Development and External Validation of a Prediction Model for Patients with Varicose Veins Suitable for Isolated Ambulatory Phlebectomy.

OBJECTIVE: Isolated ambulatory phlebectomy is a potential treatment option for patients with an incompetent great saphenous vein (GSV) or anterior accessory saphenous vein and one or more incompetent tributaries. Being able to determine which patients will most likely benefit from isolated phlebectomy is important. This study aimed to identify predictors for avoidance of secondary axial ablation after isolated phlebectomy and to develop and externally validate a multivariable model for predicting this outcome. METHODS: For model development, data from patients included in the SAPTAP trial were used. The investigated outcome was avoidance of ablation of the saphenous trunk one year after isolated ambulatory phlebectomy. Pre-defined candidate predictors were analysed with multivariable logistic regression. Predictors were selected using Akaike information criterion backward selection. Discriminative ability was assessed by the concordance index. Bootstrapping was used to correct regression coefficients, and the C index for overfitting. The model was externally validated using a population of 94 patients, with an incompetent GSV and one or more incompetent tributaries, who underwent isolated phlebectomy. RESULTS: For model development, 225 patients were used, of whom 167 (74.2%) did not undergo additional ablation of the saphenous trunk one year after isolated phlebectomy. The final model consisted of three predictors for avoidance of axial ablation: tributary length (< 15 cm vs. > 30 cm: odds ratio [OR] 0.09, 95% confidence interval [CI] 0.02 - 0.40; 15 - 30 cm vs. > 30 cm: OR 0.18, 95% CI 0.09 - 0.38); saphenofemoral junction (SFJ) reflux (absent vs. present: OR 2.53, 95% CI 0.81 - 7.87); and diameter of the saphenous trunk (per millimetre change: OR 0.63, 95% CI 0.41 - 0.96). The discriminative ability of the model was moderate (0.72 at internal validation; 0.73 at external validation). CONCLUSION: A model was developed for predicting avoidance of secondary ablation of the saphenous trunk one year after isolated ambulatory phlebectomy, which can be helpful in daily practice to determine the suitable treatment strategy in patients with an incompetent saphenous trunk and one or more incompetent tributaries. Patients having a longer tributary, smaller diameter saphenous trunk, and absence of terminal valve reflux in the SFJ are more likely to benefit from isolated phlebectomy.

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).

Commonly Used Endovenous Laser Ablation (EVLA) Parameters Do Not Influence Efficacy: Results of a Systematic Review and Meta-Analysis.

OBJECTIVES: The objective of this systematic review and meta-analysis was to summarise available randomised controlled trials (RCTs) of EVLA efficacy, and to define the differences in success rate of variations in wavelength, administered energy, outcome definition, and follow up period. METHODS: A literature search was conducted in Embase, Medline (Ovid-SP), Cochrane Central Database, and Web of Science from inception to November 2017. RCTs with follow up of more than three months were included. The studied outcome was the proportion of patients with EVLA treatment success, defined as absence of reflux or occlusion of the great saphenous vein (GSV). Pooled proportions of anatomical success were compared. Subgroup and meta-regression analysis included wavelengths (short [810, 940, and 980 nm], long [1470, 1500, and 1920 nm]), amount of energy (≤50 J/cm, > 50 J/cm), follow up (≤1 year, > 1 year), outcome definition (occlusion, no reflux), and quality of the studies (low risk of bias, unclear/high risk of bias). RESULTS: Twenty-eight RCTs, with a total of 2829 GSVs were included. The overall success rate of EVLA was 92% (95% CI 90-94%, I2 = 68%). In subgroup analysis, no statistically significant differences were found for long or short wavelengths (95% [95% CI 91-97%] vs. 92% [95% CI 89-94%], p = .15), high or low administered energy (93% [95% CI 89-95%] vs. 92% [95% CI 90-94%], p = .99), long or short follow up (89% [95% CI 84-93%] vs. 93% [95% CI 91-95%], p = .13) and outcome definition (occlusion group 94% [95% CI 91-96%] vs. absence of reflux group 91% [95% CI 87-94%], p = .26). Studies with low risk of bias reported a significantly higher success rate than high or unclear risk of bias (93% [95% CI 90-95%] vs. 89% [95% CI 83-93%], p = .04). CONCLUSIONS: The overall success rate of EVLA is high (92%), even with increasing follow up. Commonly used parameters of EVLA (wavelength, administered energy, and outcome definition) have no influence on the treatment success rate.

Endovenous laser ablation (EVLA): a review of mechanisms, modeling outcomes, and issues for debate.

Endovenous laser ablation (EVLA) is a commonly used and very effective minimally invasive therapy to manage leg varicosities. Yet, and despite a clinical history of 16 years, no international consensus on a best treatment protocol has been reached so far. Evidence presented in this paper supports the opinion that insufficient knowledge of the underlying physics amongst frequent users could explain this shortcoming. In this review, we will examine the possible modes of action of EVLA, hoping that better understanding of EVLA-related physics stimulates critical appraisal of claims made concerning the efficacy of EVLA devices, and may advance identifying a best possible treatment protocol. Finally, physical arguments are presented to debate on long-standing, but often unfounded, clinical opinions and habits. This includes issues such as (1) the importance of laser power versus the lack of clinical relevance of laser energy (Joule) as used in Joule per centimeter vein length, i.e., in linear endovenous energy density (LEED), and Joule per square centimeter vein wall area, (2) the predicted effectiveness of a higher power and faster pullback velocity, (3) the irrelevance of whether laser light is absorbed by hemoglobin or water, and (4) the effectiveness of reducing the vein diameter during EVLA therapy.

Some controversies in endovenous laser ablation of varicose veins addressed by optical-thermal mathematical modeling.

Minimally invasive treatment of varicose veins by endovenous laser ablation (EVLA) becomes more and more popular. However, despite significant research efforts performed during the last years, there is still a lack of agreement regarding EVLA mechanisms and therapeutic strategies. The aim of this article is to address some of these controversies by utilizing optical-thermal mathematical modeling. Our model combines Mordon's light absorption-based optical-thermal model with the thermal consequences of the thin carbonized blood layer on the laser fiber tip that is heated up to temperatures of around 1,000 °C due to the absorption of about 45% of the laser light. Computations were made in MATLAB. Laser wavelengths included were 810, 840, 940, 980, 1,064, 1,320, 1,470, and 1,950 nm. We addressed (a) the effect of direct light absorption by the vein wall on temperature behavior, comparing computations by using normal and zero wall absorption; (b) the prediction of the influence of wavelength on the temperature behavior; (c) the effect of the hot carbonized blood layer surrounding the fiber tip on temperature behavior, comparing wall temperatures from using a hot fiber tip and one kept at room temperature; (d) the effect of blood emptying the vein, simulated by reducing the inside vein diameter from 3 down to 0.8 mm; (e) the contribution of absorbed light energy to the increase in total energy at the inner vein wall in the time period where the highest inner wall temperature was reached; (f) the effect of laser power and pullback velocity on wall temperature of a 2-mm inner diameter vein, at a power/velocity ratio of 30 J/cm at 1,470 nm; (g) a comparison of model outcomes and clinical findings of EVLA procedures at 810 nm, 11 W, and 1.25 mm/s, and 1,470 nm, 6 W, and 1 mm/s, respectively. Interestingly, our model predicts that the dominating mechanism for heating up the vein wall is not direct absorption of the laser light by the vein wall but, rather, heat flow to the vein wall and its subsequent temperature increase from two independent heat sources. The first is the exceedingly hot carbonized layer covering the fiber tip; the second is the hot blood surrounding the fiber tip, heated up by direct absorption of the laser light. Both mechanisms are about equally effective for all laser wavelengths. Therefore, our model concurs the finding of Vuylsteke and Mordon (Ann Vasc Surg 26:424-433, 2012) of more circumferential vein wall injury in veins (nearly) devoid of blood, but it does not support their proposed explanation of direct light absorption by the vein wall. Furthermore, EVLA appears to be a more efficient therapy by the combination of higher laser power and faster pullback velocity than by the inverse combination. Our findings suggest that 1,470 nm achieves the highest EVLA efficacy compared to the shorter wavelengths at all vein diameters considered. However, 1,950 nm of EVLA is more efficacious than 1,470 nm albeit only at very small inner vein diameters (smaller than about 1 mm, i.e., veins quite devoid of blood). Our model confirms the efficacy of both clinical procedures at 810 and 1,470 nm. In conclusion, our model simulations suggest that direct light absorption by the vein wall is relatively unimportant, despite being the supposed mechanism of action of EVLA that drove the introduction of new lasers with different wavelengths. Consequently, the presumed advantage of wavelengths targeting water rather than hemoglobin is flawed. Finally, the model predicts that EVLA therapy may be optimized by using 1,470 nm of laser light, emptying of the vein before treatment, and combining a higher laser power with a greater fiber tip pullback velocity.

Quality of Life after Venous Stenting for Post-thrombotic Syndrome and the Effect of Inflow Disease.

OBJECTIVE: Patients with PTS experience an impaired quality of life (QoL). We aimed to study QoL in patients stented for post thrombotic syndrome (PTS) and analyze the influence of different parameters. METHODS: Patients stented for PTS after iliofemoral deep vein thrombosis were asked to complete the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36) in this cross-sectional study. All other data were collected retrospectively. Primary endpoints were median CIVIQ-20 and physical (PCS) and mental (MCS) component summary SF-36 scores. The influence of age, sex, and years between the procedure and completion of questionnaire were investigated using a multivariate linear regression model. Wilcoxon signed rank test compared the PCS and MCS with the normative. Effects of inflow from the deep femoral vein (DFV) and/or the femoral vein (FV) on QoL was analyzed in patients with patent stents. RESULTS: The response rate was 70.3% (n = 45/64). Time period (median) from stenting to questionnaire completion was 6.6 years (IQR: 8.0). Most stents were placed unilateral left-sided (73.3%). For patients with patent stents (n = 42) median CIVIQ-20 was 35.5 (IQR: 17.3), higher than the minimum of 20.0 (P < .001). Median PCS of 44.7 (IQR: 14.2) was lower (P < .001), and MCS of 55.9 (IQR: 7.1) higher (P = .001) than the normative (50.0). Time since stenting and sex were not associated with QoL. Age was a significant predictor [standardized coefficient ß = .36, P = .04] for QoL using the CIVIQ-20, but not for the SF-36. Inflow disease did not impact QoL, but patients with occluded stents (n = 3) had poor functioning levels. CONCLUSION: Quality of life is impaired after venous stenting for PTS, particularly physical functioning, among patients with an open stent, but was similar between patients with good and impaired inflow. Patients with a permanent stent occlusion had the lowest QoL.

Quality of Life After Early Clot Removal for Acute Iliofemoral Deep Vein Thrombosis.

Objective: To evaluate patient reported outcome measures after early clot removal for acute deep vein thrombosis (DVT), using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36). Methods: Cross sectional design. Patients who underwent early clot removal between June 2012 and November 2021 were asked to complete the two questionnaires once. Lower CIVIQ-20 and higher SF-36 scores indicate better quality of life (QoL). Primary endpoints were the median scores. The one sample Wilcoxon signed rank test was used to compare SF-36 physical and mental component summary (PCS and MCS) to the normative and CIVIQ-20 to the minimum. Secondary, non-parametric independent t test or Fisher's exact test examined how age, sex, body mass index, stent placement, re-intervention, and time of questionnaire completion related to QoL. Multivariable linear regression tested whether various variables were associated with QoL. Results: The response rate was 73.5% (n = 39). Median time of questionnaire completion was 1.8 years (interquartile range [IQR] 3.1) after clot removal. The median CIVIQ-20 of 29.0 (IQR 28.0) was slightly higher than the minimum value 20.0 (p < .001). The median PCS (50.5, IQR 16.6) and median MCS (50.2, IQR 14.2) did not differ from the normative of 50.0. However, wide IQRs indicated impairments for a subgroup of patients. None of the tested variables affected QoL except for the finding that re-interventions had a significantly negative impact on the SF-36 MCS (standardised ß coefficient of -0.4, p = .030). Conclusion: Overall patient reported outcome measures were satisfactory after early clot removal, but impaired physical and mental functioning levels were present in a subgroup of patients. Re-interventions were found to have a negative impact on mental QoL. This finding was independent of time that had passed between the procedure and questionnaire completion. This study emphasises that mental functioning deserves attention, besides the widely recognised physical consequences after invasive acute iliofemoral DVT treatment.

Efficacy of endovascular treatment of pelvic varicose veins: A single-center retrospective observational study.

OBJECTIVE: To evaluate the efficacy of endovascular embolization of pelvic varicose veins in the treatment of pelvic venous disorders (PeVD). METHODS: A single-center retrospective study was performed, including 156 women referred to the Erasmus University Medical Center between January 2011 and October 2020 for an evaluation of PeVD. Data on presenting symptoms, clinical workup, treatment, and clinical outcomes were collected. The primary end point was resolution of symptoms after treatment. Secondary outcomes were correlation between symptoms at presentation and relief of symptoms after treatment, minor or major procedural complications, recurrences, and additional treatments needed. RESULTS: Ninety patients underwent a pelvic phlebography, of which 75 received embolization of pelvic varicose veins. Median follow-up after phlebography was 13.2 months (interquartile range, 6.0-40.1 months). Of the treated patients, 53 (70.7%) had partial or complete relief of symptoms. Forty-six women (61.3%) who received embolization of pelvic varicose veins required additional treatments for leg and/or vulvar varicose veins. CONCLUSIONS: This study found that endovascular embolization of pelvic varicose veins can be an effective treatment for PeVDs. However, additional treatments are often required for leg and/or vulvar varicose veins.

[Steam ablation of varicose veins 5 years later]. / Stoomablatie van varices, 5 jaar later.

Endovenous treatment has become the treatment of choice for patients with saphenous varicose veins (great saphenous vein and small saphenous vein). Current thermal treatment modalities are endovenous laser ablation, radiofrequency ablation and steam ablation. These treatments work by heating the vein, causing the vessel to become occluded. These thermal treatment methods require tumescent anaesthesia. The outstanding effectiveness of laser and radiofrequency ablation has now been demonstrated in countless randomised trials and meta-analyses. Steam ablation seems to be just as effective as the other thermal treatment methods, but there is less pain afterwards. Since the treatment is not reimbursed, steam ablation is currently not used in the Netherlands.

[Steam ablation of varicose veins]. / Stoomablatie van varices.

In many western countries endovenous thermal ablation techniques have largely replaced classical surgery for the treatment of saphenous varicose veins as they are more effective and patient friendly. Because these treatments can be performed under local tumescent anaesthesia, patients can mobilize immediately after the procedure. A new method of thermal ablation is endovenous steam ablation, which is a fast and easy procedure. Steam ablation may cause less pain than laser ablation and it is also cheaper and more flexible than segmental radiofrequency ablation.