Follow-up results of transvenous occlusion of patent ductus arteriosus with the buttoned device

OBJECTIVES The purpose of this presentation is to document results of butto ned device (BD) occlusion of patent ductus arteriosus (PDA) in a large numb er of patients with particular emphasis on long-term follow-up in an attemp t to provide evidence for feasibility, safety and effectiveness of this met hod of PDA closure. BACKGROUND Immediate and short-term results of ED occlusion of PDA have bee n documented in a limited number of-children. METHODS During a six-year period ending August 1996, transcatheter ED closu re of PDA was attempted in 284 patients, ages 0.3 to 92 years (median 7) un der a protocol approved by the local institutional review boards and FDA wi th an investigational device exemption in U.S. cases. RESULTS The PDAs measured 1 to 15 mm (median 3) at the narrowest diameter; 20 were larger than 8 mm and 10 larger than 10 mm. They were occluded with devices measuring from 15 to 35 mm delivered via 7F (N = 140) or 8F (N = 14 4) sheaths. Successful implantation of the device was accomplished in 278 ( 98%) of 284 patients. The Qp:Qs decreased from 1.8 +/- 0.6 (mean +/- SD) to 1.09 +/- 0.19 (p < 0.001). Effective occlusion defined as no (N = 167 [60% ]) or trivial (N = 79 [28%]) residual shunt was achieved in 246 (88%) patie nts. All types of PDAs, irrespective of the shape (conical, tubular or shor t), size (small or large) or length (short or long) of the PDA and previous ly implanted Rashkind devices, could be occluded. Follow-up data, 1 to 60 m onths (median 24) after device implantation, were available in 234 (84%) pa tients. Seven (3%) patients required reintervention to treat residual shunt with (N = 2) or without (N = 5) hemolysis. Actuarial reintervention-free r ates were 95% at 1 and 5 years. There nas gradual reduction of actuarial re sidual shunts and were 40%, 28%, 21%, 14%, 11%, 10%, 6% and 0% respectively at 1 day 1, 6, 12, 24, 36, 48 and 60 months after device implantation. Inc orporation of-folding plug over the button loop in 10 additional patients p roduced immediate and complete occlusion of PDA. CONCLUSIONS This large multiinstitutional experience confirms the feasibili ty, safety and effectiveness of buttoned device closure of PDAs. All types of PDAs irrespective of the shape, length and diameter can be effectively o ccluded. Incorporation of folding plug over the button loop produces comple te PDA occlusion at the time of-device implantation. (C) 1999 by the Americ an College of Cardiology.