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Article ; Online: Inflammatory bowel disease in STAT1 gain-of-function immunodeficiency treated with precision medicine.

Schwärzler, Julian / Zollner, Andreas / Dolejsi, Theresa / Mayr, Lisa / Oberhuber, Georg / Zschocke, Johannes / Sturm, Wolfgang / Tancevski, Ivan / Adolph, Timon Erik / Tilg, Herbert

Gut

2023

Language	English
Publishing date	2023-08-24
Publishing country	England
Document type	Letter
ZDB-ID	80128-8
ISSN	1468-3288 ; 0017-5749
ISSN (online)	1468-3288
ISSN	0017-5749
DOI	10.1136/gutjnl-2023-330588
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Article ; Online: Smartwatch-derived heart rate variability: a head-to-head comparison with the gold standard in cardiovascular disease.

Theurl, Fabian / Schreinlechner, Michael / Sappler, Nikolay / Toifl, Michael / Dolejsi, Theresa / Hofer, Florian / Massmann, Celine / Steinbring, Christian / Komarek, Silvia / Mölgg, Kurt / Dejakum, Benjamin / Böhme, Christian / Kirchmair, Rudolf / Reinstadler, Sebastian / Bauer, Axel

European heart journal. Digital health

2023 Volume 4, Issue 3, Page(s) 155–164

Abstract: Aims: We aimed to investigate the concordance between heart rate variability (HRV) derived from the photoplethysmographic (PPG) signal of a commercially available smartwatch compared with the gold-standard high-resolution electrocardiogram (ECG)-derived ...

Abstract	Aims: We aimed to investigate the concordance between heart rate variability (HRV) derived from the photoplethysmographic (PPG) signal of a commercially available smartwatch compared with the gold-standard high-resolution electrocardiogram (ECG)-derived HRV in patients with cardiovascular disease. Methods and results: We prospectively enrolled 104 survivors of acute ST-elevation myocardial infarction, 129 patients after an ischaemic stroke, and 30 controls. All subjects underwent simultaneous recording of a smartwatch (Garmin vivoactive 4; Garmin Ltd, Olathe, KS, USA)-derived PPG signal and a high-resolution (1000 Hz) ECG for 30 min under standardized conditions. HRV measures in time and frequency domain, non-linear measures, as well as deceleration capacity (DC) were calculated according to previously published technologies from both signals. Lin's concordance correlation coefficient ( Conclusion: Smartwatch-derived HRV provides a practical alternative with excellent accuracy compared with ECG-based HRV for global markers and those characterizing lower frequency components. However, caution is warranted with HRV markers that predominantly assess short-term variability.
Language	English
Publishing date	2023-03-23
Publishing country	England
Document type	Journal Article
ISSN	2634-3916
ISSN (online)	2634-3916
DOI	10.1093/ehjdh/ztad022
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Article ; Online: Adult T-cells impair neonatal cardiac regeneration.

Dolejsi, Theresa / Delgobo, Murilo / Schuetz, Thomas / Tortola, Luigi / Heinze, Katrin G / Hofmann, Ulrich / Frantz, Stefan / Bauer, Axel / Ruschitzka, Frank / Penninger, Josef M / Campos Ramos, Gustavo / Haubner, Bernhard J

European heart journal

2022 Volume 43, Issue 28, Page(s) 2698–2709

Abstract: Aims: Newborn mice and humans display transient cardiac regenerative potential that rapidly declines postnatally. Patients who survive a myocardial infarction (MI) often develop chronic heart failure due to the heart's poor regeneration capacity. We ... ...

Abstract	Aims: Newborn mice and humans display transient cardiac regenerative potential that rapidly declines postnatally. Patients who survive a myocardial infarction (MI) often develop chronic heart failure due to the heart's poor regeneration capacity. We hypothesized that the cardiac 'regenerative-to-scarring' transition might be driven by the perinatal shifts observed in the circulating T-cell compartment. Methods and results: Post-MI immune responses were characterized in 1- (P1) vs. 7-day-old (P7) mice subjected to left anterior descending artery ligation. Myocardial infarction induced robust early inflammatory responses (36 h post-MI) in both age groups, but neonatal hearts exhibited rapid resolution of inflammation and full functional recovery. The perinatal loss of myocardial regenerative capacity was paralleled by a baseline increase in αβ-T cell (CD4+ and CD8+) numbers. Strikingly, P1-infarcted mice reconstituted with adult T-cells shifted to an adult-like healing phenotype, marked by irreversible cardiac functional impairment and increased fibrosis. Infarcted neonatal mice harbouring adult T-cells also had more monocyte-derived macrophage recruitment, as typically seen in adults. At the transcriptome level, infarcted P1 hearts that received isolated adult T-cells showed enriched gene sets linked to fibrosis, inflammation, and interferon-gamma (IFN-γ) signalling. In contrast, newborn mice that received isolated Ifng-/- adult T-cells prior to MI displayed a regenerative phenotype that resembled that of its age-matched untreated controls. Conclusion: Physiological T-cell development or adoptive transfer of adult IFN-γ-producing T-cells into neonates contributed to impaired cardiac regeneration and promoted irreversible structural and functional cardiac damage. These findings reveal a trade-off between myocardial regenerative potential and the development of T-cell competence.
MeSH term(s)	Adult ; Animals ; Disease Models, Animal ; Female ; Fibrosis ; Humans ; Inflammation/pathology ; Interferon-gamma ; Mice ; Myocardial Infarction ; Myocardium/pathology ; Myocytes, Cardiac/physiology ; Pregnancy ; Regeneration/physiology
Chemical Substances	Interferon-gamma (82115-62-6)
Language	English
Publishing date	2022-04-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	603098-1
ISSN	1522-9645 ; 0195-668X
ISSN (online)	1522-9645
ISSN	0195-668X
DOI	10.1093/eurheartj/ehac153
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Zs.A 1563: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial.

Rizas, Konstantinos D / Freyer, Luisa / Sappler, Nikolay / von Stülpnagel, Lukas / Spielbichler, Peter / Krasniqi, Aresa / Schreinlechner, Michael / Wenner, Felix N / Theurl, Fabian / Behroz, Amira / Eiffener, Elodie / Klemm, Mathias P / Schneidewind, Annika / Zens, Martin / Dolejsi, Theresa / Mansmann, Ulrich / Massberg, Steffen / Bauer, Axel

Nature medicine

2022 Volume 28, Issue 9, Page(s) 1823–1830

Abstract: Digital smart devices have the capability of detecting atrial fibrillation (AF), but the efficacy of this type of digital screening has not been directly compared to usual care for detection of treatment-relevant AF. In the eBRAVE-AF trial ( NCT04250220 ) ...

Abstract	Digital smart devices have the capability of detecting atrial fibrillation (AF), but the efficacy of this type of digital screening has not been directly compared to usual care for detection of treatment-relevant AF. In the eBRAVE-AF trial ( NCT04250220 ), we randomly assigned 5,551 policyholders of a German health insurance company who were free of AF at baseline (age 65 years (median; interquartile range (11) years, 31% females)) to digital screening (n = 2,860) or usual care (n = 2,691). In this siteless trial, for digital screening, participants used a certified app on their own smartphones to screen for irregularities in their pulse waves. Abnormal findings were evaluated by 14-day external electrocardiogram (ECG) loop recorders. The primary endpoint was newly diagnosed AF within 6 months treated with oral anti-coagulation by an independent physician not involved in the study. After 6 months, participants were invited to cross-over for a second study phase with reverse assignment for secondary analyses. The primary endpoint of the trial was met, as digital screening more than doubled the detection rate of treatment-relevant AF in both phases of the trial, with odds ratios of 2.12 (95% confidence interval (CI), 1.19-3.76; P = 0.010) and 2.75 (95% CI, 1.42-5.34; P = 0.003) in the first and second phases, respectively. This digital screening technology provides substantial benefits in detecting AF compared to usual care and has the potential for broad applicability due to its wide availability on ordinary smartphones. Future studies are needed to test whether digital screening for AF leads to better treatment outcomes.
MeSH term(s)	Atrial Fibrillation/diagnosis ; Atrial Fibrillation/drug therapy ; Child ; Delivery of Health Care ; Electrocardiography ; Female ; Humans ; Male ; Mass Screening ; Smartphone
Language	English
Publishing date	2022-08-28
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-022-01979-w
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Zs.A 4212: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MG 39: Show issues

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Article ; Online: Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial.

Freyer, Luisa / von Stülpnagel, Lukas / Spielbichler, Peter / Sappler, Nikolay / Wenner, Felix / Schreinlechner, Michael / Krasniqi, Aresa / Behroz, Amira / Eiffener, Elodie / Zens, Martin / Dolejsi, Theresa / Massberg, Steffen / Rizas, Konstantinos D / Bauer, Axel

American heart journal

2021 Volume 241, Page(s) 26–34

Abstract: Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison ...

Abstract	Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison with routine symptom-based screening is unknown. eBRAVE-AF is an investigator-initiated, digital, prospective, randomized, siteless, open-label, cross-over study to evaluate an e-health-based strategy for detection of AF in a real-world setting. 67,488 policyholders of a large German health insurance company (Versicherungskammer Bayern, Germany) selected by age ≥ 50 years and a CHA
MeSH term(s)	Asymptomatic Diseases/epidemiology ; Atrial Fibrillation/complications ; Atrial Fibrillation/diagnosis ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/epidemiology ; Cross-Over Studies ; Female ; Germany/epidemiology ; Humans ; Insurance, Health/statistics & numerical data ; Male ; Middle Aged ; Mobile Applications ; Monitoring, Ambulatory/instrumentation ; Monitoring, Ambulatory/methods ; Randomized Controlled Trials as Topic/methods ; Smartphone ; Telemedicine/instrumentation ; Telemedicine/methods
Language	English
Publishing date	2021-07-09
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2021.06.008
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Article ; Online: Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

Bauer, Axel / Sappler, Nikolay / von Stülpnagel, Lukas / Klemm, Mathias / Schreinlechner, Michael / Wenner, Felix / Schier, Johannes / Al Tawil, Amani / Dolejsi, Theresa / Krasniqi, Aresa / Eiffener, Elodie / Bongarth, Christa / Stühlinger, Markus / Huemer, Martin / Gori, Tommaso / Wakili, Reza / Sahin, Riza / Schwinger, Robert / Lutz, Matthias /

The Lancet. Digital health

2021 Volume 4, Issue 2, Page(s) e105–e116

Abstract: Background: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in ... ...

Abstract	Background: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. Methods: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36-50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg Findings: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57-73]); left ventricular ejection fraction 45% [40-48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40-11·78]; p<0·001). An improved detection rate by implantable cardiac monitors was observed for all types of serious arrhythmic events: atrial fibrillation 6 min or longer (47 [23%] patients vs 11 [6%] patients; p<0·001), atrioventricular block class IIb or higher (14 [7%] vs 0; p<0·001) and ventricular tachycardia or ventricular fibrillation (nine [4%] patients vs two [1%] patients; p=0·054). Interpretation: In patients at high risk after myocardial infarction and cardiac autonomic dysfunction but only moderately reduced left ventricular ejection fraction, telemedical monitoring with implantable cardiac monitors was highly effective in early detection of subclinical, prognostically relevant serious arrhythmic events. Funding: German Centre for Cardiovascular Research (DZHK) and Medtronic Bakken Research Center.
MeSH term(s)	Aged ; Arrhythmias, Cardiac/diagnosis ; Austria ; Female ; Germany ; Humans ; Male ; Middle Aged ; Monitoring, Physiologic/methods ; Myocardial Infarction/complications ; Myocardial Infarction/physiopathology ; Prospective Studies ; Risk Assessment/methods ; Telemedicine/methods
Language	English
Publishing date	2021-12-03
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	2589-7500
ISSN (online)	2589-7500
DOI	10.1016/S2589-7500(21)00253-3
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Article ; Online: Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial.

Bauer, Axel / Schreinlechner, Michael / Sappler, Nikolay / Dolejsi, Theresa / Tilg, Herbert / Aulinger, Benedikt A / Weiss, Günter / Bellmann-Weiler, Rosa / Adolf, Christian / Wolf, Dominik / Pirklbauer, Markus / Graziadei, Ivo / Gänzer, Hannes / von Bary, Christian / May, Andreas E / Wöll, Ewald / von Scheidt, Wolfgang / Rassaf, Tienush / Duerschmied, Daniel /

The Lancet. Respiratory medicine

2021 Volume 9, Issue 8, Page(s) 863–872

Abstract: Background: SARS-CoV-2 entry in human cells depends on angiotensin-converting enzyme 2, which can be upregulated by inhibitors of the renin-angiotensin system (RAS). We aimed to test our hypothesis that discontinuation of chronic treatment with ACE- ... ...

Abstract	Background: SARS-CoV-2 entry in human cells depends on angiotensin-converting enzyme 2, which can be upregulated by inhibitors of the renin-angiotensin system (RAS). We aimed to test our hypothesis that discontinuation of chronic treatment with ACE-inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) mitigates the course o\f recent-onset COVID-19. Methods: ACEI-COVID was a parallel group, randomised, controlled, open-label trial done at 35 centres in Austria and Germany. Patients aged 18 years and older were enrolled if they presented with recent symptomatic SARS-CoV-2 infection and were chronically treated with ACEIs or ARBs. Patients were randomly assigned 1:1 to discontinuation or continuation of RAS inhibition for 30 days. Primary outcome was the maximum sequential organ failure assessment (SOFA) score within 30 days, where death was scored with the maximum achievable SOFA score. Secondary endpoints were area under the death-adjusted SOFA score (AUC Findings: Between April 20, 2020, and Jan 20, 2021, 204 patients (median age 75 years [IQR 66-80], 37% females) were randomly assigned to discontinue (n=104) or continue (n=100) RAS inhibition. Within 30 days, eight (8%) of 104 died in the discontinuation group and 12 (12%) of 100 patients died in the continuation group (p=0·42). There was no significant difference in the primary endpoint between the discontinuation and continuation group (median [IQR] maximum SOFA score 0·00 (0·00-2·00) vs 1·00 (0·00-3·00); p=0·12). Discontinuation was associated with a significantly lower AUC Interpretation: Discontinuation of RAS-inhibition in COVID-19 had no significant effect on the maximum severity of COVID-19 but may lead to a faster and better recovery. The decision to continue or discontinue should be made on an individual basis, considering the risk profile, the indication for RAS inhibition, and the availability of alternative therapies and outpatient monitoring options. Funding: Austrian Science Fund and German Center for Cardiovascular Research.
MeSH term(s)	Angiotensin Receptor Antagonists/administration & dosage ; Angiotensin Receptor Antagonists/adverse effects ; Angiotensin-Converting Enzyme 2/metabolism ; Angiotensin-Converting Enzyme Inhibitors/administration & dosage ; Angiotensin-Converting Enzyme Inhibitors/adverse effects ; Area Under Curve ; COVID-19/epidemiology ; COVID-19/metabolism ; COVID-19/therapy ; Female ; Humans ; Hypertension/drug therapy ; Hypertension/epidemiology ; Male ; Middle Aged ; Organ Dysfunction Scores ; Outcome and Process Assessment, Health Care ; Renin-Angiotensin System/drug effects ; Renin-Angiotensin System/physiology ; Risk Adjustment/methods ; SARS-CoV-2/drug effects ; SARS-CoV-2/physiology ; Severity of Illness Index ; Withholding Treatment/statistics & numerical data
Chemical Substances	Angiotensin Receptor Antagonists ; Angiotensin-Converting Enzyme Inhibitors ; ACE2 protein, human (EC 3.4.17.23) ; Angiotensin-Converting Enzyme 2 (EC 3.4.17.23)
Language	English
Publishing date	2021-06-11
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2686754-0
ISSN	2213-2619 ; 2213-2600
ISSN (online)	2213-2619
ISSN	2213-2600
DOI	10.1016/S2213-2600(21)00214-9
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Article ; Online: Inflammatory bowel disease in STAT1 gain-of-function immunodeficiency treated with precision medicine.

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Article ; Online: Smartwatch-derived heart rate variability: a head-to-head comparison with the gold standard in cardiovascular disease.

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Article ; Online: Adult T-cells impair neonatal cardiac regeneration.

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Article ; Online: Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial.

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Article ; Online: Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial.

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Article ; Online: Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

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Article ; Online: Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial.

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