Objectives: The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. Background: After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. Methods: The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Results: Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. Conclusions: The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.
Bibliographical noteFunding Information:
This work was supported by Thoratec Corporation . Dr. Starling has received research funding from Thoratec . Dr. Naka has received research support from Thoratec and serves as a consultant to Thoratec, Terumo Heart Inc., and Cardiomems. Dr. Boyle has received consulting support and honoraria from Thoratec . Dr. Gonzalez-Stawinski has served on the advisory board of Maquet Cardiovascular and received speaking fees from Thoratec . Dr. John has received research grants from Thoratec , Heartware , and Levitronix . Dr. Jorde has received consulting support from Thoratec and Jarvik Heart . Dr. Russell has received research and consulting support from Thoratec . Dr. Conte has served as the Principal Investigator Heartwave for HVAD and as the Principal Investigator for Thoratec for HM II. Dr. Aaronson has received research support from Thoratec , Heartware , and Terumo ; has served on the Clinical Steering Committee for Heartware; and has a conflict management plan on file with the Conflict of Interest Board of the University of Michigan Health System for these relationships with Thoratec and Heartware. Dr. McGee has served on the scientific advisory board of Cardiac-Assist and receives consulting support from Thoratec and Heartware . Dr. DeNofrio has received consulting support from Thoratec . Dr. Farrar is an employee of Thoratec with equity ownership in the company. Dr. Pagani has received research support from Thoratec and has received research grant support administered by the University of Michigan from Terumo and Heartware . All other authors have reported that they have no relationships to disclose.
- cardiac transplantation
- heart failure
- ventricular assist device