Randomized comparison of the modified wire-guided and standard intra-aortic balloon catheters

We have designed a modified intra-aortic balloon (IAB) catheter to facilitate balloon insertion and minimize the complications of vascular dissection, perforation, and thrombosis. The modified balloon catheter is fabricated of a new polyurethane, Avcomat-100; it has a central lumen which allows for pressure monitoring, contrast injection, and introduction of a guide-wire under fluoroscopic control. In a randomized study, we compared the modified balloon with the standard Avco balloon catheter. Eighteen patients were randomized, 10 to receive a standard balloon catheter (control group) and eight to receive a modified balloon catheter. In two of the 10 patients assigned to the control group, introduction of the standard catheter failed but a central-lumen balloon was successfully introduced using the guide wire. A guide wire was needed for introduction of the modified balloon in three of the eight patients assigned to the central-lumen catheter group. The Avcomat-100 catheter material was less thrombogenic, with a lower rate of femoral thrombosis--20% in the control group and 0% in the central-lumen group. Scanning electron miroscopy also showed a reduced area of catheter surface covered with fibrin and clot. This study demonstrates the safety, decreased thrombogenicity, and increased facility of insertion of this new balloon catheter.