Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Medical Faculty, Department of Diagnostic and Interventional Radiology, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Heart Lung Circ. 2020 Dec;29(12):1847-1855. doi: 10.1016/j.hlc.2020.05.096. Epub 2020 Jun 16.
The CoreValve Evolut R and PRO (Medtronic, Minneapolis, MN, USA) are among the newest-generation of self-expandable transcatheter aortic valve replacement (TAVR) devices and show excellent results. Treating patients with severely calcified (SC) native aortic valve anatomy may be challenging because of the increased risk of periprocedural complications. This study investigated the performance of Evolut R and PRO in this special patient subset.
Patients who underwent TAVR with the CoreValve Evolut R or PRO (n=381) from September 2015 to March 2018 were divided by aortic valve calcification extent. Patients with SC aortic valve anatomy (n=98; men, >2,062 and women, >1,377 Agatston units) were compared with those with non-severely calcified (NCS) aortic valve anatomy after 1:2 propensity score matching. Outcomes were evaluated according to the updated valve academic research consortium criteria.
Patients with SC anatomy were older (83 years vs 80 years, p<0.001) and had a smaller aortic valve area (0.63 cm vs 0.70 cm, p=0.028). Pre-dilatation was more often performed (30.6% vs 15.8%, p=0.003) and a permanent pacemaker implantation was more often necessary (32.9% vs 8.8%, p<0.001) in the SC group. None/mild aortic regurgitation (AR) was evenly distributed (SC, 96.9% vs NCS, 99.5%, p=0.109); moderate AR was present in 3.1% of SC patients and in 0.5% of NSC patients. Severe AR was not observed.
The CoreValve Evolut R and PRO showed good clinical safety profiles and excellent haemodynamic results in patients with SC anatomy and who more often required permanent pacemaker implantation.
CoreValve Evolut R 和 PRO（美敦力，明尼苏达州明尼阿波利斯市）是最新一代自膨式经导管主动脉瓣置换术（TAVR）装置之一，具有出色的效果。对于严重钙化（SC）的原生主动脉瓣解剖结构的患者，由于围手术期并发症的风险增加，治疗可能具有挑战性。本研究调查了 Evolut R 和 PRO 在这一特殊患者亚组中的表现。
2015 年 9 月至 2018 年 3 月，381 例患者接受 CoreValve Evolut R 或 PRO 行 TAVR，根据主动脉瓣钙化程度进行分组。将主动脉瓣解剖结构为 SC（男性>2062 个 Agatston 单位，女性>1377 个 Agatston 单位）的患者与 1：2 倾向评分匹配后的非严重钙化（NCS）主动脉瓣解剖结构患者进行比较。根据更新的瓣膜学术研究联盟标准评估结果。
SC 解剖结构患者年龄较大（83 岁比 80 岁，p<0.001），主动脉瓣面积较小（0.63cm 比 0.70cm，p=0.028）。SC 组中更常进行预扩张（30.6%比 15.8%，p=0.003），更常需要植入永久性起搏器（32.9%比 8.8%，p<0.001）。无/轻度主动脉瓣反流（AR）的分布均匀（SC 组为 96.9%，NCS 组为 99.5%，p=0.109）；中度 AR 见于 3.1%的 SC 患者和 0.5%的 NSC 患者。未观察到严重的 AR。
CoreValve Evolut R 和 PRO 在 SC 解剖结构患者中具有良好的临床安全性和出色的血液动力学结果，且更常需要植入永久性起搏器。
