San Diego, California — Pediatric patients with certain types of congenital heart disease used to require numerous open-heart surgeries to treat their conditions. Now, a new transcatheter pulmonary valve device allows doctors to treat some of these patients with a less invasive option. A comprehensive review of U.S. Food and Drug Administration (FDA) device reports confirmed that there is no difference in the overall pattern of common adverse events associated with the transcatheter device compared to what was seen in the U.S. pivotal trial and early European experience, according to new findings to be reported at the SCAI 2015 Scientific Sessions.

The Melody Transcatheter Pulmonary Valve, which is designed to treat patients with congenital heart disease and failing heart valves, received FDA approval in 2010 under a Humanitarian Device Exemption (HDE). The device has gained rapid acceptance for use in children with right ventricular to pulmonary artery conduit dysfunction, a very serious congenital condition that compromises blood flow to the lungs and causes stress on the right ventricle.

"The valve has changed the way that we manage patients with right ventricular to pulmonary artery conduit dysfunction," said Gregory Fleming, MD, MS, of Duke University Medical Center in Durham, N.C.

The HDE approval was based on bench and animal testing, findings from the US Melody trial and the outcomes of patients treated with the Melody valve in Europe. No studies have examined reports of rare adverse events associated with device implantation or whether off-label use introduces unanticipated risks.

To fill the information gap, Dr. Fleming and colleagues analyzed the U.S. FDA MAUDE database, which houses medical reports for suspected device-related deaths, serious injuries and device malfunctions. The investigators reviewed all reports submitted to the database regarding the Melody valve between Jan. 1, 2007, and Nov. 30, 2014.

Among a total of 176 device-related adverse event reports, the researchers found that most adverse events (86.9%) occurred after implantation. More than half of the 153 post-procedure adverse events were stent fracture (n=85). Twenty-five cases of endocarditis developed. Of the 23 (13.1%) acute procedural events, coronary compression occurred in 6 patients and device embolization in 3 patients.

"These specific adverse events have been evaluated further to determine which patients are at risk for developing the events and potentially determine if there should be any patient-specific

contraindications to getting the device and/or find ways to prevent the events from happening," said Dr. Fleming.

Seven reports were associated with off-label placement of the valve in the tricuspid or mitral position. The reports included five deaths and one complication requiring heart transplantation.

The researchers’ analysis of the database also uncovered three reports of valve erosion into the aorta, a complication that had not been reported in the Melody trial or the European experience.

"Further investigation into the details of these previously unrecognized adverse events may help us identify specific risk factors for these events and to identify ways of preventing the events from occurring," said Dr. Fleming.

Dr. Fleming reports no potential conflicts of interest.

Dr. Fleming will be available at the SCAI 2015 ePoster Bar to discuss the study "Adverse Events Related to the Melody Transcatheter Pulmonary Valve Device, An Analysis of the MAUDE Database" on Friday, May 8, at 1:40 pm (Pacific Time).