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The heartmate left ventricular assist system: worldwide clinical results
1Thermo Cardiosystems Inc., Woburn, MA 01888, USA.
Insights
Over 482 patients received the HeartMate left ventricular assist system (LVAS), with 64% transplanted successfully. Device-related complications were low, and patients achieved improved quality of life.
Area of Science:
- Cardiology
- Medical Devices
- Biomedical Engineering
Background:
- Heart failure management increasingly relies on mechanical circulatory support.
- Left ventricular assist systems (LVAS) offer a therapeutic option for advanced heart failure.
- TCI's HeartMate LVAS has been utilized globally in a significant patient cohort.
Purpose of the Study:
- To summarize the clinical experience with TCI's HeartMate LVAS.
- To report on patient outcomes, including transplantation rates and complications.
- To assess the safety and efficacy of both implantable pneumatic and vented electric LVAS models.
Main Methods:
- Retrospective analysis of data from 482 patients treated at 70 clinical centers.
- Categorization of patients based on HeartMate IP (implantable pneumatic) and HeartMate VE (vented electric) devices.
- Tracking of patient outcomes, including transplantation, complications, and device-related adverse events.
Main Results:
- A total of 482 patients were treated with HeartMate LVAS (433 IP, 49 VE).
- 64% of patients were transplanted after an average support duration of 72 days, accumulating over 100 patient-years of experience.
- Neural incidents occurred in 19% of patients; device-related complications were low (2-3%).
- Fourteen patients with the VE device were discharged home for 1-7 months, demonstrating potential for improved quality of life.
Conclusions:
- The HeartMate LVAS has a substantial clinical track record with a high transplantation rate.
- Device-related complications are minimal, even with limited anticoagulant use.
- The HeartMate LVAS supports patient ambulation and enables a return to daily activities, improving quality of life.
Abstract:
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.