Feature | April 01, 2014

Melody Transcatheter Pulmonary Valve Shows Positive Clinical Outcomes in Real-World Patients

April 1, 2014 — Medtronic Inc. announced the one-year results of the Melody transcatheter pulmonary valve (TPV) U.S. post-approval study, which found that real-world use of the Melody TPV was associated with high procedural success, excellent valve function and few repeat procedures at the primary endpoint of six months. These results were sustained out to one year.

The Melody TPV was the first transcatheter valve to be approved by the U.S. Food and Drug Administration (FDA) and the first transcatheter valve available anywhere in the world. The therapy has treated more than 6,000 patients worldwide to date, more than half of who are children with congenital heart disease (CHD).

Presented as a late-breaking clinical trial at the American College of Cardiology (ACC) 63rd annual scientific session, the study results demonstrated a procedural success rate of 98 percent and showed that nearly all patients were free from major stent fracture (99 percent), transcatheter pulmonary valve dysfunction (98 percent) and reintervention (100 percent) at six months.

Following FDA approval in 2010 of the Melody TPV under a humanitarian device exemption (HDE) — the device equivalent of regulations for “orphan” drugs — the post-approval study prospectively enrolled 120 patients at 10 U.S. sites not included in the U.S. Melody TPV investigational device exemption (IDE) clinical trial. The patients had a mean age of 20 years (ranging from ages 5 to 45). The post-approval study results confirm the positive findings of the original Melody TPV U.S. IDE clinical trial, reinforcing the device’s ability to safely prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract (RVOT) caused by CHD.

“The positive results garnered in this real-world setting mirror those seen in other studies of the Melody valve,” said Aimee K. Armstrong, M.D., associate director, University of Michigan C.S. Mott Children’s Hospital Cardiac Catheterization Laboratories. “The one-year results show strong performance of the valve, which is intended to delay the time until open-heart surgery is needed. Decreasing the number of open-heart surgeries that our patients need has a significant impact on their lives and quality of life.”

Adverse events seen in the post-approval study ranged from fever to arrhythmia; and endocarditis (n=3) to confined conduit tear (n=6), the latter of which were all resolved with the use of a covered stent.

CHD is the most common birth defect in the United States; it affects an estimated 40,000 babies each year. Approximately 20 percent of those infants have deformities that disrupt the blood flow from their RVOT to the pulmonary arteries. A subset of these children will receive a connecting conduit early in life to improve that blood flow. If a patient’s RVOT conduit fails later in life but is still of adequate size to address the patient’s needs (i.e., the patient has not outgrown the conduit), then a Melody TPV may be implanted to help delay a surgical pulmonic valve replacement, which is a much more invasive procedure than transcatheter valve replacement.

“Open-heart surgery can come with significant risks, not to mention pain and discomfort, so the quality of life for these children with CHD can be compromised given the number of surgeries they typically have to endure over their lifetime,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “The Melody TPV is making a big difference in the lives of these young patients, and we’re committed to continuing to provide successful therapies for this underserved patient group.”

Following the late-breaking trial, a moderated poster, titled “Current Results of the MELODY Registry – an International Multicenter Registry of Transcatheter Pulmonary Valve Implantation (TPVI),” also was presented at ACC by the German Heart Center from Berlin. The multicenter MELODY Registry represents the largest patient series after TPV implantation to date and further confirmed the safety of the Melody TPV in more than 1,000 CHD patients in real-world clinical practice.

For more information: www.medtronic.com

Related Content

mitral valve surgery outcomes, twisting of the heart, echocardiography, NICSMR, JACC Basic to Translational Science
News | Heart Valve Technology| July 20, 2016
A novel study has found a simple pre-operative echocardiographic measurement of the amount of torsion of the heart...
TITAN II Trial, Carillon Mitral Contour System, Cardiac Dimensions, Open Heart journal, functional mitral regurgitation, FMR
News | Annuloplasty Rings| July 20, 2016
New data from the TITAN II trial confirm the safety and efficacy of the Carillon Mitral Contour System in the treatment...
ASE, SCCT, SCMR, guideline, multimodality imaging, transposition of the great arteries, TGA
News | Congenital Heart| July 20, 2016
At the end of June, experts from three different medical societies released a new guideline to help optimize lifetime...
Mitralign, Trialign system, tricuspid regurgitation. SCOUT U.S. study, phase 1 enrollment
News | Heart Valve Technology| July 19, 2016
Mitralign Inc. announced last week it has completed subject enrollment in the SCOUT early feasibility study in the...
Dictum Health, telehealth study, IDM100 tablet, neonate cardiology, in-home monitoring
Technology | Telecardiology| July 19, 2016
Dictum Health Inc. announced the launch of a post-U.S. Food and Drug Administration (FDA)-approval study of its end-to-...
Sponsored Content | Videos | Computed Tomography (CT)| July 08, 2016
An interview with Jonathan Leipsic, M.D., FSCCT, chairman of the department of radiology, St.
Cormatrix Cardiovascular, Tyke ECM, extracellular matrix, neonates and infants
News | Congenital Heart| June 30, 2016
CorMatrix Cardiovascular Inc. announced the treatment of the first patients using its CorMatrix Tyke, a product...
Sponsored Content | Videos | Cardiovascular Ultrasound| June 28, 2016
Interview with Rebecca Hahn, M.D., FASE, Columbia University Medical Center, New York, at the American Society of Ech
BHF, Reflections of Research image competition, U.K., 4-D MRI, heart blood flow

This image shows blood flow within the main pumping chambers – the ventricles – on both sides of the heart and the vessels leaving the heart. The blue flow is blood that needs oxygen and is travelling to the lungs. The red flow is blood that has been through the lungs and received oxygen. Victoria Stoll of the University of Oxford is using this type of imaging to look at the blood flow within the hearts of people with heart failure, whose hearts are not pumping effectively.

News | Cardiac Imaging| June 24, 2016
The British Heart Foundation (BHF) announced the winners of its annual ‘Reflections of Research’ image competition,...
Sponsored Content | Videos | Structural Heart Occluders| June 16, 2016
This is an animation of how a Gore Cardioform Septal Occluder is implanted for the transcatheter closure of ASDs or P
Overlay Init