Myocardial protection during coronary angioplasty with an autoperfusion balloon catheter in humans.

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Abstract
An autoperfusion balloon catheter was developed to allow passive myocardial perfusion during inflation through a central lumen and multiple side holes in the shaft proximal and distal to the balloon. We report its safety and efficacy in 11 patients undergoing elective angioplasty to a single coronary lesion. Each lesion was dilated three times with the autoperfusion inflation bracketed between two inflations by standard angioplasty catheters. Chest pain score, 12-lead electrocardiogram, heart rate, and mean aortic pressure were recorded before each inflation and at 1-minute intervals after inflation. Inflation duration during autoperfusion angioplasty (513 +/- 303 seconds) was longer than for the pre- (107 +/- 55 seconds, p = 0.0004) and post- (139 +/- 71 seconds, p = 0.0006) standard dilatations. The maximum ST-segment elevation and depression in any lead during autoperfusion angioplasty (0.3 +/- 0.5 and 0.6 +/- 0.8 mm) was significantly less than for the pre- (2.4 +/- 1.7 mm, p = 0.002 and 2.2 +/- 1.3 mm, p = 0.0004) or post- (1.9 +/- 1.3 mm, p = 0.002 and 1.6 +/- 1.3 mm, p = 0.018) standard dilatations at the same point in time. Maximal chest pain score during autoperfusion (3.2 +/- 3.5) was lower than for the pre- (6.1 +/- 2.1, p = 0.003) but not the post- (5.2 +/- 3.1, p = 0.07) standard angioplasty. All 11 patients underwent successful, uncomplicated procedures. We conclude that this autoperfusion catheter significantly reduces ischemic symptoms and signs during coronary angioplasty, allowing prolonged periods of balloon inflation.