Patients treated with the investigational device also saw beneficial changes in the structure of the heart. Twelve-month data were presented at the Technology and Heart Failure Therapeutics conference (THT 2023) and simultaneously published in the Journal of Cardiac Failure.
Dr. Nadira Hamid, an interventional echocardiographic and cardiologist at Allina Health Minneapolis Heart Institute and assistant director of the echocardiographic core lab at CRF, presented the data at the conference in Boston. Hamid also co-authored the corresponding manuscript, “Transcatheter Left Ventricular Restoration in Patients with Heart Failure.”
Data included complete 12-month clinical outcomes from an analysis of 51 symptomatic heart failure patients. These patients, treated with AccuCinch, had reduced ejection fraction (HFrEF). Those included in the analysis matched key inclusion criteria of the currently enrolling Corcinch-HF pivotal trial.
“This analysis shows patients treated with the AccuCinch System experienced meaningful improvement in efficacy measures important to both clinicians and patients,” said Dr. Hamid. “We witnessed significant and progressive reverse remodeling of the left ventricle, 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.”
More on the Ancora Heart study outcomes
The analysis had a primary outcome of the change of left ventricular end-diastolic volume (LVEDV) compared to baseline through 12 months. Other efficacy assessments included changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. The study also evaluated the six-minute walk test distances, New York Heart Association (NYHA) classification and ejection fraction (EF).
Ancora Heart’s safety measure included freedom from major adverse events related to device implantation. It also measured femoral artery access through 12 months post-procedure.
Key findings include significant and progressive improvement in LVEDV at 12 months compared to baseline. AccuCinch also demonstrated significant and sustained improvement in overall quality of life scores compared to baseline.
The device provided significant and sustained improvement in functional capacity, NYHA classification and EF at 12 months.
About the AccuCinch system
Ancora Heart designed AccuCinch as a completely transcatheter procedure for treating the enlarged left ventricle. AccuCinch offers a fundamentally different and innovative device-based therapy for improving the structure and function of the heart. It helps to bring relief to HF patients who remain symptomatic despite current guideline-directed medical care.
The device may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or heart transplant. During the procedure, a flexible implant is attached to the inner wall of the left ventricle, then sinched.
Ancora Heart received FDA breakthrough device designation in July 2022. The pivotal Corcinch-HF study is currently assessing safety and efficacy of AccuCinch in HFrEF patients.
“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 left ventricle in a safe and effective manner,” Jeff Closs, president and CEO of Ancora Heart, said in a news release. “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.”