Implantable Cardioverter Defibrillators

Transcription

1 Prtcl Implantable Cardiverter Defibrillatrs (70144) Medical Benefit Effective Date: 04/01/18 Next Review Date: 11/18 Preauthrizatin N Review Dates: 02/07, 02/08, 03/09, 01/10, 01/11, 09/11, 09/12, 01/13, 01/14, 05/14, 01/15, 11/15, 11/16, 11/17 Preauthrizatin is nt required. The fllwing prtcl cntains medical necessity criteria that apply fr this service. The criteria are als applicable t services prvided in the lcal Medicare Advantage perating area fr thse members, unless separate Medicare Advantage criteria are indicated. If the criteria are nt met, reimbursement will be denied and the patient cannt be billed. Please nte that payment fr cvered services is subject t eligibility and the limitatins nted in the patient s cntract at the time the services are rendered. Ppulatins Interventins Cmparatrs Outcmes Individuals: With a high risk f sudden cardiac death due t ischemic cardimypathy in adulthd Individuals: With a high risk f sudden cardiac death due t nnischemic cardimypathy in adulthd Individuals: With a high risk f sudden cardiac death due t hypertrphic cardimypathy in adulthd Individuals: With a high risk f sudden cardiac death due t an inherited cardiac in channelpathy Individuals: With life-threatening ventricular tachyarrhythmia r fibrillatin r wh have been resuscitated frm Interventins f interest are: Transvenus implantable cardiverter defibrillatr Interventins f interest are: Transvenus implantable cardiverter defibrillatr Interventins f interest are: Transvenus implantable cardiverter defibrillatr Interventins f interest are: Transvenus implantable cardiverter defibrillatr Interventins f interest are: Transvenus implantable cardiverter defibrillatr Cmparatrs f interest are: Medical management withut implantable cardiverter defibrillatr Cmparatrs f interest are: Medical management withut implantable cardiverter defibrillatr Cmparatrs f interest are: Medical management withut implantable cardiverter defibrillatr Cmparatrs f interest are: Medical management withut implantable cardiverter defibrillatr Cmparatrs f interest are: Medical management withut implantable cardiverter defibrillatr Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Page 1 f 16

2 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 Ppulatins Interventins Cmparatrs Outcmes Individuals: Wh need an implantable cardiverter defibrillatr and have a cntraindicatin t transvenus ICD Individuals: Wh need an implantable cardiverter defibrillatr and have a cntraindicatin t transvenus ICD Interventins f interest are: Subcutaneus implantable cardiverter defibrillatr Interventins f interest are: Subcutaneus implantable cardiverter defibrillatr Cmparatrs f interest are: Medical management withut implantable cardiverter defibrillatr Cmparatrs f interest are: Transvenus implantable cardiverter defibrillatr Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Relevant utcmes include: Overall survival Mrbid events Quality f life Treatment-related mrtality Treatment-related mrbidity Descriptin An implantable cardiverter defibrillatr (ICD) is a device designed t mnitr a patient s heart rate, recgnize ventricular fibrillatin r ventricular tachycardia, and deliver an electric shck t terminate these arrhythmias t reduce the risk f sudden death. A subcutaneus implantable cardiverter defibrillatr (S-ICD), which lacks transvenus leads, is intended t reduce lead-related cmplicatins. Summary f Evidence Fr individuals wh have a high risk f sudden cardiac death (SCD) due t ischemic r t nnischemic cardimypathy (NICM) in adulthd wh receive transvenus implantable cardiverter defibrillatr (TV-ICD) fr primary preventin, the evidence includes multiple well-designed and well-cnducted randmized cntrlled trials (RCTs) as well as systematic reviews f these trials. Relevant utcmes are verall survival, mrbid events, quality f life, and treatment-related mrtality and mrbidity. Multiple, well-dne RCTs have shwn a benefit in verall mrtality fr patients with ischemic cardimypathy and reduced ejectin fractin. RCTs assessing early ICDs fllwing recent mycardial infarctin (MI) did nt supprt a benefit fr immediate versus delayed implantatin fr at least 40 days. Fr NICM, there is less clinical trial data, but pled estimates f available evidence frm RCTs enrlling patients with NICM and frm subgrup analysis f RCTs with mixed ppulatins has supprted a survival benefit fr this grup. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh have a high risk f SCD due t hypertrphic cardimypathy (HCM) in adulthd wh receive TV-ICD fr primary preventin, the evidence includes several large registry studies. Relevant utcmes are verall survival, mrbid events, quality f life, and treatment-related mrtality and mrbidity. In these studies, the annual rate f apprpriate ICD discharge ranged frm 3.6% t 5.3%. Given the lng-term high risk f SCD in patients with HCM, with the assumptin that apprpriate shcks are life-saving, these rates are cnsidered adequate evidence t supprt use f ICDs in patients with HCM. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh have a high risk f SCD due t an inherited cardiac in channelpathy wh receive TV-ICD fr primary preventin, the evidence includes small chrt studies f patients with these cnditins treated with ICDs. Relevant utcmes are verall survival, mrbid events, quality f life, and treatment-related mrtality and mrbidity. The limited evidence fr patients with lng QT syndrme (LQTS), catechlaminergic plymrphic ventricular tachycardia (CPVT), and Brugada syndrme (BrS) has reprted high rates f apprpriate shcks. N studies were identified n the use f ICDs fr patients with shrt QT syndrme (SQTS). Studies cmparing utcmes between patients treated and untreated with ICDs are nt available. Hwever, given the Page 2 f 16

3 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 relatively small patient ppulatins and the high risk f cardiac arrhythmias, clinical trials are unlikely. Given the lng-term high risk f SCD in patients with inherited cardiac in channelpathy, with the assumptin that apprpriate shcks are life-saving, these rates are cnsidered adequate evidence t supprt use f TV-ICDs in patients with inherited cardiac in channelpathy. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh have wh have had symptmatic life-threatening sustained ventricular tachycardia (VT) r ventricular fibrillatin (VF) r wh have been resuscitated frm sudden cardiac arrest (secndary preventin) wh receive TV-ICD, the evidence includes multiple well-designed and well-cnducted RCTs as well as systematic reviews f these trials. Relevant utcmes are verall survival, mrbid events, quality f life, and treatment-related mrtality and mrbidity. Systematic reviews f RCTs have demnstrated a 25% reductin in mrtality fr ICD cmpared t medical therapy. Analysis f data frm a large administrative database has cnfirmed that this mrtality benefit is generalizable t the clinical setting. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh need an ICD and have a cntraindicatin t a TV-ICD but n indicatins fr antibradycardia pacing and n antitachycardia pacing-respnsive arrhythmias wh receive subcutaneus implantable cardiverter defibrillatr (S-ICD), the evidence includes nnrandmized studies and case series. Relevant utcmes are verall survival, mrbid events, quality f life, and treatment-related mrtality and mrbidity. Nnrandmized cntrlled studies have reprted success rates in terminating labratry-induced VF that are similar t TV-ICD. Case series have reprted high rates f detectin and successful cnversin f VF, and inapprpriate shck rates in the range reprted fr TVICD. Given the need fr ICD in this ppulatin at risk fr SCD, with the assumptin that apprpriate shcks are life-saving, these rates are cnsidered adequate evidence t supprt use f SICDs in patients with cntraindicatin t TV-ICD. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Fr individuals wh have need fr an ICD withut cntraindicatin t TV-ICD but n indicatins fr antibradycardia pacing and n antitachycardia pacing-respnsive arrhythmias wh receive S-ICD, the evidence includes nnrandmized studies and case series. Relevant utcmes are verall survival, mrbid events, quality f life, and treatment-related mrtality and mrbidity. Nnrandmized cntrlled studies have reprted success rates in terminating labratry-induced VF that are similar t TV-ICD. Hwever, there is scant evidence n cmparative clinical utcmes f bth types f ICD ver lnger perids. Case series have reprted high rates f detectin and successful cnversin f VT, and inapprpriate shck rates in the range reprted fr TV-ICD. This evidence des nt supprt cnclusins n whether there are small differences in efficacy between the tw types f devices, which may be clinically imprtant due t the nature t the disrder being treated. Als, adverse event rate is uncertain, with variable rates reprted. At least ne RCT is currently underway cmparing S-ICD with TV-ICD. The evidence is insufficient t determine the effects f the technlgy n health utcmes. Plicy Adults The use f the autmatic implantable cardiverter defibrillatr (ICD) may be cnsidered medically necessary in adults wh meet the fllwing criteria: Primary Preventin Ischemic cardimypathy with New Yrk Heart Assciatin (NYHA) functinal class II r III symptms, a histry f mycardial infarctin at least 40 days befre ICD treatment, and left ventricular ejectin fractin f 35% r less; r Page 3 f 16

4 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 ischemic cardimypathy with NYHA functinal class I symptms, a histry f mycardial infarctin at least 40 days befre ICD treatment and left ventricular ejectin fractin f 30% r less; r nnischemic dilated cardimypathy and left ventricular ejectin fractin f 35% r less, after reversible causes have been excluded, and the respnse t ptimal medical therapy has been adequately determined; r hypertrphic cardimypathy (HCM) with ne r mre majr risk factrs fr sudden cardiac death (histry f premature HCM-related sudden death in ne r mre first-degree relatives yunger than 50 years; left ventricular hypertrphy greater than 30 mm; ne r mre runs f nnsustained ventricular tachycardia at heart rates f 120 beats per minute r greater n 24-hur Hlter mnitring; prir unexplained syncpe incnsistent with neurcardigenic rigin) and judged t be at high risk fr sudden cardiac death by a physician experienced in the care f patients with HCM. diagnsis f any ne f the fllwing cardiac in channelpathies and cnsidered t be at high risk fr sudden cardiac death (see Plicy Guidelines): cngenital lng QT syndrme; OR Brugada syndrme; OR shrt QT syndrme; OR catechlaminergic plymrphic ventricular tachycardia. Secndary Preventin Patients with a histry f a life-threatening clinical event assciated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded. The use f the ICD is cnsidered investigatinal in primary preventin patients wh: have had an acute mycardial infarctin (i.e., less than 40 days befre ICD treatment); have NYHA Class IV cngestive heart failure (unless patient is eligible t receive a cmbinatin cardiac resynchrnizatin therapy ICD device); have had cardiac revascularizatin prcedure in past three mnths (crnary artery bypass graft r percutaneus transluminal crnary angiplasty) r are candidates fr a cardiac revascularizatin prcedure; r have nncardiac disease that wuld be assciated with life expectancy less than ne year. The use f the ICD fr secndary preventin is cnsidered investigatinal fr patients wh d nt meet the criteria fr secndary preventin. Pediatrics The use f the ICD may be cnsidered medically necessary in children wh meet any f the fllwing criteria: survivrs f cardiac arrest, after reversible causes have been excluded; symptmatic, sustained ventricular tachycardia in assciatin with cngenital heart disease in patients wh have undergne hemdynamic and electrphysilgic evaluatin; r cngenital heart disease with recurrent syncpe f undetermined rigin in the presence f ventricular dysfunctin r inducible ventricular arrhythmias. Page 4 f 16

5 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 HCM with ne r mre majr risk factrs fr sudden cardiac death (histry f premature HCM-related sudden death in ne r mre first-degree relatives yunger than 50 years; massive left ventricular hypertrphy based n age-specific nrms; prir unexplained syncpe incnsistent with neurcardigenic rigin) and judged t be at high risk fr sudden cardiac death by a physician experienced in the care f patients with HCM. diagnsis f any ne f the fllwing cardiac in channelpathies and cnsidered t be at high risk fr sudden cardiac death (see Plicy Guidelines): cngenital lng QT syndrme; OR Brugada syndrme; OR shrt QT syndrme; OR catechlaminergic plymrphic ventricular tachycardia. The use f the ICD is cnsidered investigatinal fr all ther indicatins in pediatric patients. Subcutaneus ICD The use f a subcutaneus ICD may be cnsidered medically necessary fr adults r children wh have an indicatin fr ICD implantatin fr primary r secndary preventin fr any f the abve reasns and meet all f the fllwing criteria: Have a cntraindicatin t a transvenus ICD due t ne r mre f the fllwing: (1) lack f adequate vascular access; (2) cmpelling reasn t preserve existing vascular access (i.e., need fr chrnic dialysis; yunger patient with anticipated lng-term need fr ICD therapy); r (3) histry f need fr explantatin f a transvenus ICD due t a cmplicatin, with nging need fr ICD therapy. Have n indicatin fr antibradycardia pacing; AND D nt have ventricular arrhythmias knwn r anticipated t respnd t antitachycardia pacing. The use f a subcutaneus ICD is cnsidered investigatinal fr individuals wh d nt meet the criteria utlined abve. Plicy Guidelines This prtcl addresses the use f ICD devices as stand-alne interventins, nt as cmbinatin devices t treat heart failure (i.e., cardiac resynchrnizatin devices) r in cmbinatin with pacemakers. Unless specified, the plicy statements are referring t transvenus ICDs. Indicatins fr pediatric ICD use are based n American Cllege f Cardilgy (ACC), American Heart Assciatin (AHA), Heart Rhythm Sciety (HRS) guidelines published in 2008 (updated in 2012), which acknwledged the lack f primary research n pediatric patients in this field. These indicatins are derived frm nnrandmized studies, extraplatin frm adult clinical trials, and expert cnsensus. Criteria fr ICD Implantatin in Patients with Cardiac In Channelpathies Individuals with cardiac in channelpathies may have a histry f a life-threatening clinical event assciated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes, in which case they shuld be cnsidered fr ICD implantatin fr secndary preventin, even if they d nt meet criteria fr primary preventin. Criteria fr ICD in patients with cardiac in channelpathies derive frm results f clinical input, a 2013 cnsensus statement frm the HRS, Eurpean Heart Rhythm Assciatin (EHRA), and the Asia-Pacific Heart Page 5 f 16

6 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 Rhythm Sciety n the diagnsis and management f patients with inherited primary arrhythmia syndrmes (Priri et al, 2013), 2012 guidelines frm ACC, AHA, and HRS n device-based therapy f cardiac rhythm abnrmalities (Epstein et al, 2013), and a reprt frm the HRS and EHRA s Secnd Cnsensus Cnference n Brugada syndrme (Antzelevitch et al, 2005). Indicatins fr cnsideratin fr ICD implantatin fr each cardiac in channelpathy are as fllws: Lng QT syndrme: Patients with a diagnsis f LQTS wh are survivrs f cardiac arrest. Patients with a diagnsis f LQTS wh experience recurrent syncpal events while n β-blcker therapy. Brugada syndrme: Patients with a diagnsis f BrS wh are survivrs f cardiac arrest. Patients with a diagnsis f BrS wh have dcumented spntaneus sustained ventricular tachycardia (VT) with r withut syncpe. Patients with a spntaneus diagnstic type 1 electrcardigram (ECG) wh have a histry f syncpe, seizure, r ncturnal agnal respiratin judged t be likely caused by ventricular arrhythmias (after nncardiac causes have been ruled ut). Patients with a diagnsis f BrS wh develp ventricular fibrillatin during prgrammed electrical stimulatin. Catechlaminergic plymrphic ventricular tachycardia: Patients with a diagnsis f CPVT wh are survivrs f cardiac arrest. Patients with a diagnsis f CPVT wh experience recurrent syncpe r plymrphic/bidirectinal VT despite ptimal medical management, and/r left cardiac sympathetic denervatin. Shrt QT syndrme: Patients with a diagnsis f SQTS wh are survivrs f cardiac arrest. Patients with a diagnsis f SQTS wh are symptmatic and have dcumented spntaneus VT with r withut syncpe. Patients with a diagnsis f SQTS r are asymptmatic r symptmatic and have a family histry f sudden cardiac death. NOTE: Fr cngenital LQTS, patients may have ne r mre clinical r histrical findings ther than thse utlined abve that culd, alne r in cmbinatin, put them at higher risk fr sudden cardiac death. These may include patients with a family histry f sudden cardiac death due t LQTS, infants with a diagnsis f LQTS with functinal 2:1 atriventricular blck, patients with a diagnsis f LQTS in cnjunctin with a diagnsis f Jervell and Lange-Nielsen syndrme r Timthy syndrme, and patients with a diagnsis f LQTS with prfund QT prlngatin (greater than 550 ms). These factrs shuld be evaluated n an individualized basis by a clinician with expertise in LQTS in cnsidering the need fr an ICD implantatin. Medicare Advantage Fr Medicare Advantage an implantable autmatic defibrillatr is medically necessary when the fllwing indicatins are met: Page 6 f 16

7 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 1. Dcumented episde f cardiac arrest due t ventricular fibrillatin (VF), nt due t a transient r reversible cause. 2. Dcumented sustained ventricular tachyarrhythmia (VT), either spntaneus r induced by an electrphysilgy (EP) study, nt assciated with an acute mycardial infarctin (MI) and nt due t a transient r reversible cause. 3. Dcumented familial r inherited cnditins with a high risk f life-threatening VT, such as lng QT syndrme r hypertrphic cardimypathy. 4. Crnary artery disease with a dcumented prir MI, a measured left ventricular ejectin fractin (LVEF) less than 0.35 and inducible, sustained VT r VF at EP study. (The MI must have ccurred mre than 40 days prir t defibrillatr insertin. The EP test must be perfrmed mre than fur weeks after the qualifying MI.) 5. Dcumented prir MI and a measured LVEF less than 0.30; patients must nt have: a. New Yrk Heart Assciatin (NYHC) classificatin IV; b. Cardigenic shck r symptmatic hyptensin while in a stable baseline rhythm; c. Had a crnary artery bypass graft (CABG) r percutaneus transluminal crnary angiplasty (PTCA) within past three mnths; d. Had an enzyme psitive MI within past mnth and must nt have had an acute MI in the past 40 days; e. Clinical symptms r findings that wuld make them a candidate fr crnary revascularizatin; r f. Any disease, ther than cardiac disease (e.g., cancer, uremia, liver failure), assciated with a likelihd f survival less than ne year. 6. Patients with ischemic dilated cardimypathy (IDCM), dcumented prir MI, NYHA Class II and III heart failure, and measured LVEF less than 35%; 7. Patients with nn-ischemic dilated cardimypathy (NIDCM) greater than nine mnths, NYHA Class II and III heart failure, and measured LVEF less than 35%; 8. Patients wh meet all current Centers fr Medicare & Medicaid Services (CMS) cverage requirements fr a cardiac resynchrnizatin therapy (CRT) device and have NYHA Class IV heart failure; All indicatins must meet the fllwing criteria: a. Patients must nt have irreversible brain damage frm preexisting cerebral disease; b. MIs must be dcumented and defined accrding t the cnsensus dcument f the Jint Eurpean Sciety f Cardilgy/American Cllege f Cardilgy Cmmittee fr the Redefinitin f Mycardial Infarctin; Indicatins 3-8 (primary preventin f sudden cardiac death) must als meet the fllwing criteria: c. Patients must be able t give infrmed cnsent; d. Patients must nt have: 1. Cardigenic shck r symptmatic hyptensin while in a stable baseline rhythm; 2. Had a CABG r PTCA within the past three mnths; 3. Had an acute MI within the past 40 days; 4. Clinical symptms r findings that wuld make them a candidate fr crnary revascularizatin; Page 7 f 16

8 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 5. Any disease, ther than cardiac disease (e.g., cancer, uremia, liver failure), assciated with a likelihd f survival less than ne year; e. Ejectin fractins must be measured by angigraphy, radinuclide scanning, r echcardigraphy; f. The patient receiving the defibrillatr implantatin fr primary preventin is enrlled in either a Fd and Drug Administratin (FDA)-apprved categry B investigatinal device exemptin (IDE) clinical trial, a trial under the CMS Clinical Trial Plicy r a qualifying data cllectin system including apprved clinical trials and registries. g. Prviders must be able t justify the medical necessity f devices ther than single lead devices. This justificatin shuld be available in the patient s medical recrd. 9. Patients with NIDCM greater than three mnths, NYHA Class II r III heart failure, and measured LVEF less than 35%, nly if the fllwing additinal criteria are als met: a. Patients must be able t give infrmed cnsent; b. Patients must nt have: 1. Cardigenic shck r symptmatic hyptensin while in a stable baseline rhythm; 2. Had a CABG r PTCA within the past three mnths; 3. Had an acute MI within the past 40 days; 4. Clinical symptms r findings that wuld make them a candidate fr crnary revascularizatin; 5. Irreversible brain damage frm preexisting cerebral disease; 6. Any disease, ther than cardiac disease (e.g., cancer, uremia, liver failure), assciated with a likelihd f survival less than ne year; c. Ejectin fractins must be measured by angigraphy, radinuclide scanning, r echcardigraphy; d. MIs must be dcumented and defined accrding t the cnsensus dcument f the Jint Eurpean Sciety f Cardilgy/American Cllege f Cardilgy Cmmittee fr the Redefinitin f Mycardial Infarctin; e. The patient receiving the defibrillatr implantatin fr this indicatin is enrlled in either an FDAapprved categry B IDE clinical trial, a trial under the CMS Rutine Services f a Clinical Trial Plicy, r a prspective data cllectin system meeting the fllwing basic criteria: 1. Written prtcl n file; 2. Institutinal Review Bard review and apprval; 3. Scientific review and apprval by tw r mre qualified individuals wh are nt part f the research team; 4. Certificatin that investigatrs have nt been disqualified. CMS will determine whether specific registries r clinical trials meet these criteria. f. Prviders must be able t justify the medical necessity f devices ther than single lead devices. This justificatin shuld be available in the patient s medical recrd. Other Indicatins All ther indicatins fr implantable autmatic defibrillatrs nt currently meeting these criteria may fall under clinical trials. Page 8 f 16

9 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 Backgrund The risk f ventricular arrhythmia and SCD may be significantly increased in varius cardiac cnditins such as individuals with ischemic cardimypathy, particularly when assciated with reduced left ventricular ejectin fractin (LVEF) and prir mycardial infarctin; nnischemic dilated cardimypathy with reduced LVEF; hypertrphic cardimypathy and additinal risk factrs; cngenital heart disease, particularly with recurrent syncpe; and cardiac in channelpathies. ICDs mnitr a patient s heart rate, recgnize ventricular fibrillatin (VF) r ventricular tachycardia (VT), and deliver an electric shck t terminate these arrhythmias t reduce the risk f SCD. Indicatins fr ICD can be bradly subdivided int (1) secndary preventin, i.e., use in patients wh have experienced a ptentially life-threatening episde f VT (near SCD); and (2) primary preventin, i.e., use in patients wh are cnsidered at high risk fr SCD but wh have nt yet experienced life-threatening VT r VF. The standard ICD surgery invlves f a generatr in the subcutaneus tissue f the chest wall. Transvenus leads are attached t the generatr and threaded intravenusly int the endcardium. The leads sense and transmit infrmatin n cardiac rhythm t the generatr, which analyzes the rhythm infrmatin and prduces an electrical shck when a malignant arrhythmia is recgnized. An S-ICD has been develped. It des nt use transvenus leads and thus avids the need fr venus access and cmplicatins assciated with the insertin f venus leads. Rather, the S-ICD uses a subcutaneus electrde implanted adjacent t the left sternum. The electrdes sense the cardiac rhythm and deliver cuntershcks thrugh the subcutaneus tissue f the chest wall. Several autmatic ICDs have been apprved by the U.S. Fd and Drug Administratin (FDA) thrugh the premarket apprval prcess. The FDA-labeled indicatins generally include patients wh have experienced lifethreatening VT assciated with cardiac arrest r VT assciated with hemdynamic cmprmise and resistance t pharmaclgic treatment. In additin, devices typically have apprval in the secndary preventin setting fr patients with a previus mycardial infarctin and reduced ejectin fractin. Regulatry Status Transvenus Implantable Cardiverter Defibrillatrs A large number f ICDs have been apprved by the FDA thrugh the premarket apprval (PMA) prcess (FDA prduct cde: LWS). A 2014 review f the FDA apprvals f cardiac implantable devices reprted that, between 1979 and 2012, the FDA apprved 19 ICDs (seven pulse generatrs, three leads, nine cmbined systems) thrugh new PMA applicatins. 1 Many riginally apprved ICDs have received multiple supplemental applicatins. A selective summary f sme currently available ICDs is prvided in Table 1. Subcutaneus ICDs In September 2012, the Subcutaneus Implantable Defibrillatr (S-ICD ) System was apprved by FDA thrugh the PMA prcess fr the treatment f life-threatening ventricular tachyarrhythmias in patients wh d nt have symptmatic bradycardia, incessant ventricular tachycardia, r spntaneus, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing (see Table 1). In March 2015, the Emblem S-ICD (Bstn Scientific), which is smaller and lnger-lasting than the riginal S- ICD, was apprved by FDA thrugh the PMA supplement prcess. Page 9 f 16

10 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 Table 1. Implantable Cardiverter Defibrillatrs With FDA Apprval Device Manufacturer Original PMA Apprval Date Transvenus Ellipse /Frtify Assura Family (riginally: Cadence Tiered Therapy Defibrillatin System) St. Jude Medical (St. Paul, MN) Jul 1993 Current Plus ICD (riginally: Cadence Tiered Therapy Defibrillatin System) Dynagen, Ingen, Origen, and Teligen Family (riginally: Ventak, Vitality, Cfient family) Evera Family (riginally: Virtuss/Entrust/Maxim/ Intrisic/Marquis family) Subcutaneus Subcutaneus Implantable Defibrillatr System (S- ICD ) FDA: Fd and Drug Administratin; PMA: premarket applicatin. St. Jude Medical (St. Paul, MN) Jul 1993 Bstn Scientific (Marlbrugh, MA) Jan 1998 Medtrnic (Minneaplis, MN) Dec 1998 Camern Health (San Clemente, CA); acquired by Bstn Scientific Sep 2012 NOTE: ICDs may be cmbined with ther pacing devices, such as pacemakers fr atrial fibrillatin, r biventricular pacemakers designed t treat heart failure. This prtcl addresses ICDs alne, when used slely t treat patients at risk fr ventricular arrhythmias. Related Prtcl Biventricular Pacemakers (Cardiac Resynchrnizatin Therapy) fr the Treatment f Heart Failure Services that are the subject f a clinical trial d nt meet ur Technlgy Assessment Prtcl criteria and are cnsidered investigatinal. Fr explanatin f experimental and investigatinal, please refer t the Technlgy Assessment Prtcl. It is expected that nly apprpriate and medically necessary services will be rendered. We reserve the right t cnduct prepayment and pstpayment reviews t assess the medical apprpriateness f the abve-referenced prcedures. Sme f this prtcl may nt pertain t the patients yu prvide care t, as it may relate t prducts that are nt available in yur gegraphic area. References We are nt respnsible fr the cntinuing viability f web site addresses that may be listed in any references belw. 1. Rme BN, Kramer DB, Kesselheim AS. FDA apprval f cardiac implantable electrnic devices via riginal and supplement premarket apprval pathways, JAMA. Jan ; 311(4): PMID Mss AJ, Hall WJ, Cannm DS, et al. Imprved survival with an implanted defibrillatr in patients with crnary disease at high risk fr ventricular arrhythmia. Multicenter Autmatic Defibrillatr Implantatin Trial Investigatrs. N Engl J Med. Dec ; 335(26): PMID Mss AJ, Zareba W, Hall WJ, et al. Prphylactic implantatin f a defibrillatr in patients with mycardial infarctin and reduced ejectin fractin. N Engl J Med. Mar ; 346(12): PMID Page 10 f 16

11 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/17 4. Bigger JT, Jr. Prphylactic use f implanted cardiac defibrillatrs in patients at high risk fr ventricular arrhythmias after crnary-artery bypass graft surgery. Crnary Artery Bypass Graft (CABG) Patch Trial Investigatrs. N Engl J Med. Nv ; 337(22): PMID Buxtn AE, Lee KL, Fisher JD, et al. A randmized study f the preventin f sudden death in patients with crnary artery disease. Multicenter Unsustained Tachycardia Trial Investigatrs. N Engl J Med. Dec ; 341(25): PMID Bardy GH, Lee KL, Mark DB, et al. Amidarne r an implantable cardiverter-defibrillatr fr cngestive heart failure. N Engl J Med. Jan ; 352(3): PMID Hhnlser SH, Kuck KH, Drian P, et al. Prphylactic use f an implantable cardiverter-defibrillatr after acute mycardial infarctin. N Engl J Med. Dec ; 351(24): PMID Steinbeck G, Andresen D, Seidl K, et al. Defibrillatr implantatin early after mycardial infarctin. N Engl J Med. Oct ; 361(15): PMID Raviele A, Bngirni MG, Brignle M, et al. Early EPS/ICD strategy in survivrs f acute mycardial infarctin with severe left ventricular dysfunctin n ptimal beta-blcker treatment. The BEta-blcker STrategy plus ICD trial. Eurpace. Jul 2005; 7(4): PMID Kadish A, Dyer A, Daubert JP, et al. Prphylactic defibrillatr implantatin in patients with nnischemic dilated cardimypathy. N Engl J Med. May 20, 2004; 350(21): PMID Bristw MR, Saxn LA, Behmer J, et al. Cardiac-resynchrnizatin therapy with r withut an implantable defibrillatr in advanced chrnic heart failure. N Engl J Med. May 20, 2004; 350(21): PMID Strickberger SA, Hummel JD, Bartlett TG, et al. Amidarne versus implantable cardiverter-defibrillatr: randmized trial in patients with nnischemic dilated cardimypathy and asymptmatic nnsustained ventricular tachycardia--amiovirt. J Am Cll Cardil. May 21, 2003; 41(10): PMID Bansch D, Antz M, Bczr S, et al. Primary preventin f sudden cardiac death in idipathic dilated cardimypathy: the Cardimypathy Trial (CAT). Circulatin. Mar ; 105(12): PMID Kber L, Thune JJ, Nielsen JC, et al. Defibrillatr implantatin in patients with nnischemic systlic heart failure. N Engl J Med. Sep ; 375(13): PMID Wds B, Hawkins N, Mealing S, et al. Individual patient data netwrk meta-analysis f mrtality effects f implantable cardiac devices. Heart. Nv 2015; 101(22): PMID Wlff G, Lin Y, Karathans A, et al. Implantable cardiverter/defibrillatrs fr primary preventin in dilated cardimypathy pst-danish: an updated meta-analysis and systematic review f randmized cntrlled trials. Clin Res Cardil. Feb PMID Stavrakis S, Asad Z, Reynlds D. Implantable cardiverter defibrillatrs fr primary preventin f mrtality in patients with nn-ischemic cardimypathy: a meta-analysis f randmized cntrlled trials. J Cardivasc Electrphysil. Mar PMID Akel T, Lafferty J. Implantable cardiverter defibrillatrs fr primary preventin in patients with nnischemic cardimypathy: a systematic review and meta-analysis. Minerva Cardiangil. Feb PMID Glwala H, Bajaj NS, Arra G, et al. Implantable cardiverter-defibrillatr fr nnischemic cardimypathy: an updated meta-analysis. Circulatin. Jan ; 135(2): PMID Desai AS, Fang JC, Maisel WH, et al. Implantable defibrillatrs fr the preventin f mrtality in patients with nnischemic cardimypathy: a meta-analysis f randmized cntrlled trials. JAMA. Dec ; 292(23): PMID Earley A, Perssn R, Garlitski AC, et al. Effectiveness f implantable cardiverter defibrillatrs fr primary preventin f sudden cardiac death in subgrups a systematic review. Ann Intern Med. Jan ; 160(2): PMID Fntenla A, Martinez-Ferrer JB, Alzueta J, et al. Incidence f arrhythmias in a large chrt f patients with current implantable cardiverter-defibrillatrs in Spain: results frm the UMBRELLA Registry. Eurpace. Nv 2016; 18(11): PMID Page 11 f 16

12 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/ Schinkel AF, Vriesendrp PA, Sijbrands EJ, et al. Outcme and cmplicatins after implantable cardiverter defibrillatr therapy in hypertrphic cardimypathy: systematic review and meta-analysis. Circ Heart Fail. Sep ; 5(5): PMID Magnussn P, Gadler F, Liv P, et al. Hypertrphic cardimypathy and implantable defibrillatrs in Sweden: inapprpriate shcks and cmplicatins requiring surgery. J Cardivasc Electrphysil. Oct 2015; 26(10): PMID Hrner JM, Kinshita M, Webster TL, et al. Implantable cardiverter defibrillatr therapy fr cngenital lng QT syndrme: a single-center experience. Heart Rhythm. Nv 2010; 7(11): PMID Cnte G, Sieira J, Cicnte G, et al. Implantable cardiverter-defibrillatr therapy in Brugada syndrme: a 20- year single-center experience. J Am Cll Cardil. Mar ; 65(9): PMID Dres H, Reis Sants K, Adraga P, et al. Lng-term prgnsis f patients with Brugada syndrme and an implanted cardiverter-defibrillatr. Rev Prt Cardil. Jun 2015; 34(6): PMID Steven D, Rberts-Thmsn KC, Inada K, et al. Lng-term fllw-up in patients with presumptive Brugada syndrme treated with implanted defibrillatrs. J Cardivasc Electrphysil. Oct 2011; 22(10): PMID Daulah A, Alsheikh-Ali AA, Ocheltree AH, et al. Outcme after implantable cardiverter-defibrillatr in patients with Brugada syndrme: the Gulf Brugada syndrme registry. J Electrcardil. May-Jun 2012; 45(3): PMID Rses-Nguer F, Jarman JW, Clague JR, et al. Outcmes f defibrillatr therapy in catechlaminergic plymrphic ventricular tachycardia. Heart Rhythm. Jan 2014; 11(1): PMID A cmparisn f antiarrhythmic-drug therapy with implantable defibrillatrs in patients resuscitated frm near-fatal ventricular arrhythmias. N Engl J Med. Nv ; 337(22): PMID Kuck KH, Cappat R, Siebels J, et al. Randmized cmparisn f antiarrhythmic drug therapy with implantable defibrillatrs in patients resuscitated frm cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). Circulatin. Aug ; 102(7): PMID Cnnlly SJ, Gent M, Rberts RS, et al. Canadian implantable defibrillatr study (CIDS): a randmized trial f the implantable cardiverter defibrillatr against amidarne. Circulatin. Mar ; 101(11): PMID Nademanee K, Veerakul G, Mwer M, et al. Defibrillatr Versus beta-blckers fr Unexplained Death in Thailand (DEBUT): a randmized clinical trial. Circulatin. May 06, 2003; 107(17): PMID Wever EF, Hauer RN, van Capelle FL, et al. Randmized study f implantable defibrillatr as first-chice therapy versus cnventinal strategy in pstinfarct sudden death survivrs. Circulatin. Apr ; 91(8): PMID Lee DS, Green LD, Liu PP, et al. Effectiveness f implantable defibrillatrs fr preventing arrhythmic events and death: a meta-analysis. J Am Cll Cardil. May 07, 2003; 41(9): PMID Natinal Institute fr Health and Care Excellence (NICE). Overview: Implantable cardiverter defibrillatrs fr the treatment f arrhythmias and cardiac resynchrnisatin therapy fr the treatment f heart failure (Review f TA95 and TA120). 2013; Accessed April 5, Cnnlly SJ, Hallstrm AP, Cappat R, et al. Meta-analysis f the implantable cardiverter defibrillatr secndary preventin trials. AVID, CASH and CIDS studies. Antiarrhythmics vs. Implantable Defibrillatr study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillatr Study. Eur Heart J. Dec 2000; 21(24): PMID Betts TR, Sadarmin PP, Tmlinsn DR, et al. Abslute risk reductin in ttal mrtality with implantable cardiverter defibrillatrs: analysis f primary and secndary preventin trial data t aid risk/benefit analysis. Eurpace. Jun 2013; 15(6): PMID Page 12 f 16

13 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/ Chan PS, Hayward RA. Mrtality reductin by implantable cardiverter-defibrillatrs in high-risk patients with heart failure, ischemic heart disease, and new-nset ventricular arrhythmia: an effectiveness study. J Am Cll Cardil. May 03, 2005; 45(9): PMID Berul CI, Van Hare GF, Kertesz NJ, et al. Results f a multicenter retrspective implantable cardiverterdefibrillatr registry f pediatric and cngenital heart disease patients. J Am Cll Cardil. Apr ; 51(17): PMID Silka MJ, Krn J, Dunnigan A, et al. Sudden cardiac death and the use f implantable cardiverter-defibrillatrs in pediatric patients. The Pediatric Electrphysilgy Sciety. Circulatin. Mar 1993; 87(3): PMID Alexander ME, Cecchin F, Walsh EP, et al. Implicatins f implantable cardiverter defibrillatr therapy in cngenital heart disease and pediatrics. J Cardivasc Electrphysil. Jan 2004; 15(1): PMID Lewandwski M, Sterlinski M, Maciag A, et al. Lng-term fllw-up f children and yung adults treated with implantable cardiverter-defibrillatr: the authrs wn experience with ptimal implantable cardiverter-defibrillatr prgramming. Eurpace. Sep 2010; 12(9): PMID Perssn R, Earley A, Garlitski AC, et al. Adverse events fllwing implantable cardiverter defibrillatr implantatin: a systematic review. J Interv Card Electrphysil. Aug 2014; 40(2): PMID Ezzat VA, Lee V, Ahsan S, et al. A systematic review f ICD cmplicatins in randmised cntrlled trials versus registries: is ur real-wrld data an underestimatin? Open Heart. 2015; 2(1):e PMID Kirkfeldt RE, Jhansen JB, Nhr EA, et al. Cmplicatins after cardiac implantable electrnic device implantatins: an analysis f a cmplete, natinwide chrt in Denmark. Eur Heart J. May 2014; 35(18): PMID van Rees JB, de Bie MK, Thijssen J, et al. Implantatin-related cmplicatins f implantable cardiverterdefibrillatrs and cardiac resynchrnizatin therapy devices: a systematic review f randmized clinical trials. J Am Cll Cardil. Aug ; 58(10): PMID Olde Nrdkamp LR, Pstema PG, Knps RE, et al. Implantable cardiverter-defibrillatr harm in yung patients with inherited arrhythmia syndrmes: A systematic review and meta-analysis f inapprpriate shcks and cmplicatins. Heart Rhythm. Feb 2016; 13(2): PMID Fd and Drug Administratin. Premature Insulatin Failure in Recalled Riata Implantable Cardiverter Defibrillatr (ICD) Leads Manufactured by St. Jude Medical, Inc.: FDA Safety Cmmunicatin. 2014; Accessed September, Hauser RG, Katsiyiannis WT, Grnick CC, et al. Deaths and cardivascular injuries due t device-assisted implantable cardiverter-defibrillatr and pacemaker lead extractin. Eurpace. Mar 2010; 12(3): PMID Prvidencia R, Kramer DB, Pimenta D, et al. Transvenus implantable cardiverter-defibrillatr (ICD) lead perfrmance: a meta-analysis f bservatinal studies. J Am Heart Assc. Nv 2015; 4(11). PMID Birnie DH, Parkash R, Exner DV, et al. Clinical predictrs f Fidelis lead failure: reprt frm the Canadian Heart Rhythm Sciety Device Cmmittee. Circulatin. Mar ; 125(10): PMID Hauser RG, Maisel WH, Friedman PA, et al. Lngevity f Sprint Fidelis implantable cardiverter-defibrillatr leads and risk factrs fr failure: implicatins fr patient management. Circulatin. Feb ; 123(4): PMID Guld PA, Gula LJ, Champagne J, et al. Outcme f advisry implantable cardiverter-defibrillatr re: ne-year fllw-up. Heart Rhythm. Dec 2008; 5(12): PMID Ple JE, Gleva MJ, Mela T, et al. Cmplicatin rates assciated with pacemaker r implantable cardiverter-defibrillatr generatr res and upgrade prcedures: results frm the REPLACE registry. Circulatin. Oct ; 122(16): PMID Ricci RP, Pignalberi C, Magris B, et al. Can we predict and prevent adverse events related t high-vltage implantable cardiverter defibrillatr lead failure? J Interv Card Electrphysil. Jan 2012; 33(1): PMID Page 13 f 16

14 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/ Cheng A, Wang Y, Curtis JP, et al. Acute lead disldgements and in-hspital mrtality in patients enrlled in the natinal cardivascular data registry implantable cardiverter defibrillatr registry. J Am Cll Cardil. Nv ; 56(20): PMID Faulknier BA, Traub DM, Aktas MK, et al. Time-dependent risk f Fidelis lead failure. Am J Cardil. Jan ; 105(1): PMID Smit J, Krup E, Schnheyder HC. Infectins assciated with permanent pacemakers and implanted cardiverter-defibrillatr devices. A 10-year reginal study in Denmark. Scand J Infect Dis. Sep 2010; 42(9): PMID Nery PB, Fernandes R, Nair GM, et al. Device-related infectin amng patients with pacemakers and implantable defibrillatrs: incidence, risk factrs, and cnsequences. J Cardivasc Electrphysil. Jul 2010; 21(7): PMID Shail MR, Hussain S, Le KY, et al. Risk factrs assciated with early-versus late-nset implantable cardiverter-defibrillatr infectins. J Interv Card Electrphysil. Aug 2011; 31(2): PMID Chua JD, Wilkff BL, Lee I, et al. Diagnsis and management f infectins invlving implantable electrphysilgic cardiac devices. Ann Intern Med. Oct ; 133(8): PMID Brleffs CJ, Thijssen J, de Bie MK, et al. Recurrent implantable cardiverter-defibrillatr re is assciated with an increasing risk f pcket-related cmplicatins. Pacing Clin Electrphysil. Aug 2010; 33(8): PMID Daubert JP, Zareba W, Cannm DS, et al. Inapprpriate implantable cardiverter-defibrillatr shcks in MADIT II: frequency, mechanisms, predictrs, and survival impact. J Am Cll Cardil. Apr ; 51(14): PMID Tan VH, Wiltn SB, Kuriachan V, et al. Impact f prgramming strategies aimed at reducing nnessential implantable cardiverter defibrillatr therapies n mrtality: a systematic review and meta-analysis. Circ Arrhythm Electrphysil. Feb 2014; 7(1): PMID Sterns LD, Meine M, Kurita T, et al. Extended detectin time t reduce shcks is safe in secndary preventin patients: The secndary preventin substudy f PainFree SST. Heart Rhythm. Jul 2016; 13(7): PMID Auricchi A, Schlss EJ, Kurita T, et al. Lw inapprpriate shck rates in patients with single- and dual/triplechamber implantable cardiverter-defibrillatrs using a nvel suite f detectin algrithms: PainFree SST trial primary results. Heart Rhythm. May 2015; 12(5): PMID Lee DS, Krahn AD, Healey JS, et al. Evaluatin f early cmplicatins related t De Nv cardiverter defibrillatr implantatin insights frm the Ontari ICD database. J Am Cll Cardil. Feb ; 55(8): PMID Furniss G, Shi B, Jimenez A, et al. Cardiac trpnin levels fllwing implantable cardiverter defibrillatin implantatin and testing. Eurpace. Feb 2015; 17(2): PMID Hnarbakhsh S, Prvidencia R, Srinivasan N, et al. A prpensity matched case-cntrl study cmparing efficacy, safety and csts f the subcutaneus vs. transvenus implantable cardiverter defibrillatr. Int J Cardil. Feb ; 228: PMID Kbe J, Hucklenbrich K, Geisendrfer N, et al. Psttraumatic stress and quality f life with the ttally subcutaneus cmpared t cnventinal cardiverter-defibrillatr systems. Clin Res Cardil. May 2017; 106(5): PMID Pedersen SS, Mastenbrek MH, Carter N, et al. A cmparisn f the quality f life f patients with an entirely subcutaneus implantable defibrillatr system versus a transvenus system (frm the EFFORTLESS S-ICD Quality f Life Substudy). Am J Cardil. Aug ; 118(4): PMID Bruwer TF, Yilmaz D, Lindebm R, et al. Lng-term clinical utcmes f subcutaneus versus transvenus implantable defibrillatr therapy. J Am Cll Cardil. Nv ; 68(19): PMID Friedman DJ, Parzynski CS, Varsy PD, et al. Trends and in-hspital utcmes assciated with adptin f the subcutaneus implantable cardiverter defibrillatr in the United States. JAMA Cardil. Nv ; 1(8): PMID Page 14 f 16

15 Prtcl Implantable Cardiverter Defibrillatrs Last Review Date: 11/ Kbe J, Reinke F, Meyer C, et al. Implantatin and fllw-up f ttally subcutaneus versus cnventinal implantable cardiverter-defibrillatrs: a multicenter case-cntrl study. Heart Rhythm. Jan 2013; 10(1): PMID Pettit SJ, McLean A, Clquhun I, et al. Clinical experience f subcutaneus and transvenus implantable cardiverter defibrillatrs in children and teenagers. Pacing Clin Electrphysil. Dec 2013; 36(12): PMID Gld MR, Theuns DA, Knight BP, et al. Head-t-head cmparisn f arrhythmia discriminatin perfrmance f subcutaneus and transvenus ICD arrhythmia detectin algrithms: the START study. J Cardivasc Electrphysil. Apr 2012; 23(4): PMID Lambiase PD, Barr C, Theuns DA, et al. Wrldwide experience with a ttally subcutaneus implantable defibrillatr: early results frm the EFFORTLESS S-ICD Registry. Eur Heart J. Jul ; 35(25): PMID Olde Nrdkamp LR, Bruwer TF, Barr C, et al. Inapprpriate shcks in the subcutaneus ICD: Incidence, predictrs and management. Int J Cardil. Sep ; 195: PMID Weiss R, Knight BP, Gld MR, et al. Safety and efficacy f a ttally subcutaneus implantable-cardiverter defibrillatr. Circulatin. Aug ; 128(9): PMID Burke MC, Gld MR, Knight BP, et al. Safety and efficacy f the ttally subcutaneus implantable defibrillatr: 2-year results frm a pled analysis f the IDE Study and EFFORTLESS Registry. J Am Cll Cardil. Apr ; 65(16): PMID Bersma L, Burke MC, Neuzil P, et al. Infectin and mrtality after implantatin f a subcutaneus ICD after transvenus ICD extractin. Heart Rhythm. Jan 2016; 13(1): PMID Lambiase PD, Gld MR, Hd M, et al. Evaluatin f subcutaneus ICD early perfrmance in hypertrphic cardimypathy frm the pled EFFORTLESS and IDE chrts. Heart Rhythm. May 2016; 13(5): PMID Bardy GH, Smith WM, Hd MA, et al. An entirely subcutaneus implantable cardiverter-defibrillatr. N Engl J Med. Jul ; 363(1): PMID Theuns DA, Crzier IG, Barr CS, et al. Lngevity f the subcutaneus implantable defibrillatr: lng-term fllw-up f the Eurpean Regulatry Trial chrt. Circ Arrhythm Electrphysil. Oct 2015; 8(5): PMID Olde Nrdkamp LR, Dabiri Abkenari L, Bersma LV, et al. The entirely subcutaneus implantable cardiverter-defibrillatr: initial clinical experience in a large Dutch chrt. J Am Cll Cardil. Nv ; 60(19): PMID Aydin A, Hartel F, Schluter M, et al. Shck efficacy f subcutaneus implantable cardiverter-defibrillatr fr preventin f sudden cardiac death: initial multicenter experience. Circ Arrhythm Electrphysil. Oct 2012; 5(5): PMID El-Chami MF, Levy M, Kelli HM, et al. Outcme f subcutaneus implantable cardiverter defibrillatr implantatin in patients with end-stage renal disease n dialysis. J Cardivasc Electrphysil. Aug 2015; 26(8): PMID Kman E, Gupta A, Subzpsh F, et al. Outcmes f subcutaneus implantable cardiverter-defibrillatr implantatin in patients n hemdialysis. J Interv Card Electrphysil. Mar 2016; 45(2): PMID Kiman KM, Knps RE, Olde Nrdkamp L, et al. Inapprpriate subcutaneus implantable cardiverterdefibrillatr shcks due t T-wave versensing can be prevented: implicatins fr management. Heart Rhythm. Mar 2014; 11(3): PMID Yancy CW, Jessup M, Bzkurt B, et al ACCF/AHA guideline fr the management f heart failure: a reprt f the American Cllege f Cardilgy Fundatin/American Heart Assciatin Task Frce n Practice Guidelines. J Am Cll Cardil. Oct ; 62(16):e PMID Page 15 f 16