TY - JOUR
T1 - A Prospective, Multicenter Trial of the VentrAssist Left Ventricular Assist Device for Bridge to Transplant
T2 - Safety and Efficacy
AU - Esmore, Donald
AU - Kaye, David
AU - Spratt, Phillip
AU - Larbalestier, Robert
AU - Ruygrok, Peter
AU - Tsui, Steven
AU - Meyers, Deborah
AU - Fiane, Arnt E.
AU - Woodard, John
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2008/6
Y1 - 2008/6
N2 - 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 ≥2.7 liters/min/m2) 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.
AB - 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 ≥2.7 liters/min/m2) 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.
UR - http://www.scopus.com/inward/record.url?scp=44149116182&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=44149116182&partnerID=8YFLogxK
U2 - 10.1016/j.healun.2008.02.012
DO - 10.1016/j.healun.2008.02.012
M3 - Article
C2 - 18503955
AN - SCOPUS:44149116182
SN - 1053-2498
VL - 27
SP - 579
EP - 588
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 6
ER -