Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Femoropopliteal Arterial Disease.

INTRODUCTION: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease. METHODS: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed. RESULTS: Fifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR. CONCLUSIONS: In this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions.

INTRODUCTION: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). METHODS: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. RESULTS: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100-260 mm], whereas the median CTO length was 100 mm (IQR=50-210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade-retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7-10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3-4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4-2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7-7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5-10.8) were associated with an increased risk for antegrade crossing failure. CONCLUSIONS: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion's location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success.

Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Common Femoral Artery Atherosclerotic Disease.

OBJECTIVES: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. METHODS: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed. RESULTS: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency. CONCLUSIONS: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. CLINICAL IMPACT: Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

Outcomes After Open Surgical, Hybrid, and Endovascular Revascularization for Acute Limb Ischemia.

PURPOSE: To report the performance of surgical treatment (ST), hybrid treatment (HT), and endovascular treatment (ET) for patients with acute limb ischemia (ALI). METHODS: This is a retrospective, comparative study of all consecutive patients with ALI treated in 2 tertiary centers between April 2010 and April 2020. Amputation and/or death (amputation-free survival; AFS) was the primary composite endpoint. Mortality, major amputation, and reintervention during follow-up were additionally analyzed. Proportional hazards modeling was used to identify confounders, results are presented as hazard ratio (HR) and 95% confidence intervals (CIs). RESULTS: In total, 395 patients (mean age=71.1±13.6 years; 51.1% female) were treated during the study period. Surgical treatment was preferred in 150 patients (38%), while 98 were treated by HT (24.8%) and 147 by ET (37.2%). Rutherford class IIa was the most common clinical presentation in the ET group (50.3%), whereas Rutherford IIb was most common in the ST (54%) and HT (48%) groups (p<0.001). Significantly, more patients presented with a de novo lesion in the ST and HT groups (79.3% and 64.3%, respectively) compared with ET (53.7%; p<0.001). Median follow-up was 20 months (range=0-111 months). In the multivariate analysis, ET showed significantly better AFS during follow-up compared with ST (HR=1.89, 95% CI=1.2-2.9, p<0.001) and HT (HR=1.73, 95% CI=1.1-3.1, p<0.001). Mortality during follow-up was also significantly lower after ET compared with ST (HR=2.21, 95% CI=1.31-3.74, p=0.003) and HT (HR=2.04, 95% CI=1.17-3.56, p=0.012). Endovascular treatment was associated with lower amputation rate compared with ST (HR=2.27, 95% CI=1.19-4.35, p=0.013) but was comparable with HT (HR=2.00, 95% CI=0.98-4.06, p=0.055). Reintervention rates did not differ significantly between the groups (ET vs ST: HR=1.52, 95% CI=0.99-2.31, p=0.053; ET vs HT: HR=1.3, 95% CI=0.81-2.07, p=0.27). CONCLUSION: Endovascular treatment for ALI was associated with improved AFS and comparable reintervention rates compared with open surgical and hybrid therapy. CLINICAL IMPACT: Treatment of acute lower limb ischemia remains a challenge for clinicians with high morbidity and mortality rates. Endovascular revascularization is considered first line treatment for many and hybrid treatments are becoming more common, however data is limited to either old trials, small series or with short follow-up. We present herein our 10-year experience with all available devices and techniques for open surgical, endovascular and hybrid acute limb ischemia treatments and compare their outcomes.

International Cross-Sectional Survey of Bullying, Undermining, and Harassment in the Vascular Workplace.

OBJECTIVE: Bullying, undermining behaviour, and harassment (BUH) may exist in healthcare settings, impacting on patient care. The aim of this international study was to evaluate the characteristics of BUH experienced by physicians treating vascular diseases at various career stages. METHODS: This was an anonymous international structured non-validated cross-sectional survey distributed via relevant professional societies in collaboration with the Research Collaborative in Peripheral Artery Disease. The survey was disseminated through societies' newsletters, emails, and social media. Data were collected online, allowing free text entries alongside structured multiple choice questions based on previous surveys. Demographics, geographical information, and data relating to stage and training environment were collected. RESULTS: Of 587 respondents from 28 countries, 86% were working in vascular surgery, mostly at a university hospital (56%); 81% were aged between 31 and 60 years, 57% were working as a consultant, and 23% as a resident. Respondents were mostly white (83%), male (63%), heterosexual (94%), and without disability (96%). Overall, 253 (43%) reported experiencing BUH personally, 75% had witnessed BUH toward colleagues, and 51% witnessed these in the last 12 months. Female sex and non-white ethnicity were associated with BUH (53% vs. 38% and 57% vs. 40% respectively; p < .001 in both cases). While working as a consultant, 171 (50%) reported experiencing BUH, more often among females, non-heterosexuals, those who were not working in their country of birth, and non-white people. Specialty and hospital type were not associated with BUH. CONCLUSION: BUH remains a major problem in the vascular workplace. Female sex, non-heterosexuality, and non-white ethnicity are associated with BUH at various career stages.

Editor's Choice - Covered vs. Bare Metal Stents in the Reconstruction of the Aortic Bifurcation: Early and Midterm Outcomes from the COBRA European Multicentre Registry.

OBJECTIVE: To report outcomes following endovascular revascularisation for severe aorto-iliac occlusive disease (AIOD) using covered (CS) or bare metal (BMS) stent(s). METHODS: This was a retrospective cohort study including patients who underwent treatment with CS or BMS for AIOD between November 2012 and March 2020 in 12 European centres. Outcome measures included death, freedom from target lesion revascularisation (TLR), major amputation, and major adverse cardiac and cerebrovascular events (MACCE). RESULTS: Overall, 252 patients (53% males; mean age 65 ± 10 years) were included (102 with a bare metal and 150 with a covered aortic stent); 122 (48%) presented with chronic limb threatening ischaemia (CLTI). Severe arterial calcification was noted in > 65% of patients, 70% presented with Trans-Atlantic Societies Consensus (TASC) D lesions, 32% and 46% had aortic or iliac chronic total occlusion (CTO), respectively. Median follow up was 17 months (range 6 - 40; none lost to follow up). Median inpatient stay was two days (range two to four). During the first 30 days, two patients died (both with covered aortic stents, because of cardiovascular events), none required TLR, two (1%) patients had a major amputation (all presented with CLTI), and three (1%) had a MACCE. At 17 months, mortality (BMS 14% vs. CS 7%, hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.42 - 2.26, p = .94, log rank test) and TLR (11% vs. 10%, HR 1.98, 95% CI 0.89 - 4.43, p = .095) did not differ statistically significantly between the two groups; only three patients had a major limb amputation during late follow up (all with a covered stent). In a multivariable model, the use of an aortic CS did not influence TLR. In a conditional Cox regression, however, the concomitant use of aortic and iliac CSs was associated with improved freedom from TLR. CONCLUSION: Endovascular reconstruction with aortic CSs or BMSs for severe AIOD showed comparable midterm performance. The use of both aortic and iliac CSs seems to be associated with reduced TLR.

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease.

OBJECTIVES: The objective is to assess the performance of the Eluvia polymer coated drug eluting stent (DES) compared to a bare metal stent (BMS) platform in patients with femoropopliteal arterial disease. METHODS: This is a retrospective, single-center analysis. Patients treated with the Eluvia DES (group Eluvia) or the EverFlex BMS (group BMS) for femoropopliteal disease between January 2013 and December 2019 were included. Primary measure outcome of this analysis was the overall mortality. The PTX specific mortality, the primary patency, the amputation free survival (AFS), and the target lesion revascularization (TLR) rates were additionally evaluated. RESULTS: A total of 124 patients were treated by BMS deployment, while the Eluvia platform was preferred in 75 subjects. In both groups the majority presented with lifestyle limiting claudication (BMS: 84% vs Eluvia: 73%, p = 0.73). Chronic total occlusions were more frequent in patients treated by BMS (BMS: 71% vs Eluvia: 84%, p = 0.027), whereas the calcification burden (BMS: 81% vs Eluvia: 76%, p = 0.43) and the median lesion length (in mm, IQR) (BMS: 160 (100 to 240) vs Eluvia: 140 (80 to 229), p = 0.17) were comparable. At 24 months, the overall survival (BMS: 93% vs Eluvia: 89%, hazard ratio (HR): 1.20, 95% confidence interval (CI): 0.55 to 2.64, p = 0.64) and the PTX specific survival (BMS: 95% vs Eluvia: 95%, HR: 1.28, 95% CI: 0.41 to 4.02, p = 0.67) did not differ significantly between the two platforms. No significant difference was observed regarding the 24 months primary patency rate (BMS: 66% vs Eluvia: 78%, HR: 0.65, 95% CI: 0.37 to 1.15, p = 0.18), the freedom from TLR (BMS: 83% vs Eluvia: 89%, HR: 0.81, 95% CI: 0.39 to 1.68, p = 0.572), and the AFS (BMS: 93 vs Eluvia: 89%, HR: 1.20, 95% CI: 0.55 to 2.64). The Cox regression analysis revealed a higher mortality risk among patients with chronic limb-threatening ischemia (CLTI) (HR: 3.14, 95% CI: 1.61 to 6.14, p = 0.008), chronic obstructive pulmonary disease (COPD) (HR: 4.65, 95% CI: 2.14 to 10.09, p = 0.001), in octagenerians (HR: 4.40, 95% CI: 1.92 to 10.44, p = 0.005), and in patients not on statins at baseline (HR: 2.44, 95% CI: 1.19 to 4.99, p=0.014). CONCLUSIONS: In this cohort, the use of the Eluvia DES did not increase the risk for mortality compared to BMS deployment. CLTI, COPD, advanced age, and the lack of statin therapy at baseline were associated with a higher risk for death.

Revascularization Outcomes in Patients With Acute Limb Ischemia and Active Neoplastic Disease.

PURPOSE: To report the outcomes of surgical (ST), endovascular (ET), and hybrid (HT) treatment in cancer patients with acute limb ischemia (ALI). MATERIALS AND METHODS: A multicenter retrospective registry collected 139 patients (mean age 72.3±12.4 years; 73 men) with ALI and active malignancy treated by ET (41, 29%), ST (70, 51%), or HT (28, 20%) in 7 European centers between July 2007 and February 2019. In 22 cases (16%) ALI was the first manifestation of the malignancy. Lung cancer was the most common diagnosis (38, 27%). The primary composite outcome was amputation-free survival (AFS). Overall survival, amputation-free time (AFT), and reintervention-free time (RFT) were also assessed. Cox regression analysis was applied to identify independent risk factors for the primary and secondary outcomes. Results are presented as the hazard ratio (HR) and 95% confidence intervals (CIs). RESULTS: ET was associated with improved 12-month AFS compared with both ST (HR 2.27, 95% CI 1.20 to 4.28, p=0.002) and HT (HR 2.14, 95% CI 1.09 to 4.18, p=0.008). ST (HR 2.50, 95% CI 1.19 to 5.53, p=0.003) and HT (HR 3.10, 95% CI 1.45 to 6.65, p<0.001) were related to an increased risk for mortality compared with ET. At 12 months, the AFT was similar between the 3 groups (ET vs ST: HR 1.52, 95% CI 0.51 to 4.53, p=0.45 and ET vs HT: HR 1.21, 95% CI 0.36 to 4.11, p=0.73). The 12-month RFT also did not differ significantly between the 3 treatment options (ET vs ST: HR 1.10, 95% CI 0.49 to 2.46, p=0.79 and ET vs HT: HR 0.51, 95% CI 0.22 to 1.17, p=0.19). ST and/or HT increased the risk for the major amputation and/or death (HR 1.76, 95% CI 1.05 to 2.05, p=0.03), while Rutherford class I ischemia (HR 0.12, 95% CI 0.02 to 0.90, p=0.04) and previous vascular interventions on the index limb (HR 0.55, 95% CI 0.32 to 0.97, p=0.04) showed a protective effect. CONCLUSION: In patients with ALI and active malignant disease, ET was associated with increased AFS and overall survival compared with both ST and HT, while the limb salvage and reintervention rates were comparable among the 3 groups.

Mediators of the Disparities in Depression Between Sexual Minority and Heterosexual Individuals: A Systematic Review.

Evidence suggests that sexual minorities (e.g., those identifying as lesbian, gay, or bisexual) experience increased rates of depression compared to heterosexual individuals. Minority stress theory suggests that this disparity is due to stigma experienced by sexual minorities. Stigma processes are proposed to contribute to reduced coping/support resources and increased vulnerability processes for mental health problems. This review provided a systematic examination of research assessing the evidence for mediating factors that help explain such disparities. A literature search was conducted using the databases PubMed, PsycINFO, and Web of Science. The review included 40 identified studies that examined mediators of sexual minority status and depressive outcomes using a between-group design (i.e., heterosexual versus sexual minority participants). Studies of adolescents and adult samples were both included. The most common findings were consistent with the suggestion that stressors such as victimization, harassment, abuse, and increased stress, as well as lower social and family support, may contribute to differing depression rates in sexual minority compared to heterosexual individuals. Differences in psychological processes such as self-esteem and rumination may also play a role but have had insufficient research attention so far. However, caution is needed because many papers had important methodological shortcomings such as the use of cross-sectional designs, inferior statistical analyses for mediation, or measures that had not been properly validated. Although firm conclusions cannot be drawn, the current evidence base highlights many factors potentially suitable for further exploration in high-quality longitudinal research or randomized studies intervening with the potential mediators.

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System.

Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry (ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Safety and Feasibility of Intravascular Lithotripsy for Treatment of Common Femoral Artery Stenoses.

PURPOSE: To evaluate the safety and feasibility of treating calcified, stenotic common femoral arteries (CFAs) using the Peripheral Intravascular Lithotripsy (IVL) System. METHODS: An analysis was performed of 21 patients (mean age 71.9±10.1 years; 16 men) across 3 sites with calcified CFA stenoses treated with the Peripheral IVL System. The outcomes of interest were the ability to deliver IVL to the target lesion, the increase in acute gain, the reduction in diameter stenosis, the rate of provisional stenting, and angiographically defined complications. RESULTS: Access to the target lesion and delivery of treatment by the IVL catheter were successful in all 21 patients. Post treatment mean diameter stenosis was 21.3%, representing an acute mean lumen gain of 3.1±1.3 mm (range 0.7-5.2). Vascular complications were minimal, with only 5 type B (non-flowing-limiting) dissections reported. The profunda femoris artery was patent in all patients following IVL, and none of the subjects experienced a perforation, distal embolization, thrombus, no reflow, or abrupt closure. CONCLUSION: These early results demonstrate that calcified, stenotic CFA lesions can be safely and successfully treated using the Peripheral IVL System.

Impact of Calcification on the Outcomes of Femoropopliteal Artery Endovascular Treatment Using a Polymer Coated Drug-Eluting Stent.

PURPOSE: The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. MATERIAL AND METHODS: A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. RESULTS: In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36). CONCLUSIONS: In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.

Complex post-traumatic stress disorder in asylum seekers and victims of trafficking: treatment considerations.

Asylum-seekers experience high levels of traumatic events pre-, post- and during migration. Poly-traumatisation is associated with complex post-traumatic stress disorder (CPTSD), which has not yet been extensively explored in this population. CPTSD is a prevalent and highly disabling disorder in the present population requiring culturally sensitive diagnostic and treatment approaches. In this service evaluation, we evidence the high prevalence of CPTSD in an asylum-seeking sample and its association with greater distress compared with PTSD. We outline the treatment needs of asylum seekers with CPTSD.

2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions.

OBJECTIVES: The aim of this study was to evaluate the 2-year performance of a polymer-based drug-eluting stent (DES) for the treatment of complex femoropopliteal lesions. BACKGROUND: Despite the promising early outcomes of the Eluvia DES, the long-term safety and efficacy of the device in a real-world scenario remain unclear. METHODS: Between March 2016 and December 2018, 130 patients (137 lesions) with symptomatic femoropopliteal disease were included in this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization, freedom from surgical conversion, and overall mortality and morbidity were additionally analyzed. RESULTS: The majority of patients presented with lifestyle-limiting claudication (n = 90 [69%]). The mean lesion length was 194 ± 108 mm, 74% of the lesions (n = 101) were chronic total occlusions, and 72% (n = 99) were calcified. Moderate to severe calcification (Peripheral Arterial Calcium Scoring Scale score 3 or 4) was observed in 48% of the treated vessels (n = 67). At 24 months, the Kaplan-Meier estimate of primary patency was 71%, whereas both the secondary patency rate and freedom from target lesion revascularization were 80%. Overall survival amounted to 85%. Freedom from major amputation was 98%, while freedom from surgical conversion was 89%. Degeneration of the vessel wall was observed in 27 lesions (20%). CONCLUSIONS: In this study, use of the Eluvia polymer-based DES for the treatment of complex femoropopliteal disease showed promising 2-year results. Nonetheless, a relatively high rate of vessel wall degeneration was observed after DES deployment.

Optical coherence tomography guided directional atherectomy with antirestenotic therapy for femoropopliteal arterial disease.

BACKGROUND: Optical coherence tomography (OCT)-guided directional atherectomy enables a real-time visualization of the arterial wall during plaque debulking and might optimize vessel preparation prior to drug-coated balloon (DCB) angioplasty. Nonetheless there is a paucity of data reporting on the outcomes of OCT-guided directional atherectomy with antirestenotic therapy (DAART). Aim of this study was to evaluate the performance of OCT-guided DAART in the treatment of femoropopliteal atherosclerosis. METHODS: Patients treated by OCT-guided DAART for femoropopliteal occlusive disease between January 2015 and December 2016 were included into this retrospective, single-center, single-arm analysis. The primary measure outcome of this study was primary patency rate (PPR). Secondary outcomes were technical success rate (TSR), secondary patency rate (SPR) and freedom from target lesion revascularization (TLR). RESULTS: Thirty-three patients (N.=33, mean age 67±8 years) and 37 lesions were included into this analysis. The median follow-up time was 15 months (interquartile ratio (IQR): 4-21). The majority of patients presented with lifestyle limiting claudication (N.=25, 75%) and de novo atherosclerotic disease (N.=25, 68%). Median lesion length was 70 mm (IQR: 27-104), while 35% (N.=13) of the lesions were chronic total occlusions. Vessel wall calcification was present in 22% (N.=8) of the treated vessels. The mean luminal gain after atherectomy was 52±17% and the median gain after DAART amounted to 68% (IQR: 58-91). The TSR was 95%. The overall 12 months PPR was 93% whereas the SPR and the freedom from TLR at 12 months were 95% and 100% respectively. A single target vessel perforation (N.=1, 3%) and 2 peripheral embolizations (N.=2, 5%) were observed. The bailout stenting rate was 3% (N.=1) and the final angiography did not reveal any flow limiting dissection. An aneurysmatic degeneration of the target vessel was observed in 2 lesions (5%). CONCLUSIONS: In this study, OCT-guided DAART was associated with sufficient luminal gain, low rates of bailout stenting and perioperative adverse events and led to very promising 12-month outcomes.

How to deal with calcium in the superficial femoral artery.

Despite the continuous evolution of endovascular therapy, severe calcification remains a major issue for the minimally invasive treatment of superficial femoral artery (SFA) disease. The presence of calcium might negatively affect both the crossing of peripheral lesions and outcomes of all available treatment modalities and is therefore associated with unfavorable acute and long-term results. This manuscript summarizes the challenges raised from severe calcified atherosclerotic lesions and presents the outcomes of the various endovascular modalities in the treatment of calcified SFA disease.

1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty.

OBJECTIVES: The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions. BACKGROUND: The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear. METHODS: Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up. RESULTS: Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel. CONCLUSIONS: The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.