International Collaborative Study Comparing Outcomes of Fenestrated Endovascular Aortic Repair in OCtogenarian vs Non-Octogenarian Patients: The FEVOC study.

OBJECTIVE: With an increasing life expectancy, more octogenarian patients are referred with complex aortic aneurysms (cAAA). The aim of this study was to evaluate short and mid-term outcomes following fenestrated aortic repair (FEVAR) in octogenarians. SUMMARY BACKGROUND DATA: Few studies looking at octogenarian-specific outcomes with diverging results. METHODS: Retrospective, multicentre cohort study including consecutive patients undergoing elective FEVAR for cAAAs or type IV thoracoabdominal aortic aneurysms between 2007-2022 in eight high-volume centres. Octogenarians vs. non-octogenarians were compared. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival and reintervention rates. RESULTS: A total of 729 patients (median age of 74.8 years [IQR 69.2 - 79.14]) were included, 169 (23%) of which were octogenarians, with 316 (43.3%) patients undergoing juxta/pararenal aneurysm repair. Although octogenarians presented less complex but larger (61 mm vs. 58 mm) aneurysms, the number of fenestrations was similar across groups. No differences in in-hospital mortality (4.1 vs. 3.0%), MAE (16.6% vs 12.2%) or reintervention rates (11.2 vs. 10%) were found. Multivariable logistic regression of in-hospital mortality identified BMI (OR 0.66, 95% CI 0.51-0.95, P=0.003), chronic heart failure (OR 7.70, 95% CI 1.36-36.15, P=0.003) and GFR<45 ml/min/1.73 m2 (OR 5.25, 95% CI 1.20-22.86, P=0.027) as independent predictors. Median follow-up was 41 months. The 1, 2 and 5-year survival rates were 91.3%, 81.8% and 49.5% in octogenarians vs 90.6%, 86.5% and 68.8% in non-octogenarian patients (Log-rank: =0.001). Freedom from aortic-related death and freedom from reintervention at five-years were similar across groups (log-rank=0.94 and .76, respectively). Age>80 was not an independent predictor of 30-day or long-term mortality on multivariable and Cox regression analysis. CONCLUSIONS: Elective FEVAR in octogenarians appears to be safe, with similar outcomes as in younger patients. Future studies looking at improved patient selection methods to ensure long-term survival benefits in both octogenarians and younger patients are warranted.

Endovascular Repair of One-hundred Urgent and Emergent free or Contained Thoraco-abdominal Aortic Aneurysms Ruptures. An International Multi-Center Trans-Atlantic experience.

OBJECTIVE: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA). BACKGROUND: Endovascular repair of rTAAA has been scarcely described in emergent setting. METHODS: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival. RESULTS: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality. CONCLUSION: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival.

Single-Center Experience on the Elective Hybrid Combination of Single Perclose + Angio-Seal VIP 8F Compared With Standard Dual Perclose During Percutaneous Endovascular Aortic Aneurysm Repair.

PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.

Outcomes of Fenestrated and Branched Endografts for Partial and Total Endovascular Repair of the Aortic Arch - A Systematic Review and Meta-Analysis.

OBJECTIVE: Fenestrated and branched thoracic endovascular aortic repair (F/B-TEVAR) of the aortic arch is a viable approach in patients unsuitable for open repair. The aim was to summarise the published results of manufactured F/B-TEVAR devices for partial and total repair of the aortic arch, and to compare fenestrated with branched configurations. DATA SOURCES: PubMed, Scopus and The Cochrane Library were searched for articles (2018 - 2021) about patients with elective, urgent, or emergency aortic requiring a proximal landing zone in the aortic arch (zone 0 - 1 - 2) and treated by F/B-TEVAR. REVIEW METHODS: The systematic review and meta-analysis were performed according to the PRISMA guidelines. Open repair, supra-aortic trunk (SAT) debranching + standard TEVAR, and in situ physician modified and parallel grafts were excluded. Primary outcomes were technical success and 30 day mortality rate. Secondary outcomes were 30 day major adverse events, and overall survival and procedure related endpoints during follow up. RESULTS: Of 458 articles screened, 18 articles involving 571 patients were selected. Indications for intervention were chronic dissections (50.1%), degenerative aneurysms (39.6%), penetrating aortic ulcers (7.4%), and pseudoaneurysms (2%). F-TEVAR, B-TEVAR, and F+B-TEVAR were used in 38.4%, 54.1%, and 7.5% of patients, respectively. Overall, technical success was 95.9% (95% confidence interval [CI] 0.93 - 0.97; I2 = 0%; p for heterogeneity (Het) = .77) and the 30 day mortality rate was 6.7% (95% CI 0.05 - 0.09; I2 = 0%; p Het = .66). No statistical differences were found comparing fenestrated with branched endografts, except for a higher rate of type I - III endoleaks in F-TEVAR (9.8% vs. 2.6%; p = .034). The overall survival rate and freedom from aortic related death at the one year follow up ranged between 82 - 96.4% and 94 - 94.7%, respectively. Thirteen and five studies were considered at moderate and high risk of bias, respectively. CONCLUSION: F/B-TEVAR for the treatment of the aortic arch, according to experience in dedicated centres, now enjoys a satisfactory level of technical success together with a progressively reduced early mortality rate. There are several limitations, and further studies are needed to reach clearer conclusions.

Complications and Technical Success on Upper Limb Vascular Access for Endovascular Repair of Complex Abdominal and Thoraco-abdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis.

BACKGROUND: Catheterization of target vessels (TV) represented by renal visceral vessels are the crucial aspect during fenestrated and branched endovascular repair. This study aims to assess the efficacy and complications associated with upper limb catheterization during complex aneurysm endovascular surgery repair. METHODS: A systematic review was conducted after Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) guidelines, involving a search across PubMed, Cochrane CENTRAL, and Web of Science. Primary endpoint was represented by 30-day stroke. Secondary endpoints were target vessels' (TVs) technical success, 30-day mortality, and local access-related complications. Meta-analyses were performed using a random-effects model. RESULTS: Sixteen observational studies encompassing 4,137 patients were included. The 30-day stroke incidence for upper limb access was 1.4% (95% CI 1.0-1.8%), which was slightly higher than lower limb, despite not statistically significant. Mortality varied between 0 and 6.8%, and local access-related complications occurred in 3.2% (95% CI 1.9-4.4%). Technical success in TV catheterization was 99.2% (95% CI 98.4-100.0%). CONCLUSIONS: This systematic review and meta-analysis demonstrate the safety and efficacy of upper limb access for Fenestrated and Branched Endovascular Aortic Repair (f/b-EVAR), with low stroke risk, mortality rates, and minimal local complications. Despite the risk of bias, the findings suggest that upper limb access may be beneficial, especially in bailout situations when femoral access fails, offering valuable insights for clinical decision-making.

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.

Midterm results of complicated penetrating abdominal aortic ulcer treated by aortobi-iliac endograft and embolization.

BACKGROUND: Penetrating aortic ulcer (PAU) is determined by atherosclerotic degeneration of the tunica media with disruption of the intima. Usually it is detected in the thoracic aorta, with few series describing an abdominal location. The aim of the study was to report early and late outcomes of the endovascular repair of complicated infrarenal abdominal PAU (a-PAU) by aortobi-iliac endograft and embolization. METHODS: Data from all complicated a-PAU submitted to endovascular repair by aortobi-iliac endograft (Cook-Zenith Alpha) between 2016 and 2021 (February) were analyzed. The a-PAU coil embolization was performed to decrease the risk of persistent type II endoleak whenever possible. Complicated a-PAU were defined according with the presence of symptoms, aortic rupture, or saccular or pseudo-aneurysm. Technical success, 30-day morbidity and mortality, and reinterventions were assessed as early outcomes. Survival, endoleaks, and freedom from reinterventions were evaluated during follow-up. RESULTS: Of 1153 endovascular aortic procedures, 45 cases (4%) of complicated a-PAU were identified. Fourteen cases (31%) were managed in urgent setting (symptoms, n = 10 [22%]; shock, n = 4 [9%]). The median diameter of a-PAU was 49 mm (interquartile range, 14 mm). Thirteen patients (29%) had severe femoral or iliac access (angle >90°, circumferential calcification [>50%], hemodynamic iliac stenosis or obstruction, an external iliac artery diameter of less than 7 mm, or a previous femoral surgical graft). The a-PAU embolization was performed in 30 cases (67%). Technical success was achieved in all patients. Postoperative cardiac, pulmonary and renal morbidity occurred in one (2%), two (4%), and eight (18%) patients, respectively. Two patients (4%) required reintervention within 30 days for access related complications. The 30-day mortality was 2%. At a median follow-up of 24 months (interquartile range, 18 months), no type I or III endoleaks, iliac leg occlusion, or graft infection occurred and no patient required late reinterventions; the 36-month survival rate was 72%. No a-PAU enlarged or ruptured during follow-up. CONCLUSIONS: Endovascular repair of complicated a-PAU by a low-profile aortobi-iliac endograft and embolization is safe and effective. Excellent technical results are reported even in challenging anatomic features. Midterm clinical results are satisfactory in terms of aortic-related complications or mortality, freedom from reintervention, and survival.

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.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Transaxillary Branch-to-Branch-to-Branch Carotid Catheterization Technique for Triple-Branch Arch Repair.

PURPOSE: To describe the transaxillary branch-to-branch-to-branch carotid catheterization technique (tranaxillary 3BRA-CCE IT) for cannulation of all supra-aortic vessels using only 1 femoral and 1 axillary access during triple-branch arch repair. TECHNIQUE: After deployment of the triple-branch arch device, catheterization and bridging of the innominate artery (IA) should be performed through a right axillary access (cutdown or percutaneous). Then, the retrograde left subclavian (LSA) branch should be catheterized (if not preloaded) from a percutaneous femoral access, and a 12×90Fr sheath should be advanced to the outside of the endograft. Subsequently, catheterization of the left common carotid artery (LCCA) antegrade branch should be performed, followed by snaring of a wire in the ascending aorta which was inserted through the axillary access, creating a branch-to-branch-to-branch through-and-through guidewire. Over the axillary access, a 12×45Fr sheath should be inserted into the IA branch and looped in the ascending aorta using a push-and-pull technique so that it faces the LCCA branch, allowing for stable catheterization of the LCCA. The retrograde LSA branch should then be bridged following the standard fashion. CONCLUSIONS: This series of 5 patients demonstrates that triple-branch arch repair can be performed with the transaxillary 3BRA-CCE IT, allowing catheterization of the supra-aortic vessels without manipulation of the carotid arteries. CLINICAL IMPACT: The transaxillary 3BRA-CCE IT allows catheterization and bridging of all supra-aortic vessels in triple-branch arch repair through only 2 vascular access points, the femoral artery and the right axillary artery. This technique avoids carotid surgical cutdown and manipulation during these procedures, reducing the risk of access site complications, including bleeding and reintervention, reintubation, cranial nerve lesions, increased operating time, and so on, and has the potential to change the current vascular access standard used during triple-branch arch repair.

New Preloaded System for Renal and Visceral Arteries in Fenestrated Endografting.

AIM/BACKGROUND: The New Preloaded System (NPS) for renal/visceral arteries (TVVs) is an emerging technology in fenestrated endografting (FEVAR) that allows TVVs cannulation and stenting through the same access of the endograft main body. However, only few preliminary experiences are currently available in the literature. The aim of this study is to report the outcomes of NPS-FEVAR in juxta/para-renal (J/P-AAAs) and thoracoabdominal (TAAAs) aneurysms repair. METHODS: This is a prospective (NCT05224219), single-center/observational study of patients submitted to NPS-FEVAR for J/PAAAs and TAAAs between 2019 and 2022 (July). Definitions and outcomes were evaluated according to the current SVS-reporting standard. Technical success (TS) and TS preloaded related, spinal cord ischemia (SCI), and 30-day mortality were assessed as early endpoints. Survival, freedom from reinterventions (FFRs), and freedom from TTVs-instability (FFTVVs-instability) were analyzed during follow-up. RESULTS: Among 157 F/B-EVAR cases, 74 (47%) NPS-FEVAR were planned and enrolled in the study [48 (65%) J/P-AAAs; 26 (35%) TAAAs]. The main indication for NPS-FEVAR was the presence of a hostile iliac axis (54%-73%) or the necessity of expeditious pelvic/lower-limb reperfusion for SCI prevention in TAAAs (20%-27%). Overall, 292 TVVs were accommodated by 289 fenestrations and 3 branches; 188 of 289 (65%) fenestrations were preloaded. NPS-FEVAR configuration was from "below" and "from below to above" in 28 (38%) and 46 (62%) cases, respectively. TS and TS preloaded system-related was 96% (71/74) and 99% (73/74), respectively. Target visceral vessels patency at the completion angiography was 99% (290/292). Failures were 2 renal arteries loss and 1 massive bleeding from a percutaneous closure system breakage. The latter patient developed postoperative multiorgans failure and died on the fifth postoperative day, causing only 30-day/in-hospital mortality (1.3%). One (1.3%) patient with a JAAA and preoperative bilateral occlusion of the hypogastric arteries suffered SCI. The median follow-up was 14 (IQR: 8) months. The estimated 3-year survival was 91% with no aneurysm-related mortality during follow-up. The estimated 3-year FFR and FFTVVs-instability were 85 and 92%, respectively. CONCLUSION: New preloaded system FEVAR is a safe and effective option in the treatment of J/PAAAs and TAAAs in the presence of hostile iliac access or to guarantee an expeditious pelvic/lower limb reperfusion, leading to satisfactory results in terms of TS, early and mid-term clinical outcomes. CLINICAL IMPACT: New preloaded system for fenestrated and branched endografting allows to increase the feasibility of the advanced endovascular aortic repair in challenging iliac access, thoracoabdominal aneurysm repair and reduce difficulties in target visceral vessels cannulation.

Additional Aortic Coverage With an Off The Shelf, Multibranched Endograft Compared With Custom Made Devices For Endovascular Repair of Pararenal Abdominal Aortic Aneurysms.

OBJECTIVE: Pararenal abdominal aortic aneurysms (p-AAA) require complex endovascular aortic repair or open surgical repair with suprarenal clamping. Custom made devices (CMD), including fenestrated and branched endovascular aortic repair (F/B-EVAR) or off the shelf (OTS) multibranched devices, are available treatment options. The aim of this study was to determine the additional healthy aortic coverage using an OTS multibranched endograft vs. a CMD for the treatment of p-AAAs. METHODS: This was a retrospective single centre analysis of prospectively collected data. Consecutive patients with p-AAAs requiring a proximal landing zone above the coeliac artery (CA), planned and treated with CMDs (Zenith Fenestrated) between January 2017 and December 2021 were included in this study. Treatment with supracoeliac coverage using available OTS multibranched devices was simulated using available pre-operative images: T-Branch; E-nside; and TAMBE. Study endpoints included the need for additional proximal aortic coverage, and the number of the segmental arteries additionally covered proximally from the CA for OTS devices compared with CMDs. RESULTS: Eighty three patients with p-AAAs were treated with CMDs (all FEVAR), including juxtarenal AAAs (n = 46; 56%), suprarenal AAAs (n = 20; 24%), and short neck AAAs (n = 17; 20%). In this study, treatment with 249 (3 × 83) OTS endografts was simulated. When compared with CMDs, OTS devices required a mean of 74 ± 19 mm of additional proximal healthy aortic coverage from the CA (CMD: 33 ± 19 mm vs. OTS: 108 ± 6 mm; p ≤ .001), as well as an average sacrifice of 2.5 additional segmental arteries (CMD: 1.3 ± 0.8 vs. OTS: 3.8 ± 0.9; p ≤ .001). In 94% of patients, at least one of the available multibranched endografts could have been implanted in accordance with instructions for use. CONCLUSION: Despite not requiring customisation time, OTS endografts for the treatment of p-AAA lead to more extensive healthy aortic coverage, as well as an average sacrifice of 2.5 additional segmental arteries, compared with CMDs. When compared with OTS devices, CMDs appear to limit the extent of unnecessary aortic coverage and the theoretical subsequent risk of spinal cord ischaemia.

Revascularisation of Chronic Limb Threatening Ischaemia in Patients with no Pedal Arteries Leads to Lower Midterm Limb Salvage.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) involving the infragenicular arteries is treated by distal angioplasty or pedal bypass; however, this is not always possible, due to chronically occluded pedal arteries (no patent pedal artery, N-PPA). This pattern represents a hurdle to successful revascularisation, which must be limited to the proximal arteries. The aim of the study was to analyse the outcome of patients with CLTI and N-PPA after a proximal revascularisation. METHODS: All patients with CLTI submitted to revascularisation in a single centre (2019 - 2020) were analysed. All angiograms were reviewed to identify N-PPA, defined as total obstruction of all pedal arteries. Revascularisation was performed with proximal surgical, endovascular, and hybrid procedures. Early and midterm survival, wound healing, limb salvage, and patency rates were compared between N-PPA and patients with one or more patent pedal artery (PPA). RESULTS: Two hundred and eighteen procedures were performed. One hundred and forty of 218 (64.2%) patients were male, mean age 73.2 ± 10.6 years. The procedure was surgical in 64/218 (29.4%) cases, endovascular in 138/218 (63.3%), and hybrid in 16/218 (7.3%). N-PPA was present in 60/218 (27.5%) cases. Eleven of 60 (18.3%) cases were treated surgically, 43/60 (71.7%) by endovascular and 6/60 (10%) by hybrid procedures. Technical success was similar in the two groups (N-PPA 85% vs. PPA 82.3%, p = .42). At a mean follow up of 24.5 ± 10.2 months, survival (N-PPA 93.7 ± 3.5% vs. PPA 95.3 ± 2.1%, p = .22) and primary patency (N-PPA 53.1 ± 8.1% vs. PPA 55.2 ± 5%, p = .56) were similar. Limb salvage was significantly lower in N-PPA patients (N-PPA 71.4 ± 6.6% vs. PPA 81.5 ± 3.4%, p = .042); N-PPA was an independent predictor of major amputation (hazard ratio [HR] 2.02, 1.07 - 3.82, p = .038) together with age > 73 years (HR 2.32, 1.17 - 4.57, p = .012) and haemodialysis (2.84, 1.48 - 5.43, p = .002). CONCLUSION: N-PPA is not uncommon in patients with CLTI. This condition does not hamper technical success, primary patency, and midterm survival; however, midterm limb salvage is significantly lower than in patients with PPA. This should be considered in the decision making process.

Use of Secondary Iliac Branch Devices after Previous Endovascular Abdominal and Thoraco-Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To assess the safety and effectiveness of iliac branch devices (IBDs), as secondary procedure, for the treatment of type Ib endoleak or evolution of iliac artery disease after prior endovascular aortic repair (EVAR) for thoraco-abdominal (TAAAs) or abdominal aortic aneurysms (AAAs). METHODS: A multicentre observational study of three European centres. The study included 75 patients (age 71 ± 9 years, 96% men) with previous EVAR (n = 64, 85%) or fenestrated or branched (FB) EVAR (n = 11, 15%). Overall, 88 IBDs were implanted to treat aneurysmal iliac artery evolution in 40 (53%) and type Ib endoleak in 35 (47%) cases, respectively. Thirteen (17%) patients received bilateral IBDs. Internal iliac artery (IIA) catheterisation was done through a transaxillary access (n = 82, 93%) or up and over (n = 6, 7%) technique. The primary endpoint was technical success. Secondary endpoints were 30 day major adverse event, early and long term freedom from re-intervention and target vessel instability. RESULTS: All procedures were technically successful (100%). During hospitalisation, there were four (5%) major adverse events and three (4%) early re-interventions, but no death, stroke, or damage to previous endografts. The median follow up was 47 (interquartile range 42) months, and the five year survival rate was 78 ± 6% with no aortic related death. Cox's regression analysis showed pre-operative renal function impairment (hazard ratio [HR] 3.4; 95% confidence interval [CI] 1.1 - 10.1; p = .033), and primary TAAA repair (HR 6.1; 95% CI 1.6-22.3; p = .006) as independent factors for long term mortality. Freedom from re-interventions was 85 ± 4% at five years with 11 (12%) cases (five endoleaks, four IBD thromboses, two stenoses). IIA instability was reported in three (3%) limbs and freedom from IIA instability was 95 ± 3% after 60 months. CONCLUSION: Secondary IBD after EVAR is a safe and effective procedure with high technical success and low complication rates. The technique of choice to revascularise the IIA seems not to affect early and follow up results. Long term durability of IBD repair is acceptable with low rates of IIA re-intervention.

Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry.

OBJECTIVE: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR). METHODS: A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete or complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at one, six, and 12 months. RESULTS: From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 ± 8% and 90 ± 9%, respectively. CONCLUSION: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year.

Infrarenal EVAR for Penetrating Aortic Ulcer: A Comparative Study with Abdominal Aortic Aneurysm.

BACKGROUND: Endovascular aortic repair (EVAR), currently the preferred treatment for abdominal aortic aneurysm (AAA), has been described also for penetrating aortic ulcers (PAU) of the infrarenal aorta. However, data on its performance in this particular setting are still sparse in the literature. Aim of this study is to compare patient clinical characteristics, aorto-iliac features, and post-operative outcomes between infrarenal PAU and AAA treated by standard EVAR. METHODS: In this retrospective observational case-control multicenter study, the patients treated for infrarenal PAU (G1) with EVAR in 2 high-volume European centers from January 2014 to December 2019 were prospectively entered into a dedicated database and retrospectively analyzed. A 4-fold control group (G2) of infrarenal AAA patients, homogeneous for age and gender, was also considered. Preoperative clinical characteristics, aorto-iliac features (rupture, aortic maximum diameter, proximal neck diameter and length, aortic bifurcation diameter, distance between the lowest renal artery and the aortic bifurcation [RA-AoBi], severe aortic calcification), technical success, 30-day (morbidity, reintervention, complications, mortality) and follow-up outcomes (freedom from reintervention [FFR] and survival) were compared in the 2 groups (chi square/Fisher exact test, t-student test, Mann-Whitney test, logistic regression and Kaplan-Meier analysis). RESULTS: Seventy-three patients (age 78 ± 7 years; male 84.9%) were included in G1 and 299 (age 78.4 ± 6.6 years; male 89.3%) in G2. At the time of diagnosis, G1 patients were more often symptomatic compared with G2 (odds ratio OR 10.21, 95% confidence interval CI 4.17-24.99, P < 0.001). At preoperative computed tomography angiography, G1 patients had more ruptures (OR 8.11, 95% CI 3.50-18.78, P < 0.001), smaller maximum diameter (OR 1.05, 95% CI 1.03-1.08, P < 0.001), longer and narrower proximal neck (OR 0.97, 95% CI 0.95-0.99, P = 0.020 and OR 1.47, 95% CI 1.32-1.64, P < 0.001, respectively) narrower aortic bifurcation (OR 1.34, 95% CI 1.24-1.45, P < 0.001), lower RA-AoBi (OR 1.09, 95% CI 1.07-1.12, P < 0.001), and more severe aortic calcification (OR 57, 95% CI 16-198, P = 0.001). Technical success (G1 98.6% vs G2 95.7% P = 0.320), 30-day morbidity (G1 2.7% vs G2 8.7% P = 0.133), reintervention (G1 2.7% vs G2 2.3% P = 0.691), complications (G1 6.8% vs G2 8% P = 0.737) and mortality (G1 1.4% vs 2% P = 0.720) were comparable in the 2 groups. The mean follow-up was 17.7 ± 16.4 months in G1 and 18.8 ± 15.1 in G2 (P = 0.576). Late FFR and survival were comparable in the 2 groups (1-year FFR: G1 94.8% vs G2 97.5%, P = 0.995; 1-year survival: G1 91.7% vs G2 92.3%, P = 0.960). CONCLUSIONS: Infrarenal PAU are more often symptomatic with a higher rupture rate compared to infrarenal AAA. Despite some negative anatomical characteristics (narrower aortic bifurcation, lower RA-AoBi, extensive calcification), the results of EVAR are extremely satisfactory in this setting, suggesting that endovascular exclusion could be considered a valid treatment for infrarenal PAU.

Anatomical feasibility of the current endovascular solutions for Juxtarenal aortic abdominal aneurysm repair.

PURPOSE: Endovascular repair of juxta-renal aneurysms (JAAAs) can be achieved by fenestrated endografts (FEVAR), parallel-grafts (CHEVAR) and standard abdominal endografts + endoanchors (ESAR). Aim of this study was to evaluate the incidence of their anatomical feasibility in JAAAs. MATERIALS AND METHODS: All patients submitted to JAAAs treatment from 2006 to 2019 were retrospectively analyzed, irrelevant of the procedure performed. Juxta-renal aneurysm was defined according with the current ESVS clinical practice guidelines. Preoperative computed tomography angiographies were analyzed to evaluate the anatomical feasibility of: FEVAR (Cook Zenith-platform; CE-marked or custom-made device), CHEVAR (Medtronic Endurant + Atrium Advanta - CE marked combination) and ESAR (Medtronic Endurant + Helifix - CE marked combination) according with the manufactures' instruction for use. The anatomical feasibility of these three endovascular solutions was assessed according with the proximal neck, target visceral vessels (TVVS) and iliac access characteristics. RESULTS: Ninety-nine cases were considered. There were no cases of frank aortic rupture and in all patients at least one arterial access from above was available. Fenestrated endograft, CHEVAR, and ESAR were anatomically feasible in 93 (94%), 37 (37%), and 27 (27%) cases, respectively (p <. 001). Fenestrated endograft requires design with <3, three and >3 fenestrations in 29 (31%), 33 (36%), and 31 (33%) cases, respectively. Parallel graft technique have required 1 or 2 parallel graft configurations in 12 (12%) and 25 (25%) cases, respectively. Among the 14 cases with aneurysm diameter >70 mm, the anatomical feasibility of FEVAR, CHEVAR, and ESAR was 13(93%), 4(29%), and 4 (29%) cases, respectively (p < .001). CONCLUSION: Fenestrated endograft is more frequently applicable than CHEVAR and ESAR as endovascular treatment of JAAAs. Since this difference is valid also in aneurysms with diameter >70 mm, the issue of a rapid availability is of paramount importance. The 6% of cases have not any endovascular solution and requires open surgery.

Effect of iliac tortuosity on outcomes after iliac branch procedures.

OBJECTIVE: To report a two-centers evaluation of the effects of iliac axis tortuosity on iliac branch device (IBD) results. METHODS: From 2015 to 2021, all IBD procedures performed at two European centers were analyzed retrospectively. The preoperative pelvic tortuosity index (PTI), external tortuosity index (ETI), and double iliac sign (DIS) were assessed for each iliac axis submitted to IBD. The primary endpoints were technical success, early and mid-term IBD complications (occlusion, stenosis, endoleaks [ELs]) and reinterventions, and the association with the PTI, ETI, and DIS. The 30-day mortality, survival, freedom from complications and freedom from reinterventions (FFR) were the secondary endpoints. RESULTS: During the study period, 224 patients had undergone 256 IBD procedures for 165 (64.5%) aortoiliac aneurysms, 44 (17.2%) isolated iliac aneurysms, 11 (4.3%) abdominal aortic aneurysms with a short iliac landing zone, and 36 (14.1%) type Ib ELs. IBD was planned with endovascular aortic aneurysm repair for 158 (61.7%), fenestrated/branched endovascular aortic aneurysm repair for 45 (7.6%), and isolated for 53 (20.7%) cases. Technical success and 30-day mortality were 99.2% (254 of 256) and 0.9% (2 of 224), respectively. A PTI >1.4, an ETI >1.7, and the DIS were tested to identify the risk factors for the endpoints. No ELs and 9 (3.5%) IBD occlusions, requiring five reinterventions (2%), had occurred within 30 days. No association with the PTI, ETI, or DIS was identified; IBD oversizing of ≥25% on the external iliac artery was independently related to occlusion (odds ratio, 4.3; 95% confidence interval [CI], 1-18.1; P = .045). The mean follow-up was 31 ± 27 months, with 11 IBD occlusions, 14 ELs, and 21 reinterventions. At 1, 3, and 5 years of follow-up survival, IBD patency, and FFR were 95%, 89%, and 80%; 93%, 91%, and 90%; and 93%, 89%, and 83%, respectively. The risk factors for overall complications (n = 34; 13.3%) and reinterventions (n = 26; 10.2%) were an ETI >1.7 (P = .037 and P = .019), a PTI >1.4 (P = .016 and P = .012), and a type Ib EL as the indication (P = .025 and P = .001), respectively. Cox regression confirmed PTI >1.4 as an independent predictor of overall complications and reinterventions (hazard ratio [HR], 2.3; 95% CI, 1.1-4.4; P = .018; and HR, 3 95% CI, 1.3-6.8; P = .018, respectively) and ETI >1.7 as an independent risk factor for ELs (HR 6; 95% CI, 2.1-17.5; P = .001). The freedom from complications and FFR were significantly lower with a PTI >1.4 at 3 years (73% vs 92% [log-rank P = .01] and 77% vs 93% [log-rank P = .001], respectively). CONCLUSIONS: We found IBDs to be safe and effective in the treatment of aortoiliac aneurysms. Early complications are uncommon and related to endograft oversizing rather than anatomic characteristics in the present study. Iliac tortuosity is a risk factor for overall complications and reinterventions, in particular for IBD-related ELs.

Use of Shockwave Intravascular Lithotripsy in Recanalization of Calcified Visceral and Renal Arteries: A Case Report and Update of the Literature.

PURPOSE: Calcifications of the visceral and renal arteries lead to chronic mesenteric ischemia and renal artery stenosis, and both open and endovascular treatments can be proposed. Intravascular lithotripsy (IVL) has emerged as a novel technique used in peripheral and coronary interventions. CASE REPORT: A 73-year-old man presented with chronic postprandial abdominal pain and weight loss. Computed-tomography-angiography (CTA) showed 93% calcified stenosis of the superior mesenteric artery (SMA). The plain old balloon angioplasty (POBA) was affected by immediate recoiling. The patient underwent ShockwaveTM IVL of the SMA via brachial access and stent-graft implantation. At 3-months follow-up, the patient showed symptoms resolution. CONCLUSIONS: The use of Shockwave IVL can be an effective treatment for severely calcified SMA stenosis. A similar approach can be employed in both celiac and renal arteries as reported in 11 cases in literature and herein summarized. Intravascular lithotripsy resulted in high technical success and uneventful follow-up. However, given the small number of patients reported, larger studies are needed to confirm these findings. CLINICAL IMPACT: This article reports a case of recanalization of superior mesenteric artery with heavily calcified lesion treated with intravascular lithotripsy (IVL) with Shockwave™ Intravascular Lithotripsy Balloon (Shockwave Medical Inc., Santa Clara, CA, USA). Beside, for the first time, we summarize the Literature on the use of IVL in the renal and visceral arteries district, providing indications, applications and useful hints for the endovascular treatment of chronic mesenteric ischemia and renal artery stenosis. This preliminary data show straightforward applicability, high technical success, and uneventful follow-up and IVL can be proposed as an useful tool for challenging revascularization of heavily calcified reno-visceral arteries.

Endovascular Repair With Triple Inner-Branch Endograft for Aberrant Subclavian Artery Aneurysm: A Case Report.

BACKGROUND: Endovascular repair of the thoracic aorta (TEVAR) is the preferred option for the treatment of the distal arch and descending thoracic aorta. Fenestrated and branched TEVAR have become an option to treat pathologies of the aortic arch, avoiding sternotomy and cardiopulmonary arrest as well as total surgical debranching. We describe here the case of a symptomatic patient with an arteria lusoria aneurysm associated with Kommerel diverticulum who underwent total endovascular repair with a triple-branched TEVAR. CASE REPORT: A 66-year-old male patient was treated for a symptomatic arteria lusoria artery associated with a Kommerel diverticulum, resulting in difficulty swallowing and choking. We used a custom-made triple inner-branch endograft (Cook Medical, Bloomington, Indiana) following implantation of a right-sided carotid-subclavian (C-S) bypass. The C-S bypass occluded in the interval time between the 2 procedures and required recanalization and stent-graft placement during the aortic arch procedure. The arteria lusoria was embolized with a vascular plug. No complications occurred and postoperative tomography showed exclusion and thrombosis of the Kommerel diverticulum and perfusion of the supra-aortic vessels. CONCLUSIONS: Treatment of arteria lusoria aneurysms can be performed with total endovascular arch inner-branch repair, avoiding increased risk of morbidity and mortality caused by open or hybrid procedures.