Chronic Venous Insufficiency, Varicose Veins
Conditions
Keywords
Varicose veins, Endovenous laser treatment, Reflux, Recurrence, Crossectomy
Brief summary
Technically successful laser crossectomy will reduce the risk of reflux recurrence at the sapheno-femoral junction without increasing the risk of endovenous heat-induced thrombosis, which may positively impact the likelihood of ultrasound- or clinical-recurrence of varicose veins. Similar technical efficacy is expected for laser crossectomy at 1940 nm and 1470 nm. A possible advantage of the 1940 nm wavelength in terms of postoperative pain intensity and the risk of adverse events cannot be ruled out.
Detailed description
Chronic venous disorder (CVD), including primary varicose veins (VV) of the lower limbs and progressive forms with chronic venous insufficiency (CVI), is an important medical and social problem due to its high prevalence in the population and its significant burden on healthcare systems. According to general data, up to 19% of the population has primary varicose veins, and up to 13.5% has signs of CVI. At present, the main approach to surgical treatment of VVs is the elimination of pathological reflux, for which minimally invasive endovascular techniques are recommended. The latter, including endovascular laser treatment (EVLT), is noninferior to open surgery in technical efficiency but is associated with a lower risk of postoperative complications. Among all adverse events after EVLT, the most important one is venous thromboembolism (VTE), including endovenous heat-induced thrombosis (EHIT). The incidence of EHIT may depend on the position of the laser fiber relative to the sapheno-femoral junction (SFJ). Recurrent varicose veins, occurring in 10-62% of patients, are the leading consequence of varicose vein surgery in long-term follow-up. The causes of recurrence depend on the type of primary intervention, with recanalization and reflux recurrence at the SFJ after EVLT being the most common. In order to reduce the risk of varicose veins recurrence, it was proposed to perform a "laser crossectomy" (flush or zero ablation), which suggests laser fiber position just near the wall of the femoral vein without a traditional 1-2 cm distance from the junction. It is aimed at eliminating the ostia of all adjacent tributaries, including the anterior accessory saphenous vein (AASV), as in a traditional open surgery. To date, the limited evidence of laser crossectomy demonstrates its relative safety and technical feasibility in 57-100%, as well as a contradictory effect on the recurrence rate, including reflux on AASV. At the same time, the vast majority of studies on laser crossectomy have been conducted at 1.5 μm (1470-1550 nm). The further development of technology has led to devices producing a wavelength of about 2 μm, which exhibit more selective absorption by water in blood and venous walls, allowing a similar depth of wall injury with lower power. First studies on its use show a high occlusion rate of up to 99%, low postoperative pain levels, and a reduced frequency of EHIT (predominantly class 1). Since EHIT of class 1 (superficial vein occlusion up to the level of the deep vein wall) aligns with the intention to perform a laser crossectomy, the use of 2 μm wavelength compared to 1,5 μm can be associated with both improved safety in terms of reducing EHIT of classes 2-4, and lower efficiency due to preservation of a stump with tributaries. Moreover, the technically successful laser crossectomy, despite the reduced risk of reflux recurrence at the SFJ, cannot guarantee the absence of reflux recurrence through other mechanisms. Thus, the question of choosing an optimal wavelength for performing a laser crossectomy, as well as its influence on further progression of GSV reflux, remains open.
Interventions
PROCEDURELaser crossectomy on 1470 nm
Attempt to perform laser crossectomy with radial fiber (core of 0.4 mm, bulb of 1.57 mm) on the 1470 nm wavelength laser with a power of 6-8 W and an LED of 60-80 J/cm. Performing the GSV trunk ablation according to the indications.
PROCEDURELaser crossectomy on 1940 nm
Attempt to perform laser crossectomy with radial fiber (core of 0.55 mm, bulb of 1.4 mm) on the 1940 nm wavelength laser with a power of 4-6 W and an LED of 40-60 J/cm. Performing the GSV trunk ablation according to the indications.
PROCEDUREStandard EVLT with a stump
Attempted laser crossectomy on 1470 nm or 1940 nm failed due to anatomical features of the SFJ or technical reasons, and the GSV trunk was obliterated with persistence of the stump.
Sponsors
Pirogov Russian National Research Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open-label pragmatic randomized controlled trial with 3 parallel groups, where allocation into two experimental groups is performed randomly (wavelength of 1470 or 1940 nm), and the third control group contains subjects for whom a laser crossectomy was technically impossible or failed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Primary VVs of Clinical Etiology Anatomy Pathophysiology (CEAP) clinical class of C2-C6 * Reflux along the GSV trunk lasting \>0.5 sec. * GSV trunk diameter ≤12 mm * Informed consent to participate in the study
Exclusion criteria
* Primary reflux outside the GSV trunk (including combined reflux) * History of deep or superficial vein thrombosis * Deep vein reflux * Non-thrombotic or post-thrombotic venous obstruction * Pelvic venous insufficiency * Use of oral anticoagulants * Indication for pharmacological prophylaxis after EVLT * Inability to use radial fiber of 1.4-1.57 mm at the surgeon's discretion * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with reflux recurrence at the sapheno-femoral junction | 12 months | Defined as the presence of reflux, with a duration of \>0.5 sec under provocation manoeuvre (Valsalva manoeuvre and/or manual distal compression), at the zone of treated SFJ, including reflux on recanalized GSV trunk, on the AASV or any other tributaries, on the lymph node venous network, on the inguinal or perineal veins as detected by duplex ultrasound scan (DUS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with technically possible laser crossectomy | 0 days | Defined as the possibility of laser fiber positioning near the femoral wall according to the SFJ anatomy during surgery under ultrasound navigation. |
| Number of patients with technically successful laser crossectomy | 3 days | Defined as the absence of the GSV stump: ablation level according to the femoral vein wall may vary from +1 mm into the femoral vein lumen to -2 mm into the GSV trunk lumen, as detected by postoperative DUS. |
| Length of GSV stump | 12 months | Defined as a distance from the femoral vein wall to the zone of GSV ablation as measured by DUS in mm. |
| Number of patients with EHIT of 2-4 classes | 12 months | Defined as thrombus propagation from the GSV trunk into the femoral vein lumen for more than 1 mm as detected by postoperative DUS. Class 2 means thrombus occupying less that 50% of the femoral vein lumen. Class 3 means thrombus occupying more 50% of the femoral vein lumen but not occluding it. Class 4 means occlusive thrombus of the femoral vein. |
| Number of patients with GSV recanalization | 12 months | The venous segment of the previously obliterated GSV with blood flow revealed by DUS, and the length of 5 cm or more. |
| Number of patients with clinical recurrence of varicose veins | 12 months | The reappearance of the visible or palpable varicose tributaries on any (treated or not-treated) lower limb. |
| Number of patients with ultrasound recurrence of varicose veins | 12 months | The appearance of invisible and non-palpable VVs on any (treated or non-treated) limb revealed by a DUS. |
| The value of VCSS score | 12 months | The severity of CVD is assessed during clinical examination using the revised Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. A maximal score indicates a more severe CVD. |
| The value of CIVIQ-20 score | 12 months | The quality of life is assessed by the patient using the vein-specific Chronic Lower Limb Venous Insufficiency Questionnaire-20 (CIVIQ-20). Range 0-100: a lower score indicates better quality of life. |
Countries
Russia
Contacts
CONTACTKirill Lobastov, PhD
PRINCIPAL_INVESTIGATORKirill Lobastov, PhD
Pirogov Russian National Research Medical University
Outcome results
None listed