Rück Andreas, Kim Won-Keun, Kawashima Hideyuki, Abdelshafy Mahmoud, Elkoumy Ahmed, Elzomor Hesham, Wang Rutao, Meduri Christopher U, Verouhis Dinos, Saleh Nawzad, Onuma Yoshinobu, Mylotte Darren, Serruys Patrick W, Soliman Osama
Department of Cardiology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Kerckhoff Heart Center, Department of Cardiology, 61231 Bad Nauheim, Germany.
J Clin Med. 2021 Oct 9;10(20):4627. doi: 10.3390/jcm10204627.
The new-generation ACURATE 2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE 2 versus the ACURATE 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 2 and ACURATE systems. The ACURATE 2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE 2 and ACURATE . Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE 2 cohort, and 108 in the ACURATE cohort. The mean AR fraction was 4.4 ± 4.8% in the 2 cohort, and 9.9 ± 8.2% in the cohort ( < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the 2 cohort and 15 aortograms (13.9%) in the cohort ( < 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 2 when compared to the first-generation ACURATE . Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data.
新一代ACURATE 2系统于2020年9月上市。在本研究中,我们试图使用定量视频密度血管造影术(qAR)比较ACURATE 2与ACURATE经导管心脏瓣膜的主动脉瓣反流(AR)严重程度。这是一项对接受ACURATE 2和ACURATE系统治疗的患者经导管主动脉瓣植入术(TAVI)后最终主动脉造影进行的回顾性核心实验室分析。ACURATE 2队列包括2020年9月至2021年1月期间在两个中心接受治疗的连续患者。ACURATE队列包括2020年9月之前接受治疗的连续患者。我们的主要目标是比较TAVI后使用ACURATE 2和ACURATE时qAR上的AR严重程度。在401张主动脉造影片中,228张(56.9%)可分析,其中ACURATE 2队列中有120张,ACURATE队列中有108张。2队列中的平均AR分数为4.4±4.8%,队列中的平均AR分数为9.9±8.2%(P<0.001)。此外,在2队列中的2张主动脉造影片(1.7%)和队列中的15张主动脉造影片(13.9%)中检测到中度或重度AR(qAR>17%)(P<0.001)。定量主动脉造影显示,与第一代ACURATE相比,在欧洲首次使用新一代自膨胀ACURATE 2的经验中,中度或重度瓣周AR的发生率较低。此外,主动脉造影数据需要与核心实验室判定的30天超声心动图数据进行关联和比较。