Coronary artery angioplasty with a helical autoperfusion balloon catheter.

ABSTRACT

The initial in-hospital and long-term clinical experience with a helical autoperfusion balloon catheter in the treatment of coronary artery disease is reported. This new catheter design allows blood to flow passively around the inflated balloon through a protected helical channel molded into the balloon surface. Twelve consecutive patients underwent PTCA. Continuous ST monitoring, heart rate, average peak distal coronary blood flow velocity (APV), coronary blood flow (CBF), dP/dt and systemic and pulmonary arterial pressures were determined during PTCA. During balloon inflation there were no hemodynamic changes, TIMI flow was 1.7 +/- 0.8, and APV was 39% of baseline. Luminal diameter stenosis improved from 61 +/- 17 to 29 +/- 13% (P < 0.05) following PTCA. Mean continuous inflation duration was 385 +/- 215 sec and 6/12 patients had > or = 7.5-min inflations. There were no in-hospital adverse cardiac events. One patient developed recurrent angina during 8 mo of follow-up and underwent successful PTCA of a restenotic lesion. We conclude that human plaques can be successfully dilated with a helical balloon catheter that provides autoperfusion and the ability to perform prolonged inflations with hemodynamic stability. A comparison of this PTCA catheter with standard balloon catheters is warranted.