30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study

IF 11.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2025-08-25 DOI:10.1016/j.jcin.2025.06.021

Hemal Gada MD , Ramzi F. Khalil MD , Stanley J. Chetcuti MD , G. Michael Deeb MD , Kendra J. Grubb MD, MHA , Adam B. Greenbaum MD , David Lorenz MD , Robert D. Jumper MD , Ibrahim Sultan MD , Dustin Kliner MD , Paul Mahoney MD , Deepak R. Talreja MD , Mustafa I. Ahmed MD , Joshua D. Rovin MD , Lang Lin MD , Paul Sorajja MD , Douglas G.W. Fraser MB, BC, BA, DM , Suneet Mittal MD , Tamim Nazif MD , Josep Rodes-Cabau MD, PhD , Steven J. Yakubov MD

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引用次数: 0

Abstract

Background

Primary results from the Optimize PRO study demonstrated that transcatheter aortic valve replacement (TAVR) with the cusp overlap technique (COT) resulted in low 30-day permanent pacemaker implantation (PPI) rates and no moderate or greater aortic regurgitation (AR).

Objectives

The aim of this study was to evaluate outcomes after Evolut FX implantation using the COT and postprocedural computed tomography (CT).

Methods

The Optimize PRO FX Addendum study is a postmarket, prospective, multicenter, nonrandomized study. Patients with severe aortic stenosis underwent TAVR with the Evolut FX using the COT protocol. Postprocedurally, COT adherence was evaluated to identify key steps, and CT-assessed transcatheter aortic valve orientation was compared with fluoroscopically guided commissural alignment.

Results

A total of 151 patients received the Evolut FX device from September 2022 to October 2023. The median duration of follow-up was 371 days (Q1-Q3: 352-388 days). Compliance with the refined COT was 86.0%. The median length of stay was 1 day. The rate of the primary endpoint of all-cause mortality or all stroke was 2.7% (95% CI: 1.0%-6.9%) at 30 days and 7.5% (95% CI: 4.2%-13.1%) at 1 year. The new PPI rate was 6.7% (95% CI: 3.7%-12.1%) at 30 days and 8.8% (95% CI: 5.2%-14.6%) at 1 year. One patient had moderate AR and none had severe AR at 1 year. The rate of commissural alignment was 91.5% (107 of 117) when assessed by marker positioning on fluoroscopy and 86.9% (113 of 130) when assessed using CT, indicating good agreement. CT indicated no severe coronary misalignment in >92% of patients.

Conclusions

Implantation of the Evolut FX device with a refined COT was associated with low PPI rates and no severe AR at 1 year. Postprocedural CT demonstrated consistent commissural and coronary alignment.

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Optimize PRO TAVR Evolut FX附录研究的30天和1年结果。

背景：Optimize PRO研究的主要结果报告了经导管主动脉瓣置换术（TAVR）与尖端重叠技术（COT）导致低30天永久性起搏器植入（PPI）率和无≥中度主动脉反流（AR）。目的：评价Evolut FX植入术后的COT和术后计算机断层扫描（CT）效果。方法：Optimize PRO FX附录研究是一项上市后、前瞻性、多中心非随机研究。严重主动脉瓣狭窄患者采用COT方案使用Evolut FX进行TAVR。术后，我们评估COT依从性以确定关键步骤，并将ct评估的TAV定向与透视引导的关节对准进行比较。结果：2022年9月至2023年10月，151例患者植入Evolut FX。中位随访时间为371天（Q1-Q3: 352-388天）。改良COT的依从性为86.0%。中位住院时间为1天。30天全因死亡率或全卒中的主要终点为2.7% (95% CI: 1.0-6.9%)， 1年为7.5% （95% CI: 4.2-13.1%）。30天PPI新发率为6.7% (95% CI 3.7-12.1%)， 1年PPI新发率为8.8% （95% CI 5.2-14.6%）。1年时，1例患者发生中度AR，无一例发生严重AR。x线检查标记物定位评估的委员对齐率为91.5% (107/117)，CT评估的委员对齐率为86.9%(113/130)，表明一致性良好。92%的患者CT显示无严重冠状动脉不对准。结论：改良COT的Evolut FX与1年的低PPI率和无严重AR相关。术后CT显示连接和冠状动脉排列一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.