Five-year follow-up of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia.

OBJECTIVE: The objective of this study was to compare the long-term results (groin-related recurrence, great saphenous vein [GSV] occlusion rate, Clinical class, Etiology, Anatomy, and Pathophysiology [CEAP] staging, and quality of life [QoL]) after the treatment of a GSV incompetence by saphenofemoral ligation and stripping (SFL/S) with endovenous laser ablation bare fiber, 980 nm (EVLA). METHODS: Patients with GSV insufficiency and varicose veins were randomized to either undergo SFL/S or EVLA, both of which were performed under tumescent anesthesia. The long-term results, which included the anatomic occlusion rate, varicose vein recurrence at the saphenofemoral junction (SFJ), relief of venous symptoms and QoL, were compared up to 5 years after treatment. RESULTS: A total of 130 legs of 121 patients were treated with either SFL/S (n = 68) or EVLA (n = 62). In the first 12 months, three recanalizations of the GSV were observed after EVLA. Up to 5 years later, more recurrent varicose veins caused by neoreflux in incompetent tributaries of the SFJ were observed in after EVLA (31%; 19/61) compared with SFL/S (7%; 4/60; P < .01). Neovascularization in the groin with clinically visible recurrence identified at 3 and 5 years post-treatment follow-up was only observed in the SFL/S group (n = 6). After 5 years, clinically visible recurrences originating from the SFJ region after EVLA were observed 33% (20/61) compared with 17% of patients (10/60) after SFL/S (P < .04). In both treatment groups, venous symptoms improved significantly. Patients in both groups reported a continuing significant cosmetic improvement measured on a visual analog scale of 1 to 10 (mean, 7.49; P < .01). There was no difference in the CEAP staging and a standardized, non-disease-specific instrument for describing and valuing health states (EuroQol-5D), between the groups up to 5 years after follow-up. CONCLUSIONS: At the 5-year follow-up, a significantly higher varicose vein recurrence rate originated at the SFJ region after EVLA compared with SFL/S. There were no differences in the relief of venous symptoms, CEAP staging, or general QoL between the groups.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence.

BACKGROUND: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). METHODS: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. RESULTS: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). CONCLUSIONS: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

The quality of life in patients after peripheral bypass surgery deteriorates at long-term follow-up.

OBJECTIVE: We aimed to study the long-term development of health-related quality of life (HR-QoL) in patients with peripheral arterial disease after they underwent peripheral bypass surgery and to evaluate the influence of adverse vascular events that occurred during follow-up. METHODS: We compared current HR-QoL scores with previous measurements in patients who participated in the Dutch Bypass and Oral Anticoagulants or Aspirin (BOA) Study between 1995 and 1998 after they underwent infrainguinal bypass surgery. Patients from six centers that contributed most to the Dutch BOA Study (n = 482) were followed up retrospectively from 1995 up to 2009. RESULTS: At a mean follow-up of 11 years since BOA randomization, 165 of the 482 patients were alive of whom 123 (75%) completed the EQ-5D and RAND-36 questionnaires. Fifty-three patients completed the questionnaires three times: at BOA entry, at BOA close-out, and at BOA long-term follow-up. In these patients the HR-QoL scores decreased over time, especially for the physical health dimension. In comparison with the general population, matched for age and gender, the HR-QoL scores at both BOA entry and long-term follow-up were substantially lower, even if the patient's graft was patent and no other vascular events had occurred. The occurrence of an adverse vascular event worsened the physical health state further. CONCLUSIONS: The physical HR-QoL in patients with peripheral arterial disease (PAD) after peripheral bypass surgery was highly impaired, independent of graft patency, and deteriorated further over time. An adverse vascular event worsened the physical health state and underlined the importance of atherosclerotic risk management as well as stimulation of physical activity in patients with peripheral arterial disease to preserve HR-QoL.

Bleeding increases the risk of ischemic events in patients with peripheral arterial disease.

BACKGROUND: Patients with peripheral arterial disease are at high risk of ischemic events and therefore are treated with antithrombotics. In patients with coronary artery disease or cerebrovascular disease, bleeding is related to the subsequent occurrence of ischemic events. Our objective was to assess whether this is also the case in patients with peripheral arterial disease. METHODS AND RESULTS: All patients from the Dutch Bypass and Oral Anticoagulants or Aspirin (BOA) Study, a multicenter randomized trial comparing oral anticoagulants with aspirin after infrainguinal bypass surgery, were included. The primary outcome event was the composite of nonfatal myocardial infarction, nonfatal ischemic stroke, major amputation, and cardiovascular death. To identify major bleeding as an independent predictor for ischemic events, crude and adjusted hazard ratios with 95% confidence intervals were calculated with multivariable Cox regression models. From 1995 until 1998, 2650 patients were included with 101 nonfatal major bleedings. During a mean follow-up of 14 months, the primary outcome event occurred in 218 patients; 22 events were preceded by a major bleeding. The mean time between major bleeding and the primary outcome event was 4 months. Major bleeding was associated with a 3-fold increased risk of subsequent ischemic events (crude hazard ratio, 3.0; 95% confidence interval, 1.9 to 4.6; adjusted hazard ratio, 3.0; 95% confidence interval, 1.9 to 4.7). CONCLUSIONS: In patients with peripheral arterial disease, as in patients with coronary artery disease or cerebrovascular disease, major bleeding was independently associated with major ischemic complications. Without compromising the benefits of antithrombotics, these findings call for caution relative to the risks of major bleeding.

Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radiofrequency-powered segmental ablation or 1470-nm endovenous laser ablation with radial-tip fibers (Varico 2 study).

BACKGROUND: Endovenous laser ablation (EVLA) and radiofrequency-powered segmental ablation (RPSA) of the incompetent great saphenous vein (GSV) are both known for their excellent technical and clinical outcomes for the treatment of varicose veins. RPSA has reduced postprocedural pain and morbidity with shorter recovery time for the patient compared with EVLA using bare-tip fibers. However, new-generation EVLA devices with less traumatic radial-tip fibers (RTFs) operating at longer wavelengths up to 1470 nm also reduce postprocedural pain. The objective of this study was to compare long-term effectiveness of GSV thermal ablation and postprocedural recovery using RPSA or 1470-nm EVLA with RTF (EVLA-RTF). METHODS: In a comparative prospective monthly altering-treatment cohort study of 311 patients (346 treated legs), each leg with incompetence of the GSV was treated with either RPSA (158 patients, 175 legs) or EVLA-RTF (153 patients, 171 legs). The primary outcome was anatomic occlusion of the GSV, assessed at 12, 24, 36, 48, and 60 months using Kaplan-Meier statistics and compared using the log-rank test. Secondary outcomes included freedom of varicose vein recurrence, clinical success measured by Venous Clinical Severity Score (VCSS), disease-specific quality of life determined using the Aberdeen Varicose Vein Questionnaire (AVVQ), postoperative pain scores, and time to return to work. RESULTS: The total primary obliteration rate after 36 and 60 months was 96.2% with RPSA and 96.7% with EVLA-RTF (P = .81). Freedom of symptomatic anterior accessory vein recurrence after 5 years was 85% after RPSA and 87% after EVLA-RTF (P = .50). VCSS and AVVQ score presented similar and durable improvements in both groups between 6 weeks and 60 months. There was no difference in postoperative pain scores after both treatments during the first 14 days (mean visual analog scale score, 0.54-2.19). The median time for return to work was 1 day after both treatments. No severe adverse events were observed. CONCLUSIONS: RPSA and EVLA-RTF have similarly high GSV obliteration rates in the long term, and the treatments are equally effective clinically. Both treatments are associated with similar minimal postprocedural pain scores and short recovery times.

A review of a new Dutch guideline for management of recurrent varicose veins.

In 2013, the new Dutch guideline for "Venous Pathology" was published. The guideline was a revision and update from the guideline "Diagnostics and Treatment of Varicose Veins" from 2009 and the guideline "Venous Ulcer" from 2005. A guideline for "Deep Venous Pathology" and one for "Compression Therapy" was added to the overall guideline "Venous Pathology." The chapter about treatment of recurrent varicose veins after initial intervention was recently updated in 2015 and is reviewed here. The Dutch term "recidief varices" or the French "récidive de varices" should be used analogous to the English term "recurrent varicose veins." The DCOP Guideline Development Group Neovarices concluded that "recidief" in Dutch actually suggests recurrence after apparent successful treatment and ignores the natural progression of venous disease in its own right. So the group opted to use the term "neovarices." In the Dutch guideline, neovarices is meant to be an all embracing term for recurrent varicose veins caused by technical or tactical failure, evolvement from residual refluxing veins or natural progression of varicose vein disease at different locations of the treated leg after intervention. This report reviews the most important issues in the treatment of varicose vein recurrence, and discusses conclusions and recommendations of the Dutch Neovarices Guideline Committee.

Long-term risk of vascular events after peripheral bypass surgery. A cohort study.

Patients with peripheral arterial disease (PAD) are at high risk of major ischaemic events. Long-term data of all major ischaemic events in PAD patients are scarce and outdated, especially for patients with severe PAD requiring bypass surgery. Our objective was to define their long-term prognosis and develop a prediction model which quantifies this risk up to a decade after surgery. We conducted a retrospective cohort study in patients from the Dutch Bypass Oral anticoagulants or Aspirin (BOA) Study; a multicentre randomised trial comparing oral anticoagulants with aspirin after infrainguinal bypass surgery. The primary outcome was the composite event of non-fatal myocardial infarction, non-fatal ischaemic stroke, major amputation, and vascular death. Cumulative risks were assessed by Kaplan-Meier analysis and independent determinants by multivariable Cox regression models. From 1995 until 2009, 482 patients were followed for a median period of 7.8 years. Follow-up was complete in 94%. Overall 60% of patients experienced a primary outcome event, of which the majority was a vascular death (30%), followed by major amputations (12%). The primary cause of vascular death was a cardiovascular event (29%), whereas the minority was due to complications directly related to PAD (6%). Within five years after bypass surgery vascular death occurred in about a quarter of patients and within 10 years in nearly half of patients. This was double the rate as for non-vascular death. The primary outcome event occurred in over a third and over half of patients in 5 and 10 years after bypass surgery, respectively. From four independent determinants for the primary outcome event: age, diabetes, critical limb ischaemia, and prior vascular interventions, we developed a risk chart, which systematically classifies the 10-year risks of the primary outcome event, ranging from 25% to 85%. This study provided a detailed insight in the course of PAD long after peripheral bypass surgery and enables individual risk assessment of major fatal and non-fatal ischaemic events by means of cumulative incidences and a risk chart.