ACS Surgery News

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

aotto@frontlinemedcom.com

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

aotto@frontlinemedcom.com

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

aotto@frontlinemedcom.com

A coordinated approach to infection control and antibiotic stewardship would dramatically reduce the number of people affected by antibiotic-resistant pathogens and health care–associated infections (HAIs), saving tens of thousands of lives and billions of dollars over the next 5 years, according to a federal report.

With a nationwide prevention and antibiotic stewardship program, the total number of HAIs could be reduced by 619,000 over the next 5 years, saving 37,000 lives and reducing direct medical costs by $7.7 billion, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said in a telebriefing sponsored by the agency.

The coordinated approach requires both a public health tracking and alerting system and robust interfacility infection control practices. “Facilities that go it alone can’t effectively protect their own patients,” he said.

A CDC Vital Signs report projected outcomes for institution-based versus coordinated responses to antibiotic-resistant infections, predicting infections and deaths from 2014-2019 in a series of three scenarios.

Rachel Slayton, Ph.D., of the Center for Emerging and Zoonotic Infectious Diseases, used carbapenem-resistant Enterobacteriaceae (CRE) as the test case to determine the effect size of coordinated compared with institution-based infection control and alerting practices.*

She and her coauthors projected that the number of health care-associated CRE infections would rise about 10% over the next 5 years, from 310,000 to 340,000, under current practices. Using these prevalence figures, a coordinated approach would result in CRE prevalence within a health care network of just 2% after 5 years, compared with a 12% baseline prevalence and an 8.6% prevalence with augmented individual efforts.

“Two percent is still two percent too much, but it’s still a whole lot better than 12%,” said Dr. Frieden.

Infection control practices that are enhanced by interfacility coordination may include maintaining regional databases that permit alerts when an individual with an HAI transfers from one facility to the other; having inter-institution agreement about best practices for gowning, gloving, and isolation; and commencing enhanced screening for HAIs when public health officials identify a potential outbreak. Antibiotic stewardship is also enhanced when institutions explicitly agree to follow best prescribing practices.

Implementation of the coordinated approach would be supported by the CDC’s Antibiotic Resistance Solutions Initiative, with $264 million requested in the federal fiscal year 2016 budget for a broad set of programs. Part of this amount would provide for funding of a coordinated prevention approach in all 50 states, with support for state and local health departments, and a network of laboratory facilities for improved surveillance for resistant pathogens.

koakes@frontlinemedcom.com

On Twitter: @karioakes

*CORRECTION 8/9/2015: The original version of this story misidentified the test case organism.

A coordinated approach to infection control and antibiotic stewardship would dramatically reduce the number of people affected by antibiotic-resistant pathogens and health care–associated infections (HAIs), saving tens of thousands of lives and billions of dollars over the next 5 years, according to a federal report.

With a nationwide prevention and antibiotic stewardship program, the total number of HAIs could be reduced by 619,000 over the next 5 years, saving 37,000 lives and reducing direct medical costs by $7.7 billion, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said in a telebriefing sponsored by the agency.

The coordinated approach requires both a public health tracking and alerting system and robust interfacility infection control practices. “Facilities that go it alone can’t effectively protect their own patients,” he said.

A CDC Vital Signs report projected outcomes for institution-based versus coordinated responses to antibiotic-resistant infections, predicting infections and deaths from 2014-2019 in a series of three scenarios.

Rachel Slayton, Ph.D., of the Center for Emerging and Zoonotic Infectious Diseases, used carbapenem-resistant Enterobacteriaceae (CRE) as the test case to determine the effect size of coordinated compared with institution-based infection control and alerting practices.*

She and her coauthors projected that the number of health care-associated CRE infections would rise about 10% over the next 5 years, from 310,000 to 340,000, under current practices. Using these prevalence figures, a coordinated approach would result in CRE prevalence within a health care network of just 2% after 5 years, compared with a 12% baseline prevalence and an 8.6% prevalence with augmented individual efforts.

“Two percent is still two percent too much, but it’s still a whole lot better than 12%,” said Dr. Frieden.

Infection control practices that are enhanced by interfacility coordination may include maintaining regional databases that permit alerts when an individual with an HAI transfers from one facility to the other; having inter-institution agreement about best practices for gowning, gloving, and isolation; and commencing enhanced screening for HAIs when public health officials identify a potential outbreak. Antibiotic stewardship is also enhanced when institutions explicitly agree to follow best prescribing practices.

Implementation of the coordinated approach would be supported by the CDC’s Antibiotic Resistance Solutions Initiative, with $264 million requested in the federal fiscal year 2016 budget for a broad set of programs. Part of this amount would provide for funding of a coordinated prevention approach in all 50 states, with support for state and local health departments, and a network of laboratory facilities for improved surveillance for resistant pathogens.

koakes@frontlinemedcom.com

On Twitter: @karioakes

*CORRECTION 8/9/2015: The original version of this story misidentified the test case organism.

A coordinated approach to infection control and antibiotic stewardship would dramatically reduce the number of people affected by antibiotic-resistant pathogens and health care–associated infections (HAIs), saving tens of thousands of lives and billions of dollars over the next 5 years, according to a federal report.

With a nationwide prevention and antibiotic stewardship program, the total number of HAIs could be reduced by 619,000 over the next 5 years, saving 37,000 lives and reducing direct medical costs by $7.7 billion, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said in a telebriefing sponsored by the agency.

The coordinated approach requires both a public health tracking and alerting system and robust interfacility infection control practices. “Facilities that go it alone can’t effectively protect their own patients,” he said.

A CDC Vital Signs report projected outcomes for institution-based versus coordinated responses to antibiotic-resistant infections, predicting infections and deaths from 2014-2019 in a series of three scenarios.

Rachel Slayton, Ph.D., of the Center for Emerging and Zoonotic Infectious Diseases, used carbapenem-resistant Enterobacteriaceae (CRE) as the test case to determine the effect size of coordinated compared with institution-based infection control and alerting practices.*

She and her coauthors projected that the number of health care-associated CRE infections would rise about 10% over the next 5 years, from 310,000 to 340,000, under current practices. Using these prevalence figures, a coordinated approach would result in CRE prevalence within a health care network of just 2% after 5 years, compared with a 12% baseline prevalence and an 8.6% prevalence with augmented individual efforts.

“Two percent is still two percent too much, but it’s still a whole lot better than 12%,” said Dr. Frieden.

Infection control practices that are enhanced by interfacility coordination may include maintaining regional databases that permit alerts when an individual with an HAI transfers from one facility to the other; having inter-institution agreement about best practices for gowning, gloving, and isolation; and commencing enhanced screening for HAIs when public health officials identify a potential outbreak. Antibiotic stewardship is also enhanced when institutions explicitly agree to follow best prescribing practices.

Implementation of the coordinated approach would be supported by the CDC’s Antibiotic Resistance Solutions Initiative, with $264 million requested in the federal fiscal year 2016 budget for a broad set of programs. Part of this amount would provide for funding of a coordinated prevention approach in all 50 states, with support for state and local health departments, and a network of laboratory facilities for improved surveillance for resistant pathogens.

koakes@frontlinemedcom.com

On Twitter: @karioakes

*CORRECTION 8/9/2015: The original version of this story misidentified the test case organism.

The other day, I had to look up “whispered pectoriloquy” to be reminded of what it meant. The last time I had seen the term was when I was a third-year medical student.

I was motivated to look it up now as I was reading the review of systems in a patient note generated from an electronic health record. Interestingly, the note was written by a consulting urologist.

I have become accustomed to only glancing at the review of systems in most of the medical letters I receive, but this particular review of systems caught my attention. As I looked carefully at it, I noticed that the urologist documented that the patient denied chest pain, shortness of breath, double vision, and – oddly – loose stools. In fairness, the note also documented that the patient denied blood in his urine and nocturia.

I was quite doubtful that the physician actually asked the patient about chest pain and double vision, so I was facing a dilemma: believe all of the note, none of the note, or just the parts I felt confident were actually asked.

For a long time, I really did not think much about the problem. I just processed the observation with a sense of mild amusement and absurdity, and mostly with an acceptance that these kinds of observations were an annoying but unavoidable side effect of systems created by computer engineers and forced upon doctors.

But I became more concerned as I read further. The physical exam documented a detailed cardiac exam with no murmurs, rubs, or gallops, and the pulmonary exam showed no wheezing or whispered pectoriloquy. These documentation inaccuracies, while amusing, truly are a source of potential liability and ultimately detract from our ability to find the important information contained within a note.

Fundamentally, medical notes are written to document what occurred during a patient visit. They should allow the physician to recall what happened at the visit, whether the patient follows up in a day, a week, or 3 years later. They also need to communicate the details of the visit to any other clinician who may see the patient at some point in the future.

In recent decades, notes also have become the sole evidence required to justify physician charges. To bill at a certain rate, a physician must document a minimum amount of information, including a specific number of elements in the review of systems and the physical exam. Recognizing that compliance with billing requirements is an important goal of clinicians, many EHRs have made it too easy to “bloat” a note by including reams of irrelevant information – thereby making it difficult to find the important information the note was intended to communicate in the first place.

Notes from some EHRs remind us of the Wendy’s commercial from the 1980s: They force us to ask, “Where’s the beef?”

This is because many EHR implementations rely on default settings. These maximize documentation for billing but unfortunately leave the “beef” (in our case, the real information relevant to patient care) buried in lines of irrelevant, specious, and sometimes downright fictitious information.

We can do better. Virtually every EHR currently in use allows clinicians to customize fields so that notes can be easily written to reflect the realities of our differing practices.

Put more simply, you really can (and should) have a review of systems that is relevant to what you do.

If you always ask about chest pain, difficulty breathing, and abdominal pain, you can include negative responses to those questions with one click and then add in any positive aspects the patient may report. If you are seeing a patient with asthma and you generally ask the same questions – exacerbations in the last month, frequency of the use of albuterol, nighttime awakenings, symptoms with exercise, etc. – most EHR systems will allow you to set up the record to populate an asthma review of systems that includes defined responses you can individualize for each patient.

Electronic documentation of the physical exam also should reflect the examination that you routinely do by default. Then you can make simple changes to adapt your personalized predefined settings and correctly reflect what occurred with each patient.

For that same asthma patient, the physical exam should give the details of the heart and lung exam but should not include any mention of an abdominal exam unless one was actually done. A current high-quality EHR also should populate the appropriate physical exam areas with one click of a button.

It has been more than 3 years since the majority of practices transitioned to electronic health records, but we still see far too many clinicians struggling with systems and describing data that reflect things they have not done, all due to the use of default settings that have never been changed. It is important to understand how to customize your EHR to meet your needs and to make the individual efforts required to learn how to effectively use the current instruments of our craft.

As for whispered pectoriloquy, it is the increased loudness of a whispered word heard on auscultation over an area of lung consolidation. It is similar to tactile fremitus, where consolidation is noted by the vibratory feel in your hand placed on the chest of a patient. It should be a very rare event in our day and age that any description of whispered pectoriloquy should sneak its way into our record, particularly for a urology visit.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

The other day, I had to look up “whispered pectoriloquy” to be reminded of what it meant. The last time I had seen the term was when I was a third-year medical student.

I was motivated to look it up now as I was reading the review of systems in a patient note generated from an electronic health record. Interestingly, the note was written by a consulting urologist.

I have become accustomed to only glancing at the review of systems in most of the medical letters I receive, but this particular review of systems caught my attention. As I looked carefully at it, I noticed that the urologist documented that the patient denied chest pain, shortness of breath, double vision, and – oddly – loose stools. In fairness, the note also documented that the patient denied blood in his urine and nocturia.

I was quite doubtful that the physician actually asked the patient about chest pain and double vision, so I was facing a dilemma: believe all of the note, none of the note, or just the parts I felt confident were actually asked.

For a long time, I really did not think much about the problem. I just processed the observation with a sense of mild amusement and absurdity, and mostly with an acceptance that these kinds of observations were an annoying but unavoidable side effect of systems created by computer engineers and forced upon doctors.

But I became more concerned as I read further. The physical exam documented a detailed cardiac exam with no murmurs, rubs, or gallops, and the pulmonary exam showed no wheezing or whispered pectoriloquy. These documentation inaccuracies, while amusing, truly are a source of potential liability and ultimately detract from our ability to find the important information contained within a note.

Fundamentally, medical notes are written to document what occurred during a patient visit. They should allow the physician to recall what happened at the visit, whether the patient follows up in a day, a week, or 3 years later. They also need to communicate the details of the visit to any other clinician who may see the patient at some point in the future.

In recent decades, notes also have become the sole evidence required to justify physician charges. To bill at a certain rate, a physician must document a minimum amount of information, including a specific number of elements in the review of systems and the physical exam. Recognizing that compliance with billing requirements is an important goal of clinicians, many EHRs have made it too easy to “bloat” a note by including reams of irrelevant information – thereby making it difficult to find the important information the note was intended to communicate in the first place.

Notes from some EHRs remind us of the Wendy’s commercial from the 1980s: They force us to ask, “Where’s the beef?”

This is because many EHR implementations rely on default settings. These maximize documentation for billing but unfortunately leave the “beef” (in our case, the real information relevant to patient care) buried in lines of irrelevant, specious, and sometimes downright fictitious information.

We can do better. Virtually every EHR currently in use allows clinicians to customize fields so that notes can be easily written to reflect the realities of our differing practices.

Put more simply, you really can (and should) have a review of systems that is relevant to what you do.

If you always ask about chest pain, difficulty breathing, and abdominal pain, you can include negative responses to those questions with one click and then add in any positive aspects the patient may report. If you are seeing a patient with asthma and you generally ask the same questions – exacerbations in the last month, frequency of the use of albuterol, nighttime awakenings, symptoms with exercise, etc. – most EHR systems will allow you to set up the record to populate an asthma review of systems that includes defined responses you can individualize for each patient.

Electronic documentation of the physical exam also should reflect the examination that you routinely do by default. Then you can make simple changes to adapt your personalized predefined settings and correctly reflect what occurred with each patient.

For that same asthma patient, the physical exam should give the details of the heart and lung exam but should not include any mention of an abdominal exam unless one was actually done. A current high-quality EHR also should populate the appropriate physical exam areas with one click of a button.

It has been more than 3 years since the majority of practices transitioned to electronic health records, but we still see far too many clinicians struggling with systems and describing data that reflect things they have not done, all due to the use of default settings that have never been changed. It is important to understand how to customize your EHR to meet your needs and to make the individual efforts required to learn how to effectively use the current instruments of our craft.

As for whispered pectoriloquy, it is the increased loudness of a whispered word heard on auscultation over an area of lung consolidation. It is similar to tactile fremitus, where consolidation is noted by the vibratory feel in your hand placed on the chest of a patient. It should be a very rare event in our day and age that any description of whispered pectoriloquy should sneak its way into our record, particularly for a urology visit.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

The other day, I had to look up “whispered pectoriloquy” to be reminded of what it meant. The last time I had seen the term was when I was a third-year medical student.

I was motivated to look it up now as I was reading the review of systems in a patient note generated from an electronic health record. Interestingly, the note was written by a consulting urologist.

I have become accustomed to only glancing at the review of systems in most of the medical letters I receive, but this particular review of systems caught my attention. As I looked carefully at it, I noticed that the urologist documented that the patient denied chest pain, shortness of breath, double vision, and – oddly – loose stools. In fairness, the note also documented that the patient denied blood in his urine and nocturia.

I was quite doubtful that the physician actually asked the patient about chest pain and double vision, so I was facing a dilemma: believe all of the note, none of the note, or just the parts I felt confident were actually asked.

For a long time, I really did not think much about the problem. I just processed the observation with a sense of mild amusement and absurdity, and mostly with an acceptance that these kinds of observations were an annoying but unavoidable side effect of systems created by computer engineers and forced upon doctors.

But I became more concerned as I read further. The physical exam documented a detailed cardiac exam with no murmurs, rubs, or gallops, and the pulmonary exam showed no wheezing or whispered pectoriloquy. These documentation inaccuracies, while amusing, truly are a source of potential liability and ultimately detract from our ability to find the important information contained within a note.

Fundamentally, medical notes are written to document what occurred during a patient visit. They should allow the physician to recall what happened at the visit, whether the patient follows up in a day, a week, or 3 years later. They also need to communicate the details of the visit to any other clinician who may see the patient at some point in the future.

In recent decades, notes also have become the sole evidence required to justify physician charges. To bill at a certain rate, a physician must document a minimum amount of information, including a specific number of elements in the review of systems and the physical exam. Recognizing that compliance with billing requirements is an important goal of clinicians, many EHRs have made it too easy to “bloat” a note by including reams of irrelevant information – thereby making it difficult to find the important information the note was intended to communicate in the first place.

Notes from some EHRs remind us of the Wendy’s commercial from the 1980s: They force us to ask, “Where’s the beef?”

This is because many EHR implementations rely on default settings. These maximize documentation for billing but unfortunately leave the “beef” (in our case, the real information relevant to patient care) buried in lines of irrelevant, specious, and sometimes downright fictitious information.

We can do better. Virtually every EHR currently in use allows clinicians to customize fields so that notes can be easily written to reflect the realities of our differing practices.

Put more simply, you really can (and should) have a review of systems that is relevant to what you do.

If you always ask about chest pain, difficulty breathing, and abdominal pain, you can include negative responses to those questions with one click and then add in any positive aspects the patient may report. If you are seeing a patient with asthma and you generally ask the same questions – exacerbations in the last month, frequency of the use of albuterol, nighttime awakenings, symptoms with exercise, etc. – most EHR systems will allow you to set up the record to populate an asthma review of systems that includes defined responses you can individualize for each patient.

Electronic documentation of the physical exam also should reflect the examination that you routinely do by default. Then you can make simple changes to adapt your personalized predefined settings and correctly reflect what occurred with each patient.

For that same asthma patient, the physical exam should give the details of the heart and lung exam but should not include any mention of an abdominal exam unless one was actually done. A current high-quality EHR also should populate the appropriate physical exam areas with one click of a button.

It has been more than 3 years since the majority of practices transitioned to electronic health records, but we still see far too many clinicians struggling with systems and describing data that reflect things they have not done, all due to the use of default settings that have never been changed. It is important to understand how to customize your EHR to meet your needs and to make the individual efforts required to learn how to effectively use the current instruments of our craft.

As for whispered pectoriloquy, it is the increased loudness of a whispered word heard on auscultation over an area of lung consolidation. It is similar to tactile fremitus, where consolidation is noted by the vibratory feel in your hand placed on the chest of a patient. It should be a very rare event in our day and age that any description of whispered pectoriloquy should sneak its way into our record, particularly for a urology visit.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.

Many techniques for repair of aortic dissection have evolved, but no trials have compared those techniques to determine which is the best. However, a study team has attempted to evaluate a surgical approach (the “David technique”) that includes three specific steps – no aortic cross clamp, the use of deep hypothermic circulatory arrest (DHCA), and the antegrade resumption of cardiopulmonary bypass. They found that this approach yielded significantly better long-term outcomes than did other approaches tried.

The study investigators, led by Dr. Jennifer S. Lawton of Washington University in St. Louis, reported their findings in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.023]). “We hypothesized that a surgical strategy to prevent cross-clamp injury or false lumen pressurization would be associated with reduced morbidity, mortality, persistent false lumen patency, and improved survival,” Dr. Lawton and her coauthors wrote. “This study was designed to determine the differences in outcomes between operative techniques.”

The study evaluated 196 patients who had surgery for acute type A aortic dissection over 17 years. Group 1, which comprised 49 patients, had the operation according to the protocol that involved the three specific steps, as Dr. Tirone David of the University of Toronto first reported in 1999 (Ann. Thorac. Surg. 1999;67:1999-2001) — the “David technique,” as the study authors called it. Group 2 consisted of patients whose repair involved a variety of techniques, including one or two steps of the David technique but not all three.

Study endpoints were 30-day mortality rate, postoperative adverse events, presence of a false aortic lumen, and overall survival, the latter defined as the time from the date of surgery to the date or death or last follow-up. The evaluation included examination of patients’ latest CT scan or MRI that was at least 6 months after the operation for false lumen, but only 78 patients had imaging at that interval.

Patients in Group 1 had a higher rate of persistent false lumen – 74% vs. 68% in Group 2. Thirty-day mortality was 6.1% in Group 1 and 15.7% in Group 2, but Dr. Lawton and her coauthors said this difference was not statistically significant.

Survival rates at 1, 5 and 10 years among both groups were “consistent with published ranges,” the authors said. At 5 years, the predicted survival was 86% for Group 1 and 56% for Group 2; and at 10 years, 72% and 37% respectively.

The study authors acknowledged the controversy that surrounds the use of retrograde resumption of cardiopulmonary bypass after replacement of the ascending aorta and that there’s no consensus on which method is best for resuming cardiopulmonary bypass after repair of a type A aortic dissection.

The study also found no difference in the incidence of false lumen between the two groups, but again, this is a source of controversy. “Persistence of a false lumen following repair for type A aortic dissection has been reported to be associated with poor prognosis and reduced long-term survival,” Dr. Lawton and her colleagues said.

“Others have reported a patent false lumen was not an independent predictor of late reoperation, but was a predictor of aortic growth following repair of type A aortic dissection.”

The study authors said one limit of their findings is its retrospective nature, but they also said that a prospective, randomized trial would be difficult to conduct.

None of the study coauthors had any relationships to disclose. They presented their original data at the American Association for Thoracic Surgery Aortic Symposium, April 24-25, 2014, in New York.

Many techniques for repair of aortic dissection have evolved, but no trials have compared those techniques to determine which is the best. However, a study team has attempted to evaluate a surgical approach (the “David technique”) that includes three specific steps – no aortic cross clamp, the use of deep hypothermic circulatory arrest (DHCA), and the antegrade resumption of cardiopulmonary bypass. They found that this approach yielded significantly better long-term outcomes than did other approaches tried.

The study investigators, led by Dr. Jennifer S. Lawton of Washington University in St. Louis, reported their findings in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.023]). “We hypothesized that a surgical strategy to prevent cross-clamp injury or false lumen pressurization would be associated with reduced morbidity, mortality, persistent false lumen patency, and improved survival,” Dr. Lawton and her coauthors wrote. “This study was designed to determine the differences in outcomes between operative techniques.”

The study evaluated 196 patients who had surgery for acute type A aortic dissection over 17 years. Group 1, which comprised 49 patients, had the operation according to the protocol that involved the three specific steps, as Dr. Tirone David of the University of Toronto first reported in 1999 (Ann. Thorac. Surg. 1999;67:1999-2001) — the “David technique,” as the study authors called it. Group 2 consisted of patients whose repair involved a variety of techniques, including one or two steps of the David technique but not all three.

Study endpoints were 30-day mortality rate, postoperative adverse events, presence of a false aortic lumen, and overall survival, the latter defined as the time from the date of surgery to the date or death or last follow-up. The evaluation included examination of patients’ latest CT scan or MRI that was at least 6 months after the operation for false lumen, but only 78 patients had imaging at that interval.

Patients in Group 1 had a higher rate of persistent false lumen – 74% vs. 68% in Group 2. Thirty-day mortality was 6.1% in Group 1 and 15.7% in Group 2, but Dr. Lawton and her coauthors said this difference was not statistically significant.

Survival rates at 1, 5 and 10 years among both groups were “consistent with published ranges,” the authors said. At 5 years, the predicted survival was 86% for Group 1 and 56% for Group 2; and at 10 years, 72% and 37% respectively.

The study authors acknowledged the controversy that surrounds the use of retrograde resumption of cardiopulmonary bypass after replacement of the ascending aorta and that there’s no consensus on which method is best for resuming cardiopulmonary bypass after repair of a type A aortic dissection.

The study also found no difference in the incidence of false lumen between the two groups, but again, this is a source of controversy. “Persistence of a false lumen following repair for type A aortic dissection has been reported to be associated with poor prognosis and reduced long-term survival,” Dr. Lawton and her colleagues said.

“Others have reported a patent false lumen was not an independent predictor of late reoperation, but was a predictor of aortic growth following repair of type A aortic dissection.”

The study authors said one limit of their findings is its retrospective nature, but they also said that a prospective, randomized trial would be difficult to conduct.

None of the study coauthors had any relationships to disclose. They presented their original data at the American Association for Thoracic Surgery Aortic Symposium, April 24-25, 2014, in New York.

Many techniques for repair of aortic dissection have evolved, but no trials have compared those techniques to determine which is the best. However, a study team has attempted to evaluate a surgical approach (the “David technique”) that includes three specific steps – no aortic cross clamp, the use of deep hypothermic circulatory arrest (DHCA), and the antegrade resumption of cardiopulmonary bypass. They found that this approach yielded significantly better long-term outcomes than did other approaches tried.

The study investigators, led by Dr. Jennifer S. Lawton of Washington University in St. Louis, reported their findings in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.023]). “We hypothesized that a surgical strategy to prevent cross-clamp injury or false lumen pressurization would be associated with reduced morbidity, mortality, persistent false lumen patency, and improved survival,” Dr. Lawton and her coauthors wrote. “This study was designed to determine the differences in outcomes between operative techniques.”

The study evaluated 196 patients who had surgery for acute type A aortic dissection over 17 years. Group 1, which comprised 49 patients, had the operation according to the protocol that involved the three specific steps, as Dr. Tirone David of the University of Toronto first reported in 1999 (Ann. Thorac. Surg. 1999;67:1999-2001) — the “David technique,” as the study authors called it. Group 2 consisted of patients whose repair involved a variety of techniques, including one or two steps of the David technique but not all three.

Study endpoints were 30-day mortality rate, postoperative adverse events, presence of a false aortic lumen, and overall survival, the latter defined as the time from the date of surgery to the date or death or last follow-up. The evaluation included examination of patients’ latest CT scan or MRI that was at least 6 months after the operation for false lumen, but only 78 patients had imaging at that interval.

Patients in Group 1 had a higher rate of persistent false lumen – 74% vs. 68% in Group 2. Thirty-day mortality was 6.1% in Group 1 and 15.7% in Group 2, but Dr. Lawton and her coauthors said this difference was not statistically significant.

Survival rates at 1, 5 and 10 years among both groups were “consistent with published ranges,” the authors said. At 5 years, the predicted survival was 86% for Group 1 and 56% for Group 2; and at 10 years, 72% and 37% respectively.

The study authors acknowledged the controversy that surrounds the use of retrograde resumption of cardiopulmonary bypass after replacement of the ascending aorta and that there’s no consensus on which method is best for resuming cardiopulmonary bypass after repair of a type A aortic dissection.

The study also found no difference in the incidence of false lumen between the two groups, but again, this is a source of controversy. “Persistence of a false lumen following repair for type A aortic dissection has been reported to be associated with poor prognosis and reduced long-term survival,” Dr. Lawton and her colleagues said.

“Others have reported a patent false lumen was not an independent predictor of late reoperation, but was a predictor of aortic growth following repair of type A aortic dissection.”

The study authors said one limit of their findings is its retrospective nature, but they also said that a prospective, randomized trial would be difficult to conduct.

None of the study coauthors had any relationships to disclose. They presented their original data at the American Association for Thoracic Surgery Aortic Symposium, April 24-25, 2014, in New York.

Coding mistakes made on behalf of physicians and other health providers led to more than $35 million in Medicare overpayments for outpatient drugs, a government watchdog has found.

An audit by the U.S. Department of Health & Human Services Office of Inspector General (OIG) discovered that Medicare contractors in 13 jurisdictions overpaid Medicare Part B providers by $35.8 million between July 2009 and June 2012. Erroneous codes and incorrect units of service submitted on behalf of those providers were the top reasons for the overpayments, according to the OIG report, released July 29.

©sndr/istockphoto.com

Incorrect units of service resulted in net overpayments of $26 million, according to the report. One provider, for instance, administered 6 units of rituximab to a patient and billed for 60 units. The same provider made this type of error on 21 separate occasions leading Medicare contractors to pay $811,562 when they should have paid $67,863. The medications most frequently overpaid because of incorrect units of service were: adenosine, rituximab, infliximab, leuprolide acetate, and bortezomib.

Other common billing mistakes by physicians that resulted in overpayments included, insufficient documentation about patient services, billing for outpatient drugs in which payment was already included in that of a primary procedure, incorrect use of Healthcare Common Procedure Coding System (HCPCS) codes, and billing Medicare for noncovered outpatient drugs.

As of May 4, the Centers for Medicare & Medicaid Services had recovered 63% of the overpayments found in the OIG audit, according to the report. However, the OIG also identified potential overpayments for outpatient drugs that were billed after its audit period. Specifically, officials said Medicare contractors could recover as much as $11.5 million in overpayments if they review outpatient drug payments billed from July 2012 through June 2014.

The OIG recommended that CMS collect the remaining overpayments, conduct reviews on the time period after the initial audit period, continue to educate providers on correct billing of outpatient drugs, and continue to implement line item and date-of-service Medically Unlikely Edits for additional outpatient drugs.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Coding mistakes made on behalf of physicians and other health providers led to more than $35 million in Medicare overpayments for outpatient drugs, a government watchdog has found.

An audit by the U.S. Department of Health & Human Services Office of Inspector General (OIG) discovered that Medicare contractors in 13 jurisdictions overpaid Medicare Part B providers by $35.8 million between July 2009 and June 2012. Erroneous codes and incorrect units of service submitted on behalf of those providers were the top reasons for the overpayments, according to the OIG report, released July 29.

©sndr/istockphoto.com

Incorrect units of service resulted in net overpayments of $26 million, according to the report. One provider, for instance, administered 6 units of rituximab to a patient and billed for 60 units. The same provider made this type of error on 21 separate occasions leading Medicare contractors to pay $811,562 when they should have paid $67,863. The medications most frequently overpaid because of incorrect units of service were: adenosine, rituximab, infliximab, leuprolide acetate, and bortezomib.

Other common billing mistakes by physicians that resulted in overpayments included, insufficient documentation about patient services, billing for outpatient drugs in which payment was already included in that of a primary procedure, incorrect use of Healthcare Common Procedure Coding System (HCPCS) codes, and billing Medicare for noncovered outpatient drugs.

As of May 4, the Centers for Medicare & Medicaid Services had recovered 63% of the overpayments found in the OIG audit, according to the report. However, the OIG also identified potential overpayments for outpatient drugs that were billed after its audit period. Specifically, officials said Medicare contractors could recover as much as $11.5 million in overpayments if they review outpatient drug payments billed from July 2012 through June 2014.

The OIG recommended that CMS collect the remaining overpayments, conduct reviews on the time period after the initial audit period, continue to educate providers on correct billing of outpatient drugs, and continue to implement line item and date-of-service Medically Unlikely Edits for additional outpatient drugs.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Coding mistakes made on behalf of physicians and other health providers led to more than $35 million in Medicare overpayments for outpatient drugs, a government watchdog has found.

An audit by the U.S. Department of Health & Human Services Office of Inspector General (OIG) discovered that Medicare contractors in 13 jurisdictions overpaid Medicare Part B providers by $35.8 million between July 2009 and June 2012. Erroneous codes and incorrect units of service submitted on behalf of those providers were the top reasons for the overpayments, according to the OIG report, released July 29.

©sndr/istockphoto.com

Incorrect units of service resulted in net overpayments of $26 million, according to the report. One provider, for instance, administered 6 units of rituximab to a patient and billed for 60 units. The same provider made this type of error on 21 separate occasions leading Medicare contractors to pay $811,562 when they should have paid $67,863. The medications most frequently overpaid because of incorrect units of service were: adenosine, rituximab, infliximab, leuprolide acetate, and bortezomib.

Other common billing mistakes by physicians that resulted in overpayments included, insufficient documentation about patient services, billing for outpatient drugs in which payment was already included in that of a primary procedure, incorrect use of Healthcare Common Procedure Coding System (HCPCS) codes, and billing Medicare for noncovered outpatient drugs.

As of May 4, the Centers for Medicare & Medicaid Services had recovered 63% of the overpayments found in the OIG audit, according to the report. However, the OIG also identified potential overpayments for outpatient drugs that were billed after its audit period. Specifically, officials said Medicare contractors could recover as much as $11.5 million in overpayments if they review outpatient drug payments billed from July 2012 through June 2014.

The OIG recommended that CMS collect the remaining overpayments, conduct reviews on the time period after the initial audit period, continue to educate providers on correct billing of outpatient drugs, and continue to implement line item and date-of-service Medically Unlikely Edits for additional outpatient drugs.

agallegos@frontlinemedcom.com

On Twitter @legal_med

The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30 kg/m²-40 kg/m² and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m² (or at least 30 kg/m² in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m² (or at least 35 kg/m² in people with at least one obesity-related comorbidity).

Courtesy ReShape Medical

The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.

The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m²; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.

After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.

Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.

The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.” While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.

“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.

The ReShape device has been available in Europe since 2007.

Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.

emechcatie@frontlinemedcom.com

The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30 kg/m²-40 kg/m² and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m² (or at least 30 kg/m² in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m² (or at least 35 kg/m² in people with at least one obesity-related comorbidity).

Courtesy ReShape Medical

The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.

The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m²; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.

After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.

Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.

The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.” While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.

“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.

The ReShape device has been available in Europe since 2007.

Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.

emechcatie@frontlinemedcom.com

The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30 kg/m²-40 kg/m² and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m² (or at least 30 kg/m² in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m² (or at least 35 kg/m² in people with at least one obesity-related comorbidity).

Courtesy ReShape Medical

The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.

The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m²; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.

After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.

Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.

The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.” While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.

“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.

The ReShape device has been available in Europe since 2007.

Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.

emechcatie@frontlinemedcom.com

Several measures of mortality declined among hospitalized Medicare fee-for-service beneficiaries from 1999 to 2013, according to a study published July 28 in JAMA.

Over that time period, in-hospital mortality declined from 1.3% to 0.71%. Meanwhile, 30-day mortality declined from 2.16% in 1999 to 1.65% in 2013 and 1-year mortality slipped from 4.49% to 3.48% among 60,056,069 individuals aged 65 years or older who were enrolled in a Medicare fee-for-service plan for at least 1 month over the study period, reported Dr. Harlan M. Krumholz of Yale University in New Haven, Conn., and his associates.

The decline in mortality was accompanied by a drop in the number of hospitalizations, which went from more than 35,000/100,000 person-years of enrollment in 1999 to just under 27,000 in 2013. The number of beneficiaries admitted to the hospital at least once went down as well, from almost 22,000/100,000 person-years to more than 17,000, as did the number of hospitalizations that involved major surgery: 3,784/100,000 person-years in 1999 and 3,105 in 2013, the investigators noted (JAMA 2015;314:355-65).

For each of these measures, “the findings did not change substantially after accounting for beneficiaries’ demographic characteristics and geographical differences,” they wrote.

Dr. Krumholz is supported by a grant from the National Heart, Lung, and Blood Institute.

rfranki@frontlinemedcom.com

Several measures of mortality declined among hospitalized Medicare fee-for-service beneficiaries from 1999 to 2013, according to a study published July 28 in JAMA.

Over that time period, in-hospital mortality declined from 1.3% to 0.71%. Meanwhile, 30-day mortality declined from 2.16% in 1999 to 1.65% in 2013 and 1-year mortality slipped from 4.49% to 3.48% among 60,056,069 individuals aged 65 years or older who were enrolled in a Medicare fee-for-service plan for at least 1 month over the study period, reported Dr. Harlan M. Krumholz of Yale University in New Haven, Conn., and his associates.

The decline in mortality was accompanied by a drop in the number of hospitalizations, which went from more than 35,000/100,000 person-years of enrollment in 1999 to just under 27,000 in 2013. The number of beneficiaries admitted to the hospital at least once went down as well, from almost 22,000/100,000 person-years to more than 17,000, as did the number of hospitalizations that involved major surgery: 3,784/100,000 person-years in 1999 and 3,105 in 2013, the investigators noted (JAMA 2015;314:355-65).

For each of these measures, “the findings did not change substantially after accounting for beneficiaries’ demographic characteristics and geographical differences,” they wrote.

Dr. Krumholz is supported by a grant from the National Heart, Lung, and Blood Institute.

rfranki@frontlinemedcom.com

Several measures of mortality declined among hospitalized Medicare fee-for-service beneficiaries from 1999 to 2013, according to a study published July 28 in JAMA.

Over that time period, in-hospital mortality declined from 1.3% to 0.71%. Meanwhile, 30-day mortality declined from 2.16% in 1999 to 1.65% in 2013 and 1-year mortality slipped from 4.49% to 3.48% among 60,056,069 individuals aged 65 years or older who were enrolled in a Medicare fee-for-service plan for at least 1 month over the study period, reported Dr. Harlan M. Krumholz of Yale University in New Haven, Conn., and his associates.

The decline in mortality was accompanied by a drop in the number of hospitalizations, which went from more than 35,000/100,000 person-years of enrollment in 1999 to just under 27,000 in 2013. The number of beneficiaries admitted to the hospital at least once went down as well, from almost 22,000/100,000 person-years to more than 17,000, as did the number of hospitalizations that involved major surgery: 3,784/100,000 person-years in 1999 and 3,105 in 2013, the investigators noted (JAMA 2015;314:355-65).

For each of these measures, “the findings did not change substantially after accounting for beneficiaries’ demographic characteristics and geographical differences,” they wrote.

Dr. Krumholz is supported by a grant from the National Heart, Lung, and Blood Institute.

rfranki@frontlinemedcom.com