|Year : 2022 | Volume
| Issue : 2 | Page : 145-150
Indian venaseal™ Experience study – Outcomes of nonthermal and nontumescent endovenous glue ablation for treatment of truncal reflux in varicose vein disease: An Indian perspective
Rutvij Asitkumar Shah, Varinder S Bedi, Ajay R Yadav, Sandeep Agarwal, Ambarish Satwik, Apurva Srivastava, Nikhil Vilas Chaudhari
Department of Vascular Surgery, Insitute of Vascular and Endovascular Sciences, Sir Ganga Ram Hospital, New Delhi, India
|Date of Submission||22-Oct-2021|
|Date of Decision||03-Jan-2022|
|Date of Acceptance||12-Jan-2022|
|Date of Web Publication||13-Jun-2022|
Rutvij Asitkumar Shah
Department of Vascular Surgery, Insitute of Vascular and Endovascular Sciences, Sir Ganga Ram Hospital, New Delhi
Source of Support: None, Conflict of Interest: None
Background: Varicose veins is a common disease in nearly 37.25% of the Indian population significantly affecting the quality of life. Endovenous thermal ablation has been the first-line treatment for superficial venous reflux. A new technique, available now, is nonthermal nontumescent vein sealing system (VenaSeal™), which comprises endovenous delivery of cyanoacrylate tissue adhesive into the vein causing obliteration of lumen and has shown better results in terms of safety and efficacy. Being a new modality, only handful of institutes across India perform this procedure and there is a scarcity of Indian data on its outcomes. Aims and Objectives: To evaluate the outcomes of VenaSeal™ glue ablation in terms of vein occlusion rates and improvement in Venous Clinical Severity Score (VCSS). Materials and Methods: Single-centre prospective study of fifty patients over 1 year and 4 months with 3- and 6-month follow-up. Results: The study showed the mean age of the study group to be 43.8 years and the majority (90%) had an early varicose vein (C2/C3) disease. The average length of vein treated per limb was 89.1 cm, and the average glue used per limb was 2.95 ml. All patients showed improvement in VCSS score from preoperative average of 2.6 ± 1.4 to 0.32 ± 0.19 (P < 0.0001, n = 89) with target vein occlusion rate of 100% at 3 months and 97.75% at 6 months. Conclusion: Thus, VenaSeal™ glue ablation procedure is a promising and effective modality for the treatment of varicose veins with excellent treatment success rates, minimal complications, and maximum patient acceptability. It is a feasible Out patient department (OPD) based procedure.
Keywords: Chronic venous insufficiency, Indian experience, N-butyl-cyanoacrylate glue, nonthermal nontumescent endovenous glue ablation, OPD procedure, varicose veins, VenaSeal™
|How to cite this article:|
Shah RA, Bedi VS, Yadav AR, Agarwal S, Satwik A, Srivastava A, Chaudhari NV. Indian venaseal™ Experience study – Outcomes of nonthermal and nontumescent endovenous glue ablation for treatment of truncal reflux in varicose vein disease: An Indian perspective. Indian J Vasc Endovasc Surg 2022;9:145-50
|How to cite this URL:|
Shah RA, Bedi VS, Yadav AR, Agarwal S, Satwik A, Srivastava A, Chaudhari NV. Indian venaseal™ Experience study – Outcomes of nonthermal and nontumescent endovenous glue ablation for treatment of truncal reflux in varicose vein disease: An Indian perspective. Indian J Vasc Endovasc Surg [serial online] 2022 [cited 2022 Jun 26];9:145-50. Available from: https://www.indjvascsurg.org/text.asp?2022/9/2/145/347249
| Introduction|| |
Varicose vein disease, characterized by tortuous, dilated, and visible veins in the lower extremities, is a common disease affecting the quality of life in nearly 37.25% of the Indian population., Endovenous thermal ablation was the first line of treatment for superficial venous reflux. A new technique, now available, is nonthermal nontumescent vein sealing system (VenaSeal™), which comprises the endovenous delivery of cyanoacrylate tissue adhesive into the vein causing obliteration of lumen and is showing better results in terms of safety and efficacy. The use of this minimally invasive nontumescent modality is limited to handful of institutes across the nation and a huge paucity in the literature regarding its outcomes in the Indian population [Figure 1].
The aim of this study was to evaluate the outcomes of VenaSeal™ endovenous glue ablation for truncal reflux in varicose veins of Indian patients.
To evaluate outcomes of VenaSeal™ glue ablation in terms of
- Treatment success (vein occlusion rate)
- Improvement in the Venous Clinical Severity Score (VCSS).
To analyze merits and demerits of VenaSeal™ glue ablation in terms of
- Postprocedure complications
- Patient acceptability.
| Subjects and Methods|| |
The study is a single-center observational prospective cohort study performed over a period of 1 year and 4 months from November 2019 to February 2021 comprising 50 patients and 89 limbs.
- Age ≥21 years and ≤70 years of age at the time of the procedure
- Reflux in the great/short saphenous/anterior accessory saphenous vein (GSV/SSV/AASV) >0.5 s
- One or more of the following symptoms related to the target vein: Visible dilated veins, pain, swelling, heaviness, pruritis, night cramps, skin changes, and ulceration
- Clinical, Etiology, Assessment, and Pathophysiology (CEAP) classification of C2 to C6
- Patient choosing VenaSeal™ nonthermal nontumescent endovenous glue ablation after understanding advantages and disadvantages of various available modalities of endovenous ablation
- Acceptability to attend follow-up visits.
- Symptomatic peripheral arterial disease with ankle-brachial index <0.8
- Tortuous target vein course
- Diameter of the target vein >20 mm (at any segment along the vein)
- Known sensitivity to cyanoacrylate adhesives
- Patient lost to follow-up.
All patients were enrolled in the study as per the inclusion and exclusion criteria. All patients underwent a preoperative clinical and duplex assessment, and findings were documented. Preoperative marking of blowouts was done in the standing position on the day of the intervention. All patients underwent the intervention in the supine position under general anesthesia or regional anesthesia (femoral and sciatic block) [Figure 2]. Adjuvant procedures for the treatment of varicose vein disease were carried out in the same setting as per the need. All patients were treated in a daycare setting. All patients were given a postprocedure compression dressing and switched over to compression stockings from the 3rd day.
Three- and 6-month follow-up was done for all the patients and was evaluated by clinical and duplex examination to document the improvement in VCSS and vein occlusion, respectively, which have been defined below.
The data were analyzed with paired t-test using the SPSS (2021) software (Statistical Product and Service Solutions - IBM, Armonk, New York).
Treatment success was measured in terms of the treated vein occlusion/obliteration as observed on duplex examination.
Treatment success was defined as complete occlusion of treated vein or nonocclusion/recanalization of <5 cm of the treated vein.
Subtotal recanalization was defined as nonocclusion/recanalization of 5–10 cm of the treated vein.
Treatment failure was defined as nonocclusion/recanalization of more than 10 cm of the treated vein.
The clinical evaluation was performed and documented as per the standard VCSS and CEAP classification as described below.
VCSS includes the hallmarks of venous disease, each scored on a severity scale from 0 to 3. These include skin changes and pigmentation, inflammation and induration, and ulcers (including number, size, and duration). The current version of the VCSS contains a category for compression, with higher scores representing greater compliance [Table 1].
CEAP classification is a standardized descriptive classification of chronic venous insufficiency in terms of clinical, etiological, anatomical, and pathophysiological criteria.
C0: No visible or palpable signs
C1: Telangiectasias (veins less than <1 mm) and reticular veins (1–3 mm in diameter)
C2: Varicose veins (>3 mm)
C2r – recurrent varicose veins (>3 mm)
C4: Secondary skin alterations
C4a: Pigmentation, eczema, or both
C4b: Lipodermatosclerosis, white atrophy, or both
C4c: Corona phlebectatica
•C5: Healed ulcer
•C6: Open ulcer (often in the ankle area)
C6r – Recurrent open ulcer.
The C classification is completed with the presence or absence of symptoms (pain, itching, heavy legs, cramps, and others):
Ep: Primary (develops independently of other diseases)
Ec: Congenital (present at birth or developing in infancy)
Es: Secondary, if it appears as a consequence of another disorder, such as trauma or thrombosis (postthrombotic syndrome)
En: Absence of identified venous etiology.
A (Anatomical): The venous system consists of a superficial venous system and a deep venous system.
AS: Superficial venous system
AD: Deep venous system (D = Deep)
Ap: Perforating veins
An: Unidentified anatomical location.
P (Pathophysiology): Indicates the presence of venous reflux or obstruction.
PR, O: Reflux/obstruction
Pn: Unidentified venous pathophysiology.
| Results|| |
A total of fifty patients (89 limbs) were studied over a period of 18 months with a 3- and 6-month follow-up.
The demographics and average age of the patients are given in the table [Table 2] and [Table 3].
The average age of the study group was 43.8 years.
The preoperative clinical staging (CEAP classification) of the fifty patients is described in the table [Table 4].
|Table 4: Preoperative clinical, etiology, assessment, and pathophysiology staging|
Click here to view
A total of 90% of patients (45 out of 50) were either C2 or C3.
Duplex examination was performed for each patient. On clinical examination confirmed by duplex scan, 78% of patients (39 of 50) had bilateral disease.
Of the total 89 limbs, the most common pathology was saphenofemoral junction (SFJ) incompetence noted in 97.75% (87 of 89 limbs). Fifty-six limbs showed saphenopopliteal junction (SPJ) incompetence along with SFJ incompetence and two limbs showed isolated SPJ incompetence alone [Table 5].
19.1% (17 out of 89 limbs) had anterior accessory saphenous vein showing reflux from incompetent SFJ and 98.88% (88 out of 89 limbs) showed concomitant perforators incompetence along with the truncal reflux.
The average preoperative diameter of great saphenous vein was 6.19 ± 1.8 mm. Maximum diameter of great saphenous vein was 12.3 mm and minimum was 3 mm.
The average length of vein treated per limb was 89.1 ± 21.1 cm, where the average length of great saphenous vein was 72.3 ± 17.5 cm, and the average length of SSV was 16.8 ± 3.7 cm.
Furthermore, 19.1% showed a refluxing anterior accessory vein which showed an average length of 17.5 ± 4.4 cm.
The average quantity of VenaSeal™ glue used was 2.95 ± 0.42 ml per limb. The mean glue utilized was calculated by dividing the average vein length treated per limb to total amount of glue used in the study population.
There were eight patients with bilateral saphenofemoral and saphenopopliteal incompetence where more than 5 ml of glue was needed and two VenaSeal™ kits were used. Out of those eight patients, three had a GSV diameter of more than 10 mm and five had a refluxing anterior accessory vein.
On the preoperative clinical examination, the average VCSS was 2.6 ± 1.4 [Graph 1].
All patients (100%) showed improvement in the VCSS score with average VCSS at 6 months of 0.32 ± 0.19 [Graph 2].
The average decrease in the VCSS score was 2.28 ± 0.42 with 95% confidence interval of 2.06–2.55. P value was statistically significant of <0.0001.
Follow-up duplex scans of all treated limbs were done which showed vein occlusion rates of 100% (89/89 limbs) at 3 months and 97.75% (87/89 limbs) at 6 months.
Subtotal recanalization was noted in 1.125% (1/89 limbs). This patient was a female patient with preoperative VCSS of 3 with unilateral saphenofemoral incompetence. She underwent adjuvant procedure of sclerotherapy and microphlebectomies. She showed clinical improvement and her VCSS at 6 months was 1.
More than 10-cm recanalization was noted in 1.125% (1/89 limbs). This patient was a male patient with preoperative VCSS of 4 and bilateral saphenofemoral incompetence. He underwent adjuvant procedure of sclerotherapy and microphlebectomies in both limbs. This patient had relief of symptoms initially but developed recurrent symptoms after 4 months with VCSS of 4 at 6 months. At 6-month duplex scan, he showed near-total recanalization of unilateral GSV along its length from junction up to the knee region. The opposite GSV also showed recanalization but was <5 cm and limited at the level of knee joint. However, bilaterally treated SSV showed complete obliteration.
On the evaluation of complications, 2% (1 patient) showed the presence of phlebitis along the GSV and 2% (1 patient) showed allergic reaction of skin at the access site to the cyanoacrylate glue. Both these patients were males with preoperative VCSS of 3 and bilateral SFJ and SPJ incompetence. GSV was accessed at ankle in both patients. Allergic skin reaction was observed intraoperatively in the form of erythema, and phlebitis was diagnosed on postoperative day 3 on follow-up visit. Both these complications were self-limiting and resolved spontaneously with symptomatic treatment. Ninety-six percent (48 patients) showed no complications at 6 months. No patients showed any ecchymosis or venous thromboembolism.
| Discussion|| |
In a first-in-man feasibility study published and presented by Dr. Jose Almeida at the American Venous Forum, 38 patients were treated with VenaSeal™ closure system (VSCS) and followed up to 2 years., Similarly, in the pioneer study of VenaSeal™ in Europe – the eSCOPE study, seventy patients were evaluated and followed up at 6 months, 1 year, and 3 years. The United States pivotal trial, VeClose, was a prospective trial with a 1:1 randomization comparing VSCS to radiofrequency ablation (RFA, ClosureFast™ catheter, Medtronic). This trial was conducted at ten sites with 242 patients, out of which, 108 patients were treated with VSCS and followed up at day 3, 1, 3, and 12 months., In recently published Singaporean ASVS study, 100 patients (151 limbs) were enrolled and followed up at 3 months. In the Korean study, which is a first report of VenaSeal™ outcomes in Korea, data of 38 patients were analyzed at 3 months. We designed our study taking these previous data into consideration and assessed fifty patients (89 limbs) at 3 and 6 months.
When comparing our study with these mentioned studies, variability exists regarding the use of adjuvant procedures along with VSCS. Patients were treated only for GSV reflux in the feasibility, eSCOPE, and VeClose study. No adjunctive measures for treatment of varicose vein disease were permitted in the feasibility study for 6 months, and in VeClose and eSCOPE study for 3 months. The patients in ASVS study were treated with adjuvant treatments of phlebectomies. The patients in our study were treated using adjunctive measures in the same setting as VSCS in the form of foam sclerotherapy and phlebectomies [Figure 3] and [Figure 4].
In ASVS study, out of 100 patients, 32.5% of patients had unilateral SFJ and 63.6% of patients had bilateral SFJ incompetence while in our study, out of 50 patients, 18% patients had unilateral and 78% patients had bilateral SFJ incompetence.
On clinical documentation, the CEAP classification of 55% of patients was C2 or C3 and 45% was C4 to C6 in the ASVS study. In contrast, our study had 90% of patients presenting with C2 or C3 disease and only 10% with C4 to C6.
The primary outcome measure in all of these studies was the vein closure rate. The feasibilty study showed an identical closure rate of 92% at 3 and 6 months. eSCOPE study reported slightly better vein closure rate of 95.8% at 3 months and 94.3% at 6 months. These data were superseded by the VeClose study, which showed a closure rate of 99% at 3 months and 97.2% at 12 months. Corelating our study to these foreign studies, our findings are corresponding to the international data. We observed closure rates of 100% at 3 months and 97.75% at 6 months. The Asian data suggests outcomes only at 3 months, with no follow-up published data available at 6 months. The closure rate was 99.3% in ASVS and 100% in Korean study which is mirroring our closure rate of 100% at 3 months.
Standardized scoring system of VCSS was used by authors of abovementioned studies to evaluate their clinical outcome. On comparing the preoperative VCSS of various studies, feasibility study had maximum (6.1 ± 2.7) and eSCOPE had minimum score (4.3 ± 2.3). Our preoperative, the mean VCSS was 2.6, which is significantly lower than these studies. Six-month VCSS was coinciding for all these studies (ranging from 1 to 1.5); however, our study shows VCSS of 0.32 ± 0.19 at 6 months, which is statistically significant (P < 0.0001) [Table 6].
On the evaluation of complications, all these studies reported a mild and self-limited phlebitis as the most common complication, responding to nonsteroidal analgesia. No thrombotic events were reported in any of them. Our study reported phlebitis in only 2% of the study population. Complication-free survival was noted in 96% of our patients at 6 months.
In a meta-analysis, twenty RCTs comprising 4570 patients treated for symptomatic varicose vein disease were analyzed for anatomic success, VCSS, pain score, and adverse events. VenaSeal™ had the highest probability of being ranked first out of various treatment modalities for treatment success rate, which was the primary outcome measure. VenaSeal™ was ranked first in reduction of postoperative pain score from baseline and was the lowest in occurrence of adverse events. The odds of occurrence of venous thromboembolism with VenaSeal™ were the least among all the interventions.
In summary, our study is comparable to all these studies in terms of study population, VCSS improvement, and closure rates. This study of VenaSeal™ in Indian patients shows an excellent treatment success rate with a better complication-free survival, better patient acceptability, and significant clinical improvement from 0 to 6 months. Moreover, the available literature shows significant paucity in the data of the use, complications, and outcomes of VenaSeal™ in the Asian population. No Indian published data are available till date regarding the outcomes of this newer modality.
| Conclusion|| |
VenaSeal™ glue ablation procedure is a promising and effective modality for the treatment of varicose veins with excellent treatment success rates, minimal complications, and maximum patient acceptability. It is a feasible option under local anesthesia, does not require tumescence, and hence is an efficient Out-patient department based procedure.
The authors would like to thank The entire team of Vascular and Endovascular Sciences, Sir Ganga Ram Hospital, New Delhi.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]