Initial clinical experience with the VentrAssist left ventricular assist device: the pilot trial.
BACKGROUND
The VentrAssist (VA) is a novel, continuous flow left ventricular assist device (LVAD). The purpose of this trial was to investigate the safety and efficacy of the VA in elderly patients with end-stage heart failure.


METHODS
In this prospective trial, patients requiring circulatory support either as destination therapy (DT) or as a bridge to transplant (BTT) were implanted with a VA device.


RESULTS
Between June 2003 and August 2006, 9 elderly patients (mean age 65 years) were implanted. The median support time was 454 (range 73 to 977) days for the DT and 35 (range 26 to 508) days for the BTT cohort. All patients survived implantation; 30-day mortality was 22% (n = 2). The adverse event profile was encouraging, with no embolic neurologic events and minimal sepsis. Cumulative trial support time was 7.3 patient-years.


CONCLUSIONS
The VentrAssist shows promise as a safe and reliable "third-generation" VAD. Having demonstrated potential as a DT and prolonged BTT device, extended clinical trials are warranted.
Esmore
Donald S
DS
Department of Cardiothoracic Surgery, Alfred Hospital, Prahran, Victoria, Australia. d.esmore@alfred.org.au
Kaye
David
D
Salamonsen
Robert
R
Buckland
Mark
M
Begg
John R
JR
Negri
Justin
J
Ayre
Peter
P
Woodard
John
J
Rosenfeldt
Franklin L
FL
D000368:Aged; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D007432:Intraoperative Period; D008297:Male; D010865:Pilot Projects; D011182:Postoperative Care; D016896:Treatment Outcome