Editor's Choice - Prevalence of Peripheral Arterial Disease, Abdominal Aortic Aneurysm, and Risk Factors in the Hamburg City Health Study: A Cross Sectional Analysis.

OBJECTIVE: There is a paucity of current figures on the prevalence of carotid and lower extremity peripheral arterial disease (PAD) and abdominal aortic aneurysm (AAA) as well as the associated cardiovascular risk factors to support considerations on screening programmes. METHODS: In the population based Hamburg City Health Study, participants between 45 and 74 years were randomly recruited. In the current cross sectional analysis of the first 10 000 participants enrolled between February 2016 and November 2018, the prevalence of carotid artery disease (intima-media thickness ≥ 1 mm), lower extremity PAD (ankle brachial index ≤ 0.9), and AAA (aortic diameter ≥ 30 mm) was determined. Multivariable logistic regression models were applied to determine the association between vascular diseases and risk factors. To account for missing values, multiple imputation was performed. RESULTS: A total of 10 000 participants were analysed (51.1% females, median age 63 years, median body mass index 26.1 kg/m2). In medians, the intima media thickness was 0.74 mm (interquartile range [IQR] 0.65 - 0.84), the ankle brachial index 1.04 (IQR 0.95 - 1.13), and the aortic diameter 17.8 mm (IQR 16.1 - 19.6). Concerning risk factors, 64% self reported any smoking, 39% hypertension, 5% coronary artery disease, 3% congestive heart failure, 5% atrial fibrillation, and 3% history of stroke or myocardial infarction, respectively. In males, the prevalence of carotid artery disease, lower extremity PAD, and AAA were 35.3%, 22.7%, and 1.3%, respectively, and in females, 23.4%, 24.8%, and 0.2%, respectively. Higher age and current smoking were likewise associated with higher prevalence while the impact of variables varied widely. CONCLUSION: In this large population based cohort study of 10 000 subjects from Hamburg, Germany, a strikingly high prevalence of PAD was revealed. Almost 45% suffered from any index disease, while AAA was only diagnosed in 1.3% of males and 0.2% of females. The high prevalence of atherosclerotic disease and associated cardiovascular risk factors underline that it is essential to increase awareness and fuel efforts for secondary prevention.

Human skin biofilm model: translational impact on swabbing and debridement.

OBJECTIVE: Wound biofilms are one of the greatest challenges in the therapy of hard-to-heal (chronic) wounds, as potent antimicrobial substances fail to eradicate bacteria within short incubation periods. Preclinical investigations using novel model systems that closely mimic the human wound environment and wound biofilm are required to identify new and effective therapeutic options. This study aims to identify bacterial colonisation patterns that are relevant for diagnosis and therapy. METHOD: In this study, a recently established human plasma biofilm model (hpBIOM) was incorporated into a wound within human dermal resectates after abdominoplasty. The interaction of the biofilm-forming bacteria meticillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa with the skin cells was investigated. Possible effects on wound healing processes in correlation with the persistence of the biofilm in the wound environment were analysed in patients with leg ulcers of different aetiologies and biofilm burden. RESULTS: Using haematoxylin and eosin staining, species-dependent infiltration modes of the bacteria into the wound tissue were determined for the pathogens MRSA and Pseudomonas aeruginosa. The spreading behaviour correlated with clinical observations of the spatial distributions of the bacteria. In particular, the clinically prominent Pseudomonas aeruginosa-specific distension of the wound margin was identified as epidermolysis due to persistent infiltration. CONCLUSION: The hpBIOM applied in this study represents a potential tool for preclinical analyses dealing with approval processes for new antimicrobial applications. In terms of clinical practice, a microbiological swabbing technique including the wound margin should be routinely applied to prevent wound exacerbation.

Fenestrated versus debranching thoracic endovascular aortic repair for endovascular treatment of distal aortic arch and descending aortic lesions.

BACKGROUND: Cervical debranching, followed by thoracic endovascular aortic repair (TEVAR), is well-established for treating aortic arch lesions. However, total endovascular repair with fenestrated endografts has not been adequately studied. Thus, we performed a comparison of the two techniques. METHODS: The present study was a single-center, retrospective study comparing the treatment of thoracic aortic lesions with custom-made fenestrated stent-grafts (fenestrated TEVAR [fTEVAR]) with a single fenestration for the left subclavian artery (LSA), a scallop for the left carotid artery, and hybrid repair with a thoracic stent-graft and cervical debranching of the LSA. Emergency cases were excluded. RESULTS: From 2012 to 2018, 19 patients (58% male) underwent elective fTEVAR (group A) and 17 patients (82% male) underwent debranching TEVAR (dTEVAR; group B). The mean age ± standard deviation in group A was 65.8 ± 2 years and 68 ± 3 years in group B. Left carotid-subclavian bypass was performed in 15 of 17 patients (88%) and transposition of the LSA in 2 of 17 patients (12%) in group B. The two groups were comparable regarding comorbidities, except for peripheral arterial disease: 5 of 19 patients in group A (26%) and none in group B had had peripheral arterial disease (P = .049). Dissection or post-dissection aneurysm was the indication for treatment in 6 of 19 patients in the fTEVAR group (group A) and in 12 of 17 patients in the dTEVAR group (group B; 31.6% vs 70.6%; P = .04). The indication for the remaining patients was a degenerative aortic aneurysm. Technical success was achieved in all cases, except for one case of dTEVAR owing to a type Ia endoleak. The mean endovascular operative time was 191 ± 120 minutes for fTEVAR and 130 ± 75 minutes for dTEVAR (P = NS). The mean operative time for the debranching procedure was 181 ± 97 minutes. No deaths or major strokes had occurred in the early postoperative period (30 days). Of the 17 patients in group B, 5 (29.4%) had experienced a local complication related to the debranching procedure. The mean follow-up was 14.6 ± 2 months for group A and 17 ± 2 months for group B. Of the 19 patients in group A and 17 patients in group B, 2 (10.5%) and 6 (35.3%) had required an unplanned reintervention related to the thoracic stent-graft during the follow-up period, respectively (P = NS). The estimated freedom from unplanned reintervention at 12 months was 86% for group A and 81% for group B. Primary patency of the LSA stent-graft or the carotid-subclavian bypass/transposition was 100% in both groups. CONCLUSIONS: Both techniques showed excellent midterm patency rates for the target vessel and high technical success rate. The operation times were shorter for the fTEVAR group and complications related to the debranching procedure were avoided.

Sex Disparities in Long Term Outcomes After Open Surgery for Chronic Limb Threatening Ischaemia: A Propensity Score Matched Analysis of Health Insurance Claims.

OBJECTIVE: Several studies suggest a disadvantage for women in peri-operative morbidity and mortality after open surgery in peripheral arterial occlusive disease. In addition to their heterogeneity regarding design and analysed cohorts, long term data are mostly missing. This study aimed to determine sex disparities in outcomes after open revascularisation in chronic limb threatening ischaemia (CLTI). METHODS: Using health insurance claims data of the second largest insurance fund in Germany, BARMER, a large cohort of patients was sampled consecutively for analysis including index open surgical revascularisations of CLTI performed between 1 January 2010, and 31 December 2018. Propensity score matching was used to adjust for confounding. Sex related differences regarding overall survival, amputation free survival (AFS), and cardiovascular event free survival (CVEFS) during the five years after surgery were determined using Kaplan-Meier time to event curves, log rank test, logistic, and Cox regression. RESULTS: Among 9 526 patients (49.5% women) in the entire cohort, 6 502 patients were matched. Before matching, women were older at presentation (78.0 vs. 71.8 years, p < .001) and suffered more often from multiple comorbidities (van Walraven score > 9, 55.5% vs. 50.6%, p < .001). During the hospital stay, there were 692 (7.3%) deaths, while 4 631 deaths (48.6%) occurred during the follow up. In the matched cohort, the median follow up was 746 days for women and 871 days for men. In the matched analyses, female sex was significantly associated with better overall survival (hazard ratio, HR, 0.80, log rank p < .001), AFS (HR 0.81, log rank p < .0001), and CVEFS (HR 0.84, log rank p < .001) five years after the index treatment. CONCLUSION: In this largest propensity score matched analysis of health insurance claims to date from Germany, evidence was found for better long term outcomes in women after open surgical revascularisations for chronic limb threatening ischaemia. Future guidelines and studies should address the impact of sex on patient selection practice and outcomes to determine the underlying reasons for existing disparities.

Modern Image Acquisition System Reduces Radiation Exposure to Patients and Staff During Complex Endovascular Aortic Repair.

OBJECTIVE: Radiation damage during complex endovascular aortic repair (EVAR) is of major concern to patients and medical staff. This study investigates primarily the influence of different acquisition systems (Allura ClarityIQ vs. Allura Xper, Philips Healthcare, Best, the Netherlands) on radiation dose. Secondly, radiation exposure was analysed for operator positions as well as for procedure and patient specific parameters. METHODS: This was a retrospective study of prospectively collected data. The study prospectively included 62 consecutive patients (mean age 71.2 ± 8.4 years; 63% males) who underwent complex EVAR including fenestrated or branched EVAR of the thoraco-abdominal or the aortic arch from 30 June 2015 to 20 May 2016. In half the patients an advanced dose and real time image noise reduction technology (Allura ClarityIQ) was used, and in the other half the reference acquisition system (Allura Xper) was used. Patient demographics included age, gender, and body mass index. RESULTS: Sixty-two patients with mean age of 71.2 ± 8.4 years (63% males; 39/62) were treated using either Allura ClarityIQ or Allura Xper. Patients treated using Allura ClarityIQ had lower cumulative dose area product (18,948.3 ± 14,648.5 cGy cm2vs. 38,512.4 ± 24,105.4 cGy cm2, p < 0.001) and air kerma (2237.9 ± 1808 mGy vs. 4031 ± 3260.2 mGy, p = .010) in comparison with patients treated using Allura Xper. CONCLUSION: Advanced dose and real time image noise reduction technology, such as Allura ClarityIQ, is a useful tool to lower the amount of radiation for patient and staff during complex endovascular aortic procedures.

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis.

OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed. CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

Editor's Choice - Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data.

OBJECTIVE: Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). METHODS: Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. RESULTS: There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. CONCLUSION: Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs.

Editor's Choice - Comorbidity Patterns Among Patients with Peripheral Arterial Occlusive Disease in Germany: A Trend Analysis of Health Insurance Claims Data.

OBJECTIVE: Patients suffering from peripheral arterial occlusive disease (PAOD) are a central target population for multidisciplinary vascular medicine. This study aimed to highlight trends in treatment patterns and comorbidities using up to date longitudinal patient related data from Germany. METHODS: This study is a retrospective health insurance claims data analysis of patients insured by the second largest health insurance provider in Germany, BARMER. All PAOD patient hospitalisations between 2008 and 2016 were included. The comorbidities were categorised with Elixhauser groups using WHO ICD-10 codes and summarised as the linear van Walraven score (vWS). A trend analysis of the comorbidities was performed after standardisation by age and sex. RESULTS: A total of 156 217 patients underwent 202 961 hospitalisations (49.4% for chronic limb threatening ischaemia in 2016) with PAOD during the study period. Although the estimated annual incidence of PAOD among the BARMER cohort decreased slightly (- 4.4%), an increase was observed in the prevalence of PAOD (+ 23.1%), number of hospitalisations (+ 25.1%), peripheral vascular interventions (PVI, + 61.1%), and disease related reimbursement costs (+ 31%) from 2008 to 2016. Meanwhile, the number of major amputations decreased (- 15.1%). The proportion of patients aged 71-80 years increased about +10% among PAOD patients and the mean vWS also increased by two points during the study period. Considerable increases were found in the rates of hypertension, renal failure, and hypothyroidism, whereas the rates of diabetes and congestive heart failure decreased over time. CONCLUSION: Increasing numbers of PVI performed on these ageing and sicker patients lead to rising costs but correlate with decreasing major amputation rates.

Rationale and Design of the Hamburg City Health Study.

The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several important risk and prognostic factors in major chronic diseases. A random sample of 45,000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, are taking part in an extensive baseline assessment at one dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting major organ system function and structures including extensive imaging examinations. The protocol includes validate self-reports via questionnaires regarding lifestyle and environmental conditions, dietary habits, physical condition and activity, sexual dysfunction, professional life, psychosocial context and burden, quality of life, digital media use, occupational, medical and family history as well as healthcare utilization. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to gather valid prevalence and incidence, and to develop complex models predicting health outcomes based on a multitude of examination data, imaging, biomarker, psychosocial and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia are invited for a visit to conduct an additional MRI examination of either heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and surveys as well as related individual routine data from involved health and pension insurances. The study is targeting the complex relationship between biologic and psychosocial risk and resilience factors, chronic disease, health care use, survivorship and health as well as favorable and bad prognosis within a unique, large-scale long-term assessment with the perspective of further examinations after 6 years in a representative European metropolitan population.

Multicenter experience with endovascular treatment of aortic coarctation in adults.

OBJECTIVE: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults. METHODS: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention. RESULTS: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%. CONCLUSIONS: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success.

Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries.

OBJECTIVE: To develop a minimum core data set for evaluation of acute limb ischaemia (ALI) revascularisation treatment and outcomes that would enable collaboration among international registries. METHODS: A modified Delphi approach was used to achieve consensus among international multidisciplinary vascular specialists and registry members of the International Consortium of Vascular Registries (ICVR). Variables identified in the literature or suggested by the expert panel, and variables, including definitions, currently used in 15 countries in the ICVR, were assessed to define both a minimum core and an optimum data set to register ALI treatment. Clinical relevance and practicability were both assessed, and consensus was defined as ≥ 80% agreement among participants. RESULTS: Of 40 invited experts, 37 completed a preliminary survey and 31 completed the two subsequent Delphi rounds via internet exchange and face to face discussions. In total, 117 different items were generated from the various registry data forms, an extensive review of the literature, and additional suggestions from the experts, for potential inclusion in the data set. Ultimately, 35 items were recommended for inclusion in the minimum core data set, including 23 core items important for all registries, and an additional 12 more specific items for registries capable of capturing more detail. These 35 items supplement previous data elements recommended for registering chronic peripheral arterial occlusive disease treatment. CONCLUSION: A modified Delphi study allowed 37 international vascular registry experts to achieve a consensus recommendation for a minimum core and an optimum data set for registries covering patients who undergo ALI revascularisation. Continued global harmonisation of registry infrastructure and definition of items allows international comparisons and global quality improvement. Furthermore, it can help to define and monitor standards of care and enable international research collaboration.

Population Based Analysis of Gender Disparities in 23,715 Percutaneous Endovascular Revascularisations in the Metropolitan Area of Hamburg.

BACKGROUND: The worldwide prevalence of peripheral artery disease (PAD) is increasing and endovascular revascularisation (ER) has become the primary invasive treatment option. This study aims to illuminate gender disparities in ER of PAD. METHODS: This is a retrospective, cross sectional study design. All inpatient invasive, percutaneous endovascular treatments of PAD conducted in the metropolitan area of Hamburg (Germany) were collected consecutively between 01/2004 and 12/2015. Relevant socio-demographic risk factors, technical assessments, procedural details, and in hospital outcomes were collected and subsequently analysed. RESULTS: A total of 23,715 ERs were identified (39.7% females). Female patients were older (74 vs. 70 years, p < .001) and more often suffered from rest pain (12.0% vs. 9.7%, p < .001) at the time of presentation. No differences were found for index lesion complexity (Trans-Atlantic Inter-Society Consensus classes) and the ankle brachial index was less often stated not to be valid in females (5.9% vs. 7.1%, p = .005 for intermittent claudication; 28.5% vs. 32.0%, p = .001 for chronic limb threatening ischaemia, CLTI). If the ER was performed for CLTI, crural vessels below the knee were less often revascularised in females (32.2% vs. 42.7%, p < .001). Peri-operative major bleeding complications including pseudoaneurysms occurred twice as often in females, and female gender was an independent predictor of bleeding complications in the adjusted analyses (OR 2.32, 95% CI 1.49-3.64, p < .001 for IC; OR 1.67, 95% CI 1.10-2.53, p = .017 for CLTI). Lastly, females were more often transferred to nursing homes when compared with males (0.3% vs. 0%, p = .001 for IC; 2.5% vs. 1.2%, p < .001 for CLTI). CONCLUSION: In this study considering percutaneous ER for PAD, female patients were older, had different clinical symptoms, suffered more often from complications, and were at risk of social isolation after discharge when compared with their male counterparts. These results emphasise the need for further studies to evaluate a gender based treatment algorithm in PAD.

Cervical Debranching in the Endovascular Era: A Single Centre Experience.

OBJECTIVE/BACKGROUND: Debranching of the supra-aortic arteries is a common practice either as part of a hybrid treatment of aortic arch pathology or owing to arterial occlusive disease. Results of the debranching techniques have not been reported frequently. METHODS: This was a retrospective single centre study of all consecutive patients with cervical debranching procedures as part of hybrid aortic arch repair. RESULTS: Between 2010 and 2017, 201 patients underwent 211 cervical debranching procedures in a tertiary centre. Mean ± SD patient age was 67.7 ± 10.7 years (70.6% males; n = 142/201) and mean ± SD body mass index (BMI) was 26.3 ± 5. In 78.7% of the cases carotid-subclavian bypass was performed alone (n = 166/211) followed by transposition of the subclavian artery to the ipsilateral carotid (n = 17/211; 8.1%) and in 28 cases (13.3%) a combination of procedures was performed. Twenty-four cases (11.4%) were complicated with local bleeding and 21 cases required re-intervention (10.4%). Nineteen patients (9.5%) developed local peripheral neurological damage post-operatively. Eight patients (3.8%) developed a chylous fistula and five (2.4%) presented with a local wound infection. One patient (0.5%) developed a bypass graft infection. The thirty day mortality was 7.6% (n = 16/211): one death occurred after isolated debranching without thoracic endovascular aneurysm repair (TEVAR; 0.5%). Whether the hybrid procedures were undertaken in a single stage (simultaneous TEVAR and cervical debranching) or two stage fashion appeared to have a significant impact on 30 day mortality (single stage n = 9/60 [15%] vs. debranching alone or two stage hybrid procedures n = 7/144 [4.9%]; p = .018). The major stroke incidence was 4.3% (n = 9/211); no strokes occurred after isolated debranching. Stroke was correlated with longer operating times (odds ratio [OR] 1.006; 95% confidence interval [CI] 1.000-1.011; p = .045) and higher BMI (OR 1.195; 95% CI 1.009-1.415; p = .039). Mean ± SD follow up was 15 ± 17 months (range 0-89 months). Primary cumulative graft patency during follow up was 98.1% (n = 207/211) and secondary patency was 100%. CONCLUSION: The results of cervical debranching procedures showed not only excellent patency rates, but also a significant rate of local complications. Carotid-subclavian bypass appeared to be safer with significantly fewer post-operative complications. Staged hybrid procedures also seemed to be safer.

Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.

GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

Treatment of Aortic Coarctation by Self-expanding Thoracic Endograft with Left Subclavian In Situ Laser Fenestration.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) with self-expanding endograft is increasingly used as a viable treatment option for adult aortic coarctation (AC). METHODS: We hereby reported a 55-year-old gentleman with late presentation of AC, treated by a novel strategy with thoracic endograft and in situ laser fenestration for left subclavian artery (LSA) revascularization. RESULTS: AC was incidentally discovered during coronary angiogram as an investigation for his angina pectoris. TEVAR with self-expanding endograft was chosen because preoperative computer tomography scan showed ectatic thoracic aorta and stenosis just distal to the LSA. The patient was planned for a timely second-stage aortic valve replacement and coronary artery bypass grafting using left internal mammary artery shortly after TEVAR, which required a patent LSA. The procedure was arranged semiurgently. A 34-mm thoracic tube endograft was placed across the coarctation with proximal landing distal to the left common carotid artery. In situ fenestration was created by laser catheter through retrograde left brachial access. The fenestration was then enlarged by balloon dilatation and bridged to the left subclavian origin with a 16-mm balloon-expandable covered stent. CONCLUSIONS: TEVAR with in situ fenestration for LSA is a reliable choice for adult AC. The technique added to the armamentarium of treatment options.

Early Outcomes After Branched and Fenestrated Endovascular Aortic Repair in Octogenarians.

AIM: To compare early outcome after complex endovascular aortic repair in octogenarians (age ≥ 80 years) versus non-octogenarians (age < 80 years) treated with fenestrated or branched stent grafts. METHODS: Single centre retrospective analysis from a prospectively collected database of all patients undergoing repair with fenestrated or branched stent grafts for para/suprarenal aortic aneurysm, type Ia endoleak after previous endovascular aortic repair, and thoraco-abdominal aortic aneurysm between January 2015 and December 2017. Early all cause mortality, major adverse events, and need for re-intervention were analysed for non-octogenarians (age < 80 years) and octogenarians (age ≥ 80 years) at the time of repair. RESULTS: 207 patients (58 [28%] females) with a median age of 73 years (IQR 68-78) underwent repair with fenestrated or branched stent grafts. There were 169 (81%) non-octogenarians with a median age of 72 years (IQR 65-76) and 38 (19%) octogenarians with a median age of 82 years (IQR 81-84). The number of patients with chronic kidney disease was significantly higher in the octogenarians (63 [37%] vs. 22 [58%], p = .03]. Nineteen patients (9%) died. The early mortality rate was higher in the octogenarians (12 [7%] vs. 7 [18%], p = .06]. Mortality rate was 4% (6/148) for elective and 22% (13/59) for urgently treated patients. Similar rates of post-operative sepsis, stroke, respiratory problems, need for dialysis, and spinal cord injury were found in both groups. Two patients in each group had early stent graft related re-interventions. The octogenarian group had increased post-operative creatinine values (1.0 [0.8-1.4] vs. 1.4 [1.0-1.9], p = .01). After multiple logistic regression, ASA class ≥4 and rupture were independent factors of early all cause mortality. CONCLUSIONS: Complex endovascular repair in octogenarians has higher early all cause mortality compared with non-octogenarians. Rupture and higher ASA class of ≥4 are independent predictors for early mortality. Age ≥80 years was found to be an independent predictor for higher early all cause mortality.

Feasibility Study of a Novel Thoraco-abdominal Aortic Hybrid Device (SPIDER-graft) in a Translational Pig Model.

BACKGROUND: The hybrid SPIDER-graft consists of a proximal descending aortic stent graft and a conventional six branched Dacron graft for open abdominal aortic repair. Technical feasibility with regard to avoiding thoracotomy and extracorporeal circulation (ECC) during thoraco-abdominal aortic hybrid repair and peri-procedural safety of this novel device are unknown. MATERIAL AND METHODS: This was a feasibility and safety study in domestic pigs (75-85 kg). The abdominal aorta including iliac bifurcation, left renal artery, and visceral arteries were exposed via retroperitoneal access. The right iliac branch was first temporarily anastomosed end to side to the distal aorta via partial clamping. During inflow reduction and infra-coeliac cross-clamping, the coeliac trunk (CT) was divided and the proximal stent graft portion of the SPIDER-graft was deployed into the descending aorta via the CT ostium. Retrograde visceral and antegrade aorto-iliac blood flow was maintained via the iliac side branch. The visceral, renal, and iliac arteries were sequentially anastomosed, finally replacing the first iliac end to side anastomosis. Technical success, blood flow, periods of ischaemia, and peri-procedural complications were evaluated after intra-operative completion angiography and post-operative computed tomography angiography. RESULTS: Six animals underwent successful thoracic stent graft deployment and distal open reconstruction without peri-operative death. The median thoracic graft implantation time was 4.5 min, and the median ischaemia times before reperfusion were 10 min for the CT, 8 min for the superior mesenteric artery, 13 min for the right renal artery, and 22 min for the left renal artery. Angiography demonstrated appropriate graft implantation and blood flow measurements confirmed sufficient blood flow through all side branches. CONCLUSION: In this translational pig model, thoraco-abdominal hybrid repair using the novel SPIDER-graft was successful in avoiding thoracotomy and ECC. Technical feasibility and safety appear promising, but need to be reassessed in humans.

Incidence, Predictors, and Outcomes of Colonic Ischaemia in Abdominal Aortic Aneurysm Repair.

OBJECTIVE/BACKGROUND: Colonic ischaemia (CI) is a severe complication following abdominal aortic aneurysm (AAA) repair, leading to high morbidity and mortality. The aim of the study was to determine the incidence, predictors, and outcomes of CI following AAA repair. METHODS: National claims from Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate CI after intact (iAAA) and ruptured (rAAA) AAA repairs. Patients undergoing endovascular (EVAR) or open surgical (OSR) repairs between January 2008 and December 2017 were included in the study. RESULTS: There were 9145 patients (8248 iAAA and 897 rAAA) undergoing EVAR or OSR procedures and the median follow up was 2.28 years. Most patients were male (79.2% iAAA, 79.3% rAAA); the median age was 73.0 years (iAAA group) and 76.0 years (rAAA group). Overall, CI occurred 97 (1.2%) times after iAAA and 95 (10.6%) after rAAA. In univariable analyses CI occurred less often after EVAR than after OSR (0.6% vs. 3.7%; p < .001). Acute post-operative renal and respiratory insufficiencies were also related to the occurrence of CI (p < .001). CI was associated with greater in hospital mortality (42.2% vs. 2.7% for iAAA, 64.2% vs. 36.3% for rAAA; p < .001) and lower long-term survival for iAAA (Kaplan-Meier analysis). In multivariable analyses, rAAA (odds ratio [OR] 5.59), and higher van Walraven comorbidity score (OR 1.09) were independently associated with greater risk of CI occurrence. EVAR use (OR 0.30) was protective. EVAR use remained protective in stratified analyses within iAAA (OR 0.32) and rAAA (OR 0.26). CONCLUSION: Post-operative CI after AAA repair is not common but is associated with worse in hospital outcomes and lower long-term survival. EVAR was protective after both rAAA and iAAA repairs. When discussing the treatment of AAA with patients the protective effect of EVAR should be considered. Future studies should validate predictive scores and advance preventive strategies.

New predictors of complications in carotid body tumor resection.

OBJECTIVE: This study examined the relationship between two new variables, tumor distance to base of skull (DTBOS) and tumor volume, with complications of carotid body tumor (CBT) resection, including bleeding and cranial nerve injury. METHODS: Patients who underwent CBT resection between 2004 and 2014 were studied using a standardized, multi-institutional database. Demographic, perioperative, and outcomes data were collected. CBT measurements were determined from computed tomography, magnetic resonance imaging, and ultrasound examination. RESULTS: There were 356 CBTs resected in 332 patients (mean age, 51 years; 72% female); 32% were classified as Shamblin I, 43% as Shamblin II, and 23% as Shamblin III. The mean DTBOS was 3.3 cm (standard deviation [SD], 2.1; range, 0-10), and the mean tumor volume was 209.7 cm3 (SD, 266.7; range, 1.1-1642.0 cm3). The mean estimated blood loss (EBL) was 257 mL (SD, 426; range, 0-3500 mL). Twenty-four percent of patients had cranial nerve injuries. The most common cranial nerves injured were the hypoglossal (10%), vagus (11%), and superior laryngeal (5%) nerves. Both Shamblin grade and DTBOS were statistically significantly correlated with EBL of surgery and cranial nerve injuries, whereas tumor volume was statistically significantly correlated with EBL. The logistic model for predicting blood loss and cranial nerve injury with all three variables-Shamblin, DTBOS, and volume (R2 = 0.171, 0.221, respectively)-was superior to a model with Shamblin alone (R2 = 0.043, 0.091, respectively). After adjusting for Shamblin grade and volume, every 1-cm decrease in DTBOS was associated with 1.8 times increase in risk of >250 mL of blood loss (95% confidence interval, 1.25-2.55) and 1.5 times increased risk of cranial nerve injury (95% confidence interval, 1.19-1.92). CONCLUSIONS: This large study of CBTs demonstrates the value of preoperatively determining tumor dimensions and how far the tumor is located from the base of the skull. DTBOS and tumor volume, when used in combination with the Shamblin grade, better predict bleeding and cranial nerve injury risk. Furthermore, surgical resection before expansion toward the base of the skull reduces complications as every 1-cm decrease in the distance to the skull base results in 1.8 times increase in >250 mL of blood loss and 1.5 times increased risk of cranial nerve injury.

Quality-of-life evaluation in chronic wounds: comparative analysis of three disease-specific questionnaires.

The study directly compared the feasibility and performance of three instruments measuring health-related quality of life (HRQoL) in chronic ulcers: the Freiburg Life Quality Assessment for wounds (FLQA-w), the Cardiff Wound Impact Schedule (CWIS) and the Würzburg Wound Score (WWS). The questionnaires were evaluated in a randomly assigned order in a longitudinal observational study of leg ulcer patients. Psychometric properties (internal consistency, responsiveness and construct validity) were analysed. Patient acceptance was recorded. Analysis of n = 154 patients revealed good internal consistency (Cronbach's alpha ≥ 0·85) for all instruments. There were minor floor effects in all questionnaires (<1%) and some ceiling effects in the CWIS. Construct validity was satisfactory, for example, correlation with EuroQoL-5D was r = 0·70 in the FLQA-w, r = 0·47/0·67/0·68 in the CWIS dimensions and r = 0·60 in the WWS. The proportion of missing values was higher in the CWIS, and overall patient acceptance was highest in the FLQA-w for wounds (54% best preferences) and lowest in the WWS (14%). In conclusion, the FLQA-w, the CWIS and the WWS are reliable, sensitive and valid instruments for the assessment of HRQoL in leg ulcers. However, they show differences in clinical feasibility and patient acceptance.