Comparison of the Sapien 3 versus the ACURATE neo valve system: A propensity score analysis

Abstract

Objectives To compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis. Background Differences in clinical outcomes between the latest‐generation balloon‐expandable S3 and self‐expanding NEO in a “real‐world transfemoral TAVI population” are still unclear. Methods We compared up to 6 months clinical outcomes using a propensity score analysis (inverse probability of treatment weighting [IPTW]) to account for differences in baseline characteristics. Results A total of 345 patients underwent transfemoral transcatheter aortic valve implantation (TAVI) with either NEO or S3 at two centers in the Netherlands. Composite device success and early safety endpoints were comparable between NEO and S3 (Device success: IPTW‐adjusted OR: 0.35 [95% CI: 0.12–1.18], and early safety: IPTW‐adjusted OR: 0.51 [95% CI: 0.19–1.38]). Six‐months mortality was 5.3 versus 3.6%, stroke was 2.8 versus 3.3%, and pacemaker rate was 6.1 versus 8.6%, respectively with p = NS. Mean aortic gradient was lower in the NEO group (5.72 ± 2.47 vs. 9.05 ± 3.48; p = <.001), with a comparable rate of moderate or severe paravalvular leak (0 versus 2.1%; p = NS). Conclusions Device success and clinical safety outcomes were comparable for both valves. Up to 6‐months follow‐up clinical outcomes and mortality rate remained excellent. Mean aortic gradient was lower after ACURATE neo implantation.

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve

“…4–7,21–36 Among 18 studies and 5617 patients with data on 30-day stroke rates, the cumulative incidence was 1.9% (95% CI, 1.6–2.3%) (Supplemental Figures, http://links.lww.com/CIR/A42). 4–7,21–31,33,35,36 In total, 11 studies and 3956 patients were available for 30-day myocardial infarction rates with a cumulative incidence of 0.5% (95% CI, 0.3–0.7%) (Supplemental Figures, http://links.lww.com/CIR/A42). 4,6,7,22,23,25,26,31–33 In total, 19 studies with 5689 subjects reported data on major bleeding, with a cumulative incidence of 5.0% (95% CI, 3.9–6.5% (Supplemental Figures, http://links.lww.com/CIR/A42).…”

“…In total, 14 studies, including 4434 patients, evaluated the VARC-2 device success rates of ACURATE neo. 4,5,[22][23][24][25][26][27][28][31][32][33]35,37 The rates ranged from 83.3% to 99.1% with a cumulative incidence proportion of 94.5% (95% confidence interval [CI], 91.4-96.5%) (Figure 2). The 30-day all-cause mortality rates were reported by 20 studies in total (including 5847 patients).…”

“…[14][15][16][17][18][19][20] Finally, 20 studies (n = 5858 ACURATE neo receivers) were included in the meta-analysis (Table 1). [4][5][6][7][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] Mean age was 81.32 years and 37.5% were females.…”

“…[4][5][6][7][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] Twenty studies (5670 patients) reported data on 30-day need for new PPI post-TAVI with a cumulative incidence of 7.7% (95% CI, 6.4-9.2%) (Figure 4). [4][5][6][7][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] In total, 20 studies (5478 patients) reported data on PVL, with a cumulative incidence of moderate/severe PVL of 4.3% (95% CI, 3.0-6.2%) (Figure 5). [4][5][6][7][21][22][23][24]…”

“…[4][5][6][7][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] In total, 20 studies (5478 patients) reported data on PVL, with a cumulative incidence of moderate/severe PVL of 4.3% (95% CI, 3.0-6.2%) (Figure 5). [4][5][6][7][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] Among 18 studies and 5617 patients with data on 30-day stroke rates, the cumulative incidence was 1.9% (95% CI, 1.6-2.3%) (Supplemental Figures, http://links. lww.com/CIR/A42).…”