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


CONCLUSIONS
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.
Slaughter
Mark S
MS
Advocate Christ Medical Center, Oak Lawn, Ill 60453, USA. mscabg@aol.com
Tsui
Steven S
SS
El-Banayosy
Aly
A
Sun
Benjamin C
BC
Kormos
Robert L
RL
Mueller
Dale K
DK
Massey
H Todd
HT
Icenogle
Timothy B
TB
Farrar
David J
DJ
Hill
J Donald
JD
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D016027:Heart Transplantation / Q000706:statistics & numerical data; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D011474:Prosthesis Design; D015996:Survival Rate; D016896:Treatment Outcome