Background: As transcatheter aortic valve replacement (TAVR) is now performed in patients with longer life expectancy, the need for coronary access (CA) after TAVR is expected to rise. Objectives: The aim of this study was to evaluate the feasibility of CA after TAVR with 4 different types of transcatheter heart valves (THVs). Methods: In the multicenter, prospective CAvEAT (Coronary Access After TAVI; NCT04647864) registry, coronary angiography was performed immediately following transfemoral TAVR using short-frame SAPIEN 3 or SAPIEN 3 Ultra (SAPIEN 3/Ultra) and tall-frame ACURATE neo or ACURATE neo2 (ACURATE neo/neo2), Portico or Navitor, and Evolut Pro or Evolut Pro+ (Evolut Pro/Pro+) THVs. The primary endpoint was defined as selective CA of both coronary arteries. Results: In total, 632 patients were enrolled (mean age 82 years, 59% women). Selective CA of both coronary arteries was achieved in 89% of SAPIEN 3/Ultra, 63% of ACURATE neo/neo2, 62% of Portico or Navitor, and 45% of Evolut Pro/Pro+ THVs (P < 0.001). Unfeasible CA of at least 1 coronary artery occurred in 2%, 6%, 6%, and 9% of cases, respectively (P = 0.06). In pairwise comparisons, the incidence of the primary endpoint was significantly higher for the SAPIEN 3/Ultra compared with all tall-frame THVs (P < 0.001). Among tall-frame devices, no significant difference was observed between the ACURATE neo/neo2 and the Portico or Navitor (P = 0.9), but both devices demonstrated higher rates of the primary endpoint than the Evolut Pro/Pro+ (P = 0.005 and P = 0.002, respectively). Multivariate analysis identified implantation depth, moderate or severe commissural misalignment, and use of a tall-frame THV as independent predictors of unfeasible or nonselective CA. Conclusions: The short-frame SAPIEN 3/Ultra THV demonstrated the highest rate of selective CA following TAVR. Among tall-frame THVs, the large-cell designs of the Portico or Navitor and ACURATE neo/neo2 outperformed the closed-cell Evolut Pro/Pro+ in terms of selective CA.

The Coronary Access After TAVI (CAvEAT) Study: A Prospective Registry of CA After TAVR / Tarantini, G., Nai Fovino, L., Belloni, F., Barbierato, M., Gallo, F., Vercellino, M., Trani, C., Burzotta, F., Asmarats Serra, L., Petronio, A.S., Bedogni, F., Berti, S., Bertolini, A., Fabris, T., Tito, A., Musto, C., Giordano, A., Corcione, N., Maisano, F., Medda, M., et al.. - In: JACC: CARDIOVASCULAR INTERVENTIONS. - ISSN 1936-8798. - 18:12(2025), pp. 1571-1583. [10.1016/j.jcin.2025.05.002]

The Coronary Access After TAVI (CAvEAT) Study: A Prospective Registry of CA After TAVR

Maisano F.;Marchese A.
Ultimo
2025-01-01

Abstract

Background: As transcatheter aortic valve replacement (TAVR) is now performed in patients with longer life expectancy, the need for coronary access (CA) after TAVR is expected to rise. Objectives: The aim of this study was to evaluate the feasibility of CA after TAVR with 4 different types of transcatheter heart valves (THVs). Methods: In the multicenter, prospective CAvEAT (Coronary Access After TAVI; NCT04647864) registry, coronary angiography was performed immediately following transfemoral TAVR using short-frame SAPIEN 3 or SAPIEN 3 Ultra (SAPIEN 3/Ultra) and tall-frame ACURATE neo or ACURATE neo2 (ACURATE neo/neo2), Portico or Navitor, and Evolut Pro or Evolut Pro+ (Evolut Pro/Pro+) THVs. The primary endpoint was defined as selective CA of both coronary arteries. Results: In total, 632 patients were enrolled (mean age 82 years, 59% women). Selective CA of both coronary arteries was achieved in 89% of SAPIEN 3/Ultra, 63% of ACURATE neo/neo2, 62% of Portico or Navitor, and 45% of Evolut Pro/Pro+ THVs (P < 0.001). Unfeasible CA of at least 1 coronary artery occurred in 2%, 6%, 6%, and 9% of cases, respectively (P = 0.06). In pairwise comparisons, the incidence of the primary endpoint was significantly higher for the SAPIEN 3/Ultra compared with all tall-frame THVs (P < 0.001). Among tall-frame devices, no significant difference was observed between the ACURATE neo/neo2 and the Portico or Navitor (P = 0.9), but both devices demonstrated higher rates of the primary endpoint than the Evolut Pro/Pro+ (P = 0.005 and P = 0.002, respectively). Multivariate analysis identified implantation depth, moderate or severe commissural misalignment, and use of a tall-frame THV as independent predictors of unfeasible or nonselective CA. Conclusions: The short-frame SAPIEN 3/Ultra THV demonstrated the highest rate of selective CA following TAVR. Among tall-frame THVs, the large-cell designs of the Portico or Navitor and ACURATE neo/neo2 outperformed the closed-cell Evolut Pro/Pro+ in terms of selective CA.
2025
aortic stenosis
coronary access
coronary artery disease
transcatheter aortic valve replacement
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/190587
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