Effects of high ligation plus endovenous laser therapy in patients with varicosis of great saphenous vein and type 2 diabetes

Abstract

To analyze the effects of high ligation plus endovenous laser therapy on intraoperative blood loss, postoperative visual analogue scale (VAS) score, and complications in patients with varicosis of great saphenous vein and type 2 diabetes. About 61 patients with varicosis of great saphenous vein and type 2 diabetes treated at our hospital were included. About 32 patients (37 affected limbs) receiving conventional surgery were included in control group, while 29 patients (34 affected limbs) receiving high ligation plus endovenous laser therapy were included in study group. The intraoperative blood loss, operation time, length of postoperative hospital stay, postoperative VAS scores, blood glucose levels, Venous Clinical Severity Score (VCSS), and incidence of complications were compared between the two groups. Compared with the control group, there were less intraoperative blood loss (P < .05), shorter operation time (P < .05), and shorter length of postoperative hospital stay in the study group (P < .05). Besides, there was also lower VAS scores at different time points after surgery in the study group than in the control group (P < .05). Blood glucose levels were decreased in both groups after surgery (P < .05). Moreover, VCSS was decreased in either group at 3 months after surgery (P < .05). Blood glucose levels of patients in the study group were lower than those of the control group after surgery (P < .05). The VCSS was also lower in the study group at 3 months after surgery than in the control group (P < .05). High ligation with endovenous laser therapy for varicosis of great saphenous vein in patients with type 2 diabetes was safe and feasible.

1. Introduction

Varicosis of great saphenous vein is most common in patients aged 30 to 70, and females are more vulnerable to this disease than males.^[1] The common causes of varicosis of great saphenous vein include poor venous wall elasticity, high vein intravascular pressure, and other risk factors. The affected limbs generally suffer from superficial varicose veins, swelling, and pain. As the main type of diabetes, type 2 diabetes is characterized by high blood glucose levels. Diabetes has been found to induce varicose veins.^[2] Many patients are affected concurrently by varicosis of great saphenous veins and type 2 diabetes, and the incidence of this comorbidity is rising. It is urgent to find effective treatment for this comorbidity. Surgery is the primary treatment for varicosis of great saphenous vein. Although surgery is generally effective, the complications may be frequent, especially in those with type 2 diabetes, and it is even more difficult to treat patients with the comorbidity. High ligation can achieve accurate, effective resection of the varicose vein, reducing the risk of recurrence.^[3] Endovenous laser therapy directly acts on the target blood vessels to eliminate the varicose vein using the thermal effect of laser. Endovenous laser therapy is a minimally invasive technique with definite efficacy.^[4] One study has pointed out that the recurrence rate of varicosis of great saphenous vein is as high as 30% to 40% when only a single treatment is given. A combined surgical procedure is generally preferred in clinical practice as it can effectively reduce the recurrence rate. Given the facts above, the patients reported in the present study received high ligation plus endovenous laser therapy for the treatment of varicosis of great saphenous vein with type 2 diabetes. The surgical procedures and outcomes are reported below.

2. Materials and Methods

2.1. Clinical data

Sixty-one patients with varicosis of great saphenous vein and type 2 diabetes treated at our hospital from January 2019 to January 2021 were included. Thirty-two patients (37 affected limbs) receiving conventional surgery were included in control group, while 29 (34 affected limbs) receiving high ligation with endovenous laser therapy were included in study group. Type 2 diabetes was confirmed in all patients, and they were prescribed hypoglycemic therapy, with their blood glucose levels controlled at 6.01 to 14.45 mmol/L. There were no significant differences in baseline clinical data between the 2 groups (P > .05; Table 1). This study has been approved by the Ethics Committee of Baoding Maternal and Child Health Hospital.

Table 1.

Comparison of clinical data.

Group	Case	Gender	Age (years)	Limbs with varicosis of great saphenous vein (case [%])
		Male/female (case [%])		Left lower limb	Right lower limb	Two lower limbs
Control group	32	14/18	28–70 (54.12 ± 7.09)	17	10	5
Study group	29	13/16	29–68 (54.08 ± 7.06)	15	9	5
χ2, t	–	0.007	0.022	0.030
P	–	.933	.982	.985

2.2. Inclusion and exclusion criteria

Inclusion criteria: conforming to the diagnostic criteria for varicosis of great saphenous vein; type 2 diabetes; no contraindications for surgery; and signed informed consent.

Exclusion criteria: Combined with hematological disorders; organ dysfunction; deep venous thrombosis; and mental illness or intolerance of surgery.

2.3. Surgical procedures

Treatment for patients in the control group: conventional surgery. High ligation and stripping of the great saphenous vein were performed after preoperative preparation. The procedures included disinfection, anesthesia, incision, bandage, and stripping.

Surgical procedures for patients in the study group: high ligation with endovenous laser therapy. Surgical instruments: Laser therapy device (manufacturer: Diomed Ltd, model: DIOMED-II); supersmooth guide wire (specification: 0.889 mm); 5F single bend catheter; diameter of the fiber laser: 600 μm; 18 F puncture needle with sleeve; laser wavelength 810 nm; laser pulse duration and interval 1 second. Surface marking of the great saphenous vein (time of marking: 1 day before surgery; marking tool: Gentian Violet Skin Marker Pen; marked position: sites with visible tortuosity and vasodilation). Epidural anesthesia was performed in a supine position. An incision of 30 mm was made at 10 mm below the inguinal ligament and medial to the femoral artery. The skin was cut open, and the subcutaneous tissues were incised layer by layer to access the deep fascia and locate the main trunk of the great saphenous vein. The great saphenous vein was severed at 10 mm from the femoral vein, with the distal and proximal ends properly handled. The proximal end of the great saphenous vein was subjected to double band ligation, while the distal end was managed using hemostatic forceps but not ligated. An incision of 10 mm was made at 10 mm above the medial malleolus. The main trunk of the great saphenous vein was located and severed, with the distal and proximal ends properly managed. The proximal end was subjected to ligation, while a supersmooth guide wire was inserted along the anterograde path into the venous cavity. In the meantime, a guidewire was inserted into the inguinal ligament. The fiber laser was inserted carefully. The insertion was guided by the indicator light until reaching the main trunk of the great saphenous vein and at 20 mm below the hemostatic forceps. The laser therapy device was turned on, and the emission frequency was set up: power 14 W, continuous pulses; the fiber laser was withdrawn at a specific rate (1 cm/s). Cauterization was performed, and wet gauze was applied along the cauterization path to compress the wound; the emission frequency was adjusted with a power of 12 W when the fiber laser reached the knee joint. Cauterization continued as before. The emission frequency was adjusted again with a power of 10 W when the fiber laser reached the calf. The ankle was the end point of cauterization. The knee joints and calves were observed. If the vein was tortuous in nontrunk position, an 18 F puncture needle with sleeve was needed. The puncture needle was inserted into the venous cavity, with the power adjusted to 10 W. The fiber laser was delivered at a specific rate (1 cm/s) for cauterization. The severed end of the great saphenous vein was ligated, and the incision was sutured. Wound compression was performed for the operated limbs using stretch bandages for medical use.

2.4. Observation indicators

Firstly, comparison of intraoperative blood loss, operation time, and length of postoperative hospital stay. Secondly, comparison of Visual Analogue Scale (VAS)^[5] scores. VAS scores were determined at 1, 12, 24, and 72 h after surgery, respectively. The VAS score ranged from 0 to 10. The closer the VAS score to 10, the more intense the pain. Thirdly, comparison of blood glucose levels and venous clinical severity score (VCSS).^[6] The blood glucose level was determined before and after surgery. VSCC was evaluated before surgery and at 3 months after surgery. VSCC ranged from 0 to 30 points. The closer VSCC to 30, the worse the patients’ situation. Finally, comparison of complications. Complications such as ecchymosis, hematoma, stabbing pain, and infection were observed, and the overall incidence of complications was estimated.

2.5. Statistical analysis

The data were analyzed using the SPSS 21.0 software. The normally distributed measurement data were expressed as mean ± standard deviation. Intragroup and intergroup comparison was performed using the t test. Counts were expressed as percentages and analyzed by the Chi-square test. P < .05 indicated a significant difference.

3. Results

3.1. Comparison of intraoperative blood loss, operation time, and length of postoperative hospital stay

Compared with the control group, there were less intraoperative blood loss (P < .05), shorter operation time (P < .05), and shorter length of postoperative hospital stay in the study group (P < .05; Table 2).

Table 2.

Comparison of intraoperative blood loss, operation time, and length of postoperative hospital stay (x̄ ± s).

Group	Case	Intraoperative blood loss (mL)	Operation time (min)	Length of hospital stay after surgery (d)
Control group	32	53.23 ± 14.14	64.62 ± 17.08	7.09 ± 2.02
Study group	29	29.16 ± 9.05	49.45 ± 8.37	4.26 ± 1.38
T	–	7.826	4.332	6.323
P	–	.000	.000	.000

3.2. Comparison of postoperative VAS scores

Compared with the control group, VAS scores were decreased in the study group at different time points after surgery (P < .05; Table 3).

Table 3.

Comparison of postoperative VAS score (x̄ ± s, points).

Group	Case	1 h after surgery	12 h after surgery	24 h after surgery	72 h after surgery
Control group	32	5.32 ± 1.51	3.63 ± 0.98	2.91 ± 0.64	2.15 ± 0.42
Study group	29	3.59 ± 1.02	2.54 ± 0.52	1.77 ± 0.31	1.06 ± 0.19
t	–	5.188	5.344	8.706	12.829
P	–	.000	.000	.000	.000

3.3. Comparison of blood glucose levels and VCSS

There were no significant differences in blood glucose levels or VCSS before surgery between the 2 groups (P > .05). Blood glucose levels were decreased in both 2 groups after surgery than before (P < .05). Moreover, VCSS was decreased in either group at 3 months after surgery (P < .05). The blood glucose level of patients in the study group after surgery was significantly lower compared to the control group (P < .05). VCSS was also lower in the study group at 3 months after surgery than in the control group (P < .05; Table 4).

Table 4.

Comparison of blood glucose levels and VCSS (x̄ ± s).

Group	Case	Blood glucose levels (mmol/L)		VCSS (points)
		Before surgery	After surgery	Before surgery	At 3 mo after surgery
Control group	32	12.63 ± 2.24	9.72 ± 1.89*	9.44 ± 1.67	4.43 ± 1.39*
Study group	29	12.57 ± 2.21	7.13 ± 1.68*	9.38 ± 1.64	3.56 ± 1.31*
t	–	0.105	5.633	0.141	2.509
P	–	.917	.000	.888	.015

^*P < .05, compared with the pretreatment level in the same group.

3.4. Comparison of complications

The incidence of complications was significantly lower in the study group compared with the control group (P < .05; Table 5).

Table 5.

Comparison of complications case (%).

Group	Case	Ecchymosis	Hematoma	Stabbing pain	Infection	Overall incidence
Control group	32	2 (6.25)	2 (6.25)	3 (9.38)	2 (6.25)	9 (28.13)
Study group	29	1 (3.45)	0 (0.00)	1 (3.45)	0 (0.00)	2 (6.90)
χ 2	–	–	–	–	–	4.638
P	–	–	–	–	–	.031

4. Discussion

Varicosis of great saphenous vein combined with type 2 diabetes is more common in the elderly, which is associated with a variety of complications, such as cerebrovascular and cardiovascular sclerosis and immune dysfunction. However, increased risks of incision infection and stress responses are common obstacles for surgery, a primary treatment for varicosis of great saphenous vein.^[7] Conventional surgery has been proved effective for this disorder, but its clinical applications are restricted by such defects as frequent complications and high risks.^[8] The choice of an appropriate surgical approach is of high importance for the comorbidity. Endovenous laser therapy has been favorably accepted due to its minimal invasiveness, definite efficacy, and wound aesthetics. It is a widely used minimally invasive approach at the present stage. The bare fiber used in endovenous laser therapy delivers energy to varicosis of great saphenous vein, directly acting on the target vessels via the heating effect while avoiding damage to the surrounding normal tissues. Endovenous laser therapy is highly precise, damaging the vascular endothelium and causing vascular contraction and fibrosis. As the main trunk and the tributaries of veins are closed, the varicose veins are eliminated, and thus the goals of minimal invasiveness and therapeutic effectiveness are achieved.^[9] One study has pointed out that endovenous laser therapy is associated with a high recurrence rate.^[10] For this reason, this technique is usually used in combination with other therapies to reduce and control recurrence.^[11] High ligation can accurately and radically cure varicose veins. The combination of endovenous laser therapy and high ligation effectively reduces the high recurrence rate.^[12,13] The combined therapy is advantageous: If secondary thrombosis already occurs in the main trunk of the great saphenous vein, the combined therapy can prevent thrombus dislocation and the entry of thrombi into blood circulation; the great saphenous vein can be completely closed by cauterization. The recanalization risk does not increase despite the impact of blood flow; anticoagulation therapy is indicated for deep vein thrombosis that occurs at the postoperative recovery stage without increasing the recanalization risk; and the laser beam can be accurately directed at the target vessels, thus avoiding damage to the deep vein.^[14,15]

Caution should be taken when the combined treatment is performed. Preparation stage: It is necessary to recognize the patients’ medical history, physical conditions, and functions of important organs (e.g., heart and liver) before surgery. If the patients are combined with cardiopulmonary diseases, it is recommended that the patients first receive relevant treatments and are treated surgically when the organs restore their normal functions. Besides, it is necessary to manage blood glucose levels of patients combined with diabetes. If the patients mainly take oral hypoglycemic agents, the medication is continued until 1 day before surgery. However, long-acting hypoglycemic drugs are an exception, and they can be discontinued at 3 days before surgery. The fasted patients are given intravenous infusion of glucose + insulin to slightly increase the blood glucose level, and 5.6 to 11.2 mmol/L is preferred. For those already receiving insulin therapy, they are prescribed with an appropriate dosage of glucose and insulin before surgery to maintain normal glucose metabolism. The blood glucose level is measured again on the morning of surgery. No more insulin is given below the threshold of 9.0 mmol/L; an appropriate dosage of insulin (intravenous infusion) is given during surgery if it is above the threshold. Procedure processes: All surgical manipulations should be gentle, considering the physiological and pathological anatomy features of patients. The operation time and anesthesia time are kept as short as possible. A guide wire is used when treating varicosis of great saphenous vein, and the fiber laser is inserted after the guide wire has been delivered to the desired position. Two points should be taken into account during cauterization: The first is the appropriate temperature, and the second is the constant withdrawal rate of the fiber laser. Three factors should be considered when treating the main trunk and tributaries of great saphenous vein below the knee: appropriate laser power, accelerated withdrawal rate, and appropriately reduced compression force. The fiber laser is correctly positioned to treat the tributaries of the great saphenous vein and the varicose vein group in the calves so that the fiber laser is kept close to the deep surface of the superficial vein. Before local puncture into the venous cavity, the puncture needle is moved for a specific distance beneath the skin. No more laser is released after the fiber laser has been withdrawn to avoid damage to the skin. Besides, blood dispersal before the laser therapy and immediate compression after the therapy can help prevent venous thrombosis. Postoperative treatment: Apart from the conventional oxygen inhalation therapy and ECG monitoring, blood glucose monitoring is also necessary for dynamic adjustment of insulin dosage. Symptomatic treatments are given if the patients are combined with other complications.

Our study showed that compared with the control group, there were less intraoperative blood loss, shorter operation time, and shorter length of hospital stay after surgery in the study group. In other words, the combined therapy was a better choice for varicosis of great saphenous vein combined with type 2 diabetes than conventional surgery, which may be explained as follows: minimal invasiveness causes less damage to the tissues and organs, while allowing for higher precision and correct targeting of the varicose vein. All manipulations of the endovenous laser therapy are in the venous cavity, leading to less intraoperative blood loss, shorter operation time, and faster postoperative recovery. Compared with the control group, there were lower VAS scores at different time points after surgery in the study group. Thus, pain related to varicosis of great saphenous vein combined with type 2 diabetes was relieved by the combined therapy. This is because conventional surgery is traumatic, and the patients are more likely to suffer from exudation and pain upon early mobilization after surgery. In contrast, endovenous laser therapy is minimally invasive, and all manipulations are performed within the venous cavity without increasing invasiveness to other parts of the body. Blood glucose levels were significantly decreased in both groups after surgery than before. Moreover, VCSS was decreased in either group at 3 months after surgery. The blood glucose level of patients in the study group after surgery was lower compared to the control group. VCSS was also lower in the study group at 3 months after surgery than in the control group. The above results indicated that the combined therapy reduced the blood glucose level and improved varicosis of great saphenous vein combined with type 2 diabetes. Both conventional surgery and the combined therapy radically cured the disease, but postoperative recovery was faster for the combined therapy. In the present study, early mobilization was achieved after surgery and recovery was faster, which explained the lower VCSS. Blood glucose control was prioritized at the preparation stage before surgery, and surgery was not performed until blood glucose levels were normal. Insulin therapy was prescribed according to the changes in blood glucose levels during surgery. Blood glucose monitoring was continued after surgery to guide medication and restore normal blood glucose levels. Compared with the control group, the incidence of complications was lower in the study group, indicating that the combined therapy did not increase the complications of patients with the comorbidity.

In conclusion, high ligation plus endovenous laser therapy had several advantages when used to treat varicosis of great saphenous vein combined with type 2 diabetes: less intraoperative blood loss, shorter operation time, shorter length of postoperative hospital stay, less severe pain, lower blood glucose level, improvement of patients’ conditions, and fewer complications. However, the present study also has some limitations, such as limited sample size and shorter duration. Our findings remain to be further confirmed.

Author contributions

Conceptualization: Zheng Yang, Qingxia Suo.

Data curation: Zheng Yang, Liang Zhang, Lei Zhao, Hongguang Zhang, Xin Guo, Qingxia Suo.

Formal analysis: Zheng Yang, Liang Zhang, Haiguang Niu, Lei Zhao, Hongguang Zhang, Xin Guo, Qingxia Suo.

Methodology: Zheng Yang, Haiguang Niu, Lei Zhao, Hongguang Zhang, Xin Guo, Qingxia Suo.

Writing—original draft: Zheng Yang, Qingxia Suo.

Writing—review & editing: Zheng Yang, Qingxia Suo.

Funding acquisition: Liang Zhang, Haiguang Niu, Xin Guo, Qingxia Suo.

Resources: Liang Zhang.

Investigation: Haiguang Niu.

Software: Lei Zhao.

Validation: Xin Guo.