Risk of Blood Clot with Thoratec Heart Pump Higher than Previously Reported
A study published Wednesday has found a higher rate of blood clots in patients treated with Thoratec Corp’s HeartMate II heart pump than that recorded in clinical trials.
About the HeartMate II Study
The HeartMate II heart pump is a left ventricular assist device (LVAD) used to keep patients alive while if they are ineligible for or are awaiting a heart transplant.
As part of a study published in the New England Journal of Medicine, researchers analyzed the outcomes of 895 HeartMate II heart pumps implanted in 837 patients between 2004 and 2013.
According to Reuters, the study found that not only were blood clots occurring more regularly than previously reported, but also closer to the time of implantation than previously believed.
Detailed Findings of the HeartMate II Study
“What’s unique to this study is their reported incidence seems to be quite a bit higher than what has been reported in the mandatory registry for LVAD. It is worrisome.” – Dr. Alex Reyentovich, medical director of the LVAD program at NYU Langone Medical Center in New York as published by Reuters
Researchers conducting the study observed the following:
- Blood clot occurred in 8.4% of HeartMate II patients – the rate was previously reported as 2.2%.
- On average, clots occurred within 2.7 months of the device being implanted since March 2011. A median of 18.6 months had been recorded prior to that date.
- A death rate of 48 percent was recorded in patients who did not recieve a heart transplant or replacement pump with in 90 days of a clot being detected.
Though Dr. Reyentovich recognizes that the HeartMate II heart pump provides life-sustaining treatment, he points out that recommendations for such devices should be made with the most accurate, up-to-date information possible.
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