Original title: Clinical and Hemodynamic Outcomes Up to 7 Years After Transcatheter Pulmonary Valve Replacement in the US Melody Valve Investigational Device Exemption Trial. Reference: Circulation. 2015 May 5. [Epub ahead of print].
Published studies on transcatheter pulmonary valve replacement with the Melody valve have shown good short term outcomes but there is no information of long term outcomes.
The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median 19 years) with right ventricular outflow tract conduit obstruction and/or regurgitation. 148 of these patients received a Melody TPV, were discharged and followed up annually according to a standard protocol.
At 4.5 year median follow up (0.4-7 years), 32 patients underwent intervention: 27 for valve stenosis, 3 for endocarditis and 2 for valve dysfunction.
At 5 years, survival rate free from reintervention was 76±4%. In 113 patients that reached 4.5 years free from reintervention, the right ventricular outflow tract gradient saw no change compared to the one obtained immediately after valve release and almost all patients were a functional class I – II.
The transcatheter pulmonary valve replacement with the Melody valve showed good hemodynamic and clinical outcomes at 7 year follow up.
The most frequent cause of valve dysfunction was stenosis associated in most cases (22 out of 27) with stent fracture. This fracture became less frequent when pre-stenting became more widely adopted.