Catheter Closure of Moderate- to Large-Sized Patent Ductus Arteriosus Using the New Amplatzer Duct Occluder: Immediate and Short-Term Results.JOZEF MASURA, MD, PHD, KEVIN P
. WALSH, MD, MRCP,* BASIL THANOPOULOUS, MD,†CHEN CHAN, MD,‡ JOHN BASS, MD,§ YOUSEF GOUSSOUS, MD, FACC\, PAUL GAVORA, MD,ZIYAD M. HIJAZI, MD, MPH, FACC¶
Bratislava, Slovak Republic; Liverpool and Leicester, England, United Kingdom; Athens, Greece; Minneapolis, Minnesota; Amman, Jordan; and Boston, Massachusetts
The aim of this study was to assess the immediate and short-term results of anterograde catheter closure of a moderate- to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder(ADO) device.
Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts.
Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7 6 1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow-up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure.
Twenty three of the 24 patients had successful device placement. Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients. The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day. There were no complications. Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure.
Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm. Further clinical trials are underway. (J Am Coll Cardiol 1998;31:878–82) ©1998 by the American College of Cardiology The Rashkind, buttoned, Botalloocluder devices and coils have been used extensively for transcatheter closure of a patent ductus arteriosus (PDA) with variable degrees of successful deployment and an incidence of residual shunting varying between 3% and 38% (1–9).
Furthermore, some of the devices require large delivery catheters, limiting their use in small infants, and the use of these devices and coils is technically challenging, especially for large PDAs. Recently, Sharafuddin et al. (10) reported on the use of a new self-expandable device (Amplatzer duct occluder [ADO]) to close surgically created aortopulmonary shunts in a canine model with very encouraging results. In the present report, we describe the immediate and short-term results using the ADO to close moderate- to large-sized PDAs.
Patients. From September 1996 to June 1997, 24 patients (18 female, 6 male) underwent attempted transcatheter closure of a PDA as an alternative to standard surgical ligation or the use of other devices. Informed consent was obtained from all patients. All patients had clinical and echocardiographic findings of a PDA. The patients median age was 3.8 years (range 0.4 to 48), and their weights ranged from 6 to 70 kg (median 15.5 kg).
All patients were asymptomatic, except for Patient 22, who had failure to thrive and pulmonary artery hypertension (mean 46 mm Hg) from the large PDA (5.7 mm). All patients From the Department of Cardiology, Children University Hospital, Bratislava, Slovak Republic; *Department of Cardiology, Royal Liverpool Children Hospital, Liverpool, England, United Kingdom; †Department of Cardiology, Agia Children Hospital, Athens, Greece; ‡Department of Cardiology, Glenfield Children’s Hospital, Leicester, England, United Kingdom; §Division of Cardiology, Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, Minnesota; \Queen Alia Heart Institute, Amman, Jordan; ¶Division of Cardiology, Department of Pediatrics, Floating Hospital for Children at New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts.