Brahman Dharmarajah

Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: The Multicentre Venefit™ versus ClariVein® for varicose veins trial

Objective Endovenous techniques are, at present, the recommended choice for truncal vein treatment. However, the thermal techniques require tumescent anaesthesia, which can be uncomfortable during administration. Non-tumescent, non-thermal techniques would, therefore, have potential benefits. This randomised controlled trial is being carried out to compare the degree of pain that patients experience while receiving mechanochemical ablation or radiofrequency ablation. The early results of this randomised controlled trial are reported here. Methods Patients attending for the treatment of primary varicose veins were randomised to receive mechanochemical ablation (ClariVein®) or radiofrequency ablation (Covidien® Venefit™). The most symptomatic limb was randomised. The primary outcome measure was intra-procedural pain using a validated visual analogue scale. The secondary outcome measures were change in quality of life and clinical scores, time to return to normal activities and work as well as the occlusion rate. Results One-hundred and nineteen patients have been randomised (60 in the mechanochemical ablation group). Baseline characteristics were similar. Maximum pain score was significantly lower in the mechanochemical ablation group (19.3 mm, standard deviation ±19 mm) compared to the radiofrequency ablation group (34.5 mm ± 23 mm; p < 0.001). Average pain score was also significantly lower in the mechanochemical ablation group (13.4 mm ± 16 mm) compared to the radiofrequency ablation group (24.4 mm ± 18 mm; p = 0.001). Sixty-six percent attended follow-up at one month, and the complete or proximal occlusion rates were 92% for both groups. At one month, the clinical and quality of life scores for both groups had similar improvements. Conclusion Early results show that the mechanochemical ablation is less painful than the radiofrequency ablation procedure. Clinical and quality of life scores were similarly improved at one month. The long-term data including occlusion rates at six months and quality of life scores are being collected.

A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins – Final results of the Venefit versus Clarivein for varicose veins trial:

Background Endovenous thermal ablation has revolutionised varicose vein treatment. New non-thermal techniques such as mechanical occlusion chemically assisted endovenous ablation (MOCA) allow treatment of entire trunks with single anaesthetic injections. Previous non-randomised work has shown reduced pain post-operatively with MOCA. This study presents a multi-centre randomised controlled trial assessing the difference in pain during truncal ablation using MOCA and radiofrequency endovenous ablation (RFA) with six months’ follow-up. Methods Patients undergoing local anaesthetic endovenous ablation for primary varicose veins were randomised to either MOCA or RFA. Pain scores using Visual Analogue Scale and number scale (0–10) during truncal ablation were recorded. Adjunctive procedures were completed subsequently. Pain after phlebectomy was not assessed. Patients were reviewed at one and six months with clinical scores, quality of life scores and duplex ultrasound assessment of the treated leg. Results A total of 170 patients were recruited over a 21-month period from 240 screened. Patients in the MOCA group experienced significantly less maximum pain during the procedure by Visual Analogue Scale (MOCA median 15 mm (interquartile range 7–36 mm) versus RFA 34 mm (interquartile range 16–53 mm), p = 0.003) and number scale (MOCA median 3 (interquartile range 1–5) versus RFA 4 mm (interquartile range 3–6.5), p = 0.002). ‘Average’ pain scores were also significantly less in the MOCA group; 74% underwent simultaneous phlebectomy. Occlusion rates, clinical severity scores, disease specific and generic quality of life scores were similar between groups at one and six months. There were two deep vein thromboses, one in each group. Conclusion Pain secondary to truncal ablation is less painful with MOCA than RFA with similar short-term technical, quality of life and safety outcomes.

Periprocedural outcomes after surgical revascularization and stenting for postradiotherapy carotid stenosis

BACKGROUND Treatment of head and neck malignancy commonly involves radiotherapy, which is associated with the development of carotid artery stenosis. There is little evidence to guide clinicians on how to intervene in significant postradiotherapy carotid stenosis. This systematic review collated data pertaining to perioperative outcomes of carotid artery surgery and carotid stenting in postradiotherapy carotid stenosis to aid the clinical decision-making process. METHODS A systematic review of the literature, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 guidelines, was performed. We screened 575 articles related to carotid artery surgery or stenting in postradiotherapy carotid stenosis, from which 21 studies were included for quantitative analysis. The primary outcome was stroke or death ≤ 30 days of the procedure. Secondary outcomes included cranial nerve injury, restenosis, stroke, and death at >30 days. RESULTS Nine publications recorded 211 surgical procedures in 179 patients. In symptomatic patients, the 30-day mortality rate was 2.6% and the stroke or death rate was 2.7%. In asymptomatic patients, the 30-day mortality rate was 0% and the stroke or death rate was 1.1%. Permanent cranial nerve palsy was experienced by 0.6% of patients. Twelve publications recorded 510 carotid artery stenting procedures in 482 patients. In symptomatic patients, the 30-day mortality rate was 5.1%, and the stroke or death rate was 5.1%. In asymptomatic patients, the 30-day mortality rate was 1.4%, and the stroke or death rate was 2.1%. There was no statistically significant difference in 30-day stroke or death rate between surgical revascularization and carotid artery stenting in all (odds ratio [OR], 0.54; 95% confidence interval [CI] 0.17-1.70; P = .43), symptomatic (OR, 0.52; 95% CI, 0.14-1.98; P = .38), or asymptomatic patients (OR, 0.55; 95% CI, 0.06-5.42; P = .99). CONCLUSIONS The published outcomes from high-volume centers demonstrate that surgical revascularization and stenting are both technically feasible in postradiotherapy carotid stenosis and have similar safety profiles to nonirradiated necks. Radiation should therefore not be considered a contraindication to surgical intervention.

Aging techniques for deep vein thrombosis: a systematic review:

Deep vein thrombosis is common with an incidence of 1 in 1000. Acute thrombus removal for extensive proximal deep vein thrombosis using catheter-directed techniques highlights the need for accurate assessment of thrombus age. This systematic review summarises experimental and clinical evidence of imaging techniques for aging deep vein thrombosis. Ultrasound elastography and magnetic resonance imaging were highlighted as the most studied imaging modalities. Elastography was shown to distinguish between acute and chronic clots, despite demonstrating difficulty in accurate aging of clots older than 10 days in rat models. Elastography is noted as a feasible adjunct to current first-line imaging for deep vein thrombosis using duplex ultrasonography. Combinations of magnetic resonance imaging techniques can identify acute, sub-acute and chronic thrombi using endogenous contrast agents and provide objective standardisation of the diagnostic process, with reduced onus upon operator dependency. Further validation is required of these novel imaging techniques prior to clinical implementation for deep vein thrombosis aging.

Safety of Carotid Intervention Following Thrombolysis in Acute Ischaemic Stroke

OBJECTIVES Thrombolysis is effective in improving clinical outcome in the treatment of acute ischaemic stroke. However, thrombolysis results in low recanalisation rates, particularly in the event of carotid occlusion. Carotid intervention is indicated in stroke resulting from significant carotid atherosclerosis, but intervention soon after thrombolysis may be associated with increased risks. This study aims to assess the safety of carotid intervention post-thrombolysis for acute ischaemic stroke. DESIGN Systematic review. MATERIALS AND METHODS MEDLINE and EMBASE were searched on 29 May 2014. Inclusion criteria were (i) intra-arterial or intravenous thrombolysis for acute ischaemic stroke; (ii) carotid intervention within 14 days of thrombolysis; and (iii) derivable primary outcome. The primary outcome was 30-day stroke or death. A meta-analysis of incidence was completed for the 30-day stroke or death rates using Freeman-Tukey arcsine transformations and assuming random effects. Point estimates with confidence intervals (CIs) were generated and heterogeneity was assessed. The strength of recommendations and quality of underlying evidence were assessed using the American College of Chest Physicians (ACCP) grading system. RESULTS Nine included publications recorded 114 carotid endarterectomy (CEA) and four angioplasty interventions. The point estimate of 30-day stroke or death for CEA was 4.93% (95% CI 1.83-9.44), representing four of 114. The strength of recommendation and quality of underlying evidence for CEA as per the ACCP grading system was determined as 1C. There were no cases of stroke or death in patients undergoing angioplasty post-thrombolysis (0/4). CONCLUSIONS Early CEA post-thrombolysis appears safe, with stroke or death rates similar to that of the operation without thrombolysis. However, the wide CI obtained highlights the uncertainty of this result. Further, we emphasise that this recommendation is supported by low-quality evidence. Additional data are required to confirm the safety of surgery and early endovascular therapy post-thrombolysis.

Venous injuries in pediatric trauma: Systematic review of injuries and management

BACKGROUND Diagnosis of vascular injury in pediatric trauma is challenging as clinical signs may be masked by physiologic compensation. We aimed to (1) investigate the prevalence of noniatrogenic pediatric venous injuries, (2) discuss options in management of traumatic venous injury, and (3) investigate mortality from venous injury in pediatric trauma. Our objective was to provide the practicing clinician with a summary of the published literature and to develop an evidence-based guide to the diagnosis and management of traumatic venous injuries in children. METHODS A systematic review of published literature (PubMed) describing noniatrogenic traumatic venous injury in the pediatric population (<17 years) was performed according to PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-Analyses] guidelines. Data were retrieved systematically under the following headings: Study Design, Population Demographics (dates of recruitment, mean age, mechanism of injury), Diagnostic Approach, Vessel Injured, Management (operative technique), and Mortality. RESULTS Thirteen articles were included in this systematic review. In total, 508 noniatrogenic traumatic venous injuries were reported in children between the year 1957 and present day. Mechanisms of injury included blunt trauma from seat belt–related injury and fall from height or penetrating trauma from gunshot and foreign object. Injury to the inferior vena cava was most frequently reported, followed by femoral vein and internal jugular injuries. Primary repair was the most frequently reported technique for surgical repair (38%), followed by ligation (25%) and end-to-end anastomosis (15%). Mortality in pediatric trauma patients who had venous injury was reported as 0% to 67% in published series, highest in the series in which the most frequently reported injury was of the inferior vena cava. CONCLUSION Traumatic venous injury in the pediatric population is uncommon but may be associated with significant morbidity and mortality. Intra-abdominal venous injuries are associated with high mortality from exsanguination. Early diagnosis and intervention are therefore essential in such cases. LEVEL OF EVIDENCE Systematic review, level IV.

Varicose vein surgery and deep vein thrombosis prophylaxis

Over 60, 000 varicose vein related operations occur each year in the UK, the vast majority of which are elective day cases. The development of a perioperative deep vein thrombosis is reported at a rate of less than 1%. The benefits of routine deep vein thrombosis (DVT) thromboprophylaxis in abdominal and pelvic surgery is well documented. However, its role in varicose vein surgery is less clear with no absolute agreement at present. In an era where policies and guidelines dominate, these authors’ hospital trust issues a single protocol on ‘blanket prophylaxis’ of low molecular weight heparin and anti-embolic stockings for ‘every patient undergoing surgery with general anaesthesia’. However, it is evident that vascular surgeons across the country vary in opinion about such a ‘blanket’ protocol. Certainly, one recent questionnaire of vascular surgeons in the UK, in 2005, revealed that only 12% of surgeons used heparin routinely in varicose vein surgery, and another that 1.4% never used heparin thromboprophylaxis. Many surgeons believe that groups undergoing varicose vein surgery within the ‘low-risk’ category of surgery lasting less than 30min or aged 40 years or less do not require heparin prophylaxis. This is supported by a retrospective study done over four years involving 2186 patients, which showed that the 903 patients who did not receive heparin thromboprophylaxis did not go on to suffer a venous thromboembolism in the three-month postoperative period. Furthermore, in a procedure which often results in a degree of bruising postoperatively, it is argued that routine use of heparin thromboprophylaxis may actually worsen such bruising or lead to haematoma formation, a common and troublesome side-effect, which surgeons aim to avoid, and therefore should be used in selective cases only. In support of this, the current North American guidelines are similar to those of the Scottish Intercollegiate Guideline Network. Both recommend that only patients with risk factors should receive DVT prophylaxis for varicose vein surgery. Such risk factors would include obesity or a previous or family history of DVT. Other prophylactic methods that may be employed in general surgical procedures, such as pneumatic foot pumps and intraoperative antiembolic stockings, are considered impractical, inconvenient and therefore less popular in varicose vein surgery. Finally, the rise of day-case treatment for varicose veins means that the majority of patients are mobile almost immediately and are often discharged with the use of elastic antiembolism stockings, all of which may reduce the incidence of perioperative DVT. However, reliable data on the incidence of DVT following varicose vein surgery randomized controlled studies are lacking. A group of surgeons from Geneva reported six cases of clinically confirmed pulmonary embolism out of 1063 cases of varicose vein stripping procedures over a 10year period. This incidence of pulmonary embolism (0.56%) was comparable to that seen in abdominal surgery. However, a study from New Zealand showed that 5.3% of patients within the study developed a DVT following varicose vein surgery, an incidence higher than previously reported values. The authors suggest that previous study estimates were made on clinical grounds and were not confirmed by imaging techniques; therefore, asymptomatic cases of DVT went unnoticed and unreported at the time of study. There is also evidence to suggest that those patients given DVT prophylaxis were not necessarily protected from the development of a DVT. One study reported that of the 20 out of 377 patients that developed a DVT, 14 had received prophylactic subcutaneous low molecular weight heparin. Another reported how four out of 1283 patients, who received heparin prophylaxis, developed a thromboembolism. This would suggest that those patients who are considered at high risk, such as those with obesity, with a past medical or family history of thromboembolism, may not be protected by a blanket policy or have to accept that they are at a higher risk of venous thromboembolism. The use of hormone therapy is also controversial. While the Royal College of Obstetricians and Gynaecologists stated, in 1995, that ‘there was insufficient evidence to support a policy of routinely stopping the oral contraceptive pill (OCP) prior to major surgery’, a questionnaire in 1999 revealed that 74% of surgeons stopped the oral contraceptive prior to surgery. It is debatable whether the risk of stopping oral contraceptives

The role of cost-effectiveness for vascular surgery service provision in the United Kingdom

OBJECTIVE The cost of health care is increasingly becoming an international issue, with many health care systems requiring evaluation of cost when agreeing to fund health care. In the United Kingdom (UK), for example, the National Institute for Health and Care Excellence highlights the importance of using cost-effectiveness analyses to facilitate the effective use of resources. This study evaluates the use of cost-effectiveness analyses and the provision of vascular surgery. METHODS A systematic review of published literature was performed. UK-based studies assessing cost-effectiveness or cost-utility of superficial venous interventions, abdominal aortic aneurysm (AAA) repair, and carotid endarterectomy (CEA) were included. All included studies were quality assessed to determine the overall strength of UK economic evidence for each intervention. RESULTS Four superficial venous, six AAA, and two CEA studies met the inclusion criteria. After quality assessment, the UK evidence supporting the cost-effectiveness of superficial venous intervention was graded strong. The economic evidence for asymptomatic and symptomatic CEA was graded limited and insufficient, respectively, owing to a paucity of UK literature in this field. There was strong UK economic evidence affirming that endovascular aneurysm repair (EVAR) is unlikely to be a cost-effective alternative to open repair. CONCLUSIONS There is strong economic evidence for symptomatic superficial venous intervention. However, funding for varicose vein treatments remains controversial. Future economic analyses are required for symptomatic and asymptomatic CEA to better advise national policy. Despite strong economic evidence, current UK guidance is for EVAR over open repair in the elective setting, with the majority of elective AAA repairs being EVAR.

Should we stop testing for asymptomatic carotid atherosclerosis

In European men aged 60–79 years, moderate to severe carotid atherosclerosis (50–99% using North American Symptomatic Carotid Endarterectomy Trial (NASCET) measurements) is found in 2.3–6.0%,1 a similar prevalence to aortic aneurysmal disease (4.9%)2 for which a UK National Screening Programme has recently been introduced for men aged 65. In high-risk populations seen in a vascular clinic, the prevalence of asymptomatic 50–99% carotid atherosclerosis is much higher: 15–25% in peripheral arterial disease,3 12% in patients with an abdominal aortic aneurysm4 and 6% in those with contralateral carotid territory cerebral or retinal ischemic events.5 Opinion is divided as to whether these individuals should be tested for asymptomatic carotid atherosclerosis. The American Society for Neuroimaging6 and the US Society for Vascular Surgery7 strongly recommend testing in high prevalence populations such as those with symptomatic peripheral arterial disease and persons aged 65 or over with multiple cardiovascular risk factors (table 1). Conversely, the UK Royal College of Physicians draft 4th National Clinical Guideline for Stroke8 does not recommend testing at all. For cardiac patients in the UK, further observational data are awaited regarding prevalence and outcomes of synchronous carotid and coronary revascularization before evidence-based recommendations can be made.9 View this table: Table 1 Recommendations from the American Society of Neuroimaging,6 the US Society for Vascular Surgery7 and the US Joint Societies26 on testing for asymptomatic carotid atherosclerosis Patients with claudication are already under the care of a …

Impact of risk scoring on decision-making in symptomatic moderate carotid atherosclerosis.

Benefit from carotid endarterectomy (CEA) in symptomatic moderate (50–69 per cent) carotid stenosis remains marginal. The Fourth National Clinical Guideline for Stroke recommends use of the risk score from the European Carotid Surgery Trial (ECST) to aid decision‐making in symptomatic carotid disease. It is not known whether clinicians are, in fact, influenced by it.