Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device⁎

Slaughter, Mark S.; Tsui, Steven S.; El-Banayosy, Aly; Sun, Benjamin C.; Kormos, Robert L.; Mueller, Dale K.; Massey, H. Todd; Icenogle, Timothy B.; Farrar, David J.; Hill, J. Donald; IVAD Study Group,

doi:10.1016/j.jtcvs.2006.11.050

« Previous Next »The Journal of Thoracic and Cardiovascular Surgery
Volume 133, Issue 6 , Pages 1573-1580.e2, June 2007

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

Mark S. Slaughter, MD
- Advocate Christ Medical Center, Oak Lawn, Ill
- Address for reprints: Mark Slaughter, MD, Advocate Christ Medical Center, 4440 W 95th St, Suite 205, Oak Lawn, Il 60453.
Steven S. Tsui, MD
- Papworth Hospital, Cambridge, UK
- S.S.T. reports consulting and lecture fees and grant support from Ventracor (UK) Pty Ltd.
Aly El-Banayosy, MD
- Heart Center NRW, Bad Oeynhausen, Germany
- A.E-B. reports consulting fees from World-Heart.
Benjamin C. Sun, MD
- Ohio State University, Columbus, Ohio
- B.S. reports consulting and lecture fees from Thoratec Corporation and lecture fees from and equity ownership in ABIOMED, Inc.
Robert L. Kormos, MD
- University of Pittsburgh Medical Center, Pittsburgh, Pa
- R.L.K. reports fellowship support from Thoratec Corporation.
Dale K. Mueller, MD
- OSF St Francis Medical Center, Peoria, Ill
H. Todd Massey, MD
- University of Rochester, Rochester, NY
Timothy B. Icenogle, MD
- Sacred Heart Medical Center, Spokane, Wash
- T.B.I. reports lecture fees from Thoratec Corporation.
David J. Farrar, PhD
- Thoratec Corporation, Pleasanton, Calif
- D.J.F. reports employment by and equity ownership in Thoratec Corporation.
J. Donald Hill, MD
- University of California Medical Center, San Francisco, Calif.
- J.D.H. reports consulting fees from and equity ownership in Thoratec Corporation.
IVAD Study Group

Received 31 August 2006; received in revised form 6 December 2006; accepted 12 December 2006.

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.

CTSNet classification: 22, 27, 34

Abbreviations and Acronyms: BTT, bridge to transplantation, FDA, Food and Drug Administration, IVAD, implantable ventricular assist device, LVAD, left ventricular assist device, LVAS, left ventricular assist system, NYHA, New York Heart Association, PVAD, paracorporeal ventricular assist device, RVAD, right ventricular assist device, VAD, ventricular assist device