Roshan Bootun

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.

The advent of non-thermal, non-tumescent techniques for treatment of varicose veins

Varicose veins are common and their management has undergone a number of changes over the years. Surgery has been the traditional treatment option, but towards the 21st century, new endovenous thermal ablation techniques, namely, radiofrequency ablation and endovenous laser ablation, were introduced which have revolutionised the way varicose veins are treated. These minimally invasive techniques are associated with earlier return to normal activity and less pain, as well as enabling procedures to be carried out as day cases. They are, however, also known to cause a number of side-effects and involve infiltration of tumescent fluid which can cause discomfort. Non-thermal, non-tumescent methods are believed to be the answer to these unwelcome effects. Ultrasound-guided foam sclerotherapy is one such non-thermal, non-tumescent method and, despite a possible lower occlusion, has been shown to improve the quality of life of patients. The early results of two recently launched non-thermal, non-tumescent methods, mechanochemical ablation and cyanoacrylate glue, are promising and are discussed.

To compress or not to compress: The eternal question of the place of compression after endovenous procedures.

The management of varicose vein disease has witnessed a dramatic transformation over the past decade. Surgery for this common condition, long considered the ‘gold-standard’ treatment, has gradually been replaced by endothermal ablation and ultrasoundguided foam sclerotherapy (UGFS). These minimally invasive techniques have allowed a more rapid improvement in patients’ quality of life and return to normal activities. The focus on enhancing patients’ experience even further has led to the introduction of newer, non-thermal, non-tumescent (NTNT) technologies. These completely obviate the need for uncomfortable thermal ablation and tumescent infiltration with possibly a similar level of efficacy as radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) in the short term. The next potential area where a substantial difference in the management of varicose veins can be made is the use of compression therapy following endovenous ablation. It is widely believed that compression reduces post-operative swelling, haematoma formation and pain following surgery for varicose veins, but no irrefutable evidence exists. Edwards et al. surveyed the members of the Vascular Society of Great Britain and Ireland and found that 75% used either elastic or non-elastic bandages post-operatively, with 77% changing to compression stockings afterwards. There was a high variability with respect to the length of time the bandages and stockings were worn for. Another questionnaire survey of the members of the same society demonstrated that following endothermal ablation, 87% of responders stated that they used compression stockings and 60% used bandages. Similar numbers used compression stockings and bandages after foam sclerotherapy. Once again, however, there was marked inconsistency in the length of time these were prescribed for. Bakker et al. carried out a randomised controlled trial looking at the use of compression stockings for two days compared to seven days following EVLA of the great saphenous vein (GSV). At one week, the physical function, vitality and pain score was significantly better in the seven-day compression group. By 6 weeks though, there were no major differences between the two groups. Elderman et al. also looked at the effect of compression stockings post-EVLA of the GSV. Patients were randomised to receiving either compression stockings or no stockings. Those in the no compression group had significantly worse pain scores up to seven days and used analgesia more frequently than the group randomised to compression. These two studies appear to indicate a benefit in the short term of compression therapy in patients undergoing EVLA, but are limited by the considerable dropouts in both studies (40 patients of the original 109 approached in the Bakker et al. study and 32 patients from Elderman et al. trial). The role of compression therapy followingUGFS has also been investigated. Hamel-Desnos et al.conducted a randomised study looking at the use of compression stockings post-foam sclerotherapy. Class 2 compression stockings (pressure exerted: 15–20mmHg) were used. No significant differences were found in the pain scores, inflammation, ecchymosis, induration, pigmentation or matting at 14 and 28 days. Compliance was an issue with only 40% of patients wearing compression stockings everyday. Due to the relatively small sample size (60 patients in total), the study may not have been powered sufficiently to enable detection of a significant difference between the groups. O’Hare et al. evaluated the use of compression bandaging for 1 and 5 days in patients having UGFS followed by TED stockings for two weeks. At the six-week point, no significant differences were noted in the

Long-term follow-up for different varicose vein therapies: is surgery still the best?

Management of varicose vein disease has changed drastically over the past decades. Since its introduction in vein practice, surgery has gone through several stages of evolution until the method of ligation with stripping eventually became and remained the standard for a long time. It was found to be effective at treating the condition and, indications of its beneficial impact on patients’ quality of life soon also became evident. However, being associated with significant morbidity, surgery gradually fell out of favour, especially, once the newer endovenous techniques were launched around the turn of the century. These endothermal methods allowed procedures to be carried out under local anaesthetic as day case interventions, often with a similar or even better effect on occlusion rates and quality of life. In addition, there is mounting evidence that these newer techniques might be more cost-effective. This review evaluates surgical treatment of varicose veins compared to endovenous methods and also assesses its place in current phlebological practice.

Should re-intervention be the definitive outcome measure for varicose vein intervention?:

Varicose veins are a frequent cause of morbidity and, with the continual advancement of endovenous treatment modalities, standardised outcome measures have become important to better determine the relative effectiveness of each modality. To date, the focus for many investigators has been the prevention and monitoring of recurrent disease, but disease recurrence is a complicated subject matter in venous varicosity literature. Recurrence rates following varicose vein intervention are arguably greater than would be acceptable in many other treated disease groups with recurrence rates of up to 47% reported five years after endovenous intervention. In addition, the definition of recurrence is expansive. The recurrent varices after surgery guidelines developed in 1998 define recurrence as true recurrent varices as well as residual veins (untreated at first intervention) or the development of new varices resultant from disease progression. Naturally, residual varices following initial treatment are different from truly recurrent varices and the inclusion of this category may complicate interventional outcomes. Furthermore, the type of recurrence is largely dependent on the treatment modality used. Neovascularisation is more likely to occur following surgical stripping and venous recanalisation following endovenous ablation. Evidence, so far, points to overall recurrence rates being similar between surgical stripping and endovenous ablation. Another issue is the degree of heterogeneity in reporting standards in clinical trials that assess varicose vein interventions, both in terms of the type of outcomes reported and the follow-up periods at which these outcomes are assessed. An attempt to solve the problem has been made in a joint statement by the American Venous Forum and the Society of Interventional Radiology in their Recommended Reporting Standards for Endovenous Ablation. In these guidelines, it is suggested that anatomic and imaging outcomes can be used as primary outcome measures for technology assessment studies – presumably because the sonographic identification of reflux, recanalisation or neovascularisation will correctly identify pathological recurrence or treatment failure regardless of symptomatology – but that these measures should not be used as outcomes for clinical studies. Yet, a large meta-analysis restricted outcome reporting to anatomical success. Taking heed of this guidance draws attention to the difference between clinical and anatomical recurrence and the relationship between anatomical disease and symptomatology. Shepherd et al. investigated the relationship between several clinical outcome measures and demonstrated that anatomical and haemodynamic measures correlate poorly with functional outcomes, though there was better correlation with quality of life measurements. Therefore, it may be prudent for treatment algorithms for recurrent disease to include symptomatic criteria as this will provide the basis for differentiating between those patients that require reintervention for recurrent disease and those that do not. Furthermore, if parallels are drawn between primary and recurrent disease, it is known that the presence of less severe primary disease does not necessarily predispose one to develop more severe disease over time. If the same is true for disease recurrence, offering treatment for asymptomatic recurrences would be unnecessary for some. A recent study demonstrated that the probability of re-intervention at five years is similar for endovenous laser ablation (EVLA), radiofrequency ablation and surgery at 26–27%. Ultrasound-guided foam sclerotherapy (UGFS) and conservative management carry greater risk with probabilities as high as 56% and 72%, respectively. A meta-analysis of generic (EQ-5D) and disease-specific (Aberdeen Varicose Vein Questionnaire [AVVQ]) quality of life scores by the same group did not demonstrate statistically significant

A systematic review of paediatric deep venous thrombolysis

Objectives The aim was to assess the effectiveness and safety of catheter-directed thrombolysis in children with deep venous thrombosis and to evaluate its long-term effect. Method and results EMBASE, Medline and Cochrane databases were searched to identify studies in which paediatric acute deep venous thrombosis patients received thrombolysis. Following title and abstract screening, seven cohort studies with a total of 183 patients were identified. Technical success was 82% and superior in regional rather than systemic thrombolysis (p < 0.00001). One cohort study identified significant difference in thrombus resolution at one year between thrombolytic and anticoagulant groups (p = 0.01). The complication rate was low, with incidence rates of major bleeding, pulmonary embolism and others at 2.8%, 1.8% and 8.4%, respectively. The overall post-thrombotic syndrome rate was 12.7%. The incidence of re-thrombosis ranged from 12.3% to 27%. Conclusion Thrombolysis for paediatric deep venous thrombosis is an effective and relatively safe therapeutic option, lowering the incidence of post-thrombotic syndrome and deep venous thrombosis recurrence.

A systematic review on the use of deep venous stenting for acute venous thrombosis of the lower limb

Objectives The aim is to evaluate venous stent patency, the development of post-thrombotic syndrome, recurrence, quality of life and the optimal post-procedural anticoagulation regimen in the treatment of iliofemoral deep venous thrombosis. Method and results EMBASE and Medline databases were interrogated to identify studies in which acute deep venous thrombosis patients were stented. Twenty-seven studies and 542 patients were identified. Primary, assisted primary and secondary patency rates 12 months after stent placement ranged from 74 to 95, 90 to 95 and 84 to 100%, respectively. The observed post-thrombotic syndrome rate was 14.6%. The incidence of stent re-thrombosis was 8%. In 26% of studies, patients received additional antiplatelet therapy. Quality of life questionnaires employed in 11% of studies, demonstrating an improvement in the chronic venous insufficiency questionnaire (22.67 ± 3.01 versus 39.34 ± 6.66). Conclusion Venous stenting appears to be an effective adjunct to early thrombus removal; however, further studies are needed to identify optimal anticoagulant regimen and effect on quality of life.

Endovenous Management of Varicose Veins

Varicose veins are a very common condition and have been the subject of a recent proliferation of treatment modalities. The advent of the endovenous treatment era has led to a confusing array of different techniques that can be daunting when making the transition from traditional surgery. All modalities offer excellent results in the right situation, and each has its own treatment profile. Thermal ablation techniques have matured and have a reassuring and reliable outcome, but the arrival of nonthermal techniques has delivered further options for both patient and surgeon. This article provides an overview of the different treatment devices and modalities available to the modern superficial vein surgeon and details the currently available evidence and summation analysis to help surgeons to make an appropriate treatment choice for their patients.

Comparison of microbubble presence in the right heart during mechanochemical and radiofrequency ablation for varicose veins

Objective Mechanochemical ablation is a novel technique for ablation of varicose veins utilising a rotating catheter and liquid sclerosant. Mechanochemical ablation and radiofrequency ablation have no reported neurological side-effect but the rotating mechanism of mechanochemical ablation may produce microbubbles. Air emboli have been implicated as a cause of cerebrovascular events during ultrasound-guided foam sclerotherapy and microbubbles in the heart during ultrasound-guided foam sclerotherapy have been demonstrated. This study investigated the presence of microbubbles in the right heart during varicose vein ablation by mechanochemical abaltion and radiofrequency abaltion. Methods Patients undergoing great saphenous vein ablation by mechanochemical abaltion or radiofrequency ablation were recruited. During the ablative procedure, the presence of microbubbles was assessed using transthoracic echocardiogram. Offline blinded image quantification was performed using International Consensus Criteria grading guidelines. Results From 32 recruited patients, 28 data sets were analysed. Eleven underwent mechanochemical abaltion and 17 underwent radiofrequency abaltion. There were no neurological complications. In total, 39% (11/28) of patients had grade 1 or 2 microbubbles detected. Thirty-six percent (4/11) of mechanochemical abaltion patients and 29% (5/17) of radiofrequency ablation patients had microbubbles with no significant difference between the groups (p=0.8065). Conclusion A comparable prevalence of microbubbles between mechanochemical abaltion and radiofrequency ablation both of which are lower than that previously reported for ultrasound-guided foam sclerotherapy suggests that mechanochemical abaltion may not confer the same risk of neurological events as ultrasound-guided foam sclerotherapy for treatment of varicose veins.