359 - Hemodynamic and Renal Effects of a New Percutaneous Support System in NYHA III-IV Patients

Abstract

Purpose: To investigate the haemodynamic and renal effects of a percutaneous circulatory support device (Reitan Catheter Pump [RCP]) in patients (NYHA III-IV) with acutely decompensated heart failure (ADHF) in need of inotropic or mechanical support. Methods and Results: The RCP is a percutaneous 14 French circulatory support system with a foldable propeller/cage inserted via the femoral artery. Once positioned in the descending aorta (10–15 cm below the left subclavian artery) the propeller, 15 mm in diameter, is deployed inside the foldable cage. The rotating propeller (8–13000 revolutions per minute) creates an afterload of the left ventricle and an increased pressure to the lower part of the body. After use the pump can be closed to the original size and removed through the introducer. The system was tested in a prospective observational study of 20 patients presenting with ADHF, with the following inclusion criteria: left ventricular ejection fraction (LVEF) < 30%, and a cardiac index (CI) < 2.1 L/min/m2. According to the ethically approved protocol, the system could be utilised up to 24 hours. The patients underwent RCP support for a mean of 18.3 (+/−6.3) hours. The RCP increased CI by 31% from 1.84 L/min/m2 (+/−0.27), to 2.41 L/min/m2 (+/−0.45, P = .04) at 24 hours. The RCP brought about a significant diuresis, starting at a mean of 71 ml / hr (+/−65), and increased to 227 ml / hr (+/−179) at 12 hours (P = .006). The system also led to a reduction in serum creatinine from a mean of 188 µmol/L (+/− 87.) to 161 µmol /L (+/−78) at 24 hours (P = .0007), and an associated improvement in the estimated glomerular filtration rate (eGFR) from 37.9 ml/min/1.73 m2 (+/−17) to 45.7 ml/min/1.73 m2 (+/−19.5, P = .002) at 24 hours using the Modification of Diet in Renal Disease Formula (MDRD formula). After haemodynamic and renal improvement 3 patients could undergo successful heart transplantation. There were no significant haemolysis, vascular injury, or thrombo-embolic complications. In the trial, a 14 F device was utilised, since then a 10 F device has been developed and will soon be available. Conclusions: The RCP resulted in a significant increase in cardiac index, with improved diuresis and renal function as measured by serum creatinine and eGFR in acutely decompensated heart failure patients. This was achieved without significant haemolysis, bleeding, or vascular complications.