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J Thorac Cardiovasc Surg 2007;133:1573-1580
© 2007 The American Association for Thoracic Surgery

Cardiopulmonary Support and Physiology

Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device^_*

^a Advocate Christ Medical Center, Oak Lawn, Ill
^b Papworth Hospital, Cambridge, UK
^c Heart Center NRW, Bad Oeynhausen, Germany
^d Ohio State University, Columbus, Ohio
^e University of Pittsburgh Medical Center, Pittsburgh, Pa
^f OSF St Francis Medical Center, Peoria, Ill
^g University of Rochester, Rochester, NY
^h Sacred Heart Medical Center, Spokane, Wash
ⁱ Thoratec Corporation, Pleasanton, Calif
^j University of California Medical Center, San Francisco, Calif.

Received for publication August 31, 2006; revisions received December 6, 2006; accepted for publication December 12, 2006.

^_* Address for reprints: Mark Slaughter, MD, Advocate Christ Medical Center, 4440 W 95th St, Suite 205, Oak Lawn, Il 60453. (Email: mscabg{at}aol.com).

Objective: The Thoratec Implantable Ventricular Assist Device (Thoratec Corporation, Pleasanton, Calif) can be used for univentricular or biventricular support in patients with a body surface area as low as 1.3 m². Results of the multicenter clinical trial are reviewed.

Methods: Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist Device. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to transplantation (n = 30) and postcardiotomy failure (n = 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device.

Results: Twenty-eight male and 11 female patients, with mean age of 48 years (16–71 years) and body surface area of 1.9 m² (1.3–2.4 m²) were supported for 3938 patient-days (10.8 patient-years). Mean left ventricular assist device flow index on the first postoperative day was 2.5 ± 0.5 L/(min · m²). Mean duration of support was 101 days (9–597 days). Eighteen patients were discharged after a mean duration of 96 days. There were no ventricular assist device failures. Complications included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infections (5%). Support to successful outcomes was 70% for bridge to transplantation and 67% for postcardiotomy recovery, versus historical results for the paracorporeal ventricular assist device of 69% for bridge to transplantation and 48% for postcardiotomy recovery.

Conclusion: The Thoratec Implantable Ventricular Assist Device is a new implantable pulsatile ventricular assist device that allows hospital discharge for patients as a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug Administration–approved implantable ventricular assist device with biventricular capability.

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