Ancora Heart’s AccuCinch System Evaluated in Analysis of HFrEF Patients

March 22, 2023—Ancora Heart, Inc., which is developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the company’s investigational AccuCinch ventricular restoration system demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart.

The 12-month data were presented by Nadira Hamid, MD, during a late-breaking clinical science session at THT 2023, the second annual Technology and Heart Failure Therapeutics conference organized by the Cardiovascular Research Foundation (CRF) and held March 20-23 in Boston, Massachusetts. Simultaneously, the study findings were published by Dr. Hamid, et al online in the Journal of Cardiac Failure. Dr. Hamid is an interventional echocardiographer and cardiologist at Allina Health Minneapolis Heart Institute in Minneapolis, Minnesota, and Assistant Director of the echocardiographic core lab at CRF.

“This analysis shows patients treated with the AccuCinch system experienced meaningful improvement in efficacy measures important to both clinicians and patients,” commented Dr. Hamid in the Ancora Heart press release. “We witnessed significant and progressive reverse remodeling of the left ventricle (LV), as well as significant and sustained improvement in quality-of-life and functional capacity measures. These results show promise that this innovative catheter-based therapy may help broaden options for treating patients with heart failure, and we look forward to results of the pivotal study that’s underway.”

Ancora Heart advised that the data include complete 12-month clinical outcomes from an analysis of 51 symptomatic HF patients with reduced ejection fraction (HFrEF) who were treated with the AccuCinch system.

Patients included in the analysis matched key inclusion criteria (LV ejection fraction [EF], 20-40%; mitral regurgitation, ≤ 2+) of the currently enrolling CORCINCH-HF pivotal trial, which is a randomized, controlled trial assessing the clinical safety and efficacy of the AccuCinch system in HFrEF patients.

According to the company, the primary outcome measure for this analysis was the change of LV end-diastolic volume (LVEDV) compared to baseline through 12 months. Other efficacy assessments included changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-minute walk test (6MWT) distances, New York Heart Association (NYHA) classification, and EF. The safety outcome measure included freedom from major adverse events related to the device implantation or femoral artery access through 12 months post procedure.

As summarized in Ancora Heart’s press release, key findings from the analysis include:

• Significant and progressive improvement in LVEDV at 12 months compared to baseline (–33.6 ± 34.8 mL; P < .001)
• Significant and sustained improvement in overall quality-of-life scores (KCCQ overall summary) at 12 months compared to baseline (16.4 ± 18.7 points; P < .001)
• Significant and sustained improvement in functional capacity (6MWT) at 12 months compared to baseline (45.9 ± 83.9 m; P < .001)
• Significant and sustained improvement in NYHA classification at 12 months (P < .001) compared to baseline (improved ≥ 1 Class: 65%; improved or unchanged: 94%)
• Significant and progressive improvement in EF at 12 months compared to baseline (3.1 ± 6.9; P < .001)

“Heart failure is a very prevalent disease, and because of its progressive nature, medications and device treatments may become less effective over time, leaving patients with persistent symptoms and limited treatment options,” commented Ulrich Jorde, MD, in Ancora Heart’s press release. “Utilizing a fully transcatheter approach to directly treat a structural driver of heart failure progression—the enlarged LV—we believe there may be a new opportunity to improve LVEDV and help patients feel better and this 12-month AccuCinch system data clearly demonstrate its potential to address this important unmet need.”

Dr. Jorde is Professor of Medicine, Albert Einstein College of Medicine, and Section Head of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support at Montefiore Health System in New York, New York.

Mark Reisman, MD, added, “The AccuCinch procedure is designed to help us achieve predictable and repeatable reduction in LV dimensions. We look forward to seeing the accelerated cadence of enrollment in the trial and assessing the impact on our patients.” Dr. Reisman is director of structural heart disease at NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, and codirector of structural heart disease for NewYork-Presbyterian Queens and NewYork-Presbyterian Brooklyn Methodist Hospital in New York, New York.

Also in the press release, Jeff Closs, president and CEO of Ancora Heart, stated, “The AccuCinch system continues to demonstrate tremendous potential to fill a need in heart failure treatment options, and today’s analysis shows its ability to improve the health of the LV in a safe and effective manner. We are excited about the significant and sustained results of this 12-month analysis and look forward to completion of the CORCINCH-HF pivotal trial and eventual submission to the FDA.”