Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03008096
Status:
UNKNOWN
Last Update Posted:
2017-01-02
First Post:
2016-12-16
Brief Title:
Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients
Sponsor:
Philipp Angleitner
Organization:
Medical University of Vienna
Study Overview
Official Title:
Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LSG-BTC-LVAD
Brief Summary:
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:
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 kgm2 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 stomachs 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 kgm2 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
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 kgm2 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 stomachs 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 kgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None