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.

The Gore Viabahn balloon-expandable stent graft as 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 mid-term performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVV). METHODS: Data from all consecutive patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR) and receiving the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary endpoints included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary endpoints 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 F/BEVAR using VBX as bridging stent, of those 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 EVAR. Included in the aortic repair were 231 out of 243 (95.1%) total visceral vessels. The intra-operative requirement of 13 additional VBX determined a TVV-related technical success of 94.4%. Mean follow-up was 26.1 ± 16.4 months. Estimated overall survival at 36-months was 73 ± 7.5%. 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. Estimated rate at 36-months for freedom from TVV-instability was 92.1 ± 3% and did not differ between branched and fenestrated configurations, while freedom from TVV-related reinterventions was 90.6 ± 3.1% and significantly in favor of fenestrations (69.4% versus 96.8%, p< .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (HR: .079; 95% CI: .016 - .403). CONCLUSION: The VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. While immediate results are deemed satisfactory, they favor fenestrations regarding need of reinterventions through 3-years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes of Endovascular Reconstructive Techniques in Trans-Atlantic Inter-Society Consensus II C-D Aortoiliac Lesions.

BACKGROUND: To describe the outcomes of the endovascular reconstruction of TASC C/D lesions involving the infrarenal aorta and aortic bifurcation with different techniques. METHODS: This is an observational, retrospective, single-center study. In a 5-year period, we selected all the patients treated with an endovascular procedure for an aorto-iliac TASC C/D lesion involving the infrarenal aorta and/or the aortic bifurcation. Early (<30 days) outcomes were mortality, major amputation, and thrombosis. Late mid-term (1 and 3 years) outcomes were primary, assisted primary and secondary patency, limb salvage rate, and freedom from reintervention. RESULTS: A total of 87 patients were treated during the index period. Kissing covered stent (cKS), covered reconstruction of aortic bifurcation (CERAB), and unimodular bifurcated AFX Unibody stent-graft (Bif-SG) implantation were performed in 35 (40.4%), 26 (29.8%), and 26 (29.8%) cases, respectively. Bif-SG group included 11 (11/26, 42.3%) patients treated for abdominal aortic aneurysm associated with the obstruction of the aortic bifurcation. Technical success was achieved in all cases and no ruptures or conversions to open surgery were recoded. Median follow-up age was 18 months (interquartile range [IQR], 8-34). Overall primary patency rate was 91.2% (95% confidence interval [CI]: 81.3-95.9) at 1 year and 83.5% (95% CI: 69.6-91.4) at 3 years. Assisted primary patency was 96.9% (95% CI: 87.8-99.2) at 1 and 3 years. Secondary patency was 97.8% (95% CI: 85.5-99.6) at 3 years. Limb salvage rate was 98.6% (95% CI: 90.1-99.7) at 1 and 3 years and, freedom from reintervention was 98.4% (95% CI: 88.9-99.7) at 1 year and 87% (95% CI: 66.1-95.4) at 3 years. Univariate analysis did not identify any factor affecting primary patency rate. CONCLUSIONS: Endovascular reconstruction in severe aorto-iliac obstructions using advanced techniques offered promising mid-term patency rates and profiles of safety. The variety of reconstructive configurations allows surgeons to customize on patients' anatomies the type of revascularization.

Elective or Urgent Carotid Endarterectomy in Symptomatic Patients: Analysis Based on the Type and Timing of Neurological Symptoms.

BACKGROUND: The aim of this study was to retrospectively analyse perioperative and long-term outcomes of carotid endarterectomy (CEA) performed in symptomatic patients in a high-volume academic vascular centre, stratifying them according to the type of preoperative symptoms and the timing of surgery with respect to the indexed neurological event. METHODS: From January 2014 to December 2020, 1,369 consecutive CEAs were performed at our institution. Data concerning these interventions were prospectively collected in a dedicated database including data concerning preoperative assessment, surgical details, perioperative (<30 days) outcomes, and long-term outcomes. A retrospective analysis of the database was performed, and 213 interventions performed in symptomatic patients were found. We identified 2 subgroups of patients: patients with stable neurological symptoms (not recent transient ischemic attack (TIA) or stable major disabling stroke, stable group, and 157 patients) and patients with unstable neurological symptoms (recent TIA, crescendo TIAs, stroke in evolution, acute/recent minor stroke, unstable group, and 56 patients). Perioperative outcomes were analysed in terms of mortality, major neurological events, and local or systemic complications The results were compared using the χ2 test; these were also analysed on the basis of the presenting symptom (isolated TIA, crescendo TIA, stroke in evolution, acute/recent minor stroke, stabilized stroke) and the timing of the intervention relative to the onset of the symptom. Long term results were analysed using the life-table analysis and Kaplan-Meier curves in terms of survival, stroke-free survival, absence of neurological symptoms, and absence of significant restenosis. RESULTS: Overall, 30-day stroke and death rate were 4.2%. (3.1% vs. 7%, P = 0.2). Two deaths occurred at 30 days, both in the stable group (mortality 1.2%, P = 0.4 compared to the unstable group), but no fatal strokes were recorded in the overall sample. No differences were found in terms of new perioperative neurological events and local complications between the 2 groups. We found a trend toward poorer perioperative results in patients operated on within 48 hr from the indexed event and in patients operated on for stroke in evolution or acute/recent stroke, whereas we found a trend toward better results in favour of patients operated on between 8 and 14 days (P = 0.08). The median duration of follow-up was 24.8 months (range 1-78); at 5 years we did not find significant differences in terms of survival and stroke-free survival rates between 2 groups. CONCLUSIONS: In our experience, carotid surgery in symptomatic patients provided satisfactory results, particularly in patients with stable neurological status. Among unstable patients, the rate of complications significantly increases, mainly among treated in the very early (<48 hr) period for stroke in evolution or acute/recent stroke. Once the perioperative risk is overcome, the results in the long-term setting are similarly good, both in stable and in unstable patients.

Total Iodine Contrast-free Strategy for the Endovascular Management of Abdominal Aortic Aneurysms in Chronic Kidney Disease Patients: A Pilot Study.

BACKGROUND: To retrospectively evaluate the feasibility and effectiveness of the endovascular treatment of patients with abdominal aortic aneurysm and chronic kidney disease (CKD) without the need for using iodinated contrast media throughout the diagnostic, therapeutic, and follow-up pathway. METHODS: A retrospective review of prospectively collected data concerning 251 consecutive patients presenting an abdominal aortic or aorto-iliac aneurysm who underwent endovascular aneurysm repair (EVAR) from January 2019 to November 2022 at our academic institution was performed in order to identify patients with feasible anatomy with respect to manufacturer's instructions for use and with CKD. Patients whose preoperative workout included duplex ultrasound and plain computed tomography for preprocedural planning were extracted from a dedicated EVAR database. EVAR was performed with the use of carbon dioxide (CO2) as the contrast media of choice, whereas follow-up examinations consisted of either duplex ultrasound, plain computed tomography, or contrast-enhanced ultrasound. Primary endpoints were technical success, perioperative mortality, and early renal function variations. Secondary endpoints were all-type endoleaks and reinterventions, midterm aneurysm-related and kidney-related mortality. RESULTS: Forty-five patients had CKD and were treated electively (45/251, 17.9%). Of them, 17 patients were managed with a total iodinated contrast media-free strategy and constituted the object of the present study (17/45, 37.8%; 17/251, 6.8%). In 7 cases, an adjunctive planned procedure was performed (7/17, 41.2%). No intraoperative bail-out procedures were needed. This extracted cohort of patients presented similar mean preoperative and postoperative (at discharge) glomerular filtration rate values, 28.14 (SD 13.09; median 28.06, interquartile range (IQR) 20.25) ml/min/1.73 m2 and 29.33 (SD 14.61; median 27.35, IQR 22) ml/min/1.73 m2, respectively (P = 0.210). Mean follow-up was 16.4 months (SD 11.89; median 18, IQR 23). During follow-up, no graft-related complications occurred in terms of either thrombosis, type I or III endoleaks, aneurysm rupture, or conversion. The mean glomerular filtration rate at follow-up was 30.39 ml/min/1.73 m2 (SD 14.45; median 30.75, IQR 21.93), with no significant worsening in comparison with preoperative and postoperative values (P = 0.327 and P = 0.856 respectively). No aneurysm- or kidney-related deaths occurred during follow-up. CONCLUSIONS: Our initial experience shows that total iodine contrast-free abdominal aortic aneurysm endovascular management in patients with CKD may be feasible and safe. Such an approach seems to guarantee the preservation of residual kidney function without increasing the risks of aneurysm-related complications in the early and midterm postoperative periods, and it could be considered even in the case of complex endovascular procedures.

The Society for Vascular Surgery clinical practice guidelines on popliteal artery aneurysms.

The Society for Vascular Surgery clinical practice guidelines on popliteal artery aneurysms (PAAs) leverage the work of a panel of experts chosen by the Society for Vascular Surgery to review the current world literature as it applies to PAAs to extract the most salient, evidence-based recommendations for the treatment of these patients. These guidelines focus on PAA screening, indications for intervention, choice of repair strategy, management of asymptomatic and symptomatic PAAs (including those presenting with acute limb ischemia), and follow-up of both untreated and treated PAAs. They offer long-awaited evidence-based recommendations for physicians taking care of these patients.

Endovascular Reconstruction for Total Aorto-Iliac Occlusion.

OBJECTIVES: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto-iliac bifurcation in a multicenter Italian registry. METHODS: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto-iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto-iliac bifurcation were included. Early (<30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. RESULTS: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. CONCLUSIONS: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto-iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization.