A Retrospective Analysis of 10-year Experience on Branched and Fenestrated Endovascular Aortic Arch Repair.

OBJECTIVE: This study aimed to present the early and mid-term outcomes of fenestrated/branched thoracic endovascular aortic repair (f/bTEVAR) for aortic arch pathologies. BACKGROUND: f/bTEVAR represents a less invasive treatment option for aortic arch diseases. Previous published series showed decreased early mortality and morbidity compared to open repair. METHODS: A single-center retrospective analysis of consecutive patients, managed with f/bTEVAR (Cook Medical, Bloomington, IN, USA) between 01.09.11and 30.06.22 was conducted. Primary outcomes were technical success, 30-day mortality and stroke. Data during follow-up and factors affecting early mortality and stroke were analyzed. RESULTS: 209 patients were included (38.3% females; mean age 69.8±3.4years; mean aortic diameter 61±4.7 mm); 14.4% were managed urgently. Fenestrations/scallop configuration was used in 39.7%, branched devices in 55.5% and branch/scallop combination in 4.8%. Landing to zone 0 was performed in 65.5% and in zone 1 in 32.1%. Non-native aortas were used for landing in 39.2%. Technical success was 97.1% and 30-day mortality 9.5%. Strokes were identified in 10%; 5.7% major. Non-native proximal aortic landing zone was an independent protective factor for stroke (P=0.002). Post-operative stroke (P<0.001) and pericardial effusion (P<0.001) were independently related to 30-day mortality. The mean follow-up was 21±8 months. The estimated survival and freedom from reintervention rates were 79.5% (standard error; SE3.1%) and 47.1% (SE 4.3%) at 24months, respectively. CONCLUSIONS: f/bTEVAR presented high technical success and acceptable 30-day mortality. Non-native proximal landing zone was related to lower stroke rate. Half of patients needed a reintervention within the 24-month follow-up.

Early and midterm outcomes of fenestrated and branched endovascular aortic repair in thoracoabdominal aneurysms types I through III.

BACKGROUND: Fenestrated and branched endovascular aortic repair (F/BEVAR) of thoracoabdominal aortic aneurysms (TAAAs) has shown high technical success and low early mortality rates. Aneurysm extent has been reported as a factor affecting outcomes. This study aimed to assess the early and midterm follow-up outcomes of patients managed by F/BEVAR for types I through III TAAAs. METHODS: A single-center retrospective analysis was conducted, including data from consecutive, elective and urgent (symptomatic and ruptured cases), patients treated for types I through III TAAAs, between October 1, 2011, and October 1, 2022, using F/BEVAR. Degenerative and postdissection TAAAs were included. Patients received prophylactic cerebrospinal fluid drainage (CSFD), except those under therapeutic anticoagulation, those who were hemodynamically unstable, or those with failed CSFD application. When an initial thoracic endovascular aortic repair was performed, as part of a staged procedure, no CSFD was used. Later stages and nonstaged procedures were performed under CSFD. Thirty-day mortality and major adverse events (MAEs) were analyzed. Kaplan-Meier estimates were used for follow-up outcomes. RESULTS: F/BEVAR for types I through III TAAAs was performed in 209 patients (56.9% males; mean age, 69.6 ± 3.2 years; mean aneurysm diameter, 65.2 ± 6.2 mm); 29.2% type I, 57.9% type II, and 12.9% type III. Urgent repair was performed in 26.7% of patients (56 cases; 23 ruptured and 33 symptomatic cases) and 153 were treated electively. Thirty-two patients (15.3%) were classified as American Society of Anesthesiologists (ASA) class IV. CSFD was used in 91% and staged thoracic endovascular aortic repair was performed in 51.2% of patients. Technical success was 93.8% (96.7% in elective vs 94.6% in urgent cases; P = .92). Thirty-day mortality was 11.0% (4.6% in elective vs 28.5% in urgent cases; P < .001) and MAEs were recorded in 17.2% of cases (7.8% in elective vs 42.8% in urgent cases; P < .001). Spinal cord ischemia rate was 20.5% (17.6% in elective vs 28.7% in urgent cases; P = .08), whereas 2.9% of patients presented paraplegia (1.3% in elective and 7.1% in urgent cases; P = .03). The mean follow-up was 16 ± 5 months. Survival was 75.0% (standard error, 4.0%) and freedom from reintervention was 73.3% (standard error, 4.4%) at 36 months. ASA IV and urgent repair were detected as independent factors related to early mortality and MAE, whereas ruptured aneurysm status was related to spinal cord ischemia evolution. CONCLUSIONS: Endovascular repair for types I through III TAAAs provides encouraging early outcomes in terms of mortality, MAE, and paraplegia, especially in an elective setting. Setting of repair and baseline ASA score should be taken into consideration during decision-making.

Branched and fenestrated endovascular aortic arch repair in patients with native proximal aortic landing zone.

OBJECTIVE: Fenestrated and branched thoracic endovascular repair (f/bTEVAR) have been successfully applied in patients with diverse aortic arch pathologies. The aim of this study is to present the early and mid-term outcomes of patients with native proximal aortic landing (NPAL) managed with f/bTEVAR. METHODS: A single-center retrospective analysis of patients with NPAL, managed with f/bTEVAR, between September 1, 2011, and June 30, 2022, was conducted. All patients were treated with custom-made devices (Cook Medical) with landing within Ishimaru zones 0 to 2. Primary outcomes were technical success, mortality, stroke, and retrograde type A dissection at 30 days. Follow-up outcomes were considered secondary. RESULTS: A total of 126 patients were included (69.8% males; mean age, 70.8 ± 4.2 years; 18.3% urgent). The main indications (60.4%) for repair were aortic arch (29.4%) and thoracoabdominal aortic aneurysms (31.0%). Seventy-two patients (57.1%) were managed with fTEVAR. Proximal landing in zone 0 and 1 was chosen in 97.6%. Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases. Retrograde type A dissection rate was 3.9%. The multivariate analysis confirmed landing in Ishimaru zone 0 as an independently related factor for stroke (P = .005), whereas stroke (P < .001), pericardial effusion (P < .001), and acute kidney injury (P < .001) were independently related to 30-day mortality. Mean follow-up was 17.5 ± 9.3 months. The estimated survival rate and the freedom from reintervention rate were 72.6% (standard error, 4.4%) and 46.4% (standard error, 6.0%) at 24-month follow-up, respectively. CONCLUSIONS: Stroke rate after endovascular arch repair was alarming among patients with NPAL. Proximal landing to zone 0 was related to higher risk of stroke. Reinterventions were common within the 24-month follow-up.

Target Vessel-Related Outcomes in Patients Managed With Branch Thoracic Aortic Endovascular Repair.

INTRODUCTION: Data on target vessel (TV)-related outcomes in patients managed with branched thoracic endovascular aortic repair (BTEVAR) are limited. This study aimed to present the TV-related outcomes of BTEVAR in patients managed for aortic arch pathologies at 30 days and during follow-up. METHODS: A retrospective analysis of consecutive patients, managed between September 1, 2011, and June 30, 2022, with custom-made aortic arch endografts (Cook Medical, Bloomington, IN, USA), presenting at least one branch configuration, were eligible. Primary outcomes were technical success, TV-related patency, and reinterventions at 30 days. RESULTS: In total, 255 TVs were revascularized using branches: 107 innominate arteries (IAs), 108 left common carotid arteries (LCCAs), and 40 left subclavian arteries (LSAs). Covered stents were used as bridging stents of which 10.2% were balloon expandable. Relining, using bare-metal stents (BMS), was performed in 14.0% of IAs, 35.2% of LCCAs, and 22.5% of LSAs. Technical success on case basis was 99.2%; no failure was related to unsuccessful TV bridging. At 30 day follow-up, no TV occlusion was detected. In 5.6% of cases, a type Ic or III endoleak, attributed to TVs, was recorded. Two patients needed early branch-related reintervention. The mean follow-up was 18.3±9.2 months. Freedom from TV instability was 94.6% (standard error [SE] 2.5%] at 12 months. No TV stenosis or occlusion was detected up to 48 months of follow-up. Freedom from TV-related reinterventions was 95.4% [SE 2.4%] at 12 months. CONCLUSION: TV stenosis or occlusion in BTEVAR cases is rare and TV-related reinterventions and instability events are mainly attributed to type Ic and III endoleak formation. CLINICAL IMPACT: Previous studies focusing on target vessel (TV) outcomes after endovascular aortic arch repair are limited. In this study, including 255 TVs revascularized using branched arch devices, bridging was performed with covered stents, of which 90% were self-expanding. Relining was at the discretion of the operator and was 14% for the innominate, 35.2% for the left common carotid and 22.5% for the left subclavian artery branches. No 30-day occlusion was detected. The freedom from TV instability was almost 95% at 12 months. TV instability and reintervention were mainly attributed to endoleaks type Ic and IIIc.

The Electrified Wire Technique in Complex Aortic Interventions: A Case Series.

OBJECTIVES: Electrosurgery has been long used in endovascular procedures, with only case reports in the aortic field. Our aim is to present a case series with the use of an electrified wire to perform catheter-based electrosurgery by applying external current through an electrocautery pen. METHODS: Single-center retrospective case series of all patients undergoing complex aortic surgery from October 2020 to August 2023, in whom the electrified wire technique was used: (1) Perforation of a dissection flap or left subclavian artery (LSA) in situ endograft fenestration-a 0.014" polytetrafluoroethylene (PTFE) insulated guidewire is detached from the insulation with a scalpel at the end and a cautery pen is here attached with a clamp. A curved tip catheter or sheath is positioned against the aortic flap or the endograft (through a left brachial access in this case) and the wire pushed, crossing the flap by activating the electrocautery pen and (2) slicing a dissection flap ("powered cheese-wire technique")-after same preparation as above, the middle section of the 0.014 guidewire is removed from the PTFE and bent into a V-shape. Once in the aorta, the guidewire crosses from the true lumen (TL) to the false lumen (FL) and a through-and-through access is obtained. Sheaths are positioned against the flap from both sides and moved up or down while the electricity is activated, slicing the flap and communicating both lumens. Technical success and technical-related complications were evaluated. RESULTS: Eleven cases concerning aortic dissections and 1 case of aortic atresia were treated. Four patients presented urgently, whereas the rest were planned procedures. Seven cases underwent perforation of a dissection flap, 2 cases underwent the powered cheese-wire technique, in 2 cases for an LSA in situ fenestration, and in 1 case to cross an aortic atresia at the aortic isthmus. The technique was in all cases successfully applied. No complications related to the technique occurred. CONCLUSIONS: The "electrified wire" technique is a feasible and ready-available tool that can be safely used in complex aortic interventions, especially to perforate aortic tissue like dissection flaps or to perform in situ fenestrated repairs by perforation of the endograft fabric. CLINICAL IMPACT: The electrified wire technique described herein is a straightforward technique that uses readily available tools to perform electrosurgery. We present its use in complex aortic procedures. However, it could be envisioned for any vascular procedure that requires crossing of the vessel or even prosthetic material. As we have described in this series, when used along with an adequate properative planning, it can be a safe tool of great utility, as has already been demonstarted in the field of the interventional cardiology.

Unintended Exchange of Target Vessels for Celiac Trunk and Superior Mesenteric Artery Branches in Complex Endovascular Aortic Repair.

PURPOSE: The treatment of thoracoabdominal aortic aneurysms (TAAAs) using branched endovascular aortic repair (BEVAR) is safe and effective. During deployment, the superior mesenteric artery (SMA) branch can unintentionally open into the celiac trunk (CT) ostium and switched catheterization of the SMA from the CT branch and the CT from the SMA branch can be used as an alternative technique in these cases. This study aimed to investigate the outcome of exchanging the intended target vessels (TVs) for the CT and SMA branches during BEVAR. MATERIALS AND METHODS: A single-center retrospective analysis of patients with TAAAs who underwent BEVAR, using off-the-shelf or custom-made devices (CMDs), with an unintended exchange of TVs for the CT and SMA branches was performed. RESULTS: Between 2014 and 2023, 397 patients were treated with BEVAR for TAAA. Eighteen (4.5%) of those patients were treated with an exchange of TVs for the CT and SMA branches. T-branch was used in 9 cases (50%) and the remaining patients were treated with CMDs. Twelve patients were treated electively, 3 were symptomatic and 3 presented with rupture. Of 36 mesenteric TVs in those 18 patients, 34 (94%) were catheterized successfully, including all 18 SMAs and 16 of the 18 CTs. No branch stenosis or occlusion of the switched mesenteric TVs was detected during follow-up. During 30-day follow-up, 3 patients died and during a median follow-up of 3 (interquartile range [IQR]: 1-15) months 3 more patients died. None of the deaths or the 2 unintended reinterventions was induced by the mesenteric TV exchange. The median hospital stay was 14 (IQR: 9-22) days with a median of 4 (IQR: 2-11) days at the intensive care unit. CONCLUSION: The exchange of the mesenteric TVs for the CT and SMA branches during BEVAR with off-the-shelf and CMD endografts is feasible with good TV patency and freedom from TV-related reinterventions. This alternative technique should be considered in selected cases when direct catheterization via the intended branch is deemed more time-consuming or not feasible. CLINICAL IMPACT: This is the first description of using an exchange of target vessels for the celiac trunk and the superior mesenteric artery branches in patients with thoracoabdominal aortic aneurysms undergoing BEVAR, using off-the-shelf or custom-made devices. The high success rate as well as the good clinical results without any branch stenosis or occlusion during follow-up highlight the feasibility of this alternative technique. It could help in challenging cases when catheterization of the intended target vessels is not possible or too time consuming, resulting in higher success rates of BEVAR and better clinical results.

Post-dissection Thoraco-abdominal Aortic Aneurysm Managed by Fenestrated or Branched Endovascular Aortic Repair.

OBJECTIVE: Fenestrated or branched endovascular aortic repair (F/B-EVAR) is a valuable treatment in patients with chronic post-dissection thoraco-abdominal aneurysm (PD-TAAA). This study aimed to analyse early and follow up outcomes of F/B-EVAR in these patients. METHODS: Thirty day and follow up outcomes of consecutive patients with PD-TAAA treated with F/B-EVAR in a tertiary centre over eight years were analysed retrospectively. All patients presenting with PD-TAAA and managed with F/B-EVAR were eligible. A modified Crawford's classification system was used. Thirty day mortality and major adverse event (MAE) rates were analysed. Time to event data were estimated with Kaplan-Meier survival analysis. RESULTS: Fifty five patients (80% men, mean age 63.7 ± 7.7 years) were included: 12 (22%) were managed urgently; 25 (46%) for chronic type B aortic dissection; and the remainder for residual type A aortic dissection. Of these patients, 88% had undergone previous thoracic endovascular aortic repair. Prophylactic cerebrospinal fluid drainage (CSFD) was used in 91%. Fifteen (27%) patients were treated with F-EVAR, nine (16%) with fenestrations and branches, and 31 (56%) with B-EVAR. False lumen adjunctive procedures were used in 56%. Technical success was achieved in 96% of patients. The thirty day mortality rate was 7% and MAE rate was 20%. Spinal cord injury (SCI) grades 1 - 3 and grade 3 rates were 13% and 2%, respectively. Mean follow up was 33.0 ± 18.4 months. Survival and freedom from unscheduled re-intervention were 86% (standard error [SE] 5%) and 55% (SE 8%) at 24 months, respectively. Freedom from target vessel stenosis and occlusion was higher in F-EVAR at the 12 month follow up (p = .006) compared with B-EVAR. CONCLUSION: Fenestrated or branched endovascular repairs in patients with PD-TAAA showed high technical success, with acceptable early mortality and MAE rates. The SCI rate was > 10%, despite CSFD use and staged procedures. Almost a half of patients needed an unscheduled re-intervention within 24 months after F/B-EVAR.

Dilated Internal Iliac Artery Confers a Higher Risk of Endoleak in Iliac Branch Devices in a Single Centre Retrospective Experience.

OBJECTIVE: Iliac branch devices (IBDs) have shown good results but there is little evidence for the risk of internal iliac artery (IIA) endoleak, so there are no clear recommendations on the maximum diameter it should be. Based on limited evidence, it was hypothesised that an IIA of ≥ 11 mm in diameter presents an increased risk of type Ic endoleak. METHODS: This was a single centre, retrospective case control study. Patients undergoing an IBD with the main trunk of the IIA as the target vessel, between 2015 and 2021, were identified. Two groups were created: those with a main trunk diameter of < 11 mm; and those with a diameter of ≥ 11 mm. Technical success, freedom from type Ic endoleak, and re-intervention rates were compared. A receiver operating characteristic (ROC) curve was performed to show a cutoff IIA diameter value for risk of type Ic endoleak. Multivariate analysis was performed to assess the risk of type Ic endoleak and the presence of calcification, stenosis, and landing zone length in the IIA. RESULTS: There were 182 IBDs identified. The dilated IIA group (54 IBDs) had significantly lower technical success (91% vs. 98.4%; p = .002), lower freedom from type Ic endoleak (77% vs. 97.1% at 24 months; p = .001), and lower freedom from re-interventions (70% vs. 92.4% at 24 months; p = .002). The ROC curve showed that 10.5 mm was the cutoff diameter for type Ic endoleak. Moderate or severe calcification as well as landing zone length < 5 mm also correlated with type Ic endoleak. CONCLUSION: IBDs have a statistically significantly higher rate of technical failure, lower freedom from type Ic endoleak, and lower freedom from re-intervention when the IIA is ≥ 11 mm in diameter.

Sex Comparative Analysis of Branched and Fenestrated Endovascular Aortic Arch Repair Outcomes.

OBJECTIVE: Female sex is a risk factor for adverse events after endovascular aortic repair. Sex comparative early and midterm outcomes of fenestrated and branched endovascular aortic arch repair (F/B-Arch) are presented. METHODS: A single centre retrospective sex comparative analysis of consecutive patients managed with F/B-Arch was conducted according to STROBE. Primary outcomes were sex comparative technical success, death, and cerebrovascular morbidity at 30 days. Kaplan-Meier estimates were used for follow up outcomes. RESULTS: Among 209 patients, 38.3% were women. Coronary artery disease (p < .001) and previous myocardial infarction (p = .001) were more common in women. Non-native proximal aortic landing was higher in women (women: 51.3%; men: 31.8%, p = .005) and the aortic dissection rate was lower (28.8% vs. 48.1%, p = .005). Proximal landing to Ishimaru zones showed no difference (zone 0: p = .18; zone 1: p = .47; zone 2: p = .39). Graft configurations were equally distributed. In total, 416 supra-aortic trunks were bridged. The median number of revascularisations per patient was two (interquartile range 1, 3), with no difference between sexes (p = .54). Technical success (women: 97.5%; men: 96.9%, p = .80), 30 day mortality rate (women: 10%; men: 9.3%, p = .86), and cerebrovascular morbidity (women: 11.3%; men: 17.1%, p = .25) were similar. Women presented more access related complications (women: 32.5%; men: 16.3%, p = .006), without affecting access related re-interventions (p = .55). Survival (women: 81.1%, 95% confidence interval [CI] 76.3 - 85.9%; men: 79.8%, 95% CI 76.0 - 83.6%) and freedom from re-intervention (women: 56.6%, 95% CI 50.4 - 62.8%; men: 55.3%, 95% CI 50.1 - 60.5%) at 12 months were similar (log rank, p = .40 and p = .41, respectively). CONCLUSION: Both sexes presented similar outcomes after F/B-Arch. Appropriate patient selection may decrease the effect of sex in F/B-Arch outcomes.

Multicentre Experience with Novel Bidirectional Double Cuffed Inner Branches for Complex Endovascular Aortic Repair.

OBJECTIVE: This study aimed to report the initial experience with a novel bidirectional double cuff inner branch design for incorporation of renal and mesenteric arteries in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective review was undertaken of the experience of F/BEVAR with grafts integrating at least one bidirectional double cuffed inner branch implanted at three tertiary aortic centres between March 2022 and June 2023. All consecutive patients were included. Baseline characteristics, operative data, and follow up data were collected. Results were presented as number or median (interquartile range) unless otherwise stated. RESULTS: Thirteen patients (10 male; median age 72 [68, 77] years) had F/BEVAR using a total of 15 bidirectional double cuffed inner branches (30 cuffs). Indications for bidirectional doubled cuffed inner branches included cranial vessel orientation or double renal arteries in four patients each, common coeliomesenteric trunk in three patients, and early renal artery bifurcation, renal artery origin from a false lumen requiring a flexible route for catheterisation, and surplus configuration in one patient each. Twenty three of the 30 cuffs were used, whereas the remaining seven cuffs were intentionally occluded with vascular plugs. Target vessel incorporation was successful in all bidirectional branches. There was one technical failure related to unsuccessful catheterisation of a left renal artery targeted through a unidirectional caudal inner branch. During a median follow up of seven months there were no instances of target vessel instability or re-interventions and two patients died of causes unrelated to the bidirectional branches. CONCLUSION: The results of the use of bidirectional double cuff inner branches are promising, with high technical success and no short term branch related complications in this preliminary experience. This could potentially expand the applicability of branch endografting of complex endovascular aortic repairs, but long term results are still missing.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe). METHODS: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously. RESULTS: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period. CONCLUSIONS: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

Endovascular navigation with Fiber Optic RealShape technology.

OBJECTIVE: Fiber Optic RealShape (FORS) technology has recently been introduced as an adjunctive guidance technology that allows real-time three-dimensional visualization of dedicated endovascular devices while avoiding radiation exposure. It consists of equipment which sends pulses of light through hair-thin optical fibers that run within a dedicated hydrophilic wire and selective catheters. The purpose of the study was to report the observed benefits and limitations related to the first edition of FORS technology. METHODS: Data were collected prospectively from the first 50 patients undergoing FORS-guided endovascular repair at a single center between February 2020 and February 2021 as part of the global multicenter FORS Learn registry. All consecutive, elective procedures with one or more navigation tasks attempted with FORS were included. Factors related to FORS navigation task success were assessed. The time required for the catheterization of each task as well as the amount of radiation exposure (fluoroscopy time, dose area product, and estimated skin dose) were collected. A per-task analysis was conducted. End points included the success rate in achieving a stable FORS-guided catheterization, catheterization time, and radiation dose during catheterization. RESULTS: During the study period from February 2020 to February 2021, 50 patients were treated using FORS technology. Forty-five patients were treated for aortic aneurysm, 4 for iliac artery aneurysm, and 1 for splenic artery aneurysm. Overall, 201 navigation tasks were completed for these procedures and FORS was used in 186 tasks (92.5%). No FORS-related complication was recorded and a success rate of 60.2% (n = 116) was observed. Target vessel (TV) angle of 45° or greater, TV stenosis, and the renal arteries as navigation tasks (compared with celiac artery or superior mesenteric artery) were associated with a lower success rate. Catheterization of a TV through a branch more frequently required a standard catheter in combination with the FORS-enabled guidewire. Successful task catheterization using FORS guidance was associated with a shorter catheterization time 6 minutes (interquartile range, 3-11 minutes) versus 16 minutes (interquartile range, 10-24 minutes) (P < .001) and lower radiation exposure compared with unsuccessful catheterization (dose area product, 4.4 cGy/cm2 vs 12.5 cGy/cm2; P < .001). CONCLUSIONS: FORS technology was implemented successfully as a new guidance technology in a complex endovascular aortic repair program and was associated with an encouraging success rate and a high potential for radiation reduction.

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

Fiber Optic RealShape (FORS) Technology for Endovascular Navigation in Severe Tortuous Vessels.

PURPOSE: The purpose of this study was to describe the use of a wire and catheters embedded with optical fiber (Fiber Optic RealShape [FORS]) to catheterize tortuous target vessels avoiding radiation. TECHNIQUE: A virtual biplane vies was simulated coupling traditional x-ray system, preoperative CT scan, and FORS system to treat an isolated hypogastric aneurysm. Despite the complex anatomy, catheterization of all target vessels was possible in 12 minutes with 19 seconds of fluoroscopy time (Radiation Exposure 3.8 mGy×cm2). A minimal invasive endovascular exclusion of the aneurysm was achieved through selective coil-embolization of the iliolumbar artery and implantation of balloon expandable covered stents, thus preserving the perfusion of the superior gluteal artery. CONCLUSION: FORS guidance allowed catheterization of a target vessel with challenging anatomy with a low radiation exposure.

The Knickerbocker Technique: Technical Aspects and Single-Center Results of a New Endovascular Method for False Lumen Occlusion in Chronic Aortic Dissection.

PURPOSE: To describe the technical aspects and early results of a new endovascular fenestration method for false lumen occlusion in chronic aortic dissection: the Knickerbocker Technique. METHODS: A retrospective observational study including all consecutively treated patients between November 1, 2012, through May 31, 2016, who underwent thoracic endovascular aortic repair with false lumen occlusion using the Knickerbocker Technique for thoracic false lumen aneurysm in chronic aortic dissection in a tertiary care center. Primary endpoints consisted of technical (correct deployment of the stent-graft) and clinical (false lumen occlusion) success. Secondary endpoints included overall survival and morbidity after 30 days. In 12 patients, follow-up computed tomography angiogram (CTA) was available and aortic remodeling was evaluated. RESULTS: We identified 16 eligible patients (75% men, mean age: 69 years, range: 52-80 years). Technical success was 94%. Overall survival after 30 days was 100%; there was 1 aortic reintervention (additional false lumen embolization due to endoleak type 1a in 1 patient). Median total follow-up was 31.5 months (range: 3-66 months). Four (25%) of 16 patients died during follow-up, in 3 of those patients the cause of death is unknown, and 1 patient developed cardiac tamponade after being treated by fenestrated thoracic endovascular aortic repair. Imaging follow-up with CTA was available in 12 patients (median imaging follow-up: 27.5 months, range: 1-57 months). Nine (75%) of 12 patients showed thoracic aortic remodeling, and in 3 patients aneurysm size was stable. No patient showed aneurysm growth. CONCLUSION: The Knickerbocker Technique is a feasible endovascular fenestration method to achieve false lumen occlusion and aortic remodeling in chronic aortic dissection with low invasiveness.

Self-occluding Candy-Plug: Implantation Technique to Obtain False Lumen Thrombosis in Chronic Aortic Dissections.

PURPOSE: To describe the implantation steps of the latest generation of candy-plug device (third CP generation [CP III]) and to illustrate its possible pitfalls by discussing a case in whom this device was employed to occlude the false lumen (FL) of a chronic type B aortic dissection. TECHNIQUE: A 69 year-old male patient who underwent a frozen elephant trunk arch repair due to residual type A aortic dissection developed a FL aneurysmal degeneration limited to the descending thoracic aorta. Two thoracic stent-grafts were deployed into the true lumen up to the celiac trunk origin. Then, the FL was occluded with a self-occluding CP III device (Cook Medical, Bloomington, Indiana), placed at the same level as the distal thoracic stent-graft. The distal un-stented sleeve was pushed upward to allow immediate occlusion of its central lumen, avoiding interference with reno-visceral arteries arising from the FL. Both intraoperative transesophageal echocardiography and follow-up computed tomographic angiography scan demonstrated complete FL thrombosis. CONCLUSION: The introduction of CP III with its self-occluding mechanism helped to shorten and standardize the procedure. However, adjunctive steps may be needed to immediately obtain FL occlusion and avoid hampering the perfusion of vessels arising from the FL.

Transfemoral Access to Implant Iliac Branch Devices After Previous Aortic Grafts.

OBJECTIVE: To report on the outcomes of patients undergoing an iliac branch device implantation after previous open or endovascular aorto-biliac repair, using exclusively femoral access for catheterization and delivery of the covering stent to the hypogastric artery. METHODS: Single-center retrospective study in which all patients in whom an iliac branch device was implanted after previous open or endovascular aorto-biliac repair were identified. Patients in whom the hypogastric artery catheterization and delivery of the bridging cover stent were achieved via exclusive femoral access were included. Different techniques were used based on surgeon preference. Technical success and access-related complications, as well as iliac branch device endoleak or occlusions during follow-up, were evaluated. RESULTS: From 2015 to 2021, 28 patients with a prior open or endovascular aorto-biliac repair underwent 34 iliac branch device implantations. Most (71%) had juxtarenal or thoracoabdominal aortic aneurysms, 82% had common iliac artery aneurysms, and 25% had hypogastric artery aneurysms. Bilateral iliac branch device implantations were performed in 21% of the patients, and in 26% of cases, landing in the superior gluteal artery was obtained. An "up-and-over" technique from the contralateral groin was used in 65% of the cases, and a steerable sheath in 35%. Technical success was 94%, with no complications related to access or technique to catheterize and deliver the stents in the hypogastric artery. The cohort had 20% of major complications, with 3 perioperative deaths. Kaplan-Meier estimated an iliac branch device freedom from occlusion and endoleak was 92% and 83% at 2 years. CONCLUSIONS: The implantation of an iliac branch device over previous aortic or open endografts involving the aortic bifurcation is feasible and safe. We suggest using a femoral approach as the primary access of choice. CLINICAL IMPACT: In this study we present 28 patients with previous aortoiliac grafts in which iliac branch devices were performed as a subsequent step.We demonstrated the feasibility of the technique despite the difficulty of crossing a neobifurcation, with a steep angle, without complications associated with the technique. Based on our experience, we recommend transfemoral access as the first option for bypassing the hypogastric artery stent, preserving upper extremity access and its possible complications.

Ascending Aorta Nose-Cone Loop Technique as Bail Out for Precise Branched Endovascular Aortic Arch Endograft Delivery Without Valve Re-Crossing.

PURPOSE: To describe a right carotid-femoral through-and-through (T&T) guidewire technique during branched thoracic endovascular aortic arch repair (B-TEVAR) to facilitate endograft delivery in a very tortuous aortic anatomy for a type Ia endoleak (EL) of a previous aortic endograft implantation. TECHNIQUE: AT&T guidewire was established between the right common carotid artery and the right common femoral artery to facilitate a difficult endograft delivery. Once in the aortic arch, a loop in the ascending aorta was formed to allow the endograft to reach the desired position without losing tension on the guidewire. This maneuver allowed the T&T guidewire to be kept in place until the desired position was reached. The nose-tip of the endograft was curved over the looped guidewire pointing toward the innominate artery without crossing the valve. After endograft deployment, the T&T guidewire was released, and the branches were bridged in a standard fashion. Completion angiography documented correct deployment of the endograft and no sign of type I/III EL. The 1-month computed tomography angiography confirmed the correct deployment. CONCLUSION: Carotid-femoral T&T guidewire to facilitate endograft delivery in difficult anatomies can be feasible even in B-TEVAR. Possible bailout maneuvers are available if the aortic valve needs to be crossed after endograft delivery. CLINICAL IMPACT: Endovascular arch repair gains popularity as a valuable alternative, especially in patients considered unfit for open repair. A through-and-through (T&T) guidewire for endovascular arch repair with a landing zone in zone 0 according to Ishimaru is usually performed through the externalization of the femoral guidewire through a transapical access, but this may not always be feasible in frail patients. A right carotid-femoral though-and-through guidewire with a loop formation in the ascending aorta is proposed to achieve the support of a T&T wire to pass tortuous aortoiliac anatomies and access the ascending aorta without the need for aortic valve crossing.