Lille University Hospital, Lille, France.
Henri Mondor Hospital, Créteil, France.
JACC Cardiovasc Interv. 2019 Mar 11;12(5):413-419. doi: 10.1016/j.jcin.2018.11.014. Epub 2019 Feb 13.
This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.
The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device.
The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2).
A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%.
TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.
本研究旨在描述经颈动脉（TC）途径行经导管主动脉瓣置换术（TAVR）并使用 Edwards Sapien 3 瓣膜的患者的手术过程和临床结果。
TC 途径 TAVR 有可能成为经股动脉金标准的最佳替代方案。目前关于使用 Edwards Sapien 3 瓣膜行 TC-TAVR 的安全性和有效性的数据有限。
法国经颈动脉 TAVR 前瞻性多中心注册研究纳入了 2014 年至 2018 年间的患者。在 13 个参与中心之一接受治疗且不符合经股动脉 TAVR 标准的连续患者被筛选行 TC-TAVR。前瞻性收集临床和超声心动图数据。根据更新的瓣膜学术研究联合会（VARC-2）标准报告围手术期和 30 天结局。
共纳入 314 例患者，中位（四分位间距）年龄为 83（78 至 88）岁，63%为男性，胸外科医生协会死亡率风险评分 5.8%（4%至 8.3%）。大多数患者存在外周动脉疾病（64%）。91%的患者在全身麻醉下进行 TC-TAVR，大多数使用左侧颈动脉（73.6%），手术成功率为 97%。报告了 3 例瓣环破裂，均导致患者死亡。30 天主要出血、新永久起搏器植入、卒中和短暂性脑缺血发作的发生率分别为 4.1%、16%和 1.6%，30 天死亡率为 3.2%。
在这项前瞻性多中心注册研究中，使用 Edwards Sapien 3 瓣膜行经颈动脉 TAVR 是安全有效的。在经股动脉入路受限的情况下，TC 途径可能被认为是 TAVR 的首选一线替代方法，尤其适用于某些特定患者。在我们的多中心队列中，Sapien 3 瓣膜是安全有效的。
