Key result
Acurate neo/neo2 TAVI achieves 100% device success in pure non-calcified aortic regurgitation.
Why the study?
No clear recommendations exist for TAVI use in patients with pure non-calcified aortic regurgitation who are not suitable for open heart surgery.
Does transfemoral TAVI using self-expandable valves provide a safe and effective treatment for high-risk patients with pure non-calcified aortic regurgitation?
Observational (n=9)
No
Does transfemoral TAVI using self-expandable valves provide a safe and effective treatment for high-risk patients with pure non-calcified aortic regurgitation?
Transfemoral TAVI using self-expandable valves appears safe and feasible for high-risk patients with pure non-calcified aortic regurgitation, demonstrating 100% device success and 0% 30-day mortality in a small series.
Supports feasibility of Acurate neo/neo2 TAVI in non-calcified AR; hypothesis-generating and requires validation in larger cohorts.
Objectives: Transcatheter aortic valve implantation (TAVI) is routinely performed in patients with severe aortic stenosis (AS). For patients with pure non-calcified aortic regurgitation (AR) who are not suitable for open heart surgery no clear recommendations exist and use of TAVI has been largely off-label. We herein report a series of patients treated with the self-expandable AcurateNeo and Neo2 (Boston Scientific Co., Marlborough, MS, USA) transcatheter heart valve (THV) for pure AR. Methods: Between 05/2017 and 03/2021, 9 patients (88.8% female, 74.4 ± 7.1 years, logEuroSCORE II 5.5 ± 3.6%, STS PROM 6.2 ± 3.0%) received transfemoral (TF) TAVI for pure non-calcified AR following an adjusted valve sizing algorithm. Data were retrospectively analyzed according to updated Valve Academic Research Consortium (VARC-2) definitions. Results: Device success was 100%. Early safety was 77.7% (7/10), due to two (22.2%) cases of acute kidney injury. Thirty-day mortality was 0%, in seven (77.7%) patients no or trace paravalvular leakage (PVL) was seen and mild PVL in two (22.2%) patients at 30-day follow-up. No permanent pacemaker (PPM) was required during 30-day follow-up. Conclusion: In this series of selected patients using the Acurate neo THV for pure non-calcified AR, safety and efficacy were demonstrated. Thirty-day mortality as well as PPM implantation and PVL rates showed excellent results in this high-risk patient cohort. These results will have to be confirmed in larger patient cohorts.
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Schneeberger et al. (2022) conducted an observational in Pure non-calcified aortic regurgitation (n=9). TAVI using Acurate neo and neo2 THV was evaluated on Device success. Transcatheter aortic valve implantation using the Acurate neo/neo2 valve in 9 high-risk patients with pure non-calcified aortic regurgitation achieved 100% device success and 0% 30-day mortality.
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