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| __NOTOC__ | | __NOTOC__ |
| {{Sudden cardiac death}} | | {{Sudden cardiac death}} |
| {{CMG}} | | {{CMG}} {{AE}} {{Sara.Zand}} {{EdzelCo}} |
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| ==Overview== | | ==Overview== |
| | | *[[Sudden cardiac death]] ([[SCD]]) is a natural, rapid, unexpected [[death]] secondary to [[cardiac]] causes within an hour of [[symptom onset]] in witnessed scenarios, and within a day in unwitnessed cases <ref name="pmid36844932">{{cite journal| author=Calvo Cuervo D| title=Comment on the ESC Guidelines 2022 for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. | journal=Eur Cardiol | year= 2023 | volume= 18 | issue= | pages= e01 | pmid=36844932 | doi=10.15420/ecr.2022.48 | pmc=9947934 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=36844932 }} </ref>. |
| ==Historical Perspective==
| | * [[Sudden cardiac arrest]] ([[SCA]]) is the unexpected cessation of pumping [[blood]] into vital [[organs]] due to electrical disturbance in the pathway of [[sinoatrial node]] ([[SA node]]), [[atrioventricular node]] ([[AV node]]), [[His Purkinje fibers]] or [[cardiac]] pumping failure due to [[cardiogenic shock]], massive [[pulmonary thromboembolism]],[[fulminant myocarditis]], and [[ruptured left ventricular free wall]]. |
| *[Disease name] was first discovered by [scientist name], a [nationality + occupation], in [year] during/following [event]. | | *Without any intervention for immediate restoration of the [[circulation]], [[biologic death]] will happen minutes to weeks after [[cardiac arrest]]. [[Sudden cardiac death]] in the United States ranges from 300,000 to 400,000 which is 50% of all causes of deaths. <ref name="pmid21513133">{{cite journal| author=Haissaguerre M, Hocini M, Sacher F, Shah A| title=[Sudden cardiac death, a major scientific challenge]. | journal=Bull Acad Natl Med | year= 2010 | volume= 194 | issue= 6 | pages= 983-93; discussion 993-5 | pmid=21513133 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=21513133 }} </ref> In-hospital [[cardiac arrest]] happens in 290,000 adults every year in the United States. The most common cause of [[sudden cardiac death]] is [[coronary artery disease]] and [[atherosclerosis]]. The presence of underlying disorders such as [[malignancy]] or [[liver disease]] at the time of [[ cardiac arrest]] makes the condition worse. Patients with [[acute myocardial infarction]] and [[in-hospital cardiac arrest]] with shockable [[rhythm]] have a better prognosis. Post [[cardiopulmonary resuscitation]] state management should be focused on [[neurologic]] [[complications]], [[hemodynamic]] stability, and [[respiratory]] support. |
| *In [year], [gene] mutations were first identified in the pathogenesis of [disease name].
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| *In [year], the first [discovery] was developed by [scientist] to treat/diagnose [disease name].
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|
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| ==Classification==
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| *[Disease name] may be classified according to [classification method] into [number] subtypes/groups:
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| :*[group1]
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| :*[group2]
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| :*[group3]
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| *Other variants of [disease name] include [disease subtype 1], [disease subtype 2], and [disease subtype 3].
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|
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| ==Pathophysiology== | |
| *The pathogenesis of [disease name] is characterized by [feature1], [feature2], and [feature3].
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| *The [gene name] gene/Mutation in [gene name] has been associated with the development of [disease name], involving the [molecular pathway] pathway.
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| *On gross pathology, [feature1], [feature2], and [feature3] are characteristic findings of [disease name].
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| *On microscopic histopathological analysis, [feature1], [feature2], and [feature3] are characteristic findings of [disease name]. | |
| {{Family tree/start}}
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| {{Family tree | | | | A01 |-| A02 |-|A03|-|A04| |A01=
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| '''Structural and functional causes of [[sudden cardiac death]]'''
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| * [[Coronary artery disease]]
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| * [[Cardiomyopathy]]
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| * [[Valvular heart disease]]
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| * [[Congenital heart disease]]
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| * [[Primary electrical abnormality]]
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| * [[Channelopathy]]|A02=
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| '''Trigger'''
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| *[[Myocardial infarction]]
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| *[[Myocardial ischemia]]/[[reperfusion]]
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| *Emotional, physical stress
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| *[[Hemodynamic decompensation]]
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| *[[Electrolyte imbalance]]
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| *[[Hypoxemia]],[[acidosis]] | |
| *[[Neurophysiological interactions]]
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| *[[Drugs]]|
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| A03='''[[Arrhythmia]] mechanism'''
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| *[[Re-entry]]
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| *[[Automaticity]]
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| *[[Triggered activity]]
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| *[[Conduction block]]
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| *|A04=
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| '''Fatal [[arrhythmia]]'''
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| *Monomorphic [[ventricular tachycardia]]
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| *Polymorphic [[ventricular tachycardia]]
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| *[[Ventricular fibrillation]]
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| *Profound [[bradycardia]]
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| *[[Asystole]]
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| *[[Pulseless electrical activity]]|}}|
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| {{Family tree/end}}
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| ==Causes== | |
| Disease name] may be caused by [cause1], [cause2], or [cause3].
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| OR
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| Common causes of [disease] include [cause1], [cause2], and [cause3].
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| OR
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| The most common cause of [disease name] is [cause 1]. Less common causes of [disease name] include [cause 2], [cause 3], and [cause 4]. | |
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| OR
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| The cause of [disease name] has not been identified. To review risk factors for the development of [disease name], click [[Pericarditis causes#Overview|here]]. | |
| ==Differentiating Cardiac sudden death from non-cardiac causes==
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| For further information about the differential diagnosis, click [[Disease_Name differential diagnosis|here]].
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| {| class="wikitable"
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| |-
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| |-bgcolor="PeachPuff"
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| | '''Cardiac causes of [[sudden death]]'''
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| |bgcolor="PeachPuff"|
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| '''Non cardiac causes of [[sudden death]]:'''
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| |-
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| |-bgcolor="PeachPuff"
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| *Acute [[aortic insufficiency]]
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| *[[Acute coronary syndrome]]
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| *[[Aortic dissection]]
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| *[[Aortic stenosis]]
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| *[[Arrhythmogenic right ventricular dysplasia]]
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| *[[Brugada syndrome]]
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| *[[Cardiac tamponade]]
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| *[[Cardiomyopathy]]
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| *[[Catecholaminergic polymorphic ventricular tachycardia]]
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| *[[Commotio cordis]]
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| *[[Complete heart block]]
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| *[[Congenital heart disease]]
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| *[[Congestive heart failure]]
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| *[[Coronary artery disease]]
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| *[[Dilated cardiomyopathy]]
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| *[[Hypertrophic cardiomyopathy]]
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| *[[Jervell and Lange-Nielsen syndrome]]
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| * [[Long QT syndrome]], both [[congenital]] and acquired
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| *[[Lyme disease]]
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| *[[Mitral valve prolapse]]
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| *[[Myocarditis]]
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| *[[Naxos disease]]
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| *[[Noncompaction Cardiomyopathy]]
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| *[[Papillary muscle rupture]]
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| *[[Prolonged Q-T Interval Syndrome]]
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| *[[Pulmonary embolism]]
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| *[[Romano-Ward syndrome ]]
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| *[[Ruptured abdominal aortic aneurysm]]
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| *[[Prosthetic valve dysfunction]]
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| *[[Short QT syndrome]]
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| *[[Short QT syndrome type 1]]
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| *[[Short QT syndrome type 2]]
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| *[[Short QT syndrome type 3]]
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| *[[Short QT syndrome type 4]]
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| *[[Short QT syndrome type 5]]
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| *[[Sick sinus syndrome]]
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| *[[ST Elevation Myocardial Infarction]]
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| *[[Stokes-Adams Syndrome]]
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| *[[Sudden Infant Death Syndrome]]
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| *[[Timothy syndrome ]]
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| *[[Uhl anomaly ]]
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| *[[Valvular Heart Disease]]
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| *[[Ventricular rupture]]
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| *[[Wolf-Parkinson-White syndrome]] with rapid conduction
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| |bgcolor="PeachPuff"|
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| *3-methylglutaconic aciduria, type 1
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| *Alpha-ketoglutarate dehydrogenase deficiency
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| *Amniotic fluid syndrome
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| *Arterial dissections with lentiginosis
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| *[[Anaphylaxis]]
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| *[[Aneurysm]]
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| *[[Apoplexy]]
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| *[[Appendicitis]]
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| *[[Asphyxia]]
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| *Birth injury
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| *[[Bleeding]] excessive
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| *Childbirth hemorrhage
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| *Diabetic ketoacidosis - typically from undiagnosed diabetes
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| *[[Drug allergy]]
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| *[[Drug]] [[overdose]]
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| *[[Encephalitis]]
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| *[[Fetal death]]
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| *[[Food allergy]]
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| *[[Gastrointestinal bleeding]]
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| *Homicide
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| *Hyperbilirubinemia transient, familial, neonatal
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| *[[Hypercalcemia]]
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| *[[Hypercapnia]]
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| *[[Hyperkalemia]]
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| *[[Hypokalemia]]
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| *[[Hypoxia]]
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| *[[Injury]]
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| *[[Insect bite]]
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| *[[Intracranial hemmorhage]]
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| *[[Marfan syndrome ]]
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| *[[Meningitis]]
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| *[[Meningococcal disease]]
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| *Motor Vehicle accident
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| *Myasthenia Gravis
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| *[[Neurocysticercosis ]]
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| *Opioid [[overdose]]
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| *[[Oxycontin]] [[overdose]]
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| *Pain killer [[overdose]]
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| *[[Pickwickian Syndrome]]
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| *[[Poisoning]]
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| *[[Pulmonary embolism]]
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| *[[Retroperitoneal bleed]]
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| *[[Sepsis syndrome]]
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| *[[Shock]]
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| *[[Sleep apnea ]]
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| *[[Snake bite]]
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| *[[Status asthmaticus]]
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| *[[Stillbirth]]
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| *[[Stroke]]
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| *[[Subarachnoid hemorrhage]]
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| *[[Sudden Infant Death Syndrome]]
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| *[[Suicide]]
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| *Sleeping pill [[overdose]]
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| *Toxic/metabolic disturbances
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| *Tranquilizer addiction
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| *[[Tension pneumothorax]]
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| * Toxic/metabolic disturbances
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| *[[Thyrotoxicosis]]
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| *[[Toxic shock syndrome]]
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| *[[Transfusion reaction]]
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| *[[Venom]]
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| |-
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| |}
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| ==Epidemiology and Demographics==
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| * The prevalence of [[sudden cardiac death]] is approximately 1.40 per 100,000 individuals in women to 6.68 per 100.000 individuals in men worldwide.<ref name="PrioriBlomström-Lundqvist2015">{{cite journal|last1=Priori|first1=Silvia G.|last2=Blomström-Lundqvist|first2=Carina|last3=Mazzanti|first3=Andrea|last4=Blom|first4=Nico|last5=Borggrefe|first5=Martin|last6=Camm|first6=John|last7=Elliott|first7=Perry Mark|last8=Fitzsimons|first8=Donna|last9=Hatala|first9=Robert|last10=Hindricks|first10=Gerhard|last11=Kirchhof|first11=Paulus|last12=Kjeldsen|first12=Keld|last13=Kuck|first13=Karl-Heinz|last14=Hernandez-Madrid|first14=Antonio|last15=Nikolaou|first15=Nikolaos|last16=Norekvål|first16=Tone M.|last17=Spaulding|first17=Christian|last18=Van Veldhuisen|first18=Dirk J.|title=2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death|journal=European Heart Journal|volume=36|issue=41|year=2015|pages=2793–2867|issn=0195-668X|doi=10.1093/eurheartj/ehv316}}</ref>
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| * In 2015, the incidence of adult in-hospital [[cardiac arrests]] was estimated to be 970 cases per 100,000 individuals in the united states.<ref name="HolmbergRoss2019">{{cite journal|last1=Holmberg|first1=Mathias J.|last2=Ross|first2=Catherine E.|last3=Fitzmaurice|first3=Garrett M.|last4=Chan|first4=Paul S.|last5=Duval-Arnould|first5=Jordan|last6=Grossestreuer|first6=Anne V.|last7=Yankama|first7=Tuyen|last8=Donnino|first8=Michael W.|last9=Andersen|first9=Lars W.|last10=Chan|first10=Paul|last11=Grossestreuer|first11=Anne V.|last12=Moskowitz|first12=Ari|last13=Edelson|first13=Dana|last14=Ornato|first14=Joseph|last15=Berg|first15=Katherine|last16=Peberdy|first16=Mary Ann|last17=Churpek|first17=Matthew|last18=Kurz|first18=Michael|last19=Starks|first19=Monique Anderson|last20=Girotra|first20=Saket|last21=Perman|first21=Sarah|last22=Goldberger|first22=Zachary|last23=Guerguerian|first23=Anne-Marie|last24=Atkins|first24=Dianne|last25=Foglia|first25=Elizabeth|last26=Fink|first26=Ericka|last27=Lasa|first27=Javier J.|last28=Roberts|first28=Joan|last29=Bembea|first29=Melanie|last30=Gaies|first30=Michael|last31=Kleinman|first31=Monica|last32=Gupta|first32=Punkaj|last33=Sutton|first33=Robert|last34=Sawyer|first34=Taylor|title=Annual Incidence of Adult and Pediatric In-Hospital Cardiac Arrest in the United States|journal=Circulation: Cardiovascular Quality and Outcomes|volume=12|issue=7|year=2019|issn=1941-7713|doi=10.1161/CIRCOUTCOMES.119.005580}}</ref>
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| ===Age===
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|
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| * [[Cardiac arrest]] is more commonly observed within the first year of life due to [[sudden infant death syndrome]] and also between 45-75 years old due to increased risk of [[coronary artery disease]].
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| * There is a significant decrease in [[sudden cardiac death]] at age 75 and older due to decreasing risk of [[coronary artery disease]].
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| ===Gender===
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|
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| *[[men]] are more commonly affected with [[sudden cardiac death]] than [[women]] in all age groups.
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| ===Race===
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| *[[Black]] individuals are more likely to develop [[cardiac arrest]].<ref name="BeckerHan1993">{{cite journal|last1=Becker|first1=Lance B.|last2=Han|first2=Ben H.|last3=Meyer|first3=Peter M.|last4=Wright|first4=Fred A.|last5=Rhodes|first5=Karin V.|last6=Smith|first6=David W.|last7=Barrett|first7=John|title=Racial Differences in the Incidence of Cardiac Arrest and Subsequent Survival|journal=New England Journal of Medicine|volume=329|issue=9|year=1993|pages=600–606|issn=0028-4793|doi=10.1056/NEJM199308263290902}}</ref>
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| ==Risk Factors==
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| *Common risk factors related to [[ischemic heart disease]] in the development of [[cardiac arrest]] are:
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| :*[[Hypertension]]
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| :*[[diabetes mellitus]]
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| :*[[hyperlipidemia]]
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| :*[[smoking]]
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| :*[[Older age]]
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| == Natural History, Complications and Prognosis==
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| *The majority of patients with [disease name] remain asymptomatic for [duration/years].
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| *Early clinical features include [manifestation 1], [manifestation 2], and [manifestation 3].
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| *If left untreated, [#%] of patients with [disease name] may progress to develop [manifestation 1], [manifestation 2], and [manifestation 3].
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| *Common complications of [disease name] include [complication 1], [complication 2], and [complication 3].
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| *Prognosis is generally [excellent/good/poor], and the [1/5/10year mortality/survival rate] of patients with [disease name] is approximately [#%].
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| == Diagnosis ==
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| ===Diagnostic Criteria===
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| *The diagnosis of [disease name] is made when at least [number] of the following [number] diagnostic criteria are met:
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| :*[criterion 1]
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| :*[criterion 2]
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| :*[criterion 3]
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| :*[criterion 4]
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| {| style="border: 2px solid #4479BA; align="left"
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| ! style="width: 200px; background: #4479BA;" | {{fontcolor|#FFF|Components}}
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| ! style="width: 300px; background: #4479BA;" | {{fontcolor|#FFF|Assessment and findings}}
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| |-
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" | Symptoms
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" |
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| * Symptoms related to [[arrhythmia]]: [[Palpitations]], [[lightheadedness]], [[syncope]], [[dyspnea]], [[chest pain]], [[cardiac arrest]]
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| * Symptoms related to underlying [[heart disease]]: [[Dyspnea]] at rest or on exertion, [[orthopnea]], [[paroxysmal nocturnal dyspnea]], [[chest pain]], [[edema]]
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| * Precipitating factors: [[Exercise]], [[emotional stress]]
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| |-
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" | Past medical history
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" |
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| * [[Heart disease]]: [[Coronary]], [[valvular]] ([[mitral valve prolapse]]), [[congenital heart disease]]
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| * [[Thyroid disease]]
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| * [[Acute kidney injury]]
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| * [[Chronic kidney disease]]
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| * [[Electrolyte abnormalities]]
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| * [[Stroke]],[[embolic events]]
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| * [[Lung disease]]
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| * [[Epilepsy]] ([[arrhythmic syncope]] can be misdiagnosed as [[epilepsy]])
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| * [[ Alcohol]], [[illicit drug]] use
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| * Use of over-the-counter medications caused [[QT prolongation]] and [[torsades de pointes]]
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| * [[ Unexplained motor vehicle accident]]
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| |-
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" | Medications
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" |
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| * [[Antiarrhythmic]] medications
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| * Medication with QT prolongation and torsades de pointes effect
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| * [[Cocaine]],[[amphetamines]]
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| * [[Anabolic steroids]]
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| * Medication-medication interaction that could cause [[QT prolongation]] and [[torsades de pointes]]
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| |-
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" | Family history
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| | style="padding: 0 5px; background: #F5F5F5; text-align: left;" |
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| * [[SCD]], [[SCA]], [[unexplained drowning]] in a first-degree relative
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| * [[SIDS]], repetitive spontaneous [[pregnancy losses]] concerning [[cardiac channelopathies]]
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| * [[IHD]]
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| * [[Cardiomyopathy]]: [[Hypertrophic]],[[ dilated]], [[ARVC]]
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| * [[Congenital heart disease]]
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| * [[ Cardiac channelopathies]]: [[Long QT]], [[Brugada]], [[Short QT]], [[CPVT]]
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| * [[Arrhythmias]]: [[conduction disorders]], [[ pacemakers]]/[[ICDs]]
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| * [[Neuromuscular disease]] associated with [[cardiomyopathies]]
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| * [[Muscular dystrophy]]
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| * [[Epilepsy]]
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| |-
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| |}
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| {{clear}}
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| {{familytree/start| | | | | | | | | | | | | |}}
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| {{familytree| | | | | | | | | | | A01 | | A01=Sustained monomorphic [[VT]]}}
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| {{familytree| | | | | | | | | | | |!| | | | | | | | }}
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| {{familytree| | | | | | | | | | | B01 | | | | | |B01=Hemodynamic stability}}
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| {{familytree| | | | |,|-|-|-|-|-|-|^|-|-|-|-|-|-|.| }}
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| {{familytree| | | | C01 | | | | | | | | | | | |C02|C01=Stable|C02=Unstable}}
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| {{familytree| | | | |!| | | | | | | | | | | | | |!| }}
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| {{familytree| | | | D01 | | | | | | | | | | | |D02|D01=12-Lead [[ECG]], [[history]], [[physical exam]]|D02=[[Dirrect current cardioversion]],[[ACLS]]}}
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| {{familytree| | | | |!| | | | | | | | | | | | | | | | | | | |}}
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| {{familytree| | | | E01 |,|-|E00|-|-|-|-|-|-|-|F02| | | | | | E01=Notifying disease causing [[VT]]|E00= Cardioversion(class1) |F02= [[VT]] termination}}
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| {{familytree| | | | |!| |!| |!| | | | | | | |,|-|^|-|.| | | | | }}
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| {{familytree| | | | F01 |+|-|F00| | | | | |S02| | S03| | |F01=[[Structural heart disease]]|F00=Intravenous [[ procainamide]] (class2a)|S02=Yes, therapy of underlying heart disease|S03=NO, [[cardioversion]] (class1)}}
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| {{familytree| | | | |!| |!| |!| | | | | | | | | | | |!| | | | |}}
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| {{familytree| | | | L01 |`|-|L00| | | | | | | | | P01 | | | | | L00= Intravenous [[amiodarone]] or [[sotalole]] (class2b)|L01= NO, [[Ideopathic VT]]|P01=[[VT]] termination}}
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| {{familytree| | | | |!| | | | | | | | | | | | | | |!| | | | | |}}
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| {{familytree| | | | S01 | | | | | | | | | | | | | |!| | | | | |S01=[[Verapamil]] sensitive [[VT]]: [[Verapamil]] outflow tract [[VT]]: [[betablocker]] (class2a) |}}
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| {{familytree| | |,|-|^|-|.| | | | | | | | | | |,|-|^|-|.| | | |}}
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| {{familytree| | |N01| |N02| | | | | | | | | Q01| | Q02| | | | | N01= Effective| N02=Non effective: [[cardioversion]]|Q01= Yes,therapy of underlying heart disease|Q02=NO, [[Sedation]] ,[[anesthesia]], reassess antiarrhythmic therapy, repeating [[cardioversion]]}}
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| {{familytree| | |!| | | | | | | | | | | | | | | | | | |!| | | |}}
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| {{familytree| | |M01| | | | | | | | | | | | | | | | | R01| | | |M01= Therapy to prevent recurrence of [[VT]] |R01= No [[VT]] termination}}
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| {{familytree|,|-|^|-|.| | | | | | | | | | | | | | | | |!| | | |}}
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| {{familytree|!| | | |!| | | | | | | | | | | | | | | | |R02| | |R02= [[Catheter ablation]] (class1) |}}
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| {{familytree|G01| |G02| | | | | | | | | | | | | | | | | | | | | G01=Catheter ablation (class1)| G02= [[ Verapamil]] , [[betablocker]] (class2a)}}
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| {{familytree| | | | | | | | | | | | | | | | | | | | | | | | | |}}
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| {{familytree/end}}
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| === Symptoms ===
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| *[Disease name] is usually asymptomatic.
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| *Symptoms of [disease name] may include the following:
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| :*[symptom 1]
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| :*[symptom 2]
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| :*[symptom 3]
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| :*[symptom 4]
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| :*[symptom 5]
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| :*[symptom 6]
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|
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| === Physical Examination ===
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| *Patients with [[cardiac arrest]] usually appear [[cyanotic]].
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| * [[Physical examination]] may be remarkable for:
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| :*[[Heart rate]] and [[regularity]], [[blood pressure]]
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| :*[[ Jugular venous pressure]]
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| :*[[Murmurs]]
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| :*[[ Pulses]], [[bruits]]
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| :*[[Edema]]
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| :*[[Sternotomy scars]]
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| === Laboratory Findings ===
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| *There are no specific laboratory findings associated with [disease name].
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| | |
| *A [positive/negative] [test name] is diagnostic of [disease name].
| |
| *An [elevated/reduced] concentration of [serum/blood/urinary/CSF/other] [lab test] is diagnostic of [disease name].
| |
| *Other laboratory findings consistent with the diagnosis of [disease name] include [abnormal test 1], [abnormal test 2], and [abnormal test 3].
| |
| ===Electrocardiogram===
| |
| There are no ECG findings associated with [disease name].
| |
| | |
| OR
| |
| | |
| An ECG may be helpful in the diagnosis of [disease name]. Findings on an ECG suggestive of/diagnostic of [disease name] include [finding 1], [finding 2], and [finding 3].
| |
| | |
| | |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:LightGreen"|[[ACC AHA Guidelines Classification Scheme#Classification of Recommendations|Class I]] ''([[ACC AHA Guidelines Classification Scheme#Level of Evidence|Level of Evidence: B]])''
| |
| | |
| |-
| |
| | bgcolor="LightGreen"|
| |
| * Ambulatory [[ECG]] monitoring is recommended in patients with symptoms of [[syncope]], [[presyncope]], [[palpitation]] suspected [[ventricular arrhythmia]]
| |
| |}
| |
| | |
| | |
| {| class="wikitable" style="margin: 1em auto 1em auto"
| |
| ! Class of recommendation || Level of evidence|| Recommendation for [[ECG]] and [[exercise tredmile test]]
| |
| |-
| |
| | 1|| B || In patients with [[wide complex tachycardia]] and [[hemodynamically stable]], 12 leads [[ECG]] should be obtained
| |
| |-
| |
| | 1 || B || [[Exercise stress test ]] should be obtained in patients suspected arrhythmia-related exercise such as [[ischemic heart disease]] or [[cathecolaminergic polymorphic ventricular tachycardia]]
| |
| |-
| |
| | 1 || B || In patients with documented [[ventricular arrhythmia]], 12 leads [[ECG]] should be obtained during sinus rhythm for evaluation of underlying [[heart disease]]
| |
| |}
| |
| | |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:LightSteelBlue"|[[ACC AHA Guidelines Classification Scheme#Classification of Recommendations|Class I]] ''([[ACC AHA Guidelines Classification Scheme#Level of Evidence|Level of Evidence: B]])''
| |
| | |
| |-
| |
| | bgcolor="LightSteelBlue"|
| |
| * In patients with [[wide complex tachycardia]] and [[hemodynamically stable]], 12 leads [[ECG]] should be obtained
| |
| *[[Exercise stress test ]] should be obtained in patients suspected arrhythmia-related exercise such as [[ischemic heart disease]] or [[cathecolaminergic polymorphic ventricular tachycardia]]
| |
| *In patients with documented [[ventricular arrhythmia]], 12 leads [[ECG]] should be obtained during sinus rhythm for evaluation of underlying [[heart disease]]
| |
| |}
| |
| | |
| ===X-ray===
| |
| There are no x-ray findings associated with [disease name].
| |
| | |
| OR
| |
| | |
| An x-ray may be helpful in the diagnosis of [disease name]. Findings on an x-ray suggestive of/diagnostic of [disease name] include [finding 1], [finding 2], and [finding 3].
| |
| | |
| OR
| |
| | |
| There are no x-ray findings associated with [disease name]. However, an x-ray may be helpful in the diagnosis of complications of [disease name], which include [complication 1], [complication 2], and [complication 3].
| |
| | |
| ===Echocardiography or Ultrasound===
| |
| There are no echocardiography/ultrasound findings associated with [disease name].
| |
| | |
| OR
| |
| | |
| Echocardiography/ultrasound may be helpful in the diagnosis of [disease name]. Findings on an echocardiography/ultrasound suggestive of/diagnostic of [disease name] include [finding 1], [finding 2], and [finding 3].
| |
| | |
| OR
| |
| | |
| There are no echocardiography/ultrasound findings associated with [disease name]. However, an echocardiography/ultrasound may be helpful in the diagnosis of complications of [disease name], which include [complication 1], [complication 2], and [complication 3].
| |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:Pink"|[[ACC AHA Guidelines Classification Scheme#Classification of Recommendations|Class I]] ''([[ACC AHA Guidelines Classification Scheme#Level of Evidence|Level of Evidence: B]])''
| |
| | |
| |-
| |
| | bgcolor="Pink"|
| |
| *[[ Echocardiography]] is recommended in patients with [[ventricular arrhythmia]] for evaluation of underlying [[structural heart disease]]
| |
| |}
| |
| | |
| ===CT scan===
| |
| There are no CT scan findings associated with [disease name].
| |
| | |
| OR
| |
| | |
| [Location] CT scan may be helpful in the diagnosis of [disease name]. Findings on CT scan suggestive of/diagnostic of [disease name] include [finding 1], [finding 2], and [finding 3].
| |
| | |
| OR
| |
| | |
| There are no CT scan findings associated with [disease name]. However, a CT scan may be helpful in the diagnosis of complications of [disease name], which include [complication 1], [complication 2], and [complication 3].
| |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:LightGreen"|[[ACC AHA Guidelines Classification Scheme#Classification of Recommendations|Class I]] ''([[ACC AHA Guidelines Classification Scheme#Level of Evidence|Level of Evidence: C]])''
| |
| | |
| |-
| |
| | bgcolor="LightGreen"|
| |
| * [[Coronary angiography]] or coronary [[CT]] angiography is recommended in patients recovered from unexplained [[cardiac arrest]] suspected [[ischemic heart disease]]
| |
| |}
| |
| | |
| ===MRI===
| |
| There are no MRI findings associated with [disease name].
| |
| | |
| OR
| |
| | |
| [Location] MRI may be helpful in the diagnosis of [disease name]. Findings on MRI suggestive of/diagnostic of [disease name] include [finding 1], [finding 2], and [finding 3].
| |
| | |
| OR
| |
| | |
| There are no MRI findings associated with [disease name]. However, MRI may be helpful in the diagnosis of complications of [disease name], which include [complication 1], [complication 2], and [complication 3].
| |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:PowderBlue"|[[ACC AHA Guidelines Classification Scheme#Classification of Recommendations|Class IIa]] ''([[ACC AHA Guidelines Classification Scheme#Level of Evidence|Level of Evidence: C]])''
| |
| | |
| |-
| |
| | bgcolor="PowderBlue"|
| |
| * [[Cardiac magnetic resonance imaging]] ([[CMR]]) or [[cardiac computer tomography]] is recommended in patients with [[ventricular arrhythmia]] for evaluation of [[structural heart disease]]
| |
| |}
| |
| | |
| ===Other Imaging Findings===
| |
| There are no other imaging findings associated with [disease name].
| |
| | |
| OR
| |
| | |
| [Imaging modality] may be helpful in the diagnosis of [disease name]. Findings on an [imaging modality] suggestive of/diagnostic of [disease name] include [finding 1], [finding 2], and [finding 3].
| |
| | |
| === Other Diagnostic Studies ===
| |
| *[Disease name] may also be diagnosed using [diagnostic study name].
| |
| *Findings on [diagnostic study name] include [finding 1], [finding 2], and [finding 3].
| |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background: Pink"|[[AHA guidelines classification scheme#Classification of Recommendations|Class I, Level of evidence:B]]
| |
| |-
| |
| |bgcolor="Pink"|In patients who recovered from [[SCA]] due to [[ventricular arrhythmia]] suspected [[ischemic heart disease]], [[coronary angiography]] and probabley revascularization is recommmended
| |
| |-
| |
| | colspan="1" style="text-align:center; background:Pink"|[[AHA guidelines classification scheme#Classification of Recommendations|Class I, Level of evidence:C]]
| |
| |-
| |
| |bgcolor="Pink"|In patients with anomalous origin of a [[coronary artery]] leading [[ventricular arrhythmia]] or [[SCA]], repair or revascularization is recommended
| |
| |-
| |
| |}
| |
| | |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:LemonChiffon"|[[AHA guidelines classification scheme#Classification of Recommendations|Class IIa, Level of evidence:B]]
| |
| |-
| |
| |bgcolor="LemonChiffon"|In patients with ischemic or [[nonischemic]] [[cardiomyopathy]] or [[congenital heart disease]] presented with [[syncope]] arrhythmia and do not meet criteria for primary prevention ICD, an electrophysiological study is recommended for assessing the risk of sustained [[VT]]
| |
| |-
| |
| | colspan="1" style="text-align:center; background:LemonChiffon"|[[AHA guidelines classification scheme#Classification of Recommendations|Class III, Level of evidence:B]]
| |
| |-
| |
| |bgcolor="LemonChiffon"|In patients who meet criteria for [[ICD]] implantation, an [[electrophysiological study]] is not recommended for only inducing [[ventricular arrhythmia]]
| |
| |-
| |
| | colspan="1" style="text-align:center; background:LemonChiffon"|[[AHA guidelines classification scheme#Classification of Recommendations|Class III, Level of evidence:B]]
| |
| |-
| |
| |bgcolor="LemonChiffon"| An electrophysiological study is not recommended for risk stratification for [[ventricular arrhythmia]] in patients with [[Long QT syndrome]], [[short QT syndrome]], [[cathecolaminergic polymorphic ventricular arrhythmia]]
| |
| |-
| |
| |}
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| {|class="wikitable"
| |
| |-
| |
| | colspan="1" style="text-align:center; background:PapayaWhip"|[[ACC AHA Guidelines Classification Scheme#Classification of Recommendations|Class I]] ''([[ACC AHA Guidelines Classification Scheme#Level of Evidence|Level of Evidence: C]])''
| |
| | |
| |-
| |
| | bgcolor="PapayaWhip"|
| |
| * In patients with [[SCA]] or [[SCD]] in their family member, genetic tests and genetic counselling is recommended
| |
| |}
| |
| | |
| == Treatment ==
| |
| === Medical Therapy ===
| |
| *There is no treatment for [disease name]; the mainstay of therapy is supportive care.
| |
|
| |
| *The mainstay of therapy for [disease name] is [medical therapy 1] and [medical therapy 2].
| |
| *[Medical therapy 1] acts by [mechanism of action 1].
| |
| *Response to [medical therapy 1] can be monitored with [test/physical finding/imaging] every [frequency/duration].
| |
| {| style="cellpadding=0; cellspacing= 0; width: 600px;"
| |
| |-
| |
| | style="padding: 0 5px; font-size: 100%; background: #4682B4; color: #FFFFFF;" align=center |'''Recommendations for management of cardiac arrest'''
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left | '''CPR ([[ACC AHA guidelines classification scheme|Class I, Level of Evidence A]]):'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ [[CPR]] should be done according to basic and advanced cardiovascular life support algorithms <br>
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''[[Amiodarone]] ([[ACC AHA guidelines classification scheme|Class I, Level of Evidence A]]) :'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In the recurrence of [[ventricular arrhythmia]] after maximum energy shock delivery and unstable hemodynamic, [[amiodarone]] should de infused<br>
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''[[Direct current cardioversion]] : ([[ACC AHA guidelines classification scheme|Class I, Level of Evidence A]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In ventricular arrhythmia and unstable hemodynamic, direct current cardioversion should be delivered
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''[[Revascularization]]:([[ACC AHA guidelines classification scheme|Class I, Level of Evidence B]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In patients with [[polymorphic VT]] and [[VF]] and evidence of acute [[STEMI]] in [[ECG]], coronary angiography and emergency revascularization is advised
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''[[ Wide QRS tachycardia]]: ([[ACC AHA guidelines classification scheme|Class I, Level of Evidence C]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ [[Wide QRS tachycardia]] should be considered as [[VT]] if the diagnosis is unclear
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left | '''Intravenous [[procainamide]] ([[ACC AHA guidelines classification scheme|Class 2a, Level of Evidence A]]):'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In hemodynamically stable [[VT]], intravenous [[procainamide]] is recommended
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''Intravenous [[lidocaine]] : ([[ACC AHA guidelines classification scheme|Class 2a, Level of Evidence B]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ [[Lidocaine ]] is recommended in witness [[cardiac arrest]] due to polymorphic [[VT]], [[VF]] unresponsed to [[CPR]], [[defibrillation]] or [[ vasopressor therapy]]
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''Intravenous [[betablocker]] : ([[ACC AHA guidelines classification scheme|Class 2a, Level of Evidence B]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In polymorphic [[VT]] due to [[myocardial ischemia]], intravenous [[betablocker]] maybe helpful
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''Intravenous [[Epinephrine]] : ([[ACC AHA guidelines classification scheme|Class 2b, Level of Evidence A]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In [[cardiac arrest]] administration of 1 mg [[epinephrine]] every 3-5 minutes during [[CPR]] is recommended
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''Intravenous [[amiodarone]] : ([[ACC AHA guidelines classification scheme|Class 2b, Level of Evidence B]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In hemodynamic stable [[VT]], infusion [[amiodarone]] or [[sotalole]] maybe considered
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |''' High dose of intravenous [[epinephrine]] : ([[ACC AHA guidelines classification scheme|Class III , Level of Evidence A]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In [[cardiac arrest]], administration of high dose epinephrine>1 mg bolouses is not beneficial<br>
| |
| ❑ In refractory [[VF]] not related to [[torsades de pointes]], administration of intravenous [[magnesium]] is not beneficial<br>
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''Intravenous [[amiodarone]] : ([[ACC AHA guidelines classification scheme|Class III , Level of Evidence B]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑In acute [[myocardial infarction]], prophylactic administration of [[lidocaine]] or [[amiodarone]] for prevention of [[VT]] is harmful
| |
| |-
| |
| |style="font-size: 100; padding: 0 5px; background: #B8B8B8" align=left |'''Intravenous [[verapamil]], [[diltiazem]] : ([[ACC AHA guidelines classification scheme|Class III , Level of Evidence C]])'''
| |
| |-
| |
| |style="padding: 0 5px; font-size: 100%; background: #F5F5F5; width: 70%" align=left|
| |
| ❑ In a wide [[QRS]] tachycardia with unknown origin, administration of [[verapamil]] and [[diltiazem]] is harmful
| |
| | |
| |}
| |
| | |
| === Surgery ===
| |
| *Surgery is the mainstay of therapy for [disease name].
| |
| *[Surgical procedure] in conjunction with [chemotherapy/radiation] is the most common approach to the treatment of [disease name].
| |
| *[Surgical procedure] can only be performed for patients with [disease stage] [disease name].
| |
|
| |
| === Prevention ===
| |
| *There are no primary preventive measures available for [disease name].
| |
|
| |
| *Effective measures for the primary prevention of [disease name] include [measure1], [measure2], and [measure3].
| |
| | |
| *Once diagnosed and successfully treated, patients with [disease name] are followed-up every [duration]. Follow-up testing includes [test 1], [test 2], and [test 3].
| |
| | |
| ==References==
| |
| {{Reflist|2}}
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|
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| [[Category:Pick One of 28 Approved]]
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| {{WS}}
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| {{WH}}
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| | |
| ==Overview==
| |
| The term '''sudden cardiac death''' refers to [[natural death]] from cardiac causes, heralded by abrupt loss of [[consciousness]] within one hour of the onset of acute symptoms.<ref>Myerburg, Robert J. "Cardiac Arrest and Sudden Cardiac Death" in ''Heart Disease: A Textbook of Cardiovascular Medicine,'' 7th edition. Philadelphia: WB Saunders, 2005.</ref> Other forms of sudden death may be noncardiac in origin and are therefore termed sudden death rather than sudden cardiac death. Examples of this include respiratory arrest (such as due to airway obstruction, which may be seen in cases of [[choking]] or [[asphyxiation]]), toxicity or poisoning, [[anaphylaxis]], or trauma.<ref>[http://poptop.hypermart.net/sudden.html Sudden Unexpected Death: Causes and Contributing Factors] on poptop.hypermart.net.</ref>
| |
| | |
| It is important to make a distinction between this term and the related term '''[[cardiac arrest]]''', which refers to cessation of cardiac pump function which may be reversible (i.e., may not be fatal). The phrase '''Sudden Cardiac Death''' is a [[public health]] concept incorporating the features of ''natural'', ''rapid'', and ''unexpected''. It does not specifically refer to the mechanism or cause of death. Although the most frequent underlying cause of Sudden Cardiac Death is [[Coronary Artery Disease]], other categories of causes are listed below.
| |
| | |
| ==Cardiac Arrest as a Subtype of Sudden Death==
| |
| A '''cardiac arrest''', also known as '''cardiorespiratory arrest''', '''cardiopulmonary arrest''' or '''circulatory arrest''', is the abrupt cessation of normal circulation of the [[blood]] due to failure of the [[heart]] to contract effectively during [[Systole (medicine)|systole]].<ref name="Harrison"> [http://books.mcgraw-hill.com/medical/harrisons/ Harrison's Principles of Internal Medicine] 16th Edition, The McGraw-Hill Companies, ISBN 0-07-140235-7</ref>
| |
| | |
| "Arrested" blood circulation prevents delivery of [[oxygen]] to ''all'' parts of the body. Cerebral [[hypoxia (medical)|hypoxia]], or lack of oxygen supply to the brain, causes victims to [[unconsciousness|lose consciousness]] and to [[respiratory arrest|stop normal breathing]]. Brain injury is likely if cardiac arrest is untreated for more than 5 minutes,<ref name="pmid3536160">{{cite journal |author=Safar P |title=Cerebral resuscitation after cardiac arrest: a review |journal=Circulation |volume=74 |issue=6 Pt 2 |pages=IV138–53 |year=1986 |month=December |pmid=3536160 |doi= |url=}}</ref> To improve survival and neurological recovery immediate response is paramount.<ref name="IrwinRippe"> [http://www.lww.com/product/?0-7817-3548-3 Irwin and Rippe's Intensive Care Medicine] by Irwin and Rippe, Fifth Edition (2003), Lippincott Williams & Wilkins, ISBN 0-7817-3548-3</ref>
| |
| | |
| Cardiac arrest is a [[medical emergency]] that, in certain groups of [[patient]]s, is potentially reversible if treated early enough (See Reversible Causes, below). When unexpected cardiac arrest leads to death this is called '''[[sudden cardiac death]]''' (SCD)<ref name="Harrison"> [http://books.mcgraw-hill.com/medical/harrisons/ Harrison's Principles of Internal Medicine] 16th Edition, The McGraw-Hill Companies, ISBN 0-07-140235-7</ref>. The primary first-aid treatment for cardiac arrest is ''[[cardiopulmonary resuscitation]]'' (commonly known as '''CPR''') to provide circulatory support until availability of definitive medical treatment, which will vary dependant on the rhythm the heart is exhibiting, but often requires [[defibrillation]].
| |
| | |
| ==FDA Guidance re Classification and Types of Cardiovascular and Non-Cardiovascular Death==
| |
| ===Definition of Cardiovascular Death <ref>FDA guinace issued October 20, 2010</ref>===
| |
| <blockquote>
| |
| The determination of the specific cause of cardiovascular death is complicated by the fact that we are particularly interested in one underlying cause of death (acute myocardial infarction (AMI)) and several modes of death (arrhythmia and heart failure/low output). It is noted that heart attack-related deaths are manifested as sudden death or heart failure, so these events need to be carefully defined.
| |
| Cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes, as follows:
| |
| | |
| ====1.Death due to Acute Myocardial Infarction ====
| |
| | |
| This refers to a death by any mechanism (arrhythmia, heart failure, low output) within 30 days after a myocardial infarction (MI) related to the immediate consequences of the myocardial infarction, such as progressive congestive heart failure (CHF), inadequate cardiac output, or recalcitrant arrhythmia. If these events occur after a “break” (e.g., a CHF and arrhythmia free period of at least a week), they should be designated by the immediate cause, even though the MI may have increased the risk of that event (e.g., late arrhythmic death becomes more likely after an acute myocardial infarction (AMI)). The acute myocardial infarction should be verified to the extent possible by the diagnostic criteria outlined for acute myocardial infarction or by autopsy findings showing recent myocardial infarction or recent coronary thrombus. Sudden cardiac death, if accompanied by symptoms suggestive of myocardial ischemia, new ST elevation, new LBBB, or evidence of fresh thrombus by coronary angiography and/or at autopsy should be considered death resulting from an acute myocardial infarction, even if death occurs before blood samples or 12-lead electrocardiogram (ECG) could be obtained, or at a time before the appearance of cardiac biomarkers in the blood.
| |
| | |
| Death resulting from a procedure to treat a myocardial infarction (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or to treat a complication resulting from myocardial infarction, should also be considered death due to acute MI.
| |
| | |
| Death resulting from a procedure to treat myocardial ischemia (angina) or death due to a myocardial infarction that occurs as a direct consequence of a cardiovascular investigation/procedure/operation should be considered as a death due to other cardiovascular causes.
| |
| | |
| ====2.Sudden Cardiac Death====
| |
| This refers to a death that occurs unexpectedly, not following an acute AMI, and includes the following deaths:
| |
| :a. Death witnessed and instantaneous without new or worsening symptoms
| |
| :b. Death witnessed within 60 minutes of the onset of new or worsening cardiac symptoms, unless the symptoms suggest AMI
| |
| :c. Death witnessed and attributed to an identified arrhythmia (e.g., captured on an electrocardiographic (ECG) recording, witnessed on a monitor, or unwitnessed but found on implantable cardioverter-defibrillator review)
| |
| :d. Death after unsuccessful resuscitation from cardiac arrest
| |
| :e. Death after successful resuscitation from cardiac arrest and without identification of a non-cardiac etiology (Post-Cardiac Arrest Syndrome)
| |
| :f. Unwitnessed death without other cause of death (information regarding the patient’s clinical status preceding death should be provided, if available)
| |
| | |
| =====General Considerations=====
| |
| *A subject seen alive and clinically stable 12-24 hours prior to being found dead without any evidence or information of a specific cause of death should be classified as :sudden cardiac death.”. Typical scenarios include
| |
| :* Subject well the previous day but found dead in bed the next day
| |
| :* Subject found dead at home on the couch with the television on
| |
| * Deaths for which there is no information beyond “Patient found dead at home” may be classified as “death due to other cardiovascular causes” or in some trials, “undetermined cause of death.” Please see Definition of Undetermined Cause of Death, below, for full details.
| |
| | |
| ====3. Death due to Heart Failure or Cardiogenic Shock ====
| |
| This refers to a death occurring in the context of clinically worsening symptoms and/or signs of heart failure (see Chapter 7) without evidence of another cause of death and not following an AMI. Note that deaths due to heart failure can have various etiologies, including one or more AMIs (late effect), ischemic or non-ischemic cardiomyopathy, or valve disease.
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| Death due to Heart Failure or Cardiogenic shock should include sudden death occurring during an admission for worsening heart failure as well as death from progressive heart failure or cardiogenic shock following implantation of a mechanical assist device.
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| New or worsening signs and/or symptoms of congestive heart failure (CHF) include any of the following:
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| :a. New or increasing symptoms and/or signs of heart failure requiring the initiation of, or an increase in, treatment directed at heart failure or occurring in a patient already receiving maximal therapy for heart failure
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| :b. Heart failure symptoms or signs requiring continuous intravenous therapy or chronic oxygen administration for hypoxia due to pulmonary edema
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| :c. Confinement to bed predominantly due to heart failure symptoms
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| :d. Pulmonary edema sufficient to cause tachypnea and distress not occurring in the context of an acute myocardial infarction, worsening renal function, or as the consequence of an arrhythmia occurring in the absence of worsening heart failure
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| : e. Cardiogenic shock not occurring in the context of an acute myocardial infarction or as the consequence of an arrhythmia occurring in the absence of worsening heart failure
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| Cardiogenic shock is defined as systolic blood pressure (SBP) < 90 mm Hg for greater than 1 hour, not responsive to fluid resuscitation and/or heart rate correction, and felt to be secondary to cardiac dysfunction and associated with at least one of the following signs of hypoperfusion:
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| :* Cool, clammy skin or
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| :* Oliguria (urine output < 30 mL/hour) or
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| :* Altered sensorium or
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| :* Cardiac index < 2.2 L/min/m2
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| Cardiogenic shock can also be defined if SBP < 90 mm Hg and increases to ≥ 90 mm Hg in less than 1 hour with positive inotropic or vasopressor agents alone and/or with mechanical support.
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| =====General Considerations=====
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| Heart failure may have a number of underlying causes, including acute or chronic ischemia, structural heart disease (e.g. hypertrophic cardiomyopathy), and valvular heart disease. Where treatments are likely to have specific effects, and it is likely to be possible to distinguish between the various causes, then it may be reasonable to separate out the relevant treatment effects. For example, obesity drugs such as fenfluramine (pondimin) and dexfenfluramine (redux) were found to be associated with the development of valvular heart disease and pulmonary hypertension. In other cases, the aggregation implied by the definition above may be more appropriate.
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| ====4.Death due to Stroke====
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| This refers to death occurring up to 30 days after a stroke that is either due to the stroke or caused by a complication of the stroke.
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| ====5.Death due to Other Cardiovascular Causes====
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| This refers to a cardiovascular death not included in the above categories (e.g. dysrhythmia unrelated to sudden cardiac death, pulmonary embolism, cardiovascular intervention (other than one related to an AMI), aortic aneurysm rupture, or peripheral arterial disease). Mortal complications of cardiac surgery or non-surgical revascularization should be classified as cardiovascular deaths.
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| ===Definition of Non-Cardiovascular Death===
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| Non-cardiovascular death is defined as any death that is not thought to be due to a cardiovascular cause. Detailed recommendations on the classification of non-cardiovascular causes of death are beyond the scope of this document. The level of detail required and the optimum classification will depend on the nature of the study population and the anticipated number and type of non-cardiovascular deaths. Any specific anticipated safety concern should be included as a separate cause of death. The following is a suggested list of non-cardiovascular* causes of death:
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| ====Non-Malignant Causes====
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| :*Pulmonary
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| :*Renal
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| :*Gastrointestinal
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| :*Hepatobiliary
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| :*Pancreatic
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| :*Infection (includes sepsis)
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| :*Non-infectious (e.g., systemic inflammatory response syndrome (SIRS))
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| :*Hemorrhage, not intracranial
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| :*Non-cardiovascular system organ failure (e.g., hepatic failure)
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| :*Non-cardiovascular surgery
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| :*Other non-cardiovascular, specify: ________________
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| :*Accidental/Trauma
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| :*Suicide
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| :*Drug Overdose
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| :*Death due to a gastrointestinal bleed should not be considered a cardiovascular death.
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| ====Malignant Causes====
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| Malignancy should be coded as the cause of death if:
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| :*Death results directly from the cancer; or
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| :*Death results from a complication of the cancer (e.g. infection, complication of surgery / chemotherapy / radiotherapy); or
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| :*Death results from withdrawal of other therapies because of concerns relating to the poor prognosis associated with the cancer
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| Cancer deaths may arise from cancers that were present prior to randomization or which developed subsequently. It may be helpful to distinguish these two scenarios (i.e. worsening of prior malignancy; new malignancy).
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| Suggested categorization includes common organ systems, hematologic, or unknown.
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| ===Definition of Undetermined Cause of Death===
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| Undetermined Cause of Death refers to a death not attributable to one of the above categories of cardiovascular death or to a non-cardiovascular cause. Inability to classify the cause of death may be due to lack of information (e.g., the only available information is “patient died”) or when there is insufficient supporting information or detail to assign the cause of death. In general, the use of this category of death should be discouraged and should apply to a minimal number of patients in well-run clinical trials.
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| A common analytic approach for cause of death analyses is to assume that all undetermined cases are included in the cardiovascular category (e.g., presumed cardiovascular death, specifically “death due to other cardiovascular causes”). Nevertheless, the appropriate classification and analysis of undetermined causes of death depends on the population, the intervention under investigation, and the disease process. The approach should be prespecified and described in the protocol and other trial documentation such as the endpoint adjudication procedures and/or the statistical analysis plan.
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| </blockquote>
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|
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|
| ==References== | | ==References== |