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

Area of Science:

• Cardiology
• Interventional Cardiology
• Pediatric Cardiology

Background:

• Technical success (TS) and procedural safety (PS) are key metrics for transcatheter device closures of atrial septal defects (ASD) and patent ductus arteriosus (PDA).
• A unified, patient-centered metric combining TS and PS for these procedures has not been previously established or evaluated.

Purpose of the Study:

• To develop and validate a composite procedural performance (PP) metric for ASD and PDA device closures.
• To assess the utility of PP in reflecting comprehensive patient outcomes beyond individual TS and PS measures.

Main Methods:

• A multicenter expert group defined criteria for TS (optimal, satisfactory, unsatisfactory) and PS using established adverse event (AE) definitions.
• Procedural performance (PP) was categorized into three classes (I-III), with class III indicating suboptimal outcomes.
• Retrospective data from 542 ASD and 688 PDA closures (2014-2017) were analyzed, excluding complex cases.

Main Results:

• Most ASD closures (99%) achieved optimal/satisfactory TS, with 2% experiencing class III PP, primarily due to new mitral valve insufficiency.
• Most PDA closures (98%) achieved optimal/satisfactory TS, with 2% experiencing class III PP, linked to younger age and lower weight, often due to new arch obstruction.
• No specific patient or procedural factors were identified for suboptimal PP in ASD closures, unlike PDA closures.

Conclusions:

• Procedural performance (PP) is introduced as a composite metric for evaluating ASD and PDA device closures.
• PP integrates technical success and procedural safety, providing a more holistic view of patient outcomes.
• This composite metric can guide quality improvement initiatives and further research in transcatheter device closures.