International Experience with Left Ventricular Assist Device Exchange to a Fully Magnetically Levitated Centrifugal Pump: Data from the ELEVATE Registry

Objectives: The multinational ELEVATE registry was initiated to collect data from patients implanted with HeartMate 3—a fully magnetically levitated centrifugal (FMLC) left ventricular assist device (LVAD)—in the post-approval era. Here, we present the 6-month outcomes for patients undergoing pump exchange due to complications from a pre-existing LVAD.

Methods: Between January 2015 and February 2017, a total of 482 consecutive patients were implanted at 26 centers and enrolled into the ELEVATE registry. Of those, 19 patients were enrolled with a preexisting LVAD pump (median support time of 530 days). The preexisting LVAD was exchanged to a HeartMate 3 LVAD due to pump thrombosis in 10 patients (53%), infection in 8 patients (42%), and in 1 patient (5%) with inflow cannula malposition. All pump exchanges where successfully performed at 5 experienced LVAD centers (1–10 exchanges/center). Adverse event rate and survival are presented for the 6 months following LVAD implant.

Results: Preoperatively, most of the patients were in stable condition (INTERMACS profile: 3–5) and 11 out of 18 patients (61%) were NYHA class III/IV. Minimally invasive operation was performed in 3 patients whereas the remaining patients underwent median resternotomy. Inlet configurations for pump exchange included ring-to-ring, tube-to-inflow cannula, and complete resection techniques. Outflow graft connections utilized direct aortic or end-to-end anastomosis. Two patients (11%) received concurrent RVAD implants. At 6 months, survival was 89% with 84% of patients discharged from the hospital. Fifteen reoperations were performed in 5 patients (26%): postoperative bleeding was the most common complication leading to reexploration in 2 patients (11%), while two patients (11%) required reoperation for infection and one patient had a temporary RVAD removed. The remaining reoperations were performed due to heart transplant (1 patient, 5%), delayed wound closure (2 patients, 10%) or other causes. Three patients (16%) experienced a stroke. There was one occurrence of ingested thrombus into the inflow cannula on post-operative day 1, but no de-novo pump thrombosis occurred at 6 months.

Conclusions: With growing experience, pump upgrade procedures to a newer pump generation are being performed safely and resolve existing device complications. The six-month adverse event profile and patient outcomes are acceptable, especially given the potential increased risk caused by the prior pump issues and exchange.