Clinical Research News

SCCOR Grant Supports Extensive LVAD Research

The Thoratec HeartMate® XVE (above) is approved as both a bridge-to-transplantation and a destination therapy.

In March 2005, the National Institutes of Health (NIH) awarded Columbia University College of Physicians & Surgeons a $17 million SCCOR (Specialized Centers of Clinically Oriented Research) grant to investigate improving outcomes for end-stage heart failure patients with implanted mechanical devices. Eric A. Rose, MD, Chairman, Department of Surgery, is the principal investigator for the grant. Alan J. Moskowitz, MD, Co-Director of InCHOIR (International Center for Health Outcomes and Innovation Research), and Mario Deng, MD, Director, Cardiac Transplantation Research, serve as co-principal investigators.

In 2001, Dr. Rose and InCHOIR published findings from the landmark REMATCH trial, proving that LVADs (left ventricular assist devices) can prolong the lives of end-stage heart failure patients who are not eligible for transplantation. (LVADs provide mechanical support to failing hearts.) Those findings resulted in FDA approval and Centers for Medicare and Medicaid Services (CMS) reimbursement for the devices in 2003. Since that time, approximately 150 LVADs have been implanted as destination therapy (for patients ineligible for transplantation) and about 500 as a bridge-to-transplantation (supporting patients until a suitable donor heart becomes available).

The number of LVAD procedures is expected to rise as both awareness of the approach and reimbursement rates improve. In fact, implantation of mechanical circulatory support devices is already becoming standard practice as a bridge-to-transplantation. Serious adverse effects remain, however, for the application of LVADs as destination therapy. Its life-saving potential notwithstanding, LVAD implantation remains an invasive, demanding mechanical therapy, with significant risks of infection, bleeding, neurological complications, and device failure.

The $17 million SCCOR grant seeks to transform LVADs into a safer and more widely accepted therapy by funding multiple basic and clinical studies to investigate adverse effects. The three main arms of the study will focus on infection, coagulation, and neurological events. "These improvements will benefit heart failure patients and make the therapy more cost-effective," according to Annetine C. Gelijns, PhD, and Alan J. Moskowitz, MD, Co-Directors, InCHOIR. This landmark project will include patients with advanced heart failure who receive LVADs as bridge-to-transplantation, destination therapy, and bridge-to-recovery (temporary support for reversible heart failure).

SCCOR is funded by the National Heart, Lung, and Blood Institute (NHLBI) of the NIH to foster translational research in order to improve prevention, diagnosis, and treatment of particular diseases. When the Columbia investigators submitted their application in 2003, they received the highest score among all applicants, and this grant represents the largest ever awarded in the field of mechanical circulatory support. "Because NYP/Columbia has such a strong program for heart failure and transplantation, it is natural that it would be a primary center for implantation of ventricular assist devices, and a central research institution in the field of mechanical circulatory support," says Mario C. Deng, MD.