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Publication Mapping out a virtual surgical curriculum: opinions on a core surgical training programme with technology-enhanced learning(Royal College of Surgeons of England, 2021-08-31) Brown, Robyn; Humphreys, Alexandra; Bamford, Richard; Mutimer, Jonathan; Coulston, James; Brown, Robyn; Humphreys, Alexandra; Mutimer, Jonathan; Medical and DentalVirtual teaching may be a useful tool for surgical training.Publication Successful Endovascular Repair of a Ruptured Popliteal Artery Aneurysm: A Case Report and Literature Review(Wiley, 2020-03-16) Muir, Duncan; Kulkarni, Sachin; Kulkarni, Sachin; Medical and DentalIntroduction. It is rare for a popliteal artery aneurysm (PAA) to present with rupture. This case reports a longer-term success in the management of a large ruptured popliteal artery aneurysm with an endovascular approach, with a literature review of management of such cases. Case Report. An 80-year-old man presented to the accident and emergency department with pain and swelling behind the left knee and at the back of the thigh. An ultrasound scan and subsequent CT angiogram revealed a large 9.4 cm ruptured PAA. The patient had significant comorbidities deeming him unfit for a major surgical intervention of drainage of haematoma and exclusion bypass. Therefore, he underwent urgent endovascular treatment of the ruptured PAA with a covered stent graft. A follow-up duplex scan at 1 year showed a patent stent with no evidence of endoleak, and the patient remained asymptomatic. A clinical follow-up at 18- and 24-month postprocedure showed a patent stent graft and complete resolution of haematoma. Conclusion. Whilst open repair with exclusion bypass may still be a treatment of choice, an endovascular approach is both safe and effective in the management of a ruptured PAA in an unfit patient with an acceptable longer-term outcome.Publication WS7.105 Effect of preoperative arm warming on arterio-venous fistula outcomes(Oxford University Press, 2020-12-07) Olivier, James; Harris, Sophie; Paravastu, Sharath; Kulkarni, Sachin; Olivier, James; Harris, Sophie; Paravastu, Sharath; Kulkarni, Sachin; Medical and DentalAims: Warming the extremity of a newly formed arterio-venous (AV) access is considered to promote vasodilatation and improve patency. However, to date there are no studies to assess whether preoperative warming of the extremity improves patency, which we evaluated in this study. Methods: In this prospective pilot study, patients who had preoperative warming along with postoperative warming (Group A) and those who had only postoperative warming (Group B) were enrolled. Between April and October 2019. Primary patency and re-interventions were the primary outcomes. Results: 35 patients were enrolled (Group A: n=18 [median age 72 years (58-89); M:F = 11:7] and Group B: n=27 [median age 68 years (54-87); M:F = 17:10]). Early primary patency in group A was 94.4% (17/18), and 92.6% in group B (25/27); p=ns. Fistuloplasty was required in 3/17 patients in group A (17.6%) and 4/25 patients in B (16%). One patient in group A re-visited the hospital for minor bleeding that didn't require any intervention. Conclusions: Our results demonstrated that preoperative extremity warming is safe and is not inferior to postoperative warming alone. There was trend towards slightly better patency with preoperative warming. Long-term results will help establish whether there is any sustainable benefit.Publication Outcomes of Critical Limb Ischaemia in a tertiary referral centre - arewe meeting standards?(Oxford University Press, 2020-12-07) Olivier, James; Jones, Henry; Platt, Nicholas; Kulkarni, Sachin; Paravastu, Sharath; Olivier, James; Jones, Henry; Platt, Nicholas; Kulkarni, Sachin; Paravastu, Sharath; Medical and DentalNo abstract availablePublication Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial(American Medical Association, 2020-09-23) Gohel, Manjit; Mora, Jocelyn; Szigeti, Matyas; Epstein, David; Heatley, Francine; Bradbury, Andrew; Bulbulia, Richard; Cullum, Nicky; Nyamekye, Isaac; Poskitt, Keith; Bulbulia, Richard; Poskitt, Keith; Medical and DentalImportance One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence.Publication Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials(SAGE Publications, 2020-02-18) Dinh, Krystal; Gomes, Miguel; Thomas, Shannon; Paravastu, Sharath; Holden, Andrew; Schneider, Peter; Varcoe, Ramon; Paravastu, Sharath; Medical and DentalPurpose: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). Materials and methods: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: The mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). Conclusion: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.Publication Reducing the risk of venous thromboembolism following superficial endovenous treatment: A UK and Republic of Ireland consensus study(SAGE Publications, 2020-07-01) Dattani, Nikesh; Shalhoub, Joseph; Nandhra, Sandip; Lane, Tristan; Abu-Own, Abdulsalam; Elbasty, Ahmed; Jones, Aled; Duncan, Andrew; Garnham, Andrew; Thapar, Ankur; Paravastu, Sharath; Paravastu, Sharath; Medical and DentalObjectives: Venous thromboembolism is a potentially fatal complication of superficial endovenous treatment. Proper risk assessment and thromboprophylaxis could mitigate this hazard; however, there are currently no evidence-based or consensus guidelines. This study surveyed UK and Republic of Ireland vascular consultants to determine areas of consensus. Methods: A 32-item survey was sent to vascular consultants via the Vascular and Endovascular Research Network (phase 1). These results generated 10 consensus statements which were redistributed (phase 2). 'Good' and 'very good' consensus were defined as endorsement/rejection of statements by >67% and >85% of respondents, respectively. Results: Forty-two consultants completed phase 1. This generated seven statements regarding risk factors mandating peri-procedural pharmacoprophylaxis and three statements regarding specific pharmacoprophylaxis regimes. Forty-seven consultants completed phase 2. Regarding venous thromboembolism risk factors mandating pharmacoprophylaxis, 'good' and 'very good' consensus was achieved for 5/7 and 2/7 statements, respectively. Regarding specific regimens, 'very good' consensus was achieved for 3/3 statements. Conclusions: The main findings from this study were that there was 'good' or 'very good' consensus that patients with any of the seven surveyed risk factors should be given pharmacoprophylaxis with low-molecular-weight heparin. High-risk patients should receive one to two weeks of pharmacoprophylaxis rather than a single dose.Publication The Relationship Between Operative Volume and Peri-operative Mortality After Non-elective Aortic Aneurysm Repair in Australia(Elsevier, 2020-07-02) Sawang, Michael; Paravastu, Sharath; Liu, Zhixin; Thomas, Shannon; Beiles, Charles; Mwipatayi, Bibombe; Verhagen, Hence; Verhoeven, Eric; Varcoe, Ramon; Paravastu, Sharath; Medical and DentalObjective Hospital and surgeon operative caseload is thought to be associated with peri-operative mortality following the non-elective repair of aortic aneurysms; however, whether such an association exists within the Australian healthcare setting is unknown. Methods The Australasian Vascular Audit was interrogated to identify patients undergoing non-elective (emergency [EMG] or semi-urgent [URG]) aortic aneurysm repair between 2010 and 2016, as well as their treating surgeon and hospital. Hierarchal logistic regression modelling was used to assess the impact of caseload on outcomes after both endovascular (EVAR) and open surgical repair (OSR). Results Volume counts were determined from 14 262 patients (4 121 OSR and 10 141 EVAR). After exclusion of elective procedures and duplicates, 1 153 EVAR (570 EMG and 583 URG) and 1 245 OSR (946 EMG and 299 URG) non-elective cases remained for the analysis. Crude mortality was 24.0% following OSR (EMG 29.2%; URG 7.7%) and 7.5% following EVAR (EMG 12.6%; URG 2.4%). Univariable analysis demonstrated an association between OSR mortality and hospital volume (quintile [Q] 1: 25.3%, Q2: 27.8%, Q3: 23.9%, Q4: 27.0%, Q5: 16.2%; p = .030), but not surgeon (Q1: 25.2%, Q2: 27.4%, Q3: 26.0%, Q4: 21.4%, Q5: 19.5%, p = .32). Multivariable analysis confirmed this association (odds ratio (OR) [95% CI]; Q1 vs 5: 1.91 [1.13–3.21], Q2 vs. 5: 2.01[1.24–3.25], Q3 vs. 5: 1.41 [0.86–2.29], Q4 vs. 5: 1.92 [1.17–3.15]; p = .020). The difference was most pronounced in the EMG OSR group [Q1 – 3 vs. 4–5] (OR 1.63 [1.07–2.48]; p = .020). Mortality after EVAR was not associated with either hospital (Q1: 6.3%, Q2: 10%, Q3: 6.8%, Q4: 4.5%, Q5: 10%; p = .14) or surgeon volume (Q1: 9.3%, Q2: 5.7%, Q3: 8.1%, Q4: 7.0%, Q5: 7.3%; p = .67). Conclusion There is an inverse correlation between hospital volume and peri-operative mortality following EMG open repair of aortic aneurysm. These data support restructuring Australian pathways of care to direct suspected ruptured aneurysm to institutions that reach a minimum volume threshold.Publication Bilateral Acute Lower Limb Ischemia Secondary to COVID-19(Sage, 2020-09-10) Veerasuri, Sowmya; Kulkarni, Sachin; Wilson, William; Paravastu, Sharath; Kulkarni, Sachin; Wilson, William; Paravastu, Sharath; Medical and DentalCOVID-19 has to date affected over 5 million people worldwide and caused in excess of 300000 deaths. One of the principal finding is that of a thrombotic tendency within the lungs leading to high mortality. There have been increasing number of reports of peripheral arterial thrombosis as well. Most cases of arterial thrombosis is noted in patient in intensive care setting. Here-in we report a case of acute bilateral lower limb arterial thrombosis in a patient recovering at home with mild COVID-19 symptoms, highlighting that patients with milder symptoms may also suffer from prothrombotic state resulting in acute arterial occlusions. Arterial thrombosis should be suspected in these patients despite the absence of predisposing factors.Publication Vessel diameter and close surveillance helps predict early patency in native arteriovenous fistulas(Sage, 2021-11-11) Kirkham, Emily; Fallon, John; Foy, Christopher; Harris, Sophie; Birch, Gemma; Bullingham, Julie; Pickett, Thomas; Kulkarni, Sachin; Paravastu, Sharath; Cooper, David; Kirkham, Emily; Fallon, John; Foy, Christopher; Harris, Sophie; Birch, Gemma; Bullingham, Julie; Pickett, Thomas; Kulkarni, Sachin; Paravastu, Sharath; Cooper, David; Medical and DentalIntroduction: Arteriovenous fistulas are the preferred method of vascular access for haemodialysis. Data suggests patency rates can be low and may be related to vessel diameters prior to creation. We use specific size criteria for fistula selection. We aimed to establish patency rates in relation to vessel size and whether other factors affect fistula patency. Methods: Consecutive patients undergoing radiocephalic (RCF) or brachiocephalic (BCF) creation between 2016 and 2018 were analysed. Preoperative arterial and venous diameters were collected. Six-week and six-month primary and secondary patency rates were analysed to establish any impact of vessel size on patency and re-intervention rates between groups. A univariate analysis was performed. Results: Ninety four RCFs and 101 BCFs were created. Median artery and vein size for RCF were 2.7 and 3.0 mm respectively. For BCF, they were 4.6 and 4.3 mm respectively. At 6-weeks, overall satisfactory patency for RCF and BCF combined was 91.8%. 89.7% demonstrated primary patency; 2.1% secondary patency. At 6-months, overall patency was 78.7%; 58.5% demonstrated primary patency, 20.2% secondary patency. A univariate analysis, for both groups, revealed vein size was a significant predictor of overall satisfactory patency at 6-weeks, with larger veins more likely to remain patent (p = 0.025 RCF, p = 0.007 BCF). However, artery size was not predictive (p = 0.1 RCF, p = 0.5 BCF). At 6-months, neither artery nor vein diameter were predictive in either group. When comparing size of vessel based on fistula type, vessels used to create RCFs were smaller than those for BCFs (p < 0.001). RCFs were more likely to receive endovascular intervention or occlude when compared to BCFs (p = 0.014). Discussion: Excellent patency and maturation rates can be achieved using fairly strict vessel size criteria. Vein size might be the more important predictor of early success. RCFs can be challenging due to smaller vessels, but maturation rates can be optimised by close surveillance and aggressive re-intervention.Publication Editor's Choice - Systematic Review and Meta-Analysis of Wound Adjuncts for the Prevention of Groin Wound Surgical Site Infection in Arterial Surgery(Elsevier, 2021-01-07) Gwilym, Brenig; Dovell, George; Dattani, Nikesh; Ambler, Graeme; Shalhoub, Joseph; Forsythe, Rachael; Benson, Ruth; Nandhra, Sandip; Preece, Ryan; Onida, Sarah; Hitcham, Louise; Coughlin, Patrick; Saratzis, Athanasios; Bosanquet, David; Preece, Ryan; Medical and DentalObjective: Groin incision surgical site infections (SSIs) following arterial surgery are common and are a source of considerable morbidity. This review evaluates interventions and adjuncts delivered immediately before, during, or after skin closure, to prevent SSIs in patients undergoing arterial interventions involving a groin incision. Data sources: MEDLINE, EMBASE, and CENTRAL databases were searched. Review methods: This review was undertaken according to established international reporting guidelines and was registered prospectively with the International prospective register of systematic reviews (CRD42020185170). The MEDLINE, EMBASE, and CENTRAL databases were searched using pre-defined search terms without date restriction. Randomised controlled trials (RCTs) and observational studies recruiting patients with non-infected groin incisions for arterial exposure were included; SSI rates and other outcomes were captured. Interventions reported in two or more studies were subjected to meta-analysis. Results: The search identified 1 532 articles. Seventeen RCTs and seven observational studies, reporting on 3 747 patients undergoing 4 130 groin incisions were included. A total of seven interventions and nine outcomes were reported upon. Prophylactic closed incision negative pressure wound therapy (ciNPWT) reduced groin SSIs compared with standard dressings (odds ratio [OR] 0.34, 95% CI 0.23 - 0.51; p < .001, GRADE strength of evidence: moderate). Local antibiotics did not reduce groin SSIs (OR 0.60 95% CI 0.30 - 1.21 p = .15, GRADE strength: low). Subcuticular sutures (vs. transdermal sutures or clips) reduced groin SSI rates (OR 0.33, 95% CI 0.17 - 0.65, p = .001, GRADE strength: low). Wound drains, platelet rich plasma, fibrin glue, and silver alginate dressings did not show any significant effect on SSI rates. Conclusion: There is evidence that ciNPWT and subcuticular sutures reduce groin SSI in patients undergoing arterial vascular interventions involving a groin incision. Local antibiotics did not reduce groin wound SSI, although the strength of this evidence is lower. No other interventions demonstrated a significant effect.Publication Outcomes in Men From the NHS Abdominal Aortic Aneurysm Screening Programme With a Large Aneurysm Referred for Intervention(Elsevier, 2020-10-24) Meecham, Lewis; Jacomelli, Jo; Davis, Meryl; Pherwani, Arun; Lees, Tim; Earnshaw, Jonothan; Earnshaw, Jonothan; Medical and DentalObjective: The NHS Abdominal Aortic Aneurysm Screening Programme (NAAASP) has been implemented since 2013. Men with a large aneurysm >54 mm, either at first screen or during surveillance, are referred for intervention. The aim of the present study was to explore outcomes in these men and to see whether there was any regional variation in treatment rates and type of repair. Methods: The study cohort included all men referred to a vascular network with a large abdominal aortic aneurysm (AAA). Basic demographic information, nurse assessment details, as well as outcome data were extracted from the national NAAASP IT system, AAA SMaRT, for analysis. Results: Some 3 026 men were referred for possible intervention (48% first screen, 52% surveillance). Some 448 men (13.3%) either declined (63, 2.1%), or were turned down for early intervention for various reasons (385, 12.7%). Some 8% were declined for medical reasons (true turn down rate). Men referred from surveillance were older, and more likely not to have had elective surgery within three months (16.0 vs. 11.2%; HR 1.37, 95% CI 1.07-1.75, p = .011). Turn down rates did not vary among local programmes, when surveillance men were taken into account. Some 2 624 (87%) men had planned AAA repair, with a peri-operative mortality of 1.3%. Thirty day surgical mortality was lower after EVAR: 0.4% compared with 2.1% after open repair. The method of repair remained consistent year on year, with roughly equal numbers undergoing endovascular (50%) and open surgical repair (48%); 2% unknown. There was regional variation in the proportion treated by endovascular repair: from 20% to 97%. Conclusion: The turn down rate after referral for treatment with a screen detected AAA was low, but there remains considerable regional variation in the proportion undergoing endovascular repair. Procedures were undertaken with low peri-operative mortality.Publication Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration: DAVE trial(BMJ Publishing Group, 2021-04-02) Onida, Sarah; Heatley, Francine; Peerbux, Sarrah; Bolton, Layla; Lane, Tristan; Epstein, David; Gohel, Manjit; Poskitt, Keith; Cullum, Nicky; Norrie, John; Lee, Robert; Bradbury, Andrew; Dhillon, Karen; Chandrasekar, Akila; Lomas, Richard; Davies, Alun; Poskitt, Keith; Medical and DentalIntroduction: Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis: This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination: Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences. Trial registration number: ISRCTN21541209.Publication Safety and Validity of the Proposed European Society for Vascular Surgery Infrarenal Endovascular Aneurysm Repair Surveillance Protocol: A Single Centre Evaluation(Elsevier, 2021-11-09) Kirkham, Emily; Nicholls, Jonathan; Wilson, Richard; Cooper, David; Paravastu, Sharath; Kulkarni, Sachin; Kirkham, Emily; Nicholls, Jonathan; Wilson, Richard; Cooper, David; Paravastu, Sharath; Kulkarni, Sachin; Medical and DentalObjective: Long term surveillance after endovascular aneurysm repair (EVAR) is essential to detect late complications, but there is variation in practice. The European Society for Vascular Surgery (ESVS) made a recommendation for a new surveillance protocol; one element involves risk stratifying patients depending on sac size reduction and presence of endoleak at their 30 day computed tomography angiogram into low risk groups (delayed imaging to five years) or higher risk groups (continue with the current protocol). The aim was to test this suggested protocol retrospectively within an EVAR patient cohort. Methods: Data on EVARs performed from October 2009 to October 2019 were collected. Information gathered from an existing surveillance programme was used to assess the proposed ESVS protocol. All patients who underwent re-intervention were reviewed to see whether adopting the proposed ESVS protocol would have detected these events. Results: In total, 309 procedures were included. Altogether, 219 of these patients had no endoleak (70.9%) and 86 had a type II (27.8%) endoleak. Only four developed a type I or III endoleak. No patient in the low risk cohort (no initial endoleak or sac shrinkage > 1 cm) required secondary intervention. Five year follow up data were available for 103 patients. In the type II endoleak group, there were 28 secondary interventions in 22 patients. No patient experienced a ruptured aneurysm within five years post-operatively. Had the proposed ESVS protocol been followed, all patients requiring a secondary intervention or with increasing sac size would have been detected/captured. Further, adherence to the ESVS guidelines would have resulted in 103 patients with a five year follow up history qualifying for reduced surveillance. A further 120 patients who had reached the three and four year follow up timepoints could have qualified for a reduced surveillance, reducing imaging cost further. Conclusion: Adopting the proposed ESVS EVAR surveillance protocol safely identified "low risk" patients who did not go on to require a secondary intervention. These patients could benefit from reduced surveillance scanning.Publication A ten-year experience of thrombolysis for lower limb ileo-femoral DVTs(Edizioni Minerva Medica, 2021) Kirkham, Emily; Hickson, Guy; Ramnarine, Raymond; Cooper, David; Kirkham, Emily; Hickson, Guy; Ramnarine, Raymond; Cooper, David; Medical and DentalBACKGROUND: Catheter-directed thrombolysis (CDT) for deep vein thrombosis (DVT) can reduce rates of post-thrombotic syndrome (PTS). We report our experience with CDT. METHODS: Consecutive patients undergoing CDT for acute proximal lower-limb DVTs from 2009-2019 were recruited. Eligibility criteria were utilized to decide a patient’s fitness for CDT. Patient demographics, complications of CDT and post-CDT stenting outcomes were collected. The Villalta Score was collected by telephone consultation between May-July 2019. RESULTS: Thirty-seven patients were thrombolyzed. Median follow-up was 63 months (12-115 months). Mean age was 48 (18-75). Fourteen patients had May-Thurner Syndrome. There was one death following CDT; secondary to multi-organ failure from chemotherapy for acute myeloid leukemia. No other immediate complications of CDT occurred. Fourteen patients (37.8%) had venous stenting; stents were patent in all initial duplex scans. Twenty-eight patients were contactable; the median Villalta Score was 0 (range 0-15, N.=2 score >5). Only two patients (7.1%) developed PTS. CONCLUSIONS: Our CDT burden for lower-limb DVTs is low. However, long-term outcomes are good, with only 7.1% developing PTS, suggesting cautious use of CDT with selective stenting in an appropriate population can produce satisfactory short- and longer-term outcomes. In light of conflicting evidence and more recent developments in technology, the long-term benefit of intervention for iliofemoral DVT over traditional conservative management warrants further investigation.Publication Decellularised Dermis Allograft For The Treatment Of Chronic Venous Leg Ulceration(SAGE Publications, 2022-09-10) Whittley, Sarah; Davies, Alun; Onida, Sarah; Lane, Tristan; Epstein, David; Gohel, Manjit; Poskitt, Keith; Cullum, Nicky; Norrie, John; Bradbury, Andrew; Dhillon, Karen; Ezeife, Emanuel; Chandrasekar, Akila; Lomas, Richard; Poskitt, Keith; Medical and DentalBackground: Chronic venous ulceration (CVU) describes a wound in the lower limbs present for at least three months, caused by inefficient drainage of venous blood. This can be due to either a primary failure of the venous system and / or secondary to previous damage, such as that caused by deep venous thrombosis. Chronic venous leg ulcers (CVLUs) affect approximately 1% of the population, with an increased prevalence of up to 4% in those over 65 years of age. Combined with the social expenses due to loss of work and productivity, this results in CVLUs costing up to 2% of the annual healthcare budget in Western societies. This is predicted to increase as a function of the ageing population. Compression bandaging is the gold standard treatment, with the aim of promoting venous drainage and reducing swelling. However, this is very time consuming and can be performed with variable efficacy. Furthermore, the reduction in community nursing numbers has resulted in increasing difficulty for patients to access this service in the community. The current management for CVLUs is therefore not sufficient to care appropriately for this patient population. Skin grafting represents an adjuvant treatment for CVUs that can promote and expedite ulcer healing. By performing an appropriately powered randomised controlled trial, it will be possible to establish whether a decellularised dermis (DCD) allograft is an effective, safe, acceptable and cost-effective treatment adjunct in CVU care. This trial will therefore explore whether the use of a DCD allograft in addition to compression therapy promotes healing in CVLU compared to compression therapy alone. Methods: This is a prospective, randomised, open, pragmatic trial for adults with CVLU randomised to either dCELL® Human Dermis allograft plus standard compression therapy (intervention) or standard compression therapy alone (control). The primary outcome measure is the proportion of adults with a healed index ulcer at 12 weeks after randomisation as ascertained by an independent blinded clinical assessor. Secondary outcome measures include time to index ulcer healing, recurrence of healed index ulcer, EQ-5D & CCVUQ questionnaires, patient resource use and cost effectiveness. Results: To detect a 25% difference in the proportion of patients with the index ulcer healed at 12 weeks (assuming a healing rate of 30% in the control group and 55% in the intervention group) and allowing for a 10% loss to follow up with a power of 90% and 5% level of significance, 196 patients are required. The study will include a formal interim analysis using a Lan-DeMets alpha spending approach with Fleming O’Brien boundaries. Conclusion: The trial is ongoing; therefore, conclusions cannot be drawn yet.Publication Significance of preoperative thrombus burden in the prediction of a persistent type II and reintervention after infrarenal endovascular aneurysm repair(Elsevier, 2022-01-05) Nicholls, Jonathan; Kirkham, Emily; Haslam, Liz; Paravastu, Sharath; Kulkarni, Sachin; Nicholls, Jonathan; Kirkham, Emily; Haslam, Liz; Paravastu, Sharath; Kulkarni, Sachin; Medical and DentalBackground: Persistent type II endoleak has necessitated prolonged surveillance and is a reason for reintervention after infrarenal endovascular aneurysm repair (EVAR). The aim of this study was to assess the association of thrombus burden (TB) within the aneurysmal sac in the prediction of a persistent type II endoleaks. Methods: Consecutive patients who underwent infrarenal EVAR from October 2009 to October 2017 in a single vascular network were included. TB was assessed on preoperative computed tomography angiogram and was defined as a percentage of thrombus across the maximal sac diameter in comparison with the luminal diameter measured orthogonally at the same level. Patients were categorized into three groups: low TB (<25%), medium TB (25%-50%), and high TB (>50%). All patients underwent postoperative EVAR surveillance comprising computed tomographic angiography or duplex ultrasound imaging. Type II endoleak observed for more than 1 year was defined as persistent type II endoleak. Odds ratio (OR) and Student's t-test were used to determine significance. Results: Some 275 EVARs were performed in the study period. A total of 45 procedures were excluded because of either iliac-only intervention (n = 9), no preoperative information (n = 7), abandoned (n = 1), or less than 1 year's follow-up data (n = 28). For the 230 procedures included, the median follow-up was 43 (12-102) months. There were no significant differences between the groups for age, gender, and comorbidities nor preoperative sac diameter. There was high interobserver reliability with a kappa value of 0.89 (0.84-0.94) with a total discordance of 7% across the cohorts. Persistent type II endoleak occurred significantly more frequently with reduced TB: 41% of the low TB cohort compared with 4% of the high TB cohort (OR, 15.36 [3.5-67.3]; P = .0003). Reintervention was also significantly more likely to occur in the presence of a persistent type II endoleak compared with its absence; n = 12 of 13 (92%) patients who underwent reintervention had a persistent type II endoleak (OR, 43.4 [5.5-242]; P = .0003). Sac size reduction was significantly greater in medium TB and high TB cohorts when compared with low TB: -25% and -27% vs -15% (P = .0046 and P < .0001). Decreased TB was associated with a significant increase in inferior mesenteric artery (IMA) patency, the mean TB, where the IMA was patent, being 29% compared with 40% where the IMA was occluded P < .0001. When considered together, patients with a low TB and a patent IMA were even more likely to have a persistent type II endoleak when compared with those with a high TB and an occluded IMA (OR, 34.1 [1.99-583]; P = .015). Conclusions: Low TB is associated with increased rates of persistent type II endoleak, especially in the presence of a patent IMA. High TB is associated with increased sac regression and low reintervention rates. TB can be assessed reliably and could be used for risk stratification in the planning of infrarenal EVAR. Pre-emptive embolization of IMA or lumbar vessels in those with low TB may be beneficial. TB could be a useful tool for designing a post-EVAR surveillance regimen.Publication Editor's Choice – Update of the European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia in Light of the COVID-19 Pandemic, Based on a Scoping Review of the Literature(Elsevier, 2021-09-05) Jongkind, Vincent; Earnshaw, Jonothan; Bastos Gonçalves, Frederico; Cochennec, Frederic; Debus, Sebastian; Hinchcliffe, Robert; Menyhei, Gabor; Svetlikov, Alexei; Tshomba, Yamume; Van Den Berg, Jos; Björck, Martin; Earnshaw, Jonothan; Medical and DentalObjective: To perform a scoping review of how patients with COVID-19 are affected by acute limb ischaemia (ALI) and evaluate the recommendations of the 2020 ESVS ALI Guidelines for these patients. Methods: Research questions were defined, and a systematic literature search was performed following the PRISMA guidelines. Abstracts and unpublished literature were not included. The definition of ALI in this review is in accordance with the ESVS guidelines. Results: Most identified papers were case reports or case series, although population based data and data from randomised controlled trials were also identified. In total, 114 unique and relevant papers were retrieved. Data were conflicting concerning whether the incidence of ALI increased, or remained unchanged, during the pandemic. Case reports and series reported ALI in patients who were younger and healthier than usual, with a greater proportion affecting the upper limb. Whether or not this is coincidental remains uncertain. The proportion of men/women affected seems unchanged. Most reported cases were in hospitalised patients with severe COVID-19. Patients with ALI as their first manifestation of COVID-19 were reported. Patients with ALI have a worse outcome if they have a simultaneous COVID-19 infection. High levels of D-dimer may predict the occurrence of arterial thromboembolic events in patients with COVID-19. Heparin resistance was observed. Anticoagulation should be given to hospitalised COVID-19 patients in prophylactic dosage. Most of the treatment recommendations from the ESVS Guidelines remained relevant, but the following were modified regarding patients with COVID-19 and ALI: 1) CTA imaging before revascularisation should include the entire aorta and iliac arteries; 2) there should be a high index of suspicion, early testing for COVID-19 infection and protective measures are advised; and 3) there should be preferential use of local or locoregional anaesthesia during revascularisation. Conclusion: Although the epidemiology of ALI has changed during the pandemic, the recommendations of the ESVS ALI Guidelines remain valid. The above mentioned minor modifications should be considered in patients with COVID-19 and ALI.Publication Quality assurance for the NHS abdominal aortic aneurysm screening programme in England(Oxford University Press, 2022-02-09) Campbell, Abigail; Armer, Morag; Waggett, Helena; Jacomelli, Jo; Earnshaw, Jonothan; Campbell, Abigail; Waggett, Helena; Earnshaw, Jonothan; Medical and DentalIntroduction: The National Health Service Abdominal Aortic Aneurysm Screening Programme (NAAASP) was introduced in England in 2009 to offer ultrasound screening to men over 65 years, in order to reduce aneurysm-related deaths. This study describes the development of a quality assurance (QA) process and conducts an analysis of the first round of QA visit reports. The aim was to identify themes where local providers can target their efforts for improvement. Methods: Forty-one providers were assessed over 4 years using a process of QA visits adapted from previously established screening programmes. A mixture of qualitative and quantitative methods was used to analyse the 41 QA reports, which identified a range of recommendations for providers. The data were coded for key words and assigned to themes. The number of recommendations per visit report was compared with experience of the providers and performance against national screening standards. Results: A total of 773 recommendations were made, with an average of 19 per QA visit. Around one third of the recommendations were based on governance and leadership standards, with 43.0 per cent of those based around commissioning and accountability. A significant relationship was seen between number of infrastructure recommendations and performance against standards. Conclusion: This review of a QA cycle found that sound infrastructure is key to the success of a local provider.Publication Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial(Elsevier, 2022-02-09) Starodubtsev, Vladimir; Mitrofanov, Vacheslav; Ignatenko, Pavel; Gostev, Alexander; Preece, Ryan; Rabtsun, Artem; Saaya, Shoraan; Popova, Irina; Karpenko, Andrey; Preece, Ryan; Medical and DentalObjective: The aim of this non-inferiority randomised trial was to compare the short and midterm safety and efficacy of hybrid repair (HR) and open reconstruction (OR) for patients with co-existing iliac and common femoral artery (CFA) occlusive disease. Methods: The study was registered on the ClinicalTrials.gov register (identifier: NCT02580084). From 2015 to 2017, eligible patients presenting with combined iliac and CFA occlusive disease were randomised to either HR or OR. HR group patients underwent recanalisation and stenting of iliac arteries combined with CFA endarterectomy and patch angioplasty. The OR group underwent aortofemoral bypass with simultaneous CFA endarterectomy. Short (30 day) and midterm (36 month) outcomes including morbidity, mortality, and patency rates were compared between groups. Results: Of 427 patients assessed, 202 were randomised (102 HR and 100 OR). The average hospital length of stay was shorter in the HR group (8.2 ± 4.2 days HR group vs. 15.7 ± 6.9 days OR group, p < .001); the 30 day peri-operative morbidity rate was 8.8% in the HR group vs. 21% in the OR group (p = .030). There was no significant difference in the 36 month mortality rate (p = .16). The cumulative primary patency rates were 93% (HR) vs. 93% (OR) at 12 months and 91% (HR) vs. 89% (OR) at 36 months (p = .38). The limb salvage rates were 99% (HR) vs. 99% (OR) at 12 months and 98% (HR) vs. 97% (OR) at 36 months (p = .49). Conclusion: The results of this first non-inferiority randomised study support the safety and midterm efficacy of hybrid procedures for patients with iliofemoral peripheral arterial disease. HR patients had a shorter length of stay with reduced peri-operative morbidity and similar medium term patency rates.
