The aim of the present study was to assess the safety of cardiac rhythm device implantation during uninterrupted oral anticoagulant therapy.
Patients at high thromboembolic risk (venous thromboembolism <3 months, nonvalvular atrial fibrillation with CHADS2 score >2, valvular atrial fibrillation, prosthetic heart valves) underwent procedures during uninterrupted warfarin (on warfarin group) and were compared to low-risk patients who underwent procedures after warfarin withdrawal (off warfarin group). Primary endpoint was a composite of hematoma requiring warfarin interruption, reoperation, or blood transfusion; death; hemothorax; and tamponade. Secondary endpoints were nonsignificant hematoma and clinical arterial thromboembolism assessed at discharge and at a 2 month follow-up.
One hundred and ninety-one patients were enrolled, 102 in the ‘on warfarin group’ and 89 in the ‘off warfarin group’. The majority of procedures were first implants (73% in the ‘on warfarin group’ vs. 87% in the ‘off warfarin group’, P= 0.01). Pacemakers, implantable cardioverter defibrillators, and biventricular devices were included. International normalized ratio at implant was 2 ± 0.28 (range 1.6–3.2) in the ‘on warfarin group’ and 1.3 ± 0.19 (range 1–1.6) in the ‘off warfarin group’ (P= 0.0001). Incidence of hemathoma was five of 102 in the ‘on warfarin group’ vs. three of 89 in the ‘off warfarin group’ (5 vs. 3%, P = not significant) and all hemathomas resolved spontaneously. There were no significant hemathomas in either group. There was no death, hemothorax, or tamponade. There were no thromboembolic events at 2 months.
Cardiac rhythm device implantation during uninterrupted warfarin was not associated with increased bleeding compared with warfarin interruption.
aDivision of Cardiology, Ospedale Civile di Treviso ‘Ca’ Foncello’, Treviso
bDivision of Cardiology, Ospedale di Cesena ‘Bufalini’, Cesena, Italy
Correspondence to Martino Crosato, Division of Cardiology, Ospedale Civile di Treviso ‘Ca’ Foncello’, 31100 Treviso, Italy Tel: +39 0 422322767; fax: +39 0 422322662; e-mail: elenamartinocrosato@gmailcom
Received 10 December, 2013
Revised 20 January, 2014
Accepted 20 January, 2014