Complex abdominal aortic aneurysms: a review of radiological and clinical assessment, endovascular interventions, and current evidence of management outcomes.

Endovascular aortic aneurysm repair (EVAR) is an established approach to treating abdominal aortic aneurysms, however, challenges arise when the aneurysm involves visceral branches with insufficient normal segment of the aorta to provide aneurysm seal without excluding those vessels. To overcome this, a range of technological developments and solutions have been proposed including fenestrated, branched, physician-modified stents, and chimney techniques. Understanding the currently available evidence for each option is essential to select the most suitable procedure for each patient. Overall, the evidence for fenestrated endovascular repair is the most comprehensive of these techniques and shows an early post-operative advantage over open surgical repair (OSR) but with a catch-up mortality in the mid-term period. In this review, we will describe these endovascular options, pre- and post-procedure radiological assessment and current evidence of outcomes.

Physician-modified endograft for symptomatic zone 2 penetrating ulcer of the aortic arch without bridging stenting of the left subclavian artery for vertebral preservation.

We report the case of a 65-year-old male patient who was deemed unfit for open surgery and underwent zone 0 endovascular repair with a physician-modified fenestrated endograft for a symptomatic penetrating ulcer. A thoracic stent graft was modified creating a large fenestration for the innominate artery and the left common carotid artery, and a second small fenestration for the left subclavian artery and the left vertebral artery, which had a common origin. No bridging stent was used for the left subclavian artery to avoid coverage of the left vertebral artery. The postoperative course was uneventful, and no leaks nor other complications were detected on postoperative computed tomography angiography. Although long-term durability needs to be better assessed, our experience suggests that physician-modified fenestrated endografts are a feasible option for the emergent treatment of aortic arch lesions in unfit patients and provide satisfactory results in the short term.

Anatomical Feasibility of the "Canaud Technique" for Physician-Modified Thoracic Endovascular Grafts for the Treatment of Aortic Arch Disease.

PURPOSE: Thoracic endovascular aortic repair (TEVAR), originally conceived for deployment distal to the left subclavian artery (LSA), has been recently extended to more proximal landing zones. Among total endovascular solutions, the "Canaud technique" for Physician-Modified Thoracic Endovascular Grafts (C-PMEGs) has gained acceptance with good early results. The aim of this study is to report the proportion of patients with zone 0, 1, and 2 aortic arch lesions that could theoretically be treated with a C-PMEG. MATERIALS AND METHODS: Computed tomography angiography (CTA) of all consecutive patient candidates to open, hybrid, or endovascular arch repair from January 2009 to July 2023 at our Institution were analyzed. The assessment of feasibility of C-PEMG was conducted following previously extensively described anatomical criteria. RESULTS: During the study period, 209 consecutive patients were candidates for an open, hybrid, or endovascular aortic arch repair. Of them, 164 patients had a preoperative CTA scan eligible for analysis. One hundred twenty-six patients were male (76.8 %), with a mean age of 67 ± 10.8 years. Ninety-four patients (57.3%) were affected by atherosclerotic aneurysms, 48 post-dissecting aneurysms (29.3%) and 22 penetrating aortic ulcers (PAUs) (13.4%). Twenty patients (12.2%) were suitable for double-fenestrated C-PMEG, and 34 patients (20.7%) for single-fenestrated C-PMEG, totaling 32.9% of the entire cohort. The combination of supra-aortic trunks (SAT) bypass or the use of covered stent in IA or left common carotid artery (LCCA) as adjunctive maneuvers, would extend the C-PMEGs feasibility to 69 patients (42.1%). The use of an iliac graft conduit in 3 (1.8%) patients with inadequate ileo-femoral accesses would increase the C-PMEG suitability to 72 patients (43.9%). The main reason for exclusion was excessive ascending aortic diameter in 78 patients (47.6%). CONCLUSIONS: The use of C-PMEG was shown to be theoretically feasible in a percentage of patients ranging from 32.9 to 43.9% affected by aortic arch aneurysms, dissections, and PAU. The main reason for exclusion was the dimension of the ascending aorta. The C-PMEG technique is a viable option in aortic arch lesions endovascular treatment. An off-the-shelf device with similar characteristics could also be used in emergency, avoiding the limitations of physician modifications (such as time for back-table procedure, sterility, off-label use). CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) has been extended to more proximal landing zones for the treatment of aortic arch aneurysm, dissections, penetrating aortic ulcers. Among total endovascular solutions, the "Canaud technique" for Physician-Modified Thoracic Endovascular Grafts (C-PMEGs) has gained acceptance with good early results. The anatomical feasibility in 164 consecutive patients was 69 patients (42.1%), with the combination of supra-aortic trunks (SAT) bypass or the use of covered stent in IA or left common carotid artery (LCCA) as adjunctive maneuvers, showing that the C-PMEG technique is a viable option in aortic arch lesions endovascular treatment.

Short-term results of fenestrated physician-modified endografts for type1a endoleak after conventional thoracic endovascular aortic repair.

Objective: This study aims to assess the feasibility and effectiveness of physician-modified fenestrated stent grafts (PMEGs) in treating type 1a endoleak after conventional thoracic endovascular aortic repair (TEVAR) in aortic arch pathologies. Methods: Patients who developed a type 1a endoleak after conventional TEVAR were included in the study. They underwent treatment with fenestrated PMEGs, which involved single or double fenestration for the supra-aortic trunks. Results: Twenty patients were treated with PMEGs between October 2018 and November 2023. Among them, 25% received single fenestrated PMEGs and 75% received double fenestrated PMEGs. The technical success rate was 100% for both types. Eighty percent of the PMEGs had a landing zone in zone 0, whereas 20% had a landing zone in zone 2. There were no in-hospital deaths. After 30 days, 1 patient died as the result of an aortic-related cause (retrograde dissection). The mean follow-up time was 16.5 months (range, 0-60 months). No major adverse events such as stroke or spinal ischemia were reported. No type 1 or type 3 endoleaks were observed, and one type 2 endoleaks required peripheral endovascular reintervention. Conclusions: The treatment of type 1a endoleaks using fenestrated PMEGs after conventional TEVAR for aortic arch pathologies is a viable option. It is associated with acceptable rates of early and midterm major morbidity and mortality.

Total aortic arch repair with double-fenestrated physician-modified endografts, at least 3-year follow-up.

OBJECTIVE: This study aims to report the efficacy and safety of double-fenestrated physician-modified endovascular grafts (PMEGs) for total aortic arch repair with at least 3 years of follow-up. METHODS: All consecutive patients with a pathological aortic arch who underwent aortic arch repair combined with a homemade double-fenestrated stent graft from 2017 to 2020 were reviewed. RESULTS: 74 patients were treated for pathological arch conditions with a double-fenestrated PMEG. Of these, 81% were male, the mean age was 69.9 years, and 59% were classified as American Society of Anesthesiology 3 or 4. Thirty-five percent were treated for a postdissection aneurysm, 36% for a degenerative aneurysm, and 14% for acute type B dissection. Fifteen percent had supra-aortic trunk dissection. Fenestration on the subclavian artery was performed in 96%; if not, a carotid-subclavian bypass was carried out. Technical success was 100%. The proximal landing zone is consistently in zone 0. Early outcomes revealed a 3% occurrence of type 1 endoleak, which was successfully treated by prompt reintervention. One retrograde dissection occurred, and one patient died from hemorrhage on an iliac conduit. A 5% stroke rate was reported. During long-term follow-up (mean time 40.7 months), one type 1 endoleak appeared and was successfully treated; no type 2 or type 3 endoleak requiring intervention occurred. No stent fractures or migrations were reported. Four percent of patients required reintervention, but no surgical conversion to open surgical repair was needed on the aortic arch. No patient died from a cause related to the main procedure. CONCLUSIONS: Total aortic arch repair with double-fenestrated PMEGs is associated with acceptable early and midterm major morbidity and mortality. It is suitable for the main aortic pathologies. Moreover, it is easily available for emergency situations.

Zone 2 Aortic Arch Repair With Single-Fenestrated Physician-Modified Endografts, at Least 3 Years of Follow-up.

OBJECTIVE: The aim of this study is to report the efficiency and safety of single-fenestrated physician-modified endografts (PMEGs) in zone 2 aortic arch pathologies with at least 3 years of follow-up. METHODS: All consecutive patients with a pathological aortic arch who underwent aortic repair combined with homemade single-fenestrated stent-graft from 2015 to 2020 were reviewed. The patients with a target vessel different from the left subclavian artery (LSA) were excluded. RESULTS: A total of 63 patients were treated for a pathological arch in zone 2 with a single-fenestrated PMEG. 73% were male, and the mean age was 65 years old. 25% were treated for a degenerative aneurysm, 19% for a post dissection aneurysm and 24% for an acute type B dissection. 52% of the patients were treated as an emergency and half of those for an aortic rupture. The LSA fenestration was stented in 70%. During 30 days of follow-up, 2 strokes (3%) were reported, 6 patients (10%) died with 4 of those treated for aortic rupture and 1 had a retrograde aortic dissection. During at least 3 years of follow-up (median 49 months), no reintervention was needed for endoleaks, there was no stent fracture or stent migration. No patient died from an aortic cause. Subgroup analysis comparing the endovascular treatment for various aortic pathologies did not find significant differences in death rate or comorbidity including stroke. When comparing emergent and elective aortic repair, operating time was similar (64 vs 65 minutes), and the LSA fenestration was less frequently stented (52%) in the emergency group. There was no difference in stroke frequency. There was a higher rate of death in the emergency group at 30 days of follow-up, but no patient died from aortic cause in the long-term follow-up. CONCLUSIONS: Aortic arch repair with single-fenestrated PMEGs for zone 2 pathological arch disease is associated with acceptable early and midterm major morbidity and mortality. It is suitable for emergency situations. CLINICAL IMPACT: Single-fenestrated PMEG for the left subclavian artery is a safe and efficient option in the short and medium term for the treatment of the aortic arch in zone 2 with 98% technical success. It allows for aortic repair and subclavian artery revascularization in a single step for all patients. It is suitable for a range of main pathologies, including degenerative, dissection-related, isthmus rupture, and embolic pathologies. Additionally, it is always available and easily utilized in emergency cases.

Urgent Juxtarenal Aortic Aneurysm Repair With Modified Off-the-shelf Endograft to Preserve Intercostal Arteries and Branch Incorporation by Transfemoral Access.

PURPOSE: To demonstrate the feasibility of the modification to preserve intercostal arteries of the t-Branch Endograft (Cook Medical, Bloomington, IN) in an urgent setting, associated with a less invasive approach for branch incorporation from percutaneous femoral access with steerable sheaths. TECHNIQUE: A 73-year-old female patient presented at our institution with intense abdominal pain. Angiotomography showed a 50-mm juxtarenal aortic aneurysm, with no signs of rupture. Urgent endovascular repair was indicated due to abdominal symptom with an off-the-shelf multi-branched endograft. To limit descending thoracic aortic coverage, we performed t-Branch modification to preserve intercostal arteries and minimize the risk of spinal cord injury, associated with a percutaneous transfemoral approach and branch incorporation with steerable sheaths to avoid the risks associated with a superior axillary or brachial access. Control angiotomography showed adequate aneurysm sac exclusion with patency of all four visceral vessels. CONCLUSION: t-Branch-modified endograft to limit aortic coverage is an alternative option in urgent cases to diminish the risk of spinal cord injury, and association of steerable sheaths with branch incorporation is leading complex aortic repairs to an even less invasive procedure. CLINICAL IMPACT: This paper highlights the possibility of performing complex endovascular aortic repair in an urgent setting with modification of an off-the-shelf multi branched endograft limiting intercostal arteries coverage, thereby diminishing the risk of spinal cord ischemia. This technical innovation provides an alternative for clinicians when treating large, rapidly expanding, or symptomatic juxtarenal, pararenal, paravisceral or type 4 thoracoabdominal aortic aneurysms that could not wait for a custom-made device and do not need extensive thoracic aortic coverage that an off-the-shelf device provides. In summary, expand the possibilities of an endovascular repair of complex aortic aneurysms.

Fenestrated Physician-Modified Endovascular Grafts for Aberrant Right Subclavian Artery and/or Kommerell's diverticulum.

OBJECTIVE: The aim of this case series is to report feasibility, efficiency, and safety of fenestrated physician-modified endografts (PMEGs) in aortic arch pathologies with aberrant right subclavian artery (ARSA) and/or Kommerell's diverticulum (KD). METHODS: All consecutive patients with ARSA and/or KD who underwent hybrid aortic arch repair combined with homemade fenestrated stent-graft from 2018 to 2022 were reviewed. RESULTS: Six patients with ARSA and/or KD underwent hybrid surgery for aortic repair, 4 of whom were men, with a mean age of 49 years. Furthermore, 2 of them were symptomatic with dysphagia, 1 was taken in emergency, 1 had a bovine arch and a KD, and 2 had right descending thoracic aortas. The mean operation time was 138 (111-216) minutes. In addition, 83% of the homemade grafts were double fenestrated. All the proximal landings were in zone 0; the mean proximal aortic diameter was 29 (23-34) mm. The range of diameters for the endografts were 24 to 38 mm. There was a 100% technical success, with 0% 30 days mortality, no stroke, and no endoleak. During the follow-up, no aortic-related death or secondary intervention was required and all supra-aortic vessels remain patent. CONCLUSION: Hybrid aortic arch repair, with fenestrated PMEGs for ARSA and/or KD, is associated with acceptable early and midterm major morbidity and mortality. CLINICAL IMPACT: This retrospective case series analyzed outcomes in 6 patients with an aberrant right subclavian artery and/or Kommerell's diverticulum treated with fenestrated PMEGs during an average 16 month follow-up. The case series suggests that the use of these fenestrated PMEGs for the management of patients with an aberrant right subclavian artery is a safe, effective and durable method in the medium-term.

Systematic Review and Meta-Analysis of Ex-Situ and In-Situ Fenestrated Stent-Grafts for Endovascular Repair of Aortic Arch Pathologies.

PURPOSE: To gain insight into safety and efficacy of in situ and ex-situ fenestration techniques for total endovascular arch repair. The term ex-situ fenestration is referring to physician-modified stent-graft technique where fenestration is performed on a back table. METHODS: Electronic search was conducted according to PRISMA (Preferred Reporting Items for Systematic review and Meta-analyses) guidelines from 2000 to 2020. The main outcomes measured were 30-day mortality, stroke, aortic-related mortality, and reintervention rates. RESULTS: Fifteen studies were eligible: 7 ex-situ fenestration (189 patients) and 8 in-situ fenestration (149 patients). In ex-situ group, dissection was the main pathology treated and proximal sealing zones were Z0 or 1 in 53.5% of patients. In in-situ group, dissection and aneurysm were equally represented in around 40% of cases and proximal sealing zones were Z0 or 1 in 46.5% of patients. Cumulative 30-day all-cause mortality was similar in both groups: 3.8% (95% confidence interval [CI]: 1.7%-8.2%) and 3.8% (95% CI: 1.6%-8.9%), respectively, in ex-situ and in-situ groups and stroke rate of 2.8% (95% CI: 1.1%-7%) and 5.3% (95% CI: 2.6%-10.5%). After a 11.1 ± 2.6 months mean follow-up for ex-situ and 16.7 ± 2.3 months for in-situ group, there were 5.2 and 1.4 reinterventions per 100 patients-years, respectively, for ex-situ and in situ groups. Aortic-related mortality rates of, respectively, 3.2% (95% CI: 1.3%-7.4%) and 2.6% (95% CI: 0.9%-7.3%) were noted in ex-situ and in situ groups. CONCLUSION: The reported data show favorable short-term results of both ex-situ and in-situ fenestration techniques with low mortality and strokes rates. However, durability is still questionable given the lack of long-term data. Both options may have their place in arch repair beyond the spectrum of emergent and urgent cases, on condition that results stand the test of time. CLINICAL IMPACT: In situ and ex-situ fenestration techniques have been initially developed to overcome emergency or as a bail out techniques however giving the promessing favorable short term results indications of these techniques may be extended to elective patients ineligible to customized stent-grafts and possibly in the futur to more elective cases as an option for total endovascular arch repair.

Three-Dimensional Printing to Guide Fenestrated/Branched TEVAR in Triple Aortic Arch Branch Reconstruction With a Curative Effect Analysis.

PURPOSE: To summarize experience with and the efficacy of fenestrated/branched thoracic endovascular repair (F/B-TEVAR) using physician-modified stent-grafts (PMSGs) under 3D printing guidance in triple aortic arch branch reconstruction. MATERIALS AND METHODS: From February 2018 to April 2022, 14 cases of aortic arch aneurysms and 30 cases of aortic arch dissection (22 acute aortic arch dissection and 8 long-term aortic arch dissection)were treated by F/B-TEVAR in our department, including 34 males and 10 females, with an average age of 59.84 ± 11.72 years. Three aortic arch branches were affected in all patients. A 3D-printed model was made according to computed tomography angiography images and used to guide the fabrication of PMSGs. All patients were followed up. RESULTS: A total of 132 branches were successfully reconstructed with no case of conversion to open surgery. The average operation time was 4.97 ± 1.40 hours, including a mean 44.05 ± 7.72 minutes for stent-graft customization, the mean postoperative hospitalization duration was 9.91 ± 4.47 days, the average intraoperative blood loss was 480.91 mL (100-2810 mL), and the mean postoperative intensive care unit monitoring duration was 1.02 days (0-5 days). No deaths occurred within 30 days of surgery. Postoperative neurological complications occurred in 1 case (2.3%), and retrograde type A dissection occurred in 1 case (2.3%). CONCLUSION: Compared with conventional surgery, triple aortic arch branch reconstruction under the guidance of 3D printing is a minimally invasive treatment method with the advantages of accurate positioning, rapid postoperative recovery, few complications, and reliable short- to mid-term effects. CLINICAL IMPACT: At present the PMSG usually depend on imaging data and software calculation. With the guidance of 3D printing technology, image data could be transformed into 3D model, which has improved the accuracy of the positioning of the fenestrations. The diameter reduction technique and the internal mini cuff technique have made a complement to the slimed-down fenestration selection process and the low rate of endoleak. As reproducible study, our results may provide reference for TEVAR in different cases.

Enlarging Paravisceral Aortic Aneurysm Treated With In Situ Laser Fenestration of Physician-Modified Stent Graft for Preservation of Accessory Renal Arteries.

PURPOSE: In situ laser fenestration (LISF) was performed as a bailout procedure to ensure renal perfusion during complex aortic aneurysm repair. CASE REPORT: A 69 year-old male patient with previous repair of abdominal aortic aneurysm who presented with increasing lower back pain and an enlarging, 6-cm, perivisceral aortic aneurysm that required urgent repair. Given potential complications and risks of redo open repair, we performed endovascular repair via deployment of a 5-vessel fenestrated physician modified stent graft (PMEG) with stent placement to the celiac, superior mesenteric, right renal, and 2 of the larger 3 left renal arteries. The renal artery planned for sacrifice was found intraoperatively to be perfusing a large portion of the kidney. Subsequently, LISF was used to cannulate and salvage perfusion to the third renal artery. Completion aortogram demonstrated patency of all renal visceral vessels with no vessel leak. Follow-up CT angiogram 1 year later demonstrated aortic graft with all visceral stents patent, no endoleak, and a reduction in residual aneurysm sac. CONCLUSION: Even with careful planning and design of a physician modified stent graft, in situ laser fenestration provides an option to successfully create additional stents intraoperatively in order to preserve perfusion to critical visceral organs. CLINICAL IMPACT: In situ laser fenestration will provide surgeons with a valuable intra-operative method to create additional stents when organ perfusion would otherwise be lost. As more surgeons develop this technical ability and more long-term outcomes are studied, this method has the possibility to not only be used for urgent and emergent cases but may one day be an acceptable variation to standard practice.

Physician-Modified Stent-Grafts Created in the Three-Dimensionally Aortic Template Have Better Reliability and Greater Alignment With the Target Vessels Than Stent-Grafts Modified Based on Measurements From Computed Tomography.

PURPOSE: Physician-modified stent-grafts (PMSG) are widely used, especially when a patient's condition precludes waiting for a custom-made device. In recent years, the modification process has been upgraded using 3-dimensional (3D) aortic templates. Nonetheless, the reliability of PMSG and accuracy of fenestration alignment with the target vessel are not known. Thus, the study is aimed to fulfill the gap in current knowledge. MATERIALS AND METHODS: Ten computed tomographic (CT) scans of aortic aneurysm previously treated with the fenestrated endovascular repair were selected to 3D-print aortic templates and elastic vessel phantoms. Two vascular surgeons performed fenestrations using the 3D template and modification plan based on CT measurements. Two operators each performed 10 fenestrated stent-grafts in the aortic template and 10 using CT measurements, for a total of 40 fenestrated stent-grafts. Then, stent-grafts were implanted in elastic vessel phantoms, which served to evaluate fenestration alignment with the target vessel. The alignment was judged in a 5-point scale: 0%, 1% to 25%, 26% to 50%, 51% to 75%, and 76% to 100%. The distances between fenestrations served to calculate interobserver variability for both methods. The measurements were processed as interclass correlation coefficient (ICC), Pearson and Spearman correlation, and Bland-Altman plots. RESULTS: PMSG created with a 3D template had higher interclass correlation coefficient values and Pearson/Spearman correlation than fenestrations created from CT measurements. The rate of fenestration alignment with the target vessel was higher for PMSG created with a 3D template (p=0.007). CONCLUSIONS: PMSGs created with a 3D template are more reliable and have better fenestration alignment with the target vessel than PMSGs created based on CT measurements.

Double Fenestrated Physician-Modified Stent Graft for Endovascular Treatment of Traumatic Aortic Isthmus Rupture With an Aberrant Right Subclavian Artery.

PURPOSE: The purpose of the study was to demonstrate the feasibility of urgent endovascular treatment of a traumatic aortic isthmus rupture in a patient with an aberrant right subclavian artery. CASE REPORT: A 23-year-old man was admitted to a regional trauma center after a motor vehicle collision and found to have cerebral trauma and a large pseudoaneurysm of the aortic arch. Trauma computed tomography (CT) identified a blunt traumatic thoracic aortic injury with an aortic false aneurysm in the context of an aberrant right subclavian artery. A hybrid repair was performed with bilateral subclavian carotid bypasses and a double fenestrated physician-modified stent graft. The patient had an uneventful postoperative course. Postoperative CT scan showed sealing of the aortic arch rupture and patency of all the supra-aortic trunks. CONCLUSION: Endovascular repair of blunt traumatic thoracic aortic injury is considered first-line therapy. Aortic arch anomalies add complexity to treatment. This report demonstrates that a hybrid strategy with bilateral carotid-axillary bypasses and homemade double fenestrated endograft of the aortic arch is a valuable approach for this challenging emergency in the context of an aberrant right subclavian artery.

Mechanical Performance Assessment of Physician Modified Aortic Stent Graft.

OBJECTIVE: This study aimed to compare various fenestration configurations of physician modified aortic stent grafts in order to identify which design parameters have a significant influence on the mechanical behaviour of the fenestration. METHODS: the fenestration configurations were considered according to different manufacturing parameters: cutting technique, fenestration reinforcement, suture material, reinforcement loop design, and number of suture points. The performance of the graft/bridging stent assembly was assessed at various levels: (1) branch pull out force; (2) fenestration enlargement and rupture strength; (3) balloon angioplasty resistance; and (4) behaviour under cyclic fatigue. RESULTS: Sixty manual fenestrations were created. The tests performed on the fenestrations had several main findings. First, reinforcement increased the radial force on the branch, which increased the pull out force; this may limit migration of the bridging stent in vivo. The phenomenon was amplified with a snare reinforced fenestration, which seemed to be the most efficient. Moreover, increasing the number of suture passes also appeared to increase the branch extraction force securing the assembly. The enlargement tests showed that non-reinforced fenestrations had the weakest radial strength. This was confirmed with the balloon angioplasty test, which showed that these latter specimens undergo the most significant textile degradation. After fatigue tests, all fenestrations were larger, showing that elastic recoil was incomplete in all samples. The largest recoil was observed in the non-reinforced ophthalmological cautery (OC) fenestrations (40%). Regarding the behaviour of the samples up to rupture, all samples behaved in a similar way; however, the double loop fenestration strength level was the highest. CONCLUSION: This study demonstrated that the snare double loop reinforcement has an advantage regarding durability of the graft branch assembly. Moreover, non-reinforced fenestrations show signs of weakness and lack of stability, which questions the in situ or laser fenestration procedures.

Total Arch Thoracic Endovascular Aortic Repair Using Double Fenestrated Physician-Modified Stent-Grafts: 100 Patients.

OBJECTIVE: The aim was to evaluate early and medium-term outcomes of double fenestrated physician-modified endovascular grafts for total endovascular aortic arch repair. METHODS: This single-center retrospective analysis of prospectively-collected data included 100 patients, from January 2017 to December 2021, undergoing thoracic endovascular aortic repair (TEVAR) for zone 0. The fenestrations were a proximal larger fenestration that incorporated the brach2iocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. RESULTS: The median duration for stent-graft modification was 23±6 minutes. Of the 100 patients, 70 were men. The mean patient age was 70±10.5 years. Indications for treatment included degenerative aortic arch aneurysm (n=32), dissecting aortic arch aneurysm after type A dissections (n=23) and (n=19) after type B dissections, acute complicated type B dissection (n=16), and other pathologies (n=10). Technical success rate was 97%. The 30 day mortality was 2% (n=2). Four patients (4%) had minor stroke with full recovery. One patient (1%) had a type IA endoleak, 1 patient (1%) had a type IB endoleak, and 2 patients (2%) have a type II endoleak from the LSA. Eight patients (8%) required reintervention: 1 type IA endoleak, 1 type IB endoleak, 1 retrograde type A dissection, and 5 because of access-related complications. During a mean follow-up of 24±7.2 months, there were no aortic rupture, paraplegia, and all supra-aortic trunks were patent. CONCLUSIONS: Double homemade fenestrated TEVAR is both feasible and effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The long-term durability will need to be assessed in studies with long-term follow-up. CLINICAL IMPACT: Double homemade fenestrated TEVAR is effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The standout feature of this double fenestrated device is its simple handling during operation with the proximal fenestrations being directed to the orifices of the BT and LCCA automatically when the LSA fenestration is catheterized and secured by covered stent placement. The deployment algorithm actively steers the operator away from superfluous manipulations of the device within the arch and avoids guidewire manipulation in carotid arteries. The long-term durability will need to be assessed in studies with long-term follow-up.

Mid-term Outcomes of Physician-Modified Fenestrated or Branched Endovascular Repair for Post-dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: To report the early experience and mid-term outcomes of physician-modified fenestrated or branched endovascular repair (PM-F/BEVAR) for patients with post-dissection thoracoabdominal aortic aneurysm (PD-TAAA). METHODS: PD-TAAA patients treated with PM-F/BEVAR between December 2014 and September 2020 in our institution were retrospectively analyzed. RESULTS: Out of the 39 patients, technical success defined as successful deployment of all stent grafts with patent target vessels (TVs) and exclusion of the lesion without type I or III endoleak was achieved in 35 patients (89.7%). A total of 126 TVs were successfully reconstructed. Thirty-day mortality was 0%. Seven major adverse events occurred including one acute kidney injury, four renal infarctions, one retroperitoneal hematoma and one left renal artery occlusion. Seven type II endoleak and three type III endoleak were detected. During a mean 29.4 ± 15.5 months follow-up period, the mortality was zero. Three renal arteries and one external iliac artery occluded in four patients. No other new onset major adverse event occurred. No patient required reintervention. One type II endoleak spontaneously resolved, while the remaining six remained stable. One early type III endoleak diminished, and one new type III endoleak occurred at 2 months. The primary patency of TV was 96.8% (120/124). Shrinkage or stability of aneurysm diameter can be observed in 38 patients (97.4%). The false lumen thrombosis rate was 89.7% (35/39). CONCLUSIONS: The present study showed encouraging results of PM-F/BEVAR for treatment of PD-TAAAs. LEVEL OF EVIDENCE: Level 4, Case Series.

Homemade fenestrated physician-modified stent grafts for arch aortic degenerative aneurysms.

OBJECTIVE: We evaluated the early- and medium-term outcomes of single- and double-fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular degenerative aortic arch aneurysm repair. METHODS: We performed a single-center, retrospective analysis of prospectively collected data from 52 patients from August 2013 through January 2021 who had undergone homemade fenestrated thoracic endovascular aortic repair for degenerative aortic aneurysms. In all cases, a distal smaller fenestration for the left subclavian artery (LSA) was fashioned and was the only one stented. For a double-fenestrated endograft, a proximal larger fenestration that incorporated both the brachiocephalic trunk and the left common carotid artery was added. RESULTS: A total of 52 patients with degenerative aortic arch aneurysms were treated. Of the 52 patients, 36 were men, the mean age was 75 ± 8 years, 31% had received a single LSA fenestration, and 69% had undergone double-fenestrated thoracic endovascular aortic repair. Of the 52 procedures, 5 (10%) were emergent procedures. The technical success was 100%. The median time required for stent graft modification was 22 ± 6 minutes. The 30-day mortality was 2% (n = 1). Five patients (10%) had experienced a cerebrovascular event, including two transient ischemic attacks, one minor stroke with full neurologic recovery, and two with sequelae. Two patients (4%) had experienced perioperative retrograde dissection during follow-up. No patient had developed a type I, II, or III endoleak from the LSA. No patient had required reintervention. All supra-aortic trunks were patent. During a mean follow-up of 18 ± 11 months, no patient had required conversion to open surgical repair, aortic rupture, or paraplegia. CONCLUSIONS: Single or double PMEG is a safe and suitable tool for the treatment of high morbidity pathology such as aortic arch degenerative aneurysm repair. In addition, this device can be used in patients requiring elective or emergency repair.

Initial Experience with Fenestrated Physician-Modified Stent Grafts Using 3D Aortic Templates.

The goal of this study was to describe the surgical results of physician-modified endografts (PMEG) utilizing a 3D aortic template in a center with no prior experience in complex endovascular aortic repairs. Forty-three patients underwent physician-modified graft stent implantation using a 3D aortic model. The inclusion criteria were juxtarenal and suprarenal aortic aneurysms, type IV thoracoabdominal aneurysms, and type IA endoleak after endovascular aortic repair. In asymptomatic patients, the diameter threshold for aneurysm repair was 5.5 cm in males and 5.0 cm in females. 3D aortic templates were prepared from the patient's computed tomography angiography scans and sterilized before use in the operating suite. Forty-three stent grafts were modified with the use of a 3D printing template. A total of 162 reinforced fenestrations (37 celiac, 43 right renal, 39 left renal, 43 superior mesenteric) with a mean of 3.8 per patient were performed. All PMEGs had a posterior reducing-diameter tie and a preloaded guidewire. The mean modification time was 86 ± 12 min. The mean follow-up was 14 ± 12 months. The 30-day mortality was 12%. During the follow-up period, the patency rate was 95% per the superior mesenteric artery, 93% per right renal artery, 95% per left renal artery, and 89% per celiac trunk. Twelve (28%) patients had endoleak, of which type I or III was present in 5 (12%) patients, and type II in 7 (16%). 3D printing can be successfully integrated into the physician's everyday practice of stent graft modification. However, the use of this approach in centers without experience performing complex aortic procedures results in worse surgical metrics than those previously reported.

Effects of Sterilization Methods on Different 3D Printable Materials for Templates of Physician-Modified Aortic Stent Grafts Used in Vascular Surgery-A Preliminary Study.

Three-dimensionally-printed aortic templates are increasingly being used to aid in the modification of stent grafts in the treatment of urgent, complex aortic disorders, often of an emergency nature. The direct contact between the aortic template and the stent graft implies the necessity of complete sterility. Currently, the efficacy of sterilizing aortic templates and the effect of sterilization on the geometry of tubular aortic models are unknown. A complex case of aortic arch dissection was selected to prepare a 3D-printed aortic arch template, which was then manufactured in six popular printing materials: polylactic acid (PLA), nylon, polypropylene (PP), polyethylene terephthalate glycol (PETG), and a rigid and flexible photopolymer resin using fused deposition modeling (FDM) and stereolithography (SLA). The 3D models were contaminated with Geobacillus stearothermophilus broth and Bacillus atrophaeus. The sterilization was performed using three different methods: heat (105 °C and 121 °C), hydrogen peroxide plasma, and ethylene oxide gas. Before and after sterilization, the aortic templates were scanned using computed tomography to detect any changes in their morphology by comparing the dimensions. All sterilization methods were effective in the elimination of microorganisms. Steam sterilization in an autoclave at 121 °C caused significant deformation of the aortic templates made of PLA, PETG, and PP. The other materials had stable geometries, and changes during mesh comparisons were found to be submillimeter. Similarly, plasma, gas, and heat at 105 °C did not change the shapes of aortic templates observed macroscopically and using mesh analysis. All mean geometry differences were smaller than 0.5 mm. All sterilization protocols tested in our study were equally effective in destroying microorganisms; however, differences occurred in the ability to induce 3D object deformation. Sterilization at high temperatures deformed aortic templates composed of PLA, PETG, and PP. This method was suitable for nylon, flexible, and rigid resin-based models. Importantly, plasma and gas sterilization were appropriate for all tested printing materials, including PLA, PETG, PP, nylon, flexible and rigid resins. Moreover, sterilization of all the printed models using our novel protocol for steam autoclaving at 105 °C was also 100% effective, which could represent a significant advantage for health centers, which can therefore use one of the most popular and cheap methods of medical equipment disinfection for the sterilization of 3D models as well.

Early and Mid-Term Durability of Surgeon-Modified and Custom-Made Fenestrated Devices for the Treatment of Complex Aortic Pathology.

BACKGROUND: Fenestrated endovascular aneurysm repair (F-EVAR) has allowed successful treatment of patients with complex aortic aneurysms. Custom-made devices (CMDs) are manufactured by companies and tailored to the patient's anatomy to incorporate target vessels, while there is also the "off label" alternative with the devices modified by a surgeon in the operating room: surgeon-modified FEVAR (sm-FEVAR). This study aims to present and compare technical durability of CMDs- and sm-FEVAR for complex abdominal and thoracoabdominal aortic pathologies. METHODS: A retrospective cohort study was undertaken including all consecutive patients treated with sm- or CMD-FEVAR during a 3-year period in a single center. Only cases with at least 3 reno-visceral target vessels were included. Primary outcomes were technical success, and freedom from endoleak (EL) (Ia or III; all branch related) and re-intervention during follow-up period. Mortality and morbidity were also recorded. RESULTS: Thirty-two sm-FEVAR patients (81,3% male) and 79 CMD-FEVAR patients (77,2% male) were included. Indication for sm-FEVAR was exclusively urgent, while all CMD- FEVAR were elective. Technical success was similar in sm-FEVAR (100%) and CMD-FEVAR (98,7%) (P = 0.523). Mean follow-up was 16.3 ± 13 and 20 ± 17.3 months for sm-FEVAR and CMD- FEVAR, respectively (P = 0.28). The freedom from EL Ia rate was 91.7% [standard error (SE) 5.7%] at 12 months in sm-FEVAR, while it was 97.7% (SE 2.2%) and 92.3% (SE 4.3%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.69). The freedom from EL III rate was 95.5% (SE 4.4%) and 88% (SE 8.2%) at 12 and 24 months, respectively in sm-FEVAR, while it was 92.1% (SE 3.8%) and 89.2% (SE 4.7%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.68). The freedom from re-intervention rate was 91.6% (SE 5.7%) and 84.6% (SE 8.6%) at 12 and 24 months, respectively in sm-FEVAR, while it was 91.7% (SE 4%) and 83.4% (SE 5.9%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.90). The survival rate was 87.5% (5.8%) and 76.3% (7.9%) at 1 and 12 months, respectively in sm-FEVAR, while it was 93.7% (2.7%) at 1 month in CMD-FEVAR without any other death during FU period. No bridging stent occlusions were noted during follow-up period in any patient. CONCLUSION: Sm-FEVAR offers good technical success and mid-term clinical outcomes in urgent cases of complex aortic pathologies. Its durability is acceptable and comparable to CMD-FEVAR with a relatively low re-intervention rate.