Related Experiment Video
Updated: May 1, 2026
06:04
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
722
First experience without pre-ballooning in transapical aortic valve implantation: a propensity score-matched analysis
Jörg Kempfert1, Alexander Meyer2, Won-Keun Kim3
1Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany kempfertj@gmail.com.
Summary
Direct transapical aortic valve implantation (TA-AVI) without balloon valvuloplasty is feasible and safe. This approach may reduce neurological events like transient ischemic attacks (TIAs) in high-risk patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Transapical aortic valve implantation (TA-AVI) with the Edwards SAPIEN™ prosthesis is standard for high-risk elderly patients.
- A new delivery system (Ascendra II+™) may allow direct valve implantation, potentially omitting pre-ballooning.
Purpose of the Study:
- To evaluate the initial experience with the Ascendra II+™ delivery system for TA-AVI.
- To assess the feasibility and safety of direct TA-AVI without prior balloon valvuloplasty (BAV).
Main Methods:
- 128 patients (Cohort I) and 79 patients with CT data (Cohort II) received SAPIEN XT™ valves via TA approach.
- TA-AVI without BAV was performed in approximately 31% of patients in both cohorts.
- Propensity score matching was used to adjust for baseline variables.
Main Results:
- Successful valve implantation in all patients.
- No significant differences in primary endpoints (aortic regurgitation, post-implantation pressure, stroke, TIA, post-dilatation, pacemaker need) between groups.
- Lower fluoroscopy time in the no-BAV group.
- Lower 30-day TIA rate observed in the no-BAV group (Cohort II).
Conclusions:
- Direct TA implantation of the SAPIEN valve without pre-ballooning is feasible and safe.
- This approach does not compromise functional outcomes.
- Direct TA implantation may be associated with a reduction in neurological events.
