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经导管主动脉瓣植入术应用 Portico 与 Evolut 装置的长期随访结果。

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices.

机构信息

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.

出版信息

Am J Cardiol. 2020 Apr 15;125(8):1209-1215. doi: 10.1016/j.amjcard.2020.01.018. Epub 2020 Jan 30.

Abstract

New-generation devices such as Evolut and Portico have provided favorable results in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, but their comparative effectiveness remains debated, despite its relevance when envisioning TAVI in low-risk patients. We evaluated the safety and efficacy of 2 leading TAVI devices (Evolut and Portico) used by the same team of experienced TAVI operators, focusing on long-term outcomes, including major adverse events (i.e., the composite of death, stroke, myocardial infarction, major vascular complication, or major bleeding). Unadjusted and propensity score-adjusted analyses were carried out. A total of 233 patients were included, 119 (51.1%) receiving Evolut and 114 (49%) Portico. Baseline and procedural data showed significant between-device differences, including functional class, surgical risk, chronic obstructive pulmonary disease, renal function, transesophageal guidance, device size, postdilation, and procedural time (all p <0.05). Yet, acute and in-hospital outcomes were not significantly different (all p >0.05). Follow-up status was ascertained in 228 (98%) patients after 15.0 ± 7.6 months. Unadjusted analysis showed similar rates of major adverse events, as well as the individual risk of death, stroke, myocardial infarction, major vascular complication, major bleeding, and pacemaker implantation (all p >0.05). Even at propensity score-adjusted analysis outcomes were not significantly different with Evolut and Portico (all p >0.05). In conclusion, Evolut and Portico devices yield similarly favorable results at long-term follow-up when used by experienced TAVI operators.

摘要

新一代设备,如 Evolut 和 Portico,在接受经导管主动脉瓣置换术(TAVI)治疗主动脉瓣狭窄的患者中取得了良好的效果,但它们的比较效果仍存在争议,尽管在考虑低危患者的 TAVI 时这一点很重要。我们评估了由经验丰富的 TAVI 操作者团队使用的 2 种领先的 TAVI 设备(Evolut 和 Portico)的安全性和疗效,重点关注长期结果,包括主要不良事件(即死亡、中风、心肌梗死、主要血管并发症或大出血的组合)。进行了未调整和倾向评分调整分析。共纳入 233 例患者,119 例(51.1%)接受 Evolut 治疗,114 例(49%)接受 Portico 治疗。基线和手术数据显示设备之间存在显著差异,包括功能分级、手术风险、慢性阻塞性肺疾病、肾功能、经食管引导、器械大小、后扩张和手术时间(均 p<0.05)。然而,急性和住院期间的结果并无显著差异(均 p>0.05)。在 15.0±7.6 个月后,228 例(98%)患者的随访状态得以确定。未调整分析显示,主要不良事件的发生率以及死亡、中风、心肌梗死、主要血管并发症、大出血和起搏器植入的个体风险相似(均 p>0.05)。即使在倾向评分调整分析中,Evolut 和 Portico 的结果也无显著差异(均 p>0.05)。总之,经验丰富的 TAVI 操作者使用 Evolut 和 Portico 设备时,长期随访结果相似。

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