Pacepress for prevention of CIED pocket hematoma: a prospective single-center clinical evaluation

Background The surgical management of cardiac implantable electronic devices (CIEDs) carries a substantial risk of bleeding complications, especially in patients on anticoagulant or antiplatelet therapy. Pocket hematoma is among the most frequent adverse events, increasing infection risk, prolonging hospitalization, and sometimes requiring surgical intervention. Conventional compression methods often fail to deliver stable, effective pressure. Purpose This study evaluates safety and efficacy of a novel electronically controlled compression system in a high-risk population in a single-center setting of a tertiary cardiology center. Methods In our center we enrolled 53 consecutive patients undergoing CIED surgery with high risk of bleeding according to PACE-DRAP scale (>5) who were randomized to receive either a standard draping without compression or novel compressive dressing. The innovative dressing was applied directly after the surgery and carried for 4 consecutive days. Study included wound monitoring with ultrasound examination of surgical site and evaluation of hematoma volume at the day following the procedure, after 7 and 30 days. Results The included population consisted of subjects aged 75.98 (+/-9.46) with females building up 31.4% of the population. The two treatment groups were well-balanced across all demographical and clinical variables (age, PACE-DRAP score, lab values, baseline hematoma volume). Higher haemoglobin concentration (r=0.33, p=0.028) and haematocrit (r=0.30, p=0.049) were associated with larger hematomas at day 7. Patients with baseline hematoma volume <0.5 cm³ showed different trajectories than those ≥0.5 cm³, but no threshold yielded statistically significant differences between treatment groups. Both groups showed initial increase (0-7 days) followed by decrease (7-30 days), with novel dressing showing larger absolute changes but high variability. No subgroup achieved statistical significance (p < 0.05) at either Day 7 or Day 30, however the patients with PACE-DRAP score ≥6 subgroup showed greater 7-30 days relative change (-70.51% vs -33.83% in standard group; p=0.088 - approaching statistical significance). When adjusted for the number of leads implanted electronically controlled dressing demonstrates larger reduction in hematoma volume (absolute: -1.5 cm³ vs +5.8 cm³, p=0.50; relative: -11.8% vs +26.9%, p=0.48) Conclusion(s) The novel dressing demonstrated consistently greater hematoma reduction than standard care, with particularly pronounced benefits in higher-risk patients. Despite variability and lack of statistical significance, the direction and magnitude of effects strongly suggest meaningful clinical advantage. These encouraging findings support compressive dressing as a promising therapy, and broader, adequately powered studies are now planned to further validate its effectiveness and confirm these positive trends.