PEERLESS-HF: Ventricular elastic support therapy associated with risk reductions in HF

Heart Failure Society of America 14th Annual Scientific Meeting

SAN DIEGO – Patients with HF treated with ventricular elastic support therapy along with optimal HF therapy safety experienced a reduced risk of HF when compared to those taking HF therapy alone, in addition to no increased risk of all cause mortality, according to new data presented here.

This prospective, randomized, controlled trial study featured patients randomized 1:1 who were 18-75 years of age with Stage C symptomatic ischemic or non-ischemic HF for at least 6 months. Patients also had stable, evidence-based HF therapy for at least 3 months before randomization, as well as left ventricular ejection fraction ≤35%. The primary safety endpoint of all cause mortality by non-inferiority analysis was assessed at 1 year.

Of the 217 randomized patients, 114 were treated with optimal HF therapy alone and 103 (92 treated, 11 not treated) were placed in the optimal HF therapy plus ventricular elastic support therapy (HeartNet Ventricular Elastic Support System, Paracor Medical, Inc.) arm. According to William T. Abraham, MD, director of the Division of Cardiovascular Medicine at Ohio State University Medical Center, and researcher involved with the study, the trial was terminated early after recommendation by the Data and Safety Monitoring Board due to futility which resulted from the lack of a demonstrable difference between treatment and control arm in change in PVO₂.

At the 12 month follow up, study results indicated a survival rate in the treatment arm of 93.4% and 92.4% in the control arm (P=.056). There was evidence of reverse remodeling favoring the treatment group at 6 months, and of a reduction in serious HF events, including CV death and HF hospitalization in the treatment group. In addition, Abraham added, “In a subgroup of patients with cardiac resynchronization therapy (CRT) at baseline, there appeared to be a better reduction in serious HF events [in the treatment group].

“These findings support undertaking a clinical trial that targets this patient population with CRT, but with an inadequate CRT response,” he concluded.

Abraham served as member and principal investigator in the steering committee in which he received consultant fees. The trial was sponsored by Paracor Medical, Inc. – by Brian Ellis

For more information:

Abraham WT. LBCT I. Presented at: Heart Failure Society of America 14th Annual Scientific Sessions; Sept. 13-16, 2010; San Diego.

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