BACKGROUND: The increasing prevalence of chronic heart failure has stimulated the ongoing development of left ventricular assist devices (LVADs) for both bridge-to-transplant (BTT) and destination therapy (DT). The aim of this prospective, multicenter clinical trial was to determine the efficacy and safety of a third-generation LVAD, the VentrAssist, in a BTT cohort. METHODS:Patients (n = 33) with end-stage chronic heart failure who required circulatory support as BTT therapy were implanted with a VentrAssist device. The primary outcome was survival until transplant or transplant eligibility with the device in situ at trial end-point (Day 154 after implant). The secondary outcomes were pump flow index and end-organ function. Safety, patient functional status and resource use were also assessed. RESULTS: At trial end-point, the success rate was 82% (39.4% transplanted, 42.4% transplant-eligible). The LVAD pump flow index (median >or=2.7 liters/min/m(2)) was sufficient to maintain an adequate circulation and significantly improve end-organ function. Of the 77 protocol-defined serious adverse events, most occurred within 30 days of implantation. No patients died as a direct result of pump failure or malfunction. After implantation, patient functional status improved, with 70% of patients achieving hospital discharge, and resource use was reduced. CONCLUSIONS: This trial demonstrated a favorable efficacy and safety profile for use of the VentrAssist LVAD in BTT patients.
RCT Entities:
BACKGROUND: The increasing prevalence of chronic heart failure has stimulated the ongoing development of left ventricular assist devices (LVADs) for both bridge-to-transplant (BTT) and destination therapy (DT). The aim of this prospective, multicenter clinical trial was to determine the efficacy and safety of a third-generation LVAD, the VentrAssist, in a BTT cohort. METHODS:Patients (n = 33) with end-stage chronic heart failure who required circulatory support as BTT therapy were implanted with a VentrAssist device. The primary outcome was survival until transplant or transplant eligibility with the device in situ at trial end-point (Day 154 after implant). The secondary outcomes were pump flow index and end-organ function. Safety, patient functional status and resource use were also assessed. RESULTS: At trial end-point, the success rate was 82% (39.4% transplanted, 42.4% transplant-eligible). The LVAD pump flow index (median >or=2.7 liters/min/m(2)) was sufficient to maintain an adequate circulation and significantly improve end-organ function. Of the 77 protocol-defined serious adverse events, most occurred within 30 days of implantation. No patients died as a direct result of pump failure or malfunction. After implantation, patient functional status improved, with 70% of patients achieving hospital discharge, and resource use was reduced. CONCLUSIONS: This trial demonstrated a favorable efficacy and safety profile for use of the VentrAssist LVAD in BTTpatients.
Authors: Elizabeth A Genovese; Mary Amanda Dew; Jeffrey J Teuteberg; Marc A Simon; Jay K Bhama; Christian A Bermudez; Kathleen L Lockard; Steve Winowich; Robert L Kormos Journal: J Heart Lung Transplant Date: 2010-07-01 Impact factor: 10.247
Authors: Elizabeth A Genovese; Mary Amanda Dew; Jeffrey J Teuteberg; Marc A Simon; Joy Kay; Michael P Siegenthaler; Jay K Bhama; Christian A Bermudez; Kathleen L Lockard; Steve Winowich; Robert L Kormos Journal: Ann Thorac Surg Date: 2009-10 Impact factor: 4.330
Authors: Kiyotaka Fukamachi; David J Horvath; Alex L Massiello; Hideyuki Fumoto; Tetsuya Horai; Santosh Rao; Leonard A R Golding Journal: J Heart Lung Transplant Date: 2009-09-26 Impact factor: 10.247