Perfusion balloon catheter.

An autoperfusion balloon catheter was developed to allow passive myocardial perfusion during balloon inflation, through a central lumen and multiple side holes in the shaft proximal and distal to the balloon. This report reviews preliminary experimental animal data and initial human clinical experience with this device. In our first study with this device, the duration of inflation in dogs was compared with the maximal duration of inflation using a standard angioplasty catheter. Coronary arteriography was performed to demonstrate distal coronary blood flow through the perfusion balloon catheter. Electrocardiographic recordings and repeated left ventriculograms were performed to detect evidence of ischemia during standard and perfusion and balloon catheter inflations. The average inflation time was 3 +/- 1 minute for the standard catheter and 37 +/- 10 minutes for the perfusion catheter. Each dog had evidence of severe myocardial ischemia during standard inflation, yet none of the animals had ST-segment elevation, ventricular arrhythmia or wall motion abnormality during dilatation with the perfusion catheter. In a second experiment, the effect of prolonged balloon inflations (30 minutes) on intimal hyperplasia was evaluated in the rabbit model. Results of this study showed reduction of intimal and medial hyperplasia after 4 weeks in iliac arteries in rabbits treated with prolonged inflations compared with the contralateral vessel in rabbits treated with standard angioplasty. Initial clinical results from patients treated with this new catheter are presented. The availability of an effective autoperfusion catheter should allow for testing the hypothesis that prolonged inflations could alter the acute angioplasty success rate and long-term restenosis rate.