Clinical Application Of Rotarex System In The Reatment Of In-stent Restenosis At The Superficial Femoral Artery

Purpose:To investigate the effectiveness and safety in the treatment of in-stent restenosis at the superficial femoral artery with Straub Rotarex Mechanical Thrombectomy System.Method:The clinical date of 30 patients with in-stent restenosis at the superficial femoral artery were collected,who received treatment with Rotarex system in our center from June 2015 to December 2016(male:19,female:11.Mean age: 64.27±10.69 years old.Intermittent claudication: 20,Rest pain: 8,Limb ulcer: 2).According to the Tosaka classification standard about in-stent restenosis,there were 4 cases in? type,7 cases in ? type,19 cases in ? type,while there were 7 cases in 1 class,6 cases in 2 class,7 class in 3 class,8 cases in 4 class and 2 case in 5 class according to the Rutherford classification criteria.At the same time of anticoagulation and antiplatelet therapy,all paients were treated with 6 F Rotarex catheter.Additional percutaneous transluminal angioplasty(PTA)was carried out if the stenosis rate was still more than 30% after 2-3 times treatment.For such patients with stent fracture and dissection after treatment,a stent implantation was necessary.The patients who were treated with PTA because of the stent restenosis many times were going be dilatated with drug coated balloon(DCB).The technical success rate,the clinical improvement of symptoms and the incidence of complications were evaluated.And the changes of ABI before and after the treatment were analyzed by paired t test.The follow-up was taken 1?3?6?9and 12 months after the treatment.Results:A total of 30 patients with in-stent restenosis accepeted Rotarex trentment without distal embolic protection system,and the technical success rate was 100%.The average length of lesions was 12.73±5.42 cm,and the average time occupied was 2.4±0.91 min.4 patients were treated by Rotarex alone,while all the rest 26 patients accepted additional PTA.A stent implantation was carried out on 10 patients of them,and only 2 persons was dilatated with drug coated balloon.The incidence of complications was 10%,including a embolization in femoral profound artery.The postoperative ABI of 30 limbs were significantly higher than those before treatment(0.80±0.21 vs0.56±0.22,p<0.005).Different improvement of lower limb ischemia occurred were recognized in all cases according to Rutherford classification,10 cases(33.3%)markedly improved and 20 cases(66.7%)moderately improved.The longest follow-up was 12 months,and the shortest follow-up was 6 months,while the average follow-up was 7.9 months.4 patients(13.3%)accepted PTA or stent implantation in the follow-up period on account of in-stent restenosis.Primary patency at 3 and 6 months was 100% and 86.7% respectively.Limb salvage rates was 100%,and both the restenosis rate and the target lesion revascularization was 13.3% at 6 months.Conclusion:In-stent restenosis of superficial femoral artery is the difficulty in clinical treatment.Rotarex is a mechanical rotational catheter which can achieve suction and thrombectomy at the same time.The procedure with Rotarex catheter is a method of high technology success rate and little complication in the treatment of in-stent restenosis with high patency rate,low restenosis rate.Larger randomised studies are needed to determine the cost/benefit advantage and longterm results compared with PTA? catheter-directed thrombolysis and other debulking devices.