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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.

Closure Devices for Patent Foramen Ovale and Atrial Septal Defects are discussed in a separate policy.

Transcatheter closure of a patent ductus arteriosus using other non–FDA-approved devices is considered investigational.

• Patients weighing less than 6 kg
• Patients less than 6 months of age
• Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained
• Active endocarditis or other infections producing bacteremia
• Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
• Patients with pulmonary hypertension with pulmonary vascular resistance of >8 Woods units or Rp/Rs of >0.4.

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.

12/13/2012: Policy reviewed; no changes.

Covered Codes

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

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