Defibrillator implantation early after myocardial infarction
Open accessAbstract
BACKGROUND: The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone. METHODS: This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. RESULTS: During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). CONCLUSIONS: Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)
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Randomized trials in patients stratified for ICD implantation based on HRV failed to demonstrate the usefulness of HRV in predicting benefit from ICD therapy.
“Despite data linking decreased HRV with increased mortality, randomized trials in patients stratified for ICD implantation based on this parameter failed to demonstrate the usefulness of HRV in predicting benefit from ICD therapy (Hohnloser et al., 2004;Steinbeck et al., 2009).”
From 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry (2017) · cites this paper as Steinbeck et al., 2009
The Results and Discussion (page not provided) report that the randomized IRIS trial found no overall survival benefit from early ICD implantation. But patients were selected using admission heart rate, LVEF, and nonsustained ventricular tachycardia—not heart rate variability (HRV). This trial therefore does not establish whether HRV predicts benefit from ICD therapy. (LLM, conf=0.89)
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References 35 · Cited by 690
Research works printed but not linked: 3
- [17]17. mann T, et al. Risk stratification follow- ing myocardial infarction in the throm- bolytic era: a two-step strategy using noninvasive and invasive methods. J Am Coll Cardiol 1999;33:131-8.
- [20]20. Steinbeck G, Andresen D, Senges J, 17. Hoffmann E, Seidl KH, Brachmann J. Im- mediate Risk-Stratification Improves Sur- vival (IRIS): study protocol. Europace 2004; 6:392-9.
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- Authors
- Steinbeck, G., Andresen, D., Seidl, K., Brachmann, J., Hoffmann, E., Wojciechowski, D., Kornacewicz-Jach, Z., Sredniawa, B., Lupkovics, G., Hofgärtner, F., Lubinski, A., Rosenqvist, M., Habets, A., Wegscheider, K., & Senges, J.
- Affiliations
- Ludwig-Maximilians-Universität München (DE)
- Klinikum Ludwigshafen (DE)
- Klinikum Coburg (DE)
- München Klinik Bogenhausen (DE)
- Kistarcsai Flór Ferenc Kórház (HU)
- Karolinska Institutet (SE)
- Medtronic (Netherlands) (NL)
- University Medical Center Hamburg-Eppendorf (DE)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-10-08
- Volume
- 361
- Issue
- 15
- Pages
- 1427-1436
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2008188455
- Cited by
- 690
- References
- 35
- Citations by year
- 2026: 15 · 2025: 13 · 2024: 20 · 2023: 27 · 2022: 34 · 2021: 43 · 2020: 36 · 2019: 40 · 2018: 41 · 2017: 63 · 2016: 43 · 2015: 47 · 2014: 39 · 2013: 54 · 2012: 58
- FWCI
- 37.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Repository of the Academy's Library (Library of the Hungarian Academy of Sciences) (acceptedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- Funders
- AstraZeneca
- Boston Scientific Corporation
- St. Jude Medical
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Emergency Medicine › Cardiac Arrest and Resuscitation
- Keywords
- implantable cardioverter-defibrillator, myocardial infarction, sudden cardiac death, all-cause mortality, non-sustained ventricular tachycardia, reduced left ventricular ejection fraction, medical therapy, risk stratification, primary prevention of sudden cardiac death, Holter monitoring
- MeSH terms
- Aged, Cause of Death, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Infarction, Registries, Risk, Time Factors, Survival Rate, Proportional Hazards Models, Death, Sudden, Cardiac, Defibrillators, Implantable
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