Attizzani Guilherme F, Dallan Luis Augusto P, Markowitz Alan, Yakubov Steven J, Deeb G Michael, Reardon Michael J, Forrest John K, Mangi Abeel A, Huang Jian, Popma Jeffrey J
Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
JACC Cardiovasc Interv. 2020 Aug 10;13(15):1816-1824. doi: 10.1016/j.jcin.2020.04.028.
This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group).
The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear.
Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2.
The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively).
The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).
本研究旨在比较经导管主动脉瓣置换术后进行瓣膜重新定位的患者（重新定位组）与未进行重新定位的手术患者（未重新定位组）的结局。
Evolut R和Evolut PRO瓣膜设计为在展开过程中允许重新定位，然而重新定位对临床结局的影响仍不明确。
将2016年6月至2018年11月期间SURTAVI（外科置换与经导管主动脉瓣植入）试验持续接入研究以及Evolut低风险试验中植入Evolut R或PRO瓣膜的患者合并。对Evolut低风险试验患者的基线多排计算机断层扫描数据进行分析。主要结局为30天全因死亡率和致残性卒中发生率。次要结局按照瓣膜学术研究联盟-2标准。
946例患者植入了Evolut R或PRO瓣膜，其中318例（33.6%）进行了重新定位。与未重新定位组患者相比，重新定位组患者的胸外科医师协会评分更低（2.3±1.3%对2.6±1.4%；p<0.001），既往经皮冠状动脉介入治疗更少（11.9%对19.7%；p=0.003）。两组间基线多排计算机断层扫描参数无差异。30天或1年时死亡（0.3%对0.3%；p=0.99）或致残性卒中（0.3%对0.5%；p=0.71）的主要结局无差异（1年时分别为1.9%对2.9%；p=0.44；以及分别为0.8%对0.9%；p=0.79）。
Evolut瓣膜重新定位功能的应用是安全的，两组在30天或1年时死亡或致残性卒中方面未观察到差异。（美敦力Evolut经导管主动脉瓣置换术治疗低风险患者；NCT02701283；美敦力CoreValve®系统治疗需要主动脉瓣置换的中度风险受试者中重度、有症状主动脉瓣狭窄的安全性和有效性研究[SURTAVI]；NCT01586910）
