Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial.Goldstein, D. J. et al.
JAMA Cardiology [record in progress].
This was a secondary analysis of the MOMENTUM 3 trial which aimed to evaluate the impact of therapeutic intent on the short-term and long term outcomes of HeartMate 3 (HM3) as compared to HeartMate II (HMII) in patients with advanced heart failure.
Patients were randomized in a 1:1 ratio to receive either the the magnetically levitated centrifugal-flow HeartMate 3 (HM3) left ventricular assist device (LVAD) or the the axial-flow HeartMate II (HMII) pump, regardless of the intended goal of therapy (bridge to transplant (BTT)/ bridge to transplant candidacy (BTC) or destination therapy (DT)).
The study enrolled 1028 patients with advanced-stage heart failure that were considered to be candidates for LVAD therapy.
The primary outcome was disabling stroke-free survival or reoperation to either remove or replace an impaired device at 2 years. The secondary outcome were adverse events, rehospitalizations, functional capacity and quality of life.
This is another report from the MOMENTUM-3 study comparing a fully magnetically levitated circulatory pump with a commercially available axial-flow pump for advanced heart failure. Previous publications had shown that the centrifugal-flow pump was associated with better outcomes at 6 months than the axial-flow pump. The trial was well-conducted, multicentre, un-blinded and randomised controlled trial with full follow up. The analysis presented here was pre-specified in the protocol. The key aim of this analysis was to see if outcomes with the two LVADs differed by the intended treatment intention of the therapy, as a bridge to transplantation or destination therapy. The primary end-point was a composite outcome of survival free from disabling stroke or reoperation to remove or replace a malfunctioning device. This outcome was significantly better for patients with the centrifugal-flow pump rather than the axial-flow pump regardless of treatment intention (HR=0.62 if bridge to transplant and HR=0.61 if destination therapy). A test of interaction showed no significant difference between the impact of the LVAD type on the two populations. The centrifugal-flow pump was associated with significantly fewer episodes of pump thrombosis, stroke and bleeding, also irrespective of treatment intention.
ClinicalTrials.gov - NCT02224755