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CLINICAL STUDIES

Further experience with transcatheter closure of the patent ductus arteriosus using the Amplatzer duct occluder

Basil (Vasilios) D. Thanopoulos, MD^*, Fakhri A. Hakim, MD, Aktham Hiari, MD, Yousef Goussous, MD, Evangelia Basta, MD^*, Armine A. Zarayelyan, MD^* and George S. Tsaousis, MD^*

^* Department of Pediatric Cardiology, "Aghia Sophia" Children’s Hospital, Athens, Greece
Department of Pediatric Cardiology, "Queen Alia" Heart Institute, Amman, Jordan

Manuscript received June 4, 1999; revised manuscript received October 15, 1999, accepted November 19, 1999.

Reprint requests and correspondence: Dr. Basil (Vasilios) D. Thanopoulos, Department of Pediatric Cardiology, "Aghia Sophia" Children’s Hospital, Thivon & Levadias Street, Athens 11527, Greece

OBJECTIVE

The aim of this study was to report further experience with transcatheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO).

BACKGROUND

The design of previously used devices is not ideal for this purpose, and their use has been associated with several drawbacks, especially in large PDAs.

METHODS

Forty-three patients, aged 0.3 to 33 years (mean 6.4 ± 6.7 years), with a moderate to large, type A to E PDA, underwent attempted transcatheter closure using the ADO. The device is a plug-shaped repositionable occluder made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9 ± 1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follow-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter.

RESULTS

The mean ADO diameter was 6.1 ± 1.4 mm (range 4 to 10 mm). Complete angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial angiographic shunt through the ADO. At 24 h, color flow mapping revealed no shunt in all patients. A 9F long sheath was required for repositioning of a misplaced 8-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9 ± 1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was noted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered.

CONCLUSIONS

Transcatheter closure using the ADO is an effective and safe therapy for the majority of patients with patency of the arterial duct. Further studies are required to establish long-term results in a larger patient population.

Abbreviations and Acronyms   ADO = Amplatzer duct occluder   CI = confidence interval   PDA = patent ductus arteriosus   Qp/Qs = pulmonary/systemic flow ratio

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