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Publications

Journal Article Randomized Controlled Trial Multicenter Study Comparative Study Ppublish 7 citations

PubMed: 41562534 DOI: 10.1016/j.jacc.2025.10.042

Chlorhexidine vs Povidone-Iodine Alcohol Solutions for Cardiac Implantable Electronic Devices: A Prospective Randomized Study.

J Am Coll Cardiol 87(2):200-211

Authors: Antoine Da Costa, Jacques Mansourati, Romain Eschalier, Francois Lesaffre, Pierre Bordachar, Jérôme Taieb, Gabriel Laurent, Antoine Milhem, Maciej Kubala, Sophie Le Page, Paul Milliez, Benjamin Gal, Antoine Dompnier, Pascal Defaye, Sandrine Bayle, Frederic Anselme, Saida Cheggour, Jean Litalien, Alexandre Duparc, Jean Luc Pasquier, Cécile Romeyer, Elisabeth Botelho-Nevers, Julie Gagnaire, Emeric Lager, Arnauld Garcin, Céline Chapelle, Aline Schimd, Karim Benali, Silvy Laporte, Jean Claude Deharo

Affiliations

  • CHU Saint-Etienne, Saint-Etienne, France.
  • CHU de Brest, Brest, France.
  • CHU de Clermont-Ferrand, Clermont-Ferrand, France.
  • CHU de Reims, Reims, France.
  • CHU de Bordeaux, Bordeaux, France.
  • CH d'Aix en Provence, Aix en Provence, France.
  • CHU de Dijon, Dijon, France.
  • CH de La Rochelle, La Rochelle, France.
  • CHU d'Amiens, Amiens France.
  • CHU d'Angers, Angers, France.
  • CHU de Caen, Caen, France.
  • CH Saint Joseph, Lyon, France.
  • CH d'Annecy, Annecy, France.
  • CHU de Grenoble, Grenoble, France.
  • CH de Chartres, Chartres, France.
  • CHU de Rouen, Rouen, France.
  • CH d'Avignon, Avignon, France.
  • CH de Périgueux, Périgueux, France.
  • CHU de Toulouse, Toulouse, France.
  • CHU de Montpellier, Montpellier, France.
  • CHU Saint-Etienne, Saint-Etienne, France.
  • CHU Saint-Etienne, Service d'Infectiologie, Saint-Étienne, France.
  • CH Emile-Roux, Le Puy en Velay, France.
  • Unité de Recherche Clinique, CHU de Saint-Étienne, Saint-Étienne, France; INSERM CIC 1408, CHU de Saint-Étienne, Saint-Étienne, France.
  • Service de Pharmacologie Clinique, CHU de Saint-Étienne, Saint-Étienne, France; Université Jean Monnet, Mines Saint-Étienne, INSERM Unité 1059, Santé Ingénierie Biologie Saint-Étienne (SAINBIOSE), Saint-Étienne, France.
  • Hôpital de la Timone - CHU Marseille, Marseille, France.

Abstract

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.

OBJECTIVES

This study sought to compare the effectiveness of 2% alcohol-based chlorhexidine with that of 4-phase povidone-iodine-alcohol skin preparation in preventing local or systemic infections after cardiac resynchronization therapy device implantation, and to assess the impact on other major cardiovascular events and treatment-related adverse effects over 24 months.

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 noninfectious side effects.

RESULTS

From April 2013 to December 2018, 2,272 patients were randomized to the chlorhexidine (n = 1,143) or the povidone-iodine group (n = 1,129). 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: 0.48-1.20; P = 0.23). Major cardiovascular events occurred in 31.5% and 31.3% of patients, respectively (subhazard ratio: 1.01; 95% CI: 0.87-1.17). Noninfectious 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 with alcoholic povidone-iodine in patients undergoing cardiac resynchronization device implantation. Both antiseptics showed similar rates of major infectious and noninfectious events. Further research is needed to optimize infection prevention strategies in this population. (Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation [CHLOVIS]; NCT01841242).

MeSH

Skin, Povidone, Antisepsis, Chlorhexidine, Cardiology, Alcoholics, Solutions, Cardiac Resynchronization Therapy, Risk Factors, Therapeutics, Povidone-Iodine, Infections