Summaries of recent phlebological abstracts

J Vasc Surg: Venous Lym Dis 2018; 6: 183–191

The purpose was to compare medical and endovascular treatment results in symptomatic chronic venous disease (CVD) patients with significant iliac vein obstruction (IVO) documented by intravascular ultrasound (IVUS). Patients with CEAP class C3 to C6 and a visual analog scale for pain (VAS pain) score > 3 were considered eligible. Limbs were randomly assigned with > 50% IVO on IVUS to undergo medical treatment alone or medical treatment plus iliac vein stenting. The patient and clinical physician were blinded. Primary outcomes included change from baseline in VAS pain score, VCSS, and 36-Item Short Form Health Survey quality of life questionnaire. Secondary outcomes included stent integrity, migration, and patency rates at six months. Of 207 CVD patients, 58 (28%) were eligible and eight (14%) were excluded; 51 of 85 class C3 to C6 limbs (60%) had > 50% IVO by IVUS. Iliac vein stenting, in randomized patients, was 100% technically successful. At six months’ follow-up, the mean VAS pain score declined from a median of 8 to 2.5 in patients receiving stents and from eight to seven in patients receiving only medical treatment (P < .001). The VCSS dropped from a median of 18.5 to 11 after stenting and from 15 to 14 with medical treatment (P < .001). The 36-Item Short Form Health Survey (0–100) improved from a total median score of 53.9 to 85.0 with stenting and 48.3 to 59.8 after medical treatment (P < .001). There was no stent fracture or migration, and the primary, assisted primary, and secondary patency rates were 92%, 96%, and 100%, respectively (median, 11.8; range, 6–18 months). Endovascular treatment of IVO with stenting is safe and promotes effective relief of symptoms and improvement in quality of life compared with medical treatment alone in symptomatic CVD patients.

Int Wound J 2018; Epub ahead of print, DOI: 10.1111/iwj.12911

The authors’ aim in this retrospective and prospective longitudinal study was to validate a novel tool for predicting ulcer recurrence over a period of 12 months. Area under the receiver operating characteristic curve (AUC) analysis was utilized to predict performance. In the retrospective study (n = 250), 55% of venous leg ulcers recurred within 12 months, and the risk assessment total score had excellent discrimination and goodness of fit with an AUC of 0.83 (95% CI, 0.76–0.90, P < .001). The prospective study (n = 143) observed that 50.4% (n = 63) of venous leg ulcers recurred within 12 months of healing. Participants were classified using the risk assessment tool as being at low risk (28%), moderate risk (59%), and high risk (13%). The proportion of wounds recurring at 12 months was 15%, 61%, and 67% for each group, respectively. Validation results indicated good discrimination and goodness of fit, with an AUC of 0.73 (95% CI, 0.64–0.82, P < .001).The authors concluded that this risk assessment tool for the recurrence of venous leg ulcers provides clinicians with a resource to identify high-risk patients.

J Cutan Aesthet Surg 2017; 10: 200–206

The authors evaluated the feasibility and potential healing capacity of scalp follicular unit grafts transplanted into the bed of chronic leg ulcers. The premise for this trial was based on the fact that restoration of epithelium after injury takes place by migration of epithelial cells adjoining a wound or by centrifugal migration from hair follicles.

A total of 15 patients with 17 nonhealing ulcers of more than six weeks were treated. Uncontrolled diabetic patients and infected ulcers were excluded. The following methods were utilized: follicular unit grafts were harvested under local anesthesia using small-diameter (1 mm) circular punches; a density of 5 follicular grafts/cm² was implanted into the ulcer bed; the ulcer was dressed with Vaseline gauze and elastic bandage for 24 h; the wound area and volume were calculated by length × width × 0.7854 and length × width × depth × 0.7854, respectively. Eighteen weeks after intervention, the outcome was defined as the percentage in change of area and volume of the ulcer. Of these 17 ulcers, 11 were venous ulcers, 2 were pyoderma gangrenosum associated with varicose veins, and other etiologies. The mean area of the ulcer was 6.72 cm² and volume was 2.87 cm³. At the end of 18 weeks, the final area of the ulcer was 3.84 cm² and the final volume was 1.21 cm³ (both measurements achieved statistical significance). The mean percentage improvement in the area and volume of the ulcer was 48.8% and 71.98%, respectively. There were no adverse events after the procedure.

The authors concluded that follicular unit grafting into wound beds is feasible and represents a promising therapeutic alternative for managing nonhealing chronic leg ulcers.

Ann Vasc Surg 2018; Epub ahead of print, pii: S0890-5096(16)30978-5

The authors in a prospective study compared patients’ outcomes to two different procedures: ligation after foam sclerotherapy (FSL) and with foam sclerotherapy (FS) alone. Ninety-four patients with varicose veins underwent FS alone; 88 patients with varicose veins received FSL. Patients were seen at 1, 3, 6, and 12 months after treatment. Patients treated with FS had higher incidence of phlebitis than the FSL cohort at four weeks (14.9% vs. 1.1%, P = 0.002) and at 6 months (10.6% vs. 0, P = 0.002), higher incidence of tenderness or discomfort (9.8% vs. 0, P = 0.003), and recanalization rate (8.5% vs. 1.1%, P = 0.007) at six months. All patients in both groups had no deep vein thrombosis or pulmonary embolism.

The authors concluded that patients treated with FSL have less postoperative complications than those with FS. FSL is an alternative procedure for management of patients with varicose veins.

Eur J Vasc Endovasc Surg 2018; 55: 222–228

A database of patients with severe PTS who successfully underwent endovascular iliofemoral stenting was reviewed retrospectively. Patients with impaired inflow with chronic post-thrombotic obstructive lesions in the femoral vein (FV), but patent profunda vein, were selected and divided into two groups: the FV stenting (FVS) group and the FV angioplasty (FV-A) group. Patients in the FV-S group were treated with concomitant iliofemoral and FV stenting, and patients in the FV-A group were treated with iliofemoral stenting and balloon angioplasty alone of the obstructed femoral vein. The clinical and stent outcomes were recorded and compared in the two groups. There were 45 patients in the FV-S group and 69 patients in the FV-A group. The groups were well matched for age, gender, and diseased limbs. The pre-procedural symptoms, CEAP classifications, VCSS scores, Villalta scores, and prevalence of active ulcers were also similar between the two groups. Immediate failure (<30 days post-procedure) in the femoral segment occurred more frequently in the FV-A group (70% in FV-A group vs. 24% in FV-S group, p < .001); however, all treated femoral vein segments had occluded at 12 months. There was no significant difference between the FV-S and FV-A groups in cumulative primary and secondary patency rates of the iliofemoral stent at three years (55% vs. 52%, p = .71, and 77% vs. 85%, p = .32, respectively). Complete pain relief, swelling relief, VCSS score, Villalta score, and freedom from ulcers at a median of 22 months (1–48 months) following the procedure were similar in the two groups. The authors concluded that stent placement to treat post-thrombotic iliofemoral obstruction with concomitant obstructed femoral vein but patent profunda vein shows cumulative patency rates and clinical outcomes similar to previous reports. Adjunctive femoral stenting or angioplasty of the obstructed femoral vein does not appear to improve clinical or stent outcomes in patients with severe PTS.

Cien Saude Colet 2018; 23: 913–922

The authors’ aim was to verify whether the association of the rural elderly patients who are overweight had self-reported co-morbid conditions, functional disabilities, as well as quality of life (QOL) issues. Three hundred seventy non-overweight elderly people and 192 overweight elderly people were evaluated with the following tools: semi-structured; Katz and Lawton and scales; World Health Organization Quality of Life – BREF and World Health Organization Quality of Life Assessment for Older Adults. Overweight was associated with morbidities, arthritis/osteoarthritis (p = 0.002), systemic arterial hypertension (p < 0.001), varicose veins (p = 0.009), heart problems (p = 0.028), diabetes mellitus (p = 0.001), cerebrovascular accident (p = 0.044), and urinary incontinence (p = 0.032). Overweight elderly had lower scores in the physical realm (p = 0.005) and higher scores in social relationships (p = 0.033) compared to those without this condition.

The authors state that it is important to monitor the nutritional status of rural elderly to prevent comorbidities and improve quality of life.

Eur J Vasc Endovasc Surg 2017; 54: 760–770

The objective of this systematic review and meta-analysis was to compare the long-term efficacy of these different treatment modalities. Randomised controlled trials (RCTs) with follow-up > 5 years were included. Pooled proportions of anatomical success, which was the primary outcome, rate of recurrent reflux at the saphenofemoral junction (SFJ), and mean difference in VCSS were compared using a z test or Student t test. Quality of life data were assessed and described. Three RCTs and 10 follow-up studies of RCTs were included, of which 12 were pooled in the meta-analysis. In total, 611 legs were treated with endovenous laser ablation (EVLA), 549 with high ligation with stripping (HL + S), 121 with ultrasound-guided foam sclerotherapy (UGFS), and 114 with HL + EVLA. UGFS had significantly lower pooled anatomical success rates than HL + S, EVLA, and EVLA with high ligation: 34% (95% CI: 26–44) versus 83% (95% CI: 72–90), 88% (95% CI: 82–92), and 88% (95% CI: 17–100) respectively; p < .001. The pooled recurrent reflux rate at the SFJ was significantly lower for HL + S than UGFS (12%, 95% CI: 7–20 vs. 29%, 95% CI: 21–38; p < .001) and EVLA (12%, 95% CI: 7-20 vs. 22%, 95% CI: 14–32; p = .038). VCSS scores were pooled for EVLA and HL + S, which showed similar improvements. The investigators concluded that EVLA and HL + S show higher success rates than UGFS five years after GSV treatment. Recurrent reflux rates at the SFJ were significantly lower in HL + S than UGFS and EVLA. VCSS scores were similar between EVLA and HL + S.

J Vasc Surg: Venous Lym Dis 2018; 6: 192–200

The objective of this study was to assess the safety and efficacy of a dedicated venous stent (the VICI VENOUS STENT; VENITI, Fremont, CA) for treatment of symptomatic iliofemoral venous outflow obstruction. Thirty patients (24 female; median age, 43 years) were enrolled in the feasibility phase of an international, multicenter investigational device exemption trial from June 2014 to February 2015. All patients exhibited unilateral venous disease with $50% stenosis in the iliofemoral veins. Patients within three months of acute deep venous thrombosis or with prior surgical or endovascular intervention of the target vessel were excluded. Lesions were primarily of postthrombotic causes (63%), with a left limb–right limb ratio of 5:1. Nine patients (30%) had lesions extending beneath the inguinal ligament. Median baseline stenosis was 91%; 11 patients (37%) had occlusions. Fifty-one stents were implanted successfully in 30 patients. Median residual stenosis was 0%, as estimated by venography and intravascular ultrasound. Median follow-up was 701 days. At 12 months, primary, assisted-primary, and secondary patency was 93%, 96%, and 100%, respectively. The stent occluded in two patients through the 12-month window (occurring at 19 and 385 days). Both occlusions occurred in patients presenting with postthrombotic obstruction. No patients in this cohort exhibited stent fracture at 12 months. Symptomatic improvement of > 2 points on the VCSS was observed in 23 patients (85%) at 12 months (median score improvement, 5 points). There was a median 12-month pain reduction of 20 mm on the visual analog scale score and 15-point improvement on the Chronic Venous Insufficiency Questionnaire score. Scores improved significantly on all three clinical and quality of life scales at 6 and 12 months. In conclusion, the VICI VENOUS STENT is safe and feasible for treatment of symptomatic iliofemoral venous obstruction, with excellent 12-month patency rates and significant improvement seen in clinical symptoms and quality of life indices. The pivotal phase (170 patients, 22 centers) of this investigational device exemption trial is currently ongoing.