InterQual Care Planning SIM plus Criteria 2014 Clinical Revisions

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1 InterQual Care Planning SIM plus Criteria 2014 Clinical Revisions The Clinical Revisions provide details of changes to InterQual Clinical Criteria. They do not provide information on changes made to CareEnhance Review Manager software. For information on Review Manager software changes, see the Review Manager Release Notes and the What's New topic in CareEnhance Review Manager Help. Review and Incorporation of Recent Medical Literature McKesson Health Solutions is committed to keeping the InterQual product suite current and accurate. Criteria are continually reviewed and updated, with new editions of every product released at least annually. McKesson Health Solutions staff of physicians, nurses, and other licensed healthcare professionals, and its extensive array of primary care and specialty consultants, participate in ongoing criteria revision as new medical information emerges. Each release of the criteria reflects a thorough review of new medical literature, society guidelines, and current practice standards and incorporates consultant and user feedback. MHS Customer Hub The MHS Customer Hub ( provides interactive support, answers to commonly asked questions, and links to other resources. Need a user ID and password? Click the link above and then click the "Need a user ID and password?" link. Global / General Criteria Changes New Procedures: Bariatric Surgery, Adolescent Colpopexy Radiofrequency Ablation (RFA), Liver Transarterial Chemoembolization (TACE), Liver Page 1 of 46

2 Criteria-Specific Changes Category: Cardiology Subset Tissue / Indication Revision Rationale Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Canadian Class III/IV angina by Hx Acute MI High risk findings by stress testing Post MI angina/ischemia Post revascularization Post revascularization Changed name of subset from "Angiogram, (Left Heart Catheterization)" to "Angiogram, +/- Left Heart Catheterization" Removed indication CAD evaluation prior to major surgery Added indication "Canadian Class III/IV angina" Changed Ventricular arrhythmia to Cardiac arrest survivor/ sustained (> 30 seconds) VT by ECG Changed Severe cardiac ischemia by stress test to Highrisk findings by stress testing Added Sx/findings unresponsive to optimal medical Rx under Positive stress test at 6 wks post MI, Angina/angina equivalent w/in 6 wks of MI, and HF w/in 6 wks of MI" Removed Unstable angina Changed Change in angina pattern and Ischemia in vascular distribution of prior procedure to High-risk findings by stress testing and Intermediate findings by stress testing and Sx/findings unresponsive to optimal medical therapy A coronary angiogram and left heart catheterization are two separate procedures. A left heart catheterization may be done during the angiogram. Current guidelines do not support routine testing for coronary artery disease prior to major surgery. Patients with Canadian Class III or IV angina may need a coronary angiogram to determine the need for revascularization. Patients with an acute myocardial infarction who survived a cardiac arrest or experienced sustained, but not nonsustained, ventricular tachycardia, should be evaluated for coronary artery disease. This change was made to reflect current terminology. angiogram is only appropriate for patients who continue to have symptoms of ischemia after their hospitalization for a myocardial infarction while receiving optimal medical treatment. Patients who experience unstable angina, even after percutaneous coronary intervention or coronary artery bypass graft, should be evaluated for coronary angiogram using the Unstable angina by history (urgent) indication. angiogram is appropriate in the evaluation of patients post revascularization who demonstrate high-risk findings on stress testing, regardless of other symptoms. It is also appropriate for patients with intermediate-risk finding on a stress test who continue to have symptoms after their percutaneous coronary intervention or coronary artery bypass graft while receiving optimal medical treatment. Angiogram, Ventricular Added Intermediate/high-risk findings by stress testing Patients with low-risk findings and nonsustained ventricular +/- Left tachycardia are not appropriate candidates for coronary Page 2 of 46

3 Heart arrhythmia under Nonsustained ( 30 secs) VT by ECG and" angiogram. Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Angiogram, +/- Left Heart Catheterization Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Ventricular arrhythmia New onset acute HF by PE/CXR Valvular heart disease Valvular heart disease Congenital heart disease Suspected concealed bypass tract by ECG Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Suspected AVNRT by ECG Added "Transient/reversible causes excluded" under "Nonsustained ( 30 secs) VT by ECG" Changed Valvular heart disease to Moderate to severe valvular heart disease" Added Preoperative assessment prior to valve surgery Added Symptomatic valve disease and along with Noninvasive imaging equivocal/inconsistent with clinical findings and Further testing needed for treatment planning Added Preoperative assessment prior to cardiac surgery Added indication "Suspected concealed bypass tract by ECG" Changed "Narrow complex tachycardia and" and "Presyncope/syncope by Hx" to "Presyncope/syncope by Hx" Changed "Syncope" to "Presyncope/syncope by Hx" Added "Palpitations" and "Chest pain/discomfort" Changed "Evaluation for catheter/surgical ablation" to "Evaluation for surgical ablation of accessory pathway" Changed "Recurrent tachycardia on beta-blocker/calcium channel blocker/digoxin Rx" to "Recurrent tachycardia on antiarrhythmic Rx" Since nonsustained ventricular tachycardia is common in patients with coronary artery disease, all transient or reversible causes for the arrhythmia should be excluded prior to coronary angiogram. angiogram would only be appropriate in patients with moderate to severe valve disease since the purpose of the study is to determine eligibility for surgery and to detect concomitant coronary artery disease. angiogram is done preoperatively to verify the severity of disease and detect concomitant coronary artery disease. angiogram is appropriate for patients with symptomatic valve disease when the noninvasive findings are inconsistent with the clinical findings and it is necessary to clarify the severity of the disease to plan further treatment. angiogram is done preoperatively to quantify shunts, determine anatomy, and detect concomitant coronary artery disease. Since a concealed bypass tract can only be suspected by electrocardiogram, electrophysiology testing is necessary to confirm a diagnosis. Electrophysiology testing may be appropriate in patients with preexcitation syndrome or Wolff-Parkinson-White syndrome who experience presyncope or syncope, even in the absence of a narrow complex tachycardia. Electrophysiology testing may be appropriate in patients with preexcitation syndrome or Wolff-Parkinson-White syndrome who have presyncope, in addition to syncope. Electrophysiology testing may be appropriate in patients with preexcitation syndrome or Wolff-Parkinson-White syndrome who have palpitations or chest pain, in addition to the other symptoms listed. Catheter ablation would be done at the time of the electrophysiology testing if necessary. The drugs are now listed in a note. Electrophysiology Narrow complex Changed "Narrow complex tachycardia/suspected AVNRT" Narrow complex tachycardias can be frequently diagnosed by Page 3 of 46

4 (EP) Testing tachycardia by ECG and etiology unknown to "Suspected AVNRT by ECG" and "Narrow complex tachycardia by ECG and etiology unknown" ECG. This criteria point covers causes where the type of narrow complex tachycardia is unknown and information about the site of origin, mechanism, and electrophysiological properties of the rhythm are necessary to determine appropriate treatment options (e.g., medication, ablation, device placement). Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Electrophysiology (EP) Testing Narrow complex tachycardia by ECG and etiology unknown Nonsustained ( 30 secs) VT by ECG Nonsustained ( 30 secs) VT by ECG Sustained (> 30 secs) VT by ECG Cardiac arrest survivor Presyncope/syncope by Hx Presyncope/syncope by Hx Presyncope/syncope by Hx Presyncope/syncope by Hx Presyncope/syncope by Hx Changed "Recurrent tachycardia on beta-blocker/calcium channel blocker/digoxin Rx" to "Recurrent tachycardia on antiarrhythmic Rx" Added "Presyncope/syncope by Hx" under "Sx/findings" Added "Transient/reversible causes excluded" Added "Transient/reversible causes excluded" Added "Transient/reversible causes excluded" Combined "Presyncope/syncope with structural heart disease/cad," "Syncope with therapeutic blood levels of antiarrhythmic drugs for treatment of V tach," and "Syncope with hypertrophic cardiomyopathy/arvd" into the new indication "Presyncope/syncope by Hx" Added "Preexcitation syndrome/wpw syndrome by ECG" Added "Narrow complex tachycardia by ECG and" along with "Suspected concealed bypass tract," "Suspected AVNRT," and "Unknown etiology" Added "Nonsustained ( 30 secs) VT by ECG and" along with "CAD evaluation performed" and "Transient/reversible causes excluded" Changed "Syncope with therapeutic blood levels of antiarrhythmic drugs for treatment of V tach" to "Patient on antiarrhythmic medication" under "After VT Rx and" The drugs are now listed in a note. Electrophysiology testing may be appropriate for evaluating patients with presyncope or syncope as a result of nonsustained ventricular tachycardia. Electrophysiology testing should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Electrophysiology testing should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Electrophysiology testing should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. This change was made to streamline the criteria. Electrophysiology study requests for evaluating presyncope or syncope are covered by this one indication. Electrophysiology studies are appropriate for evaluating a patient with preexcitation syndrome or Wolff-Parkinson-White syndrome who experiences presyncope or syncope. Electrophysiology studies are appropriate for evaluating a patient with suspected concealed bypass tract, suspected atrioventricular nodal reentrant tachycardia, or narrow complex tachycardia of unknown origin who experiences presyncope or syncope. Electrophysiology studies are appropriate for evaluating a patient with nonsustained ventricular tachycardia who experiences presyncope or syncope. Not all antiarrhythmic medications are dosed and monitored by blood levels. Electrophysiology (EP) Testing Presyncope/syncope by Hx Added "Transient/reversible causes excluded" under "After VT Rx and" Electrophysiology testing should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Page 4 of 46

5 Electrophysiology (EP) Testing Presyncope/syncope by Hx Ventricular arrhythmia Added "Palpitations preceding syncope" Combined indications Cardiac arrest survivor and coronary angiogram planned, Inducible VF at EP testing and coronary angiogram planned, Sustained V tach (> 30 secs), and Nonsustained V tach ( 30 secs)" under new indication Ventricular arrhythmia Electrophysiology studies are appropriate to evaluate patients who experience palpitations preceding presyncope or syncope. All indications for the various arrhythmias can now be found under the new indication Ventricular arrhythmia. ARVD by testing Added indication "ARVD by testing" cardioverter defibrillator insertion may be appropriate for patients with arrhythmogenic right ventricular dysplasia who have a risk factor for sudden cardiac death (e.g., cardiac arrest survivor, syncope by history, left ventricular involvement). Catecholaminergic polymorphic VT by testing Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Added indication "Catecholaminergic polymorphic VT by testing" Added "During MI hospitalization and" under "Cardiac arrest survivor" Changed "Cardiac arrest survivor and coronary angiogram performed" to "CAD evaluation performed" under "During MI hospitalization and" and "W/o concomitant acute MI and" under "Cardiac arrest survivor" Added "Arrhythmia not amenable/unresponsive to medical Rx/ablation" under "W/o concomitant acute MI and" under "Cardiac arrest survivor" Added "Transient/reversible causes excluded" under "Cardiac arrest survivor" Added "Life expectancy 1 yr" under "Cardiac arrest survivor" Added "Syncope by Hx and arrhythmia not amenable/unresponsive to medical Rx/ablation" and "SHD by TTE/TEE" under "Sx/findings" under "Inducible VF at EP testing" An implantable cardioverter defibrillator may be appropriate for patients with catecholaminergic polymorphic ventricular tachycardia and a history of syncope or cardiac arrest since they are at an increased for sudden cardiac death. Evidence supports ICD insertion for patients who experience a cardiac arrest during hospitalization for an ST-elevation myocardial infarction. Other testing (e.g., stress testing), in addition to angiogram, can be used to evaluate coronary artery disease. The tests are included in a note. An implantable cardioverter defibrillator may be appropriate if the arrhythmia continued after trying medication or ablation for patients who did not have an MI. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. Arrhythmias causing syncope should be first managed with medication or ablation prior to considering an implantable cardioverter defibrillator. Page 5 of 46

6 Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Changed "Inducible VF at EP testing and coronary angiogram performed" to "CAD evaluation performed" under "Inducible VF at EP testing" Added "Transient/reversible causes excluded" under "Inducible VF at EP testing" Added "Life expectancy 1 yr" under "Inducible VF at EP testing" Added "Syncope by Hx and arrhythmia not amenable/unresponsive to medical Rx/ablation" and "SHD by TTE/TEE" under "Sustained (> 30 secs) VT by ECG/EP testing" Added "CAD evaluation performed" under "Sustained (> 30 secs) VT by ECG/EP testing" Added "Transient/reversible causes excluded" under "Sustained (> 30 secs) VT by ECG/EP testing" Added "Life expectancy 1 yr" under "Sustained (> 30 secs) VT by ECG/EP testing" Removed "Nonsustained ( 30 secs) V tach w/o MI" along with " angiogram performed" and "EF 40% by testing" under "Nonsustained V tach ( 30 secs)" Added "MI 40 days prior" under "Nonsustained ( 30 secs) VT by ECG/EP testing" Page 6 of 46 Other testing (e.g., stress testing), in addition to angiogram, can be used to evaluate coronary artery disease. The tests are included in a note. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. cardioverter defibrillator insertion would only be appropriate for patients with inducible ventricular fibrillation or sustained ventricular tachycardia that was associated with structural heart disease or caused syncope. Arrhythmias causing syncope should be first managed with medication or ablation prior to considering an implantable cardioverter defibrillator. Because coronary artery disease (CAD) can be contributing to the development of arrhythmias, CAD or ischemia should be ruled out or treated, if possible, prior to device placement. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. Patients who develop nonsustained ventricular tachycardia in the absence of coronary artery disease are at low risk for sudden cardiac death and an implantable cardioverter defibrillator would not be appropriate. The benefit of an implantable cardioverter defibrillator in patients with coronary artery disease does not extend to patients who have an acute MI.

7 Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ventricular arrhythmia Ischemic cardiomyopathy by testing Ischemic cardiomyopathy by testing Nonischemic dilated cardiomyopathy by testing Added "EF 40%" under "Nonsustained V tach ( 30 secs) by ECG/EP testing" Added "Inducible VF/sustained (> 30 secs) VT at EP testing" under "Nonsustained V tach ( 30 secs) by ECG/EP testing" Added "CAD evaluation performed" under "Nonsustained V tach ( 30 secs) by ECG/EP testing" Added "Transient/reversible causes excluded" under "Nonsustained V tach ( 30 secs) by ECG/EP testing" Added "Life expectancy 1 yr" under "Nonsustained V tach ( 30 secs) by ECG/EP testing" Changed "MI by Hx and coronary angiogram performed" to "MI 40 days prior" and "CAD evaluation performed" Added "Life expectancy 1 yr" Added "Life expectancy 1 yr" Page 7 of 46 Because the risk of continued arrhythmias and death is increased, implantable cardioverter defibrillator insertion is recommended in patients with nonsustained VT who have an EF of 40% or less. Because the risk of continued arrhythmias and death is increased, implantable cardioverter defibrillator insertion is recommended in patients with nonsustained ventricular tachycardia (VT) who have inducible VT or ventricular fibrillation at electrophysiology testing. Because coronary artery disease (CAD) can be contributing to the development of arrhythmias, CAD or ischemia should be ruled out or treated, if possible, prior to device placement. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. The benefit of an implantable cardioverter defibrillator in patients with coronary artery disease does not extend to patients who have an acute MI. Other testing (e.g., stress testing), in addition to angiogram, can be used to evaluate coronary artery disease. The tests are included in a note. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices.

8 Hypertrophic cardiomyopathy by testing Hypertrophic cardiomyopathy by testing Hypertrophic cardiomyopathy by testing Hypertrophic cardiomyopathy by testing Brugada syndrome by ECG Brugada syndrome by ECG Brugada syndrome by ECG Long QT syndrome by ECG Long QT syndrome by ECG Added "Cardiac arrest survivor and," "Sudden cardiac death in a first degree relative 40," "Sudden cardiac death in a first degree relative with hypertrophic cardiomyopathy," "Presyncope/syncope by Hx," and "Left ventricular/septal wall thickness 30 mm by TTE/TEE" under "Risk factor for sudden cardiac death" Added "CAD evaluation performed" under "Cardiac arrest survivor and," "Inducible VF at EP testing," and "Spontaneous sustained (> 30 secs)/nonsustained ( 30 secs) VT by ECG and" Added "Transient/reversible causes excluded" under "Cardiac arrest survivor and" and "Inducible VF at EP testing," and "Spontaneous sustained (> 30 secs)/nonsustained ( 30 secs) VT by ECG and" Added "Life expectancy 1 yr" Added "CAD evaluation performed" under "VT/VF by Hx and" and "Cardiac arrest survivor and" under "Sx/findings" Added "Transient/reversible causes excluded" under "VT/VF by Hx and" and "Cardiac arrest survivor and" under "Sx/findings" Added "Life expectancy 1 yr" Added "CAD evaluation performed" under "VT/VF by Hx and" and "Cardiac arrest survivor and" under "Sx/findings" Added "Transient/reversible causes excluded" under "VT/VF by Hx and" and "Cardiac arrest survivor and" under "Sx/findings" Page 8 of 46 Patients with hypertrophic cardiomyopathy are at an increased risk for sudden cardiac death if they have a history of a previous cardiac arrest, inducible VF, sustained VT, nonsustained VT, presyncope, syncope, a left ventricular or septal wall thickness of 30 mm or greater, sudden cardiac death in a first degree relative 40 years or younger, or sudden cardiac death in a first degree relative with hypertrophic cardiomyopathy. Because coronary artery disease (CAD) can be contributing to the development of arrhythmias, CAD or ischemia should be ruled out or treated, if possible, prior to device placement. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. Because coronary artery disease (CAD) can be contributing to the development of arrhythmias, CAD or ischemia should be ruled out or treated, if possible, prior to device placement. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. Because coronary artery disease (CAD) can be contributing to the development of arrhythmias, CAD or ischemia should be ruled out or treated, if possible, prior to device placement. An implantable cardioverter defibrillator should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be

9 treated otherwise. Long QT syndrome by ECG Sinus node dysfunction by ECG Sinus node dysfunction by ECG Sinus node dysfunction by ECG AV block by ECG AV block by ECG AV block by ECG AV block by ECG AV block by ECG AV block by ECG Added "Life expectancy 1 yr" Removed "Ventricular rate < 40/min" Added "Chronotropic incompetence" Added "Transient/reversible causes excluded" Combined "Complete heart block (CHB) and" and "Mobitz Type II second degree AV block and" into the new indication "AV block by ECG" Removed "Ventricular rate < 40/min" under "Sx/findings" under "CHB" Changed "Asystole 3 secs by ECG" to "Asystole 3 secs by ECG" Changed "Post ablation" to "Post cardiac surgery/ablation" under "Sx/findings" under "CHB" Added "Neuromuscular disease" under "Sx/findings" under "CHB" Changed Mobitz Type II second degree AV block and to Second degree AV block AV block by ECG Added "Cognitive impairment" under "Ventricular rate < 60/min and" under "Second degree AV block' Page 9 of 46 Since the relevant studies used to support the use of pacemakers and defibrillators have typically excluded patients with cardiogenic shock, irreversible brain damage, or other comorbidities that would shorten their life expectancy (e.g., renal failure, liver failure, pulmonary hypertension, stroke), patients with a life expectancy of less than one year are not candidates for these devices. Bradycardia alone, without symptoms, does not warrant pacemaker insertion. Chronotropic incompetence, in addition to bradycardia, in patients with sinus node dysfunction may be treated with pacemaker insertion. A pacemaker should only be considered if the cause of the arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. This change was made to streamline the criteria. Bradycardia alone, without symptoms, does not warrant pacemaker insertion. This change was made to provide consistency across subsets. Evidence supports pacemaker insertion for patients with postoperative, as well as post ablation, complete heart block that is not expected to resolve. Neuromuscular disease is often associated with heart block. Prophylactic pacing is appropriate when conduction disease develops, regardless of symptoms. Evidence supports pacemaker insertion for second degree atrioventricular block with associated symptomatic bradycardia, regardless of the type of block. In addition to syncope and presyncope, bradycardia and atrioventricular block can cause cognitive impairment. AV block by ECG Added "Transient/reversible causes excluded" A pacemaker should only be considered if the cause of the arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Chronic bifascicular/trifascicu lar block by ECG Chronic bifascicular/trifascicu Changed "CHB and ventricular rate < 60/min" to "CHB by ECG" under "Findings" Added "Alternating bundle branch block by ECG" under "Findings" insertion is appropriate for patients with chronic bifascicular or trifascicular block who develop complete heart block, regardless of the heart rate. Chronic bifascicular and trifascicular block can result not only in complete heart block or second degree atrioventricular block but

10 lar block by ECG also alternating bundle branch block. Chronic bifascicular/trifascicu lar block by ECG Changed "Suspected CHB/Mobitz Type II second degree AV block" to "Suspected CHB/second degree AV block" under "Findings" insertion is appropriate for patients with chronic bifascicular or trifascicular block who develop second degree heart block, regardless of the type of block., Biventricular +, Biventricular + Chronic bifascicular/trifascicu lar block by ECG Acute MI with AV block by ECG Acute MI with AV block by ECG Acute MI with AV block by ECG Acute MI with AV block by ECG AF by ECG Added "Transient/reversible causes excluded" Changed "CHB" to "Persistent CHB > 24 hrs" under "Findings" Changed "Mobitz Type II second degree AV block" to "Persistent Mobitz Type II second degree AV block > 24 hrs" under "Findings" Added "CAD evaluation performed" Added "Transient/reversible causes excluded" Added "Presyncope/syncope by Hx" and "Cognitive impairment" under "Ventricular rate < 60/min and" Page 10 of 46 A pacemaker should only be considered if the cause of the arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. This change was made to clarify that the heart block is continuous. This change was made to clarify that the heart block is continuous. Because coronary artery disease (CAD) can be contributing to the development of arrhythmias, CAD or ischemia should be ruled out or treated, if possible, prior to device placement. A pacemaker should only be considered if the cause of the arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. insertion is only appropriate for patients with atrial fibrillation and bradycardia who are symptomatic. AF by ECG Added "Transient/reversible causes excluded" A pacemaker should only be considered if the cause of the arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Hypersensitive carotid sinus syndrome Hypersensitive carotid sinus syndrome HF by Hx/PE Changed rule from "ONE" to "ALL" Added "Transient/reversible causes excluded" Changed subset ", Biventricular +/- ICD " into two subsets ", Biventricular" and ", Biventricular + Defibrillation (ICD) " Changed "Class III/IV" to "Class III/Ambulatory Class IV and" under "NYHA HF Class" Evidence supports pacemaker insertion for hypersensitive carotid sinus syndrome if the patient exhibits both, not either, syncope and ventricular asystole of more than 3 seconds when the carotid sinus is stimulated. A pacemaker should only be considered if the cause of the arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. This change was made so users could easily identify criteria covering biventricular pacemaker insertion alone or biventricular pacemaker insertion with an implantable cardioverter defibrillator. The clinical trials demonstrating improved outcomes in patients with New York Heart Association (NYHA) Class IV heart failure (HF) with cardiac resynchronization therapy only included patients with ambulatory NYHA Class IV HF.

11 , Biventricular +, Biventricular +, Biventricular + HF by Hx/PE Changed QRS duration 120 msec to QRS duration 120 and < 150 msec with LBBB by ECG and QRS duration 150 msec by ECG under "Class III/Ambulatory Class IV and" under "NYHA HF Class" Page 11 of 46 Evidence supports biventricular pacemaker insertion in patients with ambulatory Class IV heart failure who have a QRS duration between 120 and 150 milliseconds when they have a left bundle branch block (LBBB) and for all other patients when their QRS duration is 150 milliseconds or greater. HF by Hx/PE Removed "No bradycardia by PE/ECG" A biventricular pacemaker may be appropriate for patients with bradycardia if an additional atrial lead is placed for atrioventricular pacing. HF by Hx/PE Single vessel disease,, Three vessel disease, and Graft stenosis Left main stenosis 50% by angiogram and CABG not feasible Removed "No known risk for sudden cardiac death," "High risk and ICD by Hx/ICD inserted as separate procedure," and "High risk and combined biventricular pacer with ICD inserted" under "Risk for sudden cardiac death" Restructured subset into new indications Single vessel disease,, Three vessel disease, and Graft stenosis Added "Acute MI," "Unstable angina," "Canadian Class III angina, "Canadian Class I/II angina," and "Postinfarction angina/ischemia" Changed "Stenosis 70% by angiogram" to "Stenosis 70%/FFR 0.80 by angiogram" throughout this subset Added indication Left main stenosis 50% by angiogram and CABG not feasible These criteria now cover insertion of a biventricular pacemaker with an implantable cardioverter defibrillator in patients who are at risk of cardiac arrest. This change was made to streamline the criteria. This change was made to streamline the criteria. Fractional flow reserve (FFR) is an invasive measure used to determine the physiological significance of a coronary stenosis and is used to guide decisions regarding revascularization when the significance of the coronary artery disease is unclear from the angiogram. An FFR of 0.80 identifies coronary artery stenoses that have the capability of producing ischemia. Although coronary artery bypass grafting remains the standard for treating significant left main disease, PCI is appropriate when CABG cannot be done. Removed "Sx/findings" under "Acute MI" Patients experiencing an acute MI who have significant stenosis by angiogram should undergo PCI regardless of other symptoms

12 or findings. Removed "Sx/findings" under "Unstable angina by Hx" Patients experiencing unstable angina who have significant stenosis by angiogram should undergo PCI regardless of other symptoms or findings. Changed "Canadian Class III angina" to "Canadian Class III/IV angina by Hx" Added Significant proximal LAD stenosis" under "Canadian Class III/IV angina by Hx Added Positive stress test and Sx/findings unresponsive to optimal medical Rx under "Canadian Class III/IV angina by Hx Removed "Severe cardiac ischemia by stress test" under "Canadian Class I/II angina by Hx" Changed "Restenosis of prior stent/graft" to "Restenosis of prior stent" under "Canadian Class III/IV angina by Hx," "Canadian Class I/II angina by Hx," and "Silent ischemia" Changed "Severe cardiac ischemia by stress test" to "Highrisk findings by stress testing" under "Silent ischemia" Changed "Positive stress test and symptoms unresponsive to maximal medical Rx" to "Intermediate-risk findings by stress testing" and "Continued findings unresponsive to optimal medical Rx" under "Silent ischemia" Added "Significant proximal LAD stenosis" under "Intermediate-risk findings by stress testing" under "Silent ischemia" Added Continued Sx/findings unresponsive to optimal medical Rx" under After MI hospitalization under Post MI angina/ischemia Page 12 of 46 Patients with Canadian Class IV angina, in addition to Class III angina, who have significant stenosis are at increased risk for myocardial infarction, heart failure, or death and should be considered for PCI. Patients with Canadian Class III or IV angina who have significant proximal left anterior descending stenosis are at increased risk for adverse cardiac events and should be evaluated for PCI. Patients with Canadian Class III or IV angina who do not have significant proximal LAD artery stenosis may be appropriate for PCI of single vessel disease if they have evidence of ischemia by stress testing. Patients with Canadian Class I or II angina and any degree of ischemia, not just severe ischemia, by stress testing may be appropriate for PCI. Patients with a restenosis of a prior graft will now meet under the Graft stenosis indication. This change was made to reflect current terminology. Patients with silent ischemia who have intermediate-risk findings by stress testing may be appropriate for PCI. Patients with lowrisk findings should be managed medically. Patients with silent ischemia who have significant proximal left anterior descending stenosis and intermediate-risk findings by stress testing are at increased risk for adverse cardiac events and should be evaluated for PCI. PCI is only appropriate for patients who are experiencing symptoms after their hospitalization for a myocardial infarction and continue to have symptoms while receiving optimal medical treatment. Changed "Restenosis of prior stent/graft" to Restenosis of Patients with significant stenosis of a graft will now meet at the

13 prior stent" under "Unstable angina by Hx," "Canadian Class III/IV angina by Hx," "Canadian Class I/II angina by Hx," and "Silent ischemia" "Graft stenosis" indication. Removed "Sx/findings" under "Acute MI" Patients experiencing an acute MI who have significant stenosis by angiogram should undergo PCI regardless of other symptoms or findings. Removed "Sx/findings" under "Unstable angina by Hx" Patients experiencing unstable angina who have significant stenosis in two vessels by angiogram should undergo PCI regardless of other symptoms or findings. Added Significant proximal LAD stenosis, EF 50% by testing and No DM by Hx under Unstable angina by Hx" Changed "Canadian Class III angina" to "Canadian Class III/IV angina by Hx" Added Significant proximal LAD stenosis" under "Canadian Class III/IV angina by Hx Added "Positive stress test" and Sx/findings unresponsive to optimal medical Rx under "Canadian Class III/IV angina by Hx Changed Severe cardiac ischemia by stress test to Highrisk findings by stress testing under Canadian Class I or II angina by Hx Changed "Positive stress test and symptoms unresponsive to maximal medical Rx" to "Intermediate-risk findings," "Low-risk findings," and "Sx/findings unresponsive to optimal medical Rx" under "Canadian Class I/II angina by Hx" Added Significant proximal LAD stenosis under "Intermediate-risk findings by stress testing" under "Canadian Class I/II angina by Hx Added Significant proximal LAD stenosis under "Low-risk findings by stress testing" under "Canadian Class I/II angina Page 13 of 46 Patients with two vessel disease that involves the proximal left anterior descending artery are at high risk for adverse cardiac events. PCI is only appropriate, however, when the ejection fraction is normal and the patient does not have diabetes mellitus. Patients with Canadian Class IV angina, in addition to Class III angina, who have a significant two vessel disease are at increased risk for myocardial infarction, heart failure, or death and should be considered for PCI. Patients with Canadian Class III or IV angina who have significant proximal LAD artery stenosis are at increased risk for adverse cardiac events and should be evaluated for PCI. Patients with Canadian Class IV angina, in addition to Class III angina, who have significant stenosis are at increased risk for myocardial infarction, heart failure, or death and should be considered for PCI. This change was made to reflect current terminology. This change was made to clarify the content since patients with high-risk findings by stress testing should undergo PCI regardless of whether they are on optimal medical therapy. Patients with Canadian Class I or II angina who have significant two vessel disease involving the proximal left anterior descending stenosis and intermediate-risk findings by stress testing are at risk for major adverse cardiac events and should be evaluated for PCI. Patients with low-risk findings by stress test and Canadian Class I or II angina should only undergo PCI if the two vessel disease

14 by Hx involves the proximal LAD artery. Changed "Severe cardiac ischemia by stress test" to "Highrisk findings by stress testing" under "Silent ischemia" This change was made to reflect current terminology. Changed "Positive stress test and symptoms unresponsive to maximal medical Rx" to "Intermediate-risk findings by stress testing," and "Sx/findings unresponsive to optimal medical Rx" under "Silent ischemia" Added "Significant proximal LAD stenosis" under "Intermediate-risk findings by stress testing" under "Silent ischemia" Added Sx/findings unresponsive to optimal medical Rx" under After MI hospitalization under Post MI angina/ischemia Page 14 of 46 Patients with silent ischemia who have intermediate-risk findings by stress testing may be appropriate for PCI. Patients with lowrisk findings should be managed medically. Patients with silent ischemia who have significant proximal left anterior descending stenosis and intermediate-risk findings by stress testing are at increased risk for adverse cardiac events and should be evaluated for PCI. PCI is only appropriate for patients who are experiencing symptoms after their hospitalization for a myocardial infarction and continue to have symptoms while receiving optimal medical treatment. Three vessel disease Removed "Sx/findings" under "Acute MI" Patients experiencing an acute MI who have significant stenosis by angiogram should undergo PCI regardless of other symptoms or findings. Three vessel disease Three vessel disease Three vessel disease Three vessel disease Three vessel disease Added EF 50% by testing under Unstable angina and patient w/o DM by Hx" Changed "Canadian Class III angina" to "Canadian Class III/IV angina by Hx" Removed "Continued symptoms despite maximal medical Rx" under "Canadian Class III/IV angina by Hx" Removed "Severe cardiac ischemia by stress test" and "Positive stress test and symptoms unresponsive to maximal medical Rx" under "Canadian Class I/II angina by Hx" Changed Positive stress test and symptoms unresponsive to maximal medical Rx to Intermediate-risk findings by stress testing and no DM by Hx" under Silent ischemia Patients with unstable angina who have three vessel disease are at increased risk for major adverse cardiac events and PCI may be appropriate if they have an ejection fraction of greater than 50%. Patients with Canadian Class IV angina, in addition to Class III angina, who have significant stenosis are at increased risk for myocardial infarction, heart failure, or death and should be considered for PCI. Patients with Canadian Class III or IV angina and three vessel disease are appropriate candidates for PCI, regardless of whether they are receiving optimal medical treatment. Patients with Canadian Class I or II angina who have three vessel disease and are not diabetic may be appropriate candidates for PCI, regardless of stress test findings or medical therapy. Patients with silent ischemia and significant three vessel disease who have intermediate-risk findings by stress testing may be appropriate for PCI, regardless of medical treatment or a low ejection fraction. Three vessel disease Added EF 50% by testing and no DM by Hx under Patients with silent ischemia who have a significant three vessel

15 "Silent ischemia" disease and a low EF are at increased risk for major adverse cardiac events and should undergo PCI. Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Three vessel disease Graft stenosis Graft stenosis Graft stenosis Graft stenosis Graft stenosis Graft stenosis Graft stenosis Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Added Sx/findings unresponsive to optimal medical Rx under After MI hospitalization under Post MI angina/ischemia Added High/intermediate-risk findings by stress testing and Low-risk findings by stress testing Changed Restenosis of prior stent/graft to Restenosis of prior stent under "Unstable angina by Hx," "Canadian Class III/IV angina by Hx," "Canadian Class I/II angina by Hx," and "Silent ischemia" Changed Canadian Class III angina to Canadian Class III/IV angina by Hx Removed and symptoms unresponsive to maximal medical Rx" under High/intermediate-risk findings by stress testing under "Canadian Class III/IV angina by Hx" Changed Severe cardiac ischemia by stress test to Highrisk findings by stress testing" under "Canadian Class I/II angina by Hx" Changed Severe cardiac ischemia by stress test to Highrisk findings by stress testing and findings unresponsive to optimal medical Rx and removed Positive stress test and symptoms unresponsive to maximal medical treatment under "Silent ischemia" Added Sx/findings unresponsive to optimal medical Rx under After MI hospitalization for the Post MI angina/ischemia pathway Added "Paroxysmal AF by ECG" under "Sx/findings" Added "Cardiac arrest survivor" under "Sx/findings" Page 15 of 46 PCI is only appropriate for patients who are experiencing symptoms after their hospitalization for a myocardial infarction and continue to have symptoms while receiving optimal medical treatment. Patients with significant stenosis in one or more grafts and Canadian Class III or IV angina may be appropriate for PCI if they have evidence of ischemia on stress testing. This change was made to clarify the content. Patients with Canadian Class IV angina, in addition to Class III angina, who have significant stenosis are at increased risk for myocardial infarction, heart failure, or death and should be considered for PCI. Patients with Canadian Class III or IV angina and low-risk findings by stress testing should only undergo PCI if they have failed medical treatment. This change was made to reflect current terminology. PCI is only appropriate for patients who are experiencing symptoms after their hospitalization for a myocardial infarction and continue to have symptoms while receiving optimal medical treatment. PCI is only appropriate for patients who are experiencing symptoms after their hospitalization for an MI and continue to have symptoms while receiving optimal medical treatment. Radiofrequency ablation may be appropriate in patients with paroxysmal AF and preexcitation syndrome or WPW syndrome. Radiofrequency ablation may be appropriate in patients with a history of a cardiac arrest and preexcitation syndrome or WPW syndrome. Radiofrequency Preexcitation Added "Narrow complex tachycardia and high-risk Radiofrequency ablation may be appropriate in patients with

16 Ablation (RFA), syndrome/wpw occupation/hobby" under "Sx/findings" narrow complex tachycardia and preexcitation syndrome or Cardiac syndrome by ECG WPW syndrome who have a high-risk occupation or hobby. Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Radiofrequency Ablation (RFA), Cardiac Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Preexcitation syndrome/wpw syndrome by ECG Concealed bypass tract at EP testing Changed "Narrow complex tachycardia with presyncope/syncope" to "Presyncope/syncope by Hx" under "Sx/findings" Added "Palpitations" under "Sx/findings" Added "Chest pain/discomfort" under "Sx/findings" Added "Transient/reversible causes excluded" Added "Transient/reversible causes excluded" Page 16 of 46 Radiofrequency ablation may be appropriate in patients with preexcitation syndrome or Wolff-Parkinson-White syndrome who experience presyncope or syncope, even in the absence of a narrow complex tachycardia. Radiofrequency ablation may be appropriate in patients with preexcitation syndrome or Wolff-Parkinson-White syndrome who have palpitations or chest pain, in addition to the other symptoms listed. Radiofrequency ablation may be appropriate in patients with preexcitation syndrome or Wolff-Parkinson-White syndrome who have palpitations or chest pain, in addition to the other symptoms listed. Radiofrequency ablation should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Radiofrequency ablation should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. AVNRT at EP testing Added "Transient/reversible causes excluded" Radiofrequency ablation should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. A flutter by ECG Added "Transient/reversible causes excluded" Radiofrequency ablation should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. AF by ECG Changed "Symptomatic on medical Rx" to "Paroxysmal/persistent AF and" along with "Continued Sx/findings unresponsive to antiarrhythmic Rx" and "Continued Sx/findings and antiarrhythmic Rx not given" Evidence supports catheter ablation for patients with persistent, symptomatic atrial fibrillation refractory to medication. AF by ECG Added "Severe pulmonary disease excluded" Studies evaluating catheter ablation for treating symptomatic atrial fibrillation show the most benefit in patients with no evidence of severe pulmonary disease. AF by ECG Added "Transient/reversible causes excluded" Radiofrequency ablation should only be considered if the cause of the ventricular arrhythmia (e.g., drug toxicity, electrolyte abnormality, myocardial ischemia) cannot be treated otherwise. Sustained (> 30 secs) VT by ECG Sustained (> 30 secs) VT by ECG Changed "RV outflow tract/lv outflow tract/lv by EP testing with presyncope/syncope" to "Spontaneous monomorphic VT and" Added "Continued Sx/findings unresponsive to medical Rx" and "Continued Sx/findings and medical Rx not given" under "Spontaneous monomorphic VT and" Catheter ablation may be appropriate for treating all forms of monomorphic ventricular tachycardia, not just tachycardia originating from the right ventricular or left ventricular outflow tracts or the left ventricle. Catheter ablation is only appropriate for patients with monomorphic ventricular tachycardia when antiarrhythmic drugs are not effective, not tolerated, or not desired.

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