Abstract：
BACKGROUND: Repair is preferable for children with mitral valve disease, but mitral valve replacement (MVR) is occasionally necessary. This report presents the results of a multiinstitutional Investigational Device Exemption trial of the 15-mm St Jude (SJM) mechanical mitral valve (Abbott Structural Heart).
METHODS: From May 2015 to March 2017, 23 children aged 0.4 to 27.4 months (mean, 7.8 months; 85% <1 year) weighing 2.9 to 10.9 kg (mean, 5.5 kg) at 15 centers underwent MVR with a 15-mm SJM mechanical mitral valve (intraannular, 45%; supraannular, 55%). A total of 21 (91%) of the children had undergone previous cardiac operations. Follow-up until death, valve explantation, or 5 years postoperatively was 100% complete.
RESULTS: There were 6 deaths, all in the first 12 months; no death was valve related. Four patients required a pacemaker (2 supraannular, 2 intraannular). Three patients had thrombosis requiring valve explantation at 13, 21, and 35 days postoperatively. Two of these 3 patients were receiving low-molecular-weight heparin for anticoagulation, and the third had factor V Leiden deficiency. There were 5 nonfatal bleeding complications within 4 months of MVR (1-year freedom from bleeding, 71.0%). The 1- and 5-year freedom from death or valve explantation was 71.0%.
CONCLUSIONS: In small children with severe mitral valve disease requiring MVR, the 15-mm SJM mechanical mitral valve provides satisfactory hemodynamics. Mortality and complications in these patients are not trivial. Low-molecular-weight heparin likely should be avoided as primary anticoagulation. Eventual valve replacement is inevitable.
METHODS: From May 2015 to March 2017, 23 children aged 0.4 to 27.4 months (mean, 7.8 months; 85% <1 year) weighing 2.9 to 10.9 kg (mean, 5.5 kg) at 15 centers underwent MVR with a 15-mm SJM mechanical mitral valve (intraannular, 45%; supraannular, 55%). A total of 21 (91%) of the children had undergone previous cardiac operations. Follow-up until death, valve explantation, or 5 years postoperatively was 100% complete.
RESULTS: There were 6 deaths, all in the first 12 months; no death was valve related. Four patients required a pacemaker (2 supraannular, 2 intraannular). Three patients had thrombosis requiring valve explantation at 13, 21, and 35 days postoperatively. Two of these 3 patients were receiving low-molecular-weight heparin for anticoagulation, and the third had factor V Leiden deficiency. There were 5 nonfatal bleeding complications within 4 months of MVR (1-year freedom from bleeding, 71.0%). The 1- and 5-year freedom from death or valve explantation was 71.0%.
CONCLUSIONS: In small children with severe mitral valve disease requiring MVR, the 15-mm SJM mechanical mitral valve provides satisfactory hemodynamics. Mortality and complications in these patients are not trivial. Low-molecular-weight heparin likely should be avoided as primary anticoagulation. Eventual valve replacement is inevitable.
摘要：
背景：对于患有二尖瓣疾病的儿童，修复是优选的；二尖瓣置换（MVR）有时是必要的。我们介绍了15mmSt.Jude机械二尖瓣的多机构研究设备豁免试验的结果。
方法：从5月开始，2015年3月,2017年，23名年龄在0.4-27.4个月（平均7.8个月；85%<1岁）的儿童，体重2.9-10.9公斤（平均5.5公斤），在15个中心接受了15毫米SJM的MVR（环内45%，超环形55%)。21人（91％）曾进行过心脏手术。跟进直到死亡，瓣膜外植术,或术后五年完成100%。
结果：前12个月有6例死亡，无瓣膜相关死亡。四名患者需要起搏器（2个上环形，2个环内）。3例患者在术后13、21和35天有血栓形成，需要瓣膜移植。3例患者中有2例接受低分子肝素抗凝治疗，第三个患有因子V莱顿缺乏症。在MVR的4个月内有5例非致命性出血并发症（1年无出血71.0％）。一年和五年无死亡或瓣膜外植术的发生率为71.0%。
结论：对于患有需要MVR的严重二尖瓣疾病的儿童，15mmSJMMHV可提供令人满意的血流动力学。这些患者的死亡率和并发症并非微不足道。低分子量肝素可能应避免作为主要抗凝药物。最终的瓣膜更换是不可避免的。
方法：从5月开始，2015年3月,2017年，23名年龄在0.4-27.4个月（平均7.8个月；85%<1岁）的儿童，体重2.9-10.9公斤（平均5.5公斤），在15个中心接受了15毫米SJM的MVR（环内45%，超环形55%)。21人（91％）曾进行过心脏手术。跟进直到死亡，瓣膜外植术,或术后五年完成100%。
结果：前12个月有6例死亡，无瓣膜相关死亡。四名患者需要起搏器（2个上环形，2个环内）。3例患者在术后13、21和35天有血栓形成，需要瓣膜移植。3例患者中有2例接受低分子肝素抗凝治疗，第三个患有因子V莱顿缺乏症。在MVR的4个月内有5例非致命性出血并发症（1年无出血71.0％）。一年和五年无死亡或瓣膜外植术的发生率为71.0%。
结论：对于患有需要MVR的严重二尖瓣疾病的儿童，15mmSJMMHV可提供令人满意的血流动力学。这些患者的死亡率和并发症并非微不足道。低分子量肝素可能应避免作为主要抗凝药物。最终的瓣膜更换是不可避免的。
