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Rationale, study design, and pilot phase of tHE Management of AntiThrOMbotic therApy (HEMATOMA) in patients undergoing electrophysiological device surgery: Italian National Multicenter Observational REgistry
- Source :
- Journal of cardiovascular medicine (Hagerstown, Md.). 18(11)
- Publication Year :
- 2017
-
Abstract
- AIMS To investigate the different strategies adopted for the management of antithrombotic therapy and the related hemorrhagic and infective complication rates in patients undergoing cardiac implantable electronic devices (CIEDs) surgery in a real-world setting. METHODS THE Management of AntiThrOMbotic therApy in patients undergoing electrophysiological device surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE) is an observational, prospective, multicenter, national cohort study (with a retrospective, multicenter, regional pilot phase) designed to enroll patients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy. The primary outcome is clinically significant pocket hematoma defined as a postprocedural hematoma, resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion. RESULTS The pilot phase included 569 patients from 11 centers in Tuscany enrolled between September 2014 and May 2015 and followed up for 1 month. Patients were categorized according to the strategy of management of antithrombotic therapy, with heparin bridging being associated with the highest incidence of clinically significant pocket hematoma (12.3%). Overall nonpocket hemorrhagic events rate was quite low (0.52%) and thromboembolic complications were negligible (0.17%). CONCLUSION Occurrence of pocket hematoma in patients undergoing CIED surgery is largely influenced by the strategy of management of antithrombotic therapy. The HEMATOMA NO MORE will assess the impact of different strategies on the risk of developing pocket hematoma and of subsequent CIED-related infections.
- Subjects :
- Pilot phase
Research design
medicine.medical_specialty
Pacemaker, Artificial
Pilot Projects
030204 cardiovascular system & hematology
03 medical and health sciences
0302 clinical medicine
Hematoma
Fibrinolytic Agents
Risk Factors
Thromboembolism
Antithrombotic
medicine
Humans
030212 general & internal medicine
Prospective Studies
Registries
Prospective cohort study
business.industry
Heparin
Incidence
General Medicine
medicine.disease
Surgery
Defibrillators, Implantable
Italy
Research Design
Concomitant
Observational study
Cardiology and Cardiovascular Medicine
business
Fibrinolytic agent
Subjects
Details
- ISSN :
- 15582035
- Volume :
- 18
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Journal of cardiovascular medicine (Hagerstown, Md.)
- Accession number :
- edsair.doi.dedup.....4c6d05b244bb69b15f327de2cef39ad4