Background: The HeartMate 3 left ventricular assist device (Abbott, Chicago, IL) is designed to provide circulatory support with enhanced hemocompatibility for patients with advanced heart failure. The purpose of this study was to compare the surgical outcomes between patients treated during the European Conformity Mark (CE Mark [CEM]) clinical trial and those treated in the postmarket era.
Methods: The prospective, observational, multinational ELEVATE (Evaluating the HeartMate 3 with Full MagLev Technology in a Post-Market Approval Setting) registry includes patients receiving the HeartMate 3 following CEM approval. Outcomes of patients in the ELEVATE registry are compared with patients in the CEM trial.
Results: Compared with the CEM trial (N = 50), the ELEVATE registry group (N = 463) was more severely ill, with more patients classified as INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 1 to 2 (32% versus 10%; p < 0.001). The CEM trial group was younger and underwent fewer concomitant valve procedures. After adjustment for differences in baseline characteristics, the 30-day survival was comparable between the ELEVATE registry and CEM trial groups (95% versus 98%; p = 0.46). Length of intensive care unit stay was similar between the ELEVATE registry (7 days) and CEM trial (6 days) groups. Most adverse event rates were comparable between the 2 groups. ELEVATE registry patients had a lower rate of cardiac arrhythmias (13% versus 28%; p = 0.009). With increasing experience, the implant technique has evolved to include more versatile approaches such as less invasive and off-pump implantation.
Conclusions: The 30-day outcomes for ELEVATE registry patients are comparable despite being sicker than CEM trial patients. Adverse event rates remain low, with no cases of pump thrombosis within the first 30 days. Implant techniques have evolved to include more versatile approaches.
Trial registration: ClinicalTrials.gov NCT02497950.
Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.