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Transfusion Rates Vary Widely at Academic Hospitals
Wide variations in perioperative blood transfusion rates among patients undergoing major noncardiac procedures across U.S. hospitals highlight the need to further investigate evidence-based "transfusion triggers" in this population of surgical patients, according to a study published ahead of print in Annals of Surgery.
"In light of the increased risk of mortality and major complications associated with blood transfusion, the extensive variability in hospital transfusion practice in noncardiac surgery may represent an important opportunity to improve surgical outcomes," wrote Feng Qian, Ph.D., of the University of Rochester (N.Y.), and associates.
The researchers used the University HealthSystem Consortium hospital database to compare transfusion rates of allogeneic red blood cells, fresh frozen plasma, and platelets in patients undergoing elective primary total hip replacement (54,405 patients), colectomy (21,334), or pancreaticoduodenectomy (7,929) at 77 hospitals between June 2006 and September 2010. Most of the hospitals were teaching hospitals with at least 500 beds.
Transfusion rates varied widely before and after adjustment for comorbidities and other patient risk factors. Patients who were treated in hospitals with high rates of transfusions were about twice as likely to receive a blood transfusion as were patients at hospitals with average transfusion rates (Ann. Surg. 2012 July 13[doi:10.1097/SLA.0b013e31825ffc37]).
In hospitals where the transfusion rate for one procedure was high, transfusion rates also tended to be high for the other two procedures. There was some evidence indicating that a higher volume of surgical cases was associated with lower transfusion rates.
After adjusting for patient risk factors, the authors determined that transfusion rates for the different blood components among those undergoing a total hip replacement ranged from 1.3% to almost 75% (red blood cells), from 0.1% to 7.7% (fresh frozen plasma), and from 0.1% to 2% (platelets). Among colectomy patients, transfusion rates ranged from 1.9% to 47.8% (RBCs), from 1.4% to 17.7% (fresh frozen plasma), and from 1.3% to 6.2% (platelets). Among those undergoing a pancreaticoduodenectomy, the rates ranged from 3% to 78.6% (RBCs), from 1% to 47% (fresh frozen plasma), and from 1.4% to 12.6% (platelets).
The variability, the authors said, "reflects, in part, the complexity of the medical decision-making process underlying transfusion therapy." Because the data included patients from 90% of academic medical centers in the United States, the results provide "a broad and contemporary picture of transfusion practices in academic surgical centers" and "reflect transfusion practices that are being taught to the next generation of academic and private-practice clinicians during residency training," they noted.
To the best of their knowledge, the authors said, there are no large randomized studies that have compared liberal and restrictive transfusion strategies in noncardiac surgery patients, and they believe that such trials are "urgently needed to better define evidence-based transfusion triggers for patients undergoing noncardiac surgery."
The study was supported by a grant from the Agency for Healthcare and Quality Research and funding from the department of anesthesiology at the University of Rochester. No disclosures were reported by the authors.
Wide variations in perioperative blood transfusion rates among patients undergoing major noncardiac procedures across U.S. hospitals highlight the need to further investigate evidence-based "transfusion triggers" in this population of surgical patients, according to a study published ahead of print in Annals of Surgery.
"In light of the increased risk of mortality and major complications associated with blood transfusion, the extensive variability in hospital transfusion practice in noncardiac surgery may represent an important opportunity to improve surgical outcomes," wrote Feng Qian, Ph.D., of the University of Rochester (N.Y.), and associates.
The researchers used the University HealthSystem Consortium hospital database to compare transfusion rates of allogeneic red blood cells, fresh frozen plasma, and platelets in patients undergoing elective primary total hip replacement (54,405 patients), colectomy (21,334), or pancreaticoduodenectomy (7,929) at 77 hospitals between June 2006 and September 2010. Most of the hospitals were teaching hospitals with at least 500 beds.
Transfusion rates varied widely before and after adjustment for comorbidities and other patient risk factors. Patients who were treated in hospitals with high rates of transfusions were about twice as likely to receive a blood transfusion as were patients at hospitals with average transfusion rates (Ann. Surg. 2012 July 13[doi:10.1097/SLA.0b013e31825ffc37]).
In hospitals where the transfusion rate for one procedure was high, transfusion rates also tended to be high for the other two procedures. There was some evidence indicating that a higher volume of surgical cases was associated with lower transfusion rates.
After adjusting for patient risk factors, the authors determined that transfusion rates for the different blood components among those undergoing a total hip replacement ranged from 1.3% to almost 75% (red blood cells), from 0.1% to 7.7% (fresh frozen plasma), and from 0.1% to 2% (platelets). Among colectomy patients, transfusion rates ranged from 1.9% to 47.8% (RBCs), from 1.4% to 17.7% (fresh frozen plasma), and from 1.3% to 6.2% (platelets). Among those undergoing a pancreaticoduodenectomy, the rates ranged from 3% to 78.6% (RBCs), from 1% to 47% (fresh frozen plasma), and from 1.4% to 12.6% (platelets).
The variability, the authors said, "reflects, in part, the complexity of the medical decision-making process underlying transfusion therapy." Because the data included patients from 90% of academic medical centers in the United States, the results provide "a broad and contemporary picture of transfusion practices in academic surgical centers" and "reflect transfusion practices that are being taught to the next generation of academic and private-practice clinicians during residency training," they noted.
To the best of their knowledge, the authors said, there are no large randomized studies that have compared liberal and restrictive transfusion strategies in noncardiac surgery patients, and they believe that such trials are "urgently needed to better define evidence-based transfusion triggers for patients undergoing noncardiac surgery."
The study was supported by a grant from the Agency for Healthcare and Quality Research and funding from the department of anesthesiology at the University of Rochester. No disclosures were reported by the authors.
Wide variations in perioperative blood transfusion rates among patients undergoing major noncardiac procedures across U.S. hospitals highlight the need to further investigate evidence-based "transfusion triggers" in this population of surgical patients, according to a study published ahead of print in Annals of Surgery.
"In light of the increased risk of mortality and major complications associated with blood transfusion, the extensive variability in hospital transfusion practice in noncardiac surgery may represent an important opportunity to improve surgical outcomes," wrote Feng Qian, Ph.D., of the University of Rochester (N.Y.), and associates.
The researchers used the University HealthSystem Consortium hospital database to compare transfusion rates of allogeneic red blood cells, fresh frozen plasma, and platelets in patients undergoing elective primary total hip replacement (54,405 patients), colectomy (21,334), or pancreaticoduodenectomy (7,929) at 77 hospitals between June 2006 and September 2010. Most of the hospitals were teaching hospitals with at least 500 beds.
Transfusion rates varied widely before and after adjustment for comorbidities and other patient risk factors. Patients who were treated in hospitals with high rates of transfusions were about twice as likely to receive a blood transfusion as were patients at hospitals with average transfusion rates (Ann. Surg. 2012 July 13[doi:10.1097/SLA.0b013e31825ffc37]).
In hospitals where the transfusion rate for one procedure was high, transfusion rates also tended to be high for the other two procedures. There was some evidence indicating that a higher volume of surgical cases was associated with lower transfusion rates.
After adjusting for patient risk factors, the authors determined that transfusion rates for the different blood components among those undergoing a total hip replacement ranged from 1.3% to almost 75% (red blood cells), from 0.1% to 7.7% (fresh frozen plasma), and from 0.1% to 2% (platelets). Among colectomy patients, transfusion rates ranged from 1.9% to 47.8% (RBCs), from 1.4% to 17.7% (fresh frozen plasma), and from 1.3% to 6.2% (platelets). Among those undergoing a pancreaticoduodenectomy, the rates ranged from 3% to 78.6% (RBCs), from 1% to 47% (fresh frozen plasma), and from 1.4% to 12.6% (platelets).
The variability, the authors said, "reflects, in part, the complexity of the medical decision-making process underlying transfusion therapy." Because the data included patients from 90% of academic medical centers in the United States, the results provide "a broad and contemporary picture of transfusion practices in academic surgical centers" and "reflect transfusion practices that are being taught to the next generation of academic and private-practice clinicians during residency training," they noted.
To the best of their knowledge, the authors said, there are no large randomized studies that have compared liberal and restrictive transfusion strategies in noncardiac surgery patients, and they believe that such trials are "urgently needed to better define evidence-based transfusion triggers for patients undergoing noncardiac surgery."
The study was supported by a grant from the Agency for Healthcare and Quality Research and funding from the department of anesthesiology at the University of Rochester. No disclosures were reported by the authors.
FROM THE ANNALS OF SURGERY
Major Finding: Transfusion rates of red blood cells, fresh frozen plasma, and platelets among patients undergoing noncardiac procedures varied widely across different U.S. academic-affiliated hospitals.
Data Source: Data from a national database of academic medical centers were used to compare transfusions in patients undergoing one of three elective noncardiac surgical procedures at 77 academic hospitals between June 2006 and September 2010.
Disclosures: The study was supported by a grant from the Agency for Healthcare and Quality Research and funding from the department of anesthesiology at the University of Rochester (N.Y.). The authors reported no disclosures.
Reversal of Lap-Band to Sleeve Gastrectomy Feasible
SAN DIEGO – Laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy is a safe and feasible operation, results from a two-center study showed.
"Since the Lap-Band was introduced in the United States in 2001, it has been a popular minimally invasive procedure for weight loss," Dr. Abdelkader A. Hawasli said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "However, recent reports have shown that there’s an increased rate of explantation (up to 49%)" because of complications or failure to lose weight. Options are removal, reversion, or reversal to a nonphysiological procedure, "such as Roux-en-Y gastric bypass or biliopancreatic diversion. However, recent reports have been showing that sleeve gastrectomy could be a possible physiologic alternative."
For the current study, Dr. Hawasli, a surgeon at St. John Hospital and Medical Center in Detroit and Beaumont Hospital in Grosse Pointe, Mich., and his associates set out to evaluate the safety of the laparoscopic reversal of the Lap-Band to sleeve gastrectomy, the feasibility of performing simultaneous laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy, and the results of the sleeve gastrectomy after reversal as the final bariatric procedure in continuing or maintaining weight loss.
Dr. Hawasli reported on 485 patients who had undergone Lap-Band placement at St. John Hospital and Medical Center and 4 who had undergone the procedure at another institution from January 2004 to October 2011.
Of the 489 patients, 34 (7%) had reversal of the Lap-Band to sleeve gastrectomy. Of these, 20 patients (group 1) underwent reversal because of slippage in 15 cases, erosion in 3 cases, and infection in 2 cases, whereas 14 patients (group 2) underwent reversal because they were dissatisfied with their weight loss. The mean time of the reversal to sleeve gastrectomy was more than 3 years from Lap-Band insertion among the slippage subset patients in group 1 and among all patients in group 2 (36.5 vs. 43.3 months, respectively).
The majority of patients (32) underwent simultaneous removal of the band with reversal to sleeve gastrectomy, whereas 2 underwent a staged sleeve gastrectomy.
Dr. Hawasli reported that there were just two complications in group 1: one leak, which occurred because of erosion, and one narrowing. Both cases were treated conservatively. There were no complications in group 2. There were no readmissions in group 1, whereas in group 2 one patient was readmitted for nausea and one for dehydration.
Patients in both groups lost weight after the reversal, but the loss was more pronounced in group 1, compared with group 2 (mean total body mass index loss, –15.8 kg/m2 vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).
To explain this difference in weight loss, Dr. Hawasli said that patients in group 1 lost most of their weight before the reversal (mean BMI loss, –11.7) and lost additional weight after the reversal (mean BMI loss, –3.8). However, group 2 patients struggled with weight loss before the reversal (mean BMI loss, –3.6) and they may have continued to struggle after the reversal, even though they lost more weight after the reversal than did group 1 patients (mean BMI loss, –7.2 vs. –3.8, respectively), which is expected.
"Another reason could be the short postreversal follow-up period (a mean of 9 months)," during which they did not get enough time to lose more weight, he explained.
In group 1, the mean operative time was 159 minutes for patients with Lap-Band slippage and 174 minutes for those with erosion or infection. The mean operative time in group 2 was 106 minutes.
Length of stay was about 2 days in both groups, but reached a mean of 3.6 days for the subset of group 1 patients who had reversal because of infection or erosion.
"The short-term results of weight loss after the reversal are better in patients who had the reversal secondary to complications," Dr. Hawasli concluded. "Concomitant removal of the band and reversal to sleeve gastrectomy did not increase the risk of complications except in patients with erosion. Thus, patients with erosion may benefit better from staged reversal."
Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.
SAN DIEGO – Laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy is a safe and feasible operation, results from a two-center study showed.
"Since the Lap-Band was introduced in the United States in 2001, it has been a popular minimally invasive procedure for weight loss," Dr. Abdelkader A. Hawasli said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "However, recent reports have shown that there’s an increased rate of explantation (up to 49%)" because of complications or failure to lose weight. Options are removal, reversion, or reversal to a nonphysiological procedure, "such as Roux-en-Y gastric bypass or biliopancreatic diversion. However, recent reports have been showing that sleeve gastrectomy could be a possible physiologic alternative."
For the current study, Dr. Hawasli, a surgeon at St. John Hospital and Medical Center in Detroit and Beaumont Hospital in Grosse Pointe, Mich., and his associates set out to evaluate the safety of the laparoscopic reversal of the Lap-Band to sleeve gastrectomy, the feasibility of performing simultaneous laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy, and the results of the sleeve gastrectomy after reversal as the final bariatric procedure in continuing or maintaining weight loss.
Dr. Hawasli reported on 485 patients who had undergone Lap-Band placement at St. John Hospital and Medical Center and 4 who had undergone the procedure at another institution from January 2004 to October 2011.
Of the 489 patients, 34 (7%) had reversal of the Lap-Band to sleeve gastrectomy. Of these, 20 patients (group 1) underwent reversal because of slippage in 15 cases, erosion in 3 cases, and infection in 2 cases, whereas 14 patients (group 2) underwent reversal because they were dissatisfied with their weight loss. The mean time of the reversal to sleeve gastrectomy was more than 3 years from Lap-Band insertion among the slippage subset patients in group 1 and among all patients in group 2 (36.5 vs. 43.3 months, respectively).
The majority of patients (32) underwent simultaneous removal of the band with reversal to sleeve gastrectomy, whereas 2 underwent a staged sleeve gastrectomy.
Dr. Hawasli reported that there were just two complications in group 1: one leak, which occurred because of erosion, and one narrowing. Both cases were treated conservatively. There were no complications in group 2. There were no readmissions in group 1, whereas in group 2 one patient was readmitted for nausea and one for dehydration.
Patients in both groups lost weight after the reversal, but the loss was more pronounced in group 1, compared with group 2 (mean total body mass index loss, –15.8 kg/m2 vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).
To explain this difference in weight loss, Dr. Hawasli said that patients in group 1 lost most of their weight before the reversal (mean BMI loss, –11.7) and lost additional weight after the reversal (mean BMI loss, –3.8). However, group 2 patients struggled with weight loss before the reversal (mean BMI loss, –3.6) and they may have continued to struggle after the reversal, even though they lost more weight after the reversal than did group 1 patients (mean BMI loss, –7.2 vs. –3.8, respectively), which is expected.
"Another reason could be the short postreversal follow-up period (a mean of 9 months)," during which they did not get enough time to lose more weight, he explained.
In group 1, the mean operative time was 159 minutes for patients with Lap-Band slippage and 174 minutes for those with erosion or infection. The mean operative time in group 2 was 106 minutes.
Length of stay was about 2 days in both groups, but reached a mean of 3.6 days for the subset of group 1 patients who had reversal because of infection or erosion.
"The short-term results of weight loss after the reversal are better in patients who had the reversal secondary to complications," Dr. Hawasli concluded. "Concomitant removal of the band and reversal to sleeve gastrectomy did not increase the risk of complications except in patients with erosion. Thus, patients with erosion may benefit better from staged reversal."
Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.
SAN DIEGO – Laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy is a safe and feasible operation, results from a two-center study showed.
"Since the Lap-Band was introduced in the United States in 2001, it has been a popular minimally invasive procedure for weight loss," Dr. Abdelkader A. Hawasli said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "However, recent reports have shown that there’s an increased rate of explantation (up to 49%)" because of complications or failure to lose weight. Options are removal, reversion, or reversal to a nonphysiological procedure, "such as Roux-en-Y gastric bypass or biliopancreatic diversion. However, recent reports have been showing that sleeve gastrectomy could be a possible physiologic alternative."
For the current study, Dr. Hawasli, a surgeon at St. John Hospital and Medical Center in Detroit and Beaumont Hospital in Grosse Pointe, Mich., and his associates set out to evaluate the safety of the laparoscopic reversal of the Lap-Band to sleeve gastrectomy, the feasibility of performing simultaneous laparoscopic removal of the Lap-Band and reversal to sleeve gastrectomy, and the results of the sleeve gastrectomy after reversal as the final bariatric procedure in continuing or maintaining weight loss.
Dr. Hawasli reported on 485 patients who had undergone Lap-Band placement at St. John Hospital and Medical Center and 4 who had undergone the procedure at another institution from January 2004 to October 2011.
Of the 489 patients, 34 (7%) had reversal of the Lap-Band to sleeve gastrectomy. Of these, 20 patients (group 1) underwent reversal because of slippage in 15 cases, erosion in 3 cases, and infection in 2 cases, whereas 14 patients (group 2) underwent reversal because they were dissatisfied with their weight loss. The mean time of the reversal to sleeve gastrectomy was more than 3 years from Lap-Band insertion among the slippage subset patients in group 1 and among all patients in group 2 (36.5 vs. 43.3 months, respectively).
The majority of patients (32) underwent simultaneous removal of the band with reversal to sleeve gastrectomy, whereas 2 underwent a staged sleeve gastrectomy.
Dr. Hawasli reported that there were just two complications in group 1: one leak, which occurred because of erosion, and one narrowing. Both cases were treated conservatively. There were no complications in group 2. There were no readmissions in group 1, whereas in group 2 one patient was readmitted for nausea and one for dehydration.
Patients in both groups lost weight after the reversal, but the loss was more pronounced in group 1, compared with group 2 (mean total body mass index loss, –15.8 kg/m2 vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).
To explain this difference in weight loss, Dr. Hawasli said that patients in group 1 lost most of their weight before the reversal (mean BMI loss, –11.7) and lost additional weight after the reversal (mean BMI loss, –3.8). However, group 2 patients struggled with weight loss before the reversal (mean BMI loss, –3.6) and they may have continued to struggle after the reversal, even though they lost more weight after the reversal than did group 1 patients (mean BMI loss, –7.2 vs. –3.8, respectively), which is expected.
"Another reason could be the short postreversal follow-up period (a mean of 9 months)," during which they did not get enough time to lose more weight, he explained.
In group 1, the mean operative time was 159 minutes for patients with Lap-Band slippage and 174 minutes for those with erosion or infection. The mean operative time in group 2 was 106 minutes.
Length of stay was about 2 days in both groups, but reached a mean of 3.6 days for the subset of group 1 patients who had reversal because of infection or erosion.
"The short-term results of weight loss after the reversal are better in patients who had the reversal secondary to complications," Dr. Hawasli concluded. "Concomitant removal of the band and reversal to sleeve gastrectomy did not increase the risk of complications except in patients with erosion. Thus, patients with erosion may benefit better from staged reversal."
Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Major Finding: Weight loss was more pronounced among patients who underwent reversal of Lap-Band to sleeve gastrectomy because of band slippage, erosion, or infection than because of dissatisfaction with weight loss (mean total BMI loss, –15.8 vs. –10.8, respectively; mean percentage of excess BMI loss, –66.5% vs. –44.6%; all P less than .05).
Data Source: The study consisted of 34 patients who underwent reversal of Lap-Band to sleeve gastrectomy at two centers from January 2004 to October 2011.
Disclosures: Dr. Hawasli disclosed that he receives compensation from Covidien as a proctor.
Antegrade Beats Retrograde Enteroscopy in Small Bowel Disease
Antegrade enteroscopy had a significantly greater diagnostic and therapeutic yield in small bowel disease, compared with retrograde enteroscopy, reported Dr. Madhusudhan R. Sanaka and colleagues in the August issue of Clinical Gastroenterology and Hepatology.
Moreover, antegrade enteroscopy had a significantly shorter mean duration, with a greater mean depth of maximal insertion, the authors added.
In what the researchers called "the first study ... to compare the efficacy of all three available enteroscopy systems between antegrade and retrograde approach" in small bowel disease, Dr. Sanaka, of the Digestive Disease Institute at the Cleveland Clinic, studied 250 such procedures performed at that institution between January 2008 and August 2009.
A total of 182 procedures were antegrade (91 with a single-balloon enteroscope, 52 with a double-balloon enteroscope, and 39 with a spiral enteroscope), and 68 were retrograde (23 with a single balloon, 37 with a double balloon, and 8 with a spiral enteroscope).
The mean age of all participants was 61.5 years, and the antegrade and retrograde groups did not differ significantly on any of the demographic factors or history of prior capsule endoscopies.
Although obscure gastrointestinal bleeding was the most common indication in both groups, "abdominal pain or suspected Crohn’s disease was a much more common indication for antegrade enteroscopy when compared to retrograde (18.7% vs. 4.4%, P less than .001)," wrote the authors.
Overall, the diagnostic yield of antegrade enteroscopy was significantly greater, at 63.7%, than the yield of the retrograde procedures (39.7%), with P less than .001 (Clin. Gastroenterol. Hepatol. 2012 [doi: 10.1016/j.cgh.2012.04.020]).
The investigators then looked at the therapeutic yield of the two procedures. "With the antegrade approach, in 59 procedures (32.4%), a therapeutic intervention was performed," including argon plasma coagulation in 52 cases (28.6%), dilatation in 1 (0.6%), and polypectomy in 4 cases (2.2%).
With the retrograde approach, therapies were initiated in just 14.7% of cases, which was significantly lower than the percentage for the antegrade approach (P less than .001).
The authors also compared the technical aspects of the different procedure types. In this study, antegrade enteroscopies lasted 44.3 minutes on average, versus 58.9 minutes for the retrograde procedures (P less than .001).
Antegrade procedures also achieved a significantly greater depth of maximal insertion on average, at 231.8 cm, compared with 103.4 cm for retrograde procedures (P less than .001).
The authors conceded that the study had several limitations. Not only was it retrospective, they wrote, "there was no randomization and hence there could have been a significant bias in patient selection and use of a particular enteroscopy approach in individual cases, particularly in patients in whom the source of small bowel disorder was not known."
Nevertheless, "our findings of higher diagnostic and therapeutic yields with antegrade enteroscopy compared to retrograde enteroscopy support the expert opinion to consider antegrade enteroscopy as a default initial approach for suspected small bowel disease," the authors concluded.
"Retrograde enteroscopy may be considered when the antegrade enteroscopy is either nondiagnostic or if the abnormalities identified are unlikely to account for the patient’s symptoms," or when capsule endoscopy or radiologic imaging studies indicate that distal small bowel disease is likely, such as in suspected Crohn’s disease.
One of the authors, Dr. John Vargo, declared that he is a consultant for Olympus America, maker of enteroscopes and other devices. The authors stated that there was no outside funding.
Antegrade enteroscopy had a significantly greater diagnostic and therapeutic yield in small bowel disease, compared with retrograde enteroscopy, reported Dr. Madhusudhan R. Sanaka and colleagues in the August issue of Clinical Gastroenterology and Hepatology.
Moreover, antegrade enteroscopy had a significantly shorter mean duration, with a greater mean depth of maximal insertion, the authors added.
In what the researchers called "the first study ... to compare the efficacy of all three available enteroscopy systems between antegrade and retrograde approach" in small bowel disease, Dr. Sanaka, of the Digestive Disease Institute at the Cleveland Clinic, studied 250 such procedures performed at that institution between January 2008 and August 2009.
A total of 182 procedures were antegrade (91 with a single-balloon enteroscope, 52 with a double-balloon enteroscope, and 39 with a spiral enteroscope), and 68 were retrograde (23 with a single balloon, 37 with a double balloon, and 8 with a spiral enteroscope).
The mean age of all participants was 61.5 years, and the antegrade and retrograde groups did not differ significantly on any of the demographic factors or history of prior capsule endoscopies.
Although obscure gastrointestinal bleeding was the most common indication in both groups, "abdominal pain or suspected Crohn’s disease was a much more common indication for antegrade enteroscopy when compared to retrograde (18.7% vs. 4.4%, P less than .001)," wrote the authors.
Overall, the diagnostic yield of antegrade enteroscopy was significantly greater, at 63.7%, than the yield of the retrograde procedures (39.7%), with P less than .001 (Clin. Gastroenterol. Hepatol. 2012 [doi: 10.1016/j.cgh.2012.04.020]).
The investigators then looked at the therapeutic yield of the two procedures. "With the antegrade approach, in 59 procedures (32.4%), a therapeutic intervention was performed," including argon plasma coagulation in 52 cases (28.6%), dilatation in 1 (0.6%), and polypectomy in 4 cases (2.2%).
With the retrograde approach, therapies were initiated in just 14.7% of cases, which was significantly lower than the percentage for the antegrade approach (P less than .001).
The authors also compared the technical aspects of the different procedure types. In this study, antegrade enteroscopies lasted 44.3 minutes on average, versus 58.9 minutes for the retrograde procedures (P less than .001).
Antegrade procedures also achieved a significantly greater depth of maximal insertion on average, at 231.8 cm, compared with 103.4 cm for retrograde procedures (P less than .001).
The authors conceded that the study had several limitations. Not only was it retrospective, they wrote, "there was no randomization and hence there could have been a significant bias in patient selection and use of a particular enteroscopy approach in individual cases, particularly in patients in whom the source of small bowel disorder was not known."
Nevertheless, "our findings of higher diagnostic and therapeutic yields with antegrade enteroscopy compared to retrograde enteroscopy support the expert opinion to consider antegrade enteroscopy as a default initial approach for suspected small bowel disease," the authors concluded.
"Retrograde enteroscopy may be considered when the antegrade enteroscopy is either nondiagnostic or if the abnormalities identified are unlikely to account for the patient’s symptoms," or when capsule endoscopy or radiologic imaging studies indicate that distal small bowel disease is likely, such as in suspected Crohn’s disease.
One of the authors, Dr. John Vargo, declared that he is a consultant for Olympus America, maker of enteroscopes and other devices. The authors stated that there was no outside funding.
Antegrade enteroscopy had a significantly greater diagnostic and therapeutic yield in small bowel disease, compared with retrograde enteroscopy, reported Dr. Madhusudhan R. Sanaka and colleagues in the August issue of Clinical Gastroenterology and Hepatology.
Moreover, antegrade enteroscopy had a significantly shorter mean duration, with a greater mean depth of maximal insertion, the authors added.
In what the researchers called "the first study ... to compare the efficacy of all three available enteroscopy systems between antegrade and retrograde approach" in small bowel disease, Dr. Sanaka, of the Digestive Disease Institute at the Cleveland Clinic, studied 250 such procedures performed at that institution between January 2008 and August 2009.
A total of 182 procedures were antegrade (91 with a single-balloon enteroscope, 52 with a double-balloon enteroscope, and 39 with a spiral enteroscope), and 68 were retrograde (23 with a single balloon, 37 with a double balloon, and 8 with a spiral enteroscope).
The mean age of all participants was 61.5 years, and the antegrade and retrograde groups did not differ significantly on any of the demographic factors or history of prior capsule endoscopies.
Although obscure gastrointestinal bleeding was the most common indication in both groups, "abdominal pain or suspected Crohn’s disease was a much more common indication for antegrade enteroscopy when compared to retrograde (18.7% vs. 4.4%, P less than .001)," wrote the authors.
Overall, the diagnostic yield of antegrade enteroscopy was significantly greater, at 63.7%, than the yield of the retrograde procedures (39.7%), with P less than .001 (Clin. Gastroenterol. Hepatol. 2012 [doi: 10.1016/j.cgh.2012.04.020]).
The investigators then looked at the therapeutic yield of the two procedures. "With the antegrade approach, in 59 procedures (32.4%), a therapeutic intervention was performed," including argon plasma coagulation in 52 cases (28.6%), dilatation in 1 (0.6%), and polypectomy in 4 cases (2.2%).
With the retrograde approach, therapies were initiated in just 14.7% of cases, which was significantly lower than the percentage for the antegrade approach (P less than .001).
The authors also compared the technical aspects of the different procedure types. In this study, antegrade enteroscopies lasted 44.3 minutes on average, versus 58.9 minutes for the retrograde procedures (P less than .001).
Antegrade procedures also achieved a significantly greater depth of maximal insertion on average, at 231.8 cm, compared with 103.4 cm for retrograde procedures (P less than .001).
The authors conceded that the study had several limitations. Not only was it retrospective, they wrote, "there was no randomization and hence there could have been a significant bias in patient selection and use of a particular enteroscopy approach in individual cases, particularly in patients in whom the source of small bowel disorder was not known."
Nevertheless, "our findings of higher diagnostic and therapeutic yields with antegrade enteroscopy compared to retrograde enteroscopy support the expert opinion to consider antegrade enteroscopy as a default initial approach for suspected small bowel disease," the authors concluded.
"Retrograde enteroscopy may be considered when the antegrade enteroscopy is either nondiagnostic or if the abnormalities identified are unlikely to account for the patient’s symptoms," or when capsule endoscopy or radiologic imaging studies indicate that distal small bowel disease is likely, such as in suspected Crohn’s disease.
One of the authors, Dr. John Vargo, declared that he is a consultant for Olympus America, maker of enteroscopes and other devices. The authors stated that there was no outside funding.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Sleeve Gastrectomy Feasible in Obese Transplant Candidates
SAN DIEGO – Laparoscopic sleeve gastrectomy is safe and effective in obese candidates for organ transplantation, results from a novel pilot study demonstrated.
Nationwide, 15%-20% of patients on the transplant waiting list are morbidly obese, with a body mass index of greater than 35 kg/m2, "but many cannot be transplanted unless they lose weight," said Dr. Matthew Y. Lin of the surgery department at the University of California, San Francisco (UCSF). "Morbid obesity can contribute to end-stage kidney or liver failure. For example, obesity-related nonalcoholic steatohepatitis is now the third most common indication for liver transplant in the United States and will likely become first in the future."
In what Dr. Lin said is the only reported case series of bariatric surgery in obese transplant candidates, he and his associates conducted a pilot study of 26 morbidly obese patients with liver or kidney failure who underwent laparoscopic sleeve gastrectomy at UCSF from 2006 to 2012. They chose sleeve gastrectomy over gastric banding "to avoid foreign body implantation, in anticipation of post-transplant immunosuppression," Dr. Lin explained at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
"We chose sleeve gastrectomy over gastric bypass to maintain endoscopic access to the biliary system, to reduce surgical complexity, and to avoid unpredictable immunosuppression absorption," he said.
Morbid obesity is a relative contraindication for solid organ transplantation at most centers because of poor post-transplant outcomes, according to Dr. Lin. "At UCSF, the selection criteria are a BMI of less than 40 for liver transplant, less than 38 for kidney transplant, and less than 34 for kidney transplant in patients with diabetes." The researchers hypothesized that laparoscopic sleeve gastrectomy could be safely performed in high-risk patients with liver or kidney failure and achieve enough weight loss to allow for transplantation.
The 26 patients had a mean age of 57 years, 17 were women, 20 were white, and their average preoperative BMI was 48. Twenty patients had liver insufficiency with a mean Model for End-Stage Liver Disease (MELD) score of 11, and 6 had kidney insufficiency with a mean glomerular filtration rate of 10 mL/min. Five of these patients were on hemodialysis.
All 26 patients had laparoscopic sleeve gastrectomy performed by the same surgeon. The mean operative time was 151 minutes, and the mean length of stay was 4.2 days. Complications that occurred within 30 days were two cases of superficial wound infection and one case each of worsened hepatic encephalopathy, acute renal insufficiency, need for blood transfusion, and staple line leak. There was no mortality within 30 days, but after that period two patients died awaiting transplant and one patient died from complications of the staple line leak and progressive liver failure 4 years after surgery.
After 2 years, the average BMI of study participants dropped from a mean of 48 to a mean of 29. "Between the 6- and 12-month marks, most patients were able to achieve a BMI that would make them acceptable for transplant," Dr. Lin said.
At 1, 3, 12, and 24 months, the percent of excess body weight lost was 17%, 26%, 50%, and 66%, respectively. "The weight-loss profile is similar to [those of] the general bariatric sleeve gastrectomy population," he noted.
Of the 13 patients who had diabetes preoperatively, 7 had complete resolution after the procedure and 1 had partial resolution. Mean postoperative albumin levels for all 26 patients after sleeve gastrectomy were 3.1 g/dL at 6 months and 3.3 g/dL at 12 months.
Eight patients went on to receive their organ transplant, Dr. Lin said. Their mean age was 56 years, and six were women. They waited a mean of 17 months for their procedures, which included six liver transplants, one liver and kidney transplant, and one kidney transplant. Their mean BMI before sleeve gastrectomy was 46, and their mean BMI prior to transplantation was 31. Immediately before transplant, their mean albumin level was 3.2 g/dL, and the most current measurement remained the same. "No increased acute rejection or difficulty maintaining immunosuppression was observed," he said.
Dr. Lin acknowledged certain limitations of the study, including its single-center design, lack of a control population, and the fact that "there is very little statistical power to estimate the true complication rate in this high-risk surgical group. Furthermore, we only have short-term follow-up."
Dr. Lin said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Laparoscopic sleeve gastrectomy is safe and effective in obese candidates for organ transplantation, results from a novel pilot study demonstrated.
Nationwide, 15%-20% of patients on the transplant waiting list are morbidly obese, with a body mass index of greater than 35 kg/m2, "but many cannot be transplanted unless they lose weight," said Dr. Matthew Y. Lin of the surgery department at the University of California, San Francisco (UCSF). "Morbid obesity can contribute to end-stage kidney or liver failure. For example, obesity-related nonalcoholic steatohepatitis is now the third most common indication for liver transplant in the United States and will likely become first in the future."
In what Dr. Lin said is the only reported case series of bariatric surgery in obese transplant candidates, he and his associates conducted a pilot study of 26 morbidly obese patients with liver or kidney failure who underwent laparoscopic sleeve gastrectomy at UCSF from 2006 to 2012. They chose sleeve gastrectomy over gastric banding "to avoid foreign body implantation, in anticipation of post-transplant immunosuppression," Dr. Lin explained at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
"We chose sleeve gastrectomy over gastric bypass to maintain endoscopic access to the biliary system, to reduce surgical complexity, and to avoid unpredictable immunosuppression absorption," he said.
Morbid obesity is a relative contraindication for solid organ transplantation at most centers because of poor post-transplant outcomes, according to Dr. Lin. "At UCSF, the selection criteria are a BMI of less than 40 for liver transplant, less than 38 for kidney transplant, and less than 34 for kidney transplant in patients with diabetes." The researchers hypothesized that laparoscopic sleeve gastrectomy could be safely performed in high-risk patients with liver or kidney failure and achieve enough weight loss to allow for transplantation.
The 26 patients had a mean age of 57 years, 17 were women, 20 were white, and their average preoperative BMI was 48. Twenty patients had liver insufficiency with a mean Model for End-Stage Liver Disease (MELD) score of 11, and 6 had kidney insufficiency with a mean glomerular filtration rate of 10 mL/min. Five of these patients were on hemodialysis.
All 26 patients had laparoscopic sleeve gastrectomy performed by the same surgeon. The mean operative time was 151 minutes, and the mean length of stay was 4.2 days. Complications that occurred within 30 days were two cases of superficial wound infection and one case each of worsened hepatic encephalopathy, acute renal insufficiency, need for blood transfusion, and staple line leak. There was no mortality within 30 days, but after that period two patients died awaiting transplant and one patient died from complications of the staple line leak and progressive liver failure 4 years after surgery.
After 2 years, the average BMI of study participants dropped from a mean of 48 to a mean of 29. "Between the 6- and 12-month marks, most patients were able to achieve a BMI that would make them acceptable for transplant," Dr. Lin said.
At 1, 3, 12, and 24 months, the percent of excess body weight lost was 17%, 26%, 50%, and 66%, respectively. "The weight-loss profile is similar to [those of] the general bariatric sleeve gastrectomy population," he noted.
Of the 13 patients who had diabetes preoperatively, 7 had complete resolution after the procedure and 1 had partial resolution. Mean postoperative albumin levels for all 26 patients after sleeve gastrectomy were 3.1 g/dL at 6 months and 3.3 g/dL at 12 months.
Eight patients went on to receive their organ transplant, Dr. Lin said. Their mean age was 56 years, and six were women. They waited a mean of 17 months for their procedures, which included six liver transplants, one liver and kidney transplant, and one kidney transplant. Their mean BMI before sleeve gastrectomy was 46, and their mean BMI prior to transplantation was 31. Immediately before transplant, their mean albumin level was 3.2 g/dL, and the most current measurement remained the same. "No increased acute rejection or difficulty maintaining immunosuppression was observed," he said.
Dr. Lin acknowledged certain limitations of the study, including its single-center design, lack of a control population, and the fact that "there is very little statistical power to estimate the true complication rate in this high-risk surgical group. Furthermore, we only have short-term follow-up."
Dr. Lin said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Laparoscopic sleeve gastrectomy is safe and effective in obese candidates for organ transplantation, results from a novel pilot study demonstrated.
Nationwide, 15%-20% of patients on the transplant waiting list are morbidly obese, with a body mass index of greater than 35 kg/m2, "but many cannot be transplanted unless they lose weight," said Dr. Matthew Y. Lin of the surgery department at the University of California, San Francisco (UCSF). "Morbid obesity can contribute to end-stage kidney or liver failure. For example, obesity-related nonalcoholic steatohepatitis is now the third most common indication for liver transplant in the United States and will likely become first in the future."
In what Dr. Lin said is the only reported case series of bariatric surgery in obese transplant candidates, he and his associates conducted a pilot study of 26 morbidly obese patients with liver or kidney failure who underwent laparoscopic sleeve gastrectomy at UCSF from 2006 to 2012. They chose sleeve gastrectomy over gastric banding "to avoid foreign body implantation, in anticipation of post-transplant immunosuppression," Dr. Lin explained at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
"We chose sleeve gastrectomy over gastric bypass to maintain endoscopic access to the biliary system, to reduce surgical complexity, and to avoid unpredictable immunosuppression absorption," he said.
Morbid obesity is a relative contraindication for solid organ transplantation at most centers because of poor post-transplant outcomes, according to Dr. Lin. "At UCSF, the selection criteria are a BMI of less than 40 for liver transplant, less than 38 for kidney transplant, and less than 34 for kidney transplant in patients with diabetes." The researchers hypothesized that laparoscopic sleeve gastrectomy could be safely performed in high-risk patients with liver or kidney failure and achieve enough weight loss to allow for transplantation.
The 26 patients had a mean age of 57 years, 17 were women, 20 were white, and their average preoperative BMI was 48. Twenty patients had liver insufficiency with a mean Model for End-Stage Liver Disease (MELD) score of 11, and 6 had kidney insufficiency with a mean glomerular filtration rate of 10 mL/min. Five of these patients were on hemodialysis.
All 26 patients had laparoscopic sleeve gastrectomy performed by the same surgeon. The mean operative time was 151 minutes, and the mean length of stay was 4.2 days. Complications that occurred within 30 days were two cases of superficial wound infection and one case each of worsened hepatic encephalopathy, acute renal insufficiency, need for blood transfusion, and staple line leak. There was no mortality within 30 days, but after that period two patients died awaiting transplant and one patient died from complications of the staple line leak and progressive liver failure 4 years after surgery.
After 2 years, the average BMI of study participants dropped from a mean of 48 to a mean of 29. "Between the 6- and 12-month marks, most patients were able to achieve a BMI that would make them acceptable for transplant," Dr. Lin said.
At 1, 3, 12, and 24 months, the percent of excess body weight lost was 17%, 26%, 50%, and 66%, respectively. "The weight-loss profile is similar to [those of] the general bariatric sleeve gastrectomy population," he noted.
Of the 13 patients who had diabetes preoperatively, 7 had complete resolution after the procedure and 1 had partial resolution. Mean postoperative albumin levels for all 26 patients after sleeve gastrectomy were 3.1 g/dL at 6 months and 3.3 g/dL at 12 months.
Eight patients went on to receive their organ transplant, Dr. Lin said. Their mean age was 56 years, and six were women. They waited a mean of 17 months for their procedures, which included six liver transplants, one liver and kidney transplant, and one kidney transplant. Their mean BMI before sleeve gastrectomy was 46, and their mean BMI prior to transplantation was 31. Immediately before transplant, their mean albumin level was 3.2 g/dL, and the most current measurement remained the same. "No increased acute rejection or difficulty maintaining immunosuppression was observed," he said.
Dr. Lin acknowledged certain limitations of the study, including its single-center design, lack of a control population, and the fact that "there is very little statistical power to estimate the true complication rate in this high-risk surgical group. Furthermore, we only have short-term follow-up."
Dr. Lin said that he had no relevant financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Survey: Long Surgical Career Raises Likelihood of Lawsuit
SAN DIEGO – The most experienced bariatric surgeons are those who are most likely to be sued, judging by responses to a survey from more than 300 members of the American Society for Metabolic and Bariatric Surgery.
"There are no resources, national registries, or easily accessible databases to analyze bariatric-specific medical malpractice claims in the United States," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice litigation and develop patient safety improvements. Nor do there exist easily accessible measures of trends in bariatric surgery litigation."
In an effort to obtain a snapshot of the liability landscape in bariatric surgery, Dr. Dallal and other members of the ASMBS Patient Safety Committee e-mailed a survey to 1,672 surgeon members of the ASMBS in July 2011. A total of 330 surgeons in 46 states responded, for a response rate of 20%. Their mean number of years in practice was 15, which represented 5,042 years of bariatric surgery–specific liability exposure. Most respondents (38%) practiced in a hospital or academic group, 26% in a single specialty group, 20% in solo practice, 13% in a multispecialty group, and 3% in other settings.
Nine respondents chose not to have malpractice insurance. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200.
Nearly half of respondents (48%) reported having no malpractice insurance cases since their careers began, but the average number of lifetime cases reported by their counterparts was 1.5.
Of the 464 lawsuits reported by 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, and 19% went to trial or arbitration.
Of those cases that went to trial, 72% were found in favor of the surgeon-defendant. The mean lifetime amount paid in lawsuits was $250,000, including one settlement for $7,000,000. The total amount paid by the respondents was $70,871,998.
Using multivariate logistic regression analysis, the researchers determined that the probability of reporting at least one lawsuit independently increased with the number of years in practice (odds ratio, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01). "In essence, our most experienced surgeons are the ones being sued the most," said Dr. Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network, Philadelphia.
The odds of having lost a malpractice case that resulted in monetary compensation independently increased with the number of years in practice (OR, 1.09; P less than .0005), and the number of lawsuits experienced (OR, 1.42; P = .02). "The type of practice and the lack of a bariatric surgeon expert witness did not independently predict a payout," Dr. Dallal said.
Nearly 7% of survey respondents reported that the primary expert witness in determining the standard of bariatric surgery care was not a bariatric surgeon. In such cases, the surgeon-defendant had an 11-fold increased risk of having a lawsuit (P = .018). However, the use of an expert witness who was not a bariatric surgeon was not associated with the chance of settlement or the case’s going to trial.
Dr. Dallal noted that many lawsuits are filed about 2 years after the alleged injury, and another 1-2 years may pass before resolution of that lawsuit occurs. "So, there is a built-in bias against surgeons who have been in practice longer," he said.
He noted that successful lawsuits that are based on patient harm "do occur and are devastating to all involved. Improving the patient safety culture is the mainstay of reducing liability risk."
Dr. Dallal said that he had no relevant financial conflicts to disclose.
SAN DIEGO – The most experienced bariatric surgeons are those who are most likely to be sued, judging by responses to a survey from more than 300 members of the American Society for Metabolic and Bariatric Surgery.
"There are no resources, national registries, or easily accessible databases to analyze bariatric-specific medical malpractice claims in the United States," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice litigation and develop patient safety improvements. Nor do there exist easily accessible measures of trends in bariatric surgery litigation."
In an effort to obtain a snapshot of the liability landscape in bariatric surgery, Dr. Dallal and other members of the ASMBS Patient Safety Committee e-mailed a survey to 1,672 surgeon members of the ASMBS in July 2011. A total of 330 surgeons in 46 states responded, for a response rate of 20%. Their mean number of years in practice was 15, which represented 5,042 years of bariatric surgery–specific liability exposure. Most respondents (38%) practiced in a hospital or academic group, 26% in a single specialty group, 20% in solo practice, 13% in a multispecialty group, and 3% in other settings.
Nine respondents chose not to have malpractice insurance. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200.
Nearly half of respondents (48%) reported having no malpractice insurance cases since their careers began, but the average number of lifetime cases reported by their counterparts was 1.5.
Of the 464 lawsuits reported by 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, and 19% went to trial or arbitration.
Of those cases that went to trial, 72% were found in favor of the surgeon-defendant. The mean lifetime amount paid in lawsuits was $250,000, including one settlement for $7,000,000. The total amount paid by the respondents was $70,871,998.
Using multivariate logistic regression analysis, the researchers determined that the probability of reporting at least one lawsuit independently increased with the number of years in practice (odds ratio, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01). "In essence, our most experienced surgeons are the ones being sued the most," said Dr. Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network, Philadelphia.
The odds of having lost a malpractice case that resulted in monetary compensation independently increased with the number of years in practice (OR, 1.09; P less than .0005), and the number of lawsuits experienced (OR, 1.42; P = .02). "The type of practice and the lack of a bariatric surgeon expert witness did not independently predict a payout," Dr. Dallal said.
Nearly 7% of survey respondents reported that the primary expert witness in determining the standard of bariatric surgery care was not a bariatric surgeon. In such cases, the surgeon-defendant had an 11-fold increased risk of having a lawsuit (P = .018). However, the use of an expert witness who was not a bariatric surgeon was not associated with the chance of settlement or the case’s going to trial.
Dr. Dallal noted that many lawsuits are filed about 2 years after the alleged injury, and another 1-2 years may pass before resolution of that lawsuit occurs. "So, there is a built-in bias against surgeons who have been in practice longer," he said.
He noted that successful lawsuits that are based on patient harm "do occur and are devastating to all involved. Improving the patient safety culture is the mainstay of reducing liability risk."
Dr. Dallal said that he had no relevant financial conflicts to disclose.
SAN DIEGO – The most experienced bariatric surgeons are those who are most likely to be sued, judging by responses to a survey from more than 300 members of the American Society for Metabolic and Bariatric Surgery.
"There are no resources, national registries, or easily accessible databases to analyze bariatric-specific medical malpractice claims in the United States," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice litigation and develop patient safety improvements. Nor do there exist easily accessible measures of trends in bariatric surgery litigation."
In an effort to obtain a snapshot of the liability landscape in bariatric surgery, Dr. Dallal and other members of the ASMBS Patient Safety Committee e-mailed a survey to 1,672 surgeon members of the ASMBS in July 2011. A total of 330 surgeons in 46 states responded, for a response rate of 20%. Their mean number of years in practice was 15, which represented 5,042 years of bariatric surgery–specific liability exposure. Most respondents (38%) practiced in a hospital or academic group, 26% in a single specialty group, 20% in solo practice, 13% in a multispecialty group, and 3% in other settings.
Nine respondents chose not to have malpractice insurance. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200.
Nearly half of respondents (48%) reported having no malpractice insurance cases since their careers began, but the average number of lifetime cases reported by their counterparts was 1.5.
Of the 464 lawsuits reported by 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, and 19% went to trial or arbitration.
Of those cases that went to trial, 72% were found in favor of the surgeon-defendant. The mean lifetime amount paid in lawsuits was $250,000, including one settlement for $7,000,000. The total amount paid by the respondents was $70,871,998.
Using multivariate logistic regression analysis, the researchers determined that the probability of reporting at least one lawsuit independently increased with the number of years in practice (odds ratio, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01). "In essence, our most experienced surgeons are the ones being sued the most," said Dr. Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network, Philadelphia.
The odds of having lost a malpractice case that resulted in monetary compensation independently increased with the number of years in practice (OR, 1.09; P less than .0005), and the number of lawsuits experienced (OR, 1.42; P = .02). "The type of practice and the lack of a bariatric surgeon expert witness did not independently predict a payout," Dr. Dallal said.
Nearly 7% of survey respondents reported that the primary expert witness in determining the standard of bariatric surgery care was not a bariatric surgeon. In such cases, the surgeon-defendant had an 11-fold increased risk of having a lawsuit (P = .018). However, the use of an expert witness who was not a bariatric surgeon was not associated with the chance of settlement or the case’s going to trial.
Dr. Dallal noted that many lawsuits are filed about 2 years after the alleged injury, and another 1-2 years may pass before resolution of that lawsuit occurs. "So, there is a built-in bias against surgeons who have been in practice longer," he said.
He noted that successful lawsuits that are based on patient harm "do occur and are devastating to all involved. Improving the patient safety culture is the mainstay of reducing liability risk."
Dr. Dallal said that he had no relevant financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Major Finding: The probability of reporting at least one lawsuit independently increased with the number of years in practice (OR, 1.03; P = .03) and among those who have performed more than 1,000 cases (OR, 8.5%; P = .01).
Data Source: The findings are based on responses to a survey from 330 members of the American Society of Metabolic and Bariatric Surgery.
Disclosures: Dr. Dallal said that he had no relevant financial conflicts to disclose.
Largest Series of Robotic-Assisted Gastric Bypass Reported
SAN DIEGO – At 30 days, the mortality rate from robotic-assisted gastric bypass surgery was zero and the rate of leak or abscess was just 0.3%, a multicenter study showed.
"Complications are few and may be less than with conventional laparoscopic techniques, even in different centers," Dr. Erik B. Wilson said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
In what he said is the largest reported series of its kind, Dr. Wilson and his associates reviewed 1,695 robotic-assisted Roux-en-Y gastric bypass procedures performed with the da Vinci Surgical System (Intuitive Surgical) between February 2003 and September 2011. The operations were performed at three centers: the University of Texas Health Science Center at Houston (578 procedures), Eastern Maine Medical Center, Bangor (708 procedures), and Florida Hospital Celebration Health (409). The mean body mass index of patients was 48.9 kg/m2, and the researchers evaluated complications and outcomes that occurred within the first 30 days of surgery.
Dr. Wilson, associate professor of surgery at the University of Texas Health Science Center at Houston, reported that the average length of stay was 2.2 days. Within the first 30 days of surgery there were 81 readmissions (4.8%), "which is not too different from what you’d expect in most populations," he said. Of these, 49 (2.9%) were for dehydration, 27 (1.6%) were for nausea/vomiting, and 5 (0.3%) were for stricture requiring dilation.
There were 46 reoperations (2.7%) within the first 30 days of surgery. Of these, 18 (1.06%) were for bowel obstruction/hernia, 17 (1%) were for bleeding/hematoma, 6 (0.35%) were for negative exploration of patients the surgeons were concerned about, and 5 (0.29%) were for abscess/leak.
There were 26 early major complications (1.5%). Of these, 14 (0.83%) were bleeding requiring transfusion, 5 (0.29%) were stricture requiring dilation, 3 (0.18%) were abscesses, 2 (0.12%) were anastomotic leaks, and 2 (0.12%) were cases of pulmonary embolism/infarct. There was no mortality, "which we think is very favorable," Dr. Wilson said.
Average operating times varied by center: 156 minutes in Houston, 128 minutes in Florida, and 104 minutes in Maine. "As time has gone on, and as we engage each other on how we do things, these operative times have continued to decrease, with current times approaching 90 minutes," Dr. Wilson said. "So long operative times are not necessary when you do robotic surgery."
He concluded by describing robotic-assisted bypass surgery as "an enabling technology that allows for excellent reproducible outcomes, because we have multiple centers doing it well. Future studies should focus on revisional and more complex procedures such as biliopancreatic conversion."
Dr. Wilson disclosed that he is a consultant for Intuitive Surgical, Ethicon Endo-Surgery, Apollo Endosurgery, and EndoGastric Solutions. He is also a proctor for Intuitive Surgical, and has received an educational grant from Gore.
SAN DIEGO – At 30 days, the mortality rate from robotic-assisted gastric bypass surgery was zero and the rate of leak or abscess was just 0.3%, a multicenter study showed.
"Complications are few and may be less than with conventional laparoscopic techniques, even in different centers," Dr. Erik B. Wilson said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
In what he said is the largest reported series of its kind, Dr. Wilson and his associates reviewed 1,695 robotic-assisted Roux-en-Y gastric bypass procedures performed with the da Vinci Surgical System (Intuitive Surgical) between February 2003 and September 2011. The operations were performed at three centers: the University of Texas Health Science Center at Houston (578 procedures), Eastern Maine Medical Center, Bangor (708 procedures), and Florida Hospital Celebration Health (409). The mean body mass index of patients was 48.9 kg/m2, and the researchers evaluated complications and outcomes that occurred within the first 30 days of surgery.
Dr. Wilson, associate professor of surgery at the University of Texas Health Science Center at Houston, reported that the average length of stay was 2.2 days. Within the first 30 days of surgery there were 81 readmissions (4.8%), "which is not too different from what you’d expect in most populations," he said. Of these, 49 (2.9%) were for dehydration, 27 (1.6%) were for nausea/vomiting, and 5 (0.3%) were for stricture requiring dilation.
There were 46 reoperations (2.7%) within the first 30 days of surgery. Of these, 18 (1.06%) were for bowel obstruction/hernia, 17 (1%) were for bleeding/hematoma, 6 (0.35%) were for negative exploration of patients the surgeons were concerned about, and 5 (0.29%) were for abscess/leak.
There were 26 early major complications (1.5%). Of these, 14 (0.83%) were bleeding requiring transfusion, 5 (0.29%) were stricture requiring dilation, 3 (0.18%) were abscesses, 2 (0.12%) were anastomotic leaks, and 2 (0.12%) were cases of pulmonary embolism/infarct. There was no mortality, "which we think is very favorable," Dr. Wilson said.
Average operating times varied by center: 156 minutes in Houston, 128 minutes in Florida, and 104 minutes in Maine. "As time has gone on, and as we engage each other on how we do things, these operative times have continued to decrease, with current times approaching 90 minutes," Dr. Wilson said. "So long operative times are not necessary when you do robotic surgery."
He concluded by describing robotic-assisted bypass surgery as "an enabling technology that allows for excellent reproducible outcomes, because we have multiple centers doing it well. Future studies should focus on revisional and more complex procedures such as biliopancreatic conversion."
Dr. Wilson disclosed that he is a consultant for Intuitive Surgical, Ethicon Endo-Surgery, Apollo Endosurgery, and EndoGastric Solutions. He is also a proctor for Intuitive Surgical, and has received an educational grant from Gore.
SAN DIEGO – At 30 days, the mortality rate from robotic-assisted gastric bypass surgery was zero and the rate of leak or abscess was just 0.3%, a multicenter study showed.
"Complications are few and may be less than with conventional laparoscopic techniques, even in different centers," Dr. Erik B. Wilson said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
In what he said is the largest reported series of its kind, Dr. Wilson and his associates reviewed 1,695 robotic-assisted Roux-en-Y gastric bypass procedures performed with the da Vinci Surgical System (Intuitive Surgical) between February 2003 and September 2011. The operations were performed at three centers: the University of Texas Health Science Center at Houston (578 procedures), Eastern Maine Medical Center, Bangor (708 procedures), and Florida Hospital Celebration Health (409). The mean body mass index of patients was 48.9 kg/m2, and the researchers evaluated complications and outcomes that occurred within the first 30 days of surgery.
Dr. Wilson, associate professor of surgery at the University of Texas Health Science Center at Houston, reported that the average length of stay was 2.2 days. Within the first 30 days of surgery there were 81 readmissions (4.8%), "which is not too different from what you’d expect in most populations," he said. Of these, 49 (2.9%) were for dehydration, 27 (1.6%) were for nausea/vomiting, and 5 (0.3%) were for stricture requiring dilation.
There were 46 reoperations (2.7%) within the first 30 days of surgery. Of these, 18 (1.06%) were for bowel obstruction/hernia, 17 (1%) were for bleeding/hematoma, 6 (0.35%) were for negative exploration of patients the surgeons were concerned about, and 5 (0.29%) were for abscess/leak.
There were 26 early major complications (1.5%). Of these, 14 (0.83%) were bleeding requiring transfusion, 5 (0.29%) were stricture requiring dilation, 3 (0.18%) were abscesses, 2 (0.12%) were anastomotic leaks, and 2 (0.12%) were cases of pulmonary embolism/infarct. There was no mortality, "which we think is very favorable," Dr. Wilson said.
Average operating times varied by center: 156 minutes in Houston, 128 minutes in Florida, and 104 minutes in Maine. "As time has gone on, and as we engage each other on how we do things, these operative times have continued to decrease, with current times approaching 90 minutes," Dr. Wilson said. "So long operative times are not necessary when you do robotic surgery."
He concluded by describing robotic-assisted bypass surgery as "an enabling technology that allows for excellent reproducible outcomes, because we have multiple centers doing it well. Future studies should focus on revisional and more complex procedures such as biliopancreatic conversion."
Dr. Wilson disclosed that he is a consultant for Intuitive Surgical, Ethicon Endo-Surgery, Apollo Endosurgery, and EndoGastric Solutions. He is also a proctor for Intuitive Surgical, and has received an educational grant from Gore.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Bariatric Surgery Yields Durable Results for Diabetic Nephropathy
SAN DIEGO – Bariatric surgery induced a significant and durable improvement in diabetic nephropathy after 5 years of follow-up, results from a single-center study showed.
"In addition to significant weight loss, [bariatric surgery] achieves profound metabolic effects, including improvements in glycemic control and insulin sensitivity, as well as a decrease in cardiovascular disease risk and mortality," lead author Dr. Helen M. Heneghan said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "We hypothesized that improving diabetic control with bariatric surgery may have positive effects on the end-organ complications of this disease, such as diabetic nephropathy. We also wanted to address one of the prevailing questions in this field: whether or not the effects of bariatric surgery on diabetes and its complications are durable."
Dr. Heneghan, a bariatric surgery fellow at the Cleveland Clinic Bariatric and Metabolic Institute, and her associates identified 52 patients who underwent bariatric surgery at the institute and had completed the 5-year follow-up. At baseline, the mean age of patients was 51 years, and 75% were women. Their preoperative mean body mass index was 49 kg/m2, 84% had hypertension, and 71% had hyperlipidemia. Preoperatively, the mean duration of diabetes was 8.6 years, and 29% were already taking insulin. Their mean hemoglobin A1c level was 7.7%, and 38% had diabetic nephropathy as indicated by microalbuminuria (30-299 mg of albumin per g of creatinine) or macroalbuminura (greater than 300 mg/g), and 22% of patients were prescribed an ACE inhibitor or angiotensin receptor blocker.
The majority of patients (69%) underwent gastric bypass; 25% had laparoscopic gastric banding and 6% had sleeve gastrectomy. Dr. Heneghan reported that 5 years after their surgery, 44% of patients had sustained remission of their type 2 diabetes, 33% had a significant improvement, and 23% had no change or worsening of their disease. This latter cohort "had the least amount of weight loss and were those who had the longest standing duration of diabetes preoperatively."
The rates of patients with remission, improvement, or change in hypertension were 16%, 50%, and 34%, respectively, whereas the rates for patients with dyslipidemia were 39%, 20%, and 41%.
Only 25% of patients who did not have diabetic nephropathy at the time of surgery went on to develop the condition. Among patients with preoperative microalbuminuria, 42% remained stable whereas 58% regressed and had no albuminuria 5 years after surgery. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years.*
There were no preoperative differences in the mean urinary albumin to creatinine ratio (ACR) between patients who were and patients who were not prescribed a renoprotective agent. However, postoperatively, patients who were not on a renoprotective agent had a significantly lower urinary ACR, compared with those who remained on a renoprotective agent (P = .039). "This probably reflects the fact that patients who had improvement of their diabetes and regression or nonprogression of their nephropathy status also had a significant improvement in – or remission of – hypertension, and were no longer prescribed an antihypertensive medication," Dr. Heneghan explained.
She characterized the study’s overall findings as "remarkable, considering that diabetes is a chronic, progressive disease, and certainly warrant further investigation in the form of a prospective and larger study."
Dr. Heneghan said that she had no relevant financial conflicts to disclose.
*CORRECTION 8/28/12: The original sentence contained an error in describing the patients. The sentence should read" "Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years."
SAN DIEGO – Bariatric surgery induced a significant and durable improvement in diabetic nephropathy after 5 years of follow-up, results from a single-center study showed.
"In addition to significant weight loss, [bariatric surgery] achieves profound metabolic effects, including improvements in glycemic control and insulin sensitivity, as well as a decrease in cardiovascular disease risk and mortality," lead author Dr. Helen M. Heneghan said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "We hypothesized that improving diabetic control with bariatric surgery may have positive effects on the end-organ complications of this disease, such as diabetic nephropathy. We also wanted to address one of the prevailing questions in this field: whether or not the effects of bariatric surgery on diabetes and its complications are durable."
Dr. Heneghan, a bariatric surgery fellow at the Cleveland Clinic Bariatric and Metabolic Institute, and her associates identified 52 patients who underwent bariatric surgery at the institute and had completed the 5-year follow-up. At baseline, the mean age of patients was 51 years, and 75% were women. Their preoperative mean body mass index was 49 kg/m2, 84% had hypertension, and 71% had hyperlipidemia. Preoperatively, the mean duration of diabetes was 8.6 years, and 29% were already taking insulin. Their mean hemoglobin A1c level was 7.7%, and 38% had diabetic nephropathy as indicated by microalbuminuria (30-299 mg of albumin per g of creatinine) or macroalbuminura (greater than 300 mg/g), and 22% of patients were prescribed an ACE inhibitor or angiotensin receptor blocker.
The majority of patients (69%) underwent gastric bypass; 25% had laparoscopic gastric banding and 6% had sleeve gastrectomy. Dr. Heneghan reported that 5 years after their surgery, 44% of patients had sustained remission of their type 2 diabetes, 33% had a significant improvement, and 23% had no change or worsening of their disease. This latter cohort "had the least amount of weight loss and were those who had the longest standing duration of diabetes preoperatively."
The rates of patients with remission, improvement, or change in hypertension were 16%, 50%, and 34%, respectively, whereas the rates for patients with dyslipidemia were 39%, 20%, and 41%.
Only 25% of patients who did not have diabetic nephropathy at the time of surgery went on to develop the condition. Among patients with preoperative microalbuminuria, 42% remained stable whereas 58% regressed and had no albuminuria 5 years after surgery. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years.*
There were no preoperative differences in the mean urinary albumin to creatinine ratio (ACR) between patients who were and patients who were not prescribed a renoprotective agent. However, postoperatively, patients who were not on a renoprotective agent had a significantly lower urinary ACR, compared with those who remained on a renoprotective agent (P = .039). "This probably reflects the fact that patients who had improvement of their diabetes and regression or nonprogression of their nephropathy status also had a significant improvement in – or remission of – hypertension, and were no longer prescribed an antihypertensive medication," Dr. Heneghan explained.
She characterized the study’s overall findings as "remarkable, considering that diabetes is a chronic, progressive disease, and certainly warrant further investigation in the form of a prospective and larger study."
Dr. Heneghan said that she had no relevant financial conflicts to disclose.
*CORRECTION 8/28/12: The original sentence contained an error in describing the patients. The sentence should read" "Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years."
SAN DIEGO – Bariatric surgery induced a significant and durable improvement in diabetic nephropathy after 5 years of follow-up, results from a single-center study showed.
"In addition to significant weight loss, [bariatric surgery] achieves profound metabolic effects, including improvements in glycemic control and insulin sensitivity, as well as a decrease in cardiovascular disease risk and mortality," lead author Dr. Helen M. Heneghan said at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "We hypothesized that improving diabetic control with bariatric surgery may have positive effects on the end-organ complications of this disease, such as diabetic nephropathy. We also wanted to address one of the prevailing questions in this field: whether or not the effects of bariatric surgery on diabetes and its complications are durable."
Dr. Heneghan, a bariatric surgery fellow at the Cleveland Clinic Bariatric and Metabolic Institute, and her associates identified 52 patients who underwent bariatric surgery at the institute and had completed the 5-year follow-up. At baseline, the mean age of patients was 51 years, and 75% were women. Their preoperative mean body mass index was 49 kg/m2, 84% had hypertension, and 71% had hyperlipidemia. Preoperatively, the mean duration of diabetes was 8.6 years, and 29% were already taking insulin. Their mean hemoglobin A1c level was 7.7%, and 38% had diabetic nephropathy as indicated by microalbuminuria (30-299 mg of albumin per g of creatinine) or macroalbuminura (greater than 300 mg/g), and 22% of patients were prescribed an ACE inhibitor or angiotensin receptor blocker.
The majority of patients (69%) underwent gastric bypass; 25% had laparoscopic gastric banding and 6% had sleeve gastrectomy. Dr. Heneghan reported that 5 years after their surgery, 44% of patients had sustained remission of their type 2 diabetes, 33% had a significant improvement, and 23% had no change or worsening of their disease. This latter cohort "had the least amount of weight loss and were those who had the longest standing duration of diabetes preoperatively."
The rates of patients with remission, improvement, or change in hypertension were 16%, 50%, and 34%, respectively, whereas the rates for patients with dyslipidemia were 39%, 20%, and 41%.
Only 25% of patients who did not have diabetic nephropathy at the time of surgery went on to develop the condition. Among patients with preoperative microalbuminuria, 42% remained stable whereas 58% regressed and had no albuminuria 5 years after surgery. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years.*
There were no preoperative differences in the mean urinary albumin to creatinine ratio (ACR) between patients who were and patients who were not prescribed a renoprotective agent. However, postoperatively, patients who were not on a renoprotective agent had a significantly lower urinary ACR, compared with those who remained on a renoprotective agent (P = .039). "This probably reflects the fact that patients who had improvement of their diabetes and regression or nonprogression of their nephropathy status also had a significant improvement in – or remission of – hypertension, and were no longer prescribed an antihypertensive medication," Dr. Heneghan explained.
She characterized the study’s overall findings as "remarkable, considering that diabetes is a chronic, progressive disease, and certainly warrant further investigation in the form of a prospective and larger study."
Dr. Heneghan said that she had no relevant financial conflicts to disclose.
*CORRECTION 8/28/12: The original sentence contained an error in describing the patients. The sentence should read" "Similarly, among patients with preoperative macroalbuminuria, 50% remained stable and 50% regressed and had no albuminuria at 5 years."
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Major Finding: Among patients with preoperative microalbuminuria, 42% remained stable 5 years after their bariatric surgery, whereas 58% regressed and had no albuminuria. Similarly, among patients with preoperative macroalbuminuria, 50% remained stable, and 50% regressed and had no albuminuria at 5 years.
Data Source: The study included 52 patients who underwent bariatric surgery at the Cleveland Clinic and had completed the 5-year follow-up.
Disclosures: Dr. Heneghan said that she had no relevant financial conflicts to disclose.
BOLD Analysis Backs Safety of Sleeve Gastrectomy
SAN DIEGO – Laparoscopic sleeve gastrectomy is positioned between gastric banding and the laparoscopic gastric bypass for both safety and efficacy, results from the largest comparative study of its kind demonstrated.
The finding comes at a time when the Centers for Medicare and Medicaid Services is reviewing evidence to consider including sleeve gastrectomy as a covered benefit. Currently, gastric bypass, vertical banded gastroplasty, duodenal switch, and gastric banding are the only CMS-sanctioned bariatric procedures.
The study, which involved nearly 300,000 patients, "shows that across the board, regardless of the procedure, bariatric surgery is safe and effective," Dr. John M. Morton said in an interview at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "The emerging new procedure, the sleeve gastrectomy, is shown to be right between the bypass and the band. As a result, we have seen more interest from payers to cover it. In fact there are about 100 million lives that are covered. Our only outlier is CMS in deciding to cover. We hope that these data will help influence CMS in granting coverage for the sleeve gastrectomy."
Dr. Morton, associate professor of surgery and director of bariatric surgery at Stanford Hospitals and Clinics at Stanford (Calif.) University, and his associates examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRNYGB), gastric banding (LAGB), and sleeve gastrectomy (LSG) from June 2007 to December 2010. BOLD, the largest bariatric-specific database, is maintained by the ASMBS Bariatric Surgery Center of Excellence program, and includes more than 1,200 surgeons at 540 hospitals. Dr. Morton described the data as a "clinically rich" variable set that includes age, gender, race, insurance status, body mass index, excess body weight, and comorbidities.
"There is a definite need for more data around comparison of different procedures," Dr. Morton said at the meeting. "Our study hypothesis is very straightforward: Do demographics and outcomes for bariatric surgery vary by procedure?"
The primary outcomes were 30-day mortality, serious complications, and readmissions. The definitions of serious complications included death, anastomotic leakage, cardiac arrest, deep venous thrombosis, evisceration, heart failure and/or pulmonary edema, liver failure, and bleeding requiring transfusion.
Dr. Morton reported outcomes from 117,365 patients in the LAGB group, 138,222 in the LRNYGB group, and 16,139 in the LSG group. Patients in each group were generally the same age (a mean of 45, 46, and 45 years, respectively), mostly female (78%, 79%, and 74%), and mostly white (72%, 73%, and 72%). "The one area where there was a sizable difference was around self-pay," Dr. Morton said. About 21% of patients in the LSG group paid out-of-pocket, compared with 6% of those in the LAGB group and 2% of those in the LRNYGB group.
The proportion of preoperative comorbidities was similar among the three groups, with two exceptions. The prevalence of diabetes was highest in the LRNYGB group (37%, compared with 30% in the LSG group and 28% in the LAGB group; P less than .0001). A similar association was seen in the proportion of patients with five or more preoperative comorbidities (62%, 55%, and 52%, respectively; P less than .0001).
The mean length of stay was 0.7 days for the LAGB group, 1.9 days for the LSG group, and 2.3 days for the LRNYGB group. The percent change in BMI at 12 months was 7.6%, 13.4%, and 16.4%, respectively; the rate of 30-day serious complications was 0.25%, 0.96%, and 1.25%; and the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%. All differences between the groups were significant (P less than .0001).
"If you look at the remainder of the safety outcomes – everything from 30-day readmission to 30-day reoperation – it’s pretty much the same order, with the band group having the lowest [percentage], and the bypass having the highest, and the sleeve being right in between," Dr. Morton said. "When we looked at age greater than 65 in isolation, we found that the order of safety remains, with the banding having the least amount of mortality and the sleeve being right between the band procedure and the bypass."
Logistic regression analysis revealed several significant factors that predicted serious adverse events at 30 days: male gender (odds ratio, 1.67), having nonprivate insurance (OR, 1.15), stepwise progression with increasing age (for example, an OR of 1.27 for those aged 26-35 years and an OR of 4.42 for those above age 65), and stepwise progression with increasing BMI (for example, an OR of 1.37 for those with a BMI of 46-55 kg/m2 and an OR of 3.03 for those with a BMI greater than 65).
The invited discussant, Dr. Matthew M. Hutter, of Massachusetts General Hospital, Boston, described the size of the overall study cohort as remarkable. "What I find most interesting about this study is that it shows that sleeve gastrectomy – a brand-new, very complex procedure – can be introduced safely and effectively when performed under the standards of a bariatric accreditation program," Dr. Hutter said. "Other surgical procedures such as laparoscopic cholecystectomy or laparoscopic colectomy had very high morbidity and conversion rates when they were first implemented. However, this new complex procedure has been safe and effective from the get-go, and that is really quite impressive. The other remarkable finding is how consistent this is with all of the other major [bariatric surgery] data collection programs."
Dr. Morton acknowledged certain limitations of the study, including the fact that 1-year follow-up was available in only 60% of patients, while 30-day follow-up was available in 98% of the cohort. "Potentially, patients could have been admitted to other hospitals," he added. "These are research-consented patients, so about 70% consented. Some of this is surgeon-directed reporting."
Dr. Morton said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Laparoscopic sleeve gastrectomy is positioned between gastric banding and the laparoscopic gastric bypass for both safety and efficacy, results from the largest comparative study of its kind demonstrated.
The finding comes at a time when the Centers for Medicare and Medicaid Services is reviewing evidence to consider including sleeve gastrectomy as a covered benefit. Currently, gastric bypass, vertical banded gastroplasty, duodenal switch, and gastric banding are the only CMS-sanctioned bariatric procedures.
The study, which involved nearly 300,000 patients, "shows that across the board, regardless of the procedure, bariatric surgery is safe and effective," Dr. John M. Morton said in an interview at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "The emerging new procedure, the sleeve gastrectomy, is shown to be right between the bypass and the band. As a result, we have seen more interest from payers to cover it. In fact there are about 100 million lives that are covered. Our only outlier is CMS in deciding to cover. We hope that these data will help influence CMS in granting coverage for the sleeve gastrectomy."
Dr. Morton, associate professor of surgery and director of bariatric surgery at Stanford Hospitals and Clinics at Stanford (Calif.) University, and his associates examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRNYGB), gastric banding (LAGB), and sleeve gastrectomy (LSG) from June 2007 to December 2010. BOLD, the largest bariatric-specific database, is maintained by the ASMBS Bariatric Surgery Center of Excellence program, and includes more than 1,200 surgeons at 540 hospitals. Dr. Morton described the data as a "clinically rich" variable set that includes age, gender, race, insurance status, body mass index, excess body weight, and comorbidities.
"There is a definite need for more data around comparison of different procedures," Dr. Morton said at the meeting. "Our study hypothesis is very straightforward: Do demographics and outcomes for bariatric surgery vary by procedure?"
The primary outcomes were 30-day mortality, serious complications, and readmissions. The definitions of serious complications included death, anastomotic leakage, cardiac arrest, deep venous thrombosis, evisceration, heart failure and/or pulmonary edema, liver failure, and bleeding requiring transfusion.
Dr. Morton reported outcomes from 117,365 patients in the LAGB group, 138,222 in the LRNYGB group, and 16,139 in the LSG group. Patients in each group were generally the same age (a mean of 45, 46, and 45 years, respectively), mostly female (78%, 79%, and 74%), and mostly white (72%, 73%, and 72%). "The one area where there was a sizable difference was around self-pay," Dr. Morton said. About 21% of patients in the LSG group paid out-of-pocket, compared with 6% of those in the LAGB group and 2% of those in the LRNYGB group.
The proportion of preoperative comorbidities was similar among the three groups, with two exceptions. The prevalence of diabetes was highest in the LRNYGB group (37%, compared with 30% in the LSG group and 28% in the LAGB group; P less than .0001). A similar association was seen in the proportion of patients with five or more preoperative comorbidities (62%, 55%, and 52%, respectively; P less than .0001).
The mean length of stay was 0.7 days for the LAGB group, 1.9 days for the LSG group, and 2.3 days for the LRNYGB group. The percent change in BMI at 12 months was 7.6%, 13.4%, and 16.4%, respectively; the rate of 30-day serious complications was 0.25%, 0.96%, and 1.25%; and the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%. All differences between the groups were significant (P less than .0001).
"If you look at the remainder of the safety outcomes – everything from 30-day readmission to 30-day reoperation – it’s pretty much the same order, with the band group having the lowest [percentage], and the bypass having the highest, and the sleeve being right in between," Dr. Morton said. "When we looked at age greater than 65 in isolation, we found that the order of safety remains, with the banding having the least amount of mortality and the sleeve being right between the band procedure and the bypass."
Logistic regression analysis revealed several significant factors that predicted serious adverse events at 30 days: male gender (odds ratio, 1.67), having nonprivate insurance (OR, 1.15), stepwise progression with increasing age (for example, an OR of 1.27 for those aged 26-35 years and an OR of 4.42 for those above age 65), and stepwise progression with increasing BMI (for example, an OR of 1.37 for those with a BMI of 46-55 kg/m2 and an OR of 3.03 for those with a BMI greater than 65).
The invited discussant, Dr. Matthew M. Hutter, of Massachusetts General Hospital, Boston, described the size of the overall study cohort as remarkable. "What I find most interesting about this study is that it shows that sleeve gastrectomy – a brand-new, very complex procedure – can be introduced safely and effectively when performed under the standards of a bariatric accreditation program," Dr. Hutter said. "Other surgical procedures such as laparoscopic cholecystectomy or laparoscopic colectomy had very high morbidity and conversion rates when they were first implemented. However, this new complex procedure has been safe and effective from the get-go, and that is really quite impressive. The other remarkable finding is how consistent this is with all of the other major [bariatric surgery] data collection programs."
Dr. Morton acknowledged certain limitations of the study, including the fact that 1-year follow-up was available in only 60% of patients, while 30-day follow-up was available in 98% of the cohort. "Potentially, patients could have been admitted to other hospitals," he added. "These are research-consented patients, so about 70% consented. Some of this is surgeon-directed reporting."
Dr. Morton said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Laparoscopic sleeve gastrectomy is positioned between gastric banding and the laparoscopic gastric bypass for both safety and efficacy, results from the largest comparative study of its kind demonstrated.
The finding comes at a time when the Centers for Medicare and Medicaid Services is reviewing evidence to consider including sleeve gastrectomy as a covered benefit. Currently, gastric bypass, vertical banded gastroplasty, duodenal switch, and gastric banding are the only CMS-sanctioned bariatric procedures.
The study, which involved nearly 300,000 patients, "shows that across the board, regardless of the procedure, bariatric surgery is safe and effective," Dr. John M. Morton said in an interview at the annual meeting of the American Society for Metabolic and Bariatric Surgery. "The emerging new procedure, the sleeve gastrectomy, is shown to be right between the bypass and the band. As a result, we have seen more interest from payers to cover it. In fact there are about 100 million lives that are covered. Our only outlier is CMS in deciding to cover. We hope that these data will help influence CMS in granting coverage for the sleeve gastrectomy."
Dr. Morton, associate professor of surgery and director of bariatric surgery at Stanford Hospitals and Clinics at Stanford (Calif.) University, and his associates examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone laparoscopic Roux-en-Y gastric bypass (LRNYGB), gastric banding (LAGB), and sleeve gastrectomy (LSG) from June 2007 to December 2010. BOLD, the largest bariatric-specific database, is maintained by the ASMBS Bariatric Surgery Center of Excellence program, and includes more than 1,200 surgeons at 540 hospitals. Dr. Morton described the data as a "clinically rich" variable set that includes age, gender, race, insurance status, body mass index, excess body weight, and comorbidities.
"There is a definite need for more data around comparison of different procedures," Dr. Morton said at the meeting. "Our study hypothesis is very straightforward: Do demographics and outcomes for bariatric surgery vary by procedure?"
The primary outcomes were 30-day mortality, serious complications, and readmissions. The definitions of serious complications included death, anastomotic leakage, cardiac arrest, deep venous thrombosis, evisceration, heart failure and/or pulmonary edema, liver failure, and bleeding requiring transfusion.
Dr. Morton reported outcomes from 117,365 patients in the LAGB group, 138,222 in the LRNYGB group, and 16,139 in the LSG group. Patients in each group were generally the same age (a mean of 45, 46, and 45 years, respectively), mostly female (78%, 79%, and 74%), and mostly white (72%, 73%, and 72%). "The one area where there was a sizable difference was around self-pay," Dr. Morton said. About 21% of patients in the LSG group paid out-of-pocket, compared with 6% of those in the LAGB group and 2% of those in the LRNYGB group.
The proportion of preoperative comorbidities was similar among the three groups, with two exceptions. The prevalence of diabetes was highest in the LRNYGB group (37%, compared with 30% in the LSG group and 28% in the LAGB group; P less than .0001). A similar association was seen in the proportion of patients with five or more preoperative comorbidities (62%, 55%, and 52%, respectively; P less than .0001).
The mean length of stay was 0.7 days for the LAGB group, 1.9 days for the LSG group, and 2.3 days for the LRNYGB group. The percent change in BMI at 12 months was 7.6%, 13.4%, and 16.4%, respectively; the rate of 30-day serious complications was 0.25%, 0.96%, and 1.25%; and the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%. All differences between the groups were significant (P less than .0001).
"If you look at the remainder of the safety outcomes – everything from 30-day readmission to 30-day reoperation – it’s pretty much the same order, with the band group having the lowest [percentage], and the bypass having the highest, and the sleeve being right in between," Dr. Morton said. "When we looked at age greater than 65 in isolation, we found that the order of safety remains, with the banding having the least amount of mortality and the sleeve being right between the band procedure and the bypass."
Logistic regression analysis revealed several significant factors that predicted serious adverse events at 30 days: male gender (odds ratio, 1.67), having nonprivate insurance (OR, 1.15), stepwise progression with increasing age (for example, an OR of 1.27 for those aged 26-35 years and an OR of 4.42 for those above age 65), and stepwise progression with increasing BMI (for example, an OR of 1.37 for those with a BMI of 46-55 kg/m2 and an OR of 3.03 for those with a BMI greater than 65).
The invited discussant, Dr. Matthew M. Hutter, of Massachusetts General Hospital, Boston, described the size of the overall study cohort as remarkable. "What I find most interesting about this study is that it shows that sleeve gastrectomy – a brand-new, very complex procedure – can be introduced safely and effectively when performed under the standards of a bariatric accreditation program," Dr. Hutter said. "Other surgical procedures such as laparoscopic cholecystectomy or laparoscopic colectomy had very high morbidity and conversion rates when they were first implemented. However, this new complex procedure has been safe and effective from the get-go, and that is really quite impressive. The other remarkable finding is how consistent this is with all of the other major [bariatric surgery] data collection programs."
Dr. Morton acknowledged certain limitations of the study, including the fact that 1-year follow-up was available in only 60% of patients, while 30-day follow-up was available in 98% of the cohort. "Potentially, patients could have been admitted to other hospitals," he added. "These are research-consented patients, so about 70% consented. Some of this is surgeon-directed reporting."
Dr. Morton said that he had no relevant financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Major Finding: The rate of 30-day serious complications was 0.25% among those who underwent laparoscopic gastric banding, 0.96% among those who underwent laparoscopic sleeve gastrectomy, and 1.25% among those who underwent laparoscopic Roux-en-Y gastric bypass, while the rate of 30-day mortality was 0.03%, 0.08%, and 0.14%, respectively.
Data Source: The data analysis was based on 271,726 patients from the Bariatric Outcomes Longitudinal Database who underwent bariatric surgery from June 2007 to December 2010.
Disclosures: Dr. Morton said that he had no relevant financial conflicts to disclose.
Race, Sex Factor Into Weight Loss After Gastric Bypass
SAN DIEGO – Being black, male, or older significantly raised the risk for weight-loss failure after gastric bypass in a single-center study of more than 1,200 patients.
"Long-term treatments of obesity are hampered by the fixed behaviors that induce obesity, the possibility of weight set points, and the ever-present exposure to high-calorie foods. The treatments of obesity all have great variability in outcome," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
To determine predictors of weight-loss failure after gastric bypass surgery, Dr. Dallal and his associate at the department of surgery at Einstein Healthcare Network, Philadelphia, reviewed the medical records of 1,256 gastric bypass patients who had a least 1 year of follow-up. They separated patients into two groups: those who were above the 75th percentile in weight loss (success) and those who were below the 25th percentile in weight loss (failure). Multivariate logistic regression was performed to examine the impact of sex, race, age, initial weight, initial glycosylated hemoglobin (HbA1c) level, and insurance type (Medicare/Medicaid vs. private insurance).
The mean preoperative body mass index of the 1,256 patients was 48.3 kg/m2, their mean age was 42 years, and 82% were women. More than one-quarter of patients (27%) had diabetes, and the mean HbA1c level was 6.6% in blacks and 6.3% in whites. The majority of patients (75%) had private insurance, 19% were on Medicare, and 6% were on Medicaid.
Dr. Dallal reported that after a mean follow-up period of 665 days, the mean excess weight loss among all patients was 70%, and was significantly different between whites and blacks (72% vs. 63%, respectively), between those aged 65 years and older and those younger than age 40 (61% vs. 71%), and between men and women (62% vs. 71%). The calculated threshold estimated weight loss for the upper 75th and lower 25th percentiles was 82% vs. 57%, respectively.
Multivariate logistic regression analysis revealed the following independent predictors of weight-loss failure: being black (odds ratio, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having a higher initial body weight (OR, 0.86; P less than .0005). Initial HbA1c and insurance type were not independent predictors of weight-loss failure.
Dr. Dallal acknowledged certain limitations of the study, including the fact that the ideal body weight calculations used "may not necessarily be valid for all ethnicities. Also, we did not distinguish between primary weight-loss failures (those who never reached adequate weight loss) and those [who had] a secondary weight-loss failure (regain of lost weight)."
Dr. Dallal said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Being black, male, or older significantly raised the risk for weight-loss failure after gastric bypass in a single-center study of more than 1,200 patients.
"Long-term treatments of obesity are hampered by the fixed behaviors that induce obesity, the possibility of weight set points, and the ever-present exposure to high-calorie foods. The treatments of obesity all have great variability in outcome," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
To determine predictors of weight-loss failure after gastric bypass surgery, Dr. Dallal and his associate at the department of surgery at Einstein Healthcare Network, Philadelphia, reviewed the medical records of 1,256 gastric bypass patients who had a least 1 year of follow-up. They separated patients into two groups: those who were above the 75th percentile in weight loss (success) and those who were below the 25th percentile in weight loss (failure). Multivariate logistic regression was performed to examine the impact of sex, race, age, initial weight, initial glycosylated hemoglobin (HbA1c) level, and insurance type (Medicare/Medicaid vs. private insurance).
The mean preoperative body mass index of the 1,256 patients was 48.3 kg/m2, their mean age was 42 years, and 82% were women. More than one-quarter of patients (27%) had diabetes, and the mean HbA1c level was 6.6% in blacks and 6.3% in whites. The majority of patients (75%) had private insurance, 19% were on Medicare, and 6% were on Medicaid.
Dr. Dallal reported that after a mean follow-up period of 665 days, the mean excess weight loss among all patients was 70%, and was significantly different between whites and blacks (72% vs. 63%, respectively), between those aged 65 years and older and those younger than age 40 (61% vs. 71%), and between men and women (62% vs. 71%). The calculated threshold estimated weight loss for the upper 75th and lower 25th percentiles was 82% vs. 57%, respectively.
Multivariate logistic regression analysis revealed the following independent predictors of weight-loss failure: being black (odds ratio, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having a higher initial body weight (OR, 0.86; P less than .0005). Initial HbA1c and insurance type were not independent predictors of weight-loss failure.
Dr. Dallal acknowledged certain limitations of the study, including the fact that the ideal body weight calculations used "may not necessarily be valid for all ethnicities. Also, we did not distinguish between primary weight-loss failures (those who never reached adequate weight loss) and those [who had] a secondary weight-loss failure (regain of lost weight)."
Dr. Dallal said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Being black, male, or older significantly raised the risk for weight-loss failure after gastric bypass in a single-center study of more than 1,200 patients.
"Long-term treatments of obesity are hampered by the fixed behaviors that induce obesity, the possibility of weight set points, and the ever-present exposure to high-calorie foods. The treatments of obesity all have great variability in outcome," Dr. Ramsey M. Dallal said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.
To determine predictors of weight-loss failure after gastric bypass surgery, Dr. Dallal and his associate at the department of surgery at Einstein Healthcare Network, Philadelphia, reviewed the medical records of 1,256 gastric bypass patients who had a least 1 year of follow-up. They separated patients into two groups: those who were above the 75th percentile in weight loss (success) and those who were below the 25th percentile in weight loss (failure). Multivariate logistic regression was performed to examine the impact of sex, race, age, initial weight, initial glycosylated hemoglobin (HbA1c) level, and insurance type (Medicare/Medicaid vs. private insurance).
The mean preoperative body mass index of the 1,256 patients was 48.3 kg/m2, their mean age was 42 years, and 82% were women. More than one-quarter of patients (27%) had diabetes, and the mean HbA1c level was 6.6% in blacks and 6.3% in whites. The majority of patients (75%) had private insurance, 19% were on Medicare, and 6% were on Medicaid.
Dr. Dallal reported that after a mean follow-up period of 665 days, the mean excess weight loss among all patients was 70%, and was significantly different between whites and blacks (72% vs. 63%, respectively), between those aged 65 years and older and those younger than age 40 (61% vs. 71%), and between men and women (62% vs. 71%). The calculated threshold estimated weight loss for the upper 75th and lower 25th percentiles was 82% vs. 57%, respectively.
Multivariate logistic regression analysis revealed the following independent predictors of weight-loss failure: being black (odds ratio, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having a higher initial body weight (OR, 0.86; P less than .0005). Initial HbA1c and insurance type were not independent predictors of weight-loss failure.
Dr. Dallal acknowledged certain limitations of the study, including the fact that the ideal body weight calculations used "may not necessarily be valid for all ethnicities. Also, we did not distinguish between primary weight-loss failures (those who never reached adequate weight loss) and those [who had] a secondary weight-loss failure (regain of lost weight)."
Dr. Dallal said that he had no relevant financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY
Major Finding: Following gastric bypass surgery, independent significant predictors of weight-loss failure were being black (OR, 3.1; P = .002), older (OR, 0.97; P = .001), or male (OR, 0.30; P less than .0005), and having higher initial body weight (OR, 0.86; P less than .0005).
Data Source: This single-center study comprised 1,256 gastric bypass patients who had a least 1 year of follow-up.
Disclosures: Dr. Dallal said that he had no relevant financial conflicts to disclose.
Type 2 Diabetes Re-Emerges After Bariatric Surgery
HOUSTON – One in five patients whose type 2 diabetes went into remission following gastric bypass surgery experienced disease re-emergence within 5 years postoperatively.
The likelihood of diabetes recurrence in this retrospective single-center study wasn’t affected by preoperative body mass index or the amount of weight regained postsurgically.
Indeed, the only significant risk factor for diabetes reemergence was a longer duration of type 2 diabetes preoperatively. Patients with a greater than 5-year preoperative history of the disease were 3.8-fold more likely to experience disease recurrence, according to Dr. Yessica Ramos of the Mayo Clinic Arizona, Scottsdale.
The clinical implication: "Early surgical intervention in the type 2 diabetic obese population may improve the durability of remission of type 2 diabetes," she said.
Dr. Ramos reported on 72 obese patients with type 2 diabetes who underwent Roux-en-Y gastric bypass at the Mayo Clinic Arizona during 2000-2007 for whom 5-year follow-up data were available. The patients’ mean preoperative body mass index was 45 kg/m2, with an average age of 49.5 years.
Sixty-six of the 72 patients (92%) experienced remission of their diabetes as defined by a hemoglobin A1c below 6.5% while off all antidiabetic medications. The other six patients had persistent type 2 diabetes throughout follow-up.
A total of 14 of 66 patients, or 21%, whose type 2 diabetes went into remission subsequently saw their disease return as defined by an HbA1c of 6.5% or more, a fasting blood glucose greater than 7 mmol/L, or use of antidiabetic drugs.
Diabetes returned as early as 2 years post surgery in five patients.
The explanation for the high rate of diabetes reemergence remains unclear. Retrospective studies of bariatric surgery patients are notoriously difficult because the surgery is often life changing and patients are frequently lost to follow-up.
Dr. Ramos’s working hypothesis is that patients with longer duration of type 2 diabetes are at a higher risk of recurrence because they have more compromised beta cell function. But definitive answers must await further reports from prospective randomized trials of surgery vs. medication as a treatment for type 2 diabetes in obese patients, such as the one reported from the Cleveland Clinic (N. Engl. J. Med. 2012;366:1567-76), or analysis of data from the large multicenter bariatric surgery registries.
Dr. Ramos reported having no financial conflicts.
HOUSTON – One in five patients whose type 2 diabetes went into remission following gastric bypass surgery experienced disease re-emergence within 5 years postoperatively.
The likelihood of diabetes recurrence in this retrospective single-center study wasn’t affected by preoperative body mass index or the amount of weight regained postsurgically.
Indeed, the only significant risk factor for diabetes reemergence was a longer duration of type 2 diabetes preoperatively. Patients with a greater than 5-year preoperative history of the disease were 3.8-fold more likely to experience disease recurrence, according to Dr. Yessica Ramos of the Mayo Clinic Arizona, Scottsdale.
The clinical implication: "Early surgical intervention in the type 2 diabetic obese population may improve the durability of remission of type 2 diabetes," she said.
Dr. Ramos reported on 72 obese patients with type 2 diabetes who underwent Roux-en-Y gastric bypass at the Mayo Clinic Arizona during 2000-2007 for whom 5-year follow-up data were available. The patients’ mean preoperative body mass index was 45 kg/m2, with an average age of 49.5 years.
Sixty-six of the 72 patients (92%) experienced remission of their diabetes as defined by a hemoglobin A1c below 6.5% while off all antidiabetic medications. The other six patients had persistent type 2 diabetes throughout follow-up.
A total of 14 of 66 patients, or 21%, whose type 2 diabetes went into remission subsequently saw their disease return as defined by an HbA1c of 6.5% or more, a fasting blood glucose greater than 7 mmol/L, or use of antidiabetic drugs.
Diabetes returned as early as 2 years post surgery in five patients.
The explanation for the high rate of diabetes reemergence remains unclear. Retrospective studies of bariatric surgery patients are notoriously difficult because the surgery is often life changing and patients are frequently lost to follow-up.
Dr. Ramos’s working hypothesis is that patients with longer duration of type 2 diabetes are at a higher risk of recurrence because they have more compromised beta cell function. But definitive answers must await further reports from prospective randomized trials of surgery vs. medication as a treatment for type 2 diabetes in obese patients, such as the one reported from the Cleveland Clinic (N. Engl. J. Med. 2012;366:1567-76), or analysis of data from the large multicenter bariatric surgery registries.
Dr. Ramos reported having no financial conflicts.
HOUSTON – One in five patients whose type 2 diabetes went into remission following gastric bypass surgery experienced disease re-emergence within 5 years postoperatively.
The likelihood of diabetes recurrence in this retrospective single-center study wasn’t affected by preoperative body mass index or the amount of weight regained postsurgically.
Indeed, the only significant risk factor for diabetes reemergence was a longer duration of type 2 diabetes preoperatively. Patients with a greater than 5-year preoperative history of the disease were 3.8-fold more likely to experience disease recurrence, according to Dr. Yessica Ramos of the Mayo Clinic Arizona, Scottsdale.
The clinical implication: "Early surgical intervention in the type 2 diabetic obese population may improve the durability of remission of type 2 diabetes," she said.
Dr. Ramos reported on 72 obese patients with type 2 diabetes who underwent Roux-en-Y gastric bypass at the Mayo Clinic Arizona during 2000-2007 for whom 5-year follow-up data were available. The patients’ mean preoperative body mass index was 45 kg/m2, with an average age of 49.5 years.
Sixty-six of the 72 patients (92%) experienced remission of their diabetes as defined by a hemoglobin A1c below 6.5% while off all antidiabetic medications. The other six patients had persistent type 2 diabetes throughout follow-up.
A total of 14 of 66 patients, or 21%, whose type 2 diabetes went into remission subsequently saw their disease return as defined by an HbA1c of 6.5% or more, a fasting blood glucose greater than 7 mmol/L, or use of antidiabetic drugs.
Diabetes returned as early as 2 years post surgery in five patients.
The explanation for the high rate of diabetes reemergence remains unclear. Retrospective studies of bariatric surgery patients are notoriously difficult because the surgery is often life changing and patients are frequently lost to follow-up.
Dr. Ramos’s working hypothesis is that patients with longer duration of type 2 diabetes are at a higher risk of recurrence because they have more compromised beta cell function. But definitive answers must await further reports from prospective randomized trials of surgery vs. medication as a treatment for type 2 diabetes in obese patients, such as the one reported from the Cleveland Clinic (N. Engl. J. Med. 2012;366:1567-76), or analysis of data from the large multicenter bariatric surgery registries.
Dr. Ramos reported having no financial conflicts.
AT THE ANNUAL MEETING OF THE ENDOCRINE SOCIETY
Major Finding: Twenty-one percent of obese patients with type 2 diabetes whose disease went into remission following gastric bypass surgery developed recurrent diabetes within 5 years post surgery.
Data Source: This was a retrospective study involving 72 patients with type 2 diabetes who underwent Roux-en-Y gastric bypass surgery at a single center and for whom 5-year follow-up data were available.
Disclosures: Dr. Ramos reported having no financial disclosures.