[Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses].

BACKGROUND

Evaluation of the efficacy and safety of a new 7F-atherectomy device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm.

MATERIAL AND METHODS

Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66 +/- 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%), stage 4: 2 (4%), stage 5: n = 2 (4%)], were treated with directional atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); in stent n = 3 (5 %). Thirty (65 %) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 +/- 11 mm, mean length of lesion was 37 +/- 37 mm.

RESULTS

6.5 +/- 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after atherectomy was reduced to 29 +/- 20% (0-60%) after additional balloon angioplasty, it was 11 +/- 10% (0-30 %). A residual stenosis of < 50% after plain atherectomy was achieved in 55 (95%) lesions, of < 30% in 49 (84%).

COMPLICATIONS

3 (6.5%) cases of embolism of debris were detected and treated successfully by aspiration. The mean ankle-brachial index increased from 0.62 +/- 0.12 to 0.92 +/- 0.36 before discharge, and to 0.86 +/- 0.17 after 30 days. Rutherford stage after 30 days: stage 0: n = 038 (83%); Stage 1: n = 4 (8%); Stage 2: n = 3 (6%); Stage 5: n = 1 (2%).

CONCLUSION

Lesions up to 8 cm in length of the femoropopliteal arteries can be treated successfully in most cases with the new atherectomy catheter. Embolism, the only complication that occurred, can be avoided by cleaning the nose cone after at least 4 passes of the lesion.