Is There a Role for Heli-FX Endoanchors in Treating Type 1B Common Iliac Artery Endoleaks?

OBJECTIVES: The management of type 1B endoleaks following endovascular aortic aneurysm repair (EVAR) can be challenging. The Heli-FX Endoanchor system effectively treats proximal type 1A endoleaks but has not been used for type 1B common iliac artery endoleaks. This study demonstrates that it is both safe and effective in being used in the common iliac artery (CIA) limb of an EVAR. METHODS: A retrospective review of patients identified through coding and medical records was performed to extract information on demographics, aneurysmal features, operative features, and postoperative outcomes. This was then collated and analysed thoroughly and compared to existing research. RESULTS: Four patients with six type 1B CIA endoleaks were treated with Heli-FX Endoanchors in the CIA limbs of EVAR grafts. There was 100% technical success rate with complete exclusion of the endoleaks at 6 months. With mean follow up of 714 days, there were no Endoanchor-specific complications. One patient required explantation of the aortic endograft due to contralateral limb fracture, where it was found that an Endoanchor had penetrated the common iliac vein, requiring primary closure. CONCLUSIONS: Heli-FX Endoanchors were effective within this cohort of patients, though key risks were identified. Adjacent anatomy to the CIA must be considered, which also have nearly half the arterial thickness compared to the aorta. Pre-operative planning is essential given the theoretical risk of placing Endoanchors.

AFX unibody stent graft: Effective and safe for the treatment of severe aorto-iliac occlusive disease.

OBJECTIVES: The primary objective of this study was to determine the primary, assisted primary and secondary patency rates of the Endologix AFX stent-graft in patients considered high risk for open surgery with complex aorto-iliac occlusive disease. The secondary objective was to determine 30-day major adverse cardiovascular and cerebrovascular events. METHODS: A retrospective review was undertaken of clinical records of 38 patients who underwent AFX stent-graft placement for aorto-iliac occlusive disease from 2016 to 2019. Patient data was de-identified and entered into a REDcap secure database. Descriptive statistical analysis (means and standard deviations) and Kaplan-Meier survival curves were created to determine the duration of patency of the AFX stent-graft system. RESULTS: Primary patency rates at 6, 12 and 24 months were 92%, 92% and 84%, respectively. Assisted primary patency rates at these times were 100%, 100% and 93% with secondary patency of 100% maintained throughout. The incidence of 30-day major adverse cardiovascular and cerebrovascular events was 8% and major adverse limb events was 3%. One death unrelated to the AFX device occurred during the study period though outside of the 30-day peri-operative period. CONCLUSIONS: Primary, assisted primary and secondary patency rates of AFX stent-grafts, when used to treat aorto-iliac occlusive disease, are high. This study supports the use of the AFX stent-graft for the endovascular treatment of complex aorto-iliac occlusive disease as an alternative to other endovascular options as well as a safe alternative to open aorto-iliac or aorto-femoral bypass in patients who are at high risk for open procedures.

A pilot study of the use of artificial intelligence with high-fidelity simulations in assessing endovascular procedural competence independent of a human examiner.

BACKGROUND: With increased need for vascular surgery trainees to gain endovascular surgery proficiency, current models of case-numbers and subjective visual assessment are inadequate in capturing the skills required in endovascular surgery. We explored the use of high-fidelity simulators in (1) assessing endovascular surgical competence; (2) clinical decision making; and (3) the reliability of an artificial intelligence (AI) assessor. METHODS: Registrars, fellows and consultants from vascular surgery, interventional radiology and general surgery performed identical procedures on a high-fidelity simulator. Performance was independently assessed using a modified Reznick scale. Scores were compared to raw metric data extracted from the simulator, objective scores extracted from the recordings and analysed by AI. RESULTS: 22 participants were enrolled from vascular surgery (n = 6, 27.3%), interventional radiology (n = 10, 45.5%) and general surgery (n = 6, 27.3%). There were 12 trainees, 2 fellows and 8 consultants. Significant correlations between raw metric data and all categories of the modified Reznick scale except 'respect for tissue' were found. An AI demonstrated positive reliability in all categories, with some predictions being moderately correlated. CONCLUSION: The use of high-fidelity simulators to assess endovascular surgical competence has comparable correlations to the traditional assessment methods with global rating scales, which can be used in formative assessment. AI demonstrates an ability to support assessment but requires further research.

Editor's Choice - Optimal Timing of Thoracic Endovascular Aortic Repair for Uncomplicated Type B Aortic Dissection: A Systematic Review and Meta-Analysis.

OBJECTIVE: Type B aortic dissections (TBAD) have a high mortality rate and are challenging to both classify and manage. There is significant evidence supporting the use of early intervention in complicated TBAD with thoracic endovascular aortic repair (TEVAR). Currently, there is equipoise regarding the optimal timing for TEVAR in TBAD. This systematic review answers whether early TEVAR in the hyperacute or acute phase of the disease has improved aorta related events in the one year follow up period with no change in mortality rate when compared with TEVAR in the subacute or chronic phase. DATA SOURCES: A systematic review and meta-analysis was performed with Preferred Reporting Items for Systematic Reviews and Meta-Analyses literature search guidelines for MEDLINE, Embase, and Cochrane Reviews until 12 April 2021. Inclusion and exclusion criteria targeting the review objective and high quality research were employed by separate authors. REVIEW METHODS: These studies were then reviewed for suitability, risk of bias, and heterogeneity using the ROBINS-I tool. Results were extracted for the meta-analysis with RevMan using odds ratios with 95% confidence intervals with I2 used to assess heterogeneity. RESULTS: Twenty articles were included. A meta-analysis showed no significant difference between acute phase TEVAR (excluding the hyperacute phase) and subacute or chronic phase TEVAR for the all cause 30 day and one year mortality rates. Aorta related events in the 30 day post-operative period were unaffected by the timing of intervention but had significant improvement in aorta related events in the one year follow up favouring TEVAR in the acute phase compared with subacute or chronic phase. Risk of confounding was high but with low heterogeneity. CONCLUSION: Without prospective randomised controlled studies, it is evident that there is improved aortic remodelling in long term follow up with intervention in the acute setting from three to 14 days after symptom onset. This suggests that TEVAR in the acute period of TBAD is both safe and beneficial, and can be considered for early stent grafting based on clinical, anatomical and patient factors.

Comparison of porcine and human acellular dermal matrix outcomes in wound healing: a deep dive into the evidence.

Acellular dermal matrices (ADM) are a novel graft. The goal of this systematic review is to evaluate the evidence behind differences in human and porcine ADM, irrelevant of manufacturing method, and to determine if there is enough of an evidence base to change clinical practice. An extensive literature search was performed through MEDLINE and Embase with search terms defining a population, intervention and outcome. Title and abstract exclusion were performed with other exclusion criteria. In 191 articles were found after exclusion of duplicates, with only 29 remaining following exclusions. Ten studies were found to have level I and II evidence (I=3, II=8), of which two were histopathological, one was an animal model, one was a systematic review, and six were clinical. The remaining studies were reviewed and considered for discussion, but did not hold high enough standards for medical evidence. Strong clinical evidence already exists for the use of human ADM, but questions of access, cost, and ethics require consideration of a xenograft. Histopathologically, evidence suggests minimal long-term differences between human and porcine ADM, although there is a short acute immune response with porcine ADM. Clinically, there is limited difference in outcomes, with a small range in effect of different ADM preparations. Considering the effectiveness of ADM in wound healing, more high-level research with appropriate statistical analysis to facilitate a future meta-analysis is recommended to justify a transition from human to porcine ADM.

PD-L1 Detection on Circulating Melanoma Cells.

The advent of personalized medicines targeting cell signaling pathways has radically improved melanoma patient outcomes. More recently, immune-modulating therapies disrupting the PD-1/PD-L1 axis have become a powerful tool in the treatment of a range of melanoma, showing a profound improvement in the overall survival outcomes. However, immune checkpoint inhibitors (ICIs) are associated with considerable toxicities and appear to only be efficacious in a subset of melanoma patients. Therefore, there is an urgent need to identify biomarkers that can determine if patients will or will not respond to ICI therapy. Here, we describe an optimized method for analyzing PD-L1 expression on circulating melanoma cells following immunomagnetic enrichment from patient blood samples.

Single-Cell Analysis of BRAFV600E and NRASQ61R Mutation Status in Melanoma Cell Lines as Method Generation for Circulating Melanoma Cells.

Molecular testing of tumor biopsies allows for the identification of the key mutations driving a patient's cancer. However, this is limited to singular nodes and may not accurately reflect cancer heterogeneity. Circulating tumor cell (CTC) analyses offer a noninvasive method of interrogating the genomic profile of patient-derived tumor material. To date, molecular analysis of CTCs has relied on the characterization of bulk or pooled CTC lysates, limiting the detection of minor tumorigenic CTC subclones. Here, we show a workflow enabling BRAFV600E/NRASQ61R mutation detection from single cultured melanoma cells by combining micromanipulation and genomic material amplification methods. This workflow can be directly integrated into circulating tumor cell analysis applications.

A systematic review of the effect of surgeon and hospital volume on survival in aortic, thoracic and fenestrated endovascular aneurysm repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) is becoming a mainstay in vascular surgery, both in metropolitan and regional hospitals. This review aims to assess the impact of hospital and surgeon volume on perioperative mortality specific to this surgery type to support the use of this treatment modality extensively. METHODS: A literature search was performed on multiple dedicated medical databases using a detailed search strategy with terms focusing on hospital volume and EVARs. Inclusion and exclusion criteria were used to screen and evaluate suitable sources, focusing on operators and hospitals performing EVARs and the morbidity/mortality as outcomes. The results were then appraised using a PRISMA framework. RESULTS: We reviewed 45 articles. Twelve articles met inclusion criteria for complete review. There was no level 1 evidence, and only a single systematic review and meta-analysis. EVAR and thoracic EVAR perioperative mortality had no correlation with hospital volume. Limited evidence was presented for fenestrated EVAR, where a mortality risk based on hospital volume remains unanswered. Open procedures for aneurysm repair had perioperative mortality outcomes that grossly correlated with hospital volume, supporting their use in high-volume centers. CONCLUSIONS: With open aneurysm repairs having an increased mortality risk in low-volume centers, and endovascular treatment options gaining momentum, there is considerable support for the use of EVAR and thoracic EVAR in smaller regional centers safely and effectively. There is very limited evidence in the use of fenestrated EVAR, which remains unanswered, but presents a significant opportunity for research.

Evaluation of tools to assess operative competence in endovascular procedures: a systematic review.

BACKGROUND: With an increase in the use of endovascular interventions as an alternative to open surgery and the unique technical skills required, current methods for assessing the competence of vascular surgery trainees may not be optimal, suggesting a need for a shift in assessment modalities. We conducted this systematic review to explore current assessment methods used in vascular surgery training to assess competence specific to endovascular procedures. METHODS: A comprehensive literature search was performed with a structured search strategy using terms focusing on endovascular procedures and assessment. Inclusion and exclusion criteria were used in order to screen for suitable articles. RESULTS: We identified 54 articles that satisfied the inclusion criteria. These included a single randomized controlled trial, a single systematic review, a single narrative review and a single literature review, with the vast majority having level 2 evidence. Global rating scales, proficiency assessments and written/oral examinations were described as standard current assessment tools. These modalities lack reproducibility and objectivity, neglecting the needs of assessment of endovascular procedures requiring specialized decision making and finger dexterity. Novel methods such as high fidelity simulation and virtual reality promote reproducible and objective assessment methods in the context of endovascular surgery, and have a promising future. CONCLUSION: While current assessment methods in vascular surgery are widely supported the changing skills required of a vascular surgery trainee warrants a shift in assessment modalities to better align to these requirements. High fidelity simulations show promise, although they require more extensive research to understand their relative merits.

Optimizing Protein Harvest From Nasal Brushings for Determining Local Allergy Responses.

Background Rhinitis is a highly prevalent yet often misdiagnosed condition. Patients who have local allergic rhinitis are regularly mislabeled as having a nonallergic etiology. Thus, a highly accurate, reproducible, and noninvasive assessment, which can be performed quickly and with minimal discomfort to the patient, is required. Objective The aim of this research was to identify the efficiency of various nasal brushes as tools for harvest and collection of epithelial proteins and its suitability for identification of rhinitis. Methods Nasal epithelial mucosa samples were taken from patients undergoing turbinate surgery using a cytology brush, a dental brush, and a nasal curette in random order. After washing in phosphate-buffered saline, the suspended cells were sonicated. Total protein content was assessed for all samples by bicinchoninic acid assay measured using a Nanodrop machine. Identification of nasal-specific immunoglobulin E (spIgE) was then assessed using immunoassay and compared to the patient's allergic status from epicutaneous and serum testing. The lower threshold limit for the spIgE in nasal brushings was determined using the results of serum spIgE tests as the reference. The diagnostic accuracy of this new established cutoff value was determined. Results The cytology brush was found to be the optimal tool for maximal nasal mucosa protein collection followed by dental brush and nasal curette (0.75 ± 0.45 mg/mL vs 0.43 ± 0.24 mg/mL vs 0.071 ± 0.55 mg/mL, respectively; P < .01). The optimal cutoff value of nasal spIgE from the cytology nasal brushings was 0.14 kUA/L to predict allergic status from serum testing. This gave a sensitivity of 75%, specificity of 86%, positive predictive value of 74%, likelihood ration positive of 5.40, and diagnostic odds ratio of 18.62. Conclusion The cytology brush is the optimal tool for protein collection. This is an easy and direct method to sample the nasal mucosa for assessment of nasal allergy or future biomarkers.