Method of hemodynamic sclerotherapy for varicose veins of lower extremities

Abstract

FIELD: vascular surgery; phlebology.SUBSTANCE: after eliminating pathological vertical reflux in the great and small saphenous veins using EVLC, the patient is placed in a vertical position using sonography to determine and mark a hemodynamically significant point, which is the location of a varix with a diameter of more than 8 mm, located at a distance of up to 20 mm from the perforating vein with pathological horizontal reflux of more than 0.5 s, then in a horizontal position, a venous catheter is installed at the marked hemodynamically significant point, the lower limb is raised at an angle of 70° to the operating table and 5 ml of a foam form of 3 % polidocanol, prepared according to the Tessari method, is introduced into the venous catheter, while the surgeon simultaneously manually carries out circulatory compression of the gastrocnemius muscle to arrest the venous sinuses, maintaining an elevated position of the lower limb and continuing ultrasound control until foam stasis is achieved in the varices according to sonography data, which indicates successful obliteration. Then the lower limb is returned to a horizontal position and local compression is created using class 2 compression hosiery.EFFECT: this method is a reliable and safe way to treat varicose veins of the lower extremities, which reduces the risk of complications and relapses and can be recommended for widespread use in specialized hospitals.1 cl, 3 ex

Description

[0001] The invention relates to medicine, namely to vascular surgery, in particular to phlebology, and can be used in foam echosclerotherapy of varicose veins of the lower extremities.

[0002] Varicose veins of the lower extremities (VLE) are one of the most common peripheral vascular diseases. According to a 2021 global epidemiological study, the prevalence of this pathology is 33.8%. [Salim S et al. Global epidemiology of chronic venous disease: a systematic review with pooled prevalence analysis. Ann Surg. 2021;274(6):971-976].

[0003] Today, minimally invasive methods are successfully used in the treatment of patients with VBNC, in particular, endovascular laser coagulation (EVLC), radiofrequency ablation (RFA) of the trunks of the great saphenous vein (GSV) and / or small saphenous vein (SSV) in combination with echosclerotherapy of varicose tributaries. However, despite the high efficiency of sclerotherapy in obliteration of varicose veins, complications such as skin hyperpigmentation (10-30%), secondary telangiectasias (5-10%), phlebitis (14-24%), deep vein thrombosis (1-5.7%), skin necrosis, allergic reactions, etc. are encountered in clinical practice. The incidence of vein neo-obliteration after the first sclerotherapy procedure reaches 32%, in 14.5% of cases there is no effect after repeated procedures [Khitaryan A.G. et al. Hemodynamic sclerotherapy in the complex treatment of varicose veins of the lower extremities in patients with morbid obesity. Outpatient surgery. 2025; 22(1)].

[0004] Conventional sclerotherapy, in which the limb is kept horizontal during injection, does not completely fill the lumen of the great saphenous vein. This is due to the fact that the foam sclerosant mixes with blood and predominantly occupies a superior parietal position within the vessel. As a result, contact between the sclerosant and the venous wall endothelium is impaired, leading to incomplete obliteration and subsequent recanalization of the veins [Baeshko A.A. et al. Foam sclerotherapy: history of development and current data. Surgical News. 2012; 20(4):101-110].

[0005] Inadequate post-sclerosurgical compression of sclerosed veins can also negatively impact treatment outcomes. Its primary purpose is to achieve obliteration and reduce the risk of thrombus formation by displacing blood from the vessel lumen and sealing its walls. Insufficient compression can cause dilution and removal of the sclerosant from the treated vein. As a result, vessel obliteration is incomplete, and the vein remains partially or completely patent. The destructive effect of the sclerosant on functioning venous valves increases pathological blood reflux, which contributes to the development of disease recurrence.

[0006] It should also be noted that ultrasound imaging of foamy bubbles migrating into the distal venous system is routine practice for phlebologists. The introduction of a sclerosant, which is aggressive toward the endothelium, into the deep venous system of the leg can lead to complications. Although the incidence of deep vein thrombosis remains low, patients often report pain in the calf muscles after sclerotherapy sessions.

[0007] The optimal duration of sclerosant administration and exposure to achieve lasting obliteration also remains controversial. Insufficient contact time between the sclerosant and the vessel wall can lead to incomplete obliteration and subsequent vein recanalization, while excessive exposure potentially increases the risk of complications. Therefore, optimization of the administration time and action of the sclerosant is considered a balance between the effectiveness of induced obliteration and the safety profile of the procedure.

[0008] Thus, one of the main tasks of modern phlebology is to improve the safety profile of sclerotherapy, which is achieved by reducing the dose of sclerosant, decreasing the number of injections and reducing the frequency of procedure sessions.

[0009] A known method of microfoam sclerotherapy with mini-phlebectomy is used for EVLT of the GSV trunk using a generally accepted technique (diode laser, 1470 nm wavelength, and radial emission light guides). After completing treatment of the main vein, microfoam sclerotherapy (MPS) of the varicose tributaries was first performed. The sclerosant was injected in small volumes (1-2 ml) at several points, rather than in a single large volume. When a parallel ultrasound examination determined that all target veins were filled with foam, the injections were stopped. The total volume of the injected drug did not exceed 5 ml per procedure. After completing MPS, tumescent anesthesia was administered along the marked veins, and a Varady mini-phlebectomy was performed. An 18G puncture needle was used to make skin punctures along the marked tributaries.The key points were identified in advance: the first was the closest point to the entry of the varicose tributary into the main vein, the second was the closest point to the drainage of reflux into the deep venous system, and the remaining points were spaced approximately 10 cm apart. Then, through skin punctures, the vein wall was grasped with a Varady hook and extracted. Once the vein was exposed, it was grasped with mosquito clamps and, using gentle traction movements at the cranial and distal ends, removed as far as possible. The number of punctures varied among patients and depended on the extent of the varicose veins. In most cases, 5-7 were used. After this stage, the operated leg was treated with a solution of hydrogen peroxide and an antiseptic. Suturing the puncture holes was not required due to their small diameter. Sterile napkins were applied to the puncture sites and a class 2 compression stocking was put on.Immediately after the surgery, patients were recommended to walk leisurely for 30-60 minutes. [Danelyan B.A. et al. Combined microfoam sclerotherapy with mini-phlebectomy as an optimal method for treating varicose tributaries after endovenous laser coagulation. Outpatient surgery. 2022;19(2):22-28. https: / / doi.org / 10.21518 / 1995-1477-2022-19-2-22-28].

[0010] The disadvantage of this method is the lack of consideration of venous hemodynamics when selecting puncture points for sclerotherapy, which leads to the lack of targeted and selective action of the sclerosant and the need to perform multiple punctures.

[0011] In addition, this method involves performing mini-phlebectomy using tumescent anesthesia, which increases the trauma of the intervention, the severity of pain, the risk of cosmetic defects and the duration of postoperative rehabilitation.

[0012] A method for sclerotherapy of varicose veins of the subcutaneous veins is known from the existing level of technology, including puncture of the subcutaneous vein and introduction into the lumen of the vein under ultrasound control of a microfoam form of sodium tetradecyl sulfate, prepared using two syringes connected through a tee for the infusion system, by mixing the sclerosant solution and atmospheric air in a ratio of 1:4, compression of the sclerosed area, characterized in that the microfoam form of a 0.5% solution of sodium tetradecyl sulfate is introduced in an amount of 2.0-5.0 ml, immediately after which a 0.5-1.0% solution of sodium tetradecyl sulfate is additionally introduced in an amount of 2.0-5.0 ml in liquid form, and the course of treatment is 1-2 procedures of combined sclerotherapy with an interval of 1 to 3 months (RU Patent No. 2669728, publication: 2018.10.15).

[0013] The disadvantages of this method are: insufficient occlusion of the vein due to the “washing out” of the sclerosant after its introduction into the vein, non-target occlusions of competent subcutaneous veins, non-target occlusions of deep veins, a high frequency of recanalization of the sclerosed vein and recurrence of varicose veins.

[0014] The closest to the claimed technical solution is a method for performing sclerotherapy of non-aphenous and / or tributaries of the saphenous veins under infiltration of perivenous tissues and ultrasound control, including puncture of non-aphenous and / or tributaries of the saphenous veins with 20G intravenous catheters under ultrasound control with the patient in a supine position; then the lower limbs are raised to reduce the diameter of the veins; then, under ultrasound control, perivenous tissues are infiltrated with a saline solution, while complete emptying and spasm of the target veins is monitored; then, saline solution is injected directly into their lumen to remove residual blood; after which repeated ultrasound control of emptying is performed and a sclerosing agent in the form of microfoam is introduced into the target veins, also under ultrasound control (RU Patent No. 2681737, publication: 2019.03.12).

[0015] The disadvantage of this method is the lack of consideration of venous hemodynamics when selecting puncture points, which leads to the lack of targeted and selective effect of the sclerosant and the need to perform multiple punctures.

[0016] Furthermore, this method eliminates the step of manual compression of the calf muscles to temporarily stop blood flow during sclerosant administration. Infiltration of perivenous tissues with saline does not prevent blood from returning to the vein, as it only creates mechanical compression and does not provide controlled blood flow.

[0017] A drawback of the prototype is the lack of an objective ultrasound criterion for the completion of sclerosant injection, making the procedure dependent on the physician's subjective assessment and experience. Finally, this method does not maintain an elevated position of the limb during injection, which impairs foam contact with the vessel wall, reducing the uniformity and effectiveness of obliteration.

[0018] The claimed invention allows to eliminate the shortcomings of the prototype.

[0019] The problem to be solved by the claimed invention is the development of a method of hemodynamic sclerotherapy that ensures increased effectiveness of treatment of varicose veins of the lower extremities by reducing the frequency of complications and relapses in the form of recanalization of obliterated veins.

[0020] The stated objective is achieved by the fact that after the elimination of pathological vertical reflux through the great and small saphenous veins in a vertical position, patients are given a hemodynamically significant point to determine and mark using sonography, which is the location of a varix with a diameter of more than 8 mm, located at a distance of up to 20 mm from the perforating vein with pathological horizontal reflux of more than 0.5 s;then, in a horizontal position, a venous catheter is inserted at a marked hemodynamically significant point, the lower limb is elevated at an angle of 70° to the operating table, and 5 ml of 3% polidocanol foam prepared using the Tessari technique is injected into the venous catheter. The surgeon then manually applies circulatory compression to the gastrocnemius muscle to arrest the venous sinuses, maintaining an elevated position of the lower limb and continuing ultrasound monitoring until foam stasis is achieved in the varices - a condition in which, according to sonography, the movement of bubbles of the foam form of the sclerosant stops, indicating successful obliteration. After which the lower limb is returned to a horizontal position, local compression is created using class 2 compression hosiery, and walking load is recommended for 30-60 minutes.

[0021] The technical result provided by the given set of features is a reduction in complications and relapses in the form of recanalization of obliterated veins, due to the obliteration of varicose-dilated tributaries located at a distance from the hemodynamically significant point.

[0022] In most known sclerotherapy methods, the sclerosing agent is administered in a horizontal position of the limb, which creates insufficient contact between the sclerosant and the venous wall endothelium. Furthermore, the presence of pathological vertical and horizontal reflux promotes the migration of foamy sclerosant bubbles to distal portions of the venous bed, increasing the risk of complications.

[0023] In the proposed method, sclerotherapy is performed after preliminary elimination of vertical reflux by EVLK of varicose veins of the great and small saphenous veins. Horizontal reflux through the perforating vein is eliminated by administering the sclerosant with the lower limb elevated at a 70° angle to the operating table. Sonography is also used to monitor sclerosant migration to prolong the elevation of the lower limb until foamostasis occurs—a condition in which, according to sonographic data, the movement of sclerosant foam bubbles ceases, indicating successful obliteration. Furthermore, to improve sclerosant contact with the venous wall endothelium, the surgeon simultaneously manually compresses the gastrocnemius muscle to achieve circulatory arrest of the venous sinuses.

[0024] Reduction in the severity of pain is achieved by reducing the number of punctures on the shin to one, since the introduction of the sclerosing substance is carried out at a hemodynamically significant point predetermined using sonography and marked - the location of the varix with a diameter of more than 8 mm, located at a distance of up to 20 mm from the perforating vein with pathological horizontal reflux of more than 0.5 seconds.

[0025] This technique eliminates pathological vertical and horizontal reflux, controls the migration of sclerosant bubbles, and applies additional manual compression, resulting in increased sclerosant exposure in the affected vein and a more intense effect on the venous wall endothelium. Selecting a hemodynamically significant injection site allows for a single puncture on the calf. As a result, we achieve a reduction in pain, a lower incidence of complications, and recanalization of obliterated veins.

[0026] Detailed description of the method and examples of its clinical implementation

[0027] The method is performed as follows. After eliminating pathological vertical reflux through the great and small saphenous veins, the patient in an upright position undergoes sonoangioscanning with Doppler mapping using a SonoScape S30 (SonoScape, China) with an L743 linear transducer in the 5-10.5 MHz frequency range. A hemodynamically significant point is identified and marked—the location of a varix greater than 8 mm in diameter, located up to 20 mm from the perforating vein with pathological horizontal reflux for more than 0.5 seconds.

[0028] Varices located above and below the hemodynamically significant point were also marked for further assessment of their obliteration. Thus, with a single puncture point and sclerosant injection, it was possible to assess how variceal obliteration occurred above and below the point where the sclerosant was not injected. This can also be considered an additional advantage of the proposed method.

[0029] Then, in a horizontal position, a venous catheter is inserted into the marked hemodynamically significant point, the lower limb is raised at an angle of 70° to the operating table, and 5 ml of 3% polidocanol foam prepared according to the Tessari method is injected into the venous catheter: using two syringes connected through a three-way adapter, by mixing the sclerosant solution and air in a ratio of 1:4 [Tessari L., Cavezzi A., Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. / / Dermatol Surg. 2001. Vol. 27, No. LP. 58-60].The surgeon manually applies circulatory compression to the gastrocnemius muscle to arrest the venous sinuses, maintaining the lower limb elevated and continuing ultrasound monitoring until foam stasis is achieved in the varicose veins. This is a condition in which, according to sonography, the movement of the foam bubbles of the sclerosant has stopped, indicating successful obliteration. The lower limb is then returned to a horizontal position and localized compression is applied using Class 2 compression stockings or a low-stretch elastic bandage. All patients are advised to walk for 30-60 minutes, apply continuous compression throughout the day, and continue compression during the day for two weeks.

[0030] The effectiveness of the claimed method is confirmed by the following clinical examples:

[0031] Example 1

[0032] Patient K., 38 years old, was admitted with a diagnosis of varicose veins. Varicose veins of the right lower extremity. Chronic venous disease C3 according to CEAP.

[0033] During a preliminary ultrasound examination in a vertical position using the SonoScape S30 (SonoScape, China) with an L743 linear transducer in the frequency range of 5-10.5 MHz, a failure of the remaining valve with the formation of vertical reflux was detected, the diameter of the trunk of the great saphenous vein (GSV) in the area of ​​the saphenofemoral junction (SFJ) was 10 mm, the diameter of the trunk of the small saphenous vein (SSV) in the area of ​​the saphenopopliteal junction (SPJ) was 5.5 mm. In the operating room, in a horizontal position, obliteration of the GSV and SSV trunks was performed by endovascular laser coagulation using a Biolitek Ceralas E15ELVES diode laser (Biolitec AG, Germany) with a wavelength of 1470 nm, a pulse of 1 s, an interval of 10 ms, a power of 10 W, and an energy density of 100 J / cm.

[0034] Next, in the vertical position, using ultrasound imaging of the varicose vein of the GSV tributary—an 8-mm-diameter varix located 20 mm from a 3.5-mm-diameter perforating vein in the upper third of the medial surface of the leg (Boyd's zone) with a horizontal reflux of 0.5 seconds—the hemodynamically significant point was identified and marked. Two varices below the hemodynamically significant point, with diameters of 4.2 mm and 5 mm, and one varice above the hemodynamically significant point, with a diameter of 4 mm, were also marked.

[0035] Then, in a horizontal position, a venous catheter with an 18G needle was inserted at the marked hemodynamically significant point. The lower limb was elevated at a 70° angle to the operating table. 5 ml of 3% polidocanol foam, prepared according to the Tessari technique, was slowly injected into the catheter at a rate of 0.5 ml / s. The surgeon simultaneously applied manual circulatory compression to the gastrocnemius muscle to arrest the venous sinuses.

[0036] Additionally, sonography was used to monitor sclerosant migration to prolong the elevation of the lower limb until the onset of foam stasis in the varix, confirming successful obliteration. The time to achieve foam stasis was 55 seconds. The lower limb was then returned to a horizontal position, and local compression was applied using class 2 compression hosiery. The patient was advised to walk for 30-60 minutes, maintain continuous compression throughout the day, and continue compression during the day for two weeks.

[0037] At a two-month follow-up examination, ultrasound results revealed complete obliteration of the varicose veins from the hemodynamically significant point to the marked varices above and below it. No phlebitis, thrombophlebitis, or other complications were observed, and there was no pain.

[0038] Example 2

[0039] Patient D., 41 years old, was admitted with a diagnosis of varicose veins. Varicose veins of the left lower extremity. Chronic venous disease C4a according to CEAP.

[0040] During a preliminary ultrasound examination in a vertical position using a SonoScape S30 (SonoScape, China) with an L743 linear sensor in the frequency range of 5-10.5 MHz, an ostial valve incompetence with the formation of vertical reflux was detected, the diameter of the GSV trunk in the SPS area was 11 mm, the diameter of the SSV trunk in the SPS area was 6 mm. Under operating conditions in a horizontal position, obliteration of the GSV and SSV trunks was performed by endovascular laser coagulation using a Biolitek Ceralas E15ELVES diode laser (Biolitec AG, Germany) with a wavelength of 1470 nm, a pulse of 1 s, an interval of 10 ms, a power of 10 W, an energy density of 100 J / cm.

[0041] Next, in the vertical position, using ultrasound imaging of a varicose vein of the SSV, 8.5 mm in diameter, located 15 mm from a perforating vein 3 mm in diameter in the lower third of the medial surface of the leg (Cockett's zone) with a horizontal reflux of 0.6 seconds, a hemodynamically significant point was identified and marked. Additionally, one varix below the hemodynamically significant point, 4 mm in diameter, and one varix above the hemodynamically significant point, 3.5 mm in diameter, were marked.

[0042] Then, in a horizontal position, an venous catheter with an 18G needle was inserted at a marked hemodynamically significant point. The lower limb was elevated at a 70° angle to the operating table. Five milliliters of 3% polidocanol foam, prepared using the Tessari technique, was slowly injected into the catheter at a rate of 0.5 ml / s. The surgeon simultaneously applied manual circulatory compression to the gastrocnemius muscle to arrest the venous sinuses. Sonography was used to monitor the migration of the sclerosant to ensure the lower limb was maintained in an elevated position until foam stasis was achieved in the varix, confirming successful obliteration. The time to achieve foam stasis was 41 seconds. After this, local compression was performed using class 2 compression hosiery, the patient was recommended to walk for 30-60 minutes, continuous compression during the day and compression during the day for 2 weeks.

[0043] At a two-month follow-up examination, ultrasound results revealed complete obliteration of the varicose veins from the hemodynamically significant point to the marked varices above and below it. No phlebitis, thrombophlebitis, or other complications were observed, and there was no pain.

[0044] Example 3

[0045] Patient A., 44 years old, was admitted with a diagnosis of varicose veins. Varicose veins of the right lower extremity. Chronic venous disease C4a according to CEAP.

[0046] During a preliminary ultrasound examination in a vertical position using the SonoScape S30 (SonoScape, China) with an L743 linear transducer in the frequency range of 5-10.5 MHz, a failure of the remaining valve with the formation of vertical reflux was detected, the diameter of the trunk of the great saphenous vein (GSV) in the area of ​​the saphenofemoral junction (SFJ) was 10.5 mm, the diameter of the trunk of the small saphenous vein (SSV) in the area of ​​the saphenopopliteal junction (SPJ) was 6.5 mm. In the operating room, in a horizontal position, obliteration of the GSV and SSV trunks was performed by endovascular laser coagulation using a Biolitek Ceralas E15ELVES diode laser (Biolitec AG, Germany) with a wavelength of 1470 nm, a pulse of 1 s, an interval of 10 ms, a power of 10 W, and an energy density of 100 J / cm.

[0047] Next, in the vertical position, using ultrasound imaging of a varicose vein of the GSV tributary—a 9.2 mm diameter varix located 13 mm from a 4 mm diameter perforating vein in the upper third of the medial surface of the leg (Boyd's zone) with a horizontal reflux of 0.7 seconds—a hemodynamically significant point was identified and marked. Additionally, one varix below the hemodynamically significant point, 4.4 mm in diameter, was marked.

[0048] Then, in a horizontal position, an venous catheter with an 18G needle was inserted at a marked hemodynamically significant point. The lower limb was elevated at a 70° angle to the operating table, and 5 ml of 3% polidocanol foam, prepared using the Tessari technique, was slowly injected into the catheter at a rate of 0.5 ml / s. The surgeon simultaneously applied manual circulatory compression to the gastrocnemius muscle to arrest the venous sinuses. Sonography was used to monitor the migration of the sclerosant to prolong the elevation of the lower limb until foam stasis was achieved in the varix, confirming successful obliteration. Foam stasis was achieved in 47 seconds. The lower limb was then returned to a horizontal position, and local compression was applied using class 2 compression hosiery.The patient was recommended to walk for 30-60 minutes, apply continuous compression throughout the day, and apply compression during the day for 2 weeks.

[0049] At a two-month follow-up examination, ultrasound results revealed complete obliteration of the varicose veins from the hemodynamically significant point to the marked varix below it. No phlebitis, thrombophlebitis, or other complications were observed, and there was no pain.

[0050] Forty patients with CVD class C3-C5 according to CEAP were treated with the declared method. According to the results, the average pain intensity score according to the visual analog scale (VAS) was 1.9±0.5 on the first day and 1.3±0.6 on the 7th. Phlebitis was observed in 5 patients (12.5%). One year later, according to ultrasound data, varicose tributaries from the hemodynamically significant point to the marked varices above and below it were obliterated in 37 patients (92.5%), with no recurrence. Compared with the treatment results in the control group, where 40 patients underwent standard sclerotherapy in the horizontal position, reliable significant differences were noted in the frequency of phlebitis and obliteration of varices above and below the hemodynamically significant point. Both groups were statistically comparable according to all preoperative criteria. Statistical data processing was performed using the Statistica v. 10.0 program.For descriptive statistics, mean values ​​(M), standard deviations (SD), and minimum and maximum values ​​were calculated. The Wilcoxon signed-rank test was used to calculate the dynamics of quantitative indicators. Differences were considered statistically significant at p < 0.05.

[0051] Advantages of the method

[0052] The method allows for the obliteration of varicose veins located at a distance from the hemodynamically significant point, reduces trauma by reducing the number of punctures on the shin to one, reduces the severity of pain and inflammation in the area of ​​​​the sclerosant injection, and also the frequency of recanalization of obliterated veins.

[0053] The claimed method is an effective and safe way to treat varicose veins of the lower extremities, which reduces the risk of complications and relapses and can be recommended for widespread use in specialized hospitals.

Claims

A method of hemodynamic sclerotherapy of varicose veins of the lower extremities, characterized in that after the elimination of pathological vertical reflux along the great and small saphenous veins using EVLT, the patient in a vertical position using sonography is determined and marked by a hemodynamically significant point, which is the location of a varix with a diameter of more than 8 mm, located at a distance of up to 20 mm from the perforating vein with pathological horizontal reflux of more than 0.5 s, then in a horizontal position a venous catheter is installed in the marked hemodynamically significant point, the lower limb is raised at an angle of 70 ° to the operating table and 5 ml of a foam form of 3% polidocanol prepared according to the Tessari method are introduced into the venous catheter, while the surgeon simultaneously manually carries out circulatory compression of the gastrocnemius muscle to arrest the venous sinuses, maintaining an elevated position of the lower limb and continuing ultrasonic control until then,until foam stasis is achieved in the varicose veins, after which the lower limb is returned to a horizontal position and local compression is created using class 2 compression hosiery.