Minimally invasive treatment of venous insufficiency using endovenous laser ablation

Background Venous insufficiency is very common and causes significant quality of life (QoL) impairment. Conventional open surgery featuring junction ligation, stripping of the axial vein and phlebectomy is known to offer significant benefits over conservative management; resulting in improved QoL. Additionally this treatment has been shown to be highly cost-effective. Despite these advantages, surgery is associated with significant post-operative morbidity; in the form of pain and immobility, even in the absence of complications. Additionally, in the long term; high recurrence rates have marred these promising early results, eventually returning patients to their pre-operative state. Unsurprisingly recurrence is unpopular with patients and patient satisfaction has been observed to be disappointingly low. At the end of the 20th century, new minimally invasive endovenous interventions were developed. Rapidly gaining popularity; it was hoped that they could address some of the limitations of surgery. Following initial cases series; the endothermal technique of endovenous laser ablation (EVLA) appeared to have the highest technical efficacy with a good safety record. Objectives Three studies were performed with the aim of perfecting the ablative procedure and evaluating it against the gold standard of conventional surgery. Study 1 was designed to establish the optimal management of saphenous tributaries and perforators following ablation of the saphenous axis. Study 2 was designed to directly compare the outcomes of EVLA with surgery to establish whether EVLA can match the effectiveness of surgery, whilst addressing its limitations. Study 3 was designed to explore the association between the magnitude of energy delivered during EVLA, procedural safety and periprocedural morbidity; in the context of evidence suggesting lower recanalisation rates following more aggressive use of laser energy. Methods Studies 1 and 2 were randomised clinical trials. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein (GSV). Study 1 randomised 50 patients to EVLA alone (Control) or EVLA with concomitant ambulatory phlebectomies (EVLTAP). Study 2 randomised 280 patients equally into groups receiving either surgery or EVLA. Outcomes were: QoL, Venous Clinical Severity Score (VCSS), technical success, requirement for secondary procedures, pain scores, time taken to return to normal function, recurrent varicose veins on clinical examination, patterns of reflux on duplex ultrasound examination, and the effect of recurrence on quality of life. Assessments were at 1, 6, 12 and 52 weeks after the procedure. Study 3 used linear and logistic regression models to study the effect of energy delivery on outcome. The models controlled for age, gender, BMI, pre-operative QoL and vein dimension. The outcomes were QoL, complications, recovery time, pain scores and analgesia requirements. The sample size calculation established that 115 patients would be required to detect any significant relationship. Results Study 1: EVLTAP took longer, but significantly decreased the requirement for subsequent interventions. There was no impairment in immediate post-procedural pain or QoL with EVLTAP. Median (IQR) Venous Clinical Severity Score (VCSS) at 3 months was lower (better) for EVLTAP than for Control (0 (0-1) versus 2 (0-2); P < 0.001), with lower (better) disease specific QoL (Aberdeen Varicose Vein Questionnaire (AVVQ) scores) at 6 weeks (7.9 (4.1-10.7) versus 13.5 (10.9-18.1); P < 0.001) and 3 months (2.0 (0.4-7.7) versus 9.6 (2.2-13.8); P = 0.015). At 1 year, there were no differences in VCSS or AVVQ scores. Study 2: Both groups had significant improvements in VCSS after treatment (P < 0.001), which resulted in improved disease-specific QoL (AVVQ, P < 0.001) and quality-adjusted life year (QALY) gain (P < 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight SF-36 domains (P < 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P < 0.001), six of eight SF-36 domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 3 days; P < 0.001). Complications were rare. Initial technical success was greater following EVLA: 99.3 versus 92.4% (P = 0.005). Surgical failures related mainly to an inability to strip the above-knee GSV. The clinical recurrence rate at 1 year was lower after EVLA: 4.0 versus 20.4% (P < 0.001). The number of patients needed to treat with EVLA rather than surgery to avoid one recurrence at 1 year was 6.3 (95 per cent confidence interval 4.0 to 12.5). 12 of 23 surgical recurrences were related to an incompetent below-knee GSV and ten to neovascularisation. Of five recurrences after EVLA, two were related to neoreflux in the groin tributaries and one to recanalisation. Clinical recurrence was associated with worse QoL (AVVQ scores) (P < 0.001). Study 3: 232 patients were included. The mean (range) age was 50 (18-83) years. 63% were women. The mean (range) energy delivery was 89.8 (44.5-158.4) Jcm-1. There was no significant effect on any outcome related to increasing energy delivery. Conclusions Concomitant phlebectomy with EVLA prolonged the procedure, but reduced the need for secondary procedures and significantly improved quality of life and the severity of venous disease. This supports a recommendation that phlebectomy is performed routinely in conjunction with EVLA. EVLA was as effective as surgery for varicose veins, but importantly had lower periprocedural morbidity as evidenced by less negative impact on early post-intervention QoL and furthermore clinical recurrence rates were also significantly lower than observed following conventional surgery. This suggests that EVLA with phlebectomy is superior to conventional surgery in the management of primary superficial venous insufficiency. Study 3 clearly confirms that EVLA is a safe procedure and that for the range of energies studied, there was no evidence demonstrating an increase in complication rates or the periprocedural morbidity of EVLA. These findings support the adoption of EVLA and concomitant phlebectomy as the gold standard treatment for primary superficial venous insufficiency

Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: A systematic review

Objective: Dialkylcarbomoyl chloride (DACC)-coated dressings (Leukomed Sorbact and Cutimed Sorbact) irreversibly bind bacteria at the wound surface that are then removed when the dressing is changed. They are a recent addition to the wound care professional's armamentarium and have been used in a variety of acute and chronic wounds. This systematic review aims to assess the evidence supporting the use of DACC-coated dressings in the clinical environment. Method: We included all reports of the clinical use of DACC-coated dressings in relation to wound infection. Medline, Embase, CENTRAL and CINAHL databases were searched to September 2016 for studies evaluating the role of DACC-coated dressings in preventing or managing wound infections. Results: We identified 17 studies with a total of 3408 patients which were included in this review. The DACC-coating was suggested to reduce postoperative surgical site infection rates and result in chronic wounds that subjectively looked cleaner and had less bacterial load on microbiological assessments. Conclusion: Existing evidence for DACC-coated dressings in managing chronic wounds or as a surgical site infection (SSI) prophylaxis is limited but encouraging with evidence in support of DACC-coated dressings preventing and treating infection without adverse effects

A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis

Purpose: Surgical arteriovenous fistula (AVF) or graft (AVG) is preferred to a central venous catheter for dialysis access. Surgical access may suffer thrombosis early after placement and systemic anticoagulation during surgical access formation may increase patency rates but would be expected to increase bleeding-related complications. A systematic review and meta-analysis of randomised controlled trials was conducted to examine the impact of systemic anticoagulation on access surgery perioperative bleeding and patency rates. Methods: We included randomised controlled trials testing systemic anticoagulation during access formation versus a control group without systemic anticoagulation reporting bleeding complications and access patency. Medline, Embase, CENTRAL and CINAHL were searched up to March 2015. Risk of bias was assessed using the Cochrane risk of bias tool and the Jadad score. Meta-analysis was performed using Cochrane Revman ® software. Results: Searches identified 445 reports of which four randomised studies involving 411 participants were included. Three studies pertained to AVF only and one included both AVF and AVG. Systemic anticoagulation led to increased bleeding events in all access [four trials; risk ratio (RR) 7.18; confidence interval (CI), 2.41 to 21.38; p < 0.001]. Patency was not improved for all access (four trials; RR, 0.64; CI, 0.37 to 1.09; p = 0.10) but was improved when AVF analysed alone (three trials; RR, 0.57; CI, 0.33 to 0.97; p = 0.04). Conclusions: The use of intraoperative systemic anticoagulation during access formation is associated with a highly significant increased risk of bleeding-related complications. A significant improvement in AVF patency was seen, though not when AVF and AVG were analysed together

Long-term outcomes of a randomized clinical trial of supervised exercise, percutaneous transluminal angioplasty or combined treatment for patients with intermittent claudication due to femoropopliteal disease

Background: To compare the long-term outcomes of angioplasty (PTA), supervised exercise (SEP) and combined treatment (PTA+SEP) in patients with intermittent claudication (IC) due to femoropopliteal disease. Methods: Patients recruited to PTA, SEP and PTA+SEP arms of RCT were invited for long-term follow-up from 2010 to 2011.Indicators of limb ischaemia were recorded (ankle-brachial pressure indices, treadmill walking distances (ICD, MWD, PRWD). Duplex ultrasound was also performed. Patients completed SF36 and Vascuqol quality of life(QOL) questionnaires. Results: Of the 178 patients recruited in the trial, 139 were alive at the time of follow-up (PTA=46, SEP=47, PTA+SEP=46). Assessments were completed for 111 patients. Median time to follow-up was 5.2years (IQR 3.8-7.4years). Median age of patients at follow up was 75years. 62.2%(N=69) of patients were symptomatic.16.2%(N= 18) had experienced major cardiovascular event since their last follow-up visit. Intra-group analysis: Improvement was observed in ankle brachial pressure index (ABPI) in all groups. QOL outcomes were inconsistent across individual groups. Inter-group analysis: PTA and PTA+SEP groups demonstrated a significantly higher ABPI as compared to SEP group. No significant difference was observed in walking distances, QOL outcomes, restenosis rates, and new ipsilateral and contralateral lesions on duplex scan. Patients required re-interventions in all group (PTA=14, SEP=10, PTA+SEP=6). Number of re-interventions was higher in PTA group(N=29) as compared to SEP(N=17) and PTA+SEP(N=9) but failed to reach statistical significance. Conclusion: PTA, SEP and combined treatment are equally effective long-term treatment options for patients with femoropopliteal claudication. Addition of SEP to PTA can reduce the symptomatic restenosis and re-intervention rates

Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: Study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

© 2017 The Author(s). Background: Peripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients' walking ability in terms of maximum walking distance (MWD) and pain-free walking distance (PFWD). Research has suggested extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue; therefore, our objective is to assess the tolerability and efficacy of ESWT as a novel treatment of intermittent claudication. Methods/design: Patients with unilateral claudication will be randomised to receive either ESWT (PiezoWave 2 shockwave system) or sham treatment to the calf muscle bulk three times per week for 3 weeks. All patients are blinded to treatment group, and all assessments will be performed by a masked assessor. Treatment tolerability using a visual analogue scale, ankle-brachial pressure index, MWD, PFWD and safety will all be formally assessed as outcome measures at baseline and at 4, 8 and 12 weeks follow-up. Discussion: This trial will be the first of its kind in terms of methodology in relation to ESWT for intermittent claudication. A double-masked randomised controlled trial will provide useful information about the potential for the use of ESWT as a non-invasive treatment option and the need for further robust research. Trial registration: ClinicalTrials.gov, NCT02652078. Registered on 17 October 2014

A systematic review of management of inadvertent arterial injury during central venous catheterisation

© 2017 Wichtig Publishing. Introduction: Central venous catheterisation (CVC) is a technique commonly used to obtain vascular access and over five million CVCs are inserted annually. This systematic review of CVC-related arterial injury aims to compare outcomes reported with different management strategies. Methods: PRISMA guidelines were followed. A search of Medline, Embase, Central and CINAHL was performed. Results were limited to papers in humans and in English with duplicates removed. Details of cases including site and nature of arterial injury, use of ultrasound, methods for identifying arterial placement, management methods used, and any reported outcomes were collated from all papers. Successful management was defined as control of haemorrhage without evidence of further complications. results: We screened 2187 abstracts and 78 full manuscripts were obtained and reviewed. Twenty-four papers were of relevance and were included in this review. Amongst the papers, 80 cases of arterial injury were reported. Successful treatment by removal and compression, endovascular methods, and open surgical repair were 5.6%, 94.6% and 100%, respectively. Discussion: Removal and compression of the arterial site is a poor management method and is associated with a high rate of complications. Endovascular approaches had a high rate of success with advantages of endovascular techniques including access to arteries which are difficult to expose surgically and avoidance of general anaesthesia. Endovascular repair might be considered depending on site of injury or local expertise though surgical repair reported the best results in this review with no complications seen

A randomised clinical trial of ultrasound guided cannulation of difficult fistulae for dialysis access

Background: Arteriovenous fistulae (AVF) are preferred for dialysis access but require accurate cannulation for effective dialysis. Evidence supports improvements in cannulation and complication rates using ultrasound guidance (USG) in cannulating other sites. This mixed methods, randomised controlled trial aimed to assess effects of USG during AVF cannulation.Methods: Participants with difficult to cannulate AVF had each cannulation event randomised to USG or standard technique (no USG). The primary outcome was the incidence and number of additional needle passes. Secondary outcomes included: the incidence and number of additional skin punctures; time to achieve two needle cannulation; pain associated with cannulation; local complications. Qualitative outcomes were assessed using patient and staff questionnaires.Results: 32 participants had 346 cannulation events randomised (170 to USG and 176 to standard cannulation). USG resulted in a significant reduction in additional needle passes (72 vs 99 p=0.007) and additional skin punctures (10 vs 25 p=0.016.) but prolonged time to cannulation (p>0.001). There was no difference in pain score (p=0.705) or complications between groups. Questionnaires demonstrated that USG cannulation is acceptable to patients and staff. Conclusion: USG cannulation of AVF is more accurate and no more painful than non-image guided cannulation, but prolonged time to cannulation. Some of the excess time involved may be due to the trial being performed early in cannulating staff’s learning curve with the USG technique. Further work to elucidate which patients gain most benefit from USG cannulation and the effect of USG on cannulation complications and AVF patency is warranted

Provision of NICE recommended Varicose Vein Treatment in the NHS

Background: Standardization of access to treatment and compliance with clinical guidelines are important to ensure the delivery ofhigh-quality care to people with varicose veins. In the National Health Service (NHS) in England, commissioning of care for people withvaricose veins is performed by Clinical Commissioning Groups (CCGs) and clinical guidelines have been developed by the NationalInstitute for Health and Care Excellence (NICE CG168). The Evidence-Based Intervention (EBI) programme was introduced in theNHS with the aim of improving care quality and supporting implementation of NICE CG168. The aim of this study was to assessaccess to varicose vein treatments in the NHS and the impact of EBI.Methods: CCG policies for the delivery of varicose vein treatments in the NHS in England were obtained from 2017 (before EBIintroduction) and 2019 (after EBI introduction) and categorized by two independent reviewers into levels of compliance with NICECG168. Hospital Episode Statistics data were compared with the NICE commissioning model predictions. A quality-adjusted life-yearwas valued at £20 000 (Euro 23 000 15 November 2022).Results: Despite the introduction of the EBI programme, CCG compliance with NICE CG168 fell from 34.0 per cent (64 of 191) to 29.0 per cent(55 of 191). Some 33.0 per cent of CCG policies (63 of 191) became less compliant and only 7.3 per cent (14 of 191) changed to become fullycompliant. Overall, 66.5 per cent of CCGs (127 of 191) provided less than the recommended intervention rate before EBI and this increasedto 73.3 per cent (140 of191) after EBI. The overall proportion of patients estimated to require treatment annually who received treatmentfell from 44.0 to 37.0 per cent. The associated estimated loss in net health benefit was between £164 and 174 million (Euro 188 million and199 million 15 November 2022) over 3 years. A compliant policy was associated with a higher intervention rate; however, commissioningpolicy was associated with only 16.8 per cent of the variation in intervention rate (R2=0.168, P<0.001).Conclusion: Many local varicose vein commissioning policies in the NHS are not compliant with NICE CG168. More than half of patientswho should be offered varicose vein treatment are not receiving it, and there is widespread geographical variation. The EBI programmehas not been associated with any improvement in commissioning or access to varicose vein treatment