Author + information
- Received July 5, 2018
- Revision received September 9, 2018
- Accepted September 16, 2018
- Published online December 10, 2018.
- Andrew D. Krahn, MDa,∗ (, )@UBC@HamHealthSci@akrahn7,
- Yves Longtin, MDb,
- François Philippon, MDc,
- David H. Birnie, MDd,
- Jaimie Manlucu, MDe,
- Paul Angaran, MDf,
- Claus Rinne, MDg,
- Benoit Coutu, MDh,
- R. Aaron Low, MDi,
- Vidal Essebag, MD, PhDj,
- Carlos Morillo, MDk,
- Damian Redfearn, MDl,
- Satish Toal, MDm,
- Giuliano Becker, MDn,
- Michel Degrâce, MDo,
- Bernard Thibault, MDp,
- Eugene Crystal, MDq,
- Stanley Tung, MDr,
- John LeMaitre, MDs,
- Omar Sultan, MDt,
- Matthew Bennett, MDu,
- Jamil Bashir, MDr,
- Felix Ayala-Paredes, MD, PhDv,
- Philippe Gervais, MDc,
- Leon Rioux, MDw,
- Martin E.W. Hemels, MD, PhDx,
- Leon H.R. Bouwels, MDy,
- Bob van Vlies, MD, PhDz,
- Jia Wang, MSck,
- Derek V. Exner, MDaa,
- Paul Dorian, MDf,
- Ratika Parkash, MDbb,
- Marco Alings, MD, PhDcc and
- Stuart J. Connolly, MDk
- aDivision of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada
- bJewish General Hospital Sir Mortimer B. Davis, McGill University, Montreal, Canada
- cDivision of Cardiology, Institut universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada
- dDivision of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
- eDivision of Cardiology, Lawson Health Research Institute, London Health Sciences, Western University, London, Ontario, Canada
- fDivision of Cardiology, Department of Medicine, University of Toronto, Division of Cardiology, St. Michael Hospital, Toronto, Ontario, Canada
- gDivision of Cardiology, St. Mary's General Hospital, Kitchener, Ontario, Canada
- hDivision of Cardiology, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal, Montreal, Quebec, Canada
- iDivision of Cardiology, Chinook Regional Hospital, Lethbridge, Alberta, Canada
- jDivision of Cardiology, McGill University Health Center, Montreal, Quebec, Canada
- kPopulation Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada
- lDivision of Cardiology, Kingston General Hospital, Queen's University, Kingston, Ontario, Canada
- mHorizon Health Network, Saint John, New Brunswick, Canada
- nDivision of Cardiology, Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, Quebec, Canada
- oDivision of Cardiology, Hôtel-Dieu de Lévis, Levis, Quebec, Canada
- pDivision of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada
- qDivision of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- rDivision of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- sDivision of Cardiology, Royal Columbian Hospital, New Westminster, British Columbia, Canada
- tDivision of Cardiology, Regina General Hospital, Saskatchewan Health Authority, Regina, Saskatchewan, Canada
- uDivision of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- vDivision of Cardiology, Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec, Canada
- wDivision of Cardiology, Centre de santé et de services sociaux de Rimouski-Neigette (CSSSRN), Rimouski, Quebec, Canada
- xDivision of Cardiology, Rijnstate Hospital, Arnhem, and Radboud University Medical Centre, Nijmegen, the Netherlands
- yDivision of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands
- zDivision of Cardiology, Spaarne Gasthuis, Haarlem, the Netherlands
- aaDivision of Cardiology, Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada
- bbDivision of Cardiology, Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada
- ccDivision of Cardiology, Amphia Ziekenhuis & Working Group on Cardiovascular Research The Netherlands (WCN), Breda, the Netherlands
- ↵∗Address for correspondence:
Dr. Andrew D. Krahn, Heart Rhythm Vancouver, 211-1033 Davie Street, Vancouver, British Columbia V6E 1M7, Canada.
Background Infection of implanted medical devices has catastrophic consequences. For cardiac rhythm devices, pre-procedural cefazolin is standard prophylaxis but does not protect against methicillin-resistant gram-positive organisms, which are common pathogens in device infections.
Objective This study tested the clinical effectiveness of incremental perioperative antibiotics to reduce device infection.
Methods The authors performed a cluster randomized crossover trial with 4 randomly assigned 6-month periods, during which centers used either conventional or incremental periprocedural antibiotics for all cardiac implantable electronic device procedures as standard procedure. Conventional treatment was pre-procedural cefazolin infusion. Incremental treatment was pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin. The primary outcome was 1-year hospitalization for device infection in the high-risk group, analyzed by hierarchical logistic regression modeling, adjusting for random cluster and cluster-period effects.
Results Device procedures were performed in 28 centers in 19,603 patients, of whom 12,842 were high risk. Infection occurred in 99 patients (1.03%) receiving conventional treatment, and in 78 (0.78%) receiving incremental treatment (odds ratio: 0.77; 95% confidence interval: 0.56 to 1.05; p = 0.10). In high-risk patients, hospitalization for infection occurred in 77 patients (1.23%) receiving conventional antibiotics and in 66 (1.01%) receiving incremental antibiotics (odds ratio: 0.82; 95% confidence interval: 0.59 to 1.15; p = 0.26). Subgroup analysis did not identify relevant patient or site characteristics with significant benefit from incremental therapy.
Conclusions The cluster crossover design efficiently tested clinical effectiveness of incremental antibiotics to reduce device infection. Device infection rates were low. The observed difference in infection rates was not statistically significant. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot] [PADIT]; NCT01002911)
Dr. Krahn has received support from the Heart and Stroke Foundation of Canada, the Sauder Family and Heart and Stroke Foundation Chair in Cardiology, and the Paul Brunes Chair in Heart Rhythm Disorders. The CANNeCTIN network (Canadian Institute of Health Research [CIHR] grant # 88370) and clinical trial grant (CIHR grant # 119442) supported the study. Dr. Essebag is the recipient of a Clinical Research Scholar Award from the Fonds de rechercheÌ du Quebec-SanteÌ (FRQS). Dr. Manlucu has been a consultant to Medtronic. Dr. Morillo has served on advisory boards for Bayer and Boston Scientific; served as a steering committee member of the Member ELIMINATE-AF trial for Daiichi-Sankyo; and has served on speakers bureaus for Medtronic and Servier. Dr. Thibault has received research support and honoraria for presentations from Abbott and Medtronic. Dr. Alings has served on advisory boards for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received July 5, 2018.
- Revision received September 9, 2018.
- Accepted September 16, 2018.
- 2018 American College of Cardiology Foundation
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