Key result
Implantation of the Medtronic Melody valve expanded to 24-mm diameter resulted in low peak systolic gradients and no more than mild regurgitation at a median follow-up of 9.5 months.
Why the study?
Can the Medtronic Melody transcatheter valve be safely and effectively implanted at a 24-mm diameter?
Observational (n=11)
Can the Medtronic Melody transcatheter valve be safely and effectively implanted at a 24-mm diameter?
The Melody transcatheter valve can be successfully implanted and expanded to 24-mm diameter with acceptable hemodynamics and valve competence.
May support larger Melody sizing in select cases; hypothesis-generating and should not yet change practice.
OBJECTIVES: We report the Melody valve implanted and/or expanded to 24-mm diameter. BACKGROUND: The Medtronic Melody valve has been implanted up to 22 mm in the pulmonary position for over a decade. METHODS: A retrospective chart review was performed on 82 patients who underwent Melody valve implant. Technical implant method, pre- and postimplant echocardiographic findings, and initial follow-up were reviewed. RESULTS: Between 04/2008 and 12/2011, 13 Melody valves were successfully implanted in 11 patients, median age 35 years (range 16-61 years), in the pulmonary (bioprosthetic valve, right ventricle to pulmonary artery conduit, native valve) position (n = 9), tricuspid position (bioprosthetic valve n = 3), and aortic position (bioprosthetic valve n = 1). Ten valves were delivered on a 24-mm balloon in balloon catheter and three were implanted using a 22-mm Ensemble balloon delivery system, followed by postdilation using a 24-mm × 2-cm Atlas balloon catheter. Postimplant, the median peak systolic gradient across the pulmonary valve was 7 mm Hg and median gradient across the tricuspid valve was 3 mm Hg. There was no change in gradient across the Melody valve in the aortic position where valve prosthesis-patient mismatch was present. Postimplant intracardiac echocardiography demonstrated none or mild valve regurgitation. No more than mild regurgitation was noted at a median follow-up of 9.5 months. CONCLUSIONS: The Melody valve can be implanted at 24 mm in the stenotic/regurgitant bioprosthetic pulmonary, tricuspid, and aortic valve, dysfunctional right ventricle to pulmonary artery conduit, and the native right ventricular outflow tract, whereas the valve remains competent with only mild regurgitation.
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Holzer et al. (2013) conducted an observational in Stenotic or regurgitant bioprosthetic valves or dysfunctional conduits (n=11). Medtronic Melody valve implanted at 24-mm diameter was evaluated on Peak systolic gradient and valve regurgitation. Implantation of the Medtronic Melody valve expanded to 24-mm diameter resulted in low peak systolic gradients and no more than mild regurgitation at a median follow-up of 9.5 months.
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