Chlorhexidine versus povidone-iodine alcoholic solutions in cardiac implantable electronic devices. The CHLOVIS randomized study
A Da Costa, J Mansourati, R Eschallier, F Lesaffre, P Bordachar, J Taieb, J C Deaharo, S On Behalf Of The Chlovis Study InvestigatorsAbstract
Background
Cardiac resynchronization therapy (CRT) improves heart failure outcomes and reduces morbidity and mortality but carries the highest infection risk among cardiac implantable electronic devices. Studies on surgical-site infections show conflicting results regarding the use of alcohol-based povidone-iodine vs. chlorhexidine for skin antisepsis, especially as CRT implantation remains insufficiently studied.
Methods
In this randomized, multicenter, open-label trial with blinded outcome adjudication, patients undergoing CRT (implantation, upgrade, or replacement) pacemaker, or defibrillator implantation were assigned 1:1 to receive skin antisepsis with either 2% alcoholic chlorhexidine or alcoholic povidone-iodine. Randomization was conducted centrally using an interactive web-response system, with stratification according to trial center. The primary outcome was local or systemic infection related to the device over a 24-month follow-up period. The secondary outcomes were major cardiovascular events and non-infectious side effects.
Results
From April 2013 to December 2018, 2272 patients were randomized to chlorhexidine (n=1143) or povidone-iodine group (n=1129). Median age was 72 years; 75.1% were men. Device-related infections occurred in 2.9% of the chlorhexidine group and 3.9% of the povidone-iodine group (adjusted subhazard ratio, 0.75; 95% CI, 0.48 to 1.20; P=0.23). Major cardiovascular events occurred in 31.5% and 31.3% of patients, respectively (subhazard ratio, 1.01; 95% CI, 0.87 to 1.17). Non-infectious local side effects occurred in 12.9% vs. 13.3%.
Conclusions
The study did not demonstrate a significant reduction in infection rates with alcoholic chlorhexidine compared to alcoholic povidone-iodine in patients undergoing cardiac resynchronization device implantation despite a 25% relative risk reduction observed with chlorhexidine. Both antiseptics showed similar rates of major infectious and non-infectious events. Further research is needed to optimize infection prevention strategies in this population.