Publications by authors named "Christine Espinola Klein"

107 Publications

Psoriasis and its impact on the clinical outcome of patients with pulmonary embolism.

Int J Cardiol 2021 Nov 1;343:114-121. Epub 2021 Sep 1.

Department of Cardiology, Cardiology I, University Medical Center Mainz (Johannes Gutenberg-University Mainz), Mainz, Germany.; Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz (Johannes Gutenberg-University Mainz), Mainz, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhine Main, Mainz, Germany.

Background: An increased risk for venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep venous thrombosis, has been reported in psoriasis patients. The impact of psoriasis on prognosis of VTE patients is widely unknown.

Methods: Hospitalized PE patients were stratified for psoriasis and the impact of psoriasis on outcome was investigated in the German nationwide inpatient sample of the years 2005-2017.

Results: Overall, 1,076,384 hospitalizations of PE patients (53.7% females, median age 72.0 [60.0-80.0] years) were recorded in Germany 2005-2017. Among these, 3145 patients had psoriasis (0.3%). Psoriatic PE patients were younger (68.0 [57.0-76.0] vs. 72.0 [60.0-80.0] years,P < 0.001) and more often male (64.1% vs. 46.3%,P < 0.001). The prevalence of VTE risk factors, traditional cardiovascular risk factors and cardiovascular comorbidities was higher in psoriatic than in non-psoriatic individuals. Psoriatic PE patients showed a lower in-hospital case-fatality rate (11.1% vs. 16.0%,P < 0.001), confirmed by logistic regressions showing an independent association of psoriasis with reduced case-fatality rate (OR 0.73 [95%CI 0.65-0.82],P < 0.001), despite higher prevalence of pneumonia (24.8% vs. 23.2%,P = 0.029). Psoriasis was an independent predictor for gastro-intestinal bleeding (OR 1.35 [95%CI 1.04-1.75],P = 0.023) and transfusion of blood constituents (OR 1.23 [95%CI 1.11-1.36],P < 0.001).

Conclusions: PE patients with psoriasis were hospitalized in median four years earlier than those without. Although psoriasis was associated with an unfavorable cardiovascular-risk and VTE-risk profile in PE patients, our data demonstrate a lower in-hospital mortality in psoriatic PE, which might be mainly driven by younger age. Our findings may improve the clinical management of these patients and contribute evidence for relevant systemic manifestation of psoriasis.

Translational Perspective: An increased risk for venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep venous thrombosis, has been reported in psoriasis patients, but the impact of psoriasis on prognosis of VTE patients is widely unknown. PE patients with psoriasis were younger and psoriasis was associated with an unfavorable cardiovascular-risk and VTE-risk profile. In-hospital mortality was lower in psoriatic PE patients, which might be mainly driven by younger age. Our findings improve the clinical management of PE patients and contribute evidence for relevant systemic manifestation of psoriasis.

One Sentence Summary: Psoriasis with chronic inflammation promotes PE development, is associated with an unfavorable cardiovascular and VTE-risk profile, but lower in-hospital mortality.
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http://dx.doi.org/10.1016/j.ijcard.2021.08.042DOI Listing
November 2021

Rationale, design and baseline characteristics of the MyoVasc study: A prospective cohort study investigating development and progression of heart failure.

Eur J Prev Cardiol 2021 Aug;28(9):1009-1018

German Centre for Cardiovascular Research (DZHK), partner site Rhine-Main, Germany.

Background: Heart failure (HF) is a poly-aetiological syndrome with large heterogeneity regarding clinical presentation, pathophysiology, clinical outcome and response to therapy. The MyoVasc study (NCT04064450) is an epidemiological cohort study investigating the development and progression of HF.

Methods: The primary objective of the study is (a) to improve the understanding of the pathomechanisms of HF across the full spectrum of clinical presentation, (b) to investigate the current clinical classifications of HF, and (c) to identify and characterize homogeneous subgroups regarding disease development using a systems-oriented approach. Worsening of HF, that is, the composite of transition from asymptomatic to symptomatic HF, hospitalization due to HF, or cardiac death, was defined as the primary endpoint of the study. During a six-year follow-up period, all study participants receive a highly standardized, biannual five-hour examination in a dedicated study centre, including detailed cardiovascular phenotyping and biobanking of various biomaterials. Annual follow-up examinations are conducted by computer-assisted telephone interviews recording comprehensively the participants´ health status, including subsequent validation and adjudication of adverse events.

Results: In total, 3289 study participants (age range: 35 to 84 years; female sex: 36.8%) including the full range of HF stages were enrolled from 2013 to 2018. Approximately half of the subjects (n=1741) presented at baseline with symptomatic HF (i.e. HF stage C/D). Among these, HF with preserved ejection fraction was the most frequent phenotype.

Conclusions: By providing a large-scale, multi-dimensional biodatabase with sequential, comprehensive medical-technical (sub)clinical phenotyping and multi-omics characterization (i.e. genome, transcriptome, proteome, lipidome, metabolome and exposome), the MyoVasc study will help to advance our knowledge about the heterogeneous HF syndrome by a systems-oriented biomedicine approach.

Trial Registration: ClinicalTrials.gov; NCT04064450.
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http://dx.doi.org/10.1177/2047487320926438DOI Listing
August 2021

Chronic venous insufficiency, cardiovascular disease, and mortality: a population study.

Eur Heart J 2021 Aug 13. Epub 2021 Aug 13.

Preventive Cardiology and Preventive Medicine, Department of Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstr. 1, Mainz 55131, Germany.

Aims : Evidence regarding the health burden of chronic venous insufficiency (CVI), its clinical determinants, and impact on outcome is scarce.

Methods And Results : Systematic phenotyping of CVI according to established CEAP (Clinical-Etiologic-Anatomic-Pathophysiologic) classification was performed in 12 423 participants (age range: 40-80 years) of the Gutenberg Health Study from April 2012 to April 2017. Prevalence was calculated age- and sex-specifically. Multivariable Poisson regression models were calculated to evaluate the relation of CVI with cardiovascular comorbidities. Survival analyses were carried out to assess the CVI-associated risk of death. Replication of findings was done in an independent cohort study (MyoVasc, NCT04064450). The prevalence of telangiectasia/reticular, varicose veins, and CVI was 36.5% [95% confidence interval (CI), 35.6-37.4%], 13.3% [12.6-13.9%], and 40.8% [39.9-41.7%], respectively. Age, female sex, arterial hypertension, obesity, smoking, and clinically overt cardiovascular disease were identified as clinical determinants of CVI. Higher CEAP classes were associated with a higher predicted 10-year risk for incident cardiovascular disease in individuals free of cardiovascular disease (n = 9923). During a mean follow-up of 6.4 ± 1.6 years, CVI was a strong predictor of all-cause death independent of the concomitant clinical profile and medication [hazard ratio (HR) 1.46 (95% CI 1.19-1.79), P = 0. 0003]. The association of CVI with an increased risk of all-cause death was externally validated in the MyoVasc cohort [HR 1.51 (95% CI 1.11-2.05), P = 0.009].

Conclusion : Chronic venous insufficiency is highly prevalent in the population and is associated with the presence of cardiovascular risk factors and disease. Individuals with CVI experience an elevated risk of death, which is independent of age and sex, and present cardiovascular risk factors and comorbidities.
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http://dx.doi.org/10.1093/eurheartj/ehab495DOI Listing
August 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 Oct;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

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

Protein expression profiling suggests relevance of noncanonical pathways in isolated pulmonary embolism.

Blood 2021 May;137(19):2681-2693

Preventive Cardiology and Preventive Medicine, Center for Cardiology.

Patients with isolated pulmonary embolism (PE) have a distinct clinical profile from those with deep vein thrombosis (DVT)-associated PE, with more pulmonary conditions and atherosclerosis. These findings suggest a distinct molecular pathophysiology and the potential involvement of alternative pathways in isolated PE. To test this hypothesis, data from 532 individuals from the Genotyping and Molecular Phenotyping of Venous ThromboEmbolism Project, a multicenter prospective cohort study with extensive biobanking, were analyzed. Targeted, high-throughput proteomics, machine learning, and bioinformatic methods were applied to contrast the acute-phase plasma proteomes of isolated PE patients (n = 96) against those of patients with DVT-associated PE (n = 276) or isolated DVT (n = 160). This resulted in the identification of shared molecular processes between PE phenotypes, as well as an isolated PE-specific protein signature. Shared processes included upregulation of inflammation, response to oxidative stress, and the loss of pulmonary surfactant. The isolated PE-specific signature consisted of 5 proteins: interferon-γ, glial cell line-derived neurotrophic growth factor, polypeptide N-acetylgalactosaminyltransferase 3, peptidyl arginine deiminase type-2, and interleukin-15 receptor subunit α. These proteins were orthogonally validated using cis protein quantitative trait loci. External replication in an independent population-based cohort (n = 5778) further validated the proteomic results and showed that they were prognostic for incident primary isolated PE in individuals without history of VTE (median time to event: 2.9 years; interquartile range: 1.6-4.2 years), supporting their possible involvement in the early pathogenesis. This study has identified molecular overlaps and differences between VTE phenotypes. In particular, the results implicate noncanonical pathways more commonly associated with respiratory and atherosclerotic disease in the acute pathophysiology of isolated PE.
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http://dx.doi.org/10.1182/blood.2019004571DOI Listing
May 2021

[Antithrombotic therapy after peripheral revascularization].

Dtsch Med Wochenschr 2021 02 29;146(3):136-140. Epub 2021 Jan 29.

Abteilung für Angiologie, Zentrum für Kardiologie/Kardiologie I, Universitätsmedizin der Johannes-Gutenberg-Universität, Mainz.

Patients with lower extremity arterial disease are at increased risk for cardiovascular events. Antithrombotic therapy improves prognosis in these patients especially after peripheral revascularization. After endovascular revascularization duale anti-platelet therapy with Aspirin and Clopidogrel is used for up to 3 months in most cases, although there is only little evidence for this practice. Following peripheral bypass grafting most guidelines recommend single anti-platelet therapy. In some patients, anticoagulation with Vitamin K antagonists or dual anti-platelet therapy is indicated. But this practice is also based on small studies. The Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease (VOYAGER PAD) study is the largest randomized trial concerning antithrombotic therapy after peripheral revascularization. In total 6564 patients were included after successful surgical or endovascular lower-extremity revascularization. Rivaroxaban 2.5 mg twice daily plus Aspirin 100 mg reduced cardiac and peripheral events compared with Aspirin 100 mg alone with increased risk for relevant but not for critical bleeding complications. In addition to antithrombotic medication risk factor management and regular follow-up examinations are important improve long-term prognosis after peripheral revascularization.
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http://dx.doi.org/10.1055/a-1129-1999DOI Listing
February 2021

Cost saving analysis of specialized, eHealth-based management of patients receiving oral anticoagulation therapy: Results from the thrombEVAL study.

Sci Rep 2021 01 28;11(1):2577. Epub 2021 Jan 28.

Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstraße 1, Mainz, 55131, Germany.

To evaluate the cost-saving of a specialized, eHealth-based management service (CS) in comparison to regular medical care (RMC) for the management of patients receiving oral anticoagulation (OAC) therapy. Costs of hospitalization were derived via diagnosis-related groups which comprise diagnoses (ICD-10) and operation and procedure classification system (OPS), which resulted in OAC-related (i.e. bleeding/ thromboembolic events) and non-OAC-related costs for both cohorts. Cost for anticoagulation management comprised INR-testing, personnel, and technical support. In total, 705 patients were managed by CS and 1490 patients received RMC. The number of hospital stays was significantly lower in the CS cohort compared to RMC (CS: 23.4/100 py; RMC: 68.7/100 py); with the most pronounced difference in OAC-related admissions (CS: 2.8/100 py; RMC: 13.3/100 py). Total costs for anticoagulation management amounted to 101 EUR/py in RMC and 311 EUR/py in CS, whereas hospitalization costs were 3261 [IQR 2857-3689] EUR/py in RMC and 683 [504-874] EUR/py in CS. This resulted in an overall cost saving 2368 EUR/py favoring the CS. The lower frequency of adverse events in anticoagulated patients managed by the telemedicine-based CS compared to RMC translated into a substantial cost-saving, despite higher costs for the specialized management of patients.Trial registration: ClinicalTrials.gov, unique identifier NCT01809015, March 8, 2013.
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http://dx.doi.org/10.1038/s41598-021-82076-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7844022PMC
January 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

Telemedicine-Based Specialized Care Improves the Outcome of Anticoagulated Individuals with Venous Thromboembolism-Results from the thrombEVAL Study.

J Clin Med 2020 Oct 13;9(10). Epub 2020 Oct 13.

Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg-University Mainz, 55131 Mainz, Germany.

Venous thromboembolism (VTE) is a life-threatening disease with risk of recurrence. Oral anticoagulation (OAC) with vitamin K antagonists (VKA) is effective to prevent thromboembolic recurrence. We aimed to investigate the quality of OAC of VTE patients in regular medical care (RMC) compared to a telemedicine-based coagulation service (CS). The thrombEVAL study (NCT01809015) is a prospective, multi-center study to investigate OAC treatment (recruitment: January 2011-March 2013). Patients were evaluated using clinical visits, computer-assisted personal interviews, self-reported data and laboratory measurements according to standard operating procedures. Overall, 360 patients with VTE from RMC and 254 from CS were included. Time in therapeutic range (TTR) was higher in CS compared to RMC (76.9% (interquartile range [IQR] 63.2-87.1%) vs. 69.5% (52.3-85.6%), < 0.001). Crude rate of thromboembolic events (rate ratio [RR] 11.33 (95% confidence interval [CI] 1.85-465.26), = 0.0015), clinically relevant bleeding (RR 6.80 (2.52-25.76), < 0.001), hospitalizations (RR 2.54 (1.94-3.39), < 0.001) and mortality under OAC (RR 5.89 (2.40-18.75), < 0.001) were consistently higher in RMC compared with CS. Patients in RMC had higher risk for primary outcome (clinically relevant bleedings, thromboembolic events and mortality, hazard ratio [HR] 5.39 (95%CI 2.81-10.33), < 0.0001), mortality (HR 5.54 (2.22-13.84), = 0.00025), thromboembolic events (HR 6.41 (1.51-27.24), = 0.012), clinically relevant bleeding (HR 5.31 (1.89-14.89), = 0.0015) and hospitalization (HR 1.84 (1.34-2.55), = 0.0002). Benefits of CS care were still observed after adjusting for comorbidities and TTR. In conclusion, anticoagulation quality and outcome of VTE patients undergoing VKA treatment was significantly better in CS than in RMC. Patients treated in CS had lower rates of adverse events, hospitalizations and lower mortality. CS was prognostically relevant, beyond providing advantages of improved international ratio (INR) monitoring.
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http://dx.doi.org/10.3390/jcm9103281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7602093PMC
October 2020

Tissue optical perfusion pressure: a simplified, more reliable, and faster assessment of pedal microcirculation in peripheral artery disease.

Am J Physiol Heart Circ Physiol 2020 12 18;319(6):H1208-H1220. Epub 2020 Sep 18.

Department of Angiology, Center for Cardiology, Cardiology I, University Hospital, Johannes Gutenberg-University Mainz, Germany.

Oscillometry is an alternative to continuous-wave Doppler (cw-Doppler) to determine peripheral artery disease (PAD) severity using the ankle-brachial index (ABI). cw-Doppler ABI differentiates systolic pressure of ATP and ADP where either one of both values in most patients is higher (high) and the other value is lower (low). In contrast, oscillometric ABI measures the strongest signal and hence misses the lower value. Both do not take pedal perfusion into consideration. Simultaneous determination of tissue microperfusion cares for pedal PAD. ABI was determined by cw-Doppler and oscillometry. Tissue optical perfusion pressure (TOPP) was taken from the first toe using photoplethysmography. 323 patients were evaluated retrospectively in 3 independent groups. (99 patients) compared TOPP and oscillometric ABI with systolic cw-Doppler-pressure and cw-Doppler ABI. In (103 patients) TOPP was compared with toe pressure (TP). In (121 symptomatic patients) TOPP and ABI at rest and after stress were compared (ultrasound examination and magnetic resonance angiography (MRA) or computer tomography angiography (CTA) as control). Bland-Altman-plot analysis presented no significant difference between oscillometric ABI and the high cw-Doppler ABI (). TOPP showed a difference of 26mmHg to the low cw-Doppler-pressure and none to the high cw-Doppler-pressure. In TOPP correlates to TP but presented a difference of 37 mmHg. showed weak or no correlation between ABI and walking distance. Oscillometric ABI correlates significantly to TOPP. To conclude, data after stress present a better correlation than at rest. We conclude that TOPP provides absolute values of pedal macro-/microcirculation at rest and after stress tests. This new application of photoplethysmography investigated the microcirculation in peripheral artery disease at the level of the toe pad and determined the tissue optical perfusion pressure as the first pulsatile signal during automatic cuff deflation at the ankle. It is the first time that this method has been integrated for simultaneous routine examination in an automatic oscillometric ankle-brachial index (ABI) system. This quick and simple measurement technique provides clinical information on the microcirculation downstream the routine ABI measurement at rest and in particular after stress test.
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http://dx.doi.org/10.1152/ajpheart.00339.2020DOI Listing
December 2020

Survival and quality of life after early discharge in low-risk pulmonary embolism.

Eur Respir J 2021 02 4;57(2). Epub 2021 Feb 4.

Emergency Dept, Clinico San Carlos Hospital, IdISSC, Madrid, Spain.

Introduction: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes.

Methods: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire) and generic (five-level five-dimension EuroQoL (EQ-5D-5L) scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale (ACTS)) after pulmonary embolism.

Results: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±sd PEmb-QoL decreased from 28.9±20.6% at 3 weeks to 19.9±15.4% at 3 months, a mean change (improvement) of -9.1% (p<0.0001). Improvement was consistent across all PEmb-QoL dimensions. The EQ-5D-5L was 0.89±0.12 at 3 weeks after enrolment and improved to 0.91±0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age was associated with faster worsening of generic quality of life. The ACTS burden score improved from 40.5±6.6 points at 3 weeks to 42.5±5.9 points at 3 months (p<0.0001).

Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.
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http://dx.doi.org/10.1183/13993003.02368-2020DOI Listing
February 2021

Aneurysms and dissections - What is new in the literature of 2019/2020 - a European Society of Vascular Medicine annual review.

Vasa 2020 08 27;49(Suppl 104):1-36. Epub 2020 Aug 27.

Department of Angiology, Johannes Gutenberg University Mainz, Germany.

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http://dx.doi.org/10.1024/0301-1526/a000865DOI Listing
August 2020

Treatment of Venous Thromboembolism in Special Populations with Direct Oral Anticoagulants.

Thromb Haemost 2020 Jun 3;120(6):899-911. Epub 2020 Jun 3.

Section of Angiology, Center of Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, Germany.

As a result of the successful completion of their respective phase III studies compared with vitamin K antagonists (VKAs), four direct oral anticoagulants (DOACs) have been approved for the treatment and secondary prevention of venous thromboembolism (VTE). These DOACs-apixaban, dabigatran, edoxaban, and rivaroxaban-have subsequently seen a steady uptake among clinicians since their approval. Despite the suitability of DOACs for a broad range of patients, they are not appropriate in certain situations, whereas in others they require additional considerations such as dose reductions. Subanalyses of phase III trials and studies on specific VTE patient populations have been conducted to evaluate the safety and efficacy of the DOACs in a broad range of settings, such as patients with renal impairment, patients with cancer, patients of childbearing potential, patients with multiple comorbidities and pediatric patients. Furthermore, many recent guidance documents from important hematological societies and other specialists have incorporated several of these developments. These documents also identify the patients for whom DOACs are not suitable and where traditional anticoagulation options such as heparins or VKAs should be considered instead. This review provides an overview of key VTE patient subgroups, the clinical evidence supporting the use of anticoagulation in these patients, and a discussion of the most appropriate approaches to their management, including considerations such as dosing, acute and extended treatment durations, and DOAC selection.
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http://dx.doi.org/10.1055/s-0040-1710314DOI Listing
June 2020

Rationale, design and baseline characteristics of the MyoVasc study: A prospective cohort study investigating development and progression of heart failure.

Eur J Prev Cardiol 2020 May 14:2047487320926438. Epub 2020 May 14.

German Centre for Cardiovascular Research (DZHK), partner site Rhine-Main, Germany.

Background: Heart failure (HF) is a poly-aetiological syndrome with large heterogeneity regarding clinical presentation, pathophysiology, clinical outcome and response to therapy. The MyoVasc study (NCT04064450) is an epidemiological cohort study investigating the development and progression of HF.

Methods: The primary objective of the study is (a) to improve the understanding of the pathomechanisms of HF across the full spectrum of clinical presentation, (b) to investigate the current clinical classifications of HF, and (c) to identify and characterize homogeneous subgroups regarding disease development using a systems-oriented approach. Worsening of HF, that is, the composite of transition from asymptomatic to symptomatic HF, hospitalization due to HF, or cardiac death, was defined as the primary endpoint of the study. During a six-year follow-up period, all study participants receive a highly standardized, biannual five-hour examination in a dedicated study centre, including detailed cardiovascular phenotyping and biobanking of various biomaterials. Annual follow-up examinations are conducted by computer-assisted telephone interviews recording comprehensively the participants´ health status, including subsequent validation and adjudication of adverse events.

Results: In total, 3289 study participants (age range: 35 to 84 years; female sex: 36.8%) including the full range of HF stages were enrolled from 2013 to 2018. Approximately half of the subjects (=1741) presented at baseline with symptomatic HF (i.e. HF stage C/D). Among these, HF with preserved ejection fraction was the most frequent phenotype.

Conclusions: By providing a large-scale, multi-dimensional biodatabase with sequential, comprehensive medical-technical (sub)clinical phenotyping and multi-omics characterization (i.e. genome, transcriptome, proteome, lipidome, metabolome and exposome), the MyoVasc study will help to advance our knowledge about the heterogeneous HF syndrome by a systems-oriented biomedicine approach.

Trial Registration: ClinicalTrials.gov; NCT04064450.
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http://dx.doi.org/10.1177/2047487320926438DOI Listing
May 2020

Thrombo-Inflammation in Cardiovascular Disease: An Expert Consensus Document from the Third Maastricht Consensus Conference on Thrombosis.

Thromb Haemost 2020 Apr 14;120(4):538-564. Epub 2020 Apr 14.

Department of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany; Haemostasis Research Unit, University College London, London, United Kingdom.

Thrombo-inflammation describes the complex interplay between blood coagulation and inflammation that plays a critical role in cardiovascular diseases. The third Maastricht Consensus Conference on Thrombosis assembled basic, translational, and clinical scientists to discuss the origin and potential consequences of thrombo-inflammation in the etiology, diagnostics, and management of patients with cardiovascular disease, including myocardial infarction, stroke, and peripheral artery disease. This article presents a state-of-the-art reflection of expert opinions and consensus recommendations regarding the following topics: (1) challenges of the endothelial cell barrier; (2) circulating cells and thrombo-inflammation, focused on platelets, neutrophils, and neutrophil extracellular traps; (3) procoagulant mechanisms; (4) arterial vascular changes in atherogenesis; attenuating atherosclerosis and ischemia/reperfusion injury; (5) management of patients with arterial vascular disease; and (6) pathogenesis of venous thrombosis and late consequences of venous thromboembolism.
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http://dx.doi.org/10.1055/s-0040-1708035DOI Listing
April 2020

Isolated Pulmonary Embolism Is Associated With a High Risk of Arterial Thrombotic Disease: Results From the VTEval Study.

Chest 2020 07 23;158(1):341-349. Epub 2020 Mar 23.

Department of Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Mainz, Germany. Electronic address:

Background: Isolated PE is associated with a higher burden of atherosclerotic disease than other manifestations of VTE.

Research Question: We hypothesized that the presence of isolated PE may signal a chronically elevated risk of arterial thrombotic disease.

Study Design And Methods: Data from the VTEval Study, a prospective cohort study enrolling individuals with clinical suspicion and imaging-based diagnosis or exclusion of VTE, were analyzed. Patients with PE received whole-leg ultrasonography to assess presence of DVT. Regularized logistic regression identified features that discriminate between isolated PE and other VTE phenotypes at clinical presentation. Survival analyses were performed to evaluate the crude and adjusted 3-year risks of arterial thrombotic disease, recurrent VTE, and death.

Results: The sample comprised 510 patients. Isolated PE patients (n = 63) had a distinct clinical profile from patients with other VTE phenotypes (n = 447). COPD, peripheral artery disease, atrial fibrillation, and coronary artery disease were significantly more prevalent among patients with isolated PE. Isolated PE patients had significantly higher risk (incidence rate ratio vs DVT-associated PE, 3.7 (95% CI, 1.3-10.8, P = .009); vs isolated DVT, 4.8 (1.7-14.3, P = .001) of arterial thrombotic events (ie, myocardial infarction, stroke/transient ischemic attack). After adjustment for clinical profile and medication intake, the risk of arterial thrombotic events for patients with isolated PE remained quadruple that of other VTE phenotypes (hazard ratio [HR], 3.8 [1.3-10.9], P = .01).

Interpretation: Patients with isolated PE are at higher risk for arterial thrombosis and may require screening for arterial disease and development of novel therapeutic strategies.

Clinical Trial Registration: NCT02156401.
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http://dx.doi.org/10.1016/j.chest.2020.01.055DOI Listing
July 2020

[Principles of angiology in lower extremity arterial disease (LEAD)].

Herz 2020 Apr;45(2):201-208

Abteilung Angiologie, Zentrum für Kardiologie/Kardiologie I, Universitätsmedizin der Johannes-Gutenberg-Universität, Langenbeckstr. 1, 55131, Mainz, Deutschland.

Lower extremity arterial disease (LEAD) is a frequent manifestation of atherosclerosis with a high risk for cardiovascular events. The measurement of the ankle-brachial index (ABI) should be used as a screening method for LEAD. A differentiation is made between a stable stage of intermittent claudication and the stage of critical limb ischemia. The control of cardiovascular risk factors is crucial. Particular emphasis should be placed on smoking cessation and lipid-lowering treatment with statins and a target low-density lipoprotein (LDL)-cholesterol level of <55 mg/dl as a core element. In patients with symptomatic LEAD an inhibition of platelet aggregation is indicated. In addition to treatment with clopidogrel 75 mg or with acetylsalicylic acid (ASS) 100 mg in high risk patients the combination of ASS 100 mg and rivaroxaban 2 × 2.5 mg can be indicated. In critical limb ischemia revascularization (percutaneous intervention, operation) is always indicated to prevent amputation. First-line treatment in patients with intermittent claudication is exercise training. Revascularization can be indicated in patients with a severe limitation of walking distance.
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http://dx.doi.org/10.1007/s00059-020-04896-1DOI Listing
April 2020

Specialized Management of Oral Anticoagulation Therapy Improves Outcome in Patients with Chronic Renal Insufficiency.

J Clin Med 2020 Feb 28;9(3). Epub 2020 Feb 28.

Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, 55131 Mainz, Germany.

Oral anticoagulation (OAC) is effective at preventing and treating thromboses and thromboembolism in patients with normal renal function. We aimed to research the impact of severe renal failure (RF) on patient outcome and to determine the potential benefit of caring for these patients in a specialized coagulation service (CS). A total of 1516 usual medical care patients and 756 CS-managed patients of the thrombEVAL multicenter (21 centers), prospective, cohort study (NCT01809015) were analyzed in a 3-year follow-up. Patients with RF (serum creatinine >3 mg/dL, no renal replacement therapy) were compared to patients without RF in usual care and a CS. The fluctuations in the international normalized ratios were significantly lower in CS-managed patients, and regardless of treatment in usual care or a CS, the time in therapeutic range was significantly lower in RF patients. Cox regression-adjusted hazard ratios for long-term outcome (1.5, 95% CI: 1.22-1.83, < 0.001), death (1.62, CI: 1.27-2.08, < 0.001), and hospitalization (1.21, CI: 1.02-1.44, = 0.032) were significantly higher in RF patients in usual care. Furthermore, there was a trend of more bleeding events in RF patients. CS-treated patients had significantly lower adjusted hazard ratios for death (0.24, CI: 0.14-0.39, < 0.001), hospitalizations (0.41, CI: 0.34-0.5, < 0.001), clinically relevant bleeding (0.29, CI: 0.18-0.47, < 0.001), and major bleeding (0.33, CI: 0.18-0.59, < 0.001). Thus, patients who required oral anticoagulation therapy benefitted significantly from being managed in a specialized coagulation service, regardless of their renal function.
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http://dx.doi.org/10.3390/jcm9030645DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141283PMC
February 2020

Contemporary results with the biosynthetic glutaraldehyde denatured ovine collagen graft (Omniflow II) in femoropopliteal position.

J Vasc Surg 2020 05 20;71(5):1630-1643. Epub 2019 Dec 20.

Department of Cardiothoracic and Vascular Surgery, Johannes Gutenberg-University School of Medicine, Mainz, Germany.

Objective: The objective of this study was to analyze the outcome of a contemporary series of femoropopliteal bypass operations with the glutaraldehyde denatured polyester mesh-reinforced ovine collagen prosthesis (OCP; Omniflow II [LeMaitre Vascular, Inc, Burlington, Mass]). The experience of two tertiary centers regarding long-term graft function, secondary reinterventions, and biodegeneration of the OCP prosthesis is presented.

Methods: Between January 2006 and January 2014, a series of 205 consecutive operations with the OCP in the femoropopliteal position (54 above knee and 151 below knee) were performed in 194 patients in 202 limbs for disabling claudication (72), chronic critical ischemia (105), acute ischemia (18), popliteal artery aneurysm (4), degeneration of a venous or prosthetic graft (5), and infection of a synthetic bypass graft (1). Grafts were observed with duplex ultrasound scan supplemented by additional angiography in case of recurrent ischemia with prospective documentation of follow-up data in a computerized vascular database. Retrospective analysis of graft patency, limb salvage, and diagnosis of aneurysmal graft degeneration was performed.

Results: The 30-day mortality was 3.9%. Early thrombotic bypass occlusion occurred in 8.2% of cases. Four early graft infections could be successfully managed by local treatment with graft preservation. After a mean (median) follow-up of 56 (55) months (range, 1-135 months), primary patency, primary assisted patency, secondary patency, and limb salvage were 71%, 78%, 78%, and 91% for above-knee bypass and 40%, 50%, 63%, and 87% for below-knee bypass at 5 years. Biodegeneration in the form of graft aneurysm or graft stenosis was detected in 26 grafts (12.6%), resulting in secondary open or endovascular procedures in 16 cases.

Conclusions: The OCP provides satisfactory medium- and long-term patency and limb salvage in the femoropopliteal position. Aneurysmal degeneration or graft stenosis may develop over time, demanding lifelong duplex ultrasound surveillance and secondary intervention if needed. Its possible infection-resistant behavior in a contaminated field combined with an acceptable graft patency and limb salvage justifies the use of this graft in the absence of autologous vein.
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http://dx.doi.org/10.1016/j.jvs.2019.08.234DOI Listing
May 2020

Editor's Choice - Follow-up of Patients After Revascularisation for Peripheral Arterial Diseases: A Consensus Document From the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases and the European Society for Vascular Surgery.

Eur J Vasc Endovasc Surg 2019 Nov;58(5):641-653

Department of Cardiology, Dupuytren University Hospital and Inserm 1098, France.

Peripheral arterial diseases comprise different clinical presentations, from cerebrovascular disease down to lower extremity artery disease, from subclinical to disabling symptoms and events. According to clinical presentation, the patient's general condition, anatomical location and extension of lesions, revascularisation may be needed in addition to best medical treatment. The 2017 European Society of Cardiology guidelines in collaboration with the European Society for Vascular Surgery have addressed the indications for revascularisation. While most cases are amenable to either endovascular or surgical revascularisation, maintaining long-term patency is often challenging. Early and late procedural complications, but also local and remote recurrences frequently lead to revascularisation failure. The rationale for surveillance is to propose the accurate implementation of preventive strategies to avoid other cardiovascular events and disease progression and avoid recurrence of symptoms and the need for redo revascularisation. Combined with vascular history and physical examination, duplex ultrasound scanning is the pivotal imaging technique for identifying revascularisation failures. Other non-invasive examinations (ankle and toe brachial index, computed tomography scan, magnetic resonance imaging) at regular intervals can optimise surveillance in specific settings. Currently, optimal revascularisation surveillance programmes are not well defined and systematic reviews addressing long-term results after revascularisation are lacking. We have systematically reviewed the literature addressing follow-up after revascularisation and we propose this consensus document as a complement to the recent guidelines for optimal surveillance of revascularised patients beyond the perioperative period.
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http://dx.doi.org/10.1016/j.ejvs.2019.06.017DOI Listing
November 2019

One simple claudication question as first step in Peripheral Arterial Disease (PAD) screening: A meta-analysis of the association with reduced Ankle Brachial Index (ABI) in 27,945 subjects.

PLoS One 2019 4;14(11):e0224608. Epub 2019 Nov 4.

DZHK (German Centre for Cardiovascular Research), partner site Greifswald, Greifswald, Germany.

Purpose And Methods: A meta-analysis using data from seven German population-based cohorts was performed by the German Epidemiological consortium of Peripheral Arterial Disease (GEPArD) to investigate whether one question about claudication is more efficient for PAD screening than established questionnaires. Claudication was defined on the basis of the answer to one question asking for pain in the leg during normal walking. This simple question was compared with established questionnaires, including the Edinburgh questionnaire. The associations of claudication with continuous ABI values and decreased ABI were analyzed by linear and logistic regression analysis, respectively. The results of the studies were pooled in a random effect meta-analysis, which included data from 27,945 individuals (14,052 women, age range 20-84 years).

Results: Meta-analysis revealed a significant negative association between claudication and ABI, which was stronger in men (β = -0.07; 95%CI -0.10, -0.04) than in women (β = -0.02; 95%CI -0.02, -0.01). Likewise, the presence of claudication symptoms was related to an increased odds of a decreased ABI in both men (Odds ratio = 5.40; 95%CI 4.20, 6.96) and women (Odds ratio = 1.99; 95%CI 1.58, 2.51).

Conclusions: Asking only one question about claudication was able to identify many individuals with a high likelihood of a reduced ABI with markedly higher sensitivity and only slightly reduced specificity compared to more complex questionnaires. At least in men, this question should be established as first screening step.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224608PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6827909PMC
April 2020

Follow-up of patients after revascularisation for peripheral arterial diseases: a consensus document from the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases and the European Society for Vascular Surgery.

Eur J Prev Cardiol 2019 12 1;26(18):1971-1984. Epub 2019 Nov 1.

Department of Cardiology, Dupuytren University Hospital and Inserm 1098, France.

Peripheral arterial diseases comprise different clinical presentations, from cerebrovascular disease down to lower extremity artery disease, from subclinical to disabling symptoms and events. According to clinical presentation, the patient's general condition, anatomical location and extension of lesions, revascularisation may be needed in addition to best medical treatment. The 2017 European Society of Cardiology guidelines in collaboration with the European Society for Vascular Surgery have addressed the indications for revascularisation. While most cases are amenable to either endovascular or surgical revascularisation, maintaining long-term patency is often challenging. Early and late procedural complications, but also local and remote recurrences frequently lead to revascularisation failure. The rationale for surveillance is to propose the accurate implementation of preventive strategies to avoid other cardiovascular events and disease progression and avoid recurrence of symptoms and the need for redo revascularisation. Combined with vascular history and physical examination, duplex ultrasound scanning is the pivotal imaging technique for identifying revascularisation failures. Other non-invasive examinations (ankle and toe brachial index, computed tomography scan, magnetic resonance imaging) at regular intervals can optimise surveillance in specific settings. Currently, optimal revascularisation surveillance programmes are not well defined and systematic reviews addressing long-term results after revascularisation are lacking. We have systematically reviewed the literature addressing follow-up after revascularisation and we propose this consensus document as a complement to the recent guidelines for optimal surveillance of revascularised patients beyond the perioperative period.
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http://dx.doi.org/10.1177/2047487319846999DOI Listing
December 2019

Impact of atrial fibrillation/flutter on the in-hospital mortality of ischemic stroke patients.

Heart Rhythm 2020 03 4;17(3):383-390. Epub 2019 Oct 4.

Center of Cardiology, Cardiology I, University Medical Center Mainz (Johannes Gutenberg-University Mainz), Mainz, Germany.

Background: Stroke is the second leading cause of death worldwide. Ischemic strokes, which are caused by atrial fibrillation/flutter (AF), may be more devastating than those that occur without AF.

Objective: The purpose of this study was to investigate the impact of AF on adverse events in hospitalized ischemic stroke patients and to estimate the elevated impact of AF on the occurrence of these adverse events.

Methods: The nationwide German inpatient sample of the years 2005-2015 was used for this analysis. Ischemic stroke patients were identified by ICD code I63 and stratified by AF. Logistic regression models were used to investigate the impact of AF on adverse in-hospital events and adjusted for age, sex, and comorbidities to prove the independence of the associations.

Results: Overall, 2,958,697 hospitalized ischemic stroke patients (50.5% female, 65.4% age >70 years) were included in the analysis. Of these patients, 849,466 (28.7%) were diagnosed with AF. Overall, 9.0% of the stroke patients died in-hospital. The case fatality rate increased with age and was higher in stroke patients with AF than in those without AF (13.0% vs 7.3%; P <.001). AF was an important predictor of in-hospital death (odds ratio 1.30; 95% confidence interval 1.28-1.31; P <.001) and adverse events during hospitalization, independent of age, sex, and comorbidities. Deterioration of patient prognosis due to AF was especially pronounced in younger patients.

Conclusion: AF in ischemic stroke patients is associated with higher in-hospital mortality and higher rate of adverse events during hospitalization, independent of age, sex, and comorbidities.
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http://dx.doi.org/10.1016/j.hrthm.2019.10.001DOI Listing
March 2020

Survival Benefit of Obese Patients With Pulmonary Embolism.

Mayo Clin Proc 2019 10;94(10):1960-1973

Center for Thrombosis and Hemostasis, University Medical Center Mainz (Johannes Gutenberg-University Mainz), Mainz, Germany; Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité-University Medicine, Berlin, Germany; Center for Cardiovascular Research, Partner Site Berlin, Berlin, Germany.

Objective: To investigate the impact of obesity and underweight on adverse in-hospital outcomes in pulmonary embolism (PE).

Patients And Methods: Patients diagnosed as having PE based on International Statistical Classification of Diseases and Related Health Problems, 10th Revision, German Modification code I26 in the German nationwide inpatient database were stratified for obesity, underweight, and normal weight/overweight (reference group) and compared regarding adverse in-hospital outcomes.

Results: From January 1, 2011, through December 31, 2014, 345,831 inpatients (53.3% females) 18 years and older were included in this analysis; 8.6% were obese and 0.5% were underweight. Obese patients were younger (67.0 vs 73.0 years), were more frequently female (60.2% vs 52.7%), had a lower cancer rate (13.6% vs 20.5%), and were more often treated with systemic thrombolysis (6.4% vs 4.3%) and surgical embolectomy (0.3% vs 0.1%) vs the reference group (P<.001 for all). Overall, 51,226 patients (14.8%) died during in-hospital stay. Obese patients had lower mortality (10.9% vs 15.2%; P<.001) vs the reference group and a reduced odds ratio (OR) for in-hospital mortality (OR, 0.74; 95% CI, 0.71-0.77; P<.001) independent of age, sex, comorbidities, and reperfusion therapies. This survival benefit of obese patients was more pronounced in obesity classes I (OR, 0.56; 95% CI, 0.52-0.60; P<.001) and II (OR, 0.63; 95% CI 0.58-0.69; P<.001). Underweight patients had higher prevalence of cancer and higher mortality rates (OR, 1.15; 95% CI, 1.00-1.31; P=.04).

Conclusion: Obesity is associated with decreased in-hospital mortality rates in patients with PE. Although obese patients were more often treated with reperfusion therapies, the survival benefit of obese patients occurred independently of age, sex, comorbidities, and reperfusion treatment.
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http://dx.doi.org/10.1016/j.mayocp.2019.04.035DOI Listing
October 2019

Reentry devices for chronic arterial occlusions.

Vasa 2019 Aug;48(5):451-452

Center of Cardiology - Cardiology I, Section of Angiology, University Medical Center of the Johannes Gutenberg University Mainz, Germany.

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http://dx.doi.org/10.1024/0301-1526/a000804DOI Listing
August 2019

Subtherapeutic Anticoagulation Control under Treatment with Vitamin K-Antagonists-Data from a Specialized Coagulation Service.

Thromb Haemost 2019 Aug 10;119(8):1347-1357. Epub 2019 Jun 10.

Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center Mainz, Johannes Gutenberg University Mainz, Mainz, Germany.

In contrast to overanticoagulation, evidence on risk factors and outcome of subtherapeutic oral anticoagulation (OAC) with vitamin K-antagonists (VKAs) under optimum care is limited. We investigated the clinical phenotype, anticoagulation control, and clinical outcome of 760 VKA patients who received OAC therapy by a specialized coagulation service in the thrombEVAL study (NCT01809015). During 281,934 treatment days, 278 patients experience ≥ 1 episode of subtherapeutic anticoagulation control and had lower quality of OAC therapy compared to 482 patients without subtherapeutic international normalized ratio: 67.6%, interquartile range (IQR) 54.9%/76.8% versus 81.0%, IQR 68.5%/90.4%;  < 0.001. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, and treatment characteristics, female sex (hazard ratio [HR], 1.4, 95% confidence interval [CI], 1.0/1.9;  = 0.03), diabetes (HR, 1.4, 95% CI, 1.0/2.0;  = 0.03), and living alone (HR, 1.5, 95% CI, 1.1/2.1;  = 0.009) were independent risk factors of subtherapeutic anticoagulation control, whereas atrial fibrillation (HR, 0.6, 95% CI, 0.4/0.9;  = 0.02) and self-management of OAC therapy (HR, 0.2, 95% CI, 0.1/0.6;  = 0.001) were protective. In addition, active smoking (HR, 1.7, 95% CI, 0.9/3.0;  = 0.086) and living in a nursing home (HR, 1.6, 95% CI, 0.8/3.2;  = 0.15) indicated an elevated risk at the borderline of statistical significance. For the prediction of recurrent subtherapeutic anticoagulation, living alone was the only independent risk factor (HR, 1.7, 95% CI, 1.1/2.5;  = 0.013). The present study suggests that women, diabetics, and patients living alone experience an increased risk of low-quality VKA therapy and might potentially benefit from treatment with direct-acting anticoagulants.
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http://dx.doi.org/10.1055/s-0039-1692175DOI Listing
August 2019

Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial.

Eur Heart J 2020 01;41(4):509-518

Helios Albert-Schweitzer-Klinik, Albert-Schweitzer-Weg 1, 37154 Northeim, Germany.

Aims: To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban.

Methods And Results: We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%).

Conclusion: Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
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http://dx.doi.org/10.1093/eurheartj/ehz367DOI Listing
January 2020

[Anti-Thrombotic Therapy of Peripheral Arterial Disease - A Review of Current Evidence, Practice and Outlook].

Dtsch Med Wochenschr 2019 05 13;144(10):683-689. Epub 2019 May 13.

Universitätsklinikum Hamburg.

Peripheral arterial occlusive disease is a frequent and chronic vascular disorder mostly affecting the lower limbs and caused by fibrous plaques in arteries that can result in stenoses and thrombi. Patients suffering from this condition show a high risk for cardiovascular complications of the complete arterial vascular system, especially post-procedural. Thus, there is a need to optimize anti-thrombotic therapy. Data on multiple antiplatelet aggregation therapy including new drug classes are expected in the coming years. In addition, recent studies showed that direct oral anticoagulation provided clinical advantages combined with a reasonable safety profile. Management of risk factors such as overweight and nicotine and correction of metabolic disorders are not to be ignored and the background to further therapy. All treating physicians should be aware of these aspects to guarantee an optimal care and motivation of their patients.
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http://dx.doi.org/10.1055/a-0826-2868DOI Listing
May 2019
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