Neethling William, Rea Alethea, Forster Guenther, Bhirangi Kiran
School of Surgery, University of Western Australia, Perth, WA, Australia.
Department of Cardiothoracic Surgery, University of Free State, Bloemfontein, South Africa.
Front Pediatr. 2020 Apr 24;8:198. doi: 10.3389/fped.2020.00198. eCollection 2020.
A Phase II Clinical Trial reviewed the performance (morbidity and calcification) of the tissue-engineered ADAPT® bovine pericardial scaffold (CardioCel®) in pediatric patients ( = 30) with congenital cardiac defects. In that study, CardioCel® demonstrated no graft-related morbidity and mortality in 25 patients, over 12 months. Five patients died due to non-graft-related events. Echocardiography revealed hemodynamically stable repairs with no calcification of the scaffold. Magnetic resonance imaging (MRI) at 12 months in 10 patients confirmed the absence of calcification. These patients were followed up for further up to 10 years. We present the results of this retrospective review of these patients that were followed for further medium to long-term (median 7.2 years, 25%: 3.6 years 75%: 9.25 years) postoperatively in these patients. Between April 2008 and September 2009, CardioCel® was implanted in 30 patients with congenital cardiac defects. Efficacy measures included graft-related mortality, morbidity and haemodynamic abnormalities. Calcification was assessed by standard 2D-M mode echocardiography and MRI at 12 months. Medium to long-term assessment included routine clinical assessments and echocardiography. Median age at surgery was 18 months (27 days-13 years). Twenty-five patients (142 patient years) were followed for up to 10 years. The 10-year survival rate is estimated as 86.9% (95% CI 71.4-100.0%) over the entire follow-up period. One patient was lost to follow-up. No graft-related mortality was encountered up to a median follow-up of 7.2 years. Two patients died (pacemaker complications >5 years and arrhythmia >7 years postoperatively). No graft failure, thromboembolic events, infections or device-related reinterventions were recorded. Non-significant residual leaks occurred in 3 patients. Echocardiography demonstrated the absence of calcification in all implants. The tissue-engineered ADAPT® bovine pericardial scaffold demonstrated excellent medium to long-term performance (up to 10 years) when used as a scaffold for repair of congenital cardiac defects in children. Durability, acellularity, biostability and non-calcifying potential of CardioCel® makes it a very attractive tissue for congenital cardiac repair procedures.
一项II期临床试验评估了组织工程化ADAPT®牛心包支架（CardioCel®）在30例先天性心脏缺陷儿科患者中的性能（发病率和钙化情况）。在该研究中，25例患者在12个月内未出现与移植物相关的发病率和死亡率。5例患者因非移植物相关事件死亡。超声心动图显示修复后的血流动力学稳定，支架无钙化。10例患者在12个月时的磁共振成像（MRI）证实无钙化。这些患者进一步随访长达10年。我们展示了对这些患者进行回顾性研究的结果，这些患者术后进行了进一步的中长期随访（中位时间7.2年，四分位间距：25%为3.6年，75%为9.25年）。2008年4月至2009年9月期间，30例先天性心脏缺陷患者植入了CardioCel®。疗效指标包括与移植物相关的死亡率、发病率和血流动力学异常。通过标准二维M型超声心动图和12个月时的MRI评估钙化情况。中长期评估包括常规临床评估和超声心动图检查。手术时的中位年龄为18个月（27天至13岁）。25例患者（142患者年）随访长达10年。整个随访期间，10年生存率估计为86.9%（95%可信区间71.4 - 100.0%）。1例患者失访。中位随访7.2年时未出现与移植物相关的死亡。2例患者死亡（术后5年以上出现起搏器并发症，术后7年以上出现心律失常）。未记录到移植物失败、血栓栓塞事件、感染或与器械相关的再次干预。3例患者出现非显著性残余渗漏。超声心动图显示所有植入物均无钙化。组织工程化ADAPT®牛心包支架在用于儿童先天性心脏缺陷修复时，展现出了优异 的中长期性能（长达10年）。CardioCel®的耐久性、无细胞性、生物稳定性和无钙化潜力使其成为先天性心脏修复手术中极具吸引力的组织。
