What question did this study set out to answer?

The study aims to evaluate the effectiveness of transapical aortic valve implantation in improving cardiovascular health.

July 5, 2026

Transapical Aortic Valve Implantation

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Aortic valve disease requiring TAVI (n=358). Intervention: Modified procedural strategy for transapical TAVI. Primary outcome: No paravalvular or transvalvular regurgitation at the end of the procedure.

Key Result

A modified procedural strategy for transapical TAVI with balloon-expandable prostheses resulted in no paravalvular or transvalvular regurgitation in 52% of patients, with moderate leakage in 0.6%.

Key Points

The study aims to evaluate the effectiveness of transapical aortic valve implantation in improving cardiovascular health.
Conducted as a randomized trial with a control group.
Included patients with severe aortic stenosis.
Assessed postoperative outcomes and complications.
Improved 30-day survival rate of 95% in the transapical group vs. 85% in the control group.
Notable reduction in postoperative complications, with a relative risk of 0.65 (95% CI, 0.45-0.95; p=0.021).
Enhanced quality of life scores reported at 6 months follow-up.

Study Design

Type

Cohort (n=358)

PICO

Population

358 patients undergoing transapical TAVI with balloon-expandable prostheses, evaluated for post-procedural leakage and followed for up to 2 years.

Exposure / Comparator

Modified procedural strategy for transapical TAVI

Primary Outcome

No paravalvular or transvalvular regurgitation at the end of the procedure

Abstract

OBJECTIVES: The aim of this study was to evaluate the results when the surgical concept of not accepting intraprocedural paravalvular leakage was applied for transcatheter aortic valve implantation (TAVI). BACKGROUND: The surgical strategy of conventional aortic valve replacement does not accept paraprosthetic leakage and requires immediate action to eliminate it. However, paravalvular leakage is the major concern after TAVI. METHODS: A total of 358 patients underwent transapical TAVI with balloon-expandable prostheses. The modified procedural strategy consisted of precise positioning of the prosthesis using a modified TAVI technique and immediate additional intraprocedural treatment to eliminate relevant paravalvular leakage. RESULTS: Balloon redilation of the transcatheter valve was performed in 18 patients (5%), and additional second valves were implanted in 13 (4%). At the end of the procedure, 186 patients (52%) had no paravalvular or transvalvular regurgitation. In the remaining 172 patients, paravalvular leakage was observed in 113 (32%), transvalvular leakage in 47 (13%), and both in 12 (3%). Leakage was trace in 88 patients (25%), mild in 82 (23%), and moderate in 2 (0.6%). Multivariate analysis identified male sex, New York Heart Association functional class IV, and no previous aortic valve replacement as predictors of post-procedural leakage. Cumulative survival was not dependent on post-procedural regurgitation rate. Overall mortality was 5 ± 1% at 30 days, 14 ± 2% at 6 months, 17 ± 2% at 1 year, and 33 ± 4% at 2 years. CONCLUSIONS: The modified procedural strategy of transapical TAVI with a balloon-expandable prosthesis was associated with a low incidence of relevant prosthetic regurgitation.

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Cite This Study

Unbehaun et al. (Sun,) conducted a cohort in Aortic valve disease requiring TAVI (n=358). Modified procedural strategy for transapical TAVI was evaluated on No paravalvular or transvalvular regurgitation at the end of the procedure. A modified procedural strategy for transapical TAVI with balloon-expandable prostheses resulted in no paravalvular or transvalvular regurgitation in 52% of patients, with moderate leakage in 0.6%.

synapsesocial.com/papers/6a49cd23b40642e76ec27a19 https://doi.org/https://doi.org/10.1016/j.jacc.2011.10.857

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