Prevalence and Outcome of High-Risk QT Prolongation Recorded in the Emergency Department from an Institution-Wide QT Alert System

Anderson, Heather N.; Bos, J. Martijn; Haugaa, Kristina H.; Morlan, Bruce W.; Tarrell, Robert F.; Caraballo, Pedro J.; Ackerman, Michael J.

doi:10.1016/j.jemermed.2017.08.073

Cited by 26 publications

(18 citation statements)

References 24 publications

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“…In another follow‐up investigation, the Mayo Clinic investigators used their QTc interval prolongation alert system to determine the prevalence of QTc interval prolongation among 7522 adult patients who were admitted to the ED and who had at least one 12‐lead ECG associated with their ED visit . The QTc alert was activated (indicating QTc interval prolongation) in 93 (1.2%) patients.…”

Section: Methodsmentioning

confidence: 99%

“…About 18% of patients admitted to cardiac intensive care units (ICUs) have a QTc interval greater than 500 ms on admission, and ~42% of those patients subsequently receive QTc interval‐prolonging drugs while hospitalized . A QTc interval prolongation develops in 24–52% of adult patients hospitalized in ICUs and is present in as many as 35% of patients in emergency departments (EDs) where the prevalence of markedly prolonged QTc interval (greater than 500 ms) is 1–8% . QTc interval prolongation has been shown to be associated with increased risk for total and cardiovascular mortality …”

mentioning

confidence: 99%

“…12 A QTc interval prolongation develops in 24-52% of adult patients hospitalized in ICUs 13,14 and is present in as many as 35% of patients in emergency departments (EDs) where the prevalence of markedly prolonged QTc interval (greater than 500 ms) is 1-8%. 15,16,17 QTc interval prolongation has been shown to be associated with increased risk for total and cardiovascular mortality. 17 Numerous risk factors have been identified for QTc interval prolongation and TdP and include older age, female sex, heart failure due to reduced ejection fraction, acute myocardial infarction, electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia), bradycardia, and concurrent use of more than one QTc interval-prolonging drug.…”

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confidence: 99%

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Predictive Analytics for Identification of Patients at Risk for QT Interval Prolongation: A Systematic Review

Muensterman

Tisdale

2018

Pharmacotherapy

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Prolongation of the heart rate-corrected QT (QTc) interval increases the risk for torsade de pointes (TdP), a potentially fatal arrhythmia. The likelihood of TdP is higher in patients with risk factors that include female sex, older age, heart failure with reduced ejection fraction, hypokalemia, hypomagnesemia, concomitant administration of two or more QTc interval-prolonging medications, among others. Assessment and quantification of risk factors may facilitate prediction of patients at highest risk for developing QTc interval prolongation and TdP. Investigators have utilized the field of predictive analytics, which generates predictions using techniques including data mining, modeling, machine learning, and others, to develop methods of risk quantification and prediction of QTc interval prolongation. Predictive analytics have also been incorporated into clinical decision support (CDS) tools to alert clinicians regarding patients at increased risk of developing QTc interval prolongation. The objectives of this article are to assess the effectiveness of predictive analytics for identification of patients at risk of drug-induced QTc interval prolongation and to discuss the efficacy of incorporation of predictive analytics into CDS tools in clinical practice. A systematic review of English-language articles (human subjects only) was performed, yielding 57 articles, with an additional 4 articles identified from other sources; a total of 10 articles were included in this review. Risk scores for QTc interval prolongation have been developed in various patient populations including those in cardiac intensive care units (ICUs) and in broader populations of hospitalized or health system patients. One group developed a risk score that includes information regarding genetic polymorphisms; this score significantly predicted TdP. Development of QTc interval prolongation risk prediction models and incorporation of these models into CDS tools reduce the risk of QTc interval prolongation in cardiac ICUs and identify health system patients at increased risk for mortality. The impact of these QTc interval prolongation predictive analytics on overall patient safety outcomes, such as TdP and sudden cardiac death relative to the cost of development and implementation, requires further study.

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Section: Methodsmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Predictive Analytics for Identification of Patients at Risk for QT Interval Prolongation: A Systematic Review

Muensterman

Tisdale

2018

Pharmacotherapy

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Section: Important Consideration Beyond the Scope Of This Paper: Strementioning

confidence: 99%

“…The creation and employment of clinical decision support systems in the context of QTc prolongation and proarrhythmic liability has been advocated by various authors, and this approach certainly has potential. [118][119][120][121] Pragmatically speaking, however, many clinicians experience "warning fatigue" from the myriad warnings that can be showered on them every time a prescription decision is being considered. The CSRC, on behalf of which this manuscript has been written, is a public-private partnership coordinated under a Memorandum of Understanding between the FDA and Duke University that was signed in 2006.…”

Section: Important Consideration Beyond the Scope Of This Paper: Strementioning

confidence: 99%

Drug‐induced Proarrhythmia and Torsade de Pointes: A Primer for Students and Practitioners of Medicine and Pharmacy

Turner

Rodríguez

Mantovani

et al. 2018

The Journal of Clinical Pharma

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Multiple marketing withdrawals due to proarrhythmic concerns occurred in the United States, Canada, and the United Kingdom in the late 1980s to early 2000s. This primer reviews the clinical implications of a drug's identified proarrhythmic liability, the issues associated with these safety-related withdrawals, and the actions taken by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and by regulatory agencies in terms of changing drug development practices and introducing new nonclinical and clinical tests to asses proarrhythmic liability. ICH Guidelines S7B and E14 were released in 2005. Since then, they have been adopted by many regional regulatory authorities and have guided nonclinical and clinical proarrhythmic cardiac safety assessments during drug development. While this regulatory paradigm has been successful in preventing drugs with unanticipated potential for inducing the rare but potentially fatal polymorphic ventricular arrhythmia torsade de pointes from entering the market, it has led to the termination of drug development programs for other potentially useful medicines because of isolated results from studies with limited predictive value. Research efforts are now exploring alternative approaches to better predict potential proarrhythmic liabilities. For example, in the domain of human electrocardiographic assessments, concentration-response modeling conducted during phase 1 clinical development has recently become an accepted alternate primary methodology to the ICH E14 "thorough QT/QTc" study for defining a drug's corrected QT interval prolongation liability under certain conditions. When a drug's therapeutic benefit is considered important at a public health level but there is also an identified proarrhythmic liability that may result from administration of the single drug in certain individuals and/or drug-drug interactions, marketing approval will be accompanied by appropriate directions in the drug's prescribing information. Health-care professionals in the fields of medicine and pharmacy need to consider the prescribing information in conjunction with individual patients' clinical characteristics and concomitant medications when prescribing and dispensing such drugs.

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Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring

et al. 2018

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Currently, there is a lack of international and national guidelines or consensus documents with specific recommendations for electrocardiogram (ECG) screening and monitoring during antidepressant treatment. To make a proper estimation of the risk of cardiac arrhythmias and sudden (cardiac) death during antidepressant use, both the drug and patient-specific factors should be taken into account; however, solid evidence on how this should be done in clinical practice is lacking. Available recommendations on the management of QT(c) prolongation (with antidepressant treatment) emphasize that special attention should be given to high-risk patients; however, clinicians are in need of more concrete suggestions about how to select patients for ECG screening and monitoring. Based on a review of the literature, a Dutch multidisciplinary expert panel aimed to formulate specific guidelines to identify patients at risk for cardiac arrhythmias and sudden death by developing a consensus statement regarding ECG screening before, and monitoring during, antidepressant use. We first reviewed the literature to identify the relative risks of various risk factors on cardiac arrhythmia and sudden (cardiac) death during antidepressant use. These relative contributions of risk factors could not be determined since no systematic reviews or meta-analyses quantitatively addressed this topic. Because evidence was insufficient, additional expert opinion was used to formulate recommendations. This resulted in readily applicable recommendations for clinical practice for selection of high-risk patients for ECG screening and monitoring. ECG screening and monitoring is recommended before and following the start of QTc-prolonging antidepressants in the presence of vulnerability to QTc prolongation or two or more risk factors (age > 65 years, female sex, concomitant use of a QTc-prolonging drug or concomitant use of a drug that influences the metabolism of a QTc-prolonging drug, cardiac disease, excessive dosing and specific electrolyte disturbances).Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0649-z) contains supplementary material, which is available to authorized users.

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Prevalence and Outcome of High-Risk QT Prolongation Recorded in the Emergency Department from an Institution-Wide QT Alert System

Cited by 26 publications

References 24 publications

Predictive Analytics for Identification of Patients at Risk for QT Interval Prolongation: A Systematic Review

Predictive Analytics for Identification of Patients at Risk for QT Interval Prolongation: A Systematic Review

Drug‐induced Proarrhythmia and Torsade de Pointes: A Primer for Students and Practitioners of Medicine and Pharmacy

Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring

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