Evaluating Procedural Performance: A Composite Outcome for Atrial Septal Defect and Patent Ductus Arteriosus Closures

Abstract

Background

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.

Methods

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.

Results

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 (P < .001) and lower weight (P = .001).

Conclusions

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.