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J Am Coll Cardiol. 2018 Dec 18;72(24):3098-3109. doi: 10.1016/j.jacc.2018.09.068.

Prevention of Arrhythmia Device Infection Trial: The PADIT Trial.

Author information

1
Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: akrahn@mail.ubc.ca.
2
Jewish General Hospital Sir Mortimer B. Davis, McGill University, Montreal, Canada.
3
Division of Cardiology, Institut universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada.
4
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
5
Division of Cardiology, Lawson Health Research Institute, London Health Sciences, Western University, London, Ontario, Canada.
6
Division of Cardiology, Department of Medicine, University of Toronto, Division of Cardiology, St. Michael Hospital, Toronto, Ontario, Canada.
7
Division of Cardiology, St. Mary's General Hospital, Kitchener, Ontario, Canada.
8
Division of Cardiology, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Quebec, Canada.
9
Division of Cardiology, Chinook Regional Hospital, Lethbridge, Alberta, Canada.
10
Division of Cardiology, McGill University Health Center, Montreal, Quebec, Canada.
11
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
12
Division of Cardiology, Kingston General Hospital, Queen's University, Kingston, Ontario, Canada.
13
Horizon Health Network, Saint John, New Brunswick, Canada.
14
Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, Quebec, Canada.
15
Division of Cardiology, Hôtel-Dieu de Lévis, Levis, Quebec, Canada.
16
Division of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada.
17
Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
18
Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
19
Division of Cardiology, Royal Columbian Hospital, New Westminster, British Columbia, Canada.
20
Division of Cardiology, Regina General Hospital, Saskatchewan Health Authority, Regina, Saskatchewan, Canada.
21
Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
22
Division of Cardiology, Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec, Canada.
23
Division of Cardiology, Centre de santé et de services sociaux de Rimouski-Neigette (CSSSRN), Rimouski, Quebec, Canada.
24
Division of Cardiology, Rijnstate Hospital, Arnhem, and Radboud University Medical Centre, Nijmegen, the Netherlands.
25
Division of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands.
26
Division of Cardiology, Spaarne Gasthuis, Haarlem, the Netherlands.
27
Division of Cardiology, Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.
28
Division of Cardiology, Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada.
29
Division of Cardiology, Amphia Ziekenhuis & Working Group on Cardiovascular Research The Netherlands (WCN), Breda, the Netherlands.

Abstract

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).

KEYWORDS:

antibiotics; implantable cardioverter defibrillator; infection; pacemaker; prophylaxis

PMID:
30545448
DOI:
10.1016/j.jacc.2018.09.068

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