Transcatheter closure of the patent ductus arteriosus with new-generation devices: comparative data and follow-up results.
BACKGROUND
Many devices currently used for the closure of the patent ductus arteriosus are claimed to be safe and cost-effective, but only few data exist with respect to the gold standard of the Rashkind occluder. The aim of this study was to assess the efficacy and safety of three new different devices and to compare the results to those of a control group of patients carrying a Rashkind occluder. This should provide the basis for further cost-analysis studies.


METHODS
The records of all patients who underwent closure of the patent ductus at our Institution from April 1989 to May 2001 were reviewed. Eighty patients (median age 10.3 years, median weight 27.6 kg) were treated (25 with a Rashkind device, 11 with Duct-Occlud coils, 35 with Cook detachable coils, 9 with the Amplatzer system).


RESULTS
Kaplan-Meyer estimates of long-term complete occlusion of the ductus showed, compared to the Rashkind device, a significant improvement for the Cook and Amplatzer (p = 0.025 and p = 0.003, respectively) devices but not for the Duct-Occlud coils (p = 0.165). One patient of the Duct-Occlud group (9%) and 3 with the Rashkind device (12%) featured a significant residual shunt and needed a second intervention. The complication rate was 4% for the Rashkind occluder, 5% for the Cook coils, 9% for the Duct-Occlud system, and 11% for the Amplatzer device (p > 0.05).


CONCLUSIONS
The new devices are as safe as the Rashkind occluder and provide effective treatment. The Cook coils and the Amplatzer occluder offer better results compared to the Rashkind and Duct-Occlud devices.
Donti
Andrea
A
University of Bologna, Bologna, Italy.
Formigari
Roberto
R
Bonvicini
Marco
M
Prandstraller
Daniela
D
Bronzetti
Gabriele
G
Picchio
Fernando M
FM
D000293:Adolescent; D000328:Adult; D002404:Catheterization / Q000009:adverse effects; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D020878:Device Removal; D004374:Ductus Arteriosus, Patent / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D015150:Echocardiography, Doppler; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000295:instrumentation; D004869:Equipment Safety; D005500:Follow-Up Studies; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D015994:Incidence; D007223:Infant; D007229:Infant Welfare; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D012189:Retrospective Studies; D013577:Syndrome; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000150:complications / Q000175:diagnosis / Q000628:therapy