Clinical Trial

. 2019 Dec 10;74(23):2845-2854.

doi: 10.1016/j.jacc.2019.09.060.

Risk Factors for Infections Involving Cardiac Implanted Electronic Devices

David H Birnie¹, Jia Wang², Marco Alings³, François Philippon⁴, Ratika Parkash⁵, Jaimie Manlucu⁶, Paul Angaran⁷, Claus Rinne⁸, Benoit Coutu⁹, R Aaron Low¹⁰, Vidal Essebag¹¹, Carlos Morillo¹², Damian Redfearn¹³, Satish Toal¹⁴, Giuliano Becker¹⁵, Michel Degrâce¹⁶, Bernard Thibault¹⁷, Eugene Crystal¹⁸, Stanley Tung¹⁹, John LeMaitre²⁰, Omar Sultan²¹, Matthew Bennett²², Jamil Bashir²³, Felix Ayala-Paredes²⁴, Philippe Gervais⁴, Leon Rioux²⁵, Martin E W Hemels²⁶, Leon H R Bouwels²⁷, Derek V Exner¹², Paul Dorian⁷, Stuart J Connolly², Yves Longtin²⁸, Andrew D Krahn²⁹

Affiliations

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

PMID: 31806127
DOI: 10.1016/j.jacc.2019.09.060

Free article

Clinical Trial

Risk Factors for Infections Involving Cardiac Implanted Electronic Devices

David H Birnie et al. J Am Coll Cardiol. 2019.

Free article

. 2019 Dec 10;74(23):2845-2854.

doi: 10.1016/j.jacc.2019.09.060.

Authors

Affiliations

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

PMID: 31806127
DOI: 10.1016/j.jacc.2019.09.060

Erratum in

Correction.
[No authors listed] [No authors listed] J Am Coll Cardiol. 2020 Feb 25;75(7):840-841. doi: 10.1016/j.jacc.2020.01.003. Epub 2020 Jan 11. J Am Coll Cardiol. 2020. PMID: 32081293 No abstract available.
Correction.
[No authors listed] [No authors listed] J Am Coll Cardiol. 2020 Aug 11;76(6):762. doi: 10.1016/j.jacc.2020.06.001. J Am Coll Cardiol. 2020. PMID: 32762915 No abstract available.

Abstract

Background: Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover trial of conventional versus incremental antibiotics.

Objectives: This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.

Methods: In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods.

Results: Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures [P], age [A], depressed renal function [D], immunocompromised [I], and procedure type [T]) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively.

Conclusions: This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot]; NCT01002911).

Keywords: antibiotics; cardiac implantable electronic device; implantable cardioverter defibrillator; infection; pacemaker.

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Comment in

Patients at High Risk for CIED Infection: Does Our Perception Mirror Reality?
Mittal S, Tsiouris SJ. Mittal S, et al. J Am Coll Cardiol. 2019 Dec 10;74(23):2855-2857. doi: 10.1016/j.jacc.2019.09.058. J Am Coll Cardiol. 2019. PMID: 31806128 No abstract available.

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Risk Factors for Infections Involving Cardiac Implanted Electronic Devices

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Risk Factors for Infections Involving Cardiac Implanted Electronic Devices

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