Preoperative skin antiseptics for prevention of cardiac implantable electronic device infections: a historical-controlled interventional trial comparing aqueous against alcoholic povidone-iodine solutions.

ABSTRACT

AIMS: Local skin antiseptic prevention against cardiac implantable electronic device (CIED) infections is not yet fully understood. This monocentre historical-controlled study sought to (i) conduct a prospective observational analysis comparing two antiseptic skin preparations over two similar consecutive periods of time, one conducted over a 1-year period using an aqueous povidone-iodine solution (Group I) and the other over the following with an alcoholic povidone-iodine solution (Group II); (ii) determine the predictive factors of CIED infection. METHODS AND RESULTS: Cardiac implantable electronic device implantation was performed in 1326 patients (pts). A total of 32 pts (2.4%) developed a CIED infection. Long-term follow-up (26 ± 3 months) revealed no significant difference between the groups infections were observed in 14 of the 648 pts (2.2%) in Group I vs. 18 of the 678 pts (2.7%) in Group II (P = 0.9). Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. The occurrence of infection was positively correlated with re-intervention (aOR, 7.16; 95% CI, 2.56-19.99; P < 0.0001), number of generator replacements, mean (aOR, 3.47; 95% CI, 2.22-5.44; P < 0.001), and haematoma (aOR, 48.4; 95% CI, 13.45-174.25; P < 0.0001). CONCLUSION: This study found that aqueous and alcoholic povidone-iodine solutions displayed similar antiseptic effects regarding CIED infection prevention. Independent predictive factors of CIED infection were re-intervention, haematoma, and number of generator replacements.