Contemporary Treatment of Popliteal Artery Aneurysms in 14 Countries: A Vascunet Report.

OBJECTIVE: Popliteal artery aneurysm (PAA) is the second most common arterial aneurysm. Vascunet is an international collaboration of vascular registries. The aim was to study treatment and outcomes. METHODS: This was a retrospective analysis of prospectively registered population based data. Fourteen countries contributed data (Australia, Denmark, Finland, France, Hungary, Iceland, Italy, Malta, New Zealand, Norway, Portugal, Serbia, Sweden, and Switzerland). RESULTS: During 2012-2018, data from 10 764 PAA repairs were included. Mean values with between countries ranges in parenthesis are given. The incidence was 10.4 cases/million inhabitants/year (2.4-19.3). The mean age was 71.3 years (66.8-75.3). Most patients, 93.3%, were men and 40.0% were active smokers. The operations were elective in 73.2% (60.0%-85.7%). The mean pre-operative PAA diameter was 32.1 mm (27.3-38.3 mm). Open surgery dominated in both elective (79.5%) and acute (83.2%) cases. A medial surgical approach was used in 77.7%, and posterior in 22.3%. Vein grafts were used in 63.8%. Of the emergency procedures, 91% (n = 2 169, 20.2% of all) were for acute thrombosis and 9% for rupture (n = 236, 2.2% of all). Thrombosis patients had larger aneurysms, mean diameter 35.5 mm, and 46.3% were active smokers. Early amputation and death were higher after acute presentation than after elective surgery (5.0% vs. 0.7%; 1.9% vs. 0.5%). This pattern remained one year after surgery (8.5% vs. 1.0%; 6.1% vs. 1.4%). Elective open compared with endovascular surgery had similar one year amputation rates (1.2% vs. 0.2%; p = .095) but superior patency (84.0% vs. 78.4%; p = .005). Veins had higher patency and lower amputation rates, at one year compared with synthetic grafts (86.8% vs. 72.3%; 1.8% vs. 5.2%; both p < .001). The posterior open approach had a lower amputation rate (0.0% vs. 1.6%, p = .009) than the medial approach. CONCLUSION: Patients presenting with acute ischaemia had high risk of amputation. The frequent use of endovascular repair and prosthetic grafts should be reconsidered based on these results.

Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices.

Importance: In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up. Objective: To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization. Design, Setting, and Participants: This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017. Exposures: Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon). Main Outcomes and Measures: The primary outcome was all-cause mortality analyzed through the end of follow-up. Results: Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48). Conclusions and Relevance: In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

BACKGROUND: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?

PURPOSE: The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany. MATERIALS AND METHODS: Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system. RESULTS: There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA. CONCLUSIONS: The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years. ClinicalTrials.gov Identifier NCT01970579.

Potential mechanisms of in-stent occlusion in the femoropopliteal artery: an angioscopic assessment.

Although stent implantation has become widespread for the treatment of patients with peripheral artery disease with femoropopliteal (FP) lesions, in-stent restenosis, especially in-stent occlusion (ISO), remains as a major concern for refractory recurrence. Furthermore, the mechanisms of ISO in FP lesions have not been well elucidated. We performed angioscopy for 6 lesions (bare-metal stent: 3, drug-eluting stent: 3) from 5 patients (mean age 74 ± 10 years, male 40 %) with ISO in the FP artery immediately after wire-passing or thrombus aspiration. The presence of thrombus as well as the presence and location of organic stenosis were evaluated. Median duration from stent implantation to angioscopic evaluation was 1099.5 (514.5-2272.5) days, while the duration from recurrence of symptoms to angioscopic evaluation was 45 (5.75-60) days. Mixed thrombi were observed in all stents. Organic stenosis was detected at the proximal edge of the stents in 5 lesions. Organic stenosis was observed at the overlapping segment of the stent in one lesion. The distal edge of the stents could be evaluated in 3 lesions, and all of them showed organic stenosis at the site. Mixed thrombi and organic stenosis were observed in all stents. Partial development of organic stenosis in a stent followed by thrombus formation may be the potential mechanism of the development of ISO in the FP artery though the sample size of this study was small and it had no serial angioscopic data so that we should consider it as preliminary one at best.

Paclitaxel-eluting stents for the treatment of femoropopliteal arterial stenoses: focus on the Zilver PTX drug-eluting peripheral stent.

Restenosis is one of the major limitations of the percutaneous treatment of peripheral artery disease, leading to the need for repeat interventions, limb loss and increased cost of therapy. The current standard of percutaneous treatment of stenotic lesions in the femoropopliteal arterial segment includes balloon angioplasty and bare-metal stenting. Recently, research in the field adapting the coronary arterial bed treatment model led to the inclusion of antimitotic drugs in the form of drug-eluting stents to combat neointimal proliferation and reduce the burden of restenosis. Randomized trial and registry data emerged indicating improved long-term outcomes with drug-eluting stents in peripheral arteries, lending the way to more widespread adaptation of this modality in the management of patients with peripheral artery disease.

Assessment of the medial head of the gastrocnemius muscle in functional compression of the popliteal artery.

OBJECTIVE: Nonfunctional popliteal entrapment is due to embryologic maldevelopment within the popliteal fossa. Functional entrapment occurs in the apparent absence of an anatomic abnormality. Gastrocnemius hypertrophy has been associated with the latter. Both forms of entrapment may cause arterial injury and lower limb ischemia. This study assessed the attachment of the medial head of the gastrocnemius muscle in healthy occluders and healthy nonoccluders. METHODS: Provocative tests were used to identify 58 nonoccluders and 16 occluders. Ten subjects from each group underwent magnetic resonance imaging evaluation of the popliteal fossa. The medial head of the gastrocnemius muscle attachment was assessed in the supracondylar, pericondylar, and intercondylar areas. RESULTS: In the occluder group, significantly more muscle was attached towards the femoral midline (supracondylar), around the lateral border of the medial condyle (pericondylar), and within the intercondylar fossa. CONCLUSION: The more extensive midline position of the medial head of the gastrocnemius in occluders is likely to be a normal embryological variation. Forceful contraction results in compression and occlusion of the adjacent popliteal artery. The clinical significance of these anatomic variations remains unclear. However, these new observations may provide insight for future analysis of the causes and natural history of functional compression and the potential progression to clinical entrapment.

Imaging popliteal artery disease in young adults with claudication: self-assessment module.

The educational objectives of this self-assessment module on imaging popliteal artery disease in young adults with intermittent claudication are for the participant to exercise, self-assess, and improve his or her knowledge of the imaging and clinical features of popliteal artery entrapment syndrome, cystic adventitial disease,and masses associated with popliteal artery obstruction.

Contrast enhanced MR angiography in the assessment of relevant stenoses in occlusive disease of the pelvic and lower limb arteries: diagnostic value of a two-step examination protocol in comparison to conventional DSA.

INTRODUCTION/OBJECTIVES: Contrast-enhanced MRA (ce-MRA) has been claimed by many authors as a replacement of conventional angiography evaluating peripheral arterial occlusive disease. However, reliable detection of relevant stenoses (>70%) has to be provided for planning vascular interventions. Only few data in the literature focuses on this crucial problem. The purpose of this study was to evaluate this topic using a two-step body-coil-based MRA protocol. METHODS AND PATIENTS: Forty three patients presenting with 82 stenoses >/=50% and 61 stenoses >70% on conventional catheter angiogram received fast Gadolinium-DTPA-enhanced high resolution 3D MR angiography at 1.5 T covering the pelvic and peripheral vascular tree in two examination steps using the body-coil. The data were evaluated double-blinded by three readers distinguishing moderate (50-70%) from severe stenoses (>70%). RESULTS: Overall sensitivity/specificity/accuracy was 84/60/70% evaluating 143 segments. Specificity was rather poor in the iliac (58%) and crural (50%) region and moderate in the femoral and popliteal level (73%). The negative predictive value ranged between 78 and 91%. The grade of stenosis tend to be overestimated rather than underestimated in all levels with positive predictive values between 55 and 78%. DISCUSSIONS AND CONCLUSIONS: Body-coil-based contrast-enhanced MRA has limited potential in distinguishing moderate from severe stenoses in peripheral occlusive disease. Overestimations are more common than underestimations. Both occur mainly in small-sized crural arteries but also in larger iliac arteries where vessel course in partition direction may cause inadequacy between voxel size and lumen diameter in severe stenosis.

Chronic critical limb ischemia: what is the benefit of radiological intervention? Indications and results.

Indications of interventional radiological procedures in patients with chronic critical limb ischemia are not clearly defined. PTA of limb arteries is used only in 3 of 4% of patients, although 20 to 40% might be candidates for a proximal intervention in the iliac arteries. Following PTA of intrapopliteal arteries, limb salvage varies from 56 to 82% and arterial patency rate from 34 to 100% after 1 to 2 years follow-up in non controlled case series studies. Arterial local thrombolysis shows better results than surgery in subgroups of patients in a few studies. Pulse spray technique does not show better clinical results than conventional infusion of the plasminogen activator. Overall, radiological interventions give similar results compared with surgery, concerning limb salvage rate, length of hospital stay, morbidity and mortality, but significantly more patients are discharged home versus a nursing institution after radiological treatment than after surgery. Radiological techniques seem to be cost effective compared to surgery. Amputation should be carried out only after all revascularization possibilities have been ruled out at a multidisciplinary vascular center.

Sonographic estimates of vein size in the lower extremities: subjective assessment compared with direct measurement.

PURPOSE: We studied whether subjective impression of vein size is a valid means of assessment during sonographic evaluation for deep vein thrombosis. METHODS: Diameter was assessed at 5 predetermined venous segments on 975 legs of 721 patients referred for evaluation for lower extremity deep vein thrombosis. The sonographer recorded a subjective assessment of whether the venous segment was enlarged, normal, or narrowed based on a visual impression of sonographic images obtained without compression. This subjective impression was then compared with the absolute measurements of vein diameter and vein diameter:artery diameter ratio at each segment. RESULTS: A significant correlation was found between the subjective characterization of vein size as enlarged, normal, and narrowed and both the absolute vein diameter and the vein:artery ratio at all 5 segments. CONCLUSIONS: Vein size can be reliably categorized by the subjective impression of experienced sonographers. Therefore, actual measurement of the vein diameter is not necessary in the evaluation for deep vein thrombosis in the majority of patients.

Assessment of popliteal arterial occlusive disease with 2D time-of-flight MRA.

OBJECTIVE: The purpose of this study was to evaluate both morphology and blood flow in peripheral arteries with occlusive lesions using MR angiography (MRA) and velocity-encoded cine MRI. MATERIALS AND METHODS: Two-dimensional time-of-flight MRA and velocity-encoded cine MRI were performed in nine patients with peripheral arterial occlusive disease. Findings on MR angiograms were verified by conventional angiography. RESULTS: All the stenotic lesions in the popliteal arteries were depicted by MRA. The degree of the stenoses in the artery was overestimated by MRA. Major collateral circulations were demonstrated. Velocity-encoded cine MRI provided flow velocity information on the arteries above and below the stenoses. The flow velocity waveform was monophasic above and below the stenosis. The peak systolic velocity in the artery below the stenosis was reduced compared with that above the stenosis (p < 0.05). CONCLUSION: The combination of MRA and velocity-encoded cine MRI has clinical potential for the evaluation of peripheral arterial occlusive disease.

Non-invasive femoropopliteal assessment: is that angiogram really necessary?

A method of non-invasive preoperative assessment of chronically ischaemic legs was developed that used clinical data and data derived from Doppler ultrasonography to produce a numerical score that could be compared with an angiographic score for stenosis of the popliteal artery trifurcation. The two scoring systems were applied retrospectively to 144 legs after femorodistal bypass. A close correlation was observed (r = 0.89, p less than 0.001), and both systems tended to predict the level of grafting undertaken. A prospective comparison was then made in 81 ischaemic legs that were examined by arteriography; the correlation between the two scoring systems remained close (r = 0.89, p less than 0.001), and the level of bypass was correctly predicted by the non-invasive assessment in 44 of 50 legs that were operated on. Use of the non-invasive assessment subsequently greatly reduced the indications for preoperative arteriography in patients requiring femorodistal vascular reconstruction.

Doppler ultrasound assessment of the femoro-popliteal segment: comparison of different methods using ROC curve analysis.

Coexisting aorto-iliac and femoro-popliteal occlusive lesions remain a problem in vascular surgery. Arteriography does not provide information on their relative contributions to the presenting symptoms. The success of proximal reconstruction alone in such cases depends to some extent on the haemodynamic significance of the femoro-popliteal disease which will remain. Several noninvasive Doppler methods have been recommended for haemodynamic assessment of the femoro-popliteal segment. These methods were studied in 72 limbs of 38 patients. The results are compared using receiver operating characteristic curve analysis. The best single test in this group of patients was normalised transit time which was significantly better than pulsatility index damping factor (p less than 0.01). The addition of damping factor to normalised transit time tended to give some improvement but this was not statistically significant in the clinically relevant part of the ROC curve.