Abstract
Favorable early results with mechanical angioplasty devices and laser-assisted balloon angioplasty have resulted in aggressive marketing and a rapid increase in the use of these devices for the treatment of femoropopliteal occlusive disease. Recent reports, however, have questioned the durability of these less invasive procedures. Since 1986 we have been involved in the clinical investigation of the Kensey dynamic angioplasty instrument and laser-assisted balloon angioplasty. One hundred two balloon angioplasty procedures assisted by the Nd:YAG laser (n = 56) and the Kensey dynamic angioplasty instrument (n = 46) were performed for the treatment of femoropopliteal occlusive lesions. Both Kensey dynamic angioplasty instrument and laser-assisted balloon angioplasty groups were similar with regard to age, operative indication, preoperative ankle-brachial index, lesion length, and distal runoff. Mean follow-up was 19 months in the Kensey dynamic angioplasty instrument group and 15 months in the laser-assisted balloon angioplasty group. Technically successful recanalization was achieved in 67% of Kensey dynamic angioplasty instrument-assisted balloon angioplasty procedures and 82% of laser-assisted balloon angioplasty procedures. Early hemodynamic and clinical improvement was obtained in 59% of Kensey dynamic angioplasty instrument-assisted balloon angioplasty procedures and 57% of laser-assisted balloon angioplasty procedures. Two-year clinical success by life-table analysis was 37% in the Kensey dynamic angioplasty instrument group and 19% in the laser-assisted balloon angioplasty group. The level of subsequent surgical revascularization was not altered in any patient by Kensey dynamic angioplasty instrument-assisted balloon angioplasty or laser-assisted balloon angioplasty. The overall long-term success of balloon angioplasty after recanalization with the Kensey dynamic angioplasty instrument or the Nd:YAG laser is unsatisfactory when compared to surgical results. Standardized evaluation and reporting is needed before the widespread marketing and clinical application of new therapeutic modalities.
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