Purpose: In order to assess the role of percutaneous peripheral rotational ablation using Rotablator, 150 symptomatic patients (94 males, 56 females; mean age 73 +/- 1 years, range 42 to 90) having 212 complex peripheral vascular lesions were treated.
Methods: Fifty percent of lesions were below the knee; 65% of patients had severe claudication, 11% moderate (24% were in stage III or IV Fontaine classification). The femoral lesions were significantly longer than those at other sites (5.7 +/- 0.4 versus 2.9 +/- 0.3 cm, p < 0.001). The mean length was 4.0 +/- 0.2 cm (range 1 to 20). All the lesions were considered complex; 93% of the lesions were clacified, and 63% were located at a bifurcation. Complementary balloon dilation (percutaneous transluminal angioplasty [PTA]) was significantly (p < 0.001) more frequent in femoropopliteal lesions (70 PTAs in 86 femoral arteries, 10 PTAs in 19 popliteal arteries) than in distal leg lesions (14 in 106 arteries).
Results: After Rotablator therapy alone, the percent stenosis decreased from 81.0% +/- 0.8% to 18.0% +/- 1.1%. The residual stenosis was greater at the femoral (44%) than at the distal level (19%) (p < 0.01). Adjunctive PTA (47 lesions) lowered residual stenosis to 10% at the femoral level and 3% at the distal level. Thirty-seven intraprocedural complications occurred (spasm, thrombosis, dissection, perforation, distal emboli, no reflow); seven procedures subsequently failed for an overall technical success of 97%. The mean follow-up period was 14.4 +/- 1.0 months (range 1 to 51). Among 125 patients having a follow-up period > or = 4 months, 114 patients representing 163 lesions underwent angiography. One hundred twenty-three lesions (76%) were patent, and 40 lesions (24%) showed restenosis (> or = 50% luminal narrowing) of 82.0% +/- 21%. The restenosis rate was higher in femoral (36%) than in distal (21%) or popliteal arteries (7%). Restenosis was more frequent for all lesions > or = 7 cm (p < 0.001) and for both above- and below-knee locations: 55% versus 19% for < 7 cm at the femoropopliteal level (p < 0.03), and 80% versus 18% at the distal level (p < 0.01).
Conclusions: In our experience, percutaneous peripheral rotational ablation has taken a pre-eminent position in the treatment of distal leg arteries, especially in complex lesions. Our results have led us to broaden its indications to complex vascular lesions < or = 6 cm. In particular, the use of this technique for treatment of runoff vessels should improve the long-term patency of proximal PTA and bypass grafts. This device has become indispensable in our laboratory, where Rotablator therapy comprises 15% of all PTA procedures.