New data presented at THT 2023 and published in JCF suggests that Ancora Heart’s investigational AccuCinch Transcatheter Left Ventricular Restoration (TLVR) system improves heart failure patients’ cardiac structure, quality of life, and function.
Ancora Heart’s AccuCinch TLVR is the first completely percutaneous device that reduces the size of the left ventricle, addressing a fundamental issue in systolic heart failure progression. The AccuCinch would be used in patients with severe HF that can no longer be managed by medications and pacemakers, and would otherwise require LVADs or heart transplants.
Twelve month analysis of the study’s 51 HFrEF subjects (LVEF 20-40%, MR ≤2+, 86% male, 56.3yrs avg) who were treated with optimal medical therapy and subsequently underwent AccuCinch TLVR, revealed significant improvements to:
- End-diastolic volume (-33.6 ml), the primary outcome
- LV free wall radius (-29.6% to 9.2 mm)
- Quality of life scores (KCCQ-OS 16.4 pts)
- Six-minute walk test distances (45.9 m)
- NYHA classifications (65% improved ≥ 1, 94% improved or unchanged)
- Ejection fraction (3.1)
Although there were no periprocedural deaths, during the follow-up period one subject died (day 280) and one subject received an LVAD (day 13).
These study results got their share of praise, and should make AccuCinch’s current CORCINCH-HF pivotal RCT trial even higher-stakes, which has the same key inclusion criteria, and would be used to support the TLVR device’s FDA Premarket Approval application.
Takeaway
After 20 years of R&D, this data reinforces TLVR’s potential to expand and improve the treatment options available to heart failure patients. There’s still plenty more work to be done, but Ancora Heart’s catheter-based left ventricle therapy seems to be on the right track.
