P1234Pocket complications after device-based therapy in patients with chronic heart failure

Abstract

Background: Recent heart failure (HF) guidelines highlight the importance of devicebased therapy as an important component in the management of patients with chronic HF (CHF). In fact implantable cardioverter-defibrillator (ICD) results in a significant reduction of mortality and cardiac resynchronization therapy (CRT) improves symptoms and left ventricular function. However patients with CHF have also important comorbidities and frailty and often anticoagulant (AC) or antiplatelet (AP) therapies are necessary. These factors expose the pts to higher risk of pocket hematoma during device implantation or replacement. Purpose(s): The purpose of the study was to identify the clinical factors associated with hematoma formation after CRT or ICD device implantation or replacement in patients with CHF, NYHA class II-III, and to compare CHF patients with a control population of patients NYHA I on AC therapy. Result(s): The study included 123 patients, with a mean age 72.0 years and a mean ejection fraction (EF) of 40%. The 35.8% underwent ICD implantation, the 13.0% CRT implantation, the 47.1% ICD o CRT replacement. Forty-two (42.1%) patients suffered atrial fibrillation, 10 (8.1%) had severe impaired renal function, 28 (23.0%) diabetes; 15 (12.2%) had previous mechanical valve replacement and 4 (3.3%) transcatheter aortic valve implantation. The 52.0% was on AC therapy (28 patients with warfarin, 30 with low molecular weight heparin (LMWH), 6 with new oral AC [NAO], the 14.6% was on AC and AP therapy, the 9.8% was on dual AP therapy. Pocket hematoma occurred in 11 pts (8.5%) in 6 cases pocket revision was necessary. At univariate analysis risk factors for pocket complications resulted AC therapy (hematoma in 15.6% vs 1.7%, p=0.007), mechanical valve prosthesis (hematoma in 33.3% vs 5.6%, p <0.001), recent TAVI implantation (hematoma in 50.0% vs 7.6%, p=0.003) at the limit of statistical significance were young age (mean age of 60.9 years in patients with hematoma vs 73.2 years, p=0.05) and EF 35% (hematoma in 4.5% vs 14.3%, p=0.05). Complications were mainly observed after ICD or CRT implantation (p=0.001). Among AC therapies, LMWH was significantly associated with pocket complication (hematoma was observed in the 7.1% of patients on warfarin, in the 23.3% of patients in LMWH and in the 9.1% of patients in NAO, p=0.007). At multivariate analysis previous mechanical valve prosthesis and young age were confirmed as predictors of pocket hematoma. Comparing the CHF population with a control population of 100 patients on AC therapy with a mean age of 75.5 615.1 years, the incidence of pocket hematoma resulted significantly lower (1% vs 8.5%, p=0.008). Conclusion(s): Patients with CHF presented a high risk of pocket complication after ICD or CRT implantation/replacement and the main predictors of hematoma are high LMWH doses for mechanical valve prosthesis. The risk of pocket hematoma resulted significantly higher than in patients NYHA I on AC therapy.