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.

Platelet function testing and clinical outcomes in peripheral arterial disease: Systematic review and narrative synthesis.

OBJECTIVE: This systematic review aims to comprehensively assess the contemporary literature on platelet function testing (PFT) in individuals undergoing revascularization therapy for peripheral arterial disease (PAD). The goal is to identify whether PFT can aid in detecting antiplatelet resistance, predicting post-procedural thrombotic complications, and informing tailored treatment strategies. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a literature review was conducted using PubMed databases. Search terms included relevant medical subject headings (MeSH) terms. Eligible articles published in English between 1990 and 2023 were analyzed. Studies that examined PFT outcomes in patients with PAD after lower extremity revascularization were included. RESULTS: Ten studies met the inclusion criteria. Various PFT methods were used, including thromboelastography with platelet mapping, multiplate analyzer, Cytochrome P450 2C19 testing, VerifyNow, corrected whole blood aggregometry, platelet function analyzer-100, and light transmission aggregometry. PFT identified individuals who were resistant or non-sensitive to antiplatelet therapy, with such patients facing increased risks of graft/stent thrombosis, amputation, and reintervention. However, substantial heterogeneity in surgical procedures, drug regimens, and testing methods was observed among the studies. CONCLUSIONS: PFTs can play a crucial role in detecting resistance and non-sensitivity to antiplatelet drugs in patients with PAD post-revascularization. However, heterogeneity of data and methods underlines the need for standardized protocols and consensus-building among PFTs. Enhancing clinical utility and reliability could help optimize antiplatelet thromboprophylaxis, minimize thrombotic complications, and improve treatment strategies in vascular surgery. Further research is necessary to solidify the role of PFTs in guiding antiplatelet therapy post-revascularization in patients with PAD.

Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft.

OBJECTIVE: This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

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.

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.

An international, expert-based, Delphi consensus document on controversial issues in the management of abdominal aortic aneurysms.

OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas.

International Cross-Sectional Survey ON TReatment Of Occluded Femoro-Popliteal Stents (SUNROOF).

PURPOSE: The aim of this project is to explore practice patterns of experienced vascular specialists involved in the treatment of patients with arterial femoro-popliteal in-stent occlusion (ISO) and to understand key concepts and shared thoughts, throughout an international cross-sectional survey. MATERIALS AND METHODS: The web-based survey was in English and included 31 questions. One-hundred experts were invited by email to fill in the survey anonymously on Google Forms using a dedicated link. Reminders were sent after the first 2 weeks. In addition to reporting of pooled responses, subanalyses of answers were also performed, according to country of origin (European vs non-European), years of experience (≤20 years vs >20 years), and type of institution (Academic/University vs Non-academic/Private). RESULTS: A total of 77 physicians from 22 countries completed the survey. Most responders were males (70/77, 91%). Most of the participants were vascular surgeons (58/77, 75%). Endovascular therapy was the preferred option in patients presenting with either acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Atherectomy/thrombectomy+Drug-Coated Balloon (DCB) was the preferred endovascular modality (32/77, 42%). No differences between country of origin, years of experience, and type of institution of the participants were found. CONCLUSIONS: The international SUrvey oN TReatment Of Occluded Femoro-Popliteal Stent (SUNROOF) survey has suggested that endovascular therapy is the preferred method for the treatment of femoro-popliteal ISO. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks good-level scientific evidence and appropriate guidelines. CLINICAL IMPACT: The international SUNROOF survey included 31 questions. It was performed by 77 vascular physicians from 22 countries. More than a half of respondents considered an endovascular approach as the preferred treatment modality in acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Most responders agreed they would intensify the follow-up protocol and anti-thrombotic medications regimen after a first in-stent occlusion episode. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks of good level scientific evidence and appropriate guidelines.

Editor's Choice - A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair. METHODS: Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting. RESULTS: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth. CONCLUSION: Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed.

Editor's Choice - Systematic Review and Meta-Analysis of Contemporary Abdominal Aortic Aneurysm Growth Rates.

OBJECTIVE: To evaluate the contemporary growth rate of small abdominal aortic aneurysms (AAAs) in view of recent epidemiological changes, such as decreasing smoking rates and establishment of population screening programmes. DATA SOURCES: MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection, and OpenGrey databases. REVIEW METHODS: Systematic review following the PRISMA guidelines. In October 2021, databases were queried for studies reporting on AAA growth rates published from 2015 onwards. The primary outcome was contemporary AAA growth rates in mm/year. Data were pooled in a random effects model meta-analysis, and heterogeneity was assessed through the I2 statistic. GRADE assessment of the findings was performed. The protocol was published in PROSPERO (CRD42022297404). RESULTS: Of 8 717 titles identified, 43 studies and 28 277 patients were included: 1 241 patients from randomised controlled trials (RCTs), 23 941 from clinical observational studies, and 3 095 from radiological or translational research studies. The mean AAA growth rate was 2.38 mm/year (95% CI 2.16 - 2.60 mm/year; GRADE = low), with meta-regression analysis adjusted for baseline diameter showing an increase of 0.08 mm/year (95% CI 0.024 - 0.137 mm/year; p = .005) for each millimetre of increased baseline diameter. When analysed by study type, the growth rate estimated from RCTs was 1.88 mm/year (95% CI 1.69 - 2.06 mm/year; GRADE = high), while it was 2.31 mm/year (95% CI 1.95 - 2.67 mm/year; GRADE = moderate) from clinical observational studies, and 2.85 mm/year (95% CI 2.44 - 3.26 mm/year; GRADE = low) from translational and radiology based studies (p < .001). Heterogeneity was high, and small study publication bias was present (p = .003), with 27 studies presenting a moderate to high risk of bias. The estimated growth rate from low risk studies was 2.09 mm/year (95% CI 1.87 - 2.32; GRADE = high). CONCLUSION: This study estimated a contemporaneous AAA growth rate of 2.38 mm/year, being unable to demonstrate any clinically meaningful AAA growth rate reduction concomitant with changed AAA epidemiology. This suggests that the RESCAN recommendations on small AAA surveillance are still valid. However, sub-analysis results from RCTs and high quality study data indicate potential lower AAA growth rates of 1.88 - 2.09 mm/year, findings that should be validated in a high quality prospective registry.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

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.

Neutrophil-to-lymphocyte ratio as a prognostic biomarker in patients with peripheral artery disease: A systematic review and meta-analysis.

BACKGROUND: The neutrophil-to-lymphocyte ratio (NLR) is a simple and routinely obtained parameter reflecting systemic inflammation, including in peripheral artery disease (PAD). METHODS: This systematic review aimed to assess the role of NLR as a prognostic biomarker in patients with PAD. A systematic search was conducted across PubMed, ScienceDirect, Web of Science, Scopus, ProQuest, EBSCO, and Cochrane. Random-effects meta-analysis was used to pool risk ratios, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). A bivariate model was used to generate summary receiver operating characteristics with the corresponding area under the curve (AUC). RESULTS: This review included 5243 patients with PAD from nine eligible studies. High NLR corresponded to at least a twofold increased risk of all-cause mortality (ACM), major adverse limb events (MALE), and major adverse cardiovascular events (MACE). NLR's performance was good for predicting 1-year ACM (AUC 0.71 [95% CI: 0.59-0.79], sensitivity 58.2% [95% CI: 45.3-71.0], specificity 72.6% [95% CI: 65.6-79.62], PPV 41.0% [95% CI: 31.2-50.7], NPV 82.7% [95% CI: 74.1-91.3]) and 1-year MALE (AUC 0.78 [95% CI: 0.75-0.80], sensitivity 65.4% [95% CI: 41.6-89.2], specificity 77.7% [95% CI: 71.0-84.3], PPV 53.7% [95% CI: 47.3-60.1], NPV 83.91% [95% CI: 73.2-94.6]). However, these values tended to decrease as the follow-up duration extended, except for the pooled specificities, which exhibited the opposite pattern. CONCLUSION: NLR emerges as a simple and cost-effective prognostic biomarker with decent performance for poor outcomes in patients with PAD (PROSPERO Registration No.: CRD42023486607).

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Incidence, diagnosis, management and outcome of acute mesenteric ischaemia: a prospective, multicentre observational study (AMESI Study).

BACKGROUND: The aim of this multicentre prospective observational study was to identify the incidence, patient characteristics, diagnostic pathway, management and outcome of acute mesenteric ischaemia (AMI). METHODS: All adult patients with clinical suspicion of AMI admitted or transferred to 32 participating hospitals from 06.06.2022 to 05.04.2023 were included. Participants who were subsequently shown not to have AMI or had localized intestinal gangrene due to strangulating bowel obstruction had only baseline and outcome data collected. RESULTS: AMI occurred in 0.038% of adult admissions in participating acute care hospitals worldwide. From a total of 705 included patients, 418 patients had confirmed AMI. In 69% AMI was the primary reason for admission, while in 31% AMI occurred after having been admitted with another diagnosis. Median time from onset of symptoms to hospital admission in patients admitted due to AMI was 24 h (interquartile range 9-48h) and time from admission to diagnosis was 6h (1-12 h). Occlusive arterial AMI was diagnosed in 231 (55.3%), venous in 73 (17.5%), non-occlusive (NOMI) in 55 (13.2%), other type in 11 (2.6%) and the subtype could not be classified in 48 (11.5%) patients. Surgery was the initial management in 242 (58%) patients, of which 59 (24.4%) underwent revascularization. Endovascular revascularization alone was carried out in 54 (13%), conservative treatment in 76 (18%) and palliative care in 46 (11%) patients. From patients with occlusive arterial AMI, revascularization was undertaken in 104 (45%), with 40 (38%) of them in one site admitting selected patients. Overall in-hospital and 90-day mortality of AMI was 49% and 53.3%, respectively, and among subtypes was lowest for venous AMI (13.7% and 16.4%) and highest for NOMI (72.7% and 74.5%). There was a high variability between participating sites for most variables studied. CONCLUSIONS: The overall incidence of AMI and AMI subtypes varies worldwide, and case ascertainment is challenging. Pre-hospital delay in presentation was greater than delays after arriving at hospital. Surgery without revascularization was the most common management approach. Nearly half of the patients with AMI died during their index hospitalization. Together, these findings suggest a need for greater awareness of AMI, and better guidance in diagnosis and management. TRIAL REGISTRATION: NCT05218863 (registered 19.01.2022).

Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.

Advanced endovascular techniques, such as fenestrated stent grafts, are nowadays available that permit minimally invasive treatment of complex abdominal aortic aneurysms. However, thoracoabdominal aortic aneurysm patients have anatomic limitations to fenestrated stent-grafts given a large lumen, that is, the gap between the endograft and the inner aortic wall. This has led to the development of branched endovascular aneurysm repair as the ideal option for such patients. The Zenith t-Branch multibranched endograft (Cook Medical, Bloomington, IN), which has been commercially available in Europe to treat thoracoabdominal aortic aneurysm since June 2012, represents a feasible off-the-shelf alternative for treatment of such pathologies, especially in the urgent setting, for patients who cannot wait the time required for manufacturing and delivery of custom-made endografts. The device's anatomical suitability should be considered, especially for female patients with smaller iliofemoral vessels. Several tips may help deal with particularly complex scenarios (such as, for instance, in case of narrow inner aortic lumens or when treating patients with failure of prior endovascular aneurysm repair), and a broad array of techniques and devices must be available to ensure technical and clinical success. Despite promising early outcomes, concerns remain particularly regarding the risk for spinal cord ischemia and further assessment of long-term durability is needed, including the rate of target vessel instability and need for secondary interventions. As the published evidence mainly comes from retrospective registries, it is likely that reported outcomes may suffer from an intrinsic bias as most procedures reported to date have been carried out at high-volume aortic centers. Nonetheless, with the never-ceasing adoption of new and refined techniques, outcomes are expected to ameliorate.

Effectiveness of Closed Incision Negative Pressure Wound Therapy for Infrainguinal Bypass in the Vascular Quality Initiative.

BACKGROUND: To analyze surgical site infections (SSIs) after infrainguinal bypass for standard dressings versus closed incision negative pressure wound therapy (ciNPWT) in the Society for Vascular Surgery's Vascular Quality Initiative (VQI). METHODS: We retrospectively analyzed SSI after infrainguinal bypass procedures in the VQI from December 2019 to December 2021 comparing ciNPWT and standard dressings. The primary outcome of any superficial or deep wound infection at 30 days was analyzed in a subset of procedures with 30-day follow-up data (cohort A, n = 1,575). Secondary outcomes including in-hospital SSI, return to the operating room (OR) for infection, and length of stay (LOS) were analyzed for all procedures (cohort B, n = 9,288). Outcomes were analyzed in propensity-matched cohorts. RESULTS: Patients who received ciNPWT (n = 1,389) were more likely to be female (34% vs. 32%, P = 0.04) with a higher rate of smoking history (90% vs. 86%, P = 0.003), diabetes (54% vs. 50%, P = 0.007), obesity (34% vs. 26%, P < 0.001), prior peripheral vascular intervention (57% vs. 51%, P < 0.001), and to prosthetic conduit (55% vs. 48%, P < 0.001) compared to patients with standard dressings (n = 7,899). After propensity matching of cohort A (n = 1,256), the 30-day SSI rate was 4% (12/341) in the ciNPWT and 6% (54/896) in the standard dressing group (P = 0.07, 95% CI 0.03-1.06). In the propensity-matched in-hospital cohort B (n = 5,435), SSI was 3% (35/1,371) in the ciNPWT group and 2% (95/4,064) in the standard dressing group (P = 0.66). There was no difference in the rate of return to the OR for infection, 1% (36/4,064) vs. 1% (19/1,371) (P = 0.13) or LOS, 9.0 vs. 9.0 days (P = 0.86) for the standard versus ciNPWT groups. CONCLUSIONS: In this analysis of the VQI registry, the use of ciNPWT after infrainguinal bypass did not result in a statistically significant decrease in 30-day SSI. We recommend that surgeons consider the use of ciNPWT as part of a bundled process of care for high risk rather than all patients, as it may reduce SSI after infrainguinal bypass.

Comparison of Different Endovascular Treatments of Femoropopliteal Artery In-Stent Restenosis: A Systematic Review and Bayesian Network Meta-Analysis.

BACKGROUND: This Bayesian network meta-analysis (NMA) sought to evaluate the efficacy of different endovascular treatments for femoropopliteal artery in-stent restenosis (FP-ISR). METHODS: PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of science for clinical trials from database inception to March 31, 2023, with no language restrictions to retrieve randomized controlled trials or cohort studies evaluating the impact of any kind of endovascular treatments for FP-ISR. Pair-wise meta-analysis and Bayesian NMA were performed to pool the outcome estimates different endovascular treatments. The primary end points under consideration were primary patency rates at both 6-month and 12-month follow-up. RESULTS: A total of 15 studies with 1,424 patients were ultimately enrolled to be analyzed, 7 types of endovascular treatment were identified for comparison. In terms of primary patency and freedom from target lesion revascularization (TLR) at 6-month and12-month follow-up, the direct meta-analysis findings showed that drug-coated balloons (DCB) and covered stent (CS) are considerably superior to plain old balloon angioplasty (POBA), Excimer laser atherectomy (ELA) + DCB is significantly better than DCB. According to the meta-analysis based on Bayesian theory, during the 6-month and 12-months follow-up, we could not find significant difference between the different treatments in terms of the primary patency and the freedom from TLR, based on the surface values under the cumulative ranking curve (SUCRA), CS was considered the best treatment in terms of primary patency (6 months SUCRA = 85.2; 12 months SUCRA = 78.9) and freedom from TLR (6 months SUCRA = 84.9; 12 months SUCRA = 70.9); directional atherectomy + POBA may lead to higher survival rate at 12 months (SUCRA = 89.1) than others treatments; in addition, both ELA + POBA and ELA + DCB have higher limb salvage than POBA. CONCLUSIONS: The findings of this NMA suggest that CS showed positive encouraging results in primary patency and TLR in FP-ISR at 6 and 12 months. However, due to the potential influence of certain confounding factors, the long-term results necessitate validation through numerous randomized controlled trials.

Neuromonitoring during Endovascular Thoracoabdominal Aortic Aneurysm Repair: A Systematic Review.

BACKGROUND: Spinal cord ischemia (SCI) is a potentially devastating complication of thoracic endovascular aortic repair (TEVAR) and fenestrated-branched endovascular aortic repair (F-BEVAR). The aim of this systematic review was to evaluate the efficacy of neuromonitoring modalities to mitigate the risk of SCI during TEVAR and F-BEVAR procedures. METHODS: Following the PRISMA guidelines, we conducted a detailed literature search of databases including PubMed, MEDLINE via Ovid, Embase, Scopus, and Cochrane CENTRAL, from 1998 to the present. Inclusion criteria were original research articles examining neuromonitoring during TEVAR and F-BEVAR. The primary outcome was the incidence of SCI, while the secondary outcome included early mortality. The quality of studies was assessed using the Newcastle-Ottawa Scale. RESULTS: From 1,450 identified articles, 11 met inclusion criteria, encompassing data from 1,069 patients. Neuromonitoring modalities included motor-evoked potentials (MEPs), somatosensory evoked potentials (SSEPs), and near-infrared spectroscopy. The combination of MEPs and SSEPs was most commonly used, with 93% sensitivity and 96% specificity for detecting SCI risks. SCI incidence ranged from 3.8 to 17.3%, with permanent deficits occurring in 2.7-5.8% of cases. In-hospital mortality ranged from 0.4 to 8%. Risk factors for SCI were identified, including operation duration and extent of aortic coverage. CONCLUSIONS: Neuromonitoring with MEPs and SSEPs appears to be effective in detecting perioperative SCI risk during TEVAR and F-BEVAR. However, discrepancies between neuromonitoring changes and actual SCI outcomes suggest the need for cautious interpretation. While the incidence of SCI remains variable, identified risk factors may guide clinical decisions, particularly in high-risk procedures. Future research should focus on prospective studies and randomized controlled trials to validate these findings and improve SCI prevention strategies in TEVAR and F-BEVAR.

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.