After a median follow-up period of 4.5 years, most patients who underwent transcatheter pulmonary valve replacement (TPVR) with the Melody valve had positive hemodynamic and clinical results, according to a prospective study.
At five years, the estimated survival was 98 percent. Four patients died during the trial, including two from unknown causes, one from multisystem failure resulting from sepsis and endocarditis and one of respiratory failure. None of the deaths were related to the Melody valve.
Lead researcher John P. Cheatham, MD, of Nationwide Children’s Hospital in Columbus, Ohio, and colleagues published their findings online in Circulation on May 5.
The Melody valve (Medtronic) was first used in the U.S. in 2007. Since then, trials have found the device reduced right ventricular outflow tract (RVOT) obstruction, eliminated pulmonary regurgitation and led to other clinical improvements in the short-term. The FDA approved the valve and its delivery catheter earlier this year.
In this trial, which was sponsored by Medtronic, researchers evaluated 148 patients who had the Melody valve implanted from January 2007 to January 2010 at five sites. The patients all had postoperative RVOT conduit dysfunction and/or pulmonary regurgitation.
As assessed by an echocardiogram at hospital discharge, 140 of the 148 patients had no or little pulmonary regurgitation, which was a significant improvement compared with before they underwent TPVR with the Melody valve.
After the procedures, the mean Doppler RVOT gradient decreased significantly from 33 mmHg to 17 mmHg.
During the follow-up period, which lasted from 0.4 to 7 years, patients received numerous interventions annually, including echocardiography, cardiopulmonary exercise testing, chest radiography and a clinical history and exam. Of the patients, 32 underwent RVOT reintervention for obstruction, three for endocarditis and two for RV dysfunction.
Researchers also found 14 patients had endocarditis or a blood stream infection, including five who underwent reintervention on the Melody valve within three months and nine who improved when receiving medical therapies.