Varicose Vein Education and Informed coNsent (VVEIN) Study: A Randomized Controlled Pilot Feasibility Study.

BACKGROUND: The primary aim of this study was to assess the feasibility of introducing a digital health education tool (dHET) for varicose vein surgery. METHODS: This randomized, feasibility study allocated 40 patients, into dHET (n = 20) or standard consent (SC) (n = 20) groups. Primary outcomes were related to feasibility. Secondary outcomes were knowledge recall, anxiety, and satisfaction. RESULTS: Recruitment and retention rates were 100% and 97.5%, respectively. Acceptability was also rated high, confirming feasibility. There was also no evidence of a difference between groups for early knowledge recall (14 [12-17] vs. 14 [11-16]; P = 0.72) or delayed (at 2 weeks) knowledge recall (15 [13-16] vs. 15 [13-16]; P = 0.89). The dHET module took significantly longer to complete compared to SC (13 min [12-18] vs. 9 min [8-12]; P < 0.01). However, the control group asked significantly more questions about the intended procedure (P = 0.03). There was no evidence of a difference between groups for patient anxiety or satisfaction. CONCLUSIONS: This trial shows that the addition of a dHET is feasible and noninferior to SC. Digital consent provides a unique opportunity to promote patient education and autonomy for better shared decision making. It also offers better documentation of the consent process.

Varicose Vein Education and Informed coNsent (VVEIN) study: a randomised controlled pilot feasibility study.

INTRODUCTION: Doctors have a legal requirement and duty of care to ensure patients are enabled to make an informed decision about their treatment, including discussion of the benefits, risks and alternatives to a procedure. A patient-centred approach to consent has been firmly established in Ireland, and fundamental to this is the ability to engage in a dialogue that offers comprehensible information to patients. Telemedicine has revolutionised the way we can deliver care to patients in the modern era of computers, tablets, and smartphones, and its use has been rapidly expanded. Novel digital strategies to improve the informed consent process for surgical procedures have been increasingly under investigation over the last 10-15 years and may offer a low cost, accessible and tailored solution to consent for surgical interventions. Within vascular surgery, superficial venous interventions have been associated with a high number medicolegal claims and also represents an area within the specialty with rapidly evolving technology and techniques. The ability to communicate comprehensible information to patients has never been greater. Thus, the author's aim is to explore whether it is feasible and acceptable to deliver a digital health education intervention to patients undergoing endovenous thermal ablation (EVTA) to supplement the consent process. METHODS: This is a prospective, single centre, randomised controlled, feasibility trial recruiting patients with chronic venous disease deemed suitable to undergo EVTA. Patients will be randomised to receive either standard consent (SC) or a newly developed digital health education tool (dHET). The primary outcome is feasibility; assessing the recruitment and retention rate of participants and assessing acceptability of the intervention. Secondary outcomes include knowledge retention, anxiety and satisfaction. This feasibility trial is designed to recruit 40 patients, which will allow for a moderate dropout rate. This pilot study will inform the authors of the appropriateness of an adequately powered multicentre trial. DISCUSSION: To examine the role of a digital consent solution for EVTA. This may improve and standardise the consent dialogue with patients and may have the potential to reduce claims related to poor consent processes and disclosure of risks. ETHICAL COMMITTEE REFERENCE: Ethical approval has been sought and received from both the Bon Secours Hospital and RCSI (202109017), on 14 May 2021 and 10 October 2021, respectively. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05261412 , registered on 1 March 2022.

A modified Delphi process to form an expert consensus in Ireland on the essential information to be included in shared decision making for varicose vein surgery.

OBJECTIVE: To reach consensus on a core set of essential information for inclusion in the informed consent process to standardize consent for VV surgery. METHODS: Using a modified electronic Delphi (e-Delphi) method, a panel of experts in Ireland, were asked to rate statements of essential information to include in the informed consent process with patients. Statements were rated using a 5-point Likert scale. The definition of consensus was declared at 70% agreement by the panel. RESULTS: Twenty-three panel members accepted the invitation to participate across three e-Delphi rounds. Consensus was reached on 33/42 statements, covering general and procedural information and the risks, benefits and alternatives of varicose veins (VV) surgery. Several statements remained equivocal, having not met consensus by the panel. CONCLUSION: Considerable consensus was reached within the panel of experts but some gaps in available research were also highlighted. This consensus may provide the framework to aid physicians to deliver a standardized discussion of the key elements of consent and shared decision making with patients.

A systematic review and meta-analysis of concomitant truncal and perforator surgery.

OBJECTIVE: Incompetent perforator veins are encountered frequently during ultrasound assessment of the venous system in chronic venous disease. Some studies have shown that concomitant treatment of truncal and perforator incompetence improves ulcer healing, yet a Cochrane review was unable to determine the potential benefits of perforator surgery in venous ulcer management due to poor quality evidence. This study aims to establish the exact role of concomitant treatment in patients with chronic venous disease. METHODS: A search of online databases including MEDLINE, Embase, and Cochrane was performed in March 2022. All studies comparing the outcomes of concomitant superficial venous plus perforator surgery with standard therapy were included. Variables assessed included ulcer healing, time to healing, and ulcer recurrence. Disease severity and quality of life, vein occlusion rates, number of incompetent perforator veins on duplex ultrasound post treatment, and reintervention and complication rates were also analyzed. Data were pooled using a random effects model. RESULTS: Seven studies (872 limbs) were included for analysis. Included studies were of reasonable methodological quality. Ulcer healing rates were similar in each group (relative risk [RR], 1.07; 95% confidence interval [CI] 0.96-1.19; P = .23). Two studies reported no difference in mean time (days) to ulcer healing between groups (mean difference, -14.60; 95% CI, -34.57 to 5.38; P = .15; I2 = 0%; P = .56). Ulcer recurrence was significantly lower in the concomitant group (3.7% vs 44%) (RR, 0.21; 95% CI, 0.07- 0.65; P = .007; I2 = 43%; P = .17). Overall, there was no difference in disease severity measured at 12-month follow-up, with a weighted mean difference between groups of -0.88 (95% CI, -2.05 to 0.29; P = .14; I2 = 84%; P = .002). Quality of life was reported in only one study. The total number of perforator veins identified at follow-up duplex ultrasound was significantly lower in the concomitant group (22.4% vs 89%) compared with standard therapy (RR, 0.31; 95% CI, 0.19-0.53; P < .0001; I2 = 88%; P = .0002). There was no difference between groups for occlusion rates of treated great saphenous vein or incompetent perforators (RR, 2.22; 95% CI, 0.10-49.74; P = .61). Reported minor (RR, 0.98; 95% CI, 0.63-1.52; P = .92) and thrombotic complications (RR, 2.04; 95% CI, 0.59-6.99; P = .26) were similar between groups. CONCLUSIONS: Concomitant truncal and perforator surgery is comparable to standard therapy in terms of ulcer healing, safety, and efficacy. Meta-analysis suggests that concomitant treatment could significantly reduce ulcer recurrence rates, but included studies were subject to some biases and short follow-up. Concomitant treatment may be considered to prevent recurrence rather than improve ulcer healing.

Digital technology in informed consent for surgery: systematic review.

BACKGROUND: Informed consent is an ethical and legal requirement in healthcare and supports patient autonomy to make informed choices about their own care. This review explores the impact of digital technology for informed consent in surgery. METHODS: A systematic search of EBSCOhost (MEDLINE/CINAHL), Embase, Cochrane Central Register of Controlled Trials and Web of Science was performed in November 2021. All RCTs comparing outcomes of both digital and non-digital (standard) consent in surgery were included. Each included study underwent an evaluation of methodological quality using the Cochrane risk of bias (2.0) tool. Outcomes assessed included comprehension, level of satisfaction and anxiety, and feasibility of digital interventions in practice. RESULTS: A total of 40 studies, across 13 countries and 15 surgical specialties were included in this analysis. Digital consent interventions used active patient participation and passive patient participation in 15 and 25 studies respectively. Digital consent had a positive effect on early comprehension in 21 of 30 (70 per cent) studies and delayed comprehension in 9 of 20 (45 per cent) studies. Only 16 of 38 (42 per cent) studies assessed all four elements of informed consent: general information, risks, benefits, and alternatives. Most studies showed no difference in satisfaction or anxiety. A minority of studies reported on feasibility of digital technology in practice. CONCLUSION: Digital technologies in informed consent for surgery were found to have a positive effect on early comprehension, without any negative effect on satisfaction or anxiety. It is recommended that future studies explore the feasibility of these applications for vulnerable patient groups and busy surgical practice.

Vascular Surgery Workforce: Evaluation and Estimation of Future Demand in the United Kingdom.

BACKGROUND: Vascular disease is a common cause of death and disability in our growing elderly population and the demand for vascular procedures is increasing worldwide. Workforce planning is essential to meet future demand and provide safe vascular services. Our aim was to evaluate the current workforce in the United Kingdom and estimate future demand for vascular surgeons. METHODS: From November 2020 to January 2021, we surveyed UK vascular surgeons for information on their work patterns. We estimated current vascular surgery (VS) workforce using the National Vascular Registry (NVR) data and population data from the Office for National Statistics. To estimate future demand, we interrogated Hospital Episode Statistic (HES) data using Hospital Admitted Patient Care Activity (HAPCA) and linear trend analysis. RESULTS: NVR data estimate that currently there are 518 consultant VS in the United Kingdom, or 1 per 128,951 population, lower than international comparisons. HAPCA data (2012-2020) suggests VS Finished Consultant Episodes (FCE), admissions, and waiting lists are growing by approximately 2% per year, and we estimate the workforce will need to grow by more than 50% over the next 10 years to meet this demand and Vascular Society of Great Britain and Ireland recommendation. CONCLUSIONS: The UK has a shortage of vascular surgeons at a time when vascular activity is increasing. The VS workforce, both VS consultant and vascular surgeons in training numbers need to expand to address the ongoing shortage and maintain a safe level of service.

Vascular Surgeon Burnout and Resilience in the United Kingdom: A Report from the Vascular Society Workforce Committee.

BACKGROUND: Occupational burnout is a growing concern in frontline roles such as vascular surgery, and is associated with medical errors and shortened careers. Our aim is to measure burnout, resilience, and associated risk factors among vascular surgeons (VS) in the United Kingdom (UK). METHODS: We carried out an electronic survey of active VS in the UK using validated self-report questionnaires, including the following: Copenhagen Burnout Inventory (CBI), Brief Resilience Scale (BRS), and information on job characteristics, health, and well-being. Univariate regression analysis looked at potential risk factors. RESULTS: One hundred forty-eight VS responded (49% participation rate), and after excluding retirees and nonconsultants, 133 VS practicing in the UK were analyzed. Mean age was 49.9 ± 7.19 years; the majority (83.5%) were male. In total, 81.3% recorded ethnic identity as White. In addition, 93.2% worked full time; 74.8% were contracted above 10 programmed activities and 87.9% worked more than 40 hr/week. On-call was 1 in 6, or above, for 87.4%. Overall, 38.4% of VS had high burnout on the CBI. Resilience was also high, with BRS mean (standard deviation) of 3.6 (0.69) and median (interquartile range) of 3.7 (3-4). Univariate regression analysis found no significant risk factor associated with high burnout or resilience. CONCLUSIONS: VS in the UK have high levels of burnout and work long hours. Resilience levels were also high, which may offer some protection. However, policymakers and our surgical leaders should address contributing factors and excessive working hours and establish measures to identify and support surgeon well-being for optimal surgeon and patient safety.

Rescue of Failed Aortic Repair with Fenestrated Endovascular Device.

INTRODUCTION: The incidence of failed endovascular (EVAR) and open repair (OR) is increasing. Redo aortic repair is required in 10% of patients. Extension of the proximal sealing zone above the visceral arteries to adequate, healthier thoracic aorta using a fenestrated graft (FEVAR) can rescue a failing repair. A custom-made device can treat proximal type 1a endoleaks or proximal dilatation post endovascular or open repair, respectively. The aim of this investigation was to present a single-centre experience with FEVAR for patients with a failing aortic repair. METHODS: A prospectively maintained database of FEVAR patients treated with a ZenithⓇ Fenestrated endovascular (ZFEN) device (Cook Medical LLC, Bloomington, Indiana, USA) was interrogated for individuals who had the device implanted as a rescue therapy after prior endovascular (EVAR) or open repair (OR). Statistical analysis was performed with SPSS v 25 software. RESULTS: Between January 1, 2011 and March 31, 2019, 17 ZFEN devices were implanted. 10 patients had a type 1a endoleak from a prior EVAR and 7 patients had proximal disease progression after prior OR. There were 12 males and 5 females, median age of 75 (interquartile range, IQR 7). 76.4% (n = 13) of patients had an American Society of Anaesthesiologists (ASA) grade of 3. Primary technical success was 70.5% (n = 12). Of the remainder, 4 cases (24%) had a type III endoleak at completion angiogram; of which, 2 patients (12%) required re-intervention within 30 days. One further case (6%) had primary assisted technical success as stenting of a flow limiting dissection flap in an iliac vessel was required. Peri-operative rate of deployment related complications and systemic complications were 5.8% (n = 1) and 35% (n = 6), respectively. Median length of hospital stay was 11 days (IQR 11). There was no mortality within the study follow up. Overall 30-day re-intervention rate was 23.5%. Overall survival was 92% at one year. CONCLUSION: FEVAR is a safe but technically challenging option for rescue of failing aortic repairs. These are a high-risk group of patients and this is reflected in the high post-operative morbidity rate. Technical success was high and 30-day mortality was low.

Trans-cervical carotid artery stenting associated with open surgical repair of carotid artery pseudoaneurysm.

Pseudoaneurysm post carotid artery endarterectomy is uncommon but with employment of a combined technique of trans-cervical carotid artery stenting with open repair can lead to a successful outcome.

Mortality rates of patients undergoing emergency laparotomy in an Irish university teaching hospital.

INTRODUCTION: Emergency laparotomy (EL) is a commonly performed operation with increased morbidity and mortality. Currently, there is a lack of published outcomes following emergency laparotomy within an Irish population. The aim of this study was to assess our outcomes and compare these to predefined outcomes from NELA. METHODS: A review of a prospectively maintained database of all patients who underwent an emergency laparotomy between January 1st 2015 and October 31st 2016 was performed. Patient demographics, operative indication and procedures, preoperative lactate, time of surgery, admission to high dependency unit (HDU) and mortality (30- and 90-day mortality) were included. Statistical analysis was performed using Minitab V18 with p < 0.05 considered significant. RESULTS: One hundred twenty-four emergency operations were performed on 120 patients. The median age was 60 years. Indications for surgery included the following (%): peritonitis (32.45%), obstruction (22.5%), complicated hernia (19.1%), mesenteric ischaemia (15%), trauma (4.1%), and acute haemorrhage (3.3%). A consultant surgeon and consultant anaesthetist were present at 79 and 78% of EL carried out, respectively. Reported 30- and 90-day mortality were 6.66 and 11.6%, respectively. Thirty-day mortality was 20% in octogenarians. Index lactate did not correlate with mortality (p = 0.43). A significant proportion of mortalities had procedures carried out between 6 pm and midnight with the highest mortality rate in patients with mesenteric ischaemia (p < 0.05). CONCLUSION: EL is associated with high mortality rates. Our mortality figures compare favourably with the NELA data. We support the development of a national database to facilitate improvements in the quality of care delivered to this high-risk cohort.

Compartmentalization regulates the interaction between the platelet integrin alpha IIb beta 3 and ICln.

The volume-regulating protein, ICln, interacts with the conserved KxGFFKR alpha-integrin signature motif. ICln is an abundant protein (4455 +/- 650 molecules/platelet) found exclusively in the soluble cytosolic fraction of unactivated platelets. In contrast, its binding partner, the platelet integrin alpha(IIb)beta(3), is present in detergent-insoluble fractions associated with membrane and cytoskeleton subcellular localizations. This study investigated factors that regulate the interaction of ICln with alpha(IIb)beta(3) during platelet activation. His-tagged recombinant ICln bound equally to purified alpha(IIb)beta(3) and to integrin from resting or activated platelets. Binding was not affected by direct integrin activation with Mn(++) or by inhibitors of integrin occupancy (abciximab, RGD). However, the capacity for interaction between integrin and recombinant ICln was slowly downregulated following prolonged platelet activation for >300 s. In parallel, ICln redistributed to membrane and cytoskeletal platelet subcellular fractions. The time-course of this redistribution preceded the downregulation of integrin binding capacity and suggests that only a short window of opportunity exists for ICln interaction with alpha(IIb)beta(3) to occur. Thus, although ICln has the inherent capacity to bind to alpha(IIb)beta(3) regardless of its activation state, it can only do so following platelet activation. Activation-dependent subcellular redistribution of ICln represents a novel, temporally-regulated mechanism for control of integrin function in platelets.

Bioinformatic discovery of novel bioactive peptides.

Short synthetic oligopeptides based on regions of human proteins that encompass functional motifs are versatile reagents for understanding protein signaling and interactions. They can either mimic or inhibit the parent protein's activity and have been used in drug development. Peptide studies typically either derive peptides from a single identified protein or (at the other extreme) screen random combinatorial peptides, often without knowledge of the signaling pathways targeted. Our objective was to determine whether rational bioinformatic design of oligopeptides specifically targeted to potentially signaling-rich juxtamembrane regions could identify modulators of human platelet function. High-throughput in vitro platelet function assays of palmitylated cell-permeable oligopeptides corresponding to these regions identified many agonists and antagonists of platelet function. Many bioactive peptides were from adhesion molecules, including a specific CD226-derived inhibitor of inside-out platelet signaling. Systematic screens of this nature are highly efficient tools for discovering short signaling motifs in molecular signaling pathways.

Bacitracin reveals a role for multiple thiol isomerases in platelet function.

The platelet-specific integrin alphaIIb beta3 has endogenous thiol isomerase activity associated with the CXXC motifs within the beta subunit. Using a highly purified form of bacitracin, a thiol isomerase inhibitor, we now provide further evidence of the functional significance of this enzymatic activity in integrin activation. In addition, we demonstrate a role for multiple thiol isomerases in platelet function. This bacitracin prevented platelet aggregation to thrombin and collagen, and directly inhibited alphaIIb beta3 activation, as detected by PAC-1 binding. In parallel, bacitracin inhibited the endogenous thiol isomerase activity of purified alphaIIb beta3 with a 50% inhibitory concentration of 15.5 micromol/l. In order to determine whether the effects of bacitracin are solely mediated by inhibition of integrin enzymatic activity, we examined integrin-independent indices of platelet activation. We found bacitracin inhibited both platelet secretion (CD62P and CD63) and thromboxane (TxA2) production, with complete inhibition at different concentrations. Thus, we demonstrated a role for multiple thiol isomerases in platelet function. Taken together, these studies support a role for the endogenous integrin thiol isomerase activity in activation of alphaIIb beta3 and highlight the novel regulation of platelet function by other, as yet undefined thiol isomerases.