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

被引:82
作者
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
机构
[1] Advocate Christ Med Ctr, Oak Lawn, IL 60453 USA
[2] Papworth Hosp, Cambridge CB3 8RE, England
[3] Heart Ctr NRW, Bad Oeynhausen, Germany
[4] Ohio State Univ, Columbus, OH 43210 USA
[5] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA
[6] OSF St Francis Med Ctr, Peoria, IL USA
[7] Univ Rochester, Rochester, NY USA
[8] Sacred Heart Med Ctr, Spokane, WA USA
[9] Thoratec Corp, Pleasanton, CA USA
[10] Univ Calif San Francisco, Med Ctr, San Francisco, CA 94143 USA
关键词
D O I
10.1016/j.jtcvs.2006.11.050
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 m(2). 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 m(2) (1.3-2.4 m(2)) 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 . m(2)). 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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收藏
页码:1573 / 1580
页数:8
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