ABSTRACT 22

MULTICENTER EXPERIENCE WITH THE REMOTE ACCESS PERFUSION CANNULA

Guido Van Nooten, Yves Van Belleghem, University Hospital Ghent, Ghent, Belgium.

Background: Cardiac surgery rapidly evolves towards less invasive procedures. Total body perfusion from femoral or iliac vessels combined with endovascular aortic clamping can be achieved using the RAP Cannula (Remote Access Perfusion Cannula - Estech Inc., Danville, CA, USA) without opening the sternum. The authors reviewed the results of reported RAP procedures.

Methods: A FDA/CE multicenter and postmarket surveillance information study from January 1999 to June 2000 evaluated 63 patients undergoing Estech RAP Procedures. Actually over 200 procedures have been performed worldwide. The series includes Mitral Valve Surgery  (46%), CABG (34%), 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 crossclamp was applied. The one reported hospital-death (1,5%) was nonprocedural-related. No strokes or emboli occurred as until this date. This is attributed to the design of the device, which delivers gentle, low velocity, anterograde blood flow. Peripheral vascular morbidity (8%) was higher during the early period but nearly disappeared after adaptation of the catheter shape.

Conclusion: This multicenter study demonstrates the safety of the RAP Procedure technique. Excellent flow characteristics and balloon stability were obtained by improved technology. Indications will be extended in the future due to enhanced safety and feasibility.