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Intragastric balloons offer weight loss surgery alternative
BOSTON – Moderately obese patients who either don’t want or don’t qualify for bariatric surgery may be able to benefit from a reversible procedure using an investigational intragastric balloon.
In a randomized controlled trial, patients with a body mass index (BMI) from 30 to 40 kg/m2 who were assigned to receive a dual intragastric balloon (ReShape Duo) plus a diet and exercise regimen lost 25% of their excess weight, compared with only 11% of patients assigned to undergo a sham procedure plus diet and exercise, reported Dr. Jaime Ponce, medical director for the Bariatric Surgery program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital in Chattanooga, Tenn.
“The ReShape procedure is a reversible intervention that can be used in patients with BMI from 30 to 40 who are not ready for surgery or did not qualify for surgery. It was effective, as it showed a 2.2 times greater weight loss, compared with the diet group,” he said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
At 48 weeks, patients sustained on average 65% of the weight loss they had achieved at week 24, he said.
Two-chamber device
The dual intragastric balloon consists of two silicone balloons connected by a flexible shaft to provide migration resistance. The deflated device is inserted over a guide wire into the stomach in a transoral endoscopic procedure. Once in place, the device is inflated with a saline and methylene blue solution by a powered pump, up to a total volume of 750 to 900 cc. The mean duration of the procedure is 8 minutes Dr. Ponce said.
Barring problems, the device is left in place for 6 months and is then emptied, captured with a standard endoscopic snare, and removed, a process that takes a mean of 14 minutes.
Dr. Ponce and colleagues enrolled obese adults with a BMD from 30 to 40 kg/m2 and one or more obesity-related comorbidities to undergo either balloon insertion, diet and exercise (187 patients), or a sham procedure plus diet and exercise (139).
All patients had monthly counseling on diet and exercise as per obesity management guidelines from the National Heart, Lung and Blood Institute published in 2000.
The participants were blinded to treatment assignment for 24 weeks, at which time patients in the diet group could exit the study or, if they wished, receive the balloon and continue in the study for an additional 24 weeks. Patients who initially received the balloon remained in the study and continued diet and exercise during the same 24 weeks.
Balloons were successfully inserted in 99.6% of cases, and all inserted balloons were retrieved successfully. Three patients had serious adverse events related to retrieval: one case of pneumonia requiring hospitalization and antibiotics, one contained perforation of the cervical esophagus, also requiring hospitalization and antibiotics, and one proximal esophageal mucosal tear requiring hemostatic clips.
The trial met its primary endpoint of a greater than 7.5% difference between the balloon and control groups, with balloon receivers having a mean excess weight loss of 25.1%, compared with 11.3% for controls (P = .0041) in an intention to treat analysis, and 27.9% vs. 12.3%, respectively, in patients who completed the study (P = .0007).
At 48 weeks, patients initially assigned to receive the balloon had significant improvements in hemoglobin A1c, cholesterol levels (HDL up, LDL down), systolic and diastolic blood pressures, and waist and hip circumference.
Among all implanted participants, 11.6% had mild to moderate nausea and vomiting on day 3, which gradually declined over the study. In addition, 34.1% had abdominal pain they rated as mild to moderate on a visual analog scale,
The safety analysis, including all 264 patients who received the balloon initially or at week 24, showed no deaths, balloon migration, obstructions, or required surgeries. Most adverse events were gastrointestinal in nature, mild to moderate, and resolved within the first 30 days.
Investigators saw gastric ulcers in 93 of the 264 patients who received the balloon. They determined the cause to be the distal tip of the device contacting the incisural wall, where more than 95% of the ulcers were observed. The manufacturer made minor changes to lower the profile of the tip and make it smoother and softer, resulting a “dramatically reduced ulcer rate and size,” Dr. Ponce said.
In all, 15% of the balloons were retrieved early, 6% after 2 months, associated with ulcers, and 9% within 2 months of insertions because of device intolerance. The authors found shorter patients had significantly fewer problems when the balloons were inflated with 750 cc rather than 900 cc.
The balloons spontaneously deflated in 6% of participants, signaled by the presence of blue-green urine in about two-thirds of these patients. All of the devices in these cases were successfully retrieved without problems, Dr. Ponce said.
Dr. Manoel P. Galvao Neto of the Gastro Obeso Center in São Paulo, Brazil, the invited discussant, commented that the study was well designed and carried out, with a clear methodology and frank assessment of adverse events, and it met all of its primary endpoints.
Excretable balloon
In a separate pilot study, eight patients who swallowed a limited-duration, self-emptying balloon (Elipse) that is excreted through the bowel lost an average of 12% of excess body weight, reported Dr. Evzen Machytka of the department of clinical studies at the University of Ostrava, Czech Republic.
For the trial, investigators used a custom device designed to self-deflate in 6 weeks. The device is packaged in a capsule and is attached to a thin capillary tube. The patient swallows the balloon without endoscopy or anesthesia. The capsule dissolves quickly, and when gastric positioning of the balloon is confirmed with x-rays, the balloon is then filled with 450 mL saline, in a process that takes approximately 15 minutes.
After a prespecified time (6 weeks, in the case of the trial, 3 months in the device intended for market) a self-releasing valve opens, the balloon empties and is then excreted normally, Dr. Machytka said.
In the pilot trial, all eight balloons were safely excreted. One had deflated early because of a manufacturing defect, and one asymptomatic patient withdrew from the study because she “no longer enjoyed eating.” In both cases, the balloons were punctured via endoscopy but not retrieved, and were excreted normally in the stool 4 days later.
The investigators hope to receive marketing approval for the device in 2015, Dr. Machytka said.
BOSTON – Moderately obese patients who either don’t want or don’t qualify for bariatric surgery may be able to benefit from a reversible procedure using an investigational intragastric balloon.
In a randomized controlled trial, patients with a body mass index (BMI) from 30 to 40 kg/m2 who were assigned to receive a dual intragastric balloon (ReShape Duo) plus a diet and exercise regimen lost 25% of their excess weight, compared with only 11% of patients assigned to undergo a sham procedure plus diet and exercise, reported Dr. Jaime Ponce, medical director for the Bariatric Surgery program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital in Chattanooga, Tenn.
“The ReShape procedure is a reversible intervention that can be used in patients with BMI from 30 to 40 who are not ready for surgery or did not qualify for surgery. It was effective, as it showed a 2.2 times greater weight loss, compared with the diet group,” he said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
At 48 weeks, patients sustained on average 65% of the weight loss they had achieved at week 24, he said.
Two-chamber device
The dual intragastric balloon consists of two silicone balloons connected by a flexible shaft to provide migration resistance. The deflated device is inserted over a guide wire into the stomach in a transoral endoscopic procedure. Once in place, the device is inflated with a saline and methylene blue solution by a powered pump, up to a total volume of 750 to 900 cc. The mean duration of the procedure is 8 minutes Dr. Ponce said.
Barring problems, the device is left in place for 6 months and is then emptied, captured with a standard endoscopic snare, and removed, a process that takes a mean of 14 minutes.
Dr. Ponce and colleagues enrolled obese adults with a BMD from 30 to 40 kg/m2 and one or more obesity-related comorbidities to undergo either balloon insertion, diet and exercise (187 patients), or a sham procedure plus diet and exercise (139).
All patients had monthly counseling on diet and exercise as per obesity management guidelines from the National Heart, Lung and Blood Institute published in 2000.
The participants were blinded to treatment assignment for 24 weeks, at which time patients in the diet group could exit the study or, if they wished, receive the balloon and continue in the study for an additional 24 weeks. Patients who initially received the balloon remained in the study and continued diet and exercise during the same 24 weeks.
Balloons were successfully inserted in 99.6% of cases, and all inserted balloons were retrieved successfully. Three patients had serious adverse events related to retrieval: one case of pneumonia requiring hospitalization and antibiotics, one contained perforation of the cervical esophagus, also requiring hospitalization and antibiotics, and one proximal esophageal mucosal tear requiring hemostatic clips.
The trial met its primary endpoint of a greater than 7.5% difference between the balloon and control groups, with balloon receivers having a mean excess weight loss of 25.1%, compared with 11.3% for controls (P = .0041) in an intention to treat analysis, and 27.9% vs. 12.3%, respectively, in patients who completed the study (P = .0007).
At 48 weeks, patients initially assigned to receive the balloon had significant improvements in hemoglobin A1c, cholesterol levels (HDL up, LDL down), systolic and diastolic blood pressures, and waist and hip circumference.
Among all implanted participants, 11.6% had mild to moderate nausea and vomiting on day 3, which gradually declined over the study. In addition, 34.1% had abdominal pain they rated as mild to moderate on a visual analog scale,
The safety analysis, including all 264 patients who received the balloon initially or at week 24, showed no deaths, balloon migration, obstructions, or required surgeries. Most adverse events were gastrointestinal in nature, mild to moderate, and resolved within the first 30 days.
Investigators saw gastric ulcers in 93 of the 264 patients who received the balloon. They determined the cause to be the distal tip of the device contacting the incisural wall, where more than 95% of the ulcers were observed. The manufacturer made minor changes to lower the profile of the tip and make it smoother and softer, resulting a “dramatically reduced ulcer rate and size,” Dr. Ponce said.
In all, 15% of the balloons were retrieved early, 6% after 2 months, associated with ulcers, and 9% within 2 months of insertions because of device intolerance. The authors found shorter patients had significantly fewer problems when the balloons were inflated with 750 cc rather than 900 cc.
The balloons spontaneously deflated in 6% of participants, signaled by the presence of blue-green urine in about two-thirds of these patients. All of the devices in these cases were successfully retrieved without problems, Dr. Ponce said.
Dr. Manoel P. Galvao Neto of the Gastro Obeso Center in São Paulo, Brazil, the invited discussant, commented that the study was well designed and carried out, with a clear methodology and frank assessment of adverse events, and it met all of its primary endpoints.
Excretable balloon
In a separate pilot study, eight patients who swallowed a limited-duration, self-emptying balloon (Elipse) that is excreted through the bowel lost an average of 12% of excess body weight, reported Dr. Evzen Machytka of the department of clinical studies at the University of Ostrava, Czech Republic.
For the trial, investigators used a custom device designed to self-deflate in 6 weeks. The device is packaged in a capsule and is attached to a thin capillary tube. The patient swallows the balloon without endoscopy or anesthesia. The capsule dissolves quickly, and when gastric positioning of the balloon is confirmed with x-rays, the balloon is then filled with 450 mL saline, in a process that takes approximately 15 minutes.
After a prespecified time (6 weeks, in the case of the trial, 3 months in the device intended for market) a self-releasing valve opens, the balloon empties and is then excreted normally, Dr. Machytka said.
In the pilot trial, all eight balloons were safely excreted. One had deflated early because of a manufacturing defect, and one asymptomatic patient withdrew from the study because she “no longer enjoyed eating.” In both cases, the balloons were punctured via endoscopy but not retrieved, and were excreted normally in the stool 4 days later.
The investigators hope to receive marketing approval for the device in 2015, Dr. Machytka said.
BOSTON – Moderately obese patients who either don’t want or don’t qualify for bariatric surgery may be able to benefit from a reversible procedure using an investigational intragastric balloon.
In a randomized controlled trial, patients with a body mass index (BMI) from 30 to 40 kg/m2 who were assigned to receive a dual intragastric balloon (ReShape Duo) plus a diet and exercise regimen lost 25% of their excess weight, compared with only 11% of patients assigned to undergo a sham procedure plus diet and exercise, reported Dr. Jaime Ponce, medical director for the Bariatric Surgery program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital in Chattanooga, Tenn.
“The ReShape procedure is a reversible intervention that can be used in patients with BMI from 30 to 40 who are not ready for surgery or did not qualify for surgery. It was effective, as it showed a 2.2 times greater weight loss, compared with the diet group,” he said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
At 48 weeks, patients sustained on average 65% of the weight loss they had achieved at week 24, he said.
Two-chamber device
The dual intragastric balloon consists of two silicone balloons connected by a flexible shaft to provide migration resistance. The deflated device is inserted over a guide wire into the stomach in a transoral endoscopic procedure. Once in place, the device is inflated with a saline and methylene blue solution by a powered pump, up to a total volume of 750 to 900 cc. The mean duration of the procedure is 8 minutes Dr. Ponce said.
Barring problems, the device is left in place for 6 months and is then emptied, captured with a standard endoscopic snare, and removed, a process that takes a mean of 14 minutes.
Dr. Ponce and colleagues enrolled obese adults with a BMD from 30 to 40 kg/m2 and one or more obesity-related comorbidities to undergo either balloon insertion, diet and exercise (187 patients), or a sham procedure plus diet and exercise (139).
All patients had monthly counseling on diet and exercise as per obesity management guidelines from the National Heart, Lung and Blood Institute published in 2000.
The participants were blinded to treatment assignment for 24 weeks, at which time patients in the diet group could exit the study or, if they wished, receive the balloon and continue in the study for an additional 24 weeks. Patients who initially received the balloon remained in the study and continued diet and exercise during the same 24 weeks.
Balloons were successfully inserted in 99.6% of cases, and all inserted balloons were retrieved successfully. Three patients had serious adverse events related to retrieval: one case of pneumonia requiring hospitalization and antibiotics, one contained perforation of the cervical esophagus, also requiring hospitalization and antibiotics, and one proximal esophageal mucosal tear requiring hemostatic clips.
The trial met its primary endpoint of a greater than 7.5% difference between the balloon and control groups, with balloon receivers having a mean excess weight loss of 25.1%, compared with 11.3% for controls (P = .0041) in an intention to treat analysis, and 27.9% vs. 12.3%, respectively, in patients who completed the study (P = .0007).
At 48 weeks, patients initially assigned to receive the balloon had significant improvements in hemoglobin A1c, cholesterol levels (HDL up, LDL down), systolic and diastolic blood pressures, and waist and hip circumference.
Among all implanted participants, 11.6% had mild to moderate nausea and vomiting on day 3, which gradually declined over the study. In addition, 34.1% had abdominal pain they rated as mild to moderate on a visual analog scale,
The safety analysis, including all 264 patients who received the balloon initially or at week 24, showed no deaths, balloon migration, obstructions, or required surgeries. Most adverse events were gastrointestinal in nature, mild to moderate, and resolved within the first 30 days.
Investigators saw gastric ulcers in 93 of the 264 patients who received the balloon. They determined the cause to be the distal tip of the device contacting the incisural wall, where more than 95% of the ulcers were observed. The manufacturer made minor changes to lower the profile of the tip and make it smoother and softer, resulting a “dramatically reduced ulcer rate and size,” Dr. Ponce said.
In all, 15% of the balloons were retrieved early, 6% after 2 months, associated with ulcers, and 9% within 2 months of insertions because of device intolerance. The authors found shorter patients had significantly fewer problems when the balloons were inflated with 750 cc rather than 900 cc.
The balloons spontaneously deflated in 6% of participants, signaled by the presence of blue-green urine in about two-thirds of these patients. All of the devices in these cases were successfully retrieved without problems, Dr. Ponce said.
Dr. Manoel P. Galvao Neto of the Gastro Obeso Center in São Paulo, Brazil, the invited discussant, commented that the study was well designed and carried out, with a clear methodology and frank assessment of adverse events, and it met all of its primary endpoints.
Excretable balloon
In a separate pilot study, eight patients who swallowed a limited-duration, self-emptying balloon (Elipse) that is excreted through the bowel lost an average of 12% of excess body weight, reported Dr. Evzen Machytka of the department of clinical studies at the University of Ostrava, Czech Republic.
For the trial, investigators used a custom device designed to self-deflate in 6 weeks. The device is packaged in a capsule and is attached to a thin capillary tube. The patient swallows the balloon without endoscopy or anesthesia. The capsule dissolves quickly, and when gastric positioning of the balloon is confirmed with x-rays, the balloon is then filled with 450 mL saline, in a process that takes approximately 15 minutes.
After a prespecified time (6 weeks, in the case of the trial, 3 months in the device intended for market) a self-releasing valve opens, the balloon empties and is then excreted normally, Dr. Machytka said.
In the pilot trial, all eight balloons were safely excreted. One had deflated early because of a manufacturing defect, and one asymptomatic patient withdrew from the study because she “no longer enjoyed eating.” In both cases, the balloons were punctured via endoscopy but not retrieved, and were excreted normally in the stool 4 days later.
The investigators hope to receive marketing approval for the device in 2015, Dr. Machytka said.
AT OBESITY WEEK 2014
Key clinical point: Intragastric balloons provide a temporary reversible alternative to bariatric surgery procedures.
Major finding: ReShape Duo plus a diet and exercise regimen was associated with a 25% loss of excess weight, compared with 11% for controls.
Data source: Randomized single-blinded study in 326 obese adults.
Disclosures: Dr. Ponce’s study was supported by ReShape Medical. Dr. Ponce is a clinical trial investigator and consultant to the company. Dr. Machytka’s study was supported by Allurion Technologies. He is principal investigator and receives travel support from the company. Dr. Neto reported having no relevant disclosures.
Hospital charges not a marker for bariatric surgery outcomes
SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.
Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.
Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.
High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.
Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.
In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.
Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.
“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.
“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.
Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”
“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”
Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”
“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.
In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”
“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.
Dr. Pryor disclosed that she had no relevant conflicts of interest.
SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.
Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.
Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.
High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.
Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.
In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.
Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.
“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.
“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.
Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”
“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”
Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”
“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.
In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”
“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.
Dr. Pryor disclosed that she had no relevant conflicts of interest.
SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.
Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.
Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.
High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.
Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.
In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.
Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.
“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.
“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.
Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”
“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”
Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”
“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.
In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”
“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.
Dr. Pryor disclosed that she had no relevant conflicts of interest.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Hospitals charging more do not have lower adjusted morbidity or mortality.
Major finding: Patients undergoing surgery at hospitals with higher and lower charges had similar risks of complications and death.
Data source: A cohort study of 46,180 patients in New York who underwent bariatric surgery.
Disclosures: Dr. Pryor disclosed that she had no relevant conflicts of interest.
VIDEO: How to halve serious reportable events in the OR
SAN FRANCISCO– Little steps, when added together, lead to big reductions in serious reportable events in the operating room, according to investigators from the Phoenix-based Banner Health system.
After slight modifications to the count, timeout, and other OR procedures, Banner saw a 52% reduction in serious reportable events (SREs), including a 70% reduction in wrong-site surgeries, across its 22 hospitals and 8 ambulatory surgery centers (J. Am. Coll. Surg. 2014 Oct. 4 [doi:http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.018]).
In an interview at the annual clinical congress of the American College of Surgeons, lead investigator Dr. Terrence Loftus, the health system’s medical director of surgery services and clinical resources, explained how they did it. He also explained why surgical SREs are seven times more common in the system’s robotic surgery program, despite overall improvements, and what Banner is planning to do about it.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO– Little steps, when added together, lead to big reductions in serious reportable events in the operating room, according to investigators from the Phoenix-based Banner Health system.
After slight modifications to the count, timeout, and other OR procedures, Banner saw a 52% reduction in serious reportable events (SREs), including a 70% reduction in wrong-site surgeries, across its 22 hospitals and 8 ambulatory surgery centers (J. Am. Coll. Surg. 2014 Oct. 4 [doi:http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.018]).
In an interview at the annual clinical congress of the American College of Surgeons, lead investigator Dr. Terrence Loftus, the health system’s medical director of surgery services and clinical resources, explained how they did it. He also explained why surgical SREs are seven times more common in the system’s robotic surgery program, despite overall improvements, and what Banner is planning to do about it.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO– Little steps, when added together, lead to big reductions in serious reportable events in the operating room, according to investigators from the Phoenix-based Banner Health system.
After slight modifications to the count, timeout, and other OR procedures, Banner saw a 52% reduction in serious reportable events (SREs), including a 70% reduction in wrong-site surgeries, across its 22 hospitals and 8 ambulatory surgery centers (J. Am. Coll. Surg. 2014 Oct. 4 [doi:http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.018]).
In an interview at the annual clinical congress of the American College of Surgeons, lead investigator Dr. Terrence Loftus, the health system’s medical director of surgery services and clinical resources, explained how they did it. He also explained why surgical SREs are seven times more common in the system’s robotic surgery program, despite overall improvements, and what Banner is planning to do about it.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACS CLINICAL CONGRESS
VIDEO: Less trauma, more success with bleeding peptic ulcer management
SAN FRANCISCO – If current trends continue, vagotomy and gastrectomy for bleeding peptic ulcers will be mostly a thing of the past, according to Dr. Mikhail Kryzhanouski, a surgery resident at the University of Illinois, Chicago.
Their use is quickly fading, eclipsed by better techniques and a steady drop in adverse outcomes, even though patients are presenting with more comorbidities, Dr. Kryzhanouski found in a review of patients in the U.S. Nationwide Inpatient Sample who were hospitalized for peptic ulcers from 1998 to 2011 (J. Am. Coll. Surg. 2014;219:e142).
Dr. Kryzhanouski shared the results of his study – and the reasons for his prediction – at the American College of Surgeons Clinical Congress.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – If current trends continue, vagotomy and gastrectomy for bleeding peptic ulcers will be mostly a thing of the past, according to Dr. Mikhail Kryzhanouski, a surgery resident at the University of Illinois, Chicago.
Their use is quickly fading, eclipsed by better techniques and a steady drop in adverse outcomes, even though patients are presenting with more comorbidities, Dr. Kryzhanouski found in a review of patients in the U.S. Nationwide Inpatient Sample who were hospitalized for peptic ulcers from 1998 to 2011 (J. Am. Coll. Surg. 2014;219:e142).
Dr. Kryzhanouski shared the results of his study – and the reasons for his prediction – at the American College of Surgeons Clinical Congress.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – If current trends continue, vagotomy and gastrectomy for bleeding peptic ulcers will be mostly a thing of the past, according to Dr. Mikhail Kryzhanouski, a surgery resident at the University of Illinois, Chicago.
Their use is quickly fading, eclipsed by better techniques and a steady drop in adverse outcomes, even though patients are presenting with more comorbidities, Dr. Kryzhanouski found in a review of patients in the U.S. Nationwide Inpatient Sample who were hospitalized for peptic ulcers from 1998 to 2011 (J. Am. Coll. Surg. 2014;219:e142).
Dr. Kryzhanouski shared the results of his study – and the reasons for his prediction – at the American College of Surgeons Clinical Congress.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE AMERICAN COLLEGE OF SURGEONS CLINICAL CONGRESS
VIDEO: An easy way to improve breast biopsy practices
SAN FRANCISCO – Surgeons improve if they know they are behind the curve, according to Dr. Judy A. Tjoe, a breast cancer surgeon with Milwaukee-based Aurora Health Care.
She and her colleagues used that principle to significantly increase Aurora’s use of minimally invasive breast biopsies, the gold standard to diagnose breast cancer.
Although Dr. Tjoe and the system’s other three dedicated breast surgeons were using MIBB as appropriate, they found that 9 of 42 general surgeons (21%) were not, opting instead for open biopsies.
All it took to fix the problem was letting those surgeons know that minimally invasive breast biopsies was the preferred method, and that most of their peers were using it.
In a video interview at the American College of Surgeons Clinical Congress, Dr. Tjoe, also chair of Aurora’s quality committee for breast cancer care, explained why that message was so powerful, and how, in an era of pay for performance, the project is a model for improving health care without punitive measures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Surgeons improve if they know they are behind the curve, according to Dr. Judy A. Tjoe, a breast cancer surgeon with Milwaukee-based Aurora Health Care.
She and her colleagues used that principle to significantly increase Aurora’s use of minimally invasive breast biopsies, the gold standard to diagnose breast cancer.
Although Dr. Tjoe and the system’s other three dedicated breast surgeons were using MIBB as appropriate, they found that 9 of 42 general surgeons (21%) were not, opting instead for open biopsies.
All it took to fix the problem was letting those surgeons know that minimally invasive breast biopsies was the preferred method, and that most of their peers were using it.
In a video interview at the American College of Surgeons Clinical Congress, Dr. Tjoe, also chair of Aurora’s quality committee for breast cancer care, explained why that message was so powerful, and how, in an era of pay for performance, the project is a model for improving health care without punitive measures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Surgeons improve if they know they are behind the curve, according to Dr. Judy A. Tjoe, a breast cancer surgeon with Milwaukee-based Aurora Health Care.
She and her colleagues used that principle to significantly increase Aurora’s use of minimally invasive breast biopsies, the gold standard to diagnose breast cancer.
Although Dr. Tjoe and the system’s other three dedicated breast surgeons were using MIBB as appropriate, they found that 9 of 42 general surgeons (21%) were not, opting instead for open biopsies.
All it took to fix the problem was letting those surgeons know that minimally invasive breast biopsies was the preferred method, and that most of their peers were using it.
In a video interview at the American College of Surgeons Clinical Congress, Dr. Tjoe, also chair of Aurora’s quality committee for breast cancer care, explained why that message was so powerful, and how, in an era of pay for performance, the project is a model for improving health care without punitive measures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE AMERICAN COLLEGE OF SURGEONS CLINICAL CONGRESS
VIDEO: Risks for anastomotic leak after colectomy identified
SAN FRANCISCO– A large retrospective study identified risk factors for anastomotic leak within 30 days of colectomy.
The analysis of data on 13,684 patients looked at a multicenter cohort, compared with previous smaller studies that generally focused on single institutions, Dr. Emily F. Midura and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview at the meeting, Dr. Midura described the risk factors identified in the study.
The 4% of patients who developed a leak averaged 13 days in the hospital, compared with 8 days for patients with no leak, said Dr. Midura of the University of Cincinnati. A total of 6% of patients who developed an anastomotic leak died, compared with a 2% mortality rate in patients without a leak.
Indications for colectomy included cancer in 42% of patients, diverticulitis in 23%, inflammatory bowel disease in 6%, and other reasons in the rest of the cohort.
Dr. Midura reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @sherryboschert
SAN FRANCISCO– A large retrospective study identified risk factors for anastomotic leak within 30 days of colectomy.
The analysis of data on 13,684 patients looked at a multicenter cohort, compared with previous smaller studies that generally focused on single institutions, Dr. Emily F. Midura and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview at the meeting, Dr. Midura described the risk factors identified in the study.
The 4% of patients who developed a leak averaged 13 days in the hospital, compared with 8 days for patients with no leak, said Dr. Midura of the University of Cincinnati. A total of 6% of patients who developed an anastomotic leak died, compared with a 2% mortality rate in patients without a leak.
Indications for colectomy included cancer in 42% of patients, diverticulitis in 23%, inflammatory bowel disease in 6%, and other reasons in the rest of the cohort.
Dr. Midura reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @sherryboschert
SAN FRANCISCO– A large retrospective study identified risk factors for anastomotic leak within 30 days of colectomy.
The analysis of data on 13,684 patients looked at a multicenter cohort, compared with previous smaller studies that generally focused on single institutions, Dr. Emily F. Midura and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview at the meeting, Dr. Midura described the risk factors identified in the study.
The 4% of patients who developed a leak averaged 13 days in the hospital, compared with 8 days for patients with no leak, said Dr. Midura of the University of Cincinnati. A total of 6% of patients who developed an anastomotic leak died, compared with a 2% mortality rate in patients without a leak.
Indications for colectomy included cancer in 42% of patients, diverticulitis in 23%, inflammatory bowel disease in 6%, and other reasons in the rest of the cohort.
Dr. Midura reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Anticoagulants sharply increase hematoma risk after thyroid, parathyroid surgery
SAN FRANCISCO – Patients undergoing thyroid or parathyroid surgery have a sharply higher risk of postoperative hematoma if they are on clopidogrel or anticoagulants – even if these agents are stopped in advance – researchers reported at the annual clinical congress of the American College of Surgeons.
“Patients with multiple factors considered high risk for postoperative hematoma formation after parathyroid or thyroid surgery should probably undergo a period of observation,” recommended lead investigator Dr. Sarah C. Oltmann, who at the time of the study was the director of endocrine surgery at Parkland Memorial Hospital, University of Texas Southwestern Medical Center, Dallas.
“The need specifically for anticoagulation in the perioperative period should really be carefully assessed, and decisions regarding their use in the perioperative period need to be made very cautiously,” she added. “This is particularly important when considering the need for an injectable bridge [anticoagulant], and discussions with the patient’s primary care provider or cardiologist should be prompted because obviously a hematoma risk of 11% [seen with injectable anticoagulants] is not insignificant.”
The researchers retrospectively studied 4,514 patients who underwent thyroid or parathyroid surgery at the center between 1994 and 2013. Most of the operations were performed by high-volume surgeons.
Overall, 25% of patients were using an antiplatelet agent and 3% were using an anticoagulant agent, defined in the study as current use or use up to 5-7 days before surgery. “We felt that there may be some alteration of hemostasis both at the time of surgery and in the days following surgery if they were resumed on their home meds,” explained Dr. Oltmann, who is now a clinical instructor of surgery at the University of Wisconsin–Madison.
Overall, 0.5% of patients developed a postoperative hematoma, with the majority of these events occurring in the first 24 hours. Three-fourths of the affected patients had to undergo repeat surgery.
In multivariate analyses, clopidogrel (Plavix) users had 5.6 times the odds of developing a hematoma. But neither lower-dose aspirin (less than 325 mg daily) alone nor higher-dose aspirin alone was associated with this complication.
Hematoma odds were elevated by an even greater extent, 7.5 and 29.5 times, for patients using oral and injectable anticoagulants, respectively. (Subcutaneous heparin was not included among injectable anticoagulants because surgeons at the center seldom use it in this setting, according to Dr. Oltmann.)
Patients also had increased odds of hematoma if they underwent thyroid surgery as compared with parathyroid surgery (odds ratio, 7.9), and had a bilateral procedure as compared with a unilateral one (OR, 4.9).
“Additional studies are needed to better clarify both the risk-benefit ratio of injectable anticoagulation in this patient population and potentially being able to better risk-stratify which patients would be better served with a period of overnight observation,” Dr. Oltmann concluded.
Invited discussant Dr. Raymon H. Grogan, director of the endocrine surgery research program at University of Chicago Medicine, commented, “I think this work represents a level of detail and granularity in regard to anticoagulants that we haven’t seen before in this literature, so it’s really important for us to see these data.
“We tend to get lulled into a false sense of security when we talk about complications related to thyroidectomy because they are so rare. But the truth of the matter is that this is a complication that causes deaths. A recent Nationwide Inpatient Sample study showed that about 1.3% of people who developed a hematoma will actually die in the United States, which is not an insignificant number of people who will die from a complication that’s directly caused by something we’ve done as surgeons,” he said.
Patients often have other risk factors for hematoma, Dr. Grogan noted. Therefore, he wondered, “Who can actually be sent home as a same-day patient after thyroidectomy? … When you combine your … people on these medications, along with all these other risk factors, as well as the risk of significant hypocalcemia postop, it starts to get to the point where, is it really safe to send anyone home the same day after thyroidectomy, given this overwhelming number of different factors that could cause problems?”
“That’s something we all struggle with to a certain degree, trying to be able to best determine who is safe to go home at night and who is not,” Dr. Oltmann replied, noting that risk in the study was greatest for the small proportion of patients on anticoagulants. “So I think a patient who is on some form of anticoagulant, I would definitely have significant reservations about sending home on the same day. They would be somebody I would at least want to keep overnight.”
“As far as the other variables – Graves disease, the size of the tumor, some people would also argue smoking and poorly controlled hypertension – it really becomes a conversation between the surgeon and the patient to know how reliable is the patient, how do you feel the operation went. … Hopefully, the next step is being able to find a way to weigh these different factors to be able to figure out, well, if my patient has A, B, and C, I must observe versus if they don’t, this might be somebody I can send home.”
Another attendee asked, “How do you [handle] aspirin use, given that it’s low risk as seen in your data set? How do you preop the patients, [do you] ask them to stop any low-risk agents, such as aspirin, or if they take the combination of aspirin and Plavix, which one do you hold and which do you continue in your practice?”
“After kind of combing through this data and becoming very familiar with it, I feel very comfortable with continuing aspirin use through the perioperative period,” Dr. Oltmann commented.
“For Plavix, obviously, you just have to juggle the risk-benefit ratio of why they are on that medication,” she said. “I think the most compelling situation is for our patients with atrial fibrillation, with the primary care provider wanting to … have them done on a Lovenox [enoxaparin] bridge, and now having some sort of objective data to get back with them and say, ‘Listen, they have an 11% risk of this really bad complication. Do you really think their risk of stroke trumps that?’ In most patients, that’s not the case, and I think [these data are] finally going to be able to give us some ammunition in that particular battle.”
Dr. Oltmann disclosed that she had no relevant conflicts of interest.
SAN FRANCISCO – Patients undergoing thyroid or parathyroid surgery have a sharply higher risk of postoperative hematoma if they are on clopidogrel or anticoagulants – even if these agents are stopped in advance – researchers reported at the annual clinical congress of the American College of Surgeons.
“Patients with multiple factors considered high risk for postoperative hematoma formation after parathyroid or thyroid surgery should probably undergo a period of observation,” recommended lead investigator Dr. Sarah C. Oltmann, who at the time of the study was the director of endocrine surgery at Parkland Memorial Hospital, University of Texas Southwestern Medical Center, Dallas.
“The need specifically for anticoagulation in the perioperative period should really be carefully assessed, and decisions regarding their use in the perioperative period need to be made very cautiously,” she added. “This is particularly important when considering the need for an injectable bridge [anticoagulant], and discussions with the patient’s primary care provider or cardiologist should be prompted because obviously a hematoma risk of 11% [seen with injectable anticoagulants] is not insignificant.”
The researchers retrospectively studied 4,514 patients who underwent thyroid or parathyroid surgery at the center between 1994 and 2013. Most of the operations were performed by high-volume surgeons.
Overall, 25% of patients were using an antiplatelet agent and 3% were using an anticoagulant agent, defined in the study as current use or use up to 5-7 days before surgery. “We felt that there may be some alteration of hemostasis both at the time of surgery and in the days following surgery if they were resumed on their home meds,” explained Dr. Oltmann, who is now a clinical instructor of surgery at the University of Wisconsin–Madison.
Overall, 0.5% of patients developed a postoperative hematoma, with the majority of these events occurring in the first 24 hours. Three-fourths of the affected patients had to undergo repeat surgery.
In multivariate analyses, clopidogrel (Plavix) users had 5.6 times the odds of developing a hematoma. But neither lower-dose aspirin (less than 325 mg daily) alone nor higher-dose aspirin alone was associated with this complication.
Hematoma odds were elevated by an even greater extent, 7.5 and 29.5 times, for patients using oral and injectable anticoagulants, respectively. (Subcutaneous heparin was not included among injectable anticoagulants because surgeons at the center seldom use it in this setting, according to Dr. Oltmann.)
Patients also had increased odds of hematoma if they underwent thyroid surgery as compared with parathyroid surgery (odds ratio, 7.9), and had a bilateral procedure as compared with a unilateral one (OR, 4.9).
“Additional studies are needed to better clarify both the risk-benefit ratio of injectable anticoagulation in this patient population and potentially being able to better risk-stratify which patients would be better served with a period of overnight observation,” Dr. Oltmann concluded.
Invited discussant Dr. Raymon H. Grogan, director of the endocrine surgery research program at University of Chicago Medicine, commented, “I think this work represents a level of detail and granularity in regard to anticoagulants that we haven’t seen before in this literature, so it’s really important for us to see these data.
“We tend to get lulled into a false sense of security when we talk about complications related to thyroidectomy because they are so rare. But the truth of the matter is that this is a complication that causes deaths. A recent Nationwide Inpatient Sample study showed that about 1.3% of people who developed a hematoma will actually die in the United States, which is not an insignificant number of people who will die from a complication that’s directly caused by something we’ve done as surgeons,” he said.
Patients often have other risk factors for hematoma, Dr. Grogan noted. Therefore, he wondered, “Who can actually be sent home as a same-day patient after thyroidectomy? … When you combine your … people on these medications, along with all these other risk factors, as well as the risk of significant hypocalcemia postop, it starts to get to the point where, is it really safe to send anyone home the same day after thyroidectomy, given this overwhelming number of different factors that could cause problems?”
“That’s something we all struggle with to a certain degree, trying to be able to best determine who is safe to go home at night and who is not,” Dr. Oltmann replied, noting that risk in the study was greatest for the small proportion of patients on anticoagulants. “So I think a patient who is on some form of anticoagulant, I would definitely have significant reservations about sending home on the same day. They would be somebody I would at least want to keep overnight.”
“As far as the other variables – Graves disease, the size of the tumor, some people would also argue smoking and poorly controlled hypertension – it really becomes a conversation between the surgeon and the patient to know how reliable is the patient, how do you feel the operation went. … Hopefully, the next step is being able to find a way to weigh these different factors to be able to figure out, well, if my patient has A, B, and C, I must observe versus if they don’t, this might be somebody I can send home.”
Another attendee asked, “How do you [handle] aspirin use, given that it’s low risk as seen in your data set? How do you preop the patients, [do you] ask them to stop any low-risk agents, such as aspirin, or if they take the combination of aspirin and Plavix, which one do you hold and which do you continue in your practice?”
“After kind of combing through this data and becoming very familiar with it, I feel very comfortable with continuing aspirin use through the perioperative period,” Dr. Oltmann commented.
“For Plavix, obviously, you just have to juggle the risk-benefit ratio of why they are on that medication,” she said. “I think the most compelling situation is for our patients with atrial fibrillation, with the primary care provider wanting to … have them done on a Lovenox [enoxaparin] bridge, and now having some sort of objective data to get back with them and say, ‘Listen, they have an 11% risk of this really bad complication. Do you really think their risk of stroke trumps that?’ In most patients, that’s not the case, and I think [these data are] finally going to be able to give us some ammunition in that particular battle.”
Dr. Oltmann disclosed that she had no relevant conflicts of interest.
SAN FRANCISCO – Patients undergoing thyroid or parathyroid surgery have a sharply higher risk of postoperative hematoma if they are on clopidogrel or anticoagulants – even if these agents are stopped in advance – researchers reported at the annual clinical congress of the American College of Surgeons.
“Patients with multiple factors considered high risk for postoperative hematoma formation after parathyroid or thyroid surgery should probably undergo a period of observation,” recommended lead investigator Dr. Sarah C. Oltmann, who at the time of the study was the director of endocrine surgery at Parkland Memorial Hospital, University of Texas Southwestern Medical Center, Dallas.
“The need specifically for anticoagulation in the perioperative period should really be carefully assessed, and decisions regarding their use in the perioperative period need to be made very cautiously,” she added. “This is particularly important when considering the need for an injectable bridge [anticoagulant], and discussions with the patient’s primary care provider or cardiologist should be prompted because obviously a hematoma risk of 11% [seen with injectable anticoagulants] is not insignificant.”
The researchers retrospectively studied 4,514 patients who underwent thyroid or parathyroid surgery at the center between 1994 and 2013. Most of the operations were performed by high-volume surgeons.
Overall, 25% of patients were using an antiplatelet agent and 3% were using an anticoagulant agent, defined in the study as current use or use up to 5-7 days before surgery. “We felt that there may be some alteration of hemostasis both at the time of surgery and in the days following surgery if they were resumed on their home meds,” explained Dr. Oltmann, who is now a clinical instructor of surgery at the University of Wisconsin–Madison.
Overall, 0.5% of patients developed a postoperative hematoma, with the majority of these events occurring in the first 24 hours. Three-fourths of the affected patients had to undergo repeat surgery.
In multivariate analyses, clopidogrel (Plavix) users had 5.6 times the odds of developing a hematoma. But neither lower-dose aspirin (less than 325 mg daily) alone nor higher-dose aspirin alone was associated with this complication.
Hematoma odds were elevated by an even greater extent, 7.5 and 29.5 times, for patients using oral and injectable anticoagulants, respectively. (Subcutaneous heparin was not included among injectable anticoagulants because surgeons at the center seldom use it in this setting, according to Dr. Oltmann.)
Patients also had increased odds of hematoma if they underwent thyroid surgery as compared with parathyroid surgery (odds ratio, 7.9), and had a bilateral procedure as compared with a unilateral one (OR, 4.9).
“Additional studies are needed to better clarify both the risk-benefit ratio of injectable anticoagulation in this patient population and potentially being able to better risk-stratify which patients would be better served with a period of overnight observation,” Dr. Oltmann concluded.
Invited discussant Dr. Raymon H. Grogan, director of the endocrine surgery research program at University of Chicago Medicine, commented, “I think this work represents a level of detail and granularity in regard to anticoagulants that we haven’t seen before in this literature, so it’s really important for us to see these data.
“We tend to get lulled into a false sense of security when we talk about complications related to thyroidectomy because they are so rare. But the truth of the matter is that this is a complication that causes deaths. A recent Nationwide Inpatient Sample study showed that about 1.3% of people who developed a hematoma will actually die in the United States, which is not an insignificant number of people who will die from a complication that’s directly caused by something we’ve done as surgeons,” he said.
Patients often have other risk factors for hematoma, Dr. Grogan noted. Therefore, he wondered, “Who can actually be sent home as a same-day patient after thyroidectomy? … When you combine your … people on these medications, along with all these other risk factors, as well as the risk of significant hypocalcemia postop, it starts to get to the point where, is it really safe to send anyone home the same day after thyroidectomy, given this overwhelming number of different factors that could cause problems?”
“That’s something we all struggle with to a certain degree, trying to be able to best determine who is safe to go home at night and who is not,” Dr. Oltmann replied, noting that risk in the study was greatest for the small proportion of patients on anticoagulants. “So I think a patient who is on some form of anticoagulant, I would definitely have significant reservations about sending home on the same day. They would be somebody I would at least want to keep overnight.”
“As far as the other variables – Graves disease, the size of the tumor, some people would also argue smoking and poorly controlled hypertension – it really becomes a conversation between the surgeon and the patient to know how reliable is the patient, how do you feel the operation went. … Hopefully, the next step is being able to find a way to weigh these different factors to be able to figure out, well, if my patient has A, B, and C, I must observe versus if they don’t, this might be somebody I can send home.”
Another attendee asked, “How do you [handle] aspirin use, given that it’s low risk as seen in your data set? How do you preop the patients, [do you] ask them to stop any low-risk agents, such as aspirin, or if they take the combination of aspirin and Plavix, which one do you hold and which do you continue in your practice?”
“After kind of combing through this data and becoming very familiar with it, I feel very comfortable with continuing aspirin use through the perioperative period,” Dr. Oltmann commented.
“For Plavix, obviously, you just have to juggle the risk-benefit ratio of why they are on that medication,” she said. “I think the most compelling situation is for our patients with atrial fibrillation, with the primary care provider wanting to … have them done on a Lovenox [enoxaparin] bridge, and now having some sort of objective data to get back with them and say, ‘Listen, they have an 11% risk of this really bad complication. Do you really think their risk of stroke trumps that?’ In most patients, that’s not the case, and I think [these data are] finally going to be able to give us some ammunition in that particular battle.”
Dr. Oltmann disclosed that she had no relevant conflicts of interest.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Clopidogrel and anticoagulants are risk factors for hematoma after thyroid or parathyroid surgery.
Major finding: The odds of hematoma were 5.6 times higher with clopidogrel use and 7.5 and 29.5 times higher with oral and injectable anticoagulant use, respectively.
Data source: A retrospective study of 4,514 patients undergoing thyroid or parathyroid surgery.
Disclosures: Dr. Oltmann disclosed that she had no relevant conflicts of interest.
Obesity, diabetes spur on group A strep infections
PHILADELPHIA – Obesity and diabetes are independent risk factors for invasive group A Streptococcus infections, with the highest risk among those with diabetes and morbid obesity.
The relative risk of invasive group A Streptococcus (iGAS) infection was 15 times higher in adults with diabetes and grade 3 morbid obesity (body mass index ≥ 40 kg/m2) than in those of normal weight, Dr. Gayle Langley reported at Infectious Diseases Week 2014.
Moreover, grades 1-2 obesity and morbid obesity increased the odds of ICU admission and death from an iGAS infection in multivariable logistic regression.
The adjusted odds ratios for ICU admission and death were 1.46 and 1.55 for patients with grades 1-2 obesity (BMI 30 < 40 kg/m2) and 2.07 and 1.62 for those with morbid obesity, she said.
Diabetes was not associated with an increased risk for either ICU admission (odds ratio, 1.06) or death (OR, 0.77) in the analysis.
Skin and soft tissue infections, which were significantly more common in obese and diabetic patients, appear to be driving the increased risk for iGAS in these groups, Dr. Langley of the Centers for Disease Control and Prevention said in an interview.
“Based on the literature, I’m not all that surprised because we definitely know that they are at increased risk for these skin and soft tissue infections, and that is a common manifestation of strep,” she said. “The mortality is slightly increased, but not to the extent of the incidence.”
The study was prompted by the limited number of prevention strategies for what Langley described as a “really serious infection” and by the rise in obesity and diabetes in the United States.
Data from select counties in 10 of the CDC’s Active Bacterial Core surveillance sites were used to identify 2,927 cases of 2010-2012 community onset iGAS. Cases were defined by isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome in a resident in the surveillance area. Clinical data were obtained from medical records, with height and weight used to calculate BMI.
Diabetes was present in 859 patients (29.3%), grades 1-2 obesity in 743 (25.4%), grade 3 obesity in 399 patients (13.6%), and skin/soft tissue infections in 976 (33.3%). Most patients were aged 18-49 years (37.6%) and male (55%).
Among diabetic patients, the relative risk of an iGAS infection was 4.09 for those who were underweight (BMI < 18.5), 1.23 for the overweight (BMI 25 < 30), 3.14 for those with grade 1-2 obesity, and 15.6 for the morbidly obese. Among nondiabetics, the corresponding relative risks were 3.29, 0.87, 1.15, and 2.95, the authors reported in the poster presentation.
Dr. Langley said the next step is to look at treatment options and whether antibiotic dosing is important and “Long term, if we have a vaccine, this might be a group that needs to be targeted for vaccination.”
ID Week is a joint meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, HIV Medicine Association, and Pediatric Infectious Diseases Society.
PHILADELPHIA – Obesity and diabetes are independent risk factors for invasive group A Streptococcus infections, with the highest risk among those with diabetes and morbid obesity.
The relative risk of invasive group A Streptococcus (iGAS) infection was 15 times higher in adults with diabetes and grade 3 morbid obesity (body mass index ≥ 40 kg/m2) than in those of normal weight, Dr. Gayle Langley reported at Infectious Diseases Week 2014.
Moreover, grades 1-2 obesity and morbid obesity increased the odds of ICU admission and death from an iGAS infection in multivariable logistic regression.
The adjusted odds ratios for ICU admission and death were 1.46 and 1.55 for patients with grades 1-2 obesity (BMI 30 < 40 kg/m2) and 2.07 and 1.62 for those with morbid obesity, she said.
Diabetes was not associated with an increased risk for either ICU admission (odds ratio, 1.06) or death (OR, 0.77) in the analysis.
Skin and soft tissue infections, which were significantly more common in obese and diabetic patients, appear to be driving the increased risk for iGAS in these groups, Dr. Langley of the Centers for Disease Control and Prevention said in an interview.
“Based on the literature, I’m not all that surprised because we definitely know that they are at increased risk for these skin and soft tissue infections, and that is a common manifestation of strep,” she said. “The mortality is slightly increased, but not to the extent of the incidence.”
The study was prompted by the limited number of prevention strategies for what Langley described as a “really serious infection” and by the rise in obesity and diabetes in the United States.
Data from select counties in 10 of the CDC’s Active Bacterial Core surveillance sites were used to identify 2,927 cases of 2010-2012 community onset iGAS. Cases were defined by isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome in a resident in the surveillance area. Clinical data were obtained from medical records, with height and weight used to calculate BMI.
Diabetes was present in 859 patients (29.3%), grades 1-2 obesity in 743 (25.4%), grade 3 obesity in 399 patients (13.6%), and skin/soft tissue infections in 976 (33.3%). Most patients were aged 18-49 years (37.6%) and male (55%).
Among diabetic patients, the relative risk of an iGAS infection was 4.09 for those who were underweight (BMI < 18.5), 1.23 for the overweight (BMI 25 < 30), 3.14 for those with grade 1-2 obesity, and 15.6 for the morbidly obese. Among nondiabetics, the corresponding relative risks were 3.29, 0.87, 1.15, and 2.95, the authors reported in the poster presentation.
Dr. Langley said the next step is to look at treatment options and whether antibiotic dosing is important and “Long term, if we have a vaccine, this might be a group that needs to be targeted for vaccination.”
ID Week is a joint meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, HIV Medicine Association, and Pediatric Infectious Diseases Society.
PHILADELPHIA – Obesity and diabetes are independent risk factors for invasive group A Streptococcus infections, with the highest risk among those with diabetes and morbid obesity.
The relative risk of invasive group A Streptococcus (iGAS) infection was 15 times higher in adults with diabetes and grade 3 morbid obesity (body mass index ≥ 40 kg/m2) than in those of normal weight, Dr. Gayle Langley reported at Infectious Diseases Week 2014.
Moreover, grades 1-2 obesity and morbid obesity increased the odds of ICU admission and death from an iGAS infection in multivariable logistic regression.
The adjusted odds ratios for ICU admission and death were 1.46 and 1.55 for patients with grades 1-2 obesity (BMI 30 < 40 kg/m2) and 2.07 and 1.62 for those with morbid obesity, she said.
Diabetes was not associated with an increased risk for either ICU admission (odds ratio, 1.06) or death (OR, 0.77) in the analysis.
Skin and soft tissue infections, which were significantly more common in obese and diabetic patients, appear to be driving the increased risk for iGAS in these groups, Dr. Langley of the Centers for Disease Control and Prevention said in an interview.
“Based on the literature, I’m not all that surprised because we definitely know that they are at increased risk for these skin and soft tissue infections, and that is a common manifestation of strep,” she said. “The mortality is slightly increased, but not to the extent of the incidence.”
The study was prompted by the limited number of prevention strategies for what Langley described as a “really serious infection” and by the rise in obesity and diabetes in the United States.
Data from select counties in 10 of the CDC’s Active Bacterial Core surveillance sites were used to identify 2,927 cases of 2010-2012 community onset iGAS. Cases were defined by isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome in a resident in the surveillance area. Clinical data were obtained from medical records, with height and weight used to calculate BMI.
Diabetes was present in 859 patients (29.3%), grades 1-2 obesity in 743 (25.4%), grade 3 obesity in 399 patients (13.6%), and skin/soft tissue infections in 976 (33.3%). Most patients were aged 18-49 years (37.6%) and male (55%).
Among diabetic patients, the relative risk of an iGAS infection was 4.09 for those who were underweight (BMI < 18.5), 1.23 for the overweight (BMI 25 < 30), 3.14 for those with grade 1-2 obesity, and 15.6 for the morbidly obese. Among nondiabetics, the corresponding relative risks were 3.29, 0.87, 1.15, and 2.95, the authors reported in the poster presentation.
Dr. Langley said the next step is to look at treatment options and whether antibiotic dosing is important and “Long term, if we have a vaccine, this might be a group that needs to be targeted for vaccination.”
ID Week is a joint meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, HIV Medicine Association, and Pediatric Infectious Diseases Society.
AT ID WEEK 2014
Key clinical point: Patients with diabetes and obesity are at increased risk for invasive group A Streptococcus infection.
Major finding: The relative risk of invasive group A Streptococcus (iGAS) infection was 15.6 in diabetics with grade 3 morbid obesity vs. normal-weight diabetics.
Data source: Active surveillance data from 2,927 cases of iGAS.
Disclosures: Dr. Langley reported having no financial disclosures. The CDC funds the ABC surveillance sites.
FDA approves simeprevir-sofosbuvir combo for hepatitis C
The Food and Drug Administration has approved the use of sofosbuvir in combination with simeprevir for treatment of patients with chronic hepatitis C virus. It is a ribavirin- and interferon-free regimen.
The approval is reflected in changes to the label of simeprevir (Olysio), an HCV NS3/4A protease inhibitor, which was approved in 2013 for chronic hepatitis C genotype 1 infection “as a component of a combination antiviral treatment regimen.”
The new label summarizes the results of COSMOS, an open label, randomized phase II trial of HCV genotype 1–infected prior null responders with a METAVIR fibrosis score of F0 F2 or treatment naive subjects and prior null responders with a METAVIR fibrosis score of F3 F4 and compensated liver disease. The sustained virologic response rates 12 weeks after planned end of treatment was 93% among those treated with the combination for 12 weeks, and 97% among those treated for 24 weeks. The study was published online (Lancet 2014 July [doi:10.1016/S0140-6736(14)61036-9]).
In COSMOS, the most common adverse reactions reported by more than 10% of treated patients during 12 weeks of combination treatment were fatigue in 25%, headache (21%), nausea (21%), insomnia (14%), pruritus (11%), rash (11%), and photosensitivity (7%). Among those treated for 24 weeks, dizziness (16%) and diarrhea (16%) were reported, according to the revised label.
When combined with sofosbuvir, treatment of treatment-naive and treatment-experienced patients is recommended for 12 weeks (for patients without cirrhosis) or 24 weeks (for patients with cirrhosis).
Simeprevir is marketed by Janssen Therapeutics. Sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor approved in December 2013 for treatment of chronic hepatitis C as a component of a combination antiviral treatment regimen, is marketed as Sovaldi by Gilead Sciences. The combination was approved Nov. 5.
The Food and Drug Administration has approved the use of sofosbuvir in combination with simeprevir for treatment of patients with chronic hepatitis C virus. It is a ribavirin- and interferon-free regimen.
The approval is reflected in changes to the label of simeprevir (Olysio), an HCV NS3/4A protease inhibitor, which was approved in 2013 for chronic hepatitis C genotype 1 infection “as a component of a combination antiviral treatment regimen.”
The new label summarizes the results of COSMOS, an open label, randomized phase II trial of HCV genotype 1–infected prior null responders with a METAVIR fibrosis score of F0 F2 or treatment naive subjects and prior null responders with a METAVIR fibrosis score of F3 F4 and compensated liver disease. The sustained virologic response rates 12 weeks after planned end of treatment was 93% among those treated with the combination for 12 weeks, and 97% among those treated for 24 weeks. The study was published online (Lancet 2014 July [doi:10.1016/S0140-6736(14)61036-9]).
In COSMOS, the most common adverse reactions reported by more than 10% of treated patients during 12 weeks of combination treatment were fatigue in 25%, headache (21%), nausea (21%), insomnia (14%), pruritus (11%), rash (11%), and photosensitivity (7%). Among those treated for 24 weeks, dizziness (16%) and diarrhea (16%) were reported, according to the revised label.
When combined with sofosbuvir, treatment of treatment-naive and treatment-experienced patients is recommended for 12 weeks (for patients without cirrhosis) or 24 weeks (for patients with cirrhosis).
Simeprevir is marketed by Janssen Therapeutics. Sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor approved in December 2013 for treatment of chronic hepatitis C as a component of a combination antiviral treatment regimen, is marketed as Sovaldi by Gilead Sciences. The combination was approved Nov. 5.
The Food and Drug Administration has approved the use of sofosbuvir in combination with simeprevir for treatment of patients with chronic hepatitis C virus. It is a ribavirin- and interferon-free regimen.
The approval is reflected in changes to the label of simeprevir (Olysio), an HCV NS3/4A protease inhibitor, which was approved in 2013 for chronic hepatitis C genotype 1 infection “as a component of a combination antiviral treatment regimen.”
The new label summarizes the results of COSMOS, an open label, randomized phase II trial of HCV genotype 1–infected prior null responders with a METAVIR fibrosis score of F0 F2 or treatment naive subjects and prior null responders with a METAVIR fibrosis score of F3 F4 and compensated liver disease. The sustained virologic response rates 12 weeks after planned end of treatment was 93% among those treated with the combination for 12 weeks, and 97% among those treated for 24 weeks. The study was published online (Lancet 2014 July [doi:10.1016/S0140-6736(14)61036-9]).
In COSMOS, the most common adverse reactions reported by more than 10% of treated patients during 12 weeks of combination treatment were fatigue in 25%, headache (21%), nausea (21%), insomnia (14%), pruritus (11%), rash (11%), and photosensitivity (7%). Among those treated for 24 weeks, dizziness (16%) and diarrhea (16%) were reported, according to the revised label.
When combined with sofosbuvir, treatment of treatment-naive and treatment-experienced patients is recommended for 12 weeks (for patients without cirrhosis) or 24 weeks (for patients with cirrhosis).
Simeprevir is marketed by Janssen Therapeutics. Sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor approved in December 2013 for treatment of chronic hepatitis C as a component of a combination antiviral treatment regimen, is marketed as Sovaldi by Gilead Sciences. The combination was approved Nov. 5.
Bariatric surgery’s long-term durability, complications still unknown
The greatest research need regarding bariatric surgery is the critical lack of information about long-term durability and complications of the procedures, according to a report published online Nov. 4 in JAMA Surgery.
Bariatric surgery “results in greater weight loss than nonsurgical treatment,” but that crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing, said Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, and Steven H. Belle, Ph.D., of the epidemiology department, University of Pittsburgh. They were speaking at a symposium sponsored by the National Institute of Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute to review the best available evidence on bariatric surgery outcomes from the most recent large observational studies and randomized clinical trials.
Very large multicenter, randomized, controlled trials are the best type of study to provide this information but are prohibitively expensive, especially given the difficulty retaining participants in weight-loss studies. Any such trial would require very large numbers of treatment centers and patients to generate results that were adequately powered and generalizable, they wrote (JAMA Surg. 2014 Nov. 4 [doi: 10.1001/jamasurg.2014.2440]).
Future research must address the substantial variability in weight loss after bariatric surgery, as well as the equally substantial variability in its effect on diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and psychological and psychosocial issues. And long-term gastrointestinal complications must be a specific focus because these procedures alter the GI anatomy, and adverse effects may take many years to manifest.
“In summary, bariatric surgery offers the potential to address the morbidity and mortality of the obesity epidemic, but important research questions remain unresolved,” according to Dr. Wolfe and Dr. Belle.
The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.
The greatest research need regarding bariatric surgery is the critical lack of information about long-term durability and complications of the procedures, according to a report published online Nov. 4 in JAMA Surgery.
Bariatric surgery “results in greater weight loss than nonsurgical treatment,” but that crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing, said Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, and Steven H. Belle, Ph.D., of the epidemiology department, University of Pittsburgh. They were speaking at a symposium sponsored by the National Institute of Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute to review the best available evidence on bariatric surgery outcomes from the most recent large observational studies and randomized clinical trials.
Very large multicenter, randomized, controlled trials are the best type of study to provide this information but are prohibitively expensive, especially given the difficulty retaining participants in weight-loss studies. Any such trial would require very large numbers of treatment centers and patients to generate results that were adequately powered and generalizable, they wrote (JAMA Surg. 2014 Nov. 4 [doi: 10.1001/jamasurg.2014.2440]).
Future research must address the substantial variability in weight loss after bariatric surgery, as well as the equally substantial variability in its effect on diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and psychological and psychosocial issues. And long-term gastrointestinal complications must be a specific focus because these procedures alter the GI anatomy, and adverse effects may take many years to manifest.
“In summary, bariatric surgery offers the potential to address the morbidity and mortality of the obesity epidemic, but important research questions remain unresolved,” according to Dr. Wolfe and Dr. Belle.
The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.
The greatest research need regarding bariatric surgery is the critical lack of information about long-term durability and complications of the procedures, according to a report published online Nov. 4 in JAMA Surgery.
Bariatric surgery “results in greater weight loss than nonsurgical treatment,” but that crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing, said Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, and Steven H. Belle, Ph.D., of the epidemiology department, University of Pittsburgh. They were speaking at a symposium sponsored by the National Institute of Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute to review the best available evidence on bariatric surgery outcomes from the most recent large observational studies and randomized clinical trials.
Very large multicenter, randomized, controlled trials are the best type of study to provide this information but are prohibitively expensive, especially given the difficulty retaining participants in weight-loss studies. Any such trial would require very large numbers of treatment centers and patients to generate results that were adequately powered and generalizable, they wrote (JAMA Surg. 2014 Nov. 4 [doi: 10.1001/jamasurg.2014.2440]).
Future research must address the substantial variability in weight loss after bariatric surgery, as well as the equally substantial variability in its effect on diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and psychological and psychosocial issues. And long-term gastrointestinal complications must be a specific focus because these procedures alter the GI anatomy, and adverse effects may take many years to manifest.
“In summary, bariatric surgery offers the potential to address the morbidity and mortality of the obesity epidemic, but important research questions remain unresolved,” according to Dr. Wolfe and Dr. Belle.
The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.
Key clinical point: The long-term durability and complications of bariatric surgery remain unknown because research is lacking.
Major finding: Crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing.
Data source: A report from a National Institutes of Health symposium reviewing the best available evidence regarding bariatric surgery outcomes.
Disclosures: The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.