Key result
Supra-annular TAVR linked to ~59% less severe prosthesis-patient mismatch versus intra-annular valves.
Why the study?
The relative performance of transcatheter supra-annular and intra-annular valves in patients with small aortic annuli has not been thoroughly investigated, and the clinical impact of prosthesis-patient mismatch after TAVI is debated.
Does transcatheter supra-annular or self-expandable valve implantation improve pre-discharge mean aortic gradient and reduce severe prosthesis-patient mismatch compared to intra-annular or balloon-expandable valves in patients with severe aortic stenosis and small annuli?
Observational (n=1,378)
Yes
Does transcatheter supra-annular or self-expandable valve implantation improve pre-discharge mean aortic gradient and reduce severe prosthesis-patient mismatch compared to intra-annular or balloon-expandable valves in patients with severe aortic stenosis and small annuli?
Absolute Event Rate: 3.6% vs 8.8%
p-value: p=0.007
In patients with severe aortic stenosis and small annuli, supra-annular and self-expandable transcatheter valves provide better forward hemodynamics and lower rates of severe prosthesis-patient mismatch compared to intra-annular and balloon-expandable valves, though with higher rates of paravalvular leak and pacemaker implantation, and no difference in mortality.
SAVs may lower PPM risk versus IAVs in small annuli; leaves open whether hemodynamic gains improve outcomes in prospective trials.
Aims In patients with severe aortic stenosis, trans-prosthetic haemodynamics after transcatheter aortic valve implantation (TAVI) tend to be more favourable than after surgical aortic valve replacement, especially after self-expandable valve (SEV) implantation. The relative performance of TAVI according to leaflet position, that is supra-annular and intra-annular valves (SAV and IAV, respectively), has not been investigated thoroughly. Moreover, prosthesis-patient mismatch (PPM) is more common in patients with small aortic annuli, even though its clinical impact after TAVI is debated. Compare haemodynamics and clinical outcomes of transcatheter SAV and IAV in patients with small annuli. Methods TAVI SMALL 2 is an international retrospective registry of 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transfemoral transcatheter SEV (Evolut R/Pro, n = 750, Acurate Neo, n = 170 and Portico n = 172) and balloon-expandable valves (BEV, Sapien 3, n = 286) in 16 high-volume centres. Analyses were performed according to mechanism of valve release, that is SEV (n = 1092) vs. BEV (n = 286), and according to leaflet position, that is SAV (Evolut R/Pro and Acurate Neo, n = 920) vs. IAV (Sapien 3 and Portico, n = 458). Primary endpoints were pre-discharge mean aortic gradient and incidence of severe PPM. Secondary endpoint was incidence of all-cause mortality. Results Pre-discharge mean aortic gradient was lower both after SAV vs. IAV (7.8 ± 3.9 vs. 12.0 ± 5.1, P <0.001) and SEV vs. BEV implantation (8.0 ± 4.1 vs. 13.6 ± 4.7, P<0.001). IAV implantation was more often complicated by severe PPM when compared to SAV implantation (8.8% vs. 3.6%, P = 0.007), and severe PPM was more common after BEV than after SEV implantation (8.7% vs. 4.6%, P = 0.041). At a median follow-up of 377 days (interquartile range 168–700 days), all-cause mortality occurred in 11.9% of patients after IAV and 9.4% after SAV implantation (P = 0.172), and in 12.3% and 9.8% of BEV and SEV groups, respectively (P = 0.218). Results were confirmed at Kaplan-Meier analysis (log-rank P = 0.748 and 0.687 for SAV vs. IAV and SEV vs. BEV, respectively, Figure 1). Pre-discharge more than mild paravalvular leak (PVL) was more common with SEV than BEV (11.6% vs. 2.6%, P <0.001), while incidence of more than moderate PVL was higher both after SAV vs. IAV (1.5% vs. 0.2%, P = 0.043) and SEV vs. BEV implantation (1.4% vs. 0%, P = 0.052). New permanent pacemaker implantation was higher after SEV than BEV (13.5% vs. 8.1%, P = 0.013). Conclusions In this high-numerosity registry of patients with small aortic annuli, TAVI with SAV and SEV yielded a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. All-cause mortality did not differ between groups.
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Leone et al. (2021) conducted an observational in Severe aortic stenosis and small annuli (n=1,378). Supra-annular valves (SAV) vs. Intra-annular valves (IAV) was evaluated on Incidence of severe prosthesis-patient mismatch (p=0.007). Supra-annular valves yielded lower pre-discharge mean aortic gradients (7.8 vs 12.0, P<0.001) and less severe prosthesis-patient mismatch (3.6% vs 8.8%, P=0.007) than intra-annular valves.
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