Worldwide experience with the TCI HeartMate system: issues and future perspective.

Until 1997, 993 patients have been treated with TCls HeartMate left-ventricular assist system (LVAS) at 122 clinical centers worldwide. Of those, 753 patients have undergone treatment with the HeartMate IP (implantable pneumatic) LVAS, while 240 patients were treated with the HeartMate VE (vented electric) LVAS. Currently, 121 patients are on the HeartMate LVAS: 62 on the pneumatic version and 59 on the electric version. Of the 993 patients, 59% were either transplanted or had the pump removed after recovery after being supported for an average duration of 92 days (range 1 - 727 days) to arrive at a cumulative experience of greater than 228 patient years. Device-related thromboembolic complications remain quite low at the 2-4% range with minimal or no anticoagulation therapy. Fifty-four patients on the electric version have been discharged to live at home for periods ranging from 1 to 15 months. Patients while being supported have successfully gone back to work or to school.