BlueCross and BlueShield of Montana Medical Policy/Codes
Automatic Implantable Cardioverter Defibrillator (AICD) and Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
Chapter: Surgery: Procedures
Current Effective Date: April 18, 2013
Original Effective Date: April 18, 2013
Publish Date: January 18, 2013
Description

The automatic implantable cardioverter defibrillator (AICD) is a device designed to monitor a patient’s heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death.

Indications for AICD implantation can be broadly subdivided into the following:

  • Primary prevention - for use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life-threatening VT or VF; and
  • Secondary prevention - for use in patients who have experienced a potentially life-threatening episode of ventricular tachyarrhythmia (near sudden cardiac death).

Several automatic implantable cardioverter defibrillators are approved by the U.S. Food and Drug Administration (FDA) through the premarket application (PMA) approval process.  The FDA-labeled indications generally include patients who have experienced life-threatening ventricular tachyarrhythmia associated with cardiac arrest, or ventricular tachyarrhythmia associated with hemodynamic compromise and resistance to pharmacologic treatment.

Devices manufactured by Guidant are approved by the FDA for use “in patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced at least one of the following: an episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained VT; or a prior myocardial infarction, left ventricular ejection fraction of less than or equal to 35%, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia.”  On July 18, 2002, the FDA expanded the approved indications for the Guidant AICD devices to include the prophylactic use of Guidant AICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is less than or equal to 30%.  This expanded indication is based on the results of the Multicenter Automatic Defibrillator Implantation Trial (MADIT II).  Medtronic devices are approved “to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.”  Other devices have approval language similar to Medtronic.

Subcutaneous Implantable Defibrillator System (S-ICD)

The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine implantable cardioverter debifrillator (ICD) placement procedure is not ideal such as patients with anatomy that makes it challenging to place one of the implantable defibrillators.  The system uses a lead that is implanted just under the skin along the bottom of the rib cage and breast bone.  Because the lead is placed under the skin rather than through a vein into the heart, a physician can implant the device without accessing a patient’s blood vessels or heart and without the need for fluoroscopy.

The S-ICD System is approved to provide an electric shock to the heart (defibrillation) when the patient’s heart is beating at a dangerous level or abnormally fast (ventricular tachyarrhythmias). It is approved only for patients who do not require a pacemaker or pacing therapy. (22)

Policy

Blue Cross and Blue Shield of Montana (BCBSMT) is not requesting prior authorization of implantable cardioverter defibrillators at this time. However, BCBSMT will conduct periodic post-payment reviews to determine if billed services are in adherence to these published guidelines. BCBSMT will seek the return of any payments made for implantable cardioverter defibrillator use that does not conform to the following medical necessity guidelines. Refer to the medical policy: Advance Member Notification - Professional Services that contains instructions on how to correctly bill for services that do not meet medical necessity guidelines. The form is available on the BCBSMT website.

Medically Necessary

Adults

BCBSMT may consider the use of the automatic implantable cardioverter defibrillator (ICD) medically necessary in adults who meet the following criteria:

Primary Prevention

  • ischemic cardiomyopathy with New York Heart Association (NYHA) functional Class II or Class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35% or less; or
  • ischemic cardiomyopathy with NYHA functional Class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or less; or
  • nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined; or
  • hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; 1 or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.

Secondary Prevention

  • Patients with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia.
  • Patient’s with familial or inherited conditions with a high risk of life-threatening VT’s such as long QT syndrome or hypertrophic cardiomyopathy.

Pediatrics

BCBSMT may consider the use of the ICD medically necessary in children who meet any of the following criteria:

  • survivors of cardiac arrest, after reversible causes have been excluded;
  • symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation; or
  • congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias.

Investigational

BCBSMT considers the use of the ICD investigational:

  • in primary prevention patients who have had an acute myocardial infarction (i.e., less than 40 days before ICD treatment);
  • in primary prevention patients who have New York Heart AssociationNYHA) Class IV congestive heart failure (unless patient is eligible to receive a combination cardiac resynchronization therapy ICD device);
  • in primary prevention patients who have had a cardiac revascularization procedure in past 3 months (coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) or are candidates for a cardiac revascularization procedure; or
  • in primary prevention patients who have noncardiac disease that would be associated with life expectancy less than 1 year.
  • for all other indications in pediatric patients.

The use of a subcutaneous ICD is considered investigational for all indications in adult and pediatric patients.  

Rationale

Automatic Implantable Cardioverter Defibrillator’s (AICDs) were first used in survivors of near sudden cardiac death.  There has been ongoing interest in using AICDs as primary preventive therapy in patients with risk factors for sudden cardiac death.  A 2002 Blue Cross Blue Shield Association Technology Evaluation Center (BCBSA TEC) Assessment (2) focused on this indication for AICDs.  The 2002 Assessment focused on two successive randomized clinical trials, known as MADIT I and MADIT II (Multicenter Automatic Defibrillator Implantation Trial) that compared the use of an AICD with conventional therapy among patients with coronary artery disease with a prior history of myocardial infarction and a current history of a reduced ejection fraction.  The key difference in the two trials was the patient selection criteria.  In the earlier MADIT I trial, patients were required to have a left ventricular ejection fraction (LVEF) of less than 35% but also ventricular tachyarrhythmia as evidenced on an electrophysiologic study.  In the subsequent MADIT II trial, patients were required to have a lower ejection fraction, less than 30%, but no electrophysiologic study was required.  Therefore, the patient selection criteria of the MADIT II trial potentially identify a much larger number of candidates for AICD implantation.

2002 BCBSA TEC Assessment Observations and Conclusions:

For patients who have coronary artery disease with prior myocardial infarction and reduced left ventricular ejection fraction and who are similar to those selected in MADIT I and MADIT II, the available evidence demonstrates a statistically significant improvement in overall mortality associated with AICD treatment compared with conventional therapy.

A 2005 BCBSA TEC Assessment focused on the results of the five randomized clinical trials (RCT) included in the 2002 BCBSA TEC Assessment (including MUSTT, MADIT, MADIT II, CABG-Patch, and CAT) and five RCTs:

1. Defibrillator in Acute Myocardial Infarction Trial (DINAMIT);

2. Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT);

3. Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION);

4. Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE); and

5. Amiodarone versus Implantable Defibrillator Randomized Trial (AMIOVIRT).

Observations of the 2005 BCBSA TEC Assessment:

Patients Who Have Prior Myocardial Infarction and Reduced LVEF:

The previous 2002 A BCBSA TEC assessment concluded that the evidence was sufficient to demonstrate that ICD therapy improves net health outcome in patients with prior myocardial infarction and reduced LVEF.  Both new studies (SCD-HeFT and COMPANION) and the re-analysis of MUSTT findings provide additional supportive evidence of improved outcomes in patients with prior MI.  The hazard ratio for all-cause mortality in the ischemic subgroup of SCD-HeFT was 0.79 (95% CI 0.60 to 1.04), which is close to that observed in MADIT II (HR=0.69, 95% CI=0.51 to 0.93), and these findings provide additional supportive evidence that ICD therapy reduces mortality.  There may be slight but not statistically significantly increased rates of adverse effects associated with implantable cardioverter defibrillator (ICD) therapy; however, serious device-related events are not common.  On balance, the significant reductions in mortality associated with ICD therapy outweigh the harms associated with ICD therapy in comparison to conventional treatment.  Thus, the available evidence again demonstrates that ICD therapy improves health outcomes in patients with coronary artery disease and prior myocardial infarction and reduced LVEF. (7)

Patients Who Have Acute Myocardial Infarction (MI) and Reduced LVEF:

The available evidence is insufficient to permit conclusions regarding the effect of ICD therapy on net health outcome for this indication.

Patients Who Have No Prior Myocardial Infarction and Reduced LVEF (e.g., Nonischemic Dilated Cardiomyopathy):

Results from subjects with nonischemic dilated cardiomyopathy included in SCD-HeFT and DEFINITE suggest a mortality benefit from ICD therapy, although statistical significance was not achieved in these studies likely related to insufficient power of the analysis.  A recently published meta-analysis of five trials including nonischemic subjects does report a statistically significant reduction in mortality associated with ICD therapy.  Furthermore, when the body of evidence for ICD therapy in both ischemic and nonischemic populations is considered together, the preponderance of evidence suggests that ICD therapy improves health outcomes compared with medical management alone with a relative risk reduction in all-cause mortality between 21% and 35%.  While the risk of adverse events is not well reported in studies of patients without prior MI, it seems reasonable to expect similar low rates of device-related adverse events as seen in studies of patients with prior MI.

Device-Related Adverse Effects:

Device-related adverse effects were inconsistently reported in the available trials although serious adverse events appear to be uncommon.  What is known about device-related adverse effects does not outweigh the significant mortality benefits demonstrated in various studies.

Conclusions of 2005 BCBSA TEC Assessment:

ICD placement has been performed and investigated in multiple centers throughout the United States, and when performed by similarly experienced personnel, it is reasonable to expect that the improvements observed in the investigational setting will be attainable outside the investigational settings.  Therefore, the use of ICD devices meets the BCBSA TEC criteria in the prevention of sudden death from ventricular tachyarrhythmia in patients who have:

  • Symptomatic ischemic dilated cardiomyopathy with a history of myocardial infarction at least 40 days before ICD treatment and left ventricular ejection fraction of 35% or less; or
  • Symptomatic nonischemic dilated cardiomyopathy for more than nine months’ duration and left ventricular ejection fraction of 35% or less.

The use of ICD devices does not meet the BCBSA TEC criteria in the prevention of sudden death from ventricular tachyarrhythmia in patients who:

  • Have had an acute myocardial infarction (i.e., less than 40 days before ICD treatment);
  • Have New York Heart Association (NYHA) Class IV congestive heart failure (unless patient is eligible to receive a combination cardiac resynchronization therapy ICD device);
  • Have had cardiac revascularization procedure in past three months coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) or are candidates for a cardiac revascularization procedure; or
  • Have noncardiac disease that would be associated with life expectancy less than one year.

Further analysis of existing trial data using patient-level meta-analysis may further delineate which subgroups of patients are likely to benefit from ICD placement and those unlikely to benefit who can be spared the morbidity of ICD placement. (8)

The TEC Assessment also noted that two additional studies addressing ICD use in patients with acute MI are in progress  The Beta-Blocker Strategy plus Implantable Cardioverter Defibrillator (BEST-ICD) trial was launched in June 1998 and is expected to enroll 1,200 patients with MI 5–21 days before ICD.  The Immediate Risk-Stratification Improves Survival (IRIS) Study compares ICD therapy with optimal medical management in patients with MI 5–31 days before ICD and is planned to enroll 700 subjects.  Both studies require abnormalities on noninvasive ECG testing, but BEST-ICD also requires EPS-inducible ventricular tachyarrhythmia.  Best-ICD requires LVEF <35% for eligibility; whereas IRIS includes LVEF<40%.

The American College of Cardiology/American Heart Association/North American Society of Pacing and Electrophysiology (ACC/AHA/NASPE)

In 2002, the ACC/AHA/NASPE issued guidelines for implantation of cardiac pacemakers and antiarrhythmia devices. (3)  As of February 2005, these guidelines have not been updated. The 2002 ACC/AHA/NASPE guideline recommendations are classified into three levels: Class I, II, and III.  Class I is defined as “conditions for which there is evidence for and/or general agreement that the procedure or treatment is useful and effective.”  Only Class I recommendations are listed here.  Each recommendation is further classified as either A, B, or C based on the weight of the evidence available.  Level A is applied when data are from multiple, randomized clinical trials; level B is when data are from a limited number of randomized trials; and level C is when the recommendation is primarily based on expert consensus.  The 2002 guidelines of the ACC/AHA/NASPE for implantation of cardiac pacemakers and antiarrhythmia devices suggest the following indications for AICDs:

  • Cardiac arrest due to ventricular fibrillation (VF) or ventricular tachyarrhythmia’s (VT) not due to a transient or reversible cause (Class A level of evidence).
  • Spontaneous sustained VT in association with structural heart disease (Class B level of evidence).
  • Syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT, or VF induced at electrophysiological study when drug therapy is ineffective, not tolerated, or not preferred (Class B level of evidence).
  • Nonsustained VT in patients with coronary disease, prior MI, LV dysfunction, and inducible VF or sustained VT at electrophysiological study that is not suppressible by a Class I antiarrhythmic drug (Class A level of evidence).
  • Spontaneous sustained VT in patients who do not have structural heart disease that is not amenable to other treatments (Class C level of evidence).

2008 Update

An additional search of literature was completed through Medline and other scientific databases for the period October 2005 through August 2008.  The search identified an update of the 2002 ACC/AHA/NASPE guidelines (now ACC/AHA/ESC guidelines), (6) an analysis of the DEFINITE trial examining timing of ICD placement in nonischemic dilated cardiomyopathy (NIDCM), and evidence on ICD effectiveness in patients with hypertrophic cardiomyopathy (HCM) at high risk of SCD.

DEFINITE Trial

ICD placement in NIDCM

Kadish and colleagues performed a post-hoc analysis of the DEFINITE trial data to examine whether the time from diagnosis of NIDCM was associated with the magnitude of benefit from ICD implantation. (12)  Survival benefit was found only for those diagnosed less than nine months prior to implantation (n=216); no benefit was apparent when NIDCM was diagnosed greater than nine months prior (n=242).  However, there was a significant difference between arms in the time from diagnosis to randomization—standard therapy patients were randomized a median of 20 months after diagnosis while those in the ICD arm were randomized a median of eight months.  The trial was neither designed nor powered to examine a time effect and the analyses conflict with findings of the smaller (n=104) “Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy: the Cardiomyopathy Trial (CAT)” trial.  Further evidence is necessary to indicate when in the natural history of the disease ICD implantation is appropriate.

ICD effectiveness in patients with HCM at high risk of SCD

Maron and colleagues reported appropriate ICD discharge rates (terminating either VT or VF) from an international registry of HCM patients enrolled at 42 referral and nonreferral institutions. (14)  Between 1986 and 2003, ICDs were implanted in 506 patients with HCM—383 for primary prevention and 123 for secondary prevention.  The mean age of patients was 42 years (standard deviation [SD] 17) and 28% were 30 years of age or younger; 36% were female; mean follow-up was 3.7 years (SD 2.8).  Criteria considered in the study that placed patients at high risk and, therefore, candidates for primary prevention included: 1) history of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years of age; 2) left-ventricular hypertrophy greater than 30 mm; 3) One or more runs of nonsustained VT at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; and 4) prior unexplained syncope inconsistent with neurocardiogenic origin.  Abnormal exercise blood pressure was not reported.  In the primary prevention group, appropriate discharges occurred at an annual rate of 3.6% (95% CI: 2.7% to 4.8%) and in the secondary prevention group at 10.6% (95% CI: 7.9% to 13.9%); the respective five-year cumulative probabilities of first appropriate discharge were 17% and 39%.  If each appropriate discharge was lifesaving, five-year numbers needed to benefit (NNTB) could be as low as 5.9 and 2.6 for primary and secondary prevention, respectively, when considering only the first appropriate discharge.

However, when analyzed in NIDCM, Ellenbogen and colleagues concluded that approximately one-half of arrhythmias terminated by appropriate ICD discharges are not life threatening. (13)  The NNTBs calculated, therefore, likely represent lower bounds or greatest potential benefit, and the true benefit is likely less (only 6.3% of primary prevention patients had more than one appropriate discharge).  Adverse event rates included one or more inappropriate discharges (27%); infections (3.8%); hemorrhage or thrombosis (1.6%); lead fractures, dislodgement, and oversensing (6.7%).  While the number of risk factors present was not associated with cumulative probability to first appropriate discharge for primary prevention, patient selection for ICD implantation was performed by experienced clinicians.  These results, obtained outside the setting of a clinical trial, apply under such conditions.  The relevant 2006 ACC/AHA/ESC guidelines, published prior to this study, classify primary prevention in HCM as a Class IIa indication (level of evidence C).  Given the evidence supporting a benefit of ICD in high-risk patients with HCM, the coverage statement of this medical policy has been changed.

2009 Update

The American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Guidelines

A significant change in the updated guidelines is specifying LVEF ranges to address varying enrollment criteria used in trials.  For example, rather than use LVEF less than 35%, the guidelines may state less than 30% to 40%.  While more extensive in scope than the previous guidelines, relevant class I recommendations are consistent with the coverage position of this policy.

The 2008 guidelines of the ACC/AHA/HRS for implantation of cardiac pacemakers and antiarrhythmia devices include the following class I indications for ICDs:

  1. ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation (VF) or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. (Level of Evidence: A).
  2. ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable.  (Level of Evidence: B).
  3. ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study.  (Level of Evidence: B).
  4. ICD therapy is indicated in patients with LVEF less than 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III.  (Level of Evidence: A) 
  5. ICD therapy is indicated in patients with NIDCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III. (Level of Evidence: B).
  6. ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than 30%, and are in NYHA functional Class I.  (Level of Evidence: A).
  7. ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF less than 40%, and inducible VF or sustained VT at electrophysiological study.  (Level of Evidence: B).

Notable is revision of LVEF from less than 40% to less than 35% for use as criteria for primary prevention—consistent with both clinical trial entry criteria and this policy.

2011 update

A literature search was performed through October 2011  For the adult population, there were no relevant clinical trials identified that compared ICD with alternative treatments.  Al-Khatib et al. published an analysis of whether ICD implantations in the U.S. followed evidence-based guidelines using a Medicare ICD registry. (20)  There were a total of 111,707 patients who received an ICD between January 2006 and June 2009.  Of these, 25,145 (22.5%) did not meet the evidence-based criteria according to ACC/AHA/HRS guidelines.  Patients who did not meet evidence-based ICD criteria had a higher mortality than patients who did meet criteria (0.57% vs. 0.18%, p<0.001), and also had a higher rate of procedural complications (3.2 vs. 2.4%, p<0.001). Electrophysiologists had a lower rate of non-evidence-based ICD use compared to non-electrophysiologists (20.8% vs. 24.8%, p<0.001).  For patients with non-ischemic cardiomyopathy, the timing of ICD implantation remains controversial.  No new direct evidence on this question was identified since the publication of the CAT and DEFINITE trials.  A substantial percent of patients diagnosed with non-ischemic cardiomyopathy (NICM) will not improve, even when a reversible cause of NICM cannot be identified, but it is not possible to predict which patients with idiopathic NICM will improve, nor is it possible to accurately estimate the time course for improvement. As a result, there is disagreement on the appropriate waiting period to implant an ICD following the diagnosis of NICM.

Some experts consider patients with recently diagnosed NICM and either sustained VT or unexplained syncope to be candidates for earlier ICD implantation due to their higher risk of lethal arrhythmias. However, evidence on this specific population is lacking and the natural history of patients in this category is not well characterized. The most recent ACC/AHA guidelines do not specifically address the optimal waiting period prior to implantation of an ICD for patients with newly diagnosed NICM.

Several publications offered new evidence on complications from ICD implantation. Cheng et al. examined the rate of lead dislodgements in patients enrolled in a national cardiovascular registry. (15) Of 226,764 patients treated with an ICD between April 2006 and September 2008, lead dislodgement occurred in 2,628 (1.2%).  Factors associated with lead dislodgement were NYHA class IV heart failure, atrial fibrillation/flutter, a combined ICD-CRT device, and having the procedure performed by a non-electrophysiologist.  Lead dislodgement was associated with an increased risk for other cardiac adverse events and death.

Lee et al. evaluated the rate of early complications among patients enrolled in a prospective, multi-center population-based registry of all newly implanted ICDs in Ontario, Canada from February 2007 through May 2009.  (16) Of 3,340 patients receiving an ICD, major complications (lead dislodgement requiring intervention, myocardial perforation, tamponade, pneumothorax, infection, skin erosion, hematoma requiring intervention) within 45 days of implantation occurred in 4.1% of new implants. Major complications were more common in women, in patients who received a combined ICD-CRT device, and in patients with a left ventricular end-systolic size of larger than 45 mm.  Direct implant-related complications were associated with a major increase in early death (hazard ration [HR] 24.9, p<0.01).

Two publications reported on infection rates in patients receiving an ICD.  Smit et al. published a retrospective, descriptive analysis of the types and distribution of infections associated with ICD’s over a ten year period in Denmark.  Of 91 total infections identified, 39 (42.8%) were localized pocket infections, 26 (28.6%) were endocarditis, 17 (18.7%) were ICD-associated bacteremic infections, and 9 (9.9%) were acute post-surgical infections. (17)   Nery et al. reported the rate of ICD-associated infections among consecutive patients treated with an ICD at a tertiary referral center.  There were a total of 24 infections among 2,417 patients for a rate of 1.0%. Twenty-two of 24 patients with infections (91.7%) required device replacement. Factors associated with infection were device replacement (versus de novo implantation) and use of a complex device (e.g., combined ICD-CRT or dual/triple chamber devices). (18)

American College of Cardiology/American Heart Association (ACC/AHA) Practice Guidelines

In April 2009, the ACC/AHA published updated guidelines on the management of chronic heart failure in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation. The guidelines follow the evidence criteria listed here for ICD placement, and only Class I recommendations are listed as follows:

  1. An ICD is recommended as secondary prevention to prolong survival in patients with current or prior symptoms of heart failure (HF) and reduced LVEF who have a history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing ventricular tachycardia. (Level of Evidence: A).
  2. ICD therapy is recommended for primary prevention of sudden cardiac death to reduce total mortality in patients with non-ischemic dilated cardiomyopathy or ischemic heart disease at least 40 days post-MI, a LVEF less than or equal to 35%, and NYHA functional Class II or III symptoms while receiving chronic optimal medical therapy, and who have reasonable expectation of survival with a good functional status for more than one year. (Level of Evidence: A).

ICD Use in the Pediatric Population

There is limited direct scientific evidence on the efficacy of ICDs in the pediatric population. The majority of published studies in this area are retrospective analyses of small case series. A review of some of the representative publications of this type is summarized below.

The largest published series was a combined series of pediatric patients and patients with congenital heart disease from four clinical centers. The median age of this population was 16 years, although some adults were included up to the age of 54. A total of 443 patients were included. The most common diagnoses were tetralogy of Fallot and hypertrophic cardiomyopathy. ICD implantation was performed for primary prevention in 52% of patients and for secondary prevention in 48%.  Over a two-year period of follow-up, appropriate shocks occurred in 26% of patients and inappropriate shocks occurred in 21%.

Silka et al. (1) compiled a database of 125 pediatric patients treated with an ICD, through query of the manufacturers of commercially available devices.  Indications for ICD placement were survivors of cardiac arrest in 95 patients (76%), drug-refractory ventricular tachycardia in 13 patients (10%), and syncope with heart disease plus inducible ventricular tachycardia in 13 patients (10%).  During a mean follow-up of 31 +/- 23 months, 73 patients (59%) received at least one appropriate shock and 25 patients (20%) received at least one inappropriate shock. The actuarial rates of sudden-death-free survival were 97% at one year, 95% at two years, and 90% at five years.

Alexander et al. reported on 90 ICD procedures in 76 young patients with a mean age of 16 years (range: 1–30).  Indications for placement were 27 patients (36%) with cardiac arrest or sustained ventricular tachycardia, 40 patients (53%) with syncope, 17 patients (22%) with palpitations, 40 patients (53%) with spontaneous ventricular arrhythmias, and 36 patients (47%) with inducible ventricular tachycardia.  Numerous patients had more than one indication for ICD in this study. Over a median of two years’ follow-up, 28% of patients received an appropriate shock, and 25% of patients received an inappropriate shock.  Lewandowski et al. reported on long-term follow-up of 63 patients between the ages of 6-21 years who were treated with an ICD device.  After a 10-year follow-up, there were 13 (21%) patients with surgical infections. Fourteen patients (22%) experienced at least one appropriate shock and 17 patients (27%) had at least one inappropriate shock.  Serious psychological sequelae developed in 27 patients (43%). (19)

The American College of Cardiology Foundation, American Heart Association, and Heart Rhythm Society

Guidelines concerning ICD use in pediatric populations have been published. These are derived from nonrandomized studies, extrapolation from adult clinical trials, and expert consensus.  The ACC/AHA/HRS published the following indications for ICD use in pediatric patients in 2008:

Class I indications

  • Survivors of cardiac arrest, after reversible causes have been excluded (Level of evidence B).
  • Symptomatic, sustained VT in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation (Level of evidence C).

Class IIa indications

  • Reasonable for patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias (Level of evidence B).

Class IIb indications

  • May be considered for patients with recurrent syncope associated with complex congenital heart disease and advanced systemic ventricular dysfunction when thorough invasive and non-invasive investigations have failed to reveal a cause (Level of evidence C).

2012 Update – Subcutaneous Implantable Defibrillator System (S-ICD)

The FDA reviewed data from a 321-patient study in which 304 patients were successfully implanted with the Subcutaneous Implantable Defibrillator System (S-ICD) System.  At the time of implantation, the investigator tested the effectiveness of the device by inducing heart arrhythmias. The S-ICD System was successful at converting all abnormal heart rhythms that it detected back to normal rhythms. Investigators followed these patients for six months following implantation, during which time the device detected and recorded 78 spontaneous arrhythmias in 21 patients; all arrhythmias were either successfully converted back to normal by the defibrillator or resolved on their own. Because the S-ICD System memory stores data from only the 22 most recent arrhythmia episodes, there may have been other detected episodes that could not be analyzed by investigators.  In addition, the FDA reviewed safety data based on the entire 321-patient study population to identify complications that can occur during and after implantation of the S-ICD System. The most common complications included inappropriate shocks, discomfort, system infection, and electrode movement, which required repositioning.  Eight patients died during the study; however, experts (who were not involved with the study) could not definitively attribute the deaths to the S-ICD System. Eleven patients required the removal of the device, and 18 had discomfort that was resolved without repositioning the device or surgery. At the end of six months, more than 90 percent of patients had no complications. As part of the approval, FDA is requiring the manufacturing company to conduct a postmarket study to assess the long-term safety and performance of the device and to assess differences in effectiveness across genders. The study will follow 1,616 patients for five years. (22)

Aydin et al (2012) conducted a study assessing the efficacy of S-ICD in a clinical setting (23).  Forty consecutive patients (42±15 years; body mass index, 27±6 kg/m2 left ventricular ejection fraction, 47±15%; 28 men) received an S-ICD for primary (n=17) or secondary prevention (n=23 [58%]) at 3 institutions in Germany. Intraoperative defibrillation efficacy testing failed in 1 patient with severely reduced left ventricular ejection fraction; testing was effective in all other patients. All episodes stored in the S-ICD were analyzed for appropriate and inappropriate detection, as well as effective shock delivery to convert ventricular tachyarrhythmia into sinus rhythm. During a median follow-up of 229 (interquartile range, 116-305) days, 4 patients experienced 21 episodes, with correct detection of ventricular tachyarrhythmia (VT) and subsequent shock therapy. A total of 28 shocks were delivered in these 4 patients. Mixed logistic regression modeling revealed a shock efficacy of 96.4% (95% CI, 12.8%-100%). The efficacy of first shocks, however, was only 57.9% (95% CI, 35.6%-77.4%). Four episodes were incorrectly classified as VT, which led to inappropriate shock delivery in 2 patients. The authors of this study conclude that ineffective shock delivery may occur in patients with S-ICD, even after successful intraoperative testing. Multicenter trials are required with close monitoring of safety and efficacy end points to identify patients who may be at risk for shock failure.

Nordkamp et al report the largest multicenter experience to date with the S-ICD with a minimum of 1-year follow-up in the first (24) 118 Dutch patients who were implanted with this device.  A total of 118 patients (75% males, mean age 50 years) received the S-ICD. After 18 months of follow-up, 8 patients experienced 45 successful appropriate shocks (98% first shock conversion efficacy). No sudden deaths occurred. Fifteen patients (13%) received inappropriate shocks, mainly due to T-wave oversensing, which was mostly solved by a software upgrade and changing the sensing vector of the S-ICD. Sixteen patients (14%) experienced complications. Adverse events were more frequent in the first 15 implantations per center compared with subsequent implantations (inappropriate shocks 19% vs. 6.7%, p = 0.03; complications 17% vs. 10%, p = 0.10).  The authors note that the S-ICD is effective in terminating ventricular arrhythmias. There is, however, a considerable percentage of ICD related adverse events, which decreases as the therapy evolves and experience increases.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes

37.94, 37.95, 37.96, 37.97, 37.98, 412, 414.8, 425.1, 425.4

ICD-10 Codes

Q20.0-Q20.9, Q21.0-Q21.9, Q22.0-Q22.9, Q23.0-Q23.9, Q24.0-Q24.9

Procedural Codes: 33202, 33203, 33216, 33217, 33230, 33231, 33240, 33249, 93640, 93641, 93282, 93283, 93284, 93285, 93287, 93289, 93295, 93296, 93297, 0319T, 0320T, 0321T, 0326T, 0327T, 0328T, G0448
References
  1. Silka M, Kron J, Dunnigan A et al. Sudden cardiac death and the use of implantable cardioverter-defibrillators in pediatric patients. Circulation 1993; 87(3):800-7.
  2. Implantable Cardioverter-Defibrillators for Primary Prevention of Ventricular Tachyarrhythmia.  Chicago, Illinois:  Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program. (2002 August) 17(10):1-40.
  3. Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASCP Committee on Pacemaker Implantation). (2002). Available at: http://www.acc.org.
  4. Desai, A.S., Fang, J.C., et al.  Implantable defibrillators for the prevention of mortality in patients with nonischemic cardiomyopathy – a meta-analysis of randomized controlled trials. The Journal of the American Medical Association (JAMA), (2004) 292(23):2874-9.
  5. Alexander ME, Cecchin F, Walsh EP et al. Implications of implantable cardioverter-defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol 2004; 15(1):72-6.
  6. Gregoratos, G., Abrams, J., et al. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Medicare policy: https://www.cms.hhs.gov.
  7. Use of Implantable Cardioverter-Defibrillators for Prevention of Sudden Death in Patients at High Risk for Ventricular Arrhythmia.  Chicago, Illinois:  Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program. (2005 March) 19(19):1-56.
  8. Special Report:  Cost-Effectiveness of Implantable Cardioverter-Defibrillators in a MADIT-II Population. Chicago, Illinois:  Blue Cross Blue Shield Association Technology Evaluation Center Assessment Program.  (2005 April) 19 (3):1-25.
  9. Raviele A, Bongiorni MG, Brignole M et al. Early EPS/ICD strategy in survivors of acute myocardial infarction with severe left ventricular dysfunction on optimal beta-blocker treatment. The Beta-blocker Strategy plus ICD trial. Europace 2005; 7(4):327-37.
  10. Hunt SA, Abraham WT, Chin MH et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2005; 46(6):e1-82. Available at: http://content.onlinejacc.org .
  11. Zipes DP, Camm AJ, Borggrefe M et al. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114(10):e385-484.
  12. Kadish A, Schaechter A, Subacius H et al. Patients with recently diagnosed nonischemic cardiomyopathy benefit from implantable cardioverter-defibrillators. J Am Coll Cardiol 2006; 47(12):2477-82.
  13. Ellenbogen KA, Levine JH, Berger RD et al. Are implantable cardioverter defibrillator shocks a surrogate for sudden cardiac death in patients with nonischemic cardiomyopathy? Circulation 2006; 113(6):776-82.
  14. Maron BJ, Spirito P, Shen WK et al. Implantable cardioverter-defibrillators and prevention of sudden cardiac death in hypertrophic cardiomyopathy. JAMA 2007; 298(4):405-12.
  15. Cheng A, Wang Y, Curtis JP et al. Acute lead dislodgement and in-hospital mortality in patients enrolled in the national cardiovascular data registry implantable cardioverter-defibrillator registry. J Am Coll Cardiol 2010; 56(20):1651-6.
  16. Lee DS, Krahn AD, Healey JS et al. Evaluation of early complications related to De Novo cardioverter-defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol 2010; 55(8):774-82.
  17. Smit J, Korup E, Schonheyder HC. Infections associated with permanent pacemakers and implanted cardioverter-defibrillator devices. A 10-year regional study in Denmark. Scand J Infect Dis 2010; 42(9):658-64.
  18. Nery PB, Fernandes R, Nair GM et al. Device-related infection among patients with pacemakers and implantable defibrillators: incidence, risk factors, and consequences. J Cardiovasc Electrophysiol 2010; 21(7):786-90.
  19. Lewandowski M, Sterlinski M, Maciag A et al. Long-term follow-up of children and young adults treated with implantable cardioverter-defibrillator: the authors’ own experience with optimal implantable cardioverter-defibrillator programming. Europace 2010; 12(9):1245-50.
  20. Al-Khatib SM, Hellkamp A, Curtis J et al. Non-evidence-based ICD implantations in the United States. JAMA 2011; 305(1):43-9.
  21. Implantable Cardioverter Defibrillator.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 July) Surgery 7.01.44.
  22. .Food and Drug Administration (FDA). FDA approves first subcutaneous heart defibrillator [news release]. September 28, 2012. Available at: www.fda.gov . Accessed November 2012.
  23. Aydin A, Hartel F, et al.  Circ Arrhythm Electrophysiol. Shock Efficacy of Subcutaneous Implantable Cardioverter-Defibrillator for Prevention of Sudden Cardiac Death: Initial Multicenter Experience.2012 Oct 1; 5(5):913-919.
  24. Nordkamp O, Dabiri, LR, et al.  The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large dutch cohort. Journal of the American College of Cardiology. Volume 60, Issue 19, 6 November 2012, Pages 1933–1939.
History
January 2013

New 2013 BCBSMT medical policy.

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CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Automatic Implantable Cardioverter Defibrillator (AICD) and Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)