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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

Standard

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; Luik, Armin; Gessler, Nele; Clemmensen, Peter; Linke, Axel; Maier, Lars S; Hinterseer, Martin; Busch, Mathias C; Blaschke, Florian; Sack, Stefan; Lennerz, Carsten; Licka, Manuela; Tilz, Roland R; Ukena, Christian; Ehrlich, Joachim R; Zabel, Markus; Schmidt, Georg; Mansmann, Ulrich; Kääb, Stefan; Rizas, Konstantinos D; Massberg, Steffen; SMART-MI-DZHK9 investigators.

In: LANCET DIGIT HEALTH, Vol. 4, No. 2, 02.2022, p. e105-e116.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Bauer, A, Sappler, N, von Stülpnagel, L, Klemm, M, Schreinlechner, M, Wenner, F, Schier, J, Al Tawil, A, Dolejsi, T, Krasniqi, A, Eiffener, E, Bongarth, C, Stühlinger, M, Huemer, M, Gori, T, Wakili, R, Sahin, R, Schwinger, R, Lutz, M, Luik, A, Gessler, N, Clemmensen, P, Linke, A, Maier, LS, Hinterseer, M, Busch, MC, Blaschke, F, Sack, S, Lennerz, C, Licka, M, Tilz, RR, Ukena, C, Ehrlich, JR, Zabel, M, Schmidt, G, Mansmann, U, Kääb, S, Rizas, KD, Massberg, S & SMART-MI-DZHK9 investigators 2022, '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', LANCET DIGIT HEALTH, vol. 4, no. 2, pp. e105-e116. https://doi.org/10.1016/S2589-7500(21)00253-3

APA

Bauer, A., Sappler, N., von Stülpnagel, L., Klemm, M., Schreinlechner, M., Wenner, F., Schier, J., Al Tawil, A., Dolejsi, T., Krasniqi, A., Eiffener, E., Bongarth, C., Stühlinger, M., Huemer, M., Gori, T., Wakili, R., Sahin, R., Schwinger, R., Lutz, M., ... SMART-MI-DZHK9 investigators (2022). 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. LANCET DIGIT HEALTH, 4(2), e105-e116. https://doi.org/10.1016/S2589-7500(21)00253-3

Vancouver

Bauer A, Sappler N, von Stülpnagel L, Klemm M, Schreinlechner M, Wenner F et al. 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. LANCET DIGIT HEALTH. 2022 Feb;4(2):e105-e116. https://doi.org/10.1016/S2589-7500(21)00253-3

Bibtex

@article{6b738eacf6504c4eaf11465dac76e0b7,
title = "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",
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 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488.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.",
keywords = "Aged, Arrhythmias, Cardiac/diagnosis, Austria, Female, Germany, Humans, Male, Middle Aged, Monitoring, Physiologic/methods, Myocardial Infarction/complications, Prospective Studies, Risk Assessment/methods, Telemedicine/methods",
author = "Axel Bauer and Nikolay Sappler and {von St{\"u}lpnagel}, Lukas and Mathias Klemm and Michael Schreinlechner and Felix Wenner and Johannes Schier and {Al Tawil}, Amani and Theresa Dolejsi and Aresa Krasniqi and Elodie Eiffener and Christa Bongarth and Markus St{\"u}hlinger and Martin Huemer and Tommaso Gori and Reza Wakili and Riza Sahin and Robert Schwinger and Matthias Lutz and Armin Luik and Nele Gessler and Peter Clemmensen and Axel Linke and Maier, {Lars S} and Martin Hinterseer and Busch, {Mathias C} and Florian Blaschke and Stefan Sack and Carsten Lennerz and Manuela Licka and Tilz, {Roland R} and Christian Ukena and Ehrlich, {Joachim R} and Markus Zabel and Georg Schmidt and Ulrich Mansmann and Stefan K{\"a}{\"a}b and Rizas, {Konstantinos D} and Steffen Massberg and {SMART-MI-DZHK9 investigators}",
note = "Copyright {\textcopyright} 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.",
year = "2022",
month = feb,
doi = "10.1016/S2589-7500(21)00253-3",
language = "English",
volume = "4",
pages = "e105--e116",
journal = "LANCET DIGIT HEALTH",
issn = "2589-7500",
publisher = "Elsevier Ltd.",
number = "2",

}

RIS

TY - JOUR

T1 - 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

AU - Bauer, Axel

AU - Sappler, Nikolay

AU - von Stülpnagel, Lukas

AU - Klemm, Mathias

AU - Schreinlechner, Michael

AU - Wenner, Felix

AU - Schier, Johannes

AU - Al Tawil, Amani

AU - Dolejsi, Theresa

AU - Krasniqi, Aresa

AU - Eiffener, Elodie

AU - Bongarth, Christa

AU - Stühlinger, Markus

AU - Huemer, Martin

AU - Gori, Tommaso

AU - Wakili, Reza

AU - Sahin, Riza

AU - Schwinger, Robert

AU - Lutz, Matthias

AU - Luik, Armin

AU - Gessler, Nele

AU - Clemmensen, Peter

AU - Linke, Axel

AU - Maier, Lars S

AU - Hinterseer, Martin

AU - Busch, Mathias C

AU - Blaschke, Florian

AU - Sack, Stefan

AU - Lennerz, Carsten

AU - Licka, Manuela

AU - Tilz, Roland R

AU - Ukena, Christian

AU - Ehrlich, Joachim R

AU - Zabel, Markus

AU - Schmidt, Georg

AU - Mansmann, Ulrich

AU - Kääb, Stefan

AU - Rizas, Konstantinos D

AU - Massberg, Steffen

AU - SMART-MI-DZHK9 investigators

N1 - Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

PY - 2022/2

Y1 - 2022/2

N2 - 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 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488.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.

AB - 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 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488.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.

KW - Aged

KW - Arrhythmias, Cardiac/diagnosis

KW - Austria

KW - Female

KW - Germany

KW - Humans

KW - Male

KW - Middle Aged

KW - Monitoring, Physiologic/methods

KW - Myocardial Infarction/complications

KW - Prospective Studies

KW - Risk Assessment/methods

KW - Telemedicine/methods

U2 - 10.1016/S2589-7500(21)00253-3

DO - 10.1016/S2589-7500(21)00253-3

M3 - SCORING: Journal article

C2 - 35090674

VL - 4

SP - e105-e116

JO - LANCET DIGIT HEALTH

JF - LANCET DIGIT HEALTH

SN - 2589-7500

IS - 2

ER -