BACKGROUND
The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable
option for treatment of advanced heart failure. There is a growing trend toward the
use of less invasive techniques in cardiac surgery, and the thoracotomy technique
for HVAD implantation may provide benefits not available with conventional approaches.
METHODS
The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial
that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically
Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States
and Canada. The primary composite end-point was success at 180 days defined as alive
on the originally implanted device and free from disabling stroke (modified Rankin
Scale score >3), transplanted or explanted for recovery. The key secondary end-point
was mean length of initial hospital stay.
RESULTS
The primary end-point was successfully achieved in 88.1% of patients and was significantly
greater than the pre-defined performance goal of 77.5% set from historical sternotomy
data (p = 0.0012). The key secondary end-point—mean length of initial hospital stay —was
18 days and was significantly shorter than the pre-defined performance goal of 26.1
days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy
approach. The overall patient survival was good, and bleeding requiring reoperation
was significantly less frequent than that observed in previous studies using the sternotomy
approach.
CONCLUSIONS
This prospective clinical trial provides validation that implantation of the HVAD
system via the thoracotomy approach used in the LATERAL study represents a safe and
effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant
indication.
KEY WORDS
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© Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.
