Pacemaker or defibrillator surgery without interruption of anticoagulation
David H Birnie, Jeff S Healey, George A Wells, Atul Verma, Anthony S Tang, Andrew D Krahn, Christopher S Simpson, Felix Ayala-Paredes, Benoit Coutu, Tiago L L Leiria, Vidal Essebag, BRUISE CONTROL Investigators, Martin Green, Pablo Nery, Robert Lemery, Michael Gollob, Darryl Davis, Calum Redpath, Lloyd Duchesne, Arieh Keren, Leslie Carlin, Karen MacDonald, Rosemary Dunne, Rochelle Fleming, Elizabeth Yeltsir, Lily 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, 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, John Sapp, Magdy Basta, Martin Gardner, Ratika Parkash, Chris Gray, Ann Fearon, Karen Giddens, Lisa Carroll, Marcio Sturmer, 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, Roberto Tofani Sant'Anna, Rafail de March Ronsoni, M A Moraes Pereira, Antonieta Moraes, Juliane Rodrigues, D Coyle, K Rajappan, Pierre Theroux, Rollin Brant, Gregory Y H Lip, David H Birnie, Jeff S Healey, George A Wells, Atul Verma, Anthony S Tang, Andrew D Krahn, Christopher S Simpson, Felix Ayala-Paredes, Benoit Coutu, Tiago L L Leiria, Vidal Essebag, BRUISE CONTROL Investigators, Martin Green, Pablo Nery, Robert Lemery, Michael Gollob, Darryl Davis, Calum Redpath, Lloyd Duchesne, Arieh Keren, Leslie Carlin, Karen MacDonald, Rosemary Dunne, Rochelle Fleming, Elizabeth Yeltsir, Lily 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, 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, John Sapp, Magdy Basta, Martin Gardner, Ratika Parkash, Chris Gray, Ann Fearon, Karen Giddens, Lisa Carroll, Marcio Sturmer, 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, Roberto Tofani Sant'Anna, Rafail de March Ronsoni, M A Moraes Pereira, Antonieta Moraes, Juliane Rodrigues, D Coyle, K Rajappan, Pierre Theroux, Rollin Brant, Gregory Y H Lip
Abstract
Background: Many patients requiring pacemaker or implantable cardioverter-defibrillator (ICD) surgery are taking warfarin. For patients at high risk for thromboembolic events, guidelines recommend bridging therapy with heparin; however, case series suggest that it may be safe to perform surgery without interrupting warfarin treatment. There have been few results from clinical trials to support the safety and efficacy of this approach.
Methods: We randomly assigned patients with an annual risk of thromboembolic events of 5% or more to continued warfarin treatment or to bridging therapy with heparin. The primary outcome was clinically significant device-pocket hematoma, which was defined as device-pocket hematoma that necessitated prolonged hospitalization, interruption of anticoagulation therapy, or further surgery (e.g., hematoma evacuation).
Results: The data and safety monitoring board recommended termination of the trial after the second prespecified interim analysis. Clinically significant device-pocket hematoma occurred in 12 of 343 patients (3.5%) in the continued-warfarin group, as compared with 54 of 338 (16.0%) in the heparin-bridging group (relative risk, 0.19; 95% confidence interval, 0.10 to 0.36; P<0.001). Major surgical and thromboembolic complications were rare and did not differ significantly between the study groups. They included one episode of cardiac tamponade and one myocardial infarction in the heparin-bridging group and one stroke and one transient ischemic attack in the continued-warfarin group.
Conclusions: As compared with bridging therapy with heparin, a strategy of continued warfarin treatment at the time of pacemaker or ICD surgery markedly reduced the incidence of clinically significant device-pocket hematoma. (Funded by the Canadian Institutes of Health Research and the Ministry of Health and Long-Term Care of Ontario; BRUISE CONTROL ClinicalTrials.gov number, NCT00800137.).
Source: PubMed