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经胸超声心动图与经导管主动脉瓣置换术治疗主动脉瓣狭窄:STS/ACC TVT 注册研究中 31mm CoreValve 与 34mm Evolut R 生物瓣的临床和超声心动图结果比较

Comparison of Clinical and Echocardiographic Outcomes After Transcatheter Aortic Valve Implantation With 31-mm CoreValve Versus 34-mm Evolut R Bioprostheses from the STS/ACC TVT Registry.

机构信息

Mount Sinai Medical Center, New York, New York.

Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas.

出版信息

Am J Cardiol. 2019 Oct 1;124(7):1091-1098. doi: 10.1016/j.amjcard.2019.07.010. Epub 2019 Jul 16.

DOI:10.1016/j.amjcard.2019.07.010
PMID:31362879
Abstract

Transcatheter aortic valve implantation with a bioprosthetic valve of insufficient size is associated with a higher risk of aortic regurgitation (AR). The 31-mm CoreValve and the next generation 34-mm Evolut R bioprostheses were designed to address the need for larger diameter aortic annuli. This analysis examined the clinical and hemodynamic outcomes following commercial transcatheter aortic valve implantation with the 31-mm CoreValve and 34-mm Evolut R in the Society of Thoracic Surgeons/the American College of Cardiology Transcatheter Valve Therapy Registry. Patients receiving a 31-mm CoreValve or 34-mm Evolut R valve for symptomatic severe native aortic stenosis from January 2014 to September 2017 in the Transcatheter Valve Therapy Registry underwent propensity score matching using baseline demographics, clinical and frailty measures, and procedural variables. Procedural characteristics, in-hospital and 30-day clinical and echocardiographic outcomes were compared. Of 4545 patients implanted with a 31-mm CoreValve and 3036 patients with a 34-mm Evolut R valve, matching resulted in 1813 patient sets. Most patients were male (>92%), elderly (∼80 years) with the Society of Thoracic Surgeons score of 6.6%. Use of the 34-mm versus 31-mm valve resulted in shorter median procedural time (113.0 [85.0, 150.0] vs 93.0 [71.0, 126.0] min, p <0.001), higher device success (98.1% vs 93.9%, p <0.001), fewer pacemakers (16.7% vs 24.6%, p <0.001), less ≥moderate AR with the 34-mm (5.5% vs 13.7%), p <0.001) and shorter hospital stay (3.0 [2.0, 4.0] vs 4.0 [3.0, 6.0] days, p <0.001). In conclusion, this largest experience with the 34-mm Evolut R valve showed higher device success, reduced hospital stay, lower pacemaker rates and less ≥moderate AR compared with the 31-mm CoreValve bioprosthesis.

摘要

经导管主动脉瓣植入术(TAVI)使用尺寸不足的生物瓣与主动脉瓣反流(AR)风险增加相关。31 毫米的 CoreValve 和下一代 34 毫米 Evolut R 生物瓣的设计目的是满足更大直径主动脉瓣环的需求。这项分析检查了在胸外科医师学会/美国心脏病学会经导管瓣膜治疗注册中心,使用 31 毫米 CoreValve 和 34 毫米 Evolut R 进行商业性 TAVI 后的临床和血流动力学结果。在经导管瓣膜治疗注册中心,从 2014 年 1 月至 2017 年 9 月,因症状性严重原发性主动脉瓣狭窄接受 31 毫米 CoreValve 或 34 毫米 Evolut R 瓣膜治疗的患者,根据基线人口统计学、临床和脆弱性指标以及手术变量,进行倾向评分匹配。比较了手术特点、住院期间和 30 天的临床和超声心动图结果。在接受 31 毫米 CoreValve 植入的 4545 例患者和接受 34 毫米 Evolut R 瓣膜植入的 3036 例患者中,匹配后得到 1813 例患者。大多数患者为男性(>92%),年龄较大(约 80 岁),胸外科医师学会评分 6.6%。与 31 毫米瓣膜相比,使用 34 毫米瓣膜导致手术时间中位数缩短(113.0[85.0,150.0]比 93.0[71.0,126.0]min,p<0.001),器械成功率更高(98.1%比 93.9%,p<0.001),起搏器更少(16.7%比 24.6%,p<0.001),≥中度 AR 发生率更低(5.5%比 13.7%,p<0.001),住院时间更短(3.0[2.0,4.0]比 4.0[3.0,6.0]天,p<0.001)。总之,这项关于 34 毫米 Evolut R 瓣膜的最大经验表明,与 31 毫米 CoreValve 生物瓣相比,器械成功率更高,住院时间更短,起搏器植入率更低,≥中度 AR 发生率更低。

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