Author's Accepted Manuscript
Is Sleeve Gastrectomy The Magic Bullet? Sudan Ranjan MD
PII: DOI: Reference:
S1550-7289(14)00202-0 http://dx.doi.org/10.1016/j.soard.2014.05.003 SOARD1998
To appear in:
Surgery for Obesity and Related Diseases
www.elsevier.com/locate/buildenv
Cite this article as: Sudan Ranjan MD, Is Sleeve Gastrectomy The Magic Bullet?, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2014.05.003 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Is Sleeve Gastrectomy the Magic Bullet? Author: Sudan, Ranjan, MD.1 1
Duke University Medical Center, Durham, NC, United States.
Corresponding Author Information Ranjan Sudan, M.D. Department of Surgery, Duke University Medical Center Box 2834 Durham, NC 27710 Telephone: 919-668-3101 Fax: 919-681-5586 Email: [email protected] Is Sleeve Gastrectomy the Magic Bullet? Abstract: Sleeve gastrectomy is becoming a more popular operation but, is it the proven to be durable long-term? This is a paired editorial to the article by Boza et al. “Long-term Outcomes of Laparoscopic Sleeve Gastrectomy as a Primary Bariatric Procedure” and specifically addresses the issue of long-term results. The paper by Boza et al. showed that patients undergoing sleeve gastrectomy (SG) had excellent weight loss and resolution of insulin resistance and dyslipidemia at 5 years with 70% follow-up. However, no patients resolved GERD and in fact 27% of their patients developed de novo GERD after SG. Five patients underwent reoperations: one for stenosis, one for leak and the others for inadequate weight loss. Fifty of their patients (45%) had a preoperative body mass index (BMI) less than 35 kg/m². Overall, this study joins an increasing body of literature that support good
results for the SG as a primary bariatric operation over the short and mid-term. The short-term benefits of SG have been shown to be comparable to other bariatric procedures such as the Rouxen-Y gastric bypass (RYGB) 1 and is no longer considered investigational by the American Society for Metabolic and Bariatric Surgery (ASMBS).2 It is now also covered by Centers for Medicaid and Medicare. Midterm studies are starting to emerge that show good weight loss and comorbidity resolution.3, 4 However, there is no truly long-term study (greater than 10 years) demonstrating that the SG is a durable procedure. In light of this, the issue of offering bariatric surgery to patients below the accepted BMI thresholds is an interesting dilemma. According to the multi-society clinical practice guidelines published in 2013 by the American Association of Clinical Endocrinologists (AACE), the Obesity Society (TOS), and ASMBS, there is insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, independent of BMI criteria.5 In the current paper 50 patients had a BMI below 35 kg/m² and currently the FDA only approves an adjustable gastric band for BMI between 30 and 35 kg/m². Boza et al. had IRB approval to perform this study and they demonstrated that lowering the BMI criteria was not necessarily detrimental in terms of excessive weight loss or nutritional problems. On the other hand the SG was less effective in achieving > 50 % excess weight loss in patients with BMI > 40 kg/m². So the ethical dilemma is; do we follow the ASMBS and NIH guidelines or do we offer an operation for glycemic control in low BMI patients? For most people in the United States payors decide the issue as they will not approve a SG for BMI < 35 kg/m². There are some studies, such as the STAMPEDE trial, that was published in New England Journal of Medicine in 2012 that recruited patients with lower BMI but, mid or longterm data for that well-run clinical trial are not available.1
Before a bariatric operation is established and widely acceptable, durability beyond 10 years is needed, or we will be repeating history. We have learned valuable lessons from previous bariatric operations such as the jejunoileal bypass, the vertical banded gastroplasty and the laparoscopic adjustable gastric band (LAGB) operations. With the jejunoileal bypass, weight loss was good but diarrhea, cirrhosis, and renal failure became apparent with longer follow-up and the operation was abandoned. In search of a safer operation, Mason and others described the vertical banded gastroplasty (VBG) with the hope that a simpler operation would reduce the technical complications, and without intestinal bypass, the nutritional consequences, such as vitamin deficiencies would also be reduced, and that the fixed restriction of the pouch outlet would prevent stomal dilation and provide durable weight loss. With time, this operation was also given up because of chronic nausea vomiting, reflux and regurgitation, band erosion problems, insufficient weight loss, and resolution of comorbid conditions. Similarly the adjustable gastric band, a low complexity and safe operation had a steep ascent in popularity in the previous decade, but the number of LAGB procedures performed has declined precipitously in the last couple of years because many patients felt they had been unsuccessful with weight loss or had device related complications. For each of these operations it took about 10 years to fully appreciate their results. I therefore caution the authors in calling a study of 5 years duration „long-term‟. The SG was initially described as a risk reduction operation for the duodenal switch. Patients undergoing the duodenal switch laparoscopically had a high complication rate particularly if the BMI was high. Several of these patients lost adequate weight and did not return for the second stage operation and surgeons started performing the SG as a primary bariatric, stand-alone, operation. Once the ASMBS endorsed the procedure and CMS agreed to reimburse it, the
numbers of SG procedures have seen a sharp rise. This operation appeals to patients and to surgeons for the same reasons that the VBG and the LAGB were appealing. It is relatively easy to perform from a technical standpoint, even in high BMI patients, chances of nutritional complications are low, and it can be offered to a variety of patients who may have had previous intestinal operations or may not be suitable for operations that involve malabsorption. Theoretically chances of ulceration should also be very low unlike the RYGB. Long-term complications of intestinal bypass, such as internal hernias, which can be devastating, and result in death or short bowel syndrome, are also virtually eliminated with the SG. As a result, the LAGB is being rapidly replaced by an increase in the volume of SG operations. Many patients will succeed with this operation as they have with the previous operations mentioned such as the VBG or the LAGB. The question is how many will succeed beyond 10 years (long-term). Bariatric surgeons have been searching for the magic bullet that will provide good weight loss and resolution of comorbidities but will have low complexity and complication rates. So the question is have we found the magic bullet? I have personally been a slow adopter of the SG, not because I did not know how to perform it (I have been performing duodenal switches for 15 years and SG is a component of it) but, because history has proven in the past that low complexity operations, although associated with a lower complication rate, have eventually not been durable. So I ask again, is the SG the magic bullet for low BMI patients? Only time will tell. Carefully designed prospective long-term trials with large numbers and excellent follow-up are needed to answer that question and the bariatric community awaits such studies. In the meantime expanding criteria for bariatric surgery to patients with lower BMI patients should only be done in these carefully designed trials and not become common clinical practice.
Bibliography 1.
Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical
therapy in obese patients with diabetes. The New England journal of medicine 2012; 366(17): 1567-76. 2.
Committee ACI. Updated position statement on sleeve gastrectomy as a bariatric
procedure. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 2012; 8(3): e21-6. 3.
Eid GM, Brethauer S, Mattar SG, Titchner RL, Gourash W, Schauer PR. Laparoscopic
sleeve gastrectomy for super obese patients: forty-eight percent excess weight loss after 6 to 8 years with 93% follow-up. Annals of surgery 2012; 256(2): 262-5. 4.
Sieber P, Gass M, Kern B, Peters T, Slawik M, Peterli R. Five-year results of
laparoscopic sleeve gastrectomy. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 2014; 10(2): 243-9. 5.
Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the
perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient-2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 2013; 9(2): 15991.
Is Sleeve Gastrectomy The Magic Bullet? Sudan Ranjan MD
PII: DOI: Reference:
S1550-7289(14)00202-0 http://dx.doi.org/10.1016/j.soard.2014.05.003 SOARD1998
To appear in:
Surgery for Obesity and Related Diseases
www.elsevier.com/locate/buildenv
Cite this article as: Sudan Ranjan MD, Is Sleeve Gastrectomy The Magic Bullet?, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2014.05.003 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Is Sleeve Gastrectomy the Magic Bullet? Author: Sudan, Ranjan, MD.1 1
Duke University Medical Center, Durham, NC, United States.
Corresponding Author Information Ranjan Sudan, M.D. Department of Surgery, Duke University Medical Center Box 2834 Durham, NC 27710 Telephone: 919-668-3101 Fax: 919-681-5586 Email: [email protected] Is Sleeve Gastrectomy the Magic Bullet? Abstract: Sleeve gastrectomy is becoming a more popular operation but, is it the proven to be durable long-term? This is a paired editorial to the article by Boza et al. “Long-term Outcomes of Laparoscopic Sleeve Gastrectomy as a Primary Bariatric Procedure” and specifically addresses the issue of long-term results. The paper by Boza et al. showed that patients undergoing sleeve gastrectomy (SG) had excellent weight loss and resolution of insulin resistance and dyslipidemia at 5 years with 70% follow-up. However, no patients resolved GERD and in fact 27% of their patients developed de novo GERD after SG. Five patients underwent reoperations: one for stenosis, one for leak and the others for inadequate weight loss. Fifty of their patients (45%) had a preoperative body mass index (BMI) less than 35 kg/m². Overall, this study joins an increasing body of literature that support good
results for the SG as a primary bariatric operation over the short and mid-term. The short-term benefits of SG have been shown to be comparable to other bariatric procedures such as the Rouxen-Y gastric bypass (RYGB) 1 and is no longer considered investigational by the American Society for Metabolic and Bariatric Surgery (ASMBS).2 It is now also covered by Centers for Medicaid and Medicare. Midterm studies are starting to emerge that show good weight loss and comorbidity resolution.3, 4 However, there is no truly long-term study (greater than 10 years) demonstrating that the SG is a durable procedure. In light of this, the issue of offering bariatric surgery to patients below the accepted BMI thresholds is an interesting dilemma. According to the multi-society clinical practice guidelines published in 2013 by the American Association of Clinical Endocrinologists (AACE), the Obesity Society (TOS), and ASMBS, there is insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, independent of BMI criteria.5 In the current paper 50 patients had a BMI below 35 kg/m² and currently the FDA only approves an adjustable gastric band for BMI between 30 and 35 kg/m². Boza et al. had IRB approval to perform this study and they demonstrated that lowering the BMI criteria was not necessarily detrimental in terms of excessive weight loss or nutritional problems. On the other hand the SG was less effective in achieving > 50 % excess weight loss in patients with BMI > 40 kg/m². So the ethical dilemma is; do we follow the ASMBS and NIH guidelines or do we offer an operation for glycemic control in low BMI patients? For most people in the United States payors decide the issue as they will not approve a SG for BMI < 35 kg/m². There are some studies, such as the STAMPEDE trial, that was published in New England Journal of Medicine in 2012 that recruited patients with lower BMI but, mid or longterm data for that well-run clinical trial are not available.1
Before a bariatric operation is established and widely acceptable, durability beyond 10 years is needed, or we will be repeating history. We have learned valuable lessons from previous bariatric operations such as the jejunoileal bypass, the vertical banded gastroplasty and the laparoscopic adjustable gastric band (LAGB) operations. With the jejunoileal bypass, weight loss was good but diarrhea, cirrhosis, and renal failure became apparent with longer follow-up and the operation was abandoned. In search of a safer operation, Mason and others described the vertical banded gastroplasty (VBG) with the hope that a simpler operation would reduce the technical complications, and without intestinal bypass, the nutritional consequences, such as vitamin deficiencies would also be reduced, and that the fixed restriction of the pouch outlet would prevent stomal dilation and provide durable weight loss. With time, this operation was also given up because of chronic nausea vomiting, reflux and regurgitation, band erosion problems, insufficient weight loss, and resolution of comorbid conditions. Similarly the adjustable gastric band, a low complexity and safe operation had a steep ascent in popularity in the previous decade, but the number of LAGB procedures performed has declined precipitously in the last couple of years because many patients felt they had been unsuccessful with weight loss or had device related complications. For each of these operations it took about 10 years to fully appreciate their results. I therefore caution the authors in calling a study of 5 years duration „long-term‟. The SG was initially described as a risk reduction operation for the duodenal switch. Patients undergoing the duodenal switch laparoscopically had a high complication rate particularly if the BMI was high. Several of these patients lost adequate weight and did not return for the second stage operation and surgeons started performing the SG as a primary bariatric, stand-alone, operation. Once the ASMBS endorsed the procedure and CMS agreed to reimburse it, the
numbers of SG procedures have seen a sharp rise. This operation appeals to patients and to surgeons for the same reasons that the VBG and the LAGB were appealing. It is relatively easy to perform from a technical standpoint, even in high BMI patients, chances of nutritional complications are low, and it can be offered to a variety of patients who may have had previous intestinal operations or may not be suitable for operations that involve malabsorption. Theoretically chances of ulceration should also be very low unlike the RYGB. Long-term complications of intestinal bypass, such as internal hernias, which can be devastating, and result in death or short bowel syndrome, are also virtually eliminated with the SG. As a result, the LAGB is being rapidly replaced by an increase in the volume of SG operations. Many patients will succeed with this operation as they have with the previous operations mentioned such as the VBG or the LAGB. The question is how many will succeed beyond 10 years (long-term). Bariatric surgeons have been searching for the magic bullet that will provide good weight loss and resolution of comorbidities but will have low complexity and complication rates. So the question is have we found the magic bullet? I have personally been a slow adopter of the SG, not because I did not know how to perform it (I have been performing duodenal switches for 15 years and SG is a component of it) but, because history has proven in the past that low complexity operations, although associated with a lower complication rate, have eventually not been durable. So I ask again, is the SG the magic bullet for low BMI patients? Only time will tell. Carefully designed prospective long-term trials with large numbers and excellent follow-up are needed to answer that question and the bariatric community awaits such studies. In the meantime expanding criteria for bariatric surgery to patients with lower BMI patients should only be done in these carefully designed trials and not become common clinical practice.
Bibliography 1.
Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical
therapy in obese patients with diabetes. The New England journal of medicine 2012; 366(17): 1567-76. 2.
Committee ACI. Updated position statement on sleeve gastrectomy as a bariatric
procedure. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 2012; 8(3): e21-6. 3.
Eid GM, Brethauer S, Mattar SG, Titchner RL, Gourash W, Schauer PR. Laparoscopic
sleeve gastrectomy for super obese patients: forty-eight percent excess weight loss after 6 to 8 years with 93% follow-up. Annals of surgery 2012; 256(2): 262-5. 4.
Sieber P, Gass M, Kern B, Peters T, Slawik M, Peterli R. Five-year results of
laparoscopic sleeve gastrectomy. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 2014; 10(2): 243-9. 5.
Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the
perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient-2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 2013; 9(2): 15991.
