Evaluation of the effectiveness of extravasal correction of deep vein valves in the complex of surgical treatment of varicose disease of the lower extremities

This dissertation research is devoted to evaluating the efficacy of incorporating extravenous correction of femoral vein valves into the complex surgical treatment of varicose disease of the lower extremities. The study was conducted on a large clinical sample using ultrasonic duplex scanning, photoplethysmography, the clinical scale and disability scale of the CEAP classification, and the CIVIQ questionnaire for quality of life assessment. Patients were distributed into clinical classes C₁ — C₃ and C₄ — C₆, which allowed for a differentiated evaluation of the hemodynamic and clinical efficacy of the operation depending on the initial severity of chronic venous insufficiency. Indications and contraindications for extravenous correction of the femoral vein valves were developed, a surgical tactics selection algorithm was formulated, and an integrated approach to assessing the long-term treatment outcomes was proposed.

The treatment of varicose disease (VD) has a centuries-long history. Nevertheless, this problem continues to remain relevant to this day [Sabelnikov V.V. et al., 2001; Feied C., 2001; Perrin M.R., et al., 2002]. First and foremost, this is due to the high prevalence of the disease. For example, in the United States and Western European countries, the incidence of VD among the adult population reaches 25%, with a substantial proportion consisting of complicated forms [Callam M.J., et al., 1985; Jimenez Cossio J.A., 1996]. In Russia, more than 30 million people suffer from various forms of VD, 15% of whom have trophic disorders [Saveliev B.C. et al., 2001].

The recurrence rate of VD in surgically treated patients remains high, ranging from 8 to 80% [Viliansky M.P. et al., 1988; Shevchenko Yu.L. et al., 1999; Saveliev B.C. et al., 2001; Berni A., et al., 1998; Fischer R., et al., 2001; Feied C., 2001; Perrin M.R., et al., 2002; Creton D., 2002]. Many authors have cited technical errors during the initial operation as one of the possible causes [Lisitsyn K.M. et al., 1983; Belichenko I.A. et al., 1983; Firsov E.F. et al., 1995; Baeshko A.A. et al., 2001; Bradbury A.W., et al., 1994; Stonebridge P.A., et al., 1995; De Maeseneer M.G., et al., 1995; Jones L., et al., 1996; Canonico S., et al., 1997; Cavilli S., et al., 1997; Perrin M.R., et al., 1997; Setacci S., et al., 1997; Turton E.P., et al., 1997; Berni A., et al., 1998]. However, at present, due to the development of an extensive phlebological service, technical errors are becoming rare. Nevertheless, the cause of recurrence often remains unknown [van Rij A.M., et al., 2004]. It is known that one of the pathogenetic factors of VD and the associated chronic venous insufficiency (CVI) is incompetence of the deep vein valve apparatus, which may cause recurrence [Vedensky A.N., 1983; Shevchenko Yu.L. et al., 1999; Dibirov M.F., 2001; Grishin I.N. et al., 2003; Perrin M.R., et al., 1997; Feied C., 2001; Thiery L., 2003]. While the common causes of VD recurrence, such as incomplete removal of superficial veins, unligated perforating veins, and others, have been well studied, the significance of functional insufficiency of the deep vein valve apparatus as a cause of recurrence requires further investigation. It is necessary to address issues such as the pathogenetic relationship between ectasias and valve insufficiency of deep veins, the development of the most effective algorithm for preoperative examination of patients with this pathology, and the search for adequate methods of surgical correction of valve insufficiency. The main objective of surgical treatment consists in eliminating hypertension and creating physiological conditions for venous blood outflow through the restoration of the deep vein valve apparatus [Vedensky A.N., 1979, 1983, 1986; Kletskin A.E., 1993; Bogdanov A.E. et al., 1993; Gavrilenko A.V. et al., 1997; Yablokov E.G. et al., 1999; Saveliev B.C. et al., 2001; Kirienko A.I. et al., 2002; Bihari I., 1990; Alam S., et al., 1991; Van-Bemmelen P., et al., 1991; Lees T., et al., 1993; Priollet P., et al., 1994; Perrin M.R., et al., 1997, 2000; Feied C., 2001].

Work in this direction began in the 1970s–1980s. Two approaches to solving this problem were gradually defined, consisting of the use of extravenous [Vedensky A.N. et al., 1978; Sabelnikov V.V. et al., 2001; Tsukanov Yu.T. et al., 2002; Abalmasov K.G. et al., 2002; Zhukov B.N. et al., 2003; Lane R.J., et al., 1994; Akesson H., et al., 1998; Wang S., et al., 1999; Sakuda H., et al., 2002] and intravenous [Gavrilenko A.V. et al., 2002; Kistner R.L., 1975] correction of the valve apparatus of the deep veins of the lower extremities, the former being considered more promising [Shoikhet Ya.N. et al., 2004]. Works by many authors have demonstrated the fundamental feasibility of extravenous valve correction (EVC) of the femoral vein using various methods; the use of a frame-like spiral prosthesis has gained the greatest popularity [Vedensky A.N. et al., 1978, 1983; Sabelnikov V.V., 2001; Makarova N.P. et al., 2001; Masuda E., et al., 1994; Sakuda H., et al., 2002]. Following the introduction of this technique into clinical practice, a boom in its use followed [Vedensky A.N., 1983; Gamberin B.L. et al., 1983; Makarova N.P., 1985; Shevchenko Yu.L. et al., 1999; Vakhitov M.Sh. et al., 2000; Sabelnikov V.V. et al., 2001]. Subsequently, interest in EVC of deep veins also sharply declined. Moreover, some authors classify valve apparatus correction among techniques whose benefit is questionable, and the prospect of implementation in broad clinical practice is problematic [Yablokov E.G. et al., 1999; Kirienko A.I. et al., 2002]. The question of the necessity of correcting deep vein valve insufficiency in the complex surgical treatment of VD remains open to this day [Bogachev V.Yu., 2003; Sakuda H., et al., 2002].

Nevertheless, discussions regarding the feasibility of using EVC of deep veins of the lower extremities in the surgical treatment of VD continue to this day [Perrin M.R., 2002; Coreos L., 2004]. There are individual studies demonstrating the effectiveness of its application, manifested in a reduction in the number of VD recurrences and improvement of long-term results [Makarova N.P. et al., 2001; Sukovatykh B.S. et al., 2003; Butkevich A.Ts. et al., 2003, 2004; Baranov G.A. et al., 2004; Sakuda H., et al., 2002; Lane R.J., et al., 2003]. In particular, the results of studies by H. Sakuda et al. (2002) demonstrate the functional and clinical significance of EVC of the femoral vein performed during surgery for VD in patients with moderate and severe reflux in deep veins. The Cochrane review presents an analysis of the efficacy of the extravenous correction variant of deep vein valves, showing undoubted advantages of the technique in patients with moderately pronounced insufficiency of the deep vein valve apparatus [Abidia A., et al., 2002].

Thus, a unified approach to the question of the feasibility of EVC of deep veins in the complex surgical treatment of VD still does not exist [Bogachev V.Yu., 2003; Butkevich A.Ts. et al., 2003, 2004; Zolotukhin I.A., 2004; Abidia A., et al., 2002; Sakuda H., et al., 2002]. Therefore, the determination of clear indications for extravenous correction of the deep vein valve apparatus of the lower extremities, as well as a comprehensive assessment of long-term results of surgical treatment, remain pressing issues. The foregoing served as the justification for this work and defined its purpose and research objectives.

PURPOSE OF THE WORK

To improve the results of surgical treatment of patients with varicose disease of the lower extremities by developing a treatment algorithm that includes the use of extravenous correction of femoral vein valves with a dacron frame-like corrector.

RESEARCH OBJECTIVES

1. To study the initial state of phlebohemodynamics of the lower extremities and the clinical picture in patients with reflux in deep veins and varying degrees of severity of chronic venous insufficiency according to the CEAP classification.

2. To evaluate the effect of extravenous valve correction on deep venous reflux and blood flow parameters in the femoral vein depending on the initial severity of chronic venous insufficiency.

3. To investigate the possibilities of extravenous valve correction in improving the function of the calf muscle-venous pump in patients with different clinical classes according to the CEAP classification.

4. To provide a quantitative assessment of long-term clinical results of the use of extravenous correction of femoral vein valves in patients with "mild" and "severe" chronic venous insufficiency.

5. To determine the indications and contraindications for extravenous correction of the femoral vein valve apparatus in varicose disease depending on the initial severity of chronic venous insufficiency.

6. To develop an integrated approach to assessing the long-term results of extravenous valve correction, including the use of ultrasonic angioscanning and photoplethysmography, as well as the use of quantitative assessment of clinical manifestations.

SCIENTIFIC NOVELTY OF THE RESEARCH

For the first time, based on the results of ultrasonic duplex scanning, photoplethysmography, comprehensive assessment of clinical manifestations and quality of life of patients, indications and contraindications for the use of EVC of the femoral vein (FV) were developed depending on the initial severity of CVI and the degree of venous reflux. An integrated approach to assessing the long-term results of extravenous correction was developed, including the following parameters:

• determination of the presence or absence of reflux in the FV, as well as assessment of blood flow velocity characteristics using ultrasonic techniques;

• study of phlebohemodynamics at the level of the calf muscle-venous pump (CMVP) using photoplethysmography;

• quantitative assessment of clinical efficacy by calculating points on the clinical scale and the disability scale of the CEAP classification;

• determination of patients' quality of life using the CIVIQ questionnaire.

On a large clinical material, it was demonstrated that the use of EVC of FV in the complex surgical treatment of patients belonging to clinical classes C₁ — C₃ eliminates relative valve insufficiency in 95.4% of cases; improves velocity parameters of blood flow in the FV by 36.9–39.0%; leads to an increase in the venous refilling time by 84.9%, and the venous ejection fraction by 41.0%; reduces the mean values of the clinical scale points of the CEAP classification by 54.9%, the disability scale by 68.1%, and the CIVIQ questionnaire by 22.8%. It was established that in patients of this group operated without EVC, progression of deep venous reflux is observed, blood flow in the FV slows down, and the function of the CMVP deteriorates. This leads to disease recurrence, exacerbation of clinical manifestations of CVI, and a decrease in quality of life.

It was proven that in patients belonging to clinical classes C₄ — C₆, the use of EVC of FV in the complex surgical treatment does not have a significant effect on the severity of clinical manifestations of CVI and does not lead to a significant improvement in quality of life. Despite elimination of reflux in the FV, such patients continue to have disorders of phlebohemodynamics at the CMVP level, and trophic disorders persist.

PRACTICAL SIGNIFICANCE OF THE RESEARCH

An algorithm for selecting the method of surgical treatment for patients with VD of the lower extremities with hemodynamically significant blood reflux in the FV is presented.

EVC of FV effectively eliminates relative valve insufficiency and the associated CVI. When a hemodynamically significant reflux in the FV is detected in a patient with VD, starting from grade II according to the Kistner classification, and in the presence of signs of clinical classes C₁ — C₃ according to the CEAP classification, the method of choice for surgical intervention is varicophlebectomy supplemented by EVC of FV.

Patients with grade I reflux are not indicated for EVC, as such reflux is eliminated independently after superficial varicophlebectomy.

In patients belonging to clinical classes C₄ — C₆ according to the CEAP classification, the use of EVC in the complex surgical treatment is inexpedient. In such patients, after EVC, disorders of phlebohemodynamics at the CMVP level persist, and trophic disorders remain.

The tactics employed improve the long-term results of surgical treatment of VD of the lower extremities, reduce the recurrence rate, and decrease the number of severe trophic disorders, which is of important medical-social and economic significance.

The absence of the need to use complex technical equipment allows this operation to be widely applied in surgical hospitals.

MAIN PROVISIONS DEFENDED

1. The use of extravenous correction of femoral vein valves in the complex surgical treatment of varicose disease in patients belonging to clinical classes C₁ — C₃ according to the CEAP classification effectively eliminates relative valve apparatus insufficiency and prevents the progression of chronic venous insufficiency. In such patients, a significant improvement is observed in blood flow parameters at the level of the femoral vein and the calf muscle-venous pump, a decrease in the mean points of the clinical scale and the disability scale of the CEAP classification and the CIVIQ questionnaire.

2. In patients with femoral vein valve apparatus insufficiency operated without the use of extravenous valve correction, further progression of deep venous reflux, deterioration of venous outflow, occurrence of disease recurrences with worsening of chronic venous insufficiency, and a decrease in quality of life are observed.

3. Extravenous correction of femoral vein valves in patients with severe trophic disorders does not eliminate all phlebohemodynamic disorders, which is confirmed by photoplethysmography data. Clinical manifestations of chronic venous insufficiency and quality of life after surgery with the use of femoral vein valve correction in such patients also do not significantly improve. The maximum effect of extravenous valve correction that can be expected in this patient group consists in stabilizing the process and slowing the progression of chronic venous insufficiency.

4. For a reliable assessment of the long-term results of surgical intervention supplemented by extravenous correction of femoral vein valves, in addition to ultrasonic angioscanning, it is necessary to use photoplethysmography, as well as to calculate points on the clinical scale and the disability scale of the CEAP classification and the CIVIQ questionnaire.

DISSERTATION APPROBATION

The main provisions of the dissertation were presented at the zonal scientific-practical conference of the Caucasian Mineral Waters "Topical Issues of Practical Medicine" (Lermontov, 2002), at the interregional conference "Topical Issues of Surgery" (Yaroslavl, 2003), at the IV and VI International Congresses of Young Scientists "Sciences of Man" (Tomsk, 2003, 2005), at the First and Second International Distance Scientific-Practical Conferences "Cardiovascular Surgery and Angiology — 2003" and "Cardiovascular Surgery and Angiology — 2004" (Saint Petersburg, 2003, 2004), at the X scientific-practical conference "Topical Issues of Surgery and Clinical Anatomy" within the framework of the International Exhibition "Medicine and Health — 2004" (Perm, 2004), at the International Surgical Congress "New Technologies in Surgery" (Rostov-on-Don, 2005).

STRUCTURE AND SCOPE OF THE DISSERTATION

The dissertation is presented on 143 pages of typescript, consists of an introduction, literature review, description of research materials and methods, three chapters of original observations, conclusions, practical recommendations, and a bibliography including 141 domestic and 171 foreign sources. The dissertation is illustrated with 26 tables, 26 figures, and contains 3 clinical examples.