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Surgery_Schwartz. at 5 years of 53%. Other prob-lems that may arise include alopecia from inadequate protein absorption, night blindness from a lack of vitamin A, and gall-stones if the gallbladder is not removed. However, of all these nutritional complications, protein-calorie malnutrition is the most severe and life-threatening. When it is diagnosed, the treat-ment is parenteral nutrition. Two episodes of required parenteral nutrition are usually considered adequate indication to lengthen the “common channel” of ileum—the ileum between the ileo-ileostomy of the biliopancreatic limb to the alimentary tract and the ileocecal valve. The amount of length that the surgeon should increase the common channel is poorly documented.Investigational Bariatric ProceduresThere is continuous evolution of the approaches to and proce-dures for bariatric surgery. The goals of this dynamic process are to minimize risk, reduce invasiveness, and maximize clini-cal effectiveness. This same benefit-risk approach/paradigm


Surgery_Schwartz

Surgery_Schwartz. to and proce-dures for bariatric surgery. The goals of this dynamic process are to minimize risk, reduce invasiveness, and maximize clini-cal effectiveness. This same benefit-risk approach/paradigm has also been adopted by the FDA for the design of clinical trials for obesity devices to help facilitate product development and approval.174 In the past, a variety of medical devices to assist with weight reduction have been studied, but only a few have been commercially available. In 2012, to address the need for more intermediate treatment options with devices, the FDA initiated a new paradigm based on a benefit-risk determina-tion to suggest appropriate levels of benefit for devices with different risk levels. In other words, it became more feasible to trial less invasive obesity treatment devices, as the threshold for weight loss was lower if the risk of the device or procedure was lower as well. Since that time, several new devices have been approved. These intermediate devices are


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Surgery_Schwartz. devices, as the threshold for weight loss was lower if the risk of the device or procedure was lower as well. Since that time, several new devices have been approved. These intermediate devices are intended to provide 5Brunicardi_Ch27_p1167-p1218.indd 119023/02/19 2:21 PM 1191THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27tools in the middle of the spectrum of care between lifestyle modification and bariatric surgery and are offered to people with BMIs between 30 and 40 kg/m2.The vagus nerve is known to play a role in satiety, metabo-lism, and autonomic control in the upper gastrointestinal tract. Studies have been conducted to determine the efficacy of vagal nerve block therapy with a treatment device that consistently delivers at least 12 hours of therapy a day and a sham control device that has no possibility of delivering therapy. A laparo-scopic abdominal procedure is performed to attach two elec-trodes to the anterior and posterior vagal trunks at the level of the


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Surgery_Schwartz. control device that has no possibility of delivering therapy. A laparo-scopic abdominal procedure is performed to attach two elec-trodes to the anterior and posterior vagal trunks at the level of the gastroesophageal junction. Customized electrodes are placed around the nerves and then secured with sutures. These electrodes are then connected to a transcutaneously recharge-able neuroregulator placed in a subcutaneous pocket on the thoracic side wall. Published results show modest weight loss in the vagal nerve blockade group of 9.2% compared to 6.0% TBWL in the sham group at 12 months and 8.8% and 3.8% TBWL in vagal nerve blockade and sham groups, respectively, at 18 months.175,176 More weight loss was sustained through 18 months in the vagal blockade group, and the device was shown to be safe, as there was a low rate of serious complications.Endoscopically placed intragastric balloons (IGBs) are once again an option for overweight and obese patients with a BMI greater than 27 kg/m2.


Surgery_Schwartz

Surgery_Schwartz. safe, as there was a low rate of serious complications.Endoscopically placed intragastric balloons (IGBs) are once again an option for overweight and obese patients with a BMI greater than 27 kg/m2. The original Garren-Edwards bub-ble (GEB) from the late 1980s was an endoscopically placed and removed balloon filled with 220 mL of air that was left in the stomach for 3 months. Adverse events related to the GEB reported in the medical literature included small-bowel obstruc-tion secondary to unplanned deflation, gastric ulcers with GI hemorrhage, and gastric perforation, so its use was abandoned. A multidisciplinary conference that followed recommended that future IGBs should (a) be effective at promoting weight loss, (b) be filled with liquid (not air), (c) be capable of adjustment to various sizes, (d) have a smooth surface with low ulcerogenic and obstructive potential, (e) contain a radiopaque marker, and (f) be constructed of durable materials.177Newer IGBs have undergone


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Surgery_Schwartz. to various sizes, (d) have a smooth surface with low ulcerogenic and obstructive potential, (e) contain a radiopaque marker, and (f) be constructed of durable materials.177Newer IGBs have undergone evaluation and approval by the FDA. These include both a single and a double lumen bal-loon, both placed endoscopically and filled with saline.178,179 Results from these two pivotal trials show weight losses of 7.6% and 10.2% TBWL at 6 months in the device group that exceeded weight loss in the control or sham groups. There were some early removals in 9% to 18% of subjects for failure to tolerate symptoms, early deflations without migration in 6%, and gastric ulcers in 10%. The precise role for these devices is yet to be determined, and they must be paired with a diet and exercise plan to maximize effectiveness. Repeat or sequential balloon therapy may be effective in enhancing and sustaining weight loss, and it is being studied in Europe. Finally, ensuring proper follow-up is important to


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Surgery_Schwartz. effectiveness. Repeat or sequential balloon therapy may be effective in enhancing and sustaining weight loss, and it is being studied in Europe. Finally, ensuring proper follow-up is important to reduce adverse events related to ulcers, spontaneous deflation, or migration of the balloon.An endoscopically placed percutaneous gastrostomy tube is approved for weight loss. It facilitates drainage of approxi-mately 30% of the calories consumed in a meal, in conjunction with lifestyle counseling. In a randomized trial, participants lost 12.1% ± 9.6% TBWL compared to 3.5% ± 6.0% TBWL in the lifestyle-only control group. The most frequent complication was abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the device group.180A duodenal-jejunal bypass liner is an endoscopic device that mimics the duodenal-jejunal exclusion component of


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Surgery_Schwartz. Serious adverse events were reported in 3.6% of participants in the device group.180A duodenal-jejunal bypass liner is an endoscopic device that mimics the duodenal-jejunal exclusion component of an RYGB and is undergoing trials in the United States. Prior studies assessing the efficacy of the DJBL have shown modest weight loss and improvements in glycemic control. There are associated adverse events of migration, obstruction, and epigas-tric pain. One study demonstrated a high (29%) early device removal rate due to these events.181 A more recent meta-analy-sis showed that the DJBL was associated with significant mean differences in TBWL for the device (12.6%) compared with lifestyle modification. The mean differences in glycated hemo-globin and fasting plasma glucose among subjects with T2DM in this meta-analysis did not reach statistical significance.182Various endoscopic and endoluminal procedures are also being utilized as less invasive approaches for bariatric surgi-cal


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Surgery_Schwartz. with T2DM in this meta-analysis did not reach statistical significance.182Various endoscopic and endoluminal procedures are also being utilized as less invasive approaches for bariatric surgi-cal procedures. These include procedures to decrease gastric pouch size and to limit gastrojejunostomy anastomotic size after “failed” LRYGB.183 Overall, reports have been disappointing for effectiveness. Gastric plication is also being approached both laparoscopically and endoscopically to mimic results of an SG but without requiring stapling or gastric resection. Fur-ther studies with long-term safety and efficacy data are required before these investigational procedures can be considered for routine clinical use.FOLLOW-UP AND POSTOPERATIVE CAREPostoperative follow-up is required following bariatric surgery to detect and treat postoperative shortand longer-term complications. Weight regain, internal hernias, ulcerations, and important nutrient deficiencies can occur years after bariatric


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Surgery_Schwartz. surgery to detect and treat postoperative shortand longer-term complications. Weight regain, internal hernias, ulcerations, and important nutrient deficiencies can occur years after bariatric surgery. These specific problems are detailed in the “Procedure-Specific Complications” and overall “Complications” sections. The frequency of follow-up varies by surgical procedure and to some extent by surgical practice, but continues, hopefully, for life. Postoperative follow-up is defined as short-term (0–2 years), medium (2–5 years), and long term (≥5 years). Recommendations are that at least 75% of patients are followed for 5 years for LAGB, SG, and LRYGB operations, and 90% are followed closely for 5 years and longer if they have malabsorptive operations (BPD and DS). Although a clinical follow-up system may be in place, it still requires patient compliance, which is generally low for long-term follow-up. In a systematic review, Puzziferri et al also identified that less than 3% of


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Surgery_Schwartz. follow-up system may be in place, it still requires patient compliance, which is generally low for long-term follow-up. In a systematic review, Puzziferri et al also identified that less than 3% of bariatric studies included >80% long-term follow-up.184 Vigorous efforts can help to improve follow-up, but these require significant staffing and funding. In the NIH-funded prospective, longitudinal bariatric study, more complete follow-up data and weight measurements were obtained for 79% of RYGB patients in the longer term with the use of these resources.169The goals of short-term follow-up are to maximize care of the patient in the postoperative period; assist in adjustment to new eating, exercise, and lifestyle patterns; be on the alert for and treat postoperative complications; and recommend measures to limit such complications. The goals of long-term follow-up are similar, but focus more on weight regain, the man-agement of comorbid condition relapse, and the emergence of recurrent


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Surgery_Schwartz. measures to limit such complications. The goals of long-term follow-up are similar, but focus more on weight regain, the man-agement of comorbid condition relapse, and the emergence of recurrent depression, substance and alcohol misuse, and nutri-tional complications. Vitamin and mineral supplements must be taken regularly for life, including oral supplements for iron, calcium, and vitamin B12 and a multivitamin. Evidence indicates that vitamin and mineral deficiencies, including deficiencies of Brunicardi_Ch27_p1167-p1218.indd 119123/02/19 2:21 PM 1192SPECIFIC CONSIDERATIONSPART IITable 27-4Recommended postoperative nutritional monitoringRECOMMENDATIONLAGBSGLRYGBBPD/DSBone density (DXA)a at 2 yearsYesYesYesYes24 hour urinary calcium excretion at 6 months and annuallyYesYesYesYesVitamin B12 annually (methylmalonic acid and homocysteine optional) then every 3–6 months if supplementedYesYesYesYesFolic acid (red blood cell folic acid optional), iron studies, vitamin D, intact


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Surgery_Schwartz. B12 annually (methylmalonic acid and homocysteine optional) then every 3–6 months if supplementedYesYesYesYesFolic acid (red blood cell folic acid optional), iron studies, vitamin D, intact parathyroid hormoneNoNoYesYesVitamin A initially and every 6–12 months thereafterNoNoOptionalYesCopper, zinc, and selenium evaluation with specific findingsNoNoYesYesThiamine evaluation with specific findingsYesYesYesYesaDXA = dual energy X-ray absorptiometry; LAGB = laparoscopic adjustable gastric banding; SG = sleeve gastrectomy; LRYGB = laparoscopic Roux-en-Y gastric bypass; BPD/DS = biliopancreatic diversion with duodenal switch.Data from 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, Obesity (Silver Spring). 2013


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Surgery_Schwartz. patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery, Obesity (Silver Spring). 2013 Mar;21 Suppl 1:S1-S27.calcium, vitamin D, iron, zinc, and copper, are common after bariatric surgery.185 Guidelines suggest screening patients for iron, vitamin B12, folic acid, and vitamin D deficiencies preop-eratively, as well.89 Patients should also be given daily nutri-tional supplementation postoperatively, including two adult multivitamin plus mineral supplements (each containing 18 mg of iron, 400 to 800 µg of folic acid, and 50 mg of thiamine), 1200 to 1500 mg of elemental calcium (1800 to 2400 mg for BPD/DS), at least 3000 IU of vitamin D, and vitamin B12, the dose of which varies by route of administration. In addition, all patients should undergo annual screening for specific deficien-cies (Table 27-4).Objective data that should be obtained after all bariatric operations include


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Surgery_Schwartz. of administration. In addition, all patients should undergo annual screening for specific deficien-cies (Table 27-4).Objective data that should be obtained after all bariatric operations include weight loss, change in BMI, resolution or improvement in medical comorbidities, and any complications that occur. Assessment of quality of life can help gauge effi-cacy as well, with the Short Form-36 (SF36) questionnaire being one frequently used example. In a retrospective review based on the bariatric outcomes longitudinal database (BOLD) dataset by Spaniolas et al, the effect of postoperative follow-up on 12-month weight loss was studied in 51,081 patients. Com-plete follow-up was independently associated with excess weight loss ≥50% and total weight loss ≥30%.186 To identify the relationship between regular follow-up and resolution of comorbidities, the same group studied a cohort of 46,381 patients (31% RYGB patients) who had minimum of 12-month follow-up. After adjusting for baseline


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Surgery_Schwartz. between regular follow-up and resolution of comorbidities, the same group studied a cohort of 46,381 patients (31% RYGB patients) who had minimum of 12-month follow-up. After adjusting for baseline characteristics, the group determined that complete follow-up in the first year after RYGB was independently associated with a higher rate of improvement or remission of comorbid conditions (T2DM, hypertension, and dyslipidemia).187 Frequent and protocolized band adjustments and postoperative support individual/group sessions were shown to be important for longer-term outcomes following LAGB.188 Finally, the 12-month postoperative visit, which coincides with the plateauing of weight loss for most procedures, presents an opportunity to intervene while bariat-ric surgery patients are still engaged. Engaging patients and the use of technology to maintain contact with a medical pro-vider are important tools to maintain follow-up after bariatric surgery.RESULTS OF BARIATRIC SURGERYShort-Term


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Surgery_Schwartz. Engaging patients and the use of technology to maintain contact with a medical pro-vider are important tools to maintain follow-up after bariatric surgery.RESULTS OF BARIATRIC SURGERYShort-Term OutcomesThe short-term (1–2 year) outcomes for bariatric surgical pro-cedures are shown in Table 27-5, which summarizes of the majority of the literature from 2009 to 2017. Average 30-day mortality is low (<1.0%) for all procedures except BPD/DS. Mortality after LRYGB is now consistently less than 0.3% to 0.5% in most large reported series.59,140 Morbidity varies by procedure, but it is the lowest for LAGB, followed by SG and then LRYGB, and highest for the malabsorptive procedure BPD/DS. In the Longitudinal Assessment of Bariatric Sur-gery (LABS) study, a composite endpoint including death, deep-vein thrombosis or venous thromboembolism, reinter-vention, or failure to be discharged by 30 days after surgery occurred in 4.8% of those who had undergone LRYGB.59 Short-term results of the SG have


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Surgery_Schwartz. thrombosis or venous thromboembolism, reinter-vention, or failure to be discharged by 30 days after surgery occurred in 4.8% of those who had undergone LRYGB.59 Short-term results of the SG have been reported from large national databases. These data show that SG is positioned between LAGB and LRYGB for efficacy of weight loss and resolution of comorbid medical problems and for morbidity and mortality.140 Few longer-term results with SG have been published.189,190In the past, large institutional series of LAGB results have been published from centers in Europe and Australia, showing better results for weight loss than those that have been observed in the United States (13–22% TBWL) (see Table 27-5). Weight loss results with BPD or DS are both excellent and comparable but come with higher surgical morbidity. The results from malabsorptive procedures are also very durable for the small percentage of people who undergo them. One 18-year follow-up study after BPD showed a mean excess


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Surgery_Schwartz. surgical morbidity. The results from malabsorptive procedures are also very durable for the small percentage of people who undergo them. One 18-year follow-up study after BPD showed a mean excess weight loss of 70% persisting for that duration of time.173 Although most of the results of BPD or DS are after open operations, one report of laparoscopic DS at an experienced center showed that for 40 patients with an average BMI of 60 kg/m2 the mean hospital stay was 4 days, average operation room time was 3.5 hours, and mean excess weight loss at 9 months was 58%.191 Buchwald and colleagues showed that the average weight loss after BPD and DS in the literature was over 70%, with a mortality rate of 1.1%, a complication rate of 27% to 33%, and a nutritional complication rate of 40% to 77%192 (see Table 27-5).Brunicardi_Ch27_p1167-p1218.indd 119223/02/19 2:21 PM 1193THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27Table 27-5Short-term bariatric surgical outcomes OUTCOMEa ALLSURGICAL


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Surgery_Schwartz. 77%192 (see Table 27-5).Brunicardi_Ch27_p1167-p1218.indd 119223/02/19 2:21 PM 1193THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27Table 27-5Short-term bariatric surgical outcomes OUTCOMEa ALLSURGICAL PROCEDURELRYGBSGLAGBBPD/DS% Mortality 30-day<1.0%0.3–0.5%0.11%0.05%1.1%% Morbidity 30-dayNA, depends on procedure12–21%3–6%2–4%27–33%% Total body weight loss (TBWL)NA, depends on procedure31–36%25–30%13–22%36–38%% Excess body weight loss (EBWL)NA, depends on procedure48–77%(mean, 68%)49–81%29–50%>70%% Diabetes remission77%60–80%60%35%75%% Dyslipidemiab remission70%63–91%72–82%78%80%% Hypertension remission62%61–81%60–92%43%60%, few reports% Sleep apnea remissionc84%80%80%68%80%aOutcomes are the averages found in the literature at 1 to 2 years postoperatively, unless otherwise noted.bDenotes any component lipid remission.cDenotes clinical remission as repeat sleep studies are uncommonly performed.Further detail on surgical morbidity for each procedure is addressed in both the


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Surgery_Schwartz. any component lipid remission.cDenotes clinical remission as repeat sleep studies are uncommonly performed.Further detail on surgical morbidity for each procedure is addressed in both the “Procedure-Specific Complications” and overall “Complications” sections.Effectiveness of Bariatric Surgery Compared to Nonsurgical TreatmentThe following section summarizes important findings of studies that compare bariatric procedures with nonsurgical management of obesity. The results of these studies concerning remission from T2DM will be discussed in more detail in “Results of Surgery for Diabetes.” A systematic review and meta-analysis by Gloy summarized all randomized controlled trials (RCTs) that compared bariatric surgery with nonsurgical treatments for obesity.193 The review analyzed 11 trials comprising nearly 800 people with a BMI of 30 to 52. These studies generally focused on cohorts with T2DM and 1 to 2 years of follow-up. They pro-vided good evidence of the effectiveness of bariatric


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Surgery_Schwartz. comprising nearly 800 people with a BMI of 30 to 52. These studies generally focused on cohorts with T2DM and 1 to 2 years of follow-up. They pro-vided good evidence of the effectiveness of bariatric procedures, including LRYGB,78-80 LAGB,77,194 BPD,79 and SG.78 These pro-cedures resulted in greater short-term (1–2 years) weight loss (mean difference −26 kg; 95% CI −31 to −21; P <0.001) and greater remission of T2DM (complete case analysis relative risk of remission: 22.1, 3.2–154.3; P = 0.002; conservative analysis: 5.3, 1.8–15.8; P = 0.003) compared with various nonsurgical treatments.77-80,194 After this meta-analysis, two additional RCTs were published that show similar short-term results for both weight loss and T2DM.83,84In addition, serum triglycerides and high-density lipoproteins were significantly reduced by bariatric procedures, but blood pressure and other lipoproteins were not (although some studies showed reduced medication use for these conditions).193 The Gloy review


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Surgery_Schwartz. were significantly reduced by bariatric procedures, but blood pressure and other lipoproteins were not (although some studies showed reduced medication use for these conditions).193 The Gloy review also noted a lack of evidence from RCTs beyond 2 years for mortality, cardiovascular diseases, and adverse events. Another systematic review by Maggard-Gibbons focused on weight loss and glycemic control in class I obese (BMI 30–34.9) adults with T2DM and identified three RCTs with results similar to those seen in class II (BMI 35–39.9) and severely obese populations. However, the review also noted a lack of longer-term studies in people with class I obesity.195Longer-Term StudiesA summary of studies with long-term outcomes are shown in Table 27-6. The following section describes these studies and other larger studies that have contributed data to the growing body of evidence with respect to some short-term and now much longer-term outcomes.Swedish Obese Subjects Study. Much of what is


Surgery_Schwartz

Surgery_Schwartz. and other larger studies that have contributed data to the growing body of evidence with respect to some short-term and now much longer-term outcomes.Swedish Obese Subjects Study. Much of what is currently known about the long-term results of bariatric surgery come from the Swedish Obese Subjects (SOS) study, which was initi-ated in 1987 as a prospective trial of 2010 subjects undergo-ing bariatric surgery compared to a usual care control group (n = 2037) that were matched on 18 clinical and demographic variables. The most common bariatric procedure performed in SOS was the VBG (68%), followed by gastric banding (19%), and RYGB (13%). Follow-up rates are high and reported at 99% for some endpoints (including mortality). The SOS investiga-tors have published widely on health outcomes beyond 10 years and up to 20 years, including: weight loss, mortality, T2DM remission and incidence, cardiovascular events, incident cancer, psychosocial outcomes, and health care use and costs. Weight


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Surgery_Schwartz. 10 years and up to 20 years, including: weight loss, mortality, T2DM remission and incidence, cardiovascular events, incident cancer, psychosocial outcomes, and health care use and costs. Weight loss among surgical subjects in SOS was greater than in con-trol subjects (mean changes in body weight at 2, 10, 15, and 20 years were −23%, −17%, −16%, and −18% in the surgery group and 0%, 1%, −1%, and −1% in the control group). After 15 years, the mean percent weight loss by procedure type was 27 + 12% for RYGB, 18 + 11% for VBG, and 13 + 14% for gastric banding.The SOS study also showed major improvements in obesityrelated comorbidities. In the surgical group, there was a 72% remission of T2DM after 2 years (OR for remission: 8.4) and 36% durable remission after 10 years (OR for remission: 3.5). In spite of the considerable relapse of T2DM over time, bariatric surgery was associated with a lower incidence of myocardial infarction and other T2DM complications. The SOS study dem-onstrated


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Surgery_Schwartz. In spite of the considerable relapse of T2DM over time, bariatric surgery was associated with a lower incidence of myocardial infarction and other T2DM complications. The SOS study dem-onstrated that bariatric surgery also reduced the risk of incident T2DM by 96%, 84%, and 78% after 2, 10, and 15 years among subjects without the condition at baseline. The SOS study also 6Brunicardi_Ch27_p1167-p1218.indd 119323/02/19 2:21 PM 1194SPECIFIC CONSIDERATIONSPART IITable 27-6Long-term studies of bariatric surgery outcomesaAUTHORSTUDY DESIGNPOPULATIONS AND PROCEDURESFOLLOW-UP DURATIONPUBLISHED OUTCOMESMORTALITY AND SURVIVALLIMITATIONSSjöström et al,196-201 2004, 2007, 2009, and 2012 (Swedish Obese Subjects study [SOS])Prospective observational with matched controls2010 Surgical cases (13% RYGB; 19% banding; 68% VBG) and 2037 matched controls10–20 years, depending on the reportSurgery was associated with: greater weight loss at 2 years (–23% vs. 0%) and at 20 y (–18% vs. –1%)16;


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Surgery_Schwartz. RYGB; 19% banding; 68% VBG) and 2037 matched controls10–20 years, depending on the reportSurgery was associated with: greater weight loss at 2 years (–23% vs. 0%) and at 20 y (–18% vs. –1%)16; greater remission of T2DM after 2 y (OR for remission, 8.4; P <.001) and 10 y (OR, 3.5; P <.001); lower incidence of T2DM (HR, 0.17; P <.001)Bariatric surgery treatment: 16 years, 29% lower risk of death from any cause (hazard ratio 0.71, 0.54 to 0.92; P = 0.01) vs. usual care; common causes of death: myocardial infarction (HR, 0.71; P = .02), stroke (HR, 0.66; P = .008), and cancer (in women only; HR, 0.58; P <.001)Not randomized; includes mostly procedures (87%) that are no longer in use; involves patients from a single country with little racial/ethnic diversityAdams et al,202 2007 (Utah Mortality study)Retrospective observational with matched controls7925 RYGB cases and 7925 weight-matched controlsMean, 7.1 yearsOnly mortality outcomes reportedBariatric surgery treatment:


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Surgery_Schwartz. (Utah Mortality study)Retrospective observational with matched controls7925 RYGB cases and 7925 weight-matched controlsMean, 7.1 yearsOnly mortality outcomes reportedBariatric surgery treatment: average 7.1 years post treatment, 40% reduction in all cause mortality (hazard ratio HR 0.60, 0.45 to 0.67; P <0.001), 49% (HR 0.51, 0.36 to 0.73; P <0.001), and 92% (HR 0.08, 0.01 to 0.47; P = 0.005), cardiovascular mortality, and T2DM mortality, respectivelyNot randomized; matching based on self-reported height and weight from driver’s license database; includes only RYGB procedures; patients from a single stateAdams et al,203,204 2012, 2017 (Utah Obesity study)Prospective observational with two matched control groups418 RYGB cases; 417 bariatric-surgery seekers who did not undergo operation (control 1); 321 population-based matched controls (control 2)6 years, 12 years6 years: RYGB group lost 27.7% body weight compared with 0.2% weight gain in control group 1 and 0% change in


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Surgery_Schwartz. (control 1); 321 population-based matched controls (control 2)6 years, 12 years6 years: RYGB group lost 27.7% body weight compared with 0.2% weight gain in control group 1 and 0% change in control group 2; T2DM remission in 62% of RYGB patients and 8% and 6% in each of the control groups (P <.001); incident T2DM was observed in 2% of RYGB patients but 17% and 15% of each of the control groups at 6 years (P <.001); surgery associated with greater improvements in blood pressure, cholesterol, and quality of life (P <.01)Deaths at 6 years: 12 (2.8%), 14 (3.3%), and 3 (0.93%) for bariatric surgery, control 1, and control 2, respectivelyNot randomized; includes only RYGB procedures; patients from a single stateBrunicardi_Ch27_p1167-p1218.indd 119423/02/19 2:21 PM 1195THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 2712 years: RYGB 26.9% body weight loss, 2.0% and 0.9% in control groups 1, 2, respectively; T2DM remission in 51% RYGB group; odds ratio for the incidence T2DM 0.08 (95% CI,


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Surgery_Schwartz. OF OBESITYCHAPTER 2712 years: RYGB 26.9% body weight loss, 2.0% and 0.9% in control groups 1, 2, respectively; T2DM remission in 51% RYGB group; odds ratio for the incidence T2DM 0.08 (95% CI, 0.03 to 0.24) for RYGB vs. control group 1 and 0.09 (95% CI, 0.03 to 0.29) RYGB vs. control group 2 (P <0.001 for both comparisons); RYGB group had higher remission rates and lower incidence rates of hypertension and dyslipidemia than did control group 1 (P <0.05 for all comparisons).Maciejewski et al,205-208 2011, 2012, 2015, 2016 (Department of Veterans Affairs)Retrospective observational with matched controls847 to 1787 to 2500 surgical cases and their matched controls6.7 yearsPatients undergoing RYGB lost 28.6% (95% CI, 19.5%–37.6%) of their baseline weight at 10 years, whereas nonsurgical matches lost 7.3% (95% CI, 1.4%–13.3%) of their baseline weight at 10 years. Patients undergoing RYGB lost 21% (95% CI, 11%–31%) more of their baseline weight at 10 years than nonsurgical matches. A


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Surgery_Schwartz. matches lost 7.3% (95% CI, 1.4%–13.3%) of their baseline weight at 10 years. Patients undergoing RYGB lost 21% (95% CI, 11%–31%) more of their baseline weight at 10 years than nonsurgical matches. A total of 405 of 564 patients undergoing RYGB (71.8%) had more than 20% body weight loss and 224 of 564 (39.7%) had more than 30% estimated weight loss at 10 years.At 4 years, patients undergoing LRYGB lost 27.5% (95% CI, 23.8%–31.2%) of their baseline weight, patients undergoing LAGB lost 10.6% (95% CI, 0.6%–20.6%), and patients undergoing SG lost 17.8% (95% CI, 9.7%–25.9%).Surgery was not significantly associated with lower health expenditures 3 years after the procedure, in first study.First study, in 2011, bariatric surgery not significantly associated with reduced mortality.Later study, at the end of 14 years, 263 deaths in the surgical group (mean follow-up, 6.9 years) and 1277 deaths in control group (mean follow-up, 6.6 years). Mortality rates were 2.4% at 1 year, 6.4% at 5


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Surgery_Schwartz. at the end of 14 years, 263 deaths in the surgical group (mean follow-up, 6.9 years) and 1277 deaths in control group (mean follow-up, 6.6 years). Mortality rates were 2.4% at 1 year, 6.4% at 5 years, and 13.8% at 10 years for surgical patients; for matched control patients, 1.7% at 1 year, 10.4% at 5 years, and 23.9% at 10 years. Significantly lower mortality after 1 to 5 years (HR, 0.45 [95% CI, 0.36–0.56]) and 5 to 14 years (HR, 0.47 [95% CI, 0.39–0.58]).Not randomized; includes older (mean age, 55 years), primarily male (74%) veterans; mortality studies mostly RYGB procedures(Continued)Brunicardi_Ch27_p1167-p1218.indd 119523/02/19 2:21 PM 1196SPECIFIC CONSIDERATIONSPART IICourcoulas et al,59,169 2009, 2013, 2017 (Longitudinal Assessment of Bariatric Surgery [LABS])Prospective observational4776 in LABS-1, 30 day safety study and 2458 in LABS-2, effectiveness study (70.7% RYGB; 24.8% LAGB; and 5% other procedures)30 days, 3 years, 7 years3 year: 31.5% for RYGB and 15.9% for


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Surgery_Schwartz. in LABS-1, 30 day safety study and 2458 in LABS-2, effectiveness study (70.7% RYGB; 24.8% LAGB; and 5% other procedures)30 days, 3 years, 7 years3 year: 31.5% for RYGB and 15.9% for LAGB; T2DM remission in 67.5% of RYGB cases and 28.6% for LAGB; incidence of T2DM was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia remission in 61.9% RYGB cases and 27.1% AGB cases; HTN remission in 38.2% RYGB cases and 17.4% AGB cases; other procedures’ results not reported7 year: 28.4% for RYGB and 14.9% for LAGB; T2DM remission in 60.2% of RYGB cases and 20.3% for LAGB30 days: 0.3% overall; 0% LAGB, 0.2% LRYGB, and 2.1% open RYGB.3 years: 0.9 per 300 person-years for TYGB and 0.8 per 300 person-years for LAGB, i.e., number of events if 100 people were followed for 3 years7 years: 3.7 per 700 person-years for RYGB and 2.7 per 700 person years for LAGB, i.e., number of events if 100 people were followed for 7 yearsNot randomized; lacks nonsurgical control population; primarily RYGB and LAGB


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Surgery_Schwartz. for RYGB and 2.7 per 700 person years for LAGB, i.e., number of events if 100 people were followed for 7 yearsNot randomized; lacks nonsurgical control population; primarily RYGB and LAGB procedures; high follow-up rates (>80% for weight) but some not in-personArterburn et al,212,213 2013 (HMO Research Network)1. Retrospective observational2. Retrospective observational with matched controls4434 RYGB cases with T2DM1395 cases; 72% RYGB, 2% SG, 4% LAGB, 13% otherMedian, 3.1 years2 years68% of patients (95% CI, 66–70) experienced an initial T2DM remission within 5 years after RYGB; among these, 35.1% (95% CI, 32–38) redeveloped T2DM within 5 years; median duration of T2DM remission, 8.3 yearsBariatric cases higher T2DM remission rates [73.7% (95% CI: 70.6, 76.5)] vs. controls [6.9% (95%CI: 6.9, 7.1)]. Bariatric cases lower relapse rates T2DM than controls (adjusted HR: 0.19; 95% CI: 0.15–0.23)Not reportedNo higher risk of death in control vs. bariatric within 2 years (adjusted HR =


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Surgery_Schwartz. 6.9, 7.1)]. Bariatric cases lower relapse rates T2DM than controls (adjusted HR: 0.19; 95% CI: 0.15–0.23)Not reportedNo higher risk of death in control vs. bariatric within 2 years (adjusted HR = 0.54; 95% CI: 0.22 to 1.23).1. Not randomized; lacks nonsurgical control population; only RYGB procedures2. Not randomized, electronic medical record data, small number SGCarlin et al,215 2013 (Michigan Bariatric Surgery Collaborative)Prospective observational8847 to 35,477, varies depending on publication30 days to 3 years, varies depending on publicationComplication rates for SG (6.3%) were significantly lower than for RYGB (10.0%; P <.001) but higher than LAGB (2.4%; P <.001). Excess body weight loss at 1 year was 13% lower for SG (60%) than for RYGB (69%; P <.001) but was 77% higher for SG than for LAGB (34%; P <.001).Not reportedNot randomized; lacks nonsurgical control; patients from a single stateaData from Courcoulas AP, Yanovski SZ2, Bonds D, et al: Long-term outcomes of bariatric


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Surgery_Schwartz. than for LAGB (34%; P <.001).Not reportedNot randomized; lacks nonsurgical control; patients from a single stateaData from Courcoulas AP, Yanovski SZ2, Bonds D, et al: Long-term outcomes of bariatric surgery: a National Institutes of Health symposium, JAMA Surg. 2014 Dec;149(12):1323-1329.Table 27-6Long-term studies of bariatric surgery outcomesa (Continued)AUTHORSTUDY DESIGNPOPULATIONS AND PROCEDURESFOLLOW-UP DURATIONPUBLISHED OUTCOMESMORTALITY AND SURVIVALLIMITATIONSBrunicardi_Ch27_p1167-p1218.indd 119623/02/19 2:21 PM 1197THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27found that bariatric surgery was associated with a reduced inci-dence of fatal or nonfatal cancer among women but not in men. Finally, at 16 years follow-up, surgery was associated with a 29% lower risk of death (the primary endpoint of the study) from any cause compared to usual care, with the most common causes of death being cancer and myocardial infarction196-201 (see Table 27-6).Utah Obesity Studies. Another


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Surgery_Schwartz. primary endpoint of the study) from any cause compared to usual care, with the most common causes of death being cancer and myocardial infarction196-201 (see Table 27-6).Utah Obesity Studies. Another important long-term obser-vational study performed in Utah from 1984 to 2002 included 7925 people who had undergone RYGB and 7925 weight, age, and sex matched controls. This study showed a 40% reduction in all-cause mortality (hazard ratio 0.60, 0.45 to 0.67; P <0.001) and a 49% (0.51, 0.36 to 0.73; P <0.001) and 92% (0.08, 0.01 to 0.47; P = 0.005) reduction in death from cardiovascular disease and death related to T2DM, respectively, at an average of 7.1 years later.202A separate ongoing prospective Utah Obesity Study involving over 400 RYGB cases and two nonrandomized, matched control groups—each with over 400 and 300 severely obese subjects (one group were people seeking surgery that did not undergo operation; the other was a population-based severely obese control group)—has found


Surgery_Schwartz

Surgery_Schwartz. with over 400 and 300 severely obese subjects (one group were people seeking surgery that did not undergo operation; the other was a population-based severely obese control group)—has found that the surgery group lost 27.7% of their initial body weight compared to 0.2% weight gain in control group 1 (surgery seekers), and 0% change in control group 2 (population-based control) at 6 years. Diabetes was in remission in 62% of RYGB patients and only 8% and 6% in each of the control groups, while incident T2DM was observed in 2% of RYGB patients and in 17% and 15% of the control groups at 6 years.203 The 12-year follow-up results were also recently published and showed long-term durability of weight loss and effective remission and prevention of T2DM, hypertension, and dyslipidemia after RYGB.204 Follow-up rates in this study were high at over 90% at 12 years. The mean per-cent change from baseline in body weight in the RYGB group was −26.9% at 12 years compared to −2.0% and 0.9% in each


Surgery_Schwartz

Surgery_Schwartz. Follow-up rates in this study were high at over 90% at 12 years. The mean per-cent change from baseline in body weight in the RYGB group was −26.9% at 12 years compared to −2.0% and 0.9% in each of the two control groups. There was remission of T2DM in 43 of 84 patients (51%) at 12 years. The OR for the incidence of T2DM at 12 years was 0.08 (95% CI, 0.03–0.24) for the RYGB group versus control group 1 and 0.09 (95% CI, 0.03–0.29) for the RYGB group versus control group 2 (P <0.001 for both comparisons). The RYGB group had higher remission rates and lower incidence rates of hypertension and dyslipidemia than did control group 1 (P <0.05 for all comparisons) (see Table 27-6).Veteran’s Administration Study. A retrospective obser-vational study involving 847 U.S. veterans who were older and more high risk than in typical bariatric studies, found no significant association between bariatric surgery and survival compared to usual care at mean 6.7 years follow-up.205 When matched to control


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Surgery_Schwartz. high risk than in typical bariatric studies, found no significant association between bariatric surgery and survival compared to usual care at mean 6.7 years follow-up.205 When matched to control subjects, the outpatient, inpatient, and total expenditures were higher for bariatric surgical cases in the 3 years leading up to the procedure and then went back to the lower cost levels of nonsurgical controls in 3 years after the procedure. The conclusion from this study was that bariatric surgery did not appear to be associated with reduced health care expenditures 3 years after the procedure.206In a follow-up retrospective cohort study, 2500 U.S. veterans (74% men) who underwent bariatric surgery (74% gastric bypass, 15% sleeve gastrectomy, 10% adjustable gastric banding, and 1% other) were matched to 7462 control patients. The primary outcome was all-cause mortality. In this study, surgical patients (n = 2500) had a mean age of 52 years and a mean BMI of 47. Matched control patients (n


Surgery_Schwartz

Surgery_Schwartz. matched to 7462 control patients. The primary outcome was all-cause mortality. In this study, surgical patients (n = 2500) had a mean age of 52 years and a mean BMI of 47. Matched control patients (n = 7462) had a mean age of 53 years and a mean BMI of 46. At the end of the 14-year study period, there were a total of 263 deaths in the surgical group (mean follow-up, 6.9 years) and 1277 deaths in the matched control group (mean follow-up, 6.6 years). Mor-tality rates were 2.4% at 1 year, 6.4% at 5 years, and 13.8% at 10 years for surgical patients; for matched control patients, 1.7% at 1 year, 10.4% at 5 years, and 23.9% at 10 years. So, in this later study, there was significantly lower all-cause mortal-ity at longer follow-up. 207Ten-year weight change in 1787 veterans who underwent RYGB compared to controls, and separately, 4-year weight change in veterans who underwent RYGB (n = 1785), SG (n = 379), and AGB (n = 246) were reported. Patients undergo-ing RYGB lost 21% more of their


Surgery_Schwartz

Surgery_Schwartz. compared to controls, and separately, 4-year weight change in veterans who underwent RYGB (n = 1785), SG (n = 379), and AGB (n = 246) were reported. Patients undergo-ing RYGB lost 21% more of their baseline weight at 10 years than nonsurgical matches. A total of 405 of 564 patients under-going RYGB (71.8%) had more than 20% weight loss, and 224 of 564 (39.7%) had more than 30% weight loss at 10 years com-pared with 134 of 1247 (10.8%) and 48 of 1247 (3.9%), respec-tively, for nonsurgical matches. At 4 years, patients undergoing LRYGB lost 27.5% of their baseline weight, patients undergo-ing LAGB lost 10.6%, and patients undergoing SG lost 17.8%. Patients undergoing RYGB lost 16.9% more of their baseline weight than patients undergoing AGB and 9.7% more than patients undergoing SG208 (see Table 27-6).The Longitudinal Assessment of Bariatric Surgery Study. The Longitudinal Assessment of Bariatric Surgery (LABS-1) study, a multicenter observational surgical cohort, prospectively


Surgery_Schwartz

Surgery_Schwartz. (see Table 27-6).The Longitudinal Assessment of Bariatric Surgery Study. The Longitudinal Assessment of Bariatric Surgery (LABS-1) study, a multicenter observational surgical cohort, prospectively assessed 30-day safety among 4776 severely obese patients who underwent a first bariatric surgical procedure (25% AGB, 62% laparoscopic RYGB, 9% open RYGB, and 3% another procedure) between 2005 and 2007.59 The 30-day mortality in the LABS study was 0.3% for all procedures with a major adverse outcome rate (a predefined composite endpoint that included death, venous thromboembolism, reintervention [percutaneous, endoscopic, or operative], or failure to be discharged from the hospital in 30 days) of 4.1%. These results did vary by procedure and approach, with no mortality in the 1198 patients who had undergone LAGB, 0.2% of the 2975 patients who had undergone LRYGB, and 2.1% of the 437 patients who had undergone open RYGB. Similarly, the rate of adverse outcomes (morbidity) occurred in 4.1%


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Surgery_Schwartz. had undergone LAGB, 0.2% of the 2975 patients who had undergone LRYGB, and 2.1% of the 437 patients who had undergone open RYGB. Similarly, the rate of adverse outcomes (morbidity) occurred in 4.1% of patients overall; 1.0% for LAGB, 4.8% for LRYGB, and 7.8% for open RYGB.59 The Longitudinal Assessment of Bariatric Surgery (LABS-2) study is another large prospective multicenter observational bariatric cohort study that was not randomized and did not include a nonsurgical control group. LABS-2 assessed weight change and comorbid conditions in 2458 participants (1738 RYGB—both open and laparoscopic, 610 LAGB, and 110 other procedures) recruited between 2005 and 2009 who were followed for 7 years.169,209 At baseline, 33% had diabetes, 63% had dyslipidemia, and 68% had hypertension. In the LABS-2 cohort, median weight change was 31.5% for RYGB and 15.9% for adjustable gastric banding after 3 years, with much variability in response to each surgical treatment. Remission of T2DM was noted


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Surgery_Schwartz. cohort, median weight change was 31.5% for RYGB and 15.9% for adjustable gastric banding after 3 years, with much variability in response to each surgical treatment. Remission of T2DM was noted in 67% and 28% of those who had undergone RYGB and LAGB, respectively. The incidence T2DM was 0.9% and 3.2%, respectively, over the 3 years169 (see Table 27-6). LABS-2 looked at both preand postoperative predictors of weight change and found that very few of many baseline variables studied (Black race, T2DM) were associated Brunicardi_Ch27_p1167-p1218.indd 119723/02/19 2:21 PM 1198SPECIFIC CONSIDERATIONSPART IIwith 3-year weight change, and the effects were small overall. Postoperatively, for RYGB only, three behaviors explained most of the variability (16%) in 3-year weight change: weekly self-weighing, continuing to eat when feeling full more than once a week, and eating continuously during the day. If a person started weekly self-weighing, stopped eating when feeling full, and stopped


Surgery_Schwartz

Surgery_Schwartz. continuing to eat when feeling full more than once a week, and eating continuously during the day. If a person started weekly self-weighing, stopped eating when feeling full, and stopped eating continuously during the day, they lost 14% more weight than those who made no positive changes (38.8% vs. 24.6% TBWL).210,211At 7 years of follow-up, in LABS, data completeness for weight was high (83%), and the median weight change was 28.4% for RYGB and 14.9% for LAGB. Weight regain between years 3 and 7 was 3.9% of baseline weight for RYGB and 1.4% for LAGB, but 75% of RYGB participants maintained at least 20% total body weight loss, and 50% of LAGB participants maintained at least 16% through 7 years. Remission of T2DM was reported in 60.2% of RYGB cases and 20.3% for LAGB. Mortality was reported as 3.7 per 700 person-years for RYGB and 2.7 per 700 person years for LAGB, i.e., number of events if 100 people were followed for 7 years. Reoperations were also much more common after LAGB


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Surgery_Schwartz. reported as 3.7 per 700 person-years for RYGB and 2.7 per 700 person years for LAGB, i.e., number of events if 100 people were followed for 7 years. Reoperations were also much more common after LAGB compared to RYGB at 7 years (see Table 27-6).HMO Research Network. Arterburn and colleagues have leveraged the integrated health network system to study bariatric outcomes using the electronic health/medical record. They studied clinical predictors of diabetes remission and relapse among patients undergoing gastric bypass. Theirs was a retrospective cohort study of adults with uncontrolled or medication-controlled T2DM who underwent gastric bypass in three integrated health care delivery systems in the United States. Remission and relapse events were defined by diabetes medication use and clinical laboratory measures of glycemic control. Of 4434 adults with T2DM who underwent RYGB, 68.2% (95% CI, 66% and 70%) experienced an initial complete diabetes remission within 5 years after


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Surgery_Schwartz. and clinical laboratory measures of glycemic control. Of 4434 adults with T2DM who underwent RYGB, 68.2% (95% CI, 66% and 70%) experienced an initial complete diabetes remission within 5 years after surgery. Among these, 35.1% (95% CI, 32% and 38%) relapsed back to T2DM within 5 years. The median duration of their remission was 8.3 years. Predictors of incomplete remission and relapse were poor preoperative glycemic control, insulin use, and longer diabetes duration212 (see Table 27-6).In a second study, they compared rates of diabetes remission, relapse, and all-cause mortality at 2 years between severely obese adults with T2DM who underwent bariatric surgery or received usual medical care. There were 1395 adults with T2DM who had bariatric surgery and 62,322 who did not. Most procedures were RYGB (72.0% laparoscopic; 8.2% open); 4.4% were gastric banding, 2.4% were sleeve gastrectomy, and 13.2% were other procedures. At 2 years, bariatric subjects experienced significantly higher


Surgery_Schwartz

Surgery_Schwartz. were RYGB (72.0% laparoscopic; 8.2% open); 4.4% were gastric banding, 2.4% were sleeve gastrectomy, and 13.2% were other procedures. At 2 years, bariatric subjects experienced significantly higher diabetes remission rates (73.7% [95% CI: 70.6, 76.5]) compared to nonsurgical subjects (6.9% [95% CI: 6.9, 7.1]). Age, site, duration of diabetes, hemoglobin A1c level, and intensity of diabetes medication treatment were significantly associated with remission. Bariatric subjects also experienced lower relapse rates than nonsurgical subjects (adjusted HR: 0.19; 95% CI: 0.15–0.23) with no higher risk of death (adjusted HR: 0.54; 95% CI: 0.22–1.30) (see Table 27-6).213 This group also studied short-term comparative effectiveness outcomes between procedures (LRYGB and LAGB) and found that LRYGB resulted in much greater weight loss than LAGB but had a higher risk of short-term complications and long-term subsequent hospitalizations.214Michigan Bariatric Surgery Collaborative. The Michigan


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Surgery_Schwartz. resulted in much greater weight loss than LAGB but had a higher risk of short-term complications and long-term subsequent hospitalizations.214Michigan Bariatric Surgery Collaborative. The Michigan Bariatric Surgery Collaborative is a statewide consortium of hospitals and surgeons that maintains an externally audited prospective clinical registry. The comparative effectiveness of SG, LRYGB, and LAGB procedures was studied in this data-set. Nearly 3000 SG patients with equal numbers of RYGB and LAGB patients were matched on 23 baseline characteristics. Outcomes assessed included 30-day complications, weight loss, quality of life, and comorbid remission up to 3 years after bar-iatric surgery. Overall complication rates for SG (6.3%) were significantly lower than for RYGB (10%) but higher than for LAGB (2.4%). Serious complication rates were similar for SG (2.4%) and LRYGB (2.5%) but higher than for LAGB (1.0%). Excess body weight loss at 1 year was 13% lower for SG (60%) than for RYGB


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Surgery_Schwartz. for LAGB (2.4%). Serious complication rates were similar for SG (2.4%) and LRYGB (2.5%) but higher than for LAGB (1.0%). Excess body weight loss at 1 year was 13% lower for SG (60%) than for RYGB (69%), but was 77% higher for SG than for LAGB (34%). Remission of comorbid conditions was similar between SG and LRYGB215 (see Table 27-6).This group also developed a risk prediction model for seri-ous 30-day complications after bariatric surgery. Overall, 2.5% of patients experienced a serious complication. Significant risk factors included prior venous thromboembolism (OR 1.90, CI 1.41–2.54); mobility limitations (OR 1.61, CI 1.23–2.13); coro-nary artery disease (OR 1.53, CI 1.17–2.02); age over 50 (OR 1.38, CI 1.18–1.61); pulmonary disease (OR 1.37, CI 1.15–1.64); male gender (OR 1.26, CI 1.06–1.50); smoking history (OR 1.20, CI 1.02–1.40); and procedure type.216 Further, to assess the rela-tionship between IVC filter insertion and complications while controlling for differences in


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Surgery_Schwartz. CI 1.06–1.50); smoking history (OR 1.20, CI 1.02–1.40); and procedure type.216 Further, to assess the rela-tionship between IVC filter insertion and complications while controlling for differences in baseline patient characteristics and medical venous thromboembolism prophylaxis, this group pub-lished an additional study, and 35,477 patients from 32 hospitals in Michigan were included. Patients receiving IVC filters had higher rates of pulmonary embolism, deep vein thrombosis, venous thromboembolism, serious complications, and death.217Recently, this group has also been evaluating the effect of surgical skill and operative technique on complications follow-ing bariatric surgery.218,219Other StudiesMetabolic and Bariatric Surgery Quality Improvement Pro-gram (MBASQIP). This is a prospective, multi-institutional, national database that has been used to compare SG to RYGB and LAGB. The study from 2011 was short term and compared 30-day, 6-month, and 1-year outcomes including morbidity


Surgery_Schwartz

Surgery_Schwartz. multi-institutional, national database that has been used to compare SG to RYGB and LAGB. The study from 2011 was short term and compared 30-day, 6-month, and 1-year outcomes including morbidity and mortality, readmissions, and reoperations as well as reduction in BMI and weight-related comorbid conditions. The findings were that SG has higher risk-adjusted morbidity, readmission and reop-eration/intervention rates compared to LAGB, but lower reopera-tion/intervention rates compared to RYGB either laparoscopic or open. There were no differences in mortality. Reduction in BMI and most of the weight-related comorbidities after SG was also between LAGB and RYGB rates.140A later study addressed the impact of various SG techniques on short-term (30-day) outcomes. Using the MBSAQIP data reg-istry, 189,477 SG operations that were performed at over 700 cen-ters in the United States were analyzed. Cases in which staple line reinforcement was used were associated with higher leak rates and


Surgery_Schwartz

Surgery_Schwartz. 189,477 SG operations that were performed at over 700 cen-ters in the United States were analyzed. Cases in which staple line reinforcement was used were associated with higher leak rates and lower bleeding rates. Bougie size ≥38 French was associated with significantly lower leak rates compared to <38 French.162 Longer-term data will eventually be available from this national dataset, but the completeness of follow-up has not yet been determined.Geisinger Health System. This is an electronic medical record database in a large rural integrated health system. They Brunicardi_Ch27_p1167-p1218.indd 119823/02/19 2:21 PM 1199THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27have published long-term results (7–12 years) of the percent-age of TBWL and preoperative predictors for LRYGB in approximately 700 patients. Over 200 preoperative clinical fac-tors were studied. At a median of 9.3 postoperative years fol-lowing surgery, the mean (SD) percentage TBWL was 22.5% (13.1%). Preoperative


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Surgery_Schwartz. 700 patients. Over 200 preoperative clinical fac-tors were studied. At a median of 9.3 postoperative years fol-lowing surgery, the mean (SD) percentage TBWL was 22.5% (13.1%). Preoperative insulin use, history of smoking, and use of 12 or more medications before surgery were associated with greater long-term weight loss; 6.8%, 2.8%, and 3.1%, respec-tively. Preoperative hyperlipidemia, older age, and higher body mass index were associated with poorer long-term weight loss (−2.8%, −8.8%, and −4.1%, respectively). Again, there were only a few preoperative clinical factors associated with differ-ences in long-term weight loss after RYGB.220This group also developed a method to predict the probability of T2DM remission after RYGB surgery on the basis of preop-erative clinical criteria in a retrospective cohort study. Over 200 clinical variables were used to identify independent predictors of remission within 5 years and to produce a score (DiaRem) to assess this likelihood. Records were


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Surgery_Schwartz. cohort study. Over 200 clinical variables were used to identify independent predictors of remission within 5 years and to produce a score (DiaRem) to assess this likelihood. Records were available for 690 patients in the pri-mary cohort, of whom 463 (63%) had achieved partial or com-plete T2DM remission. Four preoperative clinical variables were included in the final model: insulin use, age, HbA1c concentration, and type of antidiabetic drugs. The DiaRem score was developed from that, and it ranges from 0 to 22 with the proportion of patients achieving remission being highest for the lowest scores.221Comparisons Between ProceduresThere have been many systematic reviews of bariatric surgery attempting to summarize and quantify differences in the efficacy and safety of the different surgical procedures. A major challenge in summarizing this literature from the last 10 years is the fact that no single randomized trial has included all of the most com-mon procedures (RYGB, LAGB, SG, and


Surgery_Schwartz

Surgery_Schwartz. procedures. A major challenge in summarizing this literature from the last 10 years is the fact that no single randomized trial has included all of the most com-mon procedures (RYGB, LAGB, SG, and BPD/DS), so infer-ence must be made through pooled analysis of data from many disparate randomized and non-randomized studies of bariatric surgery with different lengths and completeness of follow-up. There are also no studies that have examined differences in long-term survival, incident cardiovascular events, and quality of life across bariatric procedures.1 Still one of the most compre-hensive systematic reviews by Buchwald included 136 studies and a total of 22,094 bariatric patients. Only 5 of the included studies were randomized trials (28 non-RCTs and 101 uncon-trolled case series) and the review did not include any data on the SG procedure, so will need to be updated. This review found a strong trend towards different weight loss outcomes across procedures: weighted mean percentage


Surgery_Schwartz

Surgery_Schwartz. review did not include any data on the SG procedure, so will need to be updated. This review found a strong trend towards different weight loss outcomes across procedures: weighted mean percentage of excess weight loss (%EWL) 50% for LAGB; 68% for RYGB; 69% for VBG; and 72% for BPD/DS. The rate of T2DM remission also appeared to differ across procedures: 48% for LAGB; 84% for RYGB; 72% for VBG; and 99% for BPD/DS. A similar pattern of dis-ease remission was observed for dyslipidemia, hypertension, and obstructive sleep apnea, with the greatest rates of remission observed among BPD/DS patients, followed by RYGB patients, with the least disease remission among LAGB patients.192There is still ongoing debate regarding the comparative effectiveness of the three most common procedures currently in use: LRYGB, SG, and LAGB. Several other systematic reviews have concluded that LRYGB is more effective for weight loss than LAGB; however, there have been only two small RCTs with follow-up at 4


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Surgery_Schwartz. in use: LRYGB, SG, and LAGB. Several other systematic reviews have concluded that LRYGB is more effective for weight loss than LAGB; however, there have been only two small RCTs with follow-up at 4 and 5 years addressing this issue specifically.65,222,223 There is evolving data from a number of smaller RCTs to examine differences between LRYGB, LAGB, and SG for comorbidity improvement (addressed in “Results of Surgery for Diabetes”), but systematic reviews of nonrandomized studies indicate greater remission of T2DM, dyslipidemia, hypertension, and sleep apnea with LRYGB compared to LAGB. Two recent systematic reviews have compared the outcomes of the SG with other procedures.224,225 One review identified 15 RCTs involving 1191 patients. The percent excess body weight loss (%EBWL) ranged from 49% to 81% for SG, from 62% to 94% for LRYGB, and from 29% to 48% for LAGB, with a follow-up ranging from 6 months to 3 years. The T2DM remission rate ranged from 27% to 75% for SG vs. 42% to 93%


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Surgery_Schwartz. 49% to 81% for SG, from 62% to 94% for LRYGB, and from 29% to 48% for LAGB, with a follow-up ranging from 6 months to 3 years. The T2DM remission rate ranged from 27% to 75% for SG vs. 42% to 93% for RYGB. The second review only compared SG to RYGB and identified 6 RCTs and two nonrandomized controlled studies with follow-up ranging from 3 months to 2 years. They found that LRYGB achieved significantly greater improvement in BMI than SG (1.8 kg/m2) and greater improvements in metabolic factors. Longer-term comparative effectiveness data on SG are still needed, but the effectiveness of the SG procedure, again, appears to be positioned between the LRYGB and LAGB procedures.Resolution of Specific Comorbid ConditionsBariatric surgery can improve and induce remission of many obesity-related comorbid conditions. Nevertheless, the remis-sion rates can decline over time due to relapse of disease, and as follow-up lengthens, complete and more longer-term follow-up data is needed in some


Surgery_Schwartz

Surgery_Schwartz. comorbid conditions. Nevertheless, the remis-sion rates can decline over time due to relapse of disease, and as follow-up lengthens, complete and more longer-term follow-up data is needed in some areas.Cardiovascular Disease. A recent systematic review of long-term cardiovascular risk factor reduction after bariatric surgery involved 73 studies and 19,543 subjects with a mean age of 42 years; 76% of subjects were female, and 44%, 24%, and 44% had baseline hypertension, diabetes, and hyperlipidemia, respectively.226 At a mean follow-up of 57.8 months, the aver-age excess weight loss for all bariatric procedures was 54%, and remission/improvement was 63% for hypertension, 73% for T2DM, and 65% for hyperlipidemia. Echocardiographic results from 713 subjects showed statistically significant improve-ments in hemodynamics. There are no long-term RCTs com-paring bariatric surgery with nonsurgical medical treatment of obesity that specifically evaluate cardiovascular endpoints and


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Surgery_Schwartz. improve-ments in hemodynamics. There are no long-term RCTs com-paring bariatric surgery with nonsurgical medical treatment of obesity that specifically evaluate cardiovascular endpoints and cardiovascular mortality. However, 12 cohort-matched studies comparing bariatric surgery with nonsurgical controls have been reviewed.227 Collectively, all but two of these studies support a reduced cardiovascular event rate and all-cause mortality rate conferred by bariatric surgery. Of these studies, the Swedish Obesity Subjects (SOS) study still has the longest outcomes.Gastroesophageal Reflux Disease. Patients with obesity and GERD have a higher chance of failing to obtain symptomatic relief from standard antireflux surgery. The recurrence of symp-toms is higher, likely due to a higher incidence of wrap hernia-tion into the mediastinum and other mechanical failure of the fundoplication, which in turn is likely affected by the increased intra-abdominal pressure of the obese condition. The


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Surgery_Schwartz. of wrap hernia-tion into the mediastinum and other mechanical failure of the fundoplication, which in turn is likely affected by the increased intra-abdominal pressure of the obese condition. The patient with a BMI over 35 kg/m2 who has GERD has a better chance of symptom improvement by undergoing LRYGB, which is effective for the treatment of GERD.228,229 LRYGB creates such a small gastric pouch that it has a very limited volume for acid production. LAGB may worsen or may improve GERD but to a considerably lesser extent than RYGB. A prospective analysis of 558 consecutive SG (n = 200) and LRYGB (n = 358) patients demonstrated significantly improved subjective GERD symp-toms in the bypass cohort when compared to the SG patients at Brunicardi_Ch27_p1167-p1218.indd 119923/02/19 2:21 PM 1200SPECIFIC CONSIDERATIONSPART II1 year.230 Studies show that SG can increase GERD symptoms postoperatively.Obstructive Sleep Apnea. A systematic review of 13,900 patients (69 studies) showed


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Surgery_Schwartz. PM 1200SPECIFIC CONSIDERATIONSPART II1 year.230 Studies show that SG can increase GERD symptoms postoperatively.Obstructive Sleep Apnea. A systematic review of 13,900 patients (69 studies) showed significant improvement or reso-lution of sleep apnea in more than 75% of bariatric surgery patients.231 Comparison of outcomes between procedures dem-onstrated the most benefit with BPD and RYGB and the least with LAGB. However, a randomized control trial comparing the effect of medical and surgical weight loss (LAGB) on sleep apnea found no significant difference in apnea events despite major differences in weight loss. The findings suggested that much of the improvement achieved was in the mild to moderate weight loss range, with little benefit of further weight loss.232Asthma. Another pulmonary symptom that commonly occurs in severely obese patients is asthma. Dixon and colleagues233 studied 23 asthmatic patients who underwent bariatric surgery and found a significant improvement in


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Surgery_Schwartz. symptom that commonly occurs in severely obese patients is asthma. Dixon and colleagues233 studied 23 asthmatic patients who underwent bariatric surgery and found a significant improvement in asthma control (e.g., forced expiratory volume in 1 second, forced vital capacity), asthma-related quality of life, and responsiveness to methacholine. Boulet and colleagues234 found similar results in their cohort of 12 patients with asthma who experienced significant weight loss after bariatric surgery.Nonalcoholic Fatty Liver Disease. Nonalcoholic Fatty Liver Disease (NAFLD) is a metabolically related problem associated with obesity. The disease is a spectrum of liver abnormalities including steatosis, steatohepatitis, fibrosis, and cirrhosis of the liver. It is estimated that 20% of U.S. adults have NAFLD, largely because of the high incidence of obesity. NAFLD is present in an estimated 85% of patients with severe obesity.235 Although further research is needed to accurately assess the role


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Surgery_Schwartz. NAFLD, largely because of the high incidence of obesity. NAFLD is present in an estimated 85% of patients with severe obesity.235 Although further research is needed to accurately assess the role of bariatric surgery as a potential treatment for NAFLD, there are some reports that support its use. A systematic review of the available literature found many retrospective and prospective observational cohort studies, but no RCTs or case-control series.236Musculoskeletal Disease. Degenerative joint disease and low back pain are among the most common complaints and asso-ciated comorbid problems in the severely obese population. A prospective cohort of 50 obese females age 20 to 74 years were followed for 1 year after LRYGB using the timed-get-up-and-go (TGUG) and health survey SF-36.237 The results showed a significant improvement in musculoskeletal function and likely enhanced ability to progress in rehabilitation. Patients with osteoarthritis of the neck, shoulder, spine, hip, knee,


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Surgery_Schwartz. results showed a significant improvement in musculoskeletal function and likely enhanced ability to progress in rehabilitation. Patients with osteoarthritis of the neck, shoulder, spine, hip, knee, ankle, wrist, and hand have been shown to have improved or resolved joint pain after bariatric surgery. Reduction in BMI values of 6.2 to 14.7 kg/m2 has corresponded with back and knee pain resolution in 5% to 100% of patients, whereas pain severity was reduced in 31% to 94% of patients depending on the joint and study.238The LABS-2 Study published data on pain and physical function in over 2200 participants. At year 1, clinically mean-ingful improvements were shown in 57.6% of participants for bodily pain, 76.5% for physical function, and 59.5% for walk time. Additionally, among participants with severe knee or dis-ability (633), or hip pain or disability (500) at baseline, approxi-mately three-fourths experienced joint-specific improvements in knee pain (77.1%) and in hip function


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Surgery_Schwartz. with severe knee or dis-ability (633), or hip pain or disability (500) at baseline, approxi-mately three-fourths experienced joint-specific improvements in knee pain (77.1%) and in hip function (79.2%). But between year 1 and year 3, rates of improvement significantly decreased for both bodily pain and for physical function.239Quality of Life. Few long-term studies have assessed the impact of bariatric surgery on overall quality of life. However, three studies of 6 to 10 years’ duration suggest that bariatric pro-cedures are associated with greater improvements in overall and obesity specific measures of quality of life compared to medical treatment or care.240-242 Physical functioning aspects of quality of life seem to be more responsive to bariatric procedures than mental health domains, although more research is needed, espe-cially in patients with less severe (class 1) obesity.Results of Surgery for Diabetes (Metabolic Surgery)Based on an abundance of recent observational studies


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Surgery_Schwartz. although more research is needed, espe-cially in patients with less severe (class 1) obesity.Results of Surgery for Diabetes (Metabolic Surgery)Based on an abundance of recent observational studies and RCTs, bariatric surgery is increasingly used with the primary intent to treat T2DM or metabolic disease, hence the term meta-bolic surgery.243 Observational, nonrandomized studies first demonstrated profound improvements in hyperglycemia and other cardiovascular risk factors following metabolic surgery that were followed by RCTs. Resolution or remission of T2DM is typically defined as becoming “nondiabetic” with normal HbA1c, without medications. One meta-analysis (2009) of 19 mostly observational studies (n = 4,070 patients) reported an overall T2DM remission rate of 78% after bariatric surgery with 1 to 3 years follow-up.244 The patients all had BMI >35 and gen-erally early/mild T2DM that likely increased remission rates. In the Swedish Obese Subjects study, the remission rate


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Surgery_Schwartz. surgery with 1 to 3 years follow-up.244 The patients all had BMI >35 and gen-erally early/mild T2DM that likely increased remission rates. In the Swedish Obese Subjects study, the remission rate follow-ing surgery was 72% at 2 years and 36% at 10 years compared with 21% and 13%, respectively, for the nonsurgical controls (P <.001).201 Metabolic surgery was also significantly more effective than nonsurgical treatment in preventing new onset cases of T2DM, with a relative risk reduction of 78%.A more recent systematic review (2012) evaluated long-term cardiovascular risk reduction after bariatric surgery in 73 studies and 19,543 patients.226 At a mean follow-up of 57.8 months, the average excess weight loss for all procedures was 54%, and rates of remission or improvement were 63% for hyper-tension, 73% for T2DM, and 65% for hyperlipidemia. Results from 12 cohort-matched, nonrandomized studies comparing bariatric surgery vs. nonsurgical controls demonstrated reduced cardiovascular


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Surgery_Schwartz. hyper-tension, 73% for T2DM, and 65% for hyperlipidemia. Results from 12 cohort-matched, nonrandomized studies comparing bariatric surgery vs. nonsurgical controls demonstrated reduced cardiovascular events and death (30–88% reduction) in patients with and without T2DM.227 One of these studies involving male veterans, who were mostly at high cardiovascular risk, reported a 42% reduction in mortality at 10 years compared with medical therapy.207 Similarly, in the Swedish Obese Subjects study, the mortality rate from cardiovascular disease in the bariatric surgical group was lower than for control patients (adjusted hazard ratio, 0.47; P = .002).201 For patients with T2DM in this study, surgery was associated with a 50% reduction in microvascular complica-tions (41.8 per 1000 person-years for control patients and 20.6 per 1000 person-years in the surgery group; hazard ratio, 0.44; P <.001).245 These observational, nonrandomized studies provide evidence that metabolic surgery is superior


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Surgery_Schwartz. control patients and 20.6 per 1000 person-years in the surgery group; hazard ratio, 0.44; P <.001).245 These observational, nonrandomized studies provide evidence that metabolic surgery is superior to medical manage-ment alone in improving glycemic control, reducing cardiovascu-lar risk factors, and lowering long-term morbidity and mortality of T2DM, yet supporting RCTs have been lacking until recently.During the past 10 years, 11 such RCTs have been published including 794 patients in total (Table 27-7).16,77-83,85,86,246-253 These RCTs included obese patients with T2DM (n = 794; range 38–150 patients per study) with follow-up from 6 months to 5 years (Fig. 27-27). All common metabolic surgical procedures were represented including LRYGB (9 studies), LAGB (5 studies), SG (2 studies), and BPD (1 study). T2DM severity varied significantly from mild (mean HbA1c 7.7%, <2-year onset, no insulin)253,77 to severe (mean HbA1c 9.3%, duration 8.3 years, 48% on insulin).78 The BMI ranged from


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Surgery_Schwartz. BPD (1 study). T2DM severity varied significantly from mild (mean HbA1c 7.7%, <2-year onset, no insulin)253,77 to severe (mean HbA1c 9.3%, duration 8.3 years, 48% on insulin).78 The BMI ranged from 25 to 53 kg/m2, with 11 of 12 studies including patients with BMI <35 kg/m2, also called class 1 obesity. Age, sex, and ethnic background were similar, 7Brunicardi_Ch27_p1167-p1218.indd 120023/02/19 2:21 PM 1201THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27Table 27-7Metabolic surgery randomized controlled trials for type 2 diabetes (n = 794)aSTUDYBMI (kg/m2), % OF PATIENTSDESIGNNO. OF PATIENTS RANDOMIZEDFOLLOW-UP (MONTHS)REMISSION CRITERIA*OUTCOME (REMISSION OR CHANGE IN HbA1C)Dixon77<35, 22%LAGB vs. control6024HbA1c <6.2%73% vs. 13%, P <0.001Schauer78,246,252<35, 36%RYGB vs. SG vs. control15060HbA1c ≤6.0%22% vs. 15% vs. 0, P<0.05Mingrone79,82>35, 100%RYGB vs. BPD vs. control6060HbA1c ≤6.5%42% vs. 68% vs. 0, P = 0.003Ikramuddin 80,247<35, 59%RYGB vs. control12024HbA1c <6%44% vs. 9%,


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Surgery_Schwartz. ≤6.0%22% vs. 15% vs. 0, P<0.05Mingrone79,82>35, 100%RYGB vs. BPD vs. control6060HbA1c ≤6.5%42% vs. 68% vs. 0, P = 0.003Ikramuddin 80,247<35, 59%RYGB vs. control12024HbA1c <6%44% vs. 9%, P <0.001Liang248<35, 100%RYGB vs. control10112HbA1c <6.5%**90% vs. 0 vs. 0, P <0.0001Halperin83<35, 34%RYGB vs. control3812HbA1c <6.5%58% vs. 16%, P = 0.03Courcoulas84,86<35, 43%RYGB vs. LAGB vs. control6936HbA1c <6.5%40% vs. 29% vs. 0, P = 0.004Wentworth250≤30, 100%LAGB vs. control5124Fasting blood glucose <7.0 mmol/L52% vs. 8%, P = 0.001Parikh251<35, 100%Bariatric surgery (RYGB, LAGB, SG) vs. control576HbA1c <6.5%65% vs. 0, P = 0.0001Ding85<35, 34%LAGB vs. control4512HbA1c <6.5%***33% vs. 23%, P = 0.46Cummings81<35, 25%RYGB vs. control4312HbA1c <6.0%60% vs. 5.9%, P = 0.002*Remission defined as reaching HbA1c value without medication, unless otherwise specified**Remission not precisely defined, extrapolated***On or off medicationsReproduced with permission from Schauer PR, Mingrone G2,


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Surgery_Schwartz. as reaching HbA1c value without medication, unless otherwise specified**Remission not precisely defined, extrapolated***On or off medicationsReproduced with permission from Schauer PR, Mingrone G2, Ikramuddin S, et al: Clinical Outcomes of Metabolic Surgery: Efficacy of Glycemic Control, Weight Loss, and Remission of Diabetes, Diabetes Care. 2016 Jun;39(6):902-911.although three studies80,247,248 included a significant number of Asian patients. For most studies, the primary endpoint was remission, defined as an HbA1c target at or below 6.0% to 6.5% without use of diabetes medications.Overall, these RCTs showed that surgery was signifi-cantly more effective than medical treatment in reaching remission and glycemic control (P <.05) (Fig. 27-27). The one exception showing no superiority of surgery involved gastric banding and resulted in a diabetes remission for LAGB vs. medical treatment of 33% and 23%, respectively (P >0.05).85 Overall, surgery decreased HbA1c by 2% to 3.5%, whereas


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Surgery_Schwartz. surgery involved gastric banding and resulted in a diabetes remission for LAGB vs. medical treatment of 33% and 23%, respectively (P >0.05).85 Overall, surgery decreased HbA1c by 2% to 3.5%, whereas medical treatment lowered it by 1% to 1.5%, as seen in Fig. 27-28. Most of these studies also showed superiority of surgery over medical treatment in achieving secondary endpoints such as weight loss, remission of metabolic syn-drome, reduction in diabetes and cardiovascular medications, and improvement in triglycerides, lipids, and quality of life. Results were mixed in terms of improvements in systolic and diastolic blood pressure or low-density lipoproteins after sur-gery vs. medical treatment, but many studies did show a cor-responding reduction in medication usage.Although previous guidelines and payer coverage policies had limited metabolic surgery to severely obese patients (BMI ≥35 kg/m2), nearly all RCTs showed that the surgical procedures, especially LRYGB and SG, were equally


Surgery_Schwartz

Surgery_Schwartz. and payer coverage policies had limited metabolic surgery to severely obese patients (BMI ≥35 kg/m2), nearly all RCTs showed that the surgical procedures, especially LRYGB and SG, were equally effective in patients with BMI 30 to 35 kg/m2. This is particularly important given that many patients with T2DM have a BMI <35 kg/m2. The effect of surgery in these patients with a lower class of obesity is also durable out to at least 5 years.243,252None of these RCTs were sufficiently powered to detect differences in macrovascular or microvascular complications or death, especially at the relatively short follow-up, and no such differences have been detected thus far. Four of the RCTs from Pittsburgh, Seattle, Boston, and Cleveland have combined their patient populations in a pooled study to assess 10-year out-comes. This study, Alliance of Randomized Trials of Medicine vs. Metabolic Surgery (ARMMS), aims to identify long-term risks and benefits of metabolic surgery.The evidence, as


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Surgery_Schwartz. to assess 10-year out-comes. This study, Alliance of Randomized Trials of Medicine vs. Metabolic Surgery (ARMMS), aims to identify long-term risks and benefits of metabolic surgery.The evidence, as previously summarized, was the basis for newly established international guidelines on the role of metabolic surgery in treating T2DM. In 2015, the 2nd Diabetes Surgery Summit (DSS-II) Consensus Conference generated Brunicardi_Ch27_p1167-p1218.indd 120123/02/19 2:21 PM 1202SPECIFIC CONSIDERATIONSPART IIParikh 2014 (RYGB/LAGB/SG) [6 mo; 6.5% off meds] (18)Courcoulas 2014 (RYGB/LAGB) [12 mo; 6.5% off meds] (14)Ding 2015 (LAGB) [12 mo; 6.5%] (22)Halperin 2014 (RYGB) [12 mo; 6.5% off meds] (15)Ikramuddin 2013 (RYGB) [12 mo; 7.0%] (13)Liang 2013 (RYGB) [12 mo; 7.0% off meds] (16)Schauer 2012 (RYGB/SG) [12 mo; 6.0%] (12)Cummings 2016 (RYGB) [12 mo; 6.5% off meds] (23)Dixon 2008 (LAGB) [24 mo; 6.2% off meds] (10)Ikramuddin 2015 (RYGB) [24 mo; 7.0%] (21)Mingrone 2012 (RYGB/BPD) [24 mo; 6.5%


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Surgery_Schwartz. (RYGB/SG) [12 mo; 6.0%] (12)Cummings 2016 (RYGB) [12 mo; 6.5% off meds] (23)Dixon 2008 (LAGB) [24 mo; 6.2% off meds] (10)Ikramuddin 2015 (RYGB) [24 mo; 7.0%] (21)Mingrone 2012 (RYGB/BPD) [24 mo; 6.5% off meds] (11)Wentworth 2014 (LAGB) [24 mo; 7.0%] (17)Courcoulas 2015 (RYGB/LAGB) [36 mo; 6.5% off meds] (24)Schauer 2014 (RYGB/SG) [36 mo; 6.0%] (19)Mingrone 2015 (RYGB/BPD) [60 mo; 6.5% off meds] (20)Fixed-Effects ModelStudy (Operation) [Follow-Up; HbA1c end point]WeightPeto, Fixed, 95% CIPolo Odds Ratios131861128283492226341214271920411819573199152960402337973862400531100148020002417221957704117265920251440154664.5%5.1%3.9%4.4%12.5%8.4%10.4%3.4%6.7%11.8%6.4%4.9%4.0%8.7%4.9%100.0%21.15 [5.85, 76.51]7.51 [2.24, 25.21]1.68 [0.42, 6.66]5.82 [1.59, 21.39]3.72 [1.72, 8.04]86.76 [33.89, 222.08]6.39 [2.74, 14.88]11.48 [2.63, 50.13]10.83 [3 .79, 30.96]4.25 [1.92, 9.38]30.08 [10.28, 88.06]8.11 [2.37, 27.84]6.44 [1.65, 25.21]5.73 [2.28, 14.42]8.44 [2.46, 29.01]8.45 [6.44, 11.10]SurgeryGlyc. Endp.


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Surgery_Schwartz. [2.74, 14.88]11.48 [2.63, 50.13]10.83 [3 .79, 30.96]4.25 [1.92, 9.38]30.08 [10.28, 88.06]8.11 [2.37, 27.84]6.44 [1.65, 25.21]5.73 [2.28, 14.42]8.44 [2.46, 29.01]8.45 [6.44, 11.10]SurgeryGlyc. Endp. NMedical/LifestyleGlyc. Endp. NHeterogeneity: Chi2 = 45 .43, df = 14 (P < 0.0001); I2 = 69%Test for overall effect: Z = 15.36 (P < 0.00001)FavorsMedical/Lifestyle0.0010.11011000FavorsSurgeryIncreasing Length of Follow-UpFigure 27-27. Glycemic endpoints of RCTs by length of follow-up. Forest plot of Peto odds ratios (ORs) of main glycemic end points, as defined in each trial, from published RCTs of bariatric/metabolic surgery compared with medical/lifestyle treatments for diabetes with data arranged in order of increasing length of follow-up. (Reproduced with permission from Cummings DE, Cohen RV: Bariatric/Metabolic Surgery to Treat Type 2 Diabetes in Patients With a BMI <35 kg/m2, Diabetes Care. 2016 Jun;39(6):924-933.)Brunicardi_Ch27_p1167-p1218.indd 120223/02/19 2:21 PM 1203THE


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Surgery_Schwartz. RV: Bariatric/Metabolic Surgery to Treat Type 2 Diabetes in Patients With a BMI <35 kg/m2, Diabetes Care. 2016 Jun;39(6):924-933.)Brunicardi_Ch27_p1167-p1218.indd 120223/02/19 2:21 PM 1203THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27Patients WithType 2 DiabetesObeseBMI ˙30 kg/m2or ˙27.5 for AsiansNonobeseBMI <30 kg/m2or <27.5 for AsiansClass III ObeseBMI ˙40 kg/m2or ˙37.5 for AsiansClass II ObeseBMI 35.0–39.9 kg/m2or 32.5–37.4 for AsiansClass I ObeseBMI 30.0–34.9 kg/m2or 27.5–32.4 for AsiansClass II ObeseWith PoorGlycemic ControlRecommendMetabolic SurgeryConsiderMetabolic SurgeryNonsurgicalTreatmentClass II ObeseWith AdequateGlycemic ControlClass I ObeseWith PoorGlycemic ControlClass I ObeseWith AdequateGlycemic ControlExpedited Assessment for Metabolic SurgeryOptimal Lifestyle and Medical RxOptimal Lifestyle and Medical Rx (including injectable meds and insulin)Figure 27-29. Algorithm for the treatment of type 2 diabetes as recommended by the 2nd Diabetes Surgery Summit.


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Surgery_Schwartz. and Medical RxOptimal Lifestyle and Medical Rx (including injectable meds and insulin)Figure 27-29. Algorithm for the treatment of type 2 diabetes as recommended by the 2nd Diabetes Surgery Summit. (Reproduced with permission from Rubino F, Nathan DM, Eckel RH, et al: Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations, Diabetes Care. 2016 Jun;39(6):861-877.)20–2–4–6Change in HbA1cMean baselineBMI 35 kg/m2Mean baselineBMI >35 kg/m2Wentworth 2014Liang 2013Parikh 2014Ikramuddin 2013Courcoulas 2014Courcoulas 2014Halperin 2014Ding 2015Dixon 2008Schauer 2012Schauer 2012Cummings 2016Mingrone 2012Mingrone 2012SurgeryMedical/LifestyleFigure 27-28. Change in baseline HbA1c in each of the 11 RCTs. (Reproduced with permission from Rubino F, Nathan DM, Eckel RH, et al: Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organiza-tions, Diabetes Care. 2016


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Surgery_Schwartz. permission from Rubino F, Nathan DM, Eckel RH, et al: Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organiza-tions, Diabetes Care. 2016 Jun;39(6):861-877.)guidelines that were endorsed by more than 50 diabetes and medical organizations.16 The recommendations include patient selection, preoperative evaluation, choice of procedure, postop-erative follow-up, and indications for surgery. According to the DSS-II guidelines, metabolic surgery should be recommended to treat T2DM in patients with class III obesity (BMI ≥40 kg/m2) regardless of glycemic control and in those with class II obesity (BMI 35.0–39.9 kg/m2) when hyperglycemia is inad-equately controlled by lifestyle and optimal medical therapy (Fig. 27-29). Surgery should also be considered for patients with T2DM and BMI 30.0 to 34.9 kg/m2 if hyperglycemia is inadequately controlled despite optimal treatment with either oral or injectable medications. These BMI


Surgery_Schwartz

Surgery_Schwartz. should also be considered for patients with T2DM and BMI 30.0 to 34.9 kg/m2 if hyperglycemia is inadequately controlled despite optimal treatment with either oral or injectable medications. These BMI thresholds should be reduced by 2.5 kg/m2 for Asian patients. The new treatment algorithm from DSS-II incorporates appropriate use of all three treatment modalities: lifestyle intervention, drug therapy, and surgery (see Fig. 27-29).16 The 2017 Standards of Care for Dia-betes from the American Diabetes Association include those key indications in its recommendations for metabolic surgery, as well.COMPLICATIONS OF BARIATRIC SURGERYSurgical ComplicationsNone of the surgical procedures are without risks. The periop-erative mortality for the average patient is low (<0.5%) and declining, but can vary significantly across sub-groups with perioperative mortality rates of 2.0% or higher in some patient populations.1 The incidence of complications after the various surgical procedures varies from


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Surgery_Schwartz. significantly across sub-groups with perioperative mortality rates of 2.0% or higher in some patient populations.1 The incidence of complications after the various surgical procedures varies from 4% to over 25% and depends on the definition of complication used, the type of bariatric procedure performed, and patient characteristics216,254,255 (see Table 27-5).8Brunicardi_Ch27_p1167-p1218.indd 120323/02/19 2:21 PM 1204SPECIFIC CONSIDERATIONSPART IIIn the 11 RCTs (794 patients) that have compared bariatric surgery to nonsurgical treatment, rates of adverse events were higher among surgical subjects, with follow-up up to 5 years for two of the studies and up to 2 to 3 years for others.82,252,256 There were very few cardiovascular events or deaths in either the surgical or the nonsurgical groups, and the most common adverse events after surgery were iron deficiency anemia (15% with intestinal bypass operations) and reoperations (8%). These RCTs were not large enough to compare safety


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Surgery_Schwartz. groups, and the most common adverse events after surgery were iron deficiency anemia (15% with intestinal bypass operations) and reoperations (8%). These RCTs were not large enough to compare safety between pro-cedure types, and most of the comparative data on procedure-to-procedure complications has and will come from larger observational studies.The 30-day mortality in the LABS Study was 0.3% for all procedures with a major adverse outcome rate (a predefined composite endpoint that included; death, venous thromboembo-lism, reintervention [percutaneous, endoscopic, or operative], or failure to be discharged from the hospital in 30 days) of 4.1%.59 Major predictors of an increased risk of complications in LABS were a history of venous thromboembolism, a diagnosis of obstructive sleep apnea, impaired functional status defined as inability to walk 300 feet (91 m), extreme BMI, and undergo-ing an RYGB by the open technique. Other large observational studies, such as SOS, have shown


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Surgery_Schwartz. apnea, impaired functional status defined as inability to walk 300 feet (91 m), extreme BMI, and undergo-ing an RYGB by the open technique. Other large observational studies, such as SOS, have shown higher rates of complications, with 14.5% having at least one nonfatal complication over the first 90 days, including pulmonary complications, vomiting, wound infection, hemorrhage, and anastomotic leak. However, the SOS included mostly open and VBG procedures, which are rarely performed today. Despite these older procedures and tech-niques, the 90-day mortality rate in SOS was low at 0.25%.196In a 2007 meta-analysis of 361 studies, mostly nonran-domized observational studies involving over 85,000 patients, Buchwald and colleagues reported important differences in ≤30-day mortality across different laparoscopic bariatric pro-cedures: 0.06% for LAGB; 0.21% for VBG; 0.16% for RYGB; and 1.11% for BPD/DS.257 This review also found significantly higher mortality for open procedures compared


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Surgery_Schwartz. laparoscopic bariatric pro-cedures: 0.06% for LAGB; 0.21% for VBG; 0.16% for RYGB; and 1.11% for BPD/DS.257 This review also found significantly higher mortality for open procedures compared with those per-formed laparoscopically. A U.S. study of over 300,000 patients in 12 states examined in-hospital complications before and after implementation of the CMS national policy restricting insurance coverage for bariatric surgery to “centers of excellence.” The study found no significant differences in complications before and after the policy was implemented, and overall complication rates were 7% to 8% with 3.3% to 3.6% being serious, including a 1% reoperation rate during both time periods.1,258 A clinically useful prognostic risk score was also developed and validated in 9382 patients to predict 90-day mortality after LRYGB surgery using five clinical characteristics: BMI ≥50 kg/m2, male sex, hypertension, known risk factor for pulmonary embolism, and age ≥45 years. Patients with 4 to


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Surgery_Schwartz. 90-day mortality after LRYGB surgery using five clinical characteristics: BMI ≥50 kg/m2, male sex, hypertension, known risk factor for pulmonary embolism, and age ≥45 years. Patients with 4 to 5 of these characteristics are at much higher risk of death (4.3%) by 90 days than those with 0 to 1 characteristics (0.26%).259-261 A systematic review of 15 RCTs of SG found no deaths in just under 800 patients but a 9.2% mean complication rate (range 0–18%).224 In the American College of Surgeons Bariatric Surgery Network database, mor-tality 30 days after SG was 0.11%, positioning its overall com-plication profile between that for LAGB (0.05%) and RYGB (0.14%). The 30-day complication rate was similarly positioned at 5.6% for SG, 1.4% LAGB, and 5.9% for RYGB.140An established problem now is the frequent rate of reop-eration, particularly among LAGB patients. In O’Brien and col-leagues’ prospective cohort of 3227 LAGB patients, revisional procedures occurred in 1116 (35%) and were performed


Surgery_Schwartz

Surgery_Schwartz. frequent rate of reop-eration, particularly among LAGB patients. In O’Brien and col-leagues’ prospective cohort of 3227 LAGB patients, revisional procedures occurred in 1116 (35%) and were performed for the following reasons: proximal enlargement (26%), port and tubing problems (21%), and erosion (3.4%). The need for revision due to proximal enlargement decreased dramatically over a 17-year period from 40% to 6.4% as the surgical technique evolved; however, the band was ultimately removed in 5.6% of all indi-viduals.262 Other long-term cohorts suggest that LAGB removal rates may be as high as 50%. The O’Brien systematic review of long-term studies indicates that the rate of revisional surgery for LRYGB may be similar to LAGB (22% revision for LRYGB, range 8% to 38%; 26% revision for LAGB, range of 8% to 60%). However, in the LABS Study, there was a higher rate of revision and reoperation for LAGB as compared to RYGB at both 3 and 7 years of follow-up.169 In general, more long-term


Surgery_Schwartz

Surgery_Schwartz. range of 8% to 60%). However, in the LABS Study, there was a higher rate of revision and reoperation for LAGB as compared to RYGB at both 3 and 7 years of follow-up.169 In general, more long-term data with more complete follow-up with standardized defini-tions and reporting of complications are needed to compare reoperation and complication rates of all bariatric procedures.Nonsurgical ComplicationsPostgastric bypass hypoglycemia (PGBH) in a relatively uncommon but particularly challenging problem that affects an unknown number of patients in the longer term. Prevalence rates in the literature vary from 1% to 11%, depending on the defini-tion.263,264 Hypoglycemia is characterized by documentation of Whipple’s triad (including both autonomic and neuroglycopenic symptoms or signs), at the time of a plasma glucose concentration <55 mg/dL with resolution of symptoms and signs after glucose administration. During these episodes, plasma insulin levels are inappropriately high, indicating


Surgery_Schwartz

Surgery_Schwartz. time of a plasma glucose concentration <55 mg/dL with resolution of symptoms and signs after glucose administration. During these episodes, plasma insulin levels are inappropriately high, indicating dysregulation of β-cell function. When it was initially described in patients who had undergone partial pancreatectomy, nesidioblastosis was found in the speci-mens that are characterized by hyperplasia and/or dysplasia of the pancreatic islets.265 It was initially thought to be endogenous hyperinsulinemia from increased β-cell mass hyperfunctioning islet cells; however, the current thinking is that the recalcitrant symptoms of hyperinsulinemic hypoglycemia after RYGB are related to the anatomic and physiologic changes and not from an inherent change in β-cell mass. One candidate mediator of increased insulin secretion in PGBH is GLP-1, a peptide released from intestinal neuroendocrine L-cells in response to meals. Consistent with this hypothesis, postprandial GLP-1 levels are increased


Surgery_Schwartz

Surgery_Schwartz. increased insulin secretion in PGBH is GLP-1, a peptide released from intestinal neuroendocrine L-cells in response to meals. Consistent with this hypothesis, postprandial GLP-1 levels are increased by over tenfold in post-RYGB patients, are higher in those with hyperinsulinemic hypoglycemia and neuroglyco-penia, and correlate inversely with postprandial glucose lev-els.266 PGBH needs to be distinguished from other forms of hypoglycemia such as other functional β-cell disorders such as noninsulinoma pancreatogenous hypoglycemia, insulinoma, reactive hypoglycemia, or early or late dumping syndrome. It is possible that PGBH is a spectrum of hypoglycemia with late dumping being on the end of the spectrum that is more respon-sive to dietary changes alone while more severe PGBH can be associated with severe symptoms.263 First-line therapeutic approaches to PGBH include medical nutrition therapy aimed at reducing intake of high glycemic index carbohydrates and premeal treatment with


Surgery_Schwartz

Surgery_Schwartz. with severe symptoms.263 First-line therapeutic approaches to PGBH include medical nutrition therapy aimed at reducing intake of high glycemic index carbohydrates and premeal treatment with acarbose. Additional therapies that may be considered include octreotide, diazoxide, calcium channel blockers, GLP-1 receptor antagonists, and providing nutrition solely through a gastrostomy tube placed into the bypassed duo-denum. Reversal of gastric bypass is not uniformly successful, suggesting the importance of underlying genetics and/or com-pensatory mechanisms that may persist after surgical reversal.266 Finally, although pancreatic resection was initially employed for patients with life-threatening hypoglycemia, this procedure Brunicardi_Ch27_p1167-p1218.indd 120423/02/19 2:21 PM 1205THE SURGICAL MANAGEMENT OF OBESITYCHAPTER 27is not uniformly successful in remitting hypoglycemia and should not be considered for the majority of patients, who can experience improvement in their symptoms


Surgery_Schwartz

Surgery_Schwartz. MANAGEMENT OF OBESITYCHAPTER 27is not uniformly successful in remitting hypoglycemia and should not be considered for the majority of patients, who can experience improvement in their symptoms with a combination of medical approaches. A 2017 American Society of Metabolic and Bariatric Surgery (ASMBS) position statement provides a comprehensive summary of this topic and also recommends this multimodal medical approach.267There is data to suggest that babies born to women follow-ing bariatric surgery are at risk for certain complications. In a Swedish study, bariatric surgery was originally associated with reduced risks of gestational diabetes and excessive fetal growth, shorter gestation, and an increased risk of small-for-gestational-age infants. In a later follow-up report, this same group reported a significant association between a history of bariatric surgery and an increased risk of preterm birth and spontaneous preterm birth, in particular.119,268There is also emerging data from


Surgery_Schwartz

Surgery_Schwartz. reported a significant association between a history of bariatric surgery and an increased risk of preterm birth and spontaneous preterm birth, in particular.119,268There is also emerging data from observational studies that some bariatric procedures may be associated with a greater long-term risk of substance and alcohol use disorders, suicide, and nutritional deficiencies. Pharmacokinetic studies indicate that after LRYGB and SG, the anatomic changes lead to very rapid absorption of alcohol and marked increases in blood alco-hol concentrations for a single small.269,270 In the SOS study, RYGB was associated with increased alcohol consumption and an increase in alcohol abuse events (HR: 4.9) over 20 years.196 Similarly in the LABS study, alcohol use disorders were found to be more common in the second postoperative year (9.6%) in those undergoing RYGB compared to before surgery (7.6%). Risk factors for alcohol use disorders included male gender, younger age, and preoperative smoking