MEDICAL POLICY

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POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Intracardiac Ischemia Monitoring

Number 2.02.505

Effective Date May 27, 2015

Revision Date(s) 05/12/15; 09/08/14; 09/09/13

Replaces N/A

Policy

An implantable continuous intracardiac ischemia detection system (IIDS) for monitoring cardiac ischemia is considered investigational.

Related Policies

2.02.506

Wearable Cardioverter-Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement

7.01.44

Implantable Cardioverter Defibrillator (ICD)

Policy Guidelines

Coding

CPT

0302T

Insertion or removal and replacement of intracardiac ischemia monitoring system including imaging supervision and interpretation when performed and intra-operative interrogation and programming when performed; complete system (includes device and electrode)

0303T

electrode only

0304T

device only

0305T

Programming device evaluation (in person) of intracardiac ischemia monitoring system with iterative adjustment of programmed values, with analysis, review, and report

0306T

Interrogation device evaluation (in person) of intracardiac ischemia monitoring system with analysis, review, and report

0307T

Removal of intracardiac ischemia monitoring device

See Regulatory Status for brand name of intracardiac ischemia monitoring system.

Definition of Terms

Ischemia – a decrease in blood flow caused by constriction or obstruction in blood vessels that affects the blood supply to tissues. An inadequate blood supply can cause oxygen starvation in the tissues.

ST elevated myocardial infarction (STEMI) – is a severe type of heart attack where the coronary artery is completely blocked by a blood clot and appears as an elevation in the ST segment of an electrocardiogram (ECG). The elevated ST segment indicates that serious heart muscle damage is occurring.

Description

An emerging technology in heart health is an implanted heart attack monitor that tracks the intracardiac electrogram (IEGM) signal and detects real-time changes in the ST-segment of the heart’s electrical rhythm that usually indicates cardiac ischemia, and potentially a myocardial infarction (MI). The AngelMed® Guardian System device uses a standard pacemaker lead placed in the right ventricle apex of the patient’s heart. Even if the patient feels no MI symptoms, an ST shift can be detected by the implanted device that sends a warning signal to a pager-like unit worn on a belt. The external alarm device (EXD) emits a vibration, sound and a light indicating a cardiac event is going on and emergency medical treatment is needed. Components of the system include a programmable implantable monitoring device (IMD), right ventricle lead, lead adapter, external alarm device (EXD) and a programmer. (1) The device records and stores electrogram tracings for analysis by the health care provider in the emergency room.

Because a large number of myocardial infarction s happen without symptoms or uncharacteristic symptoms, especially in patients with diabetes who are particularly at risk for coronary artery disease (CAD) (2), the monitoring device might assist these patients to seek treatment before perceivable symptoms of an MI occur. For patients who are at high-risk for cardiac events, by having this early warning that prompts rapid intervention, the intended goal is to inhibit or decrease heart muscle damage and prevent death from an acute myocardial infarction (AMI).

Regulatory Status

The AngelMed® Guardian device is only available under an FDA investigational device exemption (IDE) for investigational use in the U.S. Medical Centers where the clinical trials are scheduled. An IDE allows the investigational device to be used in a clinical study, in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification (510[k]) submission to the FDA.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

N/A

Rationale

The American Heart Association (AHA) statistics show that more than 1 in 3 adults have some form of heart disease. There are over one million acute myocardial infarction (AMI) events each year in the United States with approximately 37-38% of those events resulting in death. The major problem is that patients wait too long before seeking medical attention, or they may not have any symptoms. Early identification of changes in the heart’s status that may indicate a pending AMI, followed by rapid treatment with a coronary intervention or clot dissolving medications to open a blocked artery, has improved clinical outcomes according to research data. (3)

The AngelMed ® Guardian System (Angel Medical Systems, Shrewsbury, NJ) is an implanted intracardiac ischemia detection system (IIDS) that continuously monitors ischemia by detecting ST-segment changes. Changes in the ST-segment of the heart’s rhythm may indicate a pending cardiac event, like a life-threatening blockage in one or more of the coronary arteries. The ST-segment shifts are calculated by the device using a proprietary algorithm as the difference between the ST deviation of a current 10-second electrogram window and a baseline ST deviation value. If the ST-segment shift is greater than a heart rate-dependent programmable threshold, then the device generates an emergency alert signal. (4) The IIDS is intended for the patient population with multiple cardiovascular risk factors who are at high risk for an acute myocardial infarction (AMI) who may not be candidates for an implantable cardioverter defibrillator (ICD). Unlike the ICD that delivers a small electrical shock if a life-threatening heart rhythm is detected; the IIDS only provides an alert. The insertion of the IIDS monitoring lead requires a surgical procedure in an ambulatory care setting

In 2010 Fischell, et al. reported on two studies sponsored by the manufacturer that included a total of 37 patients considered to be at high risk for cardiac events due to prior acute coronary syndrome. The CARDIOSAVER study involved 17 patients in Brazil and the DETECT study involved 20 patients in North America who were implanted with the AngelMed® Guardian System. The implanted monitor continuously assessed the patients' ST segments sensed from a conventional pacemaker lead inserted in the right ventricle apex and issued a device-generated alert when ischemic events were detected. During the median follow-up time of 1.52 years, the median alarm-to-emergency room door time was 19.5 minutes (6, 18, 21, and 60 minutes, respectively). Device-generated alerts for demand-related ischemia at elevated heart rates, indicative of blood flow-limiting coronary obstructions, occurred in four subjects, and there were two false-positive ischemia alarms related to arrhythmias, and one alarm due to a programming error (4).

Clinical Trial

  • NCT00781118 The AngelMed for Early Recognition and Treatment of STEMI (ALERTS) trial is a prospective phase III randomized multicenter study clinical trial of patients with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery. The interventional study, sponsored by the manufacturer, intends to assess the implantable continuous intracardiac ischemia detection system’s safety and potential to reduce time to treatment, minimize heart muscle damage and increase survival in a large group of high risk cardiac patients. The study that started in 2008, is recruiting patients at 95 study locations throughout the United States with an estimated completion date of June 2015. (5, 6) The Swedish Medical Center Cardiovascular Research Center in Seattle Washington is listed as a study location.

Summary of Evidence

No intracardiac ST-segment monitoring device has been cleared by the U.S. Food and Drug Administration (FDA) for marketing in the U.S. The AngelMed® Guardian System (Angel Medical Systems, Shrewsbury, NJ) is the only intracardiac ST-segment electrogram device currently manufactured as an implantable cardiac ischemia monitor. Until further studies are completed there is insufficient scientific evidence to establish the safety and efficacy of the implantable continuous intracardiac ischemia detection system (IIDS) for monitoring cardiac ischemia.

References

  1. AngelMed Guardian – Product information. Shresbury, New Jersey: Angel Medical System. (2012). Available at http://angel-med.com/. Last accessed April, 2015.
  2. Valensi P, Lorgis L, Cottin Y. Prevalence, incidence, predictive factors and prognosis of silent myocardial infarction: a review of the literature. Arch Cardiovasc Dis (March 2011). 104 (3): 178–88.
  3. American Heart Association. AHA Statistical Update 2014, heart disease and stroke statistics. Circulation. 2014;129:e28-e292; DOI: 10.1161/01.cir.0000441139.02102.80. Available at: http://www.circ.ahajournals.org/content/129/3/e28.full.pdf+html. Last accessed April, 2015.
  4. Fischell TA, Fischell DR, Avezum A, et al. Initial clinical results using intracardiac electrogram monitoring to detect and alert patients during coronary plaque rupture and ischemia. JACC. 2010; 56(14):1089-1098. PMID: 20863952
  5. ClinicalTrials.gov – AngelMed for Early Recognition and Treatment of STEMI (ALERTS). (NCT00781118) (2012 May 23). U.S. National Institutes of Health – Clinical Trials. Available at www.clinicaltrials.gov. Last accessed April, 2015.
  6. Gibson MC, Krucoff M, Fischell D, et al. Rationale and design of the AngeLmed for early recognition and treatment of STEMI trial: A randomized, prospective clinical investigation. Am Heart J. 2014 Aug;168(2):168-174. PMID: 25066555

Coding

Codes

Number

Description

CPT

0302T

Insertion or removal and replacement of intracardiac ischemia monitoring system including imaging supervision and interpretation when performed and intra-operative interrogation and programming when performed; complete system (includes device and electrode)

 

0303T

Insertion or removal and replacement of intracardiac ischemia monitoring system including imaging supervision and interpretation when performed and intra-operative interrogation and programming when performed; electrode only

 

0304T

Insertion or removal and replacement of intracardiac ischemia monitoring system including imaging supervision and interpretation when performed and intra-operative interrogation and programming when performed; device only

 

0305T

Programming device evaluation (in person) of intracardiac ischemia monitoring system with iterative adjustment of programmed values, with analysis, review, and report

 

0306T

Interrogation device evaluation (in person) of intracardiac ischemia monitoring system with analysis, review, and report

Appendix

N/A

History

Date

Reason

10/09/12

New Policy. Policy created to address new CPT codes effective July 2012. A literature search was done through August 2012. At this time the monitoring device is not FDA approved so the policy states “Implantable continuous intracardiac ischemia detection system (IIDS) for monitoring cardiac ischemia is considered investigational”.

11/16/12

Update Related Policies - 2.02.15 is replaced with 2.02.506.

09/27/13

Replace policy. No changes to policy statement. A literature search was performed through July 2013. CPT codes 0307T, 00530, and 00400 removed from policy; they do not apply.

09/23/14

Annual Review. No change to policy statement.

12/01/14

Update Related Policies. Remove 2.02.10 and 2.02.24 as they were archived.

05/27/15

Annual Review. Policy updated with literature review through April, 2015. Definition of Terms added to Policy guidelines. Reference 6 added. Policy statements unchanged.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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