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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing CIED surgery | Patients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy (either or both antiplatelet agents and/or anticoagulants). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIED surgery | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Non-clinically significant pocket hematoma | Post-procedural hematoma not meeting diagnostic criteria for clinically significant | One month |
| Hemorrhagic complications other than pocket hematoma |
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Inclusion Criteria:
Exclusion Criteria:
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All patients taking antithrombotic therapy undergoing CIED surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Valerio Zacà , MD | AOU Senese | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Senese | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28594654 | Background | Zaca V, Breschi M, Mandorli A, Panchetti L, Ricciardi G, Viani S, Notarstefano P. Rationale, study design, and pilot phase of tHE Management of AntiThrOMbotic therApy (HEMATOMA) in patients undergoing electrophysiological device surgery: Italian National Multicenter Observational REgistry. J Cardiovasc Med (Hagerstown). 2017 Nov;18(11):897-899. doi: 10.2459/JCM.0000000000000534. | |
| Background | V Zaca', A Angeletti, C Baiocchi, M Bertini, M Biffi, P Busacca, M Iori, M Mezzetti, M Nesti, P Notarstefano; P3213 Real-world periprocedural management of antithrombotic therapy in patients undergoing electrophysiological device surgery: preliminary results of the HEMATOMA NO MORE, European Heart Journal, Volume 39, Issue suppl_1, 1 August 2018, ehy563.P3213, https://doi.org/10.1093/eurheartj/ehy563.P3213 |
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IPD will be made available on demand to other researchers.
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| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| D001145 | Arrhythmias, Cardiac |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage
| One month |
| Thromboembolic complications | Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis | Twelve months |
| All cause death | Twelve months |
| CIED-related infection | Twelve months |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |