The Sideris buttoned devices for transcatheter closure of patent ductus arteriosus

Abstract

This article reviews the experience in the last decade with Sideris buttoned devices for occlusion of patent ductus arteriosus (PDA). The devices used were the regular buttoned device, the infant buttoned device, the device with the folding plug, and the wireless device. The buttoned devices were implanted transvenously and introduced through 7Fr-8Fr long sheaths for PDAs up to 12 mm; wireless devices required 9Fr-11Fr sheaths for PDAs up to 22 mm. All different shapes of ductus were occluded. The records of 356 patients in the international and Food and Drug Administration (FDA) supervised United States (US) clinical trials were reviewed. Despite excellent long-term full occlusion rates and the absence of significant complications with the regular buttoned device, modifications were necessary to improve the full occlusion rates in 24 hours. The 24-hour rates improved from 60% with the regular device to 85% with the folding plug device. Most residual shunts disappeared on long-term follow-up without significant complications. Wireless devices were developed for very large PDAs and have excellent occlusion rates. The buttoned device with the incorporated folding plug and the wireless devices are currently under clinical trial. The safety record of the new devices needs to be established with larger clinical trials.