Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD.

Background: Anatomy is critical in risk stratification and therapeutic decision making in coronary disease. The relationship between anatomy and outcomes is not well described in PAD. We sought to develop an angiographic core lab within the VOYAGER-PAD trial. The current report describes the methods of creating this core lab, its study population, and baseline anatomic variables. Methods: Patients undergoing lower-extremity revascularization for symptomatic PAD were randomized in VOYAGER-PAD. The median follow up was 2.25 years. Events were adjudicated by a blinded Clinical Endpoint Committee. Angiograms were collected from study participants; those with available angiograms formed this core lab cohort. Angiograms were scored for anatomic and flow characteristics by trained reviewers blinded to treatment. Ten percent of angiograms were evaluated independently by two reviewers; inter-rater agreement was assessed. Clinical characteristics and the treatment effect of rivaroxaban were compared between the core lab cohort and noncore lab participants. Anatomic data by segment were analyzed. Results: Of 6564 participants randomized in VOYAGER-PAD, catheter-based angiograms from 1666 patients were obtained for this core lab. Anatomic and flow characteristics were collected across 16 anatomic segments by 15 reviewers. Concordance between reviewers for anatomic and flow variables across segments was 90.5% (24,417/26,968). Clinical characteristics were similar between patients in the core lab and those not included. The effect of rivaroxaban on the primary efficacy and safety outcomes was also similar. Conclusions: The VOYAGER-PAD angiographic core lab provides an opportunity to correlate PAD anatomy with independently adjudicated outcomes and provide insights into therapy for PAD. (ClinicalTrials.gov Identifier: NCT02504216).

Efficacy and safety of rivaroxaban versus placebo after lower extremity bypass surgery: A post hoc analysis of a "CASPAR like" outcome from VOYAGER PAD.

BACKGROUND: The Clopidogrel and Acetylsalicylic Acid in Bypass Surgery for Peripheral Arterial Disease (CASPAR) trial is the only large, double-blind, placebo-controlled trial of dual antiplatelet therapy (DAPT) versus aspirin in patients with peripheral artery disease (PAD) after lower extremity revascularization (LER). The trial was neutral for index-graft occlusion/revascularization, amputation or death (hazard ratio [HR] 0.98, 95% confidence interval [CI] 0.78-1.23, p = .87) with an excess of global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries moderate or severe bleeding (HR 2.84, 95% CI 1.32-6.08, p = .007). HYPOTHESIS AND METHODS: VOYAGER-PAD demonstrated that rivaroxaban significantly reduces acute limb ischemia (ALI), major amputation, myocardial infarction (MI), stroke and CV death but increased bleeding. The relative efficacy and safety of rivaroxaban in a CASPAR like population and for similar outcomes is unknown. The current analysis is a post-hoc exploratory analysis of a "CASPAR like" composite of ALI, unplanned index limb revascularization (UILR), amputation or CV death in surgical patients. RESULTS: In the 2185 who underwent surgical LER, rivaroxaban reduced the CASPAR endpoint at 1 (HR 0.76, 95% CI 0.62-0.95, p = .0133) and 3 years (HR 0.84, 95% CI 0.71-1.00, p = .0461, Figure). There were similar reductions in composites of ALI, amputation or CV death (HR 0.79, p = .0228) and ALI, UILR, amputation, MI, IS or CV death (HR 0.85, p = .0410). CONCLUSIONS: The combination of rivaroxaban and aspirin significantly reduces ischemic outcomes in patients with PAD after LER. Although no formal head-to-head comparison exists, in a similar population and for similar outcomes, this regimen demonstrated benefit where trials of DAPT were neutral. These data suggest that factor Xa inhibition may provide specific benefits in this population and that DAPT should not be considered a proven substitution.

Carotid endarterectomy or stenting or best medical treatment alone for moderate-to-severe asymptomatic carotid artery stenosis: 5-year results of a multicentre, randomised controlled trial.

BACKGROUND: The optimal treatment for patients with asymptomatic carotid artery stenosis is under debate. Since best medical treatment (BMT) has improved over time, the benefit of carotid endarterectomy (CEA) or carotid artery stenting (CAS) is unclear. Randomised data comparing the effect of CEA and CAS versus BMT alone are absent. We aimed to directly compare CEA plus BMT with CAS plus BMT and both with BMT only. METHODS: SPACE-2 was a multicentre, randomised, controlled trial at 36 study centres in Austria, Germany, and Switzerland. We enrolled participants aged 50-85 years with asymptomatic carotid artery stenosis at the distal common carotid artery or the extracranial internal carotid artery of at least 70%, according to European Carotid Surgery Trial criteria. Initially designed as a three-arm trial including one group for BMT alone (with a randomised allocation ratio of 2·9:2·9:1), the SPACE-2 study design was amended (due to slow recruitment) to become two substudies with two arms each comparing CEA plus BMT with BMT alone (SPACE-2a) and CAS plus BMT with BMT alone (SPACE-2b); in each case in a 1:1 randomisation. Participants and clinicians were not masked to allocation. The primary efficacy endpoint was the cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years. The primary safety endpoint was any stroke or death from any cause within 30 days after CEA or CAS. The primary analysis was by intention-to treat, which included all randomly assigned patients in SPACE-2, SPACE-2a, and SPACE-2b, analysed using meta-analysis of individual patient data. We did two-step hierarchical testing to first show superiority of CEA and CAS to BMT alone then to assess non-inferiority of CAS to CEA. Originally, we planned to recruit 3640 patients; however, the study had to be stopped prematurely due to insufficient recruitment. This report presents the primary analysis at 5-year follow-up. This trial is registered with ISRCTN, number ISRCTN78592017. FINDINGS: 513 patients across SPACE-2, SPACE-2a, and SPACE-2b were recruited and surveyed between July 9, 2009, and Dec 12, 2019, of whom 203 (40%) were allocated to CEA plus BMT, 197 (38%) to CAS plus BMT, and 113 (22%) to BMT alone. Median follow-up was 59·9 months (IQR 46·6-60·0). The cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years (primary efficacy endpoint) was 2·5% (95% CI 1·0-5·8) with CEA plus BMT, 4·4% (2·2-8·6) with CAS plus BMT, and 3·1% (1·0-9·4) with BMT alone. Cox proportional-hazard testing showed no difference in risk for the primary efficacy endpoint for CEA plus BMT versus BMT alone (hazard ratio [HR] 0·93, 95% CI 0·22-3·91; p=0·93) or for CAS plus BMT versus BMT alone (1·55, 0·41-5·85; p=0·52). Superiority of CEA or CAS to BMT was not shown, therefore non-inferiority testing was not done. In both the CEA group and the CAS group, five strokes and no deaths occurred in the 30-day period after the procedure. During the 5-year follow-up period, three ipsilateral strokes occurred in both the CAS plus BMT and BMT alone group, with none in the CEA plus BMT group. INTERPRETATION: CEA plus BMT or CAS plus BMT were not found to be superior to BMT alone regarding risk of any stroke or death within 30 days or ipsilateral stroke during the 5-year observation period. Because of the small sample size, results should be interpreted with caution. FUNDING: German Federal Ministry of Education and Research (BMBF) and German Research Foundation (DFG).

Editor's Choice - Update of the European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia in Light of the COVID-19 Pandemic, Based on a Scoping Review of the Literature.

OBJECTIVE: To perform a scoping review of how patients with COVID-19 are affected by acute limb ischaemia (ALI) and evaluate the recommendations of the 2020 ESVS ALI Guidelines for these patients. METHODS: Research questions were defined, and a systematic literature search was performed following the PRISMA guidelines. Abstracts and unpublished literature were not included. The definition of ALI in this review is in accordance with the ESVS guidelines. RESULTS: Most identified papers were case reports or case series, although population based data and data from randomised controlled trials were also identified. In total, 114 unique and relevant papers were retrieved. Data were conflicting concerning whether the incidence of ALI increased, or remained unchanged, during the pandemic. Case reports and series reported ALI in patients who were younger and healthier than usual, with a greater proportion affecting the upper limb. Whether or not this is coincidental remains uncertain. The proportion of men/women affected seems unchanged. Most reported cases were in hospitalised patients with severe COVID-19. Patients with ALI as their first manifestation of COVID-19 were reported. Patients with ALI have a worse outcome if they have a simultaneous COVID-19 infection. High levels of D-dimer may predict the occurrence of arterial thromboembolic events in patients with COVID-19. Heparin resistance was observed. Anticoagulation should be given to hospitalised COVID-19 patients in prophylactic dosage. Most of the treatment recommendations from the ESVS Guidelines remained relevant, but the following were modified regarding patients with COVID-19 and ALI: 1) CTA imaging before revascularisation should include the entire aorta and iliac arteries; 2) there should be a high index of suspicion, early testing for COVID-19 infection and protective measures are advised; and 3) there should be preferential use of local or locoregional anaesthesia during revascularisation. CONCLUSION: Although the epidemiology of ALI has changed during the pandemic, the recommendations of the ESVS ALI Guidelines remain valid. The above mentioned minor modifications should be considered in patients with COVID-19 and ALI.

Early outcomes of t-Branch off-the-shelf multibranched stent graft in urgent and emergent repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the outcomes between elective, urgent, and emergent treatment of thoracoabdominal aortic aneurysms (TAAAs) using the t-Branch off-the-shelf multibranched stent graft (Cook Medical, Bloomington, Ind). METHODS: All consecutive patients treated for TAAAs using the t-Branch between September 2012 and June 2019 were included in the present study. The patients were divided into three groups according to the urgency of repair: (1) elective, (2) urgent, and (3) emergent. The periprocedural details and 30-day outcomes were analyzed. Survival and reinterventions were analyzed using Kaplan-Meier curves and log-rank tests. RESULTS: The t-Branch stent graft was used for 100 patients during the study period. Of the 100 patients, 30 (73% male; mean age, 65 ± 10 years) were treated electively, 49 (54% male; mean age, 72 ± 7 years) urgently, and 21 (81% male; mean age, 75 ± 9 years) emergently. Transfemoral access with a steerable sheath was used more frequently for target vessel catheterization in the elective group (57%) than in the urgent (8%) and emergent (5%) groups (P = .021). The total number of targeted vessels was 111 of 120 (93%) in the elective group vs 185 of 196 (94%) in the urgent group and 82 of 84 (98%) in the emergent group. The corresponding technical success rates were 97% (29 of 30), 98% (48 of 49), and 95% (20 of 21). The median intensive care unit stay was shorter in the elective group (3 days; range, 1-41 days) than in the urgent group (5 days; range, 1-41 days) and emergent group (11 days; range, 3-37 days; P = .004). The 30-day mortality rate was lower in the elective group (2 of 30; 7%) than in the urgent group (8 of 49; 16%) and emergent group (5 of 21; 24%; P = .049). The acute kidney injury rate was lower in the elective group (2 of 30; 7%) than in the urgent group (11 of 49; 22%) and emergent group (8 of 21; 38%; P = .002). The spinal cord ischemia rate was also lower in the elective group (5 of 30; 17%) than in the urgent group (5 of 49; 10%) and emergent group (8 of 21; 38%; P = .051). The median follow-up was 8 months (interquartile range, 3.2-18.5 months). The cumulative survival rate was 95%, 87%, and 87% at 6, 12, and 24 months, respectively. The cumulative freedom from reintervention during follow-up was 92%, 86%, and 77% at 6, 12, and 24 months, respectively. CONCLUSIONS: The technical success of TAAA repair using t-Branch stent graft was not affected by an urgent or emergent presentation. However, the occurrence of worse periprocedural morbidity and mortality was significantly associated with an urgent or emergent presentation.

Early and Mid-Term Durability of Surgeon-Modified and Custom-Made Fenestrated Devices for the Treatment of Complex Aortic Pathology.

BACKGROUND: Fenestrated endovascular aneurysm repair (F-EVAR) has allowed successful treatment of patients with complex aortic aneurysms. Custom-made devices (CMDs) are manufactured by companies and tailored to the patient's anatomy to incorporate target vessels, while there is also the "off label" alternative with the devices modified by a surgeon in the operating room: surgeon-modified FEVAR (sm-FEVAR). This study aims to present and compare technical durability of CMDs- and sm-FEVAR for complex abdominal and thoracoabdominal aortic pathologies. METHODS: A retrospective cohort study was undertaken including all consecutive patients treated with sm- or CMD-FEVAR during a 3-year period in a single center. Only cases with at least 3 reno-visceral target vessels were included. Primary outcomes were technical success, and freedom from endoleak (EL) (Ia or III; all branch related) and re-intervention during follow-up period. Mortality and morbidity were also recorded. RESULTS: Thirty-two sm-FEVAR patients (81,3% male) and 79 CMD-FEVAR patients (77,2% male) were included. Indication for sm-FEVAR was exclusively urgent, while all CMD- FEVAR were elective. Technical success was similar in sm-FEVAR (100%) and CMD-FEVAR (98,7%) (P = 0.523). Mean follow-up was 16.3 ± 13 and 20 ± 17.3 months for sm-FEVAR and CMD- FEVAR, respectively (P = 0.28). The freedom from EL Ia rate was 91.7% [standard error (SE) 5.7%] at 12 months in sm-FEVAR, while it was 97.7% (SE 2.2%) and 92.3% (SE 4.3%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.69). The freedom from EL III rate was 95.5% (SE 4.4%) and 88% (SE 8.2%) at 12 and 24 months, respectively in sm-FEVAR, while it was 92.1% (SE 3.8%) and 89.2% (SE 4.7%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.68). The freedom from re-intervention rate was 91.6% (SE 5.7%) and 84.6% (SE 8.6%) at 12 and 24 months, respectively in sm-FEVAR, while it was 91.7% (SE 4%) and 83.4% (SE 5.9%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.90). The survival rate was 87.5% (5.8%) and 76.3% (7.9%) at 1 and 12 months, respectively in sm-FEVAR, while it was 93.7% (2.7%) at 1 month in CMD-FEVAR without any other death during FU period. No bridging stent occlusions were noted during follow-up period in any patient. CONCLUSION: Sm-FEVAR offers good technical success and mid-term clinical outcomes in urgent cases of complex aortic pathologies. Its durability is acceptable and comparable to CMD-FEVAR with a relatively low re-intervention rate.

How Does Female Sex Affect Complex Endovascular Aortic Repair? A Single Centre Cohort Study.

OBJECTIVE: There is growing evidence of a female patient disadvantage in complex endovascular aortic repair using fenestrated and branched endografts (FB-EVAR) primarily related to peri-procedural events including ischaemic and access vessel complications. This study aimed to determine the impact of sex differences on treatment patterns, and in hospital outcomes in a single centre cohort. METHODS: This was a retrospective cross sectional single centre cohort study of all consecutive FB-EVAR procedures provided to patients with asymptomatic pararenal and thoraco-abdominal aortic aneurysm (TAAA) between 1 January 2010 and 28 February 2021. Adjusted multivariable logistic regression models were developed using backward (Wald) elimination of variables to determine the independent impact of female sex on short term outcomes. RESULTS: In total, 445 patients (24.3% females, median age 73.0 years, IQR 66, 78) were included. Female patients had a smaller aneurysm diameter, less frequent coronary artery disease (29.6% vs. 44.8%, p = .007) and history of myocardial infarction (2.8% vs. 15.4%, p < .001) when compared with males. Females were more frequently treated for TAAA than males (49.1% vs. 25.2%, p < .001). The median length of post-procedural hospital stay was 10 days in females and 9 in males. In adjusted analyses, female sex was independently associated with higher mortality (odds ratio [OR] 10.135, 95% CI 2.264 - 45.369), post-procedural complications (OR 2.500, 95% CI 1.329 - 4.702), spinal cord ischaemia (OR 4.488, 95% CI 1.610 - 12.509), sepsis (OR 4.940, 95% CI 1.379 - 17.702), and acute respiratory insufficiency (OR 3.283, 95% CI 1.015 - 10.622) after pararenal aortic aneurysm repair during the hospital stay. CONCLUSION: In this analysis of consecutively treated patients, female sex was associated with increased in hospital mortality, peri-procedural complications, and spinal cord ischaemia after elective complex endovascular repair of pararenal aortic aneurysm, while no differences were revealed in the TAAA subgroup. These results suggest that sex related patient selection and peri-procedural management should be studied in future research.

Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.

BACKGROUND: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality. OBJECTIVES: This study assessed DCD safety and effectiveness in LER for PAD. METHODS: VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models. RESULTS: Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (Pinteraction = 0.88) and safety of rivaroxaban with respect to bleeding (Pinteraction = 0.57) were observed. CONCLUSIONS: In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216).

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair.

BACKGROUND: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200-220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. METHODS: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200-220 s. If the ACT after 5 min is < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT is > 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. DISCUSSION: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. TRIAL REGISTRATION {2A}: NTR NL8421 ClinicalTrials.gov NCT04061798 . Registered on 20 August 2019 EudraCT 2018-003393-27 TRIAL REGISTRATION: DATA SET {2B}: Data category Information Primary registry and trial identifying number ClinicalTrials.gov : NCT04061798 Date of registration in primary registry 20-08-2019 Secondary identifying numbers NTR: NL8421 EudraCT: 2018-003393-27 Source(s) of monetary or material support ZonMw: The Netherlands Organisation for Health Research and Development Dijklander Ziekenhuis Amsterdam UMC Primary sponsor Dijklander Ziekenhuis Secondary sponsor(s) N/A Contact for public queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Contact for scientific queries A.M. Wiersema, MD, PhD Arno@wiersema.nu 0031-229 208 206 Public title ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair (ACTION-1) Scientific title ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial Countries of recruitment The Netherlands. Soon the recruitment will start in Germany Health condition(s) or problem(s) studied Abdominal aortic aneurysm, arterial disease, surgery Intervention(s) ACT-guided heparinization 5000 IU of heparin Key inclusion and exclusion criteria Ages eligible for the study: ≥18 years Sexes eligible for the study: both Accepts healthy volunteers: no Inclusion criteria: Study type Interventional Allocation: randomized Intervention model: parallel assignment Masking: single blind (patient) Primary purpose: treatment Phase IV Date of first enrolment March 2020 Target sample size 750 Recruitment status Recruiting Primary outcome(s) The primary efficacy endpoint is 30-day mortality and in-hospital mortality during the same admission. The primary safety endpoint is the incidence of bleeding complications according to E-CABG classification, grade 1 and higher. Key secondary outcomes Serious complications as depicted in the Suggested Standards for Reports on Aneurysmal disease: all complications requiring re-operation, longer hospital stay, all complications.

The use of pulse pressure variation for predicting impairment of microcirculatory blood flow.

Dynamic parameters of preload have been widely recommended to guide fluid therapy based on the principle of fluid responsiveness and with regard to cardiac output. An equally important aspect is however to also avoid volume-overload. This accounts particularly when capillary leakage is present and volume-overload will promote impairment of microcirculatory blood flow. The aim of this study was to evaluate, whether an impairment of intestinal microcirculation caused by volume-load potentially can be predicted using pulse pressure variation in an experimental model of ischemia/reperfusion injury. The study was designed as a prospective explorative large animal pilot study. The study was performed in 8 anesthetized domestic pigs (German landrace). Ischemia/reperfusion was induced during aortic surgery. 6 h after ischemia/reperfusion-injury measurements were performed during 4 consecutive volume-loading-steps, each consisting of 6 ml kg-1 bodyweight-1. Mean microcirculatory blood flow (mean Flux) of the ileum was measured using direct laser-speckle-contrast-imaging. Receiver operating characteristic analysis was performed to determine the ability of pulse pressure variation to predict a decrease in microcirculation. A reduction of ≥ 10% mean Flux was considered a relevant decrease. After ischemia-reperfusion, volume-loading-steps led to a significant increase of cardiac output as well as mean arterial pressure, while pulse pressure variation and mean Flux were significantly reduced (Pairwise comparison ischemia/reperfusion-injury vs. volume loading step no. 4): cardiac output (l min-1) 1.68 (1.02-2.35) versus 2.84 (2.15-3.53), p = 0.002, mean arterial pressure (mmHg) 29.89 (21.65-38.12) versus 52.34 (43.55-61.14), p < 0.001, pulse pressure variation (%) 24.84 (17.45-32.22) versus 9.59 (1.68-17.49), p = 0.004, mean Flux (p.u.) 414.95 (295.18-534.72) versus 327.21 (206.95-447.48), p = 0.006. Receiver operating characteristic analysis revealed an area under the curve of 0.88 (CI 95% 0.73-1.00; p value < 0.001) for pulse pressure variation for predicting a decrease of microcirculatory blood flow. The results of our study show that pulse pressure variation does have the potential to predict decreases of intestinal microcirculatory blood flow due to volume-load after ischemia/reperfusion-injury. This should encourage further translational research and might help to prevent microcirculatory impairment due to excessive fluid resuscitation and to guide fluid therapy in the future.

Management of Descending Thoracic Aortic Diseases: Similarities and Differences Among Cardiovascular Guidelines.

Cardiovascular societies have developed recommendations regarding the management of thoracic aortic diseases. While improvements in treatment have been observed during the past decade in regard to patient selection, thoracic endovascular aortic repair (TEVAR) and associated techniques, and high-volume centralization, the broad expansion of TEVAR has raised considerations about its indications, appropriateness, limitations, and application. The aim of this systematic review was to assess the similarities and differences among current cardiovascular societies' guidelines for the management of thoracic aortic diseases. The MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from January 2009 to May 2020. The initial search identified 990 articles. After exclusion of duplicate or inappropriate articles, the final analysis included 5 articles from cardiovascular societies published between 2010 and 2020. Selected controversial topics were analyzed, including diagnosis, imaging, spinal cord ischemia prevention, and management of the most important thoracic aortic pathologies. The analysis included data concerning the therapeutic approach in acute and chronic type B aortic dissection, penetrating aortic ulcer, intramural hematoma, thoracic aortic aneurysm, and traumatic aortic injury, as well a discussion of inflammatory aneurysms, aortitis, and genetic syndromes. The review presents consistent and controversial recommendations, as well as "gray zone" issues that need further investigation. There was significant overlap and agreement among the 5 societies regarding the management of thoracic aortic diseases. Especially in dissection and aneurysm management, TEVAR has established its role as the treatment of choice. However, robust evidence is still needed in many aspects of the management of thoracic aortic pathologies.

Transcaval embolization for type II endoleak after endovascular aortic repair of infrarenal, juxtarenal, and type IV thoracoabdominal aortic aneurysm.

OBJECTIVE: This study aims to determine the outcomes of transcaval embolization (TCE) for type II endoleak after infrarenal endovascular aortic repair (EVAR) and fenestrated/branched EVAR (F/BEVAR). METHODS: A retrospective single-center cohort study of all consecutive TCE procedures between August 2015 and August 2019 was performed to investigate technical success, in-hospital morbidity, and 30-day mortality as well as clinical success during follow-up. The indication for TCE was an aneurysm sac growth of 5 mm or more owing to a type II endoleak after EVAR for infrarenal or F/BEVAR for juxtarenal and type IV thoracoabdominal aortic aneurysm. RESULTS: A total 25 TCE procedures in 24 patients (95.8% male) were included. Technical success was 96.0% (24/25); selective and nonselective TCE were performed in 48% of patients. The in-hospital morbidity and 30-day mortality were 0%. The median follow-up was 23.1 months (interquartile range, 10.9-40.1 months). Freedom from type II endoleak-related reintervention was 84.6% at 12 months. Comparing clinical success after TCE, reintervention was necessary in 16.7% of patients after nonselective and 20% of patients after selective TCE. Regarding TCE after EVAR vs F/BEVAR, reintervention was performed in 12.5% of EVAR and 33.3% of F/BEVAR patients during follow-up. CONCLUSIONS: TCE is an acceptable treatment alternative for type II endoleak with aneurysm sac enlargement and can be used after EVAR for infrarenal abdominal aortic aneurysms and F/BEVAR for juxtarenal abdominal aortic aneurysms and type IV thoracoabdominal aortic aneurysms.

Editor's Choice - The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease.

OBJECTIVE: Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). METHODS: In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). RESULTS: In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69-0.71) and CLTI (c statistic = 0.69, 95% CI 0.68-0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. CONCLUSION: The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent.