ROTATIONAL ATHERECTOMY WITH A NEW DEVICE - INITIAL CLINICAL-EXPERIENCE

Bard Atherectomy Catheter is a new rotational atherectomy device that consists of a flexible, hollow, thin-walled cutting catheter that, whi le rotated at 1,500 revolutions per minute, is advanced across the les ion over a special spiral guidewire system. We report the initial clin ical experience with this device in 20 peripheral lesions in ten patie nts. The majority of patients were treated for limb salvage. All lesio ns were s;uccessfully intervened on by atherectomy followed by adjunct ive balloon angioplasty. A reduction to less than 50% stenosis was ach ieved in 13 of the 20 lesions (65%) after atherectomy but in all 20 le sions (100%) after adjunctive angioplasty for all lesions and stenting for dissections in two. Baseline minimal lesion lumen diameter was 0. 8 +/- 0.7 mm with a reference vessel diameter of 4.2 +/- 1.7 mm (75 +/ - 21% stenosis). The lumen improved to 2.0 +/- 0.8 mm (45 +/- 19% sten osis) (P < 0.001) following atherectomy and to 3.9 +/- 1.9 mm (13 +/- 16% stenosis) (P < 0.001) after adjunctive angioplasty. The average we ight of removed atheroma was 45 +/- 58 mg. All ten patients had initia l improvement in symptoms. At 6 months follow-up there was persistent improvement in eight patients and two subjects had undergone amputatio ns. Our early clinical experience with this low profile, flexible athe rectomy device, that enables extraction of a large amount of atheroma, suggests that it will become a valuable addition to current atherecto my technologies in small- and medium-sized vessels. The value of this device in coronary vessels is under investigation. (C) 1996 Wiley-Liss , Inc.