title: Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device.
abstract: 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.
authors.affiliation: Advocate Christ Medical Center, Oak Lawn, Ill 60453, USA. mscabg@aol.com
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.forename: Steven S
authors.initials: SS
authors.lastname: Tsui
authors.forename: Aly
authors.initials: A
authors.lastname: El-Banayosy
authors.forename: Benjamin C
authors.initials: BC
authors.lastname: Sun
authors.forename: Robert L
authors.initials: RL
authors.lastname: Kormos
authors.forename: Dale K
authors.initials: DK
authors.lastname: Mueller
authors.forename: H Todd
authors.initials: HT
authors.lastname: Massey
authors.forename: Timothy B
authors.initials: TB
authors.lastname: Icenogle
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.forename: J Donald
authors.initials: JD
authors.lastname: Hill
mesh_terms: 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