A small interventional device to occlude persistently patent ductus arteriosus in neonates: evaluation in piglets.
OBJECTIVE
We attempted to evaluate the efficacy and tissue reaction of a new miniature interventional ductal occlusion device in neonatal pigs.


BACKGROUND
A variety of devices are used to close persistent ductus arteriosus (PDA) by interventional measures. Because of the size of these devices, they have not been applied to term or preterm neonates. Newborn piglets are comparable in size and fragility to human term and preterm neonates.


METHODS
Memory-shaped double-cone stainless steel coils were mounted on a titanium-nickel core wire. A snap-in mechanism attaches the coil to the delivery wire, allowing intravascular coil retrieval and repositioning. The system was placed through a 3F Teflon catheter. Two piglet models of PDA were used: 1) ductal patency maintained by stents (n = 6), and 2) ductal patency produced by angioplasty (n = 7) to avoid stent-coil interaction.


RESULTS
Placement of the coils within the PDA was possible in all piglets. Before final detachment, the coils were retrieved or repositioned, or both, up to eight times. In all but two piglets the ductus was closed within 1 h of the procedure. The coils were never dislocated and caused no infections or relevant aortic and pulmonary artery obstruction (95% confidence interval for missing complications [0 of 13] extends to 23%). Histologic and electron microscopic studies revealed endothelial coverage of the implants and histiocytic reaction but no local or systemic inflammation or erosion of the implant.


CONCLUSIONS
The device was effective in experimental models of PDA. The information obtained warrants initial trials of the device in neonates.
Grabitz
R G
RG
Department of Pediatric Cardiology, Aachen University of Technology, Germany. grabitz@amsd.imib.rwth-aachen.de
Neuss
M B
MB
Coe
J Y
JY
Handt
S
S
Redel
D A
DA
von Bernuth
G
G
D000818:Animals; D000831:Animals, Newborn; D001672:Biocompatible Materials; D006328:Cardiac Catheterization; D004195:Disease Models, Animal; D004374:Ductus Arteriosus, Patent / Q000628:therapy*; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005260:Female; D008297:Male; D015607:Stents; D013552:Swine
D001672:Biocompatible Materials