RESUMO
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).
Assuntos
Desfibriladores Implantáveis/efeitos adversos , Hematoma/complicações , Infecções/etiologia , Marca-Passo Artificial/efeitos adversos , Hemorragia Pós-Operatória/complicações , Medição de Risco , Idoso , Brasil/epidemiologia , Canadá/epidemiologia , Falha de Equipamento , Feminino , Seguimentos , Humanos , Incidência , Infecções/epidemiologia , Masculino , Fatores de Risco , Método Simples-Cego , Fatores de TempoRESUMO
BACKGROUND: Management of patients treated with oral anticoagulation (OAC) requiring a cardiovascular implantable electronic device (CIED) surgery is a challenge that requires balancing the risk of bleeding complications with the risk of thromboembolic events. Recently the approach of performing these procedures while the patient remains with a therapeutic international normalized ratio has gained interest due to several publications showing its relative safety. OBJECTIVES: To evaluate the safety and effectiveness of continuous use of OAC compared with heparin bridging in the perioperative setting of CIED surgery using a meta-analysis. METHODS: A systematic review of PubMed/MEDLINE, Ovid, and Elsevier databases was performed. Eligible randomized controlled trials and cohort studies were included. The outcomes studied were risk of clinically significant bleeding and of thromboembolic events. Our analysis was restricted to OAC with vitamin K antagonists. RESULTS: Of 560 manuscripts initially considered relevant, seven were included in the meta-analysis, totaling 2,191 patients. Data are reported as odds ratios (ORs) with confidence interval (CI) of 95%. Maintenance of OAC was associated with a significantly lower risk of postoperative bleeding compared with heparin bridge (OR = 0.25, 95% CI 0.17-0.36, P < 0.00001). There was no difference noted in the risk of thromboembolic events between the two strategies (OR = 1.86, 95% CI 0.29-12.17, P = 0.57). CONCLUSIONS: Uninterrupted use of OAC in the perioperative of CIED surgery was associated with a reduced risk of bleeding. This strategy should be considered the preferred one in patients at moderate-to-high risk of thromboembolic events.