Machine Learning-Based Technique for the Severity Classification of Sublingual Varices according to Traditional Chinese Medicine.

Tongue diagnosis, a noninvasive examination, is an essential step for syndrome differentiation and treatment in traditional Chinese medicine (TCM). Sublingual vein (SV) is examined to determine the presence of blood stasis and blood stasis syndrome. Many studies have shown that the degree of SV stasis positively correlates with disease severity. However, the diagnoses of SV examination are often subjective because they are influenced by factors such as physicians' experience and color perception, resulting in different interpretations. Therefore, objective and scientific diagnostic approaches are required to determine the severity of sublingual varices. This study aims at developing a computer-assisted system based on machine learning (ML) techniques for diagnosing the severity of sublingual varicose veins. We conducted a comparative study of the performance of several supervised ML models, including the support vendor machine, K-neighbor, decision tree, linear regression, and Ridge classifier and their variants. The main task was to differentiate sublingual varices into mild and severe by using images of patients' SVs. To improve diagnostic accuracy and to accelerate the training process, we proposed using two model reduction techniques, namely, the principal component analysis in conjunction with the slice inverse regression and the convolution neural network (CNN), to extract valuable features during the preprocessing of data. Our results showed that these two extraction methods can reduce the training time for the ML methods, and the Ridge-CNN method can achieve an accuracy rate as high as 87.5%, which is similar to that of experienced TCM physicians. This computer-aided tool can be used for reference clinical diagnosis. Furthermore, it can be employed by junior physicians to learn and to use in clinical settings.

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.

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.

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.

CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins.

BACKGROUND: Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins. METHODS/DESIGN: This is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period. DISCUSSION: This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.

Endovenous Laser Ablation with and Without Concomitant Phlebectomy for the Treatment of Varicose Veins: A Retrospective Analysis of 954 Limbs.

BACKGROUND: Endovenous laser ablation (EVLA) with concomitant phlebectomy is commonly performed in many institutions. However, phlebectomy is associated with cosmetic complications such as surgical scarring, hemorrhage, and hematoma. This study aims to compare the need for additional sclerotherapy during follow-up after EVLA with and without concomitant phlebectomy. METHODS: Between November 2013 and December 2018, we performed EVLA on 1,363 limbs in 1,009 patients with symptomatic primary varicose veins, of which 954 limbs in 771 patients with great saphenous vein (GSV) or small saphenous vein (SSV) insufficiency were included in this study. Data were collected prospectively and supplemented with retrospective medical record review. Demographic and clinical characteristic profiles were collected. The outcomes of EVLA with or without concomitant phlebectomy were compared. Logistic regression was used to assess predictors for additional sclerotherapy after EVLA. RESULTS: CEAP classification (P < 0.001), operative time (P < 0.001), laser device type (P < 0.001), length of the treated vein (P < 0.001), linear endovenous energy density (P < 0.001), and tumescent local anesthesia volume (P < 0.001) differed significantly. Pain after EVLA was significantly more frequent in the nonphlebectomy group than in the phlebectomy group (P = 0.005). During follow-up, 34 of 954 limbs (3.6%) underwent additional sclerotherapy for residual visible varicose veins after EVLA. No statistical difference was found in the rate of additional sclerotherapy between the groups (P = 0.849). Logistic regression showed that female sex (odds ratio [OR], 6.18; 95% confidence interval [CI], 1.86-20.6; P = 0.003) is significantly associated with additional sclerotherapy, and concomitant phlebectomy is not a significant predictor of additional sclerotherapy (OR, 0.844; 95% CI, 0.375-1.90; P = 0.682). CONCLUSIONS: Patient preference for additional sclerotherapy was comparable between those who underwent EVLA with and without concomitant phlebectomy. This result supports our present strategy of avoiding simultaneous phlebectomy at the time of primary EVLA.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein.

INTRODUCTION: Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. METHODS: Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. RESULTS: A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20-54) mm vs. (GA alone) 56 (24-70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6-17.9) vs. 4.3 (IQR 2.7-7.9) P = 0.004). CONCLUSION: The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39.

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.

Meta-analysis of nontumescent-based versus tumescent-based endovenous therapies for patients with great saphenous insufficiency and varicose veins.

OBJECTIVE: The objective of this study was to compare the nontumescent-based endovenous therapies with the standard tumescent-based endovenous therapies in regard to clinical effectiveness and procedural outcomes in patients with saphenofemoral incompetence and varicose veins. METHODS: The following databases were searched for studies that were randomized or quasi-randomized trials comparing nontumescent-based endovenous procedures with those requiring tumescence: Cochrane Central Register of Controlled Trials (1950-January 2017), MEDLINE (1946-January 2017), and Embase (1950-January 2017). There were no restrictions based on language or publication status. In the case of ongoing studies, the World Health Organization's International Clinical Trials Registry Platform and the online ClinicalTrials.gov registry were also searched. We also reviewed reference lists of articles relevant to our study to ensure a more complete review. Two authors independently screened and selected studies to be included. These two authors also independently assessed the risk of bias using the Cochrane risk of bias tool. Data were extracted and pooled using a random-effects model. RESULTS: A total of nine studies were found in the literature search, of which five were included in analysis. Four outcomes were reviewed. A significant difference was found between the comparator groups for mean intraprocedural pain score (effect estimate, -0.66), favoring nontumescent-based therapies. There was no difference for Venous Clinical Severity Score (effect estimate, -0.21) for clinical assessment and the Aberdeen Varicose Vein Questionnaire score (effect estimate, 0.27) for the disease-specific quality of life between the groups. The outcome of failure of truncal ablation at 30 days had no significant difference between the groups (risk ratio, 1.27), although a subgroup analysis demonstrated a trend toward improved results with the novel nontumescent-based treatments (risk ratio, 0.21) compared with the old nontumescent-based treatments (risk ratio, 8.6). CONCLUSIONS: Currently available evidence from reasonable-quality clinical trials comparing tumescent-based with non-tumescent-based endovenous therapies shows no overall difference between the groups on a number of outcomes. Mean intraprocedural pain score appears to favor nontumescent-based interventions. Newer randomized trials comparing the treatment modalities are needed to further clarify the benefits of nontumescent-based therapies, particularly with regard to long-term outcomes.

Three-year follow-up and quality of life of endovenous radiofrequency ablation of the great saphenous vein with the ClosureFast™ procedure: Influence of BMI and CEAP class.

Purpose Endovascular ablation of the great saphenous vein has been proposed as a less invasive alternative to conventional ligation and stripping of varicose veins. Outcomes of patients treated with the radiofrequency ablation ClosureFast™ system over an eight-year period from a single-center were evaluated. Methods Three-year follow-up data included duplex ultrasound scan, complication rate, and questionnaires to assess patients' QOL, level of pain, and days off work. Results A total of 1080 consecutive patients (49.5 ± 18.6 years, 72% female, mean body mass index: 25.44 ± 4.1 kg m-2) underwent radiofrequency ablation for incompetent saphenous veins in a single institution. Occlusion of the great saphenous vein was obtained in 98.6% and 93.8% cases at the end of the procedures and within 36 months, respectively. Only three deep venous thromboses and minor complications occurred in this series throughout the first week from the procedure. A decrease of the external vein diameter, equal to 72.7% and 31.1% of the pretreatment diameter, was observed at 1 week and 36 months, respectively. The average Aberdeen Varicose Vein Questionnaire score improved from 18.06 ± 9.47 before treatment to 11.56 ± 10.23 at 12 months, with no significant differences in the subsequent follow-up. SF-36 QOL scores significantly improved after the procedure in all domains, while there were no changes over time. Patients reported a prompt return to normal daily activities (1.5 ± 0.7 days) and work (3.1 ± 1.9 days). Body mass index influenced QOL scores, while it did not affect great saphenous vein diameter reduction during the follow-up. On the contrary, Clinical Etiologic Anatomic Pathophysiologic class significantly influenced both great saphenous vein diameter reduction after the treatment and QOL scores within 36 months. Conclusion Results of this retrospective monocentric, large patients study suggest that radiofrequency ablation of the great saphenous vein may be a safe and efficient alternative to conventional surgery.

Effect of tumescent anesthesia and patient positioning on laser tip junctional distance during endovenous laser ablation.

BACKGROUND: The correct positioning of the laser tip at the saphenofemoral or saphenopopliteal junction during endovenous laser therapy is paramount to ensure a safe and effective procedure. The aim of this study was to demonstrate how patient positioning and tumescence infiltration can affect this safe junctional distance. METHODS: A retrospective review of a prospectively maintained database was carried out for all patients who received endovenous laser treatment for symptomatic varicose veins between February 2008 and February 2014 in one surgeon's practice in a teaching hospital vascular unit. The junctional distance of the laser tip from the saphenofemoral or saphenopopliteal junction was measured two times during the procedure: before tumescence and before laser deployment with the patient in a Trendelenburg position. RESULTS: Junctional distance was found to have increased in 62% cases (490 patients; great saphenous vein [GSV], 348; small saphenous vein [SSV], 142). Of these, 17% (84) required the laser tip to be advanced (GSV, 56; SSV, 28) to maintain a desired junctional distance of 0.75 to 2 cm. In 185 patients (23%), the junctional distance was noted to have been reduced (GSV, 155; SSV, 30), with 58% (GSV, 79; SSV, 28) requiring the laser tip to be withdrawn to the desired junctional distance; 23% of patients (185) had no change in the junctional distance. CONCLUSIONS: This study has demonstrated the effect of tumescence infiltration and Trendelenburg positioning on laser tip placement, and thus a final junctional measurement before activation of the laser is recommended to maintain a safe and optimal junctional distance.

One-year results of the use of endovenous radiofrequency ablation utilising an optimised radiofrequency-induced thermotherapy protocol for the treatment of truncal superficial venous reflux.

Background In previous in vitro and ex vivo studies, we have shown increased thermal spread can be achieved with radiofrequency-induced thermotherapy when using a low power and slower, discontinuous pullback. We aimed to determine the clinical success rate of radiofrequency-induced thermotherapy using this optimised protocol for the treatment of superficial venous reflux in truncal veins. Methods Sixty-three patients were treated with radiofrequency-induced thermotherapy using the optimised protocol and were followed up after one year (mean 16.3 months). Thirty-five patients returned for audit, giving a response rate of 56%. Duplex ultrasonography was employed to check for truncal reflux and compared to initial scans. Results In the 35 patients studied, there were 48 legs, with 64 truncal veins treated by radiofrequency-induced thermotherapy (34 great saphenous, 15 small saphenous and 15 anterior accessory saphenous veins). One year post-treatment, complete closure of all previously refluxing truncal veins was demonstrated on ultrasound, giving a success rate of 100%. Conclusions Using a previously reported optimised, low power/slow pullback radiofrequency-induced thermotherapy protocol, we have shown it is possible to achieve a 100% ablation at one year. This compares favourably with results reported at one year post-procedure using the high power/fast pullback protocols that are currently recommended for this device.

Treatment Outcomes and Lessons Learned From Transilluminated Powered Phlebectomy for Varicose Veins in 1034 Patients.

INTRODUCTION: Transilluminated powered phlebectomy (TIPP) is a minimally invasive technique of varicose vein removal, which combines irrigated illumination with tumescent anesthesia for ablation of superficial varicosities and endoscopic-powered venous resection. The objective of this study was to analyze treatment outcomes of this treatment modality. METHODS: A retrospective evaluation of prospectively collected data from all patients undergoing TIPP procedure for symptomatic varicose veins during a recent 12-year period was performed. Pertinent patient demographics, disease classification, perioperative complications, quality of life, and treatment outcomes were collected and analyzed. RESULTS: A total of 1167 limbs in 1034 patients (mean age, 52.4 years) were treated during the study period. The mean procedure time was 18.4 ± 8.9 minutes (range, 6.0-82.0 minutes). The mean number of incisions for TIPP procedure was 6.3 ± 3.6. All TIPP procedures were technically successful, and no patient required conversion to hook stab phlebectomy. Fifteen (1.5%) patients developed residual or recurrent varicosities, which were treated with sclerotherapy during the follow-up period. Postoperative complications included hematoma at 2 weeks (5.8%), ecchymosis at 2 weeks (32.9%), saphenous neuropathy (0.3%), cellulitis (1.0%), and skin pigmentation (1.9%). There was no postoperative deep vein thrombosis or mortality. CONCLUSIONS: Transilluminated powered phlebectomy is an effective method for varicose vein removal and is associated with high clinical success and excellent cosmetic results. Meticulous technical steps are critical in achieving successful outcomes while minimizing complications. Technical considerations and lessons learned from our experiences are discussed in this report.

Safety and efficacy of angiographic occlusion of duodenal varices as an alternative to TIPS: review of 32 cases.

UNLABELLED: BACKGROUND/RATIONALE OF STUDY: Analyze safety and efficacy of angiographic-occlusion-with-sclerotherapy/embolotherapy-without-transjugular-intrahepatic-portosystemic-shunt (TIPS) for duodenal varices. Although TIPS is considered the best intermediate-to-long term therapy after failed endoscopic therapy for bleeding varices, the options are not well-defined when TIPS is relatively contraindicated, with scant data on alternative therapies due to relative rarity of duodenal varices. Prior cases were identified by computerized literature search, supplemented by one illustrative case. Favorable clinical outcome after angiography defined as no rebleeding during follow-up, without major procedural complications. RESULTS: Thirty-two cases of duodenal varices treated by angiographic-occlusion-with-sclerotherapy/embolotherapy- without-TIPS were analyzed. Patients averaged 59.5 ± 12.2 years old (female = 59%). Patients presented with melena-16, hematemesis & melena-5, large varices-5, growing varices-2, ruptured varices-1, and other- 3. Twenty-nine patients had cirrhosis; etiologies included: alcoholism-11, hepatitis C-11, primary biliary cirrhosis- 3, hepatitis B-2, Budd-Chiari-1, and idiopathic-1. Three patients did not have cirrhosis, including hepatic metastases from rectal cancer-1, Wilson's disease-1, and chronic liver dysfunction-1. Thirty-one patients underwent esophagogastroduodenoscopy before therapeutic angiography, including fifteen undergoing endoscopic variceal therapy. Therapeutic angiographic techniques included balloon-occluded retrograde-transvenous-obliteration (BRTO) with sclerotherapy and/or embolization-21, DBOE (double-balloon-occluded-embolotherapy)-5, and other-6. Twenty-eight patients (87.5%; 95%-confidence interval: 69-100%) had favorable clinical outcomes after therapeutic angiography. Three patients were therapeutic failures: rebleeding at 0, 5, or 10 days after therapy. One major complication (Enterobacter sepsis) and one minor complication occurred. CONCLUSIONS: This work suggests that angiographic-occlusion-with sclerotherapy/ embolotherapy-without-TIPS is relatively effective (~90% hemostasis-rate), and relatively safe (3% major-complication-rate). This therapy may be a useful treatment option for duodenal varices when endoscopic therapy fails and TIPS is relatively contraindicated.

Endovenous radiofrequency ablation and combined foam sclerotherapy treatment of multiple refluxing perforator veins in a Klippel-Trenaunay syndrome patient.

We describe an unusual pattern of venous abnormality and the use of endovenous radiofrequency ablation, using the TRans-Luminal Occlusion of Perforator technique to treat multiple refluxing perforators in a 29-year-old patient with Klippel-Trenaunay syndrome. Klippel-Trenaunay syndrome is a rare congenital anomaly characterised by a triad of features including unilateral limb overgrowth, venous varicosities and capillary malformations of the affected limb. Ultrasound findings demonstrated 22 incompetent perforator veins in the lateral aspect of the patients left leg, communicating with a complex network of large calibre varicosities causing unilateral leg oedema and pain. Staged radiofrequency ablation procedures using the Olympus Celon RFITT (radiofrequency-induced thermotherapy; please see Technical Note) device under local anaesthetic were performed. These procedures were followed with two sessions of foam sclerotherapy. This case report describes the efficacy of this treatment regime and this patient's significantly improved morbidity 18 months after initial treatment.

Embolization of the neck lymphatic varix, causing periodic neck swelling.

We report a case of a 44-year-old female patient, presented to us after years of recurrent intermittent episodes of unilateral left neck swelling. An MR lymphangiogram demonstrated a lymphatic varix at the confluence of the left upper extremity lymphatic ducts, confirmed by intranodal axillary lymphangiography. After successful catheterization of the feeding lymphatic vessels, the varix was successfully embolized with detachable microcoils and an autologous blood patch. The patient has been free from symptoms on subsequent outpatient follow-up.

Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years.

OBJECTIVE: This is the first randomized controlled trial with a 5-year follow-up comparing endovenous laser ablation (EVLA) with high ligation and pin-stripping in patients with great saphenous vein (GSV) incompetence. METHODS: One hundred twenty-one consecutive patients (137 legs) with GSV incompetence were randomized to EVLA (980 nm bare fiber) or high ligation and stripping using tumescent local anesthesia with light sedation. Mini-phlebectomies were performed in all patients. The patients were examined with duplex scanning before treatment and after 12 days, and then after 1, 3, and 6 months, and yearly thereafter for up to 5 years. The primary end point was open refluxing GSV. Secondary end points were recurrent varicose veins, frequency of reoperations, Venous Clinical Severity Score, and quality of life scores (Aberdeen Varicose Vein Symptoms Severity Score and Short Form-36). RESULTS: In the EVLA and stripping group, nine (Kaplan-Meier [KM] estimate, 17.9%) and four (KM estimate, 10.1%) of GSVs had open refluxing segments of 5 cm or more (ns). Clinical recurrence was recorded in 24 (KM estimate, 46.6%) and 25 (KM estimate, 54.6%), whereas reoperations were performed in 17 (KM estimate, 38.6%) and 15 (KM estimate, 37.7%) legs (ns). Venous Clinical Severity Score and Aberdeen Varicose Vein Symptoms Severity Score improved whereas Medical Outcomes Study Short Form-36 quality of life score improved in several domains in both groups with no difference between the groups. CONCLUSIONS: Five-year follow-up of our randomized controlled trial comparing EVLA with open surgery in patients with GSV incompetence did not show any significant difference between the two groups in primary or secondary end points, perhaps because of the small sample size. EVLA seems to be a valid alternative to open surgery.

Endovenous 808-nm diode laser occlusion of perforating veins and varicose collaterals: a prospective study of 482 limbs.

BACKGROUND: Endovenous laser ablation (EVLA) was performed in the treatment of great and small saphenous veins (GSVs, SSVs), perforating veins (PVs), and varicose collaterals (VCs). OBJECTIVE To verify the outcome in PVs and VCs. MATERIALS AND METHODS: Four hundred eighty-two limbs of 306 patients were studied. EVLA was performed on 167 GSVs, 52 SSVs, and 534 PVs of 303 limbs and on VCs of 467 limbs; 133 GSVs were stripped, 300 of saphenofemoral junctions (SFJs) and 45 saphenopopliteal junctions (SPJs) were interrupted. Limbs were selected using duplex ultrasound examination and photographs; PVs-VCs diameter (<4 mm) and VC length were measured. EVLA was performed using a 808-nm diode laser, 0.6-mm fibers, continuous emission, 4 to 10 W, and 10 to 20 J/cm. Follow-up on 467 limbs occurred over a mean 27.5 months (range 3 months to 6 years); 98 limbs were followed up for longer than 4 years. RESULTS: Operating time range from 10 to 30 minutes per limb. Blood vaporization, thrombosis, fibrosis, and atrophy prevailed in PVs and in the large VCs (>4 mm) and massive coagulation in the smaller (<4 mm). High rate of occlusion was seen, with different rates of patent PV-VC mainly in diameter >6 mm. Thirty-nine out of 511 patent PVs (7.6%) and 96 out of 778 VCs (12-13%) were re-treated using EVLA or foam sclerotherapy. Minor complications occurred in 88 of the 778 (11%). CONCLUSIONS: EVLA of PVs and VCs is effective and faster than surgery in 2- to 6-mm PVs and VCs using an 808-nm diode laser.