Gel Injected Into Left Ventricle Shows Promise in AUGMENT HF

Marlene Busko

December 08, 2014

CHICAGO, IL — AUGMENT HF, a phase 2 trial of 78 patients with advanced heart failure, showed that an injection of the novel hydrogel Algisyl-LVR hydrogel (LoneStar Heart, Dallas, TX) into their left ventricular myocardium was safe and improved functional and clinical end points over 6 months, according to researchers, who emphasized the findings are far from conclusive[1].

The novel therapy, a form of ventricular reconstruction for patients with LV dilatation, was associated with acceptable 30-day postoperative morbidity and mortality—the study's primary safety end point.

Moreover, among treated patients, peak VO2 at 6 months—the study's primary efficacy outcome—improved by 1 mL/min/kg from baseline in treated patients compared with patients who received optimal medical therapy (P=0.014).

"This study provides proof-of-concept for left ventricle reconstruction with Algisyl as a potential new therapy for patients with advanced heart failure," Dr Douglas L Mann (Washington University School of Medicine, St Louis, MO), said, presenting these findings at the American Heart Association (AHA) 2014 Scientific Sessions. "Ongoing and future studies are expected to provide insight into the potential long-term benefits and confirmatory evidence for this very novel therapy."

A year ago, investigators reported preliminary results from less than half of the patients in this trial. Then this October, the company received the CE Mark in Europe for the hydrogel implant, which is intended to reverse heart-failure progression[2].

The gel is injected directly into the heart muscle and is designed to act as an internal scaffold to increase cardiac output. "Importantly, this procedure can be done in a beating heart and does not require bypass surgery," Mann said.

The trial randomized patients in 15 centers in Austria, Italy, Romania, the Netherlands, and Germany. Patients were mainly NYHA class 3 (58 patients). The rest were NYHA class 2 (14 patients) and class 4 (five patients), with one patient with unknown classification.

After 6 months, patients treated with the hydrogel had improved by a mean of 84.7 m on the 6-minute-walk test, compared with baseline, whereas patients receiving usual care had walked an average of 15.4 m less (P<0.001).

At the same time, NYHA class had decreased by 1 in the treated group, whereas it was unchanged in the usual-care group (P<0.001).

At 30 days, three patients (8.57%) had died in the treated group, which was fewer than the prespecified end point of 5% of patients that was based on similar surgical trials.

There was no difference in the number of adverse events or serious adverse events at 6 months in the two groups of patients.

Still Far From Clinical Practice

"Any study that involves taking patients with severe heart failure to the operating room when they're not getting a new heart is a difficult study," said the assigned discussant for Manning's presentation, Dr Mariell Jessup (University of Pennsylvania, Philadelphia), congratulating Mann and colleagues.

However, despite this "successful study" showing improved exercise tolerance at 6 months, "this was an unblinded population," she pointed out. "The positive outcome that we keep getting tantalizing signals for [in this and other studies of other devices] just takes too many patients to demonstrate," she said.

Mann replied that VO2 was measured by blinded adjudicators.

Commenting to heartwire , session comoderator Dr JoAnn Lindenfeld (University of Colorado, Aurora) echoed Jessup's views that the improved ability to exercise and the reduced symptoms could have been partly due to the fact that the treated patients knew they were undergoing surgery.

On the other hand, "the gel appears safe, and there's other experience with it," she said. "It's promising that there were no extra arrhythmias and . . . in other studies there has been no evidence of fibrosis." However, left ventricular augmentation with this gel in patients with advanced heart failure is "a long way from clinical practice" in the US, she added.

Mann is on the scientific advisory board for Lone Star Heart. Disclosures for the coauthors are listed in the abstract. Jessup and Lindenfeld have reported they have no relevant financial relationships.

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