The influence of socioeconomic factors on intervention and postoperative healing of venous ulcers: a prospective study.

OBJECTIVE: In previous studies, venous ulcers (VUs) have been found to occur more often in patients with lower socioeconomic status. The aim of this study was to explore if socioeconomic factors influence the delay of referral to a vascular service or the time to healing after superficial venous intervention. METHOD: In this prospective study, patients answered a questionnaire about the duration and recurrence of their VU, comorbidities, body mass index (BMI), smoking, alcohol, social and physical activities, ambulatory status, education, marital status, housing, perceived economic status and dependence on home care. Postoperative complications, VU healing and recurrence were noted one year after superficial venous intervention. RESULTS: A total of 63 patients were included in this study (30 females and 33 males), with a mean age of 71.2 years (range: 37-92 years). Duration of the present VU in patients was: <3 months in 48%; 3-6 months in 27%; 6-12 months in 11%; and >12 months in 14%. Risk factors for delayed referral were recurrent VU (odds ratio (OR): 4.92; p=0.021); walking impairment (OR: 5.43; p=0.009) and dependence on home care (OR: 4.89: p=0.039) in a univariable analysis. The latter was the only significant finding in a multivariable analysis with socioeconomic risk factor (OR: 4.89; p=0.035). In 85% of patients, their VU healed without recurrence during one year follow-up. Healing took longer if the patients: were of older age (p=0.033); had a normal BMI (independent samples t-test, p=0.028); had a recurrent VU (OR: 5.00; p=0.049); or walking impairment (Fishers exact test, OR: 9.14; p=0.008), but no significant socioeconomic risk factors were found. CONCLUSION: In this study, socioeconomic factors were not important risk factors for delayed referral of VU patients to a vascular service or prolonged healing time after superficial venous intervention. DECLARATION OF INTEREST: This work was supported by the Scandinavian Research Foundation for Varicose Veins and other Venous Diseases (SFÅV) and by ALF funding from Region Örebro County. The authors have no conflicts of interest to declare.

Endovenous ablation for venous leg ulcers.

BACKGROUND: Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing. OBJECTIVES: To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease. SEARCH METHODS: In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence. MAIN RESULTS: The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.

Circumferential Radical Debridement and Omental Free Flap in the Treatment of Severe Chronic Venous Ulcers.

BACKGROUND: Chronic venous leg ulcers are a significant health care burden with a difficult and unreliable treatment. Free flaps may be needed for wound coverage in severe cases. Incomplete removal of dermatoliposclerosis (DLS) area and/or not addressing the underlying venous dysfunction may contribute to the reported modest long-term results. METHODS: A series of 5 patients with severe chronic venous ulcers of the leg, resistant to conservative treatment and superficial venous surgery, were treated with radical, circumferential, subfascial resection of the DLS skin and coverage with omental free flaps. Delayed arteriovenous (AV) loops were used as recipients. All patients had previous superficial venous surgery and multiple skin grafts. Mean follow-up was 8 years (4-15 years). RESULTS: One hundred percent of flaps survived completely. No major complications occurred. One patient developed ulceration of the flap at 2 years and healed with basic wound care. At a mean follow-up of 8 years, all patients were ulcer-free. One patient died 15 years after the surgery for unrelated causes. CONCLUSIONS: Radical circumferential resection of DLS area in severe chronic venous leg ulcers and coverage with a free omental flap using staged AV loop provided durable coverage in a series of 5 patients. Complete resection of DLS area, addressing the underlying venous pathology, and draining the flap to a healthy competent vein graft (AV loop) may contribute to these favorable results.

Biomarkers of Skin Graft Healing in Venous Leg Ulcers.

There is a need for biomarkers that predict the success of transplantation of venous leg ulcers (with autologous split-thickness skin grafts). The primary objective of this exploratory study was to investigate the association between split-thickness skin graft healing in venous leg ulcers and candidate wound fluid biomarkers representing inflammatory cell and endogenous proteinase activities, and bioactivity. A secondary objective was to compare biomarker levels of the 17 venous leg ulcers with sterile split-thickness skin graft donor-site wounds in another 10 patients with venous leg ulcers. Wound fluids were collected for 24 h using a validated method. The concentration of preoperative matrix metalloproteinase-9 in wound fluid was higher in venous leg ulcers showing good healing (n = 10) than in venous leg ulcers showing poor healing (n = 7) 12 weeks after transplantation with meshed split-thickness skin grafts. The diagnostic value of matrix metalloproteinase-9 was good according to receiver-operating characteristic curve analysis. Matrix metalloproteinase activity in wound fluids from split-thickness skin graft donor-site wounds increased as a function of time and healing, but was still lower than matrix metalloproteinase activity in venous leg ulcer wound fluids, which showed increased levels of most biomarkers except for matrix metalloproteinase-9 and matrix metalloproteinase-2. In conclusion, wound fluid matrix metalloproteinase-9 concentration is a potential predictive biomarker of split-thickness skin graft healing in venous leg ulcers.

A Contemporary Comparison of Cyanoacrylate, Radiofrequency, and Endovenous Laser Ablation on Healing of Active Venous Ulceration.

BACKGROUND: The goal of this study is to compare the healing rates of active lower extremity venous ulcers for patients receiving one of 3 ablation methods, compare their complications, and identify factors affecting successful healing and prevention of recurrence. METHODS: For this study, data were collected retrospectively on 146 patients at a single institution, tertiary referral center, with an active venous ulcer who underwent ablation therapy via cyanoacrylate (VenaSeal), radiofrequency (RFA), or endovenous laser ablation (EVLA) from 2010 to 2020. RESULTS: The study showed a nonsignificant difference in days to ulcer healing postintervention between ablative techniques, with 80.8 days for cyanoacrylate ablation (n = 15), 70.07 for RFA (n = 44), and 67.04 days for EVLA (n = 79). A similar, nonsignificant trend was observed for ulcer recurrence, with a rate of 35.7% (5/14) for cyanoacrylate ablation, 26.7% (20/75) for EVLA, and 23.1% (9/39) for RFA. The same nonsignificant trend occurred with deep venous thrombosis following the procedure in 6.3% (1/16) of cyanoacrylate ablation, 4.8% (4/84) of EVLA, and 2.2% (1/46) of RFA cases. The rate of endovenous glue induced thrombosis was also higher (6.3%) for cyanoacrylate than endovenous heat induced thrombosis in EVLA (3.6%) and RFA (2.2%). Cox proportional hazard was significant for compliance with compression therapy (hazard ratio [HR] 2.12, confidence interval [CI] 95% = 1.10-4.20, P = 0.031) and a lack of working with a wound clinic (HR 0.50, CI 95% = 0.33-0.75, P = 0.001) were associated with the decreased time to healing of ulcer but was not influenced by the presence of other comorbidities of smoking or diabetes mellitus. CONCLUSIONS: This study indicates a trend toward cyanoacrylate ablation having longer healing times and more complications compared to other ablation methods when used in patients with active venous ulcers. Compliance with compression treatment is predictive of venous ulcer healing and working with a wound clinic had significantly longer healing times.

Mechanochemical Endovenous Ablation of the Saphenous Vein: A Look at Contemporary Outcomes.

BACKGROUND: Endovenous ablation techniques have replaced greater saphenous vein (GSV) ligation and stripping for treatment of venous insufficiency. Our objective was to investigate our initial procedural experience and clinical presentation of patients undergoing mechanochemical ablation (MOCA) at a single institution. We hypothesized that closure level and success rate improved over time and were comparable to other endovenous ablation techniques. METHODS: We retrospectively reviewed all MOCA procedures performed at the Greater Los Angeles Veterans Affairs Hospital from 2015 - 2020. Variables included CEAP and VCSS scores, patient symptoms, post procedure duplex ultrasound, closure level, and need for anticoagulation. Success was defined as GSV thrombosis on initial post procedure duplex ultrasound. Procedure associated extension of thrombus into the deep veins was defined using the American Venous Forum (AVF) endothermal heat induced thrombosis (EHIT) classification. RESULTS: 104 venous ablation procedures were performed on 86 patients. Eleven (12.8%) patients received bilateral interventions, and six (7%) patients had asynchronous interventions on the same leg. The average age was 58.4 years (SD 12) and 93% were male. Pre-procedural symptoms included pain (102, 98.1%), varicose veins (87, 83.7%), edema (58, 55.8%), and active ulcers (19, 18.3%). A CEAP category of C2 was the most common indication (34.6%), followed by C3 (22.1%) and C6 (21.2%). Forty-five (43.2%) patients had deep system reflux, and 53% had concomitant phlebectomies. Average VCSS score was 7.5 (SD 3.5).We observed a GSV ablation rate of 92.7% (n = 89) in the 96 procedures which had post-procedure follow up, with no temporal evidence of a learning curve. On post procedure duplex of the 89 technically successful ablations, 77 (86.5%) patients had AVF EHIT level 1 closure, three (3.4%) had level 2 closure, eight (8.9%) had level 3 closure, and one had a level 4 closure. Fourteen (15.7%) patients were newly started on anticoagulation for an average of 33.2 days (SD 34.1). Of the 19 legs treated for active venous ulcers, 13 (68.4%) had improvement or resolution of their venous ulcers. No pulmonary embolic complications were reported. CONCLUSIONS: We observed a successful GSV thrombosis rate of 92.7% using MOCA without evidence of a learning curve and comparable to that reported in the literature. The rate of thrombus extension into the deep veins was 14.6%, with no adverse effects associated with anticoagulation or clinically significant sequelae of AVF EHIT level 2 or greater. Comparisons with MOCA associated thrombus extension into deep veins in the literature are limited as post procedure screening duplex are not standard of care. However, we demonstrated that MOCA ablation of the GSV is a safe procedure that may be performed with good technical success.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial.

BACKGROUND: Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. PATIENTS AND METHODS: In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. RESULTS: Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained (p = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B (p = 0.004). CONCLUSION: In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

Comparison of high saphenous ligation and stripping, radiofrequency ablation, and subfascial endoscopic perforator surgery for the treatment of active venous ulcers: Retrospective cohort with five-year follow-up.

OBJECTIVE: To compare the use of high saphenous ligation and stripping, radiofrequency ablation, and subfascial endoscopic perforator surgery for the treatment of active venous ulcers. METHODS: One hundred ninety-five (n = 195) subjects who were treated for venous leg ulcers were enrolled between 2009 and 2014. Three groups were formed (Group A: high saphenous ligation and total stripping, Group B: radiofrequency ablation of the great saphenous vein + perforators, and Group C: radiofrequency ablation of the great saphenous vein + subfascial endoscopic perforator surgery) (n = 65 for each group). The venous clinical severity score for baseline, 1st, 6th, and 12th months, great saphenous vein occlusion at the 1st, 6th, and 12th months, and ulcer rates for the 1st, 2nd, 3rd, 4th, and 5th years were recorded. RESULTS: For venous clinical severity score, only the first month decrease was significant for the subfascial endoscopic perforator surgery group (p = 0.001). Great saphenous vein occlusion was higher at the 6th and 12th months for the high saphenous ligation and stripping and subfascial endoscopic perforator surgery groups than for the radiofrequency ablation group (p = 0.036 and p = 0.037). The rate of ulcers for the subfascial endoscopic perforator surgery group was lower at the second, third, fourth, and fifth years (p = 0.011). No significant difference was found between groups for the five-year recovery rates (p > 0.05). CONCLUSION: Subfascial endoscopic perforator surgery technique in conjunction with radiofrequency ablation of axial vein was superior to both high saphenous ligation and stripping and radiofrequency ablation of axial and perforators for ulcer healing.

Outcomes of Free Flap Reconstruction for Chronic Venous Ulceration in the Lower Limb: A Systematic Review.

BACKGROUND: The mainstay of treatment for venous ulceration is conservative wound management and lifelong compression therapy. For patients with recalcitrant ulcers, free flap reconstruction has been proposed as a treatment option to reconstruct the diseased soft tissues as well as the underlying insufficient venous system. This review systematically evaluates the outcomes of free flap reconstruction for chronic venous ulcers in the lower limb. METHOD: A protocol was developed a priori and registered on the PROSPERO database. A systematic search of literature was performed in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), clinical trials registries, and OpenGrey from inception to April 2020 according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Studies of patients undergoing free tissue transfer reconstruction for chronic venous ulcers in the lower limb were included. RESULTS: A total of 5 noncomparative cohort studies featuring 56 patients with 62 recalcitrant venous ulcers treated with 64 free flaps who had a mean age of 50 years (range, 17-76 years) were included, and a narrative analysis undertaken. Mean defect size following ulcer debridement was 153.3 cm 2 (range, 24-600 cm 2 ). Defects were reconstructed with muscle (n = 39 [60.9%]), fasciocutaneous (n = 23 [35.9%]), and visceral (n = 2 [3.1%]) free flaps, with latissimus dorsi (n = 16, 25%) and rectus abdominis flaps (n = 16, 25%) being the most frequently used. Mean follow-up ranged from 24 to 125 months. Pooled flap survival rate was 95%. No recurrence within the territory of the flap was reported, but there were 20 instances (35.7%) of new ulcers outside of the flap boundaries. CONCLUSION: There is currently an absence of evidence to support the use of free flap reconstruction for recalcitrant venous ulcers compared with conventional management. Although evidence suggests that it is technically feasible, there is no evidence to suggest it prevents ulceration outside the reconstructed region. Further studies are necessary to evaluate its effectiveness for venous ulcers in the lower limb.

[Venous ulcus cruris-Surgical treatment]. / Ulcus cruris venosum ­ chirurgische Therapie.

Venous ulcus cruris is usually a chronic disease and an extreme burden for patients and their families. An analysis based on a random statutory health insurance sample of the AOK Hessen/KV Hessen estimated the number of affected people to be 400,000 in Germany. A venous ulcus cruris is always caused by an underlying chronic venous insufficiency (CVI). A spontaneous healing of this chronic disease without treatment is not to be expected. The conservative treatment includes an adequate compression treatment and exudate management. Surgical treatment is based on three pillars: an open surgical or endovenous approach to resolve the pathological venous reflux, uIcer surgery and in rare cases the various procedures of fascia surgery as well as defect coverage by a combination of negative pressure wound therapy and skin transplantation.

A Randomized Trial of Early Endovenous Ablation in Venous Ulceration.

BACKGROUND: Venous disease is the most common cause of leg ulceration. Although compression therapy improves venous ulcer healing, it does not treat the underlying causes of venous hypertension. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence, but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear. METHODS: In a trial conducted at 20 centers in the United Kingdom, we randomly assigned 450 patients with venous leg ulcers to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed (deferred-intervention group). The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life. RESULTS: Patient and clinical characteristics at baseline were similar in the two treatment groups. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group; more patients had healed ulcers with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence interval [CI], 1.13 to 1.68; P=0.001). The median time to ulcer healing was 56 days (95% CI, 49 to 66) in the early-intervention group and 82 days (95% CI, 69 to 92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85.6% in the early-intervention group and 76.3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrollment was 306 days (interquartile range, 240 to 328) in the early-intervention group and 278 days (interquartile range, 175 to 324) in the deferred-intervention group (P=0.002). The most common procedural complications of endovenous ablation were pain and deep-vein thrombosis. CONCLUSIONS: Early endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation. (Funded by the National Institute for Health Research Health Technology Assessment Program; EVRA Current Controlled Trials number, ISRCTN02335796 .).

Surgery for deep venous insufficiency.

BACKGROUND: Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000. OBJECTIVES: To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain. MAIN RESULTS: We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence). AUTHORS' CONCLUSIONS: We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.

CHIVA method for the treatment of chronic venous insufficiency.

BACKGROUND: Many surgical approaches are available to treat varicose veins secondary to chronic venous insufficiency. One of the least invasive techniques is the ambulatory conservative hemodynamic correction of venous insufficiency method (in French 'cure conservatrice et hémodynamique de l'insuffisance veineuse en ambulatoire' (CHIVA)), an approach based on venous hemodynamics with deliberate preservation of the superficial venous system. This is the second update of the review first published in 2013. OBJECTIVES: To compare the efficacy and safety of the CHIVA method with alternative therapeutic techniques to treat varicose veins. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, AMED, and the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 19 October 2020. We also searched PUBMED to 19 October 2020 and checked the references of relevant articles to identify additional studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared CHIVA to other therapeutic techniques to treat varicose veins. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed and selected studies, extracted data, and performed quantitative analysis from the selected papers. A third author solved any disagreements. We assessed the risk of bias in included trials with the Cochrane risk of bias tool. We calculated the risk ratio (RR), mean difference (MD), number of people needed to treat for an additional beneficial outcome (NNTB), and the number of people needed to treat for an additional harmful outcome (NNTH), with 95% confidence intervals (CI). We evaluated the certainty of the evidence using GRADE. The main outcomes of interest were the recurrence of varicose veins and side effects. MAIN RESULTS: For this update, we identified two new additional studies. In total, we included six RCTs with 1160 participants (62% women) and collected from them eight comparisons. Three RCTs compared CHIVA with vein stripping. One RCT compared CHIVA with compression dressings in people with venous ulcers. The new studies included three comparisons, one compared CHIVA with vein stripping and radiofrequency ablation (RFA), and one compared CHIVA with vein stripping and endovenous laser therapy. We judged the certainty of the evidence for our outcomes as low to very low due to inconsistency, imprecision caused by the low number of events and risk of bias. The overall risk of bias across studies was high because neither participants nor personnel were blinded to the interventions. Two studies attempted to blind outcome assessors, but the characteristics of the surgery limited concealment. Five studies reported the outcome clinical recurrence of varicose veins with a follow-up of 18 months to 10 years. CHIVA may make little or no difference to the recurrence of varicose veins in the lower limb compared to stripping (RR 0.74, 95% CI 0.46 to 1.20; 5 studies, 966 participants; low-certainty evidence). We are uncertain whether CHIVA reduced recurrence compared to compression dressing (RR 0.23, 95% CI 0.06 to 0.96; 1 study, 47 participants; very low-certainty evidence). CHIVA may make little or no difference to clinical recurrence compared to RFA (RR 2.02, 95% CI 0.74 to 5.53; 1 study, 146 participants; low-certainty evidence) and endovenous laser (RR 0.20, 95% CI 0.01 to 4.06; 1 study, 100 participants; low-certainty evidence). We found no clear difference between CHIVA and stripping for the side effects of limb infection (RR 0.83, 95% CI 0.33 to 2.10; 3 studies, 746 participants; low-certainty evidence), and superficial vein thrombosis (RR 1.05, 95% CI 0.51 to 2.17; 4 studies, 846 participants; low-certainty evidence). CHIVA may reduce slightly nerve injury (RR 0.14, 95% CI 0.02 to 0.98; NNTH 9, 95% CI 5 to 100; 4 studies, 846 participants; low-certainty evidence) and hematoma compared to stripping (RR 0.59, 95% CI 0.37 to 0.97; NNTH 11, 95% CI 5 to 100; 2 studies, 245 participants; low-certainty evidence). For bruising, one study found no differences between groups while another study found reduced rates of bruising in the CHIVA group compared to the stripping group. Compared to RFA, CHIVA may make little or no difference to rates of limb infection, superficial vein thrombosis, nerve injury or hematoma, but may cause more bruising (RR 1.15, 95% CI 1.04 to 1.28; NNTH 8, CI 95% 5 to 25; 1 study, 144 participants; low-certainty evidence). Compared to endovenous laser, CHIVA may make little or no difference to rates of limb infection, superficial vein thrombosis, nerve injury or hematoma. The study comparing CHIVA versus compression did not report side effects. AUTHORS' CONCLUSIONS: There may be little or no difference in the recurrence of varicose veins when comparing CHIVA to stripping (low-certainty evidence), but CHIVA may slightly reduce nerve injury and hematoma in the lower limb (low-certainty evidence). Very limited evidence means we are uncertain of any differences in recurrence when comparing CHIVA with compression (very low-certainty evidence). CHIVA may make little or no difference to recurrence compared to RFA (low-certainty evidence), but may result in more bruising (low-certainty evidence). CHIVA may make little or no difference to recurrence and side effects compared to endovenous laser therapy (low-certainty evidence). However, we based these conclusions on a small number of trials with a high risk of bias as the effects of surgery could not be concealed, and the results were imprecise due to the low number of events. New RCTs are needed to confirm these results and to compare CHIVA with approaches other than open surgery.

Complete Venous Ulceration Healing after Perforator Ablation Does Not Depend on Treatment Modality.

BACKGROUND: Venous leg ulceration (VLU) represents the most advanced form of chronic venous insufficiency (CVI). Persistent VLU that fails to respond to noninvasive treatment requires a minimally invasive endovascular treatment, which may include chemical (ultrasound-guided foam sclerotherapy [UGFS]) and thermal ablation (endovenous laser therapy [EVLT] or radiofrequency ablation [RFA]) targeting incompetent veins. Current guidelines suggest ablation of incompetent perforating veins (IPVs) juxtaposed to active or healed VLU; however, the ideal treatment modality is unknown. We hypothesize that similar to incompetent superficial vein treatment options therapies, VLU healing will be equivalent across minimally invasive IPV treatment options. METHODS: Using the Vascular Low Frequency Disease Consortium, adults with VLU across 11 medical centers were retrospectively reviewed (2013-2017). We included those who underwent IPV therapies. The primary outcome was complete ulcer healing over time compared with cumulative hazard curves, log-rank testing, and multivariable Cox proportional hazard regression. Secondary outcomes included number of subsequent procedures, which were compared using negative binomial regression. RESULTS: Of the 832 adults with VLU, 158 (19%) were exclusively treated conservatively, and 232 (28%) underwent index treatment for IPV and constitute the full and final cohort. The mean age was 60 ± 14 years, 57% were men, and the mean ulcer area was 3.0 cm2 (interquartile range, 1-6 cm2). Ninety-one (39%) were treated with EVLT, 127 (55%) RFA, and 14 (6%) UGFS. Patients treated with RFA were older (RFA 62 ± 14 years; EVLT 59 ± 14 years; UGFS 52 ± 9 years; P = 0.01), more likely to be men (RFA 68%, n = 86; EVLT 41%, n = 37; UGFS 64%, n = 9; P < 0.001), with a higher frequency of anticoagulation (RFA 36%, n = 46; EVLT 18%, n = 16; UGFS 14%, n = 2; P = 0.005). VLU did not significantly differ in size between groups (RFA 6.2 ± 8; EVLT 4.2 ± 5.4; UGFS 6.1 ± 8; P < 0.001). There were no differences in 1-year ulcer healing rates between groups (P = 0.18). The number of subsequent procedures did not differ by treatment modality (P = 0.47). CONCLUSIONS: This multi-institutional retrospective study does not demonstrate any association of IPV treatment modality with differing rates of VLU healing or number of subsequent procedures.

Iatrogenic Arteriovenous Fistula Formation after Endovenous Laser Treatment Resulting in High-output Cardiac Failure: A Case Report and Review of the Literature.

Formation of a clinically significant iatrogenic arteriovenous fistula after endovenous laser treatment of the great saphenous vein is an extremely rare complication. Because of the infrequency of reported cases, there is no clear consensus on how to best manage this complication. We present a unique case of an iatrogenic high-output superficial femoral artery-common femoral vein fistula resulting in right heart failure and a distal deep vein thrombosis. Deployment of a covered arterial stent graft resulted in resolution of the arteriovenous fistula and high-output cardiac state. Clinically significant arteriovenous fistulas resulting from inadvertent vessel injury during endovenous laser treatment appear to be amenable to percutaneous endovascular interventions. During these challenging endovascular cases, intravascular ultrasonography can be used to help delineate the morphology of the fistula tract and obtain vessel measurements to ensure accurate endoprosthesis sizing and placement.

[Long-term healing of a therapy-refractory venous leg ulcer after crural fasciectomy and split skin graft transplantation]. / Langfristige Abheilung eines therapierefraktären Ulcus cruris venosum nach kruraler Fasziektomie und Spalthauttransplantation.

A 59-year-old obese woman had been suffering from a painful, chronic leg ulcer since 1986. We diagnosed a venous leg ulcer due to functional chronic venous insufficiency in the context of obesity per magna (dependency syndrome) and arthrogenic congestion syndrome due to immobility. Although a high ligation and stripping of the great saphenous vein and several so-called shave therapies with split skin transplantation after appropriate wound bed preparation had been previously performed, the wound persisted. In 2012, the patient wanted to amputate her leg because the course of wound healing was so refractory to therapy and she suffered from severe pain. As an alternative to amputation, we performed a crural fascietomy and, after a wound bed preparation with two cycles of negative pressure wound therapy, we covered the defect with a split skin graft using the mesh graft technique. The surgery could be performed without complications and the skin healed completely. At the current presentation 7 years after the intervention, complete healing of the previously therapy-refractory venous leg ulcer was shown despite the persistent obesity per magna and immobility. This case report shows that a crural fasciectomy should be considered, especially in the case of otherwise therapy-refractory courses of venous leg ulcers.

Er:YAG laser vs. sharp debridement in management of chronic wounds: Effects on pain and bacterial load.

Chronic wounds affect roughly 6.5 million patients in the US annually. Current standard of therapy entails weekly sharp debridement. However, the sharp technique is associated with significant pain, while having minimal impact on the bioburden. Our study proposes the Er:YAG laser as an alternative method of debridement that may decrease procedural pain, reduce bioburden, and potentially improve overall healing. This pilot study was performed as a prospective, randomized, controlled, crossover clinical trial, containing two groups: (1) one group underwent single laser debridement session first, followed by single sharp debridement session one week later; and (2) the other group underwent single sharp debridement session first, followed by single laser debridement session one week later. Variables analyzed included pain during debridement, pre- and post-debridement wound sizes, pre- and post-debridement bacterial loads and patient preference. Twenty-two patients were enrolled (12 patients in Group 1, plus 10 patients in Group 2). The mean pain score for patients undergoing laser debridement was 3.0 ± 1.7 vs. 4.8 ± 2.6 for those undergoing sharp debridement (p = 0.003). The mean percent change in wound size 1-week post-laser debridement was -20.8% ± 80.1%, as compared with -36.7% ± 54.3% 1-week post-sharp debridement (p = 0.6). The percentage of patients who had a bacterial load in the low/negative category increased from 27.3% to 59.1% immediately after laser debridement (p = 0.04), vs. 54.5% to 68.2% immediately after sharp debridement (p = 0.38). Moreover, there was a sustained decrease in bacterial load 1-week post-laser debridement, as compared with no sustained decrease 1-week post-sharp debridement (p < 0.02). Overall, 52.9% of patients preferred laser debridement vs. 35.3% for sharp debridement. We believe that Er:YAG laser serves as a promising technology in chronic wounds, functioning as a potentially superior alternative to sharp debridement, the current standard of therapy.

[Modern ulcer surgery : Invasive treatment options using the example of therapy-resistant venous leg ulcers]. / Moderne Ulkuschirurgie : Invasive Behandlungsoptionen am Beispiel des therapieresistenten Ulcus cruris venosum.

The socioeconomic significance of chronic venous leg ulcers is considerable due to the high number of patients, the costs of diagnosis and therapy, the deterioration in quality of life, and the loss of working capacity during the disease. This is further increased by a progressive course and an increased tendency to recurrence. Taking these facts into account, surgical treatment options are of particular importance, especially in otherwise therapy-refractory courses. For this purpose, an extensive spectrum of surgical and new, partly not yet finally evaluated, invasive techniques are now available. Venous surgery and endovenous closure techniques are suitable for eliminating primary or secondary varicosis as a causal therapy for venous leg ulcers. Shave therapy is the method of choice in the presence of dermatolipo(fascio)sclerosis. Current long-term results show good results with cure rates of 70-80%. In individual cases, surgical techniques involving fascia cruris (faciotomy, fasciotomy) can also be used. Recurrence ulcers can often be successfully treated by repeated shave therapy, optionally with simultaneous vacuum-assisted dressing techniques or by a fasciotomy. In addition, local invasive techniques such as autologous fat tissue transplantation or autologous platelet-rich plasma can be used to promote wound healing. Thus, both surgically invasive local therapy and advanced surgery of the causes of chronic venous leg ulcers play a key role in the overall therapy concept.

Transilluminated powered phlebectomy in the treatment of large area venous leg ulcers: A case-control study with 3 years follow-up.

OBJECTIVE: To evaluate the efficacy, safety and long-term outcome of TIPP for the adjunct therapy of superficial venous reflux-related VLUs. METHODS: A total of 93 consecutive patients (104 legs) with superficial venous insufficiency-related VLUs who underwent TIPP (53 legs) or conventional phlebectomy (51 legs) between January 2010 and December 2013 were retrospectively studied. RESULTS: Compared to patients in the conventional phlebectomy group, TIPP patients had larger ulcer areas before surgery (P < 0.005). However, TIPP group required a significantly shorter operation time (P < 0.005), fewer incisions (P < 0.005) but less ulcer healing time (1.25 month vs 2.5 months, P < 0.05). No significant difference in in-hospital and follow-up complications was found between the two groups. For long-term outcome, TIPP group leaded a lower ulcer recurrence rate at 36 months (13.2% vs 29.4%, P < 0.05). CONCLUSION: TIPP may be an adjunct surgical method contributes to healing of VLUs, especially for large ulcer areas.

Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration.

BACKGROUND: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers. METHODS: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol. RESULTS: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective. CONCLUSION: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com).