Fate of primary determinate and indeterminate target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to investigate the outcomes of primary determinate and indeterminate target vessel endoleaks (TVELs) after fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: We conducted a single-center retrospective study (2014-2023) on F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). TVELs were classified as "primary" if present at the first postoperative computed tomography angiogram. Endoleaks were defined "determinate" (dELs) if the cause (type Ic or IIIc) and implicated target vessel were identifiable and "indeterminate" (iELs) if contrast enhancement was detectable at the level of fenestrations/branches without any evident source. Endoleaks involving multiple inflows (type II and target vessels) were defined as "complex" (cELs). Endpoints were endoleak spontaneous resolution, 1-year aneurysm sac failure to regress (>5 mm diameter decrease), and 4-year endoleak-related secondary interventions. Kaplan-Meier estimates and Cox regression were used for the analysis. RESULTS: There were 142 patients with JRAAs/PRAAs (n = 85; 60%) or TAAAs (n = 57; 40%), with 513 target arteries incorporated through a fenestration (n = 294; 57%) or directional branch (n = 219; 43%). Fifty-nine primary TVELs (12%) were identified in 35 patients (25%), a dEL in 20 patients (14%) and iEL in 15 (11%); 22 (15%) had a determinate or indeterminate cEL. Overall spontaneous resolution rate was 75% (95% confidence interval [CI], 51%-87%) at 4 years. cELs (odds ratio [OR], 5.00; 95% CI, 1.10-49.4; P < .001) and iELs after BEVAR (OR, 9.43; 95% CI, 3.41-56.4; P = .002) were more likely to persist >6 months, and persistent forms were associated with sac failure to regress at 1 year (OR, 1.72; 95% CI, 1.03-12.59; P = .040). Overall freedom from endoleak-related reinterventions was 85% (95% CI, 79%-92%) at 4 years, 92% (95% CI, 87%-97%) for those without primary TVELs and 62% (95% CI, 46%-84%) for those with any primary TVEL (P < .001). In particular, cELs (hazard ratio, 1.94; 95% CI, 1.4-18.81; P = .020) were associated with an increased need for reintervention. In case a secondary intervention was needed, iEL or cEL had an increased risk for multiple secondary procedures (hazard ratio, 2.67; 95% CI, 1.22-10.34; P = .034). CONCLUSIONS: Primary TVELs are frequent after F-BEVAR, and a clear characterization of the endoleak source by computed tomography angiogram is not possible in 40% of patients. Most primary TVELs spontaneously resolve, but during follow-up, patients with any primary TVEL experience a worsened freedom from endoleak-related reinterventions that is mostly driven by persistence of cELs and post-BEVAR iELs. Multiple secondary procedures may be required in case of iELs or cELs.

Effect of narrow paravisceral aorta on target vessel instability after fenestrated and branched endovascular aortic repair.

OBJECTIVE: To investigate the effect of narrow paravisceral aorta (NPA) on target vessel instability (TVI) after fenestrated-branched endovascular aortic repair. METHODS: We conducted a single-center retrospective study (2014-2023) of patients treated by fenestrated-branched endovascular aortic repair for thoracoabdominal aortic aneurysms (TAAA) or pararenal aortic aneurysms. The paravisceral aorta was defined as the aortic segment limited by the diaphragmatic hiatus proximally and the emergence of lower renal artery distally, and was considered "narrow" in case of a minimum inner diameter of <25 mm. The minimum aortic diameter, location, longitudinal extension, angulation, calcification, and thrombus thickness of NPA were evaluated at the preoperative computed tomography angiogram. End points were 30-day technical success and freedom from TVI. RESULTS: There were 142 patients with JRAA/pararenal aortic aneurysm (n = 85 [59%]) and extent IV (n = 24 [17%]) or extent I-III (n = 33 [23%]) TAAA, with 513 target arteries successfully incorporated through a fenestration (n = 294 [57%]) or directional branch (n = 219 [43%]). A NPA was present in 95 patients (70%), 73 (86%) treated by fenestrated endovascular aortic repair (FEVAR) and 22 (39%) by branched endovascular aortic repair (BEVAR). The overall 30-day mortality was 2% and technical success was 99%, without differences between NPA and non-NPA (P = .99). Kaplan-Meier estimated freedom from TVI at 4 years was 82%, 81% (95% CI, 75-95) in patients with a NPA and 80% (95% CI, 68-94) and in those without NPA (P = .220). The result was maintained for both FEVAR (NPA: 81% [95% CI, 62-88]; non-NPA: 76% [95% CI, 60-99]; P = .870) and BEVAR (NPA: 77% [95% CI, 69-99]; non-NPA: 80% [95% confidence interval (CI) 66-99]; P = .100). After multivariate analysis, the concomitant presence of a NPA <20 mm and angulation of >30° was significantly associated with TVI in FEVAR (HR, 3.21; 95% CI, 1.03-48.70; P = .036), being the result mostly driven by target vessel occlusion. In BEVAR, a NPA diameter of <25 mm was not associated with TVI (HR, 2.02; 95% CI, 0.59-5.23; P = .948); after multivariate analysis, the use of outer branches in case of a NPA longitudinal extension of >25 mm (hazard ratio [HR], 3.02; 95% CI, 1.01-36.33; P = .040) and NPA severe calcification (HR, 1.70; 95% CI, 1.00-22.42; P = .048) were associated with a higher chance for TVI. CONCLUSIONS: FEVAR and BEVAR are both feasible in cases of NPA and provide satisfactory target vessels durability. The use of outer branches should be avoided in cases with an inner aortic diameter of <25 mm with a longitudinal extension of >25 mm or moderate to severe NPA calcifications. In FEVAR, bridging stent patency may be negatively influenced by NPA of <20 mm in association with aortic angulation of >30°.

Outcomes of off-the-shelf preloaded inner branch device for urgent endovascular thoraco-abdominal aortic repair in the ItaliaN Branched Registry of E-nside EnDograft.

OBJECTIVE: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). METHODS: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. RESULTS: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. CONCLUSIONS: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair.

Role of intravascular ultrasound for the technical assessment of endovascular reconstruction of the aortic bifurcation.

OBJECTIVE: The aim of this study was to evaluate the role of intravascular ultrasound (IVUS) for the technical assessment of kissing stents (KSs) and covered endovascular reconstruction of the aortic bifurcation (CERAB) in the treatment of aortoiliac obstructive disease involving the aortic bifurcation. METHODS: We conducted a single-center retrospective review of patients undergoing endovascular treatment of severe aorto-iliac obstructive disease (2019-2023). IVUS was performed in patients treated by KSs or CERAB according to preoperative indications, in cases of moderate/severe calcifications, mural thrombus, total occlusions, and lesion extension towards the proximity of renal or hypogastric arteries. Indications for IVUS-guided intraoperative revisions were residual stenosis or compression >30%, incomplete stent-to-wall apposition, or flow-limiting dissection at the landing site. Follow-up assessment was performed at 6 and 12 months, and then yearly. Thirty-day outcomes and 2-year patency rates were evaluated. Logistic regression was used to identify factors associated with significant technical defects detected by IVUS needing intraoperative revision. RESULTS: IVUS was used for the technical assessment of 102 patients treated by KSs (n = 57; 56%) or CERAB (n = 45; 44%) presenting with severe intermittent claudication (39%), rest pain (39%), or ischemic tissue loss (25%). Twenty-nine significant technical defects were identified by IVUS in 25 patients (25%) who then had successful intraoperative correction by additional ballooning (n = 23; 80%) or stenting (n = 6; 20%). Patients with a severely calcified chronic total occlusion (odds ratio, 1.85; 95% confidence interval, 1.01-5.27; P = .044) or severely calcified narrow aortic bifurcation with <12 mm diameter (odds ratio, 2.34; 95% confidence interval, 1.10-8.64; P = .032) were at increased risk for IVUS-guided intraoperative revision. There were no postoperative deaths and no major adverse events. Two-year primary patency was 100%. CONCLUSIONS: IVUS was used for the technical assessment of KSs/CERAB in a selected cohort of patients with severe aorto-iliac obstructive disease. This allowed the identification and intraoperative correction of a significant technical defect not detected by completion angiogram in one-quarter of patients, achieving optimal 2-year results. IVUS assessment of KSs/CERAB may be considered especially in patients with a calcified total occlusion or narrow aortic bifurcation.

Comparative outcomes of aortobifemoral bypass with or without previous endovascular kissing stenting of the aortoiliac bifurcation.

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Rotational Mechanical Thrombectomy to Treat Iliac Limb Occlusion after Endovascular Aortic Aneurysm Repair: The Rotational Mechanical Thrombectomy Italian Study.

PURPOSE: To assess the safety and effectiveness of a rotational mechanical atherothrombectomy device in patients with symptomatic iliac limb occlusion after abdominal endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted on patients who underwent rotational mechanical thrombectomy using the Rotarex S device for symptomatic acute, subacute, or chronic graft limb thrombosis at 5 vascular centers between 2017 and 2021. This study comprised 23 male patients with a mean age of 74.5 years (SD ± 7.2) at the time of the procedure. The clinical presentation of the patients varied, with 1 patient experiencing acute limb ischemia and 11 patients (47.8%) experiencing disabling intermittent claudication. The remaining patients developed chronic limb-threatening ischemia after iliac limb occlusion. Early outcomes included technical success, postprocedural complications, and periprocedural mortality. Follow-up evaluations encompassed primary patency, patient survival, freedom from reintervention, and the need for surgical conversion. RESULTS: Technical success was achieved in all cases, with no occurrences of distal embolization during or after the procedure, and no periprocedural deaths were reported. Endograft relining was performed in 82.6% of patients to establish a new, nonthrombogenic surface within the graft. Over a median follow-up period of 8 months (interquartile range, 3-16 months), 2 patients experienced iliac limb reocclusion. No deaths or other reinterventions occurred during the observational follow-up period. CONCLUSIONS: Rotational mechanical thrombectomy for iliac limb occlusion after EVAR appears to be both safe and effective. This technique may uncover intraluminal defects contributing to graft occlusion and enable their resolution within the same procedure.

Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels.

OBJECTIVE: The use of intravascular ultrasound (IVUS) reduces contrast medium use and radiation exposure during conventional endovascular aneurysm repair (EVAR). The aim of this study was to evaluate the safety and efficacy of IVUS in detecting bridging stent graft (bSG) instability during fenestrated and branched EVAR (F/B-EVAR). METHODS: This was a prospective observational multicentre study. The following outcomes were evaluated: (1) technical success of the IVUS in each bSG, (2) IVUS findings compared with intra-operative angiography, (3) incidence of post-operative computed tomography angiography (CTA) findings not detected with IVUS, and (4) absence of IVUS related adverse events. Target visceral vessel (TVV) instability was defined as any branch or fenestration issues requiring an additional manoeuvre or re-intervention. Any IVUS assessment that detected stenosis, kinking, or any geometric TVV issue was considered to be branch instability. All procedures were performed in ad hoc hybrid rooms. RESULTS: Eighty patients (69% males; median age 72 years; interquartile range 59, 77 years) from four aortic centres treated with F/B-EVAR between January 2019 and September 2021 were included: 70 BEVAR (21 off the shelf; 49 custom made), eight FEVAR (custom made), and two F/B-EVAR (custom made), for a total of 300 potential TVVs. Two TVVs (0.7%) were left unstented and excluded from the analysis. The TVVs could not be accessed with the IVUS catheter in seven cases (2.3%). Furthermore, 17 (5.7%) TVVs could not be examined due to a malfunction of the IVUS catheter. The technical success of the IVUS assessment was 91.9% (274/298), with no IVUS related adverse events. Seven TVVs (2.5%) showed signs of bSG instability by means of IVUS, leading to immediate revisions. The first post-operative CTA at least 30 days after the index procedure was available in 268 of the 274 TVVs originally assessed by IVUS. In seven of the 268 TVVs (2.6%) a re-intervention became necessary due to bSG instability. CONCLUSION: This study suggests that IVUS is a safe and potentially valuable adjunctive imaging technology for intra-operative detection of TVV instability. Further long term investigations on larger cohorts are required to validate these promising results and to compare IVUS with alternative technologies in terms of efficiency, radiation exposure, procedure time, and costs.

Editor's Choice - Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

Impact of Carotid Stent Design on Embolic Filter Debris Load During Carotid Artery Stenting.

BACKGROUND: The carotid stent design may influence the risk of embolization during carotid artery stenting. The aim of the study was to assess this risk by comparing the quantity of embolized material captured by filters during carotid artery stenting, using different stent designs. METHODS: We conducted a single-center retrospective study of patients undergoing carotid artery stenting for asymptomatic carotid stenosis >70% (2010-2022) in a tertiary academic hospital (Padua University Hospital, Italy). Carotid stents were classified according to their design as open-cell (OCS), closed-cell (CCS), or micromesh stents (MMS). A distal filter protection was used in all patients, and the amount of captured embolized particles was semiautomatically analyzed using a dedicated software (Image-Pro Plus, Media Cybernetics). Primary end point was embolic filter debris (EFD) load, defined as the ratio of the filter area covered by particulate material to the total filter area. Secondary end points were 30 days major stroke and death. RESULTS: Four-hundred-eighty-one carotid artery stentings were included; 171 (35%) using an OCS, 68 (14%) a CCS, and 242 (50%) a MMS. Thirty-days mortality was 0.2% (n=1) and major stroke rate was 0.2% (P=0.987). Filters of patients receiving MMS were more likely to be free from embolized material (OCS, 30%; CCS, 13%; MMS, 41%; P<0.001) and had a lower EFD load (OCS, 9.1±14.5%; CCS, 7.9±14.0%; MMS, 5.0±9.1%; P<0.001) compared with other stent designs. After stratification by plaque characteristics, MMS had a lower EFD load in cases of hypoechogenic plaque (OCS, 13.4±9.9%; CCS, 10.9±8.7%; MMS, 6.5±13.1%; P<0.001), plaque length>15 mm (OC, 10.2±15.3; CC, 8.6±12.4; MM, 8.2±13.6; P<0.001), and preoperative ipsilateral asymptomatic ischemic cerebral lesion (OCS, 12.9±16.8%; CCS, 8.7±19.5%; MMS, 5.4±9.7%; P<0.001). After multivariate linear regression, use of MMS was associated with lower EFD load (P=0.038). CONCLUSIONS: The use of MMS seems to be associated with a lower embolization rate and EFD load, especially in hypoechogenic and long plaques and in patients with a preoperative evidence of asymptomatic ischemic cerebral lesion.

NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System.

OBJECTIVE: To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. SUMMARY BACKGROUND DATA: The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. METHODS: Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method. RESULTS: Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year. CONCLUSIONS: The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.

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.

Prevalence, risk factors, and clinical effect of coronary artery disease in patients with asymptomatic bilateral carotid stenosis.

OBJECTIVE: In the present report, we have described the prevalence, risk factors, and clinical effects of coronary artery disease (CAD) for patients with asymptomatic bilateral carotid stenosis. METHODS: We conducted a single-center, retrospective cohort study of consecutive patients referred for bilateral carotid stenosis >70% (2014-2021). All the patients had undergone systematic coronary angiography. Depending on the anatomic and clinical characteristics, the patients had undergone combined carotid endarterectomy (CEA) plus coronary artery bypass grafting, coronary percutaneous intervention followed by CEA or carotid artery stenting (CAS), or staged bilateral CEA with cardiac best medical therapy. The cumulative 30-day stroke/myocardial infarction (MI) rate after cardiac and bilateral carotid interventions and long-term survival and freedom from cardiovascular mortality were assessed. RESULTS: A total of 167 patients with bilateral carotid stenosis >70% had undergone preoperative coronary angiography, identifying severe CAD in 108 patients (65.1%). Echocardiographic abnormalities (odds ratio [OR], 2.07; 95% confidence interval [CI], 1.03-5.78; P = .04) and prior coronary intervention (OR, 11.94; 95% CI, 2.99-63.81; P = .001) were significantly associated with severe CAD. CAD was treatable in 91 patients (84%) and untreatable in 17 (16%). The cumulative MI rate was 4.8%; 5.6% for the patients with severe CAD and 1.7% for those without severe CAD (P = .262). The cumulative stroke rate was 1.8%; 1.8% for those with severe CAD and 1.7% for those without severe CAD (P = 1.00). The overall stroke/MI rate was 6.6%; 8.3% for those with severe CAD and 3.3% for patients without severe CAD (P = .33). Patients with severe CAD deemed untreatable for coronary bypass or percutaneous intervention had a higher risk of perioperative stroke/MI (OR, 1.24; 95% CI, 1.00-2.83; P = .04). At 10 years, overall survival was 67.1% (95% CI, 57%-79%), and freedom from cardiovascular mortality was 78.5% (95% CI, 69%-89%). Patients with untreatable CAD maintained a higher risk of 10-year mortality (hazard ratio, 5.5; 95% CI, 1.6-19.9; P < .01). CONCLUSIONS: In the present study, the prevalence of CAD in patients with bilateral carotid stenosis was high, especially for those with abnormal echocardiographic findings. CAD was potentially treatable in 80% of patients, and staged or simultaneous CAD treatment was performed with an acceptable stroke/MI complication rate for these patients. The presence of untreatable CAD was associated with worsened early and long-term outcomes, questioning the benefit of carotid interventions for this subset of patients.

Midterm results on a new self-expandable covered stent combined with branched stent grafts: Insights from a multicenter Italian registry.

OBJECTIVE: To investigate the technical periprocedural and midterm outcomes of endovascular repairs with multibranched endovascular repair or iliac branch devices combined with a new self-expanding covered stent. METHODS: The COvera in BRAnch registry is a physician-initiated, multicenter, ambispective, observational registry (ClinicalTrials.gov Identifier: NCT04598802) enrolling patients receiving a multibranched endovascular repair or iliac branch devices procedure mated with Bard Covera Plus (Tempe, AZ) covered stent, designed to evaluate the outcomes of the covered stent mated with patient-specific and off-the-shelf branched stent graft. Primary end points were technical success, branch instability, and freedom from aortic and branch-related reintervention within 30 days and at follow-up. Preoperative characteristics, comorbidities, and outcomes definitions were graded according to the Society for Vascular Surgery reporting standards. RESULTS: Two hundred eighty-four patients (76 years; range, 70-80 years; 79% males) in 24 centers were enrolled for a total of 708 target vessels treated. The covered stents were mated with an off-the-shelf graft in 556 vessels (79%) and a custom-made graft in 152 (21%). Three hundred seven adjunctive relining stents in 277 vessels (39%) were deployed, of which 116 (38%) were proximal, 66 (21%) intrastent, and 125 (41%) distal. Adjunctive relining stent placement was more frequent when landing in a vessel branch instead of the main trunk (59% vs 39%; P = .031), performing a percutaneous access (49% vs 35%; P < .001), using a stent with a diameter of 8 mm or greater (44% vs 36%; P = .032) and a length of 80 mm or greater (65% vs 55%; P = .005), when a post-dilatation was not performed (45% vs 29%; P < .001) and when an inner branch configuration was used (55% vs 35%; P < .001). Perioperative technical bridging success was 98%. Eight patients (3%) died in the perioperative period. Two deaths (1%) were associated with renal branch occlusion followed by acute kidney injury and paraplegia. Follow-up data were available for 638 vessels (90%) at a median of 32 months (Q1, Q3, 21, 46). Branch instability was reported in 1% of branches. Forty-six patients (17%) died during follow-up, nine (3%) of them owing to aortic-related causes. Primary patency rates at 1, 2, and 3 years were 99% (581/587), 99% (404/411), and 97% (272/279), respectively. Branch instability was associated with patient-specific devices (9% vs 4%; P = .014) and intrastent adjunctive stent placement (12% vs 2%; P = .003), especially when a bare metal balloon-expandable stent was used (25% vs 3%; P < .001). CONCLUSIONS: The use of this new self-expanding covered stent mated with branched endografts proved to be safe and feasible with high technical procedural success rates. Low rates of branch instability were observed at midterm follow-up. Comparative studies with other commercially available covered stents are warranted.

Results of iliac branch devices for hypogastric salvage after previous aortic repair.

OBJECTIVE: The aim of this multicentric study was to assess the "REsults of iliac branch deviceS for hypogastriC salvage after previoUs aortic rEpair (RESCUE)." METHODS: All consecutive patients who underwent implantation of iliac branch devices (IBDs) after previous open aortic repair (OAR) or endovascular aortic repair (EVAR) at seven centers were captured. The study cohort was divided into two groups according to the type of repair originally performed. Early outcomes included immediate technical success and perioperative adverse events. Late outcomes included survival, side branch (SB) primary patency, SB instability, and new onset buttock claudication. RESULTS: A total of 94 patients (82 male) were included in the study, 10 of them received bilateral implantation of IBDs. This resulted in a total of 104 devices included in the final analysis. Indication for treatment were endoleak 1b or progressive iliac aneurysmal degeneration or distal para-anastomotic aortic aneurysms; 73 were implanted after previous EVAR and 31 after previous OAR. Technical success was 100% in both groups. The 3-year rate of freedom from SB instability was 90.1% after previous EVAR and 85.4% after previous OAR, respectively (P = .05). The 3-year estimates of SB primary patency were significantly lower in patients who had received OAR as compared with those that had received EVAR (89.8% vs 94.9%; P = .05). CONCLUSIONS: Endovascular treatment with IBDs following previous OAR or EVAR is safe and effective up to 3 years. Freedom from SB instability during follow-up was lower in patients who had previously undergone OAR than EVAR.

Early outcomes of the Conformable endograft in severe neck angulation from the Triveneto Conformable Registry.

OBJECTIVE: The study reports retrospective evaluation of early outcomes from a multicentric experience with the Excluder conformable endograft with active control system (CEXC Device) in the treatment of abdominal aortic aneurysms. Its design allows more flexibility, given by proximal unconnected stent rows and a bending wire within the delivery catheter enables control of proximal angulation. This study specifically focuses on the severe neck angulation (SNA) subgroup (≥60°). METHODS: All patients treated with CEXC Device in nine vascular surgery centers of Triveneto area (Northeast Italy) between January 2019 and July 2022 were enrolled prospectively and analyzed retrospectively. Demographic and aortic anatomical characteristics were evaluated. Endovascular aneurysm repair in SNA were selected for analysis. Major investigated outcomes were technical success, endoleaks, morbidity, mortality, and reinterventions at 30 days and during follow-up. Endograft migration and postoperative aortic neck angulation changes were also analyzed. RESULTS: A total of 129 patients were enrolled. An infrarenal angle of ≥60° was observed in 56 patients (43%) (SNA group) and their data analyzed. The mean patient age was 78.9 ± 5.9 years and median abdominal aortic aneurysm diameter 59 mm (range, 45-94 mm). Median aortic infrarenal neck length, angulation and diameter were 22 mm (range, 13-58 mm), 77° (range, 60°-150°), and 22.0 ± 3.5 mm respectively. Analysis revealed a technical success rate of 100% and perioperative major complication rate of 1.7%. Intraoperative and perioperative morbidity and mortality rates were 3.5% (one buttock claudication and one inguinal surgical cutdown) and 0%, respectively. No perioperative type I endoleaks were observed. The median follow-up was 13 months (range, 1-40 months). Five patients died during follow-up from aneurysm-unrelated causes. Two reinterventions occurred (3.5%): one conversion for a type IA endoleak and one sac embolization for a type II endoleak. Aneurysm sac shrinkage was observed in 15 patients (26%) and aneurysm stability in 35 patients (62%), respectively. Estimated freedom from reinterventions at 24 months was 92%. Aortic neck median postoperative angulation was 75° (range, 45°-139°). CONCLUSIONS: The Triveneto Conformable Registry shows good early results of the CEXC device in severely angulated aortic infrarenal necks. These data need confirmation on longer follow-up and a wider cohort of patients to further increase endovascular aneurysm repair eligibility in SNA.

Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia.

OBJECTIVE: The aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). METHODS: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. RESULTS: At 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). CONCLUSIONS: Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

Physician-Modified Single-Fenestrated EndoSuture Aneurysm Repair (FESAR) for Urgent Juxtarenal AAA Repair.

PURPOSE: To describe the endovascular treatment of a symptomatic juxtarenal abdominal aortic aneurysm (JAAA) using a combination of endoanchors (Heli-FX EndoAnchor, Medtronic, Minneapolis, Minnesota) and a physician-modified single-fenestrated endograft. TECHNIQUE: An 85 year-old patient unfit for open aortic repair presented for a symptomatic JAAA, characterized by an infrarenal neck with 0.6 cm in length and 23 mm in diameter. A 28 mm-diameter Endurant aortic cuff (Medtronic, Minneapolis, Minnesota) was modified with a single fenestration for the left renal artery (LRA) and diameter-reducing tie, then re-sheathed and deployed. The LRA was cannulated with a 7F sheath and the constraining wire was withdrawn. Being the shortest neck length on the right side of the cuff, the endograft was anchored to the aortic wall on this side with 2 endoanchors. The LRA was stented and flared, then a distal physician-modified (without free-flow) bifurcated Endurant graft (Medtronic, Minneapolis, Minnesota) was overlapped with the proximal cuff and stabilized with 6 endoanchors. Correct positioning with complete aneurysm exclusion was confirmed with a 30 day and 9 month computed tomography angiograms. CONCLUSIONS: In extremely selected cases, association of endoanchors and single-fenestrated physician-modified graft may be useful to treat complex urgent aortic aneurysm using readily available devices. CLINICAL IMPACT: This technical note demonstrates the feasibility of a single-fenestrated physician-modified Endurant endograft deployed in combination with endosuture fixation (FESAR), to urgently treat a juxtarenal aortic aneurysm unfit for open repair and not suitable for standard endovascular repair nor off-the-shelf endografts.

Midterm Results of Intravascular Lithotripsy for Severely Calcified Common Femoral Artery Occlusive Disease: A Single-Center Experience.

PURPOSE: Common femoral artery (CFA)-occlusive disease has traditionally been treated with open surgery, yet nowadays the frailty of patients has induced to find new techniques of revascularisation by endovascular means. So far, intravascular lithotripsy (IVL) has shown promising results in several lower limbs arterial districts. The purpose of this article is to report our experience with IVL for severely calcified peripheral arterial disease (PAD) of the CFA. METHODS: From November 2018 and October 2020, 10 consecutive patients (12 limbs) treated with IVL were prospectively enrolled in a dedicated database. Inclusion criteria were CFA localization of PAD, with a severe degree of calcification, a lesion length ≥10 mm, and a degree of stenosis ≥70% (severe). The only admitted adjunctive treatment was drug-coated balloon (DCB) angioplasty. Primary outcomes were technical and procedural success, clinical success, and target lesion revascularisation (TLR). Secondary outcomes were target extremity revascularisation (TER) and major adverse events (MAEs). RESULTS: All patients underwent IVL with associated DCB angioplasty. The median percentage of achieved stenosis reduction was 55.5% (interquartile range [IQR] 50-60.75), with a technical and procedural success of 100%. Over the study period, TLR only occurred in one limb (8.3%), with a mean upgrade in Rutherford class of 2.7 ± 0.77. No target vessel and access site complications were reported, as well as no distal embolization. One death and one major amputation occurred over the follow-up period, both in the same patient. CONCLUSIONS: Based on our experience, IVL for selected cases of severely calcified CFA disease, associated with DCB angioplasty, may be considered a safe and effective technique. Of course, a long-term follow-up and a larger series of patients are needed to validate our results.

Clinical Impact and Determinants of Fenestration to Target Vessel Misalignment in Fenestrated Endovascular Aortic Repair.

OBJECTIVE: This single centre, retrospective study (2014 - 2022) on juxta-, pararenal, or thoraco-abdominal aortic aneurysms treated by fenestrated endovascular aortic repair (FEVAR) was conducted to investigate the clinical impact and determinants of fenestration to target vessel misalignment in FEVAR. METHODS: Pre-operative supracoeliac, pararenal, and infrarenal aortic angles were measured on three dimensional computed tomography angiography (CTA) reconstructions. Two components of misalignment were measured on the first post-operative CTA: horizontal misalignment (angle between the fenestration and the target vessel ostium on perpendicular CTA cuts) and vertical misalignment (vertical distance between the fenestration and the target vessel at its origin). Endpoints were freedom from target vessel instability (TVI) and alignment change over time. RESULTS: Of 65 patients treated by FEVAR, 60 (202 target arteries) with juxta-, pararenal (80%), or thoraco-abdominal aortic aneurysm (20%) were included. Mean horizontal misalignment was 9 ± 12° (median 5°; IQR 0 - 16) and mean vertical misalignment was 0.7 ± 1 mm (median 0 mm, IQR 0 - 1). Freedom from TVI was 92% (95% CI 88 - 98) at 36 months. Horizontal misalignment > 15° was significantly associated with TVI (HR 5.19; 95% CI 1.54 - 17.48; p = .008); vertical misalignment did not significantly impact TVI (HR 0.99; 95% CI 0.56 - 1.73; p = .97). By multivariable analysis, pararenal aortic angle (OR 1.01 per increased degree of angulation; 95% CI 1.00 - 1.02; p = .044), bridging distance > 5 mm (OR 1.07; 95% CI 1.02 - 1.11; p = .003), and use of higher profile endografts in tortuous iliac access (OR 7.55; 95% CI 4.55 - 1.11; p = .003) were associated with clinically significant misalignment. Bridging distance > 5 mm (OR 2.00; 95% CI 1.02 - 11.29; p = .044), degree of baseline misalignment (OR 1.04; 95% CI 1.01 - 1.08; p = .036), and persistence of any primary endoleak for > 6 months (OR 5.85; 95% CI 1.23 - 29.1; p = .023) were associated with misalignment increase during follow up. CONCLUSION: Horizontal misalignment > 15° is associated with worsened target vessel outcomes. This may occur as a result of excessive iliac access tortuosity, high pararenal aortic angulation, and bridging distance > 5 mm.

Editor's Choice - Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED).

OBJECTIVE: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. METHODS: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. RESULTS: In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. CONCLUSION: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.