Implanted pulse generator ups exercise tolerance in HF

For evaluating peak VO₂, the primary end point of this confirmatory study, investigators used a Bayesian model that allowed them incorporate some data from the corresponding subgroup of patients with ejection fractions between 25% and 45% in the previous FIX-HF-5 randomized trial.

Using this model, they found the mean difference between CCM and medical therapy groups at week 24 was 0.836 mL O₂/kg per minute (95% Bayesian credible interval, 0.123-1.552). The probability of CCM treatment’s superiority to control was 0.989, according to investigators, which exceeded the 0.975 threshold for statistical significance.

Dr. Abraham and his coinvestigators found that CCM implantation was safe, with a 90% complication-free rate, and that it improved both quality of life and functional status.

All efficacy endpoints were better in patients with ejection fractions of 35% or greater, confirming the subgroup analysis findings of the previous randomized trial, according to Dr. Abraham and his coinvestigators.