Multicenter experience with the remote access perfusion (RAP) catheter

Background. Cardiac operation has rapidly evolved toward less invasive procedures. Total body perfusion from femoral or iliac vessels combined with endovascular aortic clamping can be achieved using the remote access perfusion (RAP) catheter without opening the sternum. The results of all reported RAP procedures were reviewed. Methods. A US Food and Drug Administration/CE (Communaté Europeene) multicenter and postmark surveillance information survey from January 1999 to June 2000 evaluated 63 patients undergoing RAP procedures. The series includes coronary artery bypass grafting (46%), mitral valve operation (34%), and combined (3%) and miscellaneous procedures (17%). Results. Since optimization of the catheter shape, easy placement was obtained during most procedures (74%). Only one procedure had to be converted to a standard approach. However, no dissection or perforation was reported. Perfusion yielded excellent flow characteristics of the RAP catheter predicted by in vitro studies. Continuous transesophageal echocardiography confirmed the stability of the endovascular balloon clamp (93%), most likely related to the near cylindrical balloon shape. In four cases an additional external cross-clamp was applied. The one reported hospital death (1.5%) was nonprocedural related. No strokes were recorded. Peripheral vascular morbidity (8%) was higher during the early period but nearly disappeared after adaptation of the catheter shape. Conclusions. This multicenter study demonstrated the safety of the RAP technique. Excellent flow characteristics and balloon stability were obtained by improved technology. Indications will be extended in the future because of the device’s enhanced safety and feasibility.