Systematic review and meta-analysis of fenestrated or branched devices after previous open surgical aortic aneurysm repair.

OBJECTIVE: Despite open surgical repair (OSR) of abdominal aortic aneurysms being considered as a durable solution, disease progression and para-anastomotic aneurysms may require further repair, and fenestrated and branched endovascular aneurysm repair (F/BEVAR) may be applied to address these pathologies. The aim of this systematic review was to assess technical success, mortality, and morbidity (acute kidney injury, spinal cord ischemia) at 30 days, and mortality and reintervention rates during the available follow-up, in patients managed with F/BEVAR after previous OSR. METHODS: The PRISMA statement was followed, and the study was pre-registered to the PROSPERO (CRD42022363214). The English literature was searched, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, through November 30, 2022. Observational studies and case series with ≥5 patients (2000-2022), reporting on F/BEVAR outcomes after OSR, were considered eligible. The Newcastle-Ottawa Scale and GRADE were used to assess the risk of bias and quality of evidence. The primary outcome was technical success, mortality, and morbidity at 30 days. Data on the outcomes of interest were synthesized using proportional meta-analysis. RESULTS: The initial search yielded 1694 articles. Eight retrospective studies (476 patients) were considered eligible. In 78.3% of cases, disease progression set the indication for reintervention. Technical success was estimated at 96% (95% confidence interval [CI], 89%-98%; I2 = 0%; 95% prediction interval [PI], 79%-99%). Thirty-day mortality was 2% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-28%). The estimated spinal cord ischemia and acute kidney injury rates were 3% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-30%) and 6% (95% CI, 2%-15%; I2 = 0%; 95% PI, 1%-40%), respectively. During follow-up, overall mortality was 5% (95% CI, 2%-12%; I2 = 34%; 95% PI, 0%-45%) and aorta-related mortality was 1% (95% CI, 0%-2%; I2 = 0%; 95% PI, 0%-3%). The rate of reinterventions was 16% (95% CI, 9%-26%; I2 = 22%; 95% PI, 3%-50%). CONCLUSIONS: According to the available literature, F/BEVAR after OSR may be performed with high technical success and low mortality and morbidity during the perioperative period. Follow-up aortic-related mortality was 1%, whereas the reintervention rates were within the standard range following F/BEVAR.

A procedural step analysis of radiation exposure in fenestrated endovascular aortic repair.

OBJECTIVE: Radiation exposure during complex endovascular aortic repair may be associated with tangible adverse effects in patients and operators. This study aimed to identify the steps of highest radiation exposure during fenestrated endovascular aortic repair (FEVAR) and to investigate potential intraoperative factors affecting radiation exposure. METHODS: Prospective data of 31 consecutive patients managed exclusively with four-fenestration endografts between March 1, 2020, and July 1, 2022 were retrospectively analyzed. Leveraging the conformity of the applied technique, every FEVAR operation was considered a combination of six overall stages composed of 28 standardized steps. Intraoperative parameters, including air kerma, dose area product, fluoroscopy time, and number of digital subtraction angiographies (DSAs) and average angulations were collected and analyzed for each step. RESULTS: The mean procedure duration and fluoroscopy time was 140 minutes (standard deviation [SD], 32 minutes), and 40 minutes (SD, 9.1 minutes), respectively. The mean air kerma was 814 mGy (SD, 498 mGy), and the mean dose area product was 66.8 Gy cm2 (SD, 33 Gy cm2). The percentage of air kerma of the entire procedure was distributed throughout the following procedure stages: preparation (13.9%), main body (9.6%), target vessel cannulation (27.8%), stent deployment (29.1%), distal aortoiliac grafting (14.3%), and completion (5.3%). DSAs represented 23.0% of the total air kerma. Target vessel cannulation and stent deployment presented the highest mean lateral angulation (67 and 63 degrees, respectively). Using linear regression, each minute of continuous fluoroscopy added 18.9 mGy of air kerma (95% confidence interval, 17.6-20.2 mGy), and each DSA series added 21.1 mGy of air kerma (95% confidence interval, 17.9-24.3 mGy). Body mass index and lateral angulation were significantly associated with increased air kerma (P < .001). CONCLUSIONS: Cannulation of target vessels and bridging stent deployment are the steps requiring the highest radiation exposure during FEVAR cases. Optimized operator protection during these steps is mandatory.

Multicentric clinical evaluation of a computed tomography-based fully automated deep neural network for aortic maximum diameter and volumetric measurements.

OBJECTIVE: This study aims to evaluate a fully automatic deep learning-based method (augmented radiology for vascular aneurysm [ARVA]) for aortic segmentation and simultaneous diameter and volume measurements. METHODS: A clinical validation dataset was constructed from preoperative and postoperative aortic computed tomography angiography (CTA) scans for assessing these functions. The dataset totaled 350 computed tomography angiography scans from 216 patients treated at two different hospitals. ARVA's ability to segment the aorta into seven morphologically based aortic segments and measure maximum outer-to-outer wall transverse diameters and compute volumes for each was compared with the measurements of six experts (ground truth) and thirteen clinicians. RESULTS: Ground truth (experts') measurements of diameters and volumes were manually performed for all aortic segments. The median absolute diameter difference between ground truth and ARVA was 1.6 mm (95% confidence interval [CI], 1.5-1.7; and 1.6 mm [95% CI, 1.6-1.7]) between ground truth and clinicians. ARVA produced measurements within the clinical acceptable range with a proportion of 85.5% (95% CI, 83.5-86.3) compared with the clinicians' 86.0% (95% CI, 83.9-86.0). The median volume similarity error ranged from 0.93 to 0.95 in the main trunk and achieved 0.88 in the iliac arteries. CONCLUSIONS: This study demonstrates the reliability of a fully automated artificial intelligence-driven solution capable of quick aortic segmentation and analysis of both diameter and volume for each segment.

The sac evolution imaging follow-up after endovascular aortic repair: An international expert opinion-based Delphi consensus study.

OBJECTIVE: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. METHODS: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. RESULTS: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. CONCLUSIONS: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.

A Systematic Review on Thoracic Endovascular Repair Outcomes in Blunt Thoracic Aortic Injuries.

PURPOSE: Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR. MATERIALS AND METHODS: We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up. RESULTS: From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16-89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001, I2=0%). Mortality at 30 days was 5.0% (OR, 95% CI=0.03, 0.06, p<0.001, I2=5.56%). Spinal cord ischemia occurred in 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and stroke rate was 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%). The available follow-up was estimated at 29 months (range=3-119 months) with mortality rate at 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and re-intervention rate at 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=10.5%). CONCLUSION: Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed. CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.

Early and Midterm Outcomes of Endovascular Aortic Arch Repair Using In Situ Laser Fenestration.

INTRODUCTION: The aim of this study is to present single-center outcomes in patients treated with in situ laser fenestration thoracic endovascular aortic repair (LFTEVAR) for various aortic arch pathologies and assess the impact of increasing experience. METHODS: The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was followed. A retrospective analysis of prospectively collected single aortic center data was conducted, including baseline information and peri- and post-operative outcomes of consecutive patients managed with LFTEVAR for aortic arch pathologies. Patients were enrolled from April 1, 2017 to January 31, 2023. The cohort was dichotomized to compare early (2017-2019) and late experience (2020-2023). Primary outcomes were peri-operative mortality and cerebrovascular morbidity. RESULTS: Thirty patients were included (63.3% males, mean age 69.8±9.6 years); 21.4% presented with aortic ruptures. Aortic aneurysm involving the aortic arch was the most frequent pathology (53.3%). Forty target vessels (TVs) were revascularized, including 19 left subclavian arteries (47.5%) and 17 left common carotid arteries (42.5%). Double fenestrations were performed in 10 patients. The proximal landing zone was Ishimaru zone 0 in 5 patients (16.7%) and zone 1 in 13 patients (43.3%). Technical success was 93%. No spinal cord ischemia was recorded, and 3 patients (10%) suffered a post-operative stroke, of which 1 was major (3.3%). The median follow-up was 12 months (range=1-48 months). Thirty-day and follow-up mortality rates were 13.5% and 15.3%, respectively. Target vessel instability was 10%, of which 3.8% required reintervention. There was no statistically significant difference in outcomes between the early and late experience groups. CONCLUSIONS: Laser fenestration thoracic endovascular aortic repair of the aortic arch performed in experienced aortic centers is associated with low early mortality and stroke rates. It is a safe and effective therapeutic option in patients considered unfit for open repair. CLINICAL IMPACT: Custom-made devices for arch pathologies requiring urgent repair are not an option because of manufacturing delays. Off-the-shelf devices with single branch arch prostheses, and outside IFU techniques such as parallel-grafts and surgeon-modified endografts have been proposed in this setting. Another off-the-shelf alternative is in situ laser fenestration thoracic endovascular repair (LFTEVAR), which addresses many limitations of the other off-the-shelf options. Our study reports the outcomes of 30 patients treated with LFTEVAR, showing that it is a viable therapeutic option in patients considered unfit for open repair acknowledging that sufficient experience with complex endovascular aortic repair is mandatory to achieve acceptable outcomes in these high-risk patients with challenging aortic anatomies.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Five-Year Outcomes of Coarctoplasty with Stents in the Pediatric Population: Results from a Retrospective Single-Center Cohort with Centrally Adjudicated Outcomes.

Transcatheter stent implantation is a widely performed procedure for treating native coarctation of the aorta (CoA) in pediatric patients. However, data on mid- to long-term outcomes are limited. The aim of this study was to evaluate the mid-term safety and efficacy of transcatheter CoA stenting based on centrally adjudicated outcomes. This retrospective cohort study included patients aged 15 years or younger undergoing de novo stenting for CoA or recoarctation (reCoA) between 2006 and 2017. Immediate and 5-year outcomes were assessed. Immediate outcomes (procedural and in-hospital) were retrieved from electronic records. Rates of 5-year reCoA, stent fractures, aneurysmal/pseudoaneurysmal formation, and all-cause mortality were mid-term outcomes. The study included 274 patients (64% male and 36% female) with a median (interquartile range) age of 9 (6-12) years. Procedural success was achieved in 251 patients (91.6%). Procedural complications occurred in 4 patients (1.4%), consisting of stent migration in 1 (0.3%) and small non-expanding non-flow-limiting aortic wall injuries in 3 (1.1%). Major vascular access complications were observed in 18 patients (6.6%), acute limb ischemia in 8 (2.9%). In-hospital mortality occurred in 4 patients (1.4%). Five-year cumulative incidence rates of stent fractures, reCoA, and aortic aneurysmal/pseudoaneurysmal formation were 17/100 (17%), 73/154 (48%), and 8/101 (7.92%), respectively. Of 73 reCoAs, 47 were treated with balloon angioplasty, and 15 underwent a second stent implantation. Five-year all-cause mortality occurred in 4/251 (1.6%) patients. Coarctoplasty with stents was safe and effective in our pediatric population during a 5-year follow-up despite a high rate of reCoA.

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.

Evaluation of false lumen occluders implanted in the abdominal aorta false lumen.

OBJECTIVE: Management of postdissection thoracoabdominal aneurysms with a fenestrated and/or branched endograft (F/BEVAR) is associated with favorable outcomes. Treatment should include both true lumen endografting and false lumen occlusion (FLO). Favorable results have recently been reported for FLO in the false lumen of the thoracic aorta. The purpose of this study is to analyze the results of FLO of the abdominal aorta in patients treated for post dissection thoracoabdominal aneurysm. METHODS: A multicenter retrospective analysis of prospective data of consecutive patients managed for post dissection thoracoabdominal aortic aneurysm from April 2019 to December 2022 with F/BEVAR associated with FLO in the abdominal false lumen was conducted. The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) was followed. Baseline demographics, operative details, and early outcomes (mortality, length of stay) were recorded. Primary endpoints were technical and clinical success. FLO technical success was defined as complete occlusion of false lumen backflow above the FLO on completion angiogram. RESULTS: During the 3-year study, 23 patients were treated for post dissection thoracoabdominal aneurysm with F/BEVAR and the use of abdominal FLO. Twenty-one patients (91.3%) had received prior endovascular treatment. The technical and clinical success was 95.7%. The abdominal FLO had a technical success rate of 78.3%. The median diameter of the FLO was 34 mm. No patient died during the perioperative period, and one patient had spinal cord ischemia (4.3%) with partial recovery. Six patients (26.1%) required early reintervention. The median duration of hospitalization in the intensive care unit and overall was 1 day (interquartile range, 0-3 days) and 7.5 days (interquartile range, 2-22 days), respectively. During the mean follow-up of 9.9 ± 9.0 months, no patient died. False lumen occlusion was complete or partial in nine (39.1%) and nine (39.1%) patients, respectively. No aortic rupture occurred during follow-up. Maximum aortic diameter decreased in 48% and remained stable in 39% of cases. CONCLUSIONS: Abdominal aorta FLO during endovascular treatment of post dissection thoracic abdominal aortic aneurysm is associated with favorable outcomes. It offers an additional staging therapeutic option before extensive aorto-bi-iliac coverage, associated with low spinal cord ischemia rates. FLO also provides high rates of false lumen occlusion and false lumen remodeling during follow-up. Longer follow-up and larger cohorts are required to confirm these very promising early findings.

Renovisceral artery alterations due to branched endovascular aortic repair and respiratory-induced deformations.

OBJECTIVE: This study quantified respiratory-induced dynamics of branch vessels before and after thoracoabdominal aortic aneurysm (TAAA) branched endovascular aneurysm repair (bEVAR). METHODS: Patients with TAAA were recruited prospectively and treated with bEVAR, predominantly with Zenith t-Branch and BeGraft Peripheral PLUS bridging stents. Using SimVascular software, three-dimensional geometric models of the vessels and implants were constructed from computed tomography angiograms during both inspiratory and expiratory breath-holds, preoperatively and postoperatively. From these models, branch take-off angles, end-stent angles (transition from distal end of stent to native artery), and curvatures were computed. Paired, two-tailed t tests were performed to compare inspiratory vs expiratory geometry and pre- vs postoperative deformations. RESULTS: We evaluated 52 (12 celiac arteries [CA], 15 superior mesenteric arteries [SMA], and 25 renal arteries [RA]) branched renovisceral vessels with bridging stents in 15 patients. Implantation of bridging stents caused branch take-off angle to shift inferiorly in the SMA (P = .015) and RA (P = .014) and decreased the respiratory-induced branch angle motion in the CA and SMA by approximately 50%. End-stent angle increased from before to after bEVAR for the CA (P = .005), SMA (P = .020), and RA (P < .001); however, respiratory-induced deformation was unchanged. Bridging stents did not experience significant bending owing to respiration. CONCLUSIONS: The decrease in respiratory-induced deformation of branch take-off angle from before to after bEVAR should decrease the risk of device disengagement and endoleak. The unchanging respiratory-induced end-stent bending, from before to after bEVAR, means that bEVAR maintains native vessel dynamics distal to the bridging stents. This factor minimizes the risk of tissue irritation owing to respiratory cycles, boding well for branch vessel patency. The longer bridging stent paths associated with bEVAR may enable smoother paths subject to less dynamic bending, and potentially lower fatigue risk, compared with fenestrated EVAR.

Systematic review of reintervention with fenestrated or branched devices after failed previous endovascular aortic aneurysm repair.

BACKGROUND: A proximal seal extension, after previously failed standard endovascular abdominal aortic aneurysm repair (EVAR), has been described using various endovascular techniques. The aim of the present systematic review was to assess the technical success, 30-day mortality, and mortality and reintervention rates during the available follow-up for patients managed with endovascular methods after failed endovascular repair. METHODS: The present systematic review followed the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and was preregistered at PROSPERO (no. CRD42022350436). A search of the English literature, via Ovid, using the MEDLINE, EMBASE, and CENTRAL databases, until June 15, 2022, was performed. Observational studies (2000-2022) and case series with at least five patients who had undergone fenestrated/branched EVAR (F/BEVAR) after failed EVAR were considered eligible. Technical success and mortality at 30 days and the mortality and reintervention rates during available follow-up had to have been reported. The Newcastle-Ottawa scale was used to assess the risk of bias. The primary outcome was technical success and mortality at 30 days. RESULTS: The initial search yielded 2558 reports. Ten studies were considered eligible, two of which were prospective. A total of 423 patients had undergone F/BEVAR after failed EVAR. The indication for reintervention was the presence of a type Ia endoleak in 44.9%. Technical success was reported in seven studies, and 319 of 336 interventions were considered successful (94.9%), according to each study's criteria. Of the 423 patients, 10 had died within 30 days (2.4%). Seven patients had presented with spinal cord ischemia (2.4%). Twenty-three acute kidney injury events were reported (6.8%). The mean follow-up was 18 months (range, 1-77 months). During follow-up, 47 deaths were reported (14.8%). Finally, 50 reinterventions of 303 procedures (16.5%) had been performed. CONCLUSIONS: According to the available literature, F/BEVAR after failed EVAR can be performed with high technical success and low mortality during the perioperative period. The midterm mortality and reintervention rates were acceptable. However, further data are needed to provide firm conclusions regarding the safety and durability of F/BEVAR after failed EVAR.

One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair.

OBJECTIVE: This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year. METHODS: A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days. RESULTS: Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients. CONCLUSIONS: In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.

Spinal cord ischemia rates and prophylactic spinal drainage in patients treated with fenestrated/branched endovascular repair for thoracoabdominal aneurysms.

OBJECTIVE: Spinal cord ischemia (SCI) is a devastating complication after thoracoabdominal aortic aneurysm (TAAA) repair. The benefit of prophylactic cerebrospinal fluid drainage (pCSFD) to prevent SCI is still under investigation. The aim of this study was to evaluate the SCI rate and the impact of pCSFD following complex endovascular repair (fenestrated or branched endovascular repair [F/BEVAR]) for type I to IV TAAA. METHODS: The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was followed. A single-center retrospective study was conducted, including all consecutive patients, managed for TAAA type I to IV using F/BEVAR, between January 1, 2018, and November 1, 2022, for degenerative and post-dissection aneurysms. Patients with juxta- or pararenal aneurysms were excluded, as well as cases managed urgently for aortic rupture or acute dissection. After 2020, pCSFD in type I to III TAAAs was abandoned and replaced by therapeutic CSFD (tCSFD), performed only in patients presenting SCI. The primary outcome was the perioperative SCI rate for the entire cohort and the role of pCSFD for type I to III TAAAs. RESULTS: In total, 198 patients were included (mean age, 71.1±3.4 years; 81.8% males), including 50.5% with type I to III TAAA. The primary technical success was 94.9%. The perioperative mortality was 2.5%. and the major adverse cardiovascular event (MACE) rate was 10.6%; 4.5% presented SCI of any type (2.5% paraplegia). When comparing the SCI group with the remaining cohort, patients with SCI presented higher MACE (66.7% vs 7.9%; P < .001) rate and longer intensive care unit stay (3.5 vs 1 day; P = .002). Following type I to III repair, similar SCI, paraplegia, and paraplegia with no recovery rates were reported in the pCSFD and tCSFD groups (7.3% vs 5.1%; P = .66; 4.8% vs 3.3%; P = .72; and 2% vs 0%; P = .37). CONCLUSIONS: The incidence of SCI after TAAA I to IV endovascular repair was low. SCI was associated with significantly increased MACE and intensive care unit stay. The prophylactic use of CSFD in type I to III TAAAs was not associated with lower SCI rates and may not be justified routinely.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms.

OBJECTIVE: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). METHODS: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). RESULTS: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. CONCLUSIONS: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.

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.

Virtual Reality to Ease Endovascular Repair of Thoracoabdominal Aneurysms Under Local Anesthesia.

Purpose: Virtual reality (VR) has both a non-pharmacological analgesic and anxiolytic action that can be used as an alternative to general anesthesia for very high-risk patients. Case report: We present here the case of a patient treated for a complex endovascular thoracoabdominal aortic aneurysm exclusion using a 4-fenestrated aortic endograft using VR. The patient had no postoperative complications and was safely discharged from the hospital on postoperative day 6. Conclusion: This case demonstrates that the use of VR in addition to local anesthesia can be a safe alternative to general anesthesia.

Early Outcomes on Triple-Branch Arch Device With Retrograde Left Common Carotid Branch: A Case Series.

INTRODUCTION: Endovascular aortic arch repair using multibranch devices has been applied in patients considered at high risk for open repair. The aim of this case series was to report the early outcomes in patients managed with a new design 3 branch arch custom-made device, including a retrograde left common carotid artery (LCCA) branch. METHODS: The Preferred Reporting Of CaSe Series in Surgery (PROCESS) guidelines were followed. All consecutive patients undergoing endovascular repair of an aortic arch lesion with a custom-made triple-branch device, including a retrograde LCCA branch (Cook Medical, Bloomington, IN, USA), between October 27, 2022, and February 28, 2023, were included. The presence of an arch aneurysm (degenerative or post-dissection) with diameter ≥55 mm and high risk for a conventional open repair set the indication for treatment. The primary outcomes were technical success and mortality at 30 days. Early morbidity and reinterventions were considered as secondary outcomes. RESULTS: Eight elective patients (87.5% men, mean age 72.3±27.0 years) were included. Five of them (62.5%) had undergone a previous ascending aorta repair of an acute type A aortic dissection. All patients were asymptomatic, except one, with left recurrent laryngeal nerve compression. The mean maximum aortic diameter was 70.4±21.0 mm. Percutaneous femoral and axillary access was used in all cases except three in which a cut down for right carotid access was performed. Technical success was 100%. Femoral access to the LCCA and implantation of the bridging stent was performed without technical challenges. No death nor cerebrovascular event was recorded during the 30 day follow-up. Five patients (62.5%) presented major complications, 3 related to access needing reintervention and the remaining related to congestive heart failure (CHF), which were managed successfully with medical treatment. Follow-up (range 1-4 month) was uneventful, except for one patient who presented a secondary type Ia endoleak. CONCLUSIONS: According to our early experience, the presence of a retrograde branch facilitated the revascularization of the LCCA through femoral access, decreasing the risk of cerebrovascular morbidity. Further analyses with longer follow-up are needed to evaluate the safety and efficacy of the device. CLINICAL IMPACT: Data arising mainly from the retrograde branch for the revascularization of the LSA are encouraging from a variety of devices. The premiminary experience with a triple-branched arch device, with a retrograde branche for the LSA but also for the LCCA, was associated with no 30 day mortality and 100% technical success.The device's design allowed swift catheterization and completion of the LCCA revascularization using femoral access exclusively.

In Situ Fenestrated Thoracic Endovascular Repair Using the Upstream Peripheral Go BackTM Re-Entry Catheter.

PURPOSE: The aim is to present a case of in situ fenestrated thoracic endovascular repair, using a re-entry peripheral catheter, needing urgent repair due to recurrent episodes of hemoptysis because of an aorto-bronchial fistula after previous thoracic endovascular aortic repair (TEVAR). TECHNIQUE: A 74-year-old male with a previous TEVAR presented with hemoptysis, fever, and cachexia. An aorto-bronchial fistula and type Ia endoleak were depicted on computed tomography angiography (CTA). Due to the patient's frail general condition, a proximal TEVAR extension was planned, prior to thoracotomy for debridement, and long-term antibiotics. An in situ fenestrated TEVAR was performed to provide proximal sealing and revascularize the left common carotid and subclavian arteries. For fenestration creation, an Upstream Peripheral Go Back catheter (Bentley, Hechingen, Germany) was used. The Go Back catheter has been approved as a re-entry tool for complex peripheral arterial revascularization. In this case, both fenestrations were successfully created. Proximal seal and target vessel patency were confirmed on CTA. Thoracotomy confirmed aortic exclusion. A wedge lobectomy was performed in combination with pediculated omentectomy to exclude the exposed endograft. CONCLUSION: In urgent cases, where custom-made thoracic devices are unavailable, in situ fenestrations with the Go Back catheter are an alternative to laser fenestrations. CLINICAL IMPACT: Fenestrations are often required in acute TEVAR to achieve a proximal seal in the arch. In situ fenestrations with the Go Back catheter are an alternative to laser fenestrations and PMEGs in this setting.

Systematic Review on Early and Follow-up Mortality Rate in Octogenarians Treated With a Fenestrated and/or Branched Endovascular Aortic Repair.

PURPOSE: Advanced age has been related to conflicting outcomes after fenestrated/branched endovascular aortic aneurysm repair (F/BEVAR). The aim of this meta-analysis is to compare 30-day mortality, technical success, and 1-year and 5-year survival in octogenarians and non-octogenarians who underwent F/BEVAR for complex aortic aneurysms. MATERIALS AND METHODS: This meta-analysis was pre-registered to PROSPERO (CRD42022348659). The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) 2020 statement was followed. A search of the English literature, via Ovid, using MEDLINE, Embase, and CENTRAL databases, until August 30, 2022, was executed. Randomized Control Trials and observational studies (2000-2022), with ≥5 patients, reporting on 30-day mortality and 1-year and 5-year survival rates among octogenarians and non-octogenarians after F/BEVAR were eligible. The Risk Of Bias In Non-Randomized Studies of Interventions (ROBINS-I) tool was applied to assess the risk of bias. The primary outcome was 30-day mortality and secondary was 1-year and 5-year survival in octogenarians and non-octogenarians. The outcomes were summarized as odds ratio (OR) with 95% confidence intervals (CIs). A narrative presentation was selected in case of missing outcomes. RESULTS: The initial research isolated 3263 articles; 6 retrospective studies were finally included. A total of 7410 patients were managed with F/BEVAR; 1499 patients (20.2%) were ≥80 years old (75.5% males, 259/343). The estimated 30-day mortality was 6% among octogenarians vs 2% in younger patients, with a significantly higher 30-day mortality for patients ≥80 years old (OR 1.21, 95% CI 0.61-1.81; p=0.0.11; Ι2=36.01%). Technical success was similar between the groups (OR -0.83; 95% CI -1.74-0.07, p<0.0.001; Ι2=95.8%). Regarding survival, a narrative approach was decided due to missing data. Two studies reported a statistically significant difference in 1-year survival between groups, with higher mortality in octogenarians (82.5%-90% vs 89.5%-93%), while 3 reported a similar 1-year survival rate in both groups (87.1%-95% vs 88%-89.5%). At 5 years, 3 studies reported a statistically significant lower survival for octogenarians (26.9%-42% vs 61%-71%). CONCLUSIONS: Octogenarians treated with F/BEVAR presented higher 30-day mortality while a lower survival rate at 1 and 5 years was reported in the literature. Patient selection is thus mandatory among older patients. Further studies, especially on patient risk stratification, are needed to estimate the F/BEVAR outcomes on elder patients. CLINICAL IMPACT: Age may be a factor of increased early and long-term mortality within patients managed for aortic aneurysms. In this analysis, patients over 80 years old were compared to their younger counterparts when managed with fenestrated or branched endovascular aortic repair (F/BEVAR) . The analysis showed that early mortality was acceptable for octogenrains but significantly higher when compared to patients younger than 80 years. One-year survival rates are controversial. At 5-year follow-up, octogenarians present lower survival but data to provide metanalysis are lacking. Patient selection and risk stratification are mandatory in older candidates for F/BEVAR.