Publications by authors named "Henrik Sillesen"

131 Publications

Profiling abdominal aortic aneurysm growth with three-dimensional ultrasound.

Int Angiol 2021 Oct 21. Epub 2021 Oct 21.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark.

Background: "Profiling" is a new method based on three-dimensional ultrasound (3D-US) allowing for direct comparison of baseline and follow-up diameters along the AAA length. This study aimed to evaluate the feasibility of profiling to visualize AAA changes at sub-maximum diameters, and to categorize the growth profiles.

Methods: Retrospective analysis of prospectively and consecutively included patients under AAA surveillance at a tertiary referral centre. 3D-US images of AAAs at baseline and at one-year follow-up were segmented, generating a centerline and a mesh of the aneurysm geometry. The mesh was processed to illustrate diameter changes of a given AAA. Three growth profiles were identified: A) Peak Growth: the largest, significant (≥3.6 mm) diameter difference occurred within a 10 mm margin to either side of the maximum baseline diameter; B) Edge Growth: at least one significant diameter difference and the criteria for Peak Growth did not apply; C) No Growth: all diameter differences were nonsignificant. A centerline length of ≥60 mm was assumed to capture a comparable segment of the wall geometry at baseline and follow-up. Cohen's kappa and Kaplan Meier analysis were used to analyze data.

Results: In total, 186 patients had growth profiles generated. Of these, 28 (15%) were discarded, mainly based on inadequate centerline lengths (n= 21, 11.3%). The remaining patients were categorized into Edge Growth (n=83, 52%), No Growth (n=47, 30%), and Peak Growth (n=28, 18%).

Conclusions: Profiling interprets AAA growth at sub-maximum diameters. Half of the cohort had Edge Growth. These AAAs risk being classified as stable.
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http://dx.doi.org/10.23736/S0392-9590.21.04724-6DOI Listing
October 2021

Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD.

Circulation 2021 Oct 12. Epub 2021 Oct 12.

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO; CPC Clinical Research, Aurora, CO.

Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.055146DOI Listing
October 2021

The Short-term Predictive Value of Vessel Wall Stiffness on Abdominal Aortic Aneurysm Growth.

Ann Vasc Surg 2021 Aug 23. Epub 2021 Aug 23.

Department of Vascular Surgery, Rigshospitalet, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Background: Abdominal aortic aneurysm (AAA) surveillance programs are currently based solely on AAA diameter. The diameter criterion alone, however, seems inadequate as small AAAs comprise 5-10 % of ruptured AAAs as well as some large AAAs never rupture. Aneurysm wall stiffness has been suggested to predict rupture and growth; this study aimed to investigate the prognostic value of AAA vessel wall stiffness for growth on prospectively collected data.

Methods: Analysis was based on data from a randomised, placebo-controlled, multicentre trial investigating mast-cell-inhibitors to halt aneurysm growth (the AORTA trial). Systolic and diastolic AAA diameter was determined in 326 patients using electrocardiogram-gated ultrasound (US). Stiffness was calculated at baseline and after 1 year.

Results: Maximum AAA diameter increased from 44.1 mm to 46.5 mm during the study period. Aneurysm growth after 1 year was not predicted by baseline stiffness (-0.003 mm/U; 95 % CI: -0.007 to 0.001 mm/U; P = 0.15). Throughout the study period, stiffness remained unchanged (8.3 U; 95 % CI: -2.5 to 19.1 U; P = 0.13) and without significant correlation to aneurysm growth (R: 0.053; P = 0.38).

Conclusions: Following a rigorous US protocol, this study could not confirm AAA vessel wall stiffness as a predictor of aneurysm growth in a 1-year follow-up design. The need for new and subtle methods to complement diameter for improved AAA risk assessment is warranted.
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http://dx.doi.org/10.1016/j.avsg.2021.05.051DOI Listing
August 2021

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

Circulation 2021 Oct 12;144(14):1104-1116. Epub 2021 Aug 12.

CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER.

Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee.

Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; =0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (=0.95) and postprocedural bleeding requiring intervention (=0.93) was not significantly increased.

Conclusions: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.054835DOI Listing
October 2021

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

Eur Heart J 2021 10;42(39):4013-4024

Cardiothoracic and Vascular Department, Azienda OspedalieroUniversitaria Pisana, Pisa, Italy.

The aim of this collaborative document is to provide an update for clinicians on best antithrombotic strategies in patients with aortic and/or peripheral arterial diseases. Antithrombotic therapy is a pillar of optimal medical treatment for these patients at very high cardiovascular risk. While the number of trials on antithrombotic therapies in patients with aortic or peripheral arterial diseases is substantially smaller than for those with coronary artery disease, recent evidence deserves to be incorporated into clinical practice. In the absence of specific indications for chronic oral anticoagulation due to concomitant cardiovascular disease, a single antiplatelet agent is the basis for long-term antithrombotic treatment in patients with aortic or peripheral arterial diseases. Its association with another antiplatelet agent or low-dose anticoagulants will be discussed, based on patient's ischaemic and bleeding risk as well therapeutic paths (e.g. endovascular therapy). This consensus document aims to provide a guidance for antithrombotic therapy according to arterial disease localizations and clinical presentation. However, it cannot substitute multidisciplinary team discussions, which are particularly important in patients with uncertain ischaemic/bleeding balance. Importantly, since this balance evolves over time in an individual patient, a regular reassessment of the antithrombotic therapy is of paramount importance.
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http://dx.doi.org/10.1093/eurheartj/ehab390DOI Listing
October 2021

Low Risk of Neurological Recurrence while Awaiting Carotid Endarterectomy: Results From a Danish Multicentre Study.

Eur J Vasc Endovasc Surg 2021 08 11;62(2):160-166. Epub 2021 Jun 11.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark; Copenhagen Academy for Medical Education and Simulation (CAMES), Capital Region of Denmark, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

Objective: The risk of ipsilateral neurological recurrence (NR) was assessed in patients awaiting carotid endarterectomy (CEA) due to symptomatic carotid artery stenosis and whether current national guidelines of performing CEA within 14 days are adequate in present day practice.

Methods: This was a retrospective multicentre observational cohort study. Patients scheduled for CEA due to symptomatic carotid artery stenosis in a five year period, 1 January 2014 to 31 December 2018, from four centres were included. Data from the Danish Vascular Registry (www.karbase.dk), operative managing systems, and electronic medical records were reviewed.

Results: In total, 1 125 patients scheduled for CEA were included and 1 095 (97%) underwent the planned surgery. During a median delay from index event to CEA of 11 days (interquartile range 8-16 days), 40 patients (3.6%; 95% confidence interval [CI] 2.5%-5%) experienced a NR. One third were minor strokes (n = 12, 30%); half were transient ischaemic attacks (TIA) (n = 22, 55%); and amaurosis fugax accounted for 15% (n = 6). Twenty-six (2%) CEA procedures was cancelled, of which one was due to a disabling recurrent ischaemic event (aphasia). There were no deaths or major strokes in the waiting time for CEA. Best medical treatment (BMT) with platelet inhibitory or anticoagulation drugs and a statin was initiated in nearly all patients (98%) at first assessment. The overall 30 day risk of a post-operative major event (death or stroke) was (Kaplan-Meier [KM] estimate) 2.7% (95% CI 1.8-3.8), and not significantly correlated with the timing of surgery. Most (69%) occurred within the first three days. One, two, and three year mortality rate for CEA patients was (KM estimate) 4.8%, 7.8%, and 11.5% respectively.

Conclusion: In symptomatic carotid artery stenosis patients awaiting CEA, very few NRs occurred within 14 days. Institution of immediate BMT in specialised TIA/stroke units followed by early, but not necessarily urgent, CEA is a reasonable course of action in patients with high grade symptomatic carotid artery stenosis.
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http://dx.doi.org/10.1016/j.ejvs.2021.04.016DOI Listing
August 2021

Cardiovascular Rehabilitation Increases Walking Distance in Patients With Intermittent Claudication. Results of the CIPIC Rehab Study: A Randomised Controlled Trial.

Eur J Vasc Endovasc Surg 2021 Jun 3. Epub 2021 Jun 3.

Institute of Clinical Medicine, University of Copenhagen, Denmark; The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark.

Objective: To examine whether a cardiac rehabilitation programme in a community based setting for patients with intermittent claudication (IC) affects walking ability, quality of life, and changes in health behaviour. The trial investigated a cross sector cardiovascular rehabilitation programme compared with usual care for patients having non-operative management.

Methods: The trial allocated 118 patients, with 1:1 individual randomisation to either an intervention or control group. Data were collected at a department of vascular surgery and at a healthcare centre in Denmark. The rehabilitation intervention consisted of usual care plus 12 weeks of exercise training, pedometer, health education, and text messages. The primary outcome was maximum walking distance at six months measured by treadmill walking test. The secondary outcomes were maximum walking distance at 12 months and pain free walking distance measured by treadmill walking test, healthy diet, level of physical activity, and quality of life (QoL) at six and 12 months.

Results: In the intervention group, 46 participants were analysed, with 47 in the control group. Following three months of rehabilitation, a 37% difference (95% CI 1.10 - 1.70; p = .005) was found between groups in maximum walking distance at six and 12 months, in favour of the intervention group. The same positive effect was found in physical activity, QoL, and healthy diet, but was not statistically significant in pain free walking distance and smoking.

Conclusion: A specialised community based cardiac rehabilitation programme for patients with IC showed statistically and clinically significant effects on maximum walking distance, physical activity, quality of life, and healthy diet, but not on pain free walking distance and smoking, compared with usual care without rehabilitation.
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http://dx.doi.org/10.1016/j.ejvs.2021.04.004DOI Listing
June 2021

Three-dimensional ultrasound improves identification of patients with abdominal aortic aneurysms reaching the threshold for repair.

J Vasc Surg 2021 May 1. Epub 2021 May 1.

Department of Vascular Surgery, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Copenhagen Academy of Medical Education and Simulation, Capital Region of Denmark, Copenhagen, Denmark.

Objective: Conventional two-dimensional ultrasound (2D-US) has been the recommended and preferred modality for the diagnosis and surveillance of abdominal aortic aneurysms (AAAs). Measurement of the aneurysm diameter using three-dimensional ultrasound (3D-US) has shown promising results in a research setting, improving agreement and reproducibility. However, studies evaluating 3D-US in a clinical context are lacking, which could hinder the optimal usage of this new modality. In the present study, we investigated the clinical value of 3D-US for AAA surveillance compared with the current standard 2D-US examination.

Methods: Data from 126 patients with infrarenal AAAs <50 mm and 55 mm (female and male, respectively) were available for analysis. Eligibility was determined using the standard 2D-US anteroposterior (AP) diameter with a dual-plane technique. All the patients had subsequently undergone additional 3D-US and computed tomography angiography (CTA). Using CTA as the reference standard, the maximal standard 2D-US AP diameter was compared with that from 3D-US.

Results: All 126 AAAs were, per the inclusion criteria, small, with no intervention indicated. With the addition of 3D-US imaging to the 2D-US-based surveillance program, the AAA diameter threshold (50 and 55 mm) was exceeded for 31 of the 126 patients (25%). These 31 patients were withdrawn from the present study and referred for treatment planning. Compared with the CTA AP diameter (mean, 49 ± 7.2 mm), the mean 3D-US AP diameter (mean, 49 ± 6.7 mm) was significantly more accurate than the standard mean 2D-US AP diameter (45 ± 6.2 mm; kappa value, 0.86 ± 0.05; 95% confidence interval, 0.76-0.96; kappa value, 0.01 ± 0.04; 95% confidence interval, -0.05 to 0.09, respectively).

Conclusions: For clinical use, the AAA diameter assessment using 3D-US was significantly more accurate than that with 2D-US and can substantially change the clinical management, from surveillance to operative treatment, for approximately one fourth of patients with an AAA. Further studies evaluating the clinical consequences of the 2D to 3D paradigm shift in AAA diagnostics are warranted, including sensitivity, specificity, agreement, and reproducibility estimation.
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http://dx.doi.org/10.1016/j.jvs.2021.04.036DOI Listing
May 2021

Progress in aorta and peripheral cardiovascular disease research.

Cardiovasc Res 2021 07;117(9):2045-2053

Department of Cardiology, Dupuytren-2 University Hospital, and Inserm 1094 & IRD, Limoges University, Limoges, France.

Although coronavirus disease 2019 seems to be the leading topic in research number of outstanding studies have been published in the field of aorta and peripheral vascular diseases likely affecting our clinical practice in the near future. This review article highlights key research on vascular diseases published in 2020. Some studies have shed light in the pathophysiology of aortic aneurysm and dissection suggesting a potential role for kinase inhibitors as new therapeutic options. A first proteogenomic study on fibromuscular dysplasia (FMD) revealed a promising novel disease gene and provided proof-of-concept for a protein/lipid-based FMD blood test. The role of NADPH oxidases in vascular physiology, and particularly endothelial cell differentiation, is highlighted with potential for cell therapy development. Imaging of vulnerable plaque has been an intense field of research. Features of plaque vulnerability on magnetic resonance imaging as an under-recognized cause of stroke are discussed. Major clinical trials on lower extremity peripheral artery disease have shown added benefit of dual antithrombotic (aspirin plus rivaroxaban) treatment.
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http://dx.doi.org/10.1093/cvr/cvab144DOI Listing
July 2021

Carotid plaque inflammatory activity assessed by 2-[18F]FDG-PET imaging decrease after a neurological thromboembolic event.

EJNMMI Res 2021 Mar 23;11(1):30. Epub 2021 Mar 23.

Department of Vascular Surgery, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Background: Atherosclerotic plaque vulnerability is comprised by plaque composition driven by inflammatory activity and these features can be depicted with 3D ultrasound and 2-[18F]FDG-PET, respectively. The study investigated timely changes in carotid artery plaque inflammation and morphology after a thromboembolic event with PET/CT and novel ultrasound volumetric grayscale median (GSM) readings. Patients with a single hemisphere-specific neurological symptom and the presence of an ipsilateral carotid artery atherosclerotic plaque were prospectively included to both 2-[18F]FDG PET/CT and 3D ultrasound scans of the plaque immediately after their event and again three months later. On PET/CT images the maximum standardized uptake value (SUV) was measured and the volumetric ultrasound acquisitions were analyzed using a semiautomated software measuring GSM values.

Results: Baseline scans were performed by a mean of 7 days (range 2-14) after the symptom and again after 98 days (range 91-176). For the entire group (n = 14), we found a decrease in average SUV from baseline to follow-up of - 0.18 (95% confidence interval: - 0.34 to - 0.02, P = 0.034). GSM did not increase significantly over time (mean change: + 2.21, 95% confidence interval: - 17.02 to 21.44, P = 0.808).

Conclusion: A decrease in culprit lesion 2-[18F]FDG-uptake 3 months after an event indicates a decrease in inflammatory activity, suggesting that carotid plaque stabilization over time. 3D ultrasound morphological quantitative differences in GSM were not detectable after 3 months.
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http://dx.doi.org/10.1186/s13550-021-00773-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988031PMC
March 2021

Three-dimensional ultrasound is a reliable alternative in endovascular aortic repair surveillance.

J Vasc Surg 2021 09 5;74(3):979-987. Epub 2021 Mar 5.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Objective: Three-dimensional ultrasound (3D-US) has already demonstrated improved reproducibility with a high degree of agreement (intermodality variability), reproducibility (interoperator variability), and repeatability (intraoperator variability) compared with conventional two-dimensional ultrasound (2D-US) when estimating the maximum diameter of native abdominal aortic aneurysms (AAAs). The aim of the present study was, in a clinical, multicenter setting, to evaluate the accuracy of 3D-US with aneurysm model quantification software (3D-US abdominal aortic aneurysm [AAA] model) for endovascular aortic aneurysm repair (EVAR) sac diameter assessment vs that of computed tomography angiography (CTA) and 2D-US.

Methods: A total of 182 patients who had undergone EVAR from April 2016 to December 2017 and were compliant with a standardized EVAR surveillance program were enrolled from five different vascular centers (Rigshospitalet, Copenhagen, Denmark; Catharina Ziekenhuis, Eindhoven, Netherlands; L'hospital de la Timone, Paris, France; Cleveland Clinic, Cleveland, Ohio; and The Christ Hospital, Cincinnati, Ohio) in four countries. All image acquisitions were performed at the local sites (ie, 2D-US, 3D-US, CTA). Only the 2D-US and CTA readings were performed both locally and centrally. All images were read centrally by the US and CTA core laboratory. Anonymized image data were read in a randomized and blinded manner.

Results: The sample used to estimate the accuracy of the 3D-US AAA model and 2D-US included 164 patients and 177 patients, respectively. The Bland-Altman analysis revealed that the mean difference between CTA and 3D-US was -2.43 mm (95% confidence interval [CI], -5.20 to 0.14; P = .07) with a lower and upper limit of agreement of -8.9 mm (95% CI, -9.3 to -8.4) and 2.7 mm (95% CI, 2.3-3.2), respectively. For 2D-US and CTA, the mean difference was -3.62 mm (95% CI, -6.14 to -1.10; P = .002), with a lower and upper limit of agreement of -10.3 mm (95% CI, -10.8 to -9.8) and 2.5 mm (95% CI, 2-2.9), respectively.

Conclusions: The 3D-US AAA model showed no significant difference compared with CTA for measuring the anteroposterior diameter, indicating less bias for 3D-US compared with 2D-US. Thus, 3D-US with AAA model software is a viable modality for anteroposterior diameter assessment for surveillance after EVAR.
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http://dx.doi.org/10.1016/j.jvs.2021.02.031DOI Listing
September 2021

International public awareness of peripheral artery disease.

Vasa 2021 07 1;50(4):294-300. Epub 2021 Mar 1.

Department of Cardiology, Dupuytren University Hospital, Limoges, France.

: Peripheral artery disease (PAD) of the lower limbs is a common condition with considerable global burden. Some country-specific studies suggest low levels of public awareness. To our knowledge public awareness of PAD has never been assessed simultaneously in several countries worldwide. : This was an international, general public, internet-based quantitative survey assessing vascular health and disease understanding. Questionnaires included 23 closed-ended multiple-choice, Likert scale and binary choice questions. Data were collected from 9,098 survey respondents from nine countries in Europe, North and Latin America during May-June 2018. : Overall, familiarity with PAD was low (57% of respondents were "not at all familiar", and 9% were "moderately" or "very familiar"). Knowledge about PAD health consequences was limited, with 55% of all respondents not being aware of limb consequences of PAD. There were disparities in PAD familiarity levels between countries; highest levels of self-reported awareness were in Germany and Poland where 13% reported to be "very" or "moderately" familiar with PAD, and lowest in Scandinavian countries (5%, 3% and 2% of respondents in Norway, Sweden and Denmark, respectively). There were disparities in awareness according to age. Respondents aged 25-34 were most familiar with PAD, with 12% stating that they were "moderately" or "very" familiar with the condition, whereas those aged 18-24 were the least familiar with PAD (7% "moderately" or "very" familiar with PAD). In the 45-54, 55-64 and 65+ age groups, 9% said they were "moderately" or "very" familiar with the term. There was no important gender-based difference in PAD familiarity. : On an international level, public self-reported PAD awareness is low, even though PAD is a common condition with considerable burden. Campaigns to increase PAD awareness are needed to reduce delays in diagnosis and to motivate people to control PAD risk factors.
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http://dx.doi.org/10.1024/0301-1526/a000945DOI Listing
July 2021

Endovascular Treatment of Chronic and Acute on Chronic Mesenteric Ischaemia: Results From a National Cohort of 245 Cases.

Eur J Vasc Endovasc Surg 2021 Apr 13;61(4):603-611. Epub 2021 Feb 13.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Copenhagen Academy for Medical Education and Simulation (CAMES), Copenhagen, Denmark.

Objective: Endovascular treatment of chronic mesenteric ischaemia (CMI) is linked to low early morbidity and mortality but a higher risk of recurrence than open repair. Mid and long term outcomes after endovascular treatment remain to be proven in larger series. The aim of this study was to assess short and mid term outcome after first line endovascular revascularisation of CMI and acute on chronic mesenteric ischaemia (AoCMI).

Methods: This was a prospective population and registry based cohort study supplemented by a retrospective review of medical records and imaging files. A national cohort was created based on data extracted from the Danish National Registry for Vascular Surgery (Karbase) for all patients treated endovascularly for CMI or AoCMI between 2011 and 2015 in Denmark. Survival data, bowel resection, complications, re-intervention rate, and improvement of clinical symptoms were analysed, as were potential risk factors.

Results: In total, 245 patients had an endovascular intervention for CMI (n = 178; 72.6%) and AoCMI (n = 67; 27.3%). One and three year survival estimates were 85% (95% confidence interval [CI] 79 - 90) and 74% (95% CI 67 - 80) in the CMI-group, and 67% (95% CI 54 - 77) and 54% (95% CI 41 - 65) in the AoCMI group. The hazard ratio for death was 1.89 (95% CI 1.23 - 2.9) for AoCMI, relative to patients with CMI. Superior mesenteric artery (SMA) stenosis, rather then occlusion, significantly increased the success of SMA recanalisation: OR 19.4 (95% CI 6.2 - 61.4) and 9.3 (95% CI 1.6 - 53.6) in the CMI and AoCMI groups, respectively. The proportion of patients reporting clinical improvement was 71% (n = 127) in the CMI group and 59% (n = 39) in the AoCMI group. Five patients (3%) in the CMI and 30 (45%) in the AoCMI groups underwent bowel resection (p < .001), and the overall length of hospital stay (LoS) was a median of two days (interquartile range [IQR] 1 - 3 days) in the CMI group and seven days (IQR 3 - 23 days) in the AoCMI group. Within the first year, re-intervention was performed in 14 patients (5.7%).

Conclusion: First line endovascular treatment of CMI carries a three year mortality rate of 25%, and low risk of re-occurrence of symptomatic ischaemia. Relative to CMI, patients suffering AoCMI have significantly higher morbidity and mortality, more bowel resections, and longer LoS.
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http://dx.doi.org/10.1016/j.ejvs.2021.01.003DOI Listing
April 2021

Polyvascular disease: A narrative review of current evidence and a consideration of the role of antithrombotic therapy.

Atherosclerosis 2020 12 6;315:10-17. Epub 2020 Nov 6.

Division of Cardiology, Department of Medicine Duke University Health System, USA; Duke Clinical Research Institute, Durham, NC, USA.

Background And Aims: Polyvascular disease (PVD) affects approximately 20% of patients with atherosclerosis and is a strong independent risk factor for ischemic outcomes. However, guidelines do not address screening or treatment for PVD, and there have been no PVD-specific trials. We reviewed subgroup analyses of large randomized controlled trials of more intense antithrombotic therapy to determine whether increased intensity of therapy improved ischemic outcomes in patients with PVD.

Methods: MEDLINE, MEDLINE in-Process, EMBASE, and the Cochrane Library were queried for randomized controlled trials larger than 5000 patients evaluating secondary prevention therapies in patients with coronary artery disease or lower extremity peripheral artery disease.

Results: Thirteen trials were included ranging in size from 7243 to 27,395 patients. In 9 trials (CHARISMA, TRA 2°P-TIMI 50, PEGASUS-TIMI 54, VOYAGER PAD, TRACER, EUCLID, TRILOGY ACS, PLATO, and COMPASS), patients in the PVD subgroup treated with increased-intensity antithrombotic therapy had similar or greater relative risk reductions for ischemic events in comparison with the general trial cohorts. In four trials (DAPT, THEMIS, APPRAISE-2, and ATLAS ACS 2 TIMI 51), the PVD subgroup had an increased hazard of ischemic events with increased-intensity therapy compared with the general trial cohorts.

Conclusions: More intense antithrombotic therapy in patients with PVD was associated with a similar relative risk reduction for ischemic events compared with patients without PVD. Therefore, patients with PVD benefit from a larger absolute risk reduction because of their higher baseline risk. Future trials in patients with atherosclerotic cardiovascular disease should intentionally include PVD patients to adequately assess treatment options for this under-studied, under-treated population.
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http://dx.doi.org/10.1016/j.atherosclerosis.2020.11.001DOI Listing
December 2020

Three- and Two-Dimensional Ultrasound is as Accurate as Computed Tomography in Aortic Sac Assessment after Endovascular Aortic Repair.

Ann Vasc Surg 2021 Apr 4;72:321-329. Epub 2020 Nov 4.

Department of Vascular Surgery, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Copenhagen Academy for Medical Education and Simulation (CAMES), Capital Region of Denmark, Copenhagen, Denmark.

Background: To compare aortic sac changes after endovascular aneurysm repair (EVAR) assessed by three-dimensional ultrasound (3D-US), two-dimensional ultrasound (2D-US), and traditional computed tomographic angiography (CTA).

Methods: Using volume assessment with three-dimensional CTA (3D-CTA-volume) as the gold standard, this study investigated aortic sac changes at three and 12 months after EVAR with three different ultrasound methods (2D-US anterior-posterior (AP) diameter, 3D-US AP centerline diameter, and 3D-US partial volume), and traditional CT multiplanar outer-to-outer diameter (CT-MPR OTO diameter). From august 1st, 2011 to January 2014, consecutive EVAR patients (n = 113) were available for analysis in two time intervals; 1) between preoperative and three-month follow-up and 2) between three and 12 month follow-up.

Results: The risk of missing true aortic sac growth (false negative finding) at three-month postoperative visit using 3D-US partial volume, 3D-US AP centerline diameter, 2D-US AP diameter, and CT-MPR OTO diameter was 19%, 21%, 22%, and 18%, respectively. Corresponding low sensitivities (0% to 21%) and kappa-values (<0.50) in detecting aortic sac changes were found. The risk of missing true growth between three and 12 months were lower (6%, 5%, 6%, and 6%, respectively), and matching sensitivities 33%, 33%, 17%, and 17%, respectively.

Conclusions: All tested methods for aortic sac changes were as good as traditional CT-MPR OTO diameter and corresponded poorly with 3D-CTA-volume at three months postoperative visit but substantially better after 12 months where the residual sac change was more profound.
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http://dx.doi.org/10.1016/j.avsg.2020.09.061DOI Listing
April 2021

Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.

Circulation 2020 12 3;142(23):2219-2230. Epub 2020 Nov 3.

Department of Vascular Medicine, Klinikum Darmstadt GmbH, Germany (R.B.).

Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described.

Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization.

Results: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71-1.01) with clopidogrel and 0.86 (95% CI, 0.73-1.01) without clopidogrel without statistical heterogeneity ( for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14-1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22-1.01] without clopidogrel; for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44-7.13]) compared with shorter durations of clopidogrel ( for trend=0.06).

Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050465DOI Listing
December 2020

Vascular function in adults with cyanotic congenital heart disease.

Int J Cardiol Heart Vasc 2020 Oct 15;30:100632. Epub 2020 Sep 15.

Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.

Background: Patients with cyanotic congenital heart disease (CCHD) may have a low burden of atherosclerosis. Endothelial dysfunction is an early stage of atherosclerosis and endothelial function is previously studied in smaller CCHD groups with different techniques and variable results. We aimed to examine endothelial function and carotid atherosclerosis in a larger group of CCHD patients.

Methods: This multicentre study assessed endothelial function in adults with CCHD and controls by measuring the dilatory response of the brachial artery to post-ischemic hyperaemia (endothelium-dependent flow-mediated-vasodilatation (FMD)), and to nitroglycerin (endothelium-independent nitroglycerin-induced dilatation (NID)). Flow was measured at baseline and after ischaemia (reactive hyperaemia). Carotid-intima-media-thickness (CIMT), prevalence of carotid plaque and plaque thickness (cPT-max) were evaluated ultrasonographically. Lipoproteins, inflammatory and vascular markers, including sphingosine-1-phosphate (S1P) were measured.

Results: Forty-five patients with CCHD (median age 50 years) and 45 matched controls (median age 52 years) were included. The patients presented with lower reactive hyperaemia (409 ± 114% vs. 611 ± 248%,  < 0.0001), however preserved FMD response compared to controls (106.5 ± 8.3% vs. 106.4 ± 6.1%,  = 0.95). In contrast, NID was lower in the patients (110.5 ± 6.1% vs. 115.1 ± 7.4%,  = 0.053). There was no difference in CIMT, carotid plaque or cPT-max. The patients presented with lower high-density-lipoprotein cholesterol, and higher level of inflammatory markers and S1P.

Conclusion: Adults with CCHD had preserved FMD in the brachial artery, but impaired NID response and lower reactive hyperaemia than controls. The preserved FMD and the comparable prevalence of carotid atherosclerosis indicate that CCHD patients have the same risk of atherosclerosis as controls.
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http://dx.doi.org/10.1016/j.ijcha.2020.100632DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502339PMC
October 2020

Full-Volume Assessment of Abdominal Aortic Aneurysms by 3-D Ultrasound and Magnetic Tracking.

Ultrasound Med Biol 2020 12 28;46(12):3440-3447. Epub 2020 Sep 28.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Copenhagen Academy for Medical Education and Simulation (CAMES), Capital Region of Denmark, Copenhagen, Denmark.

Volume assessment of abdominal aortic aneurysms (AAAs) using 3-D ultrasound (US) is an innovative technique reporting good agreement with computed tomography angiography. One major limitation of the current 3-D US technique is a limited field of view, allowing full AAA acquisition in only 60% of patients. This study presents two new US acquisition protocols using magnetic field tracking, providing an "extended field of view" (XFoV-2-D and XFoV-3-D) with the aim of including both the aortic bifurcation and neck for full-volume assessment, and compares these methods with the current standard 3-D US protocol and with computed tomography angiography. A total of 20 AAA patients were included and underwent the current standard 3-D US protocol and the two novel 3-D US "extended field of view" protocols. Four patients were excluded from further analysis because of low image quality, leaving 16 patients eligible for analysis. Full AAA volume was achieved in 8 patients (50%) using the standard 3-D US protocol, in 11 patients (69%) with the XFoV-2-D protocol and in 13 patients (81%) with the XFoV-3-D protocol. In conclusion, this article describes two new and feasible US protocols applicable for full-AAA-volume estimation in most patients and should initiate further research into the added value of full volume in AAA surveillance.
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http://dx.doi.org/10.1016/j.ultrasmedbio.2020.09.002DOI Listing
December 2020

Recommendations for the Assessment of Carotid Arterial Plaque by Ultrasound for the Characterization of Atherosclerosis and Evaluation of Cardiovascular Risk: From the American Society of Echocardiography.

J Am Soc Echocardiogr 2020 08 27;33(8):917-933. Epub 2020 Jun 27.

Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Atherosclerotic plaque detection by carotid ultrasound provides cardiovascular disease risk stratification. The advantages and disadvantages of two-dimensional (2D) and three-dimensional (3D) ultrasound methods for carotid arterial plaque quantification are reviewed. Advanced and emerging methods of carotid arterial plaque activity and composition analysis by ultrasound are considered. Recommendations for the standardization of focused 2D and 3D carotid arterial plaque ultrasound image acquisition and measurement for the purpose of cardiovascular disease stratification are formulated. Potential clinical application towards cardiovascular risk stratification of recommended focused carotid arterial plaque quantification approaches are summarized.
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http://dx.doi.org/10.1016/j.echo.2020.04.021DOI Listing
August 2020

Patients with Unstable Atherosclerosis Have More Echolucent Carotid Plaques Compared with Stable Atherosclerotic Patients: A 3-D Ultrasound Study.

Ultrasound Med Biol 2020 09 7;46(9):2164-2172. Epub 2020 Jun 7.

Department of Vascular Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Using a novel 3-D ultrasound system, we aimed to determine differences in carotid plaque size and echogenicity in two atherosclerotic groups. Seventy patients admitted with acute myocardial infarction (aMI) and 69 patients known with chronic peripheral arterial disease (cPAD) were included. The cPAD group had larger plaque volumes (median: 70.24 mm, interquartile range [40.12-135.61] vs. 55.41 mm [4.24-84.31], p = 0.004), thicker plaques (2.45 mm [1.85-3.25] vs. 1.99 mm [1.55 - 2.64], p = 0.005) and higher gray-scale medians (GSMs) (mean: 71.75, standard deviation: 21.55 vs. 60.99 [24.09], p = 0.006) than the aMI group. After adjustment for traditional risk factors, the difference persisted for thickness and volume. The difference in GSM persisted after adjustment for volume only. Patients with stable atherosclerotic disease had larger and brighter carotid plaques compared with unstable atherosclerotic patients. 3-D ultrasound may prove useful in identifying thromboembolic risk.
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http://dx.doi.org/10.1016/j.ultrasmedbio.2020.04.002DOI Listing
September 2020

In Situ Vein Bypass Is Superior to Endovascular Treatment of Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia.

Ann Vasc Surg 2020 Aug 29;67:437-447. Epub 2020 Mar 29.

Department of Vascular Surgery, Rigshospitalet, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Copenhagen Academy for Medical Education and Simulation (CAMES), Copenhagen, Denmark.

Background: The objective of the study was to compare bypass surgery and endovascular revascularization of the femoropopliteal segment in patients with peripheral arterial disease and critical limb-threatening ischemia (CLTI).

Methods: This is a single-center study including patients undergoing first-time lower extremity intervention with peripheral bypass surgery or percutaneous transluminal angioplasty with or without stenting (PTA/S) of the femoropopliteal segment because of CLTI from 2011 to 2015. Based on prospective entered data from the Danish Vascular Registry, the primary end points were amputation-free survival, overall mortality, and reinterventions.

Results: A total of 679 patients with CLTI were included of which 35% (n = 239) were treated with PTA/S, 54% (n = 363) with vein bypass, and 11% (n = 77) with synthetic bypass. After 3 years, amputation-free survival was significantly better with a vein bypass (41.8% [95% CI: 35-48.4]) than both PTA/S (29.7% (95% CI: 22.7-37)) and synthetic bypass (31.7% [95% CI: 19-45.1]). Overall, the endovascular-treated patients faced more than 50% increased risk of major amputation or death than that of a vein bypass, after adjusting for comorbidity and Trans-Atlantic Inter-Society Consensus (TASC) classification (HR: 1.56 [95% CI: 1.21-2.05]). As expected, postoperative complications, length of hospital stay, and reinterventions were more frequent in the bypass groups.

Conclusions: In this nonrandomized study, autologous vein bypass was superior to both PTA/S and synthetic bypass in regard to amputation-free survival and overall mortality. Despite the increased frequency of surgical complications, a vein bypass appears justified in both shorter (TASC B-C) and longer (TASC D) femoropopliteal lesions.
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http://dx.doi.org/10.1016/j.avsg.2020.03.035DOI Listing
August 2020

Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial.

J Am Coll Cardiol 2020 05 16;75(17):2110-2118. Epub 2020 Mar 16.

Rosalind Franklin University, North Chicago, Illinois.

Background: In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, atorvastatin was compared with placebo in 4,731 participants with recent stroke or transient ischemic attack and no known coronary heart disease. Atorvastatin reduced the first occurrence of stroke and the first occurrence of a composite of vascular events.

Objectives: The aim of this post hoc analysis was to assess the occurrence of all (first and subsequent) vascular events and the effect of atorvastatin to reduce these events by vascular territory (cerebrovascular, coronary, or peripheral) in SPARCL.

Methods: Treatment effects on total adjudicated vascular events, overall and by vascular territory, were summarized by marginal proportional hazards models. Vascular event rates were estimated for each treatment group with cumulative incidence functions.

Results: The placebo group had an estimated 41.2 first and 62.7 total vascular events per 100 participants over 6 years. There were 164 fewer first and 390 fewer total vascular events in the atorvastatin group (total events hazard ratio: 0.68; 95% confidence interval: 0.60 to 0.77). The total events reduction included 177 fewer cerebrovascular, 170 fewer coronary, and 43 fewer peripheral events. Over 6 years, an estimated 20 vascular events per 100 participants were avoided with atorvastatin treatment.

Conclusions: In participants with recent stroke or transient ischemic attack, the total number of vascular events prevented with atorvastatin was more than twice the number of first events prevented. Total event reduction provides a comprehensive metric to capture the totality of atorvastatin clinical efficacy in reducing disease burden after stroke or transient ischemic attack. (Lipitor in the Prevention of Stroke, for Patients Who Have Had a Previous Stroke [SPARCL]; NCT00147602).
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http://dx.doi.org/10.1016/j.jacc.2020.03.015DOI Listing
May 2020

The Role of Routine Ultrasound Surveillance after In Situ Infrainguinal Peripheral Vein Bypass for Critical Limb-Threatening Ischemia.

Ann Vasc Surg 2020 Jul 5;66:529-536. Epub 2020 Feb 5.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark.

Background: To evaluate systematic duplex ultrasound (DUS) surveillance of patients treated with in situ great saphenous vein bypass (ISSVB) due to critical limb-threatening ischemia (CLTI) we performed a retrospective analysis of prospectively entered registry data.

Methods: Single-center study including consecutive patients undergoing elective ISSVB surgery due to CLTI between 2011 and 2015. Postoperative graft surveillance program included clinical examination, ankle-brachial indices (ABIs), and DUS at 6 weeks and 3 and 12 months. All DUS scans were performed by trained nurse sonographers. Patient data were extracted from the Danish Vascular Registry, electronic medical records and Picture Archiving and Communication System (PACS). Primary outcomes were reintervention rate, patency, and survival.

Results: In total, 363 consecutive and treatment-naive CLTI patients were revascularized with ISSVB and included in the study. Of those, 310 patients had minimum one follow-up visit and in total 1,199 DUS examinations. During the study period, 84 (23%) patients received 125 graft preserving reinterventions of which 20 were indicated solely on routine DUS without concurrent ischemic symptoms and/or significant (>15%) decrease in ABI. Hence, to find one asymptomatic graft stenosis requiring reintervention, we needed to scan 60 patients. After 1, 2, and 3 years, assisted primary patency was (Kaplan-Meier estimate) 79.4% (95% CI: 74.4, 83.5), 76.3% (95% CI: 70.7, 81.0), and 73.6% (95% CI: 66.9, 79.2), respectively. Survival rates were 82.6% (95% CI: 78.1, 86.3), 64.2% (95% CI: 57.8, 69.9) and 47.7% (95% CI: 40.6, 54.4) at 1, 2, and 3 years, respectively.

Conclusions: In this study, one in four patients received a graft preserving intervention, but very few were driven by routine DUS and most graft lesions were detected on clinical findings. These findings suggest that development of a more individualized surveillance program differentiating between high- and low-risk infrainguinal bypass patients may increase cost-effectiveness.
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http://dx.doi.org/10.1016/j.avsg.2020.01.092DOI Listing
July 2020

Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial.

Trials 2020 Jan 21;21(1):105. Epub 2020 Jan 21.

Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

Introduction: Intermittent claudication (IC) caused by peripheral artery disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behaviour. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this article is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC.

Methods And Analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, with a 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by an activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients' post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation.

Discussion: The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with IC. The study will describe how to monitor and improve rehabilitation programmes for patients with IC in a real-world setting. Mixed-method strategies can allow for both exploration and generalisation in the same study, but the research design is a complex intervention and any effects found cannot be awarded a specific component.

Trial Registration: Retrospectively registered in Clinicaltrials.gov identifier: NCT03730623.
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http://dx.doi.org/10.1186/s13063-019-4032-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6975054PMC
January 2020

Carotid atherosclerosis markers and adverse cardiovascular events.

Int J Cardiol 2020 May 13;307:178. Epub 2019 Nov 13.

Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

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http://dx.doi.org/10.1016/j.ijcard.2019.10.047DOI Listing
May 2020

Carotid Intima-Media Thickness Versus Carotid Plaque Burden for Predicting Cardiovascular Risk.

Angiology 2020 02 30;71(2):108-111. Epub 2019 Sep 30.

Stroke Prevention and Atherosclerosis Research Centre, Robarts Research Institute, Western University, London, Ontario, Canada.

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http://dx.doi.org/10.1177/0003319719878582DOI Listing
February 2020

How vascular surgeons can learn ultrasound.

Semin Vasc Surg 2019 Mar - Jun;32(1-2):33-40. Epub 2019 Jan 25.

Department of Vascular Surgery, University of Copenhagen, Rigshospitalet 3111, Blegdamsvej 9, 2100 Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Vascular ultrasound has proven to be a cornerstone for the management of patients with vascular disease, and is utilized by vascular surgeons in the outpatient clinic, the operating room, and for follow-up after revascularisation. Today vascular surgeons are among the most frequent users of ultrasound apart from radiologists. Mastering the skills of vascular ultrasound and interpretation is best acquired under supervision and is more easily learned as part of the daily practice of vascular surgery. Separating vascular ultrasound into basic and advanced procedures is useful, and basic vascular ultrasound skills should be a part of a vascular surgical training program curriculum. In Europe, certification of vascular surgeons in basic vascular ultrasound via a pass-fail test is in its infancy, preceded by local and national initiatives. In the area of clinical vascular research, duplex ultrasound is superior to most other diagnostic modalities due to its availability and noninvasive nature and ultrasound-based research will in addition to improving patient care generate physicians highly experienced in vascular ultrasound.
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http://dx.doi.org/10.1053/j.semvascsurg.2019.01.007DOI Listing
October 2019
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