R01HL159401

Prophylactic Intra-Operative VT Ablation in High-Risk LVAD Candidates - Abstract

The use of left ventricular assist devices (LVAD) for patients with advanced heart failure has continued to increase over the years. The significant improvement in survival with the current generation of LVADs is, in large part, due to the advances in device durability and mechanics. However, several important factors continue to limit the benefit of LVAD support, and ventricular tachyarrhythmias (VTA) following LVAD implantation have been suggested to be associated with subsequent repeat hospitalization and increased mortality.

Our retrospective data from the University of Rochester have shown that patients who developed VTA following LVAD implant experienced a 7-fold increase in subsequent mortality risk. Importantly, we have also shown that the most powerful predictor of VTA post LVAD implant is a history of VTA at any time prior to the LVAD. Several ablation trials have demonstrated a reduction in recurrent VTA and, in selected at-risk patient groups with ischemic heart disease, mortality. These findings suggest that effective early intervention with VTA ablation peri-LVAD implantation in high-risk patients, specifically those with a history of VTA, may reduce VTA recurrence and improve clinical outcomes.

Utilization of this strategy has varied amongst centers as there are no prospective data on the efficacy and safety of this management. Accordingly, we propose a prospective, randomized, multicenter clinical trial that will evaluate prophylactic intra-operative VTA ablation in high-risk LVAD recipients on clinical outcomes. The study cohort will consist of 100 LVAD candidate patients with a prior history of VTA and ischemic cardiomyopathy randomized to either prophylactic intra-operative VTA ablation vs. conventional medical management in a 1:1 fashion. Eight high-volume LVAD implant centers with experience in VTA ablation will participate.

The primary specific aim is to evaluate the effect of prophylactic intra-operative VTA ablation at the time of LVAD implantation on post-implant total recurrent VTA events after accounting for the competing risk of death. Secondary specific aims are: 1) to evaluate the effects of a management strategy that incorporates intra-operative VT ablation at the time of LVAD implantation on adverse clinical outcomes following LVAD implantation; 2) to collect prospective data on peri-procedural outcomes associated with the proposed novel approach of prophylactic intra-operative VT ablation.

We will also explore the mechanisms associated with: a) recurrent VTA post LVAD implant with electrophysiology studies and b) the ramifications of recurrent VTA on right ventricular hemodynamics post LVAD implant with echocardiographic ramp studies and right heart catheterization.

University Of Rochester

TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Rochester, New York 146113847 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 371% from $758,076 to $3,569,437.