Key result
Self-expanding intra-annular valve-in-valve TAVI demonstrates 0% early mortality and no paravalvular leak.
Why the study?
Data were lacking on latest-generation intra-annular self-expanding THVs for aortic ViV procedures, which might offer advantages regarding coronary access or subsequent valve reintervention.
Does valve-in-valve TAVI using a latest-generation self-expanding intra-annular transcatheter heart valve provide safe and hemodynamically effective outcomes in patients with failing aortic bioprostheses?
Observational (n=5)
No
Does valve-in-valve TAVI using a latest-generation self-expanding intra-annular transcatheter heart valve provide safe and hemodynamically effective outcomes in patients with failing aortic bioprostheses?
A latest-generation self-expanding intra-annular transcatheter heart valve demonstrated excellent 30-day safety and hemodynamics for aortic valve-in-valve procedures, even in small bioprostheses.
Small case series shows excellent 30-day hemodynamics with intra-annular SE THV in ViV; hypothesis-generating and requires larger comparative trials.
Background: Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. Aim: We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Materials and methods: Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. Results: At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients. Conclusion: The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.
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Schaefer et al. (2023) conducted an observational in Failing aortic surgical bioprostheses or transcatheter heart valves (n=5). Navitor system (self-expanding intra-annular transcatheter heart valve) was evaluated on 30-day mortality and VARC-3 adjudicated clinical endpoints. Valve-in-valve TAVI using a latest-generation self-expanding intra-annular transcatheter heart valve resulted in 0% 30-day mortality, no paravalvular leakage, and a low mean transvalvular gradient of 6.0 mmHg.
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