The heartmate left ventricular assist system: worldwide clinical results.
To date 482 patients have been treated with TCI's HeartMate left ventricular assist system (LVAS) at 70 clinical centers worldwide. Of those, 433 patients have undergone treatment with the HeartMate IP (implantable pneumatic) LVAS, while 49 patients were treated with the HeartMate VE (vented electric) LVAS. Currently 65 patients are on the HeartMate LVAS: 51 on the pneumatic version and 14 on the electric version. Of the 482 patients, 64% were transplanted after being supported for an average duration of 72 days (range 1-503 days) to arrive at a cumulative experience of greater than 100 patient years. Neural incidents occurred in 19% of the patients as a result of a variety of complications, including but not limited to air emboli, seizures, drug reactions, as well as thromboembolic complications whether device-related or not. Device-related complications remain quite low at the 2-3% range with minimal or no anticoagulant therapy. Fourteen patients on the electric version have been discharged to live at home for periods ranging from 1 to 7 months. Patients while being supported have successfully gone back to work or to school.
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Thermo Cardiosystems Inc., Woburn, MA 01888, USA.
D000388:Air; D000553:Ambulatory Care; D004560:Electricity; D004867:Equipment Design; D005260:Female; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008297:Male; D010351:Patient Discharge; D011183:Postoperative Complications; D011788:Quality of Life; D013997:Time Factors