Identifying the highest risk vascular patients: Insights from the XATOA registry.

BACKGROUND: Patients with coronary and peripheral artery disease (PAD) have a residual risk of major adverse cardiovascular and limb events despite standards of care. Among patients with coronary artery disease (CAD) and/or PAD selected for low dose rivaroxaban (2.5 mg BID) and aspirin, we sought to determine the highest risk vascular patients. METHODS: Xarelto pluc Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis (XATOA) is a single-arm registry of CAD and/or PAD patients. All participants were initiated on low dose rivaroxaban (2.5 mg BID) and aspirin. We report the incidence risk of major adverse cardiovascular events (MACE) or major adverse limb events (MALE) and major bleeding. A classification and regression tree analysis determined independent subgroups. RESULTS: Between November 2018 and May 2020, 5,808 participants were enrolled in XATOA; 5,532 were included in the full analysis. The median follow-up (interquartile range) was 462 (371-577) days. The incidence risk per 100 patient-years of MACE or MALE was highest among participants with polyvascular disease (2 or more vascular beds affected, n = 2,889). The incidence risk was 9.16 versus 2.48 per 100 patient-years in polyvascular and nonpolyvascular patients respectively. Other subgroups of high-risk patients included participants 75 years or older, with a history of diabetes, heart failure, or chronic renal insufficiency (CRI). Rates of major bleeding were low overall. A classification and regression tree analysis showed that polyvascular disease was the most dominant factor separating higher from lower risk participants, and this was heightened with CRI or diabetes. CONCLUSION: Patients with polyvascular disease represent a substantial subset of patients in clinical practice and should be prioritized to receive maximal medical therapy including low dose rivaroxaban (2.5 mg BID) and aspirin.

Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits.

BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) have a high risk of adverse limb and cardiovascular events. The results from the VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial have demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit for patients undergoing surgical revascularization. However, the efficacy and safety for those treated by surgical bypass, including stratification by bypass conduit (venous or prosthetic), has not yet been described. METHODS: In the VOYAGER PAD trial, patients who had undergone surgical and endovascular infrainguinal LER to treat PAD were randomized to rivaroxaban 2.5 mg twice daily or placebo on top of background antiplatelet therapy (aspirin 100 mg to be used in all and clopidogrel in some at the treating physician's discretion) and followed up for a median of 28 months. The primary end point was a composite of acute limb ischemia, major amputation of vascular etiology, myocardial infarction, ischemic stroke, and cardiovascular death. The principal safety outcome was major bleeding using the TIMI (thrombolysis in myocardial infarction) scale. The index procedure details, including conduit type (venous vs prosthetic), were collected at baseline. RESULTS: Among 6564 randomized patients, 2185 (33%) had undergone surgical LER. Of these 2185 patients, surgical bypass had been performed for 1448 (66%), using a prosthetic conduit for 773 patients (53%) and venous conduit for 646 patients (45%). Adjusting for the baseline differences and anatomic factors, the risk of unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving a prosthetic conduit vs a venous conduit (adjusted hazard ratio [HR], 2.53; 95% confidence interval [CI], 1.65-3.90; P < .001), and the risk of acute limb ischemia was three times greater (adjusted HR, 3.07; 95% CI, 1.84-5.11; P < .001). The use of rivaroxaban reduced the primary outcome for the patients treated with bypass surgery (HR, 0.78; 95% CI, 0.62-0.98), with consistent benefits for those receiving venous (HR, 0.66; 95% CI, 0.49-0.96) and prosthetic (HR, 0.87; 95% CI, 0.66-1.15) conduits (Pinteraction = .254). In the overall trial, major bleeding using the TIMI scale was increased with rivaroxaban. However, the numbers for those treated with bypass surgery were low (five with rivaroxaban vs nine with placebo; HR, 0.55; 95% CI, 0.18-1.65) and not powered to show statistical significance. CONCLUSIONS: Surgical bypass with a prosthetic conduit was associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjustment for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduced this risk, with an increase in the bleeding risk, but had a favorable benefit risk for patients treated with bypass surgery, regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Conflicting European and North American Society Abdominal Aortic Aneurysm (AAA) Volume Guidelines Differentially Discriminate Peri-operative Mortality After Elective Open AAA Repair.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) guidelines endorse a minimum abdominal aortic aneurysm (AAA) repair volume of 20 open (OAR) and or endovascular (EVAR) AAA repair procedures per year as a proxy for high quality care. In contrast, the Society for Vascular Surgery (SVS) espouses 10 exclusively OARs per year. Given the differences in these volume standards and definitions, debate persists regarding surgeon credentialing and healthcare resource allocation. This analysis aimed to determine which society endorsed volume benchmark better discriminates OAR mortality. METHODS: A retrospective national registry based cohort analysis. Patients undergoing elective OAR were compared between centres meeting either ESVS (≥ 20 AAA procedures/year) or SVS (≥ 10 OARs/year) volume thresholds within the Vascular Quality Initiative (2010 - 2020). The primary outcome was in hospital death. Logistic regression was used for risk adjusted comparisons. RESULTS: A total of 8 761 OARs were performed at 193 US centres, and the median (IQR) volume was 6.6 (3.3, 9.9) OARs/year. When applying the SVS centre volume definition, the proportion of centres meeting ESVS and SVS minimum case thresholds was 12% (n = 22) and 25% (n = 48), respectively. The absolute mortality difference was 0.3% between centres performing ≥ 20 vs. ≥ 10 OARs/year (2.6% vs. 2.9%; p = .51). There was an incremental association between OAR volume and crude mortality rate; however, this absolute difference between lower and higher thresholds was only 0.2%/procedure (OR 0.98, 95% CI 0.97 - 0.99; p < .001). Moreover, no difference in risk adjusted mortality was detected between volume standards (≥ 10 vs. ≥ 20; p = .78). In sub-analysis, the ESVS ≥ 20 total composite AAA repair volume threshold was not associated with mortality (p = .17); however, increasing the proportion of OAR cases making up the total annual AAA centre volume inversely correlated with mortality (p = .008). CONCLUSION: It appears that the SVS endorsed AAA centre volume threshold using exclusively OAR had a modest ability to discriminate peri-operative mortality outcomes and was superior to the current composite ESVS volume guideline in differentiating centre performance. These findings raise questions regarding the clinical validity of using EVAR as a volume proxy for OAR.

Endovascular Treatment of Aortic Pathologies in Patients With Marfan Syndrome: Single-Center Experience.

OBJECTIVES: To study the outcome of endovascular treatment of aortic pathologies in patients with Marfan syndrome (MFS) at a single institution. METHODS: Consecutive MFS patients who underwent endovascular repair or hybrid procedures for aortic pathologies from January 2010 to May 2020 were identified. Several endovascular and hybrid strategies have been used. Technical success, short- and mid-term survival, complications, and re-interventions were retrospectively analyzed. RESULTS: During the study period, 24 patients with MFS (median age, 48 [13-78] years; 58% males) were treated. Indications for intervention were chronic aortic dissection with aneurysm degeneration in 16 patients (67%), acute type B aortic dissection in 4 patients (17%), aortic aneurysm without any dissection in 3 patients (13%), and aortic intramural hematoma in 1 patient (4%). Most patients were asymptomatic (83%), three (13%) were symptomatic and one (4%) had a contained rupture. The median aneurysm diameter was 56 (35-86) mm. Hybrid procedures were performed in 7 (29%) patients. Thoracic endovascular repair was performed in 12 (50%) patients, a fenestrated or branched endovascular aortic repair in 4 (17%) patients, and placement of an iliac artery stent-graft in 1 (4%) patient. Procedures were staged in 12 (50%) patients. Technical success was achieved in all patients. The median intensive care unit stay was 6 (range, 1-30) days, and the median hospital stay was 23 (range, 3-112) days. Early mortality was reported in 1 (4%) patient. Wound infection was seen in 7 (29%) patients and gastrointestinal complications in 3 (13%) patients. The median follow-up was 42 (range, 1-127) months. The cumulative survival rate was 87% at 24 months. The cumulative freedom from re-intervention was 77% at 12 months. CONCLUSIONS: Endovascular treatment of aortic pathologies in patients with MFS appears feasible with acceptable early and mid-term outcomes in terms of mortality and re-intervention rates. Endovascular therapy plays an increasing role in MFS patients with aortic pathology.

Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD.

BACKGROUND: Peripheral artery disease (PAD) affects 200 million people worldwide and is associated with impaired quality of life, increased morbidity, and mortality. Supervised exercise therapy (SET) and lower-extremity revascularization (LER) are both proven strategies to improve patient symptoms. Short and long-term functional outcomes after LER for symptomatic PAD in a large, international cohort have not previously been described. METHODS: The VOYAGER PAD trial (ClinicalTrials.gov identifier: NCT02504216) enrolled subjects after LER for symptomatic PAD (Rutherford category 2-6). Participants completed the Walking Impairment Questionnaire (WIQ) at baseline, 1, 3 and 6 months, and every 6 months thereafter. The primary outcome analysis was degree of difficulty walking two blocks at each of the aforementioned time points. Difficulty walking three blocks and climbing one flight of stairs at these time points was also analyzed. Data about supervised and home exercise therapy before or after revascularization were not collected in the VOYAGER PAD trial. RESULTS: Of the 5614 VOYAGER PAD participants completing the WIQ at baseline, three-quarters presented with claudication and one-quarter with critical limb ischemia. Of these, the majority (62% with claudication and 74% with CLI) reported inability or much difficulty walking two blocks prior to LER. Walking improved after LER regardless of revascularization strategy, but one-fifth with claudication and one-third with CLI reported continued inability or much difficulty walking two blocks 1 month after LER. Participants who reported improved walking ability 1 month after LER experienced a durable functional result out to 3 years. Although the proportion of participants reporting significant baseline difficulty climbing one flight of stairs or walking three blocks differed, the trend in immediate and sustained improvement after LER was similar to that observed for walking two blocks. CONCLUSION: In this large, international cohort undergoing LER for symptomatic PAD, nearly two-thirds reported inability or much difficulty walking two blocks at baseline. Although many participants reported improved walking ability after LER, a substantial proportion remained severely disabled. These observations may help motivate providers, patients, and medical systems to improve awareness and engagement in SET referral after LER.

Cross-sectional analysis of the association of periodontitis with carotid intima media thickness and atherosclerotic plaque in the Hamburg City health study.

BACKGROUND: Previous epidemiological studies regarding the association between chronic periodontitis (CP) and carotid intima-media thickness (cIMT) and subclinical atherosclerosis have been inconclusive. OBJECTIVE: The aim of this study was to determine whether CP is associated with subclinical atherosclerosis in a large population-based cohort study conducted in northern Germany (the Hamburg City Health study). METHODS: Baseline data from 5781 participants of the Hamburg City Health Study with complete oral health and carotid ultrasound data (50.7% female, mean age: 62.1 ± 8.4 years) were evaluated. A standardized duplex sonography of the carotid artery was performed with measurement of carotid intima-media thickness (cIMT) and atherosclerotic plaques. Oral health was assessed by recording the decayed, missing, and filled teeth (DMFT) index, clinical attachment loss (CAL), bleeding on probing (BOP), and the dental plaque index (PI). Correlations were tested for statistical significance by means of descriptive statistics and multivariate regression analyses. RESULTS: Moderate and severe CP were associated with the prevalence of cIMT ≥ 1 mm (none or mild CP: 5.1%, moderate CP: 6.1%, severe CP: 10%) and mean cIMT (none or mild CP: 0.72 mm, moderate CP: 0.75 mm, severe CP: 0.78 mm) in bivariate analyses (p < .001). Additionally, severe and moderate CP were associated with higher prevalence of carotid atherosclerotic plaques (plaque = yes: none or mild CP: 23.9%, moderate CP: 29%, severe CP: 40.2%,). After adjustment for age, sex, smoking, diabetes, hypertension, educational level, hypercholesterolemia, and hsCRP, severe CP still correlated significantly with cIMT and the prevalence of cIMT ≥1 mm and/or presence of carotid atherosclerotic plaques. CONCLUSION: In this study, severe CP was associated with increased cIMT and higher prevalence of carotid plaques independent of common risk factors.

Antithrombotic therapies in aortic and peripheral arterial diseases in 2021: a consensus document from the ESC working group on aorta and peripheral vascular diseases, the ESC working group on thrombosis, and the ESC working group on cardiovascular pharmacotherapy.

The aim of this collaborative document is to provide an update for clinicians on best antithrombotic strategies in patients with aortic and/or peripheral arterial diseases. Antithrombotic therapy is a pillar of optimal medical treatment for these patients at very high cardiovascular risk. While the number of trials on antithrombotic therapies in patients with aortic or peripheral arterial diseases is substantially smaller than for those with coronary artery disease, recent evidence deserves to be incorporated into clinical practice. In the absence of specific indications for chronic oral anticoagulation due to concomitant cardiovascular disease, a single antiplatelet agent is the basis for long-term antithrombotic treatment in patients with aortic or peripheral arterial diseases. Its association with another antiplatelet agent or low-dose anticoagulants will be discussed, based on patient's ischaemic and bleeding risk as well therapeutic paths (e.g. endovascular therapy). This consensus document aims to provide a guidance for antithrombotic therapy according to arterial disease localizations and clinical presentation. However, it cannot substitute multidisciplinary team discussions, which are particularly important in patients with uncertain ischaemic/bleeding balance. Importantly, since this balance evolves over time in an individual patient, a regular reassessment of the antithrombotic therapy is of paramount importance.

Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial.

AIMS: In this secondary analysis of the VOYAGER trial, rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day was assessed in older adults. Advanced age is associated with elevated bleeding risk and unfavourable net benefit for dual antiplatelet therapy in chronic coronary artery disease. The risk-benefit of low-dose rivaroxaban in patients ≥75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER) has not been described. METHODS AND RESULTS: The primary endpoint was a composite of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death. The principal safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding analysed by the pre-specified age cut-off of 75 years. Of 6564 patients randomized, 1330 (20%) were >75 years. Absolute 3-year Kaplan-Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs. 1.5%) endpoints were higher in elderly vs. non-elderly patients. Efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was consistent irrespective of age. The combination of intracranial and fatal bleeding was not increased in patients >75 years (2 rivaroxaban vs. 8 placebo). Overall, benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) exceeded risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding). CONCLUSION: Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed. This suggests that low-dose rivaroxaban combined with aspirin should be considered in PAD after LER regardless of age.

Comparison of transfemoral versus upper extremity access to antegrade branches in branched endovascular aortic repair.

OBJECTIVE: We studied the outcomes of transfemoral access (TFA) vs upper extremity access (UEA) for branched endovascular aortic repair (BEVAR). METHODS: From January 2016 to October 2019, 152 consecutive patients underwent BEVAR under general anesthesia at a single institution. In 2018, an alternative approach to the antegrade branches using TFA compared with conventional UEA was introduced. The cohort was divided into TFA and UEA groups according to the access approach. The end points were technical success, adverse events (including perioperative stroke/transient ischemic attack), access complications, operation time, and radiation exposure. RESULTS: The TFA group included 60 patients (63% male; median age, 71 years; interquartile range [IQR], 65-76 years). The UEA group included 92 patients (67% male; median age, 73 years; IQR, 66-78 years). The number of target vessels (TVs) was similar in both groups (median, 4.0 TVs per procedure; range, 1-7 TVs for both). Technical success was greater in the TFA group (60 of 60 patients; 209 of 209 TVs) than in the UEA group (87 of 92 patients; 334 of 346 TVs; P < .01). The fluoroscopy time (median, 69 minutes; IQR, 48-87 minutes; vs 88 minutes; IQR, 65-104 minutes; P = .39) and contrast agent volume (median, 141 mL; IQR, 123-165 mL; vs median, 130 mL; IQR, 101-157 mL; P = .34) were similar in both groups. The radiation exposure (221 Gy × cm2; IQR, 138-406 Gy × cm2; vs median, 255 Gy × cm2; IQR, 148-425 Gy × cm2; P = .05) was lower and the operation time (median, 300 minutes; IQR, 240-356 minutes; vs median, 364 minutes; IQR, 290-475 minutes; P = .01) was shorter in the TFA group. Brachial access complications (0 of 60 vs 3 of 92 patients) and perioperative strokes/transient ischemic attacks (0 of 60 vs 8 of 92 patients) only occurred in the UEA group (P = .018). CONCLUSIONS: The use of TFA to catheterize antegrade branches was associated with a lower rate of complications in the present study and has become our preferred approach for BEVAR.

Editor's Choice - Variation in Intact Abdominal Aortic Aneurysm Repair Outcomes by Country: Analysis of International Consortium of Vascular Registries 2010 - 2016.

OBJECTIVE: Outcomes for intact abdominal aortic aneurysm (AAA) repair vary over time and by healthcare system, country, and surgeon. The aim of this study was to analyse peri-operative mortality for intact AAA repair in 11 countries over time and compare outcomes by gender, age, and geographical location. METHODS: Prospective data on primary repair of intact AAA were collected from 11 countries through the International Consortium of Vascular Registries (ICVR) and analysed for two time periods, 2010 - 2013 and 2014 - 2016. The primary outcome was peri-operative mortality after endovascular aneurysm repair (EVAR) and open surgical repair (OSR). Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: A total of 103 715 patients were included. The percentage of patients undergoing EVAR increased from 63.6% to 71.2% (p < .001) over the study period. This proportion varied by country from 35% in Hungary to 81% in the United States. Overall peri-operative mortality decreased from 2.1% to 1.6 % (p < .001). Mortality also declined significantly over time for both OSR 4.2% to 3.6 % (p = .002) and EVAR 1.0% to 0.7% (p = .002). Mortality was significantly higher for female than male patients (3.0% vs. 1.6% p < .001). The percentage of patients > 80 years old undergoing AAA repair remained constant at 23.6% (p = .91). Peri-operative mortality was higher for patients > 80 years than for those < 80 years old (2.7% vs. 1.6% p < .001). Forty-six per cent (n = 275) of all EVAR deaths occurred in the over 80s. CONCLUSION: The proportion of AAA repairs performed using EVAR has increased over time. Peri-operative mortality continues to decline for both OSR and EVAR. Outcomes however were significantly worse for both women and those aged over 80, so efforts should be focused on these patient groups to further reduce elective AAA mortality rates.

Editor's Choice - Optimal Threshold for the Volume-Outcome Relationship After Open AAA Repair in the Endovascular Era: Analysis of the International Consortium of Vascular Registries.

OBJECTIVE: As open abdominal aortic aneurysm (AAA) repair (OAR) rates decline in the endovascular era, the endorsement of minimum volume thresholds for OAR is increasingly controversial, as this may affect credentialing and training. The purpose of this analysis was to identify an optimal centre volume threshold that is associated with the most significant mortality reduction after OAR, and to determine how this reflects contemporary practice. METHODS: This was an observational study of OARs performed in 11 countries (2010 - 2016) within the International Consortium of Vascular Registry database (n = 178 302). The primary endpoint was post-operative in hospital mortality. Two different methodologies (area under the receiving operating curve optimisation and Markov chain Monte Carlo procedure) were used to determine the optimal centre volume threshold associated with the most significant mortality improvement. RESULTS: In total, 154 912 (86.9%) intact and 23 390 (13.1%) ruptured AAAs were analysed. The majority (63.1%; n = 112 557) underwent endovascular repair (EVAR) (OAR 36.9%; n = 65 745). A significant inverse relationship between increasing centre volume and lower peri-operative mortality after intact and ruptured OAR was evident (p < .001) but not with EVAR. An annual centre volume of between 13 and 16 procedures per year was associated with the most significant mortality reduction after intact OAR (adjusted predicted mortality < 13 procedures/year 4.6% [95% confidence interval 4.0% - 5.2%] vs. ≥ 13 procedures/year 3.1% [95% CI 2.8% - 3.5%]). With the increasing adoption of EVAR, the mean number of OARs per centre (intact + ruptured) decreased significantly (2010 - 2013 = 35.7; 2014 - 2016 = 29.8; p < .001). Only 23% of centres (n = 240/1 065) met the ≥ 13 procedures/year volume threshold, with significant variation between nations (Germany 11%; Denmark 100%). CONCLUSION: An annual centre volume of 13 - 16 OARs per year is the optimal threshold associated with the greatest mortality risk reduction after treatment of intact AAA. However, in the current endovascular era, achieving this threshold requires significant re-organisation of OAR practice delivery in many countries, and would affect provision of non-elective aortic services. Low volume centres continuing to offer OAR should aim to achieve mortality results equivalent to the high volume institution benchmark, using validated data from quality registries to track outcomes.

International public awareness of peripheral artery disease.

Background: Peripheral artery disease (PAD) of the lower limbs is a common condition with considerable global burden. Some country-specific studies suggest low levels of public awareness. To our knowledge public awareness of PAD has never been assessed simultaneously in several countries worldwide. Patients and methods: This was an international, general public, internet-based quantitative survey assessing vascular health and disease understanding. Questionnaires included 23 closed-ended multiple-choice, Likert scale and binary choice questions. Data were collected from 9,098 survey respondents from nine countries in Europe, North and Latin America during May-June 2018. Results: Overall, familiarity with PAD was low (57% of respondents were "not at all familiar", and 9% were "moderately" or "very familiar"). Knowledge about PAD health consequences was limited, with 55% of all respondents not being aware of limb consequences of PAD. There were disparities in PAD familiarity levels between countries; highest levels of self-reported awareness were in Germany and Poland where 13% reported to be "very" or "moderately" familiar with PAD, and lowest in Scandinavian countries (5%, 3% and 2% of respondents in Norway, Sweden and Denmark, respectively). There were disparities in awareness according to age. Respondents aged 25-34 were most familiar with PAD, with 12% stating that they were "moderately" or "very" familiar with the condition, whereas those aged 18-24 were the least familiar with PAD (7% "moderately" or "very" familiar with PAD). In the 45-54, 55-64 and 65+ age groups, 9% said they were "moderately" or "very" familiar with the term. There was no important gender-based difference in PAD familiarity. Conclusions: On an international level, public self-reported PAD awareness is low, even though PAD is a common condition with considerable burden. Campaigns to increase PAD awareness are needed to reduce delays in diagnosis and to motivate people to control PAD risk factors.

Management of Abdominal Aortic Aneurysm Disease: Similarities and Differences Among Cardiovascular Guidelines and NICE Guidance.

The development of endovascular techniques has improved abdominal aortic aneurysm (AAA) management over the past 2 decades. Different cardiovascular societies worldwide have recommended the endovascular approach as the standard of care in their currently available guidelines. While endovascular treatment has established its role in daily clinical practice, a new debate has arisen regarding the indications, appropriateness, limitations, and role of open surgery. To inform this debate, the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched from 2010 to May 2020; the systematic search identified 5 articles published between 2011 and 2020 by 4 cardiovascular societies and the National Institute of Health and Care Excellence (NICE). Four debatable domains were assessed and analyzed: diagnostic methods and screening, preoperative management, indications and treatment modalities, and postoperative follow-up and endoleak management. The review addresses controversial proposals as well as widely accepted recommendations and "gray zone" issues that need to be further investigated and analyzed, such as screening in women, medical management, and follow-up imaging. While the recommendations for AAA management have significant overlap and agreement among international cardiovascular societies, the NICE guidelines diverge regarding the role of open repair in aortic disease, recommending conventional surgery in most elective cases.

Editor's Choice - Assessment of Correlation Between Mean Size of Infrarenal Abdominal Aortic Aneurysm at Time of Intact Repair Against Repair and Rupture Rate in Nine Countries.

OBJECTIVE: This study aimed to analyse the mean abdominal aortic aneurysm (AAA) diameter for repair in nine countries, and to determine variation in mean AAA diameter for elective AAA repair and its relationship to rupture AAA repair rates and aneurysm related mortality in corresponding populations. METHODS: Data on intact (iAAA) and ruptured infrarenal AAA (rAAA) repair for the years 2010-2012 were collected from Denmark, England, Finland, Germany, Hungary, New Zealand, Norway, Sweden, and the USA. The rate of iAAA repair and rAAA per 100 000 inhabitants above 59 years old, mean AAA diameter for iAAA repair and rAAA repair, and the national rates of rAAA were assessed. National cause of death statistics were used to estimate aneurysm related mortality. Direct standardisation methods were applied to the national mortality data. Logistic regression and analysis of variance model adjustments were made for age groups, sex, and year. RESULTS: There was a variation in the mean diameter of iAAA repair (n = 34 566; range Germany = 57 mm, Denmark = 68 mm). The standardised iAAA repair rate per 100000 inhabitants varied from 10.4 (Hungary) to 66.5 (Norway), p<.01, and the standardised rAAA repair rate per 100 000 from 5.8 (USA) to 16.9 (England), p<.01. Overall, there was no significant correlation between mean diameter of iAAA repair and standardised iAAA rate (r2 = 0.04, p = .3). There was no significant correlation between rAAA repair rate (n = 12 628) with mean diameter of iAAA repair (r2 = 0.2, p = .1). CONCLUSION: Despite recommendations from learned society guidelines, data indicate variations in mean diameter for AAA repair. There was no significant correlation between mean diameter of AAA repair and rates of iAAA repair and rAAA repair. These analyses are subject to differences in disease prevalence, uncertainties in rupture rates, validations of vascular registries, causes of death and registrations.

Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach.

Recently, health insurance claims have regained the attention of the scientific community as a source of real-world evidence in health care research and quality improvement. To date, very few studies are available which investigate the validity of health insurance claims; these may be affected by bias from several sources, such as possible upcoding of co-morbidities and complications for reimbursement advantages. The IDOMENEO study investigates the inpatient treatment of peripheral arterial disease (PAD) comprehensively using various data sources with a consortium involving experts from health care research and data privacy, a large health insurance fund, biostatisticians, jurists, and computer scientists. Prospective registry data were collected from 30-40 vascular centres in Germany using the GermanVasc registry. In addition, health insurance claims data were prospectively collected from BARMER, the second largest health insurance fund in Germany. The consortium is currently developing a data privacy compliant method of health insurance claims data validation, the methodological foundations of which are described here.

Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms.

OBJECTIVE: The aim of our study was to analyze the incidence of spinal cord ischemia (SCI) in patients presenting with complex aortic aneurysms treated with endovascular aneurysm repair (EVAR) and to identify risk factors associated with this complication. METHODS: A retrospective study was undertaken of prospectively collected data including patients presenting with complex aortic aneurysm (pararenal abdominal aortic aneurysm and thoracoabdominal aortic aneurysm) treated with fenestrated EVAR (F-EVAR) or branched EVAR (B-EVAR). The primary end point was the incidence of SCI and the assessment of any associated factors. RESULTS: Between January 2011 and August 2017, a total of 243 patients (mean aneurysm diameter, 65.2 ± 15.3 mm; mean age, 72.4 ± 7.5 years; 73% male) were treated with F-EVAR or B-EVAR. Asymptomatic patients were treated in 73% of the cases (177/243, in contrast to 27% urgent), and 52% (126/243) were treated for thoracoabdominal aortic aneurysm (in contrast to 48% for pararenal abdominal aortic aneurysm). F-EVAR (mean number of fenestrations, 3.3/case) and B-EVAR (mean number of branches, 3.7/case) were undertaken in 67% (164/243) and 33% (79/243), respectively. The total incidence of SCI was 17.7% [43/243; paraplegia in 4% (10/243) and paraparesis in 13.7% (33/243)]. Most of the patients with SCI presented with immediate postoperative symptoms (72% [31/43]). A spinal drain was preoperatively placed in 53% (130/243) and was associated with the prevention of SCI (SCI with spinal drainage, 12% [16/130]; SCI without spinal drainage, 24% [27/113]; P = .018). The 30-day mortality rate was 9% (21/243). After multiple logistic regression analysis, SCI was associated with preoperative renal function (SCI with preoperative glomerular filtration rate <60 mL/min/1.73 m2: odds ratio [OR], 2.43; 95% confidence interval [CI], 1.18-4.99; P = .016) and the number of vertebral segments covered (SCI with higher position of proximal stent in terms of vertebra: OR, 1.2; 95% CI, 1.1-1.3; P = .000). A similar outcome was derived when the height of the proximal end of the stent graft was replaced by the total length of aortic coverage (SCI with preoperative glomerular filtration rate <60 mL/min/1.73 m2: OR, 2.36 [95% CI, 1.11-5.00; P = .025]; SCI with longer length of aortic coverage: OR, 1.01 [95% CI, 1.003-1.009; P = .000]). CONCLUSIONS: The majority of SCI incidence after F-EVAR or B-EVAR of complex aortic aneurysms is manifested immediately postoperatively. The use of preoperative spinal drainage may prevent SCI. Patients with GRF <60 mL/min/1.73 m2 and with longer aortic stent graft coverage are at higher risk of SCI.

Achieving Consensus to Define Curricular Content for Simulation Based Education in Vascular Surgery: A Europe Wide Needs Assessment Initiative.

OBJECTIVE: To gather consensus among European educators about technical procedures that should be included in a future simulation based curriculum in vascular surgery. METHODS: A three round modified Delphi survey was initiated among 189 key opinion leaders (KOL) from 34 countries across Europe who were identified according to their positions in the European Society for Vascular Surgery, the European Journal of Vascular and Endovascular Surgery, and Union Européenne des Médecins Spécialistes Section and Board of Vascular Surgery. The first round was a brainstorming phase to identify technical procedures that a newly qualified vascular surgeon should be able to perform. The answers were analysed qualitatively. The second round investigated how often the identified procedures are performed, the number of vascular surgeons that should be able to perform these procedures, whether the procedures pose a risk to the patients, and whether simulation based education (SBE) is feasible. In the third round, elimination and re-ranking of procedures were performed. Only procedures that gained more than 70% support were included. An international steering group consisting of open and endovascular surgeons and medical educators governed the process. RESULTS: Response rates in the three rounds were 75% (142/189), 89% (126/142), and 85% (107/126), respectively. In the final prioritised list of 30 technical procedures for SBE, the top five procedures focus on basic open vascular skills, basic endovascular skills, vascular imaging interpretation, femoral endarterectomy, and open peripheral bypass. Twenty-six procedures were eliminated, including peripheral pressure measurement, wound management, open management of complications, major amputations, and highly advanced endovascular skills. CONCLUSION: The prioritised list of technical procedures from this ESVS supported project could be used to guide planning and development of future SBE programs to meet the needs of vascular surgeons across Europe.

Endovascular Repair of a Large Ilioiliac Fistula Using a Reversed Iliac Limb Endograft.

Ilioiliac fistulae are a rare condition, for which diagnosis and treatment can be challenging. In this report, we describe the case of a 74-year-old patient with a high-flow fistula between the left common iliac artery and the ipsilateral common iliac vein presenting with heart failure. The fistula was probably iatrogenic, caused by prostatic surgery 1 year earlier. We describe imaging findings on computed tomography angiography and the treatment by 2 back-table reversed stent grafts. The satisfactory results demonstrated in our case and those in the literature suggest that an endovascular treatment for this rare condition should be considered as the first-line therapy.