Femoropopliteal Tract Research Articles

Safety and Feasibility of the BYCROSS® Atherectomy Device for the Treatment of Femoropopliteal Arterial Obstructions: Single-Center Short-Term Outcomes.

Background: Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often show limited efficacy in arterial segments with a high atherosclerotic load. The use of atherectomy devices enables the removal of calcified plaque material and may promote arterial wall remodeling. This study assessed the technical success, safety, and feasibility of the BYCROSS® atherectomy device in femoropopliteal lesions. Methods: This single-center, retrospective cohort study analyzed elective patients undergoing BYCROSS® atherectomy for chronic peripheral arterial disease from March 2022 to May 2023. Patient data, procedural details, and outcomes were retrospectively collected from electronic patient records. The primary performance endpoints of this study were technical success, complications, and patency rates. Primary safety endpoints included 30-day and short-term major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), and mortality rate. Results: The study included 19 patients (median age, 71 years; 63% male) with Fontaine class IIb (26%), III (21%), or IV (53%). The BYCROSS® atherectomy device was used to treat 22 limbs in the femoropopliteal tract, of which 11 lesions (50%) were occlusions and 11 were stenoses, with a median length of 24 cm (interquartile range: 17-38). Technical success was achieved in all cases: 4.5% required atherectomy only, 50% required additional balloon angioplasties, 41% required balloon angioplasties and stenting, and 4.5% required segments only stenting. Additional treatment of below-the-knee arteries was performed in 12 patients. Procedurally related complications (not limited to the use of the BYCROSS® device) occurred in 23% of limbs, including distal embolization and laceration. At 30 days, mortality was 5%, the MACE rate was 11%, and the MALE rate was 0%. The observed mortality rate was not directly related to the procedure. Patency (<50% restenosis at duplex ultrasound) was 83% at 30 days. Conclusions: The use of the BYCROSS® atherectomy device for the treatment of femoropopliteal lesions appears to be safe and feasible, with high technical success and low MALE and MACE rates in a challenging population with long-segment femoropopliteal lesions. Long-term follow-up in larger patient series is needed to confirm these findings and to determine the durability of this technique.

I Spy with My Little Eye – Optical Coherence Tomography in the Femoropopliteal Tract

I Spy with My Little Eye – Optical Coherence Tomography in the Femoropopliteal Tract

Drug-Coated Balloons for Complex Femoropopliteal Lesions: 2-Year Results of a Real-World Registry.

The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Intermittent Claudication: The Importance of Non-Invasive Treatment in the Femoro-Popliteal Tract

The prevalence of intermittent claudication is around 4.5% in general population aged between 55 to 74 years [1]. Even if this condition has a profound and negative impact on patients’ quality of life [2,3], because of a sense of limitation of mobility and the fear of the progression of the disease and limb loss, patient should be reassured on the relatively benign prognosis of the pathology in case of intermittent claudication. Leng et al. [4] reported a remission of symptoms in more than 60% of the patients examined after a period of 5 years. A progression of the disease in only 25%; deterioration is more likely to appear on the first year after diagnosis (7%-9%) compared with 2% to 3% per year thereafter [5] and can be related to poor adherence to treatments and exercise programs.

Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results

The use of directional atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract. From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had life limiting claudication (LLC) (n=18) and 12 a critical limb ischemia (CLI) with baseline Rutherford class 4.2±1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis>50%) by visual estimation. After the intervention patients were followed up to 12 months. Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2±1.2, ABI was 0.8±0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n=30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR=10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.

Cost-effectiveness of identifying aortoiliac and femoropopliteal arterial disease with angiography or duplex scanning

Objectives Cost-effectiveness analysis of three diagnostic imaging strategies for the assessment of aortoiliac and femoropopliteal arteries in patients with peripheral arterial occlusive disease. The strategies were: angiography as the reference strategy, duplex scanning (DS) plus supplementary angiography (S1) and DS plus confirmative angiography (S2). Design, materials and methods A decision model was built with sensitivity and specificity data from literature, supplemented with prospective hospital cost data in Euro (€). The probability of correctly identifying the status of a lesion was taken as the primary outcome. We compared strategies by assessing the extra costs per additional correctly identified case. Results Assuming no false positive or false negative results, angiography is the most effective strategy if the prevalence of significant obstructive lesions in the aortoiliac and femoropopliteal tract exceeds 70%, or if the sensitivity of duplex scanning is lower than 83%. In case of lower prevalence, strategy S1 becomes equally or even more effective than angiography. At a prevalence of 75%, performing angiography costs €8443 per extra correctly identified case compared with strategy S1. Conclusions In most situations angiography is more effective than diagnostic strategy S1. However, if society is unwilling to pay more than €8443 for knowing a patient's disease status, diagnostic strategy S1 is a cost-effective alternative to angiography, especially at lower prevalence values.

Diagnosis of arterial disease of the lower extremities with duplex ultrasonography.

The development of duplex scanning carries the prospect of an entire non-invasive work-up of patients with peripheral arterial occlusive disease. To obtain the best available estimates of its diagnostic accuracy, a meta-analysis of 71 studies evaluating duplex scanning was performed. Independent methodological judgement left 16 studies for data extraction. Pooled estimates (95 per cent confidence interval of sensitivity and specificity for detection of a stenosis greater than or equal to 50 per cent or occlusion in the aortoiliac tract were 86 (80-91) per cent and 97 (95-99) per cent respectively. The results for the femoropopliteal tract compared well with this, with a sensitivity of 80 (74-85) per cent and a specificity of 96 (94-98) per cent. The accuracy of detection of a stenosis greater than or equal to 50 per cent or an occlusion in the infragenicular arteries was lower with a sensitivity and specificity of 83 (59-96) per cent and 84 (69-93) per cent respectively. Duplex scanning is an accurate tool for assessment of atherosclerotic lesions in the aortoiliac and femoropopliteal tract and can replace routine preinterventional angiography in a substantial number of patients.

Interobserver variability in aortoiliac and femoropopliteal duplex scanning

Purpose: The interobserver variability of aortoiliac and femoropopliteal duplex scanning in peripheral arterial occlusive disease was assessed. Methods: Two experienced, independent vascular technologists investigated in random order 61 consecutive patients sent to the vascular laboratory for investigation of the aortoiliac or femoropopliteal arteries. In each aortoiliac vessel segment, the proximal, mid, and distal peak systolic velocities (PSVs) were measured, and corresponding PSV ratios were calculated. The superficial femoral artery was divided in 10-cm segments with a roll-centimeter taped from the upper patella margin. Interclass correlation coefficients (ICCs) were calculated as a means of appreciating the measurement variability of the PSV ratio values as a continuous variable and the Kappa value for the PSV ratio categories of less than 2.0, 2.0 through 3.0, more than 3.0, and occlusions. Results: The overall ICC and Kappa values were 0.72 (95% CI, 0.63-0.79) and 0.53 for the aortoiliac tract and 0.85 (95% CI, 0.79-0.89) and 0.73 for the femoropopliteal tract. Agreement in the PSV ratio categories was 85% in the aortoiliac and 87% in the femoropopliteal tract. Interobserver variation increased markedly with increasing PSV ratio. In the PSV ratio category between 2.0 to 3.0, indicating a borderline stenosis, a substantial disagreement was found (aortoiliac, 1 of 8 agreement; femoropopliteal, 2 of 8 agreement). Conclusion: A moderate interobserver agreement was found in the duplex investigation of the aortoiliac and femoropopliteal arteries. One should be aware of this in clinical decision making, especially in cases of borderline stenoses. In these cases, repetition of the measurement or additional diagnostics is advocated. (J Vasc Surg 2001;33:540-5.)

The significance of coumarin anticoagulation in laser assisted percutaneous transluminal angioplasty of femoropopliteal arterial obstructions

The optimal regime of drugs to prevent thrombocyte aggregation leading to reocclusion after percutaneous transluminal angioplasty (PTA) of peripheral vessels is not established. Both antiplatelet and antithrombotic drugs are prescribed. Prospective observations of two different anticoagulation regimes were made during an ongoing multicenter study of laser-assisted PTA (PTLA) of the femoropopliteal artery. Group I (129 patients) received coumarin at least during the first month, Group II ( n = 71) did not get oral anticoagulation. Seventy-eight patients (61%) in Group I and 29 patients (47%) in Group II received platelet inhibitors. Groups I and II did not differ in baseline characteristics and PTLA complications (20.9 vs. 18.2%). Ankle brachial indices at 1, 3, 6 and 12 months were similar in both groups. This observational study does not provide evidence for superiority of oral anticoagulation in the management of patients undergoing PTLA of the femoropopliteal tract.