Search

Randomized controlled trials can provide optimal clinical evidence to assess the benefits of new devices, and it is these data that often shape device usage in real-world practice. However, individual clinical trial results sometimes appear discordant for the same device, and alternative devices are sometimes not employed in similar patient populations. To make sound evidence-based decisions, clinicians routinely rely on cross-trial comparisons from different trials of similar but not identical patient populations to assess competing technology when head-to-head randomized comparisons are unavailable.

The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30,30-180,180-365,365-730,730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p0.0001). The total AE rate in days180-365 (EPPY = 4.09) was also significantly lower than the event rate in days30-180 (EPPY = 5.34; p0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p0.05). This changing risk over time has clinically meaningful implications toward improving patient management.