Key result
Surgical implantation of Melody and Sapien 3 valves in the mitral position in young children resulted in 80% and 83% freedom from reoperation at 24 months, respectively, with no mortality.
Why the study?
Mitral valve replacement in young children presents a clinical challenge due to limited available options.
Do surgically implanted Melody and Sapien 3 valves in the mitral position provide safe and effective outcomes in young children?
Observational (n=18)
No
Do surgically implanted Melody and Sapien 3 valves in the mitral position provide safe and effective outcomes in young children?
Absolute Event Rate: 80% vs 83%
p-value: p=0.56
Surgically implanted Melody and Sapien 3 valves in the mitral position offer a feasible and effective alternative for young children requiring mitral valve replacement, with good mid-term freedom from reoperation and no mortality.
May offer a feasible mitral replacement option in young children; leaves open durability and comparative effectiveness questions.
Objectives Mitral valve replacement in young children is a challenging situation due to limited options. In this study, we aimed to present the results of our patients who underwent mitral valve replacement using Melody (Medtronic Inc) and Sapien 3 (Edwards Inc) valves. Methods We performed a total of 18 mitral valve replacements at Phoenix Children's between 2017 and 2024. These include 12 Melody and 6 Sapien valves. The median patient age was 42.17 ± 38.9 (1.9–127.2) months and weight was 13.83 ± 9.38 (3.9–43.4) kg, respectively. The indications for implantation were mitral stenosis with or without regurgitation, following an atrioventricular septal defect (AVSD) repair, mitral valve dysplasia, and Shone's complex. Once positioned the valves were expanded using a balloon catheter to achieve the best diameter (16–30 mm). Results The postoperative mean mitral gradient was 6 ± 2.91 (2–12) mmHg. A permanent pacemaker was implanted in one patient after Sapien 3 valve replacement. One patient who received a Sapien valve had to be re-intervened for tamponade in the early post operative period. Mild LVOT obstruction was observed in one patient who underwent Melody valve replacement. One Melody valve was dilated after one year after implantation. At 24 months after implantation, Kaplan–Meier analysis indicated that 80% of Melody valves and 83% of Sapien valves would be expected to be free from reoperation (Log-rank p = 0,56).The hospital stay was 18.72 ± 3.67 days, and no mortality was observed. Conclusions Melody and Sapien valves contribute to the prognosis of patients as it shortens the operation time, is easily applicable, and provides opportunities such as postoperative redilation. The successful results we obtained show that both valves can be used reliably and effectively and can be an alternative to conventional methods.
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Sicim et al. (2025) conducted an observational in Mitral valve dysfunction requiring replacement (n=18). Melody and Sapien 3 valves vs. Sapien 3 valve (compared to Melody valve) was evaluated on Freedom from reoperation at 24 months (p=0.56). Surgical implantation of Melody and Sapien 3 valves in the mitral position in young children resulted in 80% and 83% freedom from reoperation at 24 months, respectively, with no mortality.
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