University of Queensland School of Medicine, University of Queensland, Brisbane, Australia.
Institute for Social Science Research, University of Queensland, Brisbane, Australia.
Ann Thorac Surg. 2019 Dec;108(6):1883-1888. doi: 10.1016/j.athoracsur.2019.04.085. Epub 2019 Jun 14.
The purpose of this study was to assess the performance of more than 500 tissue-engineered bovine pericardial implants (CardioCel; Admedus, Toowong, Queensland, Australia) used for the repair of congenital heart defects.
Clinical data were collected for all patients who received a CardioCel implant at three centers (Brisbane, Australia; and Leicester and Bristol, United Kingdom). During this period, 501 CardioCel patches were implanted in 377 patients. The primary endpoint was CardioCel-related surgical or catheter intervention. Secondary endpoints included implant-related thromboembolism, residual shunt, infection, calcification leading to loss of function, and hemodynamic compromise. Mortality or reintervention was considered early if the event occurred within 30 days of implantation.
The median follow-up was 31 months (range, 1 to 60). There were 11 deaths (2.9%), 1 related to CardioCel. There was no echocardiographic or radiologic evidence of patch calcification in any patient. Overall freedom from reintervention 3 and 5 years after implantation was 96% (95% confidence interval, 93% to 98%). Fourteen implants (2.8%) required 18 reinterventions (3.6%) at the site of implantation (9 catheter based and 9 operative). There was no difference in the incidence of reintervention in the pulmonary arterial or systemic circulations (P = .18). There was no difference in performance of CardioCel in neonates (aged 0 to 28 days), infants (aged 29 to 365 days), or children aged more than 1 year (P = .22).
CardioCel has good durability when used for the repair of congenital heart defects. It performs comparably in the systemic and pulmonary circulations in neonates, infants, and older children.
本研究旨在评估 500 多个用于修复先天性心脏缺陷的组织工程牛心包植入物（CardioCel；Admedus，Toowong，昆士兰，澳大利亚）的性能。
收集在三个中心（澳大利亚布里斯班；英国莱斯特和布里斯托尔）接受 CardioCel 植入的所有患者的临床数据。在此期间，共有 377 名患者植入了 501 个 CardioCel 补丁。主要终点是与 CardioCel 相关的手术或导管介入。次要终点包括植入物相关的血栓栓塞、残余分流、感染、导致功能丧失的钙化以及血液动力学受损。如果事件发生在植入后 30 天内，则认为死亡或再次干预为早期。
中位随访时间为 31 个月（范围 1 至 60）。有 11 例死亡（2.9%），其中 1 例与 CardioCel 相关。在任何患者中均未发现补丁钙化的超声心动图或影像学证据。植入后 3 年和 5 年的无再干预率分别为 96%（95%置信区间，93%至 98%）。14 个植入物（2.8%）需要在植入部位进行 18 次（9 次经导管，9 次手术）再干预。在肺动脉或体循环中，再干预的发生率没有差异（P=0.18）。新生儿（0 至 28 天）、婴儿（29 至 365 天）和 1 岁以上儿童（P=0.22）的 CardioCel 性能无差异。
CardioCel 用于修复先天性心脏缺陷时具有良好的耐久性。在新生儿、婴儿和较大儿童的体循环和肺循环中，它的性能相当。
