Key result
Telemedical monitoring with implantable cardiac monitors significantly increased the detection of serious arrhythmic events compared to conventional follow-up (30% vs 6%; HR 6.33, 95% CI 3.40-11.78).
Why the study?
Cardiac autonomic dysfunction post-myocardial infarction identifies high-risk patients despite moderately reduced LVEF, but whether implantable cardiac monitors improve early detection of serious arrhythmias was unknown.
Does telemedical monitoring with implantable cardiac monitors improve the detection of serious arrhythmic events in high-risk patients after myocardial infarction with autonomic dysfunction?
RCT (n=400)
Open-label
1:1
Yes
Does telemedical monitoring with implantable cardiac monitors improve the detection of serious arrhythmic events in high-risk patients after myocardial infarction with autonomic dysfunction?
Hazard Ratio: 6.33 (95% CI 3.4–11.78)
Absolute Event Rate: 30% vs 6%
p-value: p=<0.001
In post-MI patients with autonomic dysfunction and moderately reduced LVEF, implantable cardiac monitors significantly increased the detection of serious subclinical arrhythmias compared to conventional follow-up.
May support ICM telemonitoring for early arrhythmia detection post-MI; leaves open effects on outcomes pending randomized confirmation.
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: ) 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.
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Bauer et al. (2022) conducted an RCT in Myocardial infarction with autonomic dysfunction (n=400). Telemedical monitoring with implantable cardiac monitors vs. Conventional follow-up was evaluated on Time to detection of serious arrhythmic events (HR 6.33, 95% CI 3.40-11.78, p=<0.001). Telemedical monitoring with implantable cardiac monitors significantly increased the detection of serious arrhythmic events compared to conventional follow-up (30% vs 6%; HR 6.33, 95% CI 3.40-11.78).
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