Nonthoracotomy ICDs are believed to be the best therapeutic modality f
or treatment of life-threatening ventricular arrhythmias. Little is kn
own about the risk of infection with initial implantation of these dev
ices. We studied the incidence, clinical characteristics, and risk fac
tors associated with infections in 1,831 patients with nonthoracotomy
ICD from the Endotak-C nonthoracotomy lead registry of Cardiac Pacemak
ers, Inc. A transvenous lead was implanted in 950 patients (51.9%) and
a combination transvenous plus subcutaneous patch was used in 881 pat
ients (48.1%). Nine preselected data variables were studied, and all i
nvestigators identified as having patients with infections rt ere pers
onally contacted. Infections occurred in 22 (1.2%) of 1,831 patients r
eceiving this nonthoracotomy ICD system. The mean time to infection wa
s 5.7 +/- 6.5 months (range 1-25 months). Staphylococci were isolated
in 58% of patients with reported infection. The presence of a subcutan
eous defibrillator patch system was associated with the development of
infection. Six of 950 patients (0.63%) with a totally transvenous lea
d system developed infection versus 16 of 838 (1.9%) patients with a t
ransvenous lead plus subcutaneous patch system configuration (P = 0.01
5, Chi-square test), with an unadjusted estimated odds ratio of 3.06 (
CI 1.19-7.86). The risk of infection encountered with the nonthoracoto
my ICD is low, estimated from our data to be 1.2%. Placement of a subc
utaneous defibrillator patch appears to be an independent risk factor
for development of infection.