Original Date: February, 2013 PACEMAKER

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1 Magellan Healthcare Clinical guidelines Original Date: February, 2013 PACEMAKER Page 1 f 9 CPT Cdes: Last Review Date: March , 33207, 33208, 33212, 33213, 33214, 33227, Guideline Number: NIA_CG_322 Last Revised Date: March 2017 Respnsible Department: Clinical Operatins Implementatin Date: January 2018 INTRODUCTION Pacemakers are implantable devices used t treat bradycardia, certain tachycardias and ccasinally certain cardimypathies. Dual chamber devices are helpful fr many f patients in imprving quality f life and cngestive heart failure. Many patients with dilated cardimypathy receive implantable defibrillatrs with cardiac resynchrnizatin therapy (CRT) capability. Hwever, CRT requires separate authrizatin as CRT has specific criteria. Apprpriate use criteria have nt been established fr pacemaker insertin. Clinicians rely upn ACC/AHA/HRS guidelines, which were updated fr bradycardia indicatins in A fcused guideline update was published in 2012, which cnsidered left ventricular ejectin fractin (LVEF), QRS pattern, QRS duratin, and cnsideratin regarding the presence f atrial fibrillatin in its differentiatin between classes, I, IIa, and IIb indicatins. Initial Clinical Reviewers (ICRs) and Physician Clinical Reviewers (PCRs) must be able t apply criteria based n individual needs and based n an assessment f the lcal delivery system. INDICATIONS AND CONTRAINDICATIONS FOR PACEMAKERS BY CONDITION Indicatins fr Sinus Nde Dysfunctin: Symptmatic bradycardia (< 60 bpm), which includes syncpe, near-syncpe, dizziness, lethargy, cngestive heart failure (CHF), fatigue, r dyspnea, whether spntaneus r as a result f clinically indicated medicatins r prcedures (e.g. medical r catheter treatment fr atrial fibrillatin) that intentinally slw the heart rate, dcumented by EKG r telemetry. Symptmatic heart beat pauses, dcumented by EKG r telemetry. Symptmatic chrntrpic incmpetence, dcumented by stress test r telemetry. Heart rate less than 40 with symptms cnsistent with bradycardia. Heart rate less than 40 bserved in the waking state withut clear assciatin between symptms and heart rate. Syncpe with electrphysilgic study (EPS) findings f abnrmal sinus nde functin. 1 Pacemaker 2018 Prprietary

2 Cntraindicatins fr Sinus Nde Dysfunctin: Asymptmatic. Symptms in the absence f bradycardia. Bradycardia resulting frm nnessential drug therapy. Indicatins fr Acquired Third-Degree and Advanced Secnd-Degree Atriventricular (AV) Blck: Persistent third-degree atriventricular blck, with r withut symptms In atrial fibrillatin and while awake, pauses in heartbeat 5 secnds with r withut symptms. In sinus rhythm and while awake, pauses in heartbeat 3 secnds r heart rates less than 40 beats per minute r an escape rhythm belw the AV nde, with r withut symptms. Fllwing catheter ablatin f the AV junctin. Fllwing cardiac surgery, if expected t be permanent. In neurmuscular diseases such as mytnic muscular dystrphy, Erb dystrphy (limb-girdle muscular dystrphy), Kearns-Sayre syndrme, and perneal muscular atrphy. Exercise-induced heart blck withut mycardial ischemia. Cntraindicatins fr Acquired Third-Degree and Advanced Secnd-Degree Atriventricular Blck: AV blck is expected t reslve and is unlikely t recur (e.g. drug txicity, Lyme disease, r transient increases in vagal tne r during hypxia in sleep apnea syndrme) and withut symptms. AV blck secndary t nnessential drug therapy. Indicatins fr Other Presentatins f First- and Secnd-Degree AV Blck: Symptmatic secnd-degree AV blck. Type II secnd-degree AV blck, with r withut symptms. Secnd-degree AV blck due t EP-dcumented intra- r infra-his levels. First- r secnd-degree AV blck with pacemaker syndrme symptms r hemdynamic cmprmise (i.e. hyptensin, syncpe and pulmnary edema). In neurmuscular diseases such as mytnic muscular dystrphy, Erb dystrphy (limb-girdle muscular dystrphy), Kearns-Sayre syndrme, and perneal muscular atrphy. AV blck due t drug use and/r drug txicity AND blck is expected t recur after drug withdrawal. Exercise-induced secnd degree heart blck withut mycardial ischemia. Cntraindicatins fr Other Presentatins f First- and Secnd-Degree AV Blck: AV blck is expected t reslve and is unlikely t recur (e.g. drug txicity, Lyme disease, r transient increases in vagal tne r during hypxia in sleep apnea syndrme) and withut symptms. AV Blck secndary t nnessential drug therapy. Indicatin fr Permanent Pacing fr Chrnic Bifascicular Blck: Type II secnd-degree AV blck, advanced secnd-degree AV blck (see definitins sectin) r intermittent third-degree AV blck. 2 Pacemaker 2018 Prprietary

3 Alternating bundle-branch blck. Syncpe and bifascicular blck when ther likely causes have been excluded, specifically ventricular tachycardia. Electrphysilgic study (EPS) dcumentatin f an H-V interval >100 millisecnds, even in asymptmatic patients. Electrphysilgic study (EPS) dcumentatin f nn-physilgical, pacing-induced infra-his blck. In neurmuscular diseases such as mytnic muscular dystrphy, Erb dystrphy (limb-girdle muscular dystrphy), and perneal muscular atrphy with bifascicular blck r any fascicular blck. Cntraindicatins fr Permanent Pacing fr Chrnic Bifascicular Blck: Asymptmatic fascicular blck withut AV blck. Asymptmatic fascicular blck with first-degree AV blck. Indicatin fr Permanent Pacing After the Acute Phase f Mycardial Infarctin: Persistent secnd- r third-degree AV blck after ST-elevatin Mycardial Infarctin (STEMI). Transient secnd- r third-degree AV blck belw the AV nde after STEMI. If the site f blck is uncertain, electrphysilgic study (EPS) may be necessary. Cntraindicatins fr Permanent Pacing After the Acute Phase f Mycardial Infarctin: Bradycardia secndary t nnessential drug therapy. Transient AV blck withut intraventricular cnductin defects. Transient AV blck with islated left anterir fascicular blck. New bundle-branch blck r fascicular blck withut AV blck. Asymptmatic first-degree AV blck with bundle-branch r fascicular blck. Indicatin fr Permanent Pacing in Hypersensitive Cartid Sinus Syndrme and Neurcardigenic Syncpe: Recurrent syncpe due t spntaneusly ccurring cartid sinus stimulatin AND cartid sinus pressure induces ventricular asystle 3 secnds. Syncpe withut clear, prvcative events and with a hypersensitive cardiinhibitry respnse (asystle) f 3 secnds r lnger. Neurcardigenic syncpe assciated with bradycardia ccurring spntaneusly r at the time f tilt-table testing. Cntraindicatins fr Permanent Pacing in Hypersensitive Cartid Sinus Syndrme and Neurcardigenic Syncpe: Hypersensitive cardiinhibitry respnse t cartid sinus stimulatin withut symptms r with vague symptms. Situatinal neurcardigenic syncpe in which avidance behavir is effective and preferred. Indicatin fllwing Cardiac Transplantatin: Persistent inapprpriate r symptmatic bradycardia nt expected t reslve and fr all ther indicatins fr permanent pacing. 3 Pacemaker 2018 Prprietary

4 Prlnged bradycardia limiting rehabilitatin r discharge. Syncpe after transplantatin even when bradyarrhythmia has nt been dcumented. Cntraindicatins fr Pacing fllwing Cardiac Transplantatin: Bradycardia secndary t nnessential drug therapy. Indicatin fr Permanent Pacemakers That Autmatically Detect and Pace t Terminate Tachycardia: Symptmatic recurrent supraventricular tachycardia dcumented t be pacing terminated in the setting f failed catheter ablatin and/r drug treatment r intlerance. Cntraindicatins fr Permanent Pacemakers That Autmatically Detect and Pace t Terminate Tachycardia: Presence f an accessry pathway with capacity fr rapid antergrade cnductin. Indicatin fr Pacing t Prevent Tachycardia: Sustained pause-dependent Ventricular tachycardia (VT), with r withut QT prlngatin. High-risk cngenital lng-qt syndrme. Symptmatic, drug-refractry, recurrent atrial fibrillatin in patients with cexisting Sinus Nde Dysfunctin (SND), when the recrd dcuments that the patient has either failed atrial fibrillatin ablatin r is nt cnsidered a candidate fr a specified reasn. Cntraindicatins fr Pacing t Prevent Tachycardia: Ventricular ectpic withut sustained VT in the absence f the lng-qt syndrme. Reversible, e.g., drug-related, Trsade de pintes VT. Indicatin fr Pacing in Patients with Hypertrphic Cardimypathy: Symptmatic hypertrphic cardimypathy and hemdynamically significant resting r prvked LV utflw tract bstructin AND refractry t medical therapy. Cntraindicatins fr Pacing in Patients with Hypertrphic Cardimypathy: Asymptmatic OR symptms cntrlled n medical therapy. Withut significant LV utflw tract bstructin. Indicatin fr Pacing in Children, Adlescents, and Patients with Cngenital Heart Disease: Secnd- r third-degree AV blck with symptmatic bradycardia, ventricular dysfunctin, r lw cardiac utput. SND with symptms and age-inapprpriate bradycardia. The definitin f bradycardia varies with the patient s age and expected heart rate. Fr nrmal heart rates by age, please see the table at the end. Pstperative advanced secnd- r third-degree AV blck that is expected t be permanent r that persists >7 days after cardiac surgery. Cngenital third-degree AV blck with a wide QRS escape rhythm, cmplex ventricular ectpy, r ventricular dysfunctin. 4 Pacemaker 2018 Prprietary

5 Cngenital third-degree AV blck in the infant with a ventricular rate <55 bpm r with cngenital heart disease and a ventricular rate <70 bpm. Cngenital heart disease and sinus bradycardia fr the preventin f recurrent episdes f intra-atrial reentrant tachycardia, either intrinsic r secndary t antiarrhythmic treatment. Cngenital third-degree AV blck after age 1 year with an average heart rate <50 bpm, abrupt pauses in ventricular rate that are 2 r 3 times the basic cycle length, r assciated with symptms due t chrntrpic incmpetence. Sinus bradycardia with cmplex cngenital heart disease AND a resting heart rate < 40 bpm OR pauses in ventricular rate >3 secnds. Cngenital heart disease and impaired hemdynamics due t sinus bradycardia r lss f AV synchrny. Unexplained syncpe after prir cngenital heart surgery cmplicated by transient cmplete heart blck, with residual fascicular blck after a careful evaluatin t exclude ther causes f syncpe. Transient pstperative third-degree AV blck that reverts t sinus rhythm with residual bifascicular blck. Permanent pacemaker implantatin may be cnsidered fr cngenital third-degree AV blck in asymptmatic children r adlescents with an acceptable rate, a narrw QRS cmplex and nrmal ventricular functin. Asymptmatic sinus bradycardia fllwing biventricular repair f cngenital heart disease with a resting heart rate < 40 bpm r pauses in ventricular rate > 3 secnds. Cntraindicatins fr Pacing in Children, Adlescents, and Patients with Cngenital Heart Disease: Asymptmatic transient pstperative AV blck with return f nrmal AV cnductin. Asymptmatic bifascicular blck +/-first-degree AV blck after surgery fr cngenital heart disease in the absence f prir transient cmplete AV blck. Asymptmatic type I secnd-degree AV blck. Asymptmatic sinus bradycardia with the lngest RR interval < 3 secnds and a minimum heart rate > 40 bpm. Bradycardia secndary t nnessential drug therapy. ADDITIONAL INFORMATION: Fr Cardiac Resynchrnizatin Pacemaker Implementatins, see separate CRT Pacemaker guideline. A pacemaker system is cmpsed f a pulse generatr and ne r mre leads. The pulse generatr is implanted under the skin, usually belw ne f the cllarbnes. It cntains a battery, a micrprcessr that gverns timing and functin, and a radi antenna t allw fr nninvasive reprgramming. The leads are insulated cables that cnduct electricity frm the pulse generatr t the heart. Leads are mst cmmnly inserted int a vein and then advanced under flurscpy (X-ray guidance) t within ne r mre heart chambers. The leads are fastened within the chambers t the heart muscle using either hks r retractable/extendable screws, which are built int their tips. Timed electrical impulses are 5 Pacemaker 2018 Prprietary

6 sent frm the pulse generatr dwn the leads t the heart, where stimulatin results in heart muscle cntractin. The mst recent guidelines stress that asymptmatic bradycardia rarely qualifies as a class I indicatin fr pacemaker insertin. Hwever, there are sme asymptmatic bradycardic rhythms fr which pacemaker insertin is indicated because they present a risk f injury r death. In additin, there are als a small number f situatins in which the electrcardigram (EKG) r an invasive electrphysilgic study (EPS) can reveal evidence f specific disease in the cardiac cnductin system that warrants pacemaker insertin in the absence f symptms, fr the same reasn. Guidelines are fairly specific and technical in these instances. In the case dilated cardimypathy, near-simultaneus stimulatin f bth ventricles, referred t as cardiac resynchrnizatin therapy (CRT) has been demnstrated t imprve cardiac perfrmance and quality f life and t decrease cardiac event rates and mrtality amng a subset f patients. Device implantatin requires the insertin f leads that pace bth the right and left ventricles, mst cmmnly with a crnary sinus lead fr the LV pacing. The majrity f these patients received implantable defibrillatrs with CRT capability, but pacemakers are smetimes chsen due t patient and physician preference. A fcused ACCF/AHA/HRS guideline update was published in 2012, which cnsidered LVEF, QRS pattern, QRS duratin, and cnsideratin regarding the presence f atrial fibrillatin in its differentiatin between classes, I, IIa, and IIb indicatins. This dcument will prvide criteria fr apprval f all CRT indicatins that are presently defined as IIb r strnger. Current guidelines grup pacemaker indicatins tgether accrding t anatmic surce and clinical syndrmes, and this dcument fllws this apprach. Class I thrugh IIb indicatins are cndensed and included as apprvable in this dcument. Generally speaking, fr indicatins that are listed in this summary withut reference t symptms, the presence r absence f symptms differentiate between class I and II indicatins. NYHA Class Definitins: Class I: N limitatin f functinal activity r nly at levels f exertin that wuld limit nrmal individuals. Class II: Slight limitatin f activity. Dyspnea and fatigue with mderate exercise. Class III: Marked limitatin f activity. Dyspnea with minimal activity. Class IV: Severe limitatin f activity. Symptms even at rest. Heart Blck Definitins: First Degree: All atrial beats are cnducted t the ventricles, but with a delay f > 200ms. Secnd Degree: Intermittent failure f cnductin f single beats frm atrium t ventricles. Type I: Cnducted beats have variable cnductin times frm atrium t ventricles. Type II: Cnducted beats have unifrm cnductin times frm atrium t ventricles. Advanced: Tw r mre cnsecutive nn-cnducted beats. Third Degree: N atrial beats are cnducted frm atrium t ventricle 6 Pacemaker 2018 Prprietary

7 Abbreviatins: AV = Atriventricular CHF = cngestive heart failure CRT = Cardiac resynchrnizatin therapy EKG = Electrcardigram EPS = Electrphysilgic Study GDMT = Guideline-Directed Medical Therapy HRS = Heart Rhythm Sciety HV = His-ventricle ICD = Implantable cardiverter-defibrillatr LBBB = left bundle-branch blck LV = Left ventricular/left ventricle LVEF = Left ventricular ejectin fractin MI = mycardial infarctin MS = millisecnds NYHA =New Yrk Heart Assciatin STEMI = ST-elevatin Mycardial Infarctin SND = Sinus nde dysfunctin VT = Ventricular tachycardia Nrmal Pediatric Heart Rates: Frm: Drug-Lkup/153929/0/nrmal_pediatric_heart_rates Age Mean Heart Rate (beats/minute) Heart Rate Range (2nd 98th percentile) <1 d d d wk m m m y y y y y Adapted frm The Harriet Lane Handbk, 12th ed, Greene MG, ed, St Luis, MO: Msby Yearbk, Pacemaker 2018 Prprietary

8 REFERENCES ACC/AHA/AATS/PCNA/SCAI/STS 2014 Fcused Update f the Guideline fr the Diagnsis and Management f Patients With Stable Ischemic Heart Disease A Reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines, and the American Assciatin fr Thracic Surgery, Preventive Cardivascular Nurses Assciatin, Sciety fr Cardivascular Angigraphy and Interventins, and Sciety f Thracic Surgens. Jurnal f the American Cllege f Cardilgy, 2014, 7, di: /j.jacc Retrieved frm ACCF/AHA/ASE/ASNC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2013 Multimdality Apprpriate Use Criteria fr the Detectin and Risk Assessment f Stable Ischemic Heart Disease A Reprt f the American Cllege f Cardilgy Fundatin Apprpriate Use Criteria Task Frce, American Heart Assciatin, American Sciety f Echcardigraphy, American Sciety f Nuclear Cardilgy, Heart Failure Sciety f America, Heart Rhythm Sciety, Sciety fr Cardivascular Angigraphy and Interventins, Sciety f Cardivascular Cmputed Tmgraphy, Sciety fr Cardivascular Magnetic Resnance, and Sciety f Thracic Surgens. Jurnal f the American Cllege f Cardilgy, 2014, 63(4), di: /j.jacc Retrieved frm Antman, E.M., Anbe, D.T., Armstrng, P.W., Bates, E.R., Green, L.R., Hand, M.,... Smith, S.C. (2004). ACC/AHA guide- lines fr the management f patients with ST-elevatin mycardial infarctin: a reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines (Cmmittee t Revise the 1999 Guidelines fr the Management f patients with acute mycardial infarctin). J Am Cll Cardil. 44 e1 e211. Retrieved frm di%20fund/st%20elv%20mi.pdf Dlgin, M. (1994). The Criteria Cmmittee f the New Yrk Heart Assciatin. Nmenclature and Criteria fr Diagnsis f Diseases f the Heart and Great Vessels. 9 th ed. (pp ). Bstn, Mass: Little, Brwn & C. Epstein, A.E., DiMarc, J.P., Ellenbgen, K.A., Estes, M., Freedman, R.A., Gettes, L.S.,... Sweeney, M.O. (2008). ACC/AHA/HRS 2008 Guidelines fr Device-Based Therapy f Cardiac Rhythm Abnrmalities: Executive Summary. Jurnal f the American Cllege f Cardilgy, 51(21), di: /j.jacc Greene, M.G. (1991). The Harriet Lane Handbk, 12 th ed. St Luis, MO: Msby Yearbk. Retrieved frm Lkup/153929/0/nrmal_pediatric_heart_rates Tracy, C.M., Epstein, A.E., Darbar, D., DiMarc, J.P., Dunbar, S.B., Estes, M.,... Varsy, P.D. (2012). ACCF/AHA/HRS Fcused Update f the 2008 Guidelines fr Device-Based Therapy f Cardiac Rhythm Abnrmalities. Jurnal f the American Cllege f Cardilgy, 60(14), di: /j.jacc Pacemaker 2018 Prprietary

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INDICATIONS AND CONTRAINDICATIONS FOR PACEMAKERS BY CONDITION

INDICATIONS AND CONTRAINDICATIONS FOR PACEMAKERS BY CONDITION Natinal Imaging Assciates, Inc. Clinical guidelines CARDIAC RESYNCHRONIZATION THERAPY (CRT) CPT Cdes: 33221, 33224, 33225, 33229, 33231, 33264 Guideline Number: NIA_CG_320 Respnsible Department: Clinical