Author + information
- Received June 4, 2019
- Revision received September 18, 2019
- Accepted September 23, 2019
- Published online December 2, 2019.
- David H. Birnie, MDa,
- Jia Wang, MScb,
- Marco Alings, MD, PhDc,
- François Philippon, MDd,
- Ratika Parkash, MDe,
- Jaimie Manlucu, MDf,
- Paul Angaran, MDg,
- Claus Rinne, MDh,
- Benoit Coutu, MDi,
- R. Aaron Low, MDj,
- Vidal Essebag, MD, PhDk,
- Carlos Morillo, MDl,
- Damian Redfearn, MDm,
- Satish Toal, MDn,
- Giuliano Becker, MDo,
- Michel Degrâce, MDp,
- Bernard Thibault, MDq,
- Eugene Crystal, MDr,
- Stanley Tung, MDs,
- John LeMaitre, MDt,
- Omar Sultan, MDu,
- Matthew Bennett, MDu,v,
- Jamil Bashir, MDw,
- Felix Ayala-Paredes, MD, PhDx,
- Philippe Gervais, MDd,
- Leon Rioux, MDy,
- Martin E.W. Hemels, MD, PhDz,aa,
- Leon H.R. Bouwels, MDbb,
- Derek V. Exner, MDl,
- Paul Dorian, MDg,
- Stuart J. Connolly, MDb,
- Yves Longtin, MDcc and
- Andrew D. Krahn, MDw,∗ (, )@ccsprez
- aUniversity of Ottawa Heart Institute, Ottawa, Ontario, Canada
- bPopulation Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada
- cAmphia Ziekenhuis and Working Group on Cardiovascular Research the Netherlands, Breda, the Netherlands
- dInstitut universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada
- eQueen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada
- fLawson Health Research Institute, London Health Sciences, Western University, London, Ontario, Canada
- gDepartment of Medicine, University of Toronto, Division of Cardiology, St. Michael Hospital, Toronto, Ontario, Canada
- hSt. Mary’s General Hospital, Kitchener, Ontario, Canada
- iCentre hospitalier de l’Université de Montréal, University of Montreal, Montreal, Quebec, Canada
- jChinook Regional Hospital, Lethbridge, Alberta, Canada
- kMcGill University Health Center, Montreal, Quebec, Canada
- lLibin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada
- mKingston General Hospital, Queen’s University, Kingston, Ontario, Canada
- nHorizon Health Network, Saint John, New Brunswick, Canada
- oHôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, Quebec, Canada
- pHôtel-Dieu de Lévis, Lévis, Quebec, Canada
- qMontreal Heart Institute, Montreal, Quebec, Canada
- rSunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- sSt. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- tRoyal Columbian Hospital, New Westminster, British Columbia, Canada
- uRegina General Hospital, Saskatchewan Health Authority, Regina, Saskatchewan, Canada
- vVancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- wUniversity of British Columbia, Vancouver, British Columbia, Canada
- xCentre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- yCentre de santé et de services sociaux de Rimouski-Neigette, Rimouski, Quebec, Canada
- zRijnstate Hospital, Arnhem, the Netherlands
- aaRadboud University Medical Centre, Nijmegen, the Netherlands
- bbCanisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands
- ccJewish General Hospital Sir Mortimer B. Davis, McGill University, Montreal, Quebec, Canada
- ↵∗Address for correspondence:
Dr. Andrew D. Krahn, Heart Rhythm Vancouver, 211-1033 Davie Street, Vancouver, British Columbia V6E 1M7, Canada.
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)
- cardiac implantable electronic device
- implantable cardioverter defibrillator
Dr. Krahn has received support from the Heart and Stroke Foundation of Canada, the Sauder Family, and the Heart and Stroke Foundation Chair in Cardiology and the Paul Brunes Chair in Heart Rhythm Disorders. The study was supported by the CANNeCTIN (Canadian Network and Centre for Trials INternationally) network (Canadian Institute of Health Research grant 88370) and a clinical trial grant (Canadian Institute of Health Research grant 119442).
- Received June 4, 2019.
- Revision received September 18, 2019.
- Accepted September 23, 2019.
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