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; 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; 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

doi:10.1016/j.jacc.2016.01.009

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, Martin Green, Pablo Nery, Robert Lemery, Michael Gollob, Darryl Davis, Calum Redpath, Lloyd DuchesneLeslie 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, 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

Research output: Contribution to journal › Article › peer-review

174 Citations (Scopus)

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)

Original language	English
Pages (from-to)	1300-1308
Number of pages	9
Journal	Journal of the American College of Cardiology
Volume	67
Issue number	11
DOIs	https://doi.org/10.1016/j.jacc.2016.01.009
Publication status	Published - Mar 22 2016
Externally published	Yes

Bibliographical note

Funding Information:
Supported by an operating grant from the Canadian Institutes of Health Research (CIHR), a CIHR Clinician Scientist Award (to Dr. Essebag) and an Innovations grant from the University of Ottawa Heart Institute Academic Medical Organization Alternate Funding Program (funded by the Ministry of Health of Ontario). Dr. Coutu is a consultant for Bayer. Dr. Sapp is a consultant for Biosense Webster; and receives research funding from Biosense Webster and Philips Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Essebag and Birnie were coprincipal investigators and contributed equally to this work.

Publisher Copyright:
© 2016 American College of Cardiology Foundation.

ASJC Scopus Subject Areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2016.01.009

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Essebag, V., Verma, A., Healey, J. S., Krahn, A. D., Kalfon, E., Coutu, B., Ayala-Paredes, F., Tang, A. S., Sapp, J., Sturmer, M., Keren, A., Wells, G. A., Birnie, D. H., Green, M., Nery, P., Lemery, R., Gollob, M., Davis, D., Redpath, C., ... Rodrigues, J. (2016). Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION study. Journal of the American College of Cardiology, 67(11), 1300-1308. https://doi.org/10.1016/j.jacc.2016.01.009

Essebag, V, Verma, A, Healey, JS, Krahn, AD, Kalfon, E, Coutu, B, Ayala-Paredes, F, Tang, AS, Sapp, J, Sturmer, M, Keren, A, Wells, GA, Birnie, DH, Green, M, Nery, P, Lemery, R, Gollob, M, Davis, D, Redpath, C, Duchesne, L, Carlin, L, MacDonald, K, Dunne, R, Fleming, R, Yeltsir, E, Chen, L, Tran, ML, Coyle, D, Hadjis, T, Bernier, ML, Omelchenko, A, Rafti, F, Beaudoin, J, Bureau, J, Coutu, I, Vaillancourt, E, Manlucu, J, Yee, R, Skanes, A, Gula, L, Klein, G, Leong-Sit, P, Nyman, L, Bentley, C, Hulley, D, Morillo, C, Connolly, S, Nair, G, Divakaramenon, S, Ribas, S, Eikelboom, J, Meyer, W, Malcolm, V, Carroll, S, Simpson, CS, Baranchuk, A, Abdollah, H, Michael, K, Redfearn, D, Hammond, S, Ewart, G, Fair, S, O'Reilly, G, Novak, P, Sterns, L, Leather, R, Smith, R, Lane, C, Bastell, M, Parfett, D, Green, A, Jackson, H, Basta, M, Gardner, M, Parkash, R, Gray, C, Fearon, A, Giddens, K, Carroll, L, Kus, T, Becker, G, Langlois, A, Sirois, C, Khaykin, Y, Wulffhart, Z, Tsang, B, Pantano, A, Winger, K, Patterson, S, Nath, A, Seifer, C, Wolfe, K, Khadem, A, Tischenko, A, Polson, J, Roux, JF, Badra, M, Cote, S, Lavallee, L, Houde, R, Crystal, E, Lashevsky, I, Lau, C, Laish-Farkash, A, Costa Vitali, A, Singh, S, Tiong, I, Ahmadzai, F, Khurana, M, Lakhanpal, M, Lukomsky, M, Shurrab, M, Costi, P, Greiss, I, Mansour, F, Raymond, JM, Bergeron, M, Roby, N, Ahmad, K, Dorian, P, Mangat, I, Korley, V, Pinter, A, Aves, T, Mariano, Z, Estacio, A, Rinne, C, Janzen, I, Lowery, D, Kenyon, N, Jonson, K, Toal, S, Stevenson, R, Searles, G, Douglas, G, Bessoudo, R, Hassan, A, Collings, E, Braam, C, Fitzgerald, F, Kent, D, Mychaluk, L, Kavanagh, K, Exner, D, Burgess, J, Rothschild, J, Kuriachan, V, Sumner, GL, Keller, D, Yuen, B, Jackson-Carter, L, Dorey, S, Leiria, TLL, Sant'Anna, RT, De March Ronsoni, R, Pereira, MAM, Moraes, A & Rodrigues, J 2016, 'Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION study', Journal of the American College of Cardiology, vol. 67, no. 11, pp. 1300-1308. https://doi.org/10.1016/j.jacc.2016.01.009

@article{1f6cddbefd2d44a0ac9a726bdced1439,

title = "Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION study",

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)",

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

note = "Funding Information: Supported by an operating grant from the Canadian Institutes of Health Research (CIHR), a CIHR Clinician Scientist Award (to Dr. Essebag) and an Innovations grant from the University of Ottawa Heart Institute Academic Medical Organization Alternate Funding Program (funded by the Ministry of Health of Ontario). Dr. Coutu is a consultant for Bayer. Dr. Sapp is a consultant for Biosense Webster; and receives research funding from Biosense Webster and Philips Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Essebag and Birnie were coprincipal investigators and contributed equally to this work. Publisher Copyright: {\textcopyright} 2016 American College of Cardiology Foundation.",

year = "2016",

month = mar,

day = "22",

doi = "10.1016/j.jacc.2016.01.009",

language = "English",

volume = "67",

pages = "1300--1308",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier USA",

number = "11",

}

TY - JOUR

T1 - Clinically significant pocket hematoma increases long-term risk of device infection

T2 - BRUISE CONTROL INFECTION study

AU - Essebag, Vidal

AU - Verma, Atul

AU - Healey, Jeff S.

AU - Krahn, Andrew D.

AU - Kalfon, Eli

AU - Coutu, Benoit

AU - Ayala-Paredes, Felix

AU - Tang, Anthony S.

AU - Sapp, John

AU - Sturmer, Marcio

AU - Keren, Arieh

AU - Wells, George A.

AU - Birnie, David H.

AU - Green, Martin

AU - Nery, Pablo

AU - Lemery, Robert

AU - Gollob, Michael

AU - Davis, Darryl

AU - Redpath, Calum

AU - Duchesne, Lloyd

AU - Carlin, Leslie

AU - MacDonald, Karen

AU - Dunne, Rosemary

AU - Fleming, Rochelle

AU - Yeltsir, Elizabeth

AU - Chen, Li

AU - Tran, My Linh

AU - Coyle, Doug

AU - Hadjis, Tomy

AU - Bernier, Martin L.

AU - Omelchenko, Alexander

AU - Rafti, Fiorella

AU - Beaudoin, Johannie

AU - Bureau, Johanne

AU - Coutu, Isabelle

AU - Vaillancourt, Emilie

AU - Manlucu, Jaimie

AU - Yee, Raymond

AU - Skanes, Allan

AU - Gula, Lorne

AU - Klein, George

AU - Leong-Sit, Peter

AU - Nyman, Lynn

AU - Bentley, Cathy

AU - Hulley, Denise

AU - Morillo, Carlos

AU - Connolly, Stuart

AU - Nair, Girish

AU - Divakaramenon, S.

AU - Ribas, S.

AU - Eikelboom, John

AU - Meyer, Wendy

AU - Malcolm, Victoria

AU - Carroll, Sandra

AU - Simpson, Christopher S.

AU - Baranchuk, Adrian

AU - Abdollah, Hashiar

AU - Michael, Kevin

AU - Redfearn, Damian

AU - Hammond, Sharlene

AU - Ewart, Gwen

AU - Fair, Sharon

AU - O'Reilly, Glenda

AU - Novak, Paul

AU - Sterns, Laurence

AU - Leather, Richard

AU - Smith, Reg

AU - Lane, Chris

AU - Bastell, Mona

AU - Parfett, Debbie

AU - Green, Andrea

AU - Jackson, Heather

AU - Basta, Magdy

AU - Gardner, Martin

AU - Parkash, Ratika

AU - Gray, Chris

AU - Fearon, Ann

AU - Giddens, Karen

AU - Carroll, Lisa

AU - Kus, Teresa

AU - Becker, Guiliano

AU - Langlois, Ann

AU - Sirois, Carole

AU - Khaykin, Yaariv

AU - Wulffhart, Zaev

AU - Tsang, Bernice

AU - Pantano, Alfredo

AU - Winger, Kellie

AU - Patterson, Sherri

AU - Nath, Annette

AU - Seifer, Colette

AU - Wolfe, Kevin

AU - Khadem, Ali

AU - Tischenko, Alex

AU - Polson, Jan

AU - Roux, Jean Francois

AU - Badra, Mariano

AU - Cote, Stephanie

AU - Lavallee, Lyne

AU - Houde, Rene

AU - Crystal, Eugene

AU - Lashevsky, Ilan

AU - Lau, Ching

AU - Laish-Farkash, Avishag

AU - Costa Vitali, Atilio

AU - Singh, Sheldon

AU - Tiong, Irving

AU - Ahmadzai, Fahema

AU - Khurana, Mamta

AU - Lakhanpal, Meena

AU - Lukomsky, Maria

AU - Shurrab, Mohammed

AU - Costi, Paolo

AU - Greiss, Isabelle

AU - Mansour, Fadi

AU - Raymond, Jean Marc

AU - Bergeron, Martine

AU - Roby, Nancy

AU - Ahmad, Kamran

AU - Dorian, Paul

AU - Mangat, Iqwal

AU - Korley, Victoria

AU - Pinter, Arnold

AU - Aves, Theresa

AU - Mariano, Zana

AU - Estacio, Antonio

AU - Rinne, Claus

AU - Janzen, Irene

AU - Lowery, Donna

AU - Kenyon, Naomi

AU - Jonson, Kaler

AU - Toal, Satish

AU - Stevenson, Robert

AU - Searles, Gregory

AU - Douglas, Geoffrey

AU - Bessoudo, Ricardo

AU - Hassan, Ansar

AU - Collings, Elizabeth

AU - Braam, Corinne

AU - Fitzgerald, Fabia

AU - Kent, Donna

AU - Mychaluk, Luana

AU - Kavanagh, Katherine

AU - Exner, Derek

AU - Burgess, John

AU - Rothschild, John

AU - Kuriachan, Vikas

AU - Sumner, Glen Linnell

AU - Keller, Debbie

AU - Yuen, Brian

AU - Jackson-Carter, Leslie

AU - Dorey, Sandra

AU - Leiria, Tiago L.L.

AU - Sant'Anna, Roberto Tofani

AU - De March Ronsoni, Rafail

AU - Pereira, M. A.Moraes

AU - Moraes, Antonieta

AU - Rodrigues, Juliane

N1 - Funding Information: Supported by an operating grant from the Canadian Institutes of Health Research (CIHR), a CIHR Clinician Scientist Award (to Dr. Essebag) and an Innovations grant from the University of Ottawa Heart Institute Academic Medical Organization Alternate Funding Program (funded by the Ministry of Health of Ontario). Dr. Coutu is a consultant for Bayer. Dr. Sapp is a consultant for Biosense Webster; and receives research funding from Biosense Webster and Philips Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Essebag and Birnie were coprincipal investigators and contributed equally to this work. Publisher Copyright: © 2016 American College of Cardiology Foundation.

PY - 2016/3/22

Y1 - 2016/3/22

N2 - 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)

AB - 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)

UR - http://www.scopus.com/inward/record.url?scp=84962921637&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84962921637&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2016.01.009

DO - 10.1016/j.jacc.2016.01.009

M3 - Article

C2 - 26988951

AN - SCOPUS:84962921637

SN - 0735-1097

VL - 67

SP - 1300

EP - 1308

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 11

ER -

Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION study

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