Segmental saphenous ablation for chronic venous disease treatment

Abstract

Background

Endovenous thermal ablation for chronic venous disease treatment is recommended over traditional surgery. The present investigation compares endovenous laser ablation (EVLA) with radiofrequency (RF) for segmental endovenous sapheno–femoral junction ablation.

Methods

This is a retrospective study in which 79 patients underwent a 6 cm great saphenous vein ablation by RF or by EVLA.

Primary outcome was occlusion rate. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score, peri-procedural pain, aesthetic satisfaction.

Results

At 12 ± 1 months recanalization of shrunk tract was recorded in 5/85 (5.8%) cases (2 RF, 3 EVLA) [OR: 1.6; 95%CI: 0.2–10.4; P = 0.6689]. Two cases (1/44 RF group and 1/38 EVLA group) also showed reflux recurrence [OR: 1.0; 95%CI: 0.06–17.8; P = 1.0000]. No significant differences between groups were found in AVVQ, VCSS, peri-procedural pain, or aesthetic satisfaction.

Conclusion

Saphenous sparing is feasible and effective by means of both EVLA and RF, representing a possible alternative to surgery.

Keywords

Varicose veins recurrence saphenous sparing venous ablation

Introduction

According to the international guidelines, great saphenous vein (GSV) incompetence leading to lower limb chronic venous disease (CVD) is optimally managed by endovenous ablation using mini-invasive techniques, rather than surgical stripping.^1–4

Indeed, a recent analysis dedicated to the assessment of similarities and controversies among international recommendations pointed out how the general consensus is to prefer endovenous thermal ablation by radiofrequency (RF) or laser (EVLA) over surgical management, and this recommendation is based upon its minimally invasive nature rather than the varicose veins recurrence rate.⁵

Over the years, technical innovations in endovenous saphenous ablation have advanced but without significant changes in the recurrence rate.^6,7

To the contrary, a 2015 Cochrane analysis reported a significant improvement in CVD recurrence rate following the application of a surgical hemodynamic strategy based on GSV sparing rather than stripping.⁸ Moreover, in 2019, the improved recurrence rate following a saphenous sparing surgical approach was confirmed in the comparison to endovenous ablation.⁹

Our research group published preliminary results showing the feasibility and safety of a segmental endovenous sapheno–femoral junction (SFJ) ablation by EVLA in a saphenous sparing strategy,¹⁰ with a shrinkage of maximum 10 cm length of GSV, starting from just distal to the superficial epigastric vein.

In this way, GSV segment distal to the ablated part remained patent and allows the retrograde draining toward a re-entry perforator located distally on the same GSV^11–14 (Figure 1).

The complete ablative strategy aimed to eliminate all the GSV trunk; both EVLA and RF have demonstrated to be equally effective in occlusion rate (96.7% at 5 years including both devices analysis).¹⁵

The aim of the present study is to assess the rate of reflux recurrence, as well as changes in the Venous Clinical Severity Score (VCSS) and Aberdeen Varicose Vein Questionnaire (AVVQ) following EVLA and RF applying a saphenous-sparing strategy.

Methods

Study design and population

This is a retrospective case-control study analyzing 122 CVD patients who were referred to the University Vascular Center from 2016 to 2018.

Inclusion criteria were:

18–70 years old

C2,3EpAsPr with visible varicose veins.¹⁶

VCSS from 6 to 8

GSV diameter located 15 cm from SFJ had to be ≥4 mm but $\leq$ 9 mm

Terminal Valve incompetence at both distal comparison and Valsalva maneuver

GSV reflux ≥0.5 s

Presence of at least one re-entry perforator on the GSV, identified by pre-operative reflux elimination test (hemodynamic type I+N3 according to CHIVA classification).¹¹

Exclusion criteria were:

Pregnancy and lactation

Deep venous insufficiency

Patients requiring pharmacological thromboprophylaxis

Pelvic venous reflux

Use of hormonal therapy

Previous varicose vein treatments

History of deep venous thrombosis

Diabetes

Neurological, muscular, or orthopedic disorders.

Forty-three (43) patients dropped out from the study: 36 presented no re-entry perforator on the GSV, 3 had a thrombosis history, 1 had diabetes, and 3 underwent sclerotherapy previously.

Seventy-nine (79) patients (mean age 55 ± 10; 30/49 M/F; BMI 23 ± 3) met the study criteria.

GSV caliber at 15 cm from the SFJ, and related hemodynamics were reported in Table 1.

Table 1.

Patient population demographics, clinical and ultrasonographics characteristics at baseline.

	RF group (41)	EVLA group (38)	p	Whole group (79)
M/F	16/25	14/24		30/49
Bilateral n° out of total	3/41	2/38		5/79
Age mean ± st.dev	56 ± 10	54 ± 10	0.3549	55 ± 10
BMI	25 ± 3	24 ± 2	0.4400	24 ± 3
CEAP	C3	C3		C3
VCSS	6.9 ± 0.8	7.0 ± 0.9	0.4242	6.9 ± 0.8
AVVQ	18.0 ± 4.1	17.4 ± 4.6	0.4880	17.7 ± 4.3
GSV Ø mm_{15 cm SFJ} mean ± st.dev (min–max)	5.8 ± 1.1(4–7.8)	5.6 ± 0.9(4–7.6)	0.3636	5.7 ± 1.1(4–7.8)
Reflux time (s) mean ± st.dev (min–max)	3.5 ± 0.6(2.4–5.0)	3.7 ± 0.7(2.3–5.4)	0.3409	3.6 ± 0.6(2.3–5.4)

AVVQ: Aberdeen Varicose Vein Questionnaire; BMI: body mass index; EVLA: endovenous laser ablation; GSV: great saphenous vein; RF: radiofrequency; VCSS: Venous Clinical Severity Score; SFJ: sapheno–femoral junction; CEAP: Clinical-Etiology-Anatomy-Pathophysiology.

Six patients were treated bilaterally and 73 patients unilaterally, for a total of 85 legs that underwent the procedure.

All the patients signed the intervention informed consent including the permission to the anonymous use of their data for future studies.

Procedure technical notes

All patients underwent a 6 cm GSV ablation distal to the superficial epigastric vein confluence.

Forty-four (44) legs of 41 patients were operated on by RF (ClosureFAST™, Medtronic) and 41 legs of 38 patients by 1470 nm EVLA (LASEmaR 1500®, Eufoton).

Both groups were operated on under local anesthesia: lidocaine 1% (1 cc) at the introducer introduction site and tumescent solution (Klein solution, 4°C, 80 cc).

EVLA group was treated by emission of 80 J/cm (6 W, 1 mm/s constant pullback).

RF group was treated by 2 cycles/3 cm at 120°C with segmental pullback.

During the same procedure, under local anesthesia (Lidocaine 1%: 1 cc), a flush ligation of incompetent GSV tributaries along the leg was performed (Figure 1).

The average number and location of saphenous incompetent tributaries per leg are reported in Table 2.

Table 2.

Number and location of saphenous incompetent tributaries.

	RF group (41)	EVLA group (38)	Whole group (79)
One tributary above knee n° (%)	9/41 (22.0%)	8/38 (21.0%)	17/79 (21.5%)
One tributary below knee n° (%)	19/41 (46.3%)	17/38 (44.7%)	36/79 (45.6%)
One tributary above and one below knee n° (%)	10/41 (24.4%)	11/38 (29.0%)	21/79 (26.6%)
Two tributary above knee n° (%)	3/41 (7.3%)	2/38 (5.3%)	5/79 (6.3%)

EVLA: endovenous laser ablation; RF: radiofrequency.

All the procedures were performed by the same experienced surgeon (SG) in an office-based setting with discharge after 1 h from the procedure.

Post-operative thigh-high graduated compression (23–32 mmHg) was used in all the patients. Patients were instructed to wear it 24 h for 3 days then only during daytime for 3 weeks.

Clinical and ultrasonographic assessment

All pre-operative and 1 year follow-up clinical and sonographic assessments were performed by the same experienced assessor (EM).

The primary outcome was the occlusion rate at 1 year follow-up measured by ultrasound:

Absence of flow and non-compressible GSV along 6 cm from epigastric vein confluence and distally

GSV diameter and flow at 15 cm from SFJ.

Secondary outcomes were the objective and subjective clinical success assessed by VCSS and disease-specific quality of life AVVQ.

Peri-procedural pain was scored from 0 (no pain) to 10 (most painful experience ever) by the patient.

Procedural time in minutes, including both endovenous and surgical ligation of the GSV tributaries, was collected by the surgical team and reported on the medical reports.

At 1-year follow-up, the patients were invited to score their aesthetics satisfaction in a range from 0 (no change) to 10 (100% aesthetic discomfort disappearance).

Statistical analysis

GraphPad Prism Version 8.2.1 (GraphPad Software 2365 Northside Dr. Suite 560 San Diego, CA, USA) was used for statistical analysis. The data were expressed as mean ± standard deviation. Kolmogorov–Smirnov test was used to assess the data distribution.

The differences between pre- and post-procedural GSV diameter, VCSS, AVVQ were calculated using two-tailed Student’s t-test for paired data, Wilcoxon Signed-Ranks Test when appropriate. The differences between EVLA and RF post-procedural % GSV diameter reduction, post-procedural VCSS and AVVQ, peri-procedural pain and procedural time, aesthetic satisfaction were assessed by two-tailed Student’s t-test for unpaired data and Mann–Whitney test when appropriate.

The two-tailed Fisher’s exact test followed by odds ratios (ORs) and 95% confidence intervals (CIs) and Kaplan–Meier survival curve were used to report the reflux recurrence and the AVVQ and VCSS changes. Statistical significance was defined as P < 0.05.

Results

Objective ultrasonographic and clinical outcomes

At 12 ± 1 months mean follow-up, the occlusion of treated tract was 80/85 legs (94.2%); 42/44 (95.5%) in RF group and 38/41 legs (92.7%) in EVLA group.

Recanalization was recorded in 5/85 cases (5.8%) of which 2/44 legs (4.5%) (caliber at 15 cm from the groin: 4.0 mm, 4.5 mm) were in RF group and 3/41 legs (7.3%) (caliber at 15 cm from the groin: 4.1 mm, 4.6 mm, 5.2 mm) were in EVLA group [OR: 1.6; 95%CI: 0.2–10.4; P = 0.6689] (Figure 2). Moreover Of those recanalized, 2 (1 in the RF group, with GSV caliber 15 cm from the groin, 4.5 mm; and 1 in the EVLA group with GSV caliber 15 cm from the groin, 5.2 mm) also showed reflux recurrence [OR:1.0; 95%CI: 0.06–17.8; P = 1.0000].

A physiological drainage from the saphenous trunk toward the femoral vein was present in the recanalized (without reflux) cases. In the two reflux recurrences cases, the SFJ also presented incompetence. The saphenous segment distal to the treated tract presented a physiological drainage toward the re-entry perforator.

Mean post-operative GSV diameter 15 cm distal to the groin was 3.4 ± 0.5 mm.

A significant GSV diameter reduction was found after the RF (from 5.8 ± 1.1 mm to 3.5 ± 0.5 mm, P < 0.0001) and EVLA (from 5.6 ± 0.9 mm to 3.4 ± 0.6 mm, P<0.00001). No significant differences in the % GVS diameter reduction was recorded between the two procedures (RF: –38.5% ± –12.9%, EVLA: –37.2% ± –13.2%; P = 0.6355).

Figure 3 demonstrates the hemodynamic pathways in both recanalized refluxing and in non-recanalized situations.

No venous thrombosis, including of the SFJ and GSV, was detected with the follow-up ultrasound.

AVVQ improved from 18.0 ± 4.1 to 4.7 ± 3.0 in the RF group (P<0.00001) and from 17.4 ± 4.6 to 3.9 ± 2.0 in the EVLA group (P<0.00001).

VCSS improved from 6.9 ± 0.8 to 2.0 ± 1.5 in the RF group (P<0.00001) and from 7.0 ± 0.9 to 2.6 ± 1.6 in the EVLA group (P<0.00001).

No significant difference was found between the RF and EVLA groups according to AVVQ (P = 0.1405) and VCSS (P = 0.1239) post-operatively.

Pain, aesthetic satisfaction, procedural time, and complications

Patients reported peri-procedural pain score of 1.9 ± 0.9 in the RF and 2.2 ± 1.1 in the EVLA group (P = 0.1864).

Patients Aesthetic satisfaction score was 8.4 ± 1.0 in RF group and 8.3 ± 1.2 in EVLA group (P = 0.7758).

The average time of the EVLA procedure was 22 ± 3 min versus 24 ± 3 min of the RF procedure (P = 0.0825).

Neither major nor minor complications were reported, including paresthesia, deep and superficial venous thrombosis, skin burn and infection.

Discussion

Applying the principle of saphenous sparing, the present investigation demonstrates the feasibility and safety of segmental SFJ GSV ablation by RF or EVLA without significant difference between the two devices in occlusion rate, procedural time, peri-procedural pain, improvement in VCSS and AVVQ.

The 1 year occlusion rate of the herein described segmental treatment using the saphenous sparing approach is in line with the traditional endovenous ablative outcomes.⁶

In contrast to the previously demonstrated reduced reflux recurrence rate following a surgical saphenous sparing versus ablative approach,⁸ at 12 ± 1 months follow–up, the present investigation did not show a drop of reflux recurrence compared to the outcomes reported by endovenous ablation.⁶

This finding is in accordance with the outcome that up to 3 years follow-up there is no significant difference in recurrence rate between saphenous sparing and ablative procedure, while at 5 and 10 years follow-up, a significantly higher recurrence rate was detected in the ablative group.^17,18

Further investigation involving a randomized comparative investigation is needed to confirm the differences previously reported by the Cochrane analysis between ablative and saphenous sparing surgery.⁸

Moreover, the recurrence defined as GSV recanalization must be distinguished from the reflux reappearance: a phenomenon detected in only 2.4% of the study population, thus making the procedure competitive compared to the traditional ablative strategy.

The present study confirms the possibility of restoring a normal GSV caliber by suppressing the pressure gradient that feeds the reflux: an observation already published following surgical saphenous sparing approaches.^19,20

The study population encompassed a maximum GSV caliber of 7.8 mm at 15 cm from the groin: future investigations should assess the saphenous sparing procedures in larger diameter GSV.

The investigation included only C3 clinical class CEAP (Clinical-Etiology-Anatomy-Pathophysiology) in order to avoid the potential bias of different disease stages. Future larger data collection should assess the endovenous saphenous sparing procedure performance in other CEAP categories also; C4, 5, and 6 classes.

Limiting the treatment segment to the saphenous arch below the superficial epigastric vein implied further advantage of a faster procedure, limiting the amount of tumescence when thermal technique was applied.

A special focus must be dedicated to the patient hemodynamic assessment. Indeed, a proper re-entry perforator vein must be identified before one is subjected to a surgical or endovenous saphenous sparing procedure.

In order to determine if the re-entry perforator is draining properly, a pre-operative reflux elimination maneuver must be performed: it consists of the occlusion of incompetent tributaries along the GSV by digital compression. If flow is still detected on the GSV above the highest digitally closed tributary, then a re-entry perforator can be expected along the same GSV and considered responsible for the pressure gradient resulting in the detected flow.¹¹

In the absence of a normal perforator vein allowing drainage from the spared GSV trunk into the deep venous system, it creates stasis and consequent saphenous thrombosis.

Careful pre-operative planning of procedures which allow untreated GSV segments to drain to the deep system with re-entry perforators avoids thrombosis of these segments.

As per the surgical saphenous sparing strategy, ultrasound knowledge for proper hemodynamic assessment and indication to procedure is mandatory. This has significant clinical implications as Milone et al. demonstrated the importance of the health professional experience in saphenous sparing strategy on a successful procedural outcome.²¹

Graduated compression was prescribed at 23–32 mmHg post-operatively 24 h/day for 3 days, and then transitioned to only daytime wear for 3 weeks. The dose and timing of post-operative compression is extremely variable in the different international recommendations, ranging from 16 up to 40 mmHg, from 24 h to 3 weeks.⁵

Future investigations should explore in depth the need of a specific dose and time for the saphenous sparing versus the ablative procedure, in addition to considering previous evidence suggesting no benefit of prolonged compression after saphenous-sparing procedures.²²

Further research should address optimizing the energy setting for saphenous-sparing endovenous procedures, as already reported for traditional ablative endovenous strategy.²³

In conclusion, the present paper demonstrates the possibility of performing a saphenous sparing approach by mini-invasive endovenous thermal techniques, with no significant difference in hemodynamical and clinical outcomes between RF and EVLA. This result paves the way for a customized endovenous hemodynamic treatment, currently amendable only by surgery. Up to now, this study is the only available analysis comparing RF and EVLA via saphenous sparing segmental treatment. The main limitations of the study are its retrospective design, the short-term follow-up, the focus on CEAP clinical class C3, and lack of assessment of recurrence of varices.

Another limitation is focusing on the rate of reflux recurrence rather than on a patient meaningful endpoint and not being able to correlate the rate of reflux recurrence with the incidence of subsequent clinical recurrence.

Future investigations should include a precise assessment of the superficial epigastric vein distance from the SFJ, in order to standardize the starting point of the shrinkage. Further prospective study should include a precise assessment of the average energy delivery and its eventual role in the recurrence rate. Long-term follow-up is needed to establish the procedural performance, in particular comparing the various endovenous ablative options. Research on this topic may provide additional insights into mini-invasive technologies using the saphenous sparing principle and the related clinical and sonographic recurrence rate.

Footnotes

Acknowledgements

This scientific work was selected as free abstract oral presentation at the 2019 American Venous Forum Annual Meeting.

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.

Ethical Aproval

Retrospective study of current clinical practice where specific ethical approval was not necessary.

Guarantor

SG.

Contributorship

SG: conceived and designed the study, researched literature, data analysis, wrote the manuscript and prepared table/figures. EM: manuscript preparation, data analysis and table/figure creations.SO: data collection, critical revision of the manuscript. MG: data collection. MM: data collection. PZ: data analysis, critical revision of the manuscript.All authors reviewed and edited the manuscript and approved the final version of the manuscript.

ORCID iD

Sergio Gianesini

References

Gloviczki

Comerota

Dalsing

, American Venous Forumet al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011; 53: 2S–48S.

National Clinical Guideline Centre (UK). Varicose veins in the legs: The diagnosis and management of varicose veins. London: National Institute for Health and Care Excellence (UK), 2013 (NICE Clinical Guidelines, No. 168), https://www.nice.org.uk/guidance/cg168/evidence/full-guideline-pdf-191485261.

Pavlović

Schuller-Petrović

Pichot

, et al. Guidelines of the First International Consensus Conference on endovenous thermal ablation for varicose vein disease–ETAV Consensus Meeting 2012. Phlebology 2015; 30: 257–273.

Wittens

Davies

Bækgaard

, et al. Editors choice – management of chronic venous disease. Eur J Vasc Endovasc Surg 2015; 49: 678–737.

Gianesini

Obi

Onida

, et al. Global guidelines trends and controversies in lower limb venous and lymphatic disease: narrative literature revision and experts’ opinions following the vWINter international meeting in Phlebology, Lymphology & Aesthetics, 23-25 January 2019. Phlebology 2019; 34: 4–66.

Kürşat Bozkurt

Lawaetz

Danielsson

, et al. European College of Phlebology guideline for truncal ablation. Phlebology 2020; 35: 73–83.

Proebstle

van den Bos

Endovenous ablation of refluxing saphenous and perforating veins. Vasa 2017; 46: 159–166.

Bellmunt-Montoya

Escribano

Dilme

, et al. CHIVA method for the treatment of chronic venous insufficiency. Cochrane Database Syst Rev 2015; 29: CD009648.

Guo

Huang

Zhao

, et al. Long-term efficacy of different procedures for treatment of varicose veins: a network meta-analysis. Medicine 2019; 98: e14495.

10.

Gianesini

Menegatti

Zuolo

, et al. Laser-assisted strategy for reflux abolition in a modified CHIVA approach. Veins and Lymphatics 2015; 4. https://doi.org/10.4081/vl.2015.5246

11.

Gianesini

Occhionorelli

Menegatti

, et al. CHIVA strategy in chronic venous disease treatment: instructions for users. Phlebology 2015; 30: 157–171.

12.

Faccini

Ermini

Franceschi

CHIVA to treat saphenous vein insufficiency in chronic venous disease: characteristics and results. J Vasc Bras 2019; 18: e20180099.

13.

Franceschi

Cappelli

Ermini

, et al. CHIVA: hemodynamic concept, strategy and results. Int Angiol 2016; 35: 8–30.

14.

Zamboni

Marcellino

Cappelli

, et al. Saphenous vein sparing surgery: principles, techniques and results. J Cardiovasc Surg 1998; 39: 151–162.

15.

Lawson

Gauw

van Vlijmen

, et al. Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radiofrequency-powered segmental ablation or 1470-nm endovenous laser ablation with radial-tip fibers (Varico 2 study). J Vasc Surg Venous Lymphat Disord 2018; 6: 31–40.

16.

Lurie

Passman

Meisner

, et al. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord 2020; 8: 342–352.

17.

Parés

Juan

Tellez

, et al. Varicose vein surgery: stripping versus the CHIVA method: a randomized controlled trial. Ann Surg 2010; 251: 624–631.

18.

Carandina

Mari

De Palma

, et al. Varicose vein stripping vs haemodynamic correction (CHIVA): a long term randomised trial. Eur J Vasc Endovasc Surg 2008; 35: 230–237.

19.

Pittaluga

Chastanet

Locret

, et al. The effect of isolated phlebectomy on reflux and diameter of the great saphenous vein: a prospective study. Eur J Vasc Endovasc Surg 2010; 40: 122–128.

20.

Mendoza

Berger

Zollmann

, et al. Diameter-reduction of the great saphenous vein and common femoral vein after CHIVA. Phlebologie 2011; 40: 73–78.

21.

Milone

Salvatore

Maietta

, et al. Recurrent varicose veins of the lower limbs after surgery. Role of surgical technique (stripping vs. CHIVA) and surgeon’s experience. G Chir 2011; 32: 460.

22.

Pittaluga

Chastanet

Value of postoperative compression after mini-invasive surgical treatment of varicose vein. J Vasc Surg Venous Lymphat Disord 2013; 1: 385–391.

23.

Bosanquet

Twine

CP.

The endovenous literature: a perfect storm of limited effectiveness data, rapid technological evolution and potential conflict of interest. Eur J Vasc Endovasc Surg 2017; 54: 771.