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CLINICAL STUDY: PEDIATRIC CARDIOLOGY

The Amplatzer duct occluder: experience in 209 patients

^a Department of Pediatric Cardiology, Institut Jantung Negara, Kuala Lumpur, Malaysia

Manuscript received December 31, 1999; revised manuscript received August 9, 2000, accepted September 26, 2000.

Reprint requests and correspondence: Dr. Mazeni Alwi, Department of Pediatric Cardiology, Institut Jantung Negara, 145, Jalan Tun Razak, 50400 Kuala Lumpur, Malaysia
mazeni{at}ijn.com.my

OBJECTIVES

The aim of the study was to assess the safety and efficacy of the Amplatzer ductal occluder (ADO) in transcatheter occlusion of patent ductus arteriosus (PDA).

BACKGROUND

Transcatheter closure of small to moderate sized PDAs is an established procedure. The ADO is a self-expandable device with a number of salutary features, notably its retrievability, ease of delivery via small 5F to 7F catheters and a range of sizes suitable even for the larger PDAs.

METHODS

Between November 1997 and August 1999, the ADO was successfully implanted in 205 of 209 patients with PDA. The inclusion criteria for this device occlusion method were patients with clinical and echocardiographic features of moderate to large PDA, weighing 3.5 kg as well as asymptomatic adolescents and adults with PDA measuring 5.0 mm on two-dimensional (2D) echocardiogram. Occlusion was achieved via the antegrade venous approach. Follow-up evaluations were performed with 2D echocardiogram, color-flow mapping and Doppler measurement of the descending aorta and left pulmonary artery velocity at 24 h and 1, 3, 6 and 12 months after implantation.

RESULTS

Two hundred and five patients had successful PDA occlusion using this device. The patients were between two months and 50 years (median 1.9) and weighed between 3.4 kg and 63.2 (median 8.4). Infants made up 26% of the total patients. The PDA measured from 1.8 to 12.5 mm (mean 4.9) at the narrowest diameter. Forty-four percent of patients achieved immediate complete occlusion. On color Doppler the closure rates at 24 h and 1 month after implant were 66% and 97%, respectively. At 6 and 12 months all except one patient attained complete occlusion. Device embolization occurred in three patients; in two this was spontaneous, and in the other it was due to catheter manipulation during postimplant hemodynamic measurement. Mild aortic narrowing was seen in an infant.

CONCLUSIONS

Patent ductus arteriosus occlusion using ADO is safe and efficacious. It is particularly useful in symptomatic infants and small children with relatively large PDA. Embolization can be minimized by selection of appropriate sized devices, and caution should be exercised in infants <5 kg.

Abbreviations and Acronyms   ADO = Amplatzer duct occluder   LPA = left pulmonary artery   PA = pulmonary artery   PDA = patent ductus arteriosus   VSD = ventricular septal defect   2D = two-dimensional

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