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

Fred Hoiberg, Chicago Bulls coach, On-X aortic heart valve, education campaign

Fred Hoiberg, head coach of the NBA Chicago Bulls, is launching a new campaign to help people with heart valve problems on www.heartvalvesurgery.com. Coach Hoiberg, pictured here with his family, wanted a single, life-long solution to his aortic heart valve problem, and received an On-X aortic mechanical valve from On-X Life Technologies Inc. in April 2015.

News | Heart Valve Repair| February 10, 2016
February 10, 2016 — Fred Hoiberg, head coach of the National Basketball Assocation’s (NBA) Chicago Bulls, is launchin
HeartWare, terminated acquisition, Valtech Cardio
News | Structural Heart| February 10, 2016
February 10, 2016 — HeartWare International Inc. and Valtech Cardio Ltd.
Valtech Cardioband, reimbursement, Germany, mitral regurgitation in heart failure
News | Heart Valve Repair| February 09, 2016
Valtech Cardio Ltd. announced that it has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
medtronic corevalve, tavr
News | February 03, 2016 | Dave Fornell
Medtronic announced Feb. 3 that the U.S.
Sponsored Content | Case Study | Cardiovascular Ultrasound| January 21, 2016
This case study is from the Cardiac Imaging Department, Hospital Clinic, Barcelona, Spain.
Ernest Shackleton, hole in the heart, Endurance 100th anniversary, Ian Calder
News | Structural Heart| January 20, 2016
On the 100th anniversary of the Endurance expedition to Antarctica led by Sir Ernest Shackleton, doctors writing in the...
pulmonary artery to left atrial shunt, heart lung transplant, Oswaldo, Stanford Children's Health

2015 was a year of dramatic changes for Oswaldo and his family, seen here at his bedside, post-transplant surgery in July. Photo courtesy of Business Wire.

Feature | Cardiovascular Surgery| January 15, 2016
2016 is starting off a whole lot better than last year for 14-year-old Oswaldo Jimenez of Salem, Ore. Last year at this...
AVR, aortic valve replacement, middle-aged patients, University of Sydney study, metal, tissue
News | Heart Valve Repair| January 15, 2016
Patients between the ages of 40 and 70 who undergo aortic valve replacement (AVR) may fare better with tissue-based...
Overlay Init