Unique Stent-Graft Modification in Emergency High-Risk Patients for Aortic Arch Pathology

Abstract

Purpose:

Endovascular treatment of aortic arch pathologies remains a significant challenge due to the anatomical complexity of the supra-aortic vessels. Traditional approaches, such as custom-made devices (CMDs) or hybrid procedures, are often limited by delayed availability, invasiveness, and long production or preparation times. Physician-modified stent-grafts (PMSGs) offer a viable alternative for high-risk emergency patients requiring urgent intervention.

Methods:

This single-center study evaluated the safety and efficacy of a novel PMSG technique in 18 patients with acute aortic syndromes, including ruptured or impending rupture of aneurysms and complicated dissections. Patients were selected according to defined inclusion criteria, excluding those eligible for alternative surgical or endovascular procedures. Stent-graft modifications—including single-fenestrated and triple-fenestrated grafts—were performed on the Medtronic Valiant platform using patient-specific, sterile 3-dimensional-printed templates. Technical success, early outcomes, and medium-term follow-up data were assessed, with particular attention to neurological complications, endoleaks (EL), and survival, using serial computed tomography angiography.

Results:

Early outcomes demonstrated 100% technical success (18 of 18 patients), with no deaths during the first 30-day postoperative period. Four patients experienced non-disabling strokes. One patient required surgical revision for access-site bleeding, and another developed transient spinal cord ischemia. Mid-term follow-up (median = 43 months) revealed an overall survival rate of 83%, with 3 deaths unrelated to the endovascular procedure. Endoleaks were detected in 5 patients. No cases of graft infection or migration were reported.

Conclusion:

Physician-modified stent-grafts represent a feasible and effective treatment option for high-risk patients with aortic arch pathologies requiring urgent intervention. The technique enables tailored management in cases where off-the-shelf solutions or custom devices are unavailable, offering high technical success and promising mid-term durability. Further multicenter studies are warranted to confirm long-term safety and refine procedural techniques.

Clinical Impact

This study shows that physician-modified stent grafts (PMSGs) are a feasible option for high-risk patients who cannot undergo open surgery or access custom-made devices. Using 3D-printed templates improves fenestration accuracy and arterial alignment. The 100% technical success rate and absence of early mortality indicate strong short-term effectiveness. However, the off-label nature of the technique and lack of standardization require experienced teams and careful patient selection. If confirmed in larger cohorts, PMSGs could become part of emergency aortic treatment protocols and influence future device development.

Keywords

stent-graft 3D printing dissection aneurysm thoracic aorta

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