SAN DIEGO — Device-related adverse events were rare among children implanted with a transcatheter pulmonary valve, according to new data from the FDA Manufacturer and User Facility Device Experience database.
The Melody Transcatheter Pulmonary Valve (Medtronic) was approved by the FDA in 2010 under a Humanitarian Device Exemption (HDE) for the treatment of patients with congenital heart disease and failing heart valves. According to Gregory Fleming, MD, MS, from Duke University Medical Center, “the valve has changed the way that we manage patients with right ventricular to pulmonary artery conduit dysfunction.”
Fleming and Kevin D. Hill, MD, MS, also from Duke University Medical Center, evaluated data collected from the FDA Manufacturer and User Facility Device Experience (MAUDE) database on 175 adverse event reports among patients implanted with the valve from January 2007 through November 2014.
The FDA HDE approval was based on bench and animal testing, findings from the U.S. Melody trial and the outcomes of patients treated with the valve in Europe. However, no study had previously examined reports of rare adverse events associated with device implantation or off-label use, according to a press release. Commonly observed adverse events in clinical studies of the valve included conduit tear or rupture and compression of the coronary arteries during implantation, stent fracture and endocarditis, Fleming said during a presentation at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
Of all adverse event reports submitted within the study period, 147 were postprocedural events and 28 were acute procedural events. The most common acute device-related events were coronary compression (n = 5) and device misplacement or embolization (n = 5). The majority of postprocedural events were stent fractures (n = 85) or endocarditis (n = 25).
These findings were similar to those observed during clinical trials of the valve, according to the researchers.
During the study period, five patients died. Of those, three experienced adverse events during the procedure and two after the procedure, and one patient had a complication resulting in the need for heart transplantation. Eight events occurred among 185 patients who received off-label implantation of the valve. The events were reported most among patients implanted with a valve in the tricuspid position (n = 5) or the mitral position (n = 3).
Four patients experienced valve erosion into the ascending aorta, including one during implantation and three after implantation. Acute pulmonary insufficiency occurred immediately after valve deployment in two patients. The researchers noted that neither valve erosion nor acute pulmonary insufficiency had been observed in prospective trials of the valve.
“The most common reported adverse events with the Medtronic Melody valve seem to mirror what was seen in the prospective trials,” Fleming concluded. “Previously unrecognized safety events can occur: Device erosion and acute [pulmonary] insufficiency not seen in the prospective trials are identified here as potential safety concerns that may need to be evaluated. The safety of off-label use requires further investigation … and reporting and ongoing analysis of adverse events to the MAUDE database by those of us implanting the device is important to keep track of these potential less common adverse events.” – by Adam Taliercio
Fleming G and Hill K. #O2-02. Congenital Heart Disease Track Abstract Presentations. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions: May 6-9, 2015; San Diego.
Disclosure: Fleming and Hill report no relevant financial disclosures.