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

DOI Web Site 被引用文献1件
  • Thomas K. Jones
    Division of Cardiology, Seattle Children’s Hospital, University of Washington School of Medicine (T.K.J.).
  • Doff B. McElhinney
    Department of Cardiothoracic Surgery, Lucile Packard Children’s Hospital, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
  • Julie A. Vincent
    Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.).
  • William E. Hellenbrand
    Division of Cardiology, Department of Pediatrics, Yale School of Medicine, New Haven, CT (W.E.H.).
  • John P. Cheatham
    The Heart Center, Nationwide Children’s Hospital, Columbus, OH (J.P.C., D.P.B.).
  • Darren P. Berman
    The Heart Center, Nationwide Children’s Hospital, Columbus, OH (J.P.C., D.P.B.).
  • Evan M. Zahn
    Guerin Family Congenital Heart Program, The Heart Institute and Department of Pediatrics, Cedars-Sinai Heart Institute, Los Angeles, CA (E.M.Z.).
  • Danyal M. Khan
    Department of Pediatric Cardiology, Niklaus Children’s Hospital, Miami, FL (D.M.K.).
  • John F. Rhodes
    Congenital Heart Center, Medical University of South Carolina, Charleston (J.F.R.).
  • Shicheng Weng
    Structural Heart and Aortic Clinical Department, Medtronic, Mounds View, MN (S.W.).
  • Lisa J. Bergersen
    Department of Cardiology, Boston Children’s Hospital, MA (L.J.B.).

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<jats:sec> <jats:title>Background:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Registration:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT00740870. </jats:p> </jats:sec>

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