Short-Term Outcomes of Two Self-Expanding Transcatheter Valves in Sievers Type 1 Bicuspid Aortic Valve Stenosis: The “Proof-of-Concept” CLASS Effect Study

Background: Self-expanding transcatheter heart valves (SEVs) are often used to treat Sievers type 1 bicuspid aortic valve (BAV) stenosis. It remains unclear, however, if different SEVs yield similar outcomes in BAV stenosis, a class effect, or if the unique design features of different SEVs produce disparate clinical results. Objectives: This is a “proof-of-concept” study that compares procedural and clinical outcomes of Acurate neo2 and Evolut Pro/Pro+/Fx platforms in Sievers type 1 BAV stenosis. Methods: The CLASS effect is a retrospective, multicenter registry that enrolls patients with raphe-type 1 BAV stenosis undergoing TAVI at 29 international centers, who received Acurate neo2 and Evolut Pro/Pro+/Fx devices. An inverse probability of treatment weighting (IPTW) analysis was performed to adjust for baseline imbalances. Primary endpoints included VARC-3 technical success, 30-day device success, and early safety according to VARC-3. Results: Among 389 eligible patients, 155 and 234 patients were treated with Acurate neo2 and Evolut platforms, respectively. A higher rate of technical success was observed in the Evolut group (Acurate neo2 vs. Evolut: 93.4% vs. 97.1%, OR 0.41, 95% CI 0.19–0.83, and p = 0.017). At 30 days, device success was comparable (90.1% vs. 89.4%, OR 1.09, 95% CI 0.68–1.75, and p = 0.733), whereas Acurate neo2 was associated with a higher rate of early safety (84.1% vs. 70.4%, OR 2.22, 95% CI 1.56–3.17, and p < 0.001), which was mainly driven by a lower risk of new permanent pacemaker implantation (PPI) (6.3% vs. 19.5%, OR 0.28, 95% CI 0.16–0.46, and p < 0.001). Conclusions: Acurate neo2 and Evolut Pro/Pro+/Fx platforms provide similarly effective procedural and short-term outcomes in Sievers type 1 BAV stenosis. However, Evolut was associated with a higher technical success, while Acurate neo2 demonstrated a lower incidence of new PPI.