Six-minute walk distance and long-term outcomes in contemporary left ventricular assist device recipients: the ELEVATE Registry.

Objectives

This study aimed to assess the prognostic value of Six-minute Walk Distance (6MWD) in stable HeartMate 3 (HM3) recipients.

Methods

Data from patients with available 6MWD at six months post-implant were obtained from the prospective, multicenter ELEVATE registry. Overall survival and adverse event rates were analyzed using Cox regression models adjusted for age and sex, with 6MWD as a continuous predictor, and stratified by median distance (350 m).

Results

6MWD at six months was available in 194 HM3 recipients. Patients walking <median were older (57 vs. 52 years, p = 0.002), had more comorbidities, and reported lower quality of life. 6MWD correlated positively with hemoglobin (r = 0.20, p = 0.006) and EQ-5D VAS (r = 0.23, p = 0.004), and inversely with NYHA class (r=-0.47, p < 0.0001). Kaplan-Meier analyses of patients walking < > 350 m showed no significant differences in survival (log-rank p = 0.379), right heart failure (p = 0.334), or rehospitalization (p = 0.243), while survival free from hemocompatibility-related adverse events differed significantly, although marginally (p = 0.049). Cox models confirmed that 6MWD had no independent prognostic value for mortality (HR 0.98, 95% CI 0.96-1.01, p = 0.26) or secondary outcomes. However, patients with <median 6MWD experienced higher rates of major bleeding (IRR 2.88, p < 0.001), major infection (IRR 2.14, p < 0.0001), and renal dysfunction (IRR 4.78, p = 0.033).

Conclusions

Shorter 6MWD six months after HM3 implantation was associated with a higher risk of some AEs but was not prognostic for mortality, HF recurrence, or rehospitalization risk. The prognostic value of 6MWD in HF patients without circulatory support cannot be extrapolated to patients treated with current LVADs.