Endovenous ablation of the great saphenous varicose veins: Does the modality matter? A prospective cohort study

Abstract

Objective

Endovenous thermoablation (EVTA) is considered the reference treatment for great saphenous vein (GSV) reflux. Catheter-directed foam sclerotherapy offers a simpler and potentially safer alternative without thermal injury or tumescent anesthesia. This study compared the anatomical durability, clinical outcomes, and safety of EVTA and catheter-directed foam sclerotherapy for treatment of GSV insufficiency.

Methods

A prospective comparative study was conducted at a single tertiary center between April 2021 and June 2024, including patients with duplex-confirmed GSV reflux (CEAP C2–C4). Patients underwent EVTA (radiofrequency or laser ablation) or catheter-directed foam sclerotherapy according to clinical preference and device availability. The primary endpoint was anatomical success defined as complete GSV occlusion at 1 year on duplex ultrasound. Secondary outcomes included changes in Venous Clinical Severity Score (VCSS), Venous Disability Score (VDS), Aberdeen Varicose Vein Questionnaire (AVVQ), perioperative outcomes, and complications. Kaplan–Meier analysis was used to compare occlusion durability.

Results

A total of 250 patients were included (118 foam sclerotherapy, 132 EVTA). Baseline demographics and disease severity were similar between groups. Both treatments produced significant improvements in VCSS, VDS and AVVQ at 1 year follow-up (all p < .001), with no significant differences between groups in clinical or quality-of-life outcomes. EVTA demonstrated superior anatomical durability, with 1-year occlusion rates of 93.5% compared with 81.5% after foam sclerotherapy (log-rank p = .003). Treatment modality was the only independent predictor of recanalization on multivariable analysis. Perioperative pain, recovery time, and sick leave were comparable between groups. Sensory nerve injury occurred in 6.3% of EVTA patients and in none of those treated with sclerotherapy (p = .053). At 1-month follow-up, absence of visible/residual varicosities was observed in 97.0% of EVTA-treated limbs and 88.1% of limbs treated with catheter-directed foam sclerotherapy, while clinical scores and quality-of-life outcomes improved significantly in both groups. Sensory nerve injury occurred only after EVTA and was not observed after foam sclerotherapy.

Conclusions

EVTA provides greater anatomical durability than catheter-directed foam sclerotherapy for treatment of GSV reflux. However, both techniques result in comparable improvements in symptoms, disability, quality of life, and clinical appearance of varicosities. Foam sclerotherapy may offer a safe, less resource-intensive, and potentially cost-effective alternative for selected patients or in resource-limited settings.

Keywords

chronic venous insufficiency ultrasonography Doppler duplex venous clinical severity score minimally invasive surgical procedures ambulatory surgical procedures

Introduction

Varicose veins, a common form of CVD, affect over 25 million adults in the United States, and more than six million people have more severe forms of venous disease.¹ In the late 1990s, minimally invasive endovenous techniques were introduced and adopted for the treatment of chronic venous reflux disease. These procedures have now become the standard of care and have revolutionized treatment by moving away from hospital-based stripping surgery to office-based endovenous procedures. The use of endovenous offers several advantages, including reduced pain and faster recovery times. Long-term follow-up studies have also demonstrated the durability of both laser and radiofrequency methods.^2,3 These procedures can be costly and are not always feasible for all sectors, especially in developing countries.⁴ Another technique is catheter-directed foam sclerotherapy, in which foamed sclerosant is delivered along the incompetent saphenous trunk through an intraluminal catheter under duplex guidance. This approach allows more controlled distribution of foam along the target vein and has been proposed as a simple, inexpensive, non-thermal alternative to conventional ultrasound-guided foam sclerotherapy and thermal ablation.^5,6

Catheter-directed foam sclerotherapy has been developed as a refinement of conventional ultrasound-guided foam sclerotherapy, allowing more controlled delivery of foam along the saphenous trunk under duplex guidance.⁷ Cavezzi and Tessari emphasized that foam characteristics and clinical performance are influenced by preparation method, gas composition, liquid-to-gas ratio, catheter use, and injection technique.⁵ More recent CFS protocols have incorporated adjunctive peri-saphenous tumescence and intra-saphenous saline irrigation to reduce vein caliber and blood content before foam delivery, with reported 12-months and 36-months GSV occlusion rates of 94.3% and 89.4%, respectively.⁸ In a systematic review and meta-analysis, Lim et al. reported that catheter-directed foam sclerotherapy achieved higher complete ablation rates than conventional ultrasound-guided foam sclerotherapy during short- and medium-term follow-up, with fewer major and minor complications, although the available evidence remained limited and heterogeneous.⁶

Existing comparative studies are limited by heterogeneity in techniques, short follow-up periods, or a lack of comprehensive clinical and patient-reported outcomes.⁹ In particular, prospective data directly comparing catheter-directed foam sclerotherapy (CDFS) with contemporary Endovenous thermal ablation (EVTA) techniques remain scarce.^10,11 In randomized studies of great saphenous vein incompetence, endovenous laser ablation and radiofrequency ablation have demonstrated comparable anatomic success and early occlusion rates, supporting both techniques as effective first-line thermal options for truncal reflux.¹²

In this context, the present prospective cohort study aims to evaluate the effectiveness and safety of catheter-directed foam sclerotherapy compared with endovenous thermoablation in patients with GSV reflux. The study aimed to assess not only anatomical durability but also clinical severity, functional outcomes, and health-related quality of life, thereby providing a more integrated, clinically relevant comparison of the two treatment strategies.

Patients and methods

Study population

The study is a single-center, prospective, double-arm, nested cohort case-control observational study. The study was conducted in the Vascular Department of a tertiary hospital and was approved by the institution’s Ethical Review Board. All consecutive patients with varicose veins (C2–C4) with the following inclusion criteria duplex-verified GSV reflux and clinical classification, mean diameter of the GSV in the thigh between 5 and 12 mm. Patients with peripheral arterial disease, lymphoedema, Body Mass Index >40 kg/m², pregnancy, allergy to sclerosant or lidocaine, severe general illness, malignancy, previous deep vein thrombosis, previous varicose vein intervention in the same limb, or coagulation disorder were excluded from the study.

Patient evaluation

Patients scheduled for varicose vein ablation underwent duplex ultrasound examination in the standing position using a high-resolution color duplex system. Assessment included deep venous patency, superficial and deep venous reflux, saphenofemoral junction competence, GSV diameter and reflux extent, accessory saphenous veins, small saphenous vein reflux, and incompetent perforators. Reflux >0.5 s was considered diagnostic of incompetence. Duplex assessment was performed according to the recommendations of the Union Internationale de Phlébologie (UIP) consensus documents.^13,14 The patients were then assigned to laser ablation, radiofrequency ablation, or transcatheter sclerotherapy based on the patient’s and the surgeon’s preferences, as well as the availability of an endovenous Laser Ablation (EVLA) or radiofrequency ablation (RFA) catheter, and the presence or absence of health insurance coverage. All procedures were performed in the day-surgery unit. Local anesthesia was used for venous access and concomitant phlebectomy. Light sedation/analgesia was administered selectively according to patient discomfort, anxiety, and anesthesiologist judgment, particularly during sheath insertion, catheter manipulation, and phlebectomy; sedation was not required for foam delivery itself. Concomitant ambulatory phlebectomy of visible varicose tributaries was performed in all patients regardless of treatment allocation.

Procedural details

EVLA procedure

During EVLA procedures, patients were given tumescent anaesthesia with a solution of Ringer’s acetate and lidocaine with adrenaline. A light sedative was also administered before and during the procedure, usually propofol or opioid based fentanyl. The laser ablation was performed using a 1470-nm diode radial laser with duplex guidance and pulse mode, with a protocol to deliver 70 J/cm in GSV. The EVLA procedure involved duplex ultrasound (DUS) mapping of the venous segments to be treated, sterile preparation and draping of the leg to be treated, visualization of the access site with DUS, anesthetizing the access site, insertion of the access needle into the GSV under ultrasonographic guidance, then laser ablation of the GSV, phlebectomies were performed through 1–5 mm incisions or needle holes. The incisions were covered with surgical tape, and a class 2 compression stocking was applied. Patients were observed in the recovery room for 2–4 h and discharged when they felt ready. A prescription for paracetamol 1 g or ibuprofen 400–600 mg was given for pain relief.

RFA procedure

EVRFA procedures were performed using a VNUS Closure FAST™ catheter as the heating instrument; the same steps as EVLA were followed, with special attention given to the following: a temperature of 120° was maintained for 20 s per segment, as measured by a thermocouple on the 7 cm heating element. The first segment was ablated twice, and each subsequent segment received one energy cycle. If the temperature did not reach 120° within 5 s, a second heating cycle was administered. Phlebectomies were performed in the same manner as after the EVLA procedure, and wound treatment and aftercare were also identical.

Foam-directed sclerotherapy

The procedures were performed under local anaesthesia without tumescent infiltration. The patient was positioned supine with a cushion under the knee to improve access to the medial thigh. The GSV was accessed with an 18-G needle under ultrasound guidance, and a 5- or 6-F sheath was introduced over a short guidewire. The multipurpose or Bernstein sometimes-vertebral catheter was positioned through the sheath, with the tip 2 cm distal to the saphenofemoral junction (SFJ) under DUS guidance. 10-ml sclerosing foam was prepared using a modified Tessari method by mixing 2-ml ethanolamine oleate and 8-ml air using two syringes and a three-way connector. The vein was compressed with the US probe proximal to the catheter to prevent foam from entering the deep system. The foam was then delivered along the vein while the catheter was withdrawn steadily, with approximately 10 ml of foam being delivered. The SFJ and site of puncture were compressed for 5 min, and the extension of the vein was massaged to migrate the foam in a distal direction.

Postoperative care and follow-up

Patients were mobilized immediately after the procedure and had continuous compression therapy postoperatively. Patients were examined clinically and with DUS postoperatively and attended follow-up visits at 1 month, 3 months, 6 months, 9 months and 1 year. At the 1-month follow-up visit, wound healing for phlebectomies, haematomas, nerve injuries, pigmentation, and sick leave were assessed. Patients were also asked to estimate the minimum sick leave required after the procedure. Pain scores were measured on a Visual Analogue Scale (VAS) from 0 to 10 before and after the procedure. The diameter of the GSV was measured preoperatively at the saphenofemoral junction and at the thigh area. During follow-up visits, patients re-assessed their pain levels. To assess patient symptom severity at baseline and during follow-up, the Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS)¹⁵ were used to assess treatment-related improvement and changes in severity scores. Venous Segmental Disease Score (VSDS) was used to assess anatomical success, recurrence, or the presence of a new reflux pathway. Quality of life was assessed using the Aberdeen Quality of Life Questionnaire at 1 year.¹⁶

Definitions and endpoint

Technical Success: Defined as the successful performance of the allocated endovenous procedure (EVTA or catheter-directed sclerotherapy) with delivery of treatment to the target GSV segment as planned, confirmed by immediate procedural ultrasound. For EVTA, this included treatment of the entire incompetent segment. For sclerotherapy, this included visualization of foam filling the target segment from just distal to the SFJ to the distal point of incompetence. Anatomical Success (Occlusion): Defined as the absence of flow in the treated segment of the GSV on duplex ultrasound, assessed at 1-month and 1-year follow-up. This was further categorized as: Complete Occlusion: No compressible lumen or color Doppler flow within the treated segment. Partial Recanalization: A segment of the treated vein is patent with evidence of reflux (>0.5 s), but without the need for re-intervention. Failure (or Significant Recanalization): A continuous patent segment of the treated vein with reflux, potentially requiring further treatment. Venous Reflux: Defined as a retrograde flow duration of >0.5 s in the vein of interest (GSV, SFJ, or tributaries) as measured by duplex ultrasound with the patient standing and performing a Valsalva maneuver or distal manual compression. Clinical Success: Defined as a significant improvement in the VCSS and/or VDS from baseline to follow-up, regardless of anatomical occlusion status. Recovery outcomes: Time spent in recovery room, pain scores, days of sick leave (prescribed and subjectively needed), and number of analgesic tablets taken in the first month. Safety outcomes: Rates of complications including sensory nerve injury (numbness/paresthesia in the saphenous nerve distribution), infection, thrombophlebitis, ecchymosis, and deep vein thrombosis (DVT). Quality of Life: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score from baseline to 1-year follow-up.¹⁶ Hemodynamic remodeling: Change in diameters of the SFJ and GSV trunk. Lost to Follow-up: A patient who did not attend the scheduled 1-month or 1-year follow-up visit and could not be contacted or refused further participation in the study.

Primary Endpoint (Anatomical): Complete occlusion of the treated GSV segment at the 1-year follow-up, as defined above. Primary Endpoint (Clinical): Change in VCSS from baseline to 1-year follow-up. Secondary Endpoints: Operative outcomes: Operative time, volume of tumescent anesthesia, dosage of systemic sedatives/analgesics. VDS, VSDS changes in diameter, quality-of-life assessment using the AVVQ score, length of sick leave, and other complications.

Statistical analysis

Statistical analysis was performed using SPSS for Windows (version 22.0; SPSS Inc., Chicago, IL). Continuous variables are reported as mean, standard deviation (SD) or median and interquartile range (IQR). Baseline and follow-up variables are compared using the paired-samples t-test and the repeated-measures test. Baseline comparisons between the EVTA and catheter-directed foam sclerotherapy groups were performed using the independent-samples t test or Mann–Whitney U test for continuous variables and the Chi square or Fisher’s exact test for categorical variables. Changes in clinical scores over time were analyzed using the paired t test or the repeated-measures ANOVA test. Kaplan–Meier analysis with the log-rank test was used to compare occlusion rates between groups. Cox Multivariable logistic regression analysis was performed to identify predictors of recanalization, and the results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A two-sided p-value < .05 was considered statistically significant.

Results

Demographic, baseline characteristics, and operative details

A total of 2500 patients were screened between April 2021 and June 2024. Of these, 264 patients fulfilled the eligibility criteria, and 14 declined participation. The final cohort included 250 patients: 132 in the EVTA group and 118 in the catheter-directed foam sclerotherapy group (Figure 1). All patients completed the 1-month follow-up, while 16 patients were lost before the 1-year assessment.

Figure 1.

Flow diagram of patient selection, allocation, follow-up, and analysis in the prospective cohort.

Baseline demographic, clinical, and duplex characteristics were comparable between the two groups, including CEAP class, VDS, and GSV diameter (Table 1). Operative details are summarized in Table 2. Procedure duration and recovery-room stay did not differ significantly between groups. As expected, total tumescent volume and systemic analgesia/sedation requirements were higher in the EVTA group, whereas sclerosant use was limited to the sclerotherapy group.

Table 1.

Baseline demographic, clinical, and duplex ultrasound characteristics of the study population.

	Thermoablation (laser, RF)	Sclerotheapy	Total	p value
Age (mean, SD, IQR)	49.8 (12.7, 39–60)	50.97 (11.9, 42.5–60.5)	50.35 (12.3, 41–60)	0.587
Height (mean, SD, IQR)	170.4 (13.12, 165–176)	172.6 (10.1, 156–180)	171.4 (11.8, 163–179)	0.305
BMI kg/m² (mean, SD, IQR)	26,1 (4.5, 23.1–29.1)	26.3 (4.5, 23.7–28.6)	26.2 (4.5, 23.2–29.0)	0.896
D of GSV at SFJ (mean, SD, IQR)	8.8 (2.0, 8-10)	9.4 (2.4, 8-11.7)	9.08 (2.2, 8.0–10.8)	0.190
D of GSV, upper 20 cm (mean, SD, IQR)	6.7 (1.7, 5.7–8)	6.9 (1.9, 5.9–8)	6.79 (1.8, 5.8–8.0)	0.656
D of GSV mean (mean, SD, IQR)	6.4 (1.7, 5–7.9)	6.6 (1.6, 5.1–8)	6.49 (1.65, 5.1–7.9)	0.504
Baseline C-classification 2/3/4	76/30/26	62/28/28	69/27/26	ns
Baseline venous disability scores 0/I/II	2/68/60	0/68/50	2/68/55	ns
Varicosis drawing at the baseline^a (mean, SD, IQR)	8.1 (4.6, 5–11)	10.3 (5.7, 6–12)	9.14 (5.3, 5–12)	0.052

		C-classification of vein disease			Total
		C2	C3	C4	Total
Sclerotherapy	Count	62 (52.5%)	28 (23.7%)	28 (23.7%)	118 (100.0%)
Thermoablation	Count	76 (57.6%)	30 (22.7%)	26 (19.7%)	132 (100.0%)
	Total	138 (55.2%)	58 (23.2%)	54 (21.6%)	250 (100.0%)

SD: standard deviation; IQR: Interquartile range; D: Diameter; GSV: Great saphenous vein; SFJ: Saphenofemoral junction; ns: No statiscally significant difference.

^aCalculated from the patients’ drawings.

Table 2.

Operative details of all completed procedures presented as mean (SD).

	Thermoablation	Sclerotheapy	p value
Length of vein (cm)	40.7 (13.2)	37.8 (13.1)	0.219
Volume (ml) of tumescent for local phlebectomy during the operation	87.6 (50.9)	117.9 (65.0)	0.007
Volume (ml) of tumescent for GSV during the operation	207.9 (80.8)	0 (0)	0.0001
Total volume (ml) of tumescent under operation	287.9 (84.5)	125.0 (74.5)	0.0001
Time (min) of staying in the operating theater	65.4 (14.8)	69.9 (13.8)	0.081
Total volume of sclerosant	0 (0)	7.18 (1.7)	0.0001
Time (min) of staying in the recovery room until it is ready to be discharged	101.1 (35.7)	87.4 (44.0)	0.063
Medication under operation/Propofol (mg)	78.4 (39.1)	34.6 (22.2)	0.0001
Medication under operation/Fentanyl (mg)	0.14 (0.2)	0.12 (0.2)	0.729
Medication under operation/diazepam (mg)	4.3 (1.2)	3.6 (1.3)	0.197
Number of painkillers within 1 month	9.5 (12.1)	6.9 (11.2)	0.225
Prescribed days of sick leave	5.0 (3.8)	4.3 (3.2)	0.273
Subjective need of sick leave (days)	7.5 (4.8)	7.8 (4.6)	0.722

Values presented as mean (SD) unless otherwise specified.

Perioperative pain and early outcomes

Perioperative pain scores, discharge pain scores, and 1-week pain scores were comparable between groups (Table 3). Sick leave, subjective need for sick leave, and analgesic use during the first month were also similar (Table 2).

Table 3.

Venous clinical severity score and visual analogue score at baseline and 1-month follow-up.

	Thermoablation	Sclerotherapy	p value
VCSS assessment
Baseline VCSS	15.3 (2.2)	15.4 (2.0)	0.383
At 1 month	12.7 (2.3)	13.1 (2.3)	0.908
VAS assessment
VAS under procedure (median, IQR)	3.0 (2.0–5.0)	4.0 (2.3–7)	0.294
VAS before discharge (median, IQR)	1.0 (0.0–2)	2.0 (0.25–4)	0.435
VAS at 1 week (median, IQR)	1.0 (0.0–3)	1.0 (0.0–3)	0.991

IQR: Interquartile Range; VAS: Visual analogue scale; VCSS: Venous Clinical Severity Score—0–3 points each: pain, varicose veins, venous oedema, skin pigmentation, inflammation, induration, number of ulcers, ulcer duration, ulcer size; according to (Rutherford et al., 2000); VAS: 0–10 points.

At 1-month follow-up, complete GSV trunk occlusion was achieved in all patients in both groups. One patient in the sclerotherapy group had persistent SFJ reflux without reflux in the main GSV trunk. No reflux was detected in the accessory saphenous veins in either group.

Assessment of visible varicosities showed absence of residual varicosities in most treated limbs, with a trend favoring EVTA (97.0% vs 88.1%, p = .05). VCSS improved significantly from baseline to 1 month in both groups, without a significant between-group difference (Table 3). Sensory nerve injury occurred only in the EVTA group, while minor infection and thrombophlebitis were uncommon and occurred only after sclerotherapy (Table 4). No DVT, embolic event, or mortality occurred within 1 month.

Table 4.

Assessment of postoperative status and complications at 1-month follow-up.

	No reflux	Reflux
SFJ assessment
EVTA	66 (100%)	0 (0%)
Sclerotheapy	58 (98.3%)	1 (1.7%)
GSV trunk assessment
EVTA	66 (100%)	0 (0%)
Sclerotherapy	59 (100%)	0 (0%)

	EVTA (laser, RF)	Sclerotherapy	p value
Complications at 1-month follow-up
Number of patients treated	128	118	…
Infection under 1 month	0 (0%)	2 (1.7%)	0.285
Thrombosis under 1 month	0 (0%)	0 (0%)	ns
Embolization under 1 month	0 (0%)	0 (0%)	Ns
Nerve injury under 1 month (sensory)	8 (6.3%)	0 (0%)	0.053
Mortality pre/intraoperative/under 1 month	0 (0%)	0 (0%)	Ns
Thrombophlebitis under 1 month	0 (0%)	2 (1.7%)	0.285
Ecchymosis under 1 month	34 (26.6%)	24 (20.3%)	0.435

EVTA: Endovenous thermal ablation; GSV: Great saphenous vein; SFJ: Saphenofemoral junction; ns: No statistically significant difference.

One-year clinical, quality-of-life, and duplex outcomes

At 1 year, VCSS, VDS, and AVVQ scores had significantly improved from baseline in both treatment groups, with no significant between-group differences at follow-up (Table 5). These findings indicate comparable clinical and quality-of-life improvement despite differences in anatomical durability.

Table 5.

One-year assessment of VCSS, clinical disability score and AVVQ assessment in comparison with the baseline and 1-month results.

	EVTA (n = 124)	Sclerotherapy (n = 110)	p value^a
	Mean ± SD	Mean ± SD	p value^a
VCSS
Baseline	15.25 ± 2.22	15.41 ± 2.04	0.610
After 1 month	12.73 ± 2.33	13.10 ± 2.25	0.229
p value^b	0.000*	0.000*
After 1 year	10.60 ± 1.42	10.41 ± 1.30	0.498
p value^b	0.000*	0.000*
Clinical disability score
Baseline	2.45 ± 0.53	2.42 ± 0.50	0.748
After 1 year	1.19 ± 0.40	1.12 ± 0.33	0.314
p value^b	0.000*	0.000*
AVVQ assessment at baseline and at 1-year follow-up
Baseline	22.44 ± 6.90	23.68 ± 5.20	0.679
After 1 year	15.32 ± 5.32	15.92 ± 4.28	0.672
p value^b	0.000*	0.000*

AVVQ: Aberdeen Varicose Vein Questionnaire; EVTA: Endovenous thermal ablation; SD: Standard Deviation; VCSS: Venous Clinical Severity Score.

*Statistically significant difference (p < .05).

^aMann-Whitney Test.

^bWilcoxon Signed Ranks Test.

Duplex-derived changes in SFJ diameter, GSV trunk diameter, and reflux status are presented in Table 6. Both groups demonstrated significant reductions in SFJ and GSV trunk diameters over follow-up. EVTA was associated with smaller residual GSV trunk diameters at 1 month and 1 year. At 1 year, persistent or recurrent reflux in the treated upper GSV segment was less frequent after EVTA than after sclerotherapy.

Table 6.

GSV Diameters before and after GSV ablation in EVTLA sclerotherapy.

	EVTA (n = 124)	Sclerotherapy (n = 110)	p value^a
	Mean ± SD	Mean ± SD	p value^a
Width of saphenofemoral junction
Baseline	8.87 ± 2.05	9.45 ± 2.37	0.209
After 1 month	8.30 ± 1.90	8.58 ± 1.79	0.128
p value^b	0.028*	0.015*
After 1 year	7.08 ± 1.49	6.95 ± 1.29	0.618
p value^b	0.001*	0.002*
GSV trunk mean diameter
Baseline	6.49 ± 1.65	6.69 ± 1.60	0.324
After 1 month	5.05 ± 1.42	5.80 ± 1.56	0.007*
p value^b	0.001*	0.001*
After 1 year	2.20 ± 0.48	2.68 ± 0.96	0.003*
p value^b	0.001*	0.002*
GSV trunk upper 20 cm diameter
Baseline	6.76 ± 1.73	6.90 ± 1.95	0.528
After 1 month	5.58 ± 1.70	6.55 ± 1.84	0.002*
p value^b	0.000*	0.027*
After 1 year	2.59 ± 0.64	3.21 ± 1.18	0.005*
p value^b	0.001*	0.002*

SFJ reflux assessment	Baseline		After 1 month		After 1 year
SFJ reflux assessment	No.	%	No.	%	No.	%
Thermoablation	124		124		124
Reflux	124	100.0	0	0.0	0	0.0
No reflux	0	0.0	124	100.0	124	100.0
Sclerotherapy	110		110		110
Reflux	110	100.0	2	1.8	1	1.8
No reflux	0	0.0	108	98.1	108	98.1

Upper 20 cm reflux assessment	Baseline		After 1 month		After 1 year
Upper 20 cm reflux assessment	No.	%	No.	%	No.	%
Thermoablation	132		132		124
Reflux	0	00	0	0.0	8	6.4
No reflux	124	0.0	124	100.0	116	93.5
Sclerotherapy	118		118		110
Reflux	118	100.0	0	0.0	20	18.1
No reflux	118	0.0	110	100.0	90	81.8

EVTA: Endovenous thermal ablation; GSV: Great saphenous vein; SFJ: Saphenofemoral junction.

*Statistically significant difference (p < .05).

^aMann–Whitney Test.

^bWilcoxon Signed Ranks Test.

Kaplan–Meier analysis demonstrated superior anatomical durability after EVTA. At 12 months, estimated occlusion was 93.5% in the EVTA group compared with 81.5% in the sclerotherapy group, with earlier and more frequent recanalization events after sclerotherapy (log-rank p = .003; Figure 2). Despite this anatomical difference, clinical and quality-of-life outcomes remained comparable between groups.

Figure 2.

Kaplan–Meier estimates of anatomical occlusion following EVTA versus foam sclerotherapy.

On multivariable analysis, treatment modality was the only independent predictor of recanalization, with sclerotherapy associated with a higher risk of failure (Table 7). In contrast, baseline vein diameter and CEAP class were not independent predictors. Linear regression analysis showed that treatment type was associated with AVVQ change, whereas baseline diameter and CEAP class were not independently associated with quality-of-life improvement (Table 7).

Table 7.

Logistic regression: Predictors of recanalization & linear regression: Predictors of AVVQ change.

	Non-adjusted HR	95% CI	p-value	Adjusted HR	95% CI	p value
Predictors of recanalization
C(treatment) [T.SCL]	13.06	1.64–104.26	0.015	14.21	1.98–102.37	0.008
Diameter	0.75	0.51–1.09	0.128	—	—	—
CEAP	0.74	0.31–1.77	0.492	—	—	—
Predictors of AVVQ change
C(treatment) [T.SCL]	2.042	0.18–3.91	0.032	1.98	0.12–3.84	0.037
Diameter	−0.011	−0.60–0.58	0.970	—	—	—
CEAP	0.421	−0.73–1.58	0.474	—	—	—

CI: Confidence interval; HR: hazard ratio; SCL: Sclerotherapy; T.SCL: Treatment Sclerotherapy (reference: EVTA).

Discussion

In this prospective comparative study of patients with great saphenous vein reflux, we found that both EVTA and catheter-directed foam sclerotherapy resulted in substantial improvements in clinical severity, disability, and health-related quality of life at 1 year. Despite comparable clinical outcomes, EVTA demonstrated superior anatomical durability, with significantly higher 12-months occlusion rates (93.5% vs 81.5%) and fewer recanalization events over time. Survival analysis confirmed an earlier and more frequent decline in occlusion after sclerotherapy, and multivariable regression identified treatment modality as the only independent predictor of recanalization. Perioperative recovery profiles were broadly similar between groups, including procedural pain, analgesic requirements, and duration of sick leave; however, sensory nerve injury occurred exclusively in the EVTA group. Taken together, these findings suggest that while EVTA offers greater anatomical durability, catheter-directed foam sclerotherapy achieves comparable symptomatic and quality-of-life improvements with a slightly more favorable safety profile.

Our study examines the outcomes and compares various minimally invasive techniques for treating great saphenous varicose veins. The results show that after 1 year, both EVLA and RFA had significantly higher occlusion rates over CDFS. Other studies have reported CDFS occlusion rates of 88% to 95%, slightly higher than the 82% observed in our study. Quality-of-life outcomes did not differ significantly between the three treatment methods. This aligns with other trials, which underscore that both treatments are effective in alleviating symptoms and enhancing health-related quality of life.^17–20

From an anatomical perspective, however, EVTA was associated with higher rates of superior vein occlusion and reflux elimination than sclerotherapy. Complete occlusion was achieved in all EVTA cases in 1 year. In contrast, sclerotherapy showed a 91.5% occlusion rate, with a small proportion of patients exhibiting partial recanalization or persistent reflux at the SFJ. Additionally, EVTA achieved greater reductions in GSV trunk diameter, suggesting more durable anatomical remodeling. These results align with previous reports demonstrating higher long-term anatomical success with thermal ablation compared to foam sclerotherapy.^21,22 Brittenden et al. similarly reported higher anatomical closure rates with endovenous ablation compared with foam sclerotherapy at 5 years, although quality-of-life outcomes were comparable^21,23 The enhanced durability of thermal ablation is likely attributable to its mechanism of inducing immediate, irreversible coagulative necrosis of the endothelium and vein wall, which leads to robust fibrotic occlusion, whereas foam sclerotherapy’s mechanism of chemical endothelial damage may be susceptible to recanalization from incomplete fibrosis or thrombus dissolution.^2,24

An important methodological consideration when interpreting these anatomical outcomes is that catheter-directed foam sclerotherapy was performed without adjunctive perivenous tumescence. While tumescence is an essential component of EVTA for anesthesia, vein compression, and protection of surrounding tissues from thermal injury, it is not routinely required for thermal safety during foam sclerotherapy. Nevertheless, previous CFS protocols incorporating perisaphenous tumescence and intra-saphenous saline irrigation have reported favorable occlusion rates by reducing vein caliber and intraluminal blood volume before foam delivery, thereby improving foam–endothelium contact. Therefore, the lower occlusion rate observed after CFS in the present study should be interpreted in the context of this simplified non-tumescent protocol. Another important consideration is the sclerosant used in the foam arm. Ethanolamine oleate was employed in the present study, whereas most contemporary catheter-directed foam sclerotherapy series have utilized detergent sclerosants such as polidocanol or sodium tetradecyl sulfate. Consequently, direct comparison with published CFS outcomes should be made cautiously. Differences in sclerosant characteristics may have influenced the anatomical efficacy observed in our cohort and may partly account for discrepancies between our results and those reported in studies using detergent-based foam preparations.

In contrast, sclerotherapy was associated with a more favorable perioperative safety profile. Notably, no cases of nerve injury occurred in the sclerotherapy group, whereas 6.3% of patients treated with EVTA developed sensory nerve impairment, a complication attributable to thermal injury. This observation is consistent with earlier reports linking nerve damage primarily to thermal modalities, due to perivenous heat injury.^12,25 Other complications, including infection and thrombophlebitis, were rare and comparable between groups. Pain scores, recovery time, and sick leave duration were similar, reflecting the minimally invasive nature of both treatments.^10,12

CFS also has practical advantages related to cost, accessibility, and safety. Unlike EVTA, it does not require a thermal generator, laser fiber, radiofrequency catheter, or routine tumescent anesthesia for thermal protection. In our cohort, CFS achieved significant improvements in clinical severity, disability, and quality of life, with no sensory nerve injury, supporting its role as a safe and effective option for selected patients, particularly in resource-limited settings. However, these findings should be interpreted in light of the technical limitations of the foam protocol used in this study. Specifically, ethanolamine oleate was used rather than detergent sclerosants such as polidocanol or sodium tetradecyl sulfate, and the CFS arm did not include adjunctive perivenous tumescence or intra-saphenous irrigation. These differences may have reduced anatomical durability in the foam group and limit direct comparison with optimized contemporary CFS protocols.

Further research should focus on long-term and very long-term follow-up to determine whether the modestly lower occlusion rates of foam sclerotherapy translate into higher recurrence or retreatment rates over time. Cost-effectiveness analyses will also be critical, especially in resource-constrained healthcare systems, as sclerotherapy may offer a more accessible alternative despite its lower anatomical durability.^10,12,26 Moreover, exploring hybrid approaches, such as combining sclerotherapy with thermoablation for large-diameter or recurrent veins, may optimize both anatomical and symptomatic outcomes. Finally, incorporating patient reported outcomes such as satisfaction, return to daily activities, and cosmetic results into future trials will provide a more comprehensive understanding of treatment success from the patient’s perspective. The long-term externalities of these procedures, and the impact of work return.

This study has several limitations. First, the follow-up period was limited to 1 year, which may not capture the full extent of late recanalization, recurrence, or durability of symptom relief. Second, the study was conducted at a single center, which may limit the generalizability of the findings to other populations and healthcare settings. Third, no blind randomization was applied. The sample size, particularly for subgroup analyses (e.g., nerve injury, complications), may have been underpowered to detect differences in rare adverse events, relevant in a high-volume procedure like varicose vein surgery. Fifth, the trial focused on clinical and anatomical outcomes but did not evaluate cost-effectiveness, cosmetic satisfaction, or patient preference, which are important factors in real-world decision-making. Finally, treatment allocation combined two thermal modalities into a single EVTA group, potentially masking differences between these techniques.^9,13,15

Conclusion

In this prospective cohort study, EVTA demonstrated superior anatomical durability compared with catheter-directed foam sclerotherapy, with significantly lower rates of recanalization at 1 year. However, both treatment strategies resulted in comparable improvements in clinical severity, functional status, and health-related quality of life. These findings highlight a clinically relevant dissociation between anatomical success and patient-centered outcomes.

From a practical standpoint, EVTA should remain the preferred option when durable vein occlusion is the primary objective. Nevertheless, catheter-directed foam sclerotherapy represents a safe, effective, and resource-efficient alternative, particularly in selected patients or in healthcare settings where access to thermal technologies is limited.

Future research should focus on longer-term outcomes, recurrence patterns, and cost-effectiveness analyses to better define the optimal role of foam-based strategies within contemporary venous practice.

Supplemental material

Supplemental material - Endovenous ablation of the great saphenous varicose veins: Does the modality matter? A prospective cohort study

Supplemental material for Endovenous ablation of the great saphenous varicose veins: Does the modality matter? A prospective cohort study by Mohamed Shahat, Osman Mahmoud, João Rocha Neves, Sahar Ali, Ashraf Elnaggar in Phlebology.

Footnotes

ORCID iDs

Mohamed Shahat

Sahar Ali

Ethical approval

Institutional Review Board approval was obtained for the present study from Faculty of Medicine, Assiut University with institutional review board (IRB) local approval number 04-2023-200082.

Author contributions

Conception and design of the study: MS, AE, SA.

Acquisition of data: MS, SA, JN.

Analysis and interpretation of data: MS, AE.

Drafting the article: MS, JA, AE.

Critical revision of the article: MS, OM, JA.

Final approval of the article: JA, MS, SA, OM.

Overall responsibility: MS.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest concerning the research, authorship, and/or publication of this article.

Data Availability Statement

The data supporting the findings of this study are available from the corresponding author upon reasonable request.*

Declaration of generative

There was no use of generative AI and AI-assisted technologies in the writing process.

Guarantor

MS.

Supplemental material

Supplemental material is available online.

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