A proposal for a revision of the phlebographic classification of congenital venous malformations.

Background: Venous malformation (VM) is the most frequent type of congenital vascular malformation. In terms of functional outcome local sclerotherapy remains the most important therapeutic tool. For planning and correct estimation and prevention of complications, an exact anatomical classification of the VM is crucial. Not only the drainage, as assessed in the established classification, but also the phlebographic aspect of the internal VM structure itself plays a decisive role. In order to integrate this aspect, we aim to validate a proposal for a revised phlebographic VM classification distinguishing non-lacunar (a) and lacunar (b) types. Methods: We retrospectively analyzed all patients with VM in whom a direct puncture phlebography was performed in our clinic between 2009 and 2018 to assess morphology and flow characteristics. Phlebographic assessment included: (I) differentiation of non-lacunar vs. lacunar type; (II) drainage assignment according to the existing classification; (III) adjusted classification combining both. Inter-reader agreement was measured in percentage as well as by the Cohen's kappa coefficient (κ). Results: Overall 26 patients were classified as non-lacunar (a) and 41 patients as lacunar (b) VM. For this categorization, inter-reader agreement was 96% (κ=0.91). Classical Puig classification into types I, II, III and IV showed 87% inter-reader agreement (κ=0.78). For the adjusted classification adding the non-lacunar or lacunar characteristic to type I-IV an agreement of 82% (κ=0.77) was achieved. Conclusions: Phlebographic differentiation into non-lacunar and lacunar VM is feasible and reliable to distinguish phenotypic subgroups of patients with VM. We therefore propose to integrate this parameter of the internal VM structure into the existing classification.

Combination of Model for End-Stage Liver Disease (MELD) and Sarcopenia predicts mortality after transjugular intrahepatic portosystemic shunt (TIPS).

TIPS is the most effective treatment for portal hypertension. Patient selection remains important to achieving optimal post-TIPS outcomes. The study evaluates 1-year mortality factors in cirrhotic patients receiving TIPS. METHODS: 87 cirrhotic patients received a TIPS between 2015 - 2021. Predictors of 1-year and overall mortality were assessed by estimating cumulative incidence functions and Grey's test to adjust for liver transplantation as a risk competing with mortality. Variables with p < 0.05 were checked for collinearity and included in the multivariate Cox proportional hazards model. Model discrimination was evaluated by calculating the area under the ROC curve. RESULTS: 87 patients were included (68% men; 22% ≥70 years). ALD was the primary cirrhosis cause. Most patients were Child-Pugh class B, MELD-Na score was 13.6 ± 6.0 points. The most frequent indication for TIPS was bleeding (51.7%), followed by refractory ascites (42.5%). The variables positively associated with mortality in univariate analysis were ascites, clinically overt sarcopenia and MELD-Na score, while ongoing nutritional supplementation improved survival. In the multivariate analysis, only clinically overt sarcopenia and MELD-Na score remained independently associated with mortality. A MELD-Na/sarcopenia model demonstrated a good discrimination, AUROC: 0.86 (95% CI 0.77 - 0.95). CONCLUSION: MELD-Na score, and sarcopenia were significantly associated with 1-year survival in cirrhotic patients who received TIPS.

A cost-effective sequencing method for genetic studies combining high-depth whole exome and low-depth whole genome.

Whole genome sequencing (WGS) at high-depth (30X) allows the accurate discovery of variants in the coding and non-coding DNA regions and helps elucidate the genetic underpinnings of human health and diseases. Yet, due to the prohibitive cost of high-depth WGS, most large-scale genetic association studies use genotyping arrays or high-depth whole exome sequencing (WES). Here we propose a cost-effective method which we call "Whole Exome Genome Sequencing" (WEGS), that combines low-depth WGS and high-depth WES with up to 8 samples pooled and sequenced simultaneously (multiplexed). We experimentally assess the performance of WEGS with four different depth of coverage and sample multiplexing configurations. We show that the optimal WEGS configurations are 1.7-2.0 times cheaper than standard WES (no-plexing), 1.8-2.1 times cheaper than high-depth WGS, reach similar recall and precision rates in detecting coding variants as WES, and capture more population-specific variants in the rest of the genome that are difficult to recover when using genotype imputation methods. We apply WEGS to 862 patients with peripheral artery disease and show that it directly assesses more known disease-associated variants than a typical genotyping array and thousands of non-imputable variants per disease-associated locus.

Patient-specific risk factors for reintervention following primary endovascular treatment of iliac artery disease.

OBJECTIVE: Predictive models for reintervention may guide clinicians to optimize selection, education, and follow-up of patients undergoing endovascular iliac revascularization. Although the impact of lesion- and device-related characteristics on iliac restenosis and reintervention risk is well-defined, data on patient-specific risk factors are scarce and conflicting. This study aimed to explore the value of patient-related factors in predicting the need for clinically driven target-vessel revascularization (CD-TVR) in patients undergoing primary endovascular treatment of iliac artery disease. METHODS: Consecutively enrolled patients undergoing endovascular revascularization for symptomatic iliac artery disease at a tertiary vascular referral center between January 2008 and June 2020 were retrospectively analyzed. Primary and secondary outcomes were CD-TVR occurrence within 24 months and time to CD-TVR, respectively. Patients who died or did not require CD-TVR within 24 months were censored at the date of death or at 730 days, respectively. Multiple imputation was used to account for missing data in primary analyses. RESULTS: A total of 1538 iliac interventions were performed in 1113 patients (26% females; 68 years). CD-TVR occurred in 108 limbs (74 patients; 7.0%) with a median time to CD-TVR of 246 days. On multivariable analysis, increasing age was associated with lower likelihood of CD-TVR (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.50-0.83; P = .001) and decreased risk of CD-TVR at any given time (hazard ratio [HR], 0.66; 95% CI, 0.52-0.84; P = .001). Similarly, a lower likelihood of CD-TVR (OR, 0.75; 95% CI, 0.59-0.95; P = .017) and decreased risk of CD-TVR at any given time (HR, 0.73; 95% CI, 0.58-0.93; P = .009) were observed with higher glomerular filtration rates. Lastly, revascularization of common vs external iliac artery disease was associated with lower likelihood of CD-TVR (OR, 0.48; 95% CI, 0.24-0.93; P = .030) and decreased risk of CD-TVR at any given time (HR, 0.48; 95% CI, 0.25-0.92; P = .027). No associations were observed between traditional cardiovascular risk factors (sex, hypertension, higher low-density lipoprotein cholesterol, higher hemoglobin A1c, smoking) and CD-TVR. CONCLUSIONS: In this retrospective cohort study, younger age, impaired kidney function, and external iliac artery disease were associated with CD-TVR. Traditional markers of cardiovascular risk were not seen to predict reintervention.

Comparison of transarterial bland embolization and drug-eluting beads transarterial chemoembolization for very early and early hepatocellular carcinoma not amenable for surgery or ablation: a single center retrospective data analysis.

Background: Transarterial chemoembolization (TACE) is the accepted therapy for intermediate hepatocellular carcinoma (HCC). Although recent data suggests that bland transarterial embolization (TAE) is equally effective in intermediate HCC, not much is known about the efficacy in very early and early HCC not amenable for ablation or resection. We aimed to compare the outcome of patients with very early and early HCC treated by drug-eluting beads TACE (DEB-TACE), a specific technique of TACE using DC beads, and TAE using microparticles with a size of 100 µm up to 700 µm. Methods: Clinical data of totally 95 patients with very early and early HCC not amenable for surgery or ablation, treated between 2009 and 2019 at the Department of Visceral Surgery and Medicine and the Interdisciplinary Center of Vascular Interventions, University Hospital Bern, Switzerland, were retrospectively analyzed (52 patients in DEB-TACE and 42 patients in TAE group, respectively). All images were assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Primary endpoint was overall survival (OS). Secondary endpoints were local response rate and time to local progression. Results: Most patients presented with Child-Pugh A. Thrombocytes were significantly lower in patients treated by TAE. Minor side effects occurred equally in both groups. No differences were detected in terms of OS, local tumor recurrence and response rate. Conclusions: Compared with DEB-TACE, TAE is an equally effective and save therapy for very early and early HCC not amenable for resection or ablation without differences in local tumor control and OS.

Association of sex and cardiovascular risk factors with atherosclerosis distribution pattern in lower extremity peripheral artery disease.

Objective: Atherosclerosis expression varies across not only coronary, cerebrovascular, and peripheral arteries but also within the peripheral vascular tree. The underlying pathomechanisms of distinct atherosclerosis phenotypes in lower extremity peripheral artery disease (PAD) is poorly understood. We investigated the association of cardiovascular risk factors (CVRFs) and atherosclerosis distribution in a targeted approach analyzing symptomatic patients with isolated anatomic phenotypes of PAD. Methods: In a cross-sectional analysis of consecutive patients undergoing first-time endovascular recanalization for symptomatic PAD, data of patients with isolated anatomic phenotypes of either proximal (iliac) or distal (infrageniculate) atherosclerosis segregation were extracted. We performed a multivariable logistic regression model with backward elimination to investigate the association of proximal and distal PAD with CVRFs. Results: Of the 637 patients (29% females) with endovascular recanalization, 351 (55%) had proximal and 286 (45%) had distal atherosclerosis. Female sex [odds ratio (OR) 0.33, 95% confidence interval (CI) 0.20-0.54, p = 0.01], active smoking (OR 0.16, 95% CI 0.09-0.28, p < 0.001), and former smoking (OR 0.33, 95% CI 0.20-0.57, p < 0.001) were associated with proximal disease. Diabetes mellitus (DM) (OR 3.25, 95% CI 1.93-5.46, p < 0.001), chronic kidney disease (CKD) (OR 1.18, 95% CI 1.08-1.28, p < 0.001), and older age (OR 1.31, 95% CI 1.06-1.61, p = 0.01) were associated with distal disease. Conclusion: Female sex, particularly in the context of smoking, is associated with clinically relevant, proximal atherosclerosis expression. Our additional findings that distal atherosclerosis expression is associated with DM, CKD, and older age suggest that PAD has at least two distinct atherosclerotic phenotypes with sex-specific and individual susceptibility to atherogenic risk factors.

Early menopause and cardiovascular risk factors: a cross-sectional and longitudinal study.

OBJECTIVE: The aim of the study is to evaluate the cross-sectional and longitudinal association of early natural menopause with changes in cardiovascular risk factors (CVRFs). METHODS: Postmenopausal women from the Swiss CoLaus study, reporting age at natural menopause (ANM) and having CVRFs measurements (blood lipids, blood pressure, glucose, homeostatic model assessment for insulin resistance [HOMA-IR], and inflammatory markers) at baseline (2003-2006) and first follow-up (2009-2012) were eligible for analysis. Age at natural menopause was analyzed as a continuous variable and in categories (ANM <45 and ≥45 y old). Linear regression analysis and linear mixed models were used to assess whether ANM is associated cross-sectionally and longitudinally with changes in CVRFs. Models were adjusted for demographic characteristics, lifestyle-related factors, time since menopause, medication, and clinical conditions. RESULTS: We analyzed 981 postmenopausal women. The cross-sectional analysis showed that women with ANM younger than 45 years had lower diastolic blood pressure (ß = -3.76 mm Hg; 95% confidence interval [CI] = -5.86 to -1.65) compared with women whose ANM was 45 years or older. In the longitudinal analysis, ANM younger than 45 years was associated with changes in log insulin (ß = 0.26; 95% CI = 0.08 to 0.45) and log homeostatic model assessment for insulin resistance levels (ß = 0.28; 95% CI = 0.08 to 0.48). No associations were found between ANM and other CVRFs. CONCLUSIONS: Early menopause may be associated with changes in glucose metabolism, while it may have little to no impact on other CVRFs. Larger longitudinal studies are needed to replicate our findings.

Clinical phenotype of adolescent and adult patients with extracranial vascular malformation.

OBJECTIVE: In recent years, genotypic characterization of congenital vascular malformations (CVMs) has gained attention; however, the spectrum of clinical phenotype remains difficult to attribute to a genetic cause and is rarely described in the adult population. The aim of this study is to describe a consecutive series of adolescent and adult patients in a tertiary center, where a multimodal phenotypic approach was used for diagnosis. METHODS: We analyzed clinical findings, imaging, and laboratory results at initial presentation, and set a diagnosis according to the International Society for the Study of Vascular Anomalies (ISSVA) classification for all consecutively registered patients older than 14 years of age who were referred to the Center for Vascular Malformations at the University Hospital of Bern between 2008 and 2021. RESULTS: A total of 457 patients were included for analysis (mean age, 35 years; females, 56%). Simple CVMs were the most common (n = 361; 79%), followed by CVMs associated with other anomalies (n = 70; 15%), and combined CVMs (n = 26; 6%). Venous malformations (n = 238) were the most common CVMs overall (52%), and the most common simple CVMs (66%). Pain was the most frequently reported symptom in all patients (simple, combined, and vascular malformation with other anomalies). Pain intensity was more pronounced in simple venous and arteriovenous malformations. Clinical problems were related to the type of CVM diagnosed, with bleeding and skin ulceration in arteriovenous malformations, localized intravascular coagulopathy in venous malformations, and infectious complications in lymphatic malformations. Limb length difference occurred more often in patients with CVMs associated with other anomalies as compared with simple or combined CVM (22.9 vs 2.3%; P < .001). Soft tissue overgrowth was seen in one-quarter of all patients independent of the ISSVA group. CONCLUSIONS: In our adult and adolescent population with peripheral vascular malformations, simple venous malformations predominated, with pain as the most common clinical symptom. In one-quarter of cases, patients with vascular malformations presented with associated anomalies on tissue growth. The differentiation of clinical presentation with or without accompanying growth abnormalities need to be added to the ISSVA classification. Phenotypic characterization considering vascular and non-vascular features remains the cornerstone of diagnosis in adult as well as pediatric patients.

Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.

AIMS: Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy. METHODS AND RESULTS: Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints. CONCLUSION: Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.

Complex Lymphatic Anomalies: Report on a Patient Registry Using the Latest Diagnostic Guidelines.

Background: Generalized lymphatic anomaly (GLA), Gorham-Stout disease (GSD), kaposiform lymphangiomatosis (KLA), and central conducting lymphatic anomaly (CCLA) are rare, multisystem lymphatic disorders, referred to as complex lymphatic anomalies (CLAs). Their etiology remains poorly understood; however, somatic activating mutations have recently been discovered, and the results of targeted treatments are promising. This study aimed to elaborate on the phenotypic description of CLA. Methods: Thirty-six consecutive patients were recruited for the "GLA/GSD Registry" of the University Hospital of Freiburg, Germany (2015-2021). Clinical data were prospectively collected provided that a signed informed consent form was obtained. The latest proposed diagnostic guidelines were retrospectively applied. Results: Thirty-two patients (38% males) were included in the study; 15 GLA, 10 GSD, 3 KLA, and 4 CCLA patients were identified. Eighty-four percent already had symptoms by the age of 15 years. Osteolysis and periosseous soft-tissue infiltration were associated with GSD (p < 0.001 and p = 0.011, respectively), ascites and protein-losing enteropathy with CCLA (p = 0.007 and p = 0.004, respectively), and consumption coagulopathy with KLA (p = 0.006). No statistically significant differences were found in organ involvement, distribution of osteolytic lesions, number of affected bones and fractures. Twenty-five patients had complications; one patient with GLA died despite multimodal treatment. Spontaneous regression was seen in one patient with untreated KLA. Conclusions: CLA are rare, and their overlapping clinical presentations make differential diagnosis difficult. The characterization of our case series contributes to the phenotypic description and differentiation of these four clinical entities. A further understanding of their pathogenesis is crucial for evaluating targeted therapies and optimizing medical care.

Sex-specific and hormone-related differences in vascular remodelling in atherosclerosis.

Atherosclerosis, a lipid-driven inflammatory disease, is the main underlying cause of cardiovascular diseases (CVDs) both in men and women. Sex-related dimorphisms regarding CVDs and atherosclerosis were observed since more than a decade ago. Inflammatory mediators such as cytokines, but also endothelial dysfunction, vascular smooth muscle cell migration and proliferation lead to vascular remodelling but are differentially affected by sex. Each year a greater number of men die of CVDs compared with women and are also affected by CVDs at an earlier age (40-70 years old) while women develop atherosclerosis-related complications mainly after menopause (60+ years). The exact biological reasons behind this discrepancy are still not well-understood. From the numerous animal studies on atherosclerosis, only a few include both sexes and even less investigate and highlight the sex-specific differences that may arise. Endogenous sex hormones such as testosterone and oestrogen modulate the atherosclerotic plaque composition and the frequency of such plaques. In men, testosterone seems to act like a double-edged sword as its decrease with ageing correlates with an increased risk of atherosclerotic CVDs, while testosterone is also reported to promote inflammatory immune cell recruitment into the atherosclerotic plaque. In premenopausal women, oestrogen exerts anti-atherosclerotic effects, which decline together with its level after menopause resulting in increased CVD risk in ageing women. However, the interplay of sex hormones, sex-specific immune responses and other sex-related factors is still incompletely understood. This review highlights reported sex differences in atherosclerotic vascular remodelling and the role of endogenous sex hormones in this process.

Criteria to predict midterm outcome after stenting of chronic iliac vein obstructions (PROMISE trial).

BACKGROUND: Endovenous stent placement has become a first-line approach to prevent post-thrombotic syndrome in patients with chronic post-thrombotic obstruction (PTO) or nonthrombotic iliac vein lesions if conservative management fails. This study aims to identify factors associated with loss of patency to facilitate patient selection for endovenous stenting. METHODS: We retrospectively analyzed 108 consecutive patients after successful endovenous stenting for chronic vein obstruction performed at a single institution from January 2008 to July 2020. Using multivariable logistic regression, we explored potential predictive factors for loss of stent patency, including baseline demographics, post-thrombotic changes, and peak flow velocities measured in the common femoral vein (CFV), deep femoral vein, and femoral vein (FV) using duplex ultrasound examination. RESULTS: The mean follow-up duration was 41 ± 26 months, and participants had a mean age of 47.4 ± 15.4 years with 46.3% women. Ninety (83.3%) patients had PTO and 18 (16.7%) had nonthrombotic iliac vein lesions, predominantly due to May-Thurner syndrome. Loss of patency occurred in 20 (18.5%) patients, all treated for PTO. Comorbidities, side of intervention, and sex did not differ between patients with occluded and patent stents. Stent occlusion was more common with increasing number of stents implanted (P < .001) and with distal stent extension into and beyond the CFV (P < .001). Preinterventional predictive factors for stent occlusion were lower duplex ultrasound peak velocity in the CFV (odds ratio [OR]: 7.52, 95% confidence interval [CI]: 2.54-22.28; P < .001) and FV (OR: 10.75, 95% CI: 2.07-55.82; P < .005), and post-thrombotic changes in the deep femoral vein (OR: 4.51, 95% CI: 1.53-13.25; P = .006) and FV (OR: 3.62: 95% CI: 1.11-11.84; P = .033). Peak velocities of ≤7 cm/s (interquartile range: 0-20 cm/s) in the CVF and ≤8 cm/s (interquartile range: 5-10 cm/s) in the FV were significantly associated with loss of patency. CONCLUSIONS: Insufficient venous inflow as assessed by low peak velocities in the CFV and FV as well as post-thrombotic findings represent reliable risk predictors for stent occlusions, warranting their inclusion into the decision-making process for invasive treatment of PTO.

Sex and N-terminal pro B-type natriuretic peptide: The potential mediating role of iron biomarkers.

Background: Levels of N-terminal pro B-type natriuretic peptide (NT-proBNP), a marker of heart failure and cardiovascular risk, are generally higher in women than men. We explored whether iron biomarkers mediate sex differences in NT-proBNP levels. Methods: We included 5,343 community-dwelling individuals from the Prevention of Renal and Vascular Endstage Disease study. With linear regression analyses, we investigated the association of sex and iron biomarkers with NT-proBNP levels, independent of adjustment for potential confounders. The assessed iron biomarkers included ferritin, transferrin saturation (TSAT), hepcidin, and soluble transferrin receptor (sTfR). Next, we performed mediation analyses to investigate to which extent iron biomarkers influence the association between sex and NT-proBNP. Results: Of the included 5,343 participants, the mean standard deviation age was 52.2 ± 11.6 years and 52% were females. After adjustment for potential confounders, women compared to men, had higher NT-proBNP (ß = 0.31; 95%CI = 0.29, 0.34), but lower ferritin (ß = -0.37; 95%CI = -0.39, -0.35), hepcidin (ß = -0.22, 95%CI = -0.24, -0.20), and TSAT (ß = -0.07, 95% CI = -0.08, -0.06). Lower ferritin (ß = -0.05, 95%CI = -0.08, -0.02), lower hepcidin (ß = -0.04, 95%CI = -0.07, -0.006), and higher TSAT (ß = 0.07; 95%CI = 0.01, 0.13) were associated with higher NT-proBNP. In mediation analyses, ferritin and hepcidin explained 6.5 and 3.1% of the association between sex and NT-proBNP, respectively, while TSAT minimally suppressed (1.9%) this association. Conclusion: Our findings suggest that iron biomarkers marginally explain sex differences in levels of NT-proBNP. Future studies are needed to explore causality and potential mechanisms underlying these pathways.

Coronary artery calcium score and coronary computed tomography angiography predict one-year mortality in patients with type 2 diabetes and peripheral artery disease undergoing partial foot amputation.

METHODS: This is a single-center prospective cohort study including 199 consecutive patients with T2D, PAD (mean age 62.3 ± 7.2 years; 62.8% males), and preoperative CACS and CCTA undergoing PFA and followed-up over 1 year. RESULTS: Over a period of 1 year follow-up, a total of 35 (17.6%) participants died. The area under ROC curve to predict mortality for the CACS was 0.835 (95% CI:0.769-0.900), for CCTA 0.858 (95% CI:0.788-0.927). After adjustment for confounders, compared to no-stenosis on CCTA (reference), the risk of all-cause mortality in non-obstructive coronary atery disease (CAD) increased (HR = 1.38, 95% CI [0.75-12.86], p = .284), 1-vessel obstructive CAD (HR = 8.13, 95% CI [0.87-75.88], p = .066), 2-vessels (HR = 10.94, 95% CI [1.03-115.8], p = .047), and 3-vessels (HR = 45.73, 95% CI [4.6-454.7], p = .001) respectively. Increasing levels of CACS tended to be associated with increased risk of all-cause mortality (HR = 1.002, 95% CI [1.0-1.003], p = .061). 61/95 patients with obstructive CAD underwent coronary revascularization. CONCLUSIONS: Coronary artery calcium score and CCTA have a high predictive value for 1-year all-cause mortality in T2D patients undergoing minor amputations and may be considered for preoperative risk assessment allowing timely preventive interventions.

Upside-down positioning of a peri-interventional cava filter during endovascular thrombectomy of a septic superior vena cava thrombosis.

A 43-year-old male patient with advanced colon carcinoma presented with disseminated staphylococcus aureus bacteremia and central venous catheter associated septic thrombosis of the superior vena cava. Despite appropriate antimicrobial therapy and surgical debridement of distant foci, bacteremia persisted, so an endovascular thrombectomy was performed. Contrary to the usual application, the Capturex® peri-interventional cava filter was positioned upside down, in the direction of the blood flow, in the superior vena cava to prevent septic embolism during mechanical thrombectomy. The wall-adherent septic thrombus was mechanically detached using a RAT fragmentation basket® followed by Aspirex® rotational thrombectomy. Final phlebography showed complete thrombus removal. Small thrombus fragments could be demonstrated in the filter after retrieval. The adapted technique of a reverse positioning of the Capturex® filter in the superior vena cava seems feasible and effective.

Cone-Beam CT-assisted navigation for endovascular treatment of erection-related artery stenosis in patients with erectile dysfunction.

BACKGROUND: Angioplasty and stenting have emerged as endovascular treatment options for arteriogenic erectile dysfunction over the past few years. Considerable anatomical variation of the erection related pelvic arteries can be challenging during these procedures, leading to time-consuming repetitive super-selective angiograms for navigation. TECHNIQUE: We report a novel technique of using C-arm Cone-Beam CT and vessel navigation software to facilitate super-selective catheterization. CONCLUSION: Cone-Beam CT-guided navigation for vascular assessment of arteriogenic ED is an optional approach compared to exclusive angiographic assessment. Compared to CT angiography, C-arm Cone-Beam CT offers benefits regarding usage of contrast media and radiation exposure. It has the advantage to combine imaging with endovascular procedures in a single session, reduces time to target navigation in complex pelvic arteries anatomy and may increase therapy safety in endovascular treatment of ED.

Understanding Study Drug Discontinuation Through EUCLID.

Introduction: Disparities in the care and outcomes of peripheral artery disease (PAD) have been well-established. In part this is due to disparities in enrollment of PAD trial cohorts. However, less attention has been paid to non-random protocol non-adherence after enrollment, which may lead to inaccurate estimates of treatment effects and reduce generalizability of study results. We aimed to ascertain characteristics associated with premature study drug discontinuation in a PAD cohort. Methods: Using data from EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease), factors associated with study drug discontinuation were assessed using univariable and multivariable Cox proportional hazards models with time to study drug discontinuation as the outcome of interest. Relationships between study drug discontinuation and major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, ischemic stroke), major adverse limb events (MALE; acute limb ischemia, major amputation, and lower extremity revascularization), and all-cause hospitalization were assessed. Results: Of 13,842 eligible EUCLID participants, 3,886 (28.1%) prematurely and permanently discontinued study drug over a maximum follow-up of 42 months (annualized rate of 13.2 discontinuations per 100 patient-years). In a multivariable model, premature study drug discontinuation was associated with older age (aHR 1.16, 95%CI 1.14-1.19), eligibility based on prior lower extremity revascularization rather than ABI/TBI criteria (aHR 1.14, 95%CI 1.06-1.23), CLI status (aHR 1.23, 95%CI 1.06-1.42), COPD (aHR 1.36, 95%CI 1.24-1.49), and geographic region. In a multivariable analysis, study drug discontinuation was significantly associated with MACE (aHR 3.27, 95%CI 2.90-3.67, p < 0.001), MALE (aHR 1.84, 95%CI 1.63-2.07, p < 0.001), and all-cause hospitalization (aHR 2.37, 95%CI 2.21-2.54) following study drug discontinuation. Conclusions: This analysis of EUCLID demonstrates that premature, permanent discontinuation of study drug is relatively common in more than a quarter of PAD patients, is unevenly distributed based on geography and other baseline characteristics, and is associated with worse outcomes in a clinical trial context. Study teams leading future PAD trials may want to address the possibility of study drug discontinuation prospectively, as a proactive approach may help investigators to maintain study cohort diversity and representativeness without sacrificing power and precision.

Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD.

Background Despite high female prevalence of peripheral artery disease (PAD), little is known about sex-based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported. Methods and Results In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low-dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER. Unplanned index limb revascularization was prespecified and prospectively ascertained. The primary safety outcome was Thrombolysis in Myocardial Infarction major bleeding. Analyses of outcomes and treatment effects by sex were performed using Cox proportional hazards models. Among 6564 randomly assigned patients followed for a median of 28 months, 1704 (26.0%) were women. Among patients administered placebo, women were at similar risk for the primary efficacy outcome (hazard ratio [HR], 0.90; [95% CI, 0.74-1.09]; P=0.29) as men, while female sex was associated with a trend toward higher risk of unplanned index limb revascularization (HR, 1.18; [95% CI, 1.00-1.40]; P=0.0499). Irrespective of sex, effects of rivaroxaban were consistent for the primary efficacy outcome (P-interaction=0.22), unplanned index limb revascularization (P-interaction=0.64), and bleeding (P-interaction=0.61). Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25]; P=0.0099). Conclusions Among >1700 women with PAD undergoing LER, women and men were at similar risk for the primary outcome, but a trend for greater risk of unplanned index limb revascularization among women was observed. Effects of rivaroxaban were consistent by sex, though women more often discontinued treatment. Better understanding of sex-based outcomes and treatment adherence following LER is needed. Registration URL: http://clinicaltrials.gov; Unique identifier: NCT02504216.