Cutting balloon angioplasty for peripheral pulmonary stenosis
Lisa Bergersen, Kimberlee Gauvreau, Henri Justino, Alan Nugent, Jonathon Rome, Jacqueline Kreutzer, John Rhodes, David Nykanen, Evan Zahn, Larry Latson, Phillip Moore, James Lock and Kathy Jenkins. have evaluated the role of cutting balloon angioplasty in an investigational device exemption trial, comparing it with high pressure balloon angioplasty . After balloon dilatation at eight atmospheres of pressure, the patients were randomized to either high pressure balloon dilatation or cutting balloon angioplasty, if the low pressure dilatation was not successful. Seventy three patients were enrolled from eight centers. Seventy two vessels responded to low pressure balloon dilatation itself. One hundred and seven of the qualifying vessels which did not respond well to low pressure inflation were randomized to cutting balloon while sixty six were allotted to high pressure balloon dilatation. Those who underwent cutting balloon angioplasty had a greater increase in lumen diameter (85% versus 52%; P=0.004). The good response prompted a crossover in which twenty six of the forty seven vessels treated with high pressure balloon angioplasty later underwent cutting balloon therapy and had an additional forty eight percent increase in lumen diameter. It was noted that the final lumen diameter after cutting balloon angioplasty was almost double that of the initial diameter. No serious adverse events related to treatment was documented in a study vessel. The authors concluded that cutting balloon angioplasty for peripheral pulmonary stenosis in those not responding to low pressure angioplasty was a more effective therapy compared to high pressure balloon angioplasty, with a similar safety profile.
- Lisa Bergersen, Kimberlee Gauvreau, Henri Justino, Alan Nugent, Jonathon Rome, Jacqueline Kreutzer, John Rhodes, David Nykanen, Evan Zahn, Larry Latson, Phillip Moore, James Lock, Kathy Jenkins. Randomized Trial of Cutting Balloon Compared With High-Pressure Angioplasty for the Treatment of Resistant Pulmonary Artery Stenosis. Circulation. 2011; 124: 2388-2396.