Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study.

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.

Non-guideline-compliant endovascular abdominal aortic aneurysm repair in women is associated with increased mortality and reintervention compared with men.

OBJECTIVE: Sex-based disparities in surgical outcomes have emerged as an important focus in contemporary healthcare delivery. Likewise, the appropriate usage of endovascular abdominal aortic aneurysm repair (EVAR) in the United States remains a subject of ongoing controversy, with a significant number of U.S. EVARs failing to adhere to the Society for Vascular Surgery (SVS) clinical practice guideline (CPG) diameter thresholds. The purpose of the present study was to determine the effect of sex among patients undergoing EVAR that was not compliant with the SVS CPGs. METHODS: All elective EVAR procedures for abdominal aortic aneurysms without a concomitant iliac aneurysm (≥3.0 cm) in the SVS Vascular Quality Initiative were analyzed (2015-2019; n = 25,112). SVS CPG noncompliant repairs were defined as a size of <5.5 cm for men and <5.0 cm for women. The primary endpoint was 30-day mortality. The secondary endpoints were all-cause mortality, complications, and reintervention. Logistic regression was performed to control for surgeon- and patient-level factors. Freedom from the endpoints was determined using the Kaplan-Meier method. RESULTS: Noncompliant EVAR was performed in 9675 patients (38.5%). Although men were significantly more likely to undergo such procedures (90% vs 10%; odds ratio [OR], 3.1; 95% confidence interval [CI], 2.9-3.4; P < .0001), the 30-day mortality was greater for the women than the men (1.8% vs 0.5%; P = .0003). Women also experienced significantly higher rates of multiple complications, including postoperative myocardial infarction (1% vs 0.3%; P = .006), respiratory failure (1.4% vs 0.6%; P = .01), intestinal ischemia (0.7% vs 0.2%; P = .003), access vessel hematoma (3% vs 1.2%; P = .0006), and iliac access vessel injury (2.4% vs 0.8%; P < .0001). Additionally, women experienced increased overall 1-year reintervention rates (11.5% vs 5.8%; P < .0001). In the adjusted analysis, 30-day mortality and any in-hospital complication risk remained significantly greater for the women (30-day death: OR, 3.1; 95% CI, 1.6-5.8; P = .0005; in-hospital complication: OR, 1.9; 95% CI, 1.4-2.6; P < .0001). Women also experienced increased reintervention rates over time compared with men (OR, 1.5; 95% CI, 1.1-2.2; P = .02). CONCLUSIONS: Although men were more likely to undergo non-CPG compliant EVAR, women experienced increased short-term morbidity and 30-day mortality and higher rates of reintervention when undergoing non-CPG compliant EVAR. These unanticipated findings necessitate increased scrutiny of current U.S. sex-based EVAR practice and should caution against the use of non-CPG compliant EVAR for women.

Toward endovascular treatment of type A aortic dissection with smaller landing zones and more patient eligibility.

OBJECTIVE: Type A or ascending aortic dissection is an acute life-threatening condition with high morbidity and mortality. Open surgery remains the standard of care. The development of minimally invasive endografts for type A aortic dissection (TAAD) will require a detailed understanding of the dissection and aortic root anatomy to determine patient eligibility and optimal device specifications. METHODS: Computed tomography images of TAAD cases at our institution from 2012 to 2019 were identified, and three-dimensional reconstructions were performed using OsiriX, version 10.0 (Pixmeo SARL, Bernex, Switzerland). We analyzed key anatomic structures, including centerline length measurements, ascending aorta and aortic root dimensions, and the location and extent of dissection in relationship to the coronary ostia. RESULTS: A total of 53 patients were identified (mean ± standard deviation age, 60.4 ± 17.1 years; 36 men and 17 women), 46 of whom had undergone surgery for TAAD. Four patients had died within 30 days of surgery. In 47 patients (88.7%), the entry tear was distal to the highest coronary ostium. These cases were retrospectively considered for endovascular intervention using a nonbranched, single endograft stent. The proximal landing zone (LZ) was defined as the distance from the highest coronary ostium to the entry tear. Of the 53 patients, 35 (66.0%) had a proximal LZ length of ≥2.0 cm, 38 (71.7%) had a proximal LZ length of ≥1.5 cm, and 42 (79.2%) had a proximal LZ length of ≥1.0 cm. The median proximal and distal LZ diameters of the sinotubular junction (STJ) and distal ascending aorta regions were 3.29 cm (interquartile range [IQR], 2.73-4.10 cm) and 3.49 cm (IQR, 3.09-3.87 cm, respectively), with a median length from the STJ to the innominate takeoff of 8.08 cm (IQR, 6.96-9.40 cm). The median ascending aorta radius of curvature was 6.48 cm (IQR, 5.27-8.00 cm). Of the 53 patients, 25 (47.2%) could be treated with a straight tube graft with a ≤20% diameter mismatch between the proximal and distal LZs. CONCLUSIONS: Almost 80% of the patients with TAAD had had a proximal LZ of ≥1.0 cm. Of these patients, 47.2% had anatomy amenable for endovascular therapy with a nontapered straight tube graft using commercially available devices. To increase patient eligibility for TAAD endovascular intervention, enhanced precision deployment with an adequate seal in shorter LZs will be required. Our results can serve as a guide for endovascular device specifications designed to treat this devastating condition.

Impact of a multidisciplinary acute aortic dissection program: Improved outcomes with a comprehensive initial surgical repair strategy.

OBJECTIVE: As part of a multidisciplinary aortic dissection (AD) program, a more comprehensive repair strategy for patients with acute type A aortic dissection (ATAAD) and frequent endografting for suitable patients with type B aortic dissection (ATBAD) was adopted in 2015. The aim of this study was to evaluate the impact of these changes. METHODS: This study is a retrospective review of a prospective database containing all patients treated for acute AD between 2003 and 2020. Patients were grouped based on differing repair strategies (pre 2015 vs post 2015). Clinical characteristics, procedural details, and survival data were analyzed. RESULTS: During this time, 323 patients (210 pre, 113 post) were treated for acute AD at our institution. There were 221 patients with ATAAD (149 pre, 72 post) and 102 patients with ATBAD (61 pre, 41 post). The majority (60%) were males, with a mean age of 65.9 ± 15.2 years. There were no differences in cardiovascular risk factors or demographics between the groups. After 2015, fewer patients with ATAAD underwent medical management alone (15% pre vs 4% post; P = .014), and most that underwent surgical intervention had a total arch or aggressive hemiarch repair (27% pre vs 78% post; P < .001). Seventy-four patients (73%) with ATBAD were treated medically, whereas 28 underwent medical management and endografting (23% pre, 34% post; P = .214). For all patients with AD, 30-day mortality was significantly improved (26% pre vs 10% post; P < .001) especially among patients who underwent ATAAD surgery (23% pre vs 9% post; P = .018). Three-year Kaplan-Meier survival estimates showed survival improvement among patients with ATAAD (Log rank P-value = .019); however, this improvement does not extend to type B dissections or the overall cohort. A survival analysis landmarked to 30 days after initial presentation showed no statistical difference in survival from 30 days to 3 years post-presentation. CONCLUSIONS: A more comprehensive repair strategy in the management of patients with acute AD resulted in improved overall patient outcomes and significantly decreased 30-day mortality, even though more complex repairs were performed. The long-term impact of the changes made to our program remains to be evaluated.

Reporting of Clinical Outcomes After Endovascular Aortic Aneurysm Repair: A Systematic Review.

BACKGROUND: Endovascular aneurysm repair (EVAR) is an established treatment for many patients with infra-renal abdominal aortic aneurysm (AAA). Reporting standards were published in 2002 to ensure consistent measurement and reporting of outcomes following EVAR. We aimed to assess the range of clinical outcomes reported after EVAR and whether recent studies adhere to established reporting standards. METHODS: We searched MEDLINE and Embase from January 2014 until December 2018, using terms for 'EVAR' and 'AAA'. We included prospective studies and randomised controlled trials which reported clinical outcomes of elective infra-renal AAA repair. Data on clinical outcome reporting were extracted and compared with established reporting standards. RESULTS: 84 studies were included. Technical success was reported in 49 (58.3%) studies, but only defined in 40 (47.6%), with 22 distinct definitions. Clinical success was reported and defined in 19 (22.6%) studies. Aneurysm rupture was reported in 27 (32.1%) studies and death from rupture in 11 (13.1%) studies. All-cause and aneurysm-related mortality were reported in 72 (85.7%) and 52 (61.9%) studies, respectively. Endoleak type I (n = 61, 72.6%) and II (n = 52, 61.9%) were more commonly reported than type III (n = 45, 53.6%) or IV (n = 13, 15.5%). Complications and mortality were reported by a mean of 18 (21.4%) and 42 (50%) studies, respectively. CONCLUSIONS: A wide variety of clinical outcomes were reported following EVAR. Few studies adhered to reporting guidelines. We recommend modification of reporting standards to reflect advances in endovascular technology and creation of a core outcome set for EVAR.

A Review of UK-based National and International Scientific Meeting Published Abstracts in Response to the Draft NICE Aortic Aneurysm Guidelines.

BACKGROUND: UK National Institute for Health and Care Excellence (NICE) draft clinical guidelines (CG) (2018) regarding aortic aneurysm repair were disputed internationally. We aim to appraise the academic response to the draft CG in terms of quantity and scientific quality by reviewing published conference abstracts from three major national and international, UK meetings. METHODS: Abstracts related to aortic practice from The Vascular Societies Annual Scientific Meeting, British Society for Endovascular Therapy (BSET) & Charing Cross (CX) meetings from 2019 were reviewed for methodology, sample size, data collection period, scientific quality and conclusions that supported or conflicted the draft guideline. RESULTS: A total of 549 abstracts were identified from VSGBI, BSET and CX abstract books of which, 226 (41.2%) were related to aortic practices. Of these, 115 (50.9%) were related to EVAR. Twenty-two of these abstracts (19.1%) were identified as having findings relevant to the draft guidelines. Eighteen (15.7%) were identified as findings that potentially conflict the draft CG and 4 (3.5%) that could support the initial recommendations. Six abstracts (5.2%) made direct reference to or challenged the draft CG. The median data collection period was 4 years. The median sample size was 102 patients. In general, scientific quality was poor, with 82% of selected abstracts were graded at level 2b. CONCLUSION: We have demonstrated a concerted response to the draft NICE clinical guidelines relating to the treatment of abdominal aortic aneurysms at three large scientific meetings. As a result of which and other factors, significant changes were made to the finalized NG156. There is still paucity in evidence regarding the long-term safety and cost-effectiveness of EVAR.

Use of Thoracic Endovascular Aortic Repair in Patients with Concomitant Blunt Aortic and Traumatic Brain Injury.

BACKGROUND: Blunt aortic injury (BAI) and traumatic brain injury (TBI) represent the 2 leading causes of death after blunt trauma. The goal of this study was to examine the impact of TBI and use of thoracic endovascular aortic repair (TEVAR) on patients with BAI, using a large, national dataset. STUDY DESIGN: Patients with BAI were identified from the Trauma Quality Improvement Program (TQIP) database over 10 years, ending in 2016. Patients with BAI were stratified by the presence of concomitant TBI and compared. Multivariable logistic regression (MLR) analysis was performed to determine independent predictors of mortality in BAI patients with and without TBI. Youden's index was used to identify the optimal time to TEVAR in these patients. RESULTS: 17,040 patients with BAI were identified, with 4,748 (28%) having a TBI. Patients with BAI and TBI were predominantly male, with a higher injury burden and greater severity of shock at presentation, underwent fewer TEVAR procedures, and had increased mortality compared with BAI patients without TBI. The optimal time for TEVAR was 9 hours. Mortality was significantly increased in patients undergoing TEVAR before 9 hours (12.9% vs 6.5%, p = 0.003). For BAI patients with and without TBI, MLR identified use of TEVAR as the only modifiable risk factor significantly associated with reduced mortality (odds ratio [OR] 0.41; 95%CI 0.32-0.54, p < 0.0001). CONCLUSIONS: TBI significantly increases mortality in BAI patients. TEVAR and delayed repair both significantly reduced mortality. So, for patients with both BAI and TBI, an endovascular repair performed in a delayed fashion should be the preferred approach.

Managing Access by Generating Improvements in Cannulation: A national quality improvement project.

Cannulation is essential for haemodialysis with arteriovenous access, but also damages the arteriovenous access making it prone to failure, is associated with complications and affects patients' experiences of haemodialysis. Managing Access by Generating Improvements in Cannulation is a national UK quality improvement project, designed to improve cannulation practice in the United Kingdom, ensuring it reflects current needling recommendations. It uses a simple quality improvement method, the Model for Improvement, to structure improvement to cannulation practice. It assists units in the practical implementation of the British Renal Society and Vascular Access Society of Britain and Ireland needling recommendations, ensuring actual cannulation practice reflects what is defined as best practice in cannulation. An eLearning package and awareness materials have been developed, to assist units in changing their cannulation practice. The Kidney Quality Improvement Partnership provides a structure for Managing Access by Generating Improvements in Cannulation that promotes development and dissemination. It is hoped that Managing Access by Generating Improvements in Cannulation will raise an understanding about the cannulation of arteriovenous access and change behaviours and beliefs around correct cannulation practice, to ensure longevity of this lifeline.

Transjugular intrahepatic portosystemic stent-shunt in the management of portal hypertension.

These guidelines on transjugular intrahepatic portosystemic stent-shunt (TIPSS) in the management of portal hypertension have been commissioned by the Clinical Services and Standards Committee (CSSC) of the British Society of Gastroenterology (BSG) under the auspices of the Liver Section of the BSG. The guidelines are new and have been produced in collaboration with the British Society of Interventional Radiology (BSIR) and British Association of the Study of the Liver (BASL). The guidelines development group comprises elected members of the BSG Liver Section, representation from BASL, a nursing representative and two patient representatives. The quality of evidence and grading of recommendations was appraised using the GRADE system. These guidelines are aimed at healthcare professionals considering referring a patient for a TIPSS. They comprise the following subheadings: indications; patient selection; procedural details; complications; and research agenda. They are not designed to address: the management of the underlying liver disease; the role of TIPSS in children; or complex technical and procedural aspects of TIPSS.

Anatomic criteria in the selection of treatment modality for atherosclerotic carotid artery disease.

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) Reporting Standards for Type B Aortic Dissections.

This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.

Quality improvement in vascular access: The role of patient-reported outcome measures.

Quality improvement initiatives should be aimed to enhance clinical outcomes, service delivery and quality of life for patients. For patients reliant on haemodialysis, vascular access is a lifeline. Survival differences relating to the type of vascular access are evident and many initiatives have focussed on increasing absolute rates of arteriovenous fistulas and/or decreasing central venous catheter use. While these have achieved some success quantitatively, the qualitative effects are less obvious. The aims of this review article are to explore the concepts of quality of care in vascular access. There is a paucity of studies into the effects of vascular access on the quality of life of dialysis patients, and where studies have been performed, generalised patient-reported outcome measures have been used. To facilitate the implementation of quality improvement programmes specifically for vascular access requires suitable tools. While existing patient-reported outcome measures may be applicable to vascular access, it is likely that these will require further evaluation, and the development of vascular access-specific patient-reported outcome measures may be required.

Opinion: Aortic Graft Infection-Any Guidelines or Just Surgeon's Experience Lines!

Aggressive strategies for thoracic aortic graft infection, including resection of all infected tissues, in situ replacement with a rifampicin-bonded graft, and omental flap installation, resulted in improved survival.