Is age a real or perceived discriminator for bariatric surgery? A long-term analysis of bariatric surgery in the elderly

Surgery for Obesity and Related Diseases 15 (2019) 725–731

Original article

Is age a real or perceived discriminator for bariatric surgery? A long-term analysis of bariatric surgery in the elderly Jai Prasad, M.D. a, Ellen Vogels, D.O. a, James T. Dove, B.A. a, Craig Wood, M.S. b, Anthony T. Petrick, M.D. a, David M. Parker, M.D. a,∗ a Division

of Foregut and Bariatric Surgery, Geisinger Medical Center, Danville, Pennsylvania Research Institute, Geisinger Medical Center, Danville, Pennsylvania

b Obesity

Received 20 September 2018; received in revised form 4 December 2018; accepted 14 December 2018

Abstract

Background: Bariatric surgery is the most effective treatment of obesity. There are few studies evaluating long-term outcomes in elderly patients. Objectives: Our study was designed to evaluate the safety and long-term outcomes of bariatric surgery in the elderly compared with a contemporary medically managed cohort. Setting: University hospital. Methods: Three hundred thirty-seven patients age ≥60 who underwent a sleeve gastrectomy or Roux-en-Y gastric bypass between January 2007 and April 2017 were identified (ElderSurg) and compared with a matched cohort of medically managed elderly patients with obesity (ElderNonSurg). Results: Thirty-two patients underwent laparoscopic sleeve gastrectomy, 190 underwent laparoscopic Roux-en-Y gastric bypass, and 115 underwent open Roux-en-Y gastric bypass. The cohort was a mean of 64.4-years old, 75.4% female, mean preoperative body mass index was 46.9, and 62.6% had type 2 diabetes. During a median follow-up period of 56.2 months (confidence interval 49.5–62.9), mean percent excess weight loss (EWL) at nadir was 72.1 ± 24.7% and EWL at 36 months or beyond was 60.9 ± 27.6%. On regression analysis, diabetes, body mass index, and laparoscopic sleeve gastrectomy were negatively associated with EWL at all time periods (P < .05). Mean %EWL was greater for Roux-en-Y gastric bypass compared with laparoscopic sleeve gastrectomy (61.7 versus 41.2; P = .039). Diabetes remission rate was 45.8%. There was a statistically significant decrease in the risk of death in ElderSurg (hazard ratio .584, 95% confidence interval .362–.941) compared with ElderNonSurg. Conclusions: Our study supports that bariatric surgery is safe in elderly patients with effective long-term control of obesity, diabetes, and with improved overall survival. (Surg Obes Relat Dis 2019;15:725–731.) © 2019 Published by Elsevier Inc. on behalf of American Society for Bariatric Surgery.

Keywords:

Bariatric surgery; Roux-en-Y gastric bypass; Sleeve gastrectomy; Morbid obesity; Elderly

Obesity has become an epidemic in the United States and around the world. At the same time, we are seeing an ∗ Correspondence: David M. Parker, M.D., Division of Foregut and Bariatric Surgery, Department of Surgery, 100 N Academy Avenue, Internal Zip 21-70, Danville, PA. E-mail address: [email protected] (D.M. Parker).

aging of human populations both nationally and globally. The U.S. Census Bureau projects that the percentage of the population aged ≥65 years will increase from 13.7% in 2012 to 16.8% in 2020 to 20.3% in 2030 [1]. This trend holds true on the global scale with 8.5% of the world population being ≥65 years in 2015, and expected to nearly double to 16.7% in 2050. From 2011 to 2014 the obesity

https://doi.org/10.1016/j.soard.2018.12.019 1550-7289/© 2019 Published by Elsevier Inc. on behalf of American Society for Bariatric Surgery.

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rate in the U.S. adult population was estimated at 36.5% and the rate for the ≥60 subset was even higher at 37% [2,3]. Obesity, especially class ≥2, is associated with increased all-cause mortality [4]. Bariatric surgery remains the most effective treatment of obesity as well as type 2 diabetes. However, few large studies have evaluated long-term outcomes in elderly patients. There is a growing body of data showing that bariatric surgery is safe in the elderly population, but debate remains over the impact of bariatric surgery on co-morbidities and survival. Some studies have suggested that elderly patients have less weight loss after surgery [5–7]. Overall, similar health benefits have been shown in elderly and young bariatric surgical patients in the modern era of laparoscopic bariatric surgery [8]. It is unknown how bariatric surgery impacts co-morbidities in the elderly over and above medical management in the era of modern bariatric surgery [7,9]. Long-term outcomes are lacking, which may answer the question of whether there is a significant survival benefit with bariatric surgery. Our study was designed to evaluate the safety and long-term outcomes of bariatric surgery in the elderly compared with a contemporary medically managed cohort.

Methods After institutional review board approval, we reviewed our prospectively maintained database of all patients who underwent bariatric surgery between January 2007 and April 2017. A total of 337 patients age ≥60 who underwent a laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass, or open Roux-en-Y gastric bypass during the study period were identified (Elderly Surgical Cohort, ElderSurg). Co-morbidities were identified by the 10th revision of the International Statistical Classification of Diseases codes. As described previously, the primary care cohort of the Geisinger Health System has been used to identify a nonsurgical comparison group with obesity [10,11]. The potential control patients were active in the primary care system (>3 office visits over a >2-year period), met body mass index (BMI) and co-morbidity criteria for eligibility for bariatric surgery (BMI >40 or >35 kg/m2 with co-morbidity of diabetes, hypertension, hyperlipidemia, or sleep apnea), had no prior history of bariatric surgery, and no diagnosis of serious mental health disorder or illegal drug use. For this study, the controls were matched to the surgical group using a 2:1 ratio based on sex, age within 3 years, BMI within 3 kg/m2 , and presence or absence of diabetes (Elderly NonSurgical Cohort, ElderNonSurg). The controls were required to be active in primary care at time of bariatric surgery for the matched case. Forty-six surgical patients could not be matched. This resulted in a total matched ElderSurg group with N = 291.

We also performed a 1:2 match of patient ≥60 years of age to patients <60 years of age by BMI (within 3 points), sex, bariatric surgical procedure, and presence of diabetes. Three hundred thirty-seven patients ≥60 years were matched 674 patients younger than 60 years (YoungSurg). Weight loss outcomes were recorded as the percentage of excess weight lost (%EWL = [ weight / preoperative weight – ideal weight] × 100%). Weight loss nadir was defined as the minimum weight achieved between 6 and 36 months after surgery. The first weight recorded >36 months after surgery was also documented. Patients were initially flagged for diabetes using the 10th revision of the International Statistical Classification of Diseases codes that identified 211 patients in the surgical group. These were further evaluated to ensure that they met criteria per the American Diabetes Association guidelines for diabetes (fasting glucose >126 mg/dL or A1C >6.5%) yielding 199 patients [12]. Remission was determined by American Diabetes Association criteria that define “partial” remission as A1C <6.5%, fasting glucose <125 mg/dL, and no pharmacologic antidiabetic or ongoing procedures for a 365-day period. “Complete” remission was defined as A1C <6.0%, fasting glucose <100 mg/dL, and no pharmacologic antidiabetic or ongoing procedures for a 365-day period [13]. From the 199 patients with definite diabetes, 33 did not have adequate follow-up to determine remission status, resulting in a total of 166 diabetic surgical patients.

Statistical analysis Continuous data were represented as mean ± standard deviation and analyzed using t tests. Categoric data were represented as frequency (percentage) and analyzed using χ 2 tests. Time to event data were represented with KaplanMeier curves and analyzed using log-rank tests. Weight loss outcomes were analyzed using linear regression models with backward elimination to determine factors associated with weight loss. Overall survival and diabetes remission were analyzed using Cox proportional hazard models with stepwise selection were created to adjust for potential confounding variables. SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) was used for analysis. All tests were 2-sided and P values < .05 were considered statistically significant.

Results There were 337 patients in ElderSurg with 291 patients being matched 1:2 creating a matched ElderNonSurg group, and 76.6% of ElderNonSurg and 69.6% of ElderSurg (overall 74.2%) patients having had at least 36 months of follow-up. The median follow-up period

Jai Prasad, Ellen Vogels and James T. Dove et al. / Surgery for Obesity and Related Diseases 15 (2019) 725–731 Table 1 Percentage of yearly follow-up.

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Patient characteristics

Mo

No surgery n = 582

Surgery n = 291

12 24 36 48 60 72 84 96 108 120

573 (98%) 526 (90%) 446 (77%) 376 (65%) 293 (50%) 231 (40%) 168 (29%) 100 (17%) 57 (10%) 11 (2%)

282 (97%) 247 (85%) 202 (69%) 171 (59%) 138 (47%) 107 (37%) 77 (26%) 47 (16%) 31 (11%) 7 (2%)

Patients in ElderSurg and ElderNonSurg were evenly matched for age, BMI, sex, and presence of diabetes (Table 2). The patients in ElderNonSurg had a significantly higher number of medications (10.9 versus 8.1), with a higher incidence of peripheral vascular, cerebrovascular, and renal disease. ElderSurg had higher incidence of obstructive sleep apnea, venous stasis, and venous thromboembolism, though this was related to a specific preoperative investigation for these co-morbidities (Table 2). Weight loss

was 56.2 months (confidence interval [CI] 49.5–62.9; Table 1).

The weight loss at nadir and at 36 months plus for the surgical group is shown in Table 3. The Roux-en-Y gastric bypass was associated with significantly greater change in BMI, %EWL, and percent of total weight loss at nadir and

Table 2 Baseline characteristics of the matched cohort. Surgeryn = 291

No surgeryn = 582

P value

64.4 ± 3.4

64.8 ± 3.8

.13 >.999

219 (75.3%) 72 (24.7%) 46.5 ± 6.8 169 (58.1%)

438 (75.3%) 144 (24.7%) 45.9 ± 6.7 338 (58.1%)

.20 >.999

Unmatched variables Medication number

8.1 ± 4.1

10.9 ± 6.2

<.0001

Co-morbid conditions MI CHF Peripheral vascular Cerebrovascular Dementia Chronic pulmonary Rheumatologic Peptic ulcer Mild liver disease Moderate, severe liver disease Paraplegia & hemiplegia Renal disease Any malignancy Metastatic solid tumor AIDS Venous stasis Hyperlipidemia History of previous DVT or PE Gastroesophageal reflux Disease Obstructive sleep apnea

9 (3.1%) 29 (10%) 14 (4.8%) 13 (4.5%) 1 (0.3%) 77 (26.5%) 3 (1%) 11 (3.8%) 13 (4.5%) 0 (0%) 1 (.3%) 0 (0%) 20 (6.9%) 0 (0%) 0 103 (35.4%) 210 (72.2%) 31 (10.7%) 127 (43.6%) 158 (54.3%)

21 (3.6%) 79 (13.6%) 57 (9.8%) 47 (8.1%) 1 (0.2%) 187 (32.1%) 16 (2.8%) 15 (2.6%) 22 (3.8%) 4 (.7%) 4 (.7%) 11 (1.9%) 57 (9.8%) 2 (.3%) 0 56 (9.6%) 454 (78%) 37 (6.4%) 237 (40.7%) 89 (15.3%)

.69 .13 .01 .05 >.999 .09 .10 .32 .63 .31 .67 .02 .15 .56

Procedure Open RYGB Laparoscopic RYGB Sleeve No Surgery

104 (35.7%) 163 (56%) 24 (8.3%) 0

0 0 0 582 (100%)

Variable Matched variables Age Sex Female Male BMI baseline Diabetes

<.0001 .06 .03 .41 <.0001

BMI = body mass index; MI = myocardial infarction; CHF = congestive heart failure; AIDS = acquired immunodeficiency syndrome; DVT = deep vein thrombosis; PE = pulmonary embolism; RYGB = Roux-en-Y gastric bypass.

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Jai Prasad, Ellen Vogels and James T. Dove et al. / Surgery for Obesity and Related Diseases 15 (2019) 725–731 Table 3 Matched cohort long-term outcomes.

Decrease in BMI (at 36 mo) %TWL (at 36 mo) %EWL (at 36 mo) N of medications at baseline Change in number of medications at 1 yr (95% CI) Diabetes remission (%, CI)

Surgery(n = 291)

No surgery(n = 582)

P value

13.3 ± 4.9 25.1% ± 10.1% 62.0 % ± 27.8% 8.1 ± 4.1 −3 (−3.5, −2.6)

1.1 ± 3.4 2.4% ± 7.5% 5.3% ± 18.4% 10.9 ± 6.2 1.1 (.7, 1.5)

<.0001 <.0001 <.0001 <.0001 <.0001

47.6 (39.6, 55.7)

1.2 (.0, 2.4)

<.0001

BMI = body mass index; %TWL = percent total weight loss; %EWL = percent excess weight loss; CI = confidence interval. Table 4 Weight loss outcomes in patients age >60. Weight loss outcomes %EWL %EWL %TWL %TWL

RYGB

nadir (n = 238) 36 months plus (n = 205) nadir (n = 238) 36 mo plus (n = 205)

73.5 61.7 30.8 25.7

± ± ± ±

Sleeve 24.9 27.6 8.5 10.3

58.9 41.2 23.2 17.1

± ± ± ±

18.8 18.8 6.7 7.8

P value

Total

.007 .039 <.0001 .021

72.1 60.9 30.0 25.3

± ± ± ±

24.7 27.6 8.7 10.3

RYGB = Roux-en-Y gastric bypass; %EWL = percent excess weight loss; %TWL = percent total weight loss. Table 5 Factors associated with %EWL at nadir and at >36 months. %EWL nadir (n = 238)

%EWL at >36 mo (n = 205)

Variable

Estimate

SE

Intercept Age BMI Female CHF T2D

198.375 −.640 −1.657 0.016 −6.124 −8.925

28.471 .403 .180 3.219 3.968 2.767

Procedure ORYGB LRYGB Sleeve

Ref .987 −20.066

Ref 2.920 5.027

P value

Variable

Estimate

SE

P value

.114 <.0001 .996 .124 .001

Intercept Age BMI Female T2D n of medications

111.326 .201 −1.449 4.484 −11.488 .953

35.678 .501 .231 4.004 3.763 .538

.688 <.0001 .264 .003 .078

.736 <.0001

Procedure ORYGB LRYGB Sleeve

Ref 3.806 −20.371

Ref 3.654 9.327

.299 .030

%EWL = percent excess weight loss; SE = standard error; BMI = body mass index; CHF = congestive heart failure; T2D = type 2 diabetes; ORYGB = open Roux-en-Y gastric bypass; LRYGB = laparoscopic Roux-en-Y gastric bypass. Factors associated with %EWL nadir (n = 238) and %EWL 36 plus (n = 205), backward elimination (age, sex, and BMI forced into every model).

at >36 months (P < .05; Table 4). As expected, ElderSurg had significantly greater weight loss compared with ElderNonSurg. On regression analysis, presence of diabetes, higher initial BMI, and LSG were all associated with less %EWL at all time periods (Table 5).

ElderSurg and YoungSurg, there is a higher risk of major complications in ElderSurg undergoing open Roux-en-Y gastric bypass (11.3% versus 3.5%, P < .05). No significant differences were noted between groups for the laparoscopic Roux-en-Y gastric bypass and LSG (Table 6).

Early postoperative outcomes Minor complications, major complications, readmissions, 30-day emergency department utilization, and reoperations were compared by surgery type in ElderSurg and YoungSurg groups. Major complications were significantly increased in open Roux-en-Y gastric bypass compared with laparoscopic Roux-en-Y gastric bypass and LSG groups (11.3% versus 3.2% versus 0%, P < .05). Comparing

Diabetes resolution and medication use Of 211 patients in ElderSurg with diabetes, complete follow-up data to allow analysis for diabetes remission was available in 166 patients. The diabetes remission rate in ElderSurg was 47.6% of at a median duration of 3.8 years. No significant remission of diabetes was noted in ElderNonSurg (Table 3).

Jai Prasad, Ellen Vogels and James T. Dove et al. / Surgery for Obesity and Related Diseases 15 (2019) 725–731

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Table 6 Elderly perioperative outcomes.

Minor complication Major complication Readmissions 30-d ED visit Any reoperation Total complication 30-d mortality

LRYGB n = 190

ORYGB n = 115

Sleeve n = 32

P value

Total n = 337

25 (13.2%) 6 (3.2%) 15 (7.9%) 19 (10%) 6 (3.2%) 31 (16.3%) 1 (.5%)

26 (22.6%) 13 (11.3%) 11 (9.6%) 16 (13.9%) 4 (3.5%) 39 (33.9%) 0 (0%)

3 0 2 2 0 3 0

.052 .004 .795 .381 .800 <.001 .999

54 (16.0%) 19 (5.6%) 28 (8.3%) 37 (11.0%) 10 (3.0%) 73 (21.7%) 1 (.3%)

LRYGB = laparoscopic Roux-en-Y ED = emergency department.

gastric

bypass;

(9.4%) (0%) (6.3%) (6.3%) (0%) (9.4%) (0%)

ORYGB = open

Roux-en-Y

gastric

bypass;

Table 7 Factors affecting overall survival in surgical cohort–multivariate analysis∗ . Variable

Hazard ratio

95% CI

P value

Age BMI Medication number Female

1.034 1.047 1.160 .856

.922 .991 1.068 .340

1.160 1.106 1.260 2.154

.566 .099 .0004 .741

Co-morbid conditions MI CHF Chronic pulmonary Diabetes Malignancy, except skin neoplasm

1.249 .189 1.353 2.841 2.038

.314 .025 .556 .823 .535

4.969 1.451 3.291 9.807 7.766

.752 .109 .505 .099 .297

Overall Survival in the matched cohort Overall group No surgery Surgery

Ref .584

Ref .362

Ref .941

.027

CI = confidence interval; BMI = body mass index; MI = myocardial infarction; CHF = congestive heart failure. ∗ Overall survival multivariate analysis, factors determined from univariate analysis (P < .20).

The mean number of medications decreased by 3 (95% CI 2.6–3.5) in ElderSurg at 1 year. There was a mean increase in the number of medications used in ElderNonSurg with a mean increase of 1.1 (95% CI .7–1.5). This difference was statistically significant (Table 3). Survival On multivariate analysis the number of medications alone correlated negatively with overall survival (hazard ratio 1.160, CI 1.068–1.260). Age, BMI, sex, or co-morbid conditions (myocardial infarction, heart failure, pulmonary disease, malignancy, or diabetes) did not correlate with survival (Table 7). There was a statistically significant decrease in the risk of death in ElderSurg (hazard ratio .584, CI 95% .362–.941, P .027) compared with ElderNonSurg (Table 7, Fig. 1). Discussion Recently there has been renewed interest from the Center for Medicare Services regarding coverage determina-

tions for bariatric surgery in the Medicare population. This is borne out of the perceived lack of robust outcomes and safety data on this specific population insured through Medicare. Our study demonstrates bariatric surgery in the elderly is safe with no statistical difference in mortality or morbidity compared with the matched cohort of younger patients. There were also no significant differences reoperation rates in the 2 matched groups. The ElderSurg group demonstrated no significant difference in emergency department visits or readmissions. Our reported perioperative outcomes are similar to other recent publications supporting that bariatric surgery is safe even in elderly patients [6,8,14–18]. The ElderSurg group compared with the matched ElderNonSurg cohort had a significantly higher change in BMI, %EWL, and percent total weight loss. ElderSurg had a significantly higher rate of diabetes resolution and a reduction of medications compared with ElderNonSurg. Our study is the first study to demonstrate higher long-term survival in elderly patients undergoing bariatric surgery compared with a nonsurgical cohort [19]. In our study, elderly

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Fig. 1. Kaplan-Meier Curve depicting overall survival for elderly surgical and non-surgical patients.

patients having bariatric surgery were .58 times less likely to die compared with the nonsurgery patient. While the nonsurgical cohort had a greater incidence of cerebrovascular and peripheral vascular disease, this difference was accounted for in a logistic regression model developed for the survival analysis. In addition, our stringent requirements of longitudinal follow-up within the primary care network acted as a surrogate for continued optimum medical management. Previous studies have also demonstrated a significant improvement in mobility and quality of life after bariatric surgery [20]. The healthcare expenditure associated with mobility is certainly increased in the elderly and is likely to increase with an increase in morbid obesity. While our study did not evaluate mobility or quality of life, this is certainly an area for future investigation. This is one of the largest institutional studies of elderly patients undergoing bariatric surgery and to our knowledge, the only propensity-matched to compare bariatric surgery with nonsurgical cohort of elderly patients treated medically for morbid obesity. The study includes both gastric bypass and sleeve gastrectomy patients but excluded elderly patients with laparoscopic gastric band. The study has a several limitations. This is a retrospective analysis of prospectively collected data and does not include longterm effects of bariatric surgery on mobility or quality of life. We also did not differentiate payor status to enable a direct comparison of Medicare patients to other third party payors.

Conclusion This study adds to the mounting evidence that bariatric surgery can be done with low morbidity and mortality in elderly patients. Importantly, it is the first to demonstrate a survival benefit against a matched cohort of elderly patients managed with medical weight loss. It will be important for the Center for Medicare Services as well as commercial payors to weigh these health outcomes as they consider their coverage policies in older patients. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. Supplementary material Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.soard. 2018.12.019. References [1] Ortman JM, Velkoff VA, Hogan H. An aging nation: the older population in the United States. Suitland [monograph on the Internet]. US Census Bureau; 2014. [cited yr mo d]; Available from: https: // www.census.gov/ library/ publications/ 2014/ demo/ p25-1140.html. [2] He W, Goodkind D, Kowal P. An Aging World: 2015 [cited yr mo d]. Available from: https:// www.census.gov/ library/ publications/ 2016/ demo/ P95- 16- 1.html.

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