AUGMENT-HF: Implant procedure continues to benefit patients with HF

Issue: August 2017

Patients with advanced HF treated with an implant procedure in addition to standard medical therapy had long-term benefits, according to results presented at Heart Failure 2017.

In the AUGMENT-HF study, researchers analyzed the outcomes of 78 patients with moderate to severe HF who were treated with guideline-determined medical therapy, Andrew J. S. Coats, DSc, academic vice president of Monash University in Melbourne, Australia, and University of Warwick in Coventry, England, and director of the Monash Warwick Alliance, said in the presentation. Patients were assigned to optimal standard medical therapy (n = 38) or an implant procedure (Algisyl, LoneStar Heart Inc.) in addition to standard medical therapy (n = 40).

The primary endpoint was peak oxygen consumption (VO₂) as assessed by a blinded core lab, and secondary endpoints included 6-minute walk test, peak VO₂, symptoms, measures of left ventricular remodeling and quality of life at 12 months.

Andrew J. S. Coats

At 1 year, patients assigned the implant had mean peak VO₂ of 14 mL/kg per minute, which was superior compared with those assigned standard medical therapy (mean treatment effect, 2.1 mL/kg per minute; P < .001).

NYHA function class in the implant group decreased more at 18 months (OR = 35.04; 95% CI, 6.37-192.67) and 24 months (OR = 31.8; 95% CI, 6.07-166.57) compared with those in the standard medical therapy group.

Regarding quality of life, patients assigned the implant scored higher using the Kansas City Cardiomyopathy Questionnaire at 18 months (P < .001) and 24 months (P = .046) vs. patients assigned standard medical therapy. Similar results were seen using the Patient Global Assessment at 18 months (P < .001) and 24 months (P = .012).

Coats presented a graph showing the percentage of HF hospitalization was higher in the standard medical care group over the follow-up period vs. the implant group.

Coats said AUGMENT-HF-II, intended to confirm the findings of AUGMENT-HF with more patients (n = 240), will serve as the U.S. pivotal trial for the procedure.

“Larger prospective [randomized controlled trials] are needed to evaluate clinical outcomes, [such as] HF hospitalizations and CV mortality, including the assessment of the MyoTec percutaneous delivery system for Algisyl implantation,” Coats said in the presentation. – by Darlene Dobkowski

Reference:

Coats AJS, et al. Late-breaking trials III: Innovative and device therapies. Presented at: Heart Failure 2017; April 29-May 2, 2017; Paris.

Disclosure: Coats reports consulting for Impulse Dynamics, LoneStar Heart Inc., Resmed, Respicardia, Servier and Verona.