Medical Policies - Medicine


Cardiac Contractility Modulation (CCM) Device

Number:MED202.068

Effective Date:10-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Insertion, removal or replacement of a cardiac contractility modulation (CCM) device is considered experimental, investigational and/or unproven for all indications, including but not limited to heart failure.

Description:

Heart failure occurs when the heart is unable to pump sufficient blood to the body’s tissues and is most often the result of damage to the heart muscle from injuries such as heart attack, untreated coronary artery disease (CAD), or persistent hypertension. It can also be a genetically inherited condition or can occur as a result of an infection. Physicians evaluate cardiac status based on the ejection fraction (EF) and the New York Heart Association (NYHA) Functional Classification tool. The EF monitors the overall heart strength. A normal EF is greater than 55%, but in heart failure, it typically falls to values less than 45-50%. (1) The NYHA Functional Classification tool evaluates the patient’s physical activity limitations based on their individual heart failure symptoms. The NYHA functional classifications include (2):

NYHA class 1- No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

NYHA class II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

NYHA class III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

NYHA class IV- Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Heart failure is a chronic disease requiring lifelong management. The goal of treatment is to correct underlying pathology, decrease symptoms,prevent worsening of the condition, reduce the frequency of hospitalizations, and to prolong the patient’s life. Patients typically receive medical treatments to include diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, oraldosterone inhibitors (all drugs that block the body’s neurohormonal system). In most heart failure patients, an implantable cardioverter defibrillator (ICD) device is also recommended to treat potentially life-threatening cardiac rhythms. Patients with a prolonged QRS duration and dyssynchronous contractions (which occur in about 30% of cases) receive additional cardiac resynchronization therapy (CRT), a special type of pacemaker, on top of medications and ICD device implant. Most patients with heart failure however, have a normal QRS duration anddo notbenefit from treatment. (1)

Cardiac contractility modulation (CCM)is a novel method for treating patients with moderate to severe heart failure (NYHA class III), that remain symptomatic despite optimal medical management. CCM is typically suitable for patients with an ejection fraction (EF) >20% with a normal QRS duration independent of an underlying heart rhythm. Typically, the patient is unable to benefit from other device-based treatments such as cardiac resynchronization therapy (CRT) or biventricular pacing with pacemaker functionality. (1) CCM is an implanted electrical device, proposed to enhance ventricular contractile strength of the failing myocardium, independently of synchrony of myocardial contraction. CCM signals are non-excitatory, relatively high voltage electrical impulses applied during the myocardial absolute refractory period. These signals do not initiate a new contraction or affect activation sequence, but modify the entry of calcium into the cardiomyocyte and enhance its contractility. CCM cannot be delivered to patients with atrial fibrillation or repeated ectopy since it is designed to inhibit CCM delivery on arrhythmias and relies on detection of P wave. (3)

The Optimizer IVs™ (IPG) is a CCM device and has the following components. (1, 4)

IPG: The pulse generator generates the CCM’s non-excitatory electrical signals. The IPG is usually implanted into the subcutaneous pocket of the right pectoral region and secured to the fascia with a non-absorbable suture

Leads: CCM delivery devices use three bipolar leads. One lead is implanted into the right atrium and the other 2 leads are inserted into the right ventricle. The lead in the right atrium detects atrial electric signals and transmits them to the pulse generator. The IPG processes the atrial signal and generates the CCM signals which are transmitted to the right ventricle via the two ventricular leads.

Battery charger: The Optimizer IV mini charger, allows patients to recharge the battery of the Optimizer IVs™ independently at home. Transmission of energy between the Optimizer IV mini charger and the IPG is accomplished painlessly and non-invasively, via resonant inductive coupling. The charger should be used on a weekly basis and charging sessions typically last about 45 minutes.

Programming unit: The Omni II programming unit is used solely by the physician for device check-ups or in case of technical problems. The stimulation signal of the pulse generator can be adjusted to the needs of each patient through the programming unit.

Regulatory Status

To date, the Optimizer IVs Device™ (Impulse Dynamics, Mt. Laurel, New Jersey) is not approved by the United States Food and Drug Administration (FDA). (1)

Rationale:

This policy was originally developed in Januray 2016 and has been updated with searches of scientific literature through August 31, 2017. Following is a summary of the key literature to date.

In 2006, Neelagaru et al. evaluated nonexcitatory, cardiac contractility modulation (CCM) electrical impulse study for advanced heart failure in patients with a normal QRS duration.  The principle of this randomized, double-blind, pilot study was to determine the feasibility of safely and effectively delivering CCM signals in patients with heart failure. Forty-nine subjects with ejection fraction <35%, normal QRS duration (105 +/- 15 ms), and New York Heart Association (NYHA) class III or IV heart failure despite medical therapy received a CCM pulse generator. Patients were randomized to have their devices programmed to deliver CCM signals (n = 25, treatment group) or to remain off (n = 24, control group) for 6 months. Evaluations included NYHA class, 6-minute walk, cardiopulmonary stress test, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and Holter monitoring. Most baseline features were balanced between groups, ejection fraction (EF) (31.4% +/- 7.4% vs 24.9% +/- 6.5%, P = .003), end-diastolic dimension (52.1 +/- 21.4 mm vs 62.5 +/- 6.2 mm, P = .01), peak VO2 (V-volume, O2-oxygen)(16.0 +/- 2.9 mL O2/kg/min verses 14.3 +/- 2.8 mL O2/kg/min, P = .02), and anaerobic threshold (12.3 +/- 2.5 mL O2/kg/min vs 10.6 +/- 2.4 mL O2/kg/min, P = .01) were worse in the treatment group than in the control group. Nevertheless, one death occurred in the control group, and more patients in the treatment group were free of hospitalization for any cause at 6 months (84% verses 62%). No change in ectopy was observed. Compared with baseline, 6-minute walk (13.4 m), peak VO2 (0.2 mL O2/kg/min), and anaerobic threshold (0.8 mL O2/kg/min) increased more in the treatment group than in control. None of these differences were statistically significant (small sample size). NYHA and MLHFQ changed similarly in the two groups. The study concluded that despite a sicker population in the treatment group, no specific safety concerns emerged with chronic CCM signal administration. The author determined that further study is required to define the safety and efficacy of CCM signals. (5) This study provided neutral results in terms of NYHA class, exercise capacity and quality of life comparing 6-month CCM to no CCM. However, this was a feasibility study with a limited number of patients, and did not allow drawing firm conclusions regarding effectiveness of the therapy to improve clinical outcome. (3)

In 2008, Borggrefe et al. completed a double-blinded study which included 164 heart failure patients in Europe with an ejection fraction ≤35%, NYHA Class II to III who were ineligible for cardiac resynchronization therapy (CRT). All patients were implanted with the Optimizer™ system. The trial had a crossover design with two 3-month periods with and without treatment. Analysis at the end of the active and sham treatment periods showed significantly improved peak oxygen consumption and 6-minute walk tests and MLHFQ with CCM, although endpoints improved similarly during the first three months whether CCM was turned on or off, and there were no significant differences in NYHA. The study population was limited in size and therefore the author believed the results may be statistically underpowered. (6)

In 2011, Goliasch et al. aimed to evaluate whether the acute application of CCM leads to an increase in myocardial oxygen consumption (MVO2) in patients with chronic heart failure using C-acetate positron emission tomography (PET). Twenty-one patients with severe heart failure were enrolled. C-acetate PET was performed before and after activation of the CCM device. In 12 patients, an additional stress study with dobutamine was performed. Under resting conditions, the values of myocardial blood flow (MBF), MVO2 and work metabolic index (WMI, reflecting myocardial efficiency) with the CCM device activated did not differ significantly from the values with the device deactivated. MBF was 0.81 ± 0.18 ml min(-1) g(-1) with the device off and 0.80 ± 0.15 ml min(-1) g(-1) with the device on (p = 0.818), MVO2 was 6.81 ± 1.69 ml/min/100 g with the device off and 7.15 ± 1.62 ml/min/100 g with the device on (p = 0.241) and WMI was 4.94 ± 1.14 mmHg ml/m(2) with the device off and 5.21 ± 1.36 mmHg ml/m(2) with the device on (p = 0.344). Under dobutamine stress, the values of MBF, MVO2 and WMI with the CCM device activated did not differ from the values with the device deactivated, but were significantly increased compared with the values obtained under resting conditions. The study concluded that CCM does not induce increased MVO2, even under stress conditions. (7)

In 2011, Kadish et al. performed the FIX-HF-5 study that evaluated CCM in 428 NYHA class III or IV, narrow QRS heart failure patients with EF ≤ 35% randomized to optimal medical therapy (OMT) plus CCM (n = 215) versus OMT alone (n = 213). Efficacy was assessed by ventilatory anaerobic threshold (VAT), primary end point, peak Vo? (pVo?), and MLHFQ at 6 months. The primary safety end point was a test of noninferiority between groups at 12 months for the composite of all-cause mortality and hospitalizations. The groups were comparable for age, EF, pVo? and other characteristics. While VAT did not improve at 6 months, CCM significantly improved pVo? and MLWHFQ (by 0.65 mL kg?¹ min?¹ [P = .024] and -9.7 points [P < .0001], respectively) over OMT. Forty-eight percent of OMT and 52% of CCM patients experienced a safety end point, which satisfied the noninferiority criterion (P = .03). Post hoc, hypothesis-generating analysis identified a subgroup (characterized by baseline EF ≥ 25% and NYHA class III symptoms) in which all parameters were improved by CCM. In the overall target population, CCM did not improve VAT (the primary end point) but did improve pVo? and MLHFQ. CCM did not have an adverse effect on hospitalizations or mortality within the prespecified boundaries. The study concluded that additional study is required to clarify the role of CCM as a treatment for heart failure. (8) In this study, the primary endpoint was not met in the overall population but was limited to a predefined sub-group. Further investigations are needed before CCM can be accepted as a recommended treatment modality for Heart Failure patients. (3)

In 2016, Kloppe and colleagues (9) conducted a single center pilot evaluation study involving 19 medically refractory symptomatic patients with heart failure and reduced left ventricular function who underwent implantation of an Optimizer™ system. Patients were randomized into one of two treatment groups; 5 h/day CCM treatment or 12 h/day CCM treatment. Subjects and evaluating physicians were blinded to the study group. Subjects returned to the hospital after 12 and 24 weeks. Efficacy evaluations included changes from baseline to 24 weeks in MLHFQ score, maximal oxygen consumption in the cardio-pulmonary stress test (peak VO2), NYHA classification, 6-min walk distance (6MWD), and ejection fraction (EF). At the end of 24 weeks, clinical improvement was observed in the entire cohort in all efficacy measures. There were no significant differences, either clinically or statistically, between the groups receiving CCM for 5 hours per day verses 12 hours per day. Given the small sample size, further studies are warranted.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Title

Number enrolled

Completion Date

NCT00112125 (10)

Evaluation of the Safety and Effectiveness of the OPTIMIZER™ System in Subjects with Heart Failure: FIX-HF-5

428

July 2017 (ongoing)

NCT03102437 (11)

Continued Access Protocol for the Evaluation of the OPTIMIZER™ Smart System

250

April 2018 (recruiting)

NCT01381172 (12)

Evaluate Safety and Efficacy of the OPTIMIZER™ System in Subjects with Moderate-to-SevereHeart Failure: FIX-HF-5C (FIX-HF-5C)

160

September 2017 (ongoing)

Table Key: NCT: National Clinical Trial

Professional Guidelines and Position Statements

European Society of Cardiology (ESC)

The 2016 ESC Guidelines for the diagnosis and treatment of heart failure (13) state the effect of CCM on heart failure morbidity and mortality remains to be established.

American College of Cardiology (ACC)/American Heart Association (AHA)/ Heart Failure Society of America (HFSA)

In 2017, the ACC, AHA, and the HFSA updated their 2013 guidelines for the management of heart failure. (14) These guidelines do not mention CCM as a treatment modality for heart failure.

Summary of Evidence

Some data and small studies have shown encouraging results in terms of safety and effectiveness of cardiac contractility modulation (CCM) therapy. The FIX-CHF-5 study (3,8) showed some promising results in a select sub-group of patients but additional data from large scale randomized studies with long-term follow-up are required before this therapy may one day be recognized as a valid treatment modality in professional society guidelines. (2)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0408T, 0409T, 0410T, 0411T, 0412T, 0413T, 0414T, 0415T, 0416T, 0417T, 0418T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Impulse dynamics. What is Heart Failure? Mt. Laurel, New Jersey (2017). Available at: <http://impulse-dynamics.com> (accessed 2017 August 29).

2. American Heart Association. Classes of heart failure (September 2015). Available at: <http://www.heart.org> (accessed 2017 August 28).

3. Burri H, Bordachar P. Cardiac contractility modulation for treatment of heart failure. Cardiovascular Medicine. 2013; 16(10):259-262.

4. Applicant submitted protocol for cardiac contractility modulation (CCM) therapy for patients with cardiac heart failure. Medical Services Advisory Committee 2015. Available at: <http://msac.gov.au> (accessed 2017 August 28).

5. Neelagaru SB, Sanchez JE, Lau SK, et al. Nonexcitatory, cardiac contractility modulation electrical impulses; feasibility study for advanced heart failure in patients with normal QRS duration. Heart Rhythm. 2006; 3(10); 1140-7. PMID 17018340

6. Borggrefe MM, Lawo T, Butter C, et al. Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure. European Heart Journal. 2008; 29:1019–28. PMID 18270213

7. Goliasch G, Khorsand A, Schutz M, et al. The effect of device based cardiac contractility modulation therapy on myocardial efficiency and oxidative metabolism in patients with heart failure. European Journal of Nuclear Medicine and Molecular Imaging. 2012; 39(3):408-15. PMID 22083298

8. Kadish A, Nademanee K, Volosin K, et al. A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. American Heart Journal 2011; 161(2):329-337. PMID 21315216

9. Kloppe A, Mijic D, Schiedat F, et al. A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report. Cardiology Journal. 2016; 23(1):114-9. PMID 26503077

10. Burkhoff D. Evaluation of the safety and effectiveness of the OPTIMIZER system in subjects with heart failure: FIX-HF-5. In: ClinicalTrials.gov. Bethesda (MD): US National Institutes of Health. NCT00112125.

11. Burkhoff D. Continued access protocol for the evaluation of the OPTIMIZER smart system. In: ClinicalTrials.gov. Bethesda (MD): US National Institutes of Health. NCT03102437.

12. Burkhoff D. Evaluate safety and efficacy of the OPTIMIZER® system in subjects with moderate-to-severe heart failure: FIX-HF-5C (FIX-HF-5C). In: ClinicalTrials.gov. Bethesda (MD): US National Institutes of Health. NCT01381172

13. 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. European Heart Journal. 2016 Jul 14; 37(27):2129-200. PMID 27206819

14. ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association task force on practice guidelines (2013, revised 2017); 62(16). Available at: <http://content.onlinejacc.org> (accessed 2017 August 28).

Policy History:

Date Reason
10/1/2018 Reviewed. No changes.
10/15/2017 Document updated with literature review. Coverage unchanged.
10/1/2016 Reviewed. No changes.
1/1/2016 New medical document. Insertion, removal or replacement of a cardiac contractility modulation (CCM) device is considered experimental, investigational and/or unproven for all indications, including but not limited to heart failure.

Archived Document(s):

Title:Effective Date:End Date:
Cardiac Contractility Modulation (CCM) Device10-15-201709-30-2018
Cardiac Contractility Modulation (CCM) Device10-01-201610-14-2017
Cardiac Contractility Modulation (CCM) Device01-01-201609-30-2016
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