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CLINICAL STUDIES

Follow-up results of transvenous occlusion of patent ductus arteriosus with the buttoned device¹

P. Syamasundar Rao, MD, FACC^* , Seong Ho Kim, MD, Jae-Young Choi, MD, Christian Rey, MD^||, Jorge Haddad, MD^¶, Francois Marcon, MD^#, Kevin Walsh, MD^** and Eleftherios B. Sideris, MD

^* Division of Pediatric Cardiology, University of Wisconsin Medical School, Madison, Wisconsin, USA
Saint Louis University School of Medicine, St. Louis, Missouri, USA
Sejong General Hospital, Puchon, South Korea
Yonsei University, Seoul, South Korea
^|| Université de Lille, Lille, France
^¶ Hospital do Coracão de Ribeirão Preto, Ribeirão Preto, Brazil
^# Centre Hospitallier Université, Nancy, France
^** Royal Liverpool Children’s NHS Trust, Alder Hey, Liverpool, England, United Kingdom
Athenian Institute of Pediatric Cardiology, Athens, Greece

Manuscript received June 4, 1998; revised manuscript received August 14, 1998, accepted November 2, 1998.

Reprint requests and correspondence: Dr. P. Syamasundar Rao, Division of Pediatric Cardiology, Saint Louis University School of Medicine, 1465 South Grand Boulevard, St. Louis, Missouri 63104-1095
raops{at}SLU.EDU

OBJECTIVES

The purpose of this presentation is to document results of buttoned device (BD) occlusion of patent ductus arteriosus (PDA) in a large number of patients with particular emphasis on long-term follow-up in an attempt to provide evidence for feasibility, safety and effectiveness of this method of PDA closure.

BACKGROUND

Immediate and short-term results of BD occlusion of PDA have been documented in a limited number of children.

METHODS

During a six-year period ending August 1996, transcatheter BD closure of PDA was attempted in 284 patients, ages 0.3 to 92 years (median 7) under a protocol approved by the local institutional review boards and FDA with an investigational device exemption in U.S. cases.

RESULTS

The PDAs measured 1 to 15 mm (median 4) 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 = 144) 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%) patients. All types of PDAs, irrespective of the shape (conical, tubular or short), size (small or large) or length (short or long) of the PDA and previously implanted Rashkind devices, could be occluded. Follow-up data, 1 to 60 months (median 24) after device implantation, were available in 234 (84%) patients. Seven (3%) patients required reintervention to treat residual shunt with (N = 2) or without (N = 5) hemolysis. Actuarial reintervention-free rates were 95% at 1 and 5 years. There was gradual reduction of actuarial residual 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. Incorporation of folding plug over the button loop in 10 additional patients produced immediate and complete occlusion of PDA.

CONCLUSIONS

This large multiinstitutional experience confirms the feasibility, safety and effectiveness of buttoned device closure of PDAs. All types of PDAs irrespective of the shape, length and diameter can be effectively occluded. Incorporation of folding plug over the button loop produces complete PDA occlusion at the time of device implantation.

Abbreviations and Acronyms   BD = buttoned device   PDA = patent ductus arteriosus

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