Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins

doi:10.1016/j.jvsv.2020.05.019

Journal of Vascular Surgery: Venous and Lymphatic Disorders

Volume 9, Issue 2, March 2021, Pages 329-334

https://doi.org/10.1016/j.jvsv.2020.05.019 Get rights and content

Abstract

Objective

Cyanoacrylate closure of refluxing saphenous veins has demonstrated excellent safety and effectiveness results in feasibility and pivotal studies. This article provides the 36-month follow-up results of a prospective, multicenter, nonrandomized cohort study.

Methods

A total of 70 patients were enrolled in a prospective, multicenter study conducted at seven centers in four European countries and underwent treatment of a solitary refluxing great saphenous vein with endovenous cyanoacrylate embolization without the use of tumescent anesthesia or postprocedure compression stockings. The primary effectiveness end point was freedom from recanalization (closure rate) of the great saphenous vein at 6 months. Safety was assessed by occurrence of adverse events after the procedure and during the 6-month follow-up period. Quality of life and clinical improvement parameters were measured before and after the procedure and through a 12-month follow-up period. Anatomic success and clinical improvement were assessed through 36 months after the procedure.

Results

Of 70 treated patients, 64 (91%) were available for the 3-year follow-up. The closure rates by Kaplan-Meier life table methods at 6-, 12-, 24-, and 36-month time points were 91.4%, 90.0%, 88.5%, and 88.5%, respectively. Through 36 months, the improvement in change of the mean venous clinical severity score over time was statistically significant by dropping from 4.3 at baseline to 0.9 at the 36-month follow-up (P < .001).

Conclusions

The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued anatomic and clinical effectiveness of cyanoacrylate embolization over an extended follow-up period.

Graphical Abstract

Section snippets

Methods

The European Sapheon Closure System Observational ProspectivE (eSCOPE) study was an international, prospective, single-arm, observational, postmarket cohort study carried out in seven centers that specialize in the diagnosis and treatment of peripheral venous diseases in four European countries. Each site obtained local ethics committee approval before initiation, and all participants signed an ethics committee-approved, study-specific informed consent form before participation.

Patient

Baseline demographics

Between December 2011 and July 2012, 70 patients (55 women and 15 men) with a mean age of 48.4 years (range, 22-72 years) and mean body mass index of 25.7 (range, 18.9-43.3) were enrolled. Each patient had one solitary refluxing GSV; no deep vein reflux was observed in the study leg.

Risk factors included a family history of venous disease (30%, n = 21) and obesity (5.71%, n = 4). Other vascular risk factors included cigarette smoking (12.8%, n = 9), hypertension (7.14%, n = 5), abnormal blood

Discussion

The 3-year clinical follow-up of this eSCOPE study confirmed the continued efficacy of the studied CAC system.

Although 3-year occlusion rates are comparable with other nonthermal nontumescent technologies, when seen in context of more recent studies with this CAC system, this rate seems to be slightly lower, particularly if regarding the fact that recanalization was defined in the present study by a recanalized vein segment of at least 10 cm in length. The available clinical studies with

Conclusions

The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued efficacy of a CAC system over an extended follow-up period. The anatomic and clinical efficacy outcomes corroborate other long-term studies on the same CAC system. The study treatment is a valid option for treatment of refluxing saphenous veins without the use of tumescent local anesthesia and postinterventional use of medical compression stockings.

Author contributions

Conception and design: TP, AD

Analysis and interpretation: TP, JA, SD, LR, MW, JL, AD

Data collection: TP, JA, SD, LR, MW, JL, AD

Writing the article: TP, JA, SD, LR, MW, JL, AD

Critical revision of the article: TP, JA, SD, LR, MW, JL, AD

Final approval of the article: TP, JA, SD, LR, MW, JL, AD

Statistical analysis: Not applicable

Obtained funding: Not applicable

Overall responsibility: TP

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A systematic review on ablation techniques for larger saphenous veins in patients with symptomatic superficial venous disease
2024, Journal of Vascular Surgery: Venous and Lymphatic Disorders
The aim of this study was to summarize the existing evidence for the treatment of saphenous veins >10 mm in diameter, to determine whether there were vein size limits for treatment modalities, and to determine if there are specific technical considerations for treatment of large veins.
We searched the literature for reports of treatment methods and outcomes for patients with large-diameter saphenous veins treated with various ablation methods between 1993 and 2023. These studies were evaluated for the size of the vein determined as “large diameter,” type of ablation method, study type, outcomes, adverse events, and any technical considerations noted. A systematic review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. The COVIDENCE software was used for full-text screening and data extraction. Three reviewers reviewed the data, and the content expert served as the tiebreaker.
Seventy-one records were identified, of which 24 studies were deemed appropriate for extraction. Most of the studies identified reported outcomes of endovenous thermal ablation modalities. There were fewer studies on non-thermal, non-tumescent techniques, and these studies reported an overall lower occlusion rate compared with endovenous thermal ablation techniques.
Large head-to-head trials or randomized controlled that compare all the modalities over a long follow-up duration are yet to be performed. In the existing literature, there is considerable heterogeneity in terms of the study size, design, definition of large veins, site of vein measurement, and follow-up periods, making it challenging to make fair comparisons and draw firm conclusions. Currently available evidence supports the use of endothermal ablation techniques for the treatment of veins >10 mm in diameter as they have a more favorable efficacy and safety profile and have a larger body of evidence available compared with non-thermal, non-tumescent techniques or surgery.
Cyanoacrylate glue reactions: A systematic review, cases, and proposed mechanisms
2023, Journal of Vascular Surgery: Venous and Lymphatic Disorders
Cyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases.
We searched the literature for reports of reactions following cyanoacrylate glue use in patients with venous diseases between 2012 and 2022. The search was performed using MeSH (medical subject headings) terms. The terms included cyanoacrylate, venous insufficiency, chronic venous disorder, varicose veins, vein varicosities, venous ulcer, venous wound, CEAP (clinical, etiologic, anatomic, pathophysiologic), vein, adverse events, phlebitis, hypersensitivity, foreign body granuloma, giant cell, endovenous glue-induced thrombosis, and allergy. The search was limited to the literature reported in English. These studies were evaluated for the type of product used and the reactions noted. A systematic review, in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) method, was performed. Covidence software (Melbourne, VC, Australia) was used for full-text screening and data extraction. Two reviewers reviewed the data, and the content expert served as the tiebreaker.
We identified 102, of which, 37 reported on cyanoacrylate use other than in the context of chronic venous diseases and were excluded. Fifty-five reports were determined appropriate for data extraction. The adverse reactions to cyanoacrylate glue were phlebitis, hypersensitivity, foreign body granuloma, and endovenous glue-induced thrombosis.
Although cyanoacrylate glue closure for venous reflux is generally a safe and clinically effective treatment choice for patients with symptomatic chronic venous disease and axial reflux, some adverse events could be specific to the properties of the cyanoacrylate product. We propose mechanisms for how such reactions can occur based on histologic changes, published reports, and case examples; however, further exploration is necessary to confirm these theories.
The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology
2023, Journal of Vascular Surgery: Venous and Lymphatic Disorders
Citation Excerpt :
Nonthermal ablations include UGFS with physician-compounded foam using the Tessari technique98,99 or the use of PEM (Varithena).100 Other nonthermal ablation techniques include CAC12,90,91 using the VenaSeal system (Medtronic) or the Turkish glue kit (VariClose Vein Sealing System; Biolas) and mechanicochemical ablation, such as the MOCA procedure.94-97 All nonthermal ablations can be performed without the need for tumescent anesthesia.
The Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society collaborated to update the 2011 Society for Vascular Surgery/American Venous Forum clinical practice guidelines and provide new evidence-based recommendations on critical issues affecting the care of patients with varicose veins. Each recommendation is based on a recent, independent systematic review and meta-analysis of the diagnostic tests and treatments options for patients with lower extremity varicose veins. Part I of the guidelines includes evidence-based recommendations for the evaluation of patients with CEAP (Clinical Class, Etiology, Anatomy, Pathology) class 2 varicose vein using duplex ultrasound scanning and other diagnostic tests, open surgical treatment (ligation and stripping) vs endovenous ablation techniques, thermal vs nonthermal ablation of the superficial truncal veins, and management of incompetent perforating veins in CEAP class 2 disease. We have also made recommendations on the concomitant vs staged treatment of varicose tributaries using phlebectomy or liquid or foam sclerotherapy (with physician-compounded foam or commercially prepared polidocanol endovenous microfoam) for patients undergoing ablation of incompetent superficial truncal veins.
Biomedical adhesives: Qualification, specification, quality control, and risk mitigation
2023, Advances in Structural Adhesive Bonding, Second Edition
Adhesives as a fixing method in medical applications have been around since ancient times. Nowadays, biomedical adhesives play an important role in the medical field. Over the past few decades, the use of adhesives in a wide range of applications has been increasing. Among the clinical applications of adhesives, it is important to highlight wound healing, cosmetic and plastic surgeries, vascular surgery, dental adhesion, and orthopedics. Another important field of application has been the medical devices industry. Adhesives play an important role in the assembly of these devices, including surgical instruments, endoscopes, catheters, needles, drug delivery, pacemakers, imaging equipment, etc. Using adhesives in these applications requires them to meet certain characteristics. These necessary features are focused on biocompatibility, high bond strength, and fast curing to minimize surgical time in clinical applications or the production time in device manufacturing application. In addition, they should be sterilizable and easily stored in terms of ambient condition storage.
There are numerous adhesive technologies available for medical purposes. This variety of adhesives allows selecting the most suitable adhesive for a specific application that best meets the required needs and characteristics. Available adhesive types are classified into synthetic and biological. The first usually comes from other areas of industrial applications, and their bond strength tends to be high. However, because of their synthetic nature, the main challenge is their biocompatibility and biodegradability. Synthetic adhesives include cyanoacrylates, acrylates, epoxies, urethanes, etc. Natural or biological adhesives have also been the subject of increasing interest. Biological adhesives are lower in strength, but offer high biocompatibility and biodegradability. They are usually used in tissue-bonding applications, therefore a typical challenge to meet is adhesion to wet tissues. Finally, common for any type of material used in biomedical applications is that the standards for biocompatibility require special attention to satisfy strict regulatory requirements of the US Food and Drug Administration and the European Union European Medicines Agency.
Changes of stump length depending on starting position of glue injection related to venous diameter during cyanoacrylate closure for incompetent saphenous veins
2022, Journal of Vascular Surgery: Venous and Lymphatic Disorders
Citation Excerpt :
Therefore, the stump length should be kept as short as possible. The initial position of the catheter tip for glue injection was 5 cm distal to the junction in other studies.13-15 There have been a variety of reported stump lengths between different published trials.
A common pattern of recurrence after cyanoacrylate treatment of incompetent saphenous veins has been associated with reflux from the residual stump. The purpose of this study was to analyze the starting point of cyanoacrylate glue injection from the junction to decrease the stump length.
A retrospective review was performed using prospectively collected data of patients with cyanoacrylate closure (CAC). Preoperatively, the diameter of the saphenous vein was measured. CAC was performed according to the manufacturer's instructions. After the procedure, clinical outcomes including pain, Venous Clinical Severity Score, and quality of life using the Aberdeen Varicose Vein Questionnaire were evaluated. Postoperative duplex scanning was performed to evaluate the occlusion rate of the target vein, stump length, and presence of endovenous glue-induced thrombosis. The stump length was analyzed according to the preoperative venous diameter to determine the proper point of glue injection to decrease the stump length.
During the study period, CAC was performed in 408 patients. The mean age was 56.2 ± 11.5 years (range, 19-84 years). A total of 279 patients (68.4%) were women. Occlusion of the target vein was achieved in all patients. After the procedure, pain, Venous Clinical Severity Score, and quality of life were improved (P < .001). Endovenous glue-induced thrombosis developed in 5.8% of patients. There was a 1.53-fold linear increase in the stump length for every 1-mm increment of the preoperative venous diameter. In 20 patients with a venous diameter ≥5 mm, glue injection was performed safely 4 cm distal to the junction to decrease the stump length.
The stump length linearly increased with an increase in the saphenous vein diameter. If the diameter of the saphenous vein is more than 5 mm, cyanoacrylate glue may be injected 4 cm distal to the junction to decrease the stump length.
Hypersensitivity reaction after cyanoacrylate closure of incompetent saphenous veins in patients with chronic venous disease: A retrospective study
2021, Journal of Vascular Surgery: Venous and Lymphatic Disorders
Citation Excerpt :
Gibson et al10 reported HSR in 6% of US patients. Proebstle et al16 reported HSR in 11% of European patients. There seems to be a higher incidence of HSR in Asians when compared with Caucasian patients.
The objective of this study was to evaluate the incidence of, the risk factors for, the nature of the disease, and the management of hypersensitivity reaction (HSR) after cyanoacrylate closure (CAC) of incompetent saphenous veins in patients with chronic venous disease.
Data consisting of all incompetent saphenous veins, including great saphenous veins, anterior accessory saphenous veins, and small saphenous veins, treated with CAC at Siriraj Hospital (Bangkok, Thailand) from January 2017 to December 2018 were retrospectively evaluated.
A total of 126 saphenous veins, including 106 great saphenous veins (84.1%), 7 anterior accessory saphenous veins (5.6%), and 13 small saphenous veins (10.3%) of 126 limbs from 101 patients were included. A HSR occurred in 16 of 101 patients (15.8%), in 19 of 126 limbs (15.0%), and in 19 of 126 treated saphenous veins (15.0%). HSR-related erythema, itching, swelling, and pain occurred in 100.0%, 95.0%, 68.4%, and 52.6%, of HSR patients, respectively. HSR occurred 1 week after CAC. All HSR symptoms were mild, could be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antihistamine, and were resolved within 1 week. The risk factors for HSR were suprafascial saphenous vein with a depth <1 cm from the skin, and saphenous vein diameter of ≥8 mm.
A HSR occurred in 15.8% of patients and in 15.0% of limbs after CAC. Risk factors for HSR were a suprafascial saphenous vein located close to the skin and a large saphenous vein. All HSR symptoms were mild in severity, occurred at 1 week after CAC, and were resolved within 1 week after treatment with nonsteroidal anti-inflammatory drugs and antihistamines. To prevent HSR, CAC should be avoided in suprafascial saphenous veins that are located close to the skin, and CAC in saphenous veins with a size of ≥8 mm should be performed with caution.

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: Author conflict of interest: All authors or their institutions received research support associated with the reported study. In addition, T.P., J.L., and J.A. are consultants to the sponsor. T.P., S.D. and J.A. have been stock owners of the original sponsor.

: The original sponsor of the European Sapheon Closure System Observational ProspectivE (eSCOPE) trial was Sapheon. Sapheon was acquired by Covidien Ltd, which was then acquired by Medtronic, Inc. (Santa Rosa, Calif).

: The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.

: This trial (NCT01570101) was registered on clinicaltrials.gov.

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Clinical research studySuperficial venous diseaseThree-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins

Abstract

Objective

Methods

Results

Conclusions

Graphical Abstract

Section snippets

Methods

Baseline demographics

Discussion

Conclusions

Author contributions

J Vasc Interv Radiol

J Vasc Surg Venous Lymphat Disord

J Vasc Surg Venous Lymphat Disord

J Vasc Surg Venous Lymphat Disord

J Vasc Interv Radiol

J Vasc Surg Venous Lymphat Disord

J Vasc Surg Venous Lymphat Disord

J Vasc Surg

The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence

Phlebology

Midterm Outcome of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency

J Endovasc Ther

Endovascular management of arteriovenous malformations of the brain

Interv Neurol

Clinical research study
Superficial venous disease
Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins