Pulmonary Artery Repair With Covered Stents

Recent clinical reports from multiple pediatric cardiology programs around the world indicate that the conduit can be repaired using such a stent. In the United States there are no commercially available, FDA approved, covered stents of the size required. The Covered Cheatham Platinum Stent (CCPS) manufactured by the NuMED Corporation of Hopkinton, New York has been used in Europe since 2003 and more recently in Canada. The CCPS device is not yet approved by the Food & Drug Administration (FDA). However, it has been used at many hospitals in the U.S. to repair Right Ventricle to pulmonary artery conduits under Emergency and Compassionate Use circumstances. The NuMED Covered Cheatham-Platinum Stent (CCPS) is currently being studied for use in other areas of the body. The investigators are now studying its use in RV-PA conduits. The use of the Covered Cheatham Platinum Stent in this research study is investigational.

Only patients found to have a conduit tear during a Melody Valve implant procedure will be eligible for inclusion into the trial. Implant technique is left to the catheterization physician. Clinical data obtained during the catheterization, before and after the CCPS implant will be studied in order to understand factors leading up to the tear and to evaluate how successful the CCPS is in repairing such defects. Melody valve implant patients are routinely seen for clinical and echocardiographic reevaluation 6 months after implant. Patients who have received a CCPS during their Melody valve procedure will likewise be seen. Results from their clinical evaluation will be reviewed to make sure that the presence of a CCPS does not diminish the effectiveness of the Melody valve. Finally, the catheterization angiograms and 6 month follow up echocardiograms will be reviewed by an independent expert to confirm the clinical readings.

Inclusion criteria

Precatheterization Inclusion Criteria:

• Patient meets institutional criterion for placement of Melody® TPV
• Patient size adequate to receive Melody TPV® implantation via venous access using the Ensemble® Transcatheter Delivery System
• RV-PA conduit original size > 16 mm diameter
• Patient age between 10 and 75 years

Catheterization Inclusion Criteria:

a. Angiographic evidence for RV-PA conduit disruption including: dissection, aneurysm, pseudo-aneurysm, tears or rupture

• Recognition and treatment of conduit disruption may occur before, during or after implantation of the Melody® TPV
• Conduit disruption related to prior intervention, identified angiographically before conduit dilation is performed during the Melody® implant procedure, can be eligible for CCPS implantation and study inclusion

Exclusion criteria

Precatheterization Exclusion Criteria:

• Patient size too small for transvenous placement of the Melody® TPV
• Bloodstream infection, including endocarditis
• Pregnancy
• Prisoners and adults lacking the capacity to give consent

Catheterization Exclusion Criteria:

• Conduit size is not suitable (too small or too large) for a Melody® TPV
• Risk of coronary compression has been identified
• Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study CCPS is prohibited
• Vessel injury occurring in either the right or left branch pulmonary arteries -If injury to branch pulmonary arteries occurs during the catheterization and covered stent usage is indicated, Emergency Use guidelines must be employed