Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation.

Andreas Rück,Patrick W Serruys,Nawzad Saleh,Mahmoud Abdelshafy,Won-Keun Kim,Rutao Wang,Ahmed Elkoumy,Dinos Verouhis,Darren Mylotte,Hesham Elzomor,Christopher U Meduri,Osama Soliman,Yoshinobu Onuma,Hideyuki Kawashima

doi:10.3390/jcm10204627

Abstract

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.

Highlights

Moderate or severe aortic regurgitation (AR) following transcatheter aortic valve implantation (TAVI) has been associated with increased short- and long-term mortality [1].In the randomized SCOPE-2 trial [2] comparing the ACURATE neo transcatheter heart valve (THV) (Boston Scientific Corporation, Natick, Massachusetts, USA) with the Evolut THV series (Medtronic, Minneapolis, MN, USA), the rates of cardiac death were 2.8% vs. 0.8% (p = 0.03) at 30 days and 8.4% vs. 3.9% (p = 0.01) at one year, respectively
Among the 401 patients included in this study, no final aortogram injection was performed in 25 (6.2%) patients, while quantitative videodensitometric angiography (qAR) was analyzable in 228 (60.6%) patients, including 120 and 108 patients treated with the ACURATE neo2 and ACURATE neo THVs, respectively
Baseline characteristics, including cardiovascular risk factors, comorbidities, and hemodynamic parameters on echocardiography, were similar between patients treated with the ACURATE neo2 and ACURATE neo THVs (Table 1)

Summary

Introduction

Moderate or severe aortic regurgitation (AR) following transcatheter aortic valve implantation (TAVI) has been associated with increased short- and long-term mortality [1]. In the randomized SCOPE-2 trial [2] comparing the ACURATE neo transcatheter heart valve (THV) (Boston Scientific Corporation, Natick, Massachusetts, USA) with the Evolut THV series (Medtronic, Minneapolis, MN, USA), the rates of cardiac death were 2.8% vs 0.8% (p = 0.03) at 30 days and 8.4% vs 3.9% (p = 0.01) at one year, respectively. The newly designed, self-expanding ACURATE neo THV (Boston Scientific Corporation, Natick, MA, USA) is equipped with inner and outer pericardial skirts extended to cover the waist of the stent in order to improve conformability to calcified and irregular aortic valve anatomy, thereby preventing or mitigating paravalvular AR. The improvement in AR following post-balloon dilatation has been assessed with this technique, and its impact on long-term prognosis has been demonstrated [13]

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