Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection BRUISE CONTROL INFECTION Study

被引:147
作者
Essebag, Vidal [1 ,2 ]
Verma, Atul [3 ]
Healey, Jeff S. [4 ]
Krahn, Andrew D. [5 ]
Kalfon, Eli [1 ,6 ]
Coutu, Benoit [7 ]
Ayala-Paredes, Felix [8 ]
Tang, Anthony S. [9 ,10 ]
Sapp, John [11 ]
Sturmer, Marcio [2 ]
Keren, Arieh [10 ]
Wells, George A. [10 ]
Birnie, David H. [10 ]
机构
[1] McGill Univ, Ctr Hlth, Div Cardiol, Dept Med, 1650 Cedar Ave,Room E5-200, Montreal, PQ H3G 1A4, Canada
[2] Hop Sacre Coeur, Div Cardiol, Dept Med, Montreal, PQ H4J 1C5, Canada
[3] Southlake Reg Hlth Ctr, Newmarket, ON, Canada
[4] Populat Hlth Res Inst, Hamilton, ON, Canada
[5] Univ British Columbia, Vancouver, BC V5Z 1M9, Canada
[6] Galilee Med Ctr, Dept Cardiol, Nahariyya, Israel
[7] Ctr Hosp Univ Montreal, Div Cardiol, Dept Med, Montreal, PQ, Canada
[8] Ctr Hosp Univ Sherbrooke, Sherbrooke, PQ, Canada
[9] Univ Western Ontario, London, ON, Canada
[10] Univ Ottawa Heart Inst, Ottawa, ON, Canada
[11] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada
基金
加拿大健康研究院;
关键词
anticoagulants; hemorrhage; infection; risk factors; HEPARIN-BRIDGING THERAPY; CARDIOVERTER-DEFIBRILLATORS; PACEMAKER; IMPLANTATION; MANAGEMENT; MORTALITY; SURGERY; ANTICOAGULATION; METAANALYSIS; PREVENTION;
D O I
10.1016/j.jacc.2016.01.009
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. OBJECTIVES The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. METHODS The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. RESULTS The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CONCLUSIONS CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137) (C) 2016 by the American College of Cardiology Foundation.
引用
收藏
页码:1300 / 1308
页数:9
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