Download External Cardiac Defibrillators for the Prevention of Sudden Death

MEDICAL POLICY
POLICY TITLE
EXTERNAL CARDIAC DEFIBRILLATORS FOR THE PREVENTION OF
SUDDEN DEATH (INCLUDING WEARABLE AND AEDS)
POLICY NUMBER
MP- 2.073
Original Issue Date (Created):
April 12, 2004
Most Recent Review Date
(Revised):
July 1, 2008
Effective Date:
July 1, 2008- RETIRED
I.
DESCRIPTION/BACKGROUND
Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary
artery disease. The automatic implantable cardioverter defibrillator (AICD) has proven
effective in reducing mortality for survivors of SCA and for patients with documented
malignant ventricular arrhythmias. The use of AICDs has been potentially broadened by
studies reporting a reduction in mortality for patients at risk for ventricular arrhythmias,
such as patients with prior myocardial infarction (MI) and reduced ejection fraction.
AICDs consist of implantable leads in the heart that connect to a pulse generator implanted
beneath the skin of the chest or abdomen. In the past, AICD placement required a
thoracotomy, but current technology allows implantation with only a minor surgical
procedure, with the cardiac leads placed percutaneously. Potential adverse effects of AICD
placement are bleeding, infection, pneumothorax, and delivery of unnecessary
countershocks.
The wearable cardioverter-defibrillator (WCD) is an external device that is intended to
perform the same tasks as an AICD, without requiring any invasive procedures. It consists
of a vest that is worn continuously underneath the patient’s clothing. Part of this vest is the
‘electrode belt’ that contains the cardiac monitoring electrodes, and the therapy electrodes
that deliver a countershock. The alarm module alerts the patient to certain conditions by
lights or voice messages. The U.S. Food and Drug Administration (FDA) approved the
Lifecor WCD® 2000 system via premarket application approval in December 2001 for
“adult patients who are at risk for cardiac arrest and are either not candidates for or refuse
an implantable defibrillator.”
An automatic external defibrillator (AED) is a portable compact device, which detects and
treats cardiac arrest related to cardiac arrhythmias, ventricular fibrillation, and ventricular
tachycardia. If left uncorrected, these arrhythmias could lead to irreversible brain damage
and death. There are two main types of AEDs on the market today: semi-automatic and
fully automatic. Semi-Automatic AEDs will prompt the user to stand clear and to push a
shock button to defibrillate. Fully automatic units sound a “stand clear” alarm and then
deliver the shock automatically without the user having to push the button.
Page 1
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
EXTERNAL CARDIAC DEFIBRILLATORS FOR THE PREVENTION OF
SUDDEN DEATH (INCLUDING WEARABLE AND AEDS)
POLICY NUMBER
MP- 2.073
All AEDs, which have been approved for use in the US, utilize a synthesized voice that
prompts users through each step. AEDs have been installed in many settings such as
schools and airports and serve a role in expanding the number of opportunities for lifesaving defibrillation. The use of AEDS is taught in Basic Life Support (BLS) classes and
units are designed for non-medical operators.
II.
DEFINITIONS
ARRHYTHMIA refers to an irregularity or loss of rhythm, especially of the heart.
CARDIOVERTER is a device used to administer electrical shocks to the heart through
electrodes placed on the chest wall or on the surface of the heart itself.
DEFIBRILLATOR is an electrical device that produces defibrillation of the heart. It may be
used externally or in the form of an automatic implanted cardioverter defibrillator.
EJECTION FRACTION In cardiac physiology, it is the percentage of the blood emptied from
the ventricle during systole.
PERCUTANEOUS refers to that which is passed or affected through the skin.
THORACOTOMY refers to a surgical incision of the chest wall.
III.
POLICY
Use of wearable cardioverter-defibrillators for the prevention of sudden cardiac death may
be considered medically necessary as interim treatment for patients who meet the
following criteria:
 Meet medical necessity criteria for an implantable cardioverter-defibrillator (ICD).
NOTE: See the criteria listed in MP-1.081, Automatic Implantable CardioverterDefibrillator;
 Have a temporary contraindication to receiving an implantable cardioverterdefibrillator;
 Have been scheduled for an implantable cardioverter-defibrillator placement, or have
had an ICD removed and have been rescheduled for placement of another ICD once
the contraindication is treated.
It is uncommon for patients to have temporary contraindications to ICD placement. The
most common reason will be a systemic infection that requires treatment before the ICD
can be implanted. The wearable cardioverter-defibrillator should only be used short-term
while the temporary contraindication (e.g., systemic infection) is being clinically managed.
Once treatment is completed, the permanent ICD should be implanted.
Page 2
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
EXTERNAL CARDIAC DEFIBRILLATORS FOR THE PREVENTION OF
SUDDEN DEATH (INCLUDING WEARABLE AND AEDS)
POLICY NUMBER
MP- 2.073
Cross-reference
MP-1.081 Automatic Implantable Cardioverter-Defibrillator
IV.
EXCLUSIONS
Other than as interim treatment for the prevention of sudden cardiac death (as defined
above), use of wearable cardioverter-defibrillators for the prevention of sudden cardiac
death is considered investigational, as there is insufficient evidence to support a
conclusion concerning the health outcomes or benefits associated with this procedure.
Automatic external defibrillators are considered investigational, as there is insufficient
evidence to support a conclusion concerning the health outcomes or benefits associated
with this procedure.
V.
BENEFIT VARIATIONS
The existence of this medical policy does not mean that this service is a covered benefit
under the member's contract. Benefit determinations should be based in all cases on the
applicable contract language. Medical policies do not constitute a description of benefits.
A member’s individual or group customer benefits govern which services are covered,
which are excluded, and which are subject to benefit limits and which require
preauthorization. Members and providers should consult the member’s benefit information
or contact Capital for benefit information.
VI. DISCLAIMER
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute
medical advice and are subject to change. Treating providers are solely responsible for medical advice and
treatment of members. Members should discuss any medical policy related to their coverage or condition
with their provider and consult their benefit information to determine if the service is covered. If there is a
discrepancy between this medical policy and a member’s benefit information, the benefit information will
govern. Capital considers the information contained in this medical policy to be proprietary and it may only
be disseminated as permitted by law.
VII. REFERENCES
Auricchio A, Klein H, Geller CJ, et al. Clinical efficacy of the wearable cardioverterdefibrillator in acutely terminating episodes of ventricular fibrillation. Am J Cardiol
1998; 81(10): 1253-6.
AVID Investigators. A comparison of antiarrhythmic-drug therapy with implantable
defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The
Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med
1997; 337(22): 1576-83.
Page 3
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
EXTERNAL CARDIAC DEFIBRILLATORS FOR THE PREVENTION OF
SUDDEN DEATH (INCLUDING WEARABLE AND AEDS)
POLICY NUMBER
MP- 2.073
Beauregard LA. Personal security: clinical applications of the wearable defibrillator.
Pacing Clin Electrophysiol 2004; 27(1):1-3.
Bigger JT. Prophylactic use of implanted cardiac defibrillators in patients at high risk for
ventricular arrhythmias after coronary-artery bypass surgery. The CABG-PATCH
Trial Investigators. N Engl J Med 1997; 337(22): 1569-75.
Durable Medical Equipment Regional Carrier (DMERC) Region A Local Coverage
Determination (LCD) L13613, Automatic External Defibrillators. Effective 3/1/06.
[Website]:
http://www.tricenturion.com/content/Doc_View.cfm?type=LCDCurr&File=lcd%20for
%20automatic%20external%20defibrillators2946%2Ehtm. Accessed January 15, 2008.
ECRI Target Report. Wearable external cardioverter defibrillator for detection and
treatment of ventricular arrhythmia. 9/ 2007.
Feldman AM, Klein H, Tchou P, et al. Use of a wearable defibrillator in terminating
tachyarrhythmias in patients at high risk for sudden death: results of the
WEARIT/BIROAD. Pacing Clin Electrophysiol 2004; 27(1): 4-9. [Website]:
http://www.medscape.com/viewarticle/481238_3. Accessed January 15, 2008.
Gregoratos G, Cheitlin MD, Conill A, et al. ACC/AHA guidelines for implantation of
cardiac pacemakers and arrhythmia devices: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines
(Committee on Pacemaker Implantation). J Am Coll Cardiol 1998; 31(5): 1175-209.
Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of implantable cardioverterdefibrillator after acute myocardial infarction. N Engl J Med 2004; 351(24): 2481-8.
Murray CL, Steffensen I. Automated external defibrillators for home use. Issues Emerg
Health Technol 2005; (69): 1-4.
Reek S, Meltendorf U, Geller JC, Wollbruck A, Grund S, Klein HU. The Wearable
Cardioverter Defibrillator (WCD) for the prevention of sudden cardiac death -- a
single center experience. Z Kardiol. 2002; 91(12): 1044-52.
Taber’s Cyclopedic Medical Dictionary, 19th edition.
Witt DK, Chambers CV. Out-of-hospital cardiac arrest and use of automated external
defibrillators. Am Fam Physician. 2006; 73(6): 977-8.
U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data, P010030,
Lifecor, Inc., WCD® 2000 System. [Website]:
http://www.fda.gov/cdrh/pdf/P010030.html. Accessed January 15, 2008.
Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 Guidelines for
Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden
Cardiac Death: A Report of the American College of Cardiology/American Heart
Association Task Force and the European Society of Cardiology Committee for
Page 4
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
EXTERNAL CARDIAC DEFIBRILLATORS FOR THE PREVENTION OF
SUDDEN DEATH (INCLUDING WEARABLE AND AEDS)
POLICY NUMBER
MP- 2.073
Practice Guidelines (Writing Committee to Develop Guidelines for Management of
Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). J
Am Coll Cardiol. 2006; 48:e247-e346.
VIII. PRODUCT VARIATIONS
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] CHIP POS
[N] Indemnity
[N] PPO
[N] SpecialCare
[N] HMO
[N] POS
[N] CHIP HMO
[Y] FEP HMO*
[Y] SeniorBlue**
[Y] FEP PPO*
[Y] SeniorBlue PPO**
* The FEP program dictates that all drugs, devices or biological products approved by the
U.S. Food and Drug Administration (FDA) may not be considered investigational.
Therefore, FDA-approved drugs, devices or biological products may be assessed on the
basis of medical necessity.
**For wearable defibrillators and for non-wearable defibrillators: Refer to Durable Medical
Equipment Regional Carrier (DMERC) Region A, Tricenturion Local Coverage
Determination (LCD) L13613, Automatic External Defibrillators.
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage
Insurance Company® and Keystone Health Plan® Central. Independent licensees of the Blue Cross and Blue Shield
Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider
relations for all companies.
Page 5
[Note: Final page is signature page and is kept on file, but not issued with Policy.]
MEDICAL POLICY
POLICY TITLE
EXTERNAL CARDIAC DEFIBRILLATORS FOR THE PREVENTION OF
SUDDEN DEATH (INCLUDING WEARABLE AND AEDS)
POLICY NUMBER
MP- 2.073
IX.
POLICY HISTORY
MP-2.073
CAC 9/30/03
CAC 9/28/04
CAC 9/27/05
CAC 11/29/05
CAC 10/31/06
CAC 3/27/07
Policy approved for retirement effective 7/1/2008.
Combined into Cardioverter-Defibrillator Effective 7/1/2008
Page 6
[Note: Final page is signature page and is kept on file, but not issued with Policy.]