Key result
Transcatheter aortic valve implantation without balloon pre-dilatation is safe and feasible, resulting in a 12.5% 12-month all-cause mortality rate comparable to the standard protocol with pre-dilatation.
Why the study?
The standard TAVI protocol requires balloon pre-dilatation for native valve preparation, but its safety and feasibility without pre-dilatation have not been assessed in controlled studies.
Case-Control (n=24)
No
Answers are grounded in this paper and cite their sources.
INTRODUCTION: Transaortic valve implantation (TAVI) has a well-established position in the treatment of high-risk and inoperable patients with severe aortic stenosis (AS). The TAVI protocol requires a pre-dilatation for native valve preparation. AIM: To assess the safety and feasibility of TAVI without pre-dilatation and to compare it with the procedure with pre-dilatation. MATERIAL AND METHODS: Out of 101 TAVI patients, in 10 the procedure was performed without balloon predilatation, and 8 patients were included in the analysis. The procedural, echocardiographic, and clinical outcomes were compared with a case control matched cohort (1: 2 ratio). A 12-month follow-up was done in all cases. RESULTS: The procedure was successfully completed in all patients in the study group (SG), but there was one procedural failure in the control group (CG). All patients received a CoreValve (Medtronic) bioprosthesis. There was a significant immediate decrease in transvalvular gradients (TG) in both study arms after the procedure (SG: mean TG: from 46.0 ±14.0 mm Hg to 10.0 ±4.8 mm Hg, p < 0.001; CG: mean TG: from 55.9 ±12.0 mm Hg to 9.9 ±2.9 mm Hg, p < 0.001). A marked increase in the effective orifice areas was observed in both cohorts (SG: 1.63 ±0.13 cm(2) and CG: 1.67 ±0.25 cm(2), p = 0.75). The periprocedural complication rate was equally distributed in both arms. The 12-month all-cause mortality was 12.5% in both groups. CONCLUSIONS: The direct TAVI approach seams to be safe and feasible. The clinical and echocardiographic results are not different from those achieved in patients treated with standard TAVI protocol with pre-dilatation.
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Kochman et al. (2014) conducted a case-control in Severe aortic stenosis (n=24). Transcatheter aortic valve implantation (TAVI) without balloon pre-dilatation vs. TAVI with standard balloon pre-dilatation was evaluated on 12-month all-cause mortality (p=1.00). Transcatheter aortic valve implantation without balloon pre-dilatation is safe and feasible, resulting in a 12.5% 12-month all-cause mortality rate comparable to the standard protocol with pre-dilatation.
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