Why the study?
Following the September 2020 commercial release of the ACURATE neo2 system, the authors sought to compare aortic regurgitation severity between ACURATE neo2 and ACURATE neo transcatheter heart valves using quantitative videodensitometric angiography.
Does the ACURATE neo2 transcatheter heart valve reduce paravalvular aortic regurgitation severity compared to the first-generation ACURATE neo valve in patients undergoing TAVI?
Does the ACURATE neo2 transcatheter heart valve reduce paravalvular aortic regurgitation severity compared to the first-generation ACURATE neo valve in patients undergoing TAVI?
The new-generation ACURATE neo2 transcatheter heart valve significantly reduces the severity and incidence of moderate-to-severe paravalvular aortic regurgitation compared to the first-generation ACURATE neo system.
neo2 linked to lower moderate/severe paravalvular AR on qAR; leaves open clinical impact and need for randomized confirmation.
The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE neo2 and ACURATE neo systems. The ACURATE neo2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE neo cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE neo2 and ACURATE neo. Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE neo2 cohort, and 108 in the ACURATE neo cohort. The mean AR fraction was 4.4 ± 4.8% in the neo2 cohort, and 9.9 ± 8.2% in the neo cohort (p < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the neo2 cohort and 15 aortograms (13.9%) in the neo cohort (p < 0.001). Quantitative aortography shows a lower rate of moderate or severe paravalvular AR in what is the first European experience of the new-generation, self-expanding ACURATE neo2 when compared to the first-generation ACURATE neo. Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data.
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Rück et al. (2021) studied this question.
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