Antithrombotic Drugs, Cardiac Arrhythmia, Device Related Infection, Hematoma, Surgery--Complications
Conditions
Brief summary
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.
Interventions
OTHERCIED surgery
Sponsors
Azienda Ospedaliera Universitaria Senese
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with standard indications to CIED surgery being treated with antiplatelet agents and/or anticoagulants (any commercially available device or approved and marketed drug can be included). * Patients able to provide written informed consent * Patients willing to attend the planned follow-up visits
Exclusion criteria
* Patient with life expectancy less than 12 months as per investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant pocket hematoma | One month | Post-procedural hematoma resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-clinically significant pocket hematoma | One month | Post-procedural hematoma not meeting diagnostic criteria for clinically significant |
| Hemorrhagic complications other than pocket hematoma | One month | Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage |
| Thromboembolic complications | Twelve months | Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis |
| All cause death | Twelve months | — |
| CIED-related infection | Twelve months | — |
Countries
Italy
Outcome results
None listed