Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study
Vidal Essebag, Atul Verma, Jeff S Healey, Andrew D Krahn, Eli Kalfon, Benoit Coutu, Felix Ayala-Paredes, Anthony S Tang, John Sapp, Marcio Sturmer, Arieh Keren, George A Wells, David H Birnie, BRUISE CONTROL Investigators, Martin 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'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'Anna, Rafail de March Ronsoni, M A Moraes Pereira, Antonieta Moraes, Juliane Rodrigues, Vidal Essebag, Atul Verma, Jeff S Healey, Andrew D Krahn, Eli Kalfon, Benoit Coutu, Felix Ayala-Paredes, Anthony S Tang, John Sapp, Marcio Sturmer, Arieh Keren, George A Wells, David H Birnie, BRUISE CONTROL Investigators, Martin 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'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'Anna, Rafail de March Ronsoni, M A Moraes Pereira, Antonieta Moraes, Juliane Rodrigues
Abstract
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).
Keywords: anticoagulants; hemorrhage; infection; risk factors.
Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed