Abstract
Objective
to compare the outcomes of mechanochemical ablation (MOCA) versus saphenopopliteal junction ligation and stripping (OS) for symptomatic small saphenous vein (SSV) insufficiency.
Methods
This is a retrospective study including symptomatic SSV patients treated with MOCA using the ClariVein catheter (Merit Medical, South Jordan, Utah, USA) or OS from 2015 to 2019.
Results
A total of 60 limbs (73.3% women, mean age 54.7 ± 14.4 years) were treated with MOCA and 58 limbs (63.8% women, mean age 54 ± 11.6 years) with OS. At 18 months follow-up, recurrence rates were 7.5% (4/53) for MOCA vs. 5.7% (3/52) for the OS group. MOCA group was associated with less pain at first postoperative day, and an early return to work (MOCA 3.5 ± 2.3 days vs. OS 14.2 ± 3.8 days, p < .0001). No cases of leg paresthesia/dysesthesia were observed in the MOCA group, while two patients (3.4%) presented neurological symptoms after OS treatment.
Conclusion
MOCA and OS are both safe and effective techniques for symptomatic SSV insufficiency. MOCA group demonstrated to be associated with less postoperative pain and early return to work compared to OS.
Introduction
Chronic venous disease (CVD) is highly prevalent, and in western countries is estimated that 23% of adults are affected by varicose veins. 1 In the spectrum of CVD, in almost 20% of cases, clinical symptoms of CVD are related to the sapheno-popliteal junction (SPJ) or small saphenous vein (SSV) reflux.2,3
Traditionally, open surgical treatment (OS) of varicose veins secondary to SPJ or SSV insufficiency has always been considered challenging by physicians due to the different anatomical features of the popliteal fossa and the close anatomical relationship between the SPJ/SSV and the tibial nerve/sural nerve route.4–6 Over the last decades, endovenous techniques have been proposed as a valid treatment for SSV incompetence, reducing the possibility of neurological damage. In particular, mechanochemical ablation (MOCA) has been demonstrated to provide promising clinical outcomes.7–10 However, the number of studies analyzing different treatments for SSV remains relatively low compared with those on the great saphenous vein.
In the present study, we review our experience with the treatment of SSV incompetency, comparing the results between two cohorts of patients treated with MOCA or OS to assess the effectiveness and safety of both techniques.
Materials and methods
The present study included patients who had undergone MOCA or OS to treat isolated SSV insufficiency between January 2015 and December 2019. Procedures were performed by five staff vascular surgeons experienced in venous interventions. Baseline demographic data and clinical characteristics of the patients were retrieved from a prospectively maintained database and retrospectively analyzed. In 2017, MOCA was introduced as a treatment modality in our institution. From that moment on, the techniques’ strategies (OS vs. MOCA) were at operator’s discretion. The early results for the treatment of SSV with MOCA were previously reported. 9
Patients that were submitted to MOCA or OS treatment with age ≥18 years, primary single-axis reflux in the SPJ and/or SSV ≥0.5 second diagnosed by duplex ultrasound (DUS), average SSV diameter between 3 and 10 mm, and CEAP (clinical, etiologic, anatomic, pathophysiologic) C class ≥2, were included in the study. The exclusion criteria were active or previous deep venous thrombosis (DVT), a history of hypersensitivity, or allergy to polidocanol. Included patients were divided into two groups depending on the treatment received (MOCA group and OS group).
Patients gave informed consent for the anonymous collection of their data by signing the standard consent form provided by our institution. Ethical committee approval was waived in accordance with Italian laws. The present study followed the principles outlined in the Declaration of Helsinki and used only the information obtained from a review of the medical records.
Procedural techniques
In all cases, MOCA was performed using the ClariVein catheter (Merit Medical, South Jordan, Utah, USA) combined with 2% polidocanol (Atossisclerol; KreusslerPharma, Wiesbaden, Germany) under local anesthesia in the operating room. The percutaneous access to the SSV was obtained with the patient in a prone position under DUS guidance at the lowest level of demonstrable reflux. The characteristics of the ClariVein catheter and the step-by-step procedure have been previously described. 9 The amount of sclerosant agent injected was determined by the length of the treated segment and the SSV diameter as suggested by the non-U.S. parameters for SSV provided by the instruction for use (IFU). Next, varicose tributaries were removed, performing additional microincisions and using Mueller-style hooks or fine-tipped mosquito forceps.
Surgical treatment was performed in the operating room under regional or general anesthesia with the patient in a prone position. In the preoperative setting, the SPJ was marked with DUS to guide skin incision in the popliteal fossa reducing the risk of incorrect exposures. During the surgical dissection, the retractors were permanently placed with caution to preserve the sural and tibial nerves. The level of ligation of the SPJ was always at the point that SSV flushes into the popliteal vein and after the ligation of all tributaries. In all cases, an invagination stripping was performed by isolating the SSV at the ankle when it passes posteriorly to the external malleolus. Where appropriate, as described for the MOCA, phlebectomies were performed to remove varicose tributaries. Surgical incision at the popliteal fossa was sutured layer-by-layer, approximating fascia and skin. For both techniques, the micro incisions for performing the phlebectomies were closed using Steri-strips TM (3 M, St Paul, MN, USA). For both MOCA and OS, the patients were discharged 12 hours after the procedure and instructed to wear compression stockings (23 mmHg) for at least two weeks.
Patient’s assessment and follow-up
All patients underwent preoperative clinical evaluation, and baseline CEAP C class and venous clinical severity score (VCSS) were assigned for the assessment. Preoperative evaluation included a DUS scan of the superficial and deep venous system, identification and marking of SPJ at the level of the popliteal fossa, and SSV at the level of the ankle for OS patients. DUS examination was performed by an experienced vascular surgeon using the Philips IU22 scan (Philips Healthcare, Best, The Netherlands) with an L9-3 linear transducer. The presence of a reversal flow ≥0.5 seconds at the level of SPJ and/or SSV defined severe incompetence. In addition, for the evaluation of Quality of Life (QoL), the Aberdeen varicose vein questionnaire (AVVQ) was completed by all the patients. The pain was measured on a 100-mm visual analog scale (VAS; 0 = no pain; 100 = worst pain possible) on the first postoperative day before discharging.
Postoperative clinical evaluation and DUS were performed for both groups at 1-. 6-, 12- and 18-months follow-up. During the 1-month follow up the time needed by patients to return to work was registered. Moreover, patients were re-assigned to VCSS and were asked to re-complete the AVVQ questionnaire during each follow-up period.
Outcomes
The primary outcomes were technical success defined as accomplishing the planned procedure without any intraoperative complication, the incidence of recurrent varicose veins in the two groups defined as the recanalization of the SSV in the MOCA group, and the presence of neovascularization at the level of SPJ in the OS group. Recanalization of the SSV treated with MOCA was defined as an open segment of greater than 10 cm. 10 Neovascularization of the SSV treated with OS was defined as the presence of new vascular channels or numerous incompetent veins with turbulent flow at the site of previous SFJ ligation. 11 The secondary outcomes included change of VCSS and AVVQ over time, the periprocedural pain, the days to return to work, and perioperative complications. Patients were instructed by the surgical team to return to work at the moment they felt capable of performing normal daily activities. Neurological symptoms, including burning pain, dysesthesia, or paresthesia localized over the foot or upper calf, and DVT were considered major complications, whereas minor complications included phlebitis and ecchymosis.
Statistical analysis
The collected data are presented as the mean ± standard deviation, median and interquartile range (IQR; 25%-75%), or percentages. The data were compared using a two-tailed t-test or the Pearson χ2 test, as appropriate. P < .05 was considered statistically significant. The recurrence of recanalization for MOCA or neovascularization for OS was computed using the Kaplan-Meier method. The Kaplan-Meier curve was determined up to the value of the standard error (<0.10). The 95% confidence intervals were also computed. All statistical analyses were performed with GraphPad Prism 9.0 (GraphPad Software, Inc., San Diego, CA).
Results
During the study period, a total of 132 patients had been treated to our center for SSV incompetency. Among these, 118 patients (68.6% women, mean age 54.4 ± 14.6 years) representing 118 limbs, had been treated with OS or MOCA. The patients excluded were: 9 patients treated with radiofrequency ablation and five patients treated with foam sclerotherapy (Figure 1).
Flow chart referral.
A total of 60 patients (73.3% women, mean age 54.7 ± 14.4 years) representing 60 incompetent SSV were included in the MOCA group, whereas 58 patients (63.8% women, mean age 54 ± 11.6 years) representing 58 incompetent SSV were included in the OS group. The two groups were not statistically different for demographic and clinical characteristics. The overall population and the two groups’ characteristics are shown in Table 1.
Patients’ demographic and clinical data.
BMI: body mass index; SVT: superficial vein thrombosis; CEAP: Clinical-Etiological Anatomical-Pathophysiological. BMI and Age are expressed as mean ± standard deviation.
aContinuous data are presented as the means ± standard deviation; categorical data are given as the counts (percentage).
Technical success, defined as accomplishing the planned procedure without any intraoperative complication, was obtained in all cases. All the MOCAs were performed under local anesthesia, while OS procedures were carried out under spinal anesthesia in 54 cases and under general anesthesia in 4 cases. Additional phlebectomies were performed in 85% of cases in the overall population (101/118) divided in 76.6% (46/60) in MOCA group and 89.6% (52/58) in OS group (p = 0.08). The mean duration of the procedure was significantly lower in the MOCA group (21.7 ± 8.2 vs. 39.9 ± 12.7; p < .0001) as well as pain VAS scale in the first postoperative day (15.2 ± 11.9 vs. 22.3 ± 20.3; p = .01). Intraprocedural details are shown in Table 2.
Intraoperative details and postoperative adverse events.
VAS: Visual Analog Scale measured in the 1st postoperative day; DVT: deep vein thrombosis; NA: not applicable.
aDuration, pain VAS, and return to work are expressed as mean ± standard deviation. Categorical data are given as the counts (percentage).
*Statistically significant p value (<.05).
No cases of DVT were registered in the two groups, but 2 cases (3.4%) of peripheral neurological symptoms were observed only in the OS group: one patient presented paresthesia of the calf and foot that resolved after two months, while one patient suffered burning pain and dysesthesias at the level of the foot which at the last follow-up (18 months) was still present. Of the minor complications, 2 cases of ecchymosis and 3 cases of phlebitis were observed in the MOCA group, and 4 cases of ecchymosis and 1 case of phlebitis in the OS group (Table 2). All minor complications self-solved and did not require any further therapy.
During the total follow-up period, 13 patients were lost, 7 in the MOCA group and 6 in the OS group. MOCA group demonstrated an early return to work (MOCA 3.5 ± 2.3 days vs. OS 14.2 ± 3.8 days, p < .0001). The recanalization rates in the MOCA group and the recurrence rates in the OS were respectively 0% (0/60) vs 1.7% (1/58) at 1-month follow-up, 1.7% (1/58) vs 1.85% (1/54) at 6-month follow-up, 7.4% (4/54) vs 3.7% (2/54) at 12-month follow-up, and 7.5% (4/53) vs 5.7% (3/52) at the 18-month follow-up. The Kaplan-Meier curve for the MOCA and OS group is shown in Figure 2. The log-rank test demonstrated that the two curves are not statistically different (P = .70).
Kaplan-Meier estimated rate of recurrence or revascularization (95% confidence bands). Log-rank test was performed to assess any differences between to curves (p = 0.70).
A reduction of the severity of the venous disease was observed in the two cohorts of patients. The median baseline VCSS values significantly decreased both in MOCA group and OS group at the 18-months follow-up [MOCA: 5 (IQR 3–6) vs 1 (IQR 3–6), P < .0001; OS: 4 (IQR 2.25–5) vs 0 (IQR 0–1), P < .0001]. In the same fashion, at the 18-month follow-up both populations demonstrated a significant improvement of the QoL with a decrease of the mean AVVQ score [MOCA: 25 ± 14.61 vs 4.19 ± 3.12, P < .0001; OS: 21.5 ± 17.25 vs 3.9 ± 5.4 (IQR 0-1), P < .0001]. No differences were observed between the two groups in the trend of VCSS and AVVQ over time (Table 3).
Variation of VCCS and AVVQ over time.a
VCSS: venous clinical severity score; AVVQ: Aberdeen varicose vein questionnaire.
aContinuous data are presented as the means ± standard deviation; categorical data are given as the counts (interquartile range).
Discussion
The present study demonstrates a comparable recurrence rate of MOCA versus OS for the treatment of SSV incompetency at 18 months follow-up. The recurrence rate after SSV surgery has been reported to range from 8.6% to 30%, with better results for concomitant SPJ ligation and SSV stripping.7,12,13 In addition, follow-up data at more than one year after MOCA of the SSV are lacking,9,10,14,15 and our results go further than 18 months. Although multiple prospective trials over the last two decades compare MOCA to other endovenous procedures, and OS is no longer a primary choice in many centers, SSV ligation and stripping is not a completely abandoned procedure. Therefore, the present comparison between OS and non-thermal ablation, which has never been reported before in SSV insufficiency, demonstrated that MOCA and OS are both safe and effective techniques at 18-months follow-up.
Over the last decades, less invasive methods, such as thermal ablation and chemical ablation, have been developed and improved as an alternative to an open surgical approach to treat great and SSV incompetence. Randomized trials demonstrated that MOCA offers fewer major complications like DVT, nerve injury, and skin burns but higher reflux and recurrence of the saphenous vein after six months follow-up than thermal ablation.15 Although these potential benefits have been demonstrated between endovenous techniques to treat saphenous vein insufficiency, according to the most recent guidelines, SSV treatment remains an area lacking evidence concerning the best treatment selection. 16
In the present analysis, patients from both groups presented 100% of technical success and low rates of postoperative complications during follow-up. In previous studies, one of the major benefits of MOCA reported is the pain intensity reduction during the procedure compared with thermal ablations.15,17,18 In our study, intraoperative pain could not be evaluated in the OS group because all procedures were performed under regional or general anesthesia, and no comparison could be made between groups. However, our findings confirmed that MOCA is painless on the first postoperative day compared to OS and has a significantly lower procedural time, explaining the shorter time to return to work (MOCA 3.5 ± 2.3 days vs. OS 14.2 ± 3.8 days, p < .0001).
The main concern of OS over endovenous techniques is the risk of neurological damage to the tibial and sural nerve. In the present study, two cases (3.2%) of neurological symptoms were observed in the OS group, whereas no cases were observed in the MOCA group. In a recent meta-analysis, Boersma et al. reported 19.6% of paresthesia after SSV surgery, higher than our data. The reasons for the lower incidence of neurological symptoms in the present study could be the preoperative DUS mapping of the SPJ, which is proven an accurate method for SPJ identification leading to a reduction of the surgical exposure,19,20 and the use of invagination stripping, which is associate with lower incidence of postoperative neuralgias. 21
Although the MOCA technique presented several benefits compared to OS, we cannot wholly exclude traditional surgery to treat symptomatic SSV insufficiency. Anatomical features can be a limit and make endovenous techniques unfeasible. Deijen et al. reported that MOCA could not be performed in 12 cases in a total of 449 patients due to small vein diameter, the presence of kinking or thrombosed vein segment, which hinders puncture, and catheterization. Accordingly, Mirandola et al., 22 in a multicenter study, reported a technical success of MOCA of 99.5%. In two cases, the procedure was not concluded due to venous lumen damage and difficulty in sclerosant infusion. The authors suggest that the great spasm of the saphenous vein obstructed the injection of the sclerosant.
Limitations
This study is limited by the observational and retrospective fashion. The treatment technique, follow-up appointments, and DUS assessment were not blinded, which limit the study. The small sample size and the lack of long-term outcomes are also limitations. Moreover, the choice of the technique was at the operator's discretion, which might have influenced the overall technical success. Another limitation regards the technical aspect of the procedures: MOCA was used to treat the SSV from the SPJ to the lowest point of incompetence, while the SSV stripping was always performed from the SPJ to the lateral malleolus. The partial SSV sparing during MOCA and the complete SSV stripping might play a role in the study outcomes. Although the pain VAS scale in the first postoperative day demonstrated a significant reduction in favor of the MOCA technique, this analysis was not done in a double-blind fashion, which could be associated with a risk of measurement bias.
Conclusion
Both MOCA and OS are effective and safe for the treatment of symptomatic SSV insufficiency with a survival rate free from recurrence greater than 90% at the 18-month follow-up. Even though the QoL improvement was similar between groups, short term benefits (less pain at the first postoperative day and earlier return to work) and no cases of neurological complications favor MOCA. Long-term and randomized trials are warranted to confirm our results.
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.
Informed consent
Informed consent was obtained from all individual participants included in the study. Consent for publication was obtained for every individual person's data included in the study.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Guarantor
DB.
Contributorship
LA, VB, VA, NF, CS, RC, DB researched literature and conceived the study. LA, VA, and NF were involved in protocol development, gaining ethical approval, patient recruitment, and data analysis. DB, LA, VA, and VB wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
