Dual-balloon progressive coronary dilatation catheter: Design and initial clinical experience

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As newer interventional devices continue to enter the marketplace, balloon angioplasty remains the standard by which all devices are judged with regard to both safety and efficacy. It has been observed that predilating a stenosis with a small balloon followed by dilatation with an optimally sized larger balloon creates a more controlled arterial injury, reduces complications, and thus improves success rates. Exchanging two balloons for each lesion, however, increases the complexity and cost of the procedure in addition to increasing the amount of time required and the amount of radiation exposure. Therefore an “over-the-wire” dual-balloon catheter was developed with a small distal balloon and a larger proximal balloon on a 2.9F shaft to allow progressive coronary dilatation with a single device, without necessitating a balloon catheter exchange. The device was used successfully in 45 of 47 patients (78 lesions). The two failures were related to an inability to cross the lesion in one and failure of the device in the other. Twenty-one patients (47%) underwent a multivessel procedure. There were 29 left anterior descending/diagonal, 17 circumflex/marginal, 20 right coronary artery/posterior descending artery, and 10 vein graft lesions. The device was successfully delivered in the native anatomy to 12 distal, 27 mid, and 27, proximal lesions of which nine were osteal, for a procedural success rate of 97%. The mean stenosis was reduced from 80.7 ± 11.5% to 15.2 ± 11.9%. There were no major dissections, only 9 (11.2%) minor dissections, and no myocardial infarctions. One abrupt closure occurred at 24 hours requiring subsequent coronary artery by-pass graft. One death was recorded 5 days after the procedure and was not related to the procedure or the device. The duration of the procedure was 23.1 min/lesion and the fluoroscopy time (including passage of the wire) was 16.7 min/lesion. The amount of contrast medium used was 132.5cc/lesion. Thus this dual-balloon catheter allows progressive coronary dilatation of a stenosis with high success and low complication rates in both simple and complex lesions while possibly reducing the complexity and cost of the procedure. Further investigation is warranted.