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DESCRIPTIONThe ductus arteriosus is the vascular remnant of the left sixth aortic arch, connecting the main pulmonary artery to the aorta. A patent ductus arteriosus (PDA) is the persistent opening of the channel beyond its expected time of closure during the first few days of life. Symptoms are related to the size of the ductus; a large non-restrictive ductus with a left to right shunt can cause cardiac failure, while small restrictive PDAs are associated with an increased risk of infective endarteritis. Because of the twin threats of heart failure or endarteritis, it is recommended that all PDAs that persist after the age of 2 years be surgically closed with ligation or division of the PDA.
Open surgical treatment of the PDA is a low-risk procedure if performed electively. However, over the past several decades there has been interest in developing a catheter-based technique to close PDAs, thus eliminating the need for general anesthesia, a thoracotomy, and an extended hospital stay and convalescence. A number of devices have been developed for this purpose.
The Gianturco coil, also referred to as the Cook embolization coil, is an arterial and venous occlusive device that was marketed prior to 1976, when the U.S. Food and Drug Administration (FDA) formally acquired regulatory authority over devices. (Please note that the Gianturco coil is entirely different than the Gianturco stent, which is used in coronary arteries.) Therefore, the Gianturco device has never undergone formal FDA approval but is available for clinical use. However, the Gianturco coil has been investigated for PDA closure. Transcatheter insertion of the coil is typically an outpatient procedure performed in the catheterization lab. General anesthesia may only be required in those very young patients who cannot reliably hold still during the procedure. General anesthesia in a child younger than 1-year-old may require overnight hospitalization.
In 2003, the Amplatzer Duct Occluder received FDA approval, with the specific indication for non-surgical closure of patent ductus arteriosus. This device is a self-expandable device made from a Nitinol wire mesh and polyester fabric. As the occluder is implanted, it expands outward, and the wires push against the wall of the ductus. The polyester fabric induces thrombosis, which closes the communication.
POLICYTranscatheter closure of a patent ductus arteriosus using an FDA-approved device may be considered medically necessary.
Transcatheter closure of a patent ductus arteriosus using other non–FDA-approved devices is considered investigational.
POLICY GUIDELINESAccording to the labeled indications of the Amplatzer Duct Occluder, the following are contraindications for the use of this device:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY05/09/2012: Separate policy created. Policy information was previously included in the Amplatzer® Devices policy.
12/13/2012: Policy reviewed; no changes.
09/01/2015: Code Reference section updated for ICD-10. Remove ICD-9 procedure codes 35.50 and 35.52; removed ICD-9 diagnosis code 745.5. Added ICD-9 procedure code 38.85.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.61
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.