Barry Oliver M, Hasan Babar S, Aslam Nadeem, Batlivala Sarosh P, Crystal Matthew A, Trucco Sara M, Gudausky Todd, Holzer Ralf J, Kreutzer Jacqueline, Nicholson George, O'Byrne Michael L, Quinn Brian P, Veeram Reddy Surendranath R, Salavitabar Arash, Boe Brian A
Division of Pediatric Cardiology, NewYork-Presbyterian - Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, New York.
Division of Cardiothoracic Sciences, Sindh Institute of Urology and Transplantation, Karachi, Pakistan.
J Soc Cardiovasc Angiogr Interv. 2025 Jan 9;4(2):102459. doi: 10.1016/j.jscai.2024.102459. eCollection 2025 Feb.
Technical success (TS) and procedural safety (PS) have been reported individually for transcatheter atrial septal defect (ASD) and patent ductus arteriosus (PDA) closures. A composite procedural performance (PP) metric as a patient-centered strategy has not been developed or studied.
A multicenter expert working group created PP metrics for ASD and PDA device closures as a composite of TS and PS. TS criteria were defined and categorized into 3 classes (optimal, satisfactory, and unsatisfactory). PS was defined using established adverse event (AE) definitions from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. PP was divided into 3 outcome classes (I to III). Retrospective C3PO data were collected for all cases of isolated ASD and PDA closure from 2014 through 2017. Exclusion criteria included complex congenital heart disease, significant comorbidities, ASD patients with multiple defects or ≥2 deficient rims, and PDA patients weighing <6 kg or with pulmonary hypertension. Factors correlating with class III (suboptimal) PP were analyzed.
A total of 542 ASD and 688 PDA closure cases were included. Most ASD cases (99%) had optimal or satisfactory TS while 1% had a high severity AE. Class III PP occurred in 2% of ASD cases, mostly due to new mitral valve insufficiency. There were no identified patient or procedural factors associated with class III PP for ASD closures. Optimal or satisfactory TS occurred in 98% of PDA cases, with high severity AEs in <1%. Class III PP occurred in 2% of PDA cases, predominantly due to new arch obstruction, and was associated with younger age ( < .001) and lower weight ( = .001).
This study introduces PP as a composite variable to comprehensively measure outcomes of standard-risk ASD and PDA device closure. The incorporation of both TS and PS aims to better reflect patient outcomes compared to individual measurements alone. PP may serve as a valuable tool for identifying areas for further investigation and quality improvement.
经导管房间隔缺损（ASD）和动脉导管未闭（PDA）封堵术的技术成功率（TS）和手术安全性（PS）已分别有报道。尚未制定或研究以患者为中心的复合手术操作性能（PP）指标。
一个多中心专家工作组创建了ASD和PDA装置封堵术的PP指标，作为TS和PS的综合指标。TS标准被定义并分为3类（最佳、满意和不满意）。PS使用先天性心脏病导管介入治疗结局项目（C3PO）登记处既定的不良事件（AE）定义来定义。PP分为3个结局类别（I至III）。收集了2014年至2017年所有孤立性ASD和PDA封堵病例的C3PO回顾性数据。排除标准包括复杂先天性心脏病、严重合并症、有多个缺损或≥2个边缘缺陷的ASD患者，以及体重<6 kg或患有肺动脉高压的PDA患者。分析与III类（次优）PP相关的因素。
共纳入542例ASD封堵病例和688例PDA封堵病例。大多数ASD病例（99%）的TS为最佳或满意，而1%发生了高严重度AE。2%的ASD病例出现III类PP，主要是由于新出现的二尖瓣反流。未发现与ASD封堵术III类PP相关的患者或手术因素。98%的PDA病例TS为最佳或满意，<1%发生高严重度AE。2%的PDA病例出现III类PP，主要是由于新出现的主动脉弓梗阻，且与年龄较小（<.001）和体重较低（=.001）相关。
本研究引入PP作为一个复合变量，以全面衡量标准风险ASD和PDA装置封堵术的结局。与单独测量相比，将TS和PS纳入旨在更好地反映患者结局。PP可能是识别进一步研究领域和质量改进的有价值工具。
