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. 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. 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. 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 ImpactThis 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.

There is a lack of data regarding the use of hybrid stent graft prostheses in patients with hereditary thoracic aortic disease (HTAD) involving the aortic arch and proximal descending aorta. This retrospective analysis aimed to evaluate the short- and mid-term outcomes of hybrid stent-graft prostheses in Frozen Elephant Trunk (FET) procedures for patients with HTAD, with a particular focus on its safety and feasibility. A total 280 patients who underwent FET procedures between October 2010 and November 2024 were retrospectively analysed in compliance with the 2024 EACTS/ STS recommendations for shared decision-making within the multidisciplinary aortic team. Among them, 51 patients had genetically confirmed HTAD (Marfan syndrome (FBN1), Loeys-Dietz syndrome (TGFBR1, TGFBR2, SMAD3, TGFB2), vascular Ehlers-Danlos syndrome (COLSA1), and non-syndromic HTAD (ACTA2, MYH11, MYLK)). The Thoraflex™ prosthesis was implanted in 50 of the 51 patients. Short- and mid-term outcomes were assessed descriptively. Survival and subsequent thoracic aortic intervention rates were analysed using the Kaplan-Meier method. The overall 30-day mortality was 2.0% (n = 1). Perioperatively, permanent neurological deficit was 3.9% (n = 2), with minor disability on the modified Rankin Scale (mRS 1 and 2). There were no instances of paraplegia. The median follow-up was 4.0 years. The 1-, 3- and 5-year overall survival rate was 93.9%, 90.6%, and 90.6%, respectively. Freedom from subsequent aortic interventions was at 1, 3, 5 years 55.8%, 45.6%, and 33.1%. Early device-related complications occurred in 7 patients (13.7%), including intraluminal FET thrombosis in 4 patients (12.5%) and distal stent graft-induced new entry in 3 patients (9.4%). Mid-term device-related complications occurred 2 patients (4.3%). Hybrid stent graft prostheses can be safely implanted with the FET technique in elective and acute HTAD patients with arch and proximal descending aortic disease. Our single-center short- and mid-term outcomes are encouraging, but long-term durability and efficacy are not yet established. This warrants multi-center studies with extended follow-up.

The frozen elephant trunk (FET) technique is a well-established procedure for chronic and acute aortic arch (AA) pathologies. Over time, practice has shifted from deep to moderate hypothermic circulatory arrest (HCA), especially for elective cases. This strategy might, however, impact neurological and renal outcomes. The aim of this single-center study is to assess the safety of very mild HCA (MiHCA) in patients who underwent FET with a core temperature ≥30 ℃. Data on all consecutive patients who electively or urgently underwent FET requiring HCA at Cardiac Surgery Unit of the University of Pisa were collected. In all cases, antegrade selective cerebral perfusion was performed, and hypothermia was maintained only during circulatory arrest (CA). We assessed postoperative acute kidney injury (AKI), neurological events, and bleeding as primary endpoints. Multivariable analysis was performed to evaluate the predictors of the three outcomes. We included 92 patients, 86% of which presented with an acute aortic syndrome. Of this cohort, 17% had neurological deficits at baseline and 9% were intubated at arrival; the German Registry of Acute Aortic Dissection Type A (GERAADA) score was 24%±14%. The mean bladder temperature was 30±1.6 ℃, and the mean cardiopulmonary bypass (CPB) and CA times were 219±78 and 15 (I-III quartile, 13-19) min, respectively. Median cerebral perfusion time was 59 (I-III quartile, 31-113) min, bilateral antegrade cerebral perfusion (ACP) was performed in 96% of cases, and unilateral in 4%. Packing for bleeding was necessary in 4% of cases, and 21% of patients required surgical revision for bleeding within the first 24 hours from surgery. We had one (1%) fatal, eight (9%) disabling, and five (5%) non-disabling strokes, while 6% of patients developed renal impairment requiring temporary venovenous hemofiltration. Thirty-day mortality was 14%. Bladder temperature was not associated with outcomes, while retrograde perfusion and GERAADA score were predictors of neurological events. GERAADA score also tended to predict postoperative bleeding, while the involvement of the descending aorta tended to predict renal impairment. CA with core temperatures above 30 ℃, paired with selective bilateral cerebral perfusion, resulted in the best outcomes in patients undergoing FET in case of acute aortic syndromes.

Objective: The role of the frozen elephant trunk technique in the treatment of acute aortic dissections is currently based on results from high-volume centers only. We investigated the patient selection process, intraoperative data, the evolution of surgical practice and outcomes from a low-volume center. Methods: A retrospective analysis was conducted on 202 acute aortic dissection (AAD) patients treated between October 2014 and December 2023. Patients were categorized into those receiving less invasive open aortic repair (group 1, n = 136) and those undergoing frozen elephant trunk procedures (FETs) (group 2, n = 66). Data on demographics, surgical procedures, and outcomes were analyzed. Results: Overall 30-day mortality was 16% (13% vs. 23%; p = 0.068). Rates of postoperative disabling stroke were similar (9% vs. 8%, p = 0.190). FET procedures required longer cardiopulmonary bypass (195 min vs. 234 min, p = 0.011), hypothermic circulatory arrest (26 min vs. 43 min, p < 0.001), and selective cerebral perfusion times (26 min vs. 47 min, p < 0.001). Follow-up indicated that 17% of FET patients received completion thoracic endovascular aortic repair (TEVAR) versus 4% in non-FET patients (p = 0.002), whereas no difference was seen in open surgical reintervention. Median follow-up at 33 months showed an overall mortality of 27%, with no significant difference between groups (23% in group 1 vs. 35% in group 2, p = 0.123). Conclusions: The FET technique is feasible in low-volume centers, yielding outcomes comparable to high-volume centers. FET proximalization and a liberal use of extra-anatomical left subclavian artery (LSA) grafts ease the learning curve. Completion treatments can be effectively conducted following FET implantation to further induce positive aortic remodelling.

Marfan syndrome (MFS) is a connective tissue disease which can lead to aortic aneurysm and dissection. The performance outcomes of total aortic arch replacement with frozen elephant trunk (FET) are not well known in these patients. This study summarizes our experience with FET in MFS. Between August 2001 and December 2021, 435 patients underwent FET at Hannover Medical School. Of these, 34 patients had MFS. The mean age was 43.3±11.9 years and 27 (79%) were male. The indication for surgery was aortic aneurysm in 1 (3%), acute aortic dissection in 12 (35%), and chronic aortic dissection in 21 (62%) patients. All patients underwent total aortic arch replacement with FET. In addition, the following procedures were performed: conventional aortic root replacement (Bentall operation, n=8), valve-sparing aortic root replacement (David procedure, n=8), coronary artery bypass grafting (n=3), mitral valve surgery (n=2), and tricuspid valve surgery (n=1). Cardiopulmonary bypass (CPB) and aortic cross clamp times were 270±87 and 139±69 minutes, respectively. Postoperatively, there were 2 (6%) disabling strokes, and 0 (0%) patients required permanent dialysis or suffered from permanent paraplegia, respectively. In-hospital mortality was 12% (n=4). The mean follow-up time was 8.4±5.9 years. The 1-, 5-, 10, and 15-year survival rates were 82%, 70%, 70% and 65, respectively. There were 18 (53%) re-interventions on the distal aorta. Mean time to re-intervention was 2.7±3.1 years. The majority of patients underwent open surgical repair (n=14, 77%), while only 4 (22%) had endovascular therapy. The freedom from distal aortic re-intervention at 1-, 5-, 10- and 15 years was 86%, 61%, 55% and 44%, respectively. The main indication for FET surgery in MFS is acute or chronic aortic dissection. Despite multiple concomitant procedures, early mortality was relatively low, suggesting that FET is feasible and effective to treat complex aortic pathology in MFS. However, our study showed a high incidence of distal aortic re-interventions, underscoring the progressive nature of the disease and the need for tailored long-term management strategies.