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

V L Poirier1

  • 1Thermo Cardiosystems Inc., Woburn, MA 01888, USA.

The Thoracic and Cardiovascular Surgeon
|April 28, 1999
PubMed

Insights

The TCls HeartMate left-ventricular assist system (LVAS) has been used in 993 patients, showing low thromboembolic complications (2-4%). Many patients achieve recovery or transplant, with some returning to daily life activities.

Area of Science:

  • Cardiology
  • Medical Devices
  • Biomedical Engineering

Background:

  • The HeartMate left-ventricular assist system (LVAS) is a critical device for patients with advanced heart failure.
  • Worldwide clinical application of the HeartMate LVAS began prior to 1997, involving numerous patients and centers.

Purpose of the Study:

  • To summarize the cumulative clinical experience with the TCls HeartMate LVAS up to 1997.
  • To report on the safety and efficacy of both the implantable pneumatic (IP) and vented electric (VE) versions of the HeartMate LVAS.

Main Methods:

  • Analysis of data from 993 patients treated with HeartMate LVAS across 122 clinical centers worldwide.
  • Categorization of patients based on the type of HeartMate LVAS used: HeartMate IP (753 patients) and HeartMate VE (240 patients).
  • Assessment of patient outcomes, including transplant, explantation, duration of support, and device-related complications.

Main Results:

  • A total of 993 patients received the HeartMate LVAS, with 753 on the IP version and 240 on the VE version.
  • 59% of patients were either transplanted or had the pump removed after recovery, with an average support duration of 92 days.
  • Device-related thromboembolic complications were low, ranging from 2-4%, even with minimal anticoagulation.
  • 54 patients using the electric version were discharged home for up to 15 months, with some patients resuming work or school.

Conclusions:

  • The HeartMate LVAS demonstrates a favorable safety profile with low rates of thromboembolic complications.
  • The device facilitates patient recovery and transplant, with significant potential for improving quality of life and enabling return to daily activities.
  • The cumulative data supports the HeartMate LVAS as a viable option for managing advanced heart failure.

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