Bariatric surgery in patients older than 65 years is safe and effective

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1 Surgery for Obesity and Related Diseases 1 (2005) Original article Bariatric surgery in patients older than 65 years is safe and effective Brian Quebbemann, M.D., David Engstrom, Ph.D., Trace Siegfried, M.D., Karen Garner, M.D., Ramsey Dallal, M.D. The N.E.W. Program, Orange County, California Manuscript received April 5, 2005; revised April 26, 2005; accepted May 11, 2005 Abstract Keywords: Background: To review the short-term safety and efficacy of the laparoscopic adjustable gastric band (LAGB) and laparoscopic gastric bypass (GBP) in patients older than 65 years. Methods: A single-institution review of all bariatric procedures was performed. Results: Twenty-seven patients were identified. Of the 27 patients, 13 underwent primary GBP and 14 underwent LAGB placement. The average age was years (range 65 73). The average follow-up for the GBP group and LAGB group was 9.3 months (range 1 21) and 19.6 months (range 4 31), respectively. One minor (stricture) complication and zero major complications occurred in the GBP group. In the LAGB group, one minor complication (port fracture) and one major complication (total weight loss failure requiring conversion to GBP) occurred. The percentage of excess weight loss at 1 year for the GBP group was 71%. At 1 and 2 years, it was 32% and 35%, respectively, for the LAGB group. Only in the GBP group did patients have a significant decrease in medication use and in the number of comorbidities. Quality-of-life measurements improved equally after both procedures. Weight loss was no different after GBP surgery regardless of age, but older LAGB patients had a 12% decrease in the expected excess weight lost (P 0.05). Conclusion: Bariatric surgery can be performed with acceptable safety, excellent weight loss, resolution of comorbidities, and significant improvement in quality of life in patients older than 65 years. The GBP seems to be as safe as, and more effective than, the LAGB in this age group American Society for Bariatric Surgery. All rights reserved. Bariatric surgery; Gastric bypass; Lap-band; Adjustable gastric band; Elderly; Safety Bariatric surgery is the only proven therapy for permanent weight loss in the morbidly obese. Despite well-documented improvements in medical comorbidities and quality of life (QOL) after bariatric surgery, many surgeons refrain from offering bariatric surgery to those older than 65 years because of the fear of complications in this presumably high-risk group However, the prevalence of obesity increases with age and affects 33% of men and 39% of women between the ages of 65 and 75 years. The increasing duration of obesity is accompanied by an increased incidence of comorbidities and number of medications needed [1, 2]. The advent of specialized training in minimally invasive Reprint requests: Ramsey Dallal, M.D., The N.E.W. Program, Beach Boulevard, Suite 367, Huntington Beach, CA rdallal@thenewprogram.com weight loss surgery has allowed expert centers to perform laparoscopic adjustable gastric band (LAGB) placement and laparoscopic gastric bypass (GBP) with very low operative complication rates. As a result, the risk/benefit ratio in expert centers may favor offering bariatric surgery to patients older than 65 years. We performed a review of our comprehensive database to determine the complication rate, weight loss success, medical benefits, and QOL changes in this subgroup of patients undergoing LAGB and GBP. Methods We reviewed our comprehensive bariatric surgery database (Exemplo-Medical, Eden Prairie, MN) for patients 65 years at surgery. All patients were interviewed and examined at our center to obtain accurate weight and medical profiles. Initially, we only performed LAGB placement /05/$ see front matter 2005 American Society for Bariatric Surgery. All rights reserved. doi: /j.soard

2 390 B. Quebbemann et al. / Surgery for Obesity and Related Diseases 1 (2005) in elderly patients; however, beginning in March 2003, we offered GBP to all interested patients. Patients were free to chose their preferred procedure after completing our preoperative education program. Perioperative protocol Since 2001, all our patients have undergone a 2-week, preoperative 800 Kcal diet, which we believe is helpful in reducing the liver volume by the time of surgery (unpublished data). All GBP procedures were performed laparoscopically with a 75-cm antecolic Roux limb. All LAGB procedures were performed using the pars flaccida approach. All patients were administered continuous, intravenous, low-dose heparin infusion for deep vein thrombosis prophylaxis. The length of stay was typically 0 to 1 days after LAGB and 1 to 2 days after GBP. Postoperative protocol A structured follow-up regimen was used to maximize the patient outcomes. This included monthly visits for all LAGB patients, at which surgeons performed all adjustments, and counseling was provided on optimal eating habits. Vitamin supplementation was recommended for all patients. For GBP patients, postoperative evaluations were scheduled at 3-month intervals for the first year, 6-month intervals for 1 year, and then yearly. Routine GBP laboratory testing included measurement of B vitamins, folate, selenium, parathyroid hormone, zinc, as well as complete electrolyte, hepatic, lipid, and hematology profiles. The bariatric surgeons (B.Q., R.D.) and bariatric internists (T.S., K.G.) performed all follow-up examinations. QOL assessment The QOL was assessed by the program s bariatric psychologist (D.E.) using four global factors: physical function, self-esteem, work, and emotional function/ depression. Two self-report instruments: the Impact of Weight on Quality of Life Questionnaire-Lite Scale [3] and the internally developed Bariatric Surgery Impact Scale. Physical function, self-esteem, and work were measured by subscales on the Impact of Weight on Quality of Life Questionnaire-Lite Scale. The Bariatric Surgery Impact Scale measured emotional distress, depression, and anxiety and is a bariatricspecific modification of the Beck Depression Inventory. These questionnaires were administered to all patients 2 weeks before surgery and at the last date of follow-up after surgery. Statistical analysis The resolution of diabetes was defined as a normal glycosylated hemoglobin, normal fasting blood glucose, and the lack of a need for medications to control blood sugar. Resolution of hypertension was defined as the lack of a need for antihypertensive medications as determined by the patient s physician. Significance was determined using a paired Student s t test. The LAGB patient who underwent conversion to GBP was included in the LAGB cohort in an intent-to-treat analysis. Analysis of the percentage of excess weight loss (EWL) was completed by several methods to obtain the most accurate comparative analysis. First, a simple linear model was fit for each group using simple linear regression analysis with the number of months from surgery and the percentage of EWL. Second, a cubic regression model was fit for each group, thus allowing curvature in the regression over time. The linear and curvilinear regression analyses were completed to obtain a graph that best represented the data. Third, as a confirmatory modeling technique, repeated measures regression modeling was used to account for the correlation among multiple observations over time from the same patient (i.e., paired data; Secic Statistical Consulting, Chardon, OH). Results with P 0.05 were considered statistically significant. Results A total of 27 patients were identified. Of the 27 patients, 13 underwent GBP and 14 underwent LAGB. One patient, 19 months after LAGB surgery, had the LAGB converted to a GBP, laparoscopically, because of complete weight loss failure. All procedures were completed laparoscopically. The average hospital stay for LAGB placement was 0.8 days (range 0 to 2). The average hospital stay for GBP was 1.9 days (range 1 to 3). None of the 27 patients required readmission, reoperation, or an unscheduled office visit. One patient was sent to the emergency room 5 days after a GBP to rule out deep vein thrombosis. The GBP group experienced no major complications. One minor complication, postoperative stricture at the gastrojejunostomy, required outpatient endoscopic dilation. Two patients developed transiently low serum iron levels without anemia. Another patient had transiently low serum thiamine levels 3 months postoperatively. These laboratory abnormalities were not considered complications, because they were transient, asymptomatic, and very minor. In the LAGB group, 1 patient developed a minor complication (port fracture requiring replacement) and that same patient required conversion to GBP because of weight gain (considered a major complication). No other complications occurred in the LAGB group. We had 100% follow-up; the average follow-up for the GBP and LAGB patients was 9.3 months (range 3 to 21) and 19.6 months, respectively. The calculated percentage of EWL at 1 year in the GBP group was 72%. The calculated percentage of EWL at 1 and 2 years in the LAGB group was 32% and 35%, respectively (Fig. 1). The data was insufficient to calculate confidently the 2-year weight loss in the GBP group. However, on review of our database, no significant difference was found in the mean weight loss be-

3 B. Quebbemann et al. / Surgery for Obesity and Related Diseases 1 (2005) Fig. 1. Percentage of EWL versus time. GBP patients lost significantly more weight during the study period than did patients undergoing LAGB placement. tween patients older and younger than 65 years who underwent the GBP (75% EWL at 1 year, P 0.05). A statistically significant difference in weight loss was found between patients older and younger than 65 years who underwent LAGB (46% EWL at 1 year, P 0.05). In the period studied, the elderly GBP patients lost more weight than did the elderly LAGB patients (P 0.05). The average number of obesity-related comorbidities, and the number of medications per patient, declined significantly in the GBP group. Nine patients (30%) were diabetic before surgery. The diabetes resolved in 6 patients and improved in 3 others. Before surgery, 22 patients (81%) in the GBP group had hypertension. Hypertension resolved in 10 of the 22, improved in 8, and remained unchanged in 4. No significant change in the number of obesity-related comorbidities, or number of medications per patient, occurred in the LAGB group (Table 1). The QOL data obtained from all patients are shown in Table 2. Significant improvements in the QOL parameters were found for every measured category after both procedures. When directly comparing the combined QOL factors between the two groups, the LAGB group had greater baseline (before surgery) QOL than the GBP group. However, the difference in the improvement in QOL between the LAGB and GBP patients was not statistically significant. Discussion In July 2004, the Center for Medicare and Medicaid Services removed language in the Medicare Coverage Issues Manual stating that obesity was not an illness. Furthermore, the Medicare Coverage Advisory Committee, which convened in November 2004, found significant evidence to support the safety and efficacy of open and laparoscopic weight loss surgery, but requested more data in the population older than 65 years [4]. As physicians are aware, the ongoing controversy for offering carotid [5], aortic, colon, and cardiac surgery [6, 7] to elderly patients is minimal. Often these procedures are performed for QOL reasons and/or to prevent life-threatening complications. Obvious examples are octogenarians undergoing coronary bypass to treat stable angina or undergoing carotid endarterectomy to decrease the stroke rate by single digit percentages. We strongly believe that if the above procedures are indicated, bariatric surgery should be considered to minimize medication use, decrease comorbid disease, and improve daily QOL. Although this study was limited in size and length of follow-up, it is the first report to isolate Medicare-Age patients, that is, patients at least 65 years old. When we examined our entire database of patients who had undergone GBP, the weight loss seen in patients older than 65 years did not differ from that seen in younger patients. This is in contrast to other published studies [8, 9]. However, elderly LAGB patients lost less weight than expected. The reason why elderly LAGB patients lost less weight is unclear. The data presented here suggest that GBP and LAGB can be safely performed in patients 65 years old at expert centers. The data in this paper should not be extrapolated to practices that perform open GBP or those without substantial training and experience in laparoscopic bariatric surgery. The relationship between patient outcome and volume has been well established for other forms of surgery [10, 11], and the initial learning curve with laparoscopic GBP has been shown to include at least 100 cases [12]. The results presented here suggest that both LAGB and GBP will improve QOL for patients 65 years. The importance of these changes in QOL cannot be over stressed. Furthermore, for the period examined, GBP resulted in significant decreases in comorbidities and medication use in this age Table 1 Patient characteristics Characteristic Gastric bypass (n 13) LAGB (n 14) Age (yr) Average Range Body mass index (kg/m 2 ) Women (%) Female/male ratio 10:3 7:7 Comorbidities (before vs. after) 4.1 vs vs. 2.8 P value Medications (before vs. after) 5.5 vs vs. 4.1 P value ; NS Major complications None One conversion to GBP Minor complications One stricture One port fracture LAGB laparoscopic adjustable gastric band.

4 392 D.C. Elliott / Surgery for Obesity and Related Diseases 1 (2005) Table 2 Quality-of-life data Quality of life Range Preoperatively Postoperatively P value Gastric bypass (n 13) Physical function Self esteem Work Emotional function/depression Adjustable Band (n 14) Physical function Self esteem Work Emotional function/depression Combined values Gastric bypass Adjustable gastric band group. Although this was not true for our LAGB patient group, these differences likely correlated with the amount of weight loss obtained; thus, it is important to note that weight loss typically peaks at 12 to 18 months after GBP but continues for 3 4 years after LAGB. Although the significance of dedicated aftercare programs is difficult to quantify, we believe it is imperative to offer extensive aftercare support for all bariatric patients, including access for band adjustments and medical evaluations, support groups, in-house psychology, and bariatric internists and nurses. We believe that appropriate infrastructure is key to reducing complications and increasing weight loss success. Conclusion Bariatric surgery can be performed safely in patients 65 years of old and, in our experience, GBP is significantly more effective than LAGB in this age group. References [1] CDC Epidemiologic tables [database on the Internet]. Atlanta: Centers for Disease Control. Available at tables/2003/03hus068.pdf. Accessed: c2003. [2] Schauer PR, Burguera B, Ikramuddin S, et al. Effect of laparoscopic Roux-en-Y gastric bypass on type 2 diabetes mellitus. Ann Surg 2003;238: [3] Kolotkin R, Crosby R, Kosloski K, et al. Development of a brief measure to assess quality of life in obesity. Obes Res 2001;9: [4] Medicare Advisory Committee. Baltimore. MCAC (CAG-00250N). Available at Accessed: c2004. [5] Hingorani A, Ascher E, Schutzer R, et al. Carotid endarterectomy in octogenarians and nonagenarians: is it worth the effort? Acta Chir Belg 2004;104: [6] Wilson MF, Baig MK, Ashraf H. Quality of life in octogenarians after coronary artery bypass grafting. Am J Cardiol 2005;95: [7] St Peter SD, Craft RO, Tiede JL, et al. Impact of advanced age on weight loss and health benefits after laparoscopic gastric bypass. Arch Surg 2005;140: [8] Sugerman H, DeMaria E, Kellum J, et al. Effects of bariatric surgery in older patients. Ann Surg 2004;240: [9] Fruitman DS, MacDougall CE, Ross DB. Cardiac surgery in octogenarians: can elderly patients benefit? Quality of life after cardiac surgery. Ann Thoracic Surg 1999;68: [10] Dimick JB, Cowan JA Jr, Upchurch GR Jr, et al. Hospital volume and surgical outcomes for elderly patients with colorectal cancer in the United States. J Surg Res 2003;114:50 6. [11] Dimick JB, Pronovost PJ, Cowan JA Jr. Should older patients be selectively referred to high-volume centers for abdominal aortic surgery? Vasc Surg 2004;12:51 6. [12] Schauer P, Ikramuddin S, Hamad G, et al. The learning curve for laparoscopic Roux-en-Y gastric bypass is 100 cases. Surg Endosc 2003;17: Editorial Comment In this issue of Surgery for Obesity and Related Diseases, Quebbemann and colleagues [1] report on a retrospective series of 27 patients 65 years of age who underwent bariatric surgery (laparoscopic adjustable gastric band, 14 patients, or laparoscopic Roux-en-Y gastric bypass [GBP], 13 patients). Their results support the conclusions that laparoscopic adjustable gastric band and GBP are safe operations in the 65, Medicare-age patient; that patients 65 years gain significant benefit from bariatric surgery, in terms of weight loss, resolution of weight-related health problems, and improvement in quality of life; and that GBP appears to be more effective and just as safe compared with laparoscopic adjustable gastric band. The National Institute of Health Consensus Development Conference Statement regarding gastrointestinal surgery for severe obesity, published March 25 27, 1991, made no

5 D.C. Elliott / Surgery for Obesity and Related Diseases 1 (2005) specific recommendations regarding an upper age limit for performing bariatric surgery. Rather, the panel limited its recommendation for surgery to patients deemed safe from a global clinical standpoint, stating, A gastric restrictive or bypass procedure should be considered only for well-informed and motivated patients with acceptable operative risks [2]. Since the publication of that set of guidelines, the bariatric surgical community has continually pushed the envelope, in efforts to make the weight loss operations performed more safe, more consistently reproducible in effectiveness, and more applicable to a broader base of potential patients. Although many factors influence the outcome and risk of weight loss surgery, advanced age appears to be an independent risk factor for complications, including perioperative mortality. Livingston and colleagues [3], in a retrospective analysis of 1067 patients undergoing open GBP during 7 years, found through logistic regression analysis that patients 55 years were at no greater risk than younger patients for the development of life-threatening complications, but that these older patients were more likely to die of these complications than their younger counterparts if a major complication developed (mortality rate 3.5% versus 1.1%, P 0.05). Nguyen and colleagues [4], in a prospective study of factors influencing outcomes after laparoscopic GBP in 150 consecutive patients, discovered that age was an independent risk factor for the development of complications, with patients 50 years having an adjusted odds ratio of 11.4 for developing postoperative complications compared with their younger counterparts (P 0.01). In a retrospective logistic regression analysis of a prospectively maintained database of 2011 patients undergoing open or laparoscopic GBP at a single institution during an 11-year period, Fernandez and colleagues [5] concluded that advanced age was an independent risk factor for perioperative mortality after open GBP (P ) but not after laparoscopic GBP. Despite the increase in perioperative risks, bariatric surgery can be performed safely and effectively in older patients. Murr and colleagues [6] validated this concept in patients 50 years. MacGregor and Rand published their findings demonstrating excellent results in patients 50 years of age [7] and in patients 55 years [8]. Two recent studies have attested to the safety and effectiveness of weight loss surgery in patients 60 years of age. Sugerman and colleagues [9] published a series of 80 patients 60 years of age undergoing GBP whose rate of postoperative complications, weight loss, and amelioration of weightrelated comorbidities paralleled that of younger patients. St. Peter and colleagues [10] demonstrated no difference in complication rates, weight loss, comorbidity reduction, or medication reduction between their 110 patients 60 years of age and their 20 patients aged 60 years undergoing laparoscopic GBP. The present study continues the progress achieved through these prior studies to make weight loss surgery safe and effective for older patients, now validated in patients 65 years of age. Cogent results in this older age group are particularly pertinent, given recent acknowledgment by the Center for Medicare and Medicaid Services that obesity is an illness, and the large number of Medicare-age morbidly obese Americans who could benefit from weight loss surgery. Given that individuals 65 years have an increased risk of death from heart disease and cancer and with compelling evidence that morbid obesity drastically increases these risks [11], the bariatric surgical community now has an exciting opportunity to increase awareness among our patients and healthcare colleagues that a safe and effective surgical treatment is available that can prolong life through a reduction in cancer, heart disease, and diabetes [12] and that this treatment is safe and effective even in patients 65 years. References David C. Elliott, M.D., F.A.C.S. Healthy STEPs Weight Loss Center Santa Rosa, California [1] Quebbemann BB, Siegfried TA, Engstrom D, et al. Bariatric surgery in patients greater than 65 years old is safe and effective. Surg Obes Related Dis 2005;1: [2] Gastrointestinal surgery for severe obesity. NIH Consensus Statement Online 1991 March 25 27; 15 May. 2005;9:1 20. [3] Livingston EH, Huerta S, Arthur D, Lee S, DeShields S, Heber D. Male gender is a predictor of morbidity and age a predictor of mortality for patients undergoing gastric bypass surgery. Ann Surg 2002;236: [4] Nguyen NT, Rivers R, Wolfe BM. Factors associated with operative outcomes in laparoscopic gastric bypass. J Am Coll Surg 2003;197: [5] Fernandez AZ, DeMaria EJ, Tichansky DS, et al. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity. Ann Surg 2004;239: [6] Murr MM, Siadati MR, Sarr MG. Results of bariatric surgery for morbid obesity in patients older than 50 years. Obes Surg 1995;5: [7] Rand CS, MacGregor AM. Age, obesity surgery, and weight loss. Obes Surg 1991;1:47 9. [8] MacGregor AM, Rand CS. Gastric surgery in morbid obesity: outcome in patients aged 55 years and over. Arch Surg 1993;128: [9] Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004;240: [10] St. Peter SD, Craft RO, Tiede JL, Swain JM. Impact of advanced age on weight loss and health benefits after laparoscopic gastric bypass. Arch Surg 2005;140: [11] Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med 2003;348: [12] Christou NV, Sampalis JS, Liberman M, et al. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg 2004;240: