title: Safety of pacemaker and implantable cardioverter-defibrillator implantation during uninterrupted warfarin treatment--the FinPAC study.
abstract: BACKGROUND
  Periprocedural management of oral anticoagulation (OAC) in patients undergoing cardiac rhythm management (CRM) device implantation is controversial. Prior studies demonstrate that uninterrupted OAC may be safe, but limited data from randomized trials exist.
  
  
  METHODS
  We conducted a multicenter, randomized trial to evaluate the safety of uninterrupted OAC during CRM device implantation. Patients on long-term warfarin (N=213) treatment with contemporary indication for CRM device implantation were randomized to uninterrupted versus interrupted (2 days) OAC therapy. The primary outcome included major bleeding events necessitating additional intervention and thromboembolic events during 4 weeks follow-up.
  
  
  RESULTS
  The randomized groups were well matched in terms of bleeding and thromboembolic risk. Only one (1%) patient in the uninterrupted OAC group (N=106) needed blood transfusion due to rupture of proximal cephalic vein. Large hematomas were detected in 6% of patients in both groups, but there was no need for pocket revision in either group. Any pocket hematoma was observed in 35 patients (33%) in the uninterrupted OAC group and in 43 patients (40%) with interrupted OAC and uninterrupted OAC strategy was non-inferior to interrupted OAC (HR 0.86, 95%, p=0.001 for non-inferiority). One patient with interrupted OAC had stroke 3 days after the procedure. Hospital stay was comparable in all patient groups.
  
  
  CONCLUSIONS
  Our randomized study demonstrates that CRM devices can be safely implanted without discontinuation of warfarin treatment.
authors.affiliation: Heart Center, Turku University Hospital, Turku, Finland. Electronic address: juhani.airaksinen@tyks.fi.
authors.forename: K E Juhani
authors.initials: KE
authors.lastname: Airaksinen
authors.forename: Petri
authors.initials: P
authors.lastname: Korkeila
authors.forename: Juha
authors.initials: J
authors.lastname: Lund
authors.forename: Antti
authors.initials: A
authors.lastname: Ylitalo
authors.forename: Pasi
authors.initials: P
authors.lastname: Karjalainen
authors.forename: Vesa
authors.initials: V
authors.lastname: Virtanen
authors.forename: Pekka
authors.initials: P
authors.lastname: Raatikainen
authors.forename: Ulla-Maija
authors.initials: UM
authors.lastname: Koivisto
authors.forename: Juhani
authors.initials: J
authors.lastname: Koistinen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced / Q000175:diagnosis / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage*
chemical_list: D014859:Warfarin
keywords: Anticoagulation; Bleeding; Hematoma; Pacemaker; Warfarin