A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial).

BACKGROUND: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. METHODS: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. RESULTS: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. CONCLUSION: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months. REGISTRATION NUMBER: NTR 4821 (www.trialregister.nl).

Rationale and current evidence of aquatic exercise therapy in venous disease: A narrative review.

Chronic venous disorders (CVD) of the lower limbs can be treated with different strategies. Typically, conservative management is based on compression therapy, anticoagulants and venoactive drugs. Endovenous treatments remain the gold standard to treat saphenous insufficiency, with sclerotherapy and surgery maintaining a role in selected cases. In addition, several 'unconventional' approaches have been proposed to prevent CVD progression and complications, minimize symptoms and improve the quality of life and postoperative outcomes. Among these, balneotherapy and aquatic exercises are proving as valid and effective supporting treatments, as mentioned in a growing number of scientific publications. Moreover, aquatic protocols have been studied for both venous and lymphatic insufficiency. For these reasons, they were mentioned in the last CVD guidelines provided by the European Society for Vascular Surgery. The aim of this narrative review is to overview and summarize current literature evidences on the role and effectiveness of aquatic rehabilitative protocols in CVD, reviewing old and current literature. Furthermore, the physical basis of the effects of water immersion on lower limb venous and tissues modifications are also described.

[Truncal mechanochemical versus thermal endovenous ablation for varicose vein disease: a systematic review and meta-analysis]. / Sistematicheskii obzor i metaanaliz rezul'tatov primeneniya stvolovoi mekhanokhimicheskoi i termal'noi obliteratsii u patsientov s varikoznoi bolezn'yu.

OBJECTIVE: To compare the outcomes of thermal and mechanochemical endovenous ablative techniques in patients with varicose veins. MATERIAL AND METHODS: We searched the PubMed, EMBASE and Cochrane Library databases for studies devoted to mechanochemical and thermal endovenous ablative techniques from inception until July 2021. The primary outcome was anatomical success. Secondary endpoints were intraoperative pain syndrome, complications, modification of disease severity and quality of life. RESULTS: This meta-analysis enrolled 10 comparative studies and 1.252 participants after truncal ablations. The follow-up period ranged from 4 weeks to 36 months. With regard to overall anatomical success, 245 out of 267 (91.8%) patients after mechanochemical ablation and 249 out of 266 (93.6%) patients after thermal ablation had favorable results after a month (low-quality evidence; odds ratio [OR] 0.79; 95% CI 0.40-1.55). No statistical heterogeneity was identified (χ2=1.48; df=2; p=0.48; I2=0%). Further analysis identified different incidence of total occlusion after 12 months or later (OR 0.36; 95% CI 0.11-1.21; p=0.05; I2=68%). Mechanochemical ablation resulted less intraoperative pain. Mean difference was -1.3 (95% CI -2.53- -0.07; p=0.00001). MOCA was followed by fewer incidence of nerve injury, hematoma, deep vein thrombosis and phlebitis. There were more cases of skin pigmentation compared to thermal ablation (low-quality evidence, p>0.05). Subsequent assessment of disease severity identified significant between-group difference of means (-0.64 (95% CI -1.82-0.53; p=0.004) and -0.16 (95% CI -0.43-0.11; p=0.005) after 6 and 12 months, respectively). Further assessment of quality of life revealed no between-group differences. These data were characterized by moderate methodological quality. CONCLUSION: Mechanochemical ablation is as effective as standard TA within the first postoperative month. However, this approach is associated with lesser anatomical success after 12 months. In most studies, pain syndrome was less severe in case of mechanochemical ablation. These data suggest that mechanochemical ablation is a safe alternative for varicose veins. However, further large-scale trials are required to define the role of MOCA.

A nutraceutical formulation combined with sclerofoam-assisted laser treatment ameliorates chronic venous insufficiency.

Chronic venous insufficiency has a high impact on the healthcare system due to its high incidence worldwide. We performed a study in 30 women with thigh and leg varices due to major saphenous vein valve incontinence with saphenous trunk reflux causing phlebo-lymphoedema to assess the efficacy of sclerofoam-assisted laser treatment combined with nutraceutical administration. The patients underwent endovascular combination sealing of the saphenous trunk with sclerofoam-assisted laser treatment technique into the major saphenous veins under low-volume tumescent anesthesia followed by intraoperative phlebectomies. Post-operatively, the patients received capsules containing Aesculus Hippocastanum, chondroitin sulphate, proanthocyanidins from Pinus pinaster Aiton, proanthocyanidins from Vitis vinifera L., hydrolysed marine collagen and carcinine dihydrochloride for 3 weeks. We evaluated the extracellular fluid volume of the lower limbs using bioimpedance spectroscopy pre- (T0) and post-surgery (T2) (impedance is a vector which is composed of two components, resistance [RES] and reactance [REA)]). In addition, we evaluated the following parameters pre- and post-surgery: pain, heaviness, paresthesia, itching, swelling, daily urine volume output and leg volume. Limb volume was significantly decreased at T2 compared to T0 (p < 0.01). RES and REA were significantly increased at T2 compared to T0 (p < 0.0001 and p < 0.01, respectively). A significant improvement in heaviness, paresthesia, pain, swelling and itch was also observed (all p < 0.0001) while no changes in terms of diuresis occurred. No adverse effects were observed. The present study shows a promising approach to the treatment of chronic venous insufficiency that warrants further clinical studies in larger cohorts of patients.

Ten-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 long-term results of saphenofemoral ligation and stripping (SFL/S) were compared with 980-nm bare fiber endovenous laser ablation (EVLA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: This was a single-center, randomized, controlled trial with a follow-up time of 10 years. Patients with GSV incompetence were randomized to undergo SFL/S or EVLA under tumescent anesthesia. The primary outcome was recurrence of groin-related varicose veins seen on duplex ultrasound imaging and clinical examination. The secondary outcomes were (changes or improvement in) CEAP clinical class, venous symptoms, cosmetic results, quality of life, reinterventions, and complications. RESULTS: Between June 2007 and December 2008, 122 patients (130 limbs) were included; of these, 68 limbs were treated with SFL/S and 62 limbs with EVLA. The 10-year estimated freedom from groin recurrence as seen on duplex ultrasound imaging was higher in the SFL/S group (73% vs 44% in the EVLA group; P = .002), and the same trend was seen for clinically evident recurrence (77% vs 58%, respectively; P = .034). Nine reinterventions (17%) were deemed necessary in the SFL/S group vs 18 (36%) in the EVLA group (P = .059). All reinterventions in the SFL/S group consisted of foam sclerotherapy. Reinterventions in the EVLA group included foam sclerotherapy (n = 5), crossectomy (n = 2), and endovenous procedures (n = 11). There was no significant differences in quality of life and relief of venous symptoms. Cosmetic appearance improved, with a better cosmetic rating in the SFL/S group compared with the EVLA group (P = .026). One patient in the SFL/S group had a persisting neurosensory deficit remaining at 10 years. CONCLUSIONS: This study showed no clear long-term advantage of EVLA with a 980-nm wavelength and bare-tip fiber over high ligation and stripping of the GSV under local tumescent anesthesia.

Detection of residual varicose veins with near infrared light in the early period after varicose surgery and near infrared light assisted sclerotherapy.

OBJECTIVES: Varicose veins that cannot be seen with the naked eye can be easily detected with Near Infrared (NIR) light. With a minimally invasive procedure performed with NIR light guided, the need for reoperation is reduced, while optimal treatment of venous insufficiency and symptoms is provided. In this study, the detection of residual varicose veins after varicose vein surgery using NIR light and the results of treatment of sclerotherapy were investigated. METHODS: In this retrospective study, treatment and clinical outcomes of patients' who underwent NIR light-guided foam sclerotherapy for Clinical-Etiology-Anatomy-Pathophysiology (CEAP) (C1, C2) stage residual varicose veins after surgical varicose treatment between 2014 and 2017 were examined. Data of patients who underwent foam sclerotherapy with NIR light were collected and analyzed. RESULTS: A total of 151 patients and 171 lower extremity varicose veins were treated with surgery. 55 (35.7%) of the patients were male, and 96 (62.3%) were female. Their age ranges from 20 to 64, with an average age of 45.38. 4 (2.6%) of the patients had phlebectomy. 137 of patients (90.7%) had ligation of perforated veins, phlebectomy, and great saphenous vein (GSV) stripping, 10 of patients (6.6%) had GSV stripping, perforating vein ligation, phlebectomy, and small saphenous vein (SSV) surgery. No residual leakage was observed in the controls of GSV, SSV, and perforating veins by duplex ultrasonography (DUS). In the first month after varicose surgery, an average of 1.64 ± 1.05 sessions of sclerotherapy was applied to patients with CEAP C1, C2 stage residual varicose veins. 70 patients had one session of sclerotherapy, 37 patients had two sessions of sclerotherapy, 20 patients had three sessions of sclerotherapy, and 11 patients had four sessions of sclerotherapy administrated. The need for complementary therapy was required for all female patients; 13 of the male patients did not require complementary sclerotherapy. While single-session sclerotherapy was applied to most male patients (32 (58.18%), 10 (18.18%) patients received two sclerotherapy sessions. After completing sclerotherapy, 7 (4.63%) patients had superficial venous thrombosis, and 13 (8.60%) patients had hyperpigmentation. CONCLUSION: Surgical treatment is a safe and effective technique in venous insufficiency. Nevertheless, residual varicose veins may remain, and these can be detected noninvasively with NIR light. Foam sclerotherapy with NIR light is a minimally invasive and safe treatment method for small residual varicose veins after the operation. We think that sclerotherapy with NIR light as a complementary treatment is a practical, reliable, and demanding treatment for clinical improvement, especially in female patients.

Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. METHODS: The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. RESULTS: The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. CONCLUSIONS: RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.

Systematic review of ambulatory selective variceal ablation under local anesthetic technique for the treatment of symptomatic varicose veins.

OBJECTIVE: The ambulatory selective variceal ablation under local anesthesia (ASVAL) technique subscribes to the "ascending" theory of varicose vein etiology, which recommends primary ambulatory phlebectomy as a treatment for tributary varicosities and truncal vein incompetence. This systematic review explores the efficacy and safety of the ASVAL technique for the treatment of symptomatic varicose veins. METHODS: A comprehensive search of the Medline and Embase databases and the Cochrane Register of Controlled Trials in May 2019 revealed 11 original articles that were qualitatively reviewed. The primary outcome was the absence from recurrent varicose veins at 1-year follow-up. Secondary outcomes were resolution of great saphenous vein (GSV) reflux on duplex ultrasound, change in GSV diameter, objective and subjective clinical improvement in chronic venous disease, and patient-reported outcome measures. RESULTS: A total of 2106 limbs underwent intervention in 1734 patients reported in two randomized controlled trials, one case control study, three cohort studies, and five case series. Varicosity recurrence at 1 year ranged from 0.5% to 13.5% in patients. Of 1622 limbs with diagnosed GSV incompetence before intervention, 1114 were competent at 1 year (mean, 68.2% [±12.62%]). All studies measuring GSV diameter reported statistically significant reductions in vein size. CONCLUSIONS: ASVAL may be considered as a minimally invasive treatment for early stages of chronic venous disease in the presence of truncal reflux. The evidence base should be strengthened by prospective randomized controlled trials that follow standardized procedures and report according to recognized measures of quality of life alongside clinical and hemodynamic data.

Comparing local tumescent anesthesia and spinal anesthesia methods during and after endovenous radiofrequency ablation of great saphenous vein.

BACKGROUND: Local or spinal anesthesia methods can be used during radiofrequency ablation (RFA) of the great saphenous vein. There is a gap in the literature regarding comparing and contrasting the side effects of the mentioned two methods. This study aims to retrospectively compare the spinal anesthesia method with the local tumescent anesthesia method during RFA of the great saphenous vein that also includes mini-phlebectomy. METHODS: We retrospectively analyzed patients who underwent RFA and mini-phlebectomy divided in two groups according to the anesthesia applied method, i.e. spinal anesthesia combined with tumescent anesthesia versus local tumescent anesthesia. Pain scores, the time length of preparation interval of anesthesia and the operation time, anesthesia-related side effects such as headache, nausea-vomiting, urinary retention, quality of life scores, postoperative occlusion rates, and complications related to the intervention such as phlebitis, deep vein thrombosis (DVT) were analyzed and compared by Mann Whitney U test, Wilcoxon signed ranks test, and χ2 test. RESULTS: Between June 2015 and June 2019 a great saphenous vein RFA ablation was performed in 175 patients. A total of 103 limbs were performed under spinal anesthesia combined with tumescent anesthesia and a total of 72 limbs were performed under local tumescent anesthesia. Mini phlebectomy was applied to all patients. Pain scores of the spinal anesthesia group were lower than the other group, and there was a significant difference. There was no significant difference between the operation lengths of both groups, but the preparation phase of anesthesia was shorter in local tumescent anesthesia patients, and the difference was significant. Anesthesia related side effects such as headache, nausea-vomiting, and urinary retention showed a significant difference between the two groups, and they were lower in the local tumescent anesthesia group. Preoperative quality of life scores of both groups decreased postoperatively. The postoperative occlusion rate of group 1 was 96.1%, and group 2 was 100% at three months, but the difference was not significant. We encountered three cases of phlebitis, two cases of DVT and two cases of bruising in group 1, and one case of bruising in group 2. There was no postoperative paresis or paresthesia in either groups. CONCLUSIONS: This monocenter and retrospective report of 175 GSV RFA using tumescent local anesthesia or spinal anesthesia combined with local tumescent anesthesia demonstrated that both methods of anesthesia are effective. Although the pain scores are better with spinal anesthesia, the local tumescent anesthesia method is more efficient, requiring a shorter time, and is associated with fewer complications such as headache, nausea-vomiting, or urinary retention and deep venous thrombosis.

Comparison of ultrasound results following endovenous laser ablation and radiofrequency ablation in the treatment of varicose veins.

PURPOSE: Superficial venous insufficiency is a common problem associated with varicose veins. In addition to classical symptoms, it may result in skin changes, venous ulcers and has a great impact on patients' health-related quality of life. In the last decade, minimally invasive techniques such as endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have been developed as alternatives to surgery in an attempt to reduce morbidity and improve efficiency. The aim of this study is to evaluate the efficacy of EVLA and RF therapies in superficial venous insufficiency. MATERIAL AND METHODS: Fifty legs belonging to 50 patients with symptomatic primary venous insufficiency were treated. 25 saphenous veins treated with 1470 nmdiode laser, while 25, saphenous veins treated with bipolar Radiofrequency Induced Thermotherapy (RF). All patients underwent postoperative duplex scanning within 6 month after the procedure and followed clinically, to determine the severity of the venous disease. Complications and occlusion rates were recorded. RESULTS: Total occlusion rates in RF and EVLA groups were 100% and was 100%, respectively. There was no significant difference between groups (p=0,140). Major complications such as skin burns, deep venous thrombosis have not been detected for both groups. 2 patients treated with EVLA had erythema (8%) and 1 patient had a pain sensation (4%). 1 patient in the RF group had erythema (4%), 1 had pain (4%) and 1 had a burning sensation (4%). CONCLUSION: EVLA and RF therapies in saphenous vein insufficiency are effective, minimally invasive, safe, easy to use treatment modalities with good patient satisfaction and high occlusion rates. KEY WORDS: EVLA, Radiofrquency, Venous insufficiency.

Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial).

OBJECTIVE: Endothermal techniques have proved to be effective for treatment of incompetent truncal veins. The tumescentless mechanochemical ablation (MOCA) technique has become an alternative treatment modality, but its outcome with regard to endothermal techniques is still unclear. METHODS: A multicenter prospective randomized controlled trial was designed comparing MOCA with radiofrequency ablation (RFA) to treat great saphenous vein incompetence with the hypothesis that MOCA is associated with less postprocedural pain and a comparable anatomic and clinical success rate at 1-year follow-up. Disease-specific quality of life and general health-related quality of life (HRQoL) were measured using questionnaires. Inclusion was terminated prematurely because reimbursement was suspended. RESULTS: A total of 213 patients (46.3% of intended number of patients) were randomized, of whom 209 were treated (105 in the MOCA group and 104 in the RFA group). Overall median pain scores during the first 14 days were lower after MOCA (0.2 vs 0.5 after RFA; P = .010), although the absolute difference was small. At 30 days, similar complication numbers (MOCA, n = 62; RFA, n = 63) and HRQoL scores (Aberdeen Varicose Vein Questionnaire: MOCA, 8.9; RFA, 7.6; P = .233) were observed. Hyperpigmentation was reported in seven patients in the MOCA group and two patients in the RFA group (P = .038). In the MOCA group, there were four complete failures (3.8%) compared with none in the RFA group (P = .045), although in one patient at 1 year, the vein showed occlusion. Median 30-day Venous Clinical Severity Score (VCSS) was significantly lower at 30 days after MOCA (1.0 vs 2.0 in the RFA group; P = .001), whereas VCSS was comparable at baseline (MOCA, 4.0; RFA, 5.0; P = .155). The 1- and 2-year anatomic success rate was lower after MOCA (83.5% and 80.0%) compared with RFA (94.2% and 88.3%; P = .025 and .066), mainly driven by partial recanalizations. After 2 years of follow-up, no differences were observed in the number of complete failures. Similar clinical success rates at 1 year (MOCA, 88.7%; RFA, 93.2%; P = .315) and 2 years (MOCA, 93.0%; RFA, 90.4%; P = .699) and no differences in HRQoL scores on the Aberdeen Varicose Vein Questionnaire at 1 year (MOCA, 7.5; RFA, 7.0; P = .753) and 2 years (MOCA, 5.0%; RFA, 4.8%; P = .573) were observed. There were two cardiac serious adverse events, a ventricular fibrillation in the MOCA group (1 year) and an unstable angina in the RFA group (2 years). One deep venous thrombosis occurred in the RFA group on 1-year duplex ultrasound, without clinical sequelae. CONCLUSIONS: Unilateral treatment with MOCA in the short term resulted in less postoperative pain but more hyperpigmentation compared with RFA and a faster improvement in VCSS. More anatomic failures were reported after MOCA, mostly driven by partial recanalizations, but both techniques were associated with similar clinical outcomes at 1 year and 2 years.

Endovenous Laser Ablation with 1,470-nm Diode with Tumescence Anesthesia and Saphenofemoral Ligation: Propensity Score Match Comparison.

BACKGROUND: The aim of this study is to compare 2 groups of patients treated for great saphenous vein (GSV) reflux with open surgical saphenofemoral ligation (SFL) and endovenous laser ablation (EVLA). METHODS: Consecutive patients with primary unilateral GSV reflux undergoing EVLA treatment since 2014 were enrolled, and another series of patients treated with SFL was considered. The patients were stratified according to treatment and the results were compared using the propensity score (1:1). The covariables were age, gender, body mass index, CEAP (Clinical class, Etiology, Anatomy and Pathophysiology) staging, and GSV and saphenofemoral junction diameters. Primary outcomes were GSV occlusion or recurrent groin varicose veins at 1 year after treatment. Secondary outcomes included vein thrombosis, hyperpigmentation, paresthesia, postoperative pain, analgesic requirement, and ecchymosis assessed at discharge and CEAP stage and quality of life (QoL) assessment 1 month after surgery. RESULTS: A total of 123 patients were included in the study: 59 were treated with EVLA and 64 with SFL. At 12 months, we observed 10 recurrent groin varicose veins after SFL (15.6%) and 6 GSV recanalization after EVLA (10.2%, P = 0.369). Extra-saphenous recurrent varicose veins were observed in 36 patients (29.3%): 20 in the open group (31.2%) and 16 in EVLA group (27.1%, P = 0.615). After matching procedure 74 patients were analyzed (37 patients by group), logistic regression model showed that the risk of outcome was not associated with the surgical treatment (odds ratio 1.76, 95% confidence interval 0.52-6.01). CONCLUSIONS: Both techniques to treat saphenous impairment have demonstrated to be safe, with good results in terms of efficacy and symptomatic improvement at follow-up. EVLA with 1,470 nm seems to have lower rates of recurrence and good perceived QoL. Tumescent anesthesia is a good option with good results and may be extended to open surgical ligation.

Long-term outcome of open surgery in CVI patients concerning postoperative complications, perioperative hemodynamics and clinical efficacy, Part II1.

BACKGROUND: Chronic venous disease (CVD) is extremely common worldwide with prevalence increasing with age. It is associated with a reduced quality of life, particularly in relation to pain, physical function and mobility. Symptomatic chronic venous insufficiency (CVI) with venous ulcer at its' endpoint, indicates interventional surgery to cure venous reflux therewith promoting wound healing and preventing recurrence. In this retrospective, single-centre, consecutive case-control study in a single patient population of a university clinic in northern Germany a holistic evaluation of varicose vein surgeries has been undertaken. Part I covered postoperative complications in relation to co-morbidities, co-medication and clinical presentation. Part II of this article presents now the hemodynamic results in relation to the perioperative evolution of CVI specific symptoms. METHODS: Records of n = 429 (467 extremities) patients from 2009-2013 treated with open surgery were analysed with regards to perioperative hemodynamics. Evolution of CVI symptomology was accessed postoperatively with the help of a questionnaire and patient records in the case of complication development. Venous hemodynamics was analysed in the whole patient population and with regards to complication subgroups: no events (NE), neglectable adverse events (NAE) and non-neglectable adverse events (NNAE). RESULTS: Postoperatively, patients' CVI-symptoms like pain (p < 0.001), swelling (p < 0.001) and itching (p = 0.003) significantly improved. The venous refill time and venous pump capacity improved significantly after open vein surgery (p < 0.05). Regardless of the development of postoperative complications there was a significant improvement of venous function at 6 weeks- and one-year postoperative in follow-up (p < 0.05). Symptom regression was strongly correlated with hemodynamic improvement. CONCLUSION: A significant improvement of patients' symptoms was achieved by means of open-surgery, regardless of postoperative complication development. This was in accordance with the improvement of venous hemodynamics. A strong correlation between symptom regression and improvement in venous hemodynamics could be proven.

A Randomised Clinical Trial of Buffered Tumescent Local Anaesthesia During Endothermal Ablation for Superficial Venous Incompetence.

OBJECTIVE/BACKGROUND: Endovenous thermal ablation (EVTA) is the recommended first line intervention for superficial venous incompetence (SVI). While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort. This randomised controlled trial investigates the potential to reduce peri-procedural pain and improve patient reported outcome measures (PROMs), including quality of life (QoL) using TLA buffered to physiological pH. METHODS: Patients undergoing great saphenous vein EVTA with concomitant phlebectomies were randomised to either standard (ST) or buffered (BT) TLA. Follow up assessments were performed at weeks 1, 6, and 12. The primary outcome was patient reported peri-procedural pain on a 100 mm visual analogue scale (VAS). Secondary outcomes were one week post-procedural pain VAS and analgesia use, QoL (disease specific: Aberdeen Varicose Vein Questionnaire [AVVQ]; generic: Short Form-36 [SF-36] and EuroQol 5 Dimensions Questionnaire [EQ-5D]), patient satisfaction VAS, technical success on duplex ultrasound (DUS) examination, and complications. RESULTS: Ninety-seven patients were randomised: 50 to ST and 47 to BT. The groups had comparable baseline demographics, Clinical Etiologic Anatomic Pathological, Venous Clinical Severity Score, QoL, and DUS parameters. Equally, intra-procedural parameters (volume of TLA, length of ablation, and linear energy delivered) were also comparable. Peri-procedural pain scores were significantly lower in the BT group with a mean ± SD score of 2.86 ± 3.57 versus 4.44 ± 2.94 (p = .001). Pain scores and analgesia use over the subsequent week were equivalent. SF-36 Bodily Pain domain scores were significantly better in the BT group at week 1 (77 vs. 62; p = .008). AVVQ, SF-36, and EQ-5D scores were otherwise similar between the groups throughout follow up, significantly improving over baseline. Technical success was high in both groups, with no major complications and few minor complications. CONCLUSION: Buffered TLA offers a significantly lower peri-procedural pain experience for patients undergoing EVTA and should replace current tumescent formulae.

The Outcome of Anticoagulation on Endovenous Laser Therapy for Superficial Venous Incompetence.

OBJECTIVES: The purpose of this study was to evaluate whether anticoagulation (warfarin or direct oral inhibitors) affected the success of endovenous treatment. METHODS: Patients taking anticoagulation (warfarin or direct oral inhibitors) undergoing endovenous treatment in the form of endovenous laser ablation (EVLA) were matched against controls for sex, age, leg, and vein. Data were collected prospectively between January 2012 and March 2017. The primary endpoint was failure of treatment at 6-week postoperative duplex scan. The rates of major bleeding, hematoma, endothermal heat-induced thrombosis, venous thromboembolism, or pulmonary embolism were also compared between groups. RESULTS: Two hundred eighty-four limbs underwent EVLA during the study period. Of this, 23/284 (8.1%) procedures were done in patients on anticoagulation. 21/23 (91.3%) limbs had venous occlusion at follow-up compared with 23/23 (100%) of controls ( P = .49). The patient who failed treatment in the anticoagulation group had undergone small saphenous vein (SSV) ablation. There was no difference in the complication rates between groups. DISCUSSION: This study demonstrates that anticoagulation does not affect success rates of EVLA though there was higher recanalization rate in patients undergoing SSV ablation. Anticoagulation can be continued safely in patients undergoing this procedure.

Patient-perceived outcomes of different anaesthetic techniques in classical surgical treatment of varicose veins of lower limbs.

AIM OF THE STUDY: To evaluate the effects of spinal or locoregional anaesthesia versus local tumescent anesthesia during traditional surgical treatment of saphenous reflux, in terms of pain and postoperative functional recovery. MATERIALS AND METHODS: From January to December 2014, 195 consecutive interventions of stripping of the greater saphenous vein for valvular incompetence were performed. In 114 cases spinal or locoregional anaesthesia was performed (group 1), in the remaining 81 cases local anaesthesia with the tumescence technique was carried out (group 2). All patients underwent an assessment of perceived pain by means of verbal rating scale before and at the end of surgery, at discharge and after a month. The times of recovery of ambulation during hospital stay and at the discharge were recorded and use of analgesic drugs during hospitalization and at home. At the end of the study, patients were asked to express their approval rating on the type of anaesthesia. RESULTS: Patients in group 2 experienced mild to moderate intraoperative pain more frequently than patients in group 1 (p<0.001), while patients in group 1 had more mild adverse anaesthesia-related events than patients in group 2. Patients in group 2 had faster recovery of ambulation and earlier discharge than patients in group 1.Thirty-day results were similar in the two groups; however, patients in group 2 had a higher degree of satisfaction than patients in group 1 with regard to the type of anaesthesia (p<0.001) CONCLUSIONS: Both locoregional and local tumescent anaesthesia are effective and well accepted by the patients, with similar intra-hospital and 30-day results. KEY WORDS: Great Saphenous Vein, Local tumescent anaesthesia, Pain, Stripping.

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.

Occlusion rate, venous symptoms and patient satisfaction after radiofrequency-induced thermotherapy (RFITT®): are there differences between the great and the small saphenous veins?

BACKGROUND: Previous studies on the therapy of insufficient saphenous veins mainly compare different treatment methods. Only a few investigate differences of a specific treatment option between the great (GSV) and the small saphenous vein (SSV). The aim of this study was to evaluate the efficacy, clinical improvement and patient satisfaction after radiofrequency-induced thermotherapy (RFITT®) with regard to the treated vein. PATIENTS AND METHODS: We included 65 patients (40 women, 25 men; mean age 54.75 years) who were treated with RFITT® for incompetent saphenous veins (n = 83: 62 GSV, 21 SSV). Occlusion rates were determined by duplex-sonography. Additionally, we performed a prospective analysis of venous symptoms and signs by means of a standardized questionnaire and of patient satisfaction using a semi-quantitative rating (1 = very good, 6 = insufficient). RESULTS: The GSV group showed a significantly greater reduction of venous symptoms in comparison to the SSV group (p = 0.005) despite no significant differences in long term occlusion rates (mean time after operation: 22 months) of 90 % in the GSV group and 81.8 % in the SSV group (p = 0.598). Following the procedure, detailed analysis revealed significantly more swelling (p = 0.022), feeling of heavy legs (p = 0.002) and nightly calf cramps (p = 0.001) in the SSV group. Additionally, RFITT® led to a significant improvement in patient satisfaction in the GSV group (from 1.93 at day 1 - 3 to 1.41 after 6 - 12 months, p = 0.009) but not in the SSV group (from 2.29 to 2.07, p = 0.43). CONCLUSIONS: With regard to the improvement of venous symptoms and patient satisfaction, the benefit of RFITT® is greater for patients with incompetent GSV compared to those with incompetent SSV.

Novel treatment techniques for recanalization of femoral-popliteal deep venous occlusion from chronic thrombosis.

Patients with postthrombotic syndrome due to previous femoral-popliteal deep venous thrombosis often experience lifestyle-limiting lower-extremity pain and swelling. Conservative treatment options include compression stockings and lymphedema massage, but in many cases these treatments only temporarily and partially improve symptoms. Ultrasound and venography in patients with postthrombotic syndrome often show only partial recanalization of the femoral vein with significant collateral vein formation. These abnormal veins are insufficient for adequate venous drainage from the lower extremity as evidenced by the patient's continued symptoms. Recanalization of the occluded or partially occluded femoral vein using prolonged venoplasty, with or without chemical thrombolysis, combined with optimizing anticoagulation and conservative treatment measures, results in lasting improvement in symptoms for a high percentage of patients.

Endovenous laser ablation under general anesthesia for day surgery: feasibility and outcomes of the 300 patients.

PURPOSE: Endovenous laser ablation (EVLA) for superficial venous insufficiency is traditionally performed under tumescent local anesthesia as day case surgery. The aim of this study is to evaluate the feasibility of general anesthesia in addition to tumescent anesthesia in patients undergoing EVLA. METHODS: The anesthesia and clinical registration records of 341 extremities of 300 adult patients were reviewed and analyzed retrospectively. Demographic and clinical data, preoperative anesthetic evaluation data (ASA physical status, preoperative airway assessment, Mallampati score), type of supraglottic device, duration of anesthesia and surgery, any surgical and/or anesthetic complication, timing of mobilization and discharge, and postoperative course were evaluated. RESULTS: Mean duration of operation and anesthesia was 28 (12-55) and 40 (20-65) minutes, respectively. Mobilization and discharge timing was 25 (11-45) and 139 (110-200) minutes, respectively. All patients were discharged the same day of surgery. CONCLUSION: The combination technique of administering general anesthesia with supraglottic device and tumescent anesthesia is a safe and effective method to reduce the patients' pain and discomfort during the EVLT procedure within the scope of day case surgery.