New vs. old-generation ACURATE Neo self-expanding valve: A decrease in safety events with an increase in post-procedural gradients?

Introduction: Contemporary data comparing new versus old generation transcatheter heart valve (THV) devices are lacking with regard to several THV devices. We aimed to compare the safety and efficacy of early generation ACURATE neoTM versus the newer generation device ACURATE neo2TM THVs (Boston Scientific) in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods: An analysis of patients undergoing transfemoral TAVI with old-generation device ACURATE neoTM versus newer generation device ACURATE neo2TM from 2016 to 2021. The primary end point was early safety events at 30 days post valve implantation. Significant post implantation paravalvular leakage (PVL) was considered as >=moderate.
Results: A total of 190 patients were included in the evaluation mean age 80.7 +-7.09, 39% males,162 early generation devices). Early safety events occurred less commonly in new-generation devices (3.6% vs. 17.3%, RR 4.8, p = 0.085). Permanent pacemakers were implanted within 30 days in 6.2% in early-generation devices vs. 10.7 in new-generation (RR 0.58 P=0.41). Major vascular complications occurred more commonly in early-generation group 9.3% vs. 0 in the new-generation group (P=0.13). More than mild PVL occured in 22.8% vs. 0% and at least moderate PVL was 6.2% vs. 0% (P=0.36), accordingly. Echocardiographic mean gradient post procedure was 9 mmHg (median, IQR 6.5-12) in early-generation group vs. 12 (median IQR 9-14.5) in the new-generation group which was statistically significant (P=0.001).
Conclusion: New-generation ACURATE neo2TM devices were associated with a trend towards less safety events, a result of numerically fewer vascular complications and less significant PVL. However, this new generation valve was also associated with higher residual gradients. This trend of decrease in PVL with an increase in gradients will be further studied.