Circulation, Vol 90, 2525-2528, Copyright © 1994 by American Heart Association
LA Latson, BM McManus, C Doer, K Kilzer and JP Cheatham
BACKGROUND--The USCI PDA Umbrella is a device to close patent ductus
arteriosus (PDA) by a transcatheter technique. Human clinical trials have
shown excellent efficacy in reducing or eliminating the PDA shunt, but
concerns remain about the risk of infection with this device. The purpose
of this study was to evaluate the risk of infection using an animal model.
METHODS AND RESULTS--Susceptibility to developing endocarditis was tested
by injecting a single intravenous dose of group L streptococcus. Ten
piglets with a closed ductus served as controls. Two of these developed
valvular vegetations. PDA was produced in 19 animals by balloon dilation of
the ductus. Seven of 7 animals with PDA at the time of bacterial injection
developed endarteritis of the ductus and valvular vegetations. A PDA
Umbrella was placed in the remaining 12 animals, and bacteria were injected
2 weeks after device implantation. Infection was evident in the PDA
Umbrella only in the single animal in which the Umbrella had embolized and
been left in the left pulmonary artery. Three of the remaining 11 piglets
had a significant residual leak, and all developed infection in the ductus
and an additional valve. Similar to the control group, none of the animals
with complete (n = 8) or nearly complete (n = 2) closure of the ductus by
the PDA Umbrella had infection in or around the ductus, and only 1 had a
valvular vegetation. CONCLUSIONS--In this animal model, presence of a
significant PDA shunt (with or without a PDA Umbrella present) results in
significantly increased susceptibility to endarteritis and endocarditis.
The PDA Umbrella device does not appear to be susceptible to direct
infection as early as 2 weeks after implantation if it is properly located
in the ductus arteriosus. Animals with no shunt or a trivial shunt are no
more susceptible to developing endocarditis 2 weeks after PDA Umbrella
implantation than are controls.
ARTICLES
Endocarditis risk of the USCI PDA umbrella for transcatheter closure of patent ductus arteriosus
Department of Pediatrics and Pathology, University of Nebraska Medical School, Omaha.
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