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

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...

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Published in:Journal of clinical medicine 2020-02, Vol.9 (2), p.397
Main Authors: Gozdek, Mirosław, Zieliński, Kamil, Pasierski, Michał, Matteucci, Matteo, Fina, Dario, Jiritano, Federica, Meani, Paolo, Raffa, Giuseppe Maria, Malvindi, Pietro Giorgio, Pilato, Michele, Paparella, Domenico, Słomka, Artur, Kubica, Jacek, Jagielak, Dariusz, Lorusso, Roberto, Suwalski, Piotr, Kowalewski, Mariusz
Format: Article
Language:English
Subjects:
Aortic stenosis
Bias
Clinical medicine
Clinical outcomes
Collaboration
Kidneys
Meta-analysis
Mortality
Systematic review
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Summary: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 = 1256 vs. SAPIEN 3 = 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); < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03-3.04); = 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 ( < 0.00001) and at 30 days ( < 0.00001), along with lower risk of patient-prosthesis mismatch (RR: 0.29 (0.10-0.87); = 0.03) and pacemaker implantation (RR: 0.64 (0.50-0.81); = 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.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm9020397