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

详细信息    查看全文

• 作者：Vidal Essebag ; MD ; PhD^a ; ^b ; ^{vidal.essebag@mcgill.ca" class="auth_mail" title="E-mail the corresponding author} ; Atul Verma ; MD^c ; Jeff S. Healey ; MD^d ; Andrew D. Krahn ; MD^e ; Eli Kalfon ; MD^a ; ^f ; Benoit Coutu ; MD^g ; Felix Ayala-Paredes ; MD^h ; Anthony S. Tang ; MDⁱ ; ^j ; John Sapp ; MD^k ; Marcio Sturmer ; MD^b ; Arieh Keren ; MD^j ; George A. Wells ; PhD^j ; David H. Birnie ; MD^j ; for the BRUISE CONTROL InvestigatorsMartin Green ; Pablo Nery ; Robert Lemery ; Michael Gollob ; Darryl Davis ; Calum Redpath ; Lloyd Duchesne ; Leslie Carlin ; Karen MacDonald ; Rosemary Dunne ; Rochelle Fleming ; Elizabeth Yeltsir ; Li Chen ; My-Linh Tran ; Doug Coyle ; Tomy Hadjis ; Martin L. Bernier ; Alexander Omelchenko ; Fiorella Rafti ; Johannie Beaudoin ; Johanne Bureau ; Isabelle Coutu ; Emilie Vaillancourt ; Jaimie Manlucu ; Raymond Yee ; Allan Skanes ; Lorne Gula ; George Klein ; Peter Leong-Sit ; Lynn Nyman ; Cathy Bentley ; Denise Hulley ; Carlos Morillo ; Stuart Connolly ; Girish Nair ; S. Divakaramenon ; S. Ribas ; John Eikelboom ; Wendy Meyer ; Victoria Malcolm ; Sandra Carroll ; Christopher S. Simpson ; Adrian Baranchuk ; Hashiar Abdollah ; Kevin Michael ; Damian Redfearn ; Sharlene Hammond ; Gwen Ewart ; Sharon Fair ; Glenda O&rsquo ; Reilly ; Paul Novak ; Laurence Sterns ; Richard Leather ; Reg Smith ; Chris Lane ; Mona Bastell ; Debbie Parfett ; Andrea Green ; Heather Jackson ; Magdy Basta ; Martin Gardner ; Ratika Parkash ; Chris Gray ; Ann Fearon ; Karen Giddens ; Lisa Carroll ; Teresa Kus ; Tomy Hadjis ; Guiliano Becker ; Ann Langlois ; Carole Sirois ; Yaariv Khaykin ; Zaev Wulffhart ; Bernice Tsang ; Alfredo Pantano ; Kellie Winger ; Sherri Patterson ; Annette Nath ; Colette Seifer ; Kevin Wolfe ; Ali Khadem ; Alex Tischenko ; Jan Polson ; Jean-Francois Roux ; Mariano Badra ; Stephanie Cote ; Lyne Lavallee ; Rene Houde ; Eugene Crystal ; Ilan Lashevsky ; Ching Lau ; Avishag Laish-Farkash ; Atilio Costa Vitali ; Sheldon Singh ; Irving Tiong ; Fahema Ahmadzai ; Mamta Khurana ; Meena Lakhanpal ; Maria Lukomsky ; Mohammed Shurrab ; Paolo Costi ; Isabelle Greiss ; Fadi Mansour ; Jean-Marc Raymond ; Martine Bergeron ; Nancy Roby ; Kamran Ahmad ; Paul Dorian ; Iqwal Mangat ; Victoria Korley ; Arnold Pinter ; Theresa Aves ; Zana Mariano ; Antonio Estacio ; Claus Rinne ; Irene Janzen ; Donna Lowery ; Naomi Kenyon ; Kaler Jonson ; Satish Toal ; Robert Stevenson ; Gregory Searles ; Geoffrey Douglas ; Ricardo Bessoudo ; Ansar Hassan ; Elizabeth Collings ; Corinne Braam ; Fabia Fitzgerald ; Donna Kent ; Luana Mychaluk ; Katherine Kavanagh ; Derek Exner ; John Burgess ; John Rothschild ; Vikas Kuriachan ; Glen Linnell Sumner ; Debbie Keller ; Brian Yuen ; Leslie Jackson-Carter ; Sandra Dorey ; Tiago L.L. Leiria ; Roberto Tofani Sant&rsquo ; Anna ; Rafail de March Ronsoni ; M.A. Moraes Pereira ; Antonieta Moraes ; Juliane Rodrigues
• 关键词：anticoagulants ; hemorrhage ; infection ; risk factors
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：22 March 2016
• 年：2016
• 卷：67
• 期：11
• 页码：1300-1308
• 全文大小：252 K

文摘

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.

<h4 id="absSec_2">Objectivesh4>

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.

<h4 id="absSec_3">Methodsh4>

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.

<h4 id="absSec_4">Resultsh4>

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.

<h4 id="absSec_5">Conclusionsh4>

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]; https" data-locatorKey="//clinicaltrials.gov/ct2/show/NCT00800137?term=NCT00800137&rank=1">NCT00800137)