Background: We demonstrate our experience and outcomes of in situ fenestration (ISF) using a dedicated needle perforation device to preserve the supra-aortic vessels of the aortic arch during thoracic endovascular aortic repair (TEVAR). Methods: We included all patients with thoracic pathologies who were treated using the in situ fenestrated endografts between July 2021 and February 2024. A consecutive series of 26 patients (24 men; median age 69±10 years) received ISF TEVAR. All pathologies (16 aneurysms, 6 type B dissections, and 4 penetrating aortic ulcer [PAU]) involved the aortic arch without sufficient proximal landing zone (PLZ) distal of the left subclavian artery (LSA). Twenty-seven percent of the patients (7/26) presented in an emergent/urgent situation (symptomatic or contained rupture). One (LSA), double (LSA and left common carotid artery LCCA), and 3 (total arch) fenestrations were performed in 21, 2, and 3 patients, respectively. The perioperative and follow-up data (postoperative, 3 and 6 months, and annually) were prospectively collected. Outcomes and imaging scans were evaluated and analyzed retrospectively. Results: The technical success, defined as endovascular exclusion of the aortic arch pathology and preservation of the supra-aortic vessels using ISF, was achieved in 92% (24/26 patients). The needle perforation failed in 2 of the patients. Only one patient with aortic dissection (3.8%) had an endoleak type Ia, which resolved spontaneously after 1 month. The early perioperative neurological events occurred in 3 patients (11.5%). Two of them suffered a major stroke (7.6%). There were no mortalities in the mono and double ISF groups. However, the perioperative mortalities encountered in 2 of 3 patients in the triple ISF group, both of whom were treated due to emergent or urgent indications. The mean follow-up period was 18 months (range: 2–32). During the follow-up, 2 patients required late unplanned re-interventions (7.6%). Further transient ischemic attack occurred in one patient. No patients died due to aneurysm or procedure-related causes. At the last follow-up, no endoleaks, branch occlusion, bridging stent fractures, or dislocation were registered. Conclusion: In our experience, the use of dedicated needle device is efficacious. ISF TEVAR may serve as an initial approach as off-the-shelf endovascular treatment of the aortic arch pathologies, especially in acute situations. The triple ISF should be considered only as bailout procedure in the emergent cases. Larger series and multicenter studies are of course needed to corroborate these results.
Clinical Impact
Our study demonstrated the clinical impact in real-world practice of using In-situ fenestration TEVAR with the innovative dedicated perforation-needle technique, which is characterized by an immediate availability as off-the-shelf device, compatibility with the various pathologies and anatomies, as well as minimal invasiveness in comparison to the debranching bypass-procedure for the preservation of the supra-aortic vessels during the endovascular repair of aortic arch pathologies. According to center experience, this approach can applied in elective cases, however, due to its practicability, it can be especially valuable in emergencies, when the other methods are considered as an unfavorable.
