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  • 1
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    Online Resource
    Comparison of the investigational device exemption and post‐approval trials of the Melody transcatheter pulmonary valve
    Wiley ; 2021
    In:  Catheterization and Cardiovascular Interventions Vol. 98, No. 2 ( 2021-08)
    Details
    In: Catheterization and Cardiovascular Interventions, Wiley, Vol. 98, No. 2 ( 2021-08)
    Abstract: We compared 5‐year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post‐approval study (PAS) and the investigational device exemption (IDE) trial. Background As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real‐world” environment. The 5‐year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. Methods The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time‐related outcomes and valve‐related adverse events were compared between the two trials with Kaplan–Meier curves and log‐rank testing. Results 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction ( p  = .61) or any reintervention ( p  = .74) over time did not differ between trials. Freedom from stent fracture ( p  = .003) and transcatheter reintervention ( p  = .010) were longer in PAS, whereas freedom from explant ( p  = .020) and TPV endocarditis ( p  = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients ( p  = .056); the incidence of any particular event was low in both. Conclusions Hemodynamic and time‐related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real‐world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post‐approval studies as part of the regulatory process for Class III medical devices.
    Type of Medium: Online Resource
    ISSN: 1522-1946 , 1522-726X
    URL: Issue
    URL: Article
    DOI: 10.1002/ccd.v98.2
    DOI: 10.1002/ccd.29657
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2001555-0
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  • 2
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    Melody Valve Implant Within Failed Bioprosthetic Valves in the Pulmonary Position : A Multicenter Experience
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Circulation: Cardiovascular Interventions Vol. 5, No. 6 ( 2012-12), p. 862-870
    Details
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 5, No. 6 ( 2012-12), p. 862-870
    Abstract: Transcatheter pulmonary valve implantation using the Melody valve has emerged as an important therapy for the treatment of postoperative right ventricular outflow tract dysfunction. Melody-in-bioprosthetic valves (BPV) is currently considered an off-label indication. We review the combined experience with transcatheter pulmonary valve implantation within BPVs from 8 centers in the United States and discuss technical aspects of the Melody-in-BPV procedure. Methods and Results— A total of 104 patients underwent Melody-in-BPV in the pulmonary position at 8 US centers from April 2007 to January 2012. Ten different types of BPVs were intervened on, with Melody valve implantation at the intended site in all patients. Following Melody valve implant, the peak right ventricle-to-pulmonary artery gradient decreased from 38.7±16.3 to 10.9±6.7 mm Hg ( P 〈 0.001), and the right ventricular systolic pressure fell from 71.6±21.7 to 46.7±15.9 mm Hg ( P 〈 0.001). There was no serious procedural morbidity, and no deaths related to the catheterization or implant. At a median follow-up of 12 months (1–46 months), no patients had more than mild regurgitation, and 4 had a mean right ventricular outflow tract gradient ≥30 mm Hg. During follow-up, there were 2 stent fractures, 3 cases of endocarditis (2 managed with surgical explant), and 2 deaths that were unrelated to the Melody valve. Conclusions— Transcatheter pulmonary valve implantation using the Melody valve within BPVs can be accomplished with a high rate of success, low procedure-related morbidity and mortality, and excellent short-term results. The findings of this preliminary multicenter experience suggest that the Melody valve is an effective transcatheter treatment option for failed BPVs.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    URL: Article
    DOI: 10.1161/CIRCINTERVENTIONS.112.972216
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 2450801-9
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  • 3
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    Intentional Fracture of Bioprosthetic Valve Frames in Patients Undergoing Valve-in-Valve Transcatheter Pulmonary Valve Replacement
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Circulation: Cardiovascular Interventions Vol. 11, No. 8 ( 2018-08)
    Details
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 11, No. 8 ( 2018-08)
    Abstract: Percutaneous transcatheter pulmonary valve replacement (TPVR) has good clinical and hemodynamic outcomes in treating dysfunctional bioprosthetic valves (BPV) in the pulmonary position. Valve-in-valve therapy can further decrease the inner diameter (ID), potentially resulting in patient-prosthesis mismatch in patients with smaller BPVs. Methods and Results: To evaluate feasibility and outcomes of intentional BPV fracture to enlarge the pulmonary valve orifice with TPVR, 37 patients from 13 centers who underwent TPVR with intended BPV fracture were evaluated. A control cohort (n=70) who underwent valve-in-valve TPVR without attempted fracture was evaluated. BPV was successfully fractured in 28 patients and stretched in 5 while fracture was unsuccessful in 4. A Melody valve was implanted in 25 patients with fractured/stretched frame and a Sapien (XT 3) valve in 8. Among patients whose BPV was fractured/stretched, the final ID was a median of 2 mm larger (0–6.5 mm) than the valve’s true ID. The narrowest diameter after TPVR in controls was a median of 2 mm smaller ( P 〈 0.001) than true ID. Right ventricular outflow tract gradient decreased from median 40 to 8 mm Hg in the fracture group. Cases with fracture/stretching were matched 1:1 (weight, true ID) to controls. Post-TPVR peak gradient was lower but not significant (8.3±5.2 versus 11.8±9.2 mm Hg; P =0.070). There were no fracture-related adverse events. Conclusions: Preliminary experience shows intentional fracture of BPV frame can be useful for achieving larger ID and better hemodynamics after valve-in-valve TPVR.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    URL: Article
    DOI: 10.1161/CIRCINTERVENTIONS.118.006453
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 2450801-9
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