Why the study?
Severe aortic valve calcification increases the risk of paravalvular leakage and permanent pacemaker implantation, prompting a comparison of hemodynamics, PPI, and clinical outcomes between self-expanding and balloon-expandable valves.
Does the Evolut Pro transcatheter heart valve improve hemodynamics and clinical outcomes compared to the Sapien 3 valve in patients with severely calcified aortic valve stenosis?
Does the Evolut Pro transcatheter heart valve improve hemodynamics and clinical outcomes compared to the Sapien 3 valve in patients with severely calcified aortic valve stenosis?
In patients with severely calcified aortic stenosis, the self-expanding Evolut Pro valve provides superior hemodynamics and less patient prosthesis mismatch compared to the balloon-expandable Sapien 3 valve, with similar 30-day clinical and safety outcomes.
Answers are grounded in this paper and cite their sources.
EPro provides a comparable alternative to S3 in severely calcified AS; Level 5 data leave open valve preference pending randomized confirmation.
Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design.
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Potratz et al. (2022) studied this question.
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