背景:使用自膨式Harmony瓣膜(Medtronic)的经导管肺动脉瓣置换术(TPVR)是一种针对天然或手术修复的右心室流出道(RVOT)肺反流(PR)患者的新兴治疗方法。自2021年美国食品和药物管理局批准以来,数据有限。
目的:在本研究中,作者试图在现实世界的经验中评估自我膨胀TPVR的安全性和短期有效性.
方法:这是一项多中心注册研究,研究对象是在2022年4月30日之前连续接受TPVR的天然RVOTPR患者。
方法:主要结果是血液动力学功能障碍(PR大于轻度,RVOT平均梯度>30mmHg)和RVOT再干预的复合。
结果:共有243例患者接受TPVR,中位年龄为31岁(Q1-Q3:19-45岁)。心脏诊断为法洛四联症(71%),肺动脉瓣狭窄(21%),其他(8%)。除1例病例外,所有病例均取得了技术上的成功。4%的病例发生了程序性严重不良事件,没有装置栓塞或死亡。86%的患者住院时间为1天。19%的病例发生室性心律失常提示治疗。中位随访时间为13个月(Q1-Q3:8-19个月),98%的患者具有可接受的血流动力学功能。从复合临床结果中的估计自由在1年为99%,在2年为96%。1年时TPVR相关心内膜炎的发生率为98%。5例死于COVID-19(n=1),未知原因(n=2),和血流感染(n=2)。
结论:在这种大型多中心的现实世界体验中,自膨式TPVR治疗的短期临床和血流动力学结局良好.该队列的持续随访将为长期结果提供重要见解。
BACKGROUND: 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.
OBJECTIVE: In this study, the authors sought to evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world experience.
METHODS: This was a multicenter registry study of consecutive patients with native RVOT PR who underwent TPVR through April 30, 2022, at 11 U.S.
METHODS: The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention.
RESULTS: 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).
CONCLUSIONS: 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.