DESCRIPTION
Transcatheter closure devices are implantable devices designed to close defects between the chambers within the heart. The devices are intended as an alternative to open heart surgery, which is considered the standard of care. They are implanted in the cardiac catheterization laboratory.
A fetal heart has a normal opening between the left and right atria of the heart (foramen ovale). This small opening allows oxygen rich blood to pass from the placenta in the mother's womb to the left side of the fetus's heart. The fetus's lungs are bypassed because they are not used until the baby is born. For most individuals, the opening closes within a few months following birth. A patent foramen ovale occurs if the opening between the atria does not close. The presence of this defect is typically not treated unless symptoms develop such as pulmonary hypertension, chronic obstructive pulmonary disease, or pulmonary embolism. This condition is typically treated with anticoagulation therapy or surgical closure.
Atrial septal defects (ASD) represent a communication between the left and right atria. The mid-septal defects are called ostium secundum. Those located immediately adjacent to the atrioventricular valves are called ostium primum, and commonly occur in individuals with Down's syndrome. Sinus venous defects occur high in the atrial septum. Individuals with these defects may have few or no symptoms for several decades. Conditions, which can result from these defects, include heart failure, pulmonary hypertension, stroke or transient ischemic attack.
Ventricular septal defects (VSD) are usually present at birth but may occur after a myocardial infarction. Defects that are small may never be detected. When the defects are larger or there are multiple holes, severe symptoms may result.
Septal defects may also be created during surgical repair of certain types of congenital heart defects. In these cases, a hole is made in the septum of the repaired heart. This procedure is known as Fontan fenestration and is intended to improve recovery from the surgery, with closure occurring at a later time.
The AMPLATZER® Septal Occluder, the CardioSEAL® Septal Occlusion System with QwikLoad™ and the GORE HELEX® Septal Occluder devices are examples of U.S. Food and Drug Administration (FDA) septal occlusion devices.
POLICY
Transcatheter closure devices for the treatment of secundum atrial septal defects, closure of a fenestration following a Fontan procedure and ventricular septal defects are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transcatheter closure devices for the treatment of non-surgical patent foramen ovale is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Transcatheter closure devices for cardiac defects is considered medically appropriate if ANY ONE of the following criteria are met:
Secundum atrial septal defects and closure of a fenestration following a Fontan procedure with ALL of the following:
Echocardiographic evidence of the ostium secondum atrial septal defect
Clinical evidence of right ventricular overload (i.e., 1.5:1 degree of left to right shunt or right ventricular enlargement)
Ventricular septal defects (VSD) with ALL of the following:
Complex VSDs of significant size to warrant closure
High risk for standard transatrial or transarterial surgical closure based on overall medical conditions
High risk for standard transatrial or transarterial surgical closure based on anatomical conditions for individuals with ANY ONE of the following:
That require a left ventriculotomy or an extensive right ventriculotomy
With multiple apical and/or anterior muscular VSD, also called Swiss cheese septum
With posterior apical VSD covered by trabeculae (e.g., irregular bands and bundles of muscle projecting from the inner surfaces of the ventricles)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
According to the U.S. Food and Drug Administration (FDA), “a Humanitarian Device Exemption (HDE) is a special type of marketing approval granted for devices intended to treat fewer than 4,000 people a year in the U.S. The FDA concluded that the patient population described by the approved indication (patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a PFO and who have failed conventional drug therapy) is significantly in excess of 4,000 patients in the U.S. per year. This finding means that these devices are no longer eligible for HDE designation and therefore, no longer eligible for marketing under an HDE. In 2006, the FDA withdrew the Humanitarian Device Exemption (HDE) for the AGA Medical AMPLATZER® PFO Occluder and the NMT Medical CardioSEAL® STARFlex™ Septal Occulsion System.”
The lack of well-designed randomized controlled trials and studies provide little evidence of the safety and efficacy for the transcatheter closure devices for the treatment of non-surgical patent foramen ovale.
SOURCES
American Heart Association. (2009). Top ten things to know. Percutaneous device closure of patent foreman ovale for secondary stroke prevention. Retrieved July 1, 2009 from http://www.americanheart.org/downloadable/heart/124206901778320090511_topTenPFOStroke.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2008). Closure devices for patent foramen ovale and atrial septal defects (2.02.09). Retrieved June 30, 2009 from BlueWeb. (22 articles and/or guidelines reviewed)
Goff, D. A., Blume, E. D., Gauvreau, K., Mayer, J. E., Lock, J. E., & Jenkins, K. L. (2000). Clinical outcome of fenestrated Fontan patients after closure: The first 10 years. Circulation, 102 (17), 2094-2099.
Marelli, A. J. (2008). Congenital heart disease in adults. In L. Goldman & D. Ausiello (Eds.), Cecil Medicine (23rd ed., Chapter 68) Philadelphia: Saunders Elsevier.
Messe, S. R., Silverman, I. E., Kizer, J. R., Homma, S., Zahn, C., Gronseth, G., et al. (2004). Practice parameter: Recurrent stroke with patent foramen ovale and atrial septal aneurysm: Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 62 (7), 1042-1050.
Musto, C., Cifarelli, A., Pandolfi, C., DeFelice, F., Fiorilli, R., Caferri, G., et al. (2009). Transcatheter closure of patent foramen ovale associated with atrial septal aneurysm with Amplatzer Cribriform Septal Occluder. The Journal of Invasive Cardiology, 21 (6), 290-293. (Level 3 Evidence - Independent study)
National Institute for Health and Clinical Excellence (NICE). (2006, May). Endovascular closure of atrial septal defect. Retrieved June 30, 2009 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG096guidance.pdf.
National Institute for Health and Clinical Excellence (NICE). (2004, October). Endovascular closure of perimembranous ventricular septal defect. Retrieved June 30, 2009 from http://www.nice.org.uk/nicemedia/pdf/IPG172guidance.pdf.
O'Gara, P. T., Messe, S. R., Tuzcu, E. M., Catha, G., & Ring, J. C. (2009). Percutaneous device closure of patent foramen ovale for secondary stroke prevention: A call for completion of randomized clinical trials: A science advisory from the American Heart Association/American Stroke Association and the American College of Cardiology Foundation. Circulation; 119 (20), 2743-2747.
Park, M. K. (Ed.). (2008). Pediatric Cardiology for Practitioners (5th ed., Chapter 17). Philadelphia: Mosby Elsevier.
Slottow, T. L., Steinberg, D. H., & Waksman, R. (2007). Overview of the 2007 Food and Drug Administration circulatory system devices panel meeting on patent foramen ovale closure devices. Circulation, 116 (6), 677-682.
U. S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Premarket Approval. Amplatzer® septal occluder (ASO) and the Amplatzer® exchange system. P000039. Retrieved June 30, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P000039c.pdf.
U. S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Premarket Approval. CardioSEAL® Septal Occlusion System with QwikLoad™. P000049. Retrieved June 30, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P000049c.pdf.
U. S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. Premarket Approval. GORE HELEX® septal occluder. P050006. Retrieved July 1, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050006c.pdf.
U. S. Food and Drug Administration. (2006, October). Medical Devices. Information for physicians and patients on the withdrawal of two humanitarian device exemptions (HDEs) for patent foramen ovale (PFO) occluders. Retrieved June 30, 2009 from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/ucm135747.htm.
U. S. Food and Drug Administration. (2007, January). FDA Panel Summary. PFO trial design issues. Retrieved June 30, 2009 from http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4284b2_01.pdf.
Valente, A. M., & Rhodes, J. F. (2007). Current indications and contraindications for transcatheter atrial septal defect and patent foramen ovale device closure. American Heart Journal, 153 (4), S82-S84.
MOST RECENT REVIEW DATE: 2/14/2010
ID_BT
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