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Comment on: Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 10-year results of a prospective randomized trial
LAGB versus LRYGB: 10-Year Results / Surgery for Obesity and Related Diseases 9 (2013) 405–416
and so on, and serves only to make other physicians and the public in general wonder if our procedural approach to obesity treatment can be trusted. As a specialty, we must exercise more caution in the application of all future bariatric treatment interventions. We must anticipate that the sheer numbers of individuals suffering from obesity will continue to entice industry to develop new treatments, including proprietary devices that they will seek to sell on a wide scale. We must hold industry at arm’s length, forbid industry sponsors from limiting access to data from outcome studies, and above all, refuse to let industry control who is allowed to train and perform new interventions. Bariatric surgery fellowship training should ultimately become an essential entry criterion for those interested in providing bariatric treatment to patients so that only fully trained knowledgeable specialists make such decisions. It is time that we move to define ourselves as a subspecialty in surgery and refuse to tolerate the continued influx of insufficiently trained surgeons into bariatrics. To help make this a reality in the United States, the American Society for Metabolic and Bariatric Surgery (ASMBS), our only professional society dedicated to bariatric surgery, should accelerate their efforts to create a certification process for surgeons who practice bariatrics, including the creation of a subspecialty board examination. One can expect opposition to this objective from the American College of Surgeons and the American Board of Surgery, which are likely to resist creating yet another subspecialty
415
that further subdivides general surgery. ASMBS leadership must work to overcome this opposition from individuals who do not understand or practice our subspecialty. Alternatively, ASMBS must move forward alone, following the example of Vascular Surgery, to create their own specialty board. We must prepare now for the next new treatment fad and make every effort to ensure that specialists knowledgeable of the full range of bariatric interventions available are the ones to study it, to determine how to integrate it into the arsenal of treatment options, to determine which candidates are appropriate for its application, and to mandate sufficient training to allow for its safe and effective introduction. Those who do not learn from history are doomed to repeat it. Let us not forget the important lessons relearned from the AGB procedure. Eric J. DeMaria, M.D. Wake Specialty Physicians, General and Bariatric Surgery, WakeMed Health and Hospital System, Raleigh, North Carolina Reference [1] Angrisani L, Cutolo PP, Formisano G, Nosso G, Vitolo G. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 10-year results of a prospective randomized trial. Surg Obes Relat Dis Epub 2013.
Editorial comment
Comment on: Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 10-year results of a prospective randomized trial Randomized, controlled trials (RCTs) that compare 2 current operations and have 1-year follow-up are few and far between, so Angrisani et al. are to be congratulated for this impressive effort published here in Surgery for Obesity and Related Diseases. They randomly assigned patients to undergo laparoscopic gastric banding (n ¼ 27) or gastric bypass (n ¼ 24) and found that for those followed up at 10 years the mean excess weight loss (EWL) was greater in the bypass group (LGP) than in the banding group (LAGB), 69% ⫾ 29% versus 46 ⫾ 27 %, respectively, (P ¼ .03). But the bypass patients had higher early complication rates (8.3% versus 0%) and potentially lethal long-term complications, such as internal hernia and bowel obstruction (4.7%). Reoperation rates were high in both groups: 40.9% for those who underwent LAGB and 28.6% for who underwent gastric bypass.
This paper brings to our attention many of the challenges and pitfalls of surgical RCTs, and some of the reasons why there is such a paucity of surgical trials in peer-reviewed journals:
The difficult balance between surpassing the learning curves for 2 procedures, while maintaining clinical equipoise Challenges of recruitment and retention Rapidly evolving surgical techniques, clinical care, and patient outcomes, which may affect the relevance and generalizability of the data The greatest potential for bias in long-term studies is the loss to follow-up of those patients with the poorest outcomes, and this bias can be significant when the number of patients is small. This trial started with small numbers, and
416
L. Angrisani et al. / Surgery for Obesity and Related Diseases 9 (2013) 405–416
although the overall follow-up was 480% at 10 years, most of this was by phone, so readers should be aware that only 12 patients who underwent banding and 10 patients who underwent bypass were seen by the investigators at 10 years. The weight loss achieved by the bypass group in this study (69% mean EWL) was higher than most studies, which, as reviewed in the discussion, are generally in the range of 57% to 63% mean excess weight loss [1,2]. Most surgical procedures evolve over time, and this is true of both the gastric bypass and gastric banding, both of which have changed significantly since their inception. Paul O’Brien’s group from Melbourne, Australia, recently published an excellent paper in Annals of Surgery, which documented their outcomes in a cohort of 43200 patients over 15 years [3]. They also did a subanalysis of their data for 3 distinct eras in the evolution of the Lap-Band device itself and surgical techniques for implantation: (1) perigastric era (1994–2000), N ¼ 931; (2) pars flaccida era (2001– 2005), N ¼ 926; and (3) Lap-Band AP era (2006–2011), N ¼ 1370. The Melbourne group successfully followed up 714 patients of 919 (78%) who had their bands 410 years, and the mean excess weight loss was 47%. In this large, long-term cohort study, 5.6% of patients had their bands removed, which decreased from 9.9% in the first perigastric era to 2.2% in the current Lap-Band AP era. Significantly, revisional surgery for band slippage or pouch enlargement decreased from 40% to o7% between the first and third eras, although the authors acknowledge that there may be some lead time bias and that this revision rate is expected to increase over time. In addition, patients who had revisional surgery lost as much weight in the long-term as those who didn’t require a revision, and there were no deaths associated with any primary or revisional procedures. This paper also included a systematic review of publications of all bariatric procedures with 10 years or more of follow up, and the weighted mean EWL was 54.2% for gastric banding and 54.0% for gastric bypass. Another recent meta-analysis of large gastric banding cohorts (4500 at baseline) reported a 5% reoperation rate for dilation or slippage and a 1.5% reoperation rate for band erosion [4]. Remarkably, the patients in the Angrisani trial had extremely low prevalence of co-morbidities at baseline; only 1 of 51 (2%) patients had type 2 diabetes and only 1 of 51 (2%) patients had obstructive sleep apnea (OSA), rates far lower than in any other bariatric series, in which the prevalence is usually 25% to 45% for diabetes and 40% to 80% for OSA, particularly with routine polysomnography (PSG) [5,6]. Possible explanations are that these patients were very healthy or that there were protocol deviations in the preoperative evaluation, which included routine PSG. Unfortunately, because of the small number of patients, and the very low rates of co-morbidities, this RCT comparing 2
laparoscopic bariatric procedures was not able to contribute any information on the improvement in these serious medical conditions that are such an important aspect of bariatric surgery. This highlights the benefits and statistical power of large, long-term cohort studies such as the Melbourne study and NIH-funded LABS consortium in assessing many different clinical outcomes. The laudable quest for the ‘‘perfect’’ bariatric procedure continues by many surgeons, including Dr. Angrisani, as evidenced by his statement during the plenary session presentation of this data at the ASMBS Annual Meeting, that he has now largely abandoned the gastric bypass in favor of the sleeve. In my view, we do not currently have a perfect bariatric operation, and I doubt that one will ever exist. If there was clearly 1 procedure that was the best tolerated and most efficacious, then I would recommend that procedure for every qualified bariatric patient. We do, however, have 3 very good options, gastric banding, sleeve gastrectomy, and gastric bypass, which I currently perform in almost equal percentages. A reasonable approach is to educate patients about the risks and benefits and pros and cons of each procedure, and assist them in making an informed decision. Our responsibility is, then, to pay meticulous attention to detail in preoperative medical optimization, surgical technique, and long-term follow-up, which can be guided by clinical pathways and protocols, but also personalized, to the needs of the individual patient. Emma J. Patterson, M.D., F.A.C.S., F.R.C.S.C. Oregon Weight Loss Surgery Portland, Oregon References [1] Sugarman HJ, Wolfe LG, Sica DA, Clore JN. Diabetes and hypertension in severe obesity and effects of gastric bypass-induced weight loss. Ann Surg 2003;237:751–6. [2] Spivak H, Abdelmelek MF, Beltran OR, Ng AW, Kitahama S. Longterm outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in the United States. Surg Endosc 2012;26:1909–19. [3] O’Brien PE, MacDonald L, Anderson M, Brennan L, Brown W. Longterm outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg 2013;257:87–94. [4] Singhal R, Bryant C, Kitchen M, Khan KS, Deeks J, Guo B, Super P. Band slippage and erosion after laparoscopic adjustable gastric banding: a meta-analysis. Surg Endosc 2010;21:1272–9. [5] Longitudinal Assessment of Bariatric Surgery (LABS) Consortium Flum DR, Belle SH, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 2009;361:445–54. [6] Khan A, King WC, Patterson EJ, et al. Assessment of Obstructive Sleep Apnea in Adults Undergoing Bariatric Surgery in Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) Study. J Clin Sleep Med 2013;9:21–9.
and so on, and serves only to make other physicians and the public in general wonder if our procedural approach to obesity treatment can be trusted. As a specialty, we must exercise more caution in the application of all future bariatric treatment interventions. We must anticipate that the sheer numbers of individuals suffering from obesity will continue to entice industry to develop new treatments, including proprietary devices that they will seek to sell on a wide scale. We must hold industry at arm’s length, forbid industry sponsors from limiting access to data from outcome studies, and above all, refuse to let industry control who is allowed to train and perform new interventions. Bariatric surgery fellowship training should ultimately become an essential entry criterion for those interested in providing bariatric treatment to patients so that only fully trained knowledgeable specialists make such decisions. It is time that we move to define ourselves as a subspecialty in surgery and refuse to tolerate the continued influx of insufficiently trained surgeons into bariatrics. To help make this a reality in the United States, the American Society for Metabolic and Bariatric Surgery (ASMBS), our only professional society dedicated to bariatric surgery, should accelerate their efforts to create a certification process for surgeons who practice bariatrics, including the creation of a subspecialty board examination. One can expect opposition to this objective from the American College of Surgeons and the American Board of Surgery, which are likely to resist creating yet another subspecialty
415
that further subdivides general surgery. ASMBS leadership must work to overcome this opposition from individuals who do not understand or practice our subspecialty. Alternatively, ASMBS must move forward alone, following the example of Vascular Surgery, to create their own specialty board. We must prepare now for the next new treatment fad and make every effort to ensure that specialists knowledgeable of the full range of bariatric interventions available are the ones to study it, to determine how to integrate it into the arsenal of treatment options, to determine which candidates are appropriate for its application, and to mandate sufficient training to allow for its safe and effective introduction. Those who do not learn from history are doomed to repeat it. Let us not forget the important lessons relearned from the AGB procedure. Eric J. DeMaria, M.D. Wake Specialty Physicians, General and Bariatric Surgery, WakeMed Health and Hospital System, Raleigh, North Carolina Reference [1] Angrisani L, Cutolo PP, Formisano G, Nosso G, Vitolo G. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 10-year results of a prospective randomized trial. Surg Obes Relat Dis Epub 2013.
Editorial comment
Comment on: Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 10-year results of a prospective randomized trial Randomized, controlled trials (RCTs) that compare 2 current operations and have 1-year follow-up are few and far between, so Angrisani et al. are to be congratulated for this impressive effort published here in Surgery for Obesity and Related Diseases. They randomly assigned patients to undergo laparoscopic gastric banding (n ¼ 27) or gastric bypass (n ¼ 24) and found that for those followed up at 10 years the mean excess weight loss (EWL) was greater in the bypass group (LGP) than in the banding group (LAGB), 69% ⫾ 29% versus 46 ⫾ 27 %, respectively, (P ¼ .03). But the bypass patients had higher early complication rates (8.3% versus 0%) and potentially lethal long-term complications, such as internal hernia and bowel obstruction (4.7%). Reoperation rates were high in both groups: 40.9% for those who underwent LAGB and 28.6% for who underwent gastric bypass.
This paper brings to our attention many of the challenges and pitfalls of surgical RCTs, and some of the reasons why there is such a paucity of surgical trials in peer-reviewed journals:
The difficult balance between surpassing the learning curves for 2 procedures, while maintaining clinical equipoise Challenges of recruitment and retention Rapidly evolving surgical techniques, clinical care, and patient outcomes, which may affect the relevance and generalizability of the data The greatest potential for bias in long-term studies is the loss to follow-up of those patients with the poorest outcomes, and this bias can be significant when the number of patients is small. This trial started with small numbers, and
416
L. Angrisani et al. / Surgery for Obesity and Related Diseases 9 (2013) 405–416
although the overall follow-up was 480% at 10 years, most of this was by phone, so readers should be aware that only 12 patients who underwent banding and 10 patients who underwent bypass were seen by the investigators at 10 years. The weight loss achieved by the bypass group in this study (69% mean EWL) was higher than most studies, which, as reviewed in the discussion, are generally in the range of 57% to 63% mean excess weight loss [1,2]. Most surgical procedures evolve over time, and this is true of both the gastric bypass and gastric banding, both of which have changed significantly since their inception. Paul O’Brien’s group from Melbourne, Australia, recently published an excellent paper in Annals of Surgery, which documented their outcomes in a cohort of 43200 patients over 15 years [3]. They also did a subanalysis of their data for 3 distinct eras in the evolution of the Lap-Band device itself and surgical techniques for implantation: (1) perigastric era (1994–2000), N ¼ 931; (2) pars flaccida era (2001– 2005), N ¼ 926; and (3) Lap-Band AP era (2006–2011), N ¼ 1370. The Melbourne group successfully followed up 714 patients of 919 (78%) who had their bands 410 years, and the mean excess weight loss was 47%. In this large, long-term cohort study, 5.6% of patients had their bands removed, which decreased from 9.9% in the first perigastric era to 2.2% in the current Lap-Band AP era. Significantly, revisional surgery for band slippage or pouch enlargement decreased from 40% to o7% between the first and third eras, although the authors acknowledge that there may be some lead time bias and that this revision rate is expected to increase over time. In addition, patients who had revisional surgery lost as much weight in the long-term as those who didn’t require a revision, and there were no deaths associated with any primary or revisional procedures. This paper also included a systematic review of publications of all bariatric procedures with 10 years or more of follow up, and the weighted mean EWL was 54.2% for gastric banding and 54.0% for gastric bypass. Another recent meta-analysis of large gastric banding cohorts (4500 at baseline) reported a 5% reoperation rate for dilation or slippage and a 1.5% reoperation rate for band erosion [4]. Remarkably, the patients in the Angrisani trial had extremely low prevalence of co-morbidities at baseline; only 1 of 51 (2%) patients had type 2 diabetes and only 1 of 51 (2%) patients had obstructive sleep apnea (OSA), rates far lower than in any other bariatric series, in which the prevalence is usually 25% to 45% for diabetes and 40% to 80% for OSA, particularly with routine polysomnography (PSG) [5,6]. Possible explanations are that these patients were very healthy or that there were protocol deviations in the preoperative evaluation, which included routine PSG. Unfortunately, because of the small number of patients, and the very low rates of co-morbidities, this RCT comparing 2
laparoscopic bariatric procedures was not able to contribute any information on the improvement in these serious medical conditions that are such an important aspect of bariatric surgery. This highlights the benefits and statistical power of large, long-term cohort studies such as the Melbourne study and NIH-funded LABS consortium in assessing many different clinical outcomes. The laudable quest for the ‘‘perfect’’ bariatric procedure continues by many surgeons, including Dr. Angrisani, as evidenced by his statement during the plenary session presentation of this data at the ASMBS Annual Meeting, that he has now largely abandoned the gastric bypass in favor of the sleeve. In my view, we do not currently have a perfect bariatric operation, and I doubt that one will ever exist. If there was clearly 1 procedure that was the best tolerated and most efficacious, then I would recommend that procedure for every qualified bariatric patient. We do, however, have 3 very good options, gastric banding, sleeve gastrectomy, and gastric bypass, which I currently perform in almost equal percentages. A reasonable approach is to educate patients about the risks and benefits and pros and cons of each procedure, and assist them in making an informed decision. Our responsibility is, then, to pay meticulous attention to detail in preoperative medical optimization, surgical technique, and long-term follow-up, which can be guided by clinical pathways and protocols, but also personalized, to the needs of the individual patient. Emma J. Patterson, M.D., F.A.C.S., F.R.C.S.C. Oregon Weight Loss Surgery Portland, Oregon References [1] Sugarman HJ, Wolfe LG, Sica DA, Clore JN. Diabetes and hypertension in severe obesity and effects of gastric bypass-induced weight loss. Ann Surg 2003;237:751–6. [2] Spivak H, Abdelmelek MF, Beltran OR, Ng AW, Kitahama S. Longterm outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in the United States. Surg Endosc 2012;26:1909–19. [3] O’Brien PE, MacDonald L, Anderson M, Brennan L, Brown W. Longterm outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg 2013;257:87–94. [4] Singhal R, Bryant C, Kitchen M, Khan KS, Deeks J, Guo B, Super P. Band slippage and erosion after laparoscopic adjustable gastric banding: a meta-analysis. Surg Endosc 2010;21:1272–9. [5] Longitudinal Assessment of Bariatric Surgery (LABS) Consortium Flum DR, Belle SH, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 2009;361:445–54. [6] Khan A, King WC, Patterson EJ, et al. Assessment of Obstructive Sleep Apnea in Adults Undergoing Bariatric Surgery in Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) Study. J Clin Sleep Med 2013;9:21–9.