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.

 

MissingLinkText

No conflict of interest has been declared by the author(s).