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.

SVS WIfI score as a predictor of amputation after onset of CLI: Validation in an Irish tertiary vascular unit.

INTRODUCTION: Critical limb ischemia (CLI) in diabetic patients is defined by non-healing foot ulcer or rest pain for more than 2 weeks with ankle pressure of less than 40 mmHg. The SVS WIfI classification system stratifies CLI on the basis of perfusion, extent of wound and superadded infection to provide a composite score which guides further management and predicts final prognosis OBJECTIVE: The aim of the study was to use the SVS WIfI scoring system to predict the need for early revascularization versus early amputation depending on the composite WIfI score at presentation. METHODOLOGY: This was a retrospective observational study. Data was collected on patients admitted with CLI, in the last 2 years, to calculate composite WIfI score. The WIfI categories according to risk of limb loss were identified with endpoint being major or minor amputation. RESULTS: Among the 87 patients reviewed, 35 patients (40%) required major amputation, and 29 of those underwent vascular intervention (83%) as part of their care. Median age of the cohort was 72 and 71% were male patients. Comparative analysis between major amputations and minor amputation showed the median score on initial clinical presentation to be 7 in major amputation and 5 in minor amputations (p < 0.0001). CONCLUSION: The composite WIFi score (a summation of the Wound, Ischaemia, and Infection sub-scores) was a good predictor of need for an amputation WIfI scoring system is a useful tool and should be used early in the management of infected ischaemic limbs.

Poor patient awareness of peripheral arterial disease, it is time to optimize the clinical visit.

INTRODUCTION: Peripheral arterial disease (PAD) is a growing public health burden. The development and progression of PAD is influenced by vascular risk factor management and lifestyle changes. However, public awareness of PAD is low compared with other conditions such as heart disease and stroke, which have been the subject of widespread public health campaigns. This study aimed to determine current levels of PAD awareness among hospital patients. METHODS: This cross-sectional, tertiary hospital-based, descriptive study was conducted over 6 months in 2019. Two investigators administered the survey in face-to-face interviews to patients attending 3 different hospital-based settings including vascular clinics (VC), cardiology clinics (CVC), and Emergency Department (ED). RESULTS: A total of 150 patients were interviewed. Participants demonstrated low overall awareness of vascular disease (32% PAD and 21% AAA) compared to cardiovascular disease including stroke (71%) and myocardial infarction (63%). Awareness of PAD was higher in vascular patients (51%) compared to CVC and ED patients (p=<0.01). Of the total population, 77% and 71% identified the contributory role of smoking and limited exercise to the development of PAD respectively. VC patients were more informed of intermittent claudication (78%) and amputation (80%) (p < 0.01) compared to CVC and ED patients. CONCLUSION: In the global drive to reduce vascular morbidity, this study highlights the poor knowledge of PAD among the public. In addition, there is poor awareness about the incidence, risk factors and complications of PAD. These results highlight the need for accessible and easily understood information regarding PAD in both the clinic setting and public health campaigns.

Peri-procedural thromboprophylaxis in the prevention of DVT in varicose vein interventions: A systematic review and meta-analysis.

OBJECTIVE: A systematic review and meta-analysis was performed to determine the role of thromboprophylaxis in the prevention of venous thromboembolism in patients undergoing varicose vein interventions. METHODS: PUBMED, EMBASE and Web of Science were searched for comparative studies of patients undergoing varicose vein interventions and received either thromboprophylaxis or no thromboprophylaxis. Data were collected on the number of thrombotic events including deep vein thrombosis (DVT), pulmonary embolism (PE) and endothermal heat-induced thrombosis (EHIT) as well as bleeding events. The primary outcomes for the meta-analysis were the risk of all thrombotic events, risk of DVT and risk of bleeding. Pooled risk ratios were calculated using random effects modelling. RESULTS: Eight studies (6479 participants) were included. The use of thromboprophylaxis reduces the risk of all thrombotic events (Pooled risk ratio = 0.63, 95% Confidence interval [CI], 0.04-10.43) and the risk of DVT (Pooled risk ratio = 0.59, 95% CI, 0.08-4.60) with no increased risk of bleeding (Pooled risk ratio = 0.66, 95% CI, 0.06-7.21]. Rivaroxaban has similar efficacy in the prevention of DVT compared to Fondaparinux in patients undergoing endovenous ablation of varicose veins (Pooled risk ratio = 0.68, 95% CI, 0.06-7.41). An extended course of thromboprophylaxis reduces the risk of developing DVT compared to a short course (Pooled risk ratio = 1.40, 95% CI, 0.44-4.46). However, the two studies reporting on the duration of thromboprophylaxis did not stratify patients according to their risk of developing venous thromboembolism. CONCLUSION: The use of thromboprophylaxis in patients undergoing varicose vein interventions reduces the risk of venous thromboembolism with no significant increase in the risk of bleeding. However, the included studies were underpowered with high to moderate risk of bias. Therefore, more randomised controlled trials with a large sample size are needed in order to provide high quality evidence for clinical practice.

Internal maxillary artery to middle cerebral artery bypass for a complex recurrent middle cerebral artery aneurysm: case report and technical considerations.

We report the case of a 41-year-old male who presented with an enlarging aneurysm neck one year after clipping. The patient underwent an IMAX-MCA bypass followed by endovascular coil occlusion of the aneurysm neck incorporating an MCA branch origin. To our knowledge, this case represents the first documented IMAX-MCA bypass from a European centre. This case demonstrates that for neurosurgeons experienced in EC-IC bypass surgery, IMAX-MCA bypass is feasible and can be performed safely as long as careful attention is paid to anatomical landmarks and vascular anastomosis principles. CTA-based neuronavigation and micro-Doppler are essential intraoperative tools for identifying the IMAX.

Preparedness of newly qualified doctors in Ireland for prescribing in clinical practice.

AIM: The aim of the study was to investigate the level of preparedness of newly qualified Irish-trained doctors for prescribing, and to investigate their attitudes towards prescribing and prescribing education, through a national survey. METHODS: A 29-item online survey was distributed to 686 newly qualified doctors 1 month prior to the completion of their first year of clinical practice (internship). Only graduates from Irish medical schools were included. RESULTS: The response rate was 20.4% (n = 140; female : male 56%:44%). The majority of respondents felt confident in prescription writing (89%), medication history taking (81%) and accessing drug information in the hospital setting (80%). Only 58% of respondents felt confident in drug dose calculation, and 35% felt confident in preparing and administering drugs. When asked if their undergraduate medical education had prepared them for prescribing in clinical practice, 28% of respondents agreed. Confidence that their undergraduate education had prepared them was associated with receiving formal training in prescribing skills (P = 0.0045; 27% vs. 0%). Thirty-seven per cent of respondents agreed that they felt stressed about prescribing medications. CONCLUSION: This survey of newly qualified doctors in Ireland found that only 28% of respondents agreed that their undergraduate medical education had prepared them for prescribing, which was comparable to a previous survey of UK medical students and graduates. Investigating confidence and preparedness for prescribing provides important insights for educators. Dedicated teaching of prescribing, with an emphasis on practical training and assessment, may help graduates to feel more prepared for the challenges of prescribing in the clinical setting.

Supervised exercise therapy in the management of peripheral arterial disease - an assessment of compliance.

BACKGROUND: Supervised exercise therapy (SET) is an effective option in the management of peripheral arterial disease (PAD). Unfortunately, poor compliance remains prevalent. This study aimed to assess patient exercise compliance and to identify factors influencing symptomatic improvement and SET participation. PATIENTS AND METHODS: Data regarding attendance at SET for this cohort study were extracted from a prospectively maintained database of patients with claudication attending SET at Dublin City University. All patients had ankle brachial index confirmed PAD with associated intermittent claudication. Exercise performance and symptomatic data were gathered retrospectively using patient charts and interviews. RESULTS: Ninety-eight patients were referred for SET during the study period. The mean age was 69.2 (± 10.1) with 18 % being female. Median follow-up was 25.1 months (IQ range 17.0-31.6). Overall, the mean number of sessions attended per patient was 19.5. Exercise compliance was associated with a significant improvement in symptoms (p = 0.001). Other factors including anatomical level of claudication (P = 0.042) and educational level (p = 0.007) were found to affect the outcome of SET. Multivariate analysis revealed hypertension as a predictor of symptomatic outcome after SET (p = 0.045). Furthermore, ex-smokers (p = 0.021) and those previously diagnosed with hypercholesterolaemia (p = 0.020) or ischaemic heart disease (p = 0.029) had superior exercise compliance. Using linear regression, smoking history (p = 0.024) was identified as a predictor of compliance to SET. CONCLUSIONS: Establishing exercise compliance remains challenging in the PAD cohort. Pre-exercise patient education and personalised exercise prescriptions may result in improvements in function and compliance.

Evidence for varicose vein surgery in venous leg ulceration.

BACKGROUND: Venous leg ulcers affect 1-3% of adults with a significant economic impact, utilizing 1% of annual healthcare budgets in some western European countries. OBJECTIVES: To determine the effects of intervention for incompetent superficial veins on ulcer healing and recurrence in patients with active or healed venous ulcers. SEARCH METHODS: In October 2014, we searched Medline, CINAHL, EMBASE, Scopus, the Cochrane library and Web of Science without date or language restriction for relevant randomized or observational studies. Bibliographies of included studies were also searched for additional studies. SELECTION CRITERIA: Observational studies or randomized controlled trials comparing intervention for varicose veins with compression therapy alone for venous leg ulcers were eligible. In addition, studies compared open to endovenous therapy for varicose veins in patients with leg ulcers and those compared treating saphenous and perforating veins to treating saphenous veins only were also included. Studies had to report at least one ulcer-related outcome (healing rate, recurrence or time to healing). DATA COLLECTION AND ANALYSIS: Details of potentially eligible studies were extracted and summarized using a data extraction table. Data extraction and quality assessment were performed independently by two review authors, and any disagreements resolved by consensus or by arbitration of a third author. RESULTS: Intervention for superficial venous reflux improved ulcer healing (risk ratio = 1.11 [1.00, 1.22], 95% CI, p = 0.04) and reduced recurrence (risk ratio = 0.48 [0.32, 0.67], 95% CI, p < 0.0001) compared to compression alone, with low level of evidence. CONCLUSION: This review confirmed that the evidence for a beneficial effect of endovenous and open surgery for varicose vein in venous leg ulcer is at beast weak. A well-structured RCT is required to investigate the role of endovenous ablation of incompetent superficial veins in improving venous leg ulcer outcomes.

Remote feedback in endovascular simulation training: a mixed-methods study.

BACKGROUND: There is an increasing need to increase simulation-based learning opportunities for vascular surgery residents in endovascular skills training. This study aims to explore the effectiveness of remote expert instructional feedback of endovascular simulation-based education, as a means of increasing training opportunities in this area for vascular surgery residents. METHODS: A mixed-methods study design was adopted. Twelve vascular surgery residents from Ireland were tasked with completing two endovascular renal artery procedures: one with in-person expert feedback and the other with remote instruction. Participants ranged in experience levels from second year to final year of residency. Following the training activities, interviews and a questionnaire were employed to gather information on the usefulness of remote feedback. RESULTS: There was no significant difference reported by participants using a post-event validated questionnaire between remote and in-person feedback. During the interviews, participants expressed mixed feelings about the presence of the educator while practicing, but they eventually saw no limiting factors to their practice when the trainer provided remote feedback. When receiving performance feedback remotely, clear communication and a shared knowledge of the task development are critical to success. CONCLUSIONS: We believe these findings can inform the design and development of remote learning and assessment of endovascular skills training and ultimately provide increased opportunities for more skills practice for vascular surgical residents.

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.

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.

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.

The importance of expert feedback during endovascular simulator training.

OBJECTIVES: Complex endovascular skills are difficult to obtain in the clinical environment. Virtual reality (VR) simulator training is a valuable addition to current training curricula, but is there a benefit in the absence of expert trainers? METHODS: Eighteen endovascular novices performed a renal artery angioplasty/stenting (RAS) on the Vascular Interventional Surgical Trainer simulator. They were randomized into three groups: Group A (n = 6, control), no performance feedback; Group B (n = 6, nonexpert feedback), feedback after every procedure from a nonexpert facilitator; and Group C (n = 6, expert feedback), feedback after every procedure from a consultant vascular surgeon. Each trainee completed RAS six times. Simulator-measured performance metrics included procedural and fluoroscopy time, contrast volume, accuracy of balloon placement, and handling errors. Clinical errors were also measured by blinded video assessment. Data were analyzed using SPSS version 15. RESULTS: A clear learning curve was observed across the six trials. There were no significant differences between the three groups for the general performance metrics, but Group C made fewer errors than Groups A (P = .009) or B (P = .004). Video-based error assessment showed that Groups B and C performed better than Group A (P = .002 and P = .000, respectively). CONCLUSION: VR simulator training for novices can significantly improve general performance in the absence of expert trainers. Procedure-specific qualitative metrics are improved with expert feedback, but nonexpert facilitators can also enhance the quality of training and may represent a valuable alternative to expert clinical faculty.

Acute limb ischemia in cancer patients: should we surgically intervene?

BACKGROUND: Cancer patients have an increased risk of venous thromboembolic events. Certain chemotherapeutic agents have also been associated with the development of thrombosis. Reported cases of acute arterial ischemic episodes in cancer patients are rare. METHODS: Patients who underwent surgery for acute limb ischemia associated with malignancy in a university teaching hospital over a 10-year period were identified. Patient demographics, cancer type, chemotherapy use, site of thromboembolism, treatment and outcome were recorded. RESULTS: Four hundred nineteen patients underwent surgical intervention for acute arterial ischemia, 16 of these patients (3.8%) had associated cancer. Commonest cancer sites were the urogenital tract (n = 5) and the lungs (n = 5). Eight patients (50%) had been recently diagnosed with cancer, and four (25%) of these cancers were incidental findings after presentation with acute limb ischemia. Four patients (25%) developed acute ischemia during chemotherapy. The superficial femoral artery was the most frequent site of occlusion (50%), followed by the brachial (18%) and popliteal (12%) arteries. All patients underwent thromboembolectomy, but two (12%) patients subsequently required a bypass procedure. Six patients (37%) had limb loss, and in-patient mortality was 12%. Histology revealed that all occlusions were due to thromboembolism, with no tumor cells identified. At follow-up, 44% of patients were found to be alive after 1 year. CONCLUSION: Cancer and chemotherapy can predispose patients to acute arterial ischemia. Unlike other reports that view this finding as a preterminal event most appropriately treated by palliative measures, in this series, early diagnosis and surgical intervention enabled limb salvage and patient survival.

Five-year outcomes of patients attending a diabetic foot clinic in a tertiary referral centre.

BACKGROUND: Diabetic foot ulcers (DFU) are associated with an increased risk of lower limb amputation and death. Reported mortality rates for patients with DFU are as high as 50% after 5 years. AIMS: The aim of this retrospective study was to examine the 5-year clinical outcomes of patients with high-risk diabetic foot disease attending a specialist foot clinic in Beaumont Hospital between 2007 and 2010. METHODS: Clinical information was obtained from the CELLMA electronic patient record and laboratory results were extracted from the Beaumont Hospital information system. RESULTS: In total, data from 98 patients, who attended the foot clinic over the 4-year period, was collected. The 5-year mortality rate was 13.3% with an amputation rate of 28.6%. A significant proportion of patients (33.7%) had recurrent/new DFU after 5 years of follow-up. In this cohort, there was no association between poor glycaemic control, presence of co-existent cardiovascular disease or renal failure, and increased mortality or amputation. CONCLUSIONS: Diabetic foot disease is an important cause of morbidity and mortality in clinical practice. It remains to be seen whether implementation of the national model of foot care in 2011 will improve outcomes for patients with high-risk diabetic foot disease.

Comparing Supervised Exercise Therapy to Invasive Measures in the Management of Symptomatic Peripheral Arterial Disease.

Peripheral arterial disease (PAD) is associated with considerable morbidity and mortality. Consensus rightly demands the incorporation of supervised exercise training (SET) into PAD treatment protocols. However, the exact role of SET particularly its relationship with intervention requires further clarification. While supervised exercise is undoubtedly an excellent tool in the conservative management of mild PAD its use in more advanced disease as an adjunct to open or endovascular intervention is not clearly defined. Indeed its use in isolation in this cohort is incompletely reported. The aim of this review is to clarify the exact role of SET in the management of symptomatic PAD and in particular to assess its role in comparison with or as an adjunct to invasive intervention. A systematic literature search revealed a total 11 randomised studies inclusive of 969 patients. All studies compared SET and intervention with monotherapy. Study results suggest that exercise is a complication-free treatment. Furthermore, it appears to offer significant improvements in patients walk distances with a combination of both SET and intervention offering a superior walking outcome to monotherapy in those requiring invasive measures.

Preconditioning Shields Against Vascular Events in Surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial.

BACKGROUND: Patients undergoing vascular surgery procedures constitute a 'high-risk' group. Fatal and disabling perioperative complications are common. Complications arise via multiple aetiological pathways. This mechanistic redundancy limits techniques to reduce complications that target individual mechanisms, for example, anti-platelet agents. Remote ischaemic preconditioning (RIPC) induces a protective phenotype in at-risk tissue, conferring protection against ischaemia-reperfusion injury regardless of the trigger. RIPC is induced by repeated periods of upper limb ischaemia-reperfusion produced using a blood pressure cuff. RIPC confers some protection against cardiac and renal injury during major vascular surgery in proof-of-concept trials. Similar trials suggest benefit during cardiac surgery. Several uncertainties remain in advance of a full-scale trial to evaluate clinical efficacy. We propose a feasibility trial to fully evaluate arm-induced RIPC's ability to confer protection in major vascular surgery, assess the incidence of a proposed composite primary efficacy endpoint and evaluate the intervention's acceptability to patients and staff. METHODS/DESIGN: Four hundred major vascular surgery patients in five Irish vascular centres will be randomised (stratified for centre and procedure) to undergo RIPC or not immediately before surgery. RIPC will be induced using a blood pressure cuff with four cycles of 5 minutes of ischaemia followed by 5 minutes of reperfusion immediately before the start of operations. There is no sham intervention. Participants will undergo serum troponin measurements pre-operatively and 1, 2, and 3 days post-operatively. Participants will undergo 12-lead electrocardiograms pre-operatively and on the second post-operative day. Predefined complications within one year of surgery will be recorded. Patient and staff experiences will be explored using qualitative techniques. The primary outcome measure is the proportion of patients who develop elevated serum troponin levels in the first 3 days post-operatively. Secondary outcome measures include length of hospital and critical care stay, unplanned critical care admissions, death, myocardial infarction, stroke, mesenteric ischaemia and need for renal replacement therapy (within 30 days of surgery). DISCUSSION: RIPC is novel intervention with the potential to significantly improve perioperative outcomes. This trial will provide the first evaluation of RIPC's ability to reduce adverse clinical events following major vascular surgery. TRIAL REGISTRATION: www.clinicaltrials.gov NCT02097186 Date Registered: 24 March 2014.