title: Wound haematoma following defibrillator implantation: incidence and predictors in the Shockless Implant Evaluation (SIMPLE) trial.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Simona
authors.initials: S
authors.lastname: Masiero
authors.affiliation: Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON, CanadaL8L 2X2.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.affiliation: University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, ON, CanadaK1Y 4W7.
authors.forename: David
authors.initials: D
authors.lastname: Birnie
authors.affiliation: Klinikum Kassel, 43, Mönchebergstraße 41, 34125 Kassel, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Neuzner
authors.affiliation: J.W. Goethe University, Theodor-W.-Adorno-Platz 6, 60323 Frankfurt am Main, Germany.
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.affiliation: Hospital de Santa Creu i Sant Pau, Carrer de Sant Quintí 89, 08026 Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Vinolas
authors.affiliation: Institute for Clinical and Experimental Medicine, Vídenská 1958/9, 140 21 Prague 4-Krc, Czech Republic.
authors.forename: Josef
authors.initials: J
authors.lastname: Kautzner
authors.affiliation: Institut Universitaire de Cardiologie et de Pneumologie de Québec, 2725 Ch Ste-Foy, Québec, QC, CanadaG1V 4G5.
authors.forename: Gilles
authors.initials: G
authors.lastname: O'Hara
authors.affiliation: Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands.
authors.forename: Lieselot
authors.initials: L
authors.lastname: VanErven
authors.affiliation: Karolinska Institute, Solnavägen 1, 171 77 Stockholm, Sweden.
authors.forename: Fredrik
authors.initials: F
authors.lastname: Gadler
authors.affiliation: Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON, CanadaL8L 2X2.
authors.forename: Jia
authors.initials: J
authors.lastname: Wang
authors.affiliation: Centre Hospitalier Universitaire, 2 Rue Henri le Guilloux, 35000 Rennes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Mabo
authors.affiliation: Leviev Heart Center, Chaim Sheba Medical Center, Tel Hashomer, 52621 Tel Aviv, Israel.
authors.forename: Michael
authors.initials: M
authors.lastname: Glikson
authors.affiliation: University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY 14642, USA.
authors.forename: Valentina
authors.initials: V
authors.lastname: Kutyifa
authors.affiliation: Institute of Cardiovascular Medicine and Science Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool, Merseyside L14 3PE, UK.
authors.forename: David J
authors.initials: DJ
authors.lastname: Wright
authors.affiliation: McGill University, 845 Rue Sherbrooke O, Montrèal, QC, CanadaH3A 0G4.
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.affiliation: Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON, CanadaL8L 2X2.
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
mesh_terms: D000367:Age Factors; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016009:Chi-Square Distribution; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006406:Hematoma / Q000175:diagnosis / Q000453:epidemiology*; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017711:Nonlinear Dynamics; D016017:Odds Ratio; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016459:Prosthesis-Related Infections / Q000453:epidemiology; D012307:Risk Factors; D000072836:Surgical Wound / Q000175:diagnosis / Q000453:epidemiology*; D016896:Treatment Outcome
chemical_list: D006493:Heparin
keywords: Implantable cardioverter defibrillators; Pocket haematoma; Predictors