SWAT 84: effects of same-day consent vs delayed consent on the recruitment and retention of trial participants-an observational SWAT.

BACKGROUND AND AIM: The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered study. We aimed to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial. METHODS: This SWAT is designed as a prospective cohort design. The host trial was a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification programme in participants with peripheral arterial disease. Researchers screened the participants for inclusion and exclusion criteria. Informed consents were obtained from the participants who were willing to participate in the study on a standardized consent form. Participants were given the option to consent on the same day or to delay their consent. Following the consent, the participants were allocated to two groups (same-day consent vs. delayed consent) based on pre-determined criteria for SWAT. One hundred sixteen participants were consented to take part in the host trial. Seventy-five participants were randomized to the host trial. The primary outcome was the proportion of participants who withdrew consent at the recruitment phase. Secondary outcomes were reasons for consent withdrawal and dropout, attrition rate, and adherence with the host trial intervention. RESULTS: There was a significantly lower consent-withdrawal rate in same-day consent (17.4%, n = 8/46), compared to the delayed consent group (47.1%, n = 33/70), p = 0.001. There was a significantly lower dropout rate in participants randomized following same-day consent (10.5%, n = 4/38), compared to those randomized after delayed consent (29.7%, n = 11/37), p = 0.038. Transport was the main reason mentioned for consent withdrawal and dropout. In participants randomized to the host trial intervention arm, there was a significant difference in adherence (percentage of the 12-week programme completed) between same-day consent (96.7% ± 4.9) and delayed consent participants (86.4% ± 11.2), p = 0.003, as well as number of weeks completed (mean difference = - 1.547, 95% confidence intervals (- 2.237 to - 0.85)), p = 0.02. CONCLUSION: This SWAT found evidence that participants who gave consent on the same day seemed to have better adherence and fewer-withdrawal and dropout rates. SWAT REGISTRATION: The SWAT was registered on the Northern Ireland Network for Trials Methodology Research, SWAT 84.

Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial.

BACKGROUND: Treatment of superficial venous reflux has been shown to improve ulcer healing time and reduce the risk of ulcer recurrence. Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins. TIRS has been shown to be successful and in our experience is the option preferred by many patients, when offered as an alternative to axial ablation (AA). AIM: To determine if the proportion of ulcers healed within 6 months of endovenous treatment differs between patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy. METHODS: AAVTIRS is an assessor-blinded randomised controlled trial. Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway. All patients attending the ulcer clinic will be screened for eligibility. RANDOMISATION: Random computer-generated sequence is stratified by ulcer size. Allocation will be concealed using sealed opaque envelopes. BLINDING: Assessors reviewing wounds at follow -p visits will be blinded to patient allocation. PRIMARY ENDPOINT: The proportion of ulcers healed within 6 months of enrolment. DISCUSSION: This will be the first time that TIRS has been evaluated with a properly powered randomised trial in the setting of venous ulcer management. Streamlining the management of venous ulcers has broad health economic benefits. If it is found that TIRS is superior or non-inferior to AA, then a less expensive, less invasive injection can be offered as an alternative to AA in an attempt to encourage the healing of venous ulcers. If AA is found to be superior to TIRS, then this would suggest that all patients undergoing ablation in the management of venous ulcers should have their superficial reflux fully treated, building on the evidence of the EVRA trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04484168. Registered on 23 July 2020.

The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme-for a randomised controlled trial protocol.

BACKGROUND: Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as patients with a history of coronary or cerebrovascular disease. Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease. Atherosclerotic risk factor identification and modification play an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. In this study, we aim to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors. METHODS: This is a randomised, parallel group, active-control trial to compare the effectiveness of the risk factor modification intervention programme to standard healthcare in a tertiary vascular care centre, in the reduction of modified risk factors in PAD patients. The primary outcome of this study is to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors at 3 and 12 months. The secondary outcomes are to compare the impact of the programme on clinical outcomes in PAD patients at 12 months. Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events. DISCUSSION: This study will provide clear evidence on the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors, through a high-quality, well-powered clinical trial. TRIAL REGISTRATION: This trial was registered (11/07/2017) on the European Clinical Trials Database (EudraCT number 2017-002964-41) and ClinicalTrials.gov ( NCT03935776 ) which was registered on 02 May 2019.

The profile of patients with venous leg ulcers: A systematic review and global perspective.

BACKGROUND: A holistic profile that includes demographic, medical history and wound characteristics of individuals with venous leg ulceration is lacking. Lack of such a profile negatively impacts the ability to develop interventions to improve patient outcomes. OBJECTIVES: To describe the profile of the patient population with venous leg ulceration from published observational (non-interventional) studies and to identify gaps in the knowledge base for future research in this area. METHODS: A systematic review of observational studies that included more than 50 patients, from any world region, of any age and in any care setting. RESULTS: twenty studies, involving 3395 patients, from all world regions met our criteria. Demographic characteristics were well reported and showed a female to male ratio of 1.2:1, average age of 47-65 years, high levels of co-morbidities including hypertension (53-71%) and diabetes (16-20%), and only one study reporting ethnicity. When reported, approximately 4-30% had high levels of depression. The average wound size was 18.6-43.39 cm2; mean wound duration was 13.8-65.5 months, mean number of recurrences was four. No study reported on demographic factors plus medical history plus wound characteristics together. CONCLUSION: a comprehensive, holistic profile of the population with VLU is lacking. There is a critical need for more comprehensive profiling to enable the development of targeted interventions to improve outcomes.

Late Dacron Patch Inflammatory Reaction after Carotid Endarterectomy.

OBJECTIVE: The aim was to analyse the incidence and presentation of carotid patch inflammatory reactions following carotid endarterectomy (CEA). METHODS: This was a cohort study using a prospectively maintained database. All patients who underwent elective CEA at a tertiary vascular centre between 2002 and 2016 were included. Computed tomography scan angiogram, duplex scan, and leucocyte scintigraphy were used to assess patients with suspected inflammatory patch complications. Re-intervention procedures and outcomes were noted. Histopathology and organisms cultured from the harvested material during re-intervention were assessed. RESULTS: During the study period, 633 patients underwent elective CEA. Fifty-one underwent eversion endarterectomy: 111 did not require a patch, whereas 471 patients had a patch repair. Four hundred and twenty eight had a Dacron patch repair and 43 a biological patch. Eight patients returned with late Dacron patch inflammatory complications (1.3% of all CEA and 1.9% of Dacron patch closures) after a period ranging from 18 months to 7 years (mean 4.1 ± 2.1 years). Seven of the eight patients underwent surgical re-intervention, and the eighth patient was deemed high surgical risk. One patient underwent a vein bypass, three had vein patch repair, one required internal carotid artery (ICA) ligation after patch excision, and two were managed by debridement, with omohyoid and sternomastoid muscle covering of the patch. The patient who required ICA ligation suffered a fatal stroke. The remaining patients had a satisfactory outcome. All patients showed evidence of foreign body reaction in pathological examination with no pathological organism cultured from swabs or tissue harvested during surgery. CONCLUSION: Late wound complications after CEA may be related to inflammatory reaction of the Dacron patch rather than infection. Infection should be excluded first. Reconstruction with vein is effective. However, debridement with sternomastoid and omohyoid muscle covering of the patch may be considered in high risk patients after exclusion of infection with regular follow-up.

The Role of Sequential Pneumatic Compression in Limb Salvage in Non-reconstructable Critical Limb Ischemia.

OBJECTIVE: Critical limb ischemia (CLI) is an increasingly alarming presentation of advanced generalized circulatory failure. Most patients presenting with CLI have profound cardiovascular comorbidities that hinder surgical intervention. Moreover, some patients present with non-reconstructable arterial anatomy. For this vulnerable cohort, primary amputation is often the only available option. This study aims at answering the question: Can sequential pneumatic compression (SPC) preclude amputation? METHODS: A retrospective analysis of 187 patients (262 limbs) prescribed the Artassist SPC compared outcomes between the group of patients who acquired the device and those who did not. The primary end point was limb salvage; secondary end points were amputation-free survival and improvement in toe pressures. RESULTS: The mean age was 74.78 years, the median follow-up was 16 months, and the median duration of usage was 4 months. 81.72% of the patient acquired the device and 18.28% did not. The mean toe pressure was 61.4 mmHg pre-application, and 65 mmHg after application (p = .071). Amputation-free survival was 98% and 96% for those who acquired the device and 90% and 84% for those who did not at 6 and 12 months, respectively. There was a non-significant association between limb salvage and device acquisition (p = .714); however, there was a significant improvement in rest pain (p < .0001), reduction in minor amputation (p = .023), and amputation-free survival associated with using the device (p = .01). CONCLUSIONS: Although limb salvage is the paramount ambition for patients referred to vascular services, some patients with CLI are better served with primary amputation. Although the mechanism of SPC action is still ambiguous, there is strong evidence to support its role in preventing minor amputation, prolonging amputation-free survival, and improving rest pain in patients with non-reconstructable CLI; nevertheless, its role in prevention of major amputation lacks statistical significance.

Ten-year experience in subclavian revascularisation. A parallel comparative observational study.

INTRODUCTION: Subclavian stenosis has a prevalence of approximately 2% in the community, and 7% within a clinical population. It is closely linked with hypertension and smoking. There is a relative paucity of published data to inform clinicians on the optimal mode of treatment for subclavian artery stenosis. OBJECTIVES: To compare clinical outcomes of subclavian bypass surgery with that of subclavian endovascular re-vascularisation. Endpoints were survival time, re-intervention-free survival, and symptom-free survival. METHOD: In all, 21 subclavian interventions were performed from 2000 to 2010. We compared angioplasty vs angioplasty with stenting vs bypass. RESULTS: Technical success was 100% in all groups. Symptom-free survival, at 70 months, was 60% in the angioplasty group, 100% in the angioplasty and stenting group and 75% in the bypass group. Re-intervention rate was 40% in the angioplasty group, 0% in the angioplasty and stenting group and 25% in the bypass group. Median time for re-intervention was 9.5 months in angioplasty patients and 36 months in bypass patients (p = 0.102). Target lesion revascularisation was 20.0% for angioplasty procedures, 16.67% for angioplasty and stenting and 25% for bypass procedures. CONCLUSION: Angioplasty with stenting provides improved symptom-free survival and freedom from re-intervention in patients with symptomatic subclavian artery stenosis.

Secondary aortoduodenal fistula following endovascular repair of inflammatory abdominal aortic aneurysm due to Streptococcus anginosus infection: A case report and literature review.

INTRODUCTION: Aortoenteric fistula is a rare but very serious complication of both surgical and endovascular abdominal aortic reconstruction. Since the advent of endovascular abdominal aortic aneurysm repair (EVAR), 20 cases of aortoduodenal fistula associated with aortic stent grafts have been reported.(1) However, only a handful has been reported following inflammatory abdominal aortic aneurysm repair. It most commonly presents with bleeding, usually from the upper gastro-intestinal tract. With recent advances in the screening, diagnosis and management of abdominal aortic aneurysms either surgically or through an endovascular approach, the diagnosis of an aortoduodenal fistula in patients with gastro-intestinal bleeding must be suspected and excluded. PRESENTATION OF CASE: We describe a case of secondary aortoduodenal fistula that occurred two and a half years following endovascular stent graft repair of an inflammatory abdominal aortic aneurysm. We also outline the emergency correction plan and the attempts at repair. DISCUSSION: This case defies the general concept that patients with inflammatory abdominal aortic aneurysms are relatively immune to rupture. Although the presence of a peri-aneurysm thick inflammatory membrane decreases the possibility of rupture, these patients are more susceptible to other related complications such as aorto-enteric and aorto-caval fistulas.(2) This case also demonstrates the peculiar presence of Streptococcus anginosus as the pathological organism leading to graft infection and subsequent fistula, as opposed to enterococci which are often found in endograft infection. CONCLUSION: Aorto-enteric fistulas are associated with a grave prognosis. Early diagnosis is crucial and extra vigilance should be taken in cases of inflammatory AAA.

Endovascular aneurysm repair for multiple aneurysms as a sequel of hypereosinophilic syndrome.

This case represents the first report of multiple arterial aneurysms including aortic, iliac, visceral, and coronary aneurysms associated with hypereosinophilic syndrome. It presents an interesting case of epinephrine abuse and the unfortunate sequelae. This case illustrates novel approaches in emergency repair of internal iliac artery aneurysm rupture and the management of visceral artery aneurysms and exemplifies how multiple endovascular technologies can be utilized even in the high-risk polymorbid patient.

Does topical wound oxygen (TWO2) offer an improved outcome over conventional compression dressings (CCD) in the management of refractory venous ulcers (RVU)? A parallel observational comparative study.

OBJECTIVES: Topical wound oxygen (TWO(2)) may help wound healing in the management of refractory venous ulcers (RVU). The aim of this study was to measure the effect of TWO(2) on wound healing using the primary end-point of the proportion of ulcers healed at 12 weeks. Secondary end-points were time to full healing, percentage of reduction in ulcer size, pain reduction, recurrence rates and Quality-Adjusted Time Spent Without Symptoms of disease and Toxicity of Treatment (Q-TWiST). DESIGN: A parallel observational comparative study. METHODS: Patients with CEAP C(6,s) RVU, assessed by duplex ultrasonography, were managed with either TWO(2) (n=46) or conventional compression dressings (CCD) (n=37) for 12 weeks or till full healing. Patients were followed up at 3 monthly intervals. RESULTS: At 12 weeks, 80% of TWO(2) managed ulcers were completely healed, compared to 35% of CCD ulcers (p<0.0001). Median time to full healing was 45 days in TWO(2) patients and 182 days in CCD patients (p<0.0001). The pain score threshold in TWO(2) managed patients improved from 8 to 3 by 13 days. After 12-month follow-up, 5 of the 13 healed CCD ulcers showed signs of recurrence compared to none of the 37 TWO(2) healed ulcers. TWO(2) patients experienced a significantly improved Q-TWiST. CONCLUSION: TWO(2) reduces recurrence rates, alleviates pain and improves the Q-TWiST. We believe it is a valuable tool in the armamentarium of management of RVU.