Clinical UM Guideline


Subject: Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure
Guideline #: CG-SURG-63 Publish Date:    10/17/2018
Status: Reviewed Last Review Date:    09/13/2018

Description

This document addresses biventricular cardiac pacing to deliver cardiac resynchronization therapy (CRT) to alleviate the symptoms of moderate to severe congestive heart failure associated with left ventricular dyssynchrony.  It also addresses a hybrid device that combines CRT with an implantable cardioverter defibrillator (ICD).  In the combined device (CRT/ICD), the CRT component promotes coordinated contraction of both ventricles, while the ICD portion detects dangerous arrhythmias and shocks the heart back into a normal rhythm.

Note:  For further information regarding ICD devices, see:

Clinical Indications

Medically Necessary:

FDA-approved biventricular pacemakers for cardiac resynchronization therapy (CRT) are considered medically necessary for individuals who meet all of the following criteria:

  1. NYHA functional Class II, III, or ambulatory Class IV symptoms* secondary to heart failure who remain symptomatic despite recommended, Guideline-directed medical therapy (GDMT);** and
  2. Have either:
    1. Left bundle branch block (LBBB) morphology and QRS duration of 120 to 149 ms, or
    2. Any QRS morphology and QRS duration greater than or equal to 150 ms; and
  3. Left ventricular ejection fraction (LVEF) less than or equal to 35%; and
  4. In either:
    1. Sinus rhythm, or  
    2. Atrial fibrillation when AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing. 

*See Definition section for further information on New York Heart Association (NYHA) functional class.

**Optimal medical therapy, which is now referred to as “Guideline-directed medical therapy” (GDMT), may include use of the following medications either individually or in combination, unless contraindicated: angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, beta-blockers, digoxin, diuretics, and aldosterone antagonists, when appropriate. 

GDMT would include a trial period of prior medical management for at least 3 months.

The use of an FDA-approved ICD, in combination with cardiac resynchronization therapy (CRT/ICD), is considered medically necessary when the criteria listed above for CRT therapy AND the criteria within SURG.00033 Cardioverter-Defibrillator (ICD) are met.

Not Medically Necessary:

Biventricular pacemakers CRT, or combined biventricular pacemaker-defibrillator devices (CRT/ICD), are considered not medically necessary for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

 

 

The following codes are specific to biventricular pacemakers:

33224

Insertion of pacing electrode, cardiac venous system, for left ventricular pacing; with attachment to previously placed pacemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator)

33225

Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)

33226

Repositioning of previously implanted cardiac venous system (left ventricular) electrode (including removal, insertion and/or replacement of existing generator)

 

 

 

The following codes may be billed in association with a biventricular pacemaker for CRT or CRT/ICD

00530

Anesthesia for permanent transvenous pacemaker insertion

00534

Anesthesia for transvenous insertion or replacement of pacing cardioverter/defibrillator

33202

Insertion of epicardial electrode(s); open incision (eg, thoracotomy, median sternotomy, subxiphoid approach)

33203

Insertion of epicardial electrode(s); endoscopic approach (eg, thoracoscopy, pericardioscopy)

33207

Insertion of new or replacement of permanent pacemaker with tranvenous electrode(s); ventricular

33208

Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular

33211

Insertion or replacement of temporary transvenous dual chamber pacing electrodes

33213

Insertion of pacemaker pulse generator only; with existing dual leads

33214

Upgrade of implanted pacemaker system, conversion of single chamber system to dual chamber system (includes removal of previously placed pulse generator, testing of existing lead, insertion of new lead, insertion of new pulse generator)

33217

Insertion of 2 transvenous electrodes; permanent pacemaker or implantable defibrillator

33240

Insertion of implantable defibrillator pulse generator only; with existing single lead

33249

Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber

93640

Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement;

93641

Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation threshold evaluation (induction of arrhythmia evaluation of sensing and pacing for arrhythmia termination) at time of initial implantation or replacement; with testing of single or dual chamber pacing cardioverter-defibrillator pulse generator

93642

Electrophysiologic evaluation of single or dual chamber transvenous pacing cardioverter-defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters)

 

 

ICD-10 Procedure

 

 

The following codes are specific to CRT and CRT/ICD

0JH607Z-0JH637Z

Insertion of cardiac resynchronization pacemaker pulse generator into chest subcutaneous tissue and fascia [by approach; includes codes 0JH607Z, 0JH637Z]

0JH609Z-0JH639Z

Insertion of cardiac resynchronization defibrillator pulse generator into chest subcutaneous tissue and fascia [by approach; includes codes 0JH609Z, 0JH639Z]

0JH807Z-0JH837Z

Insertion of cardiac resynchronization pacemaker pulse generator into abdomen subcutaneous tissue and fascia [by approach; includes codes 0JH807Z, 0JH837Z]

0JH809Z-0JH839Z

Insertion of cardiac resynchronization defibrillator pulse generator into abdomen subcutaneous tissue and fascia [by approach; includes codes 0JH809Z, 0JH839Z]

 

 

 

The following codes may be billed in association with CRT or CRT/ICD:

02HK0JZ-02HK4JZ

Insertion of pacemaker lead into right ventricle [by approach; includes codes 02HK0JZ, 02HK3JZ, 02HK4JZ]

02HK0KZ-02HK4KZ

Insertion of defibrillator lead into right ventricle [by approach; includes codes 02HK0KZ, 02HK3KZ, 02HK4KZ]

02HL0JZ-02HL4JZ

Insertion of pacemaker lead into left ventricle [by approach; includes codes 02HL0JZ, 02HL3JZ, 02HL4JZ

02HL0KZ-02HL4KZ

Insertion of defibrillator lead into left ventricle [by approach; includes codes 02HL0KZ, 02HL3KZ, 02HL4KZ]

 

 

ICD-10 Diagnosis

 

109.81

Rheumatic heart failure

111.0

Hypertensive heart disease with heart failure

113.0

Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

113.2

Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease

I21.01-I21.A9

Acute myocardial infarction

142.1

Obstructive hypertrophic cardiomyopathy

I48.0-I48.2

Atrial fibrillation

148.91

Unspecified atrial fibrillation

149.01

Ventricular fibrillation

149.8

Other specified cardiac arrhythmias

149.9

Cardiac arrhythmia, unspecified

I50.1-I50.9

Heart failure

   
Discussion/General Information

There are a number of FDA approved biventricular pacemakers designed to provide cardiac resynchronization therapy (CRT).  Individuals meeting selection criteria for CRT therapy frequently are also considered candidates for an implantable cardioverter defibrillator (ICD).  These persons may receive combined therapy with a combined CRT/ICD device.  A biventricular pacemaker is designed to resynchronize the pumping action of the left ventricle.  This type of pacing is called cardiac resynchronization therapy (CRT).  Standard pacemakers pace the right side of the heart.  In contrast, biventricular pacemakers pace both the right and left sides of the heart enabling the left ventricle to pump blood more efficiently.  Biventricular pacemakers use three leads (one in the right atrium, and one in each ventricle) and have been investigated as a technique to coordinate the contraction of the ventricles, thus, improving the individual’s hemodynamic status.

The Multi-Center InSync Randomized Clinical Evaluation (MIRACLE) trial showed symptomatic improvement and improvement in cardiac function.  In this trial, all subjects received a CRT device, but were then randomized to either active (device-on) or inactive (device-off) groups.  Overall, 68% of those in the active treatment group versus 35% of those in the inactive treatment group, demonstrated improvement in primary endpoints, including quality of life, 6-minute hall walk, and NYHA functional class.  The active treatment group also reported increases in a variety of cardiodynamic measures, including peak oxygen consumption, left ventricular (LV) end diastolic dimension, and left ventricular ejection fraction (LVEF) (Abraham, 2002).  The subsequent Cardiac Resynchronization – Heart Failure (CARE-HF) trial focused on the final health outcomes of morbidity and mortality (Cleland 2005).  A total of 813 subjects with left ventricular systolic dysfunction, cardiac dyssynchrony, and symptomatic heart failure (HF) were randomized to receive either CRT or standard medical care and followed for a mean of 29.4 months.  The primary endpoint, a composite of death from any cause or an unplanned hospitalization for a major cardiovascular event, was reached by 159 subjects in the CRT group, as compared with 224 in the medical therapy group (39% vs. 55%; hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.51 to 0.77; p<0.001).  The authors concluded that CRT substantially reduced the risk of complications and death among those subjects with moderate or severe HF, due to left ventricular systolic dysfunction and cardiac dyssynchrony.  Cleland and colleagues published another article in 2009 regarding the effects of CRT on long-term quality of life with data analysis taken from the CARE-HF trial.  Quality of life (QoL) was measured at baseline and at 3 months using generic European QoL-5 Dimensions and disease-specific (Minnesota Living with Heart Failure) questionnaires and at 18 months and study-end using the latter instrument.  Median follow-up was 29.6 (interquartile range 23.6-34.6) months.  The authors concluded that CRT improves long-term QoL and survival in individuals with moderate to severe HF, adding that the effects appeared to be sustained, and therefore, the gain in quality of life with CRT should be even greater during longer-term follow-up (Cleland, 2009).

The COMPANION trial was a multicenter, randomized controlled trial to investigate whether prophylactic CRT with a biventricular pacemaker or a CRT/ICD would reduce the risk of death and hospitalization among individuals with advanced chronic HF and intra-ventricular conduction delays.  A total of 1520 subjects who had advanced HF (NYHA Class III or IV), due to ischemic or non-ischemic cardiomyopathies and a QRS interval of at least 120 ms (milliseconds), were randomly assigned in a 1:2:2 ratio to receive optimal pharmacologic therapy (for example, diuretics, angiotensin-converting enzyme inhibitors, beta-blockers and spironolactone) alone or in combination with CRT or CRT/ICD.  The primary composite endpoint was the time-to-death from, or hospitalization for, any cause.  The results showed that, compared to optimal pharmacological therapy alone, CRT with a pacemaker decreased the risk of the primary endpoint (HR, -0.81; p=0.014), as did CRT/ICD (HR, -0.80; p=0.01).  The risk of the combined endpoint of death from, or hospitalization for, HF was reduced by 34% in the pacemaker group (p<0.002) and by 40% in the pacemaker-defibrillator group (p<0.001 for the comparison with the pharmacological therapy group).  CRT therapy reduced the risk of the secondary endpoint of death from any cause by 24% (p=0.059), and CRT/ICD therapy reduced the risk by 36% (p=0.003).  The researchers concluded that in individuals with advanced HF and a prolonged QRS interval, CRT decreases the combined risk of death from any cause or of first hospitalization and, when combined with an ICD, significantly reduces mortality (Anand, 2009; Bristow, 2004).

Other studies examined the hypothesis that early use of CRT before the development of Class III HF symptoms may prevent or reverse remodeling, caused by prolonged ventricular conduction, thus preventing the progression of HF.  The REVERSE trial (REsynchronization reVErse Remodeling in Systolic left vEntricular dysfunction) was double blinded and enrolled 610 subjects with NYHA class I or II HF and a QRS interval greater than or equal to 120 ms with a LVEF of less than 40% (Linde, 2008).  All trial participants received a CRT device with or without an ICD.  Trial participants were then randomized to active CRT (device-on) or control CRT (device-off) for 12 months.  The primary endpoint was a HF clinical composite score consisting of any incidence of death, hospitalization due to worsening HF, or worsening symptoms.  Subjects were classified as, “Worsened” if any of the above criteria were met.  Subjects were classified as, “Improved” if there was an improvement in the NYHA class score or an improvement in symptoms.  The remaining subjects were classified as, “Unchanged.”  This composite outcome was chosen because those who were mildly symptomatic were unlikely to have an event rate for any individual parameter that was sufficiently high to show a treatment effect from CRT, thus requiring a more sensitive composite outcome to detect any beneficial treatment effect. 

Of the 419 subjects assigned to the CRT-on group, 16% worsened, compared to 21% of the 191 subjects assigned to the CRT-off group, a difference that was not statistically significant (p=0.10).  Therefore, the trial results did not meet the primary outcome.  There was no significant difference in the number of hospitalizations between the two groups, but the time-to-first hospitalization was significantly delayed in the CRT-on group (HR 0.47, p=0.03).  Left ventricular end-systolic volume index was evaluated as a measure of left ventricular remodeling.  Trial participants assigned to the CRT-on group experienced a greater improvement in this outcome.  These results suggest that, while CRT can improve left ventricular remodeling, this improvement did not result in a significant improvement in clinical symptoms at 1 year.  Other studies have reported that left ventricular remodeling precedes symptomatic improvement in those with advanced HF (Yu 2005), so the authors suggest that the 1-year follow-up in the REVERSE study was not long enough to detect clinical improvement (Sipahi, 2011). 

Information has been published regarding the long-term effects of CRT in the European cohort enrolled in the REVERSE study.  A total of 262 recipients (with QRS greater than or equal to 120 ms and LVEF less than or equal to 40%) were randomly assigned to either CRT or CRT-ICD and were designated either to the active arm (CRT-ON; n=180) or the control arm (CRT-OFF; n=82) for 24 months.  Mean baseline LVEF was 28.0%.  All subjects were in normal sinus rhythm (NSR) and receiving optimal medical therapy.  The primary study endpoint was the proportion worsened by the HF clinical composite response.  The main secondary study endpoint was the left ventricular end-systolic volume index (LVESVi).  In the active treatment group, 19% worsened versus 34% in the control group (p=0.01).  The LVESVi decreased by a mean of 27.5 ± 31.8 ml/m2 in the active treatment group versus 2.7 ± 25.8 ml/m2 in the control group (p<0.0001).  Time to first hospital stay (for HF) or death (HR, 0.38; p=0.003) was significantly delayed by CRT.  The authors concluded that after 24 months of CRT and compared with those of control subjects, clinical outcomes and LV function were improved and LV dimensions were decreased in this population in NYHA functional Classes I or II.  These observations suggest that CRT prevents the progression of disease in those with asymptomatic or mildly symptomatic LV dysfunction (Daubert, 2009).  However, in 2010 another article was published regarding the 2-year outcomes of the REVERSE trial which showed no differences in ventricular tachycardia/ventricular fibrillation (VT/VF) episodes or VT storm between groups.  Specifically, in the CRT-ON group, the estimated event rate was 18.7% at 2 years compared with 21.9% in the CRT-OFF group (HR, 1.05, p=0.84).  However, among CRT-ON subjects, those with reverse remodeling had a reduced incidence of VT/VF compared with those without remodeling (5.6% vs. 16.3%; HR, 0.31, p=0.001).  These authors concluded that CRT for up to 2 years does not impact VT/VF in mild HF despite the marked clinical and remodeling effects of pacing.  This neutral effect may be due to competing antiarrhythmic effects of reverse remodeling and the proarrhythmic effect of pacing (Gold, 2011, 2012).

Other trials also addressed this issue and were powered to measure morbidity and mortality rates.  The RAFT trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) was a multi-center, double-blind, randomized controlled trial that was designed to determine if the addition of CRT to optimal pharmacological therapy and ICD is effective in reducing mortality and morbidity in individuals with mild to moderate HF symptoms.  Initially those with NYHA Class II and III symptoms were included; this was changed to Class II symptoms only in 2006, due to the observation that Class III symptoms improve from CRT alone without ICD. This finding was also in alignment with updated specialty society guideline recommendations (NLM Identifier:  NCT00251251).  Results of the RAFT trial were published in 2010 which investigated a total of 1798 subjects in 34 centers in multiple countries for a mean follow-up period of 40 ± 20 months.  The primary outcome occurred in 297 of 894 subjects (33.2%) in the ICD–CRT group and 364 of 904 subjects (40.3%) in the ICD group (HR in the ICD–CRT group, -0.75; 95% CI, 0.64 to 0.87; p<0.001).  In the ICD–CRT group, 186 subjects died, as compared with 236 in the ICD group (HR, -0.75; 95% CI, 0.62 to 0.91; p=0.003), and 174 were hospitalized for HF, as compared with 236 in the ICD group (HR, -0.68; 95% CI, 0.56 to 0.83; p<0.001).  However, at 30 days after device implantation, adverse events had occurred in 124 subjects in the ICD-CRT group, as compared with 58 in the ICD group (p<0.001).  The authors concluded that among subjects with NYHA Class II or III HF, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for HF.  This improvement was accompanied by more adverse events but is thought to provide convincing evidence in support of CRT for appropriately selected subjects with less severe HF disease (Class II and III symptoms, left ventricular systolic dysfunction and a wide QRS complex).  These findings are consistent with the findings of two other major recent trials, the REVERSE and the MADIT-CRT (Moss, 2010; Tang, 2010). 

The Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Trial (MADIT-CRT) was a randomized controlled trial of subjects with NYHA Class I and II symptoms that was similarly designed to determine if CRT combined with an ICD would reduce the risk of mortality and HF events.  A total of 1820 subjects were enrolled (NLM Identifier: NCT00180271; 2008).  Results of the MADIT-CRT were reported in 2009 as follows:  during an average follow-up of 2.4 years, the primary endpoint occurred in 187 of 1089 subjects in the CRT-ICD group (17.2%) and 185 of 731 subjects in the ICD-only group (25.3%) (HR in the CRT-ICD group was 0.66; 95% CI, 0.52 to 0.84; p=0.001).  The benefit did not differ significantly between those subjects with ischemic cardiomyopathy and those with nonischemic cardiomyopathy.  The superiority of CRT was driven by a 41% reduction in the risk of HF events, a finding that was evident primarily in a prespecified subgroup with a QRS duration of 150 ms or more.  CRT was associated with a significant reduction in left ventricular volumes and improvement in the LVEF.  There was no significant difference between the 2 groups in the overall risk of death, with a 3% annual mortality rate in each treatment group.  Serious adverse events were infrequent in the two groups.  The authors concluded that CRT combined with ICD decreased the risk of HF events in relatively asymptomatic subjects with a low LVEF and wide QRS complex (Moss, 2009).  

In 2010, Solomon reported further on the results of the MADIT-CRT trial using echocardiographic changes to evaluate whether the improvement in outcomes with CRT plus an ICD was associated with favorable alterations in cardiac size and function.  Echocardiographic studies were obtained at baseline and 12 months later in 1372 of the MADIT-CRT subjects.  Changes in cardiac size and performance between treatment groups were compared, and the relationship between these changes was assessed over the first year, as well as subsequent outcomes.  Compared with the ICD-only group, the CRT-plus-ICD group had greater improvement in left ventricular end-diastolic volume index (-26.2 versus -7.4 mL/m2), left ventricular end-systolic volume index (-28.7 versus -9.1 mL/m2), LVEF (11% versus 3%), left atrial volume index (-11.9 versus -4.7 mL/m2), and right ventricular fractional area change (8% versus 5%; p<0.001 for all). Improvement in end-diastolic volume at 1 year was predictive of subsequent death or HF, with adjustment for baseline covariates and treatment group; each 10% decrease in end- diastolic volume was associated with a 40% reduction in risk (p<0.001).  The authors of this analysis concluded that CRT resulted in significant improvement in cardiac size and performance compared with an ICD-only strategy in those subjects with mildly symptomatic HF.  Improvement in these measures accounted for the outcomes benefit (Solomon, 2010).

In 2011, Sipahi published results of meta-analysis of five randomized controlled trials that reported outcomes according to QRS ranges (n=5813).  The objective was to determine if the impact of CRT on clinical endpoints is affected by the degree of baseline QRS.  The five previously reported trials that were included in this meta-analysis were the COMPANION, CARE-HF, REVERSE, MADIT-CRT and the RAFT trials.  Results of the Sipahi analysis showed the following:

The authors concluded that the degree of QRS prolongation is more important than the level of functional impairment for selection of subjects for CRT.  However, multiple limitations to these findings were acknowledged including use of summary, (versus individual), data in this meta-analysis; use of heterogeneous enrollment criteria by the five included trials with variable composite outcome measures; unknown morphology of the QRS complex in participants with a QRS duration less than 150 msec; and unknown percentages of study participants with RBBB (right bundle branch block).  It was noted that further analysis of individual subject-specific data from all relevant clinical trials can further refine the QRS cutoffs for different types of conduction abnormalities (Sipahi, 2011).

In 2018, Hernandez and colleagues published the results of a systematic review and meta-analysis with the aim to assess outcomes after CRT in inotrope-dependent individuals with HF. The systematic literature search yielded 8 studies with a total of 151 individuals, most of who were in NYHA Class IV (80.1%). All included individuals had severe systolic HF, LVEF less than 30%, and QRS complex duration greater than 130 ms. The results of the meta-analysis showed that 93% of the individuals were weaned from inotropic support after CRT (95% confidence interval [CI]: 86% to 100%). In addition, improvement in NYHA functional Class was noted [2% improved to NYHA Class I (95% CI: 2% to 6%), 36% improved to NYHA Class II (95% CI: 15% to 57%), 43% improved to NYHA Class III (95% CI: 10% to 76%), and 10% stayed in NYHA Class IV (95% CI: 3% to 18%)]. Study limitations include non-controlled, retrospective design of the included studies, and non-uniform, unspecified enrollment criteria.

In 2012, the American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society (ACCF/AHA/HRS) published a focused update to the Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities (Tracy, 2012), in which the former Class I recommendation for CRT was expanded to include those in NYHA Class II and also specified subjects with left bundle branch block (LBBB) morphology and a QRS duration of  ≥ 150 ms; (LVEF ≤ 35%, NSR and NYHA Class III and IV symptoms were unchanged in this recommendation) (Level of evidence: A for NYHA Class III/IV and B for NYHA Class II; based on CARE-HF and COMPANION) (Bristow, 2004; Cleland, 2005, 2009; Stavrakis, 2012).  

Additional new Class IIa recommendations were added as follows:

This ACCF/AHA/HRS guideline concluded that, “The congruence of results from the totality of CRT trials with regard to remodeling and HF events provides evidence supporting a common threshold of 35% for benefit from CRT in NYHA Class II through IV HF symptoms” (Tracy, 2012). 

In 2013, the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) issued an updated Guideline for the Management of Heart Failure, in which several updated recommendations for use of CRT are provided and have been revised to now align with the Tracy guideline, as well as provide a new classification system for the definitions of HF which aligns with the NYHA classifications for HF severity (Yancy, 2013).  The following is excerpted:

Class I:

CRT “is indicated” for patients who have LVEF of 35% or less, sinus rhythm, left bundle-branch block (LBBB) with a QRS duration of 150 ms or greater, and NYHA Class II, III, or ambulatory IV symptoms on GDMT; (Level of Evidence A for NYHA Class III/IV; Level of Evidence B for NYHA Class II – this recommendation was expanded to include those in NYHA Class II HF, also added LBBB and increased the QRS to 150 and above; based on Abraham, 2002; Bristow, 2004; Cleland, 2005; Hunt, 2009; Moss, 2009; Tang, 2010).

Class IIa:

The above ACCF/AHA recommendations for CRT therapy were based on the results of the RAFT and MADIT-CRT trials (Moss, 2009; Tang, 2010), as well as trials attempting to predict optimum candidate selection criteria related to atrioventricular (AV) optimization techniques and echocardiographic parameters, such as the Predictors of Response to CRT (PROSPECT) trial (Chung, 2008) and the SmartDelay determined AV optimization: a comparison to other AV delay methods used in cardiac resynchronization therapy (SMART-AV) trial (Ellenbogen, 2010).  Also, results of the ESCAPE trial (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) were reviewed which evaluated whether the use of pulmonary artery catheters (PAC) affected overall mortality in the management of HF (Binanay, 2005). The results of the ESCAPE trial indicated that use of PACs did not affect overall mortality and hospitalization but did increase adverse events.  Additional trials cited in the ACCF/AHA recommendations for CRT therapy were related to the impact of different management strategies, such as noninvasive ventilation in acute cardiogenic pulmonary edema (Masip, 2005) and use of percutaneous left ventricular assist devices vs. intra-aortic balloon pumps in cardiogenic shock (Cheng, 2009; Kar, 2011).

The following is excerpted (Yancy, 2013): 

New evidence supports extension of CRT to patients with milder symptoms. LV remodeling was consistently reversed or halted, with benefit also in reduction of HF hospitalizations. In this population with low 1-year mortality, reduction of HF hospitalization dominated the composite primary endpoints, but a mortality benefit was subsequently observed in a 2-year extended follow-up study (REVERSE trial) and in a meta-analysis of 5 trials of CRT in mild HF that included 4213 patients with Class II symptoms (Sipahi, 2011). Overall benefits in Class II HF were noted only in patients with QRS ≥ 150 ms and LBBB, with an adverse impact with shorter QRS duration or non-LBBB…

In 2016, The European Society of Cardiology (ESC) reported on guidelines created by The Task Force for the diagnosis and treatment of acute and chronic heart failure. The ESC made the following recommendations for CRT in individuals with HF:

Regarding the timeframe for prior conservative GDMT before consideration for CRT therapy, the general consensus in the practice community for prior GDMT is 3 to 6 months.  In 2013, a report of the American College of Cardiology Foundation (ACCF) Appropriate Use Criteria Task Force, Heart Rhythm Society (HRS), American Heart Association (AHA), American Society of Echocardiography (ASE), Heart Failure Society of America (HFSA), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Cardiovascular Computed Tomography (SCCT), and Society for Cardiovascular Magnetic Resonance (SCMR) was issued, in which the following is noted regarding the timeframe for GDMT:

Patients who are going to receive substantial benefit from medical treatment alone usually show some clinical improvement during the first 3 to 6 months.  Medical therapy is also assumed to include adequate rate control for tachyarrhythmias, including atrial fibrillation. Therefore, it is recommended that GDMT be provided for at least 3 months before planned reassessment of LV function to consider device implantation.  If LV function improves to the point where primary prevention indications no longer apply, then device implantation is not indicated (Russo, 2013).

Comparison of ACCF/AHA Stages of HF and NYHA Functional Classifications:

ACCF/AHA Stages of HF

NYHA Functional Classification*

A:   At high risk for HF but without structural heart disease or symptoms of HF

None

B:   Structural heart disease but without signs    

Class I    

C:   Structural heart disease with prior or current symptoms of HF

Can be Class I, II, or III and possibly IV

D:  Refractory HF requiring specialized interventions

Class IV

*NYHA Classifications (New York Heart Association):  See Definitions section for further information.

CRT in Atrial Fibrillation (AF):

The majority of studies of CRT have excluded individuals with atrial arrhythmias, which commonly occur in persons who would otherwise be considered candidates for CRT.  Therefore, there has been interest in evaluating CRT in this group.  For example, in the MUltisite STimulation In Cardiomyopathy (MUSTIC) study, 64 of the 131 enrolled subjects had atrial fibrillation (AF), in addition to HF and ventricular dyssynchrony (Cazeau, 2001).  All subjects received a biventricular implant, but during the initial 3 months of the trial, the participants were randomized to either active or inactive pacing, followed by cross over to the other arm for an additional 3 months (Linde, 2002).  Thirty-three of the participants with AF were followed up at 9 and 12 months to evaluate 6 minute walking distance, peak oxygen uptake and quality of life.  A total of 42 of the 67 subjects in NSR were similarly evaluated.  Trial subjects with AF showed similar improvements compared to those with NSR. 

Upadhyay and colleagues (2008) conducted a meta-analysis of prospective cohort studies of CRT in subjects with AF and those in NSR.  A total of 5 studies enrolling 1164 subjects met the study selection criteria.  The authors concluded that both groups benefited from CRT.  The NYHA classification improved similarly in both groups.  While those in NSR reported greater improvement in the 6 minute walk test, compared to those with AF, the AF group had greater improvement in the LVEF.

A systematic review and meta-analysis was conducted in 2011 by Wilton and colleagues which included 23 observational studies and followed a total of 7495 CRT recipients, 25.5% of whom had AF, for a mean duration of 33 months.  The purpose of this analysis was to compare outcomes in subjects with and without AF receiving CRT.  A secondary objective was to evaluate the effects of atrioventricular nodal ablation (AVN) on outcomes in subjects with AF.  All of the included studies were observational cohort studies, and most reported significant differences in the baseline characteristics of the study participants between those with and without AF.  The results showed that presence of AF is associated with an increased risk of non-response to CRT (34.5% vs. 26.7%; pooled relative risk [RR], 1.32; 95% CI, 1.12, 1.55; p=0.001) and all-cause mortality (10.8% vs. 7.1% per year; pooled RR, 1.50; 95% CI, 1.08, 2.09; p=0.015).  The presence of AF was also associated with less improvement in quality of life measures, 6-minute hall walk distance, and LV end-systolic volume but not LVEF.  Among study subjects with AF, AVN ablation appeared favorable with a lower risk of clinical non-response (RR 0.40; 95% CI 0.28, 0.58; P<0.001) and a reduced risk of death.  There was insufficient data to permit meta-analysis of hospitalization rates in those with, versus without, AF.  The authors concluded that the benefits of CRT appear to be attenuated in AF, although AF is associated with increased risk for clinical non-response and death when compared to outcomes from CRT in those without AF.  It was also noted that AVN ablation may improve CRT outcomes in individuals with AF but randomized trials are needed to confirm these findings (Wilton, 2011b).

The 2011 HFSA guideline Indications for Cardiac Resynchronization Therapy (Stevenson, 2012) included the following recommendation specific to individuals with AF:

CRT “may be considered” for patients with atrial fibrillation with a widened QRS interval (≥ 120 ms) and severe LV systolic dysfunction LVEF (≤ 35%) who have persistent mild to moderate HF (NYHA functional Class II-III) despite optimal medical therapy; (Strength of evidence B).

The 2012 ACCF/AHA/HRS focused update to the Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities (Tracy, 2012) included the following recommendation specific to individuals with AF: 

CRT “can be useful” for individuals with AF and LVEF ≤ 35% on GDMT if: a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT; (Class IIa; Level of Evidence B).

The level of evidence for this recommendation changed from C to B, based on MUSTIC (Brignole, 2011; Doshi, 2005; Gasparini, 2006; Linde, 2003).

The 2013 ACCF/AHA updated Guideline for the Management of Heart Failure (Yancy, 2013) included the exact same recommendation for individuals with AF which had been previously issued in the 2012 ACCF/AHA/HRS document (Tracy, 2012) with the same Class IIa, Level of Evidence B.

The following is excerpted from Yancy, 2013: 

…The weight of the evidence has been accumulated from patients with sinus rhythm, with meta-analyses indicating substantially less clinical benefit in patients with permanent AF.  Because effective CRT requires a high rate of ventricular pacing, the benefit for patients with AF is most evident in patients who have undergone atrioventricular nodal ablation, which ensures obligate ventricular pacing.

In 2013, a focused update to the 2012 ACCF/AHA/HRS guideline (Tracy, 2012) was incorporated into the ACCF/AHA/HRS 2008 Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities which provided:

Evidence to support use of CRT in selected individuals with LVEF > 35% and < 50% is limited. The rationale for CRT in this setting is based upon indirect evidence from trials in individuals with LVEF ≤ 35% as well as the results of the BLOCK-HF trial which demonstrated that in HF individuals (NYHA class I, II, and III symptoms and an LVEF between 30% and 50%) with AV block, CRT was superior to conventional RV pacing for a composite end point (death, HF event requiring intervention, or ventricular remodeling (45.8 versus 55.6 percent; HR 0.74, 95% CI 0.60-0.90), but failed to show a significant difference in the risk of death (St John Sutton, 2015).

The InSync® Biventricular Pacing System (Medtronic Inc., Minneapolis, MN) is an example of a biventricular pacemaker.  It’s FDA labeling states that it is indicated for:

The treatment of individuals with NYHA functional class III or IV HF, who remain symptomatic despite stable, optimal medical therapy, who additionally have a QRS duration of greater than or equal to 130 milliseconds, and a LVEF of less than or equal to 35%. (See additional information below).

The FDA approval was based on data collected in the Multi-Center InSync Randomized Clinical Evaluation (MIRACLE) trial (FDA, 2001). 

In May of 2002, the FDA approved the first hybrid device that combines CRT with an ICD, the CONTAK CD® (Guidant Corp., St. Paul, MN).  The device is indicated for:

Individuals at high-risk of sudden death due to ventricular arrhythmias and who have moderate to severe HF (NYHA Class III/IV), including a LVEF less than or equal to 35% and a QRS duration greater than or equal to 120 milliseconds, and who remain symptomatic despite stable, optimal HF drug therapy.

In June of 2004, the FDA approved additional devices, the Epic HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy (St Jude Medical® Inc., Sunnyvale, CA) for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  This device has similar criteria to the others with a QRS duration equal to or greater than 150 milliseconds (FDA, 2004).

On September 16, 2010 the FDA approved expanded indications for three CRT devices (the Cognis® CRT-D, Livian CRT-D and Contak Renewal® 3 RF HE CRT-D, Boston Scientific Corp., St. Paul, MN), based on the results of the MADIT-CRT trial as follows:

These CRT-D devices are indicated for individuals with HF who receive stable optimal pharmacologic therapy for HF and who meet any one of the following classifications:
1)   Moderate to severe HF (NYHA Class III-IV) with EF less than or equal to 35% and QRS duration greater than or equal to 120 ms; or
2)   LBBB with QRS greater than or equal to 130 ms, EF less than or equal to 30%, and mild (NYHA Class II) ischemic or nonischemic HF or asymptomatic (NYHA Class I) ischemic HF (FDA, 2010).

In 2014, additional CRT devices manufactured by Medtronics, Inc. were cleared for expanded indications to include:

Individuals with NYHA functional class I, II, or III HF, who have a LVEF of 50% or less on stable, optimal HF medical therapy, if indicated, and who have AV block that is expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing (FDA, 2014).

These Medtronics devices go by multiple trade names; most are combination CRT/D devices, and one of the new devices is a combination CRT/pacemaker device (CRT-P), the Consulta® CRT-P System which has an adaptive pacing function intended for individuals who may benefit from maintenance of AV synchrony.  Additional detailed information on the Medtronics devices is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010015S205b.pdf (FDA, April 10, 2014; accessed on August 23, 2018).

In May 2017, Boston Scientific received FDA clearance for the Resonate family of ICD and CRT-D systems.  The approval includes new features in the Resonate devices, including SmartCRT technology with multisite pacing capability for multi-electrode pacing and compatibility with the HeartLogic Heart Failure Diagnostic Services, intended to help physicians improve HF management.

Definitions

Arrhythmia: An irregular heartbeat which can be either an atrial or ventricular arrhythmia depending on which part of the heart the abnormal rhythm originates from.

Atrial fibrillation (AF): This abnormal rhythm disorder involves an irregular and often rapid heart rate that emanates from the heart's two upper chambers (the atria) resulting in chaotic beating of the atria.  This fibrillation of the atria is out of coordination with the two lower chambers (the ventricles) of the heart causing inefficient pumping of the heart and diminished blood flow throughout the body.  AF symptoms often include heart palpitations, shortness of breath and weakness.

Congestive heart failure (CHF) or heart failure: A condition in which the heart no longer adequately functions as a pump.  As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the lungs and other organs.

Defibrillation: A process in which an electronic device (a defibrillator) gives the heart an electric shock, helping reestablish normal contraction rhythms in a heart that is not properly beating.  This may be done using an external device or by a device implanted in the body, an implantable cardioverter defibrillator (ICD).

Guideline-directed medical therapy (GDMT): This term was adopted by the writing groups for the major specialty medical societies, (such as found in Tracy, 2012 and Yancy, 2013) in 2012; the term replaces and is synonymous with “Optimal medical therapy.”

Left ventricular ejection fraction (LVEF): The measurement of the heart's ability to pump blood through the body.  Normal LVEF readings would be in the 58-70% range.

Myocardial infarction (MI): The medical term for heart attack.  A heart attack occurs when the blood supply to part of the heart muscle (the myocardium) is severely reduced or blocked.

New York Heart Association (NYHA) Definitions:
The NYHA classification of heart failure is a 4-tier system that categorizes subjects based on subjective impression of the degree of functional compromise; the four NYHA functional classes are as follows:

QRS complex: Refers to a portion of a tracing within an electrocardiogram that represents the spread of the electrical impulse through the ventricles.  A prolonged QRS interval indicates a dyssynchrony of the right and left ventricle and is an important selection criterion for a biventricular pacemaker.  

Sudden cardiac death: Death resulting from an abrupt loss of heart function (also known as cardiac arrest).

Ventricular tachyarrhythmias: A medical term for a rapid heartbeat that may be regular or irregular arising from the ventricle or pumping chamber of the heart.  Two common tachyarrhythmias are ventricular tachycardia and ventricular fibrillation.

Ventricular fibrillation (Vfib or VF): A condition in which the heart's electrical activity becomes disordered. When this happens, the heart's lower (pumping) chambers contract in a rapid, unsynchronized fashion (the ventricles "quiver" rather than beat) and the heart pumps little or no blood.

Ventricular tachycardia (Vtach or VT): A fast regular heart rate that starts in the lower chambers (ventricles).  VT may result from serious heart disease and usually requires prompt treatment.

References

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  94. Thibault B, Harel F, Ducharme A, et al.; LESSER EARTH Investigators. Cardiac resynchronization therapy in patients with heart failure and a QRS complex < 120 milliseconds: the Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial. Circ. 2013; 127(8):873-881.
  95. Upadhyay GA, Choudhry NK, Auricchio A, et al. Cardiac resynchronization in patients with atrial fibrillation: a meta-analysis of prospective cohort studies. J Am Coll Cardiol. 2008; 52(15):1239-1246.
  96. van Rees JB, de Bie MK, Thijssen J, et al. Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices: a systematic review of randomized clinical trials. J Am Coll Cardiol. 2011; 58(10):995-1000.
  97. Vatankulu MA, Goktekin O, Kaya MG, et al. Effect of long-term resynchronization therapy on left ventricular remodeling in pacemaker patients upgraded to biventricular devices. Am J Cardiol. 2009; 103(9):1280-1284.
  98. Whellan DJ, Ousdigian KT, Al-Khatib SM, et al. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol. 2010; 55(17):1803-1810.
  99. Wikstrom G, Blomström-Lundqvist C, Andren B, et al. The effects of etiology on outcome in patients treated with cardiac resynchronization therapy in the CARE-HF trial. Eur Heart J. 2009; 30(7):782-788.
  100. Wilkoff BL, Cook JR, Epstein AE, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002; 288(24):3115-3123.
  101. Wilton SB, Kavanagh KM, Aggarwal SG, et al. Association of rate-controlled persistent atrial fibrillation with clinical outcome and ventricular remodeling in recipients of cardiac resynchronization therapy. Can J Cardiol. 2011a; 27(6):787-793.
  102. Wilton SB, Leung AA, Ghali WA, et al. Outcomes of cardiac resynchronization therapy in patients with versus those without atrial fibrillation: a systematic review and meta-analysis. Heart Rhythm. 2011b; 8(7):1088-1094.
  103. Yancy CW, Fonarow GC, Albert NM, et al. Influence of patient age and sex on delivery of guideline-recommended heart failure care in the outpatient cardiology practice setting: findings from IMPROVE HF. Am Heart J. 2009; 157(4):754-762.
  104. Yin J, Hu H, Wang Y, et al. Effects of atrioventricular nodal ablation on permanent atrial fibrillation patients with cardiac resynchronization therapy: a systematic review and meta-analysis. Clin Cardiol. 2014; 37(11):707-715.
  105. Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003; 289(20):2685-2694.
  106. Yu CM, Abraham WT, Bax J, et al. Predictors of response to cardiac resynchronization therapy (PROSPECT)--study design. Am Heart J. 2005; 149(4):600-605.
  107. Yu CM, Chan JY, Zhang Q, et al. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009; 361(22):2123-2134.
  108. Yu CM, Fang F, Luo XX, et al. Long-term follow-up results of the pacing to avoid cardiac enlargement (PACE) trial. Eur J Heart Fail. 2014; 16(9):1016-1025.
  109. Zareba W, Klein H, Cygankiewicz I, et al.; MADIT-CRT Investigators. Effectiveness of cardiac resynchronization therapy by QRS morphology in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Circulation. 2011; 123(10):1061-1072.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Blue Cross Blue Shield Association. Cardiac Resynchronization Therapy for Mild Congestive Heart Failure. TEC Assessment. 2011; 26(1).
  2. Boston Scientific Corporation, University of Rochester. MADIT-CRT Automatic defibrillator implantation with cardiac resynchronization therapy. NLM Identifier: NCT00180271. Last updated on January 30, 2012. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00180271?term=MADIT+CRT&rank=1. Accessed on August 23, 2018.
  3. Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013; 34(29):2281-2329.
  4. Centers for Medicare and Medicaid Services. National Coverage Determination for Cardiac Pacemakers. NCD#20.8. Effective August 13, 2013. Available at:
    https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=238&ncdver=3&DocID=20.8&generalError=Thank+you+for+your+interest+in+the+
    Medicare+Coverage+Database.+You+may+only+view+the+page+you+attempted+to+access+
    via+normal+usage+of+the+Medicare+Coverage+Database.&bc=
    gAAAABAAAAAAAA%3d3d&
    . Accessed on August 23, 2018.
  5. Centers for Medicare and Medicaid Services.  Proposed National Decision Memo for Implantable Cardioverter Defibrillators. CAG-00157R3. January 27, 2005. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=148&NCDId=110&ncdver=3&NcaName=Implantable+Defibrillators&IsPopup=y&bc=AAAAAAAAEAAA&,#Top. Accessed on August 23, 2018.
  6. Dickstein K, Vardas PE, Auricchio A, et al. 2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC Guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Eur Heart J. 2010; 31(21):2677-2687.
  7. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008; 51(21):e1-62. 
  8. Epstein AE, DiMarco JP, Ellenbogen KA, et al.; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Heart Rhythm Society. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013; 61(3):e6-75.
  9. Gorcsan J 3rd, Abraham T, Agler DA, et al. American Society of Echocardiography Dyssynchrony Writing Group. Echocardiography for cardiac resynchronization therapy: recommendations for performance and reporting--a report from the American Society of Echocardiography Dyssynchrony Writing Group endorsed by the Heart Rhythm Society. J Am Soc Echocardiogr. 2008; 21(3):191-213.
  10. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the International Society for Heart and Lung Transplantation. J Am Coll Cardiol. 2009; 53(15):e1-90. 
  11. Jessup M, Abraham WT, Casey DE, et al. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009; 53(15):1343-1382.
  12. Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease: developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society (CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD). Can J Cardiol. 2014; 30(10):e1-e63.
  13. Lindenfeld J, Albert NM, Boehmer JP, et al.; Heart Failure Society of America. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010; 16(6):e1-e194.
  14. Medtronic Cardiac Rhythm Disease Management. Medtronic, Inc.  REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE). NLM Identifier: NCT00271154.  Last updated on January 30, 2012. Available at: http://clinicaltrials.gov/ct2/show/NCT00271154?term=NCT00271154&rank=1. Accessed on August 23, 2018.
  15. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016; 37(27):2129-2200. 
  16. Rickard J, Michtalik H, Sharma R, et al. Use of Cardiac Resynchronization Therapy in the Medicare Population. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. HHSA 290-201-200007-1.) Rockville, MD: Agency for Healthcare Research and Quality. March 24, 2015. Available at:  https://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=100&bc=AAAQAAAAAAAAAA%3d%3d&. Accessed on August 23, 2018.
  17. Russo AM, Stainback RF, Bailey SR, et al. ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. J Am Coll Cardiol. 2013; 61(12):1318-1368.
  18. Stevenson WG, Hernandez AF, Carson PE, et al. Indications for cardiac resynchronization therapy: 2011 update from the Heart Failure Society of America Guideline Committee. J Cardiac Fail. 2012; 18(2):94-106. 
  19. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012; 60(14):1297-1313.
  20. Uhlig K, Balk EM, Earley A, et al. Assessment on implantable defibrillators and the evidence for primary prevention of sudden cardiac death. Evidence Report/Technology Assessment. (Prepared by the Tufts Evidence-based Practice Center under Contract No. 290-2007-10055-I.) Rockville, MD: Agency for Healthcare Research and Quality (AHRQ). June 2013.
  21. University of Ottowa Heart Institute, Canadian Institutes of Health Research (CIHR), Medtronic, Inc. Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (RAFT). NLM Identifier: NCT00251251. Last updated on June 18, 2012. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00251251?term=Resynchronization%2Fdefibrillation&rank=1  Accessed on August 23, 2018.
  22. U.S. Food and Drug Administration (FDA).  Center for Devices and Radiological Health.  Boston Scientific Corporation. Cognis CRT-D, Livian CRT-D and Contak Renewal 3 RF HE CRT-D. P010012/S230. September 16, 2010. Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf/P010012S230a.pdf. Accessed on August 23, 2018.
  23. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket Approval (PMA) Database. Ela Medical, Inc., (Plymouth, MN) Ovatio CRT-D System. PMA number P060027. May 15, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060027a.pdf. Accessed on August 23, 2018.
  24. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket Approval (PMA) Database. St. Jude Medical® Frontier and Frontier II biventricular pacing systems. PMA number P030035. Original PMA date: May 13, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030035A.pdf. Accessed on August 23, 2018.
  25. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. St. Jude Medical® Epic HF dual chamber implantable cardioverter defibrillator systems with cardiac resynchronization therapy. P030054. June 30, 2004. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p030054. Accessed on August 23, 2018.
  26. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Summary of Safety and Effectiveness for Medtronic InSync® Biventricular Pacing System. P010015. Original PMA date: August 28, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010015A.pdf. Accessed on August 23, 2018.
  27. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Expanded indications for use of CRT-P and CRT-D devices. P010015/S205. April 10, 2014. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/p010015s205a.pdf. Accessed on August 8, 2018.
  28. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 62(16):e147-239.
  29. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017; 70:776–803.
Websites for Additional Information
  1. National Heart, Lung and Blood Institute. Heart failure. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Hf/HF_WhatIs.html. Accessed on August 23, 2018.
Index

Atlas + HF
Biventricular Pacemaker
Consulta CRT-P System
Consulta CRT-D System
CONTAK RENEWAL
Epic HF
InSync Biventricular Pacing System
InSync ICD Dual Chamber ICD with CRT
Resonate CRT-D System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Reviewed

09/13/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Title changed to Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure. Updated Discussion/General Information, References, and Websites for Additional Information sections.

New

11/02/2017

MPTAC review. Initial document development. Moved content of SURG.00064 Cardiac Resynchronization Therapy with or without an ICD (CRT/ICD) for the Treatment of Heart Failure to new clinical utilization management guideline document with the same title.