Comparison of the investigational device exemption and post‐approval trials of the Melody transcatheter pulmonary valve

2021 ◽  
Author(s):  
Jacqueline Kreutzer ◽  
Aimee K. Armstrong ◽  
Jonathan J. Rome ◽  
Thomas M. Zellers ◽  
David T. Balzer ◽  
...  
Keyword(s):  
Pulmonary Valve ◽  
Investigational Device Exemption

scholarly journals Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial

2021 ◽  
Author(s):  
Thomas K. Jones ◽  
Doff B. McElhinney ◽  
Julie A. Vincent ◽  
William E. Hellenbrand ◽  
John P. Cheatham ◽  
...  
Keyword(s):  
Pulmonary Valve ◽  
Pulmonary Regurgitation ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Complex Congenital Heart Disease ◽  
Stent Fracture ◽  
Unique Identifier ◽  
Investigational Device Exemption ◽  
Melody Valve ◽  
The Us

Background: The Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease. Methods: Enrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death. Results: One hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1–Q3: 15–26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1–Q3: 12–22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1–Q3: 5.4–10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%–89%), with an annualized rate of 2.0% per patient-year. Conclusions: Ten-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00740870.

Clinical and Hemodynamic Outcomes up to 7 Years After Transcatheter Pulmonary Valve Replacement in the US Melody Valve Investigational Device Exemption Trial

Circulation ◽  
2015 ◽  
Vol 131 (22) ◽  
pp. 1960-1970 ◽  
Author(s):  
John P. Cheatham ◽  
William E. Hellenbrand ◽  
Evan M. Zahn ◽  
Thomas K. Jones ◽  
Darren P. Berman ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Pulmonary Valve ◽  
Pulmonary Valve Replacement ◽  
Investigational Device Exemption ◽  
Melody Valve ◽  
Transcatheter Pulmonary Valve Replacement ◽  
The Us

Coronary event after transcatheter pulmonary valve implantation

2012 ◽  
Vol 60 (S 01) ◽  
Author(s):  
D Biermann ◽  
J Schönebeck ◽  
M Rebel ◽  
J Weil ◽  
H Reichenspurner ◽  
...  
Keyword(s):  
Pulmonary Valve ◽  
Coronary Event ◽  
Valve Implantation ◽  
Pulmonary Valve Implantation

Histology of a Degenerated Tissue Engineered Pulmonary Valve 10 Years after Ross Procedure

2016 ◽  
Vol 64 (S 01) ◽  
Author(s):  
S. Steinbach ◽  
M.-T. Dieterlen ◽  
T. Noack ◽  
P. Dohmen ◽  
F. Mohr ◽  
...  
Keyword(s):  
Pulmonary Valve ◽  
Ross Procedure

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

2019 ◽  
Author(s):  
Keyword(s):  
Pulmonary Valve
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