Efficacy and safety of a novel ultrafiltration device for treating patients with refractory heart failure

Abstract

To evaluate the efficacy and safety of a new ultrafiltration device for treating refractory heart failure patients. A total of 52 patients (37 male, age 29-85(33±44)years) with refractory heart failure were treated using a new ultrafiltration device (FQ-16). Body weight, dyspnea score, oxygen saturation (SatO2), left ventricular ejection fraction(LVEF), BUN, creatinine, electrolytes and blood gas analysis were assessed before and after the treatment. Hypotension event and other main adverse events were recorded. Ultrafiltration duration ranged between 8-22 hours. Total ultrafiltration volume was (4 489±1 548) ml. Compared with baseline, patients' body weight decreased from (75.3±8.74) kg to (69.8±8.39) kg (P<0.01), dyspnea score improved from 2.47±1.55 to 12.87±3.61 (P<0.01) and SatO2 increased from 91.0±6.01 to 96.4±2.52 (P<0.01) and LVEF increased from (30.0±4.1)% to (36.0±4.3)% (P<0.01) after ultrafiltration. Blood creatinine, BUN, electrolytes and blood gas analysis values were similar at baseline and post ultrafiltration. No hypotension event and other main adverse events occurred during the ultrafiltration treatment. The novel ultrafiltration device adequately relieved hypervolemia and dyspnea in patients with refractory heart failure and the treatment process is safe in this patient cohort.