Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients

Study Overview
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Brief Summary
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In LVAD (Left-Ventricular Assist Device) patients, evidence is lacking regarding the safety and efficacy of Laparoscopic Sleeve Gastrectomy (LSG) as a means to reach a Body Mass Index (BMI) within listing criteria for heart transplantation. To our knowledge, this is the first prospective study to evaluate laparoscopic sleeve gastrectomy in LVAD patients as bridge-to-candidacy for heart transplantation.

Detailed Description
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Continuous-flow left-ventricular assist devices are increasingly used for the treatment of acute or chronic end-stage heart failure (Mancini 2015). Three main implantation strategies exist: destination therapy (support until end of life), bridge to transplantation (support until transplantation), and bridge to candidacy (support until transplantation criteria are met). Although LVAD support delivers excellent short-term and long-term results, the current gold standard and last resort of treatment for end-stage heart failure remains orthotopic heart transplantation (Lund 2015). Obesity increases mortality in heart transplantat recipients and therefore is included in the 2006 transplantation criteria. The heart transplant program of the Medical University of Vienna uses a BMI of 30 kg/m2 as the upper limit to be listed for heart transplantation (Mehra 2016). Ambulatory patients on CF-LVAD support have a tendency to gain weight because of reduced physical fitness, inability to work, and genetic predisposition. In many cases, binge eating is used as a coping mechanism to alleviate depression and anxiety associated with heart failure and LVAD therapy. Conservative measures to reduce weight and increase physical fitness fail in many patients. As a result, in many cases these patients remain ineligible for heart transplantation for months or years. For the entire period of ineligibility, they are subject to the constant life-threatening risks of LVAD treatment, most importantly ischemic and hemorrhagic stroke, pump thrombosis, infection, right heart failure, and bleeding episodes in the gastrointestinal tract or other organ systems (Kirklin 2015). Bariatric surgery has been shown to be superior to conservative measures of weight reduction in morbidly obese patients. Laparoscopic sleeve gastrectomy, one of the most commonly employed bariatric procedures, reduces body weight by a non-malabsorptive mechanism (Colquitt 2014). Gastric volume reduction is achieved by resection along the stomach's greater curvature and creation of a gastric tube, leading to reduced capacity for ingested food, decreased appetite and earlier satiety. In contrast to malabsorptive bariatric procedures, resorption and efficacy of immunosuppressive drugs, an inevitable feature of post-transplant therapy, are only minimally influenced following sleeve gastrectomy. Furthermore, there is less requirement for substitution of trace elements and vitamins, for example Vitamin B12. Due to the fact that the majority of obese LVAD patients are within a BMI range of 30 to 40 kg/m2, the moderate weight loss achieved by sleeve gastrectomy is expected to be sufficient for reaching the eligibility criterion for heart transplantation. It is unclear, whether laparoscopic sleeve gastrectomy is effective and safe in patients on CF-LVAD. The literature is limited to case reports and retrospective series of up to 4 patients. This is the first prospective series including more than 4 patients with the specific aim to enable obese LVAD supported patients to reach a BMI within listing criteria for heart transplantation by the means of laparoscopic sleeve gastrectomy.

Official Title
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Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients

Conditions
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Heart Failure, Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory patients on LVAD-support for end-stage heart failure Bridge-to-Candidacy strategy BMI > 35kg/m2 Failure to reach BMI < 30kg/m2 with conservative measures Age > 18 years Ability to give informed consent Exclusion Criteria: - Absolute contraindications to subsequent heart transplantation other than obesity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic Sleeve Gastrectomy|Routine Laparoscopic Sleeve Gastrectomy is performed on obese patients supported by Left-Ventricular Assist Device in order to reach a Body Mass Index sufficient for heart transplantation listing.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (Body-Mass-Index) | Patient weight is measured and BMI is calculated at the time of LSG and at 3, 6, and 12 months post-LSG. The rate of patients with successful weight reduction to a BMI lower than 30kg/m2 is calculated. | 12 months post-LSG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA (New York Heart Association) Class | Patients' NYHA Class (I, II, IIIa, IIIb, IV) is assessed pre-operatively and at 3, 6, and 12 months post-LSG and changes are noted. | 12 months post-LSG | 
| 6-min Walking Test | Patients are performing the 6-min walking test pre-operatively and at 3, 6, and 12 months post-LSG and changes of the distance walked (m) are assessed. | 12 months post-LSG | 
| EQ-5D (EuroQol five dimensions) questionnaire | Patients are undertaking the EQ-5D quality-of-life questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression, and visual analog scale) pre-operatively and at 3, 6, and 12 months post-LSG to assess changes in the post-operative quality of life. | 12 months post-LSG | 
| Work Ability questionnaire | Patients are undertaking the Work Ability questionnaire including questions about their current or former occupation pre-operatively and at 3, 6, and 12 months post-LSG to assess changes in occupational issues. | 12 months post-LSG | 
| WHOQOL-BREF (World Health Organization Quality of Life) questionnaire | Patients are undertaking the WHOQOL-BREF questionnaire including questions regarding their quality of life pre-operatively and at 3, 6, and 12 months post-LSG to assess changes regarding social, emotional, and health-related issues. | 12 months post-LSG | 
| LVEF (Left-Ventricular Ejection Fraction) | LVEF (%) is going to be measured by echocardiography pre-operatively and at 3, 6, and 12 months post-LSG to investigate changes of cardiac function. | 12 months post-LSG | 
| VO2 max (maximum rate of oxygen consumption) | Patients are undergoing spiroergometry pre-operatively and at 3, 6, and 12 months post-LSG to investigate changes of cardiac performance. | 12 months post-LSG | 
| Severe adverse events | Adverse and severe adverse events including death, unplanned hospital readmission, reoperation, major bleeding, cardiac arrhythmia, pericardial fluid collection, device malfunction, hemolysis, hepatic dysfunction, hypertension, major infection, myocardial infarction, neurological dysfunction, psychiatric episodes, renal dysfunction, respiratory failure, right heart failure, arterial non-CNS (central nervous system) thromboembolism, venous thromboembolism, wound dehiscence, gastroesophageal reflux disease, vomiting, gastric anastomotic leak, trocar site infection, trocar site hernia, gastric pouch dilation, and others are assessed in the immediately post-operative phase and at 3, 6, and 12 months post-LSG. | 12 months post-LSG |