Urgent endovascular repair of juxta/para-renal aneurysm by off-the-shelf multibranched endograft.

OBJECTIVE: To report outcomes of urgent juxta/para-renal aneurysms (J/P-AAAs) managed by off-the-shelf multibranched thoracoabdominal endografts (Cook, T-branch). METHODS: In this observational, multicenter, retrospective study, patients with J/P-AAAs treated by urgent endovascular repair by T-branch in 23 European aortic centers, from 2013 to 2023, were analyzed. Contained J/P-AAAs rupture, presence of related symptoms, and aneurysm diameter >70mm were considered as indication for urgent repair. Technical success (TS), spinal cord ischemia (SCI) and 30-day/hospital mortality were assessed as early outcomes. Survival, freedom from (FF) reinterventions and target arteries instability (TAI) were evaluated during follow-up. RESULTS: Overall, 197 patients [J-AAAs:64(33%), P-AAAs:95(48%), previous failed-EVAR 38(19%)] were analyzed. The mean age and aneurysm diameter was 75+8 years and 76+4 mm, respectively. The ASA score was 3 and 4 in 118(60%) and 79(40%) patients. Rupture, symptoms and diameter >70mm were present in 51(26%), 110(56%) and 53(27%) patients, respectively. An adjunctive proximal thoracic endograft was used in 28(14%) cases. The mean aortic coverage between the upper portion of the endograft and the lowest renal artery was 154+49mm. Single-stage repair and cerebral-spinal-fluid drainage were reported in 144(73%) and 53(27%) cases, respectively. TS was achieved in 182(92%) cases (rupture:84% vs no rupture:95%; P:.02). Failures consist of target artery loss (11-6%: renal artery - 9; celiac trunk - 2), type I-III endoleak (2-1%) and 24-h mortality (2-1%). Rupture was a risk-factor for technical failure (P:.02;OR:3.8;95%CI:1.1-12.1). Overall, 15(8%) patients had persistent SCI (rupture:14% vs no rupture:5%) with 11(6%) cases of paraplegia (rupture:10% vs no rupture:5%; P:.001). Rupture (P:.04;OR:3.1;95%CI:1.1-8.9) and adjunctive proximal thoracic endograft (P:.01;OR:4.1;95%CI:1.3-12.9) were risk-factors for SCI. Twenty-two (11%) patients died within 30-day or during a prolonged hospitalization. Previous failed-EVAR (P:.04;OR:3.6;95%CI:1.1-12.3), paraplegia (P:<.001;OR:9.9;95%CI:1.6-62.2), postoperative mesenteric complications (P:.03;OR:10.4;95%CI:1.2-93.3) as well as cardiac (P:.03;OR:8.2;95%CI:2.0-33.0) and respiratory (P:<.001;OR:10.1;95%CI:2.9-35.2) morbidities were associated with 30-day/hospital mortality. The mean follow-up was 19+5months. Estimated 3-year survival and FF-reinterventions was 58% and 77%, respectively. TAI occurred in 27(14%) patients (occlusion:15, endoleak:14) with an estimated 3-year FF-TAI of 72%. CONCLUSIONS: Urgent repair of J/P-AAAs by T-branchis feasible and effective with satisfactory TS and 30-day/hospital mortality in high-risk patients. However, extensive aortic coverage is necessary, leading to a not negligible SCI rate, especially in case of aortic rupture or when adjunctive thoracic endografts are necessary. Previous failed-EVAR, postoperative mesenteric complications as well as cardiac and respiratory morbidities were associated with 30-day/hospital mortality and they should be subjected to more research for the purpose of improving outcomes.

Closure Device Migration: An Unusual Cause of Acute Limb Ischaemia Following a Simple Endovascular Procedure.

Introduction: Acute limb ischaemia resulting from foreign body embolisation is an infrequent yet critical complication associated with vascular closure devices (VCDs). Despite the widespread use of VCDs, rare complications such as fragment emboli pose unique challenges, necessitating heightened clinical awareness. This case report presents a case of acute limb ischaemia caused by a VCD malfunction following an endovascular procedure. Report: A 70 year old male who was diagnosed with a severe claudication of the lower extremity (Rutherford III) due to right common iliac stenosis, underwent angioplasty using a FemoSeal (Terumo Ltd., Surrey, UK) to close the right femoral artery access. Two weeks later, the patient presented with acute lower limb ischaemia due to a right popliteal-tibial occlusion. Emergency surgical thrombo-embolectomy was successfully performed from a medial popliteal approach, and the thrombus, which contained a polymer disc from the VCD at its distal end, was completely removed. Discussion: Despite VCDs being proven safe and efficient, rare complications such as fragment emboli can occur, and physicians should be aware of the possible delayed onset of symptoms. Moreover, the radiolucent nature of the polymer disc in a FemoSeal complicates diagnostic imaging. While endovascular approaches exist, open surgery is a safe and effective strategy for retrieving fragments and treating the patient in acute limb ischaemia cases. Conclusion: Physicians should remain vigilant for embolic risks associated with vascular closure devices, even with suitable anatomy and following guidelines, especially considering the trend toward early ambulation and discharge.

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.

Dissection flap fenestration can reduce re-apposition force of the false lumen in type-B aortic dissection: a computational and bench study.

Thoracic endovascular aortic repair (TEVAR) has been widely adopted as a standard for treating complicated acute and high-risk uncomplicated Stanford Type-B aortic dissections. The treatment redirects the blood flow towards the true lumen by covering the proximal dissection tear which promotes sealing of the false lumen. Despite advances in TEVAR, over 30% of Type-B dissection patients require additional interventions. This is primarily due to the presence of a persistent patent false lumen post-TEVAR that could potentially enlarge over time. We propose a novel technique, called slit fenestration pattern creation, which reduces the forces for re-apposition of the dissection flap (i.e., increase the compliance of the flap). We compute the optimal slit fenestration design using a virtual design of experiment (DOE) and demonstrate its effectiveness in reducing the re-apposition forces through computational simulations and benchtop experiments using porcine aortas. The findings suggest this potential therapy can drastically reduce the radial loading required to re-appose a dissected flap against the aortic wall to ensure reconstitution of the aortic wall (remodeling).

Doppler echocardiography for surveillance of acute cardiac allograft rejection: a 28-year single-center experience.

Background: Endomyocardial biopsies (EMB) are recommended for the detection of acute cardiac rejection (ACR) despite limited sensitivity. We report the long-term post-transplant results of Doppler echocardiography as a noninvasive alternative of routine EMB. Methods: Two cohorts of heart transplantation (HT) recipients were chronologically defined as follows: the Dual Monitoring Cohort (DMC) from January 1990 to December 1997 included patients who underwent routine EMB and Doppler echocardiography within 24 hours for ACR surveillance; and the "Echo-First Cohort" (EFC), including patients transplanted from January 1998 to December 2018 with Doppler echocardiography as first-line approach for ACR surveillance. Echocardiographic measurements of interest were collected: early diastolic (E) wave peak velocity; pressure half time (PHT) and isovolumetric relaxation time (IVRT). Post-transplant outcomes were reviewed and the Kaplan-Meier approach was used for survival estimates. Inter-operator variability for ultrasound measurements was investigated. Data were collected from medical records from January 2019 to December 2020. Results: A total of 228 patients were included, 99 patients in the DMC and 129 in the EFC. Overall, 5-, 10- and 15-year survival rates were 65.4%, 55.5% and 44.1% respectively, without any significant difference between the two cohorts (log rank test, P=0.71). Echocardiography variables and EMB findings were associated with a mean area under the receiver operating characteristic curve (AUC-ROC) of 0.73 [95% confidence interval (CI): 0.54-0.91], 0.74 (95% CI: 0.54-0.94) and 0.75 (95% CI: 0.57-0.94) respectively for E wave, PHT and IVRT. IVRT and PHT were significantly decreased, and E wave significantly increased, in case of histologically proven ACR. Inter-operator variability was not significant for E wave and IVRT measurements (P=0.13 and 0.30 respectively). Conclusions: Doppler echocardiography as a first-line method for surveillance of ACR did not impair long-term results after HT. These findings suggest that this non-invasive approach might be a reasonable alternative to systematic EMB, limiting risk and improving the quality of life.

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.

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.

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.

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.