[Recommendations for the specialist further training of nursing personnel on intensive care units in the treatment of abdominal aortic aneurysms: results of a modified Delphi procedure with experts]. / Empfehlungen zur Fachweiterbildung von Pflegefachpersonen der Intensivstation bei der Behandlung des Bauchaortenaneurysmas: Ergebnisse eines modifizierten Delphi-Verfahrens mit Expert:innen.

INTRODUCTION: The medical development in the previous 15 years and the changes in treatment reality of the comprehensive elective treatment of abdominal aortic aneurysms necessitate a re-evaluation of the quality assurance guidelines of the Federal Joint Committee in Germany (QBAA-RL). In the current version this requires a specialist further training quota for nursing personnel in intensive care wards of 50%. The quota was determined in 2008 based on expert opinions, although a direct empirical evidence base for this does not exist. METHODS: Representatives from the fields of patient representation, physicians, nursing personnel and other relevant interface areas were invited to participate in a modified Delphi procedure. Following a comprehensive narrative literature search, a survey and focus group discussions with national and international experts, a total of three anonymized online-based voting rounds were carried out for which previously determined key statements were assessed with a 4­point Likert scale (totally disagree up to totally agree). In addition, the expert panel had also defined a recommendation for a minimum quota for the specialist training of nursing personnel on intensive care wards in the treatment of abdominal aortic aneurysms, whereby an a priori agreement of 80% of the participants was defined as the consensus limit. RESULTS: Overall, 37 experts participated in the discussions and three successive voting rounds (participation rate 89%). The panel confirmed the necessity of a re-evaluation of the guideline recommendations and recommended the introduction of a shift-related minimum quota of 30% of the full-time equivalent of nursing personnel on intensive care wards and the introduction of structured promotional programs for long-term elevation of the quota. CONCLUSION: In this national Delphi procedure with medical and nursing experts as well as representatives of patients, the fundamental benefits and needs of professional specialist qualifications in the field of intensive care medicine were confirmed. The corresponding minimum quota for specialist further training of intensive care nursing personnel should generally apply without limitations to specific groups. The expert panel stipulates a shift-related minimum quota for intensive care nursing personnel with specialist training of 30% of the nursing personnel on intensive care wards and the obligatory introduction of structured and transparent promotion programs for the long-term enhancement.

Aortic Vascular Graft and Endograft Infection-Patient Outcome Cannot Be Determined Based on Pre-Operative Characteristics.

Vascular graft/endograft infection (VGEI) is a serious complication after aortic surgery. This study investigates VGEI and patient characteristics, PET/CT quantification before surgical or conservative management of VGEI and post-intervention outcomes in order to identify patients who might benefit from such a procedure. PET standard uptake values (SUV) were quantitatively assessed and compared to a non-VGEI cohort. The primary endpoints were in-hospital mortality and aortic reintervention-free survival at six months. Ninety-three patients (75% male, 65 ± 10 years, 82% operated) were included. The initial operation was mainly for aneurysm (67.7%: 31% EVAR, 12% TEVAR, 57% open aortic repair). Thirty-two patients presented with fistulae. PET SUVTLR (target-to-liver ratio) showed 94% sensitivity and 89% specificity. Replacement included silver-coated Dacron (21.3%), pericardium (61.3%) and femoral vein (17.3%), yet the material did not influence the overall survival (p = 0.745). In-hospital mortality did not differ between operative and conservative treatment (19.7% vs. 17.6%, p = 0.84). At six months, 50% of the operated cohort survived without aortic reintervention. Short- and midterm morbidity and mortality remained high after aortic graft removal. Neither preoperative characteristics nor the material used for reconstruction influenced the overall survival, and, with limitations, both the in-hospital and midterm survival were similar between the surgically and conservatively managed patients.

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany.

BACKGROUND: Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. METHODS: Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph's Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. DISCUSSION: Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05665101. Registered on 23 December 2022.

Editor's Choice - Temporal fluctuations of hospital incidence and mortality of ruptured abdominal aortic aneurysms in Germany: A secondary data analysis of German hospital episode statistics 2009 - 2018.

OBJECTIVE: Abdominal aortic aneurysm rupture (rAAA) is still associated with high mortality. Recent studies have shown higher incidences in autumn and winter, and worse outcomes after rAAA treatment on weekends in some countries. This study aimed to analyse seasonal, weekday, and daytime fluctuations of the hospital incidence, treatment modalities, and outcomes of rAAA, based on the most recent nationwide German real world data. METHODS: A secondary data analysis of diagnosis related group statistics (2009 - 2018), obtained from the German Federal Statistical Office, was conducted. Cases encoded by a diagnosis of rAAA in conjunction with procedural codes for endovascular aortic repair (EVAR) or open aortic repair were included. Patient and procedural characteristics, comorbidities, and outcomes were analysed for seasonal (spring, summer, autumn, and winter), weekday (Monday - Sunday) and daytime (0:00 - 8:00, 8:00 -16:00, 16:00 -20:00, and 20:00 - 24:00) fluctuations by descriptive statistics and multivariable regression analyses. RESULTS: Thirteen thousand and seventy patients (85% male, median age 75 years) were treated for rAAA. Endovascular aortic repair was associated with lower mortality (adjusted OR 0.40, 95% CI 0.37 - 0.44). While no significant seasonal fluctuations were found, on a weekday basis lower hospital incidences were found on Mondays (12%) and Sundays (11%) compared with other weekdays (15 - 16%). Similarly, EVAR rates were lower on Mondays and Sundays (25% and 24%, respectively) compared with other weekdays (30 - 33%). Multivariable analyses revealed higher mortality rates on Mondays and Sundays. On a daytime basis, lower EVAR rates and higher mortality rates were found during the 16:00 - 8:00 period. CONCLUSION: In German hospitals, incidences and EVAR rates to treat rAAA were lowest on Mondays and Sundays. The associated overall mortality rates were highest on the respective days. Further restructuring and centralisation of AAA treatment in Germany could potentially mitigate this weekday effect.

A prospective survey study on the education and awareness about walking exercise amongst inpatients with symptomatic peripheral arterial disease in Germany.

Background: To determine the adherence to supervised exercise training and underlying reasons for non-adherence amongst patients with inpatient treatment of symptomatic lower extremity peripheral arterial disease (PAD). Patients and methods: This was a prospective questionnaire-based survey study of all consecutively treated inpatients with treatment for either intermittent claudication or chronic limb-threatening ischaemia (CLTI) surveyed at sixteen participating centres in Germany. Results: A total of 235 patients (median age 70 years) were included, thereof 29.4% females and 34.6% with CLTI. The median time from first PAD diagnosis was 4 years (IQR: 1-8). Only 11.4% have previously participated in any walking exercise programme before the index treatment, thereby 10.0% in the IC subgroup and 12.0% with CLTI. Amongst all patients, 35.6% responded they were appropriately informed about the necessity and benefits of walking exercise programmes by their hospital physicians (25.8% by general practitioners), and 65.3% agreed that adherence to supervised exercise may improve their pain-free walking distance. A total of 24.5% responded they had access to necessary information concerning local walking exercise programmes. Amongst 127 free text comments on the reasons for non-adherence to supervised exercise training, 64% of the comments contained lack of information or consent on such measures. Conclusions: Less than 12% of the patients enrolled in the current study have ever participated in a walking exercise programme during their life course. Although all practice guidelines contain corresponding class I recommendations, especially for patients suffering from IC, most patients responded that they were not appropriately informed about the necessity of exercise training along with the fact that 65% agreed that exercise may increase the pain-free walking distance. Taken all together, these results emphasise that we miss an important opportunity in the patient-physician communication. Efforts should be made to improve acceptance and application of structured walking-exercise for patients with PAD.

External Validity of Randomised Controlled Trials on Carotid Revascularisation: Trial Populations May Not Always Reflect Patients in Clinical Practice.

OBJECTIVE: The external validity of randomised controlled trials (RCTs) and their transferability to clinical practice is under investigated. This study aimed to analyse the exclusion criteria of recent carotid RCTs comparing carotid endarterectomy (CEA) and carotid artery stenting, and to assess the eligibility of consecutive clinical practice cohorts to those RCTs. METHODS: An analysis of the clinical and anatomical exclusion criteria of RCTs for asymptomatic (SPACE-2, ACST-2, CREST-1, and CREST-2) and symptomatic carotid stenosis (SPACE-1, CREST-1, ICSS, and EVA-3S) was performed. Two hundred consecutive asymptomatic and 200 consecutive symptomatic patients, treated by CEA, or transfemoral or transcarotid artery stenting at a tertiary referral university centre were assessed for their potential eligibility for each corresponding RCT. RCT patient data were pooled and differences from the clinical practice cohort analysed. Statistics were descriptive and comparative using Fisher's exact and t tests. RESULTS: The number of clinical and anatomical exclusion criteria differed widely between RCTs. Potential eligibility rates of the clinical practice cohort for RCTs with regard to asymptomatic carotid stenosis were 80.5% (ACST-2), 79.5% (SPACE-2), 47% (CREST-1), and 20% (CREST-2). For RCTs on symptomatic carotid stenosis the eligibility rates were 89% (ICSS), 86.5% (EVA-3S), 64% (SPACE-1), and 39% (CREST-1). Both clinical practice cohorts were older by about three years and patients were more often male vs. the RCTs. Furthermore, a history of smoking (asymptomatic patients), hypertension (symptomatic patients), and atrial fibrillation was diagnosed more often, whereas hypercholesterolaemia and coronary heart disease (asymptomatic patients) were less prevalent. More clinical practice patients were on antiplatelets, anticoagulants, and lipid lowering drugs. Symptomatic clinical practice patients presented more often with retinal ischaemia and less often with minor hemispheric strokes than patients in the RCTs. CONCLUSION: The external validity of contemporary carotid RCTs varies considerably. Patients in routine clinical practice differ from RCT populations with respect to age, comorbidities, and medication. These data are of interest for clinicians and guideline authors and may be relevant for the design of future comparative trials.

Vascular education through e-Learning.

Background: The COVID-19 pandemic has changed everyday life and work in many ways. As travelling to meetings and conferences was almost completely suppressed for most of healthcare professionals, e-Learning became increasingly prominent. The overall utility of e-Learning during the COVID-19 pandemic as well as its shortcomings in the international community of vascular surgery were assessed through the EL-COVID study. Regional variability was observed amongst participating nations, which is currently being addressed through several ongoing subgroup analyses. Our study completes the aforementioned efforts and aims to investigate the adherence and adoption of vascular e-Learning in Germany. Methods and participants: Using an online survey, EL-COVID gathered answers from 856 vascular surgeons, of whom 70 were located in Germany. We analyzed the answers of 62 German responders that attended at least one e-Learning activity and compared them with the remaining worldwide data. Results: Out of all European countries, Germany was best represented and ranked second worldwide after Mainland China (n=109). 30.6 percent of the German responders were female (vs. 20% worldwide; p=0.048) and 56.4% were vascular surgeons with >5 years of practice (vs. 56.3; p=0.975). The international cohort generally engaged in more e-Learning. Most German participants attended less than 4 online activities, while only 24.2% took part in more than 4 such events (vs. 56.3; p<0.0001). While the overall impression of e-Learning activities during the COVID-19 pandemic was positive, German employers were less supportive of participation during working hours (30.6% vs. 44%; p=0.042). The main reason for not attending was lack of time due to increased workload (56.5% vs. 50%; p=0.328). National and international societies played a lesser role in promoting such activities in Germany (22.6% vs. 39.2%; p=0.010), the same accounts for social media (16.1 vs. 30.3; p=0.017). Conclusions: E-Learning complements the classical training methods and has been embraced as a relevant alternative in the time of the COVID-19 pandemic. The results of this survey appeal to German employers and national societies to improve support and dissemination of e-Learning activities in the vascular medicine community.

Radiation and Chemotherapy are Associated with Altered Aortic Aneurysm Growth in Patients with Cancer: Impact of Synchronous Cancer and Aortic Aneurysm.

OBJECTIVE: The purpose of this study was to assess the associations between malignancy, therapeutic regimens, and aorto-iliac aneurysm (i.e., abdominal aortic aneurysm [AAA]) growth rates. METHODS: A retrospective single centre analysis identified patients with an AAA plus cancer. Patients who had two or more computed tomography angiograms over six months or more and additional malignancy were included. Clinical data and aneurysm diameters were analysed. AAA growth under cancer therapy (chemotherapy or radiation) was compared with a non-cancer AAA control cohort and to meta-analysis data. Statistics included t tests and a linear regression model with correction for initial aortic diameter and type of treatment. RESULTS: From 2003 to 2020, 217 patients (median age 70 years; 92% male) with 246 aneurysms (58.8% AAA) and 238 malignancies were identified. Prostate (26.7%) and lung (15.7%) cancer were most frequently seen. One hundred and fifty-seven patients (72.3%) received chemotherapy, 105 patients (48.4%) radiation, and 79 (36.4%) both. Annual AAA growth (mean ± standard deviation) was not statistically significantly different for cancer and non-cancer patients (2.0 ± 2.3 vs. 2.8 ± 2.1 mm/year; p = .20). However, subgroup analyses revealed that radiation was associated with a statistically significantly reduced mean aneurysm growth rate compared with cancer patients without radiation (1.1 ± 1.3 vs. 1.6 ± 2.1 mm/year; p = .046) and to the non-cancer control cohort (1.7 ± 1.9 vs. 2.8 ± 2.1 mm/year; p = .007). Administration of antimetabolites resulted in statistically significantly increased AAA growth (+ 0.9 mm/year; p = .011), while topoisomerase inhibitors (- 0.8 mm/year; p = .17) and anti-androgens (- 0.5 mm/year; p = .27) showed a possible trend for reduced growth. Similar observations were noted for iliac aneurysms (n = 85). Additionally, the effects persisted for chemotherapy combinations (2.6 ± 1.4 substances/patient). CONCLUSION: Patients with cancer and concomitant aortic aneurysms may require intensified monitoring when undergoing specific therapies, such as antimetabolite treatment, as they may experience an increased aneurysm growth rate. Radiation may be associated with reduced aneurysm growth.

Utilization and Regional Differences of In-Patient Services for Peripheral Arterial Disease and Acute Limb Ischemia in Germany: Secondary Analysis of Nationwide DRG Data.

BACKGROUND: Peripheral arterial disease (PAD) and acute limb ischemia (ALI) pose an increasing strain on health care systems. The objective of this study was to describe the German health care landscape and to assess hospital utilization with respect to PAD and ALI. METHODS: Secondary data analysis of diagnosis-related group statistics data (2009-2018) provided by the German Federal Statistical Office. Inclusion of cases encoded by the International Classification of Diseases (ICD-10) codes for PAD and arterial embolism or thrombosis. Construction of line diagrams and choropleth maps to assess temporal trends and regional distributions. RESULTS: A total of 2,589,511 cases (median age 72 years, 63% male) were included, of which 2,110,925 underwent surgical or interventional therapy. Overall amputation rate was 17%, with the highest rates of minor (28%) and major amputations (15%) in patients with tissue loss. In-hospital mortality (overall 4.1%) increased in accordance to Fontaine stages and was the highest in patients suffering arterial embolism or thrombosis (10%). Between 2009 and 2018, the annual number of PAD cases with tissue loss (Fontaine stage IV) increased from 97,092 to 111,268, whereby associated hospital utilization decreased from 2.2 million to 2.0 million hospital days. Hospital incidence and hospital utilization showed a clustering with the highest numbers in eastern Germany, while major amputation rate and mortality were highest in northern parts of Germany. CONCLUSIONS: Increased use of endovascular techniques was observed, while hospital utilization to treat PAD with tissue loss has decreased. This is despite an increased hospital incidence. Addressing socioeconomic inequalities and a more homogeneous distribution of dedicated vascular units might be advantageous in reducing the burden of disease associated with PAD and ALI.

Can We Still Teach Open Repair of Abdominal Aortic Aneurysm in The Endovascular Era? Single-Center Analysis on The Evolution of Procedural Characteristics Over 15 Years.

OBJECTIVE: In many vascular centers an endovascular first policy for the treatment of abdominal aortic aneurysms (AAA) has resulted in endovascular aortic repair (EVAR) outnumbering open aortic repair (OAR). The declining routine in OAR raises the question whether this might influence procedural outcomes and diminish surgical expertise for current and future vascular surgeons. We aimed to analyze OAR outcomes, AAA morphology and procedural details over the past 15 years while an endovascular first approach was successively implemented. PARTICICPANTS AND DESIGN: All patients operated for (i)ntact infra-/juxtarenal AAA between January 1, 2005 and December 31, 2019 were identified. Outcome parameters were length of stay (hospital/ICU), in-hospital mortality and medical/surgical complications. Operative details were clamping zone, access and graft configuration. AAA anatomy including neck and iliac parameters was analyzed with Endosize©. Logistic regression, uni- and multivariate analysis were applied. RESULTS: 293 patients received elective OAR for iAAA. Baseline characteristics (age, sex, hypertension, smoking, occlusive disease, coronary disease, hyperlipidemia, diabetes, renal insufficiency and obesity) did not change over time. The number of OAR dropped significantly (-0.5 cases/year p = 0.02). The procedure time (2005-2007: 192.2 ± 87.5min to 2017-2019: 235.6 ± 88.2min; p = 0.0001) and the length of stay (2005-2007: 12.0 ± 7.9 to 2017-2019: 17.0 ± 23.1; p = 0.03) increased significantly, whereas the in-hospital mortality, length of ICU stay and complication rates didn't, nor did AAA anatomy. Upon multivariate analysis, annual number of OAR and any additional anastomosis significantly influenced procedure time, trainee involvement, for example, did not. Hospital length-of-stay depended on patient age (p = 0.002), complication rates (p < 0.0001) and procedure time (p = 0.006). CONCLUSION: Mortality and complication rates for OAR have remained low and constant. With the increase of EVAR, the absolute number of OARs has decreased significantly. However, the total procedure time has increased and depends significantly on the annual number of OARs in total and per surgeon. This might influence outcome parameters and should be implanted in future surgical education.

Concomitantly discovered visceral artery aneurysms do rarely grow during cancer therapy.

Visceral artery aneurysms (VAA) are a rare entity of arterial aneurysms with the imminent threat of rupture. The impact of cancer and chemotherapy on the growth of VAAs is unknown. A retrospective dual center cohort study of patients with concomitant VAA and different types of cancer was conducted and the impact of various chemotherapeutic agents on VAA growth was studied by sequential CT analysis. For comparison, a non-cancer all comer cohort with VAAs and no cancer was studied to compare different growth rates. The primary endpoint was aneurysm progress or regression >1.75 mm. Chi-square test, Fisher's exact test and Mann-Whitney test was used for statistical comparison. In the 17-year-period from January 2003 to March 2020, 59 patients with 30 splenic artery aneurysms, 14 celiac trunk aneurysms, 11 renal artery aneurysms and 4 other VAA and additional malignancy were identified. 20% of patients suffered from prostate cancer, the rest were heterogeneous. The most prevalent chemotherapies were alkylating agents (23%), antimetabolites (14%) and mitose inhibitors (10%). Eight patients had relevant growth of their VAA and one patient showed diameter regression (average growth rate 0.1 ± 0.5 mm/year). Twenty-nine patients with 14 splenic, 11 RAAs (seven right) and 4 celiac trunk aneurysms were available in the non-cancer comparison cohort (average growth rate 0.5 ± 0.9 mm/year, p = 0.058). However, the growth rate of patients receiving operative treatment for relevant VAA growth was significantly higher (p = 0.004). VAAs grow rarely, and rather slow. Cancer and/or chemotherapy do not significantly influence the annual growth rate. Additional control examinations seem unnecessary.

Dataset of the vascular e-Learning during the COVID-19 pandemic (EL-COVID) survey.

This dataset supports the findings of the vascular e-Learning during the COVID-19 pandemic survey (the EL-COVID survey). The General Data Protection Regulation (GDPR) of the European Union was taken into consideration in all steps of data handling. The survey was approved by the institutional ethics committee of the Primary Investigator and an online English survey consisting of 18 questions was developed ad-hoc. A bilingual English-Mandarin version of the questionnaire was developed according to the instructions of the Chinese Medical Association in order to be used in mainland People's Republic of China. Differences between the two questionnaires were minor and did affect the process of data collection. Both questionnaires were hosted online. The EL-COVID survey was advertised through major social media. All national and regional contributors contacted their respective colleagues through direct messaging on social media or by email. Eight national societies or groups supported the dissemination of the EL-COVID survey. The data provided demographics information of the EL-COVID participants and an insight on the level of difficulty in accessing or citing previously attended online activities and whether participants were keen on citing these activities in their Curricula Vitae. A categorization of additional comments made by the participants are also based on the data. The survey responses were filtered, anonymized and submitted to descriptive analysis of percentage.

Vascular e-Learning During the COVID-19 Pandemic: The EL-COVID Survey.

BACKGROUND: The corona virus disease (COVID-19) pandemic has radically changed the possibilities for vascular surgeons and trainees to exchange knowledge and experience. The aim of the present survey is to inventorize the e-learning needs of vascular surgeons and trainees as well as the strengths and weaknesses of vascular e-Learning. METHODS: An online survey consisting of 18 questions was created in English, with a separate bilingual English-Mandarin version. The survey was dispersed to vascular surgeons and trainees worldwide through social media and via direct messaging from June 15, 2020 to October 15, 2020. RESULTS: Eight hundred and fifty-six records from 84 different countries could be included. Most participants attended several online activities (>4: n = 461, 54%; 2-4: n = 300, 35%; 1: n = 95, 11%) and evaluated online activities as positive or very positive (84.7%). In deciding upon participation, the topic of the activity was most important (n = 440, 51.4%), followed by the reputation of the presenter or the panel (n = 178, 20.8%), but not necessarily receiving accreditation or certification (n = 52, 6.1%). The survey identified several shortcomings in vascular e-Learning during the pandemic: limited possibility to attend due to lack of time and increased workload (n = 432, 50.5%), no protected/allocated time (n = 488, 57%) and no accreditation or certification, while technical shortcomings were only a minor problem (n = 25, 2.9%). CONCLUSIONS: During the COVID-19 pandemic vascular e-Learning has been used frequently and was appreciated by vascular professionals from around the globe. The survey identified strengths and weaknesses in current e-Learning that can be used to further improve online learning in vascular surgery.

Lenvatinib halts aortic aneurysm growth by restoring smooth muscle cell contractility.

Abdominal aortic aneurysm (AAA) is a disease with high morbidity and mortality, especially when ruptured. The rationale of this study was to evaluate the repurposing of lenvatinib, a multi-tyrosine kinase inhibitor, in limiting experimental AAA growth targeting vascular smooth muscle cells (VSMCs) and angiogenesis. We applied systemic and local lenvatinib treatment to elastase-induced murine aortic aneurysms, and RNA profiling identified myosin heavy chain 11 (Myh11) as the most deregulated transcript. Daily oral treatment substantially reduced aneurysm formation in 2 independent mouse models. In addition, a large animal aneurysm model in hypercholesterolemic low-density lipoprotein receptor-knockout (LDLR-/-) Yucatan minipigs was applied to endovascularly deliver lenvatinib via drug-eluting balloons (DEBs). Here, a single local endovascular delivery blocked AAA progression successfully compared with a DEB-delivered control treatment. Reduced VSMC proliferation and a restored contractile phenotype were observed in animal tissues (murine and porcine), as well as AAA patient-derived cells. Apart from increasing MYH11 levels, lenvatinib reduced downstream ERK signaling. Hence, lenvatinib is a promising therapy to limit aortic aneurysm expansion upon local endovascular delivery. The tyrosine kinase inhibitor was able to positively affect pathways of key relevance to human AAA disease, even in a potentially new local delivery using DEBs.

Editor's Choice - Distribution of Care and Hospital Incidence of Carotid Endarterectomy and Carotid Artery Stenting: A Secondary Analysis of German Hospital Episode Data.

OBJECTIVE: This is a description of the German healthcare landscape regarding carotid artery disease, assessment of hospital incidence time courses for carotid endarterectomy (CEA) and carotid artery stenting (CAS), and simulation of potential effects of minimum hospital caseload requirements for CEA and CAS. METHODS: The study is a secondary data analysis of diagnosis related group statistics data (2005-2016), provided by the German Federal Statistical Office. Cases encoded by German operation procedure codes for CEA or CAS and by International Classification of Diseases (ICD-10) codes for carotid artery disease were included. Hospitals were categorised into quartiles according to annual caseloads. Linear distances to the closest hospital fulfilling hypothetical caseload requirements were calculated. RESULTS: A total of 132 411 and 33 709 patients treated with CEA and CAS from 2012 to 2016 were included. CEA patients had lower rates of myocardial infarction (1.4% vs. 1.8%) and death (1.2% vs. 4.0%), and CAS patients were more often treated after emergency admission (38.1% vs. 27.1%). Age standardised annual hospital incidences were 67.2 per 100 000 inhabitants for CEA and 16.3 per 100 000 inhabitants for CAS. The incidence for CEA declined from 2005 to 2016, with CAS rising again until 2016 after having declined from 2010 to 2013. Regarding distance from home to hospital, centres offering CEA are distributed more homogeneously across Germany, compared with those performing CAS. Hypothetical introduction of minimum annual caseloads (> 20 for CEA; > 10 for CAS) imply that 75% of the population would reach their hospital after travelling 45 km for CEA and 70 km for CAS. CONCLUSION: Differences in spatial distribution mean that statutory minimum annual caseloads would have a greater impact on CAS accessibility than CEA in Germany. Presumably because of a decline in carotid artery disease and a transition towards individualised therapy for asymptomatic patients, hospital incidence for CEA has been declining.

[Relationship between regional settlement structure and hospital incidence, type of therapy and mortality of non-ruptured abdominal aortic aneurysms]. / Zusammenhang zwischen der regionalen Siedlungsstruktur und der Krankenhausinzidenz, Therapieform und Mortalität von nicht-rupturierten abdominalen Aortenaneurysmen. Sekundärdatenanalyse der deutschen DRG-Statistik von 2005­2014.

INTRODUCTION: In Germany, the regional settlement structure is heterogenous, ranging from densely populated cities with a tight network of vascular health care to large regions in which access to health care is limited in terms of space and time. Therefore, the aim of this secondary data analysis was to investigate the association between the settlement structure of the patient's home district (KT), and the hospital incidence, type of therapy, and mortality of non-ruptured abdominal aortic aneurysms (nrAAA). METHODS: The microdata of the DRG statistics of the Federal Statistical Office for the years 2005-2014 were evaluated. All patients with nrAAA (ICD-10 Code I71.4) who were admitted to a German hospital and treated by open surgery and endovascular repair were included. Classification of treatment was based on the German Operation and Procedure Code. Patients were grouped according to the settlement structure of their home district defined by the Federal Institute for Research on Building, Urban Affairs and Spatial Development (KT1 independent city, KT2 urban district, KT3 rural district, KT4 sparsely populated region). The age-, sex- and risk-adjusted association between the type of settlement structure and in-hospital mortality was analysed using a multivariable multi-level regression model. The Elixhauser co-morbidity score validated for administrative data was used for risk adjustment. RESULTS: Of 95,452 cases included, 88 % were men. Mean age was 72 years. There were 28,970 (30 %) patients in KT1, 37,759 (40 %) in KT2, 14,442 (15 %) in KT3 and 14,281 (15 %) in KT4. The hospital incidence was 12.4 per 100,000 inhabitants in KT1, 11.8 in KT2, 10.8 in KT3 and 11.2 in KT4 (p <0.001, falling trend). The proportion of EVAR treatment was 56 % in KT1, 54 % in KT2, 57 % KT3, and 59 % in KT4 (p <0.001, increasing trend). The raw hospital mortality of patients from KT1 to KT4 was 3.4 %, 3.4 %, 3.2 % and 3.6 %, respectively (p=0.553 for trend). The multivariable regression analysis revealed no statistically significant association between the KT and hospital mortality (KT1=reference, RR KT2=0.97 [95% CI 0.79-1.15], RR KT3=0.98 [0.81-1.14], RR KT4=0.98 [0.86-1.11]). CONCLUSIONS: The study shows that both the hospital incidence and the type of therapy (endovascular vs. open) differed between the settlement structural district types, but there is no urban-rural gap regarding in-hospital mortality of treated nrAAA.

Lack of durability after transarterial ethylene-vinyl alcohol copolymer-embolization of type II endoleak following endovascular abdominal aortic aneurysm repair.

Background: Type II endoleak (T2EL) after endovascular aortic repair is associated with AAA sac enlargements in up to 25%, reduction of attachment zones and rarely with aortic rupture. Indications for therapy and efficacy of interventions of T2EL are not clearly established. Transarterial embolization with application of ethylene-vinyl alcohol copolymer has been described with varying outcomes. Aim of this study is to evaluate durability of OnyxTM embolization (OE) in T2EL in a consecutive series at a single tertiary vascular center. Patients and methods: Demographic data, technical success, pre- and postoperative aneurysm growth, morbidity, mortality and reintervention rates during hospital stay as well as in follow up were recorded in patients treated with OE for T2EL between 01/2015 and 12/2017. The primary endpoint was defined as persistence or reoccurrence of T2EL (durability of OE). Results: In total 15 patients (78 ± 6 years, 13 men) were treated with OE because of sac enlargement (average growth of 12 ± 8%, n = 12), persistent bleeding after AAA rupture (n = 2) or persistent T2EL with stable but large aneurysm diameter (n = 1). Mean length of stay was 8 ± 11 days. Technical success was 93.3% (n = 14). Inhospital-morbidity was 26.7%, in-hospital- and 1-year-mortality rate were 6.6% (n = 1) and 20.0% (n = 3). T2EL persisted in 20.0% (n = 3) despite of OE. Re-EL-II occurred after 40 (30-114) days in 33.3% (n = 5). Reintervention rate was 13.3% (n = 2, at day 48 and 319). Altogether clinical success with stable aneurysm diameter was achieved in 80.0% (n = 12), but durable elimination of EL was only achieved in 46.7% of patients (n = 7). Conclusions: OE is technically possible in more than 90% of patients but might be associated with severe complications. Durability of this treatment is low, since T2EL persist or reoccur in more than 50% of all patients. OE of T2EL should be reserved for few selected cases.

Early and Midterm Outcomes of Open and Endovascular Revascularization of Chronic Mesenteric Ischemia.

BACKGROUND: Revascularization strategies for chronic mesenteric ischemia (CMI) include open (OR) and endovascular (ER) modalities. The primary objective of this study was to analyze the safety and effectiveness of OR and ER and the impact of clinical and morphological variables on early and midterm outcomes in a consecutive series of CMI patients in a tertiary referral center. PATIENTS AND METHODS: From 2004 to 2017, all CMI patients treated with OR and ER were retrospectively identified. Patient records, preoperative imaging, as well as peri- and postoperative outcomes were analyzed. Univariable and multivariable analysis was performed to identify clinical or morphological variables affecting reintervention rates within 2 years. RESULTS: In total, 63 patients (33% male; mean age 71, range 60-76 years) were treated by ER (41 patients) or OR (22 patients) for CMI. Mean follow-up was 26 (10-71) months. 30-day mortality was 0.0% after ER and 4.5% after OR (p = 0.069); 30-day morbidity was 9.8% vs. 31.8%, respectively (p = 0.030). Length of stay was significantly longer after OR (14 vs. 4 days; p < 0.001). Freedom from reintervention rate after 2 years was 82% after OR and 73% after ER (p = 0.14). Overall survival did not differ after 2 years (OR 85% vs. ER 86%; p = 0.35). Multivariable analysis revealed that smoking was associated with higher risk of reintervention (hazard ratio, HR: 4.14; 95% confidence interval, CI 1.11-15.53; p = 0.03). Additionally, a nonsignificant trend of lower reintervention rates after OR was detected (HR 0.23 95% CI 0.05-1.08; p = 0.06). CONCLUSION: Due to a lower invasiveness, despite the higher reintervention rate, an "endovascular first" strategy is justified and recommended.

Effect Modification of Sex and Age for the Hospital Volume-Outcome Relationship in Abdominal Aortic Aneurysm Treatment: Secondary Data Analysis of the Nationwide German Diagnosis Related Groups Statistics From 2005 to 2014.

Background Trials and registries associated female sex and high age with unfavorable outcomes in abdominal aortic aneurysm treatment. Many studies showed an inverse correlation between annual hospital volume and in-hospital mortality. The volume-outcome relationship has not been investigated separately for women and men or across the age range. The aim was to analyze whether sex and age are effect modifiers or confounders of the volume-outcome association. Methods and Results In a nationwide setting, all in-hospital cases from 2005 to 2014 with a diagnosis of intact abdominal aortic aneurysm and procedure codes for endovascular or open aortic repair were included. Primary outcome was in-hospital mortality. Using a multilevel multivariable regression model, hospital volume was modeled as a continuous variable. Separate analyses were performed for women and men and for predefined age groups. A total of 94 966 cases were included (12% women; median age, 72 years). Mortality was 4.9% in women and 3.0% in men (3.2% overall). Mortality increased with age. Although there was no significant volume-outcome association in women (P=0.57), there was in men (P=0.02). The strongest volume-outcome association was found in younger men. The younger female subpopulation was found to show a trend for an inverse volume-outcome relationship, whereas an opposite association was found for the women aged >79 years. Conclusions Women have a higher mortality risk after elective abdominal aortic aneurysm treatment. Sex and age are modifiers of the volume-outcome relationship. Unlike in male patients, in women there is no consistent effect of hospital volume on outcome.

The Effects of Minimum Caseload Requirements on Management and Outcome in Abdominal Aortic Aneurysm Repair.

BACKGROUND: The German quality assurance guideline on abdominal aortic aneurysm (AAA) was implemented by the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA) in 2008. The aims of this study were to verify the association between hospital case volume and outcome and to assess the hypothetical effect of minimum caseload requirements. METHODS: The German diagnosis-related groups statistics for the years 2012 to 2016 were scrutinized for AAA (ICD-10 GM I71.3/4) with procedure codes for endo - vascular or open surgical treatment. The primary endpoint was in-hospital mortality. Logistic regression models were used for risk adjustment, and odds ratios (OR) were calculated as a function of the annual hospital-level case volume of AAA. In a hypo - thetical approach, the linear distances for various minimum caseloads (MC) were evaluated to assess accessibility. RESULTS: The mortality of intact AAA (iAAA) was 2.7% (men [M] 2.4%, women [W] 4.2%); ruptured AAA (rAAA), 36.9% (M 36.9%, F 37.5%). An inverse relationship between annual hospital case volume of AAA and mortality was confirmed (iAAA/rAAA: from 3.9%/51% [<10 cases/year] through 3.3%/37% [30-39 cases/year] to 1.9%/28% [≥ 75 cases/year]). For a reference category of 30 AAA procedures/year, the following significant OR were found: 10 AAA cases/year, OR 1.21 (95% confidence interval [1.20; 1.21]); 20 cases, OR 1.09 [1.09; 1.09]; 50 cases, OR 0.89 [0.89; 0.89]; 75 cases, OR 0.82 [0.82; 0.82]. In a hypothetical centralization scenario with assumed MC of 30/year, 86% of the population would have to travel less than 100 km to the nearest hospital; with an MC of 40, this would apply to only 50% (without redistribution effects). CONCLUSION: In the observed period, a significant correlation was confirmed between high annual case volume and low in-hospital mortality. A minimum caseload requirement of 30 AAA operations/year seems reasonable in view of the accessibility of hospitals. Cite this.