Systematic review of risk factors and outcomes of post-implantation syndrome following endovascular aortic repair.

OBJECTIVE: Post implantation syndrome (PIS) is an early systemic inflammatory response following endovascular aortic repair (EVAR). The response is variable in patients and the clinical significance of PIS upon outcomes is unknown. This study aims to evaluate the incidence, risk factors, and prognostic implication of PIS. METHODS: Systematic literature review and analysis was performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and Cochrane guidelines of PubMed, Scopus, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials. Eligible English-language studies regarding PIS after infrarenal EVAR were included, after removing duplicates. RESULTS: After screening, 31 studies were included. A total of 2847 patients were reviewed, with mean age of 70.7 years, of which 2012 (90.4%) were male, with a pooled mean follow-up of 26.1 months. PIS was reported in 25.3% of cases, with mean aneurysm diameter of 56.4 cm. Polytetrafluoroethylene (PTFE) grafts were utilized in 794 patients (27.9%) with polyester in 1839 (64.6%). White blood cell count, C-reactive protein, interleukin (IL)-6, IL-8, and IL-10 levels were all significantly elevated postoperatively. Thirty-day outcomes included type I endoleak rate of 0.8%, type II endoleak rate of 1.7%, reintervention rate of 0.35%, and mortality rate of 0.25%. Subgroup pooled analysis of patients with PIS (n = 309) vs No-PIS (n = 691) revealed that polyester (n = 642), rather than PTFE (n = 234) grafts, were associated with a higher rate of PIS (94.8% vs 3.7%; P = .0001), White blood cell count was higher in the PIS group both preoperatively (7.61 vs 6.76 × 109/L; P = .04) and postoperatively (15.0 vs 9.8 × 109/L; P = .0007) and IL-6 levels were higher in the PIS group postoperatively (98.6 vs 25.2 pg/mL; P = .02). Aneurysm diameter and amount of chronic or new thrombus within the aneurysm sac was not identified as a risk factor for PIS. Pooled outcomes of patients with PIS vs No-PIS demonstrated a significantly higher rate of 30-day mortality (0.6% vs 0%; P = .03) and major adverse cardiac events (5.8% vs 0.43%; P < .0001) without any differences seen in reintervention or 30-day type I or type II endoleaks. CONCLUSIONS: This systematic review suggests that polyester grafts are strongly associated with PIS compared with PTFE. Interestingly, this report is suggestive of an association between 30-day mortality and major adverse cardiac events and PIS. Given these clinical sequelae, consideration for use of PTFE over polyester grafts to reduce the incidence of PIS may be a simple step to improve overall outcome. Further, exploration of the relationship between inflammatory mediators associated with PIS and mortality and cardiac complications may engender deeper understanding of risks, leading to eventual mitigation of harm for patients experiencing PIS.

Systematic review and meta-analysis of cerebrospinal fluid drain-related mortality and morbidity after fenestrated-branched endovascular aortic repair.

OBJECTIVE: This study aimed to investigate the incidence of cerebrospinal fluid drainage (CSFD)-related complications specifically in patients who underwent fenestrated and branched endovascular aortic repair (F/B-EVAR). This objective was chosen considering the limitations and uncertainties surrounding its efficacy in preventing spinal cord injury. METHODS: A systematic review following Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted (PROSPERO; #CRD42022359223). Literature searches of MEDLINE, Embase, and Scopus were performed until May 1, 2023, focusing on studies published after January 1, 2000. The inclusion criteria encompassed studies reporting on F/B-EVAR, CSFD, and drain-related complications. Data extraction and quality assessment using the Newcastle-Ottawa Scale were performed by multiple reviewers to ensure accuracy and reliability. A proportion meta-analysis was conducted to calculate the pooled rate and 95% confidence interval (CI). The primary and secondary outcomes were CSFD-related mortality and morbidity, respectively. RESULTS: Six retrospective, observational, single-center studies were included, totaling 1079 patients and 730 CSFD placements (all prophylactic except for one). The Newcastle-Ottawa Scale showed a high to moderate risk of bias. The analysis revealed a CSFD-related mortality rate of 1.4% (95% CI: 0.0-4.8; I2 = 67.7%) and an overall morbidity rate of 25.6% (95% CI: 13.6-39.7; I2 = 83.2%). The overall major, moderate, and minor estimated complication rates were 6.1% (95% CI: 4.1-8.5; I2 = 0%), 4.6% (95% CI: 2.4-7.3; I2 = 33.5%), and 26.4% (95% CI: 16.5-37.7; I2 = 84.9%), respectively. Severe complications included intracranial hemorrhage (2.8%), spinal hematoma (1.4%), subarachnoid hemorrhage (1.4%), and CSFD-related neurological deficits (1.1%). A pooled estimate of 11.4% for nonfunctioning drainage was found. CONCLUSIONS: F/B-EVAR patients showed a notable incidence of CSFD-related death and substantial morbidity. This study highlights the limitations of the available data, the high prevalence of complications associated with CSFD, and the need for further research to better understand the risks and benefits of CSFD in F/B-EVAR. This calls for careful consideration regarding the routine use of prophylactic drainage due to the accumulating evidence of the risks associated with CSFD without proven benefit in this specific context.

The sac evolution imaging follow-up after endovascular aortic repair: An international expert opinion-based Delphi consensus study.

OBJECTIVE: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. METHODS: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. RESULTS: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. CONCLUSIONS: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.

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

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

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Intraoperative Transit-Time Flow as a Predictor of Failure after Infrainguinal Revascularization with Heparin-Bonded Expanded Polytetrafluoroethylene Graft.

BACKGROUND: The heparin-bonded expanded polytetrafluoroethylene (He-ePTFE) conduit is an option for patients requiring infrainguinal revascularization (iIR), but the risk of failure may be unpredictable, especially in cases with poor run-off. Intraoperative transit-time flow (TTF) provides an automated and quantitative analysis of flow and may serve as an adjunct evaluation during surgical revascularization. The aim of this study was to assess TTF in patients undergoing iIR with He-PTFE at 3 referral hospitals and to establish a predictive flow threshold for graft occlusion. METHODS: A prospective registry initiated in 2020 enrolled patients undergoing iIR using He-PTFE for critical limb ischemia or severe claudication, and TTF measurement was analyzed. Preoperative assessments of anatomical and clinical characteristics were available for all patients. The HT353 Optima Meter (Transonic Systems Inc., Ithaca, NY, USA) was used in all procedures according to a standardized protocol. The institutional ethics committee approved the study. A predictive model using receiver operating characteristic curve analysis was utilized to establish the threshold of flow, and variables were compared. Anatomical and clinical evaluation were reported according to Rutherford grade, Global Limb Anatomic System and Wound, Ischemia, and foot Infection classification. The main outcome considered was the correlation between TTF and graft occlusion. Secondary outcomes included survival, other predictors of graft occlusion, freedom from major adverse cardiovascular events, and freedom from major amputation. RESULTS: Among 68 patients, 55.8% had Rutherford 5-6, 45.6% had Global Limb Anatomic System 3 and 73.5% had Wound, Ischemia, and foot Infection 3-4. Distal anastomosis was at tibial level in 23.5% and mean diameter of conduit was 6.4 mm. Basal and postoperative TTF were 27.8 ± 15.6 ml/min and 109.0 ± 53.0 ml/min, respectively. After a mean follow-up of 18 ± 13 months, 7 (10.9%) patients presented graft occlusion and 5 (7.8%) required major amputation. TTF threshold = 80 ml/min revealed a sensitivity and specificity of 81.8% (95% confidence interval 48.2-97.7) and 80.7% (95% confidence interval 68.1-90.0) respectively, and it was selected as cut-off for graft occlusion. Freedom from graft occlusion in patients with TTF >80 ml/min vs. TTF ≤80 ml/min at 6, 12, and 24 months was 95.7% (standard error (SE) = 0.030) vs. 65.5% (SE = 0.115), 95.7% (SE = 0.030) vs. 58.9% (SE = 0.120) and 90.9% (SE = 0.054) vs. 51.6% (SE = 0.126), P = 0.0003. No statistical difference in primary patency, secondary patency and limb salvage was observed. At multivariate analysis, distal anastomosis at tibial vessel (odds ratio 8.50) and TTF ≤80 ml/min (odds ratio 9.39) were independent predictors of graft occlusion. CONCLUSIONS: These results suggest that TTF may serve as a valuable tool in the management of iIR. A TTF measurement of ≤80 ml/min should be regarded as a predictor of graft occlusion, prompting consideration of additional intraoperative maneuvers to enhance arterial flow. Caution should be exercised in patients requiring direct tibial artery revascularization, as it represents a predictor of failure independent of TTF levels. Larger cohorts of patients and longer follow-up periods are necessary to confirm these findings.

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.

Development and Validation of a Risk Prediction Tool for In-hospital Mortality After Thoracic Endovascular Repair in Patients with Blunt Thoracic Aortic Injury Using the Aortic Trauma Foundation Registry.

BACKGROUND: The objective of our present effort was to use an international blunt thoracic aortic injury (BTAI) registry to create a prediction model identifying important preoperative and intraoperative factors associated with postoperative mortality, and to develop and validate a simple risk prediction tool that could assist with patient selection and risk stratification in this patient population. METHODS: For the purpose of the present study, all patients undergoing thoracic endovascular aortic repair (TEVAR) for BTAI and registered in the Aortic Trauma Foundation (ATF) database from January 2016 as of June 2022 were identified. Patients undergoing medical management or open repair were excluded. The primary outcome was binary in-hospital all-cause mortality. Two predictive models were generated: a preoperative model (i.e. only including variables before TEVAR or intention-to-treat) and a full model (i.e. also including variables after TEVAR or per-protocol). RESULTS: Out of a total of 944 cases included in the ATF registry until June 2022, 448 underwent TEVAR and were included in the study population. TEVAR for BTAI was associated with an 8.5% in-hospital all-cause mortality in the ATF dataset. These study subjects were subsequently divided using 3:1 random sampling in a derivation cohort (336; 75.0%) and a validation cohort (112; 25.0%). The median age was 38 years, and the majority of patients were male (350; 78%). A total of 38 variables were included in the final analysis. Of these, 17 variables were considered in the preoperative model, 9 variables were integrated in the full model, and 12 variables were excluded owing to either extremely low variance or strong correlation with other variables. The calibration graphs showed how both models from the ATF dataset tended to underestimate risk, mainly in intermediate-risk cases. The discriminative capacity was moderate in all models; the best performing model was the full model from the ATF dataset, as evident from both the Receiver Operating Characteristic curve (Area Under the Curve 0.84; 95% CI 0.74-0.91) and from the density graph. CONCLUSIONS: In this study, we developed and validated a contemporary risk prediction model, which incorporates several preoperative and postoperative variables and is strongly predictive of early mortality. While this model can reasonably predict in-hospital all-cause mortality, thereby assisting physicians with risk-stratification as well as inform patients and their caregivers, its intrinsic limitations must be taken into account and it should only be considered an adjunctive tool that may complement clinical judgment and shared decision-making.

Advanced Imaging Techniques for Complex Endovascular Aortic Repair: Pre-Operative, Intra-Operative and Post-Operative Advancements.

OBJECTIVES: Endovascular aortic repair requires extensive preoperative, intraoperative, and postoperative imaging for planning, surveillance, and detection of endo-leaks. There have been many advancements in imaging modalities to achieve this purpose. This review discussed different imaging modalities used at different stages of treatment of complex endovascular aortic repair. METHODS: We conducted a literature review of all the imaging modalities utilized in endovascular aortic repair by searching various databases. RESULTS: Pre-operative techniques include analysis of images obtained via modified central line using analysis software and intravascular ultrasound. Fusion imaging, CO2 angiography, intravascular ultrasound, and Fiber Optic RealShape technology have been crucial in obtaining real-time imaging for the detection of endo-leaks during operative procedures. Conventional imaging modalities like CT Angiography and MR Angiography are still employed for post-operative surveillance along with computational fluid dynamics and contrast-enhanced ultrasound. The advancements in artificial intelligence have been the breakthrough in developing robust imaging applications. CONCLUSIONS: This review explains the advantages, disadvantages, and side-effect profile of the abovementioned imaging modalities.

Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results. METHODS: This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated. RESULTS: A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%. CONCLUSIONS: The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.

Current expert-based opinions on endovascular treatment of blunt thoracic aortic injury: A state-of-the-art narrative review on indications, techniques, results, and challenges.

INTRODUCTION: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma which warrants prompt recognition with expedited management. Clinical manifestations of BTAI may not be straightforward to detect and may be misdiagnosed. Therefore, diagnosis of BTAI requires a high index of suspicion based on the mechanism of injury along with urgent transfer to centers with appropriate expertise and facilities. METHODS: We provide an expert-based narrative review on endovascular treatment of BTAI highlighting indications, techniques, results, and challenges. RESULTS: Multiple imaging modalities can be used including computed tomography angiography, transesophageal echocardiography, magnetic resonance imaging, and intravascular ultrasound. Whilst conservative pharmacological management can be a safe option in low-grade BTAI, thoracic endovascular aortic repair has become the gold-standard strategy in most cases, replacing open surgical repair. Nevertheless, it is important to account for patient demographics particularly age, severity of injury, choice of endograft including its type and size, and endovascular technique including landing zone and left subclavian artery revascularization. CONCLUSIONS: Overall, TEVAR in BTAI has been shown to be an efficacious strategy with favorable early outcomes. In contrast, less is known on the long-term clinical outcomes of TEVAR in BTAI. Hence, despite the optimal early technical and clinical success rates, concerns remain about the need for long-term surveillance. The exact timing of follow-up and the integration of different modalities that can also investigate potential downstream cardiovascular effects remain hot topics for future research. Finally, industry should focus on developing more compliant endografts to improve the stiffness mismatch between the endograft and the aorta to optimize results.

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.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA): Derivation and validation of a novel risk score.

OBJECTIVE: The aim of the present study was to develop and validate a risk prediction model for the prediction of long-term mortality for patients with severe asymptomatic de novo carotid stenosis undergoing carotid endarterectomy (PREMY2SE-CEA). METHODS: Data were collected retrospectively from a dedicated database of consecutive patients who had undergone elective CEA for severe (>70% using the NASCET [North American Symptomatic Carotid Endarterectomy Trial] criteria) asymptomatic carotid stenosis at two Italian University Hospitals from 2008 through 2016. Internal validation of the score was performed after random sampling in a 3:1 fashion. The primary end point of the PREMY2SE-CEA risk score was the 5-year mortality. RESULTS: Of the 1214 patients, 901 were included in the derivation cohort and 313 in the validation cohort. Using multivariable logistic regression with backward elimination, a parsimonious model was derived. A risk score incorporating eight risk factors was generated and found to be highly predictive of long-term mortality in the derivation (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.28-1.41; P < .001) and validation (OR, 1.29; 95% CI, 1.21-1.37; P <.001) cohorts. The discrimination power in the receiver operating characteristic curve analysis was C = 0.775 (95% CI, 0.74-.80), and the optimism-corrected area under the curve in the bootstrapped samples was 0.761 (P < .001). A strong correlation was found between the predicted and actual mortality rates in the validation cohort (r = 0.71; P < .001). CONCLUSIONS: In the present study, we have described the development, evaluation, and validation of a risk prediction model (PREMY2SE-CEA) for long-term mortality after CEA in asymptomatic patients. Physicians could use the PREMY2SE-CEA risk scoring tool to complement their estimates of life expectancy and prompt selective consideration of prophylactic CEA to improve the long-term benefits of interventions.

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

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

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

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

Two-Year Outcomes With Bentley BeGraft as Bridging Stent-Grafts for Reno-Visceral Target Vessels During Fenestrated Endovascular Aortic Repair.

INTRODUCTION: The aim of this study was to present the short-term and 2-year outcomes after use of the Bentley BeGraft as bridging stent-graft (BSG) for reno-visceral target vessel (TV) during fenestrated endovascular aortic repair (FEVAR) from a contemporary multicentric experience. METHODS: A retrospective review of all consecutive patients who underwent elective FEVAR at 7 institutions located in Italy from 2015 to 2021 was performed. The main outcomes of interest for this study were technical success and TV instability, defined in accordance with current reporting standards. Patients' survival was also assessed. RESULTS: Overall, 81 patients received elective FEVAR during the study period. Mean age of patients was 78 years, and 89% were men. Most patients were treated for a juxta-pararenal abdominal aortic aneurysm (AAA) (68%), and 23% had already received an infrarenal aortic reconstruction. Most endografts had 3-vessel or 4-vessel design (27% and 55%, respectively), and a Cook endograft was used in 73% of cases. Overall, 266 Bentley BeGraft were implanted, of which 44 (16.5%) in the celiac trunk, 69 (26%) in the superior mesenteric artery, 79 (29.5%) in the right renal artery, and 74 (28%) in the left renal artery. Technical success was 94%, with 5 instances of technical failure that were recorded and required an additional intraoperative procedure. The early mortality rate was 4%, and acute kidney injury occurred in 14 cases with 1 requiring definitive hemodialysis. Survival at 6, 12, and 24 months in the overall cohort was 98.8%, 95.3%, and 83.4%, respectively. Freedom from TV instability at 6, 12, and 24 months in the overall cohort was 98.4%, 97.9%, and 97.2%, respectively. Events of TV instability included 3 cases of type 1C endoleak and 3 cases of type 3C endoleak, while no events of BSG fracture or thrombosis were noted. Five out of 6 cases of TV instability occurred in renal arteries, and they were all successfully treated by endovascular means. CONCLUSIONS: The data from this multicentric study show favorable short-term and 2-year outcomes of the Bentley BeGraft as BSG for reno-visceral TV during FEVAR, with low rates of TV-related endoleak and no stent occlusion up to 2 years. CLINICAL IMPACT: The data from this multicentric study show satsfactory outcomes up to two years of follow-up for the Bentley BeGraft when used for brdiging reno-visceral vessels during fenestrated endovascular aortic repair. Further research will be needed to identify predictors of stent-related reinterventions and ascertain the long-term durability.

An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA).

OBJECTIVE: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA). METHODS: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts' responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round's answers was also graded using Cohen's kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa. RESULTS: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making. CONCLUSIONS: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology. CLINICAL IMPACT: This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.

The Association Between Body Mass Index and Death Following Elective Endovascular and Open Repair of Abdominal Aortic Aneurysms in the Vascular Quality Initiative.

OBJECTIVE: The effect of body mass index (BMI) on post-operative outcomes after abdominal aortic aneurysm (AAA) repair remains poorly defined. The association between BMI and death following elective endovascular aneurysm repair (EVAR) and open aneurysm repair (OAR) of AAA in a large national quality registry is investigated. METHODS: All elective AAA repairs within the Society for Vascular Surgery Vascular Quality Initiative (VQI; 2010 to September 2021) were reviewed (EVAR, n = 53 426; OAR, n = 9 479). All analyses were conducted separately for EVAR and OAR patients. The primary end points were 30 day mortality and five year survival rates. Study cohorts were divided into World Health Organisation BMI categories (C1 < 18.5, C2 18.5 ≤ BMI < 25, C3 25 ≤ BMI < 30, C4, 30 ≤ BMI < 35, C5 35 ≤ BMI < 40, C6 ≥ 40). BMI was examined as both a categorical and continuous variable. Logistic and Cox proportional hazards regression were used for risk adjustment. RESULTS: Among EVAR patients, BMI distribution was C1, 1 216 (2%); C2, 14 687 (28%); C3, 20 516 (38%); C4, 11 352 (21%); C5, 3 947 (7%); C6, 1 708 (3%). Class 1, 2, and 6 BMI patients experienced an increased 30 day mortality rate (C1 2.6%; C2 1.3%; C6 1.4% vs. C3 - 5 0.7%; p < .001) and C1 and C2 had correspondingly inferior long term survival (five years: C1 69 ± 3%; C2 79 ± 1% vs. C3 - 6 86 - 88 ± 2%; log rank p < .001). These survival disparities persisted after risk adjustment for multiple confounders. In the OAR cohort, BMI distribution was C1, 280 (3%); C2, 2 862 (30%); C3, 3 587 (38%); C4, 1 940 (21%); C5, 581 (6%); C6, 229 (2%). Crude 30 day mortality rates were increased for both the lowest and highest BMI patients (C1 12%, C6 7% vs. C2 - 5 3 - 4%; p < .001); these differences also persisted in long term survival (five years: C1 71 ± 6%, C6 82 ± 6% vs. C2 - 6 85 - 88 ± 3%; log rank p < .001). In risk adjusted analysis, both low and high BMI OAR patients had an increased 30 day and long term mortality rate. CONCLUSION: Within the VQI, both the extreme low (< 18.5) and high (≥ 40) BMI groups experienced an increased 30 day mortality rate after both elective EVAR and OAR. By comparison, while the lowest BMI cohort was significantly associated with decreased long term survival after both procedures, the highest BMI group only experienced reduced long term survival after OAR. Based upon this large real world registry analysis of elective AAA repairs, differential metabolic signatures exist within extreme BMI categories, which may inform peri-operative risk stratification and clinical decision making.

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

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