Wound haematoma following defibrillator implantation: incidence and predictors in the Shockless Implant Evaluation (SIMPLE) trial
Jazyk angličtina Země Velká Británie, Anglie Médium print
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
27353323
DOI
10.1093/europace/euw116
PII: euw116
Knihovny.cz E-zdroje
- Klíčová slova
- Implantable cardioverter defibrillators, Pocket haematoma, Predictors,
- MeSH
- chirurgická rána diagnóza epidemiologie MeSH
- defibrilátory implantabilní * škodlivé účinky MeSH
- elektrická defibrilace škodlivé účinky přístrojové vybavení mortalita MeSH
- hematom diagnóza epidemiologie MeSH
- heparin aplikace a dávkování škodlivé účinky MeSH
- implantace protézy škodlivé účinky přístrojové vybavení mortalita MeSH
- incidence MeSH
- infekce spojené s protézou epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- multivariační analýza MeSH
- nelineární dynamika MeSH
- odds ratio MeSH
- prospektivní studie MeSH
- rizikové faktory MeSH
- rozdělení chí kvadrát MeSH
- senioři MeSH
- srdeční arytmie diagnóza mortalita terapie MeSH
- věkové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- heparin MeSH
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.
Centre Hospitalier Universitaire 2 Rue Henri le Guilloux 35000 Rennes France
Clinica di Cardiologia Università Politecnica delle Marche via Conca 71 60126 Ancona Italy
Hospital de Santa Creu i Sant Pau Carrer de Sant Quintí 89 08026 Barcelona Spain
Institute for Clinical and Experimental Medicine Vídenská 1958 9 140 21 Prague 4 Krc Czech Republic
J W Goethe University Theodor W Adorno Platz 6 60323 Frankfurt am Main Germany
Karolinska Institute Solnavägen 1 171 77 Stockholm Sweden
Klinikum Kassel 43 Mönchebergstraße 41 34125 Kassel Germany
Leiden University Medical Center Albinusdreef 2 2333 ZA Leiden The Netherlands
Leviev Heart Center Chaim Sheba Medical Center Tel Hashomer 52621 Tel Aviv Israel
McGill University 845 Rue Sherbrooke O Montrèal QC CanadaH3A 0G4
University of Ottawa Heart Institute 40 Ruskin Street Ottawa ON CanadaK1Y 4W7
University of Rochester Medical Center 601 Elmwood Ave Rochester NY 14642 USA
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