Clinical evaluation of soft-tipped catheters for coronary angiography.
New soft-tipped Judkins catheters for coronary angiography were compared with conventional femoral catheters for coronary angiography in a randomized, controlled fashion with cross-over exchange of catheters when problems occurred. The problems encountered with a first generation of soft-tipped catheters (n = 113) versus conventional catheters (n = 103) were as follows: difficult introduction 27% versus 1% (p less than 0.01), difficult placement 13% versus 8% (not significant), difficult aspiration 4% versus 0% (p less than 0.05), wedging 5% versus 0% (p less than 0.05), spasm 3% versus 0% (not significant), overselectivity 7% versus 2% (not significant), cross-over necessary and successful 18% versus 1% (p less than 0.01). Problems with a second generation of soft-tipped catheters (n = 200), modified according to the experience gathered from the first generation, versus conventional catheters (n = 194) were as follows: difficult placement 10% versus 7%, difficult aspiration 2% versus 0.5%, wedging 2% versus 1%, spasm 1% versus 0%, overselectivity 3% versus 2%, ventricular fibrillation 1.5% versus 0%, cross-over necessary and successful 3% versus 2%. None of the differences attained statistical significance. The performance of soft-tipped catheters for coronary angiography was inferior for the first generation but comparable for the second generation to that of conventional catheters. In terms of safety, soft-tipped catheters were not superior on the basis of our criteria.
D000792:Angiography; D006328:Cardiac Catheterization / Q000295:instrumentation*; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation