There will be “routine application” and “broader acceptance” of minimally invasive focal therapies for early-stage prostate cancer within the next 5 years in the United States, predict a trio of clinicians in a new essay published online July 28 in JAMA Surgery.

They maintain that focal therapy (FT) offers a “middle ground” between two extremes: Treating the whole gland with radical prostatectomy or radiotherapy and not treating immediately via active surveillance or watchful waiting.

Focal therapy typically treats the primary lesion within the prostate, while leaving the rest of the gland intact. Most often performed with cryoablation or high-intensity focused ultrasound (HIFU), it can also be carried out with a variety of technologies, including transurethral ultrasound ablation and focal laser ablation.

The shift to focal therapy will coincide with maturing, long-term data from studies with various technologies, predict the authors, led by Amir Lebastchi, MD, a urologist at the University of Southern California.

“Standard adoption of focal therapy is ultimately dependent on the availability of robust level I evidence, which in turn will drive medical societies and payees,” the authors also write.

But payees are already making changes, even without such data, they add.

For example, in January the American Medical Association announced a new code for high-intensity focal ultrasound (HIFU): This approach now has a Current Procedural Terminology (CPT) code from the U.S. Centers for Medicare & Medicaid Services

This news organization reached out to Matthew Cooperberg, MD, MPH, a urologist at the University of California, San Francisco (UCSF), for comments about the essay’s optimism; he has questioned focal therapy in the past because of a lack of strong supporting evidence.

“While ‘routine’ is a bit of a vague term, now that HIFU has a CPT code, I do expect its use will in fact increase in the next 5 years,” Dr. Cooperberg wrote in an email. “The question is whether its use will increase appropriately.”

The challenge with focal therapy – regardless of energy modality – remains patient selection and accurate ablation zone definition, he added.

Notably, UCSF has launched a new HIFU program – and Dr. Cooperberg has referred selected patients. “I’m both enthusiastic and cautious about the future, and we need to track our outcomes very closely across various practice settings,” he said.
 

While waiting for CHRONOS, select wisely

The goal of focal therapy is to treat only the area with the most aggressive tumor, known as the index tumor, while leaving the remaining gland and its surrounding structures alone, according to Derek Lomas, MD, PharmD, a urologist at the Mayo Clinic in Rochester, Minn., in an explanatory article. “This approach is widely accepted in other types of cancer. For example, we commonly treat kidney cancers by removing or ablating only the tumor while leaving the rest of the kidney intact.”

However, some focal therapies also include approaches known as hemiablations, in which a full half of the prostate is destroyed, and approaches that leave very little of the gland behind.

Each of the modalities used for focal therapy has “unique indications, risks, and benefits and uses a different energy source for ablation,” Dr. Lebastchi and colleagues write in their essay.  

They assert that focal therapy can provide oncological efficacy similar to radical prostatectomy or radiotherapy “while considerably reducing or even eliminating functional morbidities, such as incontinence and erectile dysfunction.”

Overall, they say focal therapy offers an opportunity for improved care because there is “an increasing body of emerging evidence demonstrating a favorable adverse effect profile with oncological control similar to whole-gland treatment options.”
 

What is that evidence?

In the essay, Dr. Lebastchi and colleagues point to a number of single-arm studies with encouraging efficacy and safety results. They also highlight a phase 3, randomized trial that they were involved in: This compared focal therapy (partial gland ablation with vascular-targeted photodynamic therapy) with active surveillance in early-stage disease and uniformly showed better post-treatment biopsy (disease/no disease) and conversion-to-prostatectomy results with the focal therapy out to 4 years (J Urol. 2018;200:786-793).

However, that study did not have an active treatment comparator. For that gold standard, there is now anticipation for results from the CHRONOS trial in the United Kingdom, especially part A of the trial, which compares radical therapy to focal therapy (HIFU or cryotherapy), with 5-year progression-free survival as the primary outcome. That trial is slated for completion in 2027.

Until then, the lack of prospective randomized clinical trials and long-term follow-up “hinders acceptance [of focal therapy] in the urology community,” the essay authors comment.

Meanwhile, careful patient selection is very important, they say.

The latest relevant guidelines state that appropriate candidates are men with a solitary, well-defined index lesion; patients with bilateral multifocal lesions; or very advanced tumors that are not appropriate for the focal approach.

A multidisciplinary international expert panel recently convened to establish guidance for clinicians offering focal therapies and then published a consensus statement to advise practitioners and researchers.

UCSF’s Dr. Cooperberg sees plenty of room for improvement among focal therapy practitioners and investigators. “From an outcomes standpoint, follow-up protocols and definitions of success remain inconsistent. I believe we’re making progress in all these areas, but we’re not there yet,” he says.

To date, some patients have been managed poorly, Dr. Cooperberg added. “We certainly see many patients who have been inadequately counseled as to HIFU’s advantages and disadvantages, with sometimes disastrous results.”

Some of those unfortunate results may have arisen from the U.S. Food and Drug Administration’s initial approval of HIFU in 2015, which was for use in ablating prostate tissue in general and not cancer specifically. This approval generated confusion, one expert commented at the time: “The FDA doesn’t specify whether it’s for benign or malignant disease; it’s a bit vague, like saying you can drive this car, but we’re not going to tell you how to drive it,” said Manoj Monga, MD, from the Cleveland Clinic.

Dr. Lebastchi has disclosed no relevant financial relationships; co-author Inderbir Gill, MD, is an unpaid consultant for Steba Biotech, and co-author Andre Luis Abreu, MD, is a consultant for Koelis and was a proctor in training for Steba Biotech. Dr. Cooperberg is a consultant for Alessa Therapeutics.

A version of this article first appeared on Medscape.com.

There will be “routine application” and “broader acceptance” of minimally invasive focal therapies for early-stage prostate cancer within the next 5 years in the United States, predict a trio of clinicians in a new essay published online July 28 in JAMA Surgery.

They maintain that focal therapy (FT) offers a “middle ground” between two extremes: Treating the whole gland with radical prostatectomy or radiotherapy and not treating immediately via active surveillance or watchful waiting.

Focal therapy typically treats the primary lesion within the prostate, while leaving the rest of the gland intact. Most often performed with cryoablation or high-intensity focused ultrasound (HIFU), it can also be carried out with a variety of technologies, including transurethral ultrasound ablation and focal laser ablation.

The shift to focal therapy will coincide with maturing, long-term data from studies with various technologies, predict the authors, led by Amir Lebastchi, MD, a urologist at the University of Southern California.

“Standard adoption of focal therapy is ultimately dependent on the availability of robust level I evidence, which in turn will drive medical societies and payees,” the authors also write.

But payees are already making changes, even without such data, they add.

For example, in January the American Medical Association announced a new code for high-intensity focal ultrasound (HIFU): This approach now has a Current Procedural Terminology (CPT) code from the U.S. Centers for Medicare & Medicaid Services

This news organization reached out to Matthew Cooperberg, MD, MPH, a urologist at the University of California, San Francisco (UCSF), for comments about the essay’s optimism; he has questioned focal therapy in the past because of a lack of strong supporting evidence.

“While ‘routine’ is a bit of a vague term, now that HIFU has a CPT code, I do expect its use will in fact increase in the next 5 years,” Dr. Cooperberg wrote in an email. “The question is whether its use will increase appropriately.”

The challenge with focal therapy – regardless of energy modality – remains patient selection and accurate ablation zone definition, he added.

Notably, UCSF has launched a new HIFU program – and Dr. Cooperberg has referred selected patients. “I’m both enthusiastic and cautious about the future, and we need to track our outcomes very closely across various practice settings,” he said.
 

While waiting for CHRONOS, select wisely

The goal of focal therapy is to treat only the area with the most aggressive tumor, known as the index tumor, while leaving the remaining gland and its surrounding structures alone, according to Derek Lomas, MD, PharmD, a urologist at the Mayo Clinic in Rochester, Minn., in an explanatory article. “This approach is widely accepted in other types of cancer. For example, we commonly treat kidney cancers by removing or ablating only the tumor while leaving the rest of the kidney intact.”

However, some focal therapies also include approaches known as hemiablations, in which a full half of the prostate is destroyed, and approaches that leave very little of the gland behind.

Each of the modalities used for focal therapy has “unique indications, risks, and benefits and uses a different energy source for ablation,” Dr. Lebastchi and colleagues write in their essay.  

They assert that focal therapy can provide oncological efficacy similar to radical prostatectomy or radiotherapy “while considerably reducing or even eliminating functional morbidities, such as incontinence and erectile dysfunction.”

Overall, they say focal therapy offers an opportunity for improved care because there is “an increasing body of emerging evidence demonstrating a favorable adverse effect profile with oncological control similar to whole-gland treatment options.”
 

What is that evidence?

In the essay, Dr. Lebastchi and colleagues point to a number of single-arm studies with encouraging efficacy and safety results. They also highlight a phase 3, randomized trial that they were involved in: This compared focal therapy (partial gland ablation with vascular-targeted photodynamic therapy) with active surveillance in early-stage disease and uniformly showed better post-treatment biopsy (disease/no disease) and conversion-to-prostatectomy results with the focal therapy out to 4 years (J Urol. 2018;200:786-793).

However, that study did not have an active treatment comparator. For that gold standard, there is now anticipation for results from the CHRONOS trial in the United Kingdom, especially part A of the trial, which compares radical therapy to focal therapy (HIFU or cryotherapy), with 5-year progression-free survival as the primary outcome. That trial is slated for completion in 2027.

Until then, the lack of prospective randomized clinical trials and long-term follow-up “hinders acceptance [of focal therapy] in the urology community,” the essay authors comment.

Meanwhile, careful patient selection is very important, they say.

The latest relevant guidelines state that appropriate candidates are men with a solitary, well-defined index lesion; patients with bilateral multifocal lesions; or very advanced tumors that are not appropriate for the focal approach.

A multidisciplinary international expert panel recently convened to establish guidance for clinicians offering focal therapies and then published a consensus statement to advise practitioners and researchers.

UCSF’s Dr. Cooperberg sees plenty of room for improvement among focal therapy practitioners and investigators. “From an outcomes standpoint, follow-up protocols and definitions of success remain inconsistent. I believe we’re making progress in all these areas, but we’re not there yet,” he says.

To date, some patients have been managed poorly, Dr. Cooperberg added. “We certainly see many patients who have been inadequately counseled as to HIFU’s advantages and disadvantages, with sometimes disastrous results.”

Some of those unfortunate results may have arisen from the U.S. Food and Drug Administration’s initial approval of HIFU in 2015, which was for use in ablating prostate tissue in general and not cancer specifically. This approval generated confusion, one expert commented at the time: “The FDA doesn’t specify whether it’s for benign or malignant disease; it’s a bit vague, like saying you can drive this car, but we’re not going to tell you how to drive it,” said Manoj Monga, MD, from the Cleveland Clinic.

Dr. Lebastchi has disclosed no relevant financial relationships; co-author Inderbir Gill, MD, is an unpaid consultant for Steba Biotech, and co-author Andre Luis Abreu, MD, is a consultant for Koelis and was a proctor in training for Steba Biotech. Dr. Cooperberg is a consultant for Alessa Therapeutics.

A version of this article first appeared on Medscape.com.

There will be “routine application” and “broader acceptance” of minimally invasive focal therapies for early-stage prostate cancer within the next 5 years in the United States, predict a trio of clinicians in a new essay published online July 28 in JAMA Surgery.

They maintain that focal therapy (FT) offers a “middle ground” between two extremes: Treating the whole gland with radical prostatectomy or radiotherapy and not treating immediately via active surveillance or watchful waiting.

Focal therapy typically treats the primary lesion within the prostate, while leaving the rest of the gland intact. Most often performed with cryoablation or high-intensity focused ultrasound (HIFU), it can also be carried out with a variety of technologies, including transurethral ultrasound ablation and focal laser ablation.

The shift to focal therapy will coincide with maturing, long-term data from studies with various technologies, predict the authors, led by Amir Lebastchi, MD, a urologist at the University of Southern California.

“Standard adoption of focal therapy is ultimately dependent on the availability of robust level I evidence, which in turn will drive medical societies and payees,” the authors also write.

But payees are already making changes, even without such data, they add.

For example, in January the American Medical Association announced a new code for high-intensity focal ultrasound (HIFU): This approach now has a Current Procedural Terminology (CPT) code from the U.S. Centers for Medicare & Medicaid Services

This news organization reached out to Matthew Cooperberg, MD, MPH, a urologist at the University of California, San Francisco (UCSF), for comments about the essay’s optimism; he has questioned focal therapy in the past because of a lack of strong supporting evidence.

“While ‘routine’ is a bit of a vague term, now that HIFU has a CPT code, I do expect its use will in fact increase in the next 5 years,” Dr. Cooperberg wrote in an email. “The question is whether its use will increase appropriately.”

The challenge with focal therapy – regardless of energy modality – remains patient selection and accurate ablation zone definition, he added.

Notably, UCSF has launched a new HIFU program – and Dr. Cooperberg has referred selected patients. “I’m both enthusiastic and cautious about the future, and we need to track our outcomes very closely across various practice settings,” he said.
 

While waiting for CHRONOS, select wisely

The goal of focal therapy is to treat only the area with the most aggressive tumor, known as the index tumor, while leaving the remaining gland and its surrounding structures alone, according to Derek Lomas, MD, PharmD, a urologist at the Mayo Clinic in Rochester, Minn., in an explanatory article. “This approach is widely accepted in other types of cancer. For example, we commonly treat kidney cancers by removing or ablating only the tumor while leaving the rest of the kidney intact.”

However, some focal therapies also include approaches known as hemiablations, in which a full half of the prostate is destroyed, and approaches that leave very little of the gland behind.

Each of the modalities used for focal therapy has “unique indications, risks, and benefits and uses a different energy source for ablation,” Dr. Lebastchi and colleagues write in their essay.  

They assert that focal therapy can provide oncological efficacy similar to radical prostatectomy or radiotherapy “while considerably reducing or even eliminating functional morbidities, such as incontinence and erectile dysfunction.”

Overall, they say focal therapy offers an opportunity for improved care because there is “an increasing body of emerging evidence demonstrating a favorable adverse effect profile with oncological control similar to whole-gland treatment options.”
 

What is that evidence?

In the essay, Dr. Lebastchi and colleagues point to a number of single-arm studies with encouraging efficacy and safety results. They also highlight a phase 3, randomized trial that they were involved in: This compared focal therapy (partial gland ablation with vascular-targeted photodynamic therapy) with active surveillance in early-stage disease and uniformly showed better post-treatment biopsy (disease/no disease) and conversion-to-prostatectomy results with the focal therapy out to 4 years (J Urol. 2018;200:786-793).

However, that study did not have an active treatment comparator. For that gold standard, there is now anticipation for results from the CHRONOS trial in the United Kingdom, especially part A of the trial, which compares radical therapy to focal therapy (HIFU or cryotherapy), with 5-year progression-free survival as the primary outcome. That trial is slated for completion in 2027.

Until then, the lack of prospective randomized clinical trials and long-term follow-up “hinders acceptance [of focal therapy] in the urology community,” the essay authors comment.

Meanwhile, careful patient selection is very important, they say.

The latest relevant guidelines state that appropriate candidates are men with a solitary, well-defined index lesion; patients with bilateral multifocal lesions; or very advanced tumors that are not appropriate for the focal approach.

A multidisciplinary international expert panel recently convened to establish guidance for clinicians offering focal therapies and then published a consensus statement to advise practitioners and researchers.

UCSF’s Dr. Cooperberg sees plenty of room for improvement among focal therapy practitioners and investigators. “From an outcomes standpoint, follow-up protocols and definitions of success remain inconsistent. I believe we’re making progress in all these areas, but we’re not there yet,” he says.

To date, some patients have been managed poorly, Dr. Cooperberg added. “We certainly see many patients who have been inadequately counseled as to HIFU’s advantages and disadvantages, with sometimes disastrous results.”

Some of those unfortunate results may have arisen from the U.S. Food and Drug Administration’s initial approval of HIFU in 2015, which was for use in ablating prostate tissue in general and not cancer specifically. This approval generated confusion, one expert commented at the time: “The FDA doesn’t specify whether it’s for benign or malignant disease; it’s a bit vague, like saying you can drive this car, but we’re not going to tell you how to drive it,” said Manoj Monga, MD, from the Cleveland Clinic.

Dr. Lebastchi has disclosed no relevant financial relationships; co-author Inderbir Gill, MD, is an unpaid consultant for Steba Biotech, and co-author Andre Luis Abreu, MD, is a consultant for Koelis and was a proctor in training for Steba Biotech. Dr. Cooperberg is a consultant for Alessa Therapeutics.

A version of this article first appeared on Medscape.com.

The American Gastroenterological Association recently issued a clinical practice update expert review outlining tenets of high-quality colonoscopy screening and surveillance.

The update includes 15 best practice advice statements aimed at the endoscopist and/or endoscopy unit, reported lead author Rajesh N. Keswani, MD, of Northwestern University, Chicago, and colleagues.

“The efficacy of colonoscopy varies widely among endoscopists, and lower-quality colonoscopies are associated with higher interval CRC [colorectal cancer] incidence and mortality,” the investigators wrote in Gastroenterology.

According to Dr. Keswani and colleagues, quality of colonoscopy screening and surveillance is shaped by three parameters: safety, effectiveness, and value. Some metrics may be best measured at a unit level, they noted, while others are more clinician specific.

“For uncommon outcomes (e.g., adverse events) or metrics that reflect system-based practice (e.g., bowel preparation quality), measurement of aggregate unit-level performance is best,” the investigators wrote. “In contrast, for metrics that primarily reflect colonoscopist skill (e.g., adenoma detection rate), endoscopist-level measurement is preferred to enable individual feedback.”
 

Endoscopy unit best practice advice

According to the update, endoscopy units should prepare patients for, and monitor, adverse events. Prior to the procedure, patients should be informed about possible adverse events and warning symptoms, and emergency contact information should be recorded. Following the procedure, systematic monitoring of delayed adverse events may be considered, including “postprocedure bleeding, perforation, hospital readmission, 30-day mortality, and/or interval colorectal cancer cases,” with rates reported at the unit level.

Ensuring high-quality bowel preparation is also the responsibility of the endoscopy unit, according to Dr. Keswani and colleagues, and should be measured at least annually. Units should aim for a Boston Bowel Preparation Scale score of at least 6, with each segment scoring at least 2, in at least 90% of colonoscopies. The update provides best practice advice on split-dose bowel prep, with patient instructions written at a sixth-grade level in their native language. If routine quality measurement reveals suboptimal bowel prep quality, instruction revision may be needed, as well as further patient education and support.

During the actual procedure, a high-definition colonoscope should be used, the expert panel wrote. They called for measurement of endoscopist performance via four parameters: cecal intubation rate, which should be at least 90%; mean withdrawal time, which should be at least 6 minutes (aspirational, ≥9 minutes); adenoma detection rate, measured annually or when a given endoscopist has accrued 250 screening colonoscopies; and serrated lesion detection rate.
 

Endoscopist best practice advice

Both adenoma detection rate and serrated lesion detection rate should also be measured at an endoscopist level, with rates of at least 30% for adenomas and at least 7% for serrated lesions (aspirational, ≥35% and ≥10%, respectively).

“If rates are low, improvement efforts should be oriented toward both colonoscopists and pathologists,” the investigators noted.

A variety of strategies are advised to improve outcomes at the endoscopist level, including a second look at the right colon to detect polyps, either in forward or retroflexed view; use of cold-snare polypectomy for nonpedunculated polyps 3-9 mm in size and avoidance of forceps in polyps greater than 2 mm in size; evaluation by an expert in polypectomy with attempted resection for patients with complex polyps lacking “overt malignant endoscopic features or pathology consistent with invasive adenocarcinoma”; and thorough documentation of all findings.

More broadly, the update advises endoscopists to follow guideline-recommended intervals for screening and surveillance, including repeat colonoscopy in 3 years for all patients with advanced adenomas versus a 10-year interval for patients with normal risk or “only distal hyperplastic polyps.”
 

Resource-limited institutions and a look ahead

Dr. Keswani and colleagues concluded the clinical practice update with a nod to the challenges of real-world practice, noting that some institutions may not have the resources to comply with all the best practice advice statements.

“If limited resources are available, measurement of cecal intubation rates, bowel preparation quality, and adenoma detection rate should be prioritized,” they wrote.

They also offered a succinct summary of outstanding research needs, saying “we anticipate future work to clarify optimal polyp resection techniques, refine surveillance intervals based on provider skill and patient risk, and highlight the benefits of artificial intelligence in improving colonoscopy quality.”

This clinical practice update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. Dr. Keswani consults for Boston Scientific. The other authors had no disclosures.

This article was updated Aug. 20, 2021.

The American Gastroenterological Association recently issued a clinical practice update expert review outlining tenets of high-quality colonoscopy screening and surveillance.

The update includes 15 best practice advice statements aimed at the endoscopist and/or endoscopy unit, reported lead author Rajesh N. Keswani, MD, of Northwestern University, Chicago, and colleagues.

“The efficacy of colonoscopy varies widely among endoscopists, and lower-quality colonoscopies are associated with higher interval CRC [colorectal cancer] incidence and mortality,” the investigators wrote in Gastroenterology.

According to Dr. Keswani and colleagues, quality of colonoscopy screening and surveillance is shaped by three parameters: safety, effectiveness, and value. Some metrics may be best measured at a unit level, they noted, while others are more clinician specific.

“For uncommon outcomes (e.g., adverse events) or metrics that reflect system-based practice (e.g., bowel preparation quality), measurement of aggregate unit-level performance is best,” the investigators wrote. “In contrast, for metrics that primarily reflect colonoscopist skill (e.g., adenoma detection rate), endoscopist-level measurement is preferred to enable individual feedback.”
 

Endoscopy unit best practice advice

According to the update, endoscopy units should prepare patients for, and monitor, adverse events. Prior to the procedure, patients should be informed about possible adverse events and warning symptoms, and emergency contact information should be recorded. Following the procedure, systematic monitoring of delayed adverse events may be considered, including “postprocedure bleeding, perforation, hospital readmission, 30-day mortality, and/or interval colorectal cancer cases,” with rates reported at the unit level.

Ensuring high-quality bowel preparation is also the responsibility of the endoscopy unit, according to Dr. Keswani and colleagues, and should be measured at least annually. Units should aim for a Boston Bowel Preparation Scale score of at least 6, with each segment scoring at least 2, in at least 90% of colonoscopies. The update provides best practice advice on split-dose bowel prep, with patient instructions written at a sixth-grade level in their native language. If routine quality measurement reveals suboptimal bowel prep quality, instruction revision may be needed, as well as further patient education and support.

During the actual procedure, a high-definition colonoscope should be used, the expert panel wrote. They called for measurement of endoscopist performance via four parameters: cecal intubation rate, which should be at least 90%; mean withdrawal time, which should be at least 6 minutes (aspirational, ≥9 minutes); adenoma detection rate, measured annually or when a given endoscopist has accrued 250 screening colonoscopies; and serrated lesion detection rate.
 

Endoscopist best practice advice

Both adenoma detection rate and serrated lesion detection rate should also be measured at an endoscopist level, with rates of at least 30% for adenomas and at least 7% for serrated lesions (aspirational, ≥35% and ≥10%, respectively).

“If rates are low, improvement efforts should be oriented toward both colonoscopists and pathologists,” the investigators noted.

A variety of strategies are advised to improve outcomes at the endoscopist level, including a second look at the right colon to detect polyps, either in forward or retroflexed view; use of cold-snare polypectomy for nonpedunculated polyps 3-9 mm in size and avoidance of forceps in polyps greater than 2 mm in size; evaluation by an expert in polypectomy with attempted resection for patients with complex polyps lacking “overt malignant endoscopic features or pathology consistent with invasive adenocarcinoma”; and thorough documentation of all findings.

More broadly, the update advises endoscopists to follow guideline-recommended intervals for screening and surveillance, including repeat colonoscopy in 3 years for all patients with advanced adenomas versus a 10-year interval for patients with normal risk or “only distal hyperplastic polyps.”
 

Resource-limited institutions and a look ahead

Dr. Keswani and colleagues concluded the clinical practice update with a nod to the challenges of real-world practice, noting that some institutions may not have the resources to comply with all the best practice advice statements.

“If limited resources are available, measurement of cecal intubation rates, bowel preparation quality, and adenoma detection rate should be prioritized,” they wrote.

They also offered a succinct summary of outstanding research needs, saying “we anticipate future work to clarify optimal polyp resection techniques, refine surveillance intervals based on provider skill and patient risk, and highlight the benefits of artificial intelligence in improving colonoscopy quality.”

This clinical practice update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. Dr. Keswani consults for Boston Scientific. The other authors had no disclosures.

This article was updated Aug. 20, 2021.

The American Gastroenterological Association recently issued a clinical practice update expert review outlining tenets of high-quality colonoscopy screening and surveillance.

The update includes 15 best practice advice statements aimed at the endoscopist and/or endoscopy unit, reported lead author Rajesh N. Keswani, MD, of Northwestern University, Chicago, and colleagues.

“The efficacy of colonoscopy varies widely among endoscopists, and lower-quality colonoscopies are associated with higher interval CRC [colorectal cancer] incidence and mortality,” the investigators wrote in Gastroenterology.

According to Dr. Keswani and colleagues, quality of colonoscopy screening and surveillance is shaped by three parameters: safety, effectiveness, and value. Some metrics may be best measured at a unit level, they noted, while others are more clinician specific.

“For uncommon outcomes (e.g., adverse events) or metrics that reflect system-based practice (e.g., bowel preparation quality), measurement of aggregate unit-level performance is best,” the investigators wrote. “In contrast, for metrics that primarily reflect colonoscopist skill (e.g., adenoma detection rate), endoscopist-level measurement is preferred to enable individual feedback.”
 

Endoscopy unit best practice advice

According to the update, endoscopy units should prepare patients for, and monitor, adverse events. Prior to the procedure, patients should be informed about possible adverse events and warning symptoms, and emergency contact information should be recorded. Following the procedure, systematic monitoring of delayed adverse events may be considered, including “postprocedure bleeding, perforation, hospital readmission, 30-day mortality, and/or interval colorectal cancer cases,” with rates reported at the unit level.

Ensuring high-quality bowel preparation is also the responsibility of the endoscopy unit, according to Dr. Keswani and colleagues, and should be measured at least annually. Units should aim for a Boston Bowel Preparation Scale score of at least 6, with each segment scoring at least 2, in at least 90% of colonoscopies. The update provides best practice advice on split-dose bowel prep, with patient instructions written at a sixth-grade level in their native language. If routine quality measurement reveals suboptimal bowel prep quality, instruction revision may be needed, as well as further patient education and support.

During the actual procedure, a high-definition colonoscope should be used, the expert panel wrote. They called for measurement of endoscopist performance via four parameters: cecal intubation rate, which should be at least 90%; mean withdrawal time, which should be at least 6 minutes (aspirational, ≥9 minutes); adenoma detection rate, measured annually or when a given endoscopist has accrued 250 screening colonoscopies; and serrated lesion detection rate.
 

Endoscopist best practice advice

Both adenoma detection rate and serrated lesion detection rate should also be measured at an endoscopist level, with rates of at least 30% for adenomas and at least 7% for serrated lesions (aspirational, ≥35% and ≥10%, respectively).

“If rates are low, improvement efforts should be oriented toward both colonoscopists and pathologists,” the investigators noted.

A variety of strategies are advised to improve outcomes at the endoscopist level, including a second look at the right colon to detect polyps, either in forward or retroflexed view; use of cold-snare polypectomy for nonpedunculated polyps 3-9 mm in size and avoidance of forceps in polyps greater than 2 mm in size; evaluation by an expert in polypectomy with attempted resection for patients with complex polyps lacking “overt malignant endoscopic features or pathology consistent with invasive adenocarcinoma”; and thorough documentation of all findings.

More broadly, the update advises endoscopists to follow guideline-recommended intervals for screening and surveillance, including repeat colonoscopy in 3 years for all patients with advanced adenomas versus a 10-year interval for patients with normal risk or “only distal hyperplastic polyps.”
 

Resource-limited institutions and a look ahead

Dr. Keswani and colleagues concluded the clinical practice update with a nod to the challenges of real-world practice, noting that some institutions may not have the resources to comply with all the best practice advice statements.

“If limited resources are available, measurement of cecal intubation rates, bowel preparation quality, and adenoma detection rate should be prioritized,” they wrote.

They also offered a succinct summary of outstanding research needs, saying “we anticipate future work to clarify optimal polyp resection techniques, refine surveillance intervals based on provider skill and patient risk, and highlight the benefits of artificial intelligence in improving colonoscopy quality.”

This clinical practice update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. Dr. Keswani consults for Boston Scientific. The other authors had no disclosures.

This article was updated Aug. 20, 2021.

A new study sought to establish a new, clinically relevant mouse model of nonalcoholic steatohepatitis (NASH) that closely reflects human disease as well as the multitissue dynamics involved in the progression and regression of the condition, according to the researchers. This study focused on the association between progression of NASH and consumption of a Western diet, as well as the development of HCC.

The study used a model consisting of hyperphagic mice that lacked a functional ALMS1 gene (Foz/Foz), in addition to wild-type littermates. The model ultimately defined “the key signaling and cytokine pathways that are critical for disease development and resolution” associated with NASH, wrote Souradipta Ganguly, PhD, of the University of California, San Diego, and colleagues. The report was published in Cellular and Molecular Gastroenterology and Hepatology.

According to the researchers, this study is unique given “current rodent models of NASH do not reproduce the complete spectrum of metabolic and histologic” nonalcoholic fatty liver disease (NAFLD) phenotypes. Likewise, the lack of “systemic studies in a single rodent model of NASH that closely recapitulates the human pathology” reinforces the importance of the new model, the researchers added.

Over time, NASH can progress to cirrhosis and hepatocellular carcinoma (HCC). Studies that fed wild-type mice a Western diet have largely failed to mimic the full pathology of NASH to fibrosis to HCC. In addition, the models in these studies fail to reflect the multitissue injuries frequently observed in NASH.

To circumvent these challenges, Dr. Ganguly and colleagues used ALMS1-mutated mice to develop a rodent model of metabolic syndrome that included NASH with fibrosis, chronic kidney disease, and cardiovascular disease. The ALMS1 mutation also resulted in the mice becoming hyperphagic, which increases hunger and leads to early-onset obesity, among other conditions characteristic of metabolic syndrome.

Researchers fed the hyperphagic Foz/Foz mice and wild-type littermates a Western diet or standard diet during a 12-week period for NASH/fibrosis and a 24-week period for HCC. After NASH was established, mice were switched back to normal chow to see if the condition regressed.

Macronutrient distribution of the study’s Western diet included 40% fat, 15% protein, and 44% carbohydrates, based on total caloric content. In contrast, the standard chow included 12% fat, 23% protein, and 65% carbohydrates from total calories.

Within 1-2 weeks, Foz mice fed the Western diet were considered steatotic. These mice subsequently developed NASH by 4 weeks of the study and grade 3 fibrosis by 12 weeks. The researchers concurrently observed the development of chronic kidney injury in the animals. Mice continuing to the 24 weeks ultimately progressed to cirrhosis and HCC; these mice demonstrated reduced survival due to cardiac dysfunction.

Mice that developed NASH were then switched to a diet consisting of normal chow. Following this switch, NASH began to regress, and survival improved. These mice did not appear to develop HCC, and total liver weight was significantly reduced compared with the mice that didn’t enter the regression phase of the study. The researchers wrote that the resolution of hepatic steatosis was also consistent with improved glucose tolerance.

In transcriptomic and histologic analyses, the researchers found strong concordance between Foz/Foz mice NASH liver and human NASH.

The study also found that early disruption of gut barrier, microbial dysbiosis, lipopolysaccharide leakage, and intestinal inflammation preceded NASH in the Foz/Foz mice fed the Western diet, resulting in acute-phase liver inflammation. The early inflammation was reflected by an increase in several chemokines and cytokines by 1-2 weeks. As NASH progressed, the liver cytokine/chemokine profile continued to evolve, leading to monocyte recruitment predominance. “Further studies will elaborate the roles of these NASH-specific microbiomial features in the development and progression of NASH fibrosis,” wrote the researchers.

The study received financial support Janssen, in addition to funding from an ALF Liver Scholar award, ACTRI/National Institutes of Health, the SDDRC, and the NIAAA/National Institutes of Health. The authors disclosed no conflicts.

A new study sought to establish a new, clinically relevant mouse model of nonalcoholic steatohepatitis (NASH) that closely reflects human disease as well as the multitissue dynamics involved in the progression and regression of the condition, according to the researchers. This study focused on the association between progression of NASH and consumption of a Western diet, as well as the development of HCC.

The study used a model consisting of hyperphagic mice that lacked a functional ALMS1 gene (Foz/Foz), in addition to wild-type littermates. The model ultimately defined “the key signaling and cytokine pathways that are critical for disease development and resolution” associated with NASH, wrote Souradipta Ganguly, PhD, of the University of California, San Diego, and colleagues. The report was published in Cellular and Molecular Gastroenterology and Hepatology.

According to the researchers, this study is unique given “current rodent models of NASH do not reproduce the complete spectrum of metabolic and histologic” nonalcoholic fatty liver disease (NAFLD) phenotypes. Likewise, the lack of “systemic studies in a single rodent model of NASH that closely recapitulates the human pathology” reinforces the importance of the new model, the researchers added.

Over time, NASH can progress to cirrhosis and hepatocellular carcinoma (HCC). Studies that fed wild-type mice a Western diet have largely failed to mimic the full pathology of NASH to fibrosis to HCC. In addition, the models in these studies fail to reflect the multitissue injuries frequently observed in NASH.

To circumvent these challenges, Dr. Ganguly and colleagues used ALMS1-mutated mice to develop a rodent model of metabolic syndrome that included NASH with fibrosis, chronic kidney disease, and cardiovascular disease. The ALMS1 mutation also resulted in the mice becoming hyperphagic, which increases hunger and leads to early-onset obesity, among other conditions characteristic of metabolic syndrome.

Researchers fed the hyperphagic Foz/Foz mice and wild-type littermates a Western diet or standard diet during a 12-week period for NASH/fibrosis and a 24-week period for HCC. After NASH was established, mice were switched back to normal chow to see if the condition regressed.

Macronutrient distribution of the study’s Western diet included 40% fat, 15% protein, and 44% carbohydrates, based on total caloric content. In contrast, the standard chow included 12% fat, 23% protein, and 65% carbohydrates from total calories.

Within 1-2 weeks, Foz mice fed the Western diet were considered steatotic. These mice subsequently developed NASH by 4 weeks of the study and grade 3 fibrosis by 12 weeks. The researchers concurrently observed the development of chronic kidney injury in the animals. Mice continuing to the 24 weeks ultimately progressed to cirrhosis and HCC; these mice demonstrated reduced survival due to cardiac dysfunction.

Mice that developed NASH were then switched to a diet consisting of normal chow. Following this switch, NASH began to regress, and survival improved. These mice did not appear to develop HCC, and total liver weight was significantly reduced compared with the mice that didn’t enter the regression phase of the study. The researchers wrote that the resolution of hepatic steatosis was also consistent with improved glucose tolerance.

In transcriptomic and histologic analyses, the researchers found strong concordance between Foz/Foz mice NASH liver and human NASH.

The study also found that early disruption of gut barrier, microbial dysbiosis, lipopolysaccharide leakage, and intestinal inflammation preceded NASH in the Foz/Foz mice fed the Western diet, resulting in acute-phase liver inflammation. The early inflammation was reflected by an increase in several chemokines and cytokines by 1-2 weeks. As NASH progressed, the liver cytokine/chemokine profile continued to evolve, leading to monocyte recruitment predominance. “Further studies will elaborate the roles of these NASH-specific microbiomial features in the development and progression of NASH fibrosis,” wrote the researchers.

The study received financial support Janssen, in addition to funding from an ALF Liver Scholar award, ACTRI/National Institutes of Health, the SDDRC, and the NIAAA/National Institutes of Health. The authors disclosed no conflicts.

A new study sought to establish a new, clinically relevant mouse model of nonalcoholic steatohepatitis (NASH) that closely reflects human disease as well as the multitissue dynamics involved in the progression and regression of the condition, according to the researchers. This study focused on the association between progression of NASH and consumption of a Western diet, as well as the development of HCC.

The study used a model consisting of hyperphagic mice that lacked a functional ALMS1 gene (Foz/Foz), in addition to wild-type littermates. The model ultimately defined “the key signaling and cytokine pathways that are critical for disease development and resolution” associated with NASH, wrote Souradipta Ganguly, PhD, of the University of California, San Diego, and colleagues. The report was published in Cellular and Molecular Gastroenterology and Hepatology.

According to the researchers, this study is unique given “current rodent models of NASH do not reproduce the complete spectrum of metabolic and histologic” nonalcoholic fatty liver disease (NAFLD) phenotypes. Likewise, the lack of “systemic studies in a single rodent model of NASH that closely recapitulates the human pathology” reinforces the importance of the new model, the researchers added.

Over time, NASH can progress to cirrhosis and hepatocellular carcinoma (HCC). Studies that fed wild-type mice a Western diet have largely failed to mimic the full pathology of NASH to fibrosis to HCC. In addition, the models in these studies fail to reflect the multitissue injuries frequently observed in NASH.

To circumvent these challenges, Dr. Ganguly and colleagues used ALMS1-mutated mice to develop a rodent model of metabolic syndrome that included NASH with fibrosis, chronic kidney disease, and cardiovascular disease. The ALMS1 mutation also resulted in the mice becoming hyperphagic, which increases hunger and leads to early-onset obesity, among other conditions characteristic of metabolic syndrome.

Researchers fed the hyperphagic Foz/Foz mice and wild-type littermates a Western diet or standard diet during a 12-week period for NASH/fibrosis and a 24-week period for HCC. After NASH was established, mice were switched back to normal chow to see if the condition regressed.

Macronutrient distribution of the study’s Western diet included 40% fat, 15% protein, and 44% carbohydrates, based on total caloric content. In contrast, the standard chow included 12% fat, 23% protein, and 65% carbohydrates from total calories.

Within 1-2 weeks, Foz mice fed the Western diet were considered steatotic. These mice subsequently developed NASH by 4 weeks of the study and grade 3 fibrosis by 12 weeks. The researchers concurrently observed the development of chronic kidney injury in the animals. Mice continuing to the 24 weeks ultimately progressed to cirrhosis and HCC; these mice demonstrated reduced survival due to cardiac dysfunction.

Mice that developed NASH were then switched to a diet consisting of normal chow. Following this switch, NASH began to regress, and survival improved. These mice did not appear to develop HCC, and total liver weight was significantly reduced compared with the mice that didn’t enter the regression phase of the study. The researchers wrote that the resolution of hepatic steatosis was also consistent with improved glucose tolerance.

In transcriptomic and histologic analyses, the researchers found strong concordance between Foz/Foz mice NASH liver and human NASH.

The study also found that early disruption of gut barrier, microbial dysbiosis, lipopolysaccharide leakage, and intestinal inflammation preceded NASH in the Foz/Foz mice fed the Western diet, resulting in acute-phase liver inflammation. The early inflammation was reflected by an increase in several chemokines and cytokines by 1-2 weeks. As NASH progressed, the liver cytokine/chemokine profile continued to evolve, leading to monocyte recruitment predominance. “Further studies will elaborate the roles of these NASH-specific microbiomial features in the development and progression of NASH fibrosis,” wrote the researchers.

The study received financial support Janssen, in addition to funding from an ALF Liver Scholar award, ACTRI/National Institutes of Health, the SDDRC, and the NIAAA/National Institutes of Health. The authors disclosed no conflicts.

One way members get involved in CHEST’s philanthropic efforts takes place each year with the start of the NetWorks Challenge. CHEST members compete through their NetWorks – special interest groups that focus on particular areas of chest medicine – to raise funds that support Foundation microgrants.

NetWorks Challenge 2021 kicked off in June with a special twist to celebrate the Foundation’s 25th anniversary. Each NetWork is asked to complete a 25k virtual physical challenge. This can be done by walking, running, biking, swimming—or any other physical activity.

Through the challenge, members engage in friendly competition while supporting the goals of the Foundation. This year, money raised will directly help the Foundation in addressing health disparities through our microgrants program. In addition, the funds will support travel grants for doctors in training looking to attend CHEST 2021.

By participating in the NetWorks Challenge, members help fund grants that aim to lend a hand to those who need it the most. Expanding research capabilities, improving patient care, and giving access to medical equipment are just a few ways microgrants from the CHEST Foundation have been used in the past.

Inspired by the Listening Tour and the struggles experienced by underserved communities, money raised through the Network Challenge will go to a new pilot microgrant program called Rita’s Fund. The grants aim to supplement community-based projects that provide resources to individuals to help drastically change their quality of life. Funding will assist with coverage for medical equipment, transportation, and access to technology for those living with lung disease and other medical complications.

NetWork members are asked to encourage one another to join in this summer’s race to 25k.

To learn more about this initiative and this year’s NetWorks Challenge, visit chestfoundation.org/nwc21. And, don’t miss the summer issue of Donor Spotlight.

One way members get involved in CHEST’s philanthropic efforts takes place each year with the start of the NetWorks Challenge. CHEST members compete through their NetWorks – special interest groups that focus on particular areas of chest medicine – to raise funds that support Foundation microgrants.

NetWorks Challenge 2021 kicked off in June with a special twist to celebrate the Foundation’s 25th anniversary. Each NetWork is asked to complete a 25k virtual physical challenge. This can be done by walking, running, biking, swimming—or any other physical activity.

Through the challenge, members engage in friendly competition while supporting the goals of the Foundation. This year, money raised will directly help the Foundation in addressing health disparities through our microgrants program. In addition, the funds will support travel grants for doctors in training looking to attend CHEST 2021.

By participating in the NetWorks Challenge, members help fund grants that aim to lend a hand to those who need it the most. Expanding research capabilities, improving patient care, and giving access to medical equipment are just a few ways microgrants from the CHEST Foundation have been used in the past.

Inspired by the Listening Tour and the struggles experienced by underserved communities, money raised through the Network Challenge will go to a new pilot microgrant program called Rita’s Fund. The grants aim to supplement community-based projects that provide resources to individuals to help drastically change their quality of life. Funding will assist with coverage for medical equipment, transportation, and access to technology for those living with lung disease and other medical complications.

NetWork members are asked to encourage one another to join in this summer’s race to 25k.

To learn more about this initiative and this year’s NetWorks Challenge, visit chestfoundation.org/nwc21. And, don’t miss the summer issue of Donor Spotlight.

One way members get involved in CHEST’s philanthropic efforts takes place each year with the start of the NetWorks Challenge. CHEST members compete through their NetWorks – special interest groups that focus on particular areas of chest medicine – to raise funds that support Foundation microgrants.

NetWorks Challenge 2021 kicked off in June with a special twist to celebrate the Foundation’s 25th anniversary. Each NetWork is asked to complete a 25k virtual physical challenge. This can be done by walking, running, biking, swimming—or any other physical activity.

Through the challenge, members engage in friendly competition while supporting the goals of the Foundation. This year, money raised will directly help the Foundation in addressing health disparities through our microgrants program. In addition, the funds will support travel grants for doctors in training looking to attend CHEST 2021.

By participating in the NetWorks Challenge, members help fund grants that aim to lend a hand to those who need it the most. Expanding research capabilities, improving patient care, and giving access to medical equipment are just a few ways microgrants from the CHEST Foundation have been used in the past.

Inspired by the Listening Tour and the struggles experienced by underserved communities, money raised through the Network Challenge will go to a new pilot microgrant program called Rita’s Fund. The grants aim to supplement community-based projects that provide resources to individuals to help drastically change their quality of life. Funding will assist with coverage for medical equipment, transportation, and access to technology for those living with lung disease and other medical complications.

NetWork members are asked to encourage one another to join in this summer’s race to 25k.

To learn more about this initiative and this year’s NetWorks Challenge, visit chestfoundation.org/nwc21. And, don’t miss the summer issue of Donor Spotlight.

Peak inspiratory flow as a predictive therapeutic biomarker in COPD. By Drs. D. Mahler and D. Halpin.Family presence for critically ill patients during a pandemic. By Drs. J. Hart and S. Taylor.



Executive summary: diagnosis and evaluation of hypersensitivity pneumonitis: CHEST guideline and expert panel report. By Dr. L. Fernandez Perez et al.



The usefulness of chest CT imaging in patients with suspected or diagnosed COVID-19: A review of literature. By Dr. S. Machnicki et al.



Oxygen therapy in sleep-disordered breathing. By Dr. S. Zeineddine et al.

Peak inspiratory flow as a predictive therapeutic biomarker in COPD. By Drs. D. Mahler and D. Halpin.Family presence for critically ill patients during a pandemic. By Drs. J. Hart and S. Taylor.



Executive summary: diagnosis and evaluation of hypersensitivity pneumonitis: CHEST guideline and expert panel report. By Dr. L. Fernandez Perez et al.



The usefulness of chest CT imaging in patients with suspected or diagnosed COVID-19: A review of literature. By Dr. S. Machnicki et al.



Oxygen therapy in sleep-disordered breathing. By Dr. S. Zeineddine et al.

Peak inspiratory flow as a predictive therapeutic biomarker in COPD. By Drs. D. Mahler and D. Halpin.Family presence for critically ill patients during a pandemic. By Drs. J. Hart and S. Taylor.



Executive summary: diagnosis and evaluation of hypersensitivity pneumonitis: CHEST guideline and expert panel report. By Dr. L. Fernandez Perez et al.



The usefulness of chest CT imaging in patients with suspected or diagnosed COVID-19: A review of literature. By Dr. S. Machnicki et al.



Oxygen therapy in sleep-disordered breathing. By Dr. S. Zeineddine et al.

Delirium is a frequent form of organ failure among the critically ill, impacting up to 80% of mechanically ventilated patients (Ely EW et al. JAMA. 2004;291[14]:1753-62). Its cardinal manifestations include disturbances in attention and cognition that occur acutely (e.g., hours to days) that are not better explained by another disease process (such as a toxidrome or dementia) (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. 5th ed., 2013). Duration of delirium in the intensive care unit (ICU) is independently associated with poor outcomes, such as mortality and hospital length of stay, even when accounting for comorbidities, coma duration, sedative use, and severity of illness. Delirium during critical illness is an important bellwether for a patient’s clinical status, often serving as a harbinger for severe or worsening disease.

Over the last two decades, the critical care community has come to understand the importance of recognizing delirium, which is often underdiagnosed, as well as delirium prevention. In the ICU, several factors coalesce to form the perfect environment for the development of delirium. Patients often have preexisting comorbidities that predispose to delirium, such as preexisting cognitive impairment, and the severity of critical illness increases the risk of delirium further. There are also bedside factors, however, that are important for the intensivist to address, many of which are modifiable. These include routinely screening for delirium and assessing level of consciousness, implementing early mobility and rehabilitation, targeting light sedation, and avoiding deliriogenic medications such as benzodiazepines. These evidence-based care practices form the foundation of the 2018 Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (i.e., PADIS guidelines), which aim to reduce delirium and iatrogenesis from critical care (Devlin JW et al. Crit Care Med. 2018;46[9]:e825-e873). The severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) pathogen that has caused the coronavirus disease 2019 (COVID-19) pandemic, however, has brought unprecedented challenges to critical care. One unfortunate side effect has been increased use of deep sedation and, thus, a greater incidence of delirium (Pun BT et al. Lancet Respir Med. 2021;9[3]:239-50). While the impact of the pandemic is unprecedented, thoughtful and careful sedation use remains vital to providing optimal care for the critically ill patient.
 

The link between sedation and delirium

The advent of modern mechanical ventilation brought critical care medicine into a period of rapid growth. Practices derived from the operating room, such as deep sedation and paralysis, became commonplace. Yet, starting in the late 1990s and early 2000s, evidence started growing regarding the impact of delirium and the unique aspects of the ICU that made it so prevalent. Delirium is strongly linked to inpatient mortality in mechanically ventilated adults, and it is best understood as an additional form of organ failure, much like other organ failures commonly recognized and treated by intensivists, such as respiratory or renal failure. Certain medications and sedation practices are associated with the development and duration of delirium. Benzodiazepines, a common sedative medication, are strongly linked to the development of delirium. In a study comparing commonly used sedative and analgesic agents, the use of lorazepam was associated with a greater risk of delirium the following day among critically ill, mechanically ventilated patients (Pandhariphande PP et al. Anesthesiology. 2006;104[1]:21-6). Given how commonly benzodiazepines are used and delirium develops in the ICU, this association has striking implications for clinical care and outcomes such as mortality. It is also significant, given that benzodiazepine use has increased during the pandemic, potentially creating significant downstream consequences. Benzodiazepines should be actively avoided when at all possible, given their propensity to lead to delirium, in accordance with the most recent guidelines.

Which sedation agent to choose?

While the negative effects of benzodiazepine-based sedation are well established, the optimal sedation agent remains unclear. Several other drugs are commonly used in the ICU, including propofol, dexmedetomidine, and opioid agents such as fentanyl and morphine. Propofol and dexmedetomidine are used specifically for their sedative properties, though they have dramatically different effects on the depth of sedation and different mechanisms of action. Opioid agents are most commonly used for their analgesic effect; however, in higher doses or combined with other medications, they have the secondary effect of inducing sedation. No particular sedation agent, however, beyond the avoidance of benzodiazepines has been recommended for use in the most recent guidelines. In the PRODEX and MIDEX studies, dexmedetomidine was noninferior to both midazolam and propofol in achieving targeted light to moderate sedation, and dexmedetomidine was associated with a shorter duration of mechanical ventilation compared to midazolam (Jakob SM et al. JAMA. 2012;307[11]:1151-60). More recently, the SPICE-III trial studied dexmedetomidine vs. usual care and found no difference in 90-day mortality (Shehabi Y et al. N Engl J Med. 2019;380[26]:2506-17).

In choosing the best sedation agent to avoid delirium, the largest and most applicable trial to date is the “Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure,” or MENDS2 trial (Hughes CG et al. N Engl J Med. 2021;384:1424-36). This study was a double-blind, multicenter randomized controlled trial of dexmedetomidine vs propofol in critically ill patients with sepsis receiving mechanical ventilation. The primary outcome was days alive without delirium or coma over the 14-day intervention period. The study enrolled 438 patients between 13 sites, with 422 patients receiving either dexmedetomidine or propofol. Hughes and colleagues found no difference in the primary outcome of days alive without delirium or coma between the dexmedetomidine and the propofol arms. The study also found no difference in secondary outcomes, including ventilator-free days, 90-day mortality, and 6-month global cognition, as well as no difference in safety endpoints. Importantly, there was excellent compliance with guideline-recommended practices of spontaneous awakening and breathing trials and early mobility, both of which are associated with reduced sedation exposure. The study did have some notable nuances, however. The overall doses of trial drugs were relatively low, and there was a moderate use of rescue sedation. There was also a small amount of crossover use of propofol and dexmedetomidine between treatment arms (10%), although the authors note that this was lower than in prior related studies. Overall, the MENDS2 study suggests there is likely clinical equipoise between propofol and dexmedetomidine in terms of delirium outcomes when combined with best practices, such targeted light sedation, paired awakening and breathing trials, and early mobility.
 

How should we manage sedation to prevent delirium?

Building off of the recent MENDS2 study and earlier work in the field, along with the 2018 PADIS guidelines, the general paradigm of sedation management should be focused on using light sedation with sedation interruptions to minimize overall sedation exposure. Based on the best available evidence to date, targeting less overall sedation leads to improved outcomes in critically ill patients, including mortality and duration of mechanical ventilation. Benzodiazepines should be avoided due to their association with delirium, but currently there is no evidence to suggest one nonbenzodiazepine sedative is better than another. Intensivists can feel comfortable choosing between agents based on a patient’s individual clinical needs, especially when patients are receiving paired spontaneous awakening and breathing trials and early rehabilitation. These same principles should be applied to sedation management and delirium patients in COVID-19 patients as well. While certain circumstances will necessitate deeper sedation at times (e.g., refractory hypoxemia due to ARDS from COVID-19), clinicians should continually reassess the actual sedation needs of the patient with the goal of reducing overall sedation. Focusing effort on these evidence-based practices will help reduce the incidence of delirium and ultimately improve patient outcomes.
 

Dr. Mart is with the Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center; and VA Tennessee Valley Healthcare System Geriatric Research Education and Clinical Center (GRECC), Nashville, Tennessee.

Delirium is a frequent form of organ failure among the critically ill, impacting up to 80% of mechanically ventilated patients (Ely EW et al. JAMA. 2004;291[14]:1753-62). Its cardinal manifestations include disturbances in attention and cognition that occur acutely (e.g., hours to days) that are not better explained by another disease process (such as a toxidrome or dementia) (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. 5th ed., 2013). Duration of delirium in the intensive care unit (ICU) is independently associated with poor outcomes, such as mortality and hospital length of stay, even when accounting for comorbidities, coma duration, sedative use, and severity of illness. Delirium during critical illness is an important bellwether for a patient’s clinical status, often serving as a harbinger for severe or worsening disease.

Over the last two decades, the critical care community has come to understand the importance of recognizing delirium, which is often underdiagnosed, as well as delirium prevention. In the ICU, several factors coalesce to form the perfect environment for the development of delirium. Patients often have preexisting comorbidities that predispose to delirium, such as preexisting cognitive impairment, and the severity of critical illness increases the risk of delirium further. There are also bedside factors, however, that are important for the intensivist to address, many of which are modifiable. These include routinely screening for delirium and assessing level of consciousness, implementing early mobility and rehabilitation, targeting light sedation, and avoiding deliriogenic medications such as benzodiazepines. These evidence-based care practices form the foundation of the 2018 Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (i.e., PADIS guidelines), which aim to reduce delirium and iatrogenesis from critical care (Devlin JW et al. Crit Care Med. 2018;46[9]:e825-e873). The severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) pathogen that has caused the coronavirus disease 2019 (COVID-19) pandemic, however, has brought unprecedented challenges to critical care. One unfortunate side effect has been increased use of deep sedation and, thus, a greater incidence of delirium (Pun BT et al. Lancet Respir Med. 2021;9[3]:239-50). While the impact of the pandemic is unprecedented, thoughtful and careful sedation use remains vital to providing optimal care for the critically ill patient.
 

The link between sedation and delirium

The advent of modern mechanical ventilation brought critical care medicine into a period of rapid growth. Practices derived from the operating room, such as deep sedation and paralysis, became commonplace. Yet, starting in the late 1990s and early 2000s, evidence started growing regarding the impact of delirium and the unique aspects of the ICU that made it so prevalent. Delirium is strongly linked to inpatient mortality in mechanically ventilated adults, and it is best understood as an additional form of organ failure, much like other organ failures commonly recognized and treated by intensivists, such as respiratory or renal failure. Certain medications and sedation practices are associated with the development and duration of delirium. Benzodiazepines, a common sedative medication, are strongly linked to the development of delirium. In a study comparing commonly used sedative and analgesic agents, the use of lorazepam was associated with a greater risk of delirium the following day among critically ill, mechanically ventilated patients (Pandhariphande PP et al. Anesthesiology. 2006;104[1]:21-6). Given how commonly benzodiazepines are used and delirium develops in the ICU, this association has striking implications for clinical care and outcomes such as mortality. It is also significant, given that benzodiazepine use has increased during the pandemic, potentially creating significant downstream consequences. Benzodiazepines should be actively avoided when at all possible, given their propensity to lead to delirium, in accordance with the most recent guidelines.

Which sedation agent to choose?

While the negative effects of benzodiazepine-based sedation are well established, the optimal sedation agent remains unclear. Several other drugs are commonly used in the ICU, including propofol, dexmedetomidine, and opioid agents such as fentanyl and morphine. Propofol and dexmedetomidine are used specifically for their sedative properties, though they have dramatically different effects on the depth of sedation and different mechanisms of action. Opioid agents are most commonly used for their analgesic effect; however, in higher doses or combined with other medications, they have the secondary effect of inducing sedation. No particular sedation agent, however, beyond the avoidance of benzodiazepines has been recommended for use in the most recent guidelines. In the PRODEX and MIDEX studies, dexmedetomidine was noninferior to both midazolam and propofol in achieving targeted light to moderate sedation, and dexmedetomidine was associated with a shorter duration of mechanical ventilation compared to midazolam (Jakob SM et al. JAMA. 2012;307[11]:1151-60). More recently, the SPICE-III trial studied dexmedetomidine vs. usual care and found no difference in 90-day mortality (Shehabi Y et al. N Engl J Med. 2019;380[26]:2506-17).

In choosing the best sedation agent to avoid delirium, the largest and most applicable trial to date is the “Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure,” or MENDS2 trial (Hughes CG et al. N Engl J Med. 2021;384:1424-36). This study was a double-blind, multicenter randomized controlled trial of dexmedetomidine vs propofol in critically ill patients with sepsis receiving mechanical ventilation. The primary outcome was days alive without delirium or coma over the 14-day intervention period. The study enrolled 438 patients between 13 sites, with 422 patients receiving either dexmedetomidine or propofol. Hughes and colleagues found no difference in the primary outcome of days alive without delirium or coma between the dexmedetomidine and the propofol arms. The study also found no difference in secondary outcomes, including ventilator-free days, 90-day mortality, and 6-month global cognition, as well as no difference in safety endpoints. Importantly, there was excellent compliance with guideline-recommended practices of spontaneous awakening and breathing trials and early mobility, both of which are associated with reduced sedation exposure. The study did have some notable nuances, however. The overall doses of trial drugs were relatively low, and there was a moderate use of rescue sedation. There was also a small amount of crossover use of propofol and dexmedetomidine between treatment arms (10%), although the authors note that this was lower than in prior related studies. Overall, the MENDS2 study suggests there is likely clinical equipoise between propofol and dexmedetomidine in terms of delirium outcomes when combined with best practices, such targeted light sedation, paired awakening and breathing trials, and early mobility.
 

How should we manage sedation to prevent delirium?

Building off of the recent MENDS2 study and earlier work in the field, along with the 2018 PADIS guidelines, the general paradigm of sedation management should be focused on using light sedation with sedation interruptions to minimize overall sedation exposure. Based on the best available evidence to date, targeting less overall sedation leads to improved outcomes in critically ill patients, including mortality and duration of mechanical ventilation. Benzodiazepines should be avoided due to their association with delirium, but currently there is no evidence to suggest one nonbenzodiazepine sedative is better than another. Intensivists can feel comfortable choosing between agents based on a patient’s individual clinical needs, especially when patients are receiving paired spontaneous awakening and breathing trials and early rehabilitation. These same principles should be applied to sedation management and delirium patients in COVID-19 patients as well. While certain circumstances will necessitate deeper sedation at times (e.g., refractory hypoxemia due to ARDS from COVID-19), clinicians should continually reassess the actual sedation needs of the patient with the goal of reducing overall sedation. Focusing effort on these evidence-based practices will help reduce the incidence of delirium and ultimately improve patient outcomes.
 

Dr. Mart is with the Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center; and VA Tennessee Valley Healthcare System Geriatric Research Education and Clinical Center (GRECC), Nashville, Tennessee.

Delirium is a frequent form of organ failure among the critically ill, impacting up to 80% of mechanically ventilated patients (Ely EW et al. JAMA. 2004;291[14]:1753-62). Its cardinal manifestations include disturbances in attention and cognition that occur acutely (e.g., hours to days) that are not better explained by another disease process (such as a toxidrome or dementia) (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. 5th ed., 2013). Duration of delirium in the intensive care unit (ICU) is independently associated with poor outcomes, such as mortality and hospital length of stay, even when accounting for comorbidities, coma duration, sedative use, and severity of illness. Delirium during critical illness is an important bellwether for a patient’s clinical status, often serving as a harbinger for severe or worsening disease.

Over the last two decades, the critical care community has come to understand the importance of recognizing delirium, which is often underdiagnosed, as well as delirium prevention. In the ICU, several factors coalesce to form the perfect environment for the development of delirium. Patients often have preexisting comorbidities that predispose to delirium, such as preexisting cognitive impairment, and the severity of critical illness increases the risk of delirium further. There are also bedside factors, however, that are important for the intensivist to address, many of which are modifiable. These include routinely screening for delirium and assessing level of consciousness, implementing early mobility and rehabilitation, targeting light sedation, and avoiding deliriogenic medications such as benzodiazepines. These evidence-based care practices form the foundation of the 2018 Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (i.e., PADIS guidelines), which aim to reduce delirium and iatrogenesis from critical care (Devlin JW et al. Crit Care Med. 2018;46[9]:e825-e873). The severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) pathogen that has caused the coronavirus disease 2019 (COVID-19) pandemic, however, has brought unprecedented challenges to critical care. One unfortunate side effect has been increased use of deep sedation and, thus, a greater incidence of delirium (Pun BT et al. Lancet Respir Med. 2021;9[3]:239-50). While the impact of the pandemic is unprecedented, thoughtful and careful sedation use remains vital to providing optimal care for the critically ill patient.
 

The link between sedation and delirium

The advent of modern mechanical ventilation brought critical care medicine into a period of rapid growth. Practices derived from the operating room, such as deep sedation and paralysis, became commonplace. Yet, starting in the late 1990s and early 2000s, evidence started growing regarding the impact of delirium and the unique aspects of the ICU that made it so prevalent. Delirium is strongly linked to inpatient mortality in mechanically ventilated adults, and it is best understood as an additional form of organ failure, much like other organ failures commonly recognized and treated by intensivists, such as respiratory or renal failure. Certain medications and sedation practices are associated with the development and duration of delirium. Benzodiazepines, a common sedative medication, are strongly linked to the development of delirium. In a study comparing commonly used sedative and analgesic agents, the use of lorazepam was associated with a greater risk of delirium the following day among critically ill, mechanically ventilated patients (Pandhariphande PP et al. Anesthesiology. 2006;104[1]:21-6). Given how commonly benzodiazepines are used and delirium develops in the ICU, this association has striking implications for clinical care and outcomes such as mortality. It is also significant, given that benzodiazepine use has increased during the pandemic, potentially creating significant downstream consequences. Benzodiazepines should be actively avoided when at all possible, given their propensity to lead to delirium, in accordance with the most recent guidelines.

Which sedation agent to choose?

While the negative effects of benzodiazepine-based sedation are well established, the optimal sedation agent remains unclear. Several other drugs are commonly used in the ICU, including propofol, dexmedetomidine, and opioid agents such as fentanyl and morphine. Propofol and dexmedetomidine are used specifically for their sedative properties, though they have dramatically different effects on the depth of sedation and different mechanisms of action. Opioid agents are most commonly used for their analgesic effect; however, in higher doses or combined with other medications, they have the secondary effect of inducing sedation. No particular sedation agent, however, beyond the avoidance of benzodiazepines has been recommended for use in the most recent guidelines. In the PRODEX and MIDEX studies, dexmedetomidine was noninferior to both midazolam and propofol in achieving targeted light to moderate sedation, and dexmedetomidine was associated with a shorter duration of mechanical ventilation compared to midazolam (Jakob SM et al. JAMA. 2012;307[11]:1151-60). More recently, the SPICE-III trial studied dexmedetomidine vs. usual care and found no difference in 90-day mortality (Shehabi Y et al. N Engl J Med. 2019;380[26]:2506-17).

In choosing the best sedation agent to avoid delirium, the largest and most applicable trial to date is the “Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure,” or MENDS2 trial (Hughes CG et al. N Engl J Med. 2021;384:1424-36). This study was a double-blind, multicenter randomized controlled trial of dexmedetomidine vs propofol in critically ill patients with sepsis receiving mechanical ventilation. The primary outcome was days alive without delirium or coma over the 14-day intervention period. The study enrolled 438 patients between 13 sites, with 422 patients receiving either dexmedetomidine or propofol. Hughes and colleagues found no difference in the primary outcome of days alive without delirium or coma between the dexmedetomidine and the propofol arms. The study also found no difference in secondary outcomes, including ventilator-free days, 90-day mortality, and 6-month global cognition, as well as no difference in safety endpoints. Importantly, there was excellent compliance with guideline-recommended practices of spontaneous awakening and breathing trials and early mobility, both of which are associated with reduced sedation exposure. The study did have some notable nuances, however. The overall doses of trial drugs were relatively low, and there was a moderate use of rescue sedation. There was also a small amount of crossover use of propofol and dexmedetomidine between treatment arms (10%), although the authors note that this was lower than in prior related studies. Overall, the MENDS2 study suggests there is likely clinical equipoise between propofol and dexmedetomidine in terms of delirium outcomes when combined with best practices, such targeted light sedation, paired awakening and breathing trials, and early mobility.
 

How should we manage sedation to prevent delirium?

Building off of the recent MENDS2 study and earlier work in the field, along with the 2018 PADIS guidelines, the general paradigm of sedation management should be focused on using light sedation with sedation interruptions to minimize overall sedation exposure. Based on the best available evidence to date, targeting less overall sedation leads to improved outcomes in critically ill patients, including mortality and duration of mechanical ventilation. Benzodiazepines should be avoided due to their association with delirium, but currently there is no evidence to suggest one nonbenzodiazepine sedative is better than another. Intensivists can feel comfortable choosing between agents based on a patient’s individual clinical needs, especially when patients are receiving paired spontaneous awakening and breathing trials and early rehabilitation. These same principles should be applied to sedation management and delirium patients in COVID-19 patients as well. While certain circumstances will necessitate deeper sedation at times (e.g., refractory hypoxemia due to ARDS from COVID-19), clinicians should continually reassess the actual sedation needs of the patient with the goal of reducing overall sedation. Focusing effort on these evidence-based practices will help reduce the incidence of delirium and ultimately improve patient outcomes.
 

Dr. Mart is with the Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center; Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center; and VA Tennessee Valley Healthcare System Geriatric Research Education and Clinical Center (GRECC), Nashville, Tennessee.

You’ve probably noticed that we recently rolled out a new website – one that is updated, streamlined, and user-friendly (and if you haven’t, go check it out!). Our goal for this project was to ensure that chestnet.org remains your go-to resource when it comes to pulmonary, critical care, and sleep medicine, and to accomplish that, we recognized that some major changes were needed. In short, while we were on the cutting-edge of chest medicine, our website definitely was not.

That’s why we’ve redesigned everything from the ground up. Our very best tools, resources, and offerings are now front and center, which means that you’ll be able to find everything you’re looking for, plus some extras you aren’t, with a few simple clicks.

While there are a lot of new features on the site that we can’t wait for you to discover, here are the upgrades that we’re most excited about.
 

Mobile responsiveness

One of the biggest changes to the site is that it is now mobile responsive. That means you’ll have a seamless experience regardless of what device you’re on. Whether that’s a phone or a tablet, you’ll be able to log in to your account, view any of our resources, and purchase products – functions that used to be only accessible from a desktop.

Intuitive navigation

We have so much content to offer that finding a place for everything can be difficult, and, in the past, resources often got buried within the navigation. That’s why we spent months taking an inventory of our entire site so that we could reorganize all of our resources in a way that would make more sense to you – our users.

Community-centered

We know that you joined CHEST for more than our top-tier resources; you joined to be part of a community. That’s why the new site includes more community-based hubs and opportunities for peer-to-peer interaction. We’ll continue to add more features like blog commenting and Twitter feeds so that you can continue to engage with your colleagues, let your voice be heard, and expand your circle of peers.

User-focused design

What are you hoping to find when coming to our site? What do you want to accomplish? What features would make that easier? By asking these questions, employing a succinct set of design principles, and completing several rounds of member prototype testing, we believe that we redesigned the site not only for you, but with you.

While we’ve made some major upgrades, we’re not done yet. We’ll continue to enhance the site in the upcoming month with one goal in mind – to ensure you’re getting more out of your membership than ever before.

You’ve probably noticed that we recently rolled out a new website – one that is updated, streamlined, and user-friendly (and if you haven’t, go check it out!). Our goal for this project was to ensure that chestnet.org remains your go-to resource when it comes to pulmonary, critical care, and sleep medicine, and to accomplish that, we recognized that some major changes were needed. In short, while we were on the cutting-edge of chest medicine, our website definitely was not.

That’s why we’ve redesigned everything from the ground up. Our very best tools, resources, and offerings are now front and center, which means that you’ll be able to find everything you’re looking for, plus some extras you aren’t, with a few simple clicks.

While there are a lot of new features on the site that we can’t wait for you to discover, here are the upgrades that we’re most excited about.
 

Mobile responsiveness

One of the biggest changes to the site is that it is now mobile responsive. That means you’ll have a seamless experience regardless of what device you’re on. Whether that’s a phone or a tablet, you’ll be able to log in to your account, view any of our resources, and purchase products – functions that used to be only accessible from a desktop.

Intuitive navigation

We have so much content to offer that finding a place for everything can be difficult, and, in the past, resources often got buried within the navigation. That’s why we spent months taking an inventory of our entire site so that we could reorganize all of our resources in a way that would make more sense to you – our users.

Community-centered

We know that you joined CHEST for more than our top-tier resources; you joined to be part of a community. That’s why the new site includes more community-based hubs and opportunities for peer-to-peer interaction. We’ll continue to add more features like blog commenting and Twitter feeds so that you can continue to engage with your colleagues, let your voice be heard, and expand your circle of peers.

User-focused design

What are you hoping to find when coming to our site? What do you want to accomplish? What features would make that easier? By asking these questions, employing a succinct set of design principles, and completing several rounds of member prototype testing, we believe that we redesigned the site not only for you, but with you.

While we’ve made some major upgrades, we’re not done yet. We’ll continue to enhance the site in the upcoming month with one goal in mind – to ensure you’re getting more out of your membership than ever before.

You’ve probably noticed that we recently rolled out a new website – one that is updated, streamlined, and user-friendly (and if you haven’t, go check it out!). Our goal for this project was to ensure that chestnet.org remains your go-to resource when it comes to pulmonary, critical care, and sleep medicine, and to accomplish that, we recognized that some major changes were needed. In short, while we were on the cutting-edge of chest medicine, our website definitely was not.

That’s why we’ve redesigned everything from the ground up. Our very best tools, resources, and offerings are now front and center, which means that you’ll be able to find everything you’re looking for, plus some extras you aren’t, with a few simple clicks.

While there are a lot of new features on the site that we can’t wait for you to discover, here are the upgrades that we’re most excited about.
 

Mobile responsiveness

One of the biggest changes to the site is that it is now mobile responsive. That means you’ll have a seamless experience regardless of what device you’re on. Whether that’s a phone or a tablet, you’ll be able to log in to your account, view any of our resources, and purchase products – functions that used to be only accessible from a desktop.

Intuitive navigation

We have so much content to offer that finding a place for everything can be difficult, and, in the past, resources often got buried within the navigation. That’s why we spent months taking an inventory of our entire site so that we could reorganize all of our resources in a way that would make more sense to you – our users.

Community-centered

We know that you joined CHEST for more than our top-tier resources; you joined to be part of a community. That’s why the new site includes more community-based hubs and opportunities for peer-to-peer interaction. We’ll continue to add more features like blog commenting and Twitter feeds so that you can continue to engage with your colleagues, let your voice be heard, and expand your circle of peers.

User-focused design

What are you hoping to find when coming to our site? What do you want to accomplish? What features would make that easier? By asking these questions, employing a succinct set of design principles, and completing several rounds of member prototype testing, we believe that we redesigned the site not only for you, but with you.

While we’ve made some major upgrades, we’re not done yet. We’ll continue to enhance the site in the upcoming month with one goal in mind – to ensure you’re getting more out of your membership than ever before.

As of 2019, lung cancer remained the leading cause of cancer death in the United States. In March 2021, the USPSTF updated the guidelines for lung cancer screening, increasing the number of eligible patients in order to identify malignancies in the early stages when more treatment options exist. With the growth of lung cancer screening, increasingly smaller pulmonary nodules are being identified in more peripheral locations previously thought to be unreachable with bronchoscopy. While bronchoscopy has been utilized for over a century for therapeutic interventions, the development of the fiberoptic bronchoscope in 1967 ushered in an era of evolving diagnostic functions. From the initial endobronchial and transbronchial biopsy techniques, to the introduction of endobronchial ultrasound, and now the latest navigational and robotic modalities, these advances have opened a new realm of interventions available in our diagnostic approach to lung cancer.

Bronchoscopy has become essential in the diagnosis of thoracic malignancies, providing both diagnostic and staging information in one procedural setting. By first assessing the mediastinal and hilar lymph nodes with endobronchial ultrasound and transbronchial needle aspiration, involved lymph nodes can give both diagnosis and staging information required to guide treatment. This is particularly important in the case of non-small cell lung cancer, which utilizes the TNM staging system. Through the use of convex probe endobronchial ultrasound (CP-EBUS), combined with rapid on-site evaluation (ROSE) by pathologic condition, we can more accurately target the individual lymph nodes for biopsy without the need for any additional procedures that are often more complex and invasive, such as mediastinoscopy. It is important to note the role of CP-EBUS extends beyond the lymph node assessment and can also be utilized for the evaluation of other mediastinal lesions, such as central parenchymal masses. These would otherwise be difficult to access due to the lack of a clear airway to the lesion (Argento and Puchalski. Respir Med. 2016;116:55-8).

While EBUS has improved the sampling of lymph nodes, advanced imaging technologies and subsequent increases in lung cancer screening have increased the number of lung malignancies identified in earlier stages before extension to the lymph nodes occurs. This scenario requires a direct biopsy of the primary nodule or lung mass. While CP-EBUS can be utilized for some central parenchymal lesions, peripheral nodules pose a greater challenge to the bronchoscopist as they cannot be directly visualized with the conventional bronchoscope. These lesions are amenable to traditional sampling techniques such as bronchial brushings and washings in addition to transbronchial needle aspiration and transbronchial biopsy. However, the yield for peripheral lesions is less than that for central tumors and depends on lesion size, distance from hilum, spatial positioning from bronchus, and operator experience. To help localize peripheral lesions, a separate form of endobronchial ultrasound is available that can be used in combination with fluoroscopy to target a lesion. Radial probe endobronchial ultrasound (RP-EBUS) utilizes a rotating ultrasound transducer that can be advanced either through the working channel of the bronchoscope or through a guide sheath to extend to airways beyond what the conventional bronchoscope can reach. This assists the bronchoscopist with locating the correct airway and, therefore, increases the yield of sampling techniques. The use of RP-EBUS has reported diagnostic yields of almost 85% if the ultrasound is located within the lesion, but less than 50% if adjacent to the lesion (Chen et al. Ann Am Thorac Soc. 2014;11[4]:578-82). While this improves the yield beyond that achieved with conventional bronchoscopy alone, it continues to challenge the bronchoscopist to locate an accessible airway from a series of branching bronchi that are beyond the level of direct visualization.

Due to the historical difficulty in accurately reaching peripheral lesions, alternative technologies for sampling these lesions, such as image-guided biopsies or surgical resection, were employed. While CT scan-guided biopsies traditionally have high diagnostic yields, they also carry a higher rate of complications, including pneumothorax and bleeding. This has led to a significant increase over the past 2 decades in new bronchoscopic technologies targeting safer and more accurate sampling of increasingly smaller, peripheral lesions.

Traditionally, any new technologies created were intended to be used alongside flexible fiberoptic bronchoscopy. The more recently introduced technologies, however, aim to provide a safer, more accurate procedure through virtual bronchoscopy. By obtaining CT scan images prior to the procedure, a 3D visualization is constructed of the tracheobronchial tree, allowing for directed guidance of endobronchial accessories to more distal airways. Where the bronchoscopist was previously limited in navigating the bronchial tree to the subsegmental bronchi, virtual bronchoscopy can depict the airways up to the 7th order subdivision. This is a significant improvement in airway visualization – however, only when partnered with guidance technologies can the model be accurately navigated.

One modality that is often coupled with virtual bronchoscopy to accurately reach peripheral lesions is electromagnetic navigation bronchoscopy (ENB). Multiple ENB software systems have been created and continue to be highly utilized by bronchoscopists to target peripheral lesions, as it has often been likened to a GPS for the lungs. With the addition of specific hardware components, a magnetic field is created around the patient where the sensor position can be elicited to within 1-mm accuracy. When overlaid with the CT scan images, the bronchoscopist can have real-time positioning of the probe in all three planes and guide the necessary sampling tools to the lesion of interest. The reported yields for ENB vary but have been shown to increase in the presence of specific image findings such as a positive bronchus sign – an air-filled bronchus leading into the lesion. The presence of this finding can increase the yield up to almost 75% from just under 50% in the absence of a positive bronchus sign. (Ali et al. Ann Am Thorac Soc. 2018;15[8]:978-87). However, regardless of this finding, the overall diagnostic yields for ENB continue to fall below that seen with other image-guided biopsy techniques. The procedural complications, however, are significantly less and, therefore, many physicians continue to advocate for ENB as the initial procedure in attempt to decrease risk for the patient.

The newest technology to be introduced to target peripheral lung lesions and to improve upon the shortcomings of other techniques is robotic-assisted bronchoscopy. While surgical specialties have seen success with robotic techniques over many years, the first robotic bronchoscopy system was not introduced until 2018. At present, there are two systems available: the Monarch^® system by Auris Health and the Ion Endoluminal^® System by Intuitive Surgical. These systems allow for increased bronchoscope stability, improved visualization, adjustable angulation of biopsy tools, and an improved ability to make even subtle turns in the airways. Early studies on both systems were cadaver based, but an increasing number of patient trials are now being reported or actively enrolling. Both systems have shown high rates of lesion localization, greater than 85%, with varying diagnostic yields from 69-79%. Some cadaver studies that utilized artificial tumors reported higher diagnostic yields – over 90% – but this was not seen in initial patient-based studies. (Agrawal et al. J Thorac Dis. 2020;12[6]:3279-86) More data related to the robotic-assisted bronchoscopy systems can be expected in the future as more experience is gained, but initial results are promising in the system’s ability to diagnose early lung cancers safely and accurately.

With increasing technologies and equipment available, bronchoscopy has quickly become an essential step in the diagnosis of lung cancer. While other techniques exist beyond those described here, these are some of the more widely used options currently available. It is not possible at this time to define one technology as the best tool for the diagnosis of lung cancer, as patient factors will always have to be taken into consideration to ensure safety and accuracy. However, with constantly changing technologies, the bronchoscopist now has a variety of tools available to help target previously “unreachable” lesions as we aim to decrease the historically high mortality rates of lung cancer.

Dr. Jewani and Dr. Johnson are from Loyola University Medical Center, Department of Pulmonary and Critical Care Medicine, Maywood, Illinois.


1. Agrawal, Abhinav et al. “Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data.” Journal of thoracic disease vol. 12,6 (2020): 3279-3286. doi:10.21037/jtd.2020.03.35

2. Ali MS, Sethi J, Taneja A, Musani A, Maldonado F. Computed Tomography Bronchus Sign and the Diagnostic Yield of Guided Bronchoscopy for Peripheral Pulmonary Lesions. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Aug;15(8):978-987. doi: 10.1513/AnnalsATS.201711-856OC. PMID: 29877715.

3. Argento AC, Puchalski J. Convex probe EBUS for centrally located parenchymal lesions without a bronchus sign. Respir Med. 2016 Jul;116:55-8. doi: 10.1016/j.rmed.2016.04.012. Epub 2016 Apr 29. PMID: 27296821.

4. Chen A, Chenna P, Loiselle A, Massoni J, Mayse M, Misselhorn D. Radial probe endobronchial ultrasound for peripheral pulmonary lesions. A 5-year institutional experience. Ann Am Thorac Soc. 2014 May;11(4):578-82. doi: 10.1513/AnnalsATS.201311-384OC. PMID: 24635641.
 

As of 2019, lung cancer remained the leading cause of cancer death in the United States. In March 2021, the USPSTF updated the guidelines for lung cancer screening, increasing the number of eligible patients in order to identify malignancies in the early stages when more treatment options exist. With the growth of lung cancer screening, increasingly smaller pulmonary nodules are being identified in more peripheral locations previously thought to be unreachable with bronchoscopy. While bronchoscopy has been utilized for over a century for therapeutic interventions, the development of the fiberoptic bronchoscope in 1967 ushered in an era of evolving diagnostic functions. From the initial endobronchial and transbronchial biopsy techniques, to the introduction of endobronchial ultrasound, and now the latest navigational and robotic modalities, these advances have opened a new realm of interventions available in our diagnostic approach to lung cancer.

Bronchoscopy has become essential in the diagnosis of thoracic malignancies, providing both diagnostic and staging information in one procedural setting. By first assessing the mediastinal and hilar lymph nodes with endobronchial ultrasound and transbronchial needle aspiration, involved lymph nodes can give both diagnosis and staging information required to guide treatment. This is particularly important in the case of non-small cell lung cancer, which utilizes the TNM staging system. Through the use of convex probe endobronchial ultrasound (CP-EBUS), combined with rapid on-site evaluation (ROSE) by pathologic condition, we can more accurately target the individual lymph nodes for biopsy without the need for any additional procedures that are often more complex and invasive, such as mediastinoscopy. It is important to note the role of CP-EBUS extends beyond the lymph node assessment and can also be utilized for the evaluation of other mediastinal lesions, such as central parenchymal masses. These would otherwise be difficult to access due to the lack of a clear airway to the lesion (Argento and Puchalski. Respir Med. 2016;116:55-8).

While EBUS has improved the sampling of lymph nodes, advanced imaging technologies and subsequent increases in lung cancer screening have increased the number of lung malignancies identified in earlier stages before extension to the lymph nodes occurs. This scenario requires a direct biopsy of the primary nodule or lung mass. While CP-EBUS can be utilized for some central parenchymal lesions, peripheral nodules pose a greater challenge to the bronchoscopist as they cannot be directly visualized with the conventional bronchoscope. These lesions are amenable to traditional sampling techniques such as bronchial brushings and washings in addition to transbronchial needle aspiration and transbronchial biopsy. However, the yield for peripheral lesions is less than that for central tumors and depends on lesion size, distance from hilum, spatial positioning from bronchus, and operator experience. To help localize peripheral lesions, a separate form of endobronchial ultrasound is available that can be used in combination with fluoroscopy to target a lesion. Radial probe endobronchial ultrasound (RP-EBUS) utilizes a rotating ultrasound transducer that can be advanced either through the working channel of the bronchoscope or through a guide sheath to extend to airways beyond what the conventional bronchoscope can reach. This assists the bronchoscopist with locating the correct airway and, therefore, increases the yield of sampling techniques. The use of RP-EBUS has reported diagnostic yields of almost 85% if the ultrasound is located within the lesion, but less than 50% if adjacent to the lesion (Chen et al. Ann Am Thorac Soc. 2014;11[4]:578-82). While this improves the yield beyond that achieved with conventional bronchoscopy alone, it continues to challenge the bronchoscopist to locate an accessible airway from a series of branching bronchi that are beyond the level of direct visualization.

Due to the historical difficulty in accurately reaching peripheral lesions, alternative technologies for sampling these lesions, such as image-guided biopsies or surgical resection, were employed. While CT scan-guided biopsies traditionally have high diagnostic yields, they also carry a higher rate of complications, including pneumothorax and bleeding. This has led to a significant increase over the past 2 decades in new bronchoscopic technologies targeting safer and more accurate sampling of increasingly smaller, peripheral lesions.

Traditionally, any new technologies created were intended to be used alongside flexible fiberoptic bronchoscopy. The more recently introduced technologies, however, aim to provide a safer, more accurate procedure through virtual bronchoscopy. By obtaining CT scan images prior to the procedure, a 3D visualization is constructed of the tracheobronchial tree, allowing for directed guidance of endobronchial accessories to more distal airways. Where the bronchoscopist was previously limited in navigating the bronchial tree to the subsegmental bronchi, virtual bronchoscopy can depict the airways up to the 7th order subdivision. This is a significant improvement in airway visualization – however, only when partnered with guidance technologies can the model be accurately navigated.

One modality that is often coupled with virtual bronchoscopy to accurately reach peripheral lesions is electromagnetic navigation bronchoscopy (ENB). Multiple ENB software systems have been created and continue to be highly utilized by bronchoscopists to target peripheral lesions, as it has often been likened to a GPS for the lungs. With the addition of specific hardware components, a magnetic field is created around the patient where the sensor position can be elicited to within 1-mm accuracy. When overlaid with the CT scan images, the bronchoscopist can have real-time positioning of the probe in all three planes and guide the necessary sampling tools to the lesion of interest. The reported yields for ENB vary but have been shown to increase in the presence of specific image findings such as a positive bronchus sign – an air-filled bronchus leading into the lesion. The presence of this finding can increase the yield up to almost 75% from just under 50% in the absence of a positive bronchus sign. (Ali et al. Ann Am Thorac Soc. 2018;15[8]:978-87). However, regardless of this finding, the overall diagnostic yields for ENB continue to fall below that seen with other image-guided biopsy techniques. The procedural complications, however, are significantly less and, therefore, many physicians continue to advocate for ENB as the initial procedure in attempt to decrease risk for the patient.

The newest technology to be introduced to target peripheral lung lesions and to improve upon the shortcomings of other techniques is robotic-assisted bronchoscopy. While surgical specialties have seen success with robotic techniques over many years, the first robotic bronchoscopy system was not introduced until 2018. At present, there are two systems available: the Monarch^® system by Auris Health and the Ion Endoluminal^® System by Intuitive Surgical. These systems allow for increased bronchoscope stability, improved visualization, adjustable angulation of biopsy tools, and an improved ability to make even subtle turns in the airways. Early studies on both systems were cadaver based, but an increasing number of patient trials are now being reported or actively enrolling. Both systems have shown high rates of lesion localization, greater than 85%, with varying diagnostic yields from 69-79%. Some cadaver studies that utilized artificial tumors reported higher diagnostic yields – over 90% – but this was not seen in initial patient-based studies. (Agrawal et al. J Thorac Dis. 2020;12[6]:3279-86) More data related to the robotic-assisted bronchoscopy systems can be expected in the future as more experience is gained, but initial results are promising in the system’s ability to diagnose early lung cancers safely and accurately.

With increasing technologies and equipment available, bronchoscopy has quickly become an essential step in the diagnosis of lung cancer. While other techniques exist beyond those described here, these are some of the more widely used options currently available. It is not possible at this time to define one technology as the best tool for the diagnosis of lung cancer, as patient factors will always have to be taken into consideration to ensure safety and accuracy. However, with constantly changing technologies, the bronchoscopist now has a variety of tools available to help target previously “unreachable” lesions as we aim to decrease the historically high mortality rates of lung cancer.

Dr. Jewani and Dr. Johnson are from Loyola University Medical Center, Department of Pulmonary and Critical Care Medicine, Maywood, Illinois.


1. Agrawal, Abhinav et al. “Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data.” Journal of thoracic disease vol. 12,6 (2020): 3279-3286. doi:10.21037/jtd.2020.03.35

2. Ali MS, Sethi J, Taneja A, Musani A, Maldonado F. Computed Tomography Bronchus Sign and the Diagnostic Yield of Guided Bronchoscopy for Peripheral Pulmonary Lesions. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Aug;15(8):978-987. doi: 10.1513/AnnalsATS.201711-856OC. PMID: 29877715.

3. Argento AC, Puchalski J. Convex probe EBUS for centrally located parenchymal lesions without a bronchus sign. Respir Med. 2016 Jul;116:55-8. doi: 10.1016/j.rmed.2016.04.012. Epub 2016 Apr 29. PMID: 27296821.

4. Chen A, Chenna P, Loiselle A, Massoni J, Mayse M, Misselhorn D. Radial probe endobronchial ultrasound for peripheral pulmonary lesions. A 5-year institutional experience. Ann Am Thorac Soc. 2014 May;11(4):578-82. doi: 10.1513/AnnalsATS.201311-384OC. PMID: 24635641.
 

As of 2019, lung cancer remained the leading cause of cancer death in the United States. In March 2021, the USPSTF updated the guidelines for lung cancer screening, increasing the number of eligible patients in order to identify malignancies in the early stages when more treatment options exist. With the growth of lung cancer screening, increasingly smaller pulmonary nodules are being identified in more peripheral locations previously thought to be unreachable with bronchoscopy. While bronchoscopy has been utilized for over a century for therapeutic interventions, the development of the fiberoptic bronchoscope in 1967 ushered in an era of evolving diagnostic functions. From the initial endobronchial and transbronchial biopsy techniques, to the introduction of endobronchial ultrasound, and now the latest navigational and robotic modalities, these advances have opened a new realm of interventions available in our diagnostic approach to lung cancer.

Bronchoscopy has become essential in the diagnosis of thoracic malignancies, providing both diagnostic and staging information in one procedural setting. By first assessing the mediastinal and hilar lymph nodes with endobronchial ultrasound and transbronchial needle aspiration, involved lymph nodes can give both diagnosis and staging information required to guide treatment. This is particularly important in the case of non-small cell lung cancer, which utilizes the TNM staging system. Through the use of convex probe endobronchial ultrasound (CP-EBUS), combined with rapid on-site evaluation (ROSE) by pathologic condition, we can more accurately target the individual lymph nodes for biopsy without the need for any additional procedures that are often more complex and invasive, such as mediastinoscopy. It is important to note the role of CP-EBUS extends beyond the lymph node assessment and can also be utilized for the evaluation of other mediastinal lesions, such as central parenchymal masses. These would otherwise be difficult to access due to the lack of a clear airway to the lesion (Argento and Puchalski. Respir Med. 2016;116:55-8).

While EBUS has improved the sampling of lymph nodes, advanced imaging technologies and subsequent increases in lung cancer screening have increased the number of lung malignancies identified in earlier stages before extension to the lymph nodes occurs. This scenario requires a direct biopsy of the primary nodule or lung mass. While CP-EBUS can be utilized for some central parenchymal lesions, peripheral nodules pose a greater challenge to the bronchoscopist as they cannot be directly visualized with the conventional bronchoscope. These lesions are amenable to traditional sampling techniques such as bronchial brushings and washings in addition to transbronchial needle aspiration and transbronchial biopsy. However, the yield for peripheral lesions is less than that for central tumors and depends on lesion size, distance from hilum, spatial positioning from bronchus, and operator experience. To help localize peripheral lesions, a separate form of endobronchial ultrasound is available that can be used in combination with fluoroscopy to target a lesion. Radial probe endobronchial ultrasound (RP-EBUS) utilizes a rotating ultrasound transducer that can be advanced either through the working channel of the bronchoscope or through a guide sheath to extend to airways beyond what the conventional bronchoscope can reach. This assists the bronchoscopist with locating the correct airway and, therefore, increases the yield of sampling techniques. The use of RP-EBUS has reported diagnostic yields of almost 85% if the ultrasound is located within the lesion, but less than 50% if adjacent to the lesion (Chen et al. Ann Am Thorac Soc. 2014;11[4]:578-82). While this improves the yield beyond that achieved with conventional bronchoscopy alone, it continues to challenge the bronchoscopist to locate an accessible airway from a series of branching bronchi that are beyond the level of direct visualization.

Due to the historical difficulty in accurately reaching peripheral lesions, alternative technologies for sampling these lesions, such as image-guided biopsies or surgical resection, were employed. While CT scan-guided biopsies traditionally have high diagnostic yields, they also carry a higher rate of complications, including pneumothorax and bleeding. This has led to a significant increase over the past 2 decades in new bronchoscopic technologies targeting safer and more accurate sampling of increasingly smaller, peripheral lesions.

Traditionally, any new technologies created were intended to be used alongside flexible fiberoptic bronchoscopy. The more recently introduced technologies, however, aim to provide a safer, more accurate procedure through virtual bronchoscopy. By obtaining CT scan images prior to the procedure, a 3D visualization is constructed of the tracheobronchial tree, allowing for directed guidance of endobronchial accessories to more distal airways. Where the bronchoscopist was previously limited in navigating the bronchial tree to the subsegmental bronchi, virtual bronchoscopy can depict the airways up to the 7th order subdivision. This is a significant improvement in airway visualization – however, only when partnered with guidance technologies can the model be accurately navigated.

One modality that is often coupled with virtual bronchoscopy to accurately reach peripheral lesions is electromagnetic navigation bronchoscopy (ENB). Multiple ENB software systems have been created and continue to be highly utilized by bronchoscopists to target peripheral lesions, as it has often been likened to a GPS for the lungs. With the addition of specific hardware components, a magnetic field is created around the patient where the sensor position can be elicited to within 1-mm accuracy. When overlaid with the CT scan images, the bronchoscopist can have real-time positioning of the probe in all three planes and guide the necessary sampling tools to the lesion of interest. The reported yields for ENB vary but have been shown to increase in the presence of specific image findings such as a positive bronchus sign – an air-filled bronchus leading into the lesion. The presence of this finding can increase the yield up to almost 75% from just under 50% in the absence of a positive bronchus sign. (Ali et al. Ann Am Thorac Soc. 2018;15[8]:978-87). However, regardless of this finding, the overall diagnostic yields for ENB continue to fall below that seen with other image-guided biopsy techniques. The procedural complications, however, are significantly less and, therefore, many physicians continue to advocate for ENB as the initial procedure in attempt to decrease risk for the patient.

The newest technology to be introduced to target peripheral lung lesions and to improve upon the shortcomings of other techniques is robotic-assisted bronchoscopy. While surgical specialties have seen success with robotic techniques over many years, the first robotic bronchoscopy system was not introduced until 2018. At present, there are two systems available: the Monarch^® system by Auris Health and the Ion Endoluminal^® System by Intuitive Surgical. These systems allow for increased bronchoscope stability, improved visualization, adjustable angulation of biopsy tools, and an improved ability to make even subtle turns in the airways. Early studies on both systems were cadaver based, but an increasing number of patient trials are now being reported or actively enrolling. Both systems have shown high rates of lesion localization, greater than 85%, with varying diagnostic yields from 69-79%. Some cadaver studies that utilized artificial tumors reported higher diagnostic yields – over 90% – but this was not seen in initial patient-based studies. (Agrawal et al. J Thorac Dis. 2020;12[6]:3279-86) More data related to the robotic-assisted bronchoscopy systems can be expected in the future as more experience is gained, but initial results are promising in the system’s ability to diagnose early lung cancers safely and accurately.

With increasing technologies and equipment available, bronchoscopy has quickly become an essential step in the diagnosis of lung cancer. While other techniques exist beyond those described here, these are some of the more widely used options currently available. It is not possible at this time to define one technology as the best tool for the diagnosis of lung cancer, as patient factors will always have to be taken into consideration to ensure safety and accuracy. However, with constantly changing technologies, the bronchoscopist now has a variety of tools available to help target previously “unreachable” lesions as we aim to decrease the historically high mortality rates of lung cancer.

Dr. Jewani and Dr. Johnson are from Loyola University Medical Center, Department of Pulmonary and Critical Care Medicine, Maywood, Illinois.


1. Agrawal, Abhinav et al. “Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data.” Journal of thoracic disease vol. 12,6 (2020): 3279-3286. doi:10.21037/jtd.2020.03.35

2. Ali MS, Sethi J, Taneja A, Musani A, Maldonado F. Computed Tomography Bronchus Sign and the Diagnostic Yield of Guided Bronchoscopy for Peripheral Pulmonary Lesions. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Aug;15(8):978-987. doi: 10.1513/AnnalsATS.201711-856OC. PMID: 29877715.

3. Argento AC, Puchalski J. Convex probe EBUS for centrally located parenchymal lesions without a bronchus sign. Respir Med. 2016 Jul;116:55-8. doi: 10.1016/j.rmed.2016.04.012. Epub 2016 Apr 29. PMID: 27296821.

4. Chen A, Chenna P, Loiselle A, Massoni J, Mayse M, Misselhorn D. Radial probe endobronchial ultrasound for peripheral pulmonary lesions. A 5-year institutional experience. Ann Am Thorac Soc. 2014 May;11(4):578-82. doi: 10.1513/AnnalsATS.201311-384OC. PMID: 24635641.
 

Disaster response

Advancing disaster medicine and global health in times of pandemic

Worldwide hardships due to COVID-19 have revealed opportunities for improvement. Disaster education, telemedicine, knowledge sharing, and resource allocation have been highlighted as such areas. In an August 2020 publication, Hart et al. argue, “Every hospital needs a Disaster Medicine physician now” (Hart et al. “Why Every US Hospital Needs a Disaster Medicine Physician Now”).

Every physician must be prepared to be the expert in times of disaster. A survey of U.S. medical students showed that despite few respondents (<27%) feeling adequately educated, >90% are willing to respond to a natural disaster or a pandemic (Kaiser et al. Disaster Med Pub Health Prep. 2009;3[4]:210-16). While natural disasters have increased by almost 35% since the 1990s, a robust approach to disaster education is not routinely implemented across the fields of medicine, nursing, allied health, and health administration (Freebairn. World Disasters Report 2020: Executive Summary. 2020 ed. IFRC. ). Notably, disaster education provides opportunities for multidisciplinary team-building where learners build a foundation of knowledge together. While no ideal educational model has been fully adopted, high-quality educational opportunities include National Disaster Life Support Foundation courses, SALT triage, and ATLS (Homer et al. Prehospital and Disaster Medicine).

Telemedicine has emerged as a very effective means of disaster support through both direct patient encounters and provider education. Tele-triage used to delineate patients requiring urgent hospitalization from those who can be managed at home has proven effective in areas with limited health care facilities (World Health Organization. Coronavirus disease.). Knowledge sharing opportunities from organizations like Project ECHO have allowed for >368,000 learners from 146 countries to exchange information during >8,000 learning sessions (Project ECHO COVID-19 response.).

Physicians of all specialties should continue to develop skills in triage, surge capacity management, ethical/legal issues surrounding disasters, organizational interoperability, and telemedicine, and emphasize skills to ensure their own personal protection.

Christopher Miller, DO, MPH

Steering Committee Fellow-in-Training Member

Sarang Patil, MD

Steering Committee Member
 

Practice operations

Telehealth and postpandemic care

Telehealth is the use of electronic information and telecommunication technologies to provide care when the physician and the patient are not in the same place. Telehealth has been available for 40 years. The COVID-19 pandemic forced health care providers, systems, and patients to quickly adapt to virtual audio and visual visits, new documentation parameters, billing, and reimbursement structures. Emergency rules have removed the barriers to adoption of home-based diagnostics and virtual visits. It is expected that 20% to 30% post-pandemic care will be provided via telehealth.

Telehealth is particularly beneficial in providing counseling services or managing chronic illnesses, such as COPD and heart failure. There has been an explosion of monitoring devices both wearable and implantable. Some devices, which monitor PA pressure, have been shown to reduce heart failure hospitalizations and all-cause hospitalizations (Shavelle DM, et al. Circ Heart Fail. 2020;13: e006863). Studies have been conducted on home spirometry and oximetry devices in post-lung transplant, ILD (Russell AM et al. Am J Respir Crit Care Med. 2016 Oct 15; 194[8]:989-997), and CF patients (Compton M et al. Telemed J E Health . 2020 Aug;26[8]:978-84). As we move forward, we will have to ascertain what data acquisition is relevant and develop processes to address it in real time.

In this changing landscape of health care delivery, we can anticipate an increase in virtual visits and a trend toward e-consults, which will necessitate further advancements in remote monitoring and assessment and will require us to adopt new practice models.

Caitlin Baxter, MBBS

Steering Committee Fellow-in-Training

Namita Sood, MBBCh, FCCP

Steering Committee Member
 

Transplant network

The rise in lung transplant for older patients

Over the past 20 years, there has been a dramatic increase in lung transplantation in elderly patients, with wide variability in age limit amongst transplant centers. The number of recipients over the age of 65 has risen from 6.9% in 2004 to 29.6% in 2016 in the United States, and 2.6% to 17% internationally. There is a number of factors driving this increase; the prevalence of advanced lung disease with increasing age, advances in targeted therapies to treat cystic fibrosis, an increased willingness of centers to perform transplants in older patients, and the 2005 revision of the Lung Allocation Scoring System (Courtwright A, Cantu E. J Thoracic Dis. 2017:9[9]:3346-51).

In the past, outcomes posttransplant for elderly patients have been conflicting in single-center studies. More recently, Hayanga et al. found no difference in survival up to 1 year between individuals 60-69 and those over 70 (J Heart Lung Transplant. 2015;34[2]:182-88). Mosher et al., however, found the median survival dropped from 4.64 years for patients aged 65-69 to 3.07 years for patients ≥74 (J Heart Lung Transplant. 2021;40[1]:42-55). Notably, older recipients were more likely to be readmitted at 30 and 90 days, and more likely to be discharged to an inpatient rehabilitation facility following transplant (McCarthy et al. J Heart Lung Transplant. 2017;36:S115; Tang et al. Clin Transplant. 2015;29:581-587).

The use of transplant in elderly patients comes with many concerns regarding neurocognitive status, frailty, and other comorbidities, all of which must be rigorously tested prior to consideration(Biswas R et al. Ann Thorac Surg. 2015;100:443-51). Recipient age, creatinine level, bilirubin level, steroid use at the time of transplant, and hospitalization at the time of transplant were associated with increased mortality (Mosher et al. J Heart Lung Transplant. 2021;40[1]:42-55). Further research is warranted in this evolving area.

Melissa B. Lesko, DO

Grant Turner, MD, MHA

Steering Committee Members
 

Women’s lung health

Will the new pulmonary hypertension hemodynamic classification temper the PH ‘sex-paradox’?

Older and contemporary PH registries have consistently shown that PH predominantly affects women ~2 to 3.5 times than men, with female patients having better survival compared with men (Kozu K et al. Heart Vessels. 2018;33[8]:93), a fact attributed to better RV function in female than male subjects. This PH sex-paradox denotes that while estrogen leads to increased susceptibility to PH, it appears to confer better outcomes after PH develops due to improved RV function, since RV dysfunction is a strong predictor of poor outcomes in PH. Multiple preclinical studies have described how estrogen provides protective effects on the RV (Cheng TC et al. Am J Physiol Heart Circ Physiol. 2020;319:H1459; Frump AL et al. Am J Physiol Lung Cell Mol Physiol. 2015;308:L873).
 

The recent recommended updates to the hemodynamic definition reflect acknowledgment of irrefutable evidence that even mildly elevated mPAP (between 19 and 24 mm Hg) is associated with increased morbidity and mortality based on consistent data from pulmonary arterial hypertension (PAH) as well as from other forms of PH [Simonneau G et al. Eur Respir J. 2019;(Jan 24);53(1):1801913). With incorporation of the updated definition that more accurately captures the disease state and its progression, an unaddressed question still remains as to how the new classification will change PH treatment algorithm and outcomes in women compared with men. Setting the definition of PH at a mPAP of 20 mm Hg not only better represents the typical patients with PH in practice, such as those with PH due to left-sided heart disease (Group 2) or PH associated with chronic lung disease (Group 3), but incorporates the preclinical pathologic disease state of PH, in which symptoms may not be evident (Maron BA, et al. Circulation. 2016;133:1240). In adhering to the new PH definition, will earlier diagnosis across the spectrum of all individuals with PH before RV dysfunction has developed improve outcomes for all those afflicted with PH and equalize outcomes between men and women? As future studies continue to investigate the direct effects of sex hormones on the RV and dissect the mechanisms leading to the sex differences in RV function in PH, a pre-clinical diagnosis in all PH patients, particularly male patients with Group 2/3 disease, may mitigate some of the previously observed advantages of estrogen on outcomes in PH.

Lavannya Pandit, MD, FCCP

Disaster response

Advancing disaster medicine and global health in times of pandemic

Worldwide hardships due to COVID-19 have revealed opportunities for improvement. Disaster education, telemedicine, knowledge sharing, and resource allocation have been highlighted as such areas. In an August 2020 publication, Hart et al. argue, “Every hospital needs a Disaster Medicine physician now” (Hart et al. “Why Every US Hospital Needs a Disaster Medicine Physician Now”).

Every physician must be prepared to be the expert in times of disaster. A survey of U.S. medical students showed that despite few respondents (<27%) feeling adequately educated, >90% are willing to respond to a natural disaster or a pandemic (Kaiser et al. Disaster Med Pub Health Prep. 2009;3[4]:210-16). While natural disasters have increased by almost 35% since the 1990s, a robust approach to disaster education is not routinely implemented across the fields of medicine, nursing, allied health, and health administration (Freebairn. World Disasters Report 2020: Executive Summary. 2020 ed. IFRC. ). Notably, disaster education provides opportunities for multidisciplinary team-building where learners build a foundation of knowledge together. While no ideal educational model has been fully adopted, high-quality educational opportunities include National Disaster Life Support Foundation courses, SALT triage, and ATLS (Homer et al. Prehospital and Disaster Medicine).

Telemedicine has emerged as a very effective means of disaster support through both direct patient encounters and provider education. Tele-triage used to delineate patients requiring urgent hospitalization from those who can be managed at home has proven effective in areas with limited health care facilities (World Health Organization. Coronavirus disease.). Knowledge sharing opportunities from organizations like Project ECHO have allowed for >368,000 learners from 146 countries to exchange information during >8,000 learning sessions (Project ECHO COVID-19 response.).

Physicians of all specialties should continue to develop skills in triage, surge capacity management, ethical/legal issues surrounding disasters, organizational interoperability, and telemedicine, and emphasize skills to ensure their own personal protection.

Christopher Miller, DO, MPH

Steering Committee Fellow-in-Training Member

Sarang Patil, MD

Steering Committee Member
 

Practice operations

Telehealth and postpandemic care

Telehealth is the use of electronic information and telecommunication technologies to provide care when the physician and the patient are not in the same place. Telehealth has been available for 40 years. The COVID-19 pandemic forced health care providers, systems, and patients to quickly adapt to virtual audio and visual visits, new documentation parameters, billing, and reimbursement structures. Emergency rules have removed the barriers to adoption of home-based diagnostics and virtual visits. It is expected that 20% to 30% post-pandemic care will be provided via telehealth.

Telehealth is particularly beneficial in providing counseling services or managing chronic illnesses, such as COPD and heart failure. There has been an explosion of monitoring devices both wearable and implantable. Some devices, which monitor PA pressure, have been shown to reduce heart failure hospitalizations and all-cause hospitalizations (Shavelle DM, et al. Circ Heart Fail. 2020;13: e006863). Studies have been conducted on home spirometry and oximetry devices in post-lung transplant, ILD (Russell AM et al. Am J Respir Crit Care Med. 2016 Oct 15; 194[8]:989-997), and CF patients (Compton M et al. Telemed J E Health . 2020 Aug;26[8]:978-84). As we move forward, we will have to ascertain what data acquisition is relevant and develop processes to address it in real time.

In this changing landscape of health care delivery, we can anticipate an increase in virtual visits and a trend toward e-consults, which will necessitate further advancements in remote monitoring and assessment and will require us to adopt new practice models.

Caitlin Baxter, MBBS

Steering Committee Fellow-in-Training

Namita Sood, MBBCh, FCCP

Steering Committee Member
 

Transplant network

The rise in lung transplant for older patients

Over the past 20 years, there has been a dramatic increase in lung transplantation in elderly patients, with wide variability in age limit amongst transplant centers. The number of recipients over the age of 65 has risen from 6.9% in 2004 to 29.6% in 2016 in the United States, and 2.6% to 17% internationally. There is a number of factors driving this increase; the prevalence of advanced lung disease with increasing age, advances in targeted therapies to treat cystic fibrosis, an increased willingness of centers to perform transplants in older patients, and the 2005 revision of the Lung Allocation Scoring System (Courtwright A, Cantu E. J Thoracic Dis. 2017:9[9]:3346-51).

In the past, outcomes posttransplant for elderly patients have been conflicting in single-center studies. More recently, Hayanga et al. found no difference in survival up to 1 year between individuals 60-69 and those over 70 (J Heart Lung Transplant. 2015;34[2]:182-88). Mosher et al., however, found the median survival dropped from 4.64 years for patients aged 65-69 to 3.07 years for patients ≥74 (J Heart Lung Transplant. 2021;40[1]:42-55). Notably, older recipients were more likely to be readmitted at 30 and 90 days, and more likely to be discharged to an inpatient rehabilitation facility following transplant (McCarthy et al. J Heart Lung Transplant. 2017;36:S115; Tang et al. Clin Transplant. 2015;29:581-587).

The use of transplant in elderly patients comes with many concerns regarding neurocognitive status, frailty, and other comorbidities, all of which must be rigorously tested prior to consideration(Biswas R et al. Ann Thorac Surg. 2015;100:443-51). Recipient age, creatinine level, bilirubin level, steroid use at the time of transplant, and hospitalization at the time of transplant were associated with increased mortality (Mosher et al. J Heart Lung Transplant. 2021;40[1]:42-55). Further research is warranted in this evolving area.

Melissa B. Lesko, DO

Grant Turner, MD, MHA

Steering Committee Members
 

Women’s lung health

Will the new pulmonary hypertension hemodynamic classification temper the PH ‘sex-paradox’?

Older and contemporary PH registries have consistently shown that PH predominantly affects women ~2 to 3.5 times than men, with female patients having better survival compared with men (Kozu K et al. Heart Vessels. 2018;33[8]:93), a fact attributed to better RV function in female than male subjects. This PH sex-paradox denotes that while estrogen leads to increased susceptibility to PH, it appears to confer better outcomes after PH develops due to improved RV function, since RV dysfunction is a strong predictor of poor outcomes in PH. Multiple preclinical studies have described how estrogen provides protective effects on the RV (Cheng TC et al. Am J Physiol Heart Circ Physiol. 2020;319:H1459; Frump AL et al. Am J Physiol Lung Cell Mol Physiol. 2015;308:L873).
 

The recent recommended updates to the hemodynamic definition reflect acknowledgment of irrefutable evidence that even mildly elevated mPAP (between 19 and 24 mm Hg) is associated with increased morbidity and mortality based on consistent data from pulmonary arterial hypertension (PAH) as well as from other forms of PH [Simonneau G et al. Eur Respir J. 2019;(Jan 24);53(1):1801913). With incorporation of the updated definition that more accurately captures the disease state and its progression, an unaddressed question still remains as to how the new classification will change PH treatment algorithm and outcomes in women compared with men. Setting the definition of PH at a mPAP of 20 mm Hg not only better represents the typical patients with PH in practice, such as those with PH due to left-sided heart disease (Group 2) or PH associated with chronic lung disease (Group 3), but incorporates the preclinical pathologic disease state of PH, in which symptoms may not be evident (Maron BA, et al. Circulation. 2016;133:1240). In adhering to the new PH definition, will earlier diagnosis across the spectrum of all individuals with PH before RV dysfunction has developed improve outcomes for all those afflicted with PH and equalize outcomes between men and women? As future studies continue to investigate the direct effects of sex hormones on the RV and dissect the mechanisms leading to the sex differences in RV function in PH, a pre-clinical diagnosis in all PH patients, particularly male patients with Group 2/3 disease, may mitigate some of the previously observed advantages of estrogen on outcomes in PH.

Lavannya Pandit, MD, FCCP

Disaster response

Advancing disaster medicine and global health in times of pandemic

Worldwide hardships due to COVID-19 have revealed opportunities for improvement. Disaster education, telemedicine, knowledge sharing, and resource allocation have been highlighted as such areas. In an August 2020 publication, Hart et al. argue, “Every hospital needs a Disaster Medicine physician now” (Hart et al. “Why Every US Hospital Needs a Disaster Medicine Physician Now”).

Every physician must be prepared to be the expert in times of disaster. A survey of U.S. medical students showed that despite few respondents (<27%) feeling adequately educated, >90% are willing to respond to a natural disaster or a pandemic (Kaiser et al. Disaster Med Pub Health Prep. 2009;3[4]:210-16). While natural disasters have increased by almost 35% since the 1990s, a robust approach to disaster education is not routinely implemented across the fields of medicine, nursing, allied health, and health administration (Freebairn. World Disasters Report 2020: Executive Summary. 2020 ed. IFRC. ). Notably, disaster education provides opportunities for multidisciplinary team-building where learners build a foundation of knowledge together. While no ideal educational model has been fully adopted, high-quality educational opportunities include National Disaster Life Support Foundation courses, SALT triage, and ATLS (Homer et al. Prehospital and Disaster Medicine).

Telemedicine has emerged as a very effective means of disaster support through both direct patient encounters and provider education. Tele-triage used to delineate patients requiring urgent hospitalization from those who can be managed at home has proven effective in areas with limited health care facilities (World Health Organization. Coronavirus disease.). Knowledge sharing opportunities from organizations like Project ECHO have allowed for >368,000 learners from 146 countries to exchange information during >8,000 learning sessions (Project ECHO COVID-19 response.).

Physicians of all specialties should continue to develop skills in triage, surge capacity management, ethical/legal issues surrounding disasters, organizational interoperability, and telemedicine, and emphasize skills to ensure their own personal protection.

Christopher Miller, DO, MPH

Steering Committee Fellow-in-Training Member

Sarang Patil, MD

Steering Committee Member
 

Practice operations

Telehealth and postpandemic care

Telehealth is the use of electronic information and telecommunication technologies to provide care when the physician and the patient are not in the same place. Telehealth has been available for 40 years. The COVID-19 pandemic forced health care providers, systems, and patients to quickly adapt to virtual audio and visual visits, new documentation parameters, billing, and reimbursement structures. Emergency rules have removed the barriers to adoption of home-based diagnostics and virtual visits. It is expected that 20% to 30% post-pandemic care will be provided via telehealth.

Telehealth is particularly beneficial in providing counseling services or managing chronic illnesses, such as COPD and heart failure. There has been an explosion of monitoring devices both wearable and implantable. Some devices, which monitor PA pressure, have been shown to reduce heart failure hospitalizations and all-cause hospitalizations (Shavelle DM, et al. Circ Heart Fail. 2020;13: e006863). Studies have been conducted on home spirometry and oximetry devices in post-lung transplant, ILD (Russell AM et al. Am J Respir Crit Care Med. 2016 Oct 15; 194[8]:989-997), and CF patients (Compton M et al. Telemed J E Health . 2020 Aug;26[8]:978-84). As we move forward, we will have to ascertain what data acquisition is relevant and develop processes to address it in real time.

In this changing landscape of health care delivery, we can anticipate an increase in virtual visits and a trend toward e-consults, which will necessitate further advancements in remote monitoring and assessment and will require us to adopt new practice models.

Caitlin Baxter, MBBS

Steering Committee Fellow-in-Training

Namita Sood, MBBCh, FCCP

Steering Committee Member
 

Transplant network

The rise in lung transplant for older patients

Over the past 20 years, there has been a dramatic increase in lung transplantation in elderly patients, with wide variability in age limit amongst transplant centers. The number of recipients over the age of 65 has risen from 6.9% in 2004 to 29.6% in 2016 in the United States, and 2.6% to 17% internationally. There is a number of factors driving this increase; the prevalence of advanced lung disease with increasing age, advances in targeted therapies to treat cystic fibrosis, an increased willingness of centers to perform transplants in older patients, and the 2005 revision of the Lung Allocation Scoring System (Courtwright A, Cantu E. J Thoracic Dis. 2017:9[9]:3346-51).

In the past, outcomes posttransplant for elderly patients have been conflicting in single-center studies. More recently, Hayanga et al. found no difference in survival up to 1 year between individuals 60-69 and those over 70 (J Heart Lung Transplant. 2015;34[2]:182-88). Mosher et al., however, found the median survival dropped from 4.64 years for patients aged 65-69 to 3.07 years for patients ≥74 (J Heart Lung Transplant. 2021;40[1]:42-55). Notably, older recipients were more likely to be readmitted at 30 and 90 days, and more likely to be discharged to an inpatient rehabilitation facility following transplant (McCarthy et al. J Heart Lung Transplant. 2017;36:S115; Tang et al. Clin Transplant. 2015;29:581-587).

The use of transplant in elderly patients comes with many concerns regarding neurocognitive status, frailty, and other comorbidities, all of which must be rigorously tested prior to consideration(Biswas R et al. Ann Thorac Surg. 2015;100:443-51). Recipient age, creatinine level, bilirubin level, steroid use at the time of transplant, and hospitalization at the time of transplant were associated with increased mortality (Mosher et al. J Heart Lung Transplant. 2021;40[1]:42-55). Further research is warranted in this evolving area.

Melissa B. Lesko, DO

Grant Turner, MD, MHA

Steering Committee Members
 

Women’s lung health

Will the new pulmonary hypertension hemodynamic classification temper the PH ‘sex-paradox’?

Older and contemporary PH registries have consistently shown that PH predominantly affects women ~2 to 3.5 times than men, with female patients having better survival compared with men (Kozu K et al. Heart Vessels. 2018;33[8]:93), a fact attributed to better RV function in female than male subjects. This PH sex-paradox denotes that while estrogen leads to increased susceptibility to PH, it appears to confer better outcomes after PH develops due to improved RV function, since RV dysfunction is a strong predictor of poor outcomes in PH. Multiple preclinical studies have described how estrogen provides protective effects on the RV (Cheng TC et al. Am J Physiol Heart Circ Physiol. 2020;319:H1459; Frump AL et al. Am J Physiol Lung Cell Mol Physiol. 2015;308:L873).
 

The recent recommended updates to the hemodynamic definition reflect acknowledgment of irrefutable evidence that even mildly elevated mPAP (between 19 and 24 mm Hg) is associated with increased morbidity and mortality based on consistent data from pulmonary arterial hypertension (PAH) as well as from other forms of PH [Simonneau G et al. Eur Respir J. 2019;(Jan 24);53(1):1801913). With incorporation of the updated definition that more accurately captures the disease state and its progression, an unaddressed question still remains as to how the new classification will change PH treatment algorithm and outcomes in women compared with men. Setting the definition of PH at a mPAP of 20 mm Hg not only better represents the typical patients with PH in practice, such as those with PH due to left-sided heart disease (Group 2) or PH associated with chronic lung disease (Group 3), but incorporates the preclinical pathologic disease state of PH, in which symptoms may not be evident (Maron BA, et al. Circulation. 2016;133:1240). In adhering to the new PH definition, will earlier diagnosis across the spectrum of all individuals with PH before RV dysfunction has developed improve outcomes for all those afflicted with PH and equalize outcomes between men and women? As future studies continue to investigate the direct effects of sex hormones on the RV and dissect the mechanisms leading to the sex differences in RV function in PH, a pre-clinical diagnosis in all PH patients, particularly male patients with Group 2/3 disease, may mitigate some of the previously observed advantages of estrogen on outcomes in PH.

Lavannya Pandit, MD, FCCP

The Canadian Association of Gastroenterology (CAG) has published a two-part clinical practice guideline for immunizing patients with inflammatory bowel disease (IBD) that covers both live and inactivated vaccines across pediatric and adult patients.

The guideline, which has been endorsed by the American Gastroenterological Association, is composed of recommendations drawn from a broader body of data than prior publications on the same topic, according to Eric I. Benchimol, MD, PhD, of the University of Ottawa and the University of Toronto, and colleagues.

“Previous guidelines on immunizations of patients with IBD considered only the limited available evidence of vaccine safety and effectiveness in IBD populations, and failed to consider the ample evidence available in the general population or in other immune-mediated inflammatory diseases when assessing the certainty of evidence or developing their recommendations,” they wrote in Gastroenterology.
 

Part 1: Live vaccine recommendations

The first part of the guideline includes seven recommendations for use of live vaccines in patients with IBD.

In this area, decision-making is largely dependent upon use of immunosuppressive therapy, which the investigators defined as “corticosteroids, thiopurines, biologics, small molecules such as JAK [Janus kinase] inhibitors, and combinations thereof,” with the caveat that “there is no standard definition of immunosuppression,” and “the degree to which immunosuppressive therapy causes clinically significant immunosuppression generally is dose related and varies by drug.”

Before offering specific recommendations, Dr. Benchimol and colleagues provided three general principles to abide by: 1. Clinicians should review each patient’s history of immunization and vaccine-preventable diseases at diagnosis and on a routine basis; 2. Appropriate vaccinations should ideally be given prior to starting immunosuppressive therapy; and 3. Immunosuppressive therapy (when urgently needed) should not be delayed so that immunizations can be given in advance.

“[Delaying therapy] could lead to more anticipated harms than benefits, due to the risk of progression of the inflammatory activity and resulting complications,” the investigators wrote.

Specific recommendations in the guideline address measles, mumps, and rubella (MMR); and varicella. Both vaccines are recommended for susceptible pediatric and adult patients not taking immunosuppressive therapy. In contrast, neither vaccine is recommended for immunosuppressed patients of any age. Certainty of evidence ranged from very low to moderate.

Concerning vaccination within the first 6 months of life for infants born of mothers taking biologics, the expert panel did not reach a consensus.

“[T]he group was unable to recommend for or against their routine use because the desirable and undesirable effects were closely balanced and the evidence on safety outcomes was insufficient to justify a recommendation,” wrote Dr. Benchimol and colleagues. “Health care providers should be cautious with the administration of live vaccines in the first year of life in the infants of mothers using biologics. These infants should be evaluated by clinicians with expertise in the impact of exposure to monoclonal antibody biologics in utero.”
 

Part 2: Inactivated vaccine recommendations

The second part of the guideline, by lead author Jennifer L. Jones, MD, of Dalhousie University, Queen Elizabeth II Health Sciences Center, Halifax, N.S., and colleagues, provides 15 recommendations for giving inactivated vaccines to patients with IBD.

The panel considered eight vaccines: Haemophilus influenzae type B (Hib); herpes zoster (HZ); hepatitis B; influenza; Streptococcus pneumoniae (pneumococcal vaccine); Neisseria meningitidis (meningococcal vaccine); human papillomavirus (HPV); and diphtheria, tetanus, and pertussis.

Generally, the above vaccines are recommended on an age-appropriate basis, regardless of immunosuppression status, albeit with varying levels of confidence. For example, the Hib vaccine is strongly recommended for pediatric patients 5 years and younger, whereas the same recommendation for older children and adults is conditional.

For several patient populations and vaccines, the guideline panel did not reach a consensus, including use of double-dose hepatitis B vaccine for immunosuppressed adults, timing seasonal flu shots with dosing of biologics, use of pneumococcal vaccines in nonimmunosuppressed patents without a risk factor for pneumococcal disease, use of meningococcal vaccines in adults not at risk for invasive meningococcal disease, and use of HPV vaccine in patients aged 27-45 years.

While immunosuppressive therapy is not a contraindication for giving inactivated vaccines, Dr. Jones and colleagues noted that immunosuppression may hinder vaccine responses.

“Given that patients with IBD on immunosuppressive therapy may have lower immune response to vaccine, further research will be needed to assess the safety and effectiveness of high-dose vs. standard-dose vaccination strategy,” they wrote, also noting that more work is needed to determine if accelerated vaccinations strategies may be feasible prior to initiation of immunosuppressive therapy.

Because of a lack of evidence, the guideline panel did not issue IBD-specific recommendations for vaccines against SARS-CoV-2; however, Dr. Jones and colleagues suggested that clinicians reference a CAG publication on the subject published earlier this year.

The guideline was supported by grants to the Canadian Association of Gastroenterology from the Canadian Institutes of Health Research’s Institute of Nutrition, Metabolism and Diabetes; and CANImmunize. Dr. Benchimol disclosed additional relationships with the Canadian Institutes of Health Research, Crohn’s and Colitis Canada; and the Canadian Child Health Clinician Scientist Program.

The Canadian Association of Gastroenterology (CAG) has published a two-part clinical practice guideline for immunizing patients with inflammatory bowel disease (IBD) that covers both live and inactivated vaccines across pediatric and adult patients.

The guideline, which has been endorsed by the American Gastroenterological Association, is composed of recommendations drawn from a broader body of data than prior publications on the same topic, according to Eric I. Benchimol, MD, PhD, of the University of Ottawa and the University of Toronto, and colleagues.

“Previous guidelines on immunizations of patients with IBD considered only the limited available evidence of vaccine safety and effectiveness in IBD populations, and failed to consider the ample evidence available in the general population or in other immune-mediated inflammatory diseases when assessing the certainty of evidence or developing their recommendations,” they wrote in Gastroenterology.
 

Part 1: Live vaccine recommendations

The first part of the guideline includes seven recommendations for use of live vaccines in patients with IBD.

In this area, decision-making is largely dependent upon use of immunosuppressive therapy, which the investigators defined as “corticosteroids, thiopurines, biologics, small molecules such as JAK [Janus kinase] inhibitors, and combinations thereof,” with the caveat that “there is no standard definition of immunosuppression,” and “the degree to which immunosuppressive therapy causes clinically significant immunosuppression generally is dose related and varies by drug.”

Before offering specific recommendations, Dr. Benchimol and colleagues provided three general principles to abide by: 1. Clinicians should review each patient’s history of immunization and vaccine-preventable diseases at diagnosis and on a routine basis; 2. Appropriate vaccinations should ideally be given prior to starting immunosuppressive therapy; and 3. Immunosuppressive therapy (when urgently needed) should not be delayed so that immunizations can be given in advance.

“[Delaying therapy] could lead to more anticipated harms than benefits, due to the risk of progression of the inflammatory activity and resulting complications,” the investigators wrote.

Specific recommendations in the guideline address measles, mumps, and rubella (MMR); and varicella. Both vaccines are recommended for susceptible pediatric and adult patients not taking immunosuppressive therapy. In contrast, neither vaccine is recommended for immunosuppressed patients of any age. Certainty of evidence ranged from very low to moderate.

Concerning vaccination within the first 6 months of life for infants born of mothers taking biologics, the expert panel did not reach a consensus.

“[T]he group was unable to recommend for or against their routine use because the desirable and undesirable effects were closely balanced and the evidence on safety outcomes was insufficient to justify a recommendation,” wrote Dr. Benchimol and colleagues. “Health care providers should be cautious with the administration of live vaccines in the first year of life in the infants of mothers using biologics. These infants should be evaluated by clinicians with expertise in the impact of exposure to monoclonal antibody biologics in utero.”
 

Part 2: Inactivated vaccine recommendations

The second part of the guideline, by lead author Jennifer L. Jones, MD, of Dalhousie University, Queen Elizabeth II Health Sciences Center, Halifax, N.S., and colleagues, provides 15 recommendations for giving inactivated vaccines to patients with IBD.

The panel considered eight vaccines: Haemophilus influenzae type B (Hib); herpes zoster (HZ); hepatitis B; influenza; Streptococcus pneumoniae (pneumococcal vaccine); Neisseria meningitidis (meningococcal vaccine); human papillomavirus (HPV); and diphtheria, tetanus, and pertussis.

Generally, the above vaccines are recommended on an age-appropriate basis, regardless of immunosuppression status, albeit with varying levels of confidence. For example, the Hib vaccine is strongly recommended for pediatric patients 5 years and younger, whereas the same recommendation for older children and adults is conditional.

For several patient populations and vaccines, the guideline panel did not reach a consensus, including use of double-dose hepatitis B vaccine for immunosuppressed adults, timing seasonal flu shots with dosing of biologics, use of pneumococcal vaccines in nonimmunosuppressed patents without a risk factor for pneumococcal disease, use of meningococcal vaccines in adults not at risk for invasive meningococcal disease, and use of HPV vaccine in patients aged 27-45 years.

While immunosuppressive therapy is not a contraindication for giving inactivated vaccines, Dr. Jones and colleagues noted that immunosuppression may hinder vaccine responses.

“Given that patients with IBD on immunosuppressive therapy may have lower immune response to vaccine, further research will be needed to assess the safety and effectiveness of high-dose vs. standard-dose vaccination strategy,” they wrote, also noting that more work is needed to determine if accelerated vaccinations strategies may be feasible prior to initiation of immunosuppressive therapy.

Because of a lack of evidence, the guideline panel did not issue IBD-specific recommendations for vaccines against SARS-CoV-2; however, Dr. Jones and colleagues suggested that clinicians reference a CAG publication on the subject published earlier this year.

The guideline was supported by grants to the Canadian Association of Gastroenterology from the Canadian Institutes of Health Research’s Institute of Nutrition, Metabolism and Diabetes; and CANImmunize. Dr. Benchimol disclosed additional relationships with the Canadian Institutes of Health Research, Crohn’s and Colitis Canada; and the Canadian Child Health Clinician Scientist Program.

The Canadian Association of Gastroenterology (CAG) has published a two-part clinical practice guideline for immunizing patients with inflammatory bowel disease (IBD) that covers both live and inactivated vaccines across pediatric and adult patients.

The guideline, which has been endorsed by the American Gastroenterological Association, is composed of recommendations drawn from a broader body of data than prior publications on the same topic, according to Eric I. Benchimol, MD, PhD, of the University of Ottawa and the University of Toronto, and colleagues.

“Previous guidelines on immunizations of patients with IBD considered only the limited available evidence of vaccine safety and effectiveness in IBD populations, and failed to consider the ample evidence available in the general population or in other immune-mediated inflammatory diseases when assessing the certainty of evidence or developing their recommendations,” they wrote in Gastroenterology.
 

Part 1: Live vaccine recommendations

The first part of the guideline includes seven recommendations for use of live vaccines in patients with IBD.

In this area, decision-making is largely dependent upon use of immunosuppressive therapy, which the investigators defined as “corticosteroids, thiopurines, biologics, small molecules such as JAK [Janus kinase] inhibitors, and combinations thereof,” with the caveat that “there is no standard definition of immunosuppression,” and “the degree to which immunosuppressive therapy causes clinically significant immunosuppression generally is dose related and varies by drug.”

Before offering specific recommendations, Dr. Benchimol and colleagues provided three general principles to abide by: 1. Clinicians should review each patient’s history of immunization and vaccine-preventable diseases at diagnosis and on a routine basis; 2. Appropriate vaccinations should ideally be given prior to starting immunosuppressive therapy; and 3. Immunosuppressive therapy (when urgently needed) should not be delayed so that immunizations can be given in advance.

“[Delaying therapy] could lead to more anticipated harms than benefits, due to the risk of progression of the inflammatory activity and resulting complications,” the investigators wrote.

Specific recommendations in the guideline address measles, mumps, and rubella (MMR); and varicella. Both vaccines are recommended for susceptible pediatric and adult patients not taking immunosuppressive therapy. In contrast, neither vaccine is recommended for immunosuppressed patients of any age. Certainty of evidence ranged from very low to moderate.

Concerning vaccination within the first 6 months of life for infants born of mothers taking biologics, the expert panel did not reach a consensus.

“[T]he group was unable to recommend for or against their routine use because the desirable and undesirable effects were closely balanced and the evidence on safety outcomes was insufficient to justify a recommendation,” wrote Dr. Benchimol and colleagues. “Health care providers should be cautious with the administration of live vaccines in the first year of life in the infants of mothers using biologics. These infants should be evaluated by clinicians with expertise in the impact of exposure to monoclonal antibody biologics in utero.”
 

Part 2: Inactivated vaccine recommendations

The second part of the guideline, by lead author Jennifer L. Jones, MD, of Dalhousie University, Queen Elizabeth II Health Sciences Center, Halifax, N.S., and colleagues, provides 15 recommendations for giving inactivated vaccines to patients with IBD.

The panel considered eight vaccines: Haemophilus influenzae type B (Hib); herpes zoster (HZ); hepatitis B; influenza; Streptococcus pneumoniae (pneumococcal vaccine); Neisseria meningitidis (meningococcal vaccine); human papillomavirus (HPV); and diphtheria, tetanus, and pertussis.

Generally, the above vaccines are recommended on an age-appropriate basis, regardless of immunosuppression status, albeit with varying levels of confidence. For example, the Hib vaccine is strongly recommended for pediatric patients 5 years and younger, whereas the same recommendation for older children and adults is conditional.

For several patient populations and vaccines, the guideline panel did not reach a consensus, including use of double-dose hepatitis B vaccine for immunosuppressed adults, timing seasonal flu shots with dosing of biologics, use of pneumococcal vaccines in nonimmunosuppressed patents without a risk factor for pneumococcal disease, use of meningococcal vaccines in adults not at risk for invasive meningococcal disease, and use of HPV vaccine in patients aged 27-45 years.

While immunosuppressive therapy is not a contraindication for giving inactivated vaccines, Dr. Jones and colleagues noted that immunosuppression may hinder vaccine responses.

“Given that patients with IBD on immunosuppressive therapy may have lower immune response to vaccine, further research will be needed to assess the safety and effectiveness of high-dose vs. standard-dose vaccination strategy,” they wrote, also noting that more work is needed to determine if accelerated vaccinations strategies may be feasible prior to initiation of immunosuppressive therapy.

Because of a lack of evidence, the guideline panel did not issue IBD-specific recommendations for vaccines against SARS-CoV-2; however, Dr. Jones and colleagues suggested that clinicians reference a CAG publication on the subject published earlier this year.

The guideline was supported by grants to the Canadian Association of Gastroenterology from the Canadian Institutes of Health Research’s Institute of Nutrition, Metabolism and Diabetes; and CANImmunize. Dr. Benchimol disclosed additional relationships with the Canadian Institutes of Health Research, Crohn’s and Colitis Canada; and the Canadian Child Health Clinician Scientist Program.