Abstract
Objective
Recurrent varicose veins (RVVs) following open surgical procedures are common and present significant treatment challenges. Redo open surgery (rOS) presents risks leading to a need for alternative treatment options. This study compares the safety and efficacy of ultrasound-guided foam sclerotherapy (UGFS), used to treat recurrent reflux and remove neovascular and tributary venous networks in the thigh, to redo open surgery (rOS) for the treatment of C2r.
Materials and methods
A retrospective review was conducted on 133 patients with symptomatic C2r treated between 2018 and 2020. Of these, 91 patients received UGFS-based mini-invasive treatment (Group A), and 42 underwent rOS (Group B). Data were collected during perioperative, intraoperative, and postoperative times. Clinical outcomes were assessed using the CEAP and rVCSS scoring systems. Follow-up occurred within 1 week, at 1-6 months, and annually thereafter.
Results
UGFS showed a significantly shorter average procedure time (21 ± 7 minutes) compared to rOS (47 ± 13 minutes, p < .001) and time spent in the hospital (3 ± 0.5 hours vs 16 ± 2 hours, p < .001). Both groups achieved high technical success rates. The anterior saphenous vein (ASV) was found to be incompetent in 32 patients (24%). In Group A, it was treated with radiofrequency ablation (RFA) in 10 cases and with foam sclerotherapy in 11. In contrast, all ASV cases in Group B were managed with surgical stripping. UGFS patients experienced a more rapid clinical improvement within the first-week post-treatment (p < .001). The freedom from recurrences was 88.9% in the Group A, and 87.8% in the Group B at 3-year (p = .85). The freedom from reintervention was 90.9% in the Group A, and 88.5% in the Group B at 3-year (p = .89).
Conclusions
UGFS is a safe and effective alternative to rOS for treating C2r, offering significant advantages in shorter procedure times, faster recovery, and similar medium-term outcomes. This approach provides a viable option for C2r patients seeking effective treatment with reduced recovery periods.
Keywords
Introduction
Recurrent varicose veins (RVVs), classified as C2r in the CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification, are a feared complication following procedures such as crossectomy and stripping of the great saphenous vein (GSV).
Clinical studies have demonstrated that C2r, after open surgery (OS), can occur in a significant percentage of patients in the long term, 40% at 5 years, although rates may vary based on the surgical technique employed, the surgeon’s expertise, and risk factors such as obesity, pregnancy, and advanced age.1,2
Neovascularization was defined as a formation of new, thin-walled, tortuous venous channels in the groin region, typically originating after prior crossectomy and stripping of the GSV. These vessels arise in the scar tissue near the SFJ and represent a pathological reconnection between superficial and deep venous systems.
Reasons for recurrence following previous saphenofemoral crossectomy include technically inadequate primary surgery, failure to accurately identify the source of reflux before the first operation, reflux into a residual GSV stump or accessory saphenous vein (ASV), and the development of either new sites of reflux, limphovenous networks or neovascularisation at deep/truncal vein junctions.
Traditional redo open surgical (rOS) treatment of C2r is potentially threatening because scar tissue distorts the normal architecture making identification of the target anatomy difficult. As a result, there is potentially a greater risk of iatrogenic injury to neighbouring structures during dissection in redo surgery compared to primary surgery.3,4
During the past decade, increased interest in varicose vein disorders and the development of minimally invasive treatment options has led to advancement in the management of varicose veins after saphenous venous surgery. 5 Ultrasound-guided foam sclerotherapy (UGFS) is a technique proven to be effective in the treatment of C2r, including those associated with incompetent perforating veins (PVs) or lymph node venous networks near the SFJ.6,7
The aim of this study was to compare the safety and efficacy of UGFS, used to treat recurrent reflux and remove neovascular and tributary venous networks in the thigh, to rOS for the treatment of C2r in the groin region in patients who underwent previous crossectomy and stripping of the incompetent GSV.
Material and methods
This is a retrospective and nonrandomized study that includes all consecutive patients with symptomatic C2r that occurred after previous open surgery of the GSV (crossectomy and stripping), admitted at San Raffaele Hospital Vein Center between 2018 and 2020.
Patient characteristics, along with perioperative, intraoperative, and postoperative data, were collected from a prospectively maintained computerized database.
Recurrence of varicose veins was assessed both preoperatively and postoperatively using anatomical and clinical criteria. Preoperative C2r was defined as newly developed varicosities or neovascular networks, occurring after a period of clinical and ultrasound-confirmed resolution following previous surgery. Residual varicose veins defined as persistent refluxing segments that were not adequately treated in the initial intervention were excluded from recurrence analysis and noted separately.
Clinically, recurrence was characterized by the presence of symptomatic varicosities, including pain, edema, heaviness, and skin changes such as hyperpigmentation. Disease progression was further quantified using the revised Venous Clinical Severity Score (rVCSS) and CEAP classification (C1-C6 stages). 7 Patients with previous deep venous thrombosis (DVT) were excluded from this analysis.
All patients underwent a comprehensive color duplex ultrasound (CDUS) evaluation before treatment to determine the anatomic distribution of C2r and identify sources of reflux. The examination focused on identifying residual refluxing segments of the GSV or accessory saphenous vein (ASV), assessing neovascularization at the SFJ, detecting incompetent perforating veins (PVs), mapping tributaries, recurrent venous networks, CFV incompetence and ruling out DVT or other venous pathologies. Patients with an incompetent small saphenous vein (SSV) and common femoral vein (CFV) were excluded from treatment preoperatively. 8
In this study, all patients underwent screening with CDUS for May-Thurner syndrome. 9
In our series, skilled surgeons routinely perform ultrasound evaluation using also a procedure planning sheet in order to confirm correct indication, and to decide the overall strategy, access site, and associated treatment of varicose branches.
Two groups of patients were identified: patients with recurrent reflux in a residual saphenous vein stump or in neovascularized channels were considered for UGFS-based mini-invasive treatment when these segments were accessible via percutaneous injection (Group A), in contrast, patients with significant neovascularization at the SFJ or long, refluxing saphenous segments were more likely to undergo rOS (Group B).
This study followed the principles outlined in the Declaration of Helsinki and used only information obtained from the review of medical records. Patients gave consent for the anonymous collection of their data on the standard consent form provided by our institution.
Follow-up examination
All patients underwent clinical and CDUS examination within 1 week, 1 and 6 months, 1 year, and yearly thereafter. Within 1-week CDUS was performed to assess the technical success, defined as confirmation of target vein obliteration for UGFS or completeness of surgical removal for rOS, and for the detection of early complications such as hematomas, lymphoceles, or superficial phlebitis. At 1-month CDUS was performed to assess evaluation of vein recanalization or persistent reflux and to assess postoperative healing and symptomatic relief. At 6-month CDUS was performed to assess identification of any new reflux or neovascularization at the SFJ. Annually thereafter CDUS was performed for the long-term surveillance for recurrence of C2r, and monitoring for reintervention needs.
Complications were defined according to Dermody et al and were evaluated during the first postoperative visit, after 1 week. 10 This examination was performed to identify patients with recurrences and the worst of symptoms.
Color duplex ultrasound examination was performed to identify perioperative technical success and efficacy of treatment and to detect postoperative obliteration of the C2r, need for reintervention, and durability.
Clinical and anatomical outcomes were defined and assessed consistently across both groups using standardized tools. Specifically, technical success was defined as complete removal of incompetent segments in the rOS group, and as successful foam delivery and obliteration of the refluxing target vein in the UGFS group, both confirmed by CDUS within 1 week of the procedure. The durability was defined as the absence of C2r and neovascularisation (new blood vessel formation, which can occur in an abnormal tissue or position) in the groin region assessed by CDUS examination over the follow-up.
Postoperative recurrence following rOS or UGFS was similarly assessed. Anatomically, recurrence was defined by persistence of treated venous segments, new incompetent venous networks due to neovascularization, or recanalization of previously occluded veins leading to pathological venous reflux, as confirmed by CDUS examination. Clinically, recurrence was determined by the reappearance of symptomatic varicosities, including pain, swelling, or ulceration in advanced cases (C5-C6 CEAP), as well as the need for additional interventions such as repeat sclerotherapy or surgical revision.
Endpoint
The primary study endpoint was to assess the safety and efficacy of the UGFS, and recurrence rate including recanalization of the target vessel during the follow-up period.
The safety of the treatment was defined as the absence of preventable harm to a patient and the reduction of risk of unnecessary harm associated with the procedure to an acceptable minimum. Post-operative complications rate was analysed including hyperpigmentation, pain, ecchymosis, paraesthesia, phlebitis, ablation-related thrombus extension (ARTE), DVT, and pulmonary embolism (PE) within 1 week from intervention.
The efficacy of the treatment was defined as the absence of vein recanalization after the procedure. The treatment for UGFS was deemed clinically effective if, at follow-up CDUS, there was complete or near-complete obliteration of the treated vein, with absence of luminal flow or reflux.
The secondary study endpoint was to compare intraoperative and postoperative outcomes between patients undergoing to UGFS-based mini-invasive approach (Group A), and those with rOS (Group B).
Freedom from C2r and reintervention rate over the follow-up were analysed as well. Repeat treatment following redo surgery was indicated based on clinical recurrence and ultrasound-confirmed venous reflux, with similar criteria applied to both treatment groups. The primary indications for repeat treatment included persistent or recurrent symptoms, particularly pain, swelling, or venous heaviness, with worsening rVCSS or progression in CEAP classification.
The clinical outcomes were assessed using the CEAP class, revised clinical severity score (rVCSS), and visual analog scale (VAS), in both groups.11–13 Visual analog scale was used to assess the symptoms. The clinical improvement was considered significant when it decreased at least 30% versus the baseline for the rVCSS score during the follow-up.
Procedure
Patients who underwent rOS treatment were treated by a single surgeon. An incision along the inguinal fold was employed. Approximately 5 cm of deep vein, in cluding the common femoral and femoral veins, around the SFJ was exposed and dissected. All branches of the deep veins were ligated. The incision in the groin was closed in two layers with an absorbable subcuticular stitch. A spinal anaesthetic was administered in all cases. Cases in which a refluxing ASV had been identified preoperatively were managed by cannulating the vein with a stripper and removing it. In other cases, the vein was removed by phlebectomies. The duration from the initial incision to the wound closure was documented.
Patients who underwent UGSF treatment were treated with polidocanol (POL) (Atossisclerol, Kreussler Pharma, Wiesbaden, Germany) in low concentration and low doses. The patient was positioned in the supine position. The access site was selected based on the patient’s anatomy and the distribution of recurrent varicose veins. Specifically, foam injection was performed with multiple punctures distal to the reflux site, generally at the thigh level, under ultrasound guidance. The access needle was typically a 21-25G butterfly needle, depending on the diameter of the target vessel. Injection was carried out under real-time ultrasound guidance, with a controlled delivery rate to prevent dispersion and ensure optimal distribution along the treated vessel.
Sclerosant foam (SF) was prepared using the Tessari method (one part of sclerosant liquid and four parts of air). 14 The sclerosing agent concentrations were 1% for C2r diameter of 4 to 7 mm and 2% for RRVs of >7 mm. 15 The volume per session refers to the amount of sclerosing agent used specifically to retreat the groin area, with 3 mL representing the volume administered only in that region. Tributary veins were also treated, however, data regarding the amount of sclerosant used for these vessels are not available.
Additionally, targeted ligation or UGFS of malfunctioning perforating veins was also carried out. The procedure was considered technically successful if complete obliteration of the treated vessel was achieved, with the presence of foam into the target vessel. The treatment was deemed clinically effective if, during both the immediate and follow-up ultrasound assessments, the following criteria were met: absence of reflux in the treated segment, minimal or no recanalization of the vessel, resolution of the clinical varicosity associated with the treated vein.
Incompetence of ASV was treated with endovenous thermal ablation or UGSF approach. In the first case a 3 cm ClosureFast radiofrequency catheter (VNUS®, Covidien, Dublin, Ireland) was introduced through a 7 Fr sheath to the target vein, and thermal ablation was performed with temperatures between 100 and 120°C. The initial vein segment received a double cycle of energy, while subsequent segments were treated with single impulses. In cases where the ASV was not suitable for thermal ablation, it was treated with UGFS.
At the end of the procedure, elastic compression bandages were applied to enhance the effectiveness of the foam’s contact with the venous wall. Patients were instructed to wear class II compression stockings for at least 10–14 days.
All patients undergoing treatment for C2r were administered anticoagulant therapy with a LMWH once daily of 4000 IU of low molecular weight heparin for 1 week.
Statistical analysis
Data on patient demographics, anatomical features, surgical procedures, postoperative outcomes, and follow-up were stored in a specialized database (Excel software). Continuous variables were expressed as mean ± standard deviation (SD) if normally distributed, or as median and interquartile range (IQR) if non-normally distributed. Categorical variables were presented as counts and percentages. The Shapiro-Wilk test was used to assess the normality of distribution for continuous variables. For comparisons between groups, a two-tailed independent t test was applied for normally distributed continuous variables, while the Mann-Whitney U test was used for non-normally distributed variables. The Pearson’s chi-squared test or Fisher’s exact test was used for categorical data as appropriate.
Recurrences and reintervention-free survival were calculated using the Kaplan-Meier estimator. Graphs were displayed up to a standard error (SE) threshold of <0.10. A 95% confidence interval (CI) was applied to all measured variables.
All statistical analyses were conducted with the R-studio (Version 0.99.902, © 2009-2016 R-Studio, Inc., Boston, USA. Packages used were: The R Datasets package 3.6.3, graphics package 3.6.3, methods and cases 3.6.3, stats 3.6.3, survival 3.6.3, utils 3.6.3).
Results
Preoperative clinical of patients who underwent treatment for recurrent varicose veins with UGFS-based mini-invasive treatment (Group A) and redo open surgery treatment (Group B). Categorical values are expressed as n (%) and continuous data are expressed as mean ± SD, median, and interquartile range (IQR).
BMI = Body Max Index; SVT = Superficial vein thrombosis; CAD = coronary artery disease; MTS = May-Thurner Syndrome; CEAP = Clinical-Etiology-Anatomy-Pathophysiology (2: varicose vein with symptoms; 3: swollen ankle; 4: skin changes; 5: healed leg ulcer; 6: active ulcer); VCSS = Venous Clinical Severity Score; VAS = Visual Analogue Scale, used to assess patient-reported leg pain or discomfort on a scale from 0 (no pain) to 100 (worst imaginable pain); PV = Perforator vein; ASV = Accessory Saphenous Vein; GSV = Great Saphenous Vein; IQR = Interquartile Range.
No significant statistical difference was identified between the two groups. Most of the patients were females (60.1%), with a mean age of 59 ± 25 years and a body mass index (BMI) of 25.7 ± 6.5 (kg/m2). Twenty-one patients (15.7%) were current smokers, 8 (6%) had diabetes mellitus and 15 (12.3%) had a history of SVT. No statistically significant difference was identified between the two groups (Table 1).
Most patients were allowed to C2r (90% vs 95.2%; p = .31) and C3 (6.6% vs 2.4%; p = .31) of CEAP classification. All patients underwent preoperative CDUS that showed the presence of incompetent PVs in 23 patients (18.7% vs 14.3%; p = .532) and the presence of ASV incompetence in 32 patients (23.1% vs 26.2%; p = .861).
Intraoperative detail and perioperative complications analysis, within 1 week from intervention, in patients who underwent treatment for recurrent varicose veins with UGFS-based mini-invasive treatment (Group A) and redo open surgery treatment (Group B). Categorical values are expressed as n (%) and continuous data are expressed as the median and interquartile range (IQR).
ASV = Accessory Saphenous Vein; DVT = Deep vein Thrombosis; ARTE = ablation-related thrombus extension; IQR = Interquartile Range; VAS = Visual Analogue Scale, used to assess patient-reported leg pain or discomfort on a scale from 0 (no pain) to 100 (worst imaginable pain); VCSS = Venous Clinical Severity Score.
The average intervention time was 21 ± 7 minutes in group A and 47 ± 13 minutes in Group B, with a statistically significant difference (p < .001). The average time spent in the hospital was 3 ± 0.5 hours in group A and 16 ± 2 hours in Group B, with a statistically significant difference (p < .001).
The ASV was identified in 32 patients (24%) and it was incompetent in all cases (23.1% vs 26.2%; p = .861). In Group A, ASV treatment involved radiofrequency ablation (RFA) in 10 (48%) patients and foam sclerotherapy in 11 (52%). On the contrary, all patients allowed in Group B underwent surgical stripping of the ASV. 70 patients (77%) in Group A had C2r veins with diameters between 4 and 7 mm and were treated with a sclerosing agent concentration of 1%, whereas the remaining patients had RVVs >7 mm and received a concentration of 2%. All patients had 1 month of follow-up. Among these, lymphoceles were detected in no patients allowed in Group A and in 2 (4.8%) patients in Group B (p = .098). These patients had lymphovenous networks and underwent to resection during intervention. Paraesthesia was identified only in 1 (2.4%) patient in Group B (p = .31). Hyperpigmentation was identified in 5 (3.8%) patients in the overall population (2.2% vs 7.1%; p = .16). Four patients (4.4%) allowed to Group A needed a supplementary treatment with UGSF at 1 week and in 2 cases (2.2%) at 2 weeks after intervention.
Follow-up data of patients who underwent treatment for recurrent varicose veins with UGFS-based mini-invasive treatment (Group A) and redo open surgery treatment (Group B). Categorical values are expressed as n (%) and continuous data are expressed as mean ± SD, and median and interquartile range (IQR).
DVT = Deep vein Thrombosis; CEAP = Clinical-Etiology-Anatomy-Pathophysiology (2: varicose vein with symptoms; 3: swollen ankle; 4: skin changes; 5: healed leg ulcer; 6: active ulcer); VCSS = Venous Clinical Severity Score; PV = Perforator vein; IQR = Interquartile Range; VAS = Visual Analogue Scale, used to assess patient-reported leg pain or discomfort on a scale from 0 (no pain) to 100 (worst imaginable pain).
After 3 years from intervention 118 (88.7%) patients were analysed (Table 3). The recurrence rate was 12.7% (n = 15) without differences between the two groups of patients analysed (11.5% vs 28%; p = .158). Four patients underwent UGSF treatment, whereas one refused reintervention. Among patients of Group B 1 had paraesthesia (2.7%). Ninety-seven patients (79.6%) were allowed to C1 and 12 (12.7%) to C2r of CEAP classification. No significant statistical difference was identified between the two groups of patients analysed.
The freedom from recurrences was 97.8% (CI: 94.8%-100%) for patients allowed in the Group A, and 97.6% (CI: 93.1%-100%) for Group B at 1 month; 93.4% (CI: 88.4%-98.6%) in the Group A, and 92.9% (CI: 85.4%-100%) in the Group B at 1-year; 88.9% (CI: 82.6%-95.6%) in the Group A, and 87.8% (CI: 78.4%-98.4%) in the Group B at 3-year. No significant statistical differences between the two groups of patients analysed were documented (p = .85) (Figure 1). Kaplan-Meier survival curves for the recurrence rate of patients who underwent treatment for recurrent varicose veins with UGFS-based miniinvasive treatment (Group A) and redo open surgery treatment (Group B).
The freedom from reintervention was 98% (CI: 95.2%-100%) for patients allowed in Group A, and 97.6% (CI: 94.1%-100%) for Group B at 1 month; 94.8% (CI: 88.4%-99.6%) in the Group A, and 93.9% (CI: 86.4%-100%) in the Group B at 1-year; 90.9% (CI: 85.6%-96.6%) in the Group A, and 88.5% (CI: 81.4%-98.4%) in the Group B at 3-year.
The freedom from retreatment analysis showed no statistically significant difference between the two groups in terms of recurrence patterns and indications for repeat intervention (p = .89) (Figure 2). However, differences emerged in the retreatment approach: in the rOS group, 100% of retreatments (n = 2) were managed with UGFS or minor surgical revision, whereas in the UGFS group, 100% of retreatments (n = 4) consisted of repeat UGFS sessions performed within 1–2 weeks post-treatment and in 2 cases at 2 weeks after intervention. The mean foam volume used was 3 mL every section. Kaplan-Meier survival curves for reintervention rate of patients who underwent treatment for recurrent varicose veins with UGFS-based miniinvasive treatment (Group A) and redo open surgery treatment (Group B).
No cases requiring surgical revision. Despite these reinterventions, long-term recurrence rates and overall treatment efficacy remained comparable between the two groups, confirming that both UGFS and rOS provided similar durability in managing recurrent varicose veins.
In follow-up years, VCSS constantly decreased likewise in patients who had UGFS and rOS treatment. It is evident that the reduction in VCSS was greater in Group A compared to Group B during the first week after the procedure (p < .001), and subsequently, a steady progression was observed without statistically significant differences (Figure 3). Revised Venous Clinical Severity Score (rVCSS) before and after the intervention of patients who underwent treatment for recurrent varicose veins with UGFS-based miniinvasive treatment (Group A) and redo open surgery treatment (Group B). The median (line within the box) and range (error bar) are shown.
Discussion
Recurrent varicose veins following saphenous vein crossectomy and stripping represent a complex issue in management, requiring a careful evaluation of different therapeutic options. However, the choice of strategy depends on the patient’s individual characteristics, the severity, and the type of recurrence.
In the past, the traditional treatment involved surgical revision of the groin. The standard rOS treatment for C2r disease involves ligation and division of the saphenous trunk, sometimes followed by stripping and avulsion phlebectomy of tributaries. Scar tissue from the previous surgery can complicate this procedure by distorting normal anatomy, making dissection more challenging. Redo open surgery has a higher incidence of surgical complications (such as paresthesia, bleeding, infection, and scarring) and increased hospital costs. 16
The advent of endovascular procedures has reduced the rate of complications associated with rOS. In particular, thermal ablation techniques have demonstrated a favorable safety profile and benefits in terms of postoperative recovery compared to traditional surgery.
In a study by Van Groenendael L et al., EVLA was associated with lower complication rates, such as wound infections and paresthesias, compared to surgery. The authors suggest that this could be attributed to the less invasive nature of the laser procedure, which minimizes trauma to the surrounding tissues. 17 However, patients treated with EVLA reported a higher incidence of delayed tightness sensation, a side effect that, while not severe, can temporarily impact quality of life. In terms of recurrence, data do not show a statistically significant difference between EVLA and traditional surgery, although EVLA has demonstrated a reduction in hospital stay and recovery time.
Another study by N. Nwaejike compared endoluminal thermal ablation (VNUS) to traditional surgery, highlighting that VNUS is associated with less postoperative pain, fewer bruises, and shorter procedure times compared to surgery. 18 These benefits are like those observed with EVLA, suggesting that both minimally invasive techniques can offer an improved postoperative experience compared to traditional surgery. However, while VNUS seems particularly effective in reducing immediate postoperative discomfort, EVLA may offer greater versatility, as demonstrated by high ablation rates (98%) and the absence of significant recurrences reported in a cohort study of 95 patients. This suggests that, for patients with C2r, EVLA could be the preferred option, especially in complex cases or multiple recurrences.
Sclerotherapy is a widely used minimally invasive technique for the treatment of varicose veins and their recurrences, where recurrent varicose veins can be supported by incompetent perforators or the lymphatic network of the inguinal region. 6 The technique is minimally invasive, well-tolerated by patients, does not require anesthesia, and can be repeated. 19 Foam injections can be combined with other techniques (EVLA, phlebectomies) to eliminate multiple sources of reflux during the same session or subsequently.
Several studies have examined its effectiveness, and scientific evidence indicates that sclerotherapy can be effective in reducing symptoms associated with recurrence, such as pain, swelling, and the aesthetic appearance of varicose veins. 5 However, its effectiveness may vary depending on the severity of the recurrence, the sclerotherapy technique used, and individual patient characteristics.
Currently, sclerotherapy is recommended for the treatment of recurrences with or without truncal incompetence, as documented in the 2022 guidelines. 6
This study evaluated the outcomes of 133 patients who underwent treatment for recurrent varicose veins at the San Raffaele Hospital Vein Center between 2018 and 2020, using either UGFS or rOS. The results suggest both treatments are effective, but some differences were identified in terms of short-term outcomes, recovery times, and procedural characteristics.
The patient population had no significant demographic or anatomical differences between the UGFS (Group A) and rOS (Group B) groups.
In Group A, treatment was based on a UGFS-guided strategy that incorporated a combination of minimally invasive techniques. UGFS was primarily employed to treat the neovascular network and refluxing venous segments in the groin and proximal thigh. Varicose tributaries were not routinely treated during the same session and were managed selectively, depending on their anatomical distribution and clinical relevance.
One of the most notable findings was the significant difference in procedural time between the two groups. UGFS was associated with a much shorter intervention time (21 ± 7 minutes vs 47 ± 13 minutes, p < .001), and consequently, patients in Group A had significantly shorter hospitalization times (3 ± 0.5 hours vs 16 ± 2 hours, p < .001). This difference highlights the less invasive nature of UGFS compared to rOS, which requires spinal or general anaesthesia in most cases.
Technical success was achieved in all patients, and no intraoperative complications were reported in either group. This demonstrates the high safety and efficacy of both treatment modalities. However, postoperative complications, though rare, were slightly more prevalent in the rOS group, with two patients developing lymphoceles and one experiencing paraesthesia. Conversely, no complications were documented in the UGFS group at the 1-month follow-up.
At the mean follow-up of 31.9 ± 10.15 months, both treatment groups exhibited high freedom from recurrence and reintervention rates, with no statistically significant differences between them. At 1-year post-procedure, 95.5% of patients were recurrence-free. By 3 years, the recurrence rate was 11.3% based on the Kaplan-Meier survival estimation (Figure 1), with no significant differences between UGFS and rOS groups (p = .85). This suggests that while UGFS offers a less invasive and faster recovery option, its long-term efficacy is comparable to the more traditional surgical approach.
The substantial improvement in CEAP classifications observed in both groups demonstrates the efficacy of both approaches in managing the visible symptoms of C2r.
Interestingly, UGFS patients experienced a greater reduction in rVCSS (Venous Clinical Severity Score) within the first week after treatment compared to those in the rOS group (p < .001). However, this initial advantage in clinical improvement did not persist at one and 3 years, where rVCSS progression was steady in both groups without statistically significant differences.
Moreover, the study demonstrates that UGFS is a safe, efficient, and effective alternative to redo open surgery for the treatment of C2r, particularly when considering shorter operative times, quicker recovery, and comparable long-term outcomes. The rapid improvement in rVCSS observed in the UGFS group during the first week post-treatment suggests that this less invasive approach may be particularly beneficial for patients seeking quicker relief from symptoms.
Limitation of the study
A limitation of this study is its retrospective, non-randomized nature, which may have introduced selection bias regarding the choice between UGFS and rOS. Patients with more complex anatomical variations, such as extensive neovascularization or long refluxing saphenous trunks, may have been preferentially selected for rOS. Conversely, patients with accessible refluxing venous segments, shorter remnants, or less extensive recurrence may have been more likely to receive UGFS.
This heterogeneity in patient selection could impact the comparability of the groups, potentially influencing both short- and long-term outcomes. Furthermore, while preoperative duplex ultrasound played a critical role in guiding treatment decisions, the exact criteria for choosing UGFS versus ROS were not strictly defined and were based on individual surgeon judgment.
Additionally, the study did not evaluate the impact of patient lifestyle or postoperative preventive measures, which could influence long-term outcomes.
Conclusion
Both UGFS and rOS are effective treatment options for C2r, with similar long-term outcomes in terms of recurrence and reintervention rates. While UGFS offers significant advantages in terms of shorter procedure times, reduced hospitalization, and faster recovery, both approaches yield comparable clinical results at one- and 3-years post-procedure. Future studies with randomized designs and a focus on postoperative lifestyle interventions could further elucidate the optimal treatment strategy for recurrent varicose veins.
Footnotes
Acknowledgements
We would like to thank the staff and participants of the San Raffaele Hospital Vein Center for their important contributions to this study.
Author Contributions
Dr Vincenzo Ardita, Nicola Galati, Sarah Tinaglia, Carlo Campesi, Elena Miglioranza, Roberto Chiesa, and Domenico Baccellieri contributed to the conception, design of the work, the acquisition, analysis, and interpretation of data. All authors drafted the work and revised it critically for important intellectual content. All authors approved the version to be published.
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.
Guarantor (mandatory)
Dr Vincenzo Ardita and Prof. Domenico Baccellieri are the guarantor for this manuscript. They accept full responsibility for the work, had access to the data, and controlled the decision to publish.
