Department of Medicine, Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; Department of Medicine, Division of Cardiology, Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada.
Southlake Regional Health Centre, Newmarket, Ontario, Canada.
J Am Coll Cardiol. 2016 Mar 22;67(11):1300-8. doi: 10.1016/j.jacc.2016.01.009.
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.
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.
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.
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.
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).
BRUISE CONTROL 试验（Bridge 或 Continue Coumadin for Device Surgery Randomized Controlled Trial）表明，心脏植入式电子设备手术期间继续使用华法林的策略是安全的，可降低临床显著的囊袋血肿（CSH）的发生率。CSH 定义为需要进一步手术和/或导致住院时间延长至少 24 小时的术后血肿，和/或需要中断抗凝治疗。先前的研究不一致地将血肿与随后的设备感染联系起来；原因包括许多研究的回顾性性质、缺乏终点裁决，以及血肿的主观定义不同。
BRUISE CONTROL INFECTION（Bridge 或 Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection）前瞻性地检查了 CSH 与随后的设备感染之间的关系。
该研究纳入了 659 例因设备相关感染需要住院治疗的患者，主要结局为感染，定义为以下一种或多种情况：囊袋感染；心内膜炎；血流感染。结局由盲法裁决委员会验证。进行多变量分析以确定感染的预测因素。
总的 1 年设备相关感染率为 2.4%（659 例患者中有 16 例）。7 例（11%）有既往 CSH 的患者发生感染，593 例（1.5%）无 CSH 的患者发生感染。CSH 是唯一的独立预测因素，与感染风险增加 7 倍以上相关（危险比：7.7；95%置信区间：2.9 至 20.5；p<0.0001）。血肿发生时使用经验性抗生素并不能降低长期感染风险。
心脏植入式电子设备手术后 1 年内，CSH 与需要住院治疗的感染风险显著增加相关。旨在减少血肿的策略可能会降低长期感染风险。（Bridge 或 Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]；NCT00800137）。
