ORLANDO, Fla. — Algisyl in addition to standard medical therapy may be more effective than standard medical therapy alone for providing sustained benefits in exercise capacity, symptoms, and clinical status for patients with advanced chronic heart failure (HF), according to 1-year follow-up from the AUGMENT-HF trial presented at the American Heart Association Scientific Sessions.
“Treatment options are limited for heart failure patients with advanced heart failure who fail medical management. Current strategies include mechanical circulatory support and/or cardiac transplantation,” said study investigator Douglas Mann, MD of Washington University School of Medicine in St. Louis, Missouri. “The AUGMENT-HF trial was an attempt to address an unmet medical need in patients with advanced heart failure using a medical device to decrease the LV wall stress that the failing heart is subjected to.”
Dr Mann and colleagues conducted a randomized controlled study to test the hypothesis that left ventricular (LV) augmentation with Algisyl (LoneStar Heart, Inc, Dallas, TX) is superior to standard medical therapy for treatment of patients with moderate to severe HF. Results were previously reported for the 6-month primary end point analysis.
The medical device is an injectable calcium-alginate hydrogel that forms alginate beads when injected into the wall of the heart. Inclusion criteria included left ventricular ejection fraction (LVEF) ≤35%, peak VO2 of 9.0 to14.5 mL/min/kg and left ventricular end-diastolic diameter index (LVEDDi) 30-40mm/m2 (LVEDD/BSA). All the patients had been on stable, evidence-based therapy for HF at baseline.
Researchers presented data on 58 patients, who completed 12-month follow-up (mean age, 62.3 years; 57.7% had ischemic HF and 42.3% had non-ischemic HF).
“Implantation of Algisyl increases wall thickness and reduces LV wall stress … There have been other surgical approaches to reduce LV wall stress. However, this is the first surgical approach that reduces LV wall stress by increasing wall thickness,” Dr Mann told Cardiology Advisor.
The researchers found that treatment with Algisyl was associated with improved peak VO2 at 12 months with a treatment effect compared with the control arm of +2.10 mL/kg/min (95% confidence interval [CI] 0.96 to 3.24; P<.001). There were statistically significant improvements compared with the control arm at 12 months for VO2 at Anaerobic Threshold, Peak Watts, Total Exercise Time, 6MWT, NYHA functional class, and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical and Overall scores.
“If the results of AUGMENT-HF can be replicated in a larger patient cohort, it may lead to a new and novel treatment for patients with advanced heart failure,” said Dr Mann. “The results of AUGMENT-HF are provisional but very encouraging. A larger trial has been approved to go forward by the FDA.”
- Mann DL. LBCT.06 – Novel Therapies for Common Problems. One Year Follow-up Results From AUGMENT-HF: A Multicenter Randomized Controlled Clinical Trial of the Efficacy of Left Ventricular Augmentation With Algisyl-LVR in the Treatment of Heart Failure. Presented at the American Heart Association Scientific Sessions; November 7-11, 2015; Orlando, FL.