经导管主动脉瓣置换术与外科主动脉瓣置换术后的功能状态：SURTAVI 试验的 2 年分析。
Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial.
机构信息
CardioVascular Institute of North Colorado, Banner Health, Greeley, Colorado, USA.
Department of Cardiothoracic Surgery, University of California Davis Medical Center, Sacramento, California, USA.
出版信息
JACC Cardiovasc Interv. 2022 Apr 11;15(7):728-738. doi: 10.1016/j.jcin.2022.01.284.
OBJECTIVES
This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery.
BACKGROUND
Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on "hard endpoints," including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden.
METHODS
The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers.
RESULTS
Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years.
CONCLUSIONS
In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (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).
目的
本研究旨在评估接受自膨式经导管主动脉瓣置换术（TAVR）或手术治疗的 SURTAVI 试验中中度手术风险主动脉瓣狭窄患者的以患者为中心的指标，这些患者接受了 TAVR 治疗。
背景
研究表明，对于严重有症状的主动脉瓣狭窄患者，TAVR 是手术的替代方法，但这些研究主要关注“硬终点”，包括全因死亡率和中风，而不是比较以患者为中心的指标，如功能状态和症状负担。
方法
本研究分析了来自 SURTAVI 试验的 1492 例患者的基线、30 天、1 年和 2 年的功能状态（6 分钟步行试验[6MWT]）和症状负担（堪萨斯城心肌病问卷）。根据基线功能状态，患者分为慢、中、快走者三组。
结果
基线功能状态最低的患者通常为女性，胸外科医生评分较高，纽约心脏协会心功能分级 III 或 IV 级症状较多；基线功能状态下降与 2 年内主动脉瓣和心力衰竭相关住院治疗增加相关。与手术患者相比，TAVR 患者在 30 天（P < 0.001）和 1 年（P = 0.012）时 6MWT 距离改善更大，但在 2 年时，两组改善相似（P = 0.091）。在被归类为慢走者的患者中，6MWT 改善较大的患者比例最大，而在快走者中比例最低。TAVR 后 30 天，两种治疗方法后 1 年和 2 年，症状负担均有改善。
结论
在 SURTAVI 试验的亚组研究中，与手术患者相比，接受 TAVR 的患者的功能状态和症状负担改善更快；然而，两组在长期随访中都有类似的改善。（经导管主动脉瓣置换术治疗中危需行主动脉瓣置换的严重、有症状的主动脉瓣狭窄患者的美敦力 CoreValve® 系统安全性和疗效研究[SURTAVI]；NCT01586910）。
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