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:

1. Patient meets institutional criterion for placement of Melody® TPV

2. Patient size adequate to receive Melody TPV® implantation via venous access using the
Ensemble® Transcatheter Delivery System

3. RV-PA conduit original size > 16 mm diameter

4. 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:

1. Patient size too small for transvenous placement of the Melody® TPV

2. Bloodstream infection, including endocarditis

3. Pregnancy

4. Prisoners and adults lacking the capacity to give consent

Catheterization Exclusion Criteria:

1. Conduit size is not suitable (too small or too large) for a Melody® TPV

2. Risk of coronary compression has been identified

3. Lack of angiographic evidence for RV-PA conduit disruption - Prophylactic use of study
CCPS is prohibited

4. 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