Analysis of endovascular therapy for peripheral arterial disease in all German hospitals.

Background: The quality of vascular care has significantly improved in part by the expansion of endovascular techniques for the treatment of symptomatic peripheral artery disease (PAD) in recent years. In Germany these are primarily provided by the three disciplines of vascular surgery, angiology, and interventional radiology (IR). However, the relative contribute of angiologists to the total number of cases performed is unknown. Patients and methods: In the present study, we analysed the respective contribution of vascular surgery, angiology, and IR to the delivery of endovascular revascularisations in symptomatic PAD in Germany based on the legally mandatory quality reports representative for the reporting year 2018. Results: Vascular surgery is the most common speciality reporting procedures in German hospitals (n=579; 25.1%), followed by IR (n=264; 11.5%), angiology (n=189; 8.2%) and cardiology (n=17; 0.7%). The combination of vascular surgery and IR was reported in 202 (8.8%), vascular surgery and angiology in 167 (7.2%) and angiology and IR in 65 (2.8%) hospitals, and 63 (2.7%) hospitals reported the combination of all three disciplines. Not every department performed catheter interventions. The analysis of procedures per centre revealed that angiology centres provided the highest numbers for both basic procedures and more complex techniques such as atherectomy, rotational thrombectomy, lithoplasty, selective thrombolysis or the use of re-entry devices. In total, angiology centres provided 24.4% of the total procedures or 23.9% of the so-called basic procedures as a surrogate for patient numbers. Conclusions: While each of the disciplines contribute significantly to the endovascular procedures, angiology centres perform more procedures per centre and more complex procedures than the other disciplines highlighting the important quantitative and qualitative contribution of angiology specialists to the care of vascular patients. The inpatient catheter interventional care of patients with PAD is still too rarely carried out in a multi-disciplinary manner in Germany.

Best crossing of peripheral chronic total occlusions.

Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology (Deutsche Gesellschaft für Angiologie [DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient's renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)-(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.

Endovascular interventions in outpatient care.

Endovascular arterial revascularisations for the treatment of symptomatic peripheral arterial disease are constantly increasing in importance and number due to the changing age structure and high numbers of comorbidities in the German population. Patients with peripheral artery disease are often at increased risk for peri- and post-procedural complications including severe cardiovascular events. Due to limited financial and human resources and considerable risks of hospitalization, endovascular interventions that were previously reserved for hospitalized patients are now progressively considered to be performed as day case procedures. More than one third of these procedures are performed in Germany by internists with a specialization in angiology. In the current position paper the German Society of Angiology endorsed by the European Society of Vascular Medicine, summarizes the requirements and risk factors to be considered for the planning, safe performance and post procedural care of endovascular revascularizations in outpatients. The performance of endovascular procedures for peripheral artery disease both in hospitalised and outpatients should be accompanied by a mandatory quality assurance process that should not only capture procedural data, but also require documentation of complications and longterm outcome.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

OBJECTIVES: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. BACKGROUND: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. METHODS: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. RESULTS: The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. CONCLUSIONS: Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.

AIMS: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 µg/mm2. METHODS AND RESULTS: Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. CONCLUSION: Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. CLINICAL TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov (NCT02701543).

Impact of chemotherapeutic effects on the pathophysiology of the arterial wall - insights from peripheral arterial disease.

Systemic antineoplastic treatment agents represent one of the fastest developing medical fields. Oncological treatment is becoming increasingly individualized and new targets with corresponding agents, are constantly being developed. In tandem with this progress, new combinations and algorithms have evolved and patient's outcome have improved. Expanding tumors rely on a growing neovascular network to maintain their increased metabolism, which is caused by an accelerated reproduction rate. Accordingly, interrupting this supply mechanism is a major component of antineoplastic pharmaceutics and is a hallmark of cancer treatment. With advances in cancer treatment, long-term side effects have become an important consideration, especially in cases of neoplasia in young patients. While neuropathy and cardiotoxicity are well documented, vascular adverse events remain poorly understood. The mutual risk factors, like smoking and increased age, complicate the association between the vascular pathology and the earlier antineoplastic therapy. A deeper understanding of the effects of chemotherapy on peripheral arterial disease could lead to more detailed pathophysiological insight into both maladies and to new treatment options.

Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system - 12-month results from the LOCOMOTIVE EXTENDED study.

Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

Demographic and procedural characteristics in the RECording COurses of vasculaR Diseases (RECCORD) registry - the first 1000 patients.

Background: The RECcording COurses of vasculaR Diseases (RECCORD) registry established by the German Society of Angiology - Society for Vascular Medicine aimed to address the lack in contemporary real-world data regarding current practice of medical and interventional care in vascular patients. We herein report the demographic and procedural characteristics of the first 1000 patients undergoing endovascular revascularization (EVR) for symptomatic peripheral artery disease (PAD). Patients and methods: RECCORD is an observational, prospective, multicenter, all-comers registry. Only patients undergoing EVR for symptomatic PAD are included and followed up for at least 1 year. Demographic characteristics, comorbidities, previous peripheral vascular interventions, medication, clinical stage of lower extremity artery disease (Rutherford category), hemodynamic parameters, and procedural data including complications are recorded via an entirely web-based platform. Results: Of the first 1000 patients (mean age 70 ± 10 years, 35% female) with 1096 EVR at 1477 vascular segments of the lower extremities, 25.0% were at the stage of chronic limb threatening ischemia (CLTI) and 75.0% at non-CLTI. The femoropopliteal segment was the dominant target lesion site (61.0%), followed by iliac (26.4%) and below-the-knee EVR (10.3%). Only angioplasty was performed in 130 EVR (11.9%), adjunctive drug coated balloons (DCB) in 498 (45.4%), additional stenting in 633 (57.8%). Debulking devices were used in 106 (9.7%) EVR. Clinical (Rutherford categories) and hemodynamic parameters (ankle-brachial-index) as well as secondary preventive medication were significantly improved post EVR. Periprocedural complications occurred in 63 (5.7%) EVR with pseudoaneurysm as the leading complication type in 26 (2.4%) EVR. Conclusions: The baseline data of the first 1000 patients from the RECCORD registry representing the real-world setting illustrate that the majority of EVR are performed in patients with claudication. Adjunctive use of DCB and stenting are the dominant types of EVR, while periprocedural complications are at an acceptable low rate.

Carotid stenosis - basing treatment on individual patients' needs. Optimal medical therapy alone or accompanied by stenting or endarterectomy.

Though carotid artery stenosis is a known origin of stroke, risk assessment and treatment modality are not yet satisfactorily established. Guideline updates according to latest evidence are expected shortly. Current clinical weakness concerns in particular the identification of "at-risk" patients. Beside the symptomatic status and the degree of stenosis, further signs of unstable plaque on carotid and cerebral imaging should be considered. Moreover, medical and endovascular therapy are continuously improving. Randomized trials and meta-analyses have shown similar long-term results for protected carotid artery stenting and endarterectomy. However, endovascular revascularization was associated with an increased 30-day rate of minor strokes. Newly developed embolic protection devices could possibly compensate for this disadvantage. Furthermore, high-level optimal medical therapy alone is currently being evaluated comparatively. We assume that a comprehensive evaluation of plaque vulnerability, serious consideration of advanced embolic protection, and more space for optimal medical therapy alone according to latest evidence, will benefit patients with carotid stenosis.

First clinical experience with the Multi-LOC multiple stent delivery system for focal stenting in long femoro-popliteal lesions.

Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple stent delivery system in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required stenting, up to six short stents per delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14.5 ± 9.0 cm with reference vessel diameters of 5.6 ± 0.7 mm. Overall 47 ± 18 % of lesion lengths could be saved from stenting. At six months, the patency was 90.7 % (68/75) and all-cause TLR rates were 5.3 % (4/75) in the overall cohort. Conclusions: The first clinical experience at six months suggests that the MSDS strategy was safe and effective to treat femoro-popliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting while patency was high and TLR rates were acceptably low.

Credentialing in interventional therapy in Europe - comparison of curricula including endovascular therapy of arterial diseases.

The prevalence of peripheral artery disease (PAD) is continuously increasing. In addition, the treatment of PAD has changed substantially over the last decades. Novel treatment modalities and diagnostic tools were developed and endovascular therapy was established as a first-line therapy. In consequence, vascular medicine has become an interdisciplinary field, involving different specialties such as internal medicine/cardiology, internal medicine/angiology, vascular surgery, and (interventional) radiology. Attributed to the expanding field and to ensure high quality and standardized training, various curricula were developed. Not only within the different medical disciplines but across countries. We compared the training programmes in Germany, Switzerland, and Europe and found a great variety in these curricula and programmes. Nevertheless, we identified first attempts to harmonize training requirements within the various societies: the interdisciplinary guidelines of the German Society for Cardiology (DGK) and the German Society of Angiology, the adoption of European standards on a national level, and the Swiss initiative of the Union of Vascular Societies of Switzerland (UVSS). The standard and level of training is high in all curricula and societies. However, further harmonization is needed to optimize patient care and ensure a uniform quality level across different vascular societies.

Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry).

BACKGROUND: The prevalence of peripheral artery disease (PAD) is increasing worldwide. Revascularization procedures constitute a cornerstone of the therapy in PAD, not only in critical limb ischaemia but increasingly also in patients with intermittent claudication. The German Society of Angiology - Society for Vascular Medicine is establishing a nationwide, prospective, multicentre registry to address the lack of contemporary real life data regarding current practice of medical and interventional care in vascular patients and its subsequent long-term outcome. PATIENTS AND METHODS: The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform. In the initial phase, patients referred for endovascular revascularization of PAD of the lower limbs will be prospectively included and followed up for at least one year. At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed. Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits. The therapeutic management will be exclusively left to the discretion of the vascular specialists. RESULTS AND CONCLUSIONS: The RECCORD registry will provide a comprehensive dataset depicting the current real life practice and outcome of vascular care. The seven predefined quality indicators will be used for benchmarking the participating centres. Moreover, identifying factors promoting a favourable outcome might pave the way for an evidence-based therapeutic strategy and a dedicated therapeutic pathway for patients with PAD including patient-oriented best interventional approaches. In the future, the RECCORD registry may provide a general platform to study the courses of various defined vascular diseases in order to get detailed insights into the real life current practice of health care provided to vascular patients.

Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).

PURPOSE: To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). METHODS: In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. RESULTS: Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. CONCLUSION: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

Comparative analysis of carotid artery stenting practice and outcomes across operator specialties: insights from a prespecified subanalysis of a large real-world patient cohort (ROADSAVER Study).

BACKGROUND: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature. METHODS: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures. RESULTS: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively. CONCLUSIONS: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.

Navigating complexity with low-crossing profile dual-layer micromesh carotid stent: implications for contemporary carotid artery stenting outcomes (ROADSAVER study insights).

BACKGROUND: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS. METHODS: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without. RESULTS: One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence. CONCLUSIONS: In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.

Safety and Effectiveness of Debulking for the Treatment of Infrainguinal Peripheral Artery Disease. Data From the Recording Courses of vascular Diseases Registry in 2910 Patients.

We investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization (EVR) as part of the RECording Courses of vascular Diseases (RECCORD) registry. Patient and lesion specific characteristics, including the lesion complexity score (LCS) were analyzed. The primary endpoint encompassed: (i) clinical improvement in Rutherford categories, (ii) index limb re-interventions, and (iii) major amputations during follow-up. The secondary endpoint included the need for bail-out stenting. Overall, 2910 patients were analyzed; 2552 without and 358 with debulking-assisted EVR. Patients were 72 (interquartile range (IQR) = 15) years old and 1027 (35.3%) had diabetes. Overall complication rates were similarly low in the debulking vs the non-debulking group (4.7 vs 3.2%, P = .18). However, peripheral embolizations rates were low but more frequent with debulking vs. non-debulking procedures (3.9 vs 1.1%, P < .001). After adjustment for clinical and lesion-specific parameters, including LCS, no differences were noted for the primary endpoint (odds ration (OR) = 0.99, 95%CI = 0.69-1.41, P = .94). Bail-out stenting was less frequently performed in patients with debulking-assisted EVR (OR = 0.5, 95%CI = 0.38-0.65, P < .0001). Debulking-assisted EVR is currently used in ∼12% of EVR with infrainguinal lesions and is associated with lower bail-out stent rates but higher peripheral embolization rates; no differences were found regarding index limb re-intervention and amputation rates.

Crossing Algorithm for Infrainguinal Chronic Total Occlusions: An Interdisciplinary Expert Opinion Statement.

A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site. In addition, evaluation of distal vessels, including their diameters and quality, and the presence of calcification or stents within the occlusion zone. Three, antegrade wiring strategies, guidewire (GW) and support catheter technology, as well as GW escalation strategies. Stop the antegrade attempt depending on clinical indication for peripheral artery disease treatment and the presence of retrograde options. Four, retrograde access site, support catheter, or sheath insertion and wiring technology from distally. Five, considering strategy change when progress cannot by achieved, using advanced bidirectional techniques and re-entry devices. Six, in case of successful GW passage from retrograde, GW externalization and treatment from antegrade. Management of the retrograde access by internal or external hemostasis at the end of the procedure. Alternatively, stop the procedure if no progress can be obtained within 3 hours or in case of specific complications. By establishing the algorithm in the daily routine of endovascular specialists, improvements in vessel- and patient-specific outcomes are anticipated. In addition, future research, and continuous collaboration between experts is warranted.

MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients.

PURPOSE: To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117). METHODS: Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed. RESULTS: In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure. CONCLUSION: The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.

"Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)".

PURPOSE: Endovascular carotid artery stenosis treatment is associated with a higher peri- and early post-procedural stroke risk relative to surgery. Dual-layer micromesh carotid stents were specifically designed for improved plaque coverage to reduce the cerebral embolization risk and related ischemic events. ROADSAVER study aims to further confirm the safety and efficacy of the Roadsaver™ dual-layer micromesh stent for the treatment of elective patients with carotid artery stenosis. MATERIALS AND METHODS: ROADSAVER is a prospective, multi-center, observational study. Between January 2018 and February 2021, a total of 1967 patients featuring asymptomatic or symptomatic, non-occlusive and non-thrombotic carotid stenosis eligible for an elective stenting procedure were enrolled across 13 European countries (52 centers). Follow-up visits are scheduled at 30 days and at 12 months. The primary outcome measure is the major adverse event rate, i.e., cumulative incidence of any death or stroke up to 30 days post-procedure. All deaths, strokes and carotid revascularizations are adjudicated by an independent Clinical Events Committee. Sub-analyses are prespecified and focused on baseline patient characteristics (e.g., age, neurologic status), procedural features (e.g., access route, embolic protection use), advanced imaging, and treatment efficacy up to 12 months. CONCLUSION: The present study evaluates the Roadsaver™ dual-layer micromesh carotid stent in the real-world clinical practice aiming to provide valuable insights into the contemporary European treatment trends and outcomes of elective carotid artery stenting. The large study population and predefined sub-analyses should help identify the best practices and patient subsets to benefit most from the treatment. TRIAL REGISTRATION: Clinicaltrial.gov identifier: NCT03504228.

Safety and Effectiveness of Endovascular Therapy for the Treatment of Peripheral Artery Disease in Patients with and without Diabetes Mellitus.

This study investigated the distribution of risk factors, lesion characteristics and endovascular revascularization (EVR) strategies in patients with peripheral arterial disease (PAD) with vs without diabetes mellitus (DM). Data were collected within the RECcording COurses of vasculaR Diseases (RECCORD) registry. Demographic data, lesion localization (iliac vs femoropopliteal vs below-the-knee (BTK)) and lesion complexity score (LCS) based on number of affected segments, and lesion length (< 10 vs 10-20 vs > 20 cm), EVR strategies and peri-procedural complications were analysed in 786 patients with and 1337 without diabetes mellitus. Patients with diabetes mellitus were older (71.6 ± 9.6 vs 69.4 ± 10.5 years, P < .001) and had higher LCS and more often BTK lesions (P < .05 for all). Lesions were treated less frequently with stents (48.7 vs 59.6%, P < .001) in patients with diabetes mellitus, whereas a non-significant trend was noticed for higher DCB treatment rates (48.3 vs 44.4%, P = .07). Post-interventional ankle-brachial index (ABI) increase was similar (from .77 ± .28 to .92 ± .25 with diabetes mellitus and from .74 ± .21 to .90 ± .20 without diabetes mellitus, P < .001 for both). Peri-/post-procedural complications were low in both groups (4.6%). Patients with diabetes mellitus, who undergo endovascular revascularization are older, have more comorbidities and higher target lesion complexity. However, treatment success rates are similar and complication rates are low.