Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Mirosław Gozdek, Kamil Zieliński, Michał Pasierski, Matteo Matteucci, Dario Fina, Federica Jiritano, Paolo Meani, Giuseppe Maria Raffa, Pietro Giorgio Malvindi, Michele Pilato, Domenico Paparella, Artur Słomka, Jacek Kubica, Dariusz Jagielak, Roberto Lorusso, Piotr Suwalski, Mariusz Kowalewski

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Abstract

Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04-6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03-3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient-prosthesis mismatch (RR: 0.29 (0.10-0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50-0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality.

Original languageEnglish
JournalJournal of Clinical Medicine
Volume9
Issue number2
DOIs
Publication statusPublished - Feb 1 2020

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