Objectives: This study sought to evaluate the use of a continuous-flow rotary left ventricular assist device (LVAD) as a bridge to heart transplantation. Background: LVAD therapy is an established treatment modality for patients with advanced heart failure. Pulsatile LVADs have limitations in design precluding their use for extended support. Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism. Methods: In a prospective, multicenter study, 281 patients urgently listed (United Network of Organ Sharing status 1A or 1B) for heart transplantation underwent implantation of a continuous-flow LVAD. Survival and transplantation rates were assessed at 18 months. Patients were assessed for adverse events throughout the study and for quality of life, functional status, and organ function for 6 months. Results: Of 281 patients, 222 (79%) underwent transplantation, LVAD removal for cardiac recovery, or had ongoing LVAD support at 18-month follow-up. Actuarial survival on support was 72% (95% confidence interval: 65% to 79%) at 18 months. At 6 months, there were significant improvements in functional status and 6-min walk test (from 0% to 83% of patients in New York Heart Association functional class I or II and from 13% to 89% of patients completing a 6-min walk test) and in quality of life (mean values improved 41% with Minnesota Living With Heart Failure and 75% with Kansas City Cardiomyopathy questionnaires). Major adverse events included bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in 4 patients. Conclusions: A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplantation, with improved functional status and quality of life. (Thoratec HeartMate II Left Ventricular Assist System [LVAS] for Bridge to Cardiac Transplantation; NCT00121472).
Bibliographical noteFunding Information:
A complete list of study investigators has been previously published (N Engl J Med 2007;357:885–96). Dr. Pagani has received research grant support from Thoratec Corporation, was site PI for the HeartMate LVAD trial, has received research grant support from Terumo Heart Corporation, and was national Co-PI for the DuraHeart LVAD trial. Dr. Miller has received research grant support and honoraria for talks at academic medical centers from Thoratec Corporation. Dr. Russell has been a consultant and received research grant support from Thoratec Corporation. Dr. Aaronson has been a consultant for Thoratec Corporation (reimbursed for travel expenses only). Dr. John has received research support from Thoratec Corporation and has served on the Scientific Advisory Board of Ventracor. Dr. Boyle has been a consultant for Thoratec Corporation. Dr. Conte has been a PI for Thoratec Corporation, ABiomed, and Heartware, and has been a trainer for Thoratec/Abiomed. Dr. Bogaev has been a consultant to Thoratec Corporation. Dr. Naka has been a speaker for Thoratec Corporation and a consultant for Cardiomems. Dr. Farrar is an employee and stock holder of Thoratec Corporation. Drs. Miller and Pagani contributed equally to this work.
- heart failure
- heart transplantation
- left ventricular assist device