Division of Cardiovascular Surgery, The Labatt Family Heart Centre, The Hospital for Sick Children, Toronto, Ontario, Canada; Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Division of Cardiology, The Labatt Family Heart Centre, The Hospital for Sick Children, Toronto, Ontario, Canada; Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Ann Thorac Surg. 2024 Sep;118(3):623-632. doi: 10.1016/j.athoracsur.2024.04.037. Epub 2024 May 27.
The Melody valve (Medtronic, Minneapolis, MN) for mitral valve replacement (MVR) (MelodyMVR) has been an effective strategy to treat unrepairable mitral valve disease in small children. This study analyzed survival, durability, and complications of the MelodyMVR strategy.
Patients who underwent MelodyMVR between 2014 and 2023 were included. Transplant-free survival was analyzed with Kaplan-Meier analysis. The Fine and Gray subdistribution method was applied to quantify the cumulative incidence.
Twenty-five patients underwent MelodyMVR. Median age and weight were 6.3 months (interquartile range, 4.4-15.2 months) and 6.36 kg (interquartile range, 4.41-7.57 kg). Fifteen patients (60%) had congenital mitral valve disease and 13 (52%) had dominant mitral regurgitation. The median diameter of the implanted Melody was 16 mm (interquartile range, 14-18 mm). Mortality at 6 months, 1 year, and 5 years was 8.3% (95% CI, 2.2%-29.4%), 12.5% (95% CI, 4.2%-33.9%), and 17.6% (95% CI, 7.0%-40.7%), respectively. Two hospital survivors (8%) required early Melody replacement. Competing risk analysis showed that ∼50% of patients underwent mechanical MVR by 3.5 years after MelodyMVR. Freedom from bleeding and thrombosis at 4 years was 87.5% (95% CI, 74.2%-100%). Eleven patients underwent subsequent mechanical MVR with no deaths. One (9%) required pacemaker implantation after mechanical MVR.
MelodyMVR provides reasonable early and medium-term survival in small children and a high rate of successful bridge to mechanical MVR. MelodyMVR is associated with minimal pacemaker requirement, bleeding, and thrombosis. Early Melody functional deterioration necessitates early repeat MVR, which can be achieved with minimal morbidity and mortality.
用于二尖瓣置换术（MVR）的 Melody 瓣膜（美敦力，明尼苏达州明尼阿波利斯）（MelodyMVR）一直是治疗小儿不可修复二尖瓣疾病的有效策略。本研究分析了 MelodyMVR 策略的生存、耐久性和并发症。
纳入 2014 年至 2023 年间接受 MelodyMVR 的患者。采用 Kaplan-Meier 分析评估无移植生存率。采用 Fine 和 Gray 亚分布方法量化累积发生率。
25 例患者接受了 MelodyMVR。中位年龄和体重分别为 6.3 个月（四分位距，4.4-15.2 个月）和 6.36 公斤（四分位距，4.41-7.57 公斤）。15 例（60%）患者患有先天性二尖瓣疾病，13 例（52%）患者患有优势二尖瓣反流。植入的 Melody 直径中位数为 16 毫米（四分位距，14-18 毫米）。6 个月、1 年和 5 年的死亡率分别为 8.3%（95%可信区间，2.2%-29.4%）、12.5%（95%可信区间，4.2%-33.9%）和 17.6%（95%可信区间，7.0%-40.7%）。2 例住院幸存者（8%）需要早期更换 Melody。竞争风险分析显示，在 MelodyMVR 后约 3.5 年，约 50%的患者接受了机械 MVR。4 年时无出血和血栓形成的生存率为 87.5%（95%可信区间，74.2%-100%）。11 例患者随后接受了机械 MVR，无死亡病例。1 例（9%）在机械 MVR 后需要植入起搏器。
MelodyMVR 为小儿提供了合理的早期和中期生存率，并能成功桥接至机械 MVR。MelodyMVR 与最小的起搏器需求、出血和血栓形成相关。早期 Melody 功能恶化需要早期重复 MVR，可以实现最小的发病率和死亡率。
