Endovenous glue ablation for chronic venous insufficiency: A comprehensive 5-year assessment of clinical and hemodynamic outcomes

Abstract

Objectives

Chronic venous insufficiency is mainly caused by reflux, obstruction, or both. Endovenous glue ablation has become one of the widely used methods for treating reflux in recent years. Duplex ultrasonography is the most commonly used method for diagnosing and evaluating treatment. However, there is important information that plethysmographic venous hemodynamics provides, which Duplex USG cannot provide. This retrospective study aimed to evaluate the 5-year clinical, anatomical, and hemodynamic results of endovenous glue ablation in the treatment of chronic venous insufficience, accompanied by the data from the plethysmographic study.

Patients and Method

Between January 2018 and August 2018, 133 patients with symptomatic CEAP 2-6 varicose veins with reflux of the great saphenous vein lasting longer than 0.5 seconds and a diameter of 5.5 mm in the standing great saphenous vein underwent EVGA. CEAP, VCSS, CIVIQ 20, Doppler USG, GSV diameters and insufficiency times, and hemodynamically Venous Refilling Time and Venous Half-Value Time measurements were performed before the procedure. In the same way, measurements were made at the 1st, 3rd, 6th, 12th, 24th, and 60th months of the patients who were called and came to the postoperative follow-up.

Results

Procedural success was 100%, and complete occlusion was observed %93 after treatment, at the 60 month. The improvement in VCSS (from 4.4 ± 1.3 to 1.7 ± 0.9), CIVIQ20 (from 8.5 ± 3.1 to 4.7 ± 2.0), VRT (from 20.3 ± 5.0 to 131.1 ± 4.0), and TH (from 2.8 ± 0.3 to 2.4 ± 0.2) was significant (p < .001 was for all).

Conclusion

Endovenous glue ablation is a preferred method for the treatment of great saphenous vein insufficiency due to its ease of use and the comfort it provides to patients, as well as its effectiveness and safety. In particular, it can be considered an effective method for improving venous hemodynamics and relieving associated symptoms.

Keywords

Chronic venous insufficiency endovenous glue ablation venous clinical severity score quality of life plethysmography

Introduction

Chronic venous insufficiency (CVI) affects approximately 30% of the general population and over time impairs the patient’s quality of life.^1,2 CVI is mainly seen in the lower extremities and mostly associated with superficial veins.³ The untreated cases can lead to serious conditions such as causing infection, excessive swelling, soft tissue ulceration, and deep vein thrombosis (DVT).⁴ It is a major cause of the health costs and the loss of work force. In conclusion, the disease is an important public health problem and a burden on health systems.⁵

CVI is mainly caused by outlet reflux, obstruction, or both.⁶ Endovenous thermal ablations (EVTA) such as endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have taken the place of conventional surgical method in the treatment of superficial venous insufficiency (SVI).^7,8 EVTA allows to avoid general anesthesia, provides the faster recovery, and the patient’s quality of life.^8–10 However, tumescent infiltration into the surrounding tissue of the veins impairs the patient’s quality of life, and thermal ablation may cause damage to the superficial nerves and skin burns.^11,12

Some newer strategies, such as endovenous glue ablation (EVGA) and mechanochemical ablation (MOCA) techniques, are advantageous because they don’t require tumescent anesthesia.^13–16 MOCA provides a combination of mechanical injury using a rotating wire or radial shear hooks and chemical injury using sclerosing foam injection.^4,17 In EVGA, n-butyl cyanoacrylate (NBCA) is injected into the insufficient vein. NBCA polymerizes rapidly, which eventually leads to permanent venous occlusion.¹⁸

When selecting a treatment method for venous insufficiency with endovenous ablation (EVA), various parameters are considered, including the Venous Clinical Severity Score (VCSS), Quality of Life (QoL), side effects, procedure time, pain scores, and time required for recovery to normal activities.⁴ Duplex scanning and venography provide anatomical and physiological information for diagnosing and treating venous reflux and/or occlusion.¹⁹ Plethysmography, a non-invasive test that can measure venous reflux and obstruction by measuring volume changes in the leg, makes an additional contribution to the evaluation of venous hemodynamics.²⁰ It was reported that hemodynamic findings obtained by plethysmography measurement were correlated with clinical findings.²¹

In this study, it was aimed to evaluate the 60-month results of EVGA method (VenaBlock^TM; Invamed, Ankara, Turkey) in the treatment of great saphenous vein (GSV) insufficiency on the basis of clinical, anatomical, and hemodynamics findings.

Patients and Method

In this retrospective study, EVGA (VenaBlockTM; Invamed, Ankara, Türkiye) was applied to 133 patients with GSV insufficiency between January 2018 and August 2018. Approval of the Regional Ethics Committee was obtained for this retrospective screening study (Uludağ University Research Ethics Committee; issue 2022-17/26).

Written informed consent was obtained from each patient.

Patients were included in the study if they were 20 to 80 years old, had symptomatic varicose veins, had Doppler ultrasound (USG)-detected reflux of more than 0.5 seconds in the great saphenous vein (GSV), had a GSV diameter of more than 5.5 mm, had a CEAP classification of C2–C6, and were able to come to follow-up examinations. Patients were excluded from the study if they had a GSV diameter of more than 10 mm, had duplicate saphenous veins, had anterior or posterior accessory saphenous vein varicose, had an excessive GSV tortuosity, had femoral or popliteal vein insufficiency, had a history of deep vein thrombosis, were using warfarin-like oral anticoagulants, had peripheral artery disease (ankle brachial index below 0.9), were immobilized, were pregnant, had cancer, or had a life expectancy of less than 1 year (Table 1).

Table 1.

Inclusion and exclusion criteria.

Inclusion criteria

1. Age 20 years and 80 years with symptomatic varicose veins

2. CDUS detected reflux of more than 0.5 seconds in the GSV

3. Great saphenous vein (GSV) diameter of more than 5.5 mm

4. CEAP classification of C2–C6

5. Ability to come to follow-up examinations

Exclusion criteria

1. Saphenous magna diameter of more than 10 mm

2. Duplicate saphenous veins

3. Anterior or posterior accessory saphenous vein varicose

4. Excessive bend in the GSV

5. Femoral or popliteal vein insufficiency

6. Previous deep vein thrombosis

7. Use of warfarin-like oral anticoagulants

8. Peripheral artery disease (ankle brachial index below 0.9)

9. Immobilization

10. Pregnancy

11. Cancer

12. Life expectancy <1 year

CDUS: color Doppler ultrasonography; CEAP: clinical, etiology, anatomy, and pathophysiology classification; GSV: great saphenous vein.

For all enrolled patients, the preoperative CEAP, VCSS, and QoL (CIVIQ20) scores were documented. GSV diameter and insufficiency were measured by using Doppler ultrasound (DUSG). Of hemodynamic parameters, venous refilling time (VRT) and venous half-value time (TH) were measured by plethysmography according to the manufacturer instructions (Vasolab 5000, ELCAT GmbH, Wolfratshausen, Germany). The procedure was performed in the operating room environment with the standard procedure described previously.²² Table 2 demonstrates preoperative demographical and clinical characteristic of the patients.

Table 2.

Demographical and clinical characteristics of the patients.

N: 133	Mean ± SE (Range)	Value (%)
Gender (F/M)		54 (41%)/79 (59%)
Age (Years)	52.7 ± 12.9 (24–77)
Diameter of GSV (mm.)	7.2 ± 0.7 (6–8.4)
Reflux time (sec)	1.77 ± 0.7 (0.9–3.8)
Lenght of ablasion segment (cm)	28.4 ± 1.6 (12–34)
Plethysmography measurement
VFT (sec)	20.3 ± 5.0 (6–29)
TH (sec)	2.8 ± 0.3 (2.2–3.4)
CEAP	3.6 ± 1.1 (2–5)
VCSS	4.4 ± 1.3 (0–8)
QoL (CIVIQ20)	8.5 ± 3.1 (4–13)
Procedure time (min)	7 ± 0.7 (6–8.4)

GSV: great sphein vein, CEAP: clinical etiological anatomical and pathophysiological, VCSS: venous clinical severity score, QoL: quality of life, CIVIQ20: chronic venous insufficiency questionnaire 20.

Intra-procedural and post-procedural complications were recorded. Patients were reevaluated with DUSG and plethysmography at 1, 3, 6, 12, 24, and 60th postoperative months. VCSS and CIVIQ20 measurements were repeated at the postoperative 60th month.

Statistical analysis

In the data, analysis was made by IBM SPSS Version 21 and MedCalc statistical package program. Because of the compatibility of the Central Limit Theorem, the parametric tests were used without the normality test. However, non-parametric test was applied for VCSS and CIVIQ20 measurement, which are ordinal variable type. In the analysis of the data, the mean and standard deviation, minimum and maximum values of the data in the scales are made in the continuous structure; Frequency and percentage values were used to define categorical variables.²³

The Wilcoxon test was used to compare the two-repetitive measurement averages of continuous measurements. The Repeated-ANOVA test statistic was used to compare the seven repetitive measurement averages.

A p < .05 was taken for the statistical significance level.

Results

The study was initiated with 133 patients with a mean age of 52.7 ± 12.9 (range 24–77). 54 (41%) of the patients were male and 79 (59%) were female. The mean GSV diameter was 7.2 ± 0.7 mm (range 6–8.4 mm), and mean reflux time was 1.77 ± 0.7 sec (range 0.9–3.8sec). Length of ablasion segment of GSV was 28.4 ± 1.6 cm (range 12–34 cm). Mean procedure time was 7 ± 0.7 min. (range 6–8.4 min). Mean CEAP score was 3.6 ± 1.1 (range 2–5). Preprocedural average VCSS was 4.4 ± 1.3 (range 0–8), QoL (CIVIQ20) was 8.5 ± 3.1 (range 4–13). Preprocedural VFT was 20.3 ± 5.0 sec (range 6–29), and TH was 2.8 ± 0.3 (range 2.2–3.4) (Table 2).

Of the 133 patients whose baseline data were obtained and who underwent EVGA, 25 patients did not complete follow-up. Finally, 108 patients were evaluated with data at 60 months (Table 3).

Table 3.

Follow up.

Follow-up time	Controlled patients (n)	Lost to follow up (n)	Recanalization (n)
Follow-up time	Controlled patients (n)	Lost to follow up (n)	Partial	full
1st month	133	0	0	0
3rd month	132	1	0	0
6th month	132	0	3	0
12th month	128	4	2	0
24th month	120	8	5	0
60th month	108	12	6	1

Procedural success was 100%, and complete occlusion in GSV was observed after treatment, at the first and third month follow-up. In the GSV which ablated with glue, partial recanalization was observed in three (2.3%) patients at 6 months, two (1.6%) patients at 12 months, five (4.2%) patients at 24 months, and seven (6.5%) patients at 60 months. Occlusion was observed in 101 (93.5%) of 108 patients who were followed up after 60 months (Table 4).

Table 4.

Closure rates.

	n (%)
1st month	133
Total	133 (100)
Partial	0 (0)
Recanalization	0 (0)
3rd month	132
Total	132 (100)
Partial	0 (0)
Recanalization	0 (0)
6th month	132
Total	129 (97.7)
Partial	3 (2.3)
Recanalization	0 (0)
12th month	128
Total	126 (98.4)
Partial	2 (1.6)
Recanalization	0 (0)
24th month	120
Total	115 (95.8)
Partial	5 (4.2)
Recanalization	0 (0)
60th month	108
Total	101 (93.5)
Partial	7 (6.5)
Recanalization	0 (0)

The mean preoperative VCSS was 4.4 ± 1.3, ranging from 1 to 8. It was measured as 1.7 ± 0.9 (1–5) at the end of the 60-month follow-up (Table 5 and Figure 1).

Table 5.

Comparison of VCSS, CIVIQ20, VFT, and TH values at preprocedural and the follow-up periods.

	Pre-procedure	1st month	3rd month	6th month	12th month	24th month	60th month	p value
VCSS	4.4 ± 1.3 (0–8)						1.7 ± 0.9 (0-5)	p < .001
CIVIQ 20	8.5 ± 3.1 (4–13)						4.7 ± 2.0 (1-8)	p < .001
VRT (Sec)	20.3 ± 5.0 (6–29)	28.5 ± 3.7 (16–37)	29.8 ± 3.6 (19–39)	30.0 ± 3, (19–43)	30.6 ± 3.8 (21–43)	31.0 ± 4.2 (19–42)	31.1 ± 4.0 (22–42)	p < .001
TH (Sec)	2.8 ± 0.3 (2.2–3.4)	2.5 ± 0.3 (1.8–3.1)	2.4 ± 0.3 (1.9–2.9)	2.4 ± 0.3 (1.8–2.9)	2.2 ± 0.3 (1.7–2.7)	2.3 ± 0.2 (1.9–2.9)	2.4 ± 0.2 (1.9–2.9)	p < .001

VCSS: Venous Clinical Severity Score, CIVIQ20: Chronic Venous Insufficiency Questionnaire, VRT: Venous Refilling Time, TH: Venous Half-Value Time.

Figure 1.

VCSS values at preoperative and the 60th month. 225 x 132 mm (96 x 96 DPI).

The mean preoperative CIVIQ20 score changed from 8.5 ± 3.1 (ranging 4–13) to 4.7 ± 2.0 (ranging 1–8) at 60-month follow-up (p < .001) (Table 5 and Figure 2).

Figure 2.

CIVIQ20 scores at preoperative and the 60th month. 225 x 132 mm (96 x 96 DPI).

The VRT, which was 20.3 ± 5.0 sec before the operation, changed to 28.5 ± 3 sec, 29.8 ± 3 sec, 30.0 ± 3 sec, 30.6 ± 3 sec, 31.0 ± 4 sec, and 31.1 ± 4 sec at 1, 3, 6, 12, 24, and 60th months, respectively, and was statistically significant (p < .001) (Table 5 and Figure 3). The TH, which was 2.8 ± 0.3 sec before the operation, changed to 2.5 ± 0.3 sec, 2.4 ± 0.3 sec, 2.4 ± 0.3 sec, 2.2 ± 0.3 sec, 2.3 ± 0.2 sec, and 2.4 ± 0.2 sec at the same follow up, respectively (p < .001) (Table 5 and Figure 4).

Figure 3.

VFT times at preoperative and the 60th month. 225 x 132 mm (96 x 96 DPI).

Figure 4.

TH times at preoperative and the 60th month. 225 x 132 mm (96 x 96 DPI).

All patients returned to their daily lives after the procedure.

No mortality or serious side effects such as deep vein thrombosis (DVT) and pulmonary emboli (PE) were observed during the follow-up period. During the procedure, 7 patients experienced burning and 1 patient experienced pain. After the procedure, ecchymosis around the puncture developed in 10 patients and induration along the saphenous vein in 10 patients (Table 6). At subsequent checkups, they all improved.

Table 6.

Procedure-related complications.

Complication	n, (%)
Pain	1 (0.75)
Burning	7 (5.3)
Ecchymosis	10 (7.5)
Induration	10 (7.5)
Paresthsia	0 (0)
DVT	0 (0)
PE	0 (0)
Mortality	0 (0)

DVT: deep vein thrombosis; PE: pulmonary embolism.

Discussion

Although the introduction of EVTA in the late 90s radically changed CVI treatment strategies, EVGA is not inferior to EVTA in terms of therapeutic success.^24–26 EVGA has become widely used in the treatment of lower extremity venous insufficiency. One possible reason for this is that it does not require tumescent anesthesia, which is used to prevent thermal damage and potential damage to the surrounding tissue, as in EVTA.²⁷ In addition, it has some properties such as immediate occlusion, low viscosity, fast polymerization, and low tissue toxicity.^28,29

VenaBlock^TM (Invamed, Ankara, Turkey) and VenaSeal^TM (Medtronic, Santa Rosa, Ca, USA) are the most well-known products using the EVGA technique worldwide.³⁰ The main differences between them are the application techniques, the viscosity of the glue, and the polymerization time.²⁹

The mean procedural duration of EVGA can be considered quite reasonable,^29,31 ours was 7 minutes. The patients can return to their normal life within 1–2 days after the EVGA treatment.³² All of our patients returned to their normal lives within the same day.

Various parameters have been developed to evaluate the effectiveness of the methods used in the treatment of CVI. Of these, venous occlusion rate, VCSS, and QoL scores are widely used worldwide.³³ During the 5-year follow-up, similar success rates were reported for both VenaBlock^TM and VenaSeal^TM in terms of vein occlusion rate, VCSS, and QoL scores.^14,22

The occlusion rate, 93.5%, in our current 60-month follow-up study, was consistent with the results of the other studies that used VenaBlock^TM,^22,34,35 VCSS, and CIVIQ-20 which also significantly improved as in that of the other studies.^15,36,37

In addition to the current clinical assessment consisting of occlusion status, VCSS and QoL, plethysmography provides an additional contribution to the assessment of venous hemodynamics.³⁸ It can measure venous reflux and occlusion based on the volume changes in the leg.²⁰ It was observed in the reports that clinical findings obtained by DUSG, VCSS, and QoL scores correlated with hemodynamic findings measured by plethysmography.^21,38

Plethysmography can assess improvements after treatment of venous insufficiency, including acute and previous episodes of DVT.^20,39 Despite successful intervention, symptoms may reoccur due to residual reflux due to some conditions such as recurrence and insufficient lateral branch.³⁸ With additional years of follow-up, the symptoms become more apparent.⁴⁰ We forecast that plethysmography, by revealing suboptimal hemodynamic changes, provides additional data to predict some conditions like DVT.³⁹ The results of several studies have revealed that this non-invasive method can be used to predict venous surgery or radiofrequency ablation (RFA) outcomes.^38,41 However, we could not find a study examining improvements in CVD after EVGA treatment using plethysmography.

In the current study, venous refilling time (VRT) and venous half-value period (TH) were used to evaluate venous hemodynamics. The preoperative mean VRT of 20.3 ± 5.0 sec (range 6–29 sec) indicated that our cases generally had mild insufficiency. It is statistically improved to 31.1 ± 4.0 sec (range 22–42 sec) at the end of 60-month follow-up (p < .001). TH value of 2.8 ± 0.3 sec (range 2.2–3.4 sec) decreased to 2.4 ± 0.2^1,9-2,9 and shows statistical improvement (p < .001). These plethysmographic data show us that EVGA improves venous hemodynamics as well as improving the quality of life in patients with GSV insufficiency.

Limitation of the study

There are limitations to this study. Most importantly, the study population was from a single center and was assessed retrospectively by a single surgeon, which could introduce potential bias in the reporting. Furthermore, the limited number of cases and the incomplete comparison with patients treated for other venous pathologies are additional limitations that hinder the presentation of more conclusive results. There is a need for prospective multicenter studies involving more diverse case groups in order to generalize the results.

Conclusion

Our study found that the EVGA procedure is a feasible, safe, and efficient way to treat incompetent GSVs, based on the 60-month follow-up. Our study provides efficacy similar to current NBCA and endovenous ablation methods. The benefits of this procedure that appealed to patients included the avoidance of tumescent anesthesia, a shorter treatment duration, and the absence of post-treatment resting requirements. Our plethysmographic evaluation also revealed that venous hemodynamics improved with EVGA. While the initial midterm results are promising, further comparative randomized trials with extended follow-up periods are necessary to validate these findings.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Hakan Guven

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