American Journal of Transplantation 2015; 15: 1360–1368 Wiley Periodicals Inc.
Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons doi: 10.1111/ajt.13116
Addressing Morbid Obesity as a Barrier to Renal Transplantation With Laparoscopic Sleeve Gastrectomy C. M. Freeman1, E. S. Woodle1, J. Shi2, J. W. Alexander1, P. L. Leggett3, S. A. Shah1, F. Paterno1, M. C. Cuffy1, A. Govil4, G. Mogilishetty4, R. R. Alloway4, D. Hanseman1, M. Cardi5 and T. S. Diwan1,*
intensive care gastrectomy
Received 09 July 2014, revised 20 October 2014 and accepted for publication 16 November 2014
Department of Surgery, Division of Transplantation, University of Cincinnati College of Medicine, Cincinnati, OH 2 University of Cincinnati College of Medicine, Cincinnati, OH 3 Department of Surgery, University of Texas-Houston Health Science Center, Houston, TX 4 Department of Medicine, Division of Nephrology, University of Cincinnati College of Medicine, Cincinnati, OH 5 Department of Medicine, Division of Nephrology, The Christ Hospital, Cincinnati, OH Corresponding author: Tayyab S. Diwan, [email protected]
Morbid obesity is a barrier to renal transplantation and is inadequately addressed by medical therapy. We present results of a prospective evaluation of laparoscopic sleeve gastrectomy (LSG) for patients failing to achieve significant weight loss with medical therapy. Over a 25-month period, 52 obese renal transplant candidates meeting NIH guidelines for metabolic surgery underwent LSG. Mean age was 50.0 10.0 years with an average preoperative BMI of 43.0 5.4 kg/m2 (range 35.8–67.7 kg/m2). Follow-up after LSG was 220 152 days (range 26–733 days) with last BMI of 36.3 5.3 kg/m2 (range 29.2–49.8 kg/ m2) with 29 (55.8%) patients achieving goal BMI of 30 kg/m2 (2). The proportion of patients undergoing renal transplantation who are obese (BMI 30 kg/m2) at the time of transplant is currently 60% (3). Obesity is also an important risk factor for complications following renal transplantation (3–6). Recent reviews and single center experiences have shown that morbid obesity is associated with increased delayed graft function, wound complications, prolonged hospitalization, new onset diabetes mellitus, acute biopsy proven rejection and reduced graft survival (4–13,36). Higher mortality rates in obese renal transplant recipients are thought to be due to increased rates of postoperative cardiovascular complications including atrial fibrillation and congestive heart failure (14–16). Recognition of these associated complications has led to obesity becoming a relative contraindication to renal transplantation with many centers using a BMI of 35–40 kg/m2 as an upper limit for transplant candidacy. Of note, patients with obesity (class I–III) have a reported lower likelihood of transplantation when compared to a normal BMI patient (17). Kidney transplant programs often require that obese transplant candidates meet specified BMI and/or weight loss criteria prior to being approved as a transplant candidate for living donor transplantation or approved for active status on the deceased donor waitlist. Recent SRTR data has shown that obesity is the third leading cause of being inactive on the kidney transplant waitlist (18). For most obese transplant candidates, medical weight loss has traditionally been the primary approach for achieving pretransplant weight loss. However, medical weight loss regimens have historically had poor short and long-term success rates (19). Similarly, we have found medical weight
LSG in Renal Transplant
loss regimens prior to kidney transplantation to have high failure rates, with patients often spending years on hold on the deceased donor waitlist without achieving a desired target weight or BMI for transplantation. The importance of this observation is emphasized by the 5–10% per year mortality rate in the deceased donor waiting list (20). In our program, waitlist mortality rates are 7% per year. Moreover, it is likely that the deceased donor waiting list mortality is higher in obese patients with type II diabetes mellitus. Metabolic surgery provides an effective and safe alternative to medical weight loss approaches in the general population. Importantly, over the past decade, significant progress has been made in improving results in these procedures (21–23). Alexander and colleagues from our transplant program at the University of Cincinnati first demonstrated that metabolic surgery can be safely performed in the dialysis and transplant populations using the Roux-en-Y gastric bypass procedure (24). Recently we have initiated use of the laparoscopic sleeve gastrectomy (LSG) in lieu of the Roux-en-Y gastric bypass in the kidney transplant patient population, as LSG has demonstrated effective weight loss with substantial reduction in morbidity in the general population (25). Our intent was to eliminate obesity as a barrier to renal transplantation in our two kidney transplant programs. This prospective evaluation with medical weight loss followed by LSG represents the largest experience to date with LSG in ESRD patients.
Materials and Methods Data collection was approved by the institutional review board of The University of Cincinnati (IRB #2013-1761). All patients were treated at The University Hospital Cincinnati Medical Center or The Christ Hospital in Cincinnati, OH between December 2011 and January 2014. Patients were required to meet NIH guidelines to undergo surgical weight loss (BMI greater than 40 kg/m2 or BMI between 35 and 40 kg/m2 with a comorbid medical condition along with a documented inability to achieve weight loss with a medical regimen over a 6-month period) (26). There is no nationally recognized cutoff for inclusion/exclusion as it relates to eligibility for kidney transplantation. Our program does not have a definitive BMI upper limit for transplantation. Rather, patients with a BMI exceeding 38 kg/m2 are considered a relative contraindication with patients evaluated on a caseby-case basis with consideration given to comorbidities. Patients meeting NIH criteria for metabolic surgery were referred to the transplant-related interdisciplinary metabolic (TRIM) clinic and evaluated by a surgeon (TSD), a dietician, and a bariatric coordinator. Their workup for both LSG and renal transplantation was begun concurrently. If at any point during the process the patient was identified as inappropriate for either LSG or kidney transplantation, they were not included in this study. In addition, after LSG, patients were re-evaluated for transplant candidacy on a case-by-case basis with a BMI of 35 kg/m2 as the preferred target BMI. All patients, except five CKD patients, were dialysis-dependent. All patients were awaiting transplantation on the waiting list or from a living donor, or had been referred for transplant evaluation. Patients were screened for medical comorbidities of obesity including diabetes mellitus, hypertension and obstructive sleep apnea.
American Journal of Transplantation 2015; 15: 1360–1368
LSG was performed by a single surgeon (TSD) as previously described by placing a 32 French endoscope along the gastric lesser curve and partial gastrectomy performed using repeated applications with an endo-GIA stapler beginning 6 cm proximal to the pylorus and ending 1–1.5 cm lateral to the angle of His, to provide a longitudinal removal of the gastric fundus and greater curvature (27,28). The staple line was not reinforced. Total resected specimen comprised approximately 60–80% of total gastric volume and residual gastric capacity was estimated to be 90–120 mL. There was no preference in performing these procedures either robotically or laparoscopically. The robotic platform was only utilized when it was available. Patients were required to undergo multidisciplinary medical weight loss management for a 6-month period prior to LSG with documented inability to achieve substantive weight loss. The medical weight loss program consisted of monthly physician-supervised visits with the dietician and bariatric coordinator. Patients were encouraged to join a fitness facility and were referred to physical therapy for consultation. Patients were given food and exercise logs which were reviewed at each visit. Our transplant interdisciplinary metabolic surgery clinic is directed by Dr. Diwan. New referrals were evaluated for kidney transplantation and metabolic surgery concurrently, while waitlisted patients, on hold for medical obesity, underwent LSG evaluation while on hold. Weight and BMI data during medical weight loss therapy were collected retrospectively. Collected data included: demographic data, medical comorbidities (diabetes mellitus, obstructive sleep apnea, stroke, and coronary artery disease), medications, etiology of ESRD and pre-operative dialysis dependence. Prospectively collected operative data included: type of operation (laparoscopic vs. robotic assisted), operative times, blood loss and immediate complications. Prospectively collected postoperative data included: need for ICU admission, hospital length of stay, physiologic data at follow up appointments and changes in medications. Data was collected prospectively with IRB approval and retrospectively reviewed. Following LSG, patients were seen in clinic by the surgeon, coordinator, and nutritionist at 2-week intervals for the first 2 months, monthly for the next 4 months, and every 3 months up to 1 year. Nutritional labs were drawn at the first month and every third month thereafter. Patients received vitamin and micronutrient supplementation in accordance with American Dietetic Association guidelines for the management of postLSG patients (29).
Statistical analysis A student-paired t-test was used to determine statistical significance for preand posttransplant total daily insulin dose, number of anti-hypertensive medications per patient and BMI. Rates of change of percent excess weight and change in pertinent lab values were calculated using the direct method. Subgroup analysis was performed using the Student-unpaired t-test. A random effects segmented regression model was used to compare the change in both BMI and percent excess weight loss (%EWL) during medical weight loss management to that observed following LSG (30). Data collection, statistical analysis and table and figure creation were performed using SAS 9.3 (SAS Institute; Carey, NC) and SigmaPlot, version 11 (Systat Software, Inc; San Jose, CA).
Results Patient characteristics Over a 25-month period, from December 2011 to January 2014, 170 patients underwent comprehensive evaluation for weight loss. Of these 170 patients, 157 were seen during the process of transplant evaluation and 13 1361
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were seen after being waitlisted for kidney transplant and were on medical hold while attempting to achieve target weight loss via medical management. Forty-one patients were seen for weight loss evaluation at the time of their initial clinic appointment. Through the end of January 2014, 102 patients were in evaluation for LSG and 52 patients had undergone LSG. Fifty-two patients with renal failure who were deemed medically appropriate candidates for kidney transplantation formed the study group. Forty-seven patients were dialysis dependent and five had CKD stage 4. Mean age was 50.0 10.0 years (range 18–67 years) with 54% being female. Comorbidities included hypertension in 48 (92.3%) patients, previous myocardial infarction in four patients (7.7%), previous stroke in six patients (11.5%), both stroke and myocardial infarction in one patient (2%) and type II diabetes mellitus in 28 (53.4%) patients. Sleep apnea was present in 61% of patients prior to LSG (Table 1). Operative data LSG was performed by standard laparoscopic techniques in 33 patients and robotically in 19 cases. Mean operative time was 127.0 32.8 minutes (median 120.5, range 79–197 minutes) (Table 2). Mean estimated blood loss was 29.3 29.7 mL (median 25, range 0–200 mL), and no patient required transfusion. One patient required admission to the surgical intensive care unit for postoperative supraventricular tachycardia secondary to a preexisting cardiac condition. Mean hospital length of stay was 2.7 1.0 days (range 2–5 days).
Table 1: Demographics & comorbidities (n ¼ 52) Patient Demographic Male Age (years) Race White African-American Hemodialysis dependent Prior CAD & CVD Prior CAD Prior CVD Sleep apnea Renal failure etiology Hypertension Diabetes mellitus FSGS IgA nephropathy Acute tubular necrosis RPGN Other
n, % 24 (46.2%) 50.0 10.0 (18–67) 27 (51.9%) 25 (48.1%) 90.4% 1.9% (n ¼ 1) 7.7% (n ¼ 4) 11.5% (n ¼ 6) 57.7% (n ¼ 30) 43% 40% 5% 3% 3% 3% 3%
CAD, coronary artery disease; CVD, cerebrovascular disease; FSGS, focal segmental glomerulosclerosis; RPGN, rapidly progressive glomerulonephritis.
Table 2: Operative data (n ¼ 52) mean SD (range), n, % Operative time (minutes) Estimated blood loss (mL) Length of stay (days) Post-op complications ICU admissions
127.0 32.8 (79–197) 29.3 29.7 (0–200) 2.7 1.0 (2–5) 1 (Supraventricular tachycardia) 1 (1.9%)
ICU, intensive care unit.
Response to LSG Mean BMI decreased from 43.0 5.4 kg/m2 (median 42.1, range 35.8–67.7 kg/m2) pre-LSG to 36.4 5.4 kg/m2 (median 34.6, range 29.2–49.8 kg/m2) postLSG. Percent of excess weight loss at last follow-up appointment was 29.8 18.7% (median 27.5, range 6.7–93.8%). At last follow-up, 29 (55.8%) patients had achieved a goal BMI of