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.

Effect of a Novel Pocket Compression Device on Hematomas Following Cardiac Electronic Device Implantation in Patients Receiving Direct Oral Anticoagulants

“…Several studies have assessed the occurrence of pocket hematoma, from 0.9% to 28.7%. (16,(22)(23)(24)(25)(26). In BRUISE CONTROL trial, the clinically significant device-pocket hematoma occurred in 12 of 343 patients (3.5%) in the continued-warfarin group, as compared with 54 of 338 (16.0%) in the heparin bridging group (27).…”

Effectiveness of Aspiration in Treating Cardiac Implantable Electronic Device-Induced Pocket Hematoma and Characteristics of Patients with Pocket Hematoma

“…It is known that device complexity and the number of leads were significantly associated with increased infection risk [17]. In one study, the infection risk was higher in implantable device replacement procedures than in first implants [18]. Also, patients with comorbidities such as congestive heart failure, renal failure, and thrombocytopenia have an increased risk of pocket hematoma formation [13,14].…”

Predictors of pocket hematoma after cardiac implantable electronic device surgery: A nationwide cohort study

“…published. 3,4,6,7,16,19,[24][25][26] However, the BRUISE CONTROL study 1 correspondingly found aspirin to be an independent predictor of CSH (RR 2.04; 1.19-3.48), and a subsequent combined analysis of BRUISE CONTROL 1 and 2 concluded that concominant antiplatelet therapy doubles the risk of CSH. 27 When taking into consideration the widespread use of aspirin, especially among older adults, 28 the patient specific benefit/risk of holding aspirin when undergoing elective or semi-urgent CIED surgery, should be carefully considered.…”