Indoxyl sulphate-initiated activation of cardiac fibroblasts is modulated by aryl hydrocarbon receptor and nuclear factor-erythroid-2-related factor 2.

In the last decade, extensive attention has been paid to the uremic toxin indoxyl sulphate (IS) as an inducer of cardiac fibroblast (cFib) activation and cardiac fibrosis in chronic kidney disease. At cellular level, IS engages aryl hydrocarbon receptor (AhR) and regulates many biological functions. We analysed how AhR inhibition by CH-223191 (CH) and overexpression of non-functional (dominant negative, DN) nuclear factor-erythroid-2-related factor 2 (NRF2), a transcription factor recruited by AhR, modulate the response of neonatal mouse (nm) cFib to IS. We also evaluated nm-cardiomyocytes after incubation with the conditioned medium (CM) of IS±CH-treated nm-cFib. IS induced activation, collagen synthesis, TLR4 and-downstream-MCP-1, and the genes encoding angiotensinogen, angiotensin-converting enzyme, angiotensin type 1 receptor (AT1r) and neprilysin (Nepr) in nm-cFib. CH antagonized IS-initiated nm-cFib activation, but did not affect or even magnified the other features. IS promoted NRF2 nuclear translocation and expression the NRF2 target Nqo1. Both pre-incubation with CH and transfection of DN-NRF2 resulted in loss of NRF2 nuclear localization. Moreover, DN-NRF2 overexpression led to greater TLR4 and MCP-1 levels following exposure to IS. The CM of IS-primed nm-cFib and to a larger extent the CM of IS+CH-treated nm-cFib upregulated AT1r, Nepr and TNFα and myostatin genes in nm-cardiomyocytes. Hence, IS triggers pro-inflammatory activation of nm-cFib partly via AhR, and AhR-NRF2 counteract it. Strategies other than AhR inhibition are needed to target IS detrimental actions on cardiac cells.

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.

OBJECTIVES: To report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside, Artivion - Kennesaw, GA - USA). 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 (48.4%) patients, a contained rupture in 8 (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I-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 (97.2%) target vessels 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 min per target vessel. Thirty-days cumulative MAE rate was 28% and mortality occurred in 5 patients (9.1%). There were 1 postoperative stroke (1.6%) and SCI rate was 8% (n=5). For the 249 target vessels successfully incorporated through an inner branch, one-year freedom from target vessel instability was 93±3% after 1 year. CONCLUSION: 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.

Cardiac risk after elective endovascular repair for infrarenal abdominal aortic aneurysm: Results from the Italian Collaborators for EVAR multicenter registry.

OBJECTIVE: Major adverse cardiac events (MACEs) were common complications after endovascular aortic repair (EVAR) causing significant postoperative morbidity and mortality. The aim of the study was to evaluate the cardiac risk after elective EVAR for uncomplicated noninfected infrarenal abdominal aortic aneurysm in a large multicenter cohort. METHODS: This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study conducted by four academic tertiary referral hospitals from January 2018 to March 2021. Baseline, perioperative, and postoperative information of elective EVARs was evaluated. The primary outcome was the incidence of MACEs after EVAR, which was defined as acute coronary syndrome, non-ST-elevation myocardial infarction, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, and revascularization as well as cardiovascular death. Secondary outcomes were 1-year overall survival (all-cause mortality) and freedom from aorta-related mortality. Comparative analysis was conducted between MACE and overall population, and univariate and multivariate logistic regression analyses were used to analyze factors associated with the risk of the MACE occurrence and early 1-year mortality. RESULTS: The study has enrolled 497 patients (35 females, 7%) with a mean age of 75.3 ± 7.8 years. The MACE rate was 6.4% (32/497, events/patients), and the majority of the events were recorded in the postoperative period (24/32, 75%; overall 24/497, 4.8%). One-year survival from all-cause mortality was 94% (95% confidence interval [CI]: 91-96), and the MACE population showed a significantly lower survival estimation rate (Overall - MACEs, 95.8% [95% CI: 93-97] - 67.9% [95% CI: 47-82], log-rank 41.950, P = .0001). Freedom from aorta-related mortality was 99.3% (95% CI: 98-100). The perioperative need for red blood cell transfusions was strongly related to the MACE occurrence (odds ratio: 2.67, 95% CI: 1.52-4.68, P = .001) and 1-year mortality (hazard ratio: 2.14, 95% CI: 1.48-3.09, P = .0001). CONCLUSIONS: MACEs represent a common complication in the postoperative and early period after elective EVAR. Blood loss requiring red blood cell transfusions is associated with increased postoperative MACEs and early mortality, suggesting that all the efforts should be carried out to reduce the bleeding during and after elective interventions.

Results of the Italian Collaborators for Evar Registry on Acute Kidney Injury After Elective Endovascular Aortic Repair of Infrarenal Abdominal Aortic Aneurysm.

OBJECTIVES: To analyze the incidence and predictive factors of postoperative acute kidney injury (AKI) after elective standard endovascular aortic repair (EVAR) in a large recent, multicenter cohort. MATERIALS AND METHODS: This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study. Between January 2018 and March 2021, only patients treated with elective standard EVAR for infrarenal non-infected abdominal aortic aneurysm were analyzed. Patients already on hemodialysis (HD) were excluded. AKI was defined as an increase in serum creatinine (sCr) ≥0.3 mg/dL within 48 hours or an increase in sCr to ≥1.5 times baseline known or presumed to have occurred within 7 days, or a urine volume of <0.5 mL/kg/h for 6 hours. Primary outcomes of interest were AKI incidence at 30 days and freedom from HD at 1-year follow-up. Secondary outcomes were freedom from severe postoperative complication, and freedom from aorta-related mortality (ARM) at 1 year. RESULTS: The final cohort analyzed 526 (29.8%). There were 489 (93%) males and 37 (7%) females: the median age was 76 years (interquartile range [IQR], 71-81). Chronic kidney disease (CKD) was present in 86 (16.3%) patients. Early mortality was observed in 8 (1.5%) patients, none was aorta-related. Complication rate was 17.1% (n=89). AKI was observed in 17 (3.2%). Renal replacement therapy was needed in 4 (0.8%). HD was transitory in 2 cases and definitive in 1. Binary logistic regression analysis identified CKD (odds ratio [OR]: 4.68, 95% confidence interval [CI]: 2.10-10.45, p<0.001), and the presence of renal artery stenosis (OR: 3.80, 95% CI: 1.35-10.66, p=0.011) to be associated with an increased risk of postoperative AKI. Estimated freedom from ARM was 94.9% at 1 year. Estimated freedom from HD rate at 1 year was 94%: This was significantly different between patients with preoperative CKD and those who did not have preoperative CKD (log-rank, p=0.042). CONCLUSION: AKI after elective standard EVAR still occurs but with an acceptably low incidence rate. Preoperative CKD is the most important predictor for postoperative AKI, which was not associated with the need for HD at 1-year follow-up but with a higher propensity of mortality. CLINICAL IMPACT: This "real world" experience confirm that EVAR performed with standard contrats agent protocol remains safe for acute kidney injury development. Therefore, only patients presenting with preoperative borderline or ascertained chronic kidney disease will take the most advantage from the use of carbon dioxide contrast.

Visceral Aorta Electrocautery Septotomy to Allow Branched Endovascular Aortic Repair in Ruptured Chronic Post-Dissection Thoraco-Abdominal Aneurysm.

PURPOSE: Endovascular repair of chronic post-dissection thoraco-abdominal aortic aneurysms (PD-TAAA) presents specific technical challenges due to the presence of chronic septum. Small true lumen diameter and false lumen visceral vessel origin can make branched endograft prohibitive. Septotomy may allow to overcome these challenges in cases of high complex anatomy. TECHNIQUE: We describe the application of electrocautery septotomy to the visceral aorta segment to deploy an off-the-shelf branched endograft in a chronic PD-TAAA rupture with true lumen collapse. CONCLUSIONS: Electrocautery septotomy can be an effective adjunctive technique to facilitate branched endograft, overcoming technical challenges associated with the endovascular treatment of chronic PD-TAAA. CLINICAL IMPACT: Electrocautery septotomy is an adjunctive technique that can facilitate endovascular treatment of post-dissection thoraco-abdominal aneurysm. By creating a common lumen, this technique might reduce the number of re-interventions associated with PD-TAAA endovascular exclusion.

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.

Geometric Analysis of the Gore Excluder Conformable Endoprosthesis in the Infrarenal Aortic Neck: One Year Results of the EXCeL Registry.

OBJECTIVE: The Gore Excluder Conformable Endoprosthesis (CEXC) is designed to treat challenging infrarenal anatomy because of its active angulation control, repositionability, and enhanced conformability. This study evaluated 30 day and one year position and apposition of the CEXC in the infrarenal neck. METHODS: Patients treated with the CEXC between 2018 and 2022 with an available 30 day computed tomography angiogram (CTA) were selected from four hospitals in a prospective registry. Endograft apposition (shortest apposition length [SAL]) and position (shortest fabric distance [SFD]) were assessed on the 30 day and one year CTAs. Maximum infrarenal aortic curvature was compared between the pre- and post-operative CTAs to evaluate conformability of the CEXC. RESULTS: There were 87 patients with a 30 day CTA, and for 56 of these patients the one year CTA was available. Median (interquartile range [IQR]) pre-operative neck length was 22 mm (IQR 15, 32) and infrarenal angulation was 52° (IQR 31, 72). Median SAL was 21.2 mm (IQR 14.0, 29.3) at 30 days for all included patients. The SAL in 13 patients (15%) was < 10 mm at 30 days, and one patient had a SAL of 0 mm and a type Ia endoleak. There was no significant difference in SAL between patients within and outside instructions for use. The SAL significantly increased by 1.1 mm (IQR -2.3, 4.7; p = .042) at one year. The SAL decreased in seven patients (13%), increased in 13 patients (23%), and remained stable in 36 patients (64%). Median SFD was 2.0 mm (IQR 0.5, 3.6) at 30 days, which slightly increased by 0.3 mm (IQR -0.5, 1.8; p = .019) at one year. One patient showed migration (SFD increase ≥ 5 mm). Median endograft tilt was 15.8° (IQR 9.7, 21.4). Pre-operative maximum infrarenal curvature was 36 m-1 (IQR 26, 56) and did not significantly change thereafter. CONCLUSION: In most patients, the CEXC was implanted close to the renal arteries, and sufficient (≥ 10 mm) post-operative apposition was achieved at 30 days, which slightly increased at one year. Post-operative endograft tilt was relatively low, and aortic geometry remained unchanged after implantation of the CEXC, probably due to its high conformability.

Reconsidering the Impact of Endovascular Repair on Short-Term and Mid-Term Outcomes in Peripheral Arterial Disease: A Retrospective Analysis.

BACKGROUND: The aim of the study is to compare the short-term and medium-term outcomes in patients who underwent open repair (OR) or endovascular repair (ER) for peripheral arterial disease (PAD) also including stratifications based on severity and year of the first intervention. METHODS: We conducted an observational retrospective single-center cohort study. We evaluated patients with PAD that primarily underwent ER, OR, minor, and major amputations in a single center from 2005 to 2020. The patients were then subdivided according to the type of intervention (OR versus ER), and stratified according to the International Classification of Diseases 9 code reported in the operating documents and to the year intervention. Mortality, minor, and major amputation rates occurring at 30 days, 2 years, and 5 years after the first intervention were evaluated as primary outcomes and compared between patient groups in both stratifications. Moreover, Kaplan-Maier curves were analyzed for these outcomes. RESULTS: One thousand four hundred ninety two patients (67.0% males) with PAD were evaluated. Their clinical presentations were intermittent claudication in 51.4% of cases, rest pain in 16.8%, ulcers in 10.3%, and gangrene in 21.5%. Nine hundred ninety seven (66.8%) underwent OR and 495 (33.2%) ER as first intervention for PAD. No statistical differences were observed in terms of mortality in the 2 groups (OR versus ER, P = 1,000, P = 0.357, and P = 0.688 at 30 days, 2 years, and 5 years, respectively). The rate of minor amputations was significantly higher (P < 0.012, P < 0.002, and P < 0.007 at 30 days, 2 years, and 5 years, respectively) for ER group in any of the observed follow-up periods. Also, we have observed that OR and ER do not have any significant short-term and medium-term major amputation rate differences. CONCLUSIONS: In our experience, the impact of ER does not significantly change short-term and mid-term major outcomes in patients with PAD.

Endosutured Aneurysm Repair of Abdominal Aortic Aneurysms with Short Necks Achieves Acceptable Midterm Outcomes-Results from the Peru Registry.

BACKGROUND: The study aims to describe midterm outcomes following treatment of infrarenal abdominal aortic aneurysms (AAAs) with short necks by endosutured aneurysm repair using the Heli-FX EndoAnchor system. METHODS: This is a retrospective study of prospectively collected data from 9 vascular surgery departments between June 2010 and December 2019, including treated AAAs with neck lengths ≤10 mm. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. There were 2 Groups further assessed according to neck length, A (≥4 and <7 mm) and B (≥7 and ≤10 mm). The main outcomes analyzed were technical success, freedom from type Ia endoleaks (TIaELs), sac size increase, all-cause and aneurysm-related mortality. RESULTS: Seventy-six patients were included in the study, 17 fell into Group A and 59 into Group B. Median follow-up for the cohort was 40.5 (interquartile range 12-61) months. A median of 6 (interquartile range 3) EndoAnchors were deployed in each subject. Technical success was 86.8% for the total group, 82.4% and 88.1% (P = 0.534) for Groups A and B respectively. Six out of 10 (60%) of TIaELs at the completion angiographies showed spontaneous resolution. Cumulative freedom from TIaEL at 3 and 5 years for the total group was 89% and 84% respectively; this was 93% and 74% for Group A and 88% at both intervals in Group B (P = 0.545). In total, there were 7 (9.2%) patients presenting with TIaELs over the entire study period. Two (11.8%) in Group A and 5 (8.5%) in Group B (P = 0.679). There were more patients with sac regression in Group B (Group A = 6-35.3% vs. Group B = 34-57.6%, P = 0.230) with no statistical significance. All-cause mortality was 19 (25%) patients, with no difference (4-23.5% vs. 15-25.4%, P = 0.874) between groups; whereas aneurysm-related mortality occurred in 1 patient from Group A and 3 from Group B. CONCLUSIONS: This study demonstrates reasonable outcomes for patients with short-necked AAAs treated by endosutured aneurysm repair in terms of TIaELs up to 5-year follow-up. EndoAnchor use should be judiciously evaluated in short necks and may be a reasonable option when anatomical constraints are encountered, mainly for those with 7-10 mm neck lengths. Shorter neck length aspects, as indicated by the results from Group A, may be an alternative when no other options are available or feasible.

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.

Endovascular aortic repair impact on myocardial contractility: A prospective study.

BACKGROUND: This study aimed to estimate if the altered sphygmic wave transmission may affect the left ventricular (LV) contractile function in patients undergoing endovascular aortic repair (EVAR). METHODS: A prospective single-centre study was carried out on consecutive patients undergoing EVAR for abdominal aortic aneurysm. A preoperative and 6-month single photon emission computed tomography (SPECT) with arterial stiffness measurement were performed to evaluate variations in pressure wave curve and myocardial perfusion parameters. RESULTS: From 2018 to 2020 a total of 16 patients were included in the study. Among the parameters evaluated, we found a measurable reduction of the reflected wave transit time from pre- to postoperative period, for both stress (115.13 ± 7.2 ms-111.1 ± 7.0 ms, p = .08) and rest SPECT acquisitions (115.3 ± 6.2 ms-112.2 ± 5.6 ms, p = .1). Unidirectional increase of both LV end-systolic volume (34 ± 9 mL-39 ± 8 mL, p = .02) and end-diastolic volume (85 ± 34 mL-89 ± 29 mL, p = .6) was also observed. Lastly, the ratio between the end-systolic pressure and the end-systolic volume (maximal systolic myocardial stiffness) decreased from 3.6 ± 1.5 mmHg/mL to 2.66 ± .74 mmHg/mL (p = .03). CONCLUSIONS: Our data showed that EVAR induced an altered transmission of the sphygmic wave associated with an early LV contractile impairment.

Temporary Reperfusion of the Aneurysm Sac as a Prevention of Spinal Cord Ischemia After Endovascular Treatment of Thoracoabdominal Aortic Aneurysm: Systematic Review and Meta-analysis.

BACKGROUND: Spinal cord ischemia (SCI) is still a feared complication for patients suffering from thoracoabdominal aortic aneurysm (TAAA) who undergo endovascular treatment. The aims of this work are to review the available literature on different reperfusion methods of the aneurysm sac, and to analyze whether the different reperfusion methods, also in combination with other factors, are effective in reducing SCI risk and if the impact varies with the patient's age. METHODS: PubMed/MEDLINE library was searched for studies published until November 2020 concerning TAAA, endovascular repair, and SCI preventive measures. Systematic review and meta-analysis were conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses criteria. Primary outcome consisted of correlation between endovascular repair techniques (type A: single step; type B: staged approach with reperfusion branches; type C: staged sequential approach with positioning of the thoracic component). A logistic-weighted regression for each event (SCI, transient, and permanent) was then performed with type of treatment, age, and interaction between them as input factors. Finally, another logistic-weighted regression was performed to analyze the other relevant factors for which observations are available together with the endovascular technique. RESULTS: Data from 53 studies with a total of 3095 patients were analyzed. Type A, type B, and type C endovascular strategies were adopted in 75%, 13%, and 12% of studied patients, respectively. Data showed that both type B and type C treatments are associated with lower risk of SCI, with a higher reduction of type C with respect to type B, although this positive trend is limited for elder patients. Moreover, a greater aortic diameter, a reduced aneurysm extent, and the absence of cerebrospinal fluid drainage positioning contribute to lower the risk of SCI. Concerning permanent SCI, both type B and type C are effective in reducing percentages for all ages, with type C treatment more beneficial for younger patients and type B for elder ones. CONCLUSION: According to the anatomy and the endovascular repair feasibility criteria, staged endovascular treatment appears to offer relevant advantages over single-step treatment in reducing the risk of SCI, regardless of the reperfusion method adopted.

Early Experience of Inner Branch Retrograde Cannulation With E-nside Branch Stent Graft for Thoracoabdominal Aortic Aneurysms.

PURPOSE: The aim of our study is to investigate the feasibility of retrograde cannulation using devices with inner branches (IB) for the endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs). MATERIALS AND METHODS: A retrospective analysis using IB configuration with retrograde cannulation was carried out on TAAAs patients undergoing endovascular treatment. RESULTS: Seven patients underwent IB endovascular treatment with retrograde cannulation between September 2020 and November 2021. The mean age was 80.4 years and 4 patients were male. A total of 26 of 28 target vessels were cannulated by retrograde access with a technical success of 93% (2 of 26 target vessels). Two intra-procedural complications were observed (1 renal artery dissection and 1 collateral renal artery rupture). In total, 26 of 28 treated vessels were retrograde cannulated with a technical success of 93%. A total of 39 stent bridges were used (all Viabahn VBX devices). The mean duration of the procedure was 321±102 minutes, and the mean scan time was 134±62 minutes. Mortality at 30 days was observed in 1 case. During the follow-up, 1 stent bridge occlusion was observed without the need for reintervention. CONCLUSION: Retrograde cannulation can also be successfully performed in the case of inner branches. CLINICAL IMPACT: In inner branched cases, retrograde cannulation should be taken into consideration in particular cases or it could become the option of choice. Dedicated endovascular material available such as steerable catheters and latest generation covered stents is fundamental for the success of the treatment.

European Expert Opinion on Infrarenal Sealing Zone Definition and Management in Endovascular Aortic Repair Patients: A Delphi Consensus.

PURPOSE: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). METHODS: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. RESULTS: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. CONCLUSIONS: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions.

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.

Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry.

OBJECTIVES: We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). METHODS: The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. RESULTS: Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. CONCLUSIONS: This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

Prediction model of isolated iliac and abdominal aneurysms.

OBJECTIVES: We analyse the cardiovascular risk factors in patients undergoing screening for Isolated Iliac Aneurysm (IIA) and Abdominal Aortic Aneurysm (AAA) and propose a logistic regression model to indicate patients at risk of IIA and/or AAA. METHODS: A screening programme was carried out to identify the presence of aneurysm based on Duplex scan examination. Cardiovascular risk factors information was collected from each subject. A descriptive analysis for the incidence of IIA and AAA stratified by age and sex was carried out to evaluate factors incidence. A logistic regression model was developed to predict the probability of developing an aneurysm based on the observed risk factor levels. A threshold probability of aneurysm risk for a datum patient was also identified to effectively direct screening protocols to patients most at risk. RESULTS: A cohort of 10 842 patients was evaluated: 1.52% affected by IIA, 2.69% by AAA and 3.90% by at least one. Risk factors analysis showed that: IIA was correlated with cardiological status, diabetes, cardiovascular disease family history, and dyslipidaemia; AAA was correlated with cardiological status, body mass index, hypertension, and dyslipidaemia; diabetes and dyslipidaemia were the most relevant factors with at least one aneurysm. The prediction tool based on the logistic regression and the threshold probability predict the presence of IIA and AAA in 69.7% and 83.8% of cases, under k-fold cross-validation. CONCLUSIONS: The proposed regression model can represent a valid aid to predict IIA and AAA presence and to select patients to be screened.

Results of Iliac Branch Devices in Octogenarians Within the pELVIS Registry.

Purpose: To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9±2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI). Results: Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1-127) and 29.3 months (range 1-127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%). Conclusion: IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation.

Initial Clinical Experience With a New Conformable Abdominal Aortic Endograft: Aortic Neck Coverage and Curvature Analysis in Challenging Aortic Necks.

OBJECTIVES: Aim of this work was to investigate precision of deployment and conformability of a new generation GORE EXCLUDER Conformable Endoprosthesis with active control system (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) by analyzing aortic neck coverage and curvature. METHODS: All consecutive elective patients affected by abdominal aortic aneurysm or aortoiliac aneurysm treated at our institution between November 2018 and June 2019 with the new CEXC Device were enrolled. Validated software was adopted to determine the available apposition surface area into the aortic neck, apposition of the endograft to the aortic wall, shortest apposition length (SAL), shortest distance between the endograft fabric and the lowest renal arteries (SFD) and between the endograft fabric and the contralateral renal artery (CFD). Pointwise centerline curvature was also computed. RESULTS: Twelve patients (10 men, median age 78 years (71.75, 81.0)) with available pre- and postoperative computed tomography angiography (CTA) were included. Technical success was obtained in all the cases. Preoperative median length of the proximal aortic neck was 16.1 mm (10.7, 21.7) and suprarenal (α) and infrarenal (ß) neck angulation were, respectively, 28.9° (15.7°, 47.5°) and 75.0° (66.9°, 81.4°). Postoperative median apposition surface coverage was 79% (69.25%, 90.75%) of the available apposition surface. SFD and CFD were 1.5 mm (0.75, 5.25) and 7 mm (4.5, 21.5), respectively. Average curvature over the infrarenal aorta decreased from 25 m-1 (21.75, 29.0) to 22.5 m-1 (18.75, 24.5) postoperatively (p=0.02). Maximum curvature did not decrease significantly from 64.5 m-1 (54.25, 92.0) to 62 m-1 (41.75, 71.5) (p=0.1). CONCLUSIONS: Our early experience showed that deployment of the CEXC Device is safe and effective for patients with challenging proximal aortic necks. Absence of significant changes between pre- and postoperative proximal aortic neck angulations and curvature confirms the high conformability of this endograft.

COVID-19 Impact on Vascular Surgery Practice: Experience From an Italian University Regional Hub Center for Vascular Pathology.

BACKGROUND: The aim of the study is to evaluate the impact of COVID-19 pandemic on vascular surgery practice in a regional hub center for complex vascular disease. METHODS: This is an observational single-center study in which we collected clinical and surgical data during (P1) and after (P2) the COVID-19 outbreak and the lockdown measures implemented in Northern Italy. We compared those data with the two-month period before the pandemic (P0). RESULTS: Compared to P0, ambulatory activities were severely reduced during P1 and limited to hospitalized patients and outpatients with urgent criteria. We performed 61 operations (18 urgent and 43 elective), with a decrease in both aortic (-17.8%), cerebrovascular (-53.3%), and peripheral artery (-42.6%) disease treatments. We also observed a greater drop in open procedures (-53.2%) than in endovascular ones (-22%). All the elective patients were treated for notdeferrable conditions and they were COVID-19 negative at the ward admission screening; despite this one of them developed COVID19 during the hospital stay. Four COVID-19 positive patients were treated in urgent setting for acute limb ischemia. Throughout P2 we gradually rescheduled elective ambulatory (+155.5%) and surgical (+18%) activities, while remaining substantially lower than during P0 (respectively -45.6% and -25.7%). CONCLUSIONS: Despite COVID-19 pandemic, our experience shows that with careful patient's selection, dedicated prehospitalization protocol and proper use of personal protective equipment it is possible to guarantee continuity of care.