Better bariatric surgery outcomes with lower preoperative BMI

Results confirm benefits of BMI below 30 after bariatric surgery
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Delaying bariatric surgery until body mass index is highly elevated may reduce the likelihood of achieving a BMI of less than 30 within a year, according toa paper published online July 26 in JAMA Surgery.

A retrospective study using prospectively gathered clinical data of 27,320 adults who underwent bariatric surgery in Michigan showed around one in three (36%) achieved a BMI below 30 within a year after surgery (JAMA Surgery 2017, July 26. doi: 10.1001/jamasurg.2017.2348). But obese patients with a body mass index of less than 40 kg/m2 before undergoing bariatric surgery are significantly more likely to achieve a postoperative BMI of under 30.

Individuals who had a preoperative BMI of less than 40 had a 12-fold higher chance of getting their BMI below 30, compared to those whose preoperative BMI was 40 or above (95% confidence interval 1.71-14.16, P less than .001). Only 8.5% of individuals with a BMI at or above 50 achieved a postoperative BMI below 30.

Dr. Oliver A. Varban
“It is important to note that EWL [excess weight loss] percentage may appear exaggerated in relation to actual mass lost in patients with lower initial BMI in these studies,” wrote Oliver A. Varban, MD, FACS, of the University of Michigan Health Systems, and his coauthors. “However, it also highlights the advantages of early surgical management of obesity in that smaller amounts of weight loss are required to achieve the desired effect.”

The likelihood of getting below 30 within a year was eightfold higher in patients who had a sleeve gastrectomy, 21 times greater in those who underwent Roux-en-Y bypass, and 82 times higher in those who had a duodenal switch, compared with patients who had adjustable gastric banding (P less than .001).

The researchers also compared other outcomes in individuals whose BMI dropped below 30 and in those who did not achieve this degree of weight loss. The analysis showed that those with a BMI below 30 after 1 year had at least a twofold greater chance of discontinuing cholesterol-lowering medications, insulin, diabetes medications, antihypertensives, and CPAP for sleep apnea, compared with those whose BMI remained at 30 or above. They were also more than three times more likely to report being ‘very satisfied’ with the outcomes of surgery.

The authors noted that the cohort’s mean BMI was 48, which was above the established threshold for bariatric surgery, namely a BMI of 40, or 35 with weight-related comorbidities.

“Our results suggest that patients with morbid obesity should be targeted for surgery when their BMI is still less than 40, as these patients are more likely to achieve a target BMI that results in substantial reduction in weight-related comorbidities,” the authors wrote.

However, they stressed that their findings should not be taken as a reason to exclude patients with a BMI above 40 from surgery, pointing out that even for patients with higher preoperative BMIs, bariatric surgery offered substantial health and quality of life benefits.

They also acknowledged that 1-year weight data was available for around 50% of patients in the registry, which may have led to selection bias.

“Policies and practice patterns that delay or incentivize patients to pursue bariatric surgery only once the BMI is highly elevated can result in inferior outcomes,” the investigators concluded.

Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.

Patients with obesity need a multidisciplinary approach to achieve a healthy weight, and AGA believes that gastroenterologists are in a unique position to lead the care team.

To provide gastroenterologists with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management, including a model for how to operationalize business issues, AGA has created an Obesity Practice Guide. The program includes an obesity program to help gastroenterologists manage their patients with obesity, as well as a framework focused on the business operational issues related to the management of obese patients. Learn more at www.gastro.org/obesity.

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The authors’ conclusion that bariatric surgery should be more liberally applied to patients with less severe obesity is consistent with multiple reports of improved control of type 2 diabetes, if not remission, among lower-BMI patient populations following MBS [metabolic and bariatric surgery]. However, these reports generally do not refute the importance of weight loss in achieving important clinical benefit among patients with obesity-related comorbid disease.

One strength of the present study is that it is a clinical database. However, 50% attrition of the follow-up weight loss data at 1 year is potentially problematic.
 

Bruce M. Wolfe, MD, FACS, and Elizaveta Walker, MPH, are in the division of bariatric surgery, department of surgery, at Oregon Health & Science University, Portland. These comments are taken from an accompanying editorial (JAMA Surgery 2017 Jul 26. doi: 10.1001/jamasurg.2017.2349). No conflicts of interest were declared.

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The authors’ conclusion that bariatric surgery should be more liberally applied to patients with less severe obesity is consistent with multiple reports of improved control of type 2 diabetes, if not remission, among lower-BMI patient populations following MBS [metabolic and bariatric surgery]. However, these reports generally do not refute the importance of weight loss in achieving important clinical benefit among patients with obesity-related comorbid disease.

One strength of the present study is that it is a clinical database. However, 50% attrition of the follow-up weight loss data at 1 year is potentially problematic.
 

Bruce M. Wolfe, MD, FACS, and Elizaveta Walker, MPH, are in the division of bariatric surgery, department of surgery, at Oregon Health & Science University, Portland. These comments are taken from an accompanying editorial (JAMA Surgery 2017 Jul 26. doi: 10.1001/jamasurg.2017.2349). No conflicts of interest were declared.

Body

 

The authors’ conclusion that bariatric surgery should be more liberally applied to patients with less severe obesity is consistent with multiple reports of improved control of type 2 diabetes, if not remission, among lower-BMI patient populations following MBS [metabolic and bariatric surgery]. However, these reports generally do not refute the importance of weight loss in achieving important clinical benefit among patients with obesity-related comorbid disease.

One strength of the present study is that it is a clinical database. However, 50% attrition of the follow-up weight loss data at 1 year is potentially problematic.
 

Bruce M. Wolfe, MD, FACS, and Elizaveta Walker, MPH, are in the division of bariatric surgery, department of surgery, at Oregon Health & Science University, Portland. These comments are taken from an accompanying editorial (JAMA Surgery 2017 Jul 26. doi: 10.1001/jamasurg.2017.2349). No conflicts of interest were declared.

Title
Results confirm benefits of BMI below 30 after bariatric surgery
Results confirm benefits of BMI below 30 after bariatric surgery

 

Delaying bariatric surgery until body mass index is highly elevated may reduce the likelihood of achieving a BMI of less than 30 within a year, according toa paper published online July 26 in JAMA Surgery.

A retrospective study using prospectively gathered clinical data of 27,320 adults who underwent bariatric surgery in Michigan showed around one in three (36%) achieved a BMI below 30 within a year after surgery (JAMA Surgery 2017, July 26. doi: 10.1001/jamasurg.2017.2348). But obese patients with a body mass index of less than 40 kg/m2 before undergoing bariatric surgery are significantly more likely to achieve a postoperative BMI of under 30.

Individuals who had a preoperative BMI of less than 40 had a 12-fold higher chance of getting their BMI below 30, compared to those whose preoperative BMI was 40 or above (95% confidence interval 1.71-14.16, P less than .001). Only 8.5% of individuals with a BMI at or above 50 achieved a postoperative BMI below 30.

Dr. Oliver A. Varban
“It is important to note that EWL [excess weight loss] percentage may appear exaggerated in relation to actual mass lost in patients with lower initial BMI in these studies,” wrote Oliver A. Varban, MD, FACS, of the University of Michigan Health Systems, and his coauthors. “However, it also highlights the advantages of early surgical management of obesity in that smaller amounts of weight loss are required to achieve the desired effect.”

The likelihood of getting below 30 within a year was eightfold higher in patients who had a sleeve gastrectomy, 21 times greater in those who underwent Roux-en-Y bypass, and 82 times higher in those who had a duodenal switch, compared with patients who had adjustable gastric banding (P less than .001).

The researchers also compared other outcomes in individuals whose BMI dropped below 30 and in those who did not achieve this degree of weight loss. The analysis showed that those with a BMI below 30 after 1 year had at least a twofold greater chance of discontinuing cholesterol-lowering medications, insulin, diabetes medications, antihypertensives, and CPAP for sleep apnea, compared with those whose BMI remained at 30 or above. They were also more than three times more likely to report being ‘very satisfied’ with the outcomes of surgery.

The authors noted that the cohort’s mean BMI was 48, which was above the established threshold for bariatric surgery, namely a BMI of 40, or 35 with weight-related comorbidities.

“Our results suggest that patients with morbid obesity should be targeted for surgery when their BMI is still less than 40, as these patients are more likely to achieve a target BMI that results in substantial reduction in weight-related comorbidities,” the authors wrote.

However, they stressed that their findings should not be taken as a reason to exclude patients with a BMI above 40 from surgery, pointing out that even for patients with higher preoperative BMIs, bariatric surgery offered substantial health and quality of life benefits.

They also acknowledged that 1-year weight data was available for around 50% of patients in the registry, which may have led to selection bias.

“Policies and practice patterns that delay or incentivize patients to pursue bariatric surgery only once the BMI is highly elevated can result in inferior outcomes,” the investigators concluded.

Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.

Patients with obesity need a multidisciplinary approach to achieve a healthy weight, and AGA believes that gastroenterologists are in a unique position to lead the care team.

To provide gastroenterologists with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management, including a model for how to operationalize business issues, AGA has created an Obesity Practice Guide. The program includes an obesity program to help gastroenterologists manage their patients with obesity, as well as a framework focused on the business operational issues related to the management of obese patients. Learn more at www.gastro.org/obesity.

 

Delaying bariatric surgery until body mass index is highly elevated may reduce the likelihood of achieving a BMI of less than 30 within a year, according toa paper published online July 26 in JAMA Surgery.

A retrospective study using prospectively gathered clinical data of 27,320 adults who underwent bariatric surgery in Michigan showed around one in three (36%) achieved a BMI below 30 within a year after surgery (JAMA Surgery 2017, July 26. doi: 10.1001/jamasurg.2017.2348). But obese patients with a body mass index of less than 40 kg/m2 before undergoing bariatric surgery are significantly more likely to achieve a postoperative BMI of under 30.

Individuals who had a preoperative BMI of less than 40 had a 12-fold higher chance of getting their BMI below 30, compared to those whose preoperative BMI was 40 or above (95% confidence interval 1.71-14.16, P less than .001). Only 8.5% of individuals with a BMI at or above 50 achieved a postoperative BMI below 30.

Dr. Oliver A. Varban
“It is important to note that EWL [excess weight loss] percentage may appear exaggerated in relation to actual mass lost in patients with lower initial BMI in these studies,” wrote Oliver A. Varban, MD, FACS, of the University of Michigan Health Systems, and his coauthors. “However, it also highlights the advantages of early surgical management of obesity in that smaller amounts of weight loss are required to achieve the desired effect.”

The likelihood of getting below 30 within a year was eightfold higher in patients who had a sleeve gastrectomy, 21 times greater in those who underwent Roux-en-Y bypass, and 82 times higher in those who had a duodenal switch, compared with patients who had adjustable gastric banding (P less than .001).

The researchers also compared other outcomes in individuals whose BMI dropped below 30 and in those who did not achieve this degree of weight loss. The analysis showed that those with a BMI below 30 after 1 year had at least a twofold greater chance of discontinuing cholesterol-lowering medications, insulin, diabetes medications, antihypertensives, and CPAP for sleep apnea, compared with those whose BMI remained at 30 or above. They were also more than three times more likely to report being ‘very satisfied’ with the outcomes of surgery.

The authors noted that the cohort’s mean BMI was 48, which was above the established threshold for bariatric surgery, namely a BMI of 40, or 35 with weight-related comorbidities.

“Our results suggest that patients with morbid obesity should be targeted for surgery when their BMI is still less than 40, as these patients are more likely to achieve a target BMI that results in substantial reduction in weight-related comorbidities,” the authors wrote.

However, they stressed that their findings should not be taken as a reason to exclude patients with a BMI above 40 from surgery, pointing out that even for patients with higher preoperative BMIs, bariatric surgery offered substantial health and quality of life benefits.

They also acknowledged that 1-year weight data was available for around 50% of patients in the registry, which may have led to selection bias.

“Policies and practice patterns that delay or incentivize patients to pursue bariatric surgery only once the BMI is highly elevated can result in inferior outcomes,” the investigators concluded.

Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.

Patients with obesity need a multidisciplinary approach to achieve a healthy weight, and AGA believes that gastroenterologists are in a unique position to lead the care team.

To provide gastroenterologists with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management, including a model for how to operationalize business issues, AGA has created an Obesity Practice Guide. The program includes an obesity program to help gastroenterologists manage their patients with obesity, as well as a framework focused on the business operational issues related to the management of obese patients. Learn more at www.gastro.org/obesity.

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FROM JAMA SURGERY

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Key clinical point: A BMI below 40 prior to undergoing bariatric surgery gives patients a significantly better chance of achieving a 1-year postoperative BMI under 30.

Major finding: Obese patients with a BMI less than 40 before undergoing bariatric surgery are more than 12 times more likely to achieve a postoperative BMI of under 30.

Data source: A retrospective study using prospectively gathered clinical data of 27, 320 adults who underwent bariatric surgery.

Disclosures: Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.

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Elective open conversion after failed EVAR safer than emergent

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Emergency open conversion after failed endovascular aortic aneurysm repair shows significantly higher mortality and morbidity, compared with elective conversion, according to the results of a retrospective, observational study of 31 patients at a single institution.

The primary endpoints of the study were 30-day and in-hospital mortality. Secondary endpoints included moderate to severe complications, secondary interventions, length of ICU stay, and length of hospital stay (LOS), according to I. Ben Abdallah, MD, of the Hôpital Européen Georges Pompidou and his colleagues.

During the study period, a total of 338 patients received EVAR at the institution. Of these, 31 patients underwent open conversion (19 elective, 12 emergent) after EVAR between August 2008 and September 2016. The median time from the index EVAR to the open conversion was 35 months, with the most common indications for intervention being endoleaks (24 patients, 77%), stent graft infection (3, 10%), thrombosis (3, 10%) and kinking (1, 3%). Stents removed were manufactured by various device makers, according to the report (Eur J Vasc Endovasc Surg. 2017;53:831-6).

The patient population had a mean age of 73 years and comprised 84% men. The two groups, elective and emergent, were highly similar in numerous comorbidities, with the only significant difference between them being a greater incidence of chronic renal disease among the emergent group, as compared with the elective (42% vs. 5%).

Overall in-hospital mortality was 10%, and significantly greater in emergent vs. elective conversion (25% vs. 0%). Renal and pulmonary complications were significantly higher in the emergency group (42% vs. 5% and 42% vs. 0%, respectively). There was no significant difference between elective and emergent hospital stay (14 days vs. 20 days), but ICU stay was significantly shorter for elective conversion (2 days vs. 7 days).

There were no late complications or death seen in either group after a mean follow-up of 18 months.

“In this series, open conversion seems to be significantly safer and more effective when performed electively with no mortality, a lower incidence of morbidity (renal and pulmonary), and shorter ICU stay. These results underline that close surveillance, allowing planned elective open conversion, is the key to better outcomes after failed EVAR,” the researchers concluded.

The authors reported that they had no conflicts of interest, and the study received no outside funding.

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Emergency open conversion after failed endovascular aortic aneurysm repair shows significantly higher mortality and morbidity, compared with elective conversion, according to the results of a retrospective, observational study of 31 patients at a single institution.

The primary endpoints of the study were 30-day and in-hospital mortality. Secondary endpoints included moderate to severe complications, secondary interventions, length of ICU stay, and length of hospital stay (LOS), according to I. Ben Abdallah, MD, of the Hôpital Européen Georges Pompidou and his colleagues.

During the study period, a total of 338 patients received EVAR at the institution. Of these, 31 patients underwent open conversion (19 elective, 12 emergent) after EVAR between August 2008 and September 2016. The median time from the index EVAR to the open conversion was 35 months, with the most common indications for intervention being endoleaks (24 patients, 77%), stent graft infection (3, 10%), thrombosis (3, 10%) and kinking (1, 3%). Stents removed were manufactured by various device makers, according to the report (Eur J Vasc Endovasc Surg. 2017;53:831-6).

The patient population had a mean age of 73 years and comprised 84% men. The two groups, elective and emergent, were highly similar in numerous comorbidities, with the only significant difference between them being a greater incidence of chronic renal disease among the emergent group, as compared with the elective (42% vs. 5%).

Overall in-hospital mortality was 10%, and significantly greater in emergent vs. elective conversion (25% vs. 0%). Renal and pulmonary complications were significantly higher in the emergency group (42% vs. 5% and 42% vs. 0%, respectively). There was no significant difference between elective and emergent hospital stay (14 days vs. 20 days), but ICU stay was significantly shorter for elective conversion (2 days vs. 7 days).

There were no late complications or death seen in either group after a mean follow-up of 18 months.

“In this series, open conversion seems to be significantly safer and more effective when performed electively with no mortality, a lower incidence of morbidity (renal and pulmonary), and shorter ICU stay. These results underline that close surveillance, allowing planned elective open conversion, is the key to better outcomes after failed EVAR,” the researchers concluded.

The authors reported that they had no conflicts of interest, and the study received no outside funding.

 

Emergency open conversion after failed endovascular aortic aneurysm repair shows significantly higher mortality and morbidity, compared with elective conversion, according to the results of a retrospective, observational study of 31 patients at a single institution.

The primary endpoints of the study were 30-day and in-hospital mortality. Secondary endpoints included moderate to severe complications, secondary interventions, length of ICU stay, and length of hospital stay (LOS), according to I. Ben Abdallah, MD, of the Hôpital Européen Georges Pompidou and his colleagues.

During the study period, a total of 338 patients received EVAR at the institution. Of these, 31 patients underwent open conversion (19 elective, 12 emergent) after EVAR between August 2008 and September 2016. The median time from the index EVAR to the open conversion was 35 months, with the most common indications for intervention being endoleaks (24 patients, 77%), stent graft infection (3, 10%), thrombosis (3, 10%) and kinking (1, 3%). Stents removed were manufactured by various device makers, according to the report (Eur J Vasc Endovasc Surg. 2017;53:831-6).

The patient population had a mean age of 73 years and comprised 84% men. The two groups, elective and emergent, were highly similar in numerous comorbidities, with the only significant difference between them being a greater incidence of chronic renal disease among the emergent group, as compared with the elective (42% vs. 5%).

Overall in-hospital mortality was 10%, and significantly greater in emergent vs. elective conversion (25% vs. 0%). Renal and pulmonary complications were significantly higher in the emergency group (42% vs. 5% and 42% vs. 0%, respectively). There was no significant difference between elective and emergent hospital stay (14 days vs. 20 days), but ICU stay was significantly shorter for elective conversion (2 days vs. 7 days).

There were no late complications or death seen in either group after a mean follow-up of 18 months.

“In this series, open conversion seems to be significantly safer and more effective when performed electively with no mortality, a lower incidence of morbidity (renal and pulmonary), and shorter ICU stay. These results underline that close surveillance, allowing planned elective open conversion, is the key to better outcomes after failed EVAR,” the researchers concluded.

The authors reported that they had no conflicts of interest, and the study received no outside funding.

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FROM THE EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY

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Key clinical point: Elective open conversion should be performed before an emergency repair is needed.

Major finding: Overall in-hospital mortality was 10% and significantly greater in emergent vs. elective conversion (25% vs. 0%).

Data source: A retrospective database analysis of 31 patients undergoing EVAR open conversion at a single institution.

Disclosures: The authors reported that they had no conflicts of interest, and the study received no outside funding.

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Fujifilm issues recall to update ED-530XT duodenoscopes

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Fujifilm has issued an Urgent Medical Device Correction and Removal notification for all ED-530XT duodenoscopes, according to a Safety Alert from the Food and Drug Administration.

The recall, initiated voluntarily by Fujifilm, includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new operation manuals. The FDA authorized the changes on July 21, 2017.

The FDA recommends that all health care providers acknowledge Fujifilm’s notification and identify any affected products and be aware of the reprocessing procedure found in the FDA’s December 2015 Safety Communication regarding the Fujifilm duodenoscope. When new operation manuals are received, old manuals should be removed and destroyed properly.

“Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes,” the FDA said in the press release.

Find the full Safety Alert on the FDA website.

The AGA Center for GI Innovation and Technology is committed to working towards zero device-associated infections and will keep you apprised of any future updates. Learn more at www.gastro.org/CGIT.

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Fujifilm has issued an Urgent Medical Device Correction and Removal notification for all ED-530XT duodenoscopes, according to a Safety Alert from the Food and Drug Administration.

The recall, initiated voluntarily by Fujifilm, includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new operation manuals. The FDA authorized the changes on July 21, 2017.

The FDA recommends that all health care providers acknowledge Fujifilm’s notification and identify any affected products and be aware of the reprocessing procedure found in the FDA’s December 2015 Safety Communication regarding the Fujifilm duodenoscope. When new operation manuals are received, old manuals should be removed and destroyed properly.

“Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes,” the FDA said in the press release.

Find the full Safety Alert on the FDA website.

The AGA Center for GI Innovation and Technology is committed to working towards zero device-associated infections and will keep you apprised of any future updates. Learn more at www.gastro.org/CGIT.

 

Fujifilm has issued an Urgent Medical Device Correction and Removal notification for all ED-530XT duodenoscopes, according to a Safety Alert from the Food and Drug Administration.

The recall, initiated voluntarily by Fujifilm, includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new operation manuals. The FDA authorized the changes on July 21, 2017.

The FDA recommends that all health care providers acknowledge Fujifilm’s notification and identify any affected products and be aware of the reprocessing procedure found in the FDA’s December 2015 Safety Communication regarding the Fujifilm duodenoscope. When new operation manuals are received, old manuals should be removed and destroyed properly.

“Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes,” the FDA said in the press release.

Find the full Safety Alert on the FDA website.

The AGA Center for GI Innovation and Technology is committed to working towards zero device-associated infections and will keep you apprised of any future updates. Learn more at www.gastro.org/CGIT.

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Student Hospitalist Scholars: Discovering a passion for research

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Leaving finance to study bone biopsies in osteomyelitis.

 

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

When I decided to leave the business world to pursue a career in medicine, I envisioned myself in a clinic or an operating room helping the people in my community with the knowledge and skills acquired in my medical training. The thought of becoming a researcher had never even crossed my mind.

I grew up in Scottsdale, Arizona, a city which has no major academic medical centers. Prior to entering medical school, I was enrolled in a postbaccalaureate program at Johns Hopkins University, where I took the basic science classes necessary to apply. I was quite surprised to learn that, even at this level of education, I was required to participate in a research project. This experience changed the way I envisioned my entire career as a physician.

I am now a fourth year medical student and a pioneer of the “new curriculum” at Weill Cornell Medical College. In contrast to the traditional medical school curriculum, Cornell carved out 6 months of protected research time for all medical students by condensing the preclinical curriculum from 2 years to 1.5 years. I learned how much I enjoyed research at Johns Hopkins, which is one of the main reasons I applied here.

Despite my interest in research, I still struggled with the ultimate career question: What kind of doctor do I want to be?

After completing my medicine clerkship, I remember feeling intellectually stimulated in a way I hadn’t experienced in the previous years. While this may have had to do with the subject matter, I attribute much of this feeling to my clerkship director whose passion for medicine and teaching was contagious. I ultimately chose Ernie Esquivel, MD, to be my research mentor because of how much he impacted my education.

Cole Hirschfeld


Together we came up with a project to study the utility of bone biopsies in the management of osteomyelitis. We are doing this by analyzing changes from empiric to final antibiotics after bone biopsy results become available to determine how clinicians use this information to guide their management of the disease. We were also interested in analyzing predictors of positive bone cultures in this population. The success of this project will mostly be based on our ability to perform these analyses, regardless of what the results may be. We hypothesize that, in fact, bone biopsy results are not likely to have a significant impact on antibiotic management of osteomyelitis in nonvertebral bones.

I was one of the lucky few to be awarded a grant from the Society of Hospital Medicine, which will be instrumental in the success of the project. This grant will not only support my ongoing research efforts but will also afford me the opportunity to attend the annual SHM conference and become integrated into the medical community in a way that would otherwise never be possible.

Cole Hirschfeld is originally from Phoenix, Ariz. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a fourth year medical student at Weill Cornell Medical College and plans to apply for residency in internal medicine.

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Leaving finance to study bone biopsies in osteomyelitis.
Leaving finance to study bone biopsies in osteomyelitis.

 

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

When I decided to leave the business world to pursue a career in medicine, I envisioned myself in a clinic or an operating room helping the people in my community with the knowledge and skills acquired in my medical training. The thought of becoming a researcher had never even crossed my mind.

I grew up in Scottsdale, Arizona, a city which has no major academic medical centers. Prior to entering medical school, I was enrolled in a postbaccalaureate program at Johns Hopkins University, where I took the basic science classes necessary to apply. I was quite surprised to learn that, even at this level of education, I was required to participate in a research project. This experience changed the way I envisioned my entire career as a physician.

I am now a fourth year medical student and a pioneer of the “new curriculum” at Weill Cornell Medical College. In contrast to the traditional medical school curriculum, Cornell carved out 6 months of protected research time for all medical students by condensing the preclinical curriculum from 2 years to 1.5 years. I learned how much I enjoyed research at Johns Hopkins, which is one of the main reasons I applied here.

Despite my interest in research, I still struggled with the ultimate career question: What kind of doctor do I want to be?

After completing my medicine clerkship, I remember feeling intellectually stimulated in a way I hadn’t experienced in the previous years. While this may have had to do with the subject matter, I attribute much of this feeling to my clerkship director whose passion for medicine and teaching was contagious. I ultimately chose Ernie Esquivel, MD, to be my research mentor because of how much he impacted my education.

Cole Hirschfeld


Together we came up with a project to study the utility of bone biopsies in the management of osteomyelitis. We are doing this by analyzing changes from empiric to final antibiotics after bone biopsy results become available to determine how clinicians use this information to guide their management of the disease. We were also interested in analyzing predictors of positive bone cultures in this population. The success of this project will mostly be based on our ability to perform these analyses, regardless of what the results may be. We hypothesize that, in fact, bone biopsy results are not likely to have a significant impact on antibiotic management of osteomyelitis in nonvertebral bones.

I was one of the lucky few to be awarded a grant from the Society of Hospital Medicine, which will be instrumental in the success of the project. This grant will not only support my ongoing research efforts but will also afford me the opportunity to attend the annual SHM conference and become integrated into the medical community in a way that would otherwise never be possible.

Cole Hirschfeld is originally from Phoenix, Ariz. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a fourth year medical student at Weill Cornell Medical College and plans to apply for residency in internal medicine.

 

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

When I decided to leave the business world to pursue a career in medicine, I envisioned myself in a clinic or an operating room helping the people in my community with the knowledge and skills acquired in my medical training. The thought of becoming a researcher had never even crossed my mind.

I grew up in Scottsdale, Arizona, a city which has no major academic medical centers. Prior to entering medical school, I was enrolled in a postbaccalaureate program at Johns Hopkins University, where I took the basic science classes necessary to apply. I was quite surprised to learn that, even at this level of education, I was required to participate in a research project. This experience changed the way I envisioned my entire career as a physician.

I am now a fourth year medical student and a pioneer of the “new curriculum” at Weill Cornell Medical College. In contrast to the traditional medical school curriculum, Cornell carved out 6 months of protected research time for all medical students by condensing the preclinical curriculum from 2 years to 1.5 years. I learned how much I enjoyed research at Johns Hopkins, which is one of the main reasons I applied here.

Despite my interest in research, I still struggled with the ultimate career question: What kind of doctor do I want to be?

After completing my medicine clerkship, I remember feeling intellectually stimulated in a way I hadn’t experienced in the previous years. While this may have had to do with the subject matter, I attribute much of this feeling to my clerkship director whose passion for medicine and teaching was contagious. I ultimately chose Ernie Esquivel, MD, to be my research mentor because of how much he impacted my education.

Cole Hirschfeld


Together we came up with a project to study the utility of bone biopsies in the management of osteomyelitis. We are doing this by analyzing changes from empiric to final antibiotics after bone biopsy results become available to determine how clinicians use this information to guide their management of the disease. We were also interested in analyzing predictors of positive bone cultures in this population. The success of this project will mostly be based on our ability to perform these analyses, regardless of what the results may be. We hypothesize that, in fact, bone biopsy results are not likely to have a significant impact on antibiotic management of osteomyelitis in nonvertebral bones.

I was one of the lucky few to be awarded a grant from the Society of Hospital Medicine, which will be instrumental in the success of the project. This grant will not only support my ongoing research efforts but will also afford me the opportunity to attend the annual SHM conference and become integrated into the medical community in a way that would otherwise never be possible.

Cole Hirschfeld is originally from Phoenix, Ariz. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a fourth year medical student at Weill Cornell Medical College and plans to apply for residency in internal medicine.

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Less lenalidomide may be more in frail elderly multiple myeloma patients

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In frail elderly patients with multiple myeloma, starting lenalidomide at low doses was associated with fewer adverse events and less treatment discontinuation, and did not compromise overall response rates, in a single-center, retrospective study conducted in Japan.

Although most of the 56 study patients received 5-10 mg/day of lenalidomide, not the recommended 25-mg/day dose, their overall response rate was 73% (complete response in 17% of patients, very good partial response in 19%, and partial response in 37%), Aya Nakaya, MD, PhD, of Kansai Medical University, Hirakata, and colleagues wrote (Acta Haematol. 2017;138:55-60). In addition, 23% of patients had stable disease and 4% had disease progression. Nine patients developed other types of malignancies during treatment with lenalidomide.

Starting patients on a reduced dose and increasing it gradually while monitoring carefully for adverse events meant that patients did not have to stop treatment, the researchers said. Continuous treatment may improve survival, and “treatment with lenalidomide for long periods of time, even in small doses, may yield favorable outcomes.”

The 30 men and 26 women, mean age 76.5 years, were consecutively diagnosed as transplant-ineligible patients with relapsed/refractory multiple myeloma; 34%, 32%, and 34% had stages I-III disease, respectively. The M-protein consisted of IgG in 52% of patients and IgA in 30%, with Bence-Jones protein detected in 14%.

They were treated with lenalidomide plus dexamethasone at a starting dose determined by the treating physician; 73% were treated with lenalidomide as a second-line regimen and 14% as a third-line regimen. During each 28-day treatment cycle, patients received lenalidomide on days 1-21 and dexamethasone (20 or 40 mg) on days 1, 8, 15, and 22.

The most common starting lenalidomide dose was 10 mg/day (45%), followed by 5 mg/day (21%), 15 mg/day (20%), 20 mg/day (4%), and 25 mg/day (10%). The treatment dose used for the longest period was 10 mg/day (46% of patients), followed by 5 mg/day (25%), 15 mg/day (16%), 20 mg/day (4%), and 25 mg/day (9%).

The most frequent reasons for dose reduction were renal dysfunction (54%), fatigue (20%), hematologic disorder (14%), and rash (9%).

The median treatment period was 9 months (range 1-60 months) and the median follow-up period was 16 months.

The median time to disease progression was 11.8 months (range 8.4-21.9), and the median overall survival was 39.2 months. For those who took 5-10 mg of lenalidomide, the median time to progression was 14.5 months; for those who took lenalidomide at a dose of more than 10 mg, the median time to progression was 8.9 months. The median overall survival of the patients who received a 5- to 10-mg dose of lenalidomide was 38.9 months; the median overall survival of the patients given a dose of more than 10 mg was not available.

The authors declared no competing financial interests in relation to this work.

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In frail elderly patients with multiple myeloma, starting lenalidomide at low doses was associated with fewer adverse events and less treatment discontinuation, and did not compromise overall response rates, in a single-center, retrospective study conducted in Japan.

Although most of the 56 study patients received 5-10 mg/day of lenalidomide, not the recommended 25-mg/day dose, their overall response rate was 73% (complete response in 17% of patients, very good partial response in 19%, and partial response in 37%), Aya Nakaya, MD, PhD, of Kansai Medical University, Hirakata, and colleagues wrote (Acta Haematol. 2017;138:55-60). In addition, 23% of patients had stable disease and 4% had disease progression. Nine patients developed other types of malignancies during treatment with lenalidomide.

Starting patients on a reduced dose and increasing it gradually while monitoring carefully for adverse events meant that patients did not have to stop treatment, the researchers said. Continuous treatment may improve survival, and “treatment with lenalidomide for long periods of time, even in small doses, may yield favorable outcomes.”

The 30 men and 26 women, mean age 76.5 years, were consecutively diagnosed as transplant-ineligible patients with relapsed/refractory multiple myeloma; 34%, 32%, and 34% had stages I-III disease, respectively. The M-protein consisted of IgG in 52% of patients and IgA in 30%, with Bence-Jones protein detected in 14%.

They were treated with lenalidomide plus dexamethasone at a starting dose determined by the treating physician; 73% were treated with lenalidomide as a second-line regimen and 14% as a third-line regimen. During each 28-day treatment cycle, patients received lenalidomide on days 1-21 and dexamethasone (20 or 40 mg) on days 1, 8, 15, and 22.

The most common starting lenalidomide dose was 10 mg/day (45%), followed by 5 mg/day (21%), 15 mg/day (20%), 20 mg/day (4%), and 25 mg/day (10%). The treatment dose used for the longest period was 10 mg/day (46% of patients), followed by 5 mg/day (25%), 15 mg/day (16%), 20 mg/day (4%), and 25 mg/day (9%).

The most frequent reasons for dose reduction were renal dysfunction (54%), fatigue (20%), hematologic disorder (14%), and rash (9%).

The median treatment period was 9 months (range 1-60 months) and the median follow-up period was 16 months.

The median time to disease progression was 11.8 months (range 8.4-21.9), and the median overall survival was 39.2 months. For those who took 5-10 mg of lenalidomide, the median time to progression was 14.5 months; for those who took lenalidomide at a dose of more than 10 mg, the median time to progression was 8.9 months. The median overall survival of the patients who received a 5- to 10-mg dose of lenalidomide was 38.9 months; the median overall survival of the patients given a dose of more than 10 mg was not available.

The authors declared no competing financial interests in relation to this work.

 

In frail elderly patients with multiple myeloma, starting lenalidomide at low doses was associated with fewer adverse events and less treatment discontinuation, and did not compromise overall response rates, in a single-center, retrospective study conducted in Japan.

Although most of the 56 study patients received 5-10 mg/day of lenalidomide, not the recommended 25-mg/day dose, their overall response rate was 73% (complete response in 17% of patients, very good partial response in 19%, and partial response in 37%), Aya Nakaya, MD, PhD, of Kansai Medical University, Hirakata, and colleagues wrote (Acta Haematol. 2017;138:55-60). In addition, 23% of patients had stable disease and 4% had disease progression. Nine patients developed other types of malignancies during treatment with lenalidomide.

Starting patients on a reduced dose and increasing it gradually while monitoring carefully for adverse events meant that patients did not have to stop treatment, the researchers said. Continuous treatment may improve survival, and “treatment with lenalidomide for long periods of time, even in small doses, may yield favorable outcomes.”

The 30 men and 26 women, mean age 76.5 years, were consecutively diagnosed as transplant-ineligible patients with relapsed/refractory multiple myeloma; 34%, 32%, and 34% had stages I-III disease, respectively. The M-protein consisted of IgG in 52% of patients and IgA in 30%, with Bence-Jones protein detected in 14%.

They were treated with lenalidomide plus dexamethasone at a starting dose determined by the treating physician; 73% were treated with lenalidomide as a second-line regimen and 14% as a third-line regimen. During each 28-day treatment cycle, patients received lenalidomide on days 1-21 and dexamethasone (20 or 40 mg) on days 1, 8, 15, and 22.

The most common starting lenalidomide dose was 10 mg/day (45%), followed by 5 mg/day (21%), 15 mg/day (20%), 20 mg/day (4%), and 25 mg/day (10%). The treatment dose used for the longest period was 10 mg/day (46% of patients), followed by 5 mg/day (25%), 15 mg/day (16%), 20 mg/day (4%), and 25 mg/day (9%).

The most frequent reasons for dose reduction were renal dysfunction (54%), fatigue (20%), hematologic disorder (14%), and rash (9%).

The median treatment period was 9 months (range 1-60 months) and the median follow-up period was 16 months.

The median time to disease progression was 11.8 months (range 8.4-21.9), and the median overall survival was 39.2 months. For those who took 5-10 mg of lenalidomide, the median time to progression was 14.5 months; for those who took lenalidomide at a dose of more than 10 mg, the median time to progression was 8.9 months. The median overall survival of the patients who received a 5- to 10-mg dose of lenalidomide was 38.9 months; the median overall survival of the patients given a dose of more than 10 mg was not available.

The authors declared no competing financial interests in relation to this work.

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Key clinical point: In frail elderly patients with multiple myeloma, starting lenalidomide at low doses was associated with fewer adverse events and less treatment discontinuation, and did not compromise overall response rates.

Major finding: Although most of the 56 study patients received 5-10 mg/day of lenalidomide, not the recommended 25-mg/day dose, their overall response rate was 73%.

Data source: A single-center, retrospective study of 56 consecutively diagnosed transplant-ineligible patients in Japan.

Disclosures: The authors declared no competing financial interests in relation to this work.

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Eye spy: Name that IUD

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Eye spy: Name that IUD
Can you identify the specific intrauterine device found on ultrasound?

A) Mirena or Liletta (52 mg LNG-IUD) CORRECT
Mirena (Bayer) and Liletta (Allergan) are progestin-releasing intrauterine devices (IUDs) of similar size and shape. On ultrasonography, both the arms and the distal tip are echogenic. The progestin-containing plastic sleeve surrounding the stem in the middle demonstrates a laminated acoustic shadowing with distinctive parallel lines.1–4

(A) Transvaginal pelvic ultrasound demonstrates a well-positioned (fundally positioned) Mirena or Liletta levonorgestrel (LNG) IUD. Note the laminated appearance of the stem (short arrow). (B) Illustration of Mirena IUD with the plastic sleeve surrounding the stem (long arrow) corresponds to the laminated appearance on ultrasound.

 

B) Small-framed LNG-IUDs: Skyla (13.5 mg) or Kyleena (19.5 mg) INCORRECT
Skyla (Bayer) and Kyleena (Bayer) are small-framed LNG-IUDs. The ultrasound appearance of Skyla (LNG 13.5 mg) is similar to that of Mirena but has a markedly echogenic silver ring superiorly just below the crossbar, best seen with 2D (sagittal) views but also imaged with 3D ultrasound.1,2,5

The Kyleena device (LNG 19.5 mg) uses the same smaller T-shaped frame and metal ring, but the plastic sleeve is longer to accommodate the greater quantity of progestin.6

(A) Transvaginal ultrasound and (B) 3D surface-rendered ultrasound of the uterus demonstrate the echogenic ring (short arrow) below the crossbar. (C) Illustration of Skyla shows the silver ring (long arrow).

 

C) Paragard (intrauterine copper contraceptive) INCORRECT
Paragard (Teva Women’s Health) is a nonhormonal IUD containing copper wire wrapped around its stem and solid copper bands on each crossbar. On ultrasonography, the stem is uniformly and markedly echogenic due to the copper wire.1,2,7

(A) Transvaginal ultrasound of the uterus demonstrates a uniformly and markedly echogenic stem seen in its entirety (short arrow). (B) 3D surface-rendered ultrasound of the uterus shows the solid copper bands on the crossbars (arrowhead). (C) Illustration of the Paragard IUD with the copper wire in the stem (long arrow) and solid copper bands on the crossbars (arrow heads).

References
  1. Stalnaker ML, Kaunitz AM. How to identify and localize IUDs on ultrasound. OBG Manag. 2014;26(8):38,40–41,44.
  2. Boortz HE, Margolis DJ, Ragavendra N, Patel MK, Kadell BM. Migration of intrauterine devices: Radiologic findings and implications for patient care. Radiographics. 2012;32(2):335–352.
  3. Mirena [package insert]. Whippany, NJ: Bayer; 2000.
  4. Liletta [package insert]. Parsippany, NJ: Allergan; 2015.
  5. Skyla [package insert]. Whippany, NJ: Bayer; 2000.
  6. Kyleena [package insert]. Whippany, NJ: Bayer; 2000.
  7. Paragard [package insert]. North Wales, PA: Teva Women’s Health, Inc; 2014.
Author and Disclosure Information

Dr. Kanmaniraja is Assistant Professor and Chief, Division of Abdominal Imaging, Department of Radiology, University of Florida College of Medicine–Jacksonville.

Dr. Kaunitz is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women’s Health Specialists–Emerson. He also serves on the OBG Management Board of Editors.

Dr. Kaunitz reports serving on Bayer Advisory Boards. The University of FL receives research funding from Bayer. Dr. Kanmaniraja reports no additional financial relationships relevant to this quiz.

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Dr. Kanmaniraja is Assistant Professor and Chief, Division of Abdominal Imaging, Department of Radiology, University of Florida College of Medicine–Jacksonville.

Dr. Kaunitz is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women’s Health Specialists–Emerson. He also serves on the OBG Management Board of Editors.

Dr. Kaunitz reports serving on Bayer Advisory Boards. The University of FL receives research funding from Bayer. Dr. Kanmaniraja reports no additional financial relationships relevant to this quiz.

Author and Disclosure Information

Dr. Kanmaniraja is Assistant Professor and Chief, Division of Abdominal Imaging, Department of Radiology, University of Florida College of Medicine–Jacksonville.

Dr. Kaunitz is University of Florida Research Foundation Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He is Medical Director and Director of Menopause and Gynecologic Ultrasound Services at UF Women’s Health Specialists–Emerson. He also serves on the OBG Management Board of Editors.

Dr. Kaunitz reports serving on Bayer Advisory Boards. The University of FL receives research funding from Bayer. Dr. Kanmaniraja reports no additional financial relationships relevant to this quiz.

Can you identify the specific intrauterine device found on ultrasound?
Can you identify the specific intrauterine device found on ultrasound?

A) Mirena or Liletta (52 mg LNG-IUD) CORRECT
Mirena (Bayer) and Liletta (Allergan) are progestin-releasing intrauterine devices (IUDs) of similar size and shape. On ultrasonography, both the arms and the distal tip are echogenic. The progestin-containing plastic sleeve surrounding the stem in the middle demonstrates a laminated acoustic shadowing with distinctive parallel lines.1–4

(A) Transvaginal pelvic ultrasound demonstrates a well-positioned (fundally positioned) Mirena or Liletta levonorgestrel (LNG) IUD. Note the laminated appearance of the stem (short arrow). (B) Illustration of Mirena IUD with the plastic sleeve surrounding the stem (long arrow) corresponds to the laminated appearance on ultrasound.

 

B) Small-framed LNG-IUDs: Skyla (13.5 mg) or Kyleena (19.5 mg) INCORRECT
Skyla (Bayer) and Kyleena (Bayer) are small-framed LNG-IUDs. The ultrasound appearance of Skyla (LNG 13.5 mg) is similar to that of Mirena but has a markedly echogenic silver ring superiorly just below the crossbar, best seen with 2D (sagittal) views but also imaged with 3D ultrasound.1,2,5

The Kyleena device (LNG 19.5 mg) uses the same smaller T-shaped frame and metal ring, but the plastic sleeve is longer to accommodate the greater quantity of progestin.6

(A) Transvaginal ultrasound and (B) 3D surface-rendered ultrasound of the uterus demonstrate the echogenic ring (short arrow) below the crossbar. (C) Illustration of Skyla shows the silver ring (long arrow).

 

C) Paragard (intrauterine copper contraceptive) INCORRECT
Paragard (Teva Women’s Health) is a nonhormonal IUD containing copper wire wrapped around its stem and solid copper bands on each crossbar. On ultrasonography, the stem is uniformly and markedly echogenic due to the copper wire.1,2,7

(A) Transvaginal ultrasound of the uterus demonstrates a uniformly and markedly echogenic stem seen in its entirety (short arrow). (B) 3D surface-rendered ultrasound of the uterus shows the solid copper bands on the crossbars (arrowhead). (C) Illustration of the Paragard IUD with the copper wire in the stem (long arrow) and solid copper bands on the crossbars (arrow heads).

A) Mirena or Liletta (52 mg LNG-IUD) CORRECT
Mirena (Bayer) and Liletta (Allergan) are progestin-releasing intrauterine devices (IUDs) of similar size and shape. On ultrasonography, both the arms and the distal tip are echogenic. The progestin-containing plastic sleeve surrounding the stem in the middle demonstrates a laminated acoustic shadowing with distinctive parallel lines.1–4

(A) Transvaginal pelvic ultrasound demonstrates a well-positioned (fundally positioned) Mirena or Liletta levonorgestrel (LNG) IUD. Note the laminated appearance of the stem (short arrow). (B) Illustration of Mirena IUD with the plastic sleeve surrounding the stem (long arrow) corresponds to the laminated appearance on ultrasound.

 

B) Small-framed LNG-IUDs: Skyla (13.5 mg) or Kyleena (19.5 mg) INCORRECT
Skyla (Bayer) and Kyleena (Bayer) are small-framed LNG-IUDs. The ultrasound appearance of Skyla (LNG 13.5 mg) is similar to that of Mirena but has a markedly echogenic silver ring superiorly just below the crossbar, best seen with 2D (sagittal) views but also imaged with 3D ultrasound.1,2,5

The Kyleena device (LNG 19.5 mg) uses the same smaller T-shaped frame and metal ring, but the plastic sleeve is longer to accommodate the greater quantity of progestin.6

(A) Transvaginal ultrasound and (B) 3D surface-rendered ultrasound of the uterus demonstrate the echogenic ring (short arrow) below the crossbar. (C) Illustration of Skyla shows the silver ring (long arrow).

 

C) Paragard (intrauterine copper contraceptive) INCORRECT
Paragard (Teva Women’s Health) is a nonhormonal IUD containing copper wire wrapped around its stem and solid copper bands on each crossbar. On ultrasonography, the stem is uniformly and markedly echogenic due to the copper wire.1,2,7

(A) Transvaginal ultrasound of the uterus demonstrates a uniformly and markedly echogenic stem seen in its entirety (short arrow). (B) 3D surface-rendered ultrasound of the uterus shows the solid copper bands on the crossbars (arrowhead). (C) Illustration of the Paragard IUD with the copper wire in the stem (long arrow) and solid copper bands on the crossbars (arrow heads).

References
  1. Stalnaker ML, Kaunitz AM. How to identify and localize IUDs on ultrasound. OBG Manag. 2014;26(8):38,40–41,44.
  2. Boortz HE, Margolis DJ, Ragavendra N, Patel MK, Kadell BM. Migration of intrauterine devices: Radiologic findings and implications for patient care. Radiographics. 2012;32(2):335–352.
  3. Mirena [package insert]. Whippany, NJ: Bayer; 2000.
  4. Liletta [package insert]. Parsippany, NJ: Allergan; 2015.
  5. Skyla [package insert]. Whippany, NJ: Bayer; 2000.
  6. Kyleena [package insert]. Whippany, NJ: Bayer; 2000.
  7. Paragard [package insert]. North Wales, PA: Teva Women’s Health, Inc; 2014.
References
  1. Stalnaker ML, Kaunitz AM. How to identify and localize IUDs on ultrasound. OBG Manag. 2014;26(8):38,40–41,44.
  2. Boortz HE, Margolis DJ, Ragavendra N, Patel MK, Kadell BM. Migration of intrauterine devices: Radiologic findings and implications for patient care. Radiographics. 2012;32(2):335–352.
  3. Mirena [package insert]. Whippany, NJ: Bayer; 2000.
  4. Liletta [package insert]. Parsippany, NJ: Allergan; 2015.
  5. Skyla [package insert]. Whippany, NJ: Bayer; 2000.
  6. Kyleena [package insert]. Whippany, NJ: Bayer; 2000.
  7. Paragard [package insert]. North Wales, PA: Teva Women’s Health, Inc; 2014.
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A 25-year-old woman using an IUD presented to her ObGyn’s office for follow-up care of a 4- to 5-cm left simple ovarian cyst. A pelvic ultrasound was performed. The ovarian cyst had resolved and a fundally-positioned IUD was imaged.

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Tips and tricks for appealing an audit

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CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

Abby Pendleton
If the amount of money is nominal, the audit involves a one-time mistake and the decision is not really disputable, a doctor may just want to pay the audit request, Mr. Comley said in an interview.

“In other words, the provider would spend more money and time to appeal the audit than to pay the audit, and the issue or mistake is not likely repeated in past or future claims,” it might make sense to just pay, he said.

H. Rusty Comley
On the other hand, if the findings are arguable, the monetary amount is significant, and/or the audit could affect more than just one billing, the doctor may want to consider appealing. Paying a small monetary amount could become problematic when the audit issue or “mistake” may have been repeated or will be repeated, Mr. Comley cautioned, adding that paying without dispute could create a precedent for future audits.

If the basis of the findings stem from an interpretation of a local coverage decision that the physician disagrees with, he or she may also want to appeal, Ms. Pendleton added.

“If you don’t fight it, there’s an argument that, ‘Well, guess what? You had that issue going back 6 years for all these other claims, and now we get into the [Medicare] 60 day overpayment identification [rule],’ ” she said at the meeting. “If a physician is [not] aware of payments they’re not entitled to, even if they think they were right on the front end, but they later become aware, they have 60 days to refund it or its a false claim. Those are considerations that really need to be looked at.”
 

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

 

 

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

 

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Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: The most effective way to handle an audit is not to be involved in one. This requires an appropriate knowledge of coding and billing tempered with a strong dose of honesty. While CMS rules for coding and billing can occasionally be confusing, they are not intended to “trick” physicians into making errors. Rather, either through lack of understanding, poor documentation, or dishonesty (upcoding), mistakes can be made. Unfortunately, the physician is considered guilty until proven otherwise. The 37% success rate of appeals argues that this is true more often than not. As noted in the article, a CMS audit can be a very anxiety-provoking, time-consuming, and expensive process that one should avoid at all costs. The key to doing this and improving the physician success rate if one is audited is through education of the providers and advocating to amend poorly written CMS policy. Dishonesty will have to correct itself.  

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Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: The most effective way to handle an audit is not to be involved in one. This requires an appropriate knowledge of coding and billing tempered with a strong dose of honesty. While CMS rules for coding and billing can occasionally be confusing, they are not intended to “trick” physicians into making errors. Rather, either through lack of understanding, poor documentation, or dishonesty (upcoding), mistakes can be made. Unfortunately, the physician is considered guilty until proven otherwise. The 37% success rate of appeals argues that this is true more often than not. As noted in the article, a CMS audit can be a very anxiety-provoking, time-consuming, and expensive process that one should avoid at all costs. The key to doing this and improving the physician success rate if one is audited is through education of the providers and advocating to amend poorly written CMS policy. Dishonesty will have to correct itself.  

Body

Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: The most effective way to handle an audit is not to be involved in one. This requires an appropriate knowledge of coding and billing tempered with a strong dose of honesty. While CMS rules for coding and billing can occasionally be confusing, they are not intended to “trick” physicians into making errors. Rather, either through lack of understanding, poor documentation, or dishonesty (upcoding), mistakes can be made. Unfortunately, the physician is considered guilty until proven otherwise. The 37% success rate of appeals argues that this is true more often than not. As noted in the article, a CMS audit can be a very anxiety-provoking, time-consuming, and expensive process that one should avoid at all costs. The key to doing this and improving the physician success rate if one is audited is through education of the providers and advocating to amend poorly written CMS policy. Dishonesty will have to correct itself.  

 

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

Abby Pendleton
If the amount of money is nominal, the audit involves a one-time mistake and the decision is not really disputable, a doctor may just want to pay the audit request, Mr. Comley said in an interview.

“In other words, the provider would spend more money and time to appeal the audit than to pay the audit, and the issue or mistake is not likely repeated in past or future claims,” it might make sense to just pay, he said.

H. Rusty Comley
On the other hand, if the findings are arguable, the monetary amount is significant, and/or the audit could affect more than just one billing, the doctor may want to consider appealing. Paying a small monetary amount could become problematic when the audit issue or “mistake” may have been repeated or will be repeated, Mr. Comley cautioned, adding that paying without dispute could create a precedent for future audits.

If the basis of the findings stem from an interpretation of a local coverage decision that the physician disagrees with, he or she may also want to appeal, Ms. Pendleton added.

“If you don’t fight it, there’s an argument that, ‘Well, guess what? You had that issue going back 6 years for all these other claims, and now we get into the [Medicare] 60 day overpayment identification [rule],’ ” she said at the meeting. “If a physician is [not] aware of payments they’re not entitled to, even if they think they were right on the front end, but they later become aware, they have 60 days to refund it or its a false claim. Those are considerations that really need to be looked at.”
 

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

 

 

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

 

 

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

Abby Pendleton
If the amount of money is nominal, the audit involves a one-time mistake and the decision is not really disputable, a doctor may just want to pay the audit request, Mr. Comley said in an interview.

“In other words, the provider would spend more money and time to appeal the audit than to pay the audit, and the issue or mistake is not likely repeated in past or future claims,” it might make sense to just pay, he said.

H. Rusty Comley
On the other hand, if the findings are arguable, the monetary amount is significant, and/or the audit could affect more than just one billing, the doctor may want to consider appealing. Paying a small monetary amount could become problematic when the audit issue or “mistake” may have been repeated or will be repeated, Mr. Comley cautioned, adding that paying without dispute could create a precedent for future audits.

If the basis of the findings stem from an interpretation of a local coverage decision that the physician disagrees with, he or she may also want to appeal, Ms. Pendleton added.

“If you don’t fight it, there’s an argument that, ‘Well, guess what? You had that issue going back 6 years for all these other claims, and now we get into the [Medicare] 60 day overpayment identification [rule],’ ” she said at the meeting. “If a physician is [not] aware of payments they’re not entitled to, even if they think they were right on the front end, but they later become aware, they have 60 days to refund it or its a false claim. Those are considerations that really need to be looked at.”
 

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

 

 

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

 

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Lasers still play a role in treatment of dermatologic conditions in children

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CHICAGO – Multiple laser and light options are available to treat children with infantile hemangiomas, port wine birthmarks, and angiofibromas, according to Kristen M. Kelly, MD.

“Combination treatments with procedures and medications can improve treatment in many cases,” Dr. Kelly said at the World Congress of Pediatric Dermatology.

Dr. Kelly, professor of dermatology and surgery at the University of California, Irvine, said that the use of lasers and other light sources for infantile hemangiomas has dramatically decreased since propranolol, timolol, and other beta-blockers have become available. Most children are candidates for beta-blocker therapy, she said, but for those who are not, the pulsed dye laser (PDL) may be a good option. She also considers using the PDL for ulcerated lesions. “Of course concern comes up, because lasers can sometimes cause ulcerations, so you have to be aware of that,” she said.

Dr. Kristen M. Kelly
In her clinical opinion, the PDL is a good adjunct to beta-blocker treatment when a superficial component to infantile hemangioma exists. It allows you to achieve more complete removal, she noted, and can decrease the time required for beta-blocker therapy. PDLs also are good for when there is recurrence as a beta-blocker is tapered or stopped, and for treating residua such as redness or textural changes that may be left after beta-blocker therapy.

“For the more proliferative phase of infantile hemangiomas, I’ll use a larger spot size: 10-12 mm, and short pulse durations: 0.45 to 1.5 milliseconds, and low energies,” Dr. Kelly said. “I would start with an energy of 5 or 5.5 J/cm2. I may creep that up a little with time, but I don’t feel that you need to use very high energies. For lesions that are starting to involute, you could consider higher energies.”

Consider the combination of PDL and propranolol for patients who have a superficial component, for ulcerated lesions, or for rapidly progressing lesions that are not responding to your treatment. “You can also use the combination of PDL and timolol,” she said. “Starting treatment can avoid the need for reconstruction later.”

Dr. Kelly then discussed her approach to treating port wine birthmarks. She almost exclusively uses the PDL and the 755-nm Alexandrite lasers for these lesions. “For some of the resistant lesions, I’ll consider some of the combined treatments, like the combined 1064/532 nm system,” she said. “If I have really young patients, I use the PDL almost exclusively. I find the Alexandrite laser useful when I have thicker lesions that have hypertrophied.”

For optimal effect, she recommends treating lesions as early as possible and increasing chromophore target by placing patients with facial lesions in the Trendelenburg position during treatment sessions. Her preferred PDL parameters are a wavelength of 585 nm or 595 nm with a pulse duration of 0.45 to 1.5 milliseconds for the vast majority of lesions. “I try to vary the pulse duration over time, so if I’m getting a great result with 0.45 milliseconds, I’ll do that a couple of times,” Dr. Kelly said. “Once I feel I’ve reached a plateau, I might change to 1.5 milliseconds, or consider doing a second pass.”

Whenever possible she uses larger spot sizes and chooses the level of energy based on the type of lesion she’s treating. “I think it’s important to look for an endpoint,” she said. “I like to see deep purpura but I don’t like to see gray, because I feel that’s where you’re going to get epidermal injury or [there is] the chance for scarring and dyspigmentation, which can be permanent in some patients.”

Patients with port wine birthmarks require 3-15 treatments or more, typically 4 weeks apart. “Some people do 2- or 3-week intervals; that’s something to consider,” Dr. Kelly said. “In a darker-skinned patient with hyperpigmentation, I will use longer intervals, especially on an extremity that may take a little longer to heal.”

Alternative treatments are being studied, including the use of lasers in combination with antiangiogenic agents. “Rapamycin has been looked at most extensively, and it’s been shown to have a significant benefit,” she said.

According to Dr. Kelly, a new device for treating port wine birthmarks is being developed that combines pulse dye laser, Nd:YAG, and radiofrequency. “The potential advantage of this is that when we use the PDL alone, we probably cannot get very deep into those vessels,” she said. “The combination of the PDL and radiofrequency may allow us to more completely coagulate these vessels and get better response.”

Dr. Kelly closed her presentation by discussing angiofibromas, disfiguring skin lesions that are associated with tuberous sclerosis and have a fairly rapid recurrence. Topical and/or oral rapamycin are treatment options, but so are laser and light sources. She cited approaches published by Roy Geronemus MD, of the Laser and Skin Surgery Center of New York, and his associates, which included PDL treatment with a 10-mm spot size delivered at 7.5 J/cm2 with a pulse duration of 1.5 ms, and dynamic cooling spray duration of 30 ms (Lasers Surg Med 2013;45:555-7). This was followed by ablative fractional resurfacing with a 15-mm spot size at 70 mJ per pulse and 40% coverage. Other treatment options for angiofibromas include pinpoint electrosurgery to papular, fibrotic lesions and topical rapamycin ointment twice a day.

Dr. Kelly disclosed having drugs or devices donated by Light Sciences Oncology, Solta Medical, Cynosure, Syneron Candela, and Novartis. She is a consultant for MundiPharma, Allergan, and Syneron Candela, and has received research funding from the American Society of Laser Medicine and Surgery, the National Institutes of Health, the Sturge-Weber Foundation, and the UC Irvine Institute of Clinical and Translational Science.
 

 

 

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CHICAGO – Multiple laser and light options are available to treat children with infantile hemangiomas, port wine birthmarks, and angiofibromas, according to Kristen M. Kelly, MD.

“Combination treatments with procedures and medications can improve treatment in many cases,” Dr. Kelly said at the World Congress of Pediatric Dermatology.

Dr. Kelly, professor of dermatology and surgery at the University of California, Irvine, said that the use of lasers and other light sources for infantile hemangiomas has dramatically decreased since propranolol, timolol, and other beta-blockers have become available. Most children are candidates for beta-blocker therapy, she said, but for those who are not, the pulsed dye laser (PDL) may be a good option. She also considers using the PDL for ulcerated lesions. “Of course concern comes up, because lasers can sometimes cause ulcerations, so you have to be aware of that,” she said.

Dr. Kristen M. Kelly
In her clinical opinion, the PDL is a good adjunct to beta-blocker treatment when a superficial component to infantile hemangioma exists. It allows you to achieve more complete removal, she noted, and can decrease the time required for beta-blocker therapy. PDLs also are good for when there is recurrence as a beta-blocker is tapered or stopped, and for treating residua such as redness or textural changes that may be left after beta-blocker therapy.

“For the more proliferative phase of infantile hemangiomas, I’ll use a larger spot size: 10-12 mm, and short pulse durations: 0.45 to 1.5 milliseconds, and low energies,” Dr. Kelly said. “I would start with an energy of 5 or 5.5 J/cm2. I may creep that up a little with time, but I don’t feel that you need to use very high energies. For lesions that are starting to involute, you could consider higher energies.”

Consider the combination of PDL and propranolol for patients who have a superficial component, for ulcerated lesions, or for rapidly progressing lesions that are not responding to your treatment. “You can also use the combination of PDL and timolol,” she said. “Starting treatment can avoid the need for reconstruction later.”

Dr. Kelly then discussed her approach to treating port wine birthmarks. She almost exclusively uses the PDL and the 755-nm Alexandrite lasers for these lesions. “For some of the resistant lesions, I’ll consider some of the combined treatments, like the combined 1064/532 nm system,” she said. “If I have really young patients, I use the PDL almost exclusively. I find the Alexandrite laser useful when I have thicker lesions that have hypertrophied.”

For optimal effect, she recommends treating lesions as early as possible and increasing chromophore target by placing patients with facial lesions in the Trendelenburg position during treatment sessions. Her preferred PDL parameters are a wavelength of 585 nm or 595 nm with a pulse duration of 0.45 to 1.5 milliseconds for the vast majority of lesions. “I try to vary the pulse duration over time, so if I’m getting a great result with 0.45 milliseconds, I’ll do that a couple of times,” Dr. Kelly said. “Once I feel I’ve reached a plateau, I might change to 1.5 milliseconds, or consider doing a second pass.”

Whenever possible she uses larger spot sizes and chooses the level of energy based on the type of lesion she’s treating. “I think it’s important to look for an endpoint,” she said. “I like to see deep purpura but I don’t like to see gray, because I feel that’s where you’re going to get epidermal injury or [there is] the chance for scarring and dyspigmentation, which can be permanent in some patients.”

Patients with port wine birthmarks require 3-15 treatments or more, typically 4 weeks apart. “Some people do 2- or 3-week intervals; that’s something to consider,” Dr. Kelly said. “In a darker-skinned patient with hyperpigmentation, I will use longer intervals, especially on an extremity that may take a little longer to heal.”

Alternative treatments are being studied, including the use of lasers in combination with antiangiogenic agents. “Rapamycin has been looked at most extensively, and it’s been shown to have a significant benefit,” she said.

According to Dr. Kelly, a new device for treating port wine birthmarks is being developed that combines pulse dye laser, Nd:YAG, and radiofrequency. “The potential advantage of this is that when we use the PDL alone, we probably cannot get very deep into those vessels,” she said. “The combination of the PDL and radiofrequency may allow us to more completely coagulate these vessels and get better response.”

Dr. Kelly closed her presentation by discussing angiofibromas, disfiguring skin lesions that are associated with tuberous sclerosis and have a fairly rapid recurrence. Topical and/or oral rapamycin are treatment options, but so are laser and light sources. She cited approaches published by Roy Geronemus MD, of the Laser and Skin Surgery Center of New York, and his associates, which included PDL treatment with a 10-mm spot size delivered at 7.5 J/cm2 with a pulse duration of 1.5 ms, and dynamic cooling spray duration of 30 ms (Lasers Surg Med 2013;45:555-7). This was followed by ablative fractional resurfacing with a 15-mm spot size at 70 mJ per pulse and 40% coverage. Other treatment options for angiofibromas include pinpoint electrosurgery to papular, fibrotic lesions and topical rapamycin ointment twice a day.

Dr. Kelly disclosed having drugs or devices donated by Light Sciences Oncology, Solta Medical, Cynosure, Syneron Candela, and Novartis. She is a consultant for MundiPharma, Allergan, and Syneron Candela, and has received research funding from the American Society of Laser Medicine and Surgery, the National Institutes of Health, the Sturge-Weber Foundation, and the UC Irvine Institute of Clinical and Translational Science.
 

 

 

 

CHICAGO – Multiple laser and light options are available to treat children with infantile hemangiomas, port wine birthmarks, and angiofibromas, according to Kristen M. Kelly, MD.

“Combination treatments with procedures and medications can improve treatment in many cases,” Dr. Kelly said at the World Congress of Pediatric Dermatology.

Dr. Kelly, professor of dermatology and surgery at the University of California, Irvine, said that the use of lasers and other light sources for infantile hemangiomas has dramatically decreased since propranolol, timolol, and other beta-blockers have become available. Most children are candidates for beta-blocker therapy, she said, but for those who are not, the pulsed dye laser (PDL) may be a good option. She also considers using the PDL for ulcerated lesions. “Of course concern comes up, because lasers can sometimes cause ulcerations, so you have to be aware of that,” she said.

Dr. Kristen M. Kelly
In her clinical opinion, the PDL is a good adjunct to beta-blocker treatment when a superficial component to infantile hemangioma exists. It allows you to achieve more complete removal, she noted, and can decrease the time required for beta-blocker therapy. PDLs also are good for when there is recurrence as a beta-blocker is tapered or stopped, and for treating residua such as redness or textural changes that may be left after beta-blocker therapy.

“For the more proliferative phase of infantile hemangiomas, I’ll use a larger spot size: 10-12 mm, and short pulse durations: 0.45 to 1.5 milliseconds, and low energies,” Dr. Kelly said. “I would start with an energy of 5 or 5.5 J/cm2. I may creep that up a little with time, but I don’t feel that you need to use very high energies. For lesions that are starting to involute, you could consider higher energies.”

Consider the combination of PDL and propranolol for patients who have a superficial component, for ulcerated lesions, or for rapidly progressing lesions that are not responding to your treatment. “You can also use the combination of PDL and timolol,” she said. “Starting treatment can avoid the need for reconstruction later.”

Dr. Kelly then discussed her approach to treating port wine birthmarks. She almost exclusively uses the PDL and the 755-nm Alexandrite lasers for these lesions. “For some of the resistant lesions, I’ll consider some of the combined treatments, like the combined 1064/532 nm system,” she said. “If I have really young patients, I use the PDL almost exclusively. I find the Alexandrite laser useful when I have thicker lesions that have hypertrophied.”

For optimal effect, she recommends treating lesions as early as possible and increasing chromophore target by placing patients with facial lesions in the Trendelenburg position during treatment sessions. Her preferred PDL parameters are a wavelength of 585 nm or 595 nm with a pulse duration of 0.45 to 1.5 milliseconds for the vast majority of lesions. “I try to vary the pulse duration over time, so if I’m getting a great result with 0.45 milliseconds, I’ll do that a couple of times,” Dr. Kelly said. “Once I feel I’ve reached a plateau, I might change to 1.5 milliseconds, or consider doing a second pass.”

Whenever possible she uses larger spot sizes and chooses the level of energy based on the type of lesion she’s treating. “I think it’s important to look for an endpoint,” she said. “I like to see deep purpura but I don’t like to see gray, because I feel that’s where you’re going to get epidermal injury or [there is] the chance for scarring and dyspigmentation, which can be permanent in some patients.”

Patients with port wine birthmarks require 3-15 treatments or more, typically 4 weeks apart. “Some people do 2- or 3-week intervals; that’s something to consider,” Dr. Kelly said. “In a darker-skinned patient with hyperpigmentation, I will use longer intervals, especially on an extremity that may take a little longer to heal.”

Alternative treatments are being studied, including the use of lasers in combination with antiangiogenic agents. “Rapamycin has been looked at most extensively, and it’s been shown to have a significant benefit,” she said.

According to Dr. Kelly, a new device for treating port wine birthmarks is being developed that combines pulse dye laser, Nd:YAG, and radiofrequency. “The potential advantage of this is that when we use the PDL alone, we probably cannot get very deep into those vessels,” she said. “The combination of the PDL and radiofrequency may allow us to more completely coagulate these vessels and get better response.”

Dr. Kelly closed her presentation by discussing angiofibromas, disfiguring skin lesions that are associated with tuberous sclerosis and have a fairly rapid recurrence. Topical and/or oral rapamycin are treatment options, but so are laser and light sources. She cited approaches published by Roy Geronemus MD, of the Laser and Skin Surgery Center of New York, and his associates, which included PDL treatment with a 10-mm spot size delivered at 7.5 J/cm2 with a pulse duration of 1.5 ms, and dynamic cooling spray duration of 30 ms (Lasers Surg Med 2013;45:555-7). This was followed by ablative fractional resurfacing with a 15-mm spot size at 70 mJ per pulse and 40% coverage. Other treatment options for angiofibromas include pinpoint electrosurgery to papular, fibrotic lesions and topical rapamycin ointment twice a day.

Dr. Kelly disclosed having drugs or devices donated by Light Sciences Oncology, Solta Medical, Cynosure, Syneron Candela, and Novartis. She is a consultant for MundiPharma, Allergan, and Syneron Candela, and has received research funding from the American Society of Laser Medicine and Surgery, the National Institutes of Health, the Sturge-Weber Foundation, and the UC Irvine Institute of Clinical and Translational Science.
 

 

 

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CT scoring system may improve sacroiliitis treatment in IBD

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A standardized scoring system to identify sacroiliitis could enable patients with inflammatory bowel disease to get earlier rheumatology referrals and improve treatment, according to an analysis of IBD patients with pre-existing abdominal CT scans.

Of the 316 patients recruited from an IBD clinic in Toronto, the validated CT scan scoring system identified 49 with sacroiliitis, of whom only 5 had been referred to an outpatient rheumatology clinic in the city. Rates of sacroiliitis were similar between the 233 patients with Crohn’s disease (15%) and the 83 with ulcerative colitis (16.9%). The scoring system indicated sacroiliitis in 6 (5.6%) of the 108 control subjects, who were recruited from a urology clinic and had no prior history of chronic back pain, reported Jonathan Chan, MD, of the University of Toronto and his associates (Arthritis Care Res. 2017 Jul 21. doi: 10.1002/acr.23323).“Previous studies using CT scan to detect sacroiliitis have relied upon an adaptation of the [modified New York] criteria or a radiologist’s gestalt. Such an adaptation may not be appropriate since changes suggestive of sacroiliitis can be found in the healthy population due to the increased sensitivity of CT scans,” the investigators said. They developed a CT-scan scoring system in which the sacroiliac joints are divided into left/right and iliac/sacral segments. The slice with the greatest number of erosions in each of the four segments contributes that value to the total erosion score, with a score of 3 or greater identifying the presence of sacroiliitis.

By demonstrating that sacroiliitis is three times more prevalent among IBD patients and can be reliably detected in CT scans performed in the clinical care of those patients, this study suggests that “more timely referral for rheumatology assessment” could avoid unnecessary treatment with biologics, Dr. Chan and his associates wrote.

The study was supported in part by a fellowship grant from the Assessment of Spondyloarthritis International Society and in part by Janssen. The investigators reported having no conflicts of interest for the study.

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A standardized scoring system to identify sacroiliitis could enable patients with inflammatory bowel disease to get earlier rheumatology referrals and improve treatment, according to an analysis of IBD patients with pre-existing abdominal CT scans.

Of the 316 patients recruited from an IBD clinic in Toronto, the validated CT scan scoring system identified 49 with sacroiliitis, of whom only 5 had been referred to an outpatient rheumatology clinic in the city. Rates of sacroiliitis were similar between the 233 patients with Crohn’s disease (15%) and the 83 with ulcerative colitis (16.9%). The scoring system indicated sacroiliitis in 6 (5.6%) of the 108 control subjects, who were recruited from a urology clinic and had no prior history of chronic back pain, reported Jonathan Chan, MD, of the University of Toronto and his associates (Arthritis Care Res. 2017 Jul 21. doi: 10.1002/acr.23323).“Previous studies using CT scan to detect sacroiliitis have relied upon an adaptation of the [modified New York] criteria or a radiologist’s gestalt. Such an adaptation may not be appropriate since changes suggestive of sacroiliitis can be found in the healthy population due to the increased sensitivity of CT scans,” the investigators said. They developed a CT-scan scoring system in which the sacroiliac joints are divided into left/right and iliac/sacral segments. The slice with the greatest number of erosions in each of the four segments contributes that value to the total erosion score, with a score of 3 or greater identifying the presence of sacroiliitis.

By demonstrating that sacroiliitis is three times more prevalent among IBD patients and can be reliably detected in CT scans performed in the clinical care of those patients, this study suggests that “more timely referral for rheumatology assessment” could avoid unnecessary treatment with biologics, Dr. Chan and his associates wrote.

The study was supported in part by a fellowship grant from the Assessment of Spondyloarthritis International Society and in part by Janssen. The investigators reported having no conflicts of interest for the study.

[email protected]

 

A standardized scoring system to identify sacroiliitis could enable patients with inflammatory bowel disease to get earlier rheumatology referrals and improve treatment, according to an analysis of IBD patients with pre-existing abdominal CT scans.

Of the 316 patients recruited from an IBD clinic in Toronto, the validated CT scan scoring system identified 49 with sacroiliitis, of whom only 5 had been referred to an outpatient rheumatology clinic in the city. Rates of sacroiliitis were similar between the 233 patients with Crohn’s disease (15%) and the 83 with ulcerative colitis (16.9%). The scoring system indicated sacroiliitis in 6 (5.6%) of the 108 control subjects, who were recruited from a urology clinic and had no prior history of chronic back pain, reported Jonathan Chan, MD, of the University of Toronto and his associates (Arthritis Care Res. 2017 Jul 21. doi: 10.1002/acr.23323).“Previous studies using CT scan to detect sacroiliitis have relied upon an adaptation of the [modified New York] criteria or a radiologist’s gestalt. Such an adaptation may not be appropriate since changes suggestive of sacroiliitis can be found in the healthy population due to the increased sensitivity of CT scans,” the investigators said. They developed a CT-scan scoring system in which the sacroiliac joints are divided into left/right and iliac/sacral segments. The slice with the greatest number of erosions in each of the four segments contributes that value to the total erosion score, with a score of 3 or greater identifying the presence of sacroiliitis.

By demonstrating that sacroiliitis is three times more prevalent among IBD patients and can be reliably detected in CT scans performed in the clinical care of those patients, this study suggests that “more timely referral for rheumatology assessment” could avoid unnecessary treatment with biologics, Dr. Chan and his associates wrote.

The study was supported in part by a fellowship grant from the Assessment of Spondyloarthritis International Society and in part by Janssen. The investigators reported having no conflicts of interest for the study.

[email protected]

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Potential new role for FFR

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– Fractional flow reserve is under study for a potential major application: guidance on percutaneous coronary intervention (PCI) optimization immediately after stent placement, Roberto Diletti, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News
Dr. Robert Diletti
He reported on preliminary results from the ongoing FFR-SEARCH study, a prospective registry of 1,000 patients who underwent measurement of fractional flow reserve (FFR) after completion of stenting of coronary lesions and whose angiographic results were deemed satisfactory by the operator. One-third of patients in the all-comers registry had stable angina, one-third had unstable angina, and one-third had ST-elevation MI. The preliminary analysis included 959 patients with 1,165 stented lesions in vessels with a diameter of at least 2.5 mm.

At the end of the procedure, FFR measurement using a novel monorail optical pressure sensor catheter revealed that 43% of the lesions had a suboptimal FFR value of 0.90 or less.

“Just this year, two meta-analyses showed that a cutoff of 0.90 is important to define a group of patients at high risk for major adverse cardiovascular events and revascularization,” noted Dr. Diletti of Erasmus University Medical Center in Rotterdam, the Netherlands.

Using the older, more conservative cutoff of an FFR of 0.85 or less, 20% of the lesions would potentially benefit from further action to optimize the physiologic result, most often in the form of additional expansion of the stent.

“We are used to thinking of FFR as a tool to understand whether a lesion has to be treated or not. Now we can also start thinking about FFR as a tool to guide PCI optimization,” the cardiologist said.

Optimization wasn’t actually performed in this observational registry. That will be the focus of FFR-REACT, a planned randomized trial investigating the clinical impact of intravascular ultrasound (IVUS)-directed FFR optimization of PCI.

In a per-patient analysis, 48% of FFR-SEARCH participants had a poststent FFR of 0.90 or less in one or more treated lesions. Another 22% had a postprocedure FFR of 0.85 or less in at least one treated lesion, while 8.9% had an FFR of 0.80, which is below the threshold for ischemia.

The primary endpoint in the ongoing FFR-SEARCH study is the 2-year composite rate of major adverse cardiovascular events, defined as MI, any revascularization, or all-cause mortality. Only the 30-day MACE rate was available at the time of Dr. Diletti’s presentation in Paris. The rate was 1.5% in patients with a postprocedure FFR greater than 0.90, 2.0% in those with an FFR of 0.86-0.90, 2.6% with an FFR of 0.81-0.85, and 2.8% with a poststent FFR of 0.80 or less. While those early between-group differences weren’t statistically significant, the trend is encouraging, he noted.

Postprocedure FFR measurement took an average of 5 minutes. The procedure was simple and safe, according to Dr. Diletti. There were no complications related to the use of the Navvus MicroCatheter technology. He explained that the device profile is comparable to a 0.022-inch diameter at the lesion site. Wire access to the vessel was maintained throughout. The rapid-exchange monorail microcatheter was inserted over the previously used standard 0.014-inch coronary guidewire. The optical pressure sensor was positioned roughly 20 mm distal to the distal stent edge. Manual pullback with measurements obtained at various locations in the vicinity of the stented lesion was repeated as necessary in order to identify where optimization, if appropriate, should be focused.

Operators were unable to crossover the microcatheter in 3.5% of cases, mostly because of vessel tortuosity or calcification.

Audience members commented that many of the low FFRs after stenting may reflect diffuse coronary disease, which can be corrected only by placing numerous additional stents, creating its own problems. Dr. Diletti offered reassurance on that score. He explained that in an IVUS substudy of FFR-SEARCH, an unstented physiologically important focal lesion or stent underexpansion was identified in 86% of the cases of low FFR.

“That means you can do something about it. In the other 14% of cases, in my opinion, you cannot do a lot because of very diffuse disease distally,” he said.

He reported having no financial conflicts of interest in connection with the study, supported by ACIST Medical Systems. The Navvus MicroCatheter is approved by both the Food and Drug Administration and the European regulatory agency.

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– Fractional flow reserve is under study for a potential major application: guidance on percutaneous coronary intervention (PCI) optimization immediately after stent placement, Roberto Diletti, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News
Dr. Robert Diletti
He reported on preliminary results from the ongoing FFR-SEARCH study, a prospective registry of 1,000 patients who underwent measurement of fractional flow reserve (FFR) after completion of stenting of coronary lesions and whose angiographic results were deemed satisfactory by the operator. One-third of patients in the all-comers registry had stable angina, one-third had unstable angina, and one-third had ST-elevation MI. The preliminary analysis included 959 patients with 1,165 stented lesions in vessels with a diameter of at least 2.5 mm.

At the end of the procedure, FFR measurement using a novel monorail optical pressure sensor catheter revealed that 43% of the lesions had a suboptimal FFR value of 0.90 or less.

“Just this year, two meta-analyses showed that a cutoff of 0.90 is important to define a group of patients at high risk for major adverse cardiovascular events and revascularization,” noted Dr. Diletti of Erasmus University Medical Center in Rotterdam, the Netherlands.

Using the older, more conservative cutoff of an FFR of 0.85 or less, 20% of the lesions would potentially benefit from further action to optimize the physiologic result, most often in the form of additional expansion of the stent.

“We are used to thinking of FFR as a tool to understand whether a lesion has to be treated or not. Now we can also start thinking about FFR as a tool to guide PCI optimization,” the cardiologist said.

Optimization wasn’t actually performed in this observational registry. That will be the focus of FFR-REACT, a planned randomized trial investigating the clinical impact of intravascular ultrasound (IVUS)-directed FFR optimization of PCI.

In a per-patient analysis, 48% of FFR-SEARCH participants had a poststent FFR of 0.90 or less in one or more treated lesions. Another 22% had a postprocedure FFR of 0.85 or less in at least one treated lesion, while 8.9% had an FFR of 0.80, which is below the threshold for ischemia.

The primary endpoint in the ongoing FFR-SEARCH study is the 2-year composite rate of major adverse cardiovascular events, defined as MI, any revascularization, or all-cause mortality. Only the 30-day MACE rate was available at the time of Dr. Diletti’s presentation in Paris. The rate was 1.5% in patients with a postprocedure FFR greater than 0.90, 2.0% in those with an FFR of 0.86-0.90, 2.6% with an FFR of 0.81-0.85, and 2.8% with a poststent FFR of 0.80 or less. While those early between-group differences weren’t statistically significant, the trend is encouraging, he noted.

Postprocedure FFR measurement took an average of 5 minutes. The procedure was simple and safe, according to Dr. Diletti. There were no complications related to the use of the Navvus MicroCatheter technology. He explained that the device profile is comparable to a 0.022-inch diameter at the lesion site. Wire access to the vessel was maintained throughout. The rapid-exchange monorail microcatheter was inserted over the previously used standard 0.014-inch coronary guidewire. The optical pressure sensor was positioned roughly 20 mm distal to the distal stent edge. Manual pullback with measurements obtained at various locations in the vicinity of the stented lesion was repeated as necessary in order to identify where optimization, if appropriate, should be focused.

Operators were unable to crossover the microcatheter in 3.5% of cases, mostly because of vessel tortuosity or calcification.

Audience members commented that many of the low FFRs after stenting may reflect diffuse coronary disease, which can be corrected only by placing numerous additional stents, creating its own problems. Dr. Diletti offered reassurance on that score. He explained that in an IVUS substudy of FFR-SEARCH, an unstented physiologically important focal lesion or stent underexpansion was identified in 86% of the cases of low FFR.

“That means you can do something about it. In the other 14% of cases, in my opinion, you cannot do a lot because of very diffuse disease distally,” he said.

He reported having no financial conflicts of interest in connection with the study, supported by ACIST Medical Systems. The Navvus MicroCatheter is approved by both the Food and Drug Administration and the European regulatory agency.

 

– Fractional flow reserve is under study for a potential major application: guidance on percutaneous coronary intervention (PCI) optimization immediately after stent placement, Roberto Diletti, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News
Dr. Robert Diletti
He reported on preliminary results from the ongoing FFR-SEARCH study, a prospective registry of 1,000 patients who underwent measurement of fractional flow reserve (FFR) after completion of stenting of coronary lesions and whose angiographic results were deemed satisfactory by the operator. One-third of patients in the all-comers registry had stable angina, one-third had unstable angina, and one-third had ST-elevation MI. The preliminary analysis included 959 patients with 1,165 stented lesions in vessels with a diameter of at least 2.5 mm.

At the end of the procedure, FFR measurement using a novel monorail optical pressure sensor catheter revealed that 43% of the lesions had a suboptimal FFR value of 0.90 or less.

“Just this year, two meta-analyses showed that a cutoff of 0.90 is important to define a group of patients at high risk for major adverse cardiovascular events and revascularization,” noted Dr. Diletti of Erasmus University Medical Center in Rotterdam, the Netherlands.

Using the older, more conservative cutoff of an FFR of 0.85 or less, 20% of the lesions would potentially benefit from further action to optimize the physiologic result, most often in the form of additional expansion of the stent.

“We are used to thinking of FFR as a tool to understand whether a lesion has to be treated or not. Now we can also start thinking about FFR as a tool to guide PCI optimization,” the cardiologist said.

Optimization wasn’t actually performed in this observational registry. That will be the focus of FFR-REACT, a planned randomized trial investigating the clinical impact of intravascular ultrasound (IVUS)-directed FFR optimization of PCI.

In a per-patient analysis, 48% of FFR-SEARCH participants had a poststent FFR of 0.90 or less in one or more treated lesions. Another 22% had a postprocedure FFR of 0.85 or less in at least one treated lesion, while 8.9% had an FFR of 0.80, which is below the threshold for ischemia.

The primary endpoint in the ongoing FFR-SEARCH study is the 2-year composite rate of major adverse cardiovascular events, defined as MI, any revascularization, or all-cause mortality. Only the 30-day MACE rate was available at the time of Dr. Diletti’s presentation in Paris. The rate was 1.5% in patients with a postprocedure FFR greater than 0.90, 2.0% in those with an FFR of 0.86-0.90, 2.6% with an FFR of 0.81-0.85, and 2.8% with a poststent FFR of 0.80 or less. While those early between-group differences weren’t statistically significant, the trend is encouraging, he noted.

Postprocedure FFR measurement took an average of 5 minutes. The procedure was simple and safe, according to Dr. Diletti. There were no complications related to the use of the Navvus MicroCatheter technology. He explained that the device profile is comparable to a 0.022-inch diameter at the lesion site. Wire access to the vessel was maintained throughout. The rapid-exchange monorail microcatheter was inserted over the previously used standard 0.014-inch coronary guidewire. The optical pressure sensor was positioned roughly 20 mm distal to the distal stent edge. Manual pullback with measurements obtained at various locations in the vicinity of the stented lesion was repeated as necessary in order to identify where optimization, if appropriate, should be focused.

Operators were unable to crossover the microcatheter in 3.5% of cases, mostly because of vessel tortuosity or calcification.

Audience members commented that many of the low FFRs after stenting may reflect diffuse coronary disease, which can be corrected only by placing numerous additional stents, creating its own problems. Dr. Diletti offered reassurance on that score. He explained that in an IVUS substudy of FFR-SEARCH, an unstented physiologically important focal lesion or stent underexpansion was identified in 86% of the cases of low FFR.

“That means you can do something about it. In the other 14% of cases, in my opinion, you cannot do a lot because of very diffuse disease distally,” he said.

He reported having no financial conflicts of interest in connection with the study, supported by ACIST Medical Systems. The Navvus MicroCatheter is approved by both the Food and Drug Administration and the European regulatory agency.

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