Initial experience with reuse of coronary angioplasty catheters in the United States

Objectives. We sought to evaluate the performance of angioplasty catheters, 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 significant cost savings. Because of quality and legal concerns, reuse in the United States has been limited. We investigated the reuse of percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, restored 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 tested for endotoxin using the limulus amebocyte lystate (LAL) gel clot method, Physical testing and quality assurance were performed. The products were packaged and sterilized,vith ethylene oxide, Catheter performance 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 acute myocardial infarction in 16, Of the 107 patients enrolled, 106 had a successful laboratory outcome, and 1 required coronary artery bypass graft surgery after failed rescue stenting. There were 122 lesions attempted (American College of Cardiology/American Heart Association classification 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 further 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 new balloons in other studies. Conclusions. Restoration of disposable coronary angioplasty catheters using a highly controlled process appears to be safe and effective, with success rates similar to those of new products and no detectable sacrifice in performance. Cost analysis suggests that implementation of reuse technology for expensive disposable equipment may offer cost savings for U.S. hospitals, without sacrifice of quality. (C) 1997 by the American College of Cardiology.