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Endoluminal procedures for bariatric patients: expectations among bariatric surgeons
Surgery for Obesity and Related Diseases 5 (2009) 231–236
Original article
Endoluminal procedures for bariatric patients: expectations among bariatric surgeons Stacy A. Brethauer, M.D.a,*, Aurora D. Pryor, M.D.b, Bipan Chand, M.D.a, Philip Schauer, M.D.a, Raul Rosenthal, M.D.c, William Richards, M.D.d, Marc Bessler, M.D.e, for the American Society for Metabolic and Bariatric Surgery Emerging Technologies Committee a
Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio Department of Surgery, Duke University School of Medicine, Durham, North Carolina c Bariatric Institute, Cleveland Clinic, Weston, Florida d Department of Surgery, Vanderbilt University Medical School, Nashville, Tennessee e Department of Surgery, New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York Received May 14, 2008; revised September 14, 2008; accepted September 24, 2008 b
Abstract
Background: Primary and revisional bariatric endoluminal procedures are currently being developed. Acceptable levels of risk and weight loss for these procedures have not yet been established. The aim of this study was to evaluate the expectations and concerns among bariatric surgeons regarding these procedures. Methods: The American Society for Metabolic and Bariatric Surgery Emerging Technologies Committee developed a questionnaire that was distributed to the membership. Risk tolerance was assessed with comparison to commonly performed endoscopic and bariatric procedures. The percentage of excess weight loss (EWL) ranges were provided to assess the expectations for results 1 year after the procedure. Results: A total of 214 responses were returned. The acceptable level of risk to achieve 10 –20% EWL after primary and revisional procedures was equivalent to, or less than, that of a therapeutic endoscopic procedure for 81% and 76% of respondents, respectively. The acceptable level of risk to achieve 30 – 40% EWL after primary and revisional procedures was equivalent to that after laparoscopic adjustable gastric banding for 45% and 35% of respondents, respectively and equivalent to that after laparoscopic Roux-en-Y gastric bypass for 8% and 22%, respectively. In addition, 62% of respondents responded that 10 –30% EWL would be acceptable for revisional procedures, and 35% responded that 10 –30% EWL would be acceptable after a primary procedure. The primary concern was unproven efficacy, followed by durability, poor weight loss, availability of equipment, and procedural risk. Finally, 58% would not be willing to recommend an endoluminal procedure until the efficacy has been established, regardless of the risk. Conclusion: Risk tolerance and weight loss expectations among bariatric surgeons are different for primary and revisional endoscopic procedures. Most surgeons were unwilling to consider endoluminal procedures for their patients until the efficacy has been proven. (Surg Obes Relat Dis 2009;5:231–236.) © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Endoluminal; Bariatric; Revision; Primary; Risk; Expectations
*Reprint requests: Stacy Brethauer, M.D., Bariatric and Metabolic Institute, Cleveland Clinic, 9500 Euclid Avenue, M61, Cleveland, OH 44195. E-mail: [email protected]
Many endoluminal bariatric procedures and technologies are currently being developed and tested [1–3]. Despite the enthusiasm among many bariatric surgeons, gastroenterologists, and industry regarding this emerging field, benchmarks have not been established regarding acceptable out-
1550-7289/09/$ – see front matter © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2008.09.019
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comes for these procedures. Additionally, the expectations regarding the outcomes after primary and revisional procedures could differ. The greater risk of complications after surgical revision for failed bariatric surgery [4 – 6] has been an important factor driving the development of less-invasive options for revisional procedures. The feasibility of several endoscopic treatments for weight regain after gastric bypass has been demonstrated. These therapies are designed to improve the degree of restriction by decreasing the gastric pouch or gastrojejunostomy size [7–10]. Large multicenter randomized trials are currently underway to assess the efficacy of these revisional procedures. Endoscopic management of early and late postoperative complications after bariatric surgery has also been reported [11–16]. These therapies could facilitate closure of fistulas and leaks and eliminate the need for more invasive surgical treatment. However, few data on the efficacy of these procedures are available. Primary endoscopic bariatric procedures are also being developed. The perceived risk of complications and death after bariatric surgery among primary care physicians is an important barrier for patients to receive appropriate care [17]. The development of lower risk endoscopic procedures to induce weight loss could have an important effect on referral patterns and patient access to bariatric surgeons. To date, there are a few series or single case reports of the early results of primary endoluminal bariatric procedures, and other studies are underway [18 –22]. The purpose of this study was to evaluate the expectations and concerns among bariatric surgeons regarding primary and revisional endoluminal bariatric procedures. Methods A questionnaire was developed by the American Society for Metabolic and Bariatric Surgery (ASMBS) Emerging Technologies Committee to assess bariatric surgeons’ expectations regarding risk and weight loss for endoluminal bariatric procedures. Primary procedures were defined as those procedures performed to induce weight loss in patients with no previous bariatric surgery. Revisional procedures were defined as those procedures intended to improve weight loss through gastric pouch or stomal reduction after gastric bypass. Risk levels were assessed with comparison to commonly performed endoscopic and bariatric procedures representing a continuum of procedural risk (i.e., diagnostic endoscopy, endoscopic polypectomy, endoscopic retrograde cholangiopancreatography [ERCP], laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass). Weight loss ranges were provided in terms of the percentage of excess weight loss (%EWL) 1 year after the procedure. The questionnaires were distributed to the ASMBS membership by a professional survey administration service, and the results were accessed directly and analyzed by the committee members.
Statistical analysis comparing the responses for primary and revisional procedures was performed using GraphPad InStat, version 3.00, for Windows 95 (GraphPad Software, San Diego, CA). Chi-square analysis or Fisher’s exact test was used to compare the groups, as appropriate. Differences were considered statistically significant at P ⬍.05. Results The questionnaires were sent electronically to 1301 ASMBS members. A total of 214 surveys (16%) were returned. Of the respondents, 69% had credentials to perform endoscopy and 52% performed endoscopic procedures regularly (average of ⱖ1–2/wk). For those who did not perform endoscopy, 91% referred their bariatric patients to a gastroenterologist for endoscopic procedures, and 9% referred their patients to another surgeon who performed endoscopy. Of the surgeons who did not perform endoscopy regularly, 70% stated they were interested in obtaining additional training to perform endoscopic and endoluminal bariatric procedures. Revisional procedures When asked “What level of risk would you be willing to accept for a revisional endoluminal bariatric procedure (i.e., anastomotic reduction) that achieves 10 –20% EWL 1 year after the procedure,” 76% of the respondents reported they would accept the risk equivalent to an endoscopic procedure (diagnostic or therapeutic), and only 24% reported they would be willing to accept the risk of laparoscopic banding or gastric bypass to achieve this degree of weight loss (Fig. 1). When the %EWL range was increased to 30 – 40% at 1 year after a revisional endoscopic procedure, 56% responded they would be willing to accept the risk of a laparoscopic bariatric procedure (Fig. 2). When asked “What %EWL would you accept as a good outcome 1 year after an endoscopic anastomotic reduction procedure for weight regain after gastric bypass,” 62% were
60 50
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9% 4%
0 Diagnostic Endoscopy
Endoscopic Polypectomy
ERCP
Laparoscopic Adjustable Gastric Banding
Laparoscopic Gastric Bypass
Equivalent Risk Procedure
Fig. 1. Graph showing responses to “What level of risk would you be willing to accept for revisional endoluminal bariatric procedure (i.e., anastomotic reduction) that achieves 10 –20% EWL at 1 year postoperatively?”
S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 5 (2009) 231–236
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40.5% 40
% Respondents 30
% Respondents 30
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0 Diagnostic Endoscopy
Endoscopic Polypectomy
ERCP
Laparoscopic Adjustable Gastric Banding
Diagnostic Endoscopy
Laparoscopic Gastric Bypass
Endoscopic Polypectomy
ERCP
Laparoscopic Laparoscopic Adjustable Gastric Bypass Gastric Banding
Equivalent Risk Procedure
Equivalent Risk Procedure
Fig. 2. Graph showing responses to “What level of risk would you be willing to accept for revisional endoluminal bariatric procedure (i.e., anastomotic reduction) that achieves 30 – 40% EWL at 1 year postoperatively?”
willing to accept 10 –30% EWL, and only 14% expected ⬎40% EWL (Fig. 3). Primary procedures When asked “What level of risk would you be willing to accept for an endoluminal bariatric procedure used as a primary weight loss procedure (e.g., endoluminal suturing, stapling, or plication) that achieves 10 –20% EWL at 1 year after the procedure,” 81% stated they would accept the risk equivalent to an endoscopic procedure (diagnostic or therapeutic) and only 19% would be willing to accept the risk of laparoscopic banding or gastric bypass to achieve this degree of weight loss (Fig. 4). When the %EWL was 10 –20%, no significant differences were found for the acceptable levels of risk between the primary and revisional groups. When the %EWL was increased to 30 – 40% at 1 year after a primary procedure, 53% stated they would be willing to accept the risk of a laparoscopic bariatric procedure (Fig. 5). Specifically, more respondents were willing to accept the risk equivalent to the laparoscopic band to achieve 30 – 40% EWL after a primary endoluminal procedure compared with after a revisional procedure (45% ver-
Fig. 4. Graph showing responses to “What level of risk would you be willing to accept for primary endoluminal bariatric procedure (e.g., endoluminal suturing, stapling, or plication) that achieves 10 –20% EWL at 1 year postoperatively?”
sus 35%, P ⫽ .04). Alternatively, more respondents reported they would be willing to accept the risk equivalent to laparoscopic gastric bypass for a revisional endoluminal procedure compared with a primary procedure for this degree of weight loss (22% versus 8%, P ⫽ .0002). When asked “What %EWL would you accept 1 year after a primary endoscopic bariatric procedure,” 35% were willing to accept 10 –30% EWL and 32% expected ⬎40% EWL (Fig. 6). The weight loss expectations were lower for revisional than for primary endoluminal procedures, with 64% of respondents expecting ⬎40% EWL after a primary endoluminal procedure and only 38% expecting this same degree of weight loss after a revisional endoluminal procedure (P ⬍.0001). Patients and concerns Of the respondents, 24% believed that primary endoluminal bariatric procedures should be performed only on patients who
60 40
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28%
% Respondents 30
25%
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% Respondents 20
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45%
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0 Diagnostic Endoscopy
Endoscopic Polypectomy
ERCP
Laparoscopic Laparoscopic Adjustable Gastric Bypass Gastric Banding
Equivalent Risk Procedure
% Excess Weight Loss
Fig. 3. Graph showing responses to “What %EWL would you accept as a good outcome 1 year after an endoscopic anastomotic reduction procedure performed for weight regain after gastric bypass?”
Fig. 5. Graph showing responses to “What level of risk would you be willing to accept for primary endoluminal bariatric procedure (e.g., endoluminal suturing, stapling, or plication) that achieves 30 – 40% EWL at 1 year postoperatively?”
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40 35
32%
30
26%
25 % Respondents 20
17%
16%
15 10 5 0
8% 1% <10%
10-20%
20-30%
30-40%
40-50
>50%
% Excess Weight Loss
Fig. 6. Graph showing responses to “What %EWL would you accept as a good outcome 1 year after a primary endoscopic bariatric procedure?”
meet the National Institutes of Health criteria for bariatric surgery (Fig. 7). However, 45% believed that the patient groups undergoing these procedures should include patients with a lower body mass index (BMI). In addition, 22% believed that a primary procedure should be performed only on high-risk patients (e.g., severe co-morbidities, BMI ⬎55 kg/m2) as a bridge to a surgical procedure. The greatest concern among respondents regarding the application of endoluminal procedures/devices for bariatric patients was the unproven efficacy followed by durability, poor weight loss, availability of equipment/training, and risk. Of the respondents, 68% agreed or strongly agreed that the effectiveness of a new procedure should be proved before they would consider using it on their patients and 58% would be unwilling to refer their bariatric patients a new procedure or device until the efficacy has been proved, regardless of the risk. Discussion The field of endoluminal bariatric surgery is currently in its infancy. Many obstacles need to be overcome before primary or revisional endoscopic bariatric procedures are widely accepted and used. Some of the challenges that lie ahead include establishing safety and durability through well-designed clinical trials, defining indications and appropriate patient groups to undergo these procedures, ensuring adequate training among those performing the procedures, and obtaining reimbursement for these procedures. The expectations regarding these procedures should be discussed early in the development of this field to better frame the discussions and debates regarding the success or failure of these new procedures. The questionnaire reported in the present study was designed to examine the expectations among bariatric surgeons regarding the acceptable risk and outcomes of endoluminal bariatric procedures. The Emerging Technologies Committee believed that risk stratification compared with procedures that are commonly performed today would be an appropriate method of evaluating the opinions and differentiating between
primary and revisional endoluminal procedures. Weight loss ranges were provided that would reasonably differentiate the expectations between primary and revisional endoluminal procedures. Three studies to date have reported on the short-term results of primary endoscopic gastroplasty procedures. Using a transoral endoscopically guided stapler to create a vertical gastroplasty, Deviere et al. [18] reported a 24% EWL at 6 months after the procedure in 21 patients who had a mean preprocedure BMI of 43 kg/m2. No serious adverse events occurred. The most common procedure or device-related adverse events were pain (n ⫽ 13), vomiting (n ⫽ 7), nausea (n ⫽ 6), and dysphagia (n ⫽ 6). With the exception of 1 patient who had dysphagia for 18 days, all these symptoms had resolved within 1 week after the procedure. In the second human trial using the same device, Moreno et al. [22] reported a 46% EWL 6 months after the procedure and reported no serious adverse events. Fogel et al. [19] performed endoscopic vertical sutured gastroplasty in 64 patients who had a mean BMI of 40 kg/m2 (range 28 – 60). Two patients reported transient heartburn symptoms, and one vomited in the recovery room, but no serious complications occurred. At 1 year after the procedure, patients had lost an average of 58% EWL. The subgroup of patients with a preprocedure BMI of ⬍35 kg/m2 had an 85% EWL at 12 months after the procedure. The early results of an endoscopically placed duodenaljejunal bypass sleeve have also been reported [20,21]. The device was left in place for 3 months in 12 patients with an average preprocedure BMI of 43 kg/m2. No device-related severe adverse events occurred. Two patients had the device removed at 9 days because of abdominal pain. The average %EWL for the 10 patients who completed the study was 23.6%. All 10 patients who completed the study achieved ⱖ10% EWL [21]. The cause of weight regain after gastric bypass is poorly understood, and this problem is likely multifactorial. It has not been clearly established that pouch or stoma enlarge-
Fig. 7. Graph showing responses to “Primary endoluminal bariatric procedures should be performed on which group of patients?” NIH ⫽ National Institutes of Health.
S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 5 (2009) 231–236
ment is solely responsible for weight regain after gastric bypass, and behavioral issues might play an important role in this problem. Nevertheless, procedures designed to improve the restrictive component of the operation through pouch or stoma reduction are being performed and investigated. Surgical revision of gastric bypass carries a significant risk for the patient, and endoscopic therapy provides a potentially safer alternative. Sclerotherapy, anastomotic suturing, and plication of the pouch have all been performed safely and have shown some promise in terms of early weight loss [7–10,15]. Additional studies are necessary to establish the durability, and several randomized trials are currently underway in the United States. The results of this study have shown that, among the membership of the ASMBS who responded to this survey, surgeons are willing to accept greater risk and lower weight loss for revisional endoluminal procedures compared with primary endoluminal procedures. Most surgeons who do not perform endoscopy expressed interest in obtaining additional endoscopic training. As these endoluminal technologies are developed, a greater emphasis on training bariatric surgeons in basic and advanced endoscopic techniques will be necessary. The development of guidelines by the Emerging Technologies Committee and the ASMBS for this type of training will be important to ensure patient safety as these technologies become widely available. Most surgeons responding to the questionnaire expected ⬎30% EWL after a primary endoluminal procedure and 16% expected ⬎50% EWL. The acceptable level of risk for a primary endoluminal procedure (achieving 30 – 40% EWL at 1 year) was equivalent to that of laparoscopic adjustable gastric banding or a therapeutic endoscopic procedure such as ERCP. Although only 8% were willing to accept the risk equivalent to that of laparoscopic gastric bypass for 30 – 40% EWL after primary therapy, 22% were willing to accept this level of risk for the same result after a revisional endoscopic procedure. The main concerns among surgeons who responded to this questionnaire regarding these procedures were durability and efficacy, and these remain the focus of ongoing clinical investigations. Most respondents were unwilling to perform or refer patients for these procedures until the efficacy has been established. This finding is concerning, because the early adoption of these procedures by more bariatric surgeons as a part of prospective studies will provide the cumulative experience necessary for the safe and proper development of these technologies. One issue not included in this questionnaire was whether it would be acceptable for patients to need annual endoscopic revision or “touch up” procedures to maintain the durability of gastric suturing or stapling. Although this would increase the cost and compliance issues, it might represent a realistic scenario for some of these procedures. Risk was the lowest concern for these procedures, and this might be because of
235
the published data that have already established the safety for some of these devices. The ideal patient group for primary endoluminal procedures has yet to be defined. No clear consensus was reached among the respondents regarding the group of patients who should undergo primary endoluminal bariatric procedures. As successful outcomes are demonstrated in patients who met the current National Institutes of Health criteria for bariatric surgery, the indications will likely expand to specific groups of patients. The present study had several limitations. First, the questions were not validated or scientifically formulated but were simply an attempt by the Committee to gain some insight into the perceptions, expectations, and concerns regarding endoluminal therapies among bariatric surgeons. Additionally, the questionnaire did not have the respondents quantify the perceived risk associated with the procedures used for comparison. The continuum of risk from diagnostic endoscopy and therapeutic endoscopy to laparoscopic banding and gastric bypass that was presented was believed by the Committee to represent a progressive level of risk. In certain cases, however, ERCP with sphincterotomy might involve a greater risk of morbidity than a laparoscopic bariatric procedure. Therefore, it is possible that some respondents underestimated the risk of ERCP and overestimated the risk of laparoscopic gastric bypass on the basis of their clinical experience. Second, the data we have reported might not be representative of the bariatric surgery community as a whole. The response rate of 16% to this survey suggest a low level of interest in endoluminal therapy among the nonresponders at present, and these surgeons might have had different expectations for these procedures. Finally, we were not able to discern from the survey results the differences in responses between respondents who performed endoscopy regularly and those who did not. This might have provided some additional insight into how the endoscopic expertise of the respondent affected their expectations.
Conclusion The results of this study have shown that the risk tolerance and weight loss expectations among bariatric surgeons are different for primary and revisional endoscopic procedures. The respondents were willing to accept less weight loss and more risk for revisional endoluminal procedures than for primary endoluminal procedures. The durability of these procedures was a chief concern. Most surgeons were unwilling to consider endoluminal procedures for their patients until the efficacy has been proved. The expectations and concerns among bariatric surgeons regarding endoluminal therapy need to be periodically re-assessed as this field evolves.
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Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article.
[11]
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Original article
Endoluminal procedures for bariatric patients: expectations among bariatric surgeons Stacy A. Brethauer, M.D.a,*, Aurora D. Pryor, M.D.b, Bipan Chand, M.D.a, Philip Schauer, M.D.a, Raul Rosenthal, M.D.c, William Richards, M.D.d, Marc Bessler, M.D.e, for the American Society for Metabolic and Bariatric Surgery Emerging Technologies Committee a
Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio Department of Surgery, Duke University School of Medicine, Durham, North Carolina c Bariatric Institute, Cleveland Clinic, Weston, Florida d Department of Surgery, Vanderbilt University Medical School, Nashville, Tennessee e Department of Surgery, New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York Received May 14, 2008; revised September 14, 2008; accepted September 24, 2008 b
Abstract
Background: Primary and revisional bariatric endoluminal procedures are currently being developed. Acceptable levels of risk and weight loss for these procedures have not yet been established. The aim of this study was to evaluate the expectations and concerns among bariatric surgeons regarding these procedures. Methods: The American Society for Metabolic and Bariatric Surgery Emerging Technologies Committee developed a questionnaire that was distributed to the membership. Risk tolerance was assessed with comparison to commonly performed endoscopic and bariatric procedures. The percentage of excess weight loss (EWL) ranges were provided to assess the expectations for results 1 year after the procedure. Results: A total of 214 responses were returned. The acceptable level of risk to achieve 10 –20% EWL after primary and revisional procedures was equivalent to, or less than, that of a therapeutic endoscopic procedure for 81% and 76% of respondents, respectively. The acceptable level of risk to achieve 30 – 40% EWL after primary and revisional procedures was equivalent to that after laparoscopic adjustable gastric banding for 45% and 35% of respondents, respectively and equivalent to that after laparoscopic Roux-en-Y gastric bypass for 8% and 22%, respectively. In addition, 62% of respondents responded that 10 –30% EWL would be acceptable for revisional procedures, and 35% responded that 10 –30% EWL would be acceptable after a primary procedure. The primary concern was unproven efficacy, followed by durability, poor weight loss, availability of equipment, and procedural risk. Finally, 58% would not be willing to recommend an endoluminal procedure until the efficacy has been established, regardless of the risk. Conclusion: Risk tolerance and weight loss expectations among bariatric surgeons are different for primary and revisional endoscopic procedures. Most surgeons were unwilling to consider endoluminal procedures for their patients until the efficacy has been proven. (Surg Obes Relat Dis 2009;5:231–236.) © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Endoluminal; Bariatric; Revision; Primary; Risk; Expectations
*Reprint requests: Stacy Brethauer, M.D., Bariatric and Metabolic Institute, Cleveland Clinic, 9500 Euclid Avenue, M61, Cleveland, OH 44195. E-mail: [email protected]
Many endoluminal bariatric procedures and technologies are currently being developed and tested [1–3]. Despite the enthusiasm among many bariatric surgeons, gastroenterologists, and industry regarding this emerging field, benchmarks have not been established regarding acceptable out-
1550-7289/09/$ – see front matter © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2008.09.019
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S. A. Brethauer et al. / Surgery for Obesity and Related Diseases 5 (2009) 231–236
comes for these procedures. Additionally, the expectations regarding the outcomes after primary and revisional procedures could differ. The greater risk of complications after surgical revision for failed bariatric surgery [4 – 6] has been an important factor driving the development of less-invasive options for revisional procedures. The feasibility of several endoscopic treatments for weight regain after gastric bypass has been demonstrated. These therapies are designed to improve the degree of restriction by decreasing the gastric pouch or gastrojejunostomy size [7–10]. Large multicenter randomized trials are currently underway to assess the efficacy of these revisional procedures. Endoscopic management of early and late postoperative complications after bariatric surgery has also been reported [11–16]. These therapies could facilitate closure of fistulas and leaks and eliminate the need for more invasive surgical treatment. However, few data on the efficacy of these procedures are available. Primary endoscopic bariatric procedures are also being developed. The perceived risk of complications and death after bariatric surgery among primary care physicians is an important barrier for patients to receive appropriate care [17]. The development of lower risk endoscopic procedures to induce weight loss could have an important effect on referral patterns and patient access to bariatric surgeons. To date, there are a few series or single case reports of the early results of primary endoluminal bariatric procedures, and other studies are underway [18 –22]. The purpose of this study was to evaluate the expectations and concerns among bariatric surgeons regarding primary and revisional endoluminal bariatric procedures. Methods A questionnaire was developed by the American Society for Metabolic and Bariatric Surgery (ASMBS) Emerging Technologies Committee to assess bariatric surgeons’ expectations regarding risk and weight loss for endoluminal bariatric procedures. Primary procedures were defined as those procedures performed to induce weight loss in patients with no previous bariatric surgery. Revisional procedures were defined as those procedures intended to improve weight loss through gastric pouch or stomal reduction after gastric bypass. Risk levels were assessed with comparison to commonly performed endoscopic and bariatric procedures representing a continuum of procedural risk (i.e., diagnostic endoscopy, endoscopic polypectomy, endoscopic retrograde cholangiopancreatography [ERCP], laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass). Weight loss ranges were provided in terms of the percentage of excess weight loss (%EWL) 1 year after the procedure. The questionnaires were distributed to the ASMBS membership by a professional survey administration service, and the results were accessed directly and analyzed by the committee members.
Statistical analysis comparing the responses for primary and revisional procedures was performed using GraphPad InStat, version 3.00, for Windows 95 (GraphPad Software, San Diego, CA). Chi-square analysis or Fisher’s exact test was used to compare the groups, as appropriate. Differences were considered statistically significant at P ⬍.05. Results The questionnaires were sent electronically to 1301 ASMBS members. A total of 214 surveys (16%) were returned. Of the respondents, 69% had credentials to perform endoscopy and 52% performed endoscopic procedures regularly (average of ⱖ1–2/wk). For those who did not perform endoscopy, 91% referred their bariatric patients to a gastroenterologist for endoscopic procedures, and 9% referred their patients to another surgeon who performed endoscopy. Of the surgeons who did not perform endoscopy regularly, 70% stated they were interested in obtaining additional training to perform endoscopic and endoluminal bariatric procedures. Revisional procedures When asked “What level of risk would you be willing to accept for a revisional endoluminal bariatric procedure (i.e., anastomotic reduction) that achieves 10 –20% EWL 1 year after the procedure,” 76% of the respondents reported they would accept the risk equivalent to an endoscopic procedure (diagnostic or therapeutic), and only 24% reported they would be willing to accept the risk of laparoscopic banding or gastric bypass to achieve this degree of weight loss (Fig. 1). When the %EWL range was increased to 30 – 40% at 1 year after a revisional endoscopic procedure, 56% responded they would be willing to accept the risk of a laparoscopic bariatric procedure (Fig. 2). When asked “What %EWL would you accept as a good outcome 1 year after an endoscopic anastomotic reduction procedure for weight regain after gastric bypass,” 62% were
60 50
44%
40 % Respondents 30 23% 20%
20 10
9% 4%
0 Diagnostic Endoscopy
Endoscopic Polypectomy
ERCP
Laparoscopic Adjustable Gastric Banding
Laparoscopic Gastric Bypass
Equivalent Risk Procedure
Fig. 1. Graph showing responses to “What level of risk would you be willing to accept for revisional endoluminal bariatric procedure (i.e., anastomotic reduction) that achieves 10 –20% EWL at 1 year postoperatively?”
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% Respondents 30
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0 Diagnostic Endoscopy
Endoscopic Polypectomy
ERCP
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Diagnostic Endoscopy
Laparoscopic Gastric Bypass
Endoscopic Polypectomy
ERCP
Laparoscopic Laparoscopic Adjustable Gastric Bypass Gastric Banding
Equivalent Risk Procedure
Equivalent Risk Procedure
Fig. 2. Graph showing responses to “What level of risk would you be willing to accept for revisional endoluminal bariatric procedure (i.e., anastomotic reduction) that achieves 30 – 40% EWL at 1 year postoperatively?”
willing to accept 10 –30% EWL, and only 14% expected ⬎40% EWL (Fig. 3). Primary procedures When asked “What level of risk would you be willing to accept for an endoluminal bariatric procedure used as a primary weight loss procedure (e.g., endoluminal suturing, stapling, or plication) that achieves 10 –20% EWL at 1 year after the procedure,” 81% stated they would accept the risk equivalent to an endoscopic procedure (diagnostic or therapeutic) and only 19% would be willing to accept the risk of laparoscopic banding or gastric bypass to achieve this degree of weight loss (Fig. 4). When the %EWL was 10 –20%, no significant differences were found for the acceptable levels of risk between the primary and revisional groups. When the %EWL was increased to 30 – 40% at 1 year after a primary procedure, 53% stated they would be willing to accept the risk of a laparoscopic bariatric procedure (Fig. 5). Specifically, more respondents were willing to accept the risk equivalent to the laparoscopic band to achieve 30 – 40% EWL after a primary endoluminal procedure compared with after a revisional procedure (45% ver-
Fig. 4. Graph showing responses to “What level of risk would you be willing to accept for primary endoluminal bariatric procedure (e.g., endoluminal suturing, stapling, or plication) that achieves 10 –20% EWL at 1 year postoperatively?”
sus 35%, P ⫽ .04). Alternatively, more respondents reported they would be willing to accept the risk equivalent to laparoscopic gastric bypass for a revisional endoluminal procedure compared with a primary procedure for this degree of weight loss (22% versus 8%, P ⫽ .0002). When asked “What %EWL would you accept 1 year after a primary endoscopic bariatric procedure,” 35% were willing to accept 10 –30% EWL and 32% expected ⬎40% EWL (Fig. 6). The weight loss expectations were lower for revisional than for primary endoluminal procedures, with 64% of respondents expecting ⬎40% EWL after a primary endoluminal procedure and only 38% expecting this same degree of weight loss after a revisional endoluminal procedure (P ⬍.0001). Patients and concerns Of the respondents, 24% believed that primary endoluminal bariatric procedures should be performed only on patients who
60 40
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0 Diagnostic Endoscopy
Endoscopic Polypectomy
ERCP
Laparoscopic Laparoscopic Adjustable Gastric Bypass Gastric Banding
Equivalent Risk Procedure
% Excess Weight Loss
Fig. 3. Graph showing responses to “What %EWL would you accept as a good outcome 1 year after an endoscopic anastomotic reduction procedure performed for weight regain after gastric bypass?”
Fig. 5. Graph showing responses to “What level of risk would you be willing to accept for primary endoluminal bariatric procedure (e.g., endoluminal suturing, stapling, or plication) that achieves 30 – 40% EWL at 1 year postoperatively?”
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40 35
32%
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17%
16%
15 10 5 0
8% 1% <10%
10-20%
20-30%
30-40%
40-50
>50%
% Excess Weight Loss
Fig. 6. Graph showing responses to “What %EWL would you accept as a good outcome 1 year after a primary endoscopic bariatric procedure?”
meet the National Institutes of Health criteria for bariatric surgery (Fig. 7). However, 45% believed that the patient groups undergoing these procedures should include patients with a lower body mass index (BMI). In addition, 22% believed that a primary procedure should be performed only on high-risk patients (e.g., severe co-morbidities, BMI ⬎55 kg/m2) as a bridge to a surgical procedure. The greatest concern among respondents regarding the application of endoluminal procedures/devices for bariatric patients was the unproven efficacy followed by durability, poor weight loss, availability of equipment/training, and risk. Of the respondents, 68% agreed or strongly agreed that the effectiveness of a new procedure should be proved before they would consider using it on their patients and 58% would be unwilling to refer their bariatric patients a new procedure or device until the efficacy has been proved, regardless of the risk. Discussion The field of endoluminal bariatric surgery is currently in its infancy. Many obstacles need to be overcome before primary or revisional endoscopic bariatric procedures are widely accepted and used. Some of the challenges that lie ahead include establishing safety and durability through well-designed clinical trials, defining indications and appropriate patient groups to undergo these procedures, ensuring adequate training among those performing the procedures, and obtaining reimbursement for these procedures. The expectations regarding these procedures should be discussed early in the development of this field to better frame the discussions and debates regarding the success or failure of these new procedures. The questionnaire reported in the present study was designed to examine the expectations among bariatric surgeons regarding the acceptable risk and outcomes of endoluminal bariatric procedures. The Emerging Technologies Committee believed that risk stratification compared with procedures that are commonly performed today would be an appropriate method of evaluating the opinions and differentiating between
primary and revisional endoluminal procedures. Weight loss ranges were provided that would reasonably differentiate the expectations between primary and revisional endoluminal procedures. Three studies to date have reported on the short-term results of primary endoscopic gastroplasty procedures. Using a transoral endoscopically guided stapler to create a vertical gastroplasty, Deviere et al. [18] reported a 24% EWL at 6 months after the procedure in 21 patients who had a mean preprocedure BMI of 43 kg/m2. No serious adverse events occurred. The most common procedure or device-related adverse events were pain (n ⫽ 13), vomiting (n ⫽ 7), nausea (n ⫽ 6), and dysphagia (n ⫽ 6). With the exception of 1 patient who had dysphagia for 18 days, all these symptoms had resolved within 1 week after the procedure. In the second human trial using the same device, Moreno et al. [22] reported a 46% EWL 6 months after the procedure and reported no serious adverse events. Fogel et al. [19] performed endoscopic vertical sutured gastroplasty in 64 patients who had a mean BMI of 40 kg/m2 (range 28 – 60). Two patients reported transient heartburn symptoms, and one vomited in the recovery room, but no serious complications occurred. At 1 year after the procedure, patients had lost an average of 58% EWL. The subgroup of patients with a preprocedure BMI of ⬍35 kg/m2 had an 85% EWL at 12 months after the procedure. The early results of an endoscopically placed duodenaljejunal bypass sleeve have also been reported [20,21]. The device was left in place for 3 months in 12 patients with an average preprocedure BMI of 43 kg/m2. No device-related severe adverse events occurred. Two patients had the device removed at 9 days because of abdominal pain. The average %EWL for the 10 patients who completed the study was 23.6%. All 10 patients who completed the study achieved ⱖ10% EWL [21]. The cause of weight regain after gastric bypass is poorly understood, and this problem is likely multifactorial. It has not been clearly established that pouch or stoma enlarge-
Fig. 7. Graph showing responses to “Primary endoluminal bariatric procedures should be performed on which group of patients?” NIH ⫽ National Institutes of Health.
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ment is solely responsible for weight regain after gastric bypass, and behavioral issues might play an important role in this problem. Nevertheless, procedures designed to improve the restrictive component of the operation through pouch or stoma reduction are being performed and investigated. Surgical revision of gastric bypass carries a significant risk for the patient, and endoscopic therapy provides a potentially safer alternative. Sclerotherapy, anastomotic suturing, and plication of the pouch have all been performed safely and have shown some promise in terms of early weight loss [7–10,15]. Additional studies are necessary to establish the durability, and several randomized trials are currently underway in the United States. The results of this study have shown that, among the membership of the ASMBS who responded to this survey, surgeons are willing to accept greater risk and lower weight loss for revisional endoluminal procedures compared with primary endoluminal procedures. Most surgeons who do not perform endoscopy expressed interest in obtaining additional endoscopic training. As these endoluminal technologies are developed, a greater emphasis on training bariatric surgeons in basic and advanced endoscopic techniques will be necessary. The development of guidelines by the Emerging Technologies Committee and the ASMBS for this type of training will be important to ensure patient safety as these technologies become widely available. Most surgeons responding to the questionnaire expected ⬎30% EWL after a primary endoluminal procedure and 16% expected ⬎50% EWL. The acceptable level of risk for a primary endoluminal procedure (achieving 30 – 40% EWL at 1 year) was equivalent to that of laparoscopic adjustable gastric banding or a therapeutic endoscopic procedure such as ERCP. Although only 8% were willing to accept the risk equivalent to that of laparoscopic gastric bypass for 30 – 40% EWL after primary therapy, 22% were willing to accept this level of risk for the same result after a revisional endoscopic procedure. The main concerns among surgeons who responded to this questionnaire regarding these procedures were durability and efficacy, and these remain the focus of ongoing clinical investigations. Most respondents were unwilling to perform or refer patients for these procedures until the efficacy has been established. This finding is concerning, because the early adoption of these procedures by more bariatric surgeons as a part of prospective studies will provide the cumulative experience necessary for the safe and proper development of these technologies. One issue not included in this questionnaire was whether it would be acceptable for patients to need annual endoscopic revision or “touch up” procedures to maintain the durability of gastric suturing or stapling. Although this would increase the cost and compliance issues, it might represent a realistic scenario for some of these procedures. Risk was the lowest concern for these procedures, and this might be because of
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the published data that have already established the safety for some of these devices. The ideal patient group for primary endoluminal procedures has yet to be defined. No clear consensus was reached among the respondents regarding the group of patients who should undergo primary endoluminal bariatric procedures. As successful outcomes are demonstrated in patients who met the current National Institutes of Health criteria for bariatric surgery, the indications will likely expand to specific groups of patients. The present study had several limitations. First, the questions were not validated or scientifically formulated but were simply an attempt by the Committee to gain some insight into the perceptions, expectations, and concerns regarding endoluminal therapies among bariatric surgeons. Additionally, the questionnaire did not have the respondents quantify the perceived risk associated with the procedures used for comparison. The continuum of risk from diagnostic endoscopy and therapeutic endoscopy to laparoscopic banding and gastric bypass that was presented was believed by the Committee to represent a progressive level of risk. In certain cases, however, ERCP with sphincterotomy might involve a greater risk of morbidity than a laparoscopic bariatric procedure. Therefore, it is possible that some respondents underestimated the risk of ERCP and overestimated the risk of laparoscopic gastric bypass on the basis of their clinical experience. Second, the data we have reported might not be representative of the bariatric surgery community as a whole. The response rate of 16% to this survey suggest a low level of interest in endoluminal therapy among the nonresponders at present, and these surgeons might have had different expectations for these procedures. Finally, we were not able to discern from the survey results the differences in responses between respondents who performed endoscopy regularly and those who did not. This might have provided some additional insight into how the endoscopic expertise of the respondent affected their expectations.
Conclusion The results of this study have shown that the risk tolerance and weight loss expectations among bariatric surgeons are different for primary and revisional endoscopic procedures. The respondents were willing to accept less weight loss and more risk for revisional endoluminal procedures than for primary endoluminal procedures. The durability of these procedures was a chief concern. Most surgeons were unwilling to consider endoluminal procedures for their patients until the efficacy has been proved. The expectations and concerns among bariatric surgeons regarding endoluminal therapy need to be periodically re-assessed as this field evolves.
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Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article.
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