Aims: Perioperative management of antiplatelet (AP) therapy in patients undergoing implantation of cardiac rhythm management devices (CRMD) remains an issue of concern that has not been prospectively evaluated in a large series. We sought to describe the morbidity associated with three different AP regimens in this setting.
Methods and results: We conducted a prospective observational study including 849 consecutive patients who were classified in three groups according to the presence of any AP treatment: Group 1 (n= 220): single AP therapy; Group 2 (n= 60): dual AP therapy; and Group 3 (n= 40): oral anticoagulant (OAC) + enoxaparin 'bridging' + AP therapy. Two other groups served as controls: Group 4 (n= 375): no AP or OAC therapy; and Group 5 (n= 154): OAC + enoxaparin 'bridging'. The incidence of pocket haematoma, pocket revisions, hospital stays duration, and unscheduled follow-up visits due to pocket-related complications were compared. Patients on Groups 2, 3 and 5 had significantly higher incidences of pocket haematoma (13.3, 15, and 14.9%, respectively) when compared with Groups 1 and 4 (3.2 and 2.4%, respectively), as well as longer hospital stays and more unscheduled follow-up visits. Of note, only patients on enoxaparin 'bridging' required surgical revision of the pocket. Dual AP therapy (P< 0.001), enoxaparin 'bridging' (P< 0.001) and renal insufficiency (P= 0.02) were independent predictors of pocket haematoma in multivariate analysis.
Conclusion: Dual AP therapy and OAC + AP therapy is strongly associated with a significant risk of pocket haematoma, longer hospital stays, and unscheduled follow-up visits. Importantly, surgical revision of the pocket was associated with enoxaparin 'bridging' strategy but was never necessary in patients taking exclusively antiaggregant agents.