DESTINATION THERAPY TRIAL
The destination-therapy arm of the pivotal clinical trial was a prospective, randomized evaluation of the HeartMate II LVAD. The destination therapy arm of the trial studied the device in patients ineligible for a heart transplant. The primary endpoint at two years was survival, while remaining free from stroke and the need for reoperation for pump repair or replacement. The control group were treated with the HeartMate™ XVE LVAD.
Highlights of the data included:6
- Survival was 68% and 58% at 1 year and 2 years, respectively
- The level of adverse events, including infection, sepsis and right heart failure, in patients implanted with the HeartMate II LVAD was lower in major categories versus patients in the control group
- HeartMate II LVAD recipients experienced significantly improved quality of life and functional status
The bridge-to-transplantation arm of the pivotal clinical trial studied patients eligible for cardiac transplantation.
Highlights of the data included:7,8
- Survival to cardiac transplantation, recovery or ongoing on HeartMate II LVAD was 79% at 18 months
- Kaplan-Meier survival for patients who continued on LVAD support was 72% at 18 months
- Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status
- The incidence of major adverse events with comparable definitions, including infections, strokes and bleeding requiring surgery, was significantly lower than what was clinically observed in study of the HeartMate™ I (VE) LVAD
- The majority of patients demonstrated vast improvement, progressing from severe heart failure symptoms even at rest to being able to resume normal activities with little or no limitation; 83% of the patients improved to NYHA Class I or II
ROADMAP CLINICAL STUDY
The ROADMAP study compared the HeartMate II LVAD and optimal medical management (OMM) on patients not yet treated with inotropic support but eligible for destination therapy. Researchers found that HeartMate II LVAD patients had higher survival and function after 12 months than their OMM counterparts. Thirty-nine percent of the HeartMate II LVAD patients were alive and on the original therapy and improved their 6-minute walking test distance by at least 75 meters, compared with 21 percent of OMM patients.9
*Results from clinical trials are not directly comparable. Information provided for educational purposes only.
1. Abbott. Data on file. SJM-HM-0817-0090.
2. Abbott. Data on file. SJM-HM-1016-0032(3).
3. Rose, E. A., Gelijns, A. C., Moskowitz, A. J., Heitjan, D. F., Stevenson, L. W., Dembitsky, W., … Poirier V. L., for the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. (2001). Long-term use of a left ventricular assist device for end-stage heart failure. New England Journal of Medicine, 345(20), 1435-1443. http://www.ncbi.nlm.nih.gov/pubmed/11794191
4. Park, S. J., Milano, C. A., Tatooles, A. J., Rogers, J. G., Adamson, R. M., Steidley, D. E., … Slaughter, M. S., for the HeartMate II Clinical Investigators. (2012). Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circulation: Heart Failure, 5(2), 241-248. http://www.dx.doi.org/10.1161/CIRCHEARTFAILURE.111.963991
5. Starling, R. C., Naka, Y., Boyle, A. J., Gonzalez-Stawinski, G., John, R., Jorde, U., … Pagani, F. D. (2011). Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: A prospective study using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Journal of the American College of Cardiology, 57(19), 1890-1898. http://www.dx.doi.org/10.1016/j.jacc.2010.10.062
6. Slaughter, M. S., Rogers, J. G., Milano, C. A., Russell, S. D., Conte, J. V., Feldman, D., … Frazier, O. H., for the HeartMate II Investigators. (2009). Advanced heart failure treated with continuous-flow left ventricular assist device. New England Journal of Medicine, 361(23) 2241-2251. http://www.dx.doi.org/10.1056/NEJMoa0909938
7. Pagani, F. D., Miller, L. W., & Russell, S. D. (2009). Extended mechanical circulatory support with a continuous flow rotary left ventricular assist device. Journal of the American College of Cardiology, 54, 312-321. http://dx.doi.org/10.1016/j.jacc.2009.03.055
8. HeartMate II LVAD Instructions for Use.
9. Estep, J. D., Starling, R. C., Horstmanshof, D. A., Milano, C. A., Selzman, C. H., Shah, K. B., ... & Kasirajan, V. (2015). Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: results from the ROADMAP study. Journal of the American College of Cardiology, 66(16), 1747-1761. http://dx.doi.org/10.1016/j.jacc.2015.07.075.