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View Public Comments for Implantable Cardioverter Defibrillators (CAG-00157R4)

Commenter:
Kato, Norman
Title:
ICD for Non-ischemic cardiomyopathy
Date:
06/29/2017
Comment:

June 29, 2017

David A. Dolan, MBA, MA, Lead Analyst (david.dolan@cms.hhs.gov)
Daniel Canos, PhD, Lead Analyst (daniel.canos@cms.hhs.gov)
Centers for Medicare and Medicaid Services

NCA: Implantable Cardioverter Defibrillators

Dear Sirs:

I am responding to the May 30, 2017 Centers for Medicare and Medicaid Services National Coverage Analysis (NCA) Tracking Sheet for Implantable Cardioverter Defibrillators (CAG-00157R4) opening this national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators. Public Comment Period is from May 30, 2017 to June 29, 2017. The use of ICD pacemakers for primary prevention against sudden cardiac death for ischemic cardiomyopathy with the usual exclusion criteria (no acute myocardial infarction within 40 days; no percutaneous coronary intervention or coronary artery bypass graft surgery within 3 months; no guideline directed optimal medical management for at least 3 months; limitations in life expectancy anticipated to be less than one year; organ brain injury or disease) is well-established.

The topic of my comments is specifically directed at the use of ICD pacemakers for non-ischemic cardiomyopathy for primary prevention against sudden cardiac death. By definition, non-ischemic cardiomyopathy indicates a reduced left ventricular ejection fraction less than or equal to 35% and absence of less than 75% stenosis of no more than one (1) main coronary artery vessels (Left Main coronary artery, Left Anterior Descending coronary artery, Circumflex coronary artery, and the Right Coronary artery).

I am referencing the criteria from the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4) (Publication Number 100-3; Version Number 3; Manual Section Number 20.4; Effective Date: January 27, 2005; Implementation Date: January 27, 2005). The Covered Indications Sections 7 and Section 9 that are difficult to understand and contrary to several randomized controlled clinical trials:

  1. Patients with non-ischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%

And

  1. Patients with NIDCM > 3 months, NYHA Class II or III heart failure, and measured LVEF ≤ 35%, only if the following additional criteria are also met:
    1. Patients must be able to give informed consent;
    2. Patients must not have:
      • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
      • Had a CABG or PTCA within the past 3 months;
      • Had an acute MI within the past 40 days;
      • Clinical symptoms or findings that would make them a candidate for coronary revascularization;
      • Irreversible brain damage from preexisting cerebral disease;
      • Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year;
    3. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;
    4. MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction;
    5. The beneficiary receiving the defibrillator implantation for this indication is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR ˜405.201), a trial under the CMS Clinical Trial Policy (NCD Manual ˜310.1), or a prospective data collection system meeting the following basic criteria:
      • Written protocol on file;
      • Institutional Review Board review and approval;
      • Scientific review and approval by two or more qualified individuals who are not part of the research team;
      • Certification that investigators have not been disqualified.
    6. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.

As published in CMS IOM [Internet Only Manuals] 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. A service is reasonable and necessary under Section 1862(a)(1)(A):

  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient's medical needs and condition.
  • Ordered and furnished by qualified personnel.
  • One that meets, but does not exceed, the patient's medical need.
  • At least as beneficial as an existing and available medically appropriate alternative.

Here are my comments:

  1. Since patients with nonischemic cardiomyopathy do not have coronary artery disease, criteria #7 and criteria #9 appear to be conflicting. The National Coverage Determination has both a three (3) month and a nine (9) month period of presumably treatment with guideline directed optimal medical management presumably followed by clinical re-evaluation prior to ICD pacemaker implantation. The three (3) or nine (9) month period following diagnosis should be reconciled. This waiting period is presumably to allow myocardial recovery on optimal medical management.
  2. The presence of criteria #7 and criteria #9 have always appeared to be redundant and in some cases criteria conflict. A patient with a non-ischemic cardiomyopathy should not be undergoing PCI or CABG. Admittedly, there is a subset of patients with normal coronary arteries that do have acute myocardial infarction. Survival likelihood and informed consent should not be limited to non-ischemic cardiomyopathy. Pre-existing cerebral disease should include dementia. Patients with dementia should not receive an ICD pacemaker.
  3. There is no reference to guideline directed optimal medical management. Guideline directed optimal medical management is now Class I requirement by the American College of Cardiology/American Heart Association guidelines regarding the medical management of heart failure.1 I would recommend that a summary of guideline directed optimal medical management be included in the NCD including target systolic blood pressure.
  4. There are now four (4) randomized controlled clinical trials that have reached the same conclusion regarding the use of ICD pacemaker for non-ischemic cardiomyopathy in the setting of primary prevention against sudden cardiac death. These trials include CAT2 (Circulation, 2002, 105:1453-1458), AMIOVIRT3 (Journal of the American College of Cardiology, 2003, 41:1707-1712), DEFINITE (New England Journal of Medicine, 2004, 350:2151-2158), and DANISH (New England Journal of Medicine, August 28, 2016, DOI: 10.1056/NEJMoa1608029.
  5. Non-ischemic cardiomyopathy and ICD pacemakers have been evaluated in randomized controlled clinical trials.

    The 2002 Cardiomyopathy Trial (CAT) authors stated:

    The trial was terminated after the inclusion of 104 patients because the all-cause mortality rate at 1 year did not reach the expected 30% in the control group. In August 2000, the vital status of all patients was updated by contacting patients, relatives, or local registration offices. One hundred four patients were enrolled in the trial: Fifty were assigned to ICD therapy and 54 to the control group. Mean follow-up was 22.8}4.3 months, on the basis of investigatorsf follow-up. After 1 year, 6 patients were dead (4 in the ICD group and 2 in the control group). No sudden death occurred during the first and second years of follow-up. In August 2000, after a mean follow-up of 5.5±2.2 years, 30 deaths had occurred (13 in the ICD group and 17 in the control group). Cumulative survival was not significantly different between the two groups (93% and 80% in the control group versus 92% and 86% in the ICD group after 2 and 4 years, respectively).

    The 2002 CAT trial authors concluded:

    ICD therapy did not reveal any survival benefit in the setting of DCM [dilated cardiomyopathy] of recent onset and impaired LV function (EF ≤ 30%). This was most likely due to the low overall mortality rate in the control group. However, even in patients with a significantly increased mortality rate caused by a lower EF [ejection fraction] and nonsustained VTs [ventricular tachycardias], ICD therapy did not reveal any survival benefit. Therefore, the results of CAT do not favor prophylactic ICD implantation in patients with DCM of recent onset and impaired LVEF without any further risk stratification.

    The 2003 AMIOVERT trial, the authors stated:

    The Trial randomized 219 patients into an ICD pacemaker group and Amiodarone group. The study was stopped when the prospective stopping rule for futility was reached. The percent of patients surviving at one year (90% vs. 96%) and three years (88% vs. 87%) in the amiodarone and ICD groups, respectively, were not statistically different (p = 0.8). Quality of life was also similar with each therapy (p = NS).

    The 2003 AMIOVERT trial authors concluded:

    Not only was total mortality found not to be statistically different with amiodarone and ICD in patients with NIDCM [nonischemic dilated cardiomyopathy] and NSVT [nonsustained ventricular tachycardia], but there was also a trend towards amiodarone being more effective than the ICD in preventing symptomatic VT [ventricular tachycaradia]. The lack of statistically different survival rates and the trend towards a substantial cost savings with amiodarone provide an argument favoring amiodarone as the initial therapy to prevent death among patients with NIDCM [nonischemic dilated cardiomyopathy] and NSVT [nonsustained ventricular tachycardia].

    The 2004 DEFINITE trial4, the authors stated:

    We enrolled 458 patients with nonischemic dilated cardiomyopathy, a left ventricular ejection fraction of less than 36 percent, and premature ventricular complexes or nonsustained ventricular tachycardia. A total of 229 patients were randomly assigned to receive standard medical therapy, and 229 to receive standard medical therapy plus a single-chamber ICD.

    Patients were followed for a mean (}SD) of 29.0}14.4 months. The mean left ventricular ejection fraction was 21 percent. The vast majority of patients were treated with angiotensin-converting.enzyme (ACE) inhibitors (86 percent) and beta-blockers (85 percent). There were 68 deaths: 28 in the ICD group, as compared with 40 in the standard-therapy group (hazard ratio, 0.65; 95 percent confidence interval, 0.40 to 1.06; P=0.08).

    The 2004 DEFINITE trial authors concluded:

    On the basis of our results, the routine implantation of a cardioverter.defibrillator cannot be recommended for all patients with nonischemic cardiomyopathy and severe left ventricular dysfunction.

    The 2016 DANISH trial5, the authors stated:

    In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death.

    After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval [CI], 0.68 to 1.12; P = 0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P = 0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P = 0.29).

    The 2016 DANISH trial authors concluded:

    In conclusion, in our trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure that was not caused by coronary artery disease was not found to reduce long-term mortality.

  6. Based upon four (4) randomized controlled clinical trials, the routine use of ICD pacemaker implantation for non-ischemic cardiomyopathy for the primary prevention of sudden cardiac death is not associated with any survival benefit compared with optimal medical therapy. This conclusion indicates that criteria #7 or criteria #9 in the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4) (Publication Number 100-3; Version Number 3; Manual Section Number 20.4; Effective Date: January 27, 2005; Implementation Date: January 27, 2005) may no longer valid.

    Thank you very much for your consideration.

    Sincerely,

    /s/
    Norman S. Kato, MD
    FACC, FCCP, FACS, FAHA
    5535 Balboa Boulevard, Suite 112
    Encino, California 91316

    1 Yancy, C. W., et al. "2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure", Journal of the American College of Cardiology, 2016;68:1476.88 and Jessup, M., et al. g2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: 2009 WRITING GROUP TO REVIEW NEW EVIDENCE AND UPDATE THE 2005 GUIDELINE FOR THE MANAGEMENT OF PATIENTS WITH CHRONIC HEART FAILURE WRITING ON BEHALF OF THE 2005 HEART FAILURE WRITING COMMITTEEh, Circulation, 2009, 119:1977-2016.
    2 Bansch, D., et al. "Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy: The cardiomyopathy trial (CAT)", Circulation, 2002, 105:1453-1458.
    3 AMIOVIRT trial: Amiodarone versus Implantable Cardioverter-Defibrillator: Randomized Trial in Patients with Nonischemic Dilated Cardiomyopathy and Asymptomatic Nonsustained Ventricular Tachycardia, Journal of the American College of Cardiology, 2003, 41:1707-1712.
    4 Kadish, A., et al. "Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy", New England Journal of Medicine, 2004, 150:2151-2158.
    5 Kober, L., et al."Defibrillator implantation in patients with nonischemic systolic heart failure", New England Journal of Medicine, August 28, 2016, DOI: 10.1056/NEJMoa1608029.
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