Clinical predictors of pocket hematoma after cardiac device implantation and replacement.

ABSTRACT

AIMS: Pocket hematoma is a common complication of cardiac implantable electronic device (CIED) procedures. the aim of the study was to research the clinical factors associated with pocket hematoma formation after CIED implantation or replacement and to identify the best perioperative antithrombotic management. METHODS: We retrospectively analyzed 500 consecutive patients who underwent to CIED implantation or replacement at our center from November 2014. RESULTS: Among our population, 206 patients (41.2%) were on anticoagulant therapy at the time of the intervention 68 (13.6%) on ongoing Warfarin; 111 (22.2%) on low-molecular-weight heparin (LMWH); and 27 (5.4%) on ongoing direct oral anticoagulants. Antiplatelet therapy was present in 262 (52.4%) patients in particular, 50 (10%) were on dual antiplatelet therapy, 64 (12.8%) were on single antiplatelet therapy and anticoagulant therapy, whereas 12 (2.4%) were on anticoagulant with dual antiplatelet therapy.Incidence of pocket hematoma after CIEDs implantation was of 4.6%. Considering the different perioperative anticoagulant strategies, patients on LMWH presented the higher hematoma rate [11/100 patients (11.0%), P < 0.001]. At the multivariate analysis, anticoagulant with dual antiplatelet therapy (P = 0.021, OR 6.3, IC 1.3-30.8), left ventricular ejection fraction (LVEF) less than 30% (P < 0.001, OR 7.4, IC 2.7-20.4), and use of LMWH (P = 0.008, OR 3.8, IC 1.4-10.6) resulted the strongest predictors of pocket hematoma (Hosmer test = 0.899).Considering replacement procedures, incidence of pocket hematoma was of 4.4%. The incidence was higher after ICD/CRT-D replacement. The majority of pocket hematoma occurred in patients with mechanical valve prosthesis (3/4 cases, 75%, P < 0.001). CONCLUSION: The use of LMWH and a low LVEF expose patients to a higher risk of pocket hematoma after CIED procedures. Anticoagulant with dual antiplatelet therapy and LMWH should be avoided.