A Novel Fenestrating Device: Quick Fenestrater for Reconstructing Supra-aortic Arteries In Situ During Thoracic Endovascular Aortic Repair.

BACKGROUND: In situ fenestration (ISF) is an effective approach for reconstructing supra-aortic branches during thoracic endovascular aortic repair (TEVAR). A dedicated device is needed for ISF. METHODS: The Quick Fenestrater (QF) underwent in vitro, animal-based, and initial clinical testing. In vitro, the polytetrafluoroethylene and Dacron aortic endografts were fenestrated using the QF, and the structure of the graft, fenestration hole, and shed particulate material were evaluated. Eight white swine had QF-aided ISF combined with TEVAR and bridge-stent implantation. The outcomes were assessed using intraoperative angiography and biopsy. Finally, 13 patients were treated with QF-assisted ISF combined with TEVAR, and the success rate, technical details, and intra- and postoperative complications were recorded. RESULTS: The endograft structure was not damaged during in vitro testing. The fenestration hole was clean, and no particulate material was detected. In animal studies, all animals survived, the supra-aortic arteries were patent, and the endografts and bridge stents had normal morphology. In clinical studies, the technical success rate was 100%, and no fenestration-related neurologic complications or death occurred. One patient had a local access-related hematoma perioperatively and recovered after conservative treatment. Three patients had type III endoleaks, which resolved with no additional treatment. During a mean follow-up of 22.1 ± 6 months, no thoracic complications were identified, and the bridge stents were patent with no endoleaks. No adverse cerebrovascular events, cardiovascular events, or death occurred. CONCLUSIONS: QF-assisted ISF is a safe and effective method for the reconstruction of supra-aortic branches during TEVAR. Intermediate-term follow-up results validate the application of the novel fenestration device.