A first‐in‐man study of the reitan catheter pump for circulatory support in patients undergoing high‐risk percutaneous coronary intervention

Objectives : To investigate the safety of a novel percutaneous circulatory support device during high‐risk percutaneous coronary intervention (PCI). Background : The Reitan catheter pump (RCP) consists of a catheter‐mounted pump‐head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion. Methods : Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 ± 9; LVEF 34% ± 11%; jeopardy score 8 ± 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose? sutures. PCI was performed via the radial artery. Outcomes included in‐hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal. Results : The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 ± 1,424 rpm maintained an aortic gradient of 9.8 ± 2 mm Hg. Although fHb increased, there was no significant hemolysis (4.7 ± 2.4 mg/dl pre vs. 11.9 ± 10.5 post, P = 0.04, reference 20 mg/dl). Platelets were unchanged (pre 257 ± 74 × 10⁹ vs. 245 ± 63, P = NS). Renal function improved (cre pre 110 ± 27 μmol/l vs. 99 ± 28, P = 0.004). The RCP was not used in one patient following femoral introducer sheath related aortic dissection. All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal. Conclusions : The RCP can be used safely in high‐risk PCI patients. This device may be an alternative to other percutaneous systems when substantial cardiac support is needed. © 2009 Wiley‐Liss, Inc.