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Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients with End-Stage Heart Failure and Left Ventricular Assist Device: Medium-Term Results Umer I. Chaudhry MD, Aliyah Kanji MD, Chittoor B. Sai-Sudhakar MBBS, Robert S. Higgins MD, Bradley J. Needleman MD www.elsevier.com/locate/buildenv

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Cite this article as: Umer I. Chaudhry MD, Aliyah Kanji MD, Chittoor B. Sai-Sudhakar MBBS, Robert S. Higgins MD, Bradley J. Needleman MD, Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients with End-Stage Heart Failure and Left Ventricular Assist Device: Medium-Term Results, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2014.04.003 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

TITLE Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients with End-Stage Heart Failure and Left Ventricular Assist Device: Medium-Term Results

AUTHORS Umer I. Chaudhry MD,a Aliyah Kanji MD,a Chittoor B. Sai-Sudhakar MBBS,b Robert S. Higgins MD,b Bradley J. Needleman MDa

INSTITUTION a

Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical

Center, Columbus, OH b

Heart Transplantation Center, The Ohio State University Wexner Medical Center,

Columbus, OH

RUNNING TITLE Laparoscopic Sleeve Gastrectomy for Cardiac Transplantation

CORRESPONDING AUTHOR Bradley J. Needleman, MD Center for Minimally Invasive Surgery The Ohio State University Wexner Medical Center 558 Doan Hall 410 West 10th Avenue Columbus, OH 43210 Tel: (614) 293-7399 Fax: (614) 293-7852 e-mail: [email protected]

ACKNOWLEDGEMENTS We also thank Rebecca Dettorre and Andrew Suzo for administrative and data-collection support.

DISCLOSURES The authors have no financial conflict of interests related to this study.

ABSTRACT BACKGROUND: Morbid obesity precludes patients with end-stage heart failure from becoming cardiac transplant candidates.

OBJECTIVES: This study evaluates the safety and efficacy of laparoscopic sleeve gastrectomy (LSG) as a means to transplant candidacy in such patients.

SETTING: Academic Medical Center, USA.

METHODS: Morbidly obese patients with end-stage heart failure, who were ineligible for cardiac transplantation and underwent LSG between 2008 and 2013, were reviewed retrospectively. Demographics, perioperative details, percentage of excess weight loss (%EWL), and status of transplant candidacy were analyzed.

RESULTS: Six patients (3 men) with end-stage heart failure and morbid obesity underwent LSG. Three patients (50%) had a left ventricular assist device (LVAD) in place at the time of surgery. Median age was 34 (31-66) years and mean preoperative Body Mass Index (BMI) was 47.6±3.0 kg/m2. Median operative time was 90 (66-141) minutes, with a median length of stay of 7 (4-16) days. There were no perioperative deaths. One patient suffered a spontaneous flank hematoma. The same patient also had thrombosis of the LVAD pump at 3 weeks postoperatively, requiring an uneventful device exchange. At median follow-up of 22 (12-70) months, the mean %EWL was 51.4±10.3% with a decrease in BMI to 34.3±2.4 kg/m2 (p < 0.05). All patients had lost

sufficient weight to become transplant eligible within 12 months of surgery. Two patients had undergone successful transplantation and another 2 were on the transplant list.

CONCLUSION: LSG appears to be a safe, technically feasible, and effective method for obtaining adequate weight loss in morbidly obese patients with end-stage heart failure and mechanical circulatory support, subsequently improving their access to cardiac transplantation. This is the largest case series to date of this high-risk group of patients undergoing LSG.

KEYWORDS: Bariatric Surgery; Heart Failure; Laparoscopic Sleeve Gastrectomy; Left Ventricular Assist Device; Morbid Obesity; Cardiac Transplantation

INTRODUCTION The prevalence of obesity in the United States is currently estimated to be 35%.(1) Patients with morbid obesity are at high risk for developing multiple medical comorbidities, including diabetes, hypertension, hyperlipidemia, obstructive sleep apnea, coronary artery disease, and heart failure.(2)

Due to paucity of organ allocation and plethora of data showing increased perioperative morbidity and reduced graft survival in obese recipients,(3-5) patients with end-stage heart failure and morbid obesity are ineligible for cardiac transplantation. Mechanical circulatory support has been shown to improve survival in these patients and serve as a potential bridge to transplantation.(6) Yet, as their poor cardiac function prohibits them from exercising and dietary weight-reducing programs are difficult to initiate and maintain, these patients usually succumb to their disease without ever being considered for transplantation. Bariatric surgery has become the gold standard for achieving meaningful and durable weight loss in morbidly obese patients.(7) However, due to inherent risk of major surgery, it is not routinely considered as a feasible option in morbidly obese patients with end-stage heart failure.

This study reviews our institutional experience in morbidly obese patients with end-stage heart failure and left ventricular assist device (LVAD) that underwent laparoscopic sleeve gastrectomy (LSG) over a 4.5-year period. The primary goals of this study were to assess the safety and feasibility of LSG in a cohort at high risk for perioperative morbidity and mortality. Secondary aims were to evaluate its effectiveness in achieving durable weight

loss and the subsequent impact on patients’ candidacy for cardiac transplantation. To date, this report represents the largest series of morbidly obese patients with end-stage heart failure who have undergone bariatric surgery, and also offers the longest follow-up interval.

METHODS Patients Under a protocol approved by the Institutional Review Board, retrospective analysis was performed of six morbidly obese (Body Mass Index [BMI] > 40 kg/m2) patients with end-stage heart failure, who were referred to The Ohio State University Wexner Medical Center (OSUWMC) Division of Bariatric Surgery by their transplant cardiologist, for consideration for weight-loss surgery. Three patients had a HeartMate II (Thoratec Corp., Pleasanton, CA) LVAD in place at the time of consultation. All patients were ineligible for transplantation due to failure to meet the BMI requirement. (The BMI cutoff for heart transplantation at OSUWMC is 35 kg/m2.) All patients met the 1991 National Institute of Health Consensus Criteria for weight-loss surgery and underwent the same pre-bariatric screening and counseling program as non-transplant bariatric patients would at OSUWMC.

From August 2008 to January 2013, one attending surgeon (BJN) performed LSG in all patients. In January 2014, charts were reviewed and the following data were collected for analysis: demographics, preoperative weight and BMI, operative details, perioperative complications, length of stay, postoperative weight and BMI at follow-ups, and status of transplantation candidacy.

Operative Technique Peritoneal access was obtained using a Veress needle approach, and four working trocars were introduced. Special care was taken during trocar placement to avoid injury to the

LVAD and its drive cord. A Nathanson liver retractor was used to retract the left lobe of the liver. The LSG was performed by mobilizing the greater curvature of the stomach with the LigaSure™ (Covidien, Mansfield, MA), starting 4-5 cm proximal to the pylorus and continuing to the angle of His. The sleeve was created around a 34-42F bougie, using a 4.8 mm Endo GIA™ linear stapler (Covidien) for the antrum and body and a 3.5 mm stapler for the fundus. SEAMGUARD® (W.L. Gore, Newark, DE) was used for stapleline reinforcement. Intraoperative endoscopy was performed to inspect the staple-line and test its integrity. Intraabdominal drains were not routinely used.

Postoperative Management Post-operatively, all patients were managed according to a standardized postoperative pathway for LSG with some variations. Briefly, patients went directly from the operating room to the cardiac intensive care unit. Nasogastric tubes were not regularly used. A low calorie, noncarbonated liquid diet was started on the first postoperative day or when extubated. Patients were discharged home on a full liquid diet for 4 weeks. We did not routinely obtain postoperative imaging studies.

Analysis Data were analyzed using Stata 12 (Statacorp, College Station, TX). All data are presented as mean ± standard deviation or median (range) as appropriate. Wilcoxon signed-rank test was used for statistical comparison of quantitative data. A p value less than 0.05 was considered statistically significant.

RESULTS Between August 2008 and January 2013, a total of 6 morbidly obese (BMI > 40 kg/m2) patients with end-stage heart failure underwent LSG at our institution. All patients were ineligible for cardiac transplantation at their current weights. Three were female. The median age was 34 (31-66) years at the time of surgery and the average preoperative BMI was 47.6 ± 3.0 kg/m2. Three patients had New York Heart Association (NYHA) Class III disease with a mean left ventricular ejection fraction (LVEF) of less than 20%. Remaining 3 patients (2 females), with NYHA Class IV disease, had an LVAD in place at the time of surgery, with a median time on LVAD prior to surgery of 20 (4-37) months. Etiology of heart failure was as follows: 3 non-ischemic/idiopathic cardiomyopathy, 2 ischemic cardiomyopathy, and 1 right-sided heart failure secondary to congenital tricuspid valve disease.

All cases were successfully completed using a laparoscopic approach. The median operative time and estimated blood loss (EBL) were 90 (66-141) minutes and 48 (40-200) ml, respectively. All patients had a standard LSG as detailed above. One individual had the sleeve constructed with a 34-Fr bougie, while the rest had their sleeve fashioned with a bougie size of 40-Fr or above. There were no perioperative deaths. Median hospital length of stay was 7 (4-16) days. One patient experienced a spontaneous flank hematoma, which was managed nonoperatively. The same patient also suffered thrombosis of their LVAD pump at 3 weeks postoperatively and underwent a successful device exchange, with no further complications.

At 12-month follow-up, all patients had experienced substantial weight loss with mean %EWL of 54.3 ± 10.8 %, thus making everyone eligible for cardiac transplantation from a BMI standpoint (Figure 1). At longer-term follow-up of median time of 22 (12-70) months, patients continued to experience durable weight loss with mean %EWL remaining steady at 51.4 ± 10.3 %. After sub-group analysis, patients with an LVAD, as compared to patients without mechanical circulatory support, experienced slightly longer operative time (106 ± 31 vs. 80 ± 19 minutes), higher EBL (107 ± 82 vs. 43 ± 6 ml) and longer hospital length of stay (10.0 ± 5.2 vs. 6.7 ± 3.1 days). However, both groups had comparable weight loss at 12-months and at median follow-up of 22 months (Figure 2).

At the end of the study period, two patients with LVAD had undergone successful cardiac transplantation with mean time-to-transplant post LSG of 13 ± 1 months. One of these patients subsequently died due to antibody-mediated rejection 3 years after the transplant. The other was alive and well at 4 months post transplantation. Two patients were on the transplant list awaiting an organ. One patient showed marked improvement in symptoms and was being managed medically. The remaining one individual was ineligible for transplant due to severe depression, which was being managed with medications and counseling.

DISCUSSION In this single institution case series of 6 morbidly obese (BMI > 40 kg/m2) patients with end-stage heart failure, who were ineligible for cardiac transplantation due to their excess weight, we demonstrated that LSG appears to be safe, technically feasible, and provides excellent weight loss at median follow-up of 2 years, subsequently improving candidacy for cardiac transplantation. Patients lost substantial weight and became eligible for transplantation as early as 1 month after surgery, with all patients becoming eligible within 12 months (Figure 1). To the best of our knowledge, this represents the largest series, with the longest follow-up, to describe the use of LSG in morbidly obese precardiac transplant patients.

Morbid obesity is a significant risk factor for heart failure; with each increment of 1 in BMI corresponding to a 5% increase in the risk of heart failure in men and 7% in women.(2) Currently, one in three Americans is considered obese.(1) Simultaneously, 5.1 million Americans suffer from heart failure.(8) Although the “obesity-paradox” (i.e. an association between obesity, as compared to normal weight, and reduced mortality) has been reported in patients with heart failure and other diseases,(9-12) fact remains that many obese patients with heart failure progress to end-stage disease, whether due to obesity related comorbidities or an idiopathic etiology. Additionally, the “obesity-paradox” may not be relevant in morbidly obese patients,(13) and some recent publications are beginning to challenge this inverse relationship.(14)

In patients with end-stage heart failure, cardiac transplantation represents the most durable means of improving quality of life and survival.(5) However, due to paucity of

available organs, many of these patients succumb to their disease prior to receiving a transplant. The situation is even grimmer for morbidly obese patients, since multiple studies have shown that obesity negatively impacts transplant outcomes.(3-5) As it is imperative to allocate organs to patients with the greatest need and the greatest chance to derive the maximum benefit, many centers do not transplant obese patients or advocate using higher BMI as contraindication to transplantation.(4, 15) At our institution, cardiac transplantation is contraindicated in patients with BMI greater than 35 kg/m2.

Since their underlying disease precludes them from exercising and weight loss is not effective or durable with dieting alone,(16) morbidly obese patients with end-stage heart failure present a distinct challenge for the medical community. Bariatric surgery represents a viable option in these high-risk patients. Successful weight loss in obese patients requiring kidney, liver, pancreas and lung transplantation has been achieved with bariatric surgery.(17-19) However, to date, only two case series exist of bariatric surgery as a means to improving transplant candidacy in morbidly obese patients with severe heart failure. In a multi-institutional study of 14 morbidly obese patients with systolic heart failure,(20) McCloskey and colleagues showed that bariatric surgery is safe, feasible, and provides substantial weight loss at 6 months, with mean %EWL of 50.4%. Majority of the patients in the study underwent Roux-en-Y gastric bypass (RYGB). Two patients had received transplant evaluations preoperatively and underwent organ transplantation after weight loss. Recently, the same group reported on 3 patients that received heart transplant after successful bariatric surgery.(21)

In our series of LSG in 6 transplant-ineligible morbidly obese patients (3 with LVAD), at a median follow-up of 2 years, 2 patients had undergone successful cardiac transplantation, with a mean time to transplantation of 13 months. Another 2 patients were on the transplant list awaiting an organ, after briefly experiencing subjective improvement in symptoms with weight loss. One patient (NYHA Class III) showed dramatic symptomatic improvement. Although his LVEF did not change from a preoperative value of less than 20%, his home inotrope therapy was gradually tapered off and he was being managed with oral medications, thus delaying or potentially mitigating his need for transplant with further weight loss. Several studies have shown that weight loss from bariatric surgery can improve cardiac function.(22, 23) However, we did not observe this in the majority of our patients, perhaps due to the severity and end-stage nature of the disease.

The use of LVAD as a bridge to transplantation or destination therapy is increasing, with greater than 9,000 LVADs having been implanted in the United States since June 2006.(6) Three of our patients had an LVAD in place at the time of LSG and our results indicate that LSG also appears to be safe, feasible, and effective in heart failure patients with mechanical circulatory support (Figure 2). One patient with an LVAD (HeartMate II) was readmitted at 3 weeks following LSG with signs of severe hemolysis, jaundice, and congestive heart failure. An acute pump thrombosis was confirmed and the patient underwent an uneventful device exchange. The patient had had two previous episodes of LVAD pump thromboses, both prior to undergoing LSG. It is difficult to discern whether this particular thrombosis was a direct or indirect result of the LSG itself. Based on

preapproval clinical-trail results and initial experience, HeartMate II has a reported thrombosis occurrence rate of 2 to 4%.(24, 25) However, in a recent study of 66 patients with HeartMate II LVAD, a substantial increase in thrombosis at 3 months after implantation was noted, from 2.2% before March 2011 to 8.4% by January 2013. Authors correlated a presaged increase in serum lactate dehydrogenase (LDH) level, signifying hemolysis, with the occurrence of thrombosis. Predisposing patient and device factors remain elusive.

A single case report exists of LSG in a patient with an LVAD for the purpose of improving patient’s candidacy for transplant. Ahmed et al described a 25 year-old patient, who underwent a LSG to become eligible for transplantation.(26) Pre- or perioperative data was not provided, however the patient did undergo a successful organ transplant at a future date. Lockard and colleagues reported on a 37 year-old heart failure patient with an LVAD and a BMI of 52.2 kg/m2, who underwent a laparoscopic RYGB.(27) At one year, the BMI had decreased to 40.8 kg/m2 and the patient was working towards a goal of 36 kg/m2 to qualify for transplant. Recently, another successful outcome of laparoscopic RYGB in a patient with an LVAD was described.(28)

We chose LSG, rather than RYGB, as the weight-loss operation because of its technical simplicity, shorter operative time, and lower perioperative morbidity, while still providing substantial and durable weight loss.(7) Additionally, when compared to RYGB, LSG potentially has minimal effect on absorption of immunosuppressive medications, majority of which are absorbed in the proximal small bowel.(29) Our patients experienced

an average %EWL of 54% and a decrease in BMI to 34.3 kg/m2 at 12 months. This weight loss was maintained at median follow-up of 2 years. These results are consistent with results observed in patients who undergo LSG for morbid obesity.

Staple line leaks after LSG are one of the most feared complications of the operation. They are seen in 2 to 3% of the patients and can be associated with significant morbidity,(30) especially in high-risk patients such as our cohort. Our index patient had their sleeve fashioned with a 34-Fr bougie. However, in the proceeding 5 patients we changed our technique to utilize a bougie size of 40-Fr or greater to decrease the risk of a potentially catastrophic leak. In a large meta-analysis of 9991 patients,(31) Parikh et al showed that a bougie size of 40-Fr or greater decreases the sleeve leak rate by two-fold, without affecting excessive weight loss. We did not observe any leaks in our series.

CONCLUSION In summary, LSG appears to be a safe, feasible, and effective method for achieving substantial and durable weight loss in morbidly obese patients with end-stage heart failure and mechanical circulatory support. At medium-term follow-up, this operation provides excellent weight loss results and improves candidacy for transplantation. Additional studies with long-term follow-up are needed to determine whether LSG will continue to provide durable weight loss in these high-risk patients.

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FIGURE LEGENDS FIGURE 1 − (A) Comparison of pre- and postoperative Body Mass Index (BMI). (B) BMI of individual patients at 1, 3, 6, 9, and 12 months after laparoscopic sleeve gastrectomy. Dotted line represents the BMI cutoff value for cardiac transplantation at our institution. *P < 0.05.

FIGURE 2 − Comparison of perioperative outcomes and pre- and postoperative weight loss in patients with heart failure (HF) alone and patients with heart failure and left ventricular assist device (HF+LVAD).

Laparoscopic sleeve gastrectomy in morbidly obese patients with end-stage heart failure and left ventricular assist device: medium-term results.

Morbid obesity precludes patients with end-stage heart failure from becoming cardiac transplant candidates. This study evaluates the safety and effica...
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