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. 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.
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. 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.
Authors: T Krabatsch; M Schweiger; A Stepanenko; T Drews; E Potapov; M Pasic; Y Weng; M Huebler; R Hetzer Journal: Herz Date: 2011-10 Impact factor: 1.443
Authors: Howard K Song; Jill M Gelow; James Mudd; Christopher Chien; Frederick A Tibayan; Kathryn Hollifield; David Naftel; James Kirklin Journal: Ann Thorac Surg Date: 2016-04-30 Impact factor: 4.330
Authors: Guruprasad A Giridharan; Thomas J Lee; Mickey Ising; Michael A Sobieski; Steven C Koenig; Laman A Gray; Mark S Slaughter Journal: Artif Organs Date: 2012-08 Impact factor: 3.094
Authors: John B O'Connell; Patrick M McCarthy; George Sopko; Gerasimos S Filippatos; Ileana L Piña; Marvin A Konstam; James B Young; Leslie W Miller; Mandeep R Mehra; Edmond Roland; John E A Blair; David J Farrar; Mihai Gheorghiade Journal: Heart Fail Rev Date: 2008-06-12 Impact factor: 4.214