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In Vivo Feasibility And Comparative Evaluation Of Novel Vascular Connection Strategies For Long-term Extracorporeal Support
Xiayimaierdan Yibulayin1, Janina Emunds1, Valentine Gesché2, Felix Vorwold1, Prescher Andreas1, Ehsan Arkin1, Kalverkamp Sebastian1, Johannes Greven1, Jan Spillner1.
1University hospital of RWTH, Aachen, Germany, 2PerAGraft GmbH, Aachen, Germany.


1.BACKGROUND: Current extracorporeal lung support systems like ECMO are limited to short-term use and require invasive procedures. There is no implantable solution available for patients with chronic lung failure. To enable long-term support and patient mobility, safe and efficient vascular connection strategies for artificial lungs close or directly connected to the hearrt must be developed. This study investigates the feasibility of novel central connections in a porcine model. To address this need, we developed and experimentally validated a novel vascular connector system based on an "inside-out" deployment pathway.The study aims to evaluate the ex vivo and in vivo feasibility of different vascular connection strategies for extracorporeal support in a porcine model, including:
1.1 To conduct the first in vivo evaluation of novel vascular access strategies following extensive in vitro and ex vivo development.
1.2 Technical feasibility of novel thoracic access using minimally invasive surgical techniques.
1.3 To investigate a stent-based "inside-out" access system as a long-term central vascular interface.

2.METHODS:
2.1 Model & Study Design "Dübel" stent and Inside-Out"Elephant trunk"stentPorcine models (German Landrace, 65-80 kg) were used to evaluate central and peripheral vascular connections. All procedures were performed under general anesthesia and in accordance with institutional guidelines. Inside-out technique was evaluated in ex vivo models of pig aorta, using monopolar electrocautery and customized delivery systems.
2.2 Cannulation TechniquesTwo novel stents (laser-cut "Dübel" and an Inside Out elephant trunk stent) were tested. Central connections were performed via inside-out and open surgery techniques.
3.RESULTS: This study presents in vivo and ex vivo data on:
3.1 Various central and peripheral vascular access configurations were tested for feasibility, sealing, and flow performance.
3.2 Ex vivo feasibility studies showed that the Inside-Out elephant trunk mechanism could be applied through the development of a novel stent type. 3.3 Sealing performance and positional stability of novel stent-based cannulation devices.

4.CONCLUSIONS:
This study establishes a comprehensive framework for evaluating novel vascular connection strategies for artificial lung support in a large animal model. By combining stent-based cannulation, minimally invasive access, and advanced hemodynamic assessment, we aim to define clinically translatable approaches for long-term, mobile lung support. The results provide critical insights for the development of next-generation implantable artificial lungs and help bridge the gap between acute ECMO and chronic respiratory care.



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