INITIAL EXPERIENCE WITH REUSE OF CORONARY ANGIOPLASTY CATHETERS IN THE UNITED-STATES

Objectives. We sought to evaluate the performance of angioplasty cathe ters, restored under a strict manufacturing process, in patients with coronary artery disease. Background. Most countries outside the United States routinely reuse disposable medical equipment, resulting in sig nificant cost savings. Because of quality and legal concerns, reuse in the United States has been limited. We investigated the reuse of perc utaneous transluminal coronary angioplasty (PTCA) balloon catheters, r estored by a process strictly controlled for bioburden and sterility, in patients undergoing PTCA. Methods. Used PTCA balloon catheters were shipped to a central facility and were decontaminated, cleaned and te sted for endotoxin using the limulus amebocyte lystate (LAL) gel clot method, Physical testing and quality assurance were performed. The pro ducts were packaged and sterilized,vith ethylene oxide, Catheter perfo rmance was assessed in a pilot study powered to detect a 5% difference in the angiographic failure rates of new and reused balloons (beta 0. 8). Results. The study enrolled 107 patients. The indication for PTCA was stable angina pectoris in 69 patients, unstable angina in 22 and a cute myocardial infarction in 16, Of the 107 patients enrolled, 106 ha d a successful laboratory outcome, and 1 required coronary artery bypa ss graft surgery after failed rescue stenting. There were 122 lesions attempted (American College of Cardiology/American Heart Association c lassification A, n = 32; B1, n = 33; greater than or equal to B2, n = 35; C, n = 12). Of the 110 lesions initially approached with restored PTCA catheters, 108 were crossed and dilated. Sixty-four required no f urther procedures. Stenting was performed in 37 patients (29 planned, 8 rescue). Thus, the angiographic failure rate was 7% (10 of 108, 95% confidence interval 2% to 12%), comparable to the 10% rate seen with n ew balloons in other studies. Conclusions. Restoration of disposable c oronary angioplasty catheters using a highly controlled process appear s to be safe and effective, with success rates similar to those of new products and no detectable sacrifice in performance. Cost analysis su ggests that implementation of reuse technology for expensive disposabl e equipment may offer cost savings for U.S. hospitals, without sacrifi ce of quality. (C) 1997 by the American College of Cardiology.