Morbidity burden elevated for Black vs. white patients receiving LVAD
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Compared with white patients, Black patients who received a left ventricular assist device experienced a higher morbidity burden and smaller gains in functional capacity and quality of life, according to new MOMENTUM 3 trial data.
According to Mandeep R. Mehra, MD,MSc, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and medical director of Brigham and Women’s Hospital Heart and Vascular Center and professor of medicine at Harvard Medical School, the catalyst for this new study was the need to ascertain representativeness and generalizability of clinical trial outcomes to various populations being cared for by clinicians.
“The MOMENTUM 3 trial portfolio enrolled a substantial representation of racially diverse patients,” Mehra told Healio, “and we prespecified an analysis to examine the interaction of the primary outcome with race, especially as it pertains to Black patients with refractory heart failure. The current analysis was an in-depth look to characterize comprehensive outcomes between these ethnically distinct populations since prior data with older LVADs has pointed to possible differences. We wanted to see if those prior differences persisted with the novel HeartMate 3 platform of devices.”
For the analysis, Mehra and colleagues included 1,015 patients who received an LVAD (HeartMate 3, Abbott), 675 of whom were self-identified as white and 285 as Black.
Overall, compared with the white cohort, Black patients were younger, were more obese, were more likely to have a history of hypertension and were more likely to have a nonischemic cause of HF.
The primary endpoint, defined as survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years, did not significantly differ between groups (Black, 81.1%; white, 77.9%; HR = 1.08; 95% CI, 0.76-1.54; P= .6568). However, Black patients demonstrated a higher risk for adverse events, including bleeding (P < .0001), stroke (P = .0183) and hypertension (P < .0001).
In other data, at baseline and 6 months, the 6-minute walk distance was similar between groups, although the absolute change from baseline was higher for white patients (P = .01). Using the EuroQoL patient-reported, health-related instrument, researchers observed an improvement in absolute quality of life at baseline and 6 months in the Black patient group, but a higher relative improvement during that 6-month period in white patients (P = .0298).
The study was not designed to determine reasons underlying the observed differences, but Mehra said his team believes that they could result from socioeconomic factors or other biological underlying mechanisms that are not yet well understood. “Late referral for advanced therapy could also be in play here,” he said.
Mehra further noted that although the study shows differences in morbidity between racially diverse populations, “the overall survival was in fact excellent and parallels that of heart transplant, particularly in those without the option of a transplant,” he said. “We urge readers to consider timely referrals for refractory patients with heart failure since we also know that the sicker the patient comes in to receive LVAD therapy, the greater may be the chance for adverse effects, particularly bleeding. These tend to limit the outcomes that can be gained after such therapy.”
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