Background: The aim of the present study was to investigate whether transfemoral implantation of the Acurate neo transcatheter heart valve without pre-dilation is feasible.
Methods: Between December 2014 and December 2016, 294 patients were treated with the Acurate neo prosthesis at our center. Of these, 72 cases were performed without pre-dilation. The decision to omit pre-dilation was at the discretion of the operator, preferably in the case of mild to moderate aortic valve calcification (AVC). Propensity matching (1:1) resulted in 48 cases in each group. Main outcomes of interest were device success according to VARC-2 criteria, residual aortic regurgitation (AR) ≥ 2°, and rate of post-dilation.
Results: Median [IQR] age in patients without pre-dilation was 82.7 years [78.6–85.6], STS score was 4.6% [3.4–6.1], and AVC-score was 1436 AU [1043–1682] with mild and moderate AVC in 63.9% and 36.1% of cases, respectively. Device success was achieved in 94.4% of cases, post-dilation was necessary in 26.4%, and one (1.4%) patient had moderate AR. In the matched population, there were no differences regarding device success, rate of AR ≥ 2°, need for post-dilation, and post-procedural mean gradient, but the group without pre-dilation had shorter procedure (34.0 min [27.0–38.8] vs. 43.0 min [34.3–52.0]; p < 0.001) and fluoroscopy times (7.4 min [5.7–9.0] vs. 9.9 min [7.9–13.5]; p < 0.001).
Conclusion: In select patients with mild to moderate AVC, transfemoral implantation of the Acurate neo without pre-dilation is feasible and safe. This allows for a straightforward procedure that may be performed without rapid pacing in the majority of cases.
Keywords: Aortic stenosis; Pre-dilation; Rapid pacing; TAVI.