Publications by authors named "Katharina Feil"

72 Publications

Effectivity of a mHealth intervention for individuals with obesity: a study protocol for a controlled intervention study.

BMC Sports Sci Med Rehabil 2021 Sep 17;13(1):112. Epub 2021 Sep 17.

Institute for Sport and Sport Science, Karlsruhe Institute of Technology, Engler-Bunte-Ring 15, 76131, Karlsruhe, Germany.

Background: Obesity is considered an epidemic problem with an increasing number of individuals affected. The physical and psychological complaints associated with obesity point to the importance of implementing effective interventions. Innovative mHealth applications appear to be promising in helping provide a continuous and flexible support during the intervention. Since research on mHealth interventions is still relatively sparse, the main goal of the current study is to assess the effectiveness of an mHealth obesity intervention in terms of weight reduction, health behaviours as well as health-related quality of life. In addition, the study aims to investigate various psychological explicit and implicit processes associated with physical activity behaviour.

Methods: The study includes quantitative and qualitative methods. Regarding the quantitative methods, the goal is to recruit up to 450 individuals at baseline in different obesity centres across Germany with some of these centres offering an mHealth intervention. All individuals who agree to take part in the mHealth intervention will be assigned to the intervention group, while all other individuals will be assigned to the control group. The mHealth obesity intervention consists of three stays at an obesity centre, with approximately six months between stays during which patients are supported by the digital platform CASPAR. The study includes three measurements with a baseline measurement and two follow-up measurements, one after six months and one after twelve months. To assess the effectiveness of the intervention, body weight, physical activity behaviour, eating behaviour as well as health related quality of life will be assessed. In addition, motivation, intentions, self-efficacy, enjoyment, and habit will be used to assess the psychological processes related with physical activity behaviour. A multivariate analysis of variance with repeated measurement and latent growth curve models will be used to compare the development of the variables within the two groups. In relation to the qualitative methods, interviews with individuals of the intervention group will be conducted to shed light on the applicability, acceptance, and usability of the mHealth intervention.

Discussion: This study may provide a valuable insight into the potential of mHealth obesity interventions and the psychological processes related to physical activity behaviour. Trial registration The trial has been registered with the German Register of Clinical Studies (DRKS) on June 30, 2021 under the registration number: DRKS00024836.
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http://dx.doi.org/10.1186/s13102-021-00337-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8446725PMC
September 2021

EndoVAscular treatment and ThRombolysis for Ischemic Stroke Patients (EVA-TRISP) registry: basis and methodology of a pan-European prospective ischaemic stroke revascularisation treatment registry.

BMJ Open 2021 08 9;11(8):e042211. Epub 2021 Aug 9.

Department of Neurology, University of Zurich, Zurich, Switzerland.

Purpose: The Thrombolysis in Ischemic Stroke Patients (TRISP) collaboration was a concerted effort initiated in 2010 with the purpose to address relevant research questions about the effectiveness and safety of intravenous thrombolysis (IVT). The collaboration also aims to prospectively collect data on patients undergoing endovascular treatment (EVT) and hence the name of the collaboration was changed from TRISP to EVA-TRISP. The methodology of the former TRISP registry for patients treated with IVT has already been published. This paper focuses on describing the EVT part of the registry.

Participants: All centres committed to collecting predefined variables on consecutive patients prospectively. We aim for accuracy and completeness of the data and to adapt local databases to investigate novel research questions. Herein, we introduce the methodology of a recently constructed academic investigator-initiated open collaboration EVT registry built as an extension of an existing IVT registry in patients with acute ischaemic stroke (AIS).

Findings To Date: Currently, the EVA-TRISP network includes 20 stroke centres with considerable expertise in EVT and maintenance of high-quality hospital-based registries. Following several successful randomised controlled trials (RCTs), many important clinical questions remain unanswered in the (EVT) field and some of them will unlikely be investigated in future RCTs. Prospective registries with high-quality data on EVT-treated patients may help answering some of these unanswered issues, especially on safety and efficacy of EVT in specific patient subgroups.

Future Plans: This collaborative effort aims at addressing clinically important questions on safety and efficacy of EVT in conditions not covered by RCTs. The TRISP registry generated substantial novel data supporting stroke physicians in their daily decision making considering IVT candidate patients. While providing observational data on EVT in daily clinical practice, our future findings may likewise be hypothesis generating for future research as well as for quality improvement (on EVT). The collaboration welcomes participation of further centres willing to fulfill the commitment and the outlined requirements.
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http://dx.doi.org/10.1136/bmjopen-2020-042211DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354282PMC
August 2021

Recurrent Spontaneous Miscarriage: a Comparison of International Guidelines.

Geburtshilfe Frauenheilkd 2021 Jul 23;81(7):769-779. Epub 2021 Apr 23.

Medical University Innsbruck, Department of Gynaecological Endocrinology and Reproductive Medicine, Innsbruck, Austria.

While roughly 30% of all women experience a spontaneous miscarriage in their lifetime, the incidence of recurrent (habitual) spontaneous miscarriage is 1 - 3% depending on the employed definition. The established risk factors include endocrine, anatomical, infection-related, genetic, haemostasis-related and immunological factors. Diagnosis is made more difficult by the sometimes diverging recommendations of the respective international specialist societies. The present study is therefore intended to provide a comparison of existing international guidelines and recommendations. The guidelines of the ESHRE, ASRM, the DGGG/OEGGG/SGGG and the recommendations of the RCOG were analysed. It was shown that investigation is indicated after 2 clinical pregnancies and the diagnosis should be made using a standardised timetable that includes the most frequent causes of spontaneous miscarriage. The guidelines concur that anatomical malformations, antiphospholipid syndrome and thyroid dysfunction should be excluded. Moreover, the guidelines recommend carrying out pre-conception chromosomal analysis of both partners (or of the aborted material). Other risk factors have not been included in the recommendations by all specialist societies, on the one hand because of a lack of diagnostic criteria (luteal phase insufficiency) and on the other hand because of the different age of the guidelines (chronic endometritis). In addition, various economic and consensus aspects in producing the guidelines influence the individual recommendations. An understanding of the underlying decision-making process should lead in practice to the best individual diagnosis and resulting treatment being offered to each couple.
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http://dx.doi.org/10.1055/a-1380-3657DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277441PMC
July 2021

Comparison of Risk Factors, Safety, and Efficacy Outcomes of Mechanical Thrombectomy in Posterior vs. Anterior Circulation Large Vessel Occlusion.

Front Neurol 2021 22;12:687134. Epub 2021 Jun 22.

Department of Neurology & Stroke, Eberhard-Karls University, Tübingen, Germany.

It is believed that stroke occurring due to posterior circulation large vessel occlusion (PCLVO) and that occurring due to anterior circulation large vessel occlusion (ACLVO) differ in terms of their pathophysiology and the outcome of their acute management in relation to endovascular mechanical thrombectomy (MT). Limited sample size and few randomized controlled trials (RCTs) with respect to PCLVO make the safety and efficacy of MT, which has been confirmed in ACLVO, difficult to assess in the posterior circulation. We therefore conducted a meta-analysis to study to which extent MT in PCLVO differs from ACLVO. We searched the databases PubMed, Cochrane, and EMBASE for studies published between 2010 and January 2021, with information on risk factors, safety, and efficacy outcomes of MT in PCLVO vs. ACLVO and conducted a systematic review and meta-analysis; we compared baseline characteristics, reperfusion treatment profiles [including rates of intravenous thrombolysis (IVT) and onset-to-IVT and onset-to-groin puncture times], recanalization success [Thrombolysis In Cerebral Infarction scale (TICI) 2b/3], symptomatic intracranial hemorrhage (sICH), and favorable functional outcome [modified Rankin Score (mRS) 0-2] and mortality at 90 days. Sixteen studies with MT PCLVO (1,172 patients) and ACLVO (7,726 patients) were obtained from the search. The pooled estimates showed higher baseline National Institutes of Health Stroke Scale (NIHSS) score (SMD 0.32, 95% CI 0.15-0.48) in the PCLVO group. PCLVO patients received less often IVT (OR 0.65, 95% CI 0.53-0.79). Onset-to-IVT time (SMD 0.86, 95% CI 0.45-1.26) and onset-to-groin puncture time (SMD 0.59, 95% CI 0.33-0.85) were longer in the PCLVO group. The likelihood of obtaining successful recanalization and favorable functional outcome at 90 days was comparable between the two groups. PCLVO was, however, associated with less sICH (OR 0.56, 95% CI 0.37-0.85) but higher mortality (OR 1.92, 95% CI 1.46-2.53). This meta-analysis indicates that MT in PCLVO may be comparably efficient in obtaining successful recanalization and 90 day favorable functional outcome just as in ACLVO. Less sICH in MT-treated PCLVO patients might be the result of the lower IVT rate in this group. Higher baseline NIHSS and longer onset-to-IVT and onset-to-groin puncture times may have contributed to a higher 90 day mortality in PCLVO patients.
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http://dx.doi.org/10.3389/fneur.2021.687134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8258169PMC
June 2021

No evidence for a specific vitamin D deficit in benign paroxysmal positional vertigo.

Eur J Neurol 2021 Sep 7;28(9):3182-3186. Epub 2021 Jul 7.

Department of Neurology, University Hospital, LMU Munich, Munich, Germany.

Background And Purpose: The aim was to investigate whether there is a difference in serum 25-hydroxyvitamin D (25(OH)D) concentration between patients with benign paroxysmal positional vertigo (BPPV), patients with other vestibular diseases and patients with other neurological non-vestibular diseases presenting in a tertiary neurological academic outpatient clinic.

Methods: The serum 25(OH)D concentration was measured in 680 patients (368 male, mean age ± SD 58 ± 17 years, 661 Caucasian) without vitamin D supplementation. 158 patients had BPPV; 221 had other vestibular diseases (including 122 with peripheral vestibular disorders, such as unilateral vestibulopathy or Ménière's disease; 46 with central vestibular disorders, such as vestibular migraine or cerebellar dizziness; 53 with functional dizziness); and 301 patients with other neurological non-vestibular diseases.

Results: There was no significant difference in the serum 25(OH)D concentration between patients with BPPV (mean ± SD 23.4 ± 9.4 ng/ml) and those with other vestibular disorders (24.9 ± 10.1 ng/ml, p = 0.324). Patients with other neurological disorders had even lower concentrations (21.4 ± 10.6 ng/ml) than patients with BPPV (p < 0.005), patients with other vestibular disorders (p < 0.005) and all patients with vestibular disorders (24.9 ± 10.1 ng/ml, p < 0.005).

Conclusion: Our analysis does not support the theory of a specific relationship between serum 25(OH)D concentration and the occurrence of BPPV or other vestibular disorders.
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http://dx.doi.org/10.1111/ene.14980DOI Listing
September 2021

Late Thrombectomy in Clinical Practice : Retrospective Application of DAWN/DEFUSE3 Criteria within the German Stroke Registry.

Clin Neuroradiol 2021 Sep 7;31(3):799-810. Epub 2021 Jun 7.

Institute of Neuroradiology, Ludwig Maximilians University (LMU) Munich, Campus Grosshadern, Marchioninistraße 15, 81377, Munich, Germany.

Background And Purpose: To provide real-world data on outcome and procedural factors of late thrombectomy patients.

Methods: We retrospectively analyzed patients from the multicenter German Stroke Registry. The primary endpoint was clinical outcome on the modified Rankin scale (mRS) at 3 months. Trial-eligible patients and the subgroups were compared to the ineligible group. Secondary analyses included multivariate logistic regression to identify predictors of good outcome (mRS ≤ 2).

Results: Of 1917 patients who underwent thrombectomy, 208 (11%) were treated within a time window ≥ 6-24 h and met the baseline trial criteria. Of these, 27 patients (13%) were eligible for DAWN and 39 (19%) for DEFUSE3 and 156 patients were not eligible for DAWN or DEFUSE3 (75%), mainly because there was no perfusion imaging (62%; n = 129). Good outcome was not significantly higher in trial-ineligible (27%) than in trial-eligible (20%) patients (p = 0.343). Patients with large trial-ineligible CT perfusion imaging (CTP) lesions had significantly more hemorrhagic complications (33%) as well as unfavorable outcomes.

Conclusion: In clinical practice, the high number of patients with a good clinical outcome after endovascular therapy ≥ 6-24 h as in DAWN/DEFUSE3 could not be achieved. Similar outcomes are seen in patients selected for EVT ≥ 6 h based on factors other than CTP. Patients triaged without CTP showed trends for shorter arrival to reperfusion times and higher rates of independence.
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http://dx.doi.org/10.1007/s00062-021-01033-1DOI Listing
September 2021

Thrombolytic therapy for wake-up stroke: A systematic review and meta-analysis.

Eur J Neurol 2021 06 15;28(6):2006-2016. Epub 2021 Apr 15.

Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

Background And Purpose: According to evidence-based clinical practice guidelines, patients presenting with disabling stroke symptoms should be treated with intravenous tissue plasminogen activator (IV tPA) within 4.5 h of time last known well. However, 25% of strokes are detected upon awakening (i.e., wake-up stroke [WUS]), which renders patients ineligible for IV tPA administered via time-based treatment algorithms, because it is impossible to establish a reliable time of symptom onset. We performed a systematic review and meta-analysis of the efficacy and safety of IV tPA compared with normal saline, placebo, or no treatment in patients with WUS using imaging-based treatment algorithms.

Methods: We searched MEDLINE, Web of Science, and Scopus between January 1, 2006 and April 30, 2020. We included controlled trials (randomized or nonrandomized), observational cohort studies (prospective or retrospective), and single-arm studies in which adults with WUS were administered IV tPA after magnetic resonance imaging (MRI)- or computed tomography (CT)-based imaging. Our primary outcome was recovery at 90 days (defined as a modified Rankin Scale [mRS] score of 0-2), and our secondary outcomes were symptomatic intracranial hemorrhage (sICH) within 36 h, mortality, and other adverse effects.

Results: We included 16 studies that enrolled a total of 14,017 patients. Most studies were conducted in Europe (37.5%) or North America (37.5%), and 1757 patients (12.5%) received IV tPA. All studies used MRI-based (five studies) or CT-based (10 studies) imaging selection, and one study used a combination of modalities. Sixty-one percent of patients receiving IV tPA achieved an mRS score of 0 to 2 at 90 days (95% confidence interval [CI]: 51%-70%, 12 studies), with a relative risk (RR) of 1.21 compared with patients not receiving IV tPA (95% CI: 1.01-1.46, four studies). Three percent of patients receiving IV tPA experienced sICH within 36 h (95% CI: 2.5%-4.1%; 16 studies), which is an RR of 4.00 compared with patients not receiving IV tPA (95% CI: 2.85-5.61, seven studies).

Conclusions: This systematic review and meta-analysis suggests that IV tPA is associated with a better functional outcome at 90 days despite the increased but acceptable risk of sICH. Based on these results, IV tPA should be offered as a treatment for WUS patients with favorable neuroimaging findings.
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http://dx.doi.org/10.1111/ene.14839DOI Listing
June 2021

Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial.

Lancet Neurol 2021 05 23;20(5):341-350. Epub 2021 Mar 23.

Department of Neurology and Stroke Centre, University Hospital Basel and University of Basel, Basel, Switzerland; Neurology and Neurorehabilitation, University Hospital for Geriatric Medicine Felix Platter, University of Basel, Basel, Switzerland.

Background: Cervical artery dissection is a major cause of stroke in young people (aged <50 years). Historically, clinicians have preferred using oral anticoagulation with vitamin K antagonists for patients with cervical artery dissection, although some current guidelines-based on available evidence from mostly observational studies-suggest using aspirin. If proven to be non-inferior to vitamin K antagonists, aspirin might be preferable, due to its ease of use and lower cost. We aimed to test the non-inferiority of aspirin to vitamin K antagonists in patients with cervical artery dissection.

Methods: We did a multicentre, randomised, open-label, non-inferiority trial in ten stroke centres across Switzerland, Germany, and Denmark. We randomly assigned (1:1) patients aged older than 18 years who had symptomatic, MRI-verified, cervical artery dissection within 2 weeks before enrolment, to receive either aspirin 300 mg once daily or a vitamin K antagonist (phenprocoumon, acenocoumarol, or warfarin; target international normalised ratio [INR] 2·0-3·0) for 90 days. Randomisation was computer-generated using an interactive web response system, with stratification according to participating site. Independent imaging core laboratory adjudicators were masked to treatment allocation, but investigators, patients, and clinical event adjudicators were aware of treatment allocation. The primary endpoint was a composite of clinical outcomes (stroke, major haemorrhage, or death) and MRI outcomes (new ischaemic or haemorrhagic brain lesions) in the per-protocol population, assessed at 14 days (clinical and MRI outcomes) and 90 days (clinical outcomes only) after commencing treatment. Non-inferiority of aspirin would be shown if the upper limit of the two-sided 95% CI of the absolute risk difference between groups was less than 12% (non-inferiority margin). This trial is registered with ClinicalTrials.gov, NCT02046460.

Findings: Between Sept 11, 2013, and Dec 21, 2018, we enrolled 194 patients; 100 (52%) were assigned to the aspirin group and 94 (48%) were assigned to the vitamin K antagonist group. The per-protocol population included 173 patients; 91 (53%) in the aspirin group and 82 (47%) in the vitamin K antagonist group. The primary endpoint occurred in 21 (23%) of 91 patients in the aspirin group and in 12 (15%) of 82 patients in the vitamin K antagonist group (absolute difference 8% [95% CI -4 to 21], non-inferiority p=0·55). Thus, non-inferiority of aspirin was not shown. Seven patients (8%) in the aspirin group and none in the vitamin K antagonist group had ischaemic strokes. One patient (1%) in the vitamin K antagonist group and none in the aspirin group had major extracranial haemorrhage. There were no deaths. Subclinical MRI outcomes were recorded in 14 patients (15%) in the aspirin group and in 11 patients (13%) in the vitamin K antagonist group. There were 19 adverse events in the aspirin group, and 26 in the vitamin K antagonist group.

Interpretation: Our findings did not show that aspirin was non-inferior to vitamin K antagonists in the treatment of cervical artery dissection.

Funding: Swiss National Science Foundation, Swiss Heart Foundation, Stroke Funds Basel, University Hospital Basel, University of Basel, Academic Society Basel.
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http://dx.doi.org/10.1016/S1474-4422(21)00044-2DOI Listing
May 2021

A Systematic Review Examining the Relationship Between Habit and Physical Activity Behavior in Longitudinal Studies.

Front Psychol 2021 4;12:626750. Epub 2021 Mar 4.

Department of Health Education and Sport Psychology, Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.

To explain physical activity behavior, social-cognitive theories were most commonly used in the past. Besides conscious processes, the approach of dual processes additionally incorporates non-conscious regulatory processes into physical activity behavior theories. Habits are one of various non-conscious variables that can influence behavior and thus play an important role in terms of behavior change. The aim of this review was to examine the relationship between habit strength and physical activity behavior in longitudinal studies. According to the PRISMA guidelines, a systematic search was conducted in three databases. Only peer-reviewed articles using a longitudinal study design were included. Both, habit and physical activity were measured at least once, and habit was related to physical activity behavior. Study quality was evaluated by assessment tools of the NHLBI. Of 3.382 identified publications between 2016 and 2019, fifteen studies with different study designs were included. Most studies supported that positive correlations between habit and physical activity exist. Some positive direct and indirect effects of habit on physical activity were detected and only a minority of studies showed the influence of physical activity on habit strength. Studies differentiating between instigation and execution habit found positive correlations and revealed instigation habit as a stronger predictor of physical activity. The quality of studies was rated as reasonable using assessment tools of the NHLBI. This review revealed a bidirectional relationship between habit and physical activity. Whether habit predicts physical activity or vice versa is still unclear. The observation of habit influencing physical activity may be most appropriate in studies fostering physical activity maintenance while the influence of physical activity on habit may be reasonable in experimental studies with physical activity as intervention content to form a habit. Future investigations should differentiate between habit formation and physical activity maintenance studies depending on the research objective. Long-term study designs addressing the complexity of habitual behavior would be beneficial for establishing cue-behavior associations for the formation of habits. Furthermore, studies should differentiate between instigation and execution habit in order to investigate the influence of both variables on physical activity behavior independently.
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http://dx.doi.org/10.3389/fpsyg.2021.626750DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969808PMC
March 2021

Immunological Risk Factors in Recurrent Pregnancy Loss: Guidelines Versus Current State of the Art.

J Clin Med 2021 Feb 20;10(4). Epub 2021 Feb 20.

Department of Gynecological Endocrinology and Reproductive Medicine, Medical University Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria.

Around 1-5% of all couples experience recurrent pregnancy loss (RPL). Established risk factors include anatomical, genetic, endocrine, and hemostatic alterations. With around 50% of idiopathic cases, immunological risk factors are getting into the scientific focus, however international guidelines hardly take them into account. Within this review, the current state of immunological risk factors in RPL in international guidelines of the European Society of Reproduction and Embryology (ESHRE), American Society of Reproductive Medicine (ASRM), German/Austrian/Swiss Society of Obstetrics and Gynecology (DGGG/OEGGG/SGGG) and the Royal College of Obstetricians and Gynecologists (RCOG) are evaluated. Special attention was drawn to recommendations in the guidelines regarding diagnostic factors such as autoantibodies, natural killer cells, regulatory T cells, dendritic cells, plasma cells, and human leukocyte antigen system (HLA)-sharing as well as treatment options such as corticosteroids, intralipids, intravenous immunoglobulins, aspirin and heparin in RPL. Finally, the current state of the art focusing on both diagnostic and therapeutic options was summarized.
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http://dx.doi.org/10.3390/jcm10040869DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923780PMC
February 2021

[Diagnosis and Differential Diagnosis of Peripheral and Central Vestibular Disorders].

Laryngorhinootologie 2021 03 26;100(3):176-183. Epub 2021 Feb 26.

The diagnosis of the various peripheral and central vestibular disorders is mainly based on the patient history (time course, type of symptoms, modulating factors, and accompanying symptoms) and a systematic clinical examination of the vestibular, ocular motor, and cerebellar systems (examination for nystagmus, head impulse test, positional maneuvers, Romberg test and examination for central ocular motor signs). The two most important laboratory tests are the "video-head impulse test" and caloric irrigation. Fortunately, the diagnosis of vestibular disorders has become easier and more precise as a result of the very clinically oriented diagnostic criteria of the Bárány Society (www.jvr-web.org/ICVD.html).
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http://dx.doi.org/10.1055/a-1057-3239DOI Listing
March 2021

General Anesthesia versus Conscious Sedation in Mechanical Thrombectomy.

J Stroke 2021 Jan 31;23(1):103-112. Epub 2021 Jan 31.

Department of Neurology, Ludwig Maximilian University (LMU), Munich, Germany.

Background And Purpose: Anesthesia regimen in patients undergoing mechanical thrombectomy (MT) is still an unresolved issue.

Methods: We compared the effect of anesthesia regimen using data from the German Stroke Registry-Endovascular Treatment (GSR-ET) between June 2015 and December 2019. Degree of disability was rated by the modified Rankin Scale (mRS), and good outcome was defined as mRS 0-2. Successful reperfusion was assumed when the modified thrombolysis in cerebral infarction scale was 2b-3.

Results: Out of 6,635 patients, 67.1% (n=4,453) patients underwent general anesthesia (GA), 24.9% (n=1,650) conscious sedation (CS), and 3.3% (n=219) conversion from CS to GA. Rate of successful reperfusion was similar across all three groups (83.0% vs. 84.2% vs. 82.6%, P=0.149). Compared to the CA-group, the GA-group had a delay from admission to groin (71.0 minutes vs. 61.0 minutes, P<0.001), but a comparable interval from groin to flow restoration (41.0 minutes vs. 39.0 minutes). The CS-group had the lowest rate of periprocedural complications (15.0% vs. 21.0% vs. 28.3%, P<0.001). The CS-group was more likely to have a good outcome at follow-up (42.1% vs. 34.2% vs. 33.5%, P<0.001) and a lower mortality rate (23.4% vs. 34.2% vs. 26.0%, P<0.001). In multivariable analysis, GA was associated with reduced achievement of good functional outcome (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.71 to 0.94; P=0.004) and increased mortality (OR, 1.42; 95% CI, 1.23 to 1.64; P<0.001). Subgroup analysis for anterior circulation strokes (n=5,808) showed comparable results.

Conclusions: We provide further evidence that CS during MT has advantages over GA in terms of complications, time intervals, and functional outcome.
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http://dx.doi.org/10.5853/jos.2020.02404DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900389PMC
January 2021

Different Background: Natural Killer Cell Profiles in Secondary versus Primary Recurrent Pregnancy Loss.

J Clin Med 2021 Jan 7;10(2). Epub 2021 Jan 7.

Department of Gynecological Endocrinology and Reproductive Medicine, Medical University Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria.

(1) Background: Prior studies suggested a significant impact of previous live births on peripheral natural killer cells (pNK) in patients with recurrent pregnancy loss (RPL). Patients with primary RPL (pRPL, no live birth) showed higher numbers of pNK than secondary RPL patients (sRPL, ≥ 1 live birth). (2) Methods: To further determine immunological differences between RPL patients and controls, we analysed pNK subpopulations and activation markers in pRPL ( = 47), sRPL ( = 24) and controls with previous live birth (sCtrl, = 25) and nullipara (pCtrl, = 60) within a prospective study. Percentages and numbers of CD56CD16 cells, subpopulations and activation markers (CD57+, CD62L+, NKG2D+, NKp46+) were measured in non-pregnant RPL patients and = 85 controls ( = 60 pCtrl, = 25 sCtrl) in the mid-luteal phase by flow cytometry. (3) Results: Compared to sRPL patients, sCtrls showed higher CD56 and CD56CD16 numbers. Further, sRPL patients showed lower numbers of CD56CD16NKG2D and CD56CD16NKp46 than sCtrls. (4) Conclusion: We suggest a chronic immune stimulation leading to a lower NK-cell count in sRPL patients with a lower NK cytotoxicity. This underlines the necessity to investigate pNK subpopulations as well as pRPL and sRPL separately to delineate the immune alterations in RPL.
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http://dx.doi.org/10.3390/jcm10020194DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7826987PMC
January 2021

Endovascular stroke treatment in orally anticoagulated patients: an analysis from the German Stroke Registry-Endovascular Treatment.

J Neurol 2021 May 29;268(5):1762-1769. Epub 2020 Dec 29.

Department of Neurology, Ludwig-Maximilians University, Marchioninistraße 15, 81377, Munich, Germany.

Background: Endovascular treatment (ET) in orally anticoagulated (OAC) patients has not been evaluated in randomized clinical trials and data regarding this issue are sparse.

Methods: We analyzed data from the German Stroke Registry-Endovascular Treatment (GSR-ET; NCT03356392, date of registration: 22 Nov 2017). The primary outcomes were successful reperfusion defined as modified thrombolysis in cerebral infarction (mTICI 2b-3), good outcome at 3 months (modified Rankin scale [mRS] 0-2 or back to baseline), and intracranial hemorrhage (ICH) on follow-up imaging at 24 h analyzed by unadjusted univariate and adjusted binary logistic regression analysis. Additionally, we analyzed mortality at 3 months with adjusted binary logistic regression analysis.

Results: Out of 6173 patients, there were 1306 (21.2%) OAC patients, 479 (7.8%) with vitamin K antagonists (VKA) and 827 (13.4%) with non-vitamin K antagonist oral anticoagulation (NOAC). The control group consisted of 4867 (78.8%) non-OAC patients. ET efficacy with the rates of mTICI 2b-3 was similar among the three groups (85.6%, 85.3% vs 84.3%, p = 0.93 and 1). On day 90, good outcome was less frequent in OAC patients (27.8%, 27.9% vs 39.5%, p < 0.005 and < 0.005). OAC status was not associated with ICH at 24 h (NOAC: odd's ratio [OR] 0.89, 95% confidence interval [CI] 0.67-1.20; VKA: OR 1.04, CI 0.75-1.46). Binary logistic regression analysis revealed no influence of OAC status on good outcome at 3 months (NOAC: OR 1.25, CI 0.99-1.59; VKA: OR 1.18, CI 0.89-1.56) and mortality at 3 months (NOAC: OR 1.03, CI 0.81-1.30; VKA: OR 1.04, CI 0.78-1.1.37).

Conclusions: ET can be performed safely and successfully in LVO stroke patients treated with OAC. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03356392.
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http://dx.doi.org/10.1007/s00415-020-10369-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8068620PMC
May 2021

Extracorporeal life support in therapy-refractory cardiocirculatory failure: looking beyond 30 days.

Interact Cardiovasc Thorac Surg 2021 04;32(4):607-615

Department of Cardiac Surgery, University Hospital Munich, Ludwig-Maximilian-University, Munich, Germany.

Objectives: Venoarterial extracorporeal life support (ECLS) has emerged as a potentially life-saving treatment option in therapy-refractory cardiocirculatory failure, but longer-term outcome is poorly defined. Here, we present a comprehensive follow-up analysis covering all major organ systems.

Methods: From February 2012 to December 2016, 180 patients were treated with ECLS for therapy-refractory cardiogenic shock or cardiac arrest. The 30-day survival was 43.9%, and 30-day survivors (n = 79) underwent follow-up analysis with the assessment of medium-term survival, quality of life, neuropsychological, cardiopulmonary and end-organ status.

Results: After a median of 1.9 (1.1-3.6) years (182.4 patient years), 45 of the 79 patients (57.0%) were alive, 35.4% had died and 7.6% were lost to follow-up. Follow-up survival estimates were 78.0% at 1, 61.2% at 3 and 55.1% at 5 years. NYHA class at follow-up was ≤II for 83.3%. The median creatinine was 1.1 (1.0-1.4) mg/dl, and the median bilirubin was 0.8 (0.5-1.0) mg/dl. No patient required dialysis. Overall, 94.4% were free from moderate or severe disability, although 11.1% needed care. Full re-integration into social life was reported by 58.3%, and 39.4% were working. Quality of life was favourable for mental components, but a subset showed deficits in physical aspects. While age was the only peri-implantation parameter significantly predicting medium-term survival, adverse events and functional status at discharge or 30 days were strong predictors.

Conclusions: This study demonstrates positive medium-term outcome with high rates of independence in daily life and self-care but a subset of 10-20% suffered from sustained impairments. Our results indicate that peri-implantation parameters lack predictive power but downstream morbidity and functional status at discharge or 30 days can help identify patients at risk for poor recovery.
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http://dx.doi.org/10.1093/icvts/ivaa312DOI Listing
April 2021

Safety and efficacy of mechanical thrombectomy in infective endocarditis: A matched case-control analysis from the German Stroke Registry-Endovascular Treatment.

Eur J Neurol 2021 03 6;28(3):861-867. Epub 2021 Jan 6.

Department of Neurology, Ludwig Maximilians University, Munich, Germany.

Background And Purpose: Up to 30% of infective endocarditis (IE) patients have ischemic stroke as a complication. Standard treatment with mechanical thrombectomy (MT) with or without intravenous thrombolysis for large vessel occlusion (LVO) has not been evaluated formally in these patients.

Methods: Patients enrolled in the German Stroke Registry-Endovascular Treatment (GSR-ET) between June 2015 and December 2019 were analyzed. Patients with stroke due to IE and patients with cardioembolic stroke and atrial fibrillation (AF) were compared using propensity score matching. Successful reperfusion was defined as modified Thrombolysis in Cerebral Infarction score = 2b-3. Modified Rankin Scale (mRS) = 0-2 at 3 months indicated good outcome.

Results: Of 6635 patients, 55 patients (age = 69.0 ± 13.3 years, 43.6% female, median premorbid mRS (pmRS) = 1, interquartile range [IQR] = 0-1, National Institutes of Health Stroke Scale [NIHSS] = 15, IQR = 10-21) presented with septic embolic stroke due to IE and were compared to 104 patients (age = 66.5 ± 13.4 years, 39.4% female, pmRS = 0, IQR = 0-2, NIHSS = 16, IQR = 10-20) with cardioembolic stroke due to AF. Successful recanalization was achieved in 74.5% of endocarditis patients compared to 87.5% of controls (p = 0.039). Intracranial hemorrhage rates were comparable (30.9% vs. 21.6%, p = 0.175). Good functional outcome was 20.0% in patients with IE compared to 43.3% in matched patients (p = 0.006), with a significantly higher mortality (60.0% vs. 28.8%, p < 0.001). IE was strongly associated with poor outcome (odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.11-0.87, p = 0.03 for good outcome) and mortality (OR = 4.49, 95% CI = 1.80-10.68, p = 0.001).

Conclusions: Although MT results in high successful recanalization rates with acceptable safety profile, patients with LVO stroke due to IE have poor outcome.
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http://dx.doi.org/10.1111/ene.14686DOI Listing
March 2021

Performance of Automated Attenuation Measurements at Identifying Large Vessel Occlusion Stroke on CT Angiography.

Clin Neuroradiol 2021 Sep 16;31(3):763-772. Epub 2020 Sep 16.

Department of Radiology, University Hospital, LMU Munich, Marchioninistr. 15, 81377, Munich, Germany.

Purpose: Computed tomography angiography (CTA) is routinely used to detect large-vessel occlusion (LVO) in patients with suspected acute ischemic stroke; however, visual analysis is time consuming and prone to error. To evaluate solutions to support imaging triage, we tested performance of automated analysis of CTA source images (CTASI) at identifying patients with LVO.

Methods: Stroke patients with LVO were selected from a prospectively acquired cohort. A control group was selected from consecutive patients with clinically suspected stroke without signs of ischemia on CT perfusion (CTP) or infarct on follow-up. Software-based automated segmentation and Hounsfield unit (HU) measurements were performed on CTASI for all regions of the Alberta Stroke Program Early CT score (ASPECTS). We derived different parameters from raw measurements and analyzed their performance to identify patients with LVO using receiver operating characteristic curve analysis.

Results: The retrospective analysis included 145 patients, 79 patients with LVO stroke and 66 patients without stroke. The parameters hemispheric asymmetry ratio (AR), ratio between highest and lowest regional AR and M2-territory AR produced area under the curve (AUC) values from 0.95-0.97 (all p < 0.001) for detecting presence of LVO in the total population. Resulting sensitivity (sens)/specificity (spec) defined by the Youden index were 0.87/0.97-0.99. Maximum sens/spec defined by the specificity threshold ≥0.70 were 0.91-0.96/0.77-0.83. Performance in a small number of patients with isolated M2 occlusion was lower (AUC: 0.72-0.85).

Conclusion: Automated attenuation measurements on CTASI identify proximal LVO stroke patients with high sensitivity and specificity. This technique can aid in accurate and timely patient selection for thrombectomy, especially in primary stroke centers without CTP capacity.
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http://dx.doi.org/10.1007/s00062-020-00956-5DOI Listing
September 2021

The gait disorder in primary orthostatic tremor.

J Neurol 2020 Dec 11;267(Suppl 1):285-291. Epub 2020 Sep 11.

German Center for Vertigo and Balance Disorders, University Hospital, LMU Munich, Munich, Germany.

Objective: To uncover possible impairments of walking and dynamic postural stability in patients with primary orthostatic tremor (OT).

Methods: Spatiotemporal gait characteristics were quantified in 18 patients with primary OT (mean age 70.5 ± 5.9 years, 10 females) and 18 age-matched healthy controls. One-third of patients reported disease-related fall events. Walking performance was assessed on a pressure-sensitive carpet under seven conditions: walking at preferred, slow, and maximal speed, with head reclination or eyes closed, and while performing a cognitive or motor dual-task paradigm.

Results: Patients exhibited a significant gait impairment characterized by a broadened base of support (p = 0.018) with increased spatiotemporal gait variability (p = 0.010). Walking speed was moderately reduced (p = 0.026) with shortened stride length (p = 0.001) and increased periods of double support (p = 0.001). Gait dysfunction became more pronounced during slow walking (p < 0.001); this was not present during fast walking. Walking with eyes closed aggravated gait disability as did walking during cognitive dual task (p < 0.001).

Conclusion: OT is associated with a specific gait disorder with a staggering wide-based walking pattern indicative of a sensory and/or a cerebellar ataxic gait. The aggravation of gait instability during visual withdrawal and the normalization of walking with faster speeds further suggest a proprioceptive or vestibulo-cerebellar deficit as the primary source of gait disturbance in OT. In addition, the gait decline during cognitive dual task may imply cognitive processing deficits. In the end, OT is presumably a complex network disorder resulting in a specific spino-cerebello-frontocortical gait disorder that goes beyond mere tremor networks.
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http://dx.doi.org/10.1007/s00415-020-10177-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718181PMC
December 2020

Inter-hospital transfer for mechanical thrombectomy within the supraregional stroke network NEVAS.

J Neurol 2021 Feb 5;268(2):623-631. Epub 2020 Sep 5.

Department of Neurology, Ludwig Maximilians University (LMU), Marchioninistrasse 15, 81377, Munich, Germany.

Background: Telemedicine stroke networks are mandatory to provide inter-hospital transfer for mechanical thrombectomy (MT). However, studies on patient selection in daily practice are sparse.

Methods: Here, we analyzed consecutive patients from 01/2014 to 12/2018 within the supraregional stroke network "Neurovascular Network of Southwest Bavaria" (NEVAS) in terms of diagnoses after consultation, inter-hospital transfer and predictors for performing MT. Degree of disability was rated by the modified Rankin Scale (mRS), good outcome was defined as mRS ≤ 2. Successful reperfusion was assumed when the modified thrombolysis in cerebral infarction (mTICI) was 2b-3.

Results: Of 5722 telemedicine consultations, in 14.1% inter-hospital transfer was performed, mostly because of large vessel occlusion (LVO) stroke. A total of n = 350 patients with LVO were shipped via NEVAS to our center for MT. While n = 52 recanalized spontaneously, MT-treatment was performed in n = 178 patients. MT-treated patients had more severe strokes according to the median National institute of health stroke scale (NIHSS) (16 vs. 13, p < 0.001), were more often treated with intravenous thrombolysis (64.5% vs. 51.7%, p = 0.026) and arrived significantly earlier in our center (184.5 versus 228.0 min, p < 0.001). Good outcome (27.5% vs. 30.8%, p = 0.35) and mortality (32.6% versus 23.5%, p = 0.79) were comparable in MT-treated versus no-MT-treated patients. In patients with middle cerebral artery occlusion in the M1 segment or carotid artery occlusion good outcome was twice as often in the MT-group (21.8% vs. 12.8%, p = 0.184). Independent predictors for performing MT were higher NIHSS (OR 1.096), higher ASPECTS (OR 1.28), and earlier time window (OR 0.99).

Conclusion: Within a telemedicine network stroke care can successfully be organized as only a minority of patients has to be transferred. Our data provide clinical evidence that all MT-eligible patients should be shipped with the fastest transportation modality as possible.
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http://dx.doi.org/10.1007/s00415-020-10165-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880976PMC
February 2021

Recurrent miscarriage is not associated with a higher prevalence of inherited and acquired thrombophilia.

Am J Reprod Immunol 2021 01 10;85(1):e13327. Epub 2020 Sep 10.

Department of Gynecological Endocrinology and Fertility Disorders, Ruprecht-Karls University Heidelberg, Heidelberg, Germany.

Problem: Although not being recommended in guidelines, many physicians perform routine screening for thrombophilia in RM patients suspecting a higher prevalence in these patients. The aim of this study was to analyze the prevalence of inherited and acquired thrombophilia in a large cohort of RM patients.

Method Of Study: Within a multicenter case-control study, n = 820 RM patients and n = 141 controls were included. The prevalence of inherited and acquired thrombophilia including deficiency of protein C/S and antithrombin, elevation of factor VIII activity, APC resistance including mutation in the factor V Leiden gene, mutation in the prothrombin gene and antiphospholipid antibodies were assessed. Further, we performed a meta-analysis of the prevalence of thrombophilia in RM patients including studies between 01/2000 and 01/2020.

Results: An antiphospholipid syndrome (APLS) was only present in RM patients. Increased factor VIII concentration was significantly more prevalent in controls (RM vs controls: 5.8% vs 11.0%). None of the other thrombophilia did differ significantly between RM patients and controls. The meta-analysis revealed no significant difference in the occurrence of these thrombophilia between RM patients and controls.

Conclusion: The prevalence of inherited thrombophilia does not differ between RM patients and controls. When analyzing rare events like thrombophilia, a high number of patients are needed to obtain reliable results, which might explain contradictory findings in previous studies analyzing small cohorts of RM patients. Despite being less prevalent than previously described, we still recommend screening for APLS as it is associated with severe pregnancy complications.
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http://dx.doi.org/10.1111/aji.13327DOI Listing
January 2021

Cerebral attenuation on single-phase CT angiography source images: Automated ischemia detection and morphologic outcome prediction after thrombectomy in patients with ischemic stroke.

PLoS One 2020 13;15(8):e0236956. Epub 2020 Aug 13.

Department of Radiology, University Hospital, LMU Munich, Munich, Germany.

Objectives: Stroke triage using CT perfusion (CTP) or MRI gained importance after successful application in recent trials on late-window thrombectomy but is often unavailable and time-consuming. We tested the clinical value of software-based analysis of cerebral attenuation on Single-phase CT angiography source images (CTASI) as CTP surrogate in stroke patients.

Methods: Software-based automated segmentation and Hounsfield unit (HU) measurements for all regions of the Alberta Stroke Program Early CT Score (ASPECTS) on CTASI were performed in patients with large vessel occlusion stroke who underwent thrombectomy. To normalize values, we calculated relative HU (rHU) as ratio of affected to unaffected hemisphere. Ischemic regions, regional ischemic core and final infarction were determined on simultaneously acquired CTP and follow-up imaging as ground truth. Receiver operating characteristics analysis was performed to calculate the area-under-the-curve (AUC). Resulting cut-off values were used for comparison with visual analysis and to calculate an 11-point automated CTASI ASPECTS.

Results: Seventy-nine patients were included. rHU values enabled significant classification of ischemic involvement on CTP in all ten regions of the ASPECTS (each p<0.001, except M4-cortex p = 0.002). Classification of ischemic core and prediction of final infarction had best results in subcortical regions but produced lower AUC values with significant classification for all regions except M1, M3 and M5. Relative total hemispheric attenuation provided strong linear correlation with CTP total ischemic volume. Automated classification of regional ischemia on CTASI was significantly more accurate in most regions and provided better agreement with CTP cerebral blood flow ASPECTS than visual assessment.

Conclusions: Automated attenuation measurements on CTASI provide excellent performance in detecting acute ischemia as identified on CTP with improved accuracy compared to visual analysis. However, value for the approximation of ischemic core and morphologic outcome in large vessel occlusion stroke after thrombectomy was regionally dependent and limited. This technique has the potential to facilitate stroke imaging as sensitive surrogate for CTP-based ischemia.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236956PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425881PMC
October 2020

Juvenile stroke caused by calcific bicuspid aortic valve: A case report.

Clin Neurol Neurosurg 2020 08 9;195:106079. Epub 2020 Jul 9.

Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.clineuro.2020.106079DOI Listing
August 2020

Diaschisis revisited: quantitative evaluation of thalamic hypoperfusion in anterior circulation stroke.

Neuroimage Clin 2020 26;27:102329. Epub 2020 Jun 26.

Department of Radiology, University Hospital, LMU Munich, Germany. Electronic address:

Purpose: Ipsilateral thalamic diaschisis (ITD) refers to the phenomenon of thalamic hypoperfusion or hypometabolism due to a distant cerebral injury. To further investigate the characteristics and spectrum of ITD, we analyzed quantitative measurements of thalamic hypoperfusion in acute anterior circulation stroke.

Methods: We selected consecutive patients with large-vessel occlusion (LVO) anterior circulation stroke and available CT perfusion (CTP) examination on admission who underwent endovascular thrombectomy. Thalamic perfusion parameters on CTP were tested between ipsi- and contralesional thalamus and ischemic territory. Values were compared with thresholds from CTP analysis software. Associations of thalamic perfusion parameters with acute imaging and clinical data were determined in uni- and multivariate logistic regression analyses.

Results: Ninety-nine patients were included. All perfusion parameters indicated significant non-ischemic hypoperfusion of the thalamus, not reaching the levels of ischemia in the middle cerebral artery territory due to LVO (all p < 0.002). Multiple perfusion parameters exhibited significant association with ischemic lesion extent (relative cerebral blood flow [CBF]: β =  - 0.23, p = 0.022; Δtime to drain: β = 0.33, p < 0.001; ΔTmax: β =  - 0.36, p < 0.001) and involvement of the Lentiform Nucleus (Δmean transit time: β = 0.64, p = 0.04; Δtime to drain: β = 0.81, p = 0.01; ΔTmax: β =  - 0.82, p = 0.01). Symptom severity on admission exhibited minor significant association with reduction of thalamic CBF in uncorrected analysis (Odds ratio: 0.05, p = 0.049), but short- and long-term outcomes were unaffected by perfusion status. ITD reached guideline-based software-threshold levels in only one patient.

Conclusions: ITD in acute stroke is a non-binary phenomenon affected by lesion extent and involvement of the lentiform nucleus. We found uncorrected association of ITD with early clinical presentation, but no association with short- or long-term outcome was evident. Relevant misclassification of ITD by guideline-based CTP software was not indicated, which needs further dedicated testing.
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http://dx.doi.org/10.1016/j.nicl.2020.102329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7334597PMC
June 2021

Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study.

Front Neurol 2020 30;11:294. Epub 2020 Apr 30.

Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.

Treatment of aphasia is still challenging for clinicians and patients. So far, there is proven evidence for "face-to-face" speech therapy. However, the digital age potentially offers new and complementary strategies that may add to treatment outcome in a cost-effective way. Neolexon® is a commercial tablet-based software for treatment of aphasia, which can be applied with the help of a therapist or as self-training by the patient. In the Lexi study, we aim to determine whether treatment with Neolexon® is superior to standard therapy in acute post-stroke aphasia. A sample size of 180 patients, 90 for each group, will be included with an assumed dropout rate of ~20%. Prospective, randomized, parallel group, open-label, blinded-endpoint clinical, and experimental controlled non-invasive trial (PROBE). Adult German native speakers with acute aphasia after stroke are included. Computer-generated, blocked, and stratified randomization by aphasia severity will assign patients to one of two groups: 4 weeks of either standard logopedic speech therapy or logopedic speech therapy with the app version of Neolexon®. Both groups will be instructed in self-training: the frequency and duration of self-training will be documented. Screening for aphasia will be performed using the Language Screening Test (LAST). The severity of aphasia in general and in subitems will be assessed using the Bielefelder Aphasie Screening (BIAS) and the Aphasia Check List (ACL). Follow-up will be assessed after 3 months. Based on the consensus in our study team, we considered a 10% mean difference in the change of percentile rank (PR) of BIAS to be a minimal and clinically important difference. The primary endpoint is defined as a significant difference in BIAS comparing the two groups. Differences in quality of life, Beck Depression Inventory (BDI), and modified Ranking Scale (mRS) will be evaluated as secondary outcome parameters. This trial will determine whether speech therapy with the use of Neolexon® is superior to standard logopedic therapy. Subgroups with the greatest response to Neolexon® will be described. The trial was prospectively registered on the "EU Clinical Trials Register" (NCT04080817).
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http://dx.doi.org/10.3389/fneur.2020.00294DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212356PMC
April 2020

Real-time detection and differentiation of direct oral anticoagulants (rivaroxaban and dabigatran) using modified thromboelastometric reagents.

Thromb Res 2020 06 18;190:103-111. Epub 2020 Apr 18.

Department of Anaesthesiology, University Hospital, LMU Munich, Germany. Electronic address:

Introduction: Timely measurement of direct oral anticoagulants (DOACs) is challenging, though clinically important. We tested the hypotheses, that thromboelastometry is able to detect dabigatran and rivaroxaban and discriminates between dabigatran and rivaroxaban as representatives of the two groups of DOACs.

Methods And Materials: We conducted a prospective-observational study: In-vitro dose-effect-curves for rivaroxaban and dabigatran were performed (n = 10). Ex-vivo: Patients with indication of DOAC treatment (stroke; dabigatran/rivaroxaban) were included (n = 21). Blood samples were analyzed before first intake, at first estimated peak level and at 24 h after first but before following intake and 3 h after 24 h-intake. Standard and modified thromboelastometric-assays, using low tissue factor concentrations (TFTEM) or ecarin (ECATEM) were used. Receiver-operating-characteristics-curve-analysis (ROC), regression-analysis and two-way-ANOVA were performed.

Results: In-vitro: TFTEM detected dabigatran and rivaroxaban (ROC_AUC: 0.99; sensitivity/specificity: 100%/98%) but could not discriminate. Dabigatran prolongs CT whereas rivaroxaban did not. Clotting Time (CT)-ratio TFTEM/ECATEM discriminated highly sensitive (100%) and specific (100%) between dabigatran and rivaroxaban even at very low concentrations (ROC_AUC:1.0). CT correlated with dabigatran spiked concentrations (r = 0.9985; p < 0.001) and CT (r = 0.9363; p = 0.006) with rivaroxaban. Similarly results could be demonstrated with patient data: We confirmed the performance for the differentiation of CT-ratio TFTEM/ECATEM (sensitivity 100%/specificity 100%) at any time after first intake of either DOAC.

Conclusion: The thromboelastometric tests TFTEM and ECATEM detect and differentiate rivaroxaban and dabigatran. Further investigations evaluate the other DOACs and the differentiation to phenprocoumon. However, results need to be confirmed in a larger study, and especially cut off values for differentiation need to be calculated from a larger sample size.
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http://dx.doi.org/10.1016/j.thromres.2020.04.019DOI Listing
June 2020

A Variation in FGF14 Is Associated with Downbeat Nystagmus in a Genome-Wide Association Study.

Cerebellum 2020 Jun;19(3):348-357

Department of Neurology and German Center for Vertigo and Balance Disorders, Ludwig Maximilians University, Munich Campus Großhadern, Marchioninistr. 15, 81377, Munich, Germany.

Downbeat nystagmus (DBN) is a frequent form of acquired persisting central fixation nystagmus, often associated with other cerebellar ocular signs, such as saccadic smooth pursuit or gaze-holding deficits. Despite its distinct clinical features, the underlying etiology of DBN often remains unclear. Therefore, a genome-wide association study (GWAS) was conducted in 106 patients and 2609 healthy controls of European ancestry to identify genetic variants associated with DBN. A genome-wide significant association (p < 5 × 10) with DBN was found for a variation on chromosome 13 located within the fibroblast growth factor 14 gene (FGF14). FGF14 is expressed in Purkinje cells (PCs) and a reduction leads to a decreased spontaneous firing rate and excitability of PCs, compatible with the pathophysiology of DBN. In addition, mutations in the FGF14 gene cause spinocerebellar ataxia type 27. Suggestive associations (p < 1 × 10) could be detected for 15 additional LD-independent loci, one of which is also located in the FGF14 gene. An association of a region containing the dihydrofolate reductase (DHFR) and MutS Homolog 3 (MSH3) genes on chromosome 5 was slightly below the genome-wide significance threshold. DHFR is relevant for neuronal regulation, and a dysfunction is known to induce cerebellar damage. Among the remaining twelve suggestive associations, four genes (MAST4, TPPP, FTMT, and IDS) seem to be involved in cerebral pathological processes. Thus, this GWAS analysis has identified a potential genetic contribution to idiopathic DBN, including suggestive associations to several genes involved in postulated pathological mechanisms of DBN (i.e., impaired function of cerebellar PCs).
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http://dx.doi.org/10.1007/s12311-020-01113-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7198638PMC
June 2020

Recurrent Stroke in a Young Patient with Embolic Stroke of Undetermined Source and Patent Foramen Ovale: Quo Vadis?

Case Rep Neurol 2020 Jan-Apr;12(1):45-49. Epub 2020 Jan 29.

Department of Neurology, Ludwig Maximilian University, Munich, Germany.

So far, there has been no generally accepted diagnostic and therapeutic algorithm for patients with embolic stroke of undetermined source (ESUS). As recent clinical trials on secondary stroke prevention in ESUS did not support the use of oral anticoagulation and the concept of ESUS comprises heterogeneous subgroups of patients, including a wide age range, concomitant patent foramen ovale (PFO), variable cardiovascular risk factors as well as a variable probability for atrial fibrillation (AF), an individualized clinical approach is needed. In this context, we here present a case of recurrent stroke in a young patient with ESUS and PFO. During treatment according to our Catch-up-ESUS registry study, prolonged cardiac monitoring diagnosed AF, and PFO closure was omitted.
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http://dx.doi.org/10.1159/000505180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7036551PMC
January 2020
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