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, Jahrgang 4, Nr. 2, 02.2022, S. e105-e116.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
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 -