Integrated system combining cerebral protection and active steering directional puncture for thoracic aortic in situ...

This study aims to introduce and systematically evaluate the preclinical performance and safety of a novel integrated interventional device that simultaneously addresses the cerebral embolism risk and the difficulty of puncture and fenestration during thoracic aortic in situ fenestration.

A study design combining in vitro experiments with anatomically accurate human aortic arch models and in vivo large animal experiments was adopted. (1) In in vitro experiments, a closed-loop pulsatile flow system was used to test the device's capture efficiency for 100 , 120 , and 150 μm embolic microspheres, and to verify its puncture accuracy for the three supra-aortic branch vessels under types Ⅰ to Ⅲ aortic arch configurations. (2) In in vivo experiments, six healthy Ukrainian White pigs were used as the animal model to assess the surgical technical success rate, procedural efficiency, operator usability feedback, and immediate safety of the device.

In in vitro experiments, the device achieved capture rates of (98.1 ± 0.9)% and (87.1 ± 2.7)% for the stroke-causing critical particle sizes of 150 and 120 μm, respectively, capture efficiency exhibited a size-dependent trend (F = 174,771; P < .001). Across all types Ⅰ to Ⅲ aortic arch scenarios, the puncture coverage ratio ranged from 41.9% to 68.8%, with no out-of-bounds puncture events. In in vivo experiments, the surgical technical success rate was 100%, with a mean fenestration time of only 9 seconds (range, 5-11 seconds) and a total procedural time of 38.92 ± 4.36 minutes. The overall operator usability score was 7.47 ± 0.89, among which the directional accuracy dimension received the highest score (7.83 ± 0.75). After the procedure, the device was retrieved with intact structural integrity, only mild vascular intimal injury was observed, and successful capture of thrombus debris by the embolic protection filter was confirmed.

This integrated system offers a potential approach to the inherent challenge of incompatible access for cerebral protection and puncture during in situ fenestration procedures. Preclinical results indicate it may facilitate improved puncture success and holds potential for clinical translation.

This study addresses two core clinical challenges of thoracic endovascular aortic repair: the high risk of perioperative stroke and the technical difficulty of in situ fenestration (ISF) in complex aortic arch anatomies. The integrated device provides a novel, single-access solution that synchronizes cerebral protection and precision puncture, with the potential to improve procedural safety and efficiency, and expand the application of ISF for complex aortic pathologies.