Femoropopliteal Lesions In Patients Research Articles

Clinical Outcome of Drug-Eluting Balloon Endovascular Treatment for Femoropopliteal Lesions in Patients with Intermittent Claudication

Clinical Outcome of Drug-Eluting Balloon Endovascular Treatment for Femoropopliteal Lesions in Patients with Intermittent Claudication

Lutonix® 014 DCB global Below the Knee Registry Study: interim 6-month outcomes.

The most common clinical presentation of peripheral artery disease (PAD) comprises intermittent claudication (IC), but about one third of patients will progress to critical limb ischemia (CLI), characterized by rest pain and/or tissue loss, which is the most severe limb manifestation of PAD. Paclitaxel-coated balloons are well established for the endovascular treatment of femoropopliteal lesions in patients with IC and CLI. This ongoing multicenter registry study is exploring the role of the Lutonix® 014 drug-coated balloon (DCB) in the treatment of below-the-knee (BTK) arteries and CLI. Three hundred fourteen (314) patients were enrolled from 26 sites and 12 countries. The real-world patients represent those undergoing intervention for BTK arteries with the Lutonix® 014 DCB. The study had both, primary safety and primary efficacy endpoints. The primary safety endpoint was freedom at 30 days from BTK major adverse limb event (MALE) + perioperative death (POD). Primary efficacy was freedom from clinically driven target lesion reintervention (fTLR) at 6 months. Additional secondary endpoints related to safety were reported. The interim 6 months' results showed freedom from MALE and POD at 30 days of 98.6% and at 6 months (180 days) of 96.0%. Primary efficacy of fTLR at 6 months (180 days) was 87.9%. Safety related secondary endpoints at 6 months (180 days) showed freedom from all of the following: all cause death of 91.2%, above ankle amputation 97.1%, reintervention for thrombosis 95.2%, reintervention for distal embolization 100.0%, and target vessel revascularization of 88.0%. There were no unexpected device or drug related events reported. The interim 6-month outcomes demonstrate the safety and efficacy of the Lutonix® 014 DCB for the treatment of BTK arteries.

Outcomes of Popliteal-To-Distal Bypass Combined with Femoropopliteal Artery Endovascular Treatment for Critical Limb Ischemia.

Objective: The aim of this study was to evaluate outcomes of combined popliteal-to-distal bypass and endovascular treatment (EVT) for femoropopliteal lesions in patients with critical limb ischemia (CLI).Patients and Methods: We reviewed data of 14 CLI patients who were treated by popliteal-to-distal bypass combined with femoropopliteal EVT. The femoropopliteal lesions included 3 TASC II-A, 8 TASC II-B, and 3TASC II-C but no TASC II-D, and balloon dilatation was performed in 9 cases and a stent was placed in 5 cases. The saphenous vein graft was used in all bypasses, and the target arteries were the dorsalis pedis artery in 12 cases and the posterior tibial artery in 2 cases.Results: At 12 and 24 months, primary patency rates were both 79%, primary assisted and secondary patency rates were both 93%, limb salvage rates were both 93%, and survival rates were 92% and 84%, respectively. Restenosis after femoropopliteal EVT occurred in 2 cases, and both were successfully revised by additional endovascular balloon dilatation.Conclusion: Combined popliteal-to-distal bypass and femoropopliteal EVT might be a useful therapeutic option for appropriately selected CLI patients. Intensive follow-up for endovascular treated lesions and vein graft is mandatory.

Use of the directional atherectomy for the treatment of femoro-popliteal lesions in patients with critical lower limb ischemia.

From March 2012 to March 2013 18 consecutive patients with critical limb ischemia were treated with DCA (Turbohawk/Covidien-ev3 Endovascular Inc., North Plymouth, Minnesota, USA) for the treatment of femoro-popliteal obstructive disease. Patients were evaluated at 12 months. Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiovascular events occurred. Primary endpoint: freedom from any amputation was obtained in all patients. Secondary endpoints: clinical (Rutherford class improvement) and hemodynamic success (Ankle-brachial index improvement) was achieved in all patients. The use of DCA for the treatment of femoro-popliteal obstructive disease is a safe and effective therapeutic strategy for patients with critical limb ischemia. The data included in our study should be considered hypothesis-generating in order to design of a randomized trial comparison with conventional PTA.

4:21 PMAbstract No. 157 - Use of carbon dioxide as a contrast medium during peripheral endovascular procedures significantly reduces the risk of contrast-induced nephropathy

Purpose: To compare our experience using paclitaxel-coated balloon angioplasty (PCBA) of femoropopliteal lesions in patients undergoing revascularization in the setting of CLI compared with current data in the literature. Materials: Angiography, diagnostic imaging, demographics, risk factors, and clinical notes of patients who underwent PCBA from October 2014 to September 2015 for treatment of CLI were reviewed. Study outcome measures include latest follow up study demonstrating luminal patency, amputation and death attributable to CLI. Patients were excluded if PCBA was used within a stent, the target lesion was stented in the same case, treatment was performed with a planned subsequent amputation, or there is lack of any follow up (defined as subsequent ankle-brachial index (ABI), arterial duplex ultrasound, angiography, or clinical exam). Results: A total of 58 stenoses in 41 patients (24 men; mean age 64.8) underwent PCBA during lower extremity revascularization in this interval. Of these, 19 patients (Rutherford class 4, 5, or 6) with 21 lesions met inclusion criteria. These lesions were pretreated with plain-old balloon angioplasty for predilation or atherectomy followed by PCBA. 5 patients were chronically occluded (26%), and 11 (58%) patients also underwent infrapopliteal disease treatment. Average target lesion length was 4.8 cm and luminal narrowing was 79.6%. Mean follow up was 131.7 days (range 8-339 days, median 108 days) and reintervention was performed only in 2 of 21 lesions (92%). Two patients died of other causes with last documented patency at 56 and 83 days follow up. In patients that have available pre and post PCBA ABIs, the average ratio was 0.61 compared to 0.80 following revascularization. Conclusions: Early follow up demonstrates promising patency rates of femoro-popliteal PCBA in the setting of CLI, as well as high rate of concurrent additional infrapopliteal intervention. Current PCBA data in the literature is comprised of significantly lower Rutherford class patients and minimal concurrent infra-popliteal interventions.

4:12 PMAbstract No. 156 - Paclitaxel-coated balloon angioplasty (PCBA) use in the treatment critical limb ischemia (CLI)

Purpose: To compare our experience using paclitaxel-coated balloon angioplasty (PCBA) of femoropopliteal lesions in patients undergoing revascularization in the setting of CLI compared with current data in the literature. Materials: Angiography, diagnostic imaging, demographics, risk factors, and clinical notes of patients who underwent PCBA from October 2014 to September 2015 for treatment of CLI were reviewed. Study outcome measures include latest follow up study demonstrating luminal patency, amputation and death attributable to CLI. Patients were excluded if PCBA was used within a stent, the target lesion was stented in the same case, treatment was performed with a planned subsequent amputation, or there is lack of any follow up (defined as subsequent ankle-brachial index (ABI), arterial duplex ultrasound, angiography, or clinical exam). Results: A total of 58 stenoses in 41 patients (24 men; mean age 64.8) underwent PCBA during lower extremity revascularization in this interval. Of these, 19 patients (Rutherford class 4, 5, or 6) with 21 lesions met inclusion criteria. These lesions were pretreated with plain-old balloon angioplasty for predilation or atherectomy followed by PCBA. 5 patients were chronically occluded (26%), and 11 (58%) patients also underwent infrapopliteal disease treatment. Average target lesion length was 4.8 cm and luminal narrowing was 79.6%. Mean follow up was 131.7 days (range 8-339 days, median 108 days) and reintervention was performed only in 2 of 21 lesions (92%). Two patients died of other causes with last documented patency at 56 and 83 days follow up. In patients that have available pre and post PCBA ABIs, the average ratio was 0.61 compared to 0.80 following revascularization. Conclusions: Early follow up demonstrates promising patency rates of femoro-popliteal PCBA in the setting of CLI, as well as high rate of concurrent additional infrapopliteal intervention. Current PCBA data in the literature is comprised of significantly lower Rutherford class patients and minimal concurrent infra-popliteal interventions.

New Insights from Real-World Femoral-Popliteal Drug-Coated Balloon Treatment: 1-Year Results from IN.PACT Global Study, Including Long Lesions

Purpose Randomized trial data have demonstrated superior safety and efficacy of IN.PACT Admiral Drug-coated Balloon (DCB; Medtronic, Santa Rosa, California) vs. PTA for the revascularization of mostly TransAtlantic InterSociety Consensus (TASC) A-B femoro-popliteal lesions in patients with claudication and rest pain. A prospective, single-arm study, the IN.PACT global study, was conceived to expand the appraisal of DCB towards the real-world treatment of patients with the same peripheral artery disease symptoms, including those patients with lesions > 15 cm in length. Material and Methods The IN.PACT global study is a rigorous, independently adjudicated and monitored multicenter, international, 1500 patient, single-arm study of DCB revascularization of femoro-popliteal stenosis and occlusions with a minimum length of 2 cm. One-year results from the first 655 patients enrolled are presented. The majority had severe (58.2%) or moderate (27.3%) claudication or ischemic rest pain (10.9%) at baseline, and 41.2% were diabetic. The mean lesion length was 12.23 cm, 35.8% of lesions were total occlusions, and 21.4% of lesions represented in-stent restenosis. The primary endpoint was clinically driven target lesion revascularization at 12 months. Results At 12 months, the rate of clinically driven target lesion revascularization was 8.7%. An analysis by lesion length on the subset of subjects (N=514) with unilateral limb treatment of single lesions was also performed. The clinically driven target lesion revascularization rate in lesion lengths greater than 15 cm was 11.5% (22/191), confirming the performance of the IN.PACT Admiral DCB in long lesions. Conclusions Preliminary results from the IN.PACT Global Study indicate that the IN.PACT Admiral DCB is safe and efficacious in the treatment of real-world femoro-popliteal lesions, and continues to perform well in long lesions.

Aortoiliac and femoropopliteal lesions in patients with concomitant peripheral arterial disease and medial arterial calcification

Objective: To characterize stenosis and/or occlusion in patients with concomitant peripheral arterial disease (PAD) and medial arterial calcifi cation (MAC). Patients and methods: We performed continuous-wave Doppler technique (to measure the ankle-brachial index - ABI) and duplex ultrasonography in 75 consecutive patients at risk for PAD (57 males, age 72.6±6.3 years) admitted to a Medical Clinic between January and March 2006. Group A was composed of 15 subjects with plaques and ABI higher than 1.3 (MAC - 20%). Normal ABI was found in 43 patients (group B - 57.33%). Group C included 17 patients with ABI lower than 0.9 (ischemia - 22.67%). Results: Nonsignifi cant aortoiliac stenosis (less than 50%) was found in 70 subjects (15 in group A, 39 in group B, and 16 in group C - nonsignifi cant). Signifi cant femoropopliteal stenosis (greater than 50%) was detected in eight patients (fi ve in group A, one in group B, and two in group C – p<0.001). Nonsignifi cant femoropopliteal stenosis was identifi ed in 54 subjects (seven in group A, 42 in group B, and fi ve in group C - p<0.001). Conclusion: Signifi cant femoropopliteal stenosis signifi cantly correlated with presence of MAC. Nonsignifi cant femoropopliteal stenosis was identifi ed in patients with normal ABI.