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

Autor: Gilles O'Hara, Stefan H. Hohnloser, Jeff S. Healey, David Wright, Valentina Kutyifa, Xavier Viñolas, Lieselot VanErven, Stuart J. Connolly, Vidal Essebag, Michael Glikson, Fredrik Gadler, Philippe Mabo, Jia Wang, Simona Masiero, Jörg Neuzner, David H. Birnie, Josef Kautzner
Rok vydání: 2016
Předmět:
Zdroj: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 19(6)
ISSN: 1532-2092
Popis: 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.
Databáze: OpenAIRE