societies support the use of obesity pharmacotherapy as an effective adjunct to lifestyle interventions.¹⁹ AOMs are classified as peripherally-acting to prevent nutrition absorption (e.g. orlistat), centrally acting to suppress appetite and/or cravings (e.g., phentermine/topiramate or naltrexone/bupropion), or incretin mimetics such as glucagonlike peptide–1 agonists (e.g., liraglutide, semaglutide).²⁰ With the exception of orlistat, most agents have some effects on the hypothalamus to suppress appetite.²¹ Obesity medications tend to lead to a minimum weight loss of 3-10 kg after 12 months of treatment, and newer medications have even greater efficacy.²² Despite these results, discontinuation rates of the popular GLP-1 agonists can be as high as 47.7% and 70.1% at 12 and 24 months, respectively, because of the high cost of medications, gastrointestinal side effects, and poor tolerance.^23,24

An ongoing challenge for patients is maintaining weight loss following cessation of pharmacotherapy when weight loss goals have been achieved. In this context, the combination of obesity pharmacotherapy and EBMTs can be utilized for long-term weight loss and weight maintenance given the chronic, relapsing, and complex nature of obesity.²⁵

Advantages of less-invasive therapies in obesity management

The advantages of both pharmacologic and endoscopic weight-loss therapies are numerous. Pharmacotherapies are noninvasive, and their multiple mechanisms allow for combined use to synergistically promote weight reduction.^26,27 Medications can be used in both the short- and long-term management of obesity, allowing for flexibility in use for patients pending fluctuations in weight. Furthermore, medications can improve markers of cardiovascular health including total cholesterol, LDL cholesterol, blood pressure, and glycemic control.²⁸

As minimally invasive therapies, EBMTs have less morbidity and mortality, compared with bariatric surgeries.²⁹ The most common side effects of IGBs or ESG include abdominal pain, nausea, and worsening of acid reflux symptoms, which can be medically managed unlike some of the AEs associated with surgery, such as bowel obstruction, anastomotic dehiscence, fistulization, and postoperative infections.³⁰ Long-term AEs from surgery also include malabsorption, nutritional deficiencies, cholelithiasis, and anastomotic stenosis.³¹ Even with improvement in surgical techniques, the rate of perioperative and postoperative mortality in Roux-en-Y gastric bypass is estimated to be 0.4% and 0.7%, respectively, compared with only 0.08% with IGBs.^30,32

In addition, EBMTs are also more cost effective than surgery, as they are often same-day outpatient procedures, leading to decreased length of stay (LOS) for patients. In ongoing research conducted by Sharaiha and colleagues, it was found that patients undergoing ESG had an average LOS of only 0.13 days, compared with 3.09 days for laparoscopic sleeve gastrectomy and 1.68 for laparoscopic gastric banding. The cost for ESG was approximately $12,000, compared with $15,000-$22,000 for laparoscopic bariatric surgeries.³³ With their availability to patients with lower BMIs and their less-invasive nature, EBMTs and pharmacotherapy can be utilized on the spectrum of obesity care as bridge therapies both before and after surgery.

Our clinical approach

In 2015, the first Veterans Affairs hospital-based endoscopic bariatric program was established at the VA New York Harbor Healthcare System utilizing IGBs and weight loss pharmacotherapy in conjunction with the VA MOVE! Program to treat obesity and metabolic comorbidities in veterans. Since then, EBMTs have expanded to include ESG and novel medications. Our treatment algorithm accounts for the chronic nature of obesity, the risk of weight regain after any intervention, and the need for longitudinal patient care.

Patients undergo work-up by a multidisciplinary team (MD team) with a nutritionist, psychologist, primary care physician, gastroenterologist, and endocrinologist to determine the optimal treatment plan (Fig. 1).²⁹

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Patients are required to attend multiple information sessions, where all weight-loss methods are presented, including surgery, bariatric endoscopy, and pharmacotherapy. Other specialists also help manage comorbid conditions. Prior to selecting an initial intervention, patients undergo intensive lifestyle and behavioral therapy (Fig. 2 and 3). Depending on the selected therapy, initial treatment lasts between 3 and 12 months with ongoing support from the MD team.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

If patients do not achieve their targeted weight loss after initial treatment, a new strategy is selected. This includes a different EBMT such as ESG, alternate pharmacotherapy, or surgery until the weight and health goals of the patient are achieved and sustained (Fig. 3). From the start, patients are informed that our program is a long-term intervention and that active participation in the MOVE! Program, as well as follow-up with the MD team are keys to success. EBMTs and medications are presented as effective tools that only work to enhance the effects of lifestyle changes.

Courtesy Dr. Young, Dr. Zenger, Dr. Holwanger, and Dr. Popov

Our multidisciplinary approach provides flexibility for patients to trial different options depending on their progress. Research on long-term outcomes with weight loss and metabolic parameters is ongoing, though early results are promising. Thus far, we have observed that patients undergoing a combination therapy of EBMTs and AOMs have greater weight loss than patients on a single therapeutic approach with either EBMT or AOMs alone.³⁴ Racial and socioeconomic disparities in referrals to bariatric surgery are yet another barrier for patients to access weight reduction and improvement in cardiovascular health.³⁵ EBMTs and pharmacotherapy are no longer just on the horizon; they are here as accessible, effective, and long-term treatments for all patients with obesity. More expansive insurance coverage is needed for EBMTs and AOMs in order to prevent progression of obesity-related comorbidities, reduce high costs, and ensure more equitable access to these effective therapies.
 

Dr. Young and Dr. Zenger are resident physicians in the department of internal medicine at New York University. Dr. Holzwanger is an advanced endoscopy fellow in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. Dr. Popov is director of bariatric endoscopy at VA New York Harbor Healthcare System, and assistant professor of medicine at New York University. Dr. Popov reported relationships with Obalon, Microtech, and Spatz, but the remaining authors reported no competing interests.

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