Hundreds of thousands patients undergo implantation or replacement of cardiac implantable electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of developing pocket hematoma which in turn is associated with an increased risk of potentially fatal device-related infections when clinically significant. Aim of the registry is to retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national registry in Italy) investigate the different strategies for the management of antithrombotic therapy and the related complication rates (1-month and 12-months) in patients undergoing CIED surgery in a real-world setting. The registry will also provide data on the economic impact of different management strategies and complications.
Study Type
OBSERVATIONAL
Enrollment
1,450
AOU Senese
Siena, Italy
Clinically significant pocket hematoma
Post-procedural hematoma resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion
Time frame: One month
Non-clinically significant pocket hematoma
Post-procedural hematoma not meeting diagnostic criteria for clinically significant
Time frame: One month
Hemorrhagic complications other than pocket hematoma
Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage
Time frame: One month
Thromboembolic complications
Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis
Time frame: Twelve months
All cause death
Time frame: Twelve months
CIED-related infection
Time frame: Twelve months
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