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.
D000328:Adult; D000368:Aged; D001243:Assisted Circulation / Q000295:instrumentation*; D001772:Blood Cell Count; D001777:Blood Coagulation; D002404:Catheterization / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D008875:Middle Aged