Post Approval Study Confirms Clinical Trial Results for HeartMate II® in Destination Therapy
Results presented today at the International Society for Heart and Lung Transplantation
MONTREAL, April 25, 2013 – Today, researchers will reveal the latest findings on a post-approval study for destination therapy (DT) at the International Society for Heart and Lung Transplantation (ISHLT) 33rd Annual Meeting and Scientific Sessions in Montreal, Canada. The study focused on comparing commercial results to the multicenter clinical trial conducted from 2005-2010 using the HeartMate II® Left Ventricular Assist Device (LVAD). Results in a commercial patient care setting support the findings in the original clinical trial. Data suggests that use of this technology, following approval by the Federal Drug Administration (FDA) for the DT indication, was associated with continued excellent results.
The post approval study analyzed the first 247 HeartMate II® patients preoperatively identified in the national INTERMACS registry as destination therapy. A total of 61 U.S. centers participated with implants from Jan. – Sept. 2010, and patients were followed for two years. Results show a trend toward improved survival over two years in the post approval study, and adverse event rates were similar to or lower than the clinical trial experience. In addition, the median length of stay after surgery was reduced by six days in post approval versus in the clinical trial.
INTERMACS is a database supported by the US National Institutes of Health (NIH)/ National Heart, Lung, and Blood Institute (NHLBI) to track the use of MCS (mechanical circulatory support) devices in patients in U.S. hospitals. To date, more than 5,000 MCS patients from over 100 hospitals are registered in INTERMACS.
“The positive results from this study further validate the use of the HeartMate II for the treatment of advanced heart failure,” said Dr. Ulrich Jorde, Medical Director of the Mechanical Circulatory Support Program at New York-Presbyterian Hospital/Columbia and lead investigator for the study. “Particularly for patients who do not have the option of heart transplantation, we are seeing results in the broader commercial setting that confirm the clinical trial results with continued excellent outcomes and good quality of life. The results of the HeartMate II trial and its successful implementation in clinical practice set the bar for all destination therapy trials in the future.”
Overall, the data, showing strong trends toward improved survival and reduced adverse events, are as good as or better than the original clinical trial, and they indicate continued excellent results for DT with the HeartMate II® LVAD.
About HeartMate II
The HeartMate II® is intended for a broad range of advanced heart failure patients and is the only continuous-flow left ventricular assist device (LVAD) approved by the FDA for both Bridge to Transplantation and Destination Therapy. More than 250 peer-reviewed publications have featured studies regarding the HeartMate II®, far exceeding the volume of published data on all other LVADs combined. To date, over 14,000 patients have been implanted with the HeartMate II®, with nearly 6,000 currently on support including a patient supported for nearly 8 years, the longest reported period of time on a single heart assist device.
The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit professional organization with more than 2,700 members from over 45 countries dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy. For more information, visit www.ishlt.org.
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