Multi center experience with Cocoon Duct Occluder for closure of different types of patent ductus arteriosus (PDA)

Abstract

Background

Transcatheter closure of patent ductus arteriosus (PDA) is a widely practiced procedure using various duct occluder devices.

Objective

To assess the safety and efficacy of the Cocoon Duct Occluder for PDA closure.

Methods

This single-arm cohort study, conducted in the Pediatric Cardiology Departments of NICVD Karachi, TMK, and Sukkur, included both prospective and retrospective recruitment. Using non-probability consecutive sampling, a minimum sample size of 35 was calculated to achieve a 90 % success rate with a 95 % confidence level. A total of 195 patients met the inclusion criteria over 2.5 years. Comprehensive preprocedural assessments were performed, including medical history, clinical examination, electrocardiography, chest X-ray, full blood count, and detailed echocardiographic measurements of PDA dimensions and left ventricular function. Procedures were performed by experienced pediatric cardiologists.

Results

PDA closure was successfully achieved in 186 of 195 patients (95.3 %). The most common PDA type was Type A (86.6 %), followed by Type B (4.6 %), Type C (2.6 %), Type D (3 %), and Type E (3 %) per Krichenko's classification. Minor complications included peripheral vascular injury (6.6 %), arterial thrombosis (4 patients), venous thrombosis (7 patients), and arrhythmias (5 patients: 4 with supra-ventricular tachycardia [SVT] and 1 with ventricular tachycardia [VT], of which 2 SVT cases required adenosine therapy). One major complication, i.e. infective endocarditis, and no other major complications, such as device embolization or vascular injury, were observed.

Conclusion

The Cocoon Duct Occluder is a safe and effective device for PDA closure across all anatomical types. The procedure's success is enhanced through meticulous device sizing, proper technique, and operator experience, minimizing the risk of major complications.