Key result
Transcatheter aortic valve-in-valve implantation with the SAPIEN 3 resulted in a 30-day all-cause mortality of 0.6% compared to 3.5% with the SAPIEN XT (p=0.077), though residual stenosis remains a concern.
Why the study?
Does transcatheter valve-in-valve implantation with SAPIEN 3 improve clinical and haemodynamic outcomes compared to SAPIEN XT in patients with failed surgical aortic bioprostheses?
Observational (n=514)
Yes
Does transcatheter valve-in-valve implantation with SAPIEN 3 improve clinical and haemodynamic outcomes compared to SAPIEN XT in patients with failed surgical aortic bioprostheses?
Absolute Event Rate: 0.6% vs 3.5%
p-value: p=0.077
Transcatheter aortic valve-in-valve implantation with the SAPIEN 3 device is as safe and effective as the SAPIEN XT, though residual stenosis remains a concern in smaller bioprostheses and deeper implantation increases pacemaker risk.
VinV with SAPIEN 3 matches XT in safety and efficacy; leaves open optimal depth strategies to reduce residual stenosis in small bioprostheses.
AIMS: Transcatheter valve-in-valve implantation (VinV) is established for the treatment of degenerated surgical bioprostheses in patients at high operative risk. Our aim was to report on the first large assessment of VinV with next-generation balloon-expandable transcatheter heart valves. METHODS AND RESULTS: After SAPIEN XT or SAPIEN 3 VinV, 514 patients were analysed using an inverse probability of treatment weighting. Standardised clinical and haemodynamic outcomes were compared, and core laboratory evaluation of implantation depth was performed. Thirty-day all-cause mortality was 0.6% and 3.5% for SAPIEN 3 and SAPIEN XT (p=0.077). Residual transprosthetic gradient ≥20 mmHg was observed in 38.3% (SAPIEN 3) and 35.7% (SAPIEN XT) of patients (p=0.627) with increased rates in small bioprostheses (≤21 mm true ID). In SAPIEN 3 VinV, low implantation depth >20% THV stent frame length was associated with a higher rate of elevated transaortic gradients (p=0.048). Similarly, an implantation depth >5 mm was linked to more pacemaker implantations (p=0.01). Overall, a trend towards higher pacemaker implantation rates was observed after SAPIEN 3 VinV (6% vs. 2.5% in SAPIEN XT, p=0.071). CONCLUSIONS: Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.
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Seiffert et al. (2018) conducted an observational in Degenerated surgical aortic bioprostheses (n=514). SAPIEN 3 transcatheter heart valve vs. SAPIEN XT transcatheter heart valve was evaluated on 30-day all-cause mortality (p=0.077). Transcatheter aortic valve-in-valve implantation with the SAPIEN 3 resulted in a 30-day all-cause mortality of 0.6% compared to 3.5% with the SAPIEN XT (p=0.077), though residual stenosis remains a concern.
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