Abstract 2360: Bridge to Transplant Experience with the VentrAssist LVAS: A Novel Third Generation Left Ventricular Assist Device.
Background: Cardiac transplantation remains the most effective therapy for refractory, advanced heart failure, however access to this therapy is increasingly limited by donor shortage. As a consequence there is an increasing requirement for robust left ventricular assist support systems (LVAS) capable of delivering long-term bridge to transplant (BTT) support. Accordingly, the third generation VentrAssist LVAS was specifically designed for long term cardiac support, by incorporating a novel non-contact hydrodynamically suspended pump rotor. The goal of this trial was to establish the safety and efficacy of this system as a bridge to cardiac transplantation.
Methods: Thirty patients (6 females, 24 males; mean age 52±15 years) requiring BTT were enrolled. The trial was conducted at 5 Australasian and 2 European centers. The primary study endpoint was transplantation or transplant eligibility at 154 days post implant.
Results: Of 26 currently completed patients, the mean support time was 96±57 days. Eleven patients were transplanted (mean support 69 days) and 10 were transplant eligible at 154 days. Thirty-day mortality was 10%. NYHA status at the patients’ last visit was improved by 2.2±0.7 classes from baseline. The adverse event profile of the device was favorable, with an average of 3.6 events/patient, principally driven by infection and early post-operative anti-coagulation related bleeding.
Conclusions: Deployment of the VentrAssist LVAS as a BTT device was associated with an 85% success rate, higher than that in recently reported studies. In conjunction VentrAssist LVAS therapy was associated with a concomitant improvement in functional status.