De Rita Fabrizio, Griselli Massimo, Sandica Eugen, Miera Oliver, Karimova Ann, d'Udekem Yves, Goldwasser Ranny, Januszewska Katarzyna, Amodeo Antonio, Jurrmann Nadine, Ersel Simon, Menon Ares K
Department of Paediatric Heart Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
Department of Surgery for Congenital Heart Defects, Heart and Diabetes Center Nordrhein-Westfalen, Bad Oeynhausen, Germany.
Interact Cardiovasc Thorac Surg. 2017 May 1;24(5):768-771. doi: 10.1093/icvts/ivw437.
The Berlin Heart EXCOR ® (EXCOR) paediatric ventricular assist device is used worldwide for mechanical support of infants and small children with end-stage heart failure. A clinically important gap between the smallest EXCOR blood pump (10 ml) and the next larger size (25 ml) limited the choice of pump size in patients with a body surface area (BSA) between 0.33 and 0.5 m 2 . We present the first clinical experience from the early product surveillance (EPS) of the new EXCOR 15-ml blood pump.
After CE and U.S. Food and Drug Administration approval in January 2013, 20 patients with a mean age of 1.6 years (range 0.5-3.5 years) and a mean BSA of 0.45 m 2 (range 0.33-0.59 m 2 ) were enrolled in the EPS. The main diagnosis was idiopathic cardiomyopathy in 13 patients; the majority ( n = 16) of children were in INTERMACS level 1 or 2. Data from high-volume paediatric transplant centres were collected prospectively for a defined follow-up period of 60 days after device implantation.
Mean time on the EXCOR 15-ml blood pump was 43 days; the survival rate was 100% at the end of the EPS period. Seven patients underwent a heart transplant from the device; 2 children were weaned; and 11 patients remained on support. Infection of cannula exit sites occurred in 3 patients. Two patients had minor thromboembolic strokes but made a complete neurological recovery.
The new EXCOR 15-ml blood pump demonstrated optimal ventricular assist device support of children with a BSA of 0.33-0.5 m 2 .
柏林心脏EXCOR®（EXCOR）小儿心室辅助装置在全球范围内用于为终末期心力衰竭的婴幼儿和小儿提供机械支持。最小的EXCOR血泵（10毫升）与次大尺寸（25毫升）之间存在临床上的重要差距，这限制了体表面积（BSA）在0.33至0.5平方米之间患者的泵尺寸选择。我们展示了新型EXCOR 15毫升血泵早期产品监测（EPS）的首次临床经验。
2013年1月获得CE和美国食品药品监督管理局批准后，20例平均年龄1.6岁（范围0.5 - 3.5岁）、平均BSA为0.45平方米（范围0.33 - 0.59平方米）的患者被纳入EPS。主要诊断为特发性心肌病的患者有13例；大多数（n = 16）儿童处于INTERMACS 1级或2级。前瞻性收集来自大容量小儿移植中心的数据，在装置植入后进行60天的明确随访。
使用EXCOR 15毫升血泵的平均时间为43天；在EPS期末生存率为100%。7例患者通过该装置接受了心脏移植；2例儿童脱机；11例患者仍在接受支持。3例患者发生了插管出口部位感染。2例患者发生轻微血栓栓塞性中风，但神经功能完全恢复。
新型EXCOR 15毫升血泵对BSA为0.33 - 0.5平方米的儿童显示出最佳的心室辅助装置支持效果。
