Preliminary experience of the isolate left subclavian artery in-situ fenestration during "zone 2" thoracic endovascular aortic repair.

OBJECTIVES: To evaluate the results of isolate left subclavian artery (LSA) in-situ fenestration (ISF) during "zone 2" thoracic endovascular aortic repair (TEVAR) using a new adjustable needle puncturing device system. METHODS: It is a multicentre, retrospective, physician-initiated cohort study of patients treated from July 28th 2021 to April 3rd 2024. Inclusion criteria were isolate LSA revascularization for elective or urgent/emergent "zone 2" TEVAR. The primary outcome was technical success and freedom from ISF TEVAR-related reintervention or endoleak. RESULTS: We treated 50 patients: 28 (56.0%) atherosclerotic thoracic aneurysms, 12 (24.0%) type B aortic dissection, and 10 (20.0%) penetrating aortic ulcers. Elective intervention was carried out in 46 (92.0%) cases. ISF was successful in all cases, with a procedural primary technical success in 47 (94.0%) cases. Median time of intervention was 184 min (IQR, 135-220) with a median fenestration time of 20 min (IQR, 13-35). Operative mortality did not occur. We observed 1 case of spinal cord ischaemia, and 2 cases of bilateral posterior non-disabling stroke. Mortality at 30 days occurred in 1 (2.0%) patient (not aorta-related). The median follow-up median follow-up of 4 months (IQR, 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. In-situ fenestration-related reintervention was never required. CONCLUSIONS: ISF TEVAR using the Ankura™-II device with the self-centering adjustable needle system showed high technical success, promising stability, and stable aortic-related outcomes. Owing to these results, it represents a safe and effective alternative for standard "zone 2" TEVAR.

The Gore Viabahn balloon-expandable stent graft as a bridging stent in complex endovascular aortic procedures at 3 years performs better in fenestrations.

OBJECTIVE: Complex endovascular procedures are now recognized as the gold standard treatments for extensive aortic diseases. Bridging stents (covered stents used to couple the aortic graft to the visceral vessels) play a pivotal role, yet there is currently no dedicated device available on the market. The aim of the study was to evaluate the midterm performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVVs). METHODS: Data from all consecutive patients who underwent a fenestrated and branched endovascular aortic repair and received the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary end points included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary end points were overall survival, procedure and TVV-related (in an intent-to-treat basis) technical success, freedom from type IC/IIIC endoleak, and freedom from TVV patency loss. RESULTS: Sixty-three patients were treated with a fenestrated and branched endovascular aortic repair using the VBX stent graft as a bridging stent, of whom 47 (74.6%) presented an atherosclerotic aneurysm, 7 (11.1%) a post-dissecative aneurysm, and 9 (14.3%) an anastomotic pseudoaneursym or a type IA endoleak in a previous endovascular aortic repair. Included in the aortic repair were 231 of 243 (95.1%) total visceral vessels. The intraoperative requirement of 13 additional VBX stent grafts determined a TVV-related technical success of 94.4%. The mean follow-up was 26.1 ± 16.4 months. The estimated overall survival at 36 months was 73% ± 7.5%. The estimated rates at 36 months for freedom from type IC/IIIC endoleaks and TVV primary patency were 90.6% ± 3.9% and 99% ± 0.7%, respectively. The estimated rate at 36 months for freedom from TVV instability was 92.1% ± 3% and did not differ between branched and fenestrated configurations, whereas freedom from TVV-related reinterventions was 90.6% ± 3.1% and significantly in favor of fenestrations (69.4% vs 96.8%, P < .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (hazard ratio: 0.079; 95% confidence interval: 0.016-0.403). CONCLUSIONS: The VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. Although immediate results are deemed satisfactory, they favor fenestrations regarding the need of reinterventions through 3 years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent.

Cranial nerve injuries post carotid endarterectomy: a 15-year prospective study with routine otolaryngologist and neurological evaluation.

OBJECTIVE: The aim of this prospective monocentric cohort study was to analyze the risk of otolaryngologist-assessed cranial nerve injuries (CNIs) following carotid endarterectomy (CEA) in our academic center during a 15-year period, and to identify possible risk factors for CNI development. METHODS: From January 2007 to December 2022, 3749 consecutive CEAs were performed and their data prospectively recorded in a dedicated database. CNIs were assessed and defined according to a standardized protocol. Instrumental ear, nose, and throat (ENT) evaluations were conducted within 30 days before intervention and before discharge. Preoperative neurological assessments were carried out in all patients with symptomatic carotid stenosis, whereas postoperative neurological evaluations were performed in all patients. Patients with newly onset CNIs underwent follow-up assessments at 30 days and, if necessary, at 6, 12, and 24 months. Perioperative results, including mortality, major central neurological events, and postoperative CNIs, were analyzed. Regression or persistence of lesions during follow-up visits was assessed, and multivariate analysis (binary logistic regression) was conducted to evaluate clinical, anatomical, and surgical technique factors influencing the occurrence of CNIs. RESULTS: CEAs were performed more frequently in male patients (2453 interventions; 65.5%) than in females (1296 interventions; 34.5%). The interventions were performed in asymptomatic patients in 3078 cases (82%). In 66 cases, the interventions followed a previous ipsilateral CEA. At preoperative ENT evaluation, no cases of ipsilateral pre-existent CNI were recorded. The 30-day stroke and death rate was 1%. In 113 patients (3%), a postoperative neck bleeding requiring surgical revision and drainage was noted. Pre-discharge ENT evaluations identified 259 motor CNIs, accounting for 6.9% of the entire study group. Eighteen patients had lesions in more than one cranial nerve. ENT and neurological evaluations at 30 days showed the complete resolution of 161 lesions, whereas in 98 cases (2.6%), the CNI persisted. At 1 year, the rate of persistent CNI was 0.4% (10 patients), whereas at 2 years, it was 0.25% (6 cases), in all but one asymptomatic. At multivariate analysis, urgent intervention in unstable patients, secondary intervention, a clamping time >40 minutes, a hematoma requiring revision, and a postoperative stroke were independent predictors of CNIs. CONCLUSIONS: Data from this prospective monocentric cohort study showed that the occurrence of CNI following CEA was low, even when an independent multi-specialist evaluation was performed. The percentage of persistent lesions at 2 years was negligible and, in most cases, asymptomatic.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

The Use of Pressure Recording Analytical Method in Patients Undergoing Endovascular Repair for Abdominal Aortic Aneurysm: The Impact on Clinical Decisions for the Appropriate Postoperative Setting and Cost-effective Analysis.

OBJECTIVE: To analyze the use of the Pressure Recording Analytical Method (PRAM), an hemodynamic monitoring system, in evaluating intraoperative and postoperative hemodynamic instability in patients undergoing endovascular repair for abdominal aortic aneurysm, and to evaluate if the decision to refer patients to a ordinary ward or to a Cardiac Step-Down Unit (CSDU) after the intervention on the basis of intraoperative hemodynamic monitoring could be more cost-effective. MATERIALS AND METHODS: After preoperative clinical evaluation, 44 patients were divided in this non-randomised study into two groups according to their postoperative destination: Group 1-ward (N=22) and Group 2-CSDU (N=22). All patients underwent monitoring with PRAM during the intervention and in the 24 postoperative hours, measuring several indices of myocardial contractility and other hemodynamic variables. RESULTS: According to the variability of two parameters, Stroke Volume Variation and Pulse Pressure Variation, patients were classified as stable or unstable. Unstable patients showed a significant alteration in several hemodynamic indices, in comparison to stable ones. According to the intraoperative monitoring, eight high risk patients could have been sent to an ordinary ward due to their stability, with a reduction in the improper use of CSDU and, consequently, in costs. CONCLUSIONS: Hemodynamic monitoring with PRAM can be useful in these patients, both for intraoperative management and for the choice of the more appropriate postoperative setting, possibly reducing the improper use of CSDU for hemodynamically stable patients who are judged to be at high risk preoperatively, and re-evaluating low surgical risk patients with an unstable intraoperative pattern, with a possible reduction in costs.

Perceptions, awareness, and implementation surrounding the assessment of frailty amongst vascular surgeons in Italy: Results from a nationwide cross-sectional survey.

OBJECTIVES: We conducted this survey to gain insight into the real-life application and perceptions regarding the importance of peri-operative frailty assessment amongst vascular surgeons in Italy. METHODS: Italian vascular surgeons were invited to participate in the survey using the list provided by the Italian Society for Vascular and Endovascular Surgery (1050 invited participants). A dedicated link to the survey was emailed through Google Forms, and reminders were automatically sent on a bi-weekly basis for a total of 8 weeks before stopping data collection. RESULTS: The survey was completed by 225 respondents, thereby yielding an overall 21.5% response rate. While the vast majority of respondents stated they were aware of the meaning of frailty (93%) and agreed that its assessment was clinically relevant for patients undergoing vascular surgery (99%), only 44% of surveyed surgeons reported that they used a specific tool for peri-operative frailty assessment. However, most respondents indicated that routine evaluation of frailty was not performed at their institution (87%). The main limitations were identified as being the lack of confidence in choosing the best tool, followed by lack of awareness, lack of skilled operators, and lack of time. CONCLUSIONS: Our study showed that whilst most vascular surgeons in Italy are aware of the importance of frailty in affecting surgical outcomes across various interventions in the elective and non-elective settings, there is poor implementation of formal frailty assessment.

Gender-Related Disparities Among Vascular Surgeons in Italy: Results from a Cross-Sectional Survey.

BACKGROUND: To assess the presence, quality and impact of gender-related discrepancies in academic vascular surgery at a national level. METHODS: This was an anonymous national structured nonvalidated cross-sectional survey on gender disparity perceptions, named "I love it when you call me Señorita", distributed to 645 participants from academic Italian vascular centers. Endpoints were related to job-related characteristics, satisfaction, and sexual harassment. RESULTS: The survey yielded a 27% response rate (n = 174, 78 males and 96 females). Significant differences between male and female responders were found in terms of job satisfaction (83.3% vs. 53.1%, P < 0.001), perception of career opportunities (91.7% vs. 67.9%, P < 0.001), surgical activity in the operating theater (34.6% vs. 7.3%, P < 0.001), involvement in scientific activities (contribution in peer-reviewed articles: 37.2% vs. 9.4%, P < 0.001; scientific meeting attendance/year: 42.3% vs. 20.8%, P = 0.002), and perception of lower peer support at work (2.6% vs. 22.9%, P < 0.001). In addition, female physicians more frequently suffered sexual harassment from male peers/colleagues (10% vs. 34%, P < 0.001), male health-care workers (7% vs. 26%, P = 0.001), or patients/caregivers independently from their sex (6% vs. 38.5%, P < 0.001 for males and 5% vs. 22%, P = 0.001 for females). CONCLUSIONS: A significant number of the female vascular surgeons in Italian academic vascular centers responding to the survey have experienced workplace inequality and sexual harassment. Substantial efforts and ongoing initiatives are still required to address gender disparities, emphasizing the need for the promotion of specific guidelines within scientific societies.

CO2 is the contrast media to choose in patients with initial Chronic Kidney Disease undergoing endovascular aneurysm repair to prevent further renal function deterioration.

OBJECTIVE: Even low quantities of iodine contrast media (ICM) could be responsible for exacerbation of a chronic kidney disease (CKD). Aim of this study was to determine whether it is more reasonable to perform endovascular aneurysm repair (EVAR) procedures in patients with initial CKD using CO2 rather than ICM to prevent further kidney deterioration. METHODS: A retrospective analysis was performed at our institution to identify patients with preoperative CKD at initial stage (class G3a-G3b according to KDOQI-KDIGO classification) who underwent either CO2-EVAR or ICM-EVAR. Primary endpoint was renal function evaluation; secondary endpoints were technical success, perioperative complications, hospital stay, and reinterventions and overall mortality at follow-up. RESULTS: Both CO2-EVAR and ICM-EVAR groups were composed of 21 patients. There were no differences in demographics, anatomy, and comorbidities, apart from worse ASA score in CO2-EVAR group (100% vs 57.1%, p = .001). Preoperative serum creatinine and glomerular filtration rates (GFR) were comparable (1.73 vs 1.6 mg/dl, p = .082 and 39.71 vs 43.04 mL/min/1.73 m2, p = .935). At follow-up (16.7 ± 18.1 months), CO2-EVAR was not associated with significant changes in creatinine and GFR, whereas ICM-EVAR determined a significant increase in creatinine (1.6 mg/dl vs 1.91 mg/dl, p = .04) and decrease in GFR values (43 vs 37.9 mL/min/1.73 m2, p = .04), determining the need for dialysis in one patient. CONCLUSIONS: ICM seems to be a determining factor in worsening renal function; therefore, an effort should be made to standardize the use of CO2 as the contrast medium of choice in patients with initial renal insufficiency undergoing EVAR.

Endovascular aneurysm repair under local anesthesia through bilateral percutaneous femoral access is a safe strategy to improve early outcomes and reduce hospital stay.

BACKGROUND: To estimate the impact of anesthetic conduct, alone and in combination with the type of femoral access, on early results after endovascular aneurysm repair (EVAR). METHODS: A retrospective multicenter analysis on patients undergoing elective standard EVAR at four academic centers was performed. Patients undergoing the procedure through either local or general anesthesia were compared. Comparative subanalyses of the two groups were performed for the type of femoral access to evaluate further impact on outcomes. RESULTS: Five hundred twenty-four patients underwent elective standard EVAR, of which 207 (39.5%) under general anesthesia and 317 (60.5%) under local anesthesia. Patients who underwent general anesthesia had higher 30-day mortality rates (3.4% vs. 0.3%, P=0.005), as well as slightly worse 30-day major systemic complication rates (8.2% vs. 5.4%, P=0.195). There were no differences in terms of reinterventions (2.1% vs. 2.5%, P=0.768) and aneurysm-related mortality (0% vs. 0.4%, P=0.422) at one year. Total intervention times were significantly longer in the general anesthesia group (126 vs. 89 minutes, P=0.001), as well as the total length of hospital stay (7.6 vs. 5.3 days, P=0.007). At subanalyses, the combination of local anesthesia with bilateral percutaneous femoral access further improved 30-day outcomes and determined an additional reduction in total intervention times and ICU stays. CONCLUSIONS: EVAR performed under local anesthesia has a significantly better impact on early results when compared to general anesthesia. Combining percutaneous bilateral femoral access to local anesthesia reduced procedural times, ICU stays and consequently improved early results.

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.

Systematic Review and Meta-Analysis of Elective Open Conversion versus Fenestrated and Branched Endovascular Repair for Previous Non-Infected Failed Endovascular Aneurysm Repair.

OBJECTIVE: To evaluate outcomes of patients electively undergoing fenestrated and branched endovascular repair (F/B-EVAR) or open conversion for failed previous non-infected endovascular aneurysm repair (EVAR). DATA SOURCES: Embase, MEDLINE, Cochrane Library. REVIEW METHOD: The protocol was prospectively registered on PROSPERO (CRD42023404091). The review followed the PRISMA guidelines; certainty was assessed through the GRADE and quality through MINORS tools. Outcomes data were pooled separately for F/B-EVAR and open conversion. A random effects meta-analysis of proportions was conducted; heterogeneity was assessed with the I2 statistic. RESULTS: Thirty eight studies were included, for a total of 1 645 patients of whom 1 001 (60.9%) underwent an open conversion and 644 (39.1%) a F/B-EVAR. The quality of evidence was generally limited. GRADE certainty was judged low for 30 day death (in both groups) and F/B-EVAR technical success, and very low for the other outcomes. Pooled 30 day death was 2.3% (I2 33%) in the open conversion group and 2.4% (I2 0%) in the F/B-EVAR conversion group (p = .36). Technical success for F/B-EVAR was 94.1% (I2 23%). The pooled 30 day major systemic complications rate was higher in the open conversion (21.3%; I2 74%) than in the F/B-EVAR (15.7%; I2 78%) group (p = .52). At 18 months follow up, the pooled re-intervention rate was 4.5% (I2 58%) in the open conversion and 26% (I2 0%) in the F/B-EVAR group (p < .001), and overall survival was 92.5% (I2 59%) and 81.6% (I2 68%), respectively (p = .005). CONCLUSION: In the elective setting, and excluding infections, the early results of both open conversion and F/B-EVAR after failed EVAR appear satisfactory. Although open conversion presented with higher complication rates in the first 30 days after surgery, at follow up it seemed to be associated with fewer re-interventions and better survival compared with F/B-EVAR.

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.

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, and overall survival. METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation, given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic. RESULTS: Eight studies were included in the review after full text screening. A total of 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions; the aortic sac was opened in 96.1% of cases; in 93.3% of cases, ligation/suture of one or more culprit arteries were performed; and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2 = 24.9%) and 13.4% (I2 = 54.3%), respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2 = 83.2%), and the rate of reinterventions was 7% (I2 = 50.1%); the semi-conversion failure rate was 5.5% (I2 = 54.1%), and the overall survival was 84.6% (I2 = 33.3%). CONCLUSIONS: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures, and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross-clamping is not ideal.

Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM).

The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended.

Early and long-term results of surgical treatment of popliteal artery aneurysms using a heparin-bonded expanded polytetrafluorethilene graft.

BACKGROUND: The aim of the present study was to assess early and long-term results of open surgical interventions for popliteal artery aneurysms (PAAs) with the use of heparin-bonded expanded polytetrafluorethylene (HePTFE) in a single center, retrospective, non-comparative cohort study. METHODS: A retrospective analysis of a prospectively maintained dataset, including 207 open interventions for PAAs between 2002 and 2022, was performed and 170 procedures carried on with the use of a HePTFE graft were found. Perioperative results were analyzed in terms of mortality, graft thrombosis and amputation rates. Follow-up results were analyzed in terms of survival, primary and secondary patency, freedom from amputation, freedom from reintervention with life-table analysis and Kaplan Meier curves. Follow-up results were considered as primary outcomes, whereas perioperative results were considered as secondary outcomes. RESULTS: In 82 interventions (48%) the PAA was asymptomatic. In 140 cases a medial approach was used, while in 30 cases a posterior approach was preferred. The level of the distal anastomosis was the p3 tract of the popliteal artery in 89% of the cases. One perioperative death occurred; early thromboses occurred in eight cases and the overall perioperative amputation rate was 2.8%. The median duration of follow-up was 48 months (range 1-251). Estimated survival rate at 10 years was 55% (standard error, SE, 0.065). The 10-year rates of primary and secondary patency and freedom from amputation were 40.8% (SE 0.06), 47.6% (SE 0.065) and 93.4% (SE 0.04), respectively. The estimated freedom from reintervention rate at 10 years was 57% (SE 0.05). CONCLUSIONS: The results of this large monocentric experience showed that open surgical repair of PAAs with HePTFE is a safe procedure, with low rates of perioperative complications, and excellent results in the long-term setting.

Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry.

PURPOSE: Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. MATERIALS AND METHODS: Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan-Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. RESULTS: The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12-43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%-93.1%), 95.8% (95% CI: 92.7%-97.1%), 93.6% (95% CI: 90.2%-96.8%), 87% (95% CI: 83.3%-91.6%), and 97.7% (95% CI: 95.1%-98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%-95.5%] vs ZISL 94.3% [95% CI: 90.1%-95.9%], p=0.342; log-rank 0.903). CONCLUSION: Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. CLINICAL IMPACT: The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.

Sex-Related Outcomes in Asymptomatic Patients Undergoing Carotid Artery Stenting.

PURPOSE: Aim of the study was to evaluate the influence of sex in asymptomatic patients undergoing carotid artery stenting (CAS). MATERIALS AND METHODS: A retrospective observational study was conducted from January 2006 to December 2020. A total of 438 consecutive patients with asymptomatic carotid artery stenosis >70% underwent transfemoral CAS and were stratified in males (M) and females (F). Periprocedural 30-day outcomes were: stroke, death, and myocardial infarction (MI). Follow-up outcomes were: death and stroke rates (primary) and freedom from restenosis (FFR) and reintervention rates (secondary). Follow-up data were analyzed at 1, 5, and 10 years. Data were analyzed with χ2 test and Fisher's exact test and follow-up outcomes with Kaplan-Meier curves. The log-rank test was used to determine differences between the groups and univariate analysis to identify the association between risk factors and intraoperative details with mortality and restenosis rates. RESULTS: A total of 462 procedures were performed (M: n=321, 69.4%), in which 24 CAS were bilateral (5.5%). Mean age was 71.9±7.6 years (M: 72.1±7.8; F: 71.7±7.3). Periprocedural outcomes were: stroke rate 2.2% (n=10; M: n=5, 1.6%; F: n=5, 3.5%; p=0.176), mortality rate 0.6% (M: n=3, p=0.334), and stroke/death rate 2.8% (n=13; M: n=8, 2.5%; F: n=5, 3.5%; p=0.528); no cardiac events (MI) were recorded. A not-disabling (minor) stroke was detected in 3 males (0.9%), while a disabling (major) stroke was reported in 7 patients (1.7%) of whom 5 were ischemic events (M: n=2, 0.6%; F: n=3, 2.2%) and 2 were cerebral hemorrhages (F: 1.3%, p=0.046). Mean follow-up was 73.66±40.83 months (M: 72.66; F: 76.01; p=0.246). Overall survival rate was 96.1% (95% confidence interval [CI]: 93-98), 81.8% (95% CI: 77-86), and 45.5% (95% CI: 38-53) at 1, 5, and 10 years, respectively (p=0.236). The overall stroke rate was 0.3% (freedom from stroke [FFS]: 99.7%; 95% CI: 98-100), 0.9% (FFS: 99%; 95% CI: 98-100), and 4.3% (FFS: 95.7%; 95% CI: 89-98; M: n=6; F: n=2; p=0.774). Stroke-related mortality rate was 0.7% (FFS: 99.3%; 95% CI: 97-100) and 2.9% (FFS: 97.1%; 95% CI: 91-99) at 5 and 10 years, respectively, without differences between the groups (M: n=4; F: n=2; p=0.763). Overall FFR rate was 97.4% (95% CI: 95-99), 93.4% (95% CI: 90-96), and 89.5% (95% CI: 84-93; p=0.322). Two severe symptomatic restenosis (>70%, M) required a new endovascular revascularization. CONCLUSION: The sex variable does not influence outcomes of CAS in asymptomatic patients at short- and long-term follow-up, although females show a worst incidence of periprocedural major strokes. Carotid artery stenting may be safely proposed when a careful patient selection is applied. CLINICAL IMPACT: The sex variable has been advocated as a considerable factor that could influence the outcomes of transfemoral carotid artery stenting (CAS). Literature data are contrasting, even if different papers mainly reported that CAS is associated to worst outcomes in female patients. Our study shows that the sex-variable does not influence outcomes of CAS in asymptomatic patients at short and long-term follow-up, although females had a worst incidence of periprocedural major strokes. CAS may be safely proposed when a careful patient selection is applied.

Fate of target visceral vessels in fenestrated and branched complex endovascular aortic repair.

OBJECTIVE: To assess branch vessel outcomes after endovascular repair of complex aortic aneurysms analyzing possible factors influencing early and long-term results. METHODS: The Italian Multicentre Fenestrated and Branched registry enrolled 596 consecutive patients treated with fenestrated and branched endografts for complex aortic disease from January 2008 to December 2019 by four Italian academic centers. The primary end points of the study were technical success (defined as target visceral vessel [TVV] patency and absence of bridging device-related endoleak at final intraoperative control), and freedom from TVV instability (defined as the combined results of type IC/IIIC endoleaks and patency loss) during follow-up. Secondary end points were overall survival and TVV-related reinterventions. RESULTS: We excluded 591 patients (3 patients with a surgical debranching and 2 patients who died before completion from the study cohort) were treated for a total of 1991 visceral vessels targeted by either a directional branch or a fenestration. The overall technical success rate was 98.4%. Failure was related to the use of an off-the-shelf (OTS) device (custom-made device vs OTS, HR, 0.220; P = .007) and a preoperative TVV stenosis of >50% (HR, 12.460; P < .001). The mean follow-up time was 25.1 months (interquartile range, 3-39 months). The overall estimated survival rates were 87%, 77.4%, and 67.8% at 1, 3, and 5 years, respectively (standard error [SE], 0.015, 0.022, and 0.032). During follow-up, TVV branch instability was observed in 91 vessels (5%): 48 type IC/IIIC endoleaks (2.6%) and 43 stenoses-thromboses (2.4%). The extent of aneurysm disease (thoracoabdominal aortic aneurysm [TAAA] types I-III vs TAAA type IV/juxtarenal aortic aneurysm/pararenal aortic aneurysm) was the only independent predictor for developing a TVV-related type IC/IIIC endoleak (HR, 3.899; 95% confidence interval [CI]:, 1.924-7.900; P < .001). Risk of patency loss was independently associated with branch configuration (HR, 8.883; P < .001; 95% CI, 3.750-21.043) and renal arteries (HR, 2.848; P = .030; 95% CI, 1.108-7.319). Estimated rates at 1, 3, and 5 years of freedom from TVV instability and freedom from TVV-related reintervention were 96.6%, 93.8%, and 90% (SE, 0.005, 0.007, and 0.014) and 97.4%, 95.0%, and 91.6% (SE, 0.004, 0.007, and 0.013), respectively. CONCLUSIONS: Intraoperative failure to bridge a TVV was associated with a preoperative TVV stenosis of >50% and the use of OTS devices. Midterm outcomes were satisfying, with an estimated 5-year freedom from TVV instability and reintervention of 90.0% and 91.6%, respectively. During follow-up, the larger extent of aneurysm disease was associated with an increased risk of TVV-related endoleaks, whereas a branch configuration and renal arteries were more prone to patency loss.

Results of current endovascular treatments for visceral artery aneurysms.

OBJECTIVE: This single-center retrospective cohort study aimed to analyze the early and long-term results of endovascular treatment for true visceral artery aneurysms (VAAs). Moreover, a comparison with the results of our previously published historical series of open surgical procedures was performed. METHODS: From January 2008 to December 2021, 78 consecutive patients were treated at our institution for true VAAs. All demographic data, procedural details, perioperative outcomes, and follow-up data were collected prospectively from a dedicated database. A retrospective analysis identified 72 patients who underwent endovascular surgery. Early results were analyzed in terms of technical success, conversion to open surgery, mortality, and local and systemic morbidities. Follow-up results were analyzed in terms of survival, need for open or endovascular reintervention, and freedom from complications at the level of the treated visceral artery. These results were then compared with those of our historical open surgical group (1982-2007), which included 54 interventions. RESULTS: In four cases, the planned endovascular procedure could not be completed, and the overall technical success rate was 94.5%. No deaths occurred during the hospital stay or within 30 days after surgery. Overall, the 30-day perioperative complication rate was 5.8%, with an early reintervention rate of 2.9%. The median follow-up time was 29 months (range, 1-132 months). The estimated 7-year survival rate was 88% (standard error [SE]. 0.05). The estimated 7-year aneurysm-related complication-free rate was 85.5% (SE, 0.06), with reintervention-free and aneurysm-related complication-free survival rates of 93.3% (SE, 0.04) and 75.6% (SE, 0.07), respectively. At the 7-year follow-up, the survival rate was similar between the endovascular and open groups. There was a trend toward a higher aneurysm-related complication rate in the endovascular group than in the open group (14.5% vs 6.4%; P = .07). However, no significant differences in reintervention-free and overall estimated aneurysm-related complication-free survival rates were found between the two groups. CONCLUSIONS: Endovascular repair is safe and effective in patients with VAAs, with low perioperative complication rates. The long-term outcomes were satisfactory and comparable with those of the historical series of open surgical repairs. Even if there is a trend toward a higher risk of late aneurysm-related complications among endovascular patients, it does not imply an increased need for late reinterventions.

Endovascular repair using parallel grafts to treat a suprarenal pancreatitis-related abdominal aortic pseudoaneurysm.

Arterial pseudoaneurysms represent an uncommon complication of acute pancreatic inflammation or chronic pancreatitis. We describe a contained rupture of a suprarenal abdominal aortic pseudoaneurysm. An aorto-uni-iliac stent-graft was adopted as the aortic main body and was combined with two chimneys and two periscope stents for celiac/superior mesenteric artery and renal arteries, respectively. The procedure was complicated by the entrapment of the celiac sheath into the barbs of the aortic stent-graft and the attempts to remove the sheath resulted in an upward migration of the stent-grafts. A bail-out endovascular procedure was used to reline the stent-grafts and the pseudoaneurysmal sac was embolized with coils.