Division of Pediatric Cardiology, University of Pittsburgh School of Medicine and Heart Institute, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Departments of Cardiothoracic Surgery and Pediatrics (Cardiology), Stanford University School of Medicine, Palo Alto, California, USA.
J Am Coll Cardiol. 2024 Apr 9;83(14):1310-1321. doi: 10.1016/j.jacc.2024.02.010.
Transcatheter pulmonary valve replacement (TPVR) with the self-expanding Harmony valve (Medtronic) is an emerging treatment for patients with native or surgically repaired right ventricular outflow tract (RVOT) pulmonary regurgitation (PR). Limited data are available since U.S. Food and Drug Administration approval in 2021.
In this study, the authors sought to evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world experience.
This was a multicenter registry study of consecutive patients with native RVOT PR who underwent TPVR through April 30, 2022, at 11 U.S.
The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention.
A total of 243 patients underwent TPVR at a median age of 31 years (Q1-Q3: 19-45 years). Cardiac diagnoses were tetralogy of Fallot (71%), valvular pulmonary stenosis (21%), and other (8%). Acute technical success was achieved in all but 1 case. Procedural serious adverse events occurred in 4% of cases, with no device embolization or death. Hospital length of stay was 1 day in 86% of patients. Ventricular arrhythmia prompting treatment occurred in 19% of cases. At a median follow-up of 13 months (Q1-Q3: 8-19 months), 98% of patients had acceptable hemodynamic function. Estimated freedom from the composite clinical outcome was 99% at 1 year and 96% at 2 years. Freedom from TPVR-related endocarditis was 98% at 1 year. Five patients died from COVID-19 (n = 1), unknown causes (n = 2), and bloodstream infection (n = 2).
In this large multicenter real-world experience, short-term clinical and hemodynamic outcomes of self-expanding TPVR therapy were excellent. Ongoing follow-up of this cohort will provide important insights into long-term outcomes.
带瓣支架肺动脉瓣置换术（TPVR）联合自膨式 Harmony 瓣膜（美敦力）是一种治疗原发性或修复后的右心室流出道（RVOT）肺动脉瓣反流（PR）的新兴治疗方法。自 2021 年获得美国食品和药物管理局（FDA）批准以来，相关数据有限。
本研究旨在评估自膨式 TPVR 在真实世界中的安全性和短期疗效。
这是一项多中心连续患者登记研究，纳入了 2022 年 4 月 30 日前在美国 11 个中心接受自膨式 TPVR 治疗的原发性 RVOT PR 患者。主要终点是血流动力学功能障碍（PR 大于轻度和 RVOT 平均梯度>30mmHg）和 RVOT 再介入的复合终点。
共 243 例患者接受了 TPVR 治疗，中位年龄 31 岁（19-45 岁）。心脏诊断包括法洛四联症（71%）、瓣膜性肺动脉狭窄（21%）和其他（8%）。除 1 例外，所有患者均达到了急性技术成功。4%的病例发生了严重的程序不良事件，无器械栓塞或死亡。86%的患者住院时间为 1 天。19%的病例发生了需要治疗的室性心律失常。中位随访时间为 13 个月（8-19 个月），98%的患者血流动力学功能可接受。1 年时，复合临床终点的估计无事件生存率为 99%，2 年时为 96%。1 年时，TPVR 相关心内膜炎的无事件生存率为 98%。5 例患者死于 COVID-19（n=1）、原因不明（n=2）和血流感染（n=2）。
在这项大型多中心真实世界研究中，自膨式 TPVR 治疗的短期临床和血流动力学结果非常出色。对该队列的持续随访将为长期结果提供重要的见解。
