The impact of nitroglycerine and volume on gastric tube microperfusion assessed by indocyanine green fluorescence imaging.

The influence of hypervolemia and intraoperative administration of nitroglycerine on gastric tube microperfusion remains unclear The present study aimed to investigate the impact of different hemodynamic settings on gastric tube microperfusion quantified by fluorescence imaging with Indocyanine green (ICG-FI) as a promising tool for perfusion evaluation. Three groups with seven pigs each were formed using noradrenaline, nitroglycerin, and hypervolemia for hemodynamic management, respectively. ICG-FI, hemodynamic parameters, and transit-time flow measurement (TTFM) in the right gastroepiploic artery were continuously assessed. Fluorescent microspheres (FM) were administered, and the partial pressure of tissue oxygen was quantified. The administration of nitroglycerine and hypervolemia were both associated with significantly impaired microperfusion compared to the noradrenaline group quantified by ICG-FI. Even the most minor differences in microperfusion could be sufficiently predicted which, however, could not be represented by the mean arterial pressure measurement. Histopathological findings supported these results with a higher degree of epithelial damage in areas with impaired perfusion. The values measured by ICG-FI significantly correlated with the FM measurement. Using tissue oxygenation and TTFM for perfusion measurement, changes in microperfusion could not be comprehended. Our results support current clinical practice with restrictive volume and catecholamine administration in major surgery. Hypervolemia and continuous administration of nitroglycerine should be avoided.

A cross-sectional survey study on the nutrition patterns of patients with peripheral artery disease.

Background: Even though nutrition was demonstrated to have an impact on chronic atherosclerotic disease, there is a paucity of corresponding recommendations for patients with peripheral artery disease (PAD). A Mediterranean Diet based on daily intake of fruits and vegetables with high fibre, vegetable oil, and unsalted nuts including fish several times a week may have protective effects. This cross-sectional survey aimed to determine nutritional patterns amongst inpatients with PAD. Methods: All inpatients with symptomatic PAD who underwent revascularisation at a single centre between 1st May 2018 and 31st December 2021 were asked to fill out a questionnaire on nutritional intake. An 8-item frequency rating scale (from never to three times a day) was used for 15 food groups. For 11 of them, an adapted Mediterranean Diet score was calculated using the answers. The descriptive results were stratified by sex and disease stage (intermittent claudication vs. chronic limb-threatening ischaemia). Results: A total of 319 patients (31.7% female, 69.4 years in mean) were included. Thereof, 71.8% reported they did never receive any nutritional information considering their PAD disease. The mean adapted Mediterranean Diet score was 2.7 points (of maximum 11) with most patients not achieving the recommended servings per week for fruits (1.6%), vegetables (1.0%), and unsalted nuts (12.2%). The intake of cereals was sufficient (43.3%). When compared with men, women consumed more fruits and less meat. Conclusions: This survey demonstrated that although healthy nutrition may have a positive impact on patients with PAD, the education and adherence to a Mediterranean Diet was inappropriate. Nutritional patterns should be more focused in future PAD studies to derive specific recommendations and nutritional programmes as well as patient education in clinical practice.

Intraoperative quality assessment of tissue perfusion with indocyanine green (ICG) in a porcine model of mesenteric ischemia.

BACKGROUND: Mesenteric ischemia is a severe and potentially lethal event. Assessment of intestine perfusion is eminently depending on the skills, and the experience of the surgeon. Thus, the therapy is biased by the right evaluation. Aim of this study is to determine the applicability, and the usefulness of fluorescent-imaging (FI) with indocyanine green (ICG) in a porcine model of mesenteric ischemia. Second end-point is the verification of a visual and quantitative assessment tool of the intestinal perfusion. METHODS: In 18 pigs (54,2 ±2,9kg) an occlusion of a side-branch of the mesenteric artery was performed for 3 (group I, n = 7), 6 (group II, n = 7), and 10 hours (group III, n = 4). After reperfusion a 60 minutes observation period was carried out. 3 regions of interest were defined: ischemic bowel (D1), transitional zone (D2), and non-ischemic bowel (D3). ICG-FI was performed during baseline (T0), occlusion (T1), reperfusion (T2) and after an observation period of 60 minutes (T4). RESULTS: All experiments could be finished successfully. ICG-FI was assessed using assessment of background-subtracted peak fluorescence intensity (BSFI), slope of fluorescence intensity (SFI), and a baseline adjusted ratio of both parameters. ICG-FI confirmed loss of perfusion in D1, decreased perfusion in D2, and increased perfusion in D3. After reperfusion ICG-FI increased in group 2 due to a severe tissue damage resulting in a capillary leakage. In group I ICG-FI was equal to baseline values indicating the totally reversible loss of perfusion. CONCLUSION: Using ICG-FI to estimate intestine perfusion after different durations of ischemia is viable using a porcine model of mesenteric ischemia. Even small differences in perfusion can be reliably determined by ICG-FI. Thus, ICG-FI is an encouraging method to evaluate intestine perfusion intraoperatively.

The interrelationship between diabetes mellitus and peripheral arterial disease.

This systematic review examined the interrelationship between concomitant diabetes mellitus (DM) and peripheral arterial disease (PAD). The objective was to determine differences in the prevalence as well as in the outcomes in diabetic vs. non-diabetic PAD patients. The current review followed a study protocol that was published online in German in 2017. The search included societal practice guidelines, consensus statements, systematic reviews, meta-analyses, and observational studies published from 2007 to 2020 reporting symptomatic PAD and concomitant DM in patients undergoing invasive open-surgical and endovascular revascularizations. German and English literature has been considered. Eligibility criteria were verified by three independent reviewers. Disagreement was resolved by discussion involving a fourth reviewer. 580 articles were identified. After exclusion of non-eligible studies, 61 papers from 30 countries remained, respectively 850,072 patients. The included studies showed that PAD prevalence differed between diabetic vs. non-diabetic populations (20-50% vs. 10-26%), and further by age, gender, ethnicity, duration of existing diabetes, and geographic region. The included studies revealed worse outcomes regarding perioperative complications, amputation rate, and mortality rate in diabetic patients when compared to non-diabetic patients. In both groups, the amputation rates decreased during the research period. This review emphasizes an interrelationship between PAD and DM. To improve the outcomes, early detection of PAD in diabetic patients, and vice versa, should be recommended. The results of this systematic review may help to update societal practice guidelines.

Validation of quantitative assessment of indocyanine green fluorescent imaging in a one-vessel model.

OBJECTIVES: Evaluation of intestinal perfusion remains subjective and depends on the surgeon´s individual experience. Intraoperative quality assessment of tissue perfusion with indocyanine green (ICG) fluorescence using a near-infrared camera system has been described in different ways and for different indications. The aim of the present study was to evaluate fluorescent imaging (FI) in the quantitative assessment of intestinal perfusion in a gastric tube model in pigs and to compare the results to results obtained with florescent microspheres (FM), the gold standard for tissue perfusion. METHODS: Seven pigs (56.0±3.0 kg), both males and females, underwent gastric tube formation after transection and ligation of the gastric arteries, except the right gastroepiploic artery, to avoid collateral blood flow. After baseline assessment (T0), hypotension (T1) was induced by propofol (Karampinis et al 2017) (< 60 mmHg). Then, propofol was paused to obtain normotension (T2, Mean arterial pressure (MAP) 60-90 mmHg). Finally, hypertension (T3, MAP>90 mmHg) was induced by norepinephrine. Measurements were performed in three regions of interest (ROIs) under standardized conditions: the fundus (D1), corpus (D2), and prepyloric area (D3). Hemodynamic parameters and transit-time flow measurement (TTFM) in the right gastroepiploic artery were continuously assessed. FI, FM and the partial pressure of tissue oxygen (TpO2) were quantified in each ROI. RESULTS: The study protocol could successfully be performed during stable hemodynamics. Flow in the gastroepiploic artery measured by transit time flow measurement (TTFM) was related to hemodynamic changes between the measurements, indicating improved blood flow with increasing MAP. The distal part of the gastric tube (D1) showed significantly (p<0.05) impaired perfusion compared to the proximal parts D3 and D2 using FM. ICG-FI also showed the highest values in D3 and the lowest values in D1 at all hemodynamic levels (T1-T3; p<0,05). CONCLUSION: Visual and quantitative assessment of gastric tube perfusion is feasible in an experimental setting using ICG-FI. This might be a promising tool for intraoperative assessment during visceral surgery in the future.

Long-term incidence of cancer after index treatment for symptomatic peripheral arterial disease - a health insurance claims data analysis.

Background: Cancer as a concomitant condition in symptomatic peripheral arterial disease (PAD) patients could have an impact on further therapy and the long-term prognosis of these patients. Aim of this study was to investigate whether there is an increased incidence of cancer in PAD patients and to quantify the corresponding effect size. Materials and methods: Between January 1st, 2008 and December 31st, 2017, we analysed health insurance claims data from Germany's second-largest insurance fund, BARMER. Symptomatic PAD patients suffering from intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) were stratified by gender at index treatment. PAD patients were then followed until an incident cancer diagnosis was recorded. To adjust for age and gender, standardized incidence ratios (SIR) were computed using the 2012 German standard population as reference. Results: 96,528 PAD patients (47% female, 44% IC, mean age 72 years) were included in the current study. When compared to the overall population, female and male PAD patients have a significantly increased risk of incident cancer of the lung (SIR 3.5 vs. 2.6), bladder (SIR 3.2 vs. 4.0), pancreas (SIR 1.4 vs. 1.6), and colon (SIR 1.3 vs. 1.3). During ten years of follow-up, some 7% of males and 4% of females developed lung cancer. For bladder, colon and pancreas cancer, the cumulative hazards were 1% vs. 3.2%, 2.2% vs. 2.8%, and 0.7% vs. 0.9%, respectively. Conclusions: Patients suffering from symptomatic PAD face a markedly higher risk for incident cancer in the long-term follow-up. The cancer risk increased continuously for certain types and PAD was strongly associated with cancer of the lung, bladder, pancreas, and colon. Taking these results into account, PAD patients could benefit from secondary and tertiary screening. These results also emphasize the impact of common risk factors such as tobacco smoke as target for health prevention.

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.

Ten Years of Urgent Care of Ruptured Abdominal Aortic Aneurysms in a High-Volume-Center.

BACKGROUND: The urgent treatment of ruptured abdominal aortic aneurysms (rAAA) remains a challenging condition with devastating morbidity and mortality. Available studies are often limited due to a significant selection bias. This study aims to illuminate real-world evidence using comprehensive data from electronic health records, registries, postmortem findings, and administrative data on all consecutively treated patients presenting with rAAA at a tertiary care center. METHODS: This is a retrospective cross-sectional cohort study covering consecutively treated patients with rAAA between 2009 and 2018. All noninvasive treatments, fatalities, and invasive repairs were included. Information on patient's characteristics, prehospital, and inpatient care was gathered. Short-term outcomes and long-term survival were analyzed for relevant subgroups. RESULTS: In total, 139 patients with rAAA (median age 75 years and 20.9% females, 79.9% infrarenal) were treated increasingly frequent by endovascular aortic repair (EVAR) when compared to open-surgical aortic repair (OSR) during the study period (16.7% in 2009 to 33.3% in 2018, P < 0.05). The rate of patients who had been turned down for rAAA repair was 10.8%, and the overall in-hospital mortality was 43.2%. Perioperative morbidity and mortality were similar for EVAR and OSR, although patients treated by OSR presented with a lower mean Glasgow Coma Scale during the prehospital (12.7 vs. 14.3) and inpatient care (12.7 vs. 14.4) (both P < 0.001), higher rates of intubation (12.8% vs. 10.9%, P < 0.001), lower systolic blood pressure (115 mm Hg vs. 127 mm Hg, P = 0.042), and more often had a cardiac arrest before the operation (14.1% vs. 2.3%, P < 0.001). Higher patient's age (Odds Ratio, OR 1.09; Hazard Ratio, HR 1.06), history of stroke or transient ischemic attack (OR 5.30; HR 2.64), higher serum creatinine (OR 1.81; HR 1.31), and occurrence of colonic ischemia (OR 11.31; HR 2.82) were significantly associated with higher odds of dying in hospital and in the longer term, respectively. CONCLUSIONS: We observed comparable outcomes following OSR and EVAR, although hemodynamically unstable patients were more likely to be treated by OSR. This study also confirmed the impact of colonic ischemia as a devastating complication following rAAA repair emphasizing the need for further reflection by the vascular community.

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.

Predictors of bleeding or anemia requiring transfusion in complex endovascular aortic repair and its impact on outcomes in health insurance claims.

OBJECTIVE: This study aimed to determine predictors and outcomes associated with bleeding or anemia requiring transfusion (BAT) after fenestrated or branched endovascular aneurysm repair (FB-EVAR). METHODS: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate BAT in elective FB-EVAR performed between 2008 and 2017. International Classification of Diseases and German Operations and Procedure Key codes were used. RESULTS: A total of 959 patients (24.8% with BAT) matching the inclusion criteria were identified during the study period. Compared with patients without BAT, patients with BAT were older (74.4 vs 73.0 years; P = .015) and suffered more frequently from congestive heart failure (18.5% vs 9.4%), cardiac arrhythmias (26.9% vs 14.7%), and hereditary or acquired coagulopathy (31.9% vs 6.2%; all P < .001). Coagulopathy (odds ratio [OR], 3.65; 95% confidence interval [CI], 2.29-5.84), female sex (OR, 2.67; 95% CI, 1.78-4.00), and multiple comorbidities (OR, 1.10; 95% CI, 1.07-1.14) were independent predictors of BAT (all P < .001). BAT was associated with higher in-hospital (11.3% vs 2.6%), 30-day (12.2% vs 3.1%), and 90-day (18.5% vs 4.4%) mortality (all P < .001). Furthermore, myocardial infarction (23.9% vs 2.8%) and paraplegia (9.7% vs 0.7%) were more frequent in the BAT group (all P < .001). In multivariable analyses, BAT was associated with worse short-term (OR, 3.19; 95% CI, 1.63-6.33; P = .001) and long-term survival (hazard ratio, 1.62; 95% CI, 1.24-2.11; P < .001). CONCLUSIONS: Patients with hereditary or acquired coagulopathy, patients with multiple comorbidities, and women are at higher risk for development of BAT after FB-EVAR. The occurrence of this event was strongly associated with higher major complication rates and worse short-term and long-term survival. This emphasizes a need to further illuminate the value of patient blood management in FB-EVAR.

Quality Indicators in Peripheral Arterial Occlusive Disease Treatment: A Systematic Review.

OBJECTIVES: This systematic review aimed to identify evidence based quality indicators for invasive revascularisation of symptomatic peripheral arterial occlusive disease (PAOD). METHODS: A systematic search of clinical practice guidelines, consensus statements, systematic reviews, and meta-analyses reporting quality indicators in patients undergoing invasive open and percutaneous revascularisations for symptomatic PAOD (PROSPERO registration number: CRD42019116317) was performed. Furthermore, a grey literature search was conducted involving databases of professional vascular medical organisations. The identified publications were screened independently by two reviewers for possible inclusion and full texts of potentially relevant records were independently evaluated for eligibility. Disagreement was resolved by discussion involving a third reviewer. RESULTS: From 685 articles initially identified, one systematic review and one consensus statement focusing on quality indicators were selected for inclusion in the review. From these sources, a total of three process quality indicators matched the search criteria: one on pharmacological intervention, another on smoking cessation, and a third on surveillance of lower extremity vein bypass grafts. The grey literature search revealed an additional 31 structure, process, and outcome quality indicators. CONCLUSIONS: This study revealed a lack of published evidence based quality indicators concerning invasive treatment for PAOD in the literature. An additional 31 indicators from the databases of professional societies and organisations have not been incorporated in prior guidelines. Interestingly, no indicator related to patient reported outcomes could be identified from either high quality sources or grey literature. Further research and harmonisation of different quality indicators is needed to enhance their evidence and subsequently improve patient centred decision making on invasive treatment.

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.

Multidisciplinary team decision is rare and decreasing in percutaneous vascular interventions despite positive impact on in-hospital outcomes.

Background: Worldwide prevalence of peripheral artery disease (PAD) is increasing and peripheral vascular intervention (PVI) has become the primary invasive treatment. There is evidence that multidisciplinary team decision-making (MTD) has an impact on in-hospital outcomes. This study aims to depict practice patterns and time changes regarding MTD of different medical specialties. Methods: This is a retrospective cross-sectional study design. 20,748 invasive, percutaneous PVI of PAD conducted in the metropolitan area of Hamburg (Germany) were consecutively collected between January 2004 and December 2014. Results: MTD prior to PVI was associated with lower odds of early unsuccessful termination of the procedures (Odds Ratio 0.662, p < 0.001). The proportion of MTD decreased over the study period (30.9 % until 2009 vs. 16.6 % from 2010, p < 0.001) while rates of critical limb-threatening ischemia (34.5 % vs. 42.1 %), patients´ age (70 vs. 72 years), PVI below-the-knee (BTK) (13.2 % vs. 22.4 %), and rates of severe TASC C/D lesions BTK (43.2 % vs. 54.2 %) increased (all p < 0.001). Utilization of MTD was different between medical specialties with lowest frequency in procedures performed by internists when compared to other medical specialties (7.1 % vs. 25.7 %, p < 0.001). Conclusions: MTD prior to PVI is associated with technical success of the procedure. Nonetheless, rates of MTD prior to PVI are decreasing during the study period. Future studies should address the impact of multidisciplinary vascular teams on long-term outcomes.

Impact of weekend treatment on short-term and long-term survival after urgent repair of ruptured aortic aneurysms in Germany.

OBJECTIVE: There is some evidence that weekend admission to the hospital is associated with worse outcomes compared with weekday admission. However, only a few studies have focused on weekend vs weekday surgery outcomes. This study aimed to determine whether there is a weekend effect on outcomes in the treatment of ruptured aortic aneurysms in Germany. METHODS: Health insurance claims of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate short-term and long-term mortality after weekend vs weekday treatment of ruptured aortic aneurysm. Patients undergoing endovascular repair (ER) or open surgical repair (OSR) between January 2008 and December 2016 were included in the study. Both propensity score matching and regression methods were used to adjust for confounding. RESULTS: There were 1477 patients in the cohort, of whom 517 (35.0%) underwent ER and 960 (65.0%) OSR. Overall, 995 (67.4%) patients underwent an operation on weekdays (Monday to Thursday), and 482 (32.6%) patients underwent an operation on a weekend (Friday to Sunday). In multivariable models, patients who underwent an operation on a weekend were at higher risk of in-hospital death after OSR (49.2% vs 38.0%; odds ratio [OR], 1.61; P = .001), and there was a trend toward higher in-hospital mortality after ER (29.5% vs 21.2%; OR, 1.55; P = .056). The ER of thoracic or thoracoabdominal aortic ruptures was associated with significantly higher in-hospital mortality compared with ER of abdominal aortic aneurysm (OR, 1.69; P = .026). CONCLUSIONS: Weekend repairs of ruptured aortic aneurysms are associated with worse in-hospital survival compared with weekday surgery. ER of thoracic or thoracoabdominal aortic ruptures is associated with worse in-hospital survival compared with ER of ruptured abdominal aortic ruptures. This might be an international phenomenon requiring joint learning and action in times of centralization of aortic procedures.

Gender disparities in fenestrated and branched endovascular aortic repair.

OBJECTIVES: Gender disparities in risk factors and outcomes following aortic repair are important issues in healthcare. To date, no large-scale multicentre study addresses this topic in complex endovascular aortic repair. We aimed to determine the outcomes following fenestrated or branched endovascular aortic repair of aneurysms and dissections in female and male patients. METHODS: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate gender disparities in elective fenestrated or branched endovascular aortic repair of thoraco-abdominal or abdominal aortic aneurysms or dissections performed between 2008 and 2017. Elixhauser comorbidities and the linear van Walraven score were used to adjust for confounders in the multivariable analyses. RESULTS: There were 959 patients in the cohort, in whom 163 (17%) were female. The mean age was 73 ± 8 years with no differences between females and males. No gender disparities were observed regarding the van Walraven comorbidity score (6.9 vs 6.8, P = 0.83), but complications occurred more frequently in females. Acute renal failure (relative risk 1.71, 95% confidence interval 1.06-2.77), paraplegia (relative risk 2.71, 95% confidence interval 1.28-5.77) and bleeding or anaemia requiring transfusion (relative risk 1.76, 95% confidence interval 1.39-2.22) were more common in women. In multivariable models, female patients were at a higher risk of in-hospital death (odds ratio 3.206, P < 0.001). Consequently, female gender was associated with lower long-term survival (hazard ratio 1.506, P = 0.006). CONCLUSIONS: In complex endovascular aortic repair, females are more likely to experience complications and have worse in-hospital and, consequently, long-term survival when compared to males. Future studies should include anatomic parameters to determine the impact of anatomy on outcome disparities.

Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry.

BACKGROUND: Atherosclerotic disease of the lower extremity arteries (PAD) remains a significant burden on global healthcare systems with increasing prevalence. Various guidelines on the diagnosis and treatment of patients with PAD are available but they often lack a sufficient evidence base for high-grade recommendations since randomized and controlled trials (RCT) remain rare or are frequently subject to conflicts of interest. This registry trial aims to evaluate the outcomes of catheter-based endovascular revascularisations vs. open-surgical endarterectomy vs. bypass surgery for symptomatic PAD on medical and patient-reported outcomes. METHODS AND DESIGN: The study is a prospective non-randomized multicentre registry trial including invasive revascularisations performed in 10 000 patients treated for symptomatic PAD at 30 to 40 German vascular centres. All patients matching the inclusion criteria are consecutively included for a recruitment period of six months (between May and December 2018) or until 10 000 patients have been included in the study registry. There are three follow-up measures at three, six, and 12 months. Automated completeness and plausibility checks as well as independent site visit monitoring will be performed to assure high internal and external validity of the study data. Study endpoints include relevant major cardiovascular and limb events and patient-reported outcomes from two Delphi studies with experts in vascular medicine and registry-based research. DISCUSSION: It remains unclear if results from RCT can reflect daily treatment practice. Furthermore, great costs and complexity make it challenging to accomplish high quality randomized trials in PAD treatment. Prospective registry-based studies to collect real-world evidence can help to overcome these limitations.

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.

International Variations in Amputation Practice: A VASCUNET Report.

OBJECTIVES: To study international differences in incidence and practice patterns as well as time trends in lower limb amputations related to peripheral arterial disease and/or diabetes mellitus. METHODS: Data on lower limb amputations during 2010-2014 were collected from population based administrative data from countries in Europe and Australasia participating in the VASCUNET collaboration. Amputation rates, time trends, in hospital or 30 day mortality and reimbursement systems were analysed. RESULTS: Data from 12 countries covering 259 million inhabitants in 2014 were included. Individuals aged ≥ 65 years ranged from 12.9% (Slovakia) to 20.7% (Germany) and diabetes prevalence among amputees from 25.7% (Finland) to 74.3% (Slovakia). The mean incidence of major amputation varied between 7.2/100,000 (New Zealand) and 41.4/100,000 (Hungary), with an overall declining time trend with the exception of Slovakia, while minor amputations increased over time. The older age group (≥65 years) was up to 4.9 times more likely to be amputated compared with those younger than 65 years. Reported mortality rates were lowest in Finland (6.3%) and highest in Hungary (20.3%). Countries with a fee for service reimbursement system had a lower incidence of major amputation compared with countries with a population based reimbursement system (14.3/100,000 versus 18.4/100,000, respectively, p < .001). CONCLUSIONS: This international audit showed large geographical differences in major amputation rates, by a factor of almost six, and an overall declining time trend during the 4 year observation of this study. Diabetes prevalence, age distribution, and mortality rates were also found to vary between countries. Despite limitations attributable to registry data, these findings are important, and warrant further research on how to improve limb salvage in different demographic settings.