Cholewa Klaudia, Kurtyka Przemysław, Janiczak Karolina, Kapis Artur, Szuber-Dynia Agnieszka, Janecki Mateusz, Walke Witold, Wilk Karolina, Gawlikowski Maciej
Faculty of Biomedical Engineering, Silesian University of Technology, Roosevelta 40 Str., 41-800 Zabrze, Poland.
Institute of Heart Prostheses, Foundation of Cardiac Surgery Development, Wolności 345a Str., 41-800 Zabrze, Poland.
J Clin Med. 2025 Jun 30;14(13):4621. doi: 10.3390/jcm14134621.
Heart failure in pediatric patients remains a major cause of morbidity and mortality, often associated with congenital heart defects and cardiomyopathies. Mechanical circulatory support (MCS) devices have emerged as critical therapeutic options, particularly as bridges to transplantation or recovery. The complexity of their use in children necessitates highly specialized solutions. This study aimed to evaluate the quality and performance of selected connection technologies between prosthetic vascular grafts and the outflow cannula of the Religa Heart PED pediatric pulsatile pump, with a focus on tightness, surface smoothness, and structural integrity. Mechanical testing was conducted on various connection types, including static tensile strength and long-term durability under pulsatile flow conditions with biological fluid analogs. Macro and microscopic evaluations assessed the surface quality and potential thrombogenic risks, biological testing encompassed permeability analysis in static and dynamic settings, and hemocompatibility was determined by acute thrombogenicity. Additionally, in vivo observations in a large animal model were used for final qualitative validation. All connection types demonstrated sufficient mechanical strength, with no structural degradation or leakage observed in any samples following long-term testing. Thrombus formation was absent in adhesive connections with Dacron and polytetrafluoroethylene (PTFE) grafts but was observed in the mechanical connection with the PTFE prosthesis. In addition, in vivo studies confirmed the tightness, hemocompatibility, and mechanical stability of the adhesive connection with the Dacron prosthesis. The adhesive connection between the outflow cannula and a Dacron prosthesis demonstrated superior mechanical and biological performance, including resistance to thrombogenesis and hemolysis, as well as stable integration under in vivo conditions. This solution shows high potential for safe application in the Religa Heart PED system.
小儿心力衰竭仍然是发病和死亡的主要原因，通常与先天性心脏缺陷和心肌病有关。机械循环支持（MCS）设备已成为关键的治疗选择，尤其是作为移植或康复的桥梁。它们在儿童中的使用复杂性需要高度专业化的解决方案。本研究旨在评估人工血管移植物与Religa Heart PED小儿搏动泵流出插管之间选定连接技术的质量和性能，重点关注密封性、表面光滑度和结构完整性。对各种连接类型进行了机械测试，包括静态拉伸强度以及在模拟生物流体的脉动流条件下的长期耐久性测试。宏观和微观评估评估了表面质量和潜在的血栓形成风险，生物学测试包括静态和动态环境下的渗透性分析，通过急性血栓形成测定血液相容性。此外，在大型动物模型中的体内观察用于最终的定性验证。所有连接类型均表现出足够机械强度，长期测试后任何样品均未观察到结构降解或泄漏。与涤纶和聚四氟乙烯（PTFE）移植物的粘结连接中未观察到血栓形成，但在与PTFE假体的机械连接中观察到血栓形成。此外，体内研究证实了与涤纶假体的粘结连接的密封性、血液相容性和机械稳定性。流出插管与涤纶假体之间的粘结连接表现出优异理化性能，包括抗血栓形成和溶血能力，以及在体内条件下的稳定整合。该解决方案在Religa Heart PED系统中具有很高的安全应用潜力。
