Key result
Direct TAVI without BAV yields similar 95% technical success versus TAVI with BAV.
Why the study?
No reports exist about the feasibility and safety of direct ACURATE neo2 TAVI without balloon aortic valvuloplasty compared to the standard practice with BAV.
Does direct TAVI using ACURATE neo2 without balloon aortic valvuloplasty maintain procedural success and safety compared to TAVI with systematic balloon valvuloplasty in patients with severe aortic stenosis?
Cohort (n=499)
Yes
Does direct TAVI using ACURATE neo2 without balloon aortic valvuloplasty maintain procedural success and safety compared to TAVI with systematic balloon valvuloplasty in patients with severe aortic stenosis?
Answers are grounded in this paper and cite their sources.
Direct TAVI using the ACURATE neo2 valve without pre-dilation appears feasible and yields comparable early outcomes to systematic balloon valvuloplasty in patients with mild or less valve calcification.
BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: ; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.
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Elkoumy et al. (2024) conducted a cohort in Severe aortic stenosis (n=499). Direct TAVI without balloon aortic valvuloplasty vs. TAVI with balloon aortic valvuloplasty was evaluated on VARC-3 device technical success. Direct TAVI using ACURATE neo2 without balloon aortic valvuloplasty demonstrated similar VARC-3 device technical success (95%) compared to TAVI with balloon valvuloplasty in a matched cohort.
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