Optimized Balloon-Expandable Transcatheter Aortic Valve Implantation and Clinical Outcomes.
Two studies this morning sharpen the durability-and-selection tension that has defined the low-risk expansion debate.
The Bern cohort (N=1,032, Sapien S3/Ultra, single-center, non-randomized) found that 43% of implants met at least one criterion for suboptimal deployment — noncoaxial (23%), too deep (25%), or underexpanded (5%).
BACKGROUND: The expansion of transcatheter aortic valve replacement (TAVR) to younger patients with longer life expectancy requires procedural optimization to enhance long-term valve durability. OBJECTIVES: To evaluate the relationship between fluoroscopic determinants of optimal transcatheter heart valve (THV) implantation-coaxiality, implantation depth, and expansion-and clinical and valve-related outcomes. METHODS: In this cohort study, consecutive patients undergoing transfemoral TAVR with balloon-expandable prostheses (Sapien S3, Sapien S3 Ultra) between February 2014 and June 2022 were included. THV coaxiality, implantation depth, and expansion were assessed in the 3-cusp view following deployment using standardized protocols. Suboptimal implantation was defined as ≥1 unfavorable determinants (coaxiality ≥4.8°, depth ≥6 mm, or underexpansion ≥20%). Outcomes included the modified early safety endpoint, moderate or severe hemodynamic valve deterioration, and stage 2 bioprosthetic valve failure. RESULTS: Among 1,032 patients (mean age 81 ± 6 years, 35.1% female), suboptimal THV implantation occurred in 443 (42.9%) patients and was driven by noncoaxial deployment (n = 240, 23.3%), excessive implantation depth (n = 261, 25.3%), and underexpansion (n = 54, 5.2%). Suboptimal implantation was associated with a higher likelihood of the modified early safety endpoint at 30 days (43.3% vs 19.9%; adjusted odds ratio: 3.05; 95% CI: 2.30-4.04) and stage 2 bioprosthetic valve failure at 5 years (subHR: 4.40; 95% CI: 1.25-13.59). Patients with ≥2 determinants demonstrated higher rates of hemodynamic valve deterioration at 5 years (subHR: 3.48; 95% CI: 1.24-9.80). CONCLUSIONS: Optimal THV implantation was associated with improved early procedural safety and long-term THV durability in balloon-expandable TAVR. Systematic fluoroscopic assessment of optimized valve implantation may enhance patient outcomes.
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