PCR London Valves 2025 - Dr Vlasis Ninios (Interbalkan European Medical Center, GR) discusses one-year outcomes from the AltaValve Early Feasibility Study, evaluating a novel atrial fixation system for transcatheter mitral valve replacement in patients with severe mitral regurgitation.

This prospective, single-arm, multicenter study enrolled high surgical risk patients with moderate to severe or severe mitral regurgitation across 12 centers in the United States. The study evaluated both technical feasibility and clinical outcomes, with patients followed through one year post-procedure to assess device performance, safety endpoints, and durability of MR reduction.

The early feasibilty study demonstrated high efficacy with a 97% success rate and established the device's broad applicability, achieving a unique and high 77% acceptance rate of screened patients, many of whom were recruited because they had been rejected by other technologies. Furthermore, the procedure proved safe, reporting low 30-day mortality and 0% one-year cardiac mortality in the transseptal cohort, with no evidence of early valve failure, thrombosis, strokes, or need for reintervention among the patients treated.

Interview Questions:
1. What are the current limitations of existing TMVR technologies?
2. What are the unique features of the AltaValve System?
3. Could you tell us about the study design and patient population?
4. What are your key findings? How did the device perform in terms of safety?
5. What are the clinical implications of these findings?
6. What are your take-home messages for clinicians?

Recorded on-site at London Valves 2025, London.
Editors: Jordan Rance, Mirjam Boros
Videographer: Oliver Miles

Support: This is an independent interview produced by Radcliffe Cardiology.