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Wound haematoma following defibrillator implantation: incidence and predictors in the Shockless Implant Evaluation (SIMPLE) trial

S. Masiero, SJ. Connolly, D. Birnie, J. Neuzner, SH. Hohnloser, X. Vinolas, J. Kautzner, G. O'Hara, L. VanErven, F. Gadler, J. Wang, P. Mabo, M. Glikson, V. Kutyifa, DJ. Wright, V. Essebag, JS. Healey, . ,

. 2017 ; 19 (6) : 1002-1006.

Language English Country England, Great Britain

Document type Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc18034115

Aims: Pocket haematoma is a common complication after defibrillator [implantable cardioverter defibrillator (ICD)] implantation, which is not only painful, but also increases the risk of device-related infection, and possibly embolic events. The present study seeks to evaluate the rate and predictors of clinically significant pocket haematoma. Methods and results: This study included 2500 patients receiving an ICD in the SIMPLE trial. A clinically significant pocket haematoma was defined as a haematoma that required re-operation or interruption of oral anticoagulation (OAC) therapy. Clinically significant pocket haematoma occurred in 56 of 2500 patients (2.2%) of which 6 (10.7%) developed device-related infection. Patients who developed pocket haematoma were older (mean age 67.6 ± 8.8 years vs. 62.7 ± 11.6 years, P < 0.001), were more likely to have permanent atrial fibrillation (30.4 vs. 6.7%, P < 0.001) and a history of stroke (17.9 vs. 6.7%, P = 0.004), or were more likely to receive peri-operative OAC (50.0 vs. 28.4%, P < 0.001), unfractionated heparin (16.1 vs. 5.2%, P = 0.003), or low-molecular-weight heparin (37.5 vs. 17.5%, P < 0.001). Independent predictors of wound haematoma on multivariable analysis included the use of heparin bridging (OR 2.65, 95% CI 1.48-4.73, P = 0.001), sub-pectoral location of ICD (OR 2.00, 95% CI 1.12-3.57, P =0.020), previous stroke (OR 2.47, 95% CI 1.20-5.10, P = 0.015), an upgrade from permanent pacemaker (OR 2.52, 95% CI 1.07-5.94, P = 0.035), and older age (OR 1.03, 95% CI 1.00-1.06, P = 0.049). Conclusion: Pocket haematoma remains an important complication of ICD implantation and is associated with a high risk of infection. Independent predictors of pocket haematoma include heparin bridging, prior stroke, sub-pectoral placement of ICD, older age, and upgrade from a pacemaker.

References provided by Crossref.org

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$a Masiero, Simona $u Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON, Canada L8L 2X2. Clinica di Cardiologia, Università Politecnica delle Marche, via Conca 71, 60126 Ancona, Italy.
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$a Wound haematoma following defibrillator implantation: incidence and predictors in the Shockless Implant Evaluation (SIMPLE) trial / $c S. Masiero, SJ. Connolly, D. Birnie, J. Neuzner, SH. Hohnloser, X. Vinolas, J. Kautzner, G. O'Hara, L. VanErven, F. Gadler, J. Wang, P. Mabo, M. Glikson, V. Kutyifa, DJ. Wright, V. Essebag, JS. Healey, . ,
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$a Aims: Pocket haematoma is a common complication after defibrillator [implantable cardioverter defibrillator (ICD)] implantation, which is not only painful, but also increases the risk of device-related infection, and possibly embolic events. The present study seeks to evaluate the rate and predictors of clinically significant pocket haematoma. Methods and results: This study included 2500 patients receiving an ICD in the SIMPLE trial. A clinically significant pocket haematoma was defined as a haematoma that required re-operation or interruption of oral anticoagulation (OAC) therapy. Clinically significant pocket haematoma occurred in 56 of 2500 patients (2.2%) of which 6 (10.7%) developed device-related infection. Patients who developed pocket haematoma were older (mean age 67.6 ± 8.8 years vs. 62.7 ± 11.6 years, P < 0.001), were more likely to have permanent atrial fibrillation (30.4 vs. 6.7%, P < 0.001) and a history of stroke (17.9 vs. 6.7%, P = 0.004), or were more likely to receive peri-operative OAC (50.0 vs. 28.4%, P < 0.001), unfractionated heparin (16.1 vs. 5.2%, P = 0.003), or low-molecular-weight heparin (37.5 vs. 17.5%, P < 0.001). Independent predictors of wound haematoma on multivariable analysis included the use of heparin bridging (OR 2.65, 95% CI 1.48-4.73, P = 0.001), sub-pectoral location of ICD (OR 2.00, 95% CI 1.12-3.57, P =0.020), previous stroke (OR 2.47, 95% CI 1.20-5.10, P = 0.015), an upgrade from permanent pacemaker (OR 2.52, 95% CI 1.07-5.94, P = 0.035), and older age (OR 1.03, 95% CI 1.00-1.06, P = 0.049). Conclusion: Pocket haematoma remains an important complication of ICD implantation and is associated with a high risk of infection. Independent predictors of pocket haematoma include heparin bridging, prior stroke, sub-pectoral placement of ICD, older age, and upgrade from a pacemaker.
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$a Connolly, Stuart J $u Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON, CanadaL8L 2X2.
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$a Birnie, David $u University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, ON, CanadaK1Y 4W7.
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$a Neuzner, Jörg $u Klinikum Kassel, 43, Mönchebergstraße 41, 34125 Kassel, Germany.
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$a Hohnloser, Stefan H $u J.W. Goethe University, Theodor-W.-Adorno-Platz 6, 60323 Frankfurt am Main, Germany.
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$a Wright, David J $u Institute of Cardiovascular Medicine and Science Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool, Merseyside L14 3PE, UK.
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