Costs of endovascular and open repair of thoracic aortic aneurysms.

BACKGROUND: Repair of thoracic aortic aneurysms with either endovascular repair (TEVAR) or open surgical repair (OSR) represents major surgery, is costly and associated with significant complications. The aim of this study was to establish accurate costs of delivering TEVAR and OSR in a cohort of UK NHS patients suitable for open and endovascular treatment for the whole treatment pathway from admission and to discharge and 12-month follow-up. METHODS: A prospective study of UK NHS patients from 30 NHS vascular/cardiothoracic units in England aged ≥18, with distal arch/descending thoracic aortic aneurysms (CTAA) was undertaken. A multicentre prospective cost analysis of patients (recruited March 2014-July 2018, follow-up until July 2019) undergoing TEVAR or OSR was performed. Patients deemed suitable for open or endovascular repair were included in this study. A micro-costing approach was adopted. RESULTS: Some 115 patients having undergone TEVAR and 35 patients with OSR were identified. The mean (s.d.) cost of a TEVAR procedure was higher £26 536 (£9877) versus OSR £17 239 (£8043). Postoperative costs until discharge were lower for TEVAR £7484 (£7848) versus OSR £28 636 (£23 083). Therefore, total NHS costs from admission to discharge were lower for TEVAR £34 020 (£14 301), versus OSR £45 875 (£43 023). However, mean NHS costs for 12 months following the procedure were slightly higher for the TEVAR £5206 (£11 585) versus OSR £5039 (£11 994). CONCLUSIONS: Surgical procedure costs were higher for TEVAR due to device costs. Total in-hospital costs were higher for OSR due to longer hospital and critical care stay. Follow-up costs over 12 months were slightly higher for TEVAR due to hospital readmissions.

Inequalities for women diagnosed with distal arch and descending thoracic aortic aneurysms: results from the Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) cohort study.

BACKGROUND: Women with thoracic aortic aneurysms within the arch or descending thoracic aorta have poorer survival than men. Sex differences in relative thoracic aortic aneurysm size may account for some of the discrepancy. The aim of this study was to explore whether basing clinical management on aneurysm size index (maximum aneurysm diameter/body surface area) rather than aneurysm size can restore equality of survival by sex. METHODS: The Effective Treatments for Thoracic Aortic Aneurysms (ETTAA; ISRCTN04044627) study was a prospective, observational cohort study. Adults referred to National Health Service hospitals in England with new/existing arch or descending thoracic aorta aneurysms greater than or equal to 4 cm in diameter were followed from March 2014 to March 2022. Baseline characteristics and survival to intervention and overall were compared for men and women. Survival models were used to assess the association between all-cause survival and sex, with and without adjustment for aneurysm diameter or aneurysm size index. RESULTS: A total of 886 thoracic aortic aneurysm patients were recruited: 321 (36.2%) women and 565 (63.8%) men. The mean(s.d.) aneurysm diameter was the same for women and men (5.7(1.1) versus 5.7(1.2) cm respectively; P = 0.751), but the mean(s.d.) aneurysm size index was greater for women than for men (3.32(0.80) versus 2.83(0.63) respectively; P < 0.001). Women had significantly worse survival without intervention: 110 (34.3%) women and 135 (23.9%) men (log rank test, P < 0.001). All-cause mortality remained greater for women after adjustment for diameter (HR 1.65 (95% c.i. 1.35 to 2.02); P < 0.001), but was attenuated after adjustment for aneurysm size index (HR 1.11 (95% c.i. 0.89 to 1.38); P = 0.359). Similar results were found for all follow-up, with or without intervention, and findings were consistent for descending thoracic aorta aneurysms alone. CONCLUSION: Guidelines for referral to specialist services should consider including aneurysm size index rather than diameter to reduce inequity due to patient sex.

Use of Artificial Intelligence With Deep Learning Approaches for the Follow-up of Infrarenal Endovascular Aortic Repair.

INTRODUCTION: Endoleaks represent one of the main complications after endovascular aortic repair (EVAR) and can lead to increased re-intervention rates and secondary rupture. Serial lifelong surveillance is required and traditionally involves cross-sectional imaging with manual axial measurements. Artificial intelligence (AI)-based imaging analysis has been developed and may provide a more precise and faster assessment. This study aims to evaluate the ability of an AI-based software to assess post-EVAR morphological changes over time, detect endoleaks, and associate them with EVAR-related adverse events. METHODS: Patients who underwent EVAR at a tertiary hospital from January 2017 to March 2020 with at least 2 follow-up computed tomography angiography (CTA) were analyzed using PRAEVAorta 2 (Nurea). The software was compared to the ground truth provided by human experts using Sensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), and Positive Predictive Value (PPV). Endovascular aortic repair-related adverse events were defined as aneurysm-related death, rupture, endoleak, limb occlusion, and EVAR-related re-interventions. RESULTS: Fifty-six patients were included with a median imaging follow-up of 27 months (interquartile range [IQR]: 20-40). There were no significant differences overtime in the evolution of maximum aneurysm diameters (55.62 mm [IQR: 52.33-59.25] vs 54.34 mm [IQR: 46.13-59.47]; p=0.2162) or volumes (130.4 cm3 [IQR: 113.8-171.7] vs 125.4 cm3 [IQR: 96.3-169.1]; p=0.1131) despite a -13.47% decrease in the volume of thrombus (p=0.0216). PRAEVAorta achieved a Se of 89.47% (95% confidence interval [CI]: 80.58 to 94.57), a Sp of 91.25% (95% CI: 83.02 to 95.70), a PPV of 90.67% (95% CI: 81.97 to 95.41), and an NPV of 90.12% (95% CI: 81.70 to 94.91) in detecting endoleaks. Endovascular aortic repair-related adverse events were associated with global volume modifications with an area under the curve (AUC) of 0.7806 vs 0.7277 for maximum diameter. The same trend was observed for endoleaks (AUC of 0.7086 vs 0.6711). CONCLUSIONS: The AI-based software PRAEVAorta enabled a detailed anatomic characterization of aortic remodeling post-EVAR and showed its potential interest for automatic detection of endoleaks during follow-up. The association of aortic aneurysmal volume with EVAR-related adverse events and endoleaks was more robust compared with maximum diameter. CLINICAL IMPACT: The integration of PRAEVAorta AI software into clinical practice promises a transformative shift in post-EVAR surveillance. By offering precise and rapid detection of endoleaks and comprehensive anatomic assessments, clinicians can expect enhanced diagnostic accuracy and streamlined patient management. This innovation reduces reliance on manual measurements, potentially reducing interpretation errors and shortening evaluation times. Ultimately, PRAEVAorta's capabilities hold the potential to optimize patient care, leading to more timely interventions and improved outcomes in endovascular aortic repair.

Health Related Quality of Life Following Intervention for Thoracoabdominal Aortic Aneurysm: A Systematic Review and Narrative Synthesis.

BACKGROUND: Thoracoabdominal aortic aneurysms (TAAA) pose significant risks of morbidity and mortality. Considering the evolving techniques for TAAA intervention and the growing interest in quality of life (QoL) outcomes for decision-making, we aimed to evaluate the impact of patient and perioperative characteristics on short-term, medium-term, and long-term postoperative QoL in TAAA repair patients. METHODS: A systematic search was conducted in CINAHL, APA PsycINFO, EMBASE, Medline and Cochrane to identify primary research studies evaluating QoL post TAAA surgery, published in English or Swedish between January 01, 2012 and September 26, 2022. A narrative synthesis was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The quality of evidence was assessed using the Critical Appraisal Skills Program and Joanna Briggs Institute checklists. RESULTS: Eight studies of low or moderate quality with 455 patients were included. Preoperative QoL in TAAA patients was lower compared to the general population. While there is an initial short-term improvement in postoperative QoL, patients fail to reach baseline levels even after 7 years, with physical activity and functioning domains being particularly affected. Experiencing postoperative complications, including paraplegia and cardiovascular events, negatively impacts postoperative QoL. Patients with uncomplicated postoperative status had improved QoL. Prolonged hospital stay negatively affects physical functioning. CONCLUSIONS: Individuals with TAAA are likely to have lower baseline QoL compared to the general population. Following TAAA repair, postoperative QoL may remain lower than baseline levels, persisting over the long-term. Comorbidities, postoperative complications, and hospitalization duration appear to exert adverse effects on postoperative QoL.

Consensus statement on the interhospital transfer of patients with acute aortic syndrome: TRAVERSING Delphi study.

BACKGROUND: Standardisation of referral pathways and the transfer of patients with acute aortic syndromes (AAS) to regional centres are recommended by NHS England in the Acute Aortic Dissection Toolkit. The aim of the Transfer of Thoracic Aortic Vascular Emergencies to Regional Specialist INstitutes Group study was to establish an interdisciplinary consensus on the interhospital transfer of patients with AAS to specialist high-volume aortic centres. METHODS: Consensus on the key aspects of interhospital transfer of patients with AAS was established using the Delphi method, in line with Conducting and Reporting of Delphi Studies guidelines. A national patient charity for aortic dissection was involved in the design of the Delphi study. Vascular and cardiothoracic surgeons, emergency physicians, interventional radiologists, cardiologists, intensivists and anaesthetists in the United Kingdom were invited to participate via their respective professional societies. RESULTS: Three consecutive rounds of an electronic Delphi survey were completed by 212, 101 and 58 respondents, respectively. Using predefined consensus criteria, 60 out of 117 (51%) statements from the survey were included in the consensus statement. The study concluded that patients can be taken directly to a specialist aortic centre if they have typical symptoms of AAS on the background of known aortic disease or previous aortic intervention. Accepted patients should be transferred in a category 2 ambulance (response time <18 min), ideally accompanied by transfer-trained personnel or Adult Critical Care Transfer Services. A clear plan should be agreed in case of a cardiac arrest occurring during the transfer. Patients should reach the aortic centre within 4 hours of the initial referral from their local hospital. CONCLUSIONS: This consensus statement is the first set of national interdisciplinary recommendations on the interhospital transfer of patients with AAS. Its implementation is likely to contribute to safer and more standardised emergency referral pathways to regional high-volume specialist aortic units.

Quantifying the burden of survivorship associated with infrarenal abdominal aortic aneurysms.

OBJECTIVES: Survivorship encompasses the physical, psychological, social, functional, and economic experience of a living with a chronic condition for both the patient and their caregiver. It is made up of nine distinct domains and remains understudied in nononcological pathologies, including infrarenal abdominal aortic aneurysmal disease (AAA). This review aims to quantify the extent to which existing AAA literature addresses the burden of survivorship. METHODS: The MEDLINE, EMBASE, and PsychINFO databases were searched from 1989 through September 2022. Randomized controlled trials, observational studies, and case series were included. Eligible studies had to detail outcomes related to survivorship in patients with AAA. Owing to the heterogeneity between studies and outcomes, no meta-analysis was conducted. Study quality was assessed with specific risk of bias tools. RESULTS: A total of 158 studies were included. Of these, only five (treatment complications, physical functioning, comorbidities, caregivers, and mental health) of the nine domains of survivorship have been studied previously. The available evidence is of variable quality; most studies display a moderate to high risk of bias, are of an observational study design, are based within a limited number of countries, and consist of an insufficient follow-up period. The most frequent complication after EVAR was endoleak. EVAR is associated with poorer long-term outcomes compared with open surgical repair in most studies retrieved. EVAR showed better outcomes in regard to physical functioning in the short term, but this advantage was lost in the long term. The most common comorbidity studied was obesity. No significant differences were found between open surgical repair and EVAR in terms of impact on caregivers. Depression is associated with various comorbidities and increased the risk of a nonhospital discharge. CONCLUSIONS: This review highlights the absence of robust evidence regarding survivorship in AAA. As a result, contemporary treatment guidelines rely on historic quality-of-life data that are narrow in scope and nonrepresentative of contemporary clinical practice. As such, there is an urgent need to reevaluate the aims and methodology associated with traditional quality-of-life research moving forward.

Sex-specific differences in the standard of care for infrarenal abdominal aortic aneurysm repair, and risk of major adverse cardiovascular events and death.

BACKGROUND: This study investigated whether sex-specific differences in preoperative/perioperative standard of care (SOC) account for disparity in outcomes after elective infrarenal abdominal aortic aneurysm repair. METHODS: This was a retrospective cohort study of elective infrarenal abdominal aortic aneurysm repairs (2013-2020) using depersonalized patient-level National Vascular Registry data. SOC was defined for waiting times, preoperative assessment (multidisciplinary/anaesthetic review), cardiovascular risk prevention, and perioperative medication. The primary outcome was major cardiovascular event and/or death (MACED). RESULTS: Some 21 810 patients with an infrarenal abdominal aortic aneurysm were included, 2380 women and 19 430 men. Women less often underwent aneurysm repair within SOC waiting times (51.5 versus 59.3 per cent; P < 0.001), but were equally likely to receive preoperative assessment (72.1 versus 72.5 per cent; P = 0.742). Women were less likely to receive secondary prevention for known cardiac disease (34.9 versus 39.6 per cent; P = 0.015), but more often met overall cardiovascular risk prevention standards (52.1 versus 47.3 per cent; P < 0.001). Women were at greater risk of MACED (open: 12.0 versus 8.9 per cent, P < 0.001; endovascular: 4.9 versus 2.9 per cent, P < 0.001; risk-adjusted OR 1.33, 95 per cent c.i. 1.12 to 1.59). A significant reduction in the odds of MACED was associated with preoperative assessment (OR 0.86, 0.75 to 0.98) and SOC waiting times (OR 0.78, 0.69 to 0.87). There was insufficient evidence to confirm a significant sex-specific difference in the effect of SOC preoperative assessment (women: OR 0.69, 0.50 to 0.97; men: OR 0.89, 0.77 to 1.03; interaction P = 0.170) or SOC waiting times (women: OR 0.84, 0.62 to 1.16; men: OR 0.76, 0.67 to 0.87; interaction P = 0.570) on the risk of MACED. CONCLUSION: SOC waiting times and preoperative assessment were not met for both sexes, which was associated with an increased risk of MACED. Sex-specific differences in SOC attenuated but did not fully account for the increased risk of MACED in women.

European Expert Opinion on Infrarenal Sealing Zone Definition and Management in Endovascular Aortic Repair Patients: A Delphi Consensus.

PURPOSE: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). METHODS: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. RESULTS: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. CONCLUSIONS: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions.

Aneurysm growth, survival, and quality of life in untreated thoracic aortic aneurysms: the effective treatments for thoracic aortic aneurysms study.

AIMS: To observe, describe, and evaluate management and timing of intervention for patients with untreated thoracic aortic aneurysms. METHODS AND RESULTS: Prospective study of UK National Health Service (NHS) patients aged ≥18 years, with new/existing arch or descending thoracic aortic aneurysms of ≥4 cm diameter, followed up until death, intervention, withdrawal, or July 2019. Outcomes were aneurysm growth, survival, quality of life (using the EQ-5D-5L utility index), and hospital admissions. Between 2014 and 2018, 886 patients were recruited from 30 NHS vascular/cardiothoracic units. Maximum aneurysm diameter was in the descending aorta in 725 (82%) patients, growing at 0.2 cm (0.17-0.24) per year. Aneurysms of ≥4 cm in the arch increased by 0.07 cm (0.02-0.12) per year. Baseline diameter was related to age and comorbidities, and no clinical correlates of growth were found. During follow-up, 129 patients died, 64 from aneurysm-related events. Adjusting for age, sex, and New York Heart Association dyspnoea index, risk of death increased with aneurysm size at baseline [hazard ratio (HR): 1.88 (95% confidence interval: 1.64-2.16) per cm, P < 0.001] and with growth [HR: 2.02 (1.70-2.41) per cm, P < 0.001]. Hospital admissions increased with aneurysm size [relative risk: 1.21 (1.05-1.38) per cm, P = 0.008]. Quality of life decreased annually for each 10-year increase in age [-0.013 (-0.019 to -0.007), P < 0.001] and for current smoking [-0.043 (-0.064 to -0.023), P = 0.004]. Aneurysm size was not associated with change in quality of life. CONCLUSION: International guidelines should consider increasing monitoring intervals to 12 months for small aneurysms and increasing intervention thresholds. Individualized decisions about surveillance/intervention should consider age, sex, size, growth, patient characteristics, and surgical risk.

Outcomes of patients with aortic vascular graft and endograft infections initially contra-indicated for complete graft explantation.

OBJECTIVE: Complete excision in patients with aortic vascular graft and endograft infections (VGEIs) is a significant undertaking, and many patients never undergo definitive treatment. Knowing their fate is important to be able to assess the risks of graft excision vs alternative strategies. This study analyzed their life expectancy and sepsis-free survival. METHODS: VGEIs were diagnosed according to the Aortic Graft Infection (MAGIC) criteria, and patients turned down for graft removal from November 2006 to December 2020 were included. Primary endpoints were aortic-related and sepsis-free survival estimated using the Kaplan-Meier method. A Cox proportional hazards regression analysis was used to compute the hazard ratio (HR) and 95% confidence interval (CI) as estimates of survival without sepsis. RESULTS: Seventy-four patients were included, with a median age of 71 years (range, 63-79 years). The index aortic repair was either open (n = 33; 44.6%), endovascular (n = 19; 25.7%), or hybrid (n = 22; 29.7%). Causative organisms were identified in 56 patients (75.7%). At presentation, 26 patients (35.1%) required salvage surgery, open (n = 22; 29.7%) or endovascular (n = 8; 10.8%), and 17 radiological drainage (23.0%). During follow-up, eight required drainage and 11 (14.9%) graft removal (five complete). Infectious complications included pseudoaneurysms (n = 14; 18.9%), rupture (n = 9; 12.2%), gastro-intestinal bleeding (n = 13; 17.6%), septic embolisms (n = 4; 5.4%), and thrombosis (n = 12; 16.2%). In-hospital mortality was 20.3% (n = 15), freedom from aortic-related death and overall survival was 77.1% (95% CI, 65.2%-85.3%) and 70.4% (95% CI, 58.3%-79.7%) at 1 year, and 61.7% (95% CI, 46.1%-74.0%) and 43.1% (95% CI, 29.2%-56.3%) at 5 years. Sepsis recurrence occurred in 37 patients (50.0%). Seven (16.3%) developed acquired antimicrobial resistance. Malnutrition (HR, 3.3; 95% CI, 1.4-7.6; P = .005), hemorrhagic shock at presentation (HR, 2.9; 95% CI, 1.0-8.2; P = .048), aorto-enteric fistulae (HR, 3.3; 95% CI, 1.3-8.4; P = .011), fungal coinfection (HR, 3.5; 95% CI, 1.2-11.5; P = .030), and infection with resistant micro-organisms (HR, 3.1; 95% CI, 1.1-8.3; P = .023) were significantly associated with worse survival without sepsis. CONCLUSIONS: In-hospital and aortic-related mortality were significant, but with salvage surgery and antibiotic therapy, the median survival was 3 years. Sepsis recurrence remained frequent, and further procedures were needed. These outcomes should be considered when graft excision is proposed. Known predictors of adverse outcomes should become important points for discussion in multidisciplinary team meetings.

Patient Views on Surgeon-specific Outcome Reporting in Vascular Surgery: Novel Validated Patient Questionnaire Study.

BACKGROUND: SSMD are used to enhance transparency, improve quality and facilitate patient choice. The use of SSMD is controversial, but patients' views on such data are largely unknown. OBJECTIVES: The aim of this study was therefore to explore the views of patients and to identify their priorities for outcome reporting in vascular surgery. METHODS: A prospective questionnaire study of 165 patients receiving care in a single academic vascular unit was performed. Data on patients' current understanding and use of SSMD, together with future priorities were collected. RESULTS: Of the 165 patients 80% were unaware of SSMD. 72% thought they should be made aware of the data, although 63% thought they were likely to misinterpret the results. The majority recognized the utility of SSMD to inform treatment (60%) and surgeon (53%) choice. The majority prioritize the patient-surgeon relationship (90%) and past experiences of care (71%) when making treatment decisions. A significant majority (66% vs 49%; P < 0.005) would favour hospital-level to surgeon-level data. The main patient priorities for future outcome reporting were waiting list length (56%), the quality of hospital facilities (55%), and patient satisfaction (54%). CONCLUSIONS: The aims of SSMD reporting are not currently being met, and both patients and healthcare professionals have shared concerns over the nature and usefulness of the data. Patients express a preference for hospital-level outcomes and prioritize the experience of receiving care over outcomes when making treatment decisions. Future outcome reporting should include patient-directed hospital-level metrics that are readily accessible and understood by all.

Four-year results of the Bolton relay proximal scallop endograft in the management of thoracic and thoracoabdominal aortic pathology with unfavorable proximal landing zone.

BACKGROUND: Thoracic endovascular aortic repair with a scallop design (scallop-TEVAR) is a useful treatment strategy to extend the proximal landing zone (PLZ), while maintaining perfusion to one or more of the supra-aortic trunks (SATs) when treating aortic pathology with an unfavorable PLZ. The durability of this approach with the Bolton Relay scallop endograft (Terumo Aortic, Sunrise, Fla) has not been established. METHODS: A retrospective review of prospectively collected data on consecutive patients that received scallop-TEVAR in zones 0 to 2 at a tertiary aortic unit was undertaken. The main outcome was durability, characterized by survival estimates, freedom from reintervention to the thoracic aorta and PLZ, migration and aneurysm sac regression. RESULTS: Between 2009 and 2019, 38 patients (71% male; median age, 70 years) underwent scallop-TEVAR for thoracic aortic pathology (n = 28, 74%) or as a part of thoracoabdominal aneurysm repair (n = 10 [26%]). The use of scallop-TEVAR significantly extended the PLZ (median, 5 mm preoperative PLZ vs 26 mm extended PLZ; P = .0001). A total of 41 SATs were perfused with a scallop, including the left subclavian artery (n = 25), left common carotid artery (n = 6), neo/innominate artery (n = 4), left subclavian artery, and vertebral artery (n = 1), innominate artery, and left common carotid artery (n = 2) in conjunction with 15 extra-anatomical bypasses. The PLZ was at Ishimaru zone 0 and 1 in 6 cases (16%), respectively, and zone 2 in 26 cases (68%). Technical success was 98%. The 30-day mortality was 5% (2/38; 1 death from myocardial infarction and 1 from multiorgan failure). A minor stroke occurred in three patients (8%) and temporary spinal cord ischemia in two patients (5%). The median follow-up was 4.5 years (range, 0-10.53 years) during which two patients (5%) developed type Ia endoleak and required intervention to the PLZ (one from device-related migration and one from disease progression). All-cause and aorta-related survival were 72% and 85% and freedom from thoracic and PLZ reintervention was 92% and 97%, respectively. There were no cases of early or late thoracic aortic rupture, retrograde type A aortic dissection or SAT occlusion. CONCLUSIONS: Scallop-TEVAR offers a less invasive treatment option to extend the seal zone in selected patients with an unfavorable PLZ, allowing for a durable repair in terms of overall survival and reintervention. Periprocedural stroke remains a principle concern.

Editor's Choice - Systematic Review and Meta-Analysis of Sex Specific Differences in Adverse Events After Open and Endovascular Intact Abdominal Aortic Aneurysm Repair: Consistently Worse Outcomes for Women.

OBJECTIVE: Previously, reports have shown that women experience a higher mortality rate than men after elective open (OAR) and endovascular (EVAR) repair of abdominal aortic aneurysm (AAA). With recent improvements in overall AAA repair outcomes, this study aimed to identify whether sex specific disparity has been ameliorated by modern practice, and to define sex specific differences in peri- and post-operative complications and pre-operative status; factors which may contribute to poor outcome. METHODS: This was a systematic review, meta-analysis, and meta-regression of sex specific differences in 30 day mortality and complications conducted according to PRISMA guidance (Prospero registration CRD42020176398). Papers with ≥ 50 women, reporting sex specific outcomes, following intact primary AAA repair, from 2000 to 2020 worldwide were included; with separate analyses for EVAR and OAR. Data sources were Medline, Embase, and CENTRAL databases 2005 - 2020 searched using ProQuest Dialog. RESULTS: Twenty-six studies (371 215 men, 65 465 women) were included. Meta-analysis and meta-regression indicated that sex specific odds ratios (ORs) for 30 day mortality were unchanged from 2000 to 2020. Mortality risk was higher in women for OAR and more so for EVAR (OR [95% CI] 1.49 [1.37 - 1.61]; 1.86 [1.59 - 2.17], respectively) and this remained following multivariable risk adjustment. Transfusion, pulmonary complications, and bowel ischaemia were more common in women after OAR and EVAR (OAR: ORs 1.81 [1.60 - 2.04], 1.40 [1.28 - 1.53], 1.54 [1.36 - 1.75]; EVAR: ORs 2.18 [2.08 - 2.29] 1.44 [1.17 - 1.77], 1.99 [1.51 - 2.62], respectively). Arterial injury, limb ischaemia, renal and cardiac complications were more common in women after EVAR (ORs 3.02 [1.62 - 5.65], 2.13 [1.48 - 3.06], 1.46 [1.22 - 1.72] and 1.19 [1.03 - 1.37], respectively); the latter was associated with greater mortality risk on meta-regression. CONCLUSION: Increased mortality risk for women following AAA repair remains. Women had a higher incidence of transfusion, pulmonary and bowel complications after EVAR and OAR. Higher mortality risk ratios for EVAR may result from cardiac complications, additional arterial injury, and embolisation, leading to renal and limb ischaemia. These findings indicate possible causes for observed outcome disparities and targets for quality improvement.

Wearable Activity Monitors in Home Based Exercise Therapy for Patients with Intermittent Claudication: A Systematic Review.

OBJECTIVE: Intermittent claudication (IC) can severely limit functional capacity and quality of life. Supervised exercise therapy is the recommended first line management; however, this is often limited by accessibility, compliance and cost. As such, there has been an increased interest in the use of wearable activity monitors (WAMs) in home based telemonitoring exercise programmes for claudicants. This review aims to evaluate the efficacy of WAM as a feedback and monitoring tool in home based exercise programmes for patients with IC. DATA SOURCES: A search strategy was devised. The databases MEDLINE, EMBASE, and Web of Science were searched through to April 2020. REVIEW METHODS: Randomised trials and prospective trials were included. Eligible trials had to incorporate WAMs as a feedback tool to target walking/exercise behaviour. The primary outcome was the change in walking ability. Study quality was assessed with risk of bias tool. RESULTS: A total of 1148 records were retrieved. Of these, eight randomised controlled trials and one prospective cohort study, all of which compared a WAM intervention against standard care and/or supervised exercise, met the inclusion criteria. Owing to heterogeneity between studies, no meta-analysis was conducted. WAM interventions improved measures of walking ability (heterogeneous outcomes such as maximum walking distance, claudication distance and six minute walk distance), increased daily walking activity (steps/day), cardiovascular metrics (maximum oxygen consumption), and quality of life. CONCLUSION: There is some evidence that home based WAM interventions are beneficial for improving walking ability and quality of life in patients with IC. However, existing studies are limited by inadequate sample size, duration, and appropriate power. Achieving consensus on outcome reporting and study methods, as well as maximising device adherence, is needed.

Short- and long-term outcomes in isolated penetrating aortic ulcer disease.

BACKGROUND: The optimum management of isolated penetrating aortic ulceration (PAU), with no associated intramural hematoma or aortic dissection is not clear. We evaluate the short- and long-term outcomes in isolated PAU to better inform management strategies. METHODS: We conducted a retrospective review of 43 consecutive patients (mean age, 72.2 years; 26 men) with isolated PAU (excluding intramural hematoma/aortic dissection) managed at a single tertiary vascular unit between November 2007 and April 2019. Twenty-one percent had PAU of the arch, 62% of the thoracic aorta, and 17% of the abdominal aorta. Conservative and surgical groups were analyzed separately. Primary outcomes included mortality, PAU progression, and interventional complications. RESULTS: Initially, 67% of patients (29/43) were managed conservatively; they had significantly smaller PAU neck widths (P = .04), PAU depths (P = .004), and lower rates of associated aneurysmal change (P = .004) compared with those initially requiring surgery. Four patients (4/29) initially managed conservatively eventually required surgical management at a mean time interval of 49.75 months (range, 9.03-104.33 months) primarily owing to aneurysmal degeneration. Initially, 33% of patients (14/43) underwent surgical management; 7 of the 14 procedures were urgent. Of the 18 patients, 17 eventually managed with surgical intervention had an endovascular repair; 2 of the 17 endovascular cases involved supra-aortic debranching, six used scalloped, fenestrated, or chimney stents. The overall long-term mortality was 30% (mean follow-up, 48 months; range, 0-136 months) with no significant difference between the conservatively and surgically managed groups (P = .98). No aortic-related deaths were documented during follow-up in those managed conservatively. There was no in-hospital mortality after surgical repair. Of these 18 patients, two required reintervention within 30 days for type I or III endoleaks. Among the 18 patients, seven died during follow-up (mean survival, 90.24 months; range, 66.48-113.88) with 1 of the 18 having a confirmed aortic-related death. CONCLUSIONS: Isolated, asymptomatic, small PAUs may be safely managed conservatively with regular surveillance. Those with high-risk features or aneurysmal progression require complex strategies for successful treatment with acceptable long-term survival.

Surgical Decision Making in Uncomplicated Type B Aortic Dissection: A Survey of Australian/New Zealand and European Surgeons.

OBJECTIVE: There is controversy about the role of pre-emptive thoracic endovascular aortic repair (TEVAR) in uncomplicated type B aortic dissection (TBAD). The aim was to understand expert opinions and the factors influencing decision making. METHODS: In 2018, surgeons from Australia/New Zealand (ANZ) and Europe (EUR) were contacted to participate in an online survey which comprised questions about preferences for pre-emptive TEVAR, followed by five case scenarios, and two ranking questions for anatomical and technical risk factors respectively. Case 1 was designed to favour TEVAR in a hypertensive patient with partial false lumen thrombosis and large diameter (aortic ≥ 40 mm, false lumen ≥ 22 mm). Case 2 had no risk factors mandating TEVAR, according to current evidence. Cases 3, 4, and 5 were designed to test one risk factor respectively, large entry tear on the inner aortic curvature (≥10 mm), partial false lumen thrombosis, and large diameter alone. RESULTS: There were 75 responses, 42 from EUR and 33 from ANZ. Almost half of surgeons (49.3%) endorsed pre-emptive TEVAR with 82.3% preferring to perform TEVAR in the subacute phase. In Case 1 and 5, 58.3% and 52.8% of surgeons respectively chose TEVAR, the highest rates obtained in the survey. Cases 1 and 5 included large diameters ≥40 mm, which were ranked the highest in importance when surgeons considered anatomical risk factors. Surgeons who recommend pre-emptive TEVAR were more likely to choose TEVAR in both Case 1 (83.3% vs. 33.3%, p < .001, 95% CI 27.6%-65.8%) and Case 5 (69.4% vs. 38.2%, p = .008, 95% CI 8.2%-50.0%). CONCLUSION: In this survey about uncomplicated TBAD, about half of surgeons recommended pre-emptive TEVAR in selected cases. The surgeon's predisposition towards intervention and large diameters appear to be the most influential factors in decision making. These findings underline the uncertainty in today's practice and emphasise the need for better predictive tools.

Treatment of distal deep vein thrombosis.

BACKGROUND: The treatment of distal (below the knee) deep vein thrombosis (DVT) is not clearly established. Distal DVT can either be treated with anticoagulation, or monitored with close follow-up to detect progression to the proximal veins (above the knee), which requires anticoagulation. Proponents of this monitoring strategy base their decision to withhold anticoagulation on the fact that progression is rare and most people can be spared from potential bleeding and other adverse effects of anticoagulation. OBJECTIVES: To assess the effects of different treatment interventions for people with distal (below the knee) deep vein thrombosis (DVT). SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 February 2019. We also undertook reference checking to identify additional studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) for the treatment of distal DVT. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials and extracted data. We resolved disagreements by discussion. Primary outcomes of interest were recurrence of venous thromboembolism (VTE), DVT and major bleeding and follow up ranged from three months to two years. We performed fixed-effect model meta-analyses with risk ratio (RRs) and 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We identified eight RCTs reporting on 1239 participants. Five trials randomised participants to anticoagulation for up to three months versus no anticoagulation. Three trials compared anticoagulation treatment for different time periods. Anticoagulant compared to no intervention or placebo for distal DVT treatment Anticoagulation with a vitamin K antagonist (VKA) reduced the risk of recurrent VTE during follow-up compared with participants receiving no anticoagulation (RR 0.34, 95% CI 0.15 to 0.77; 5 studies, 496 participants; I2 = 3%; high-certainty evidence), and reduced the risk of recurrence of DVT (RR 0.25, 95% CI 0.10 to 0.67; 5 studies, 496 participants; I2 = 0%; high-certainty evidence). There was no clear effect on risk of pulmonary embolism (PE) (RR 0.81, 95% CI 0.18 to 3.59; 4 studies, 480 participants; I2 = 0%; low-certainty evidence). There was little to no difference in major bleeding with anticoagulation compared to placebo (RR 0.76, 95% CI 0.13 to 4.62; 4 studies, 480 participants; I2 = 26%; low-certainty evidence). There was an increase in clinically relevant non-major bleeding events in the group treated with anticoagulants (RR 3.34, 95% CI 1.07 to 10.46; 2 studies, 322 participants; I2 = 0%; high-certainty evidence). There was one death, not related to PE or major bleeding, in the anticoagulation group. Anticoagulation for three months or more compared to anticoagulation for six weeks for distal DVT treatment Three RCTs of 736 participants compared three or more months of anticoagulation with six weeks of anticoagulation. Anticoagulation with a VKA for three months or more reduced the incidence of recurrent VTE to 5.8% compared with 13.9% in participants treated for six weeks (RR 0.42, 95% CI 0.26 to 0.68; 3 studies, 736 participants; I2 = 50%; high-certainty evidence). The risk for recurrence of DVT was also reduced (RR 0.32, 95% CI 0.16 to 0.64; 2 studies, 389 participants; I2 = 48%; high-certainty evidence), but there was probably little or no difference in PE (RR 1.05, 95% CI 0.19 to 5.88; 2 studies, 389 participants; I2 = 0%; low-certainty evidence). There was no clear difference in major bleeding events (RR 3.42, 95% CI 0.36 to 32.35; 2 studies, 389 participants; I2 = 0%; low-certainty evidence) or clinically relevant non-major bleeding events (RR 1.76, 95% CI 0.90 to 3.42; 2 studies, 389 participants; I2 = 1%; low-certainty evidence) between three months or more of treatment and six weeks of treatment. There were no reports for overall mortality or PE and major bleeding-related deaths. AUTHORS' CONCLUSIONS: Our review found a benefit for people with distal DVT treated with anticoagulation therapy using VKA with little or no difference in major bleeding events although there was an increase in clinically relevant non-major bleeding when compared to no intervention or placebo. The small number of participants in this meta-analysis and strength of evidence prompts a call for more research regarding the treatment of distal DVT. RCTs comparing different treatments and different treatment periods with placebo or compression therapy, are required.

Designing a paediatric hospital information tool with children, parents, and healthcare staff: a UX study.

BACKGROUND: The hospital patient pathway for having treatment procedures can be daunting for younger patients and their family members, especially when they are about to undergo a complex intervention. Opportunities to mentally prepare young patients for their hospital treatments, e.g. for surgical procedures, include tools such as therapeutic clowns, medical dolls, or books and board games. However, while promising in reducing pre-operative anxiety and negative behaviours, they may be resource intensive, costly, and not always readily available. In this study, we co-designed a digital hospital information system with children, parents and clinicians, in order to prepare children undergoing medical treatment. METHOD: The study took place in the UK and consisted of two parts: In part 1, we purposively sampled 37 participants (n=22 parents, and n=15 clinicians) to understand perceptions and concerns of an hospital information platform specifically design for and addressed to children. In part 2, 14 children and 11 parents attended an audio and video recorded co-design workshop alongside a graphic designer and the research team to have their ideas explored and reflected on for the design of such information technology. Consequently, we used collected data to conduct thematic analysis and narrative synthesis. RESULTS: Findings from the survey were categorised into four themes: (1) the prospect of a hospital information system (parents' inputs); (2) content-specific information needed for the information system (parents' and clinicians' inputs); (3) using the virtual information system to connect young patients and parents (parents' inputs); and (4) how to use the virtual hospital information system from a clinician's perspective (clinicians' inputs). In contrast, the workshop highlighted points in times children were most distressed/relaxed, and derived the ideal hospital visit in both their and their parents' perspectives. CONCLUSIONS: The findings support the use of virtual information systems for children, in particular to explore and learn about the hospital, its facilities, and the responsibilities of healthcare professionals. Our findings call for further investigations and experiments in developing safer and more adequate delivery of care for specific age groups of healthcare users. Practical and theoretical implications for improving the quality and safety in healthcare delivery are discussed.

Surgery, Complications, and Quality of Life: A Longitudinal Cohort Study Exploring the Role of Psychosocial Factors.

OBJECTIVE: To determine whether psychosocial factors moderate the relationship between surgical complications and quality of life (QoL). BACKGROUND: Patients who experience surgical complications have significantly worse postoperative QoL than patients with an uncomplicated recovery. Psychosocial factors, such as coping style and level of social support influence how people deal with stressful events, but it is unclear whether they affect QoL following a surgical complication. These findings can inform the development of appropriate interventions that support patients postoperatively. METHODS: This is a longitudinal cohort study; data were collected pre-op, 1 month post-op, 4 months post-op, and 12 months post-op. A total of 785 patients undergoing major elective gastrointestinal, vascular, or cardiothoracic surgery who were recruited from 28 National Health Service sites in England and Scotland took part in the study. RESULTS: Patients who experience major surgical complications report significantly reduced levels of physical and mental QoL (P < 0.05) but they make a full recovery over time. Findings indicate that a range of psychosocial factors such as the use of humor as a coping style and the level of health care professional support may moderate the impact of surgical complications on QoL. CONCLUSIONS: Surgical complications alongside other sociodemographic and psychosocial factors contribute to changes in QoL; the results from this exploratory study suggest that interventions that increase the availability of healthcare professional support and promote more effective coping strategies before surgery may be useful, particularly in the earlier stages of recovery where QoL is most severely compromised. However, these relationships should be further explored in longitudinal studies that include other types of surgery and employ rigorous recruitment and follow-up procedures.

The use of video motion analysis to determine the impact of anatomic complexity on endovascular performance in carotid artery stenting.

OBJECTIVE: Video motion analysis (VMA) uses fluoroscopic sequences to derive information on catheter and guidewire movement and is able to calculate two-dimensional catheter tip path length (PL) on the basis of frame-by-frame pixel coordinates. The objective of this study was to evaluate the effect of anatomic complexity on the efficiency of completion of defined stages of simulated carotid artery stenting as measured by VMA. METHODS: Twenty interventionists each performed a standardized easy, medium, and difficult carotid artery stenting case in random order on an ANGIO Mentor (Simbionix, Airport City, Israel) simulator. Videos of all procedures were analyzed using VMA software, and performance was expressed in terms of two-dimensional guidewire tip trajectory distance (PL). Comparisons of PL were used to identify differences in cannulation performance of the participants between the three cases of varying difficulty. The procedure was subdivided into four procedural phases: arch navigation, common carotid artery (CCA) cannulation, external carotid manipulation, and carotid lesion crossing. Comparisons of PL were used to identify differences in performance between the three cases of varying difficulty for each of the procedural phases. RESULTS: There were significant differences in PL in relation to anatomic complexity, with a stepwise increase in PL from easy to difficult cases: easy, median of 5000 pixels (interquartile range, 4075-5403 pixels); intermediate, 9059 (5974-14,553) pixels; difficult, 17,373 (11,495-26,594) pixels (P < .001). Similarly, during CCA cannulation, there was a stepwise increase in PL from easy to difficult cases: easy, 749 (603-1403) pixels; intermediate, 3274 (1544-8142) pixels; difficult, 8845 (5954-15,768) pixels (P < .001). There were no observed differences across the groups of anatomic difficulty for the phases of arch navigation, external carotid manipulation, and carotid lesion crossing. CONCLUSIONS: Increasing anatomic complexity leads to significant increases in PL of endovascular tools, in particular during CCA cannulation. This increase in tool movement may have a bearing on clinical outcome.