Mechanochemical Ablation Research Articles

Midterm Outcome of Mechanochemical Endovenous Ablation for the Treatment of Great Saphenous Vein Insufficiency

Purpose: To report the midterm results of mechanochemical ablation (MOCA) for treating great saphenous vein (GSV) insufficiency. Methods: In a 1-year period, 85 consecutive patients (median age 51.4 years; 71 women) undergoing MOCA with polidocanol in 104 limbs were enrolled in a prospective registry. The patients were evaluated at baseline and during follow-up (4 weeks and 1, 2, and 3 years) using duplex ultrasound, the CEAP (clinical, etiologic, anatomic and pathophysiologic) classification, the Venous Clinical Severity Score (VCSS), the RAND Short Form 36-Item Health Survey (RAND-SF36), and the Aberdeen Varicose Vein Questionnaire (AVVQ). Primary outcome measures were clinical and anatomic success. Secondary outcome measures included general and disease-specific quality of life and reinterventions. Results: Technical success (99%) was achieved in all but 1 patient in whom technical problems with the device led to conversion to another method for treatment of 2 limbs. After a median follow-up of 36 months (interquartile range 12.5, 46.3), recanalization occurred in 15 (15%) of 102 successfully treated vein segments. Anatomic success was 92%, 90%, and 87% after 1, 2, and 3 years, respectively. The VCSS improved at all time intervals compared to the preprocedure median. The clinical success at 3 years was 83%. The AVVQ and RAND-SF36 scores showed an improvement at all time intervals compared to baseline values. Between 12 and 36 months, however, a significant deterioration was observed in VCSS, which was accompanied by worsening of disease-specific and general quality of life. Conclusion: In the longest follow-up of MOCA to date, this study shows MOCA to be an effective treatment modality for GSV insufficiency at midterm follow-up, but clinical results seem to drop over time.

Mechanochemical Ablation vs. Thermoablation in the Treatment of GSV Reflux: A Randomized Trial

Mechanochemical Ablation vs. Thermoablation in the Treatment of GSV Reflux: A Randomized Trial

Mechanochemical ablation for symptomatic great saphenous vein reflux: A two-year follow-up.

Background Several studies have shown comparable early efficacy of mechanochemical ablation to endothermal techniques. The goal of this report was to show if early efficacy is maintained at 24 months. Methods This was a two-year analysis on the efficacy of mechanochemical ablation in patients with symptomatic C2 or more advanced chronic venous disease. Patients with reflux in the great saphenous vein involving the sapheno-femoral junction and no previous venous interventions were included. Demographic information, clinical, and procedural data were collected. The occlusion rate of treated veins was assessed with duplex ultrasound. Patient clinical improvement was assessed by Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class and venous clinical severity score. Results Of the initial 126 patients, there were 65 patients with 24 month follow-up. Of these 65 patients, 70% were female, with a mean age of 70 ± 14 years and an average body mass index (BMI) of BMI of 30.5 ± 6. The mean great saphenous vein diameter in the upper thigh was 7.6 mm and the mean treatment length was 39 cm. Adjunctive treatment of the varicosities was performed in 14% of patients during the procedure. Closure rates were 100% at one week, 98% at three months, 95% at 12 months, and 92% at 24 months. There was one patient with complete and four with partial recanalization ranging from 7 to 12 cm (mean length 9 cm). There was significant improvement in CEAP and venous clinical severity score (P < .001) for all time intervals. Conclusion Early high occlusion rate with mechanochemical ablation is associated with significant clinical improvement which is maintained at 24 months, making it a very good option for the treatment of great saphenous vein incompetence.

PC186. Mechanochemical Ablation Improves Venous Ulcer Healing Compared to Thermal Ablation

PC186. Mechanochemical Ablation Improves Venous Ulcer Healing Compared to Thermal Ablation

Glue, steam and Clarivein--Best practice techniques and evidence.

In July 2013, the National Institute of Health and Clinical Excellence (NICE) recommended "endothermal" ablation (meaning endovenous thermal ablation) is the first line treatment for truncal venous reflux in varicose veins. The initial endovenous thermoablation devices were radiofrequency ablation and endovenous laser ablation. More recently, Glue (cyanoacrylate), endovenous steam and Clarivein (mechanochemical ablation or MOCA) have entered the market as new endovenous techniques for the treatment of varicose veins. Glue and Clarivein do not require tumescent anaesthesia and do not use heat and therefore termed non-tumescent non-thermal (NTNT). Steam both requires tumescence and is also a thermal technique (TT). This article reviews the current position of these 3 new technologies in the treatment of varicose veins.

Injection Sclerotherapy and Ablation

Closure of incompetent superficial veins via endovenous techniques has become the standard of care for treatment of patients with chronic venous insufficiency and symptomatic varicose veins. The safety and efficacy of these procedures have been supported by the peer-reviewed literature, and these procedures have largely replaced the surgical treatments of high ligation and stripping. Three major developments have led to the current endovenous techniques: laser and radiofrequency catheters that deliver thermal energy, tumescent anesthesia, and duplex ultrasonography. This review covers relevant anatomy, pathophysiology, clinical signs and symptoms, diagnostics, treatment, tumescentless therapy, ClariVein (mechanochemical ablation), and the VenaSeal Closure System. Figures show telangiectasias, reticular veins, varicose veins, edema/swelling, hyperpigmentation, venous stasis ulcers, the ClosureFast Catheter, access using the great saphenous vein proximal to the popliteal region, application of tumescent anesthesia, segmental ablation using the ClosureFAST system, the NeverTouch Direct Procedure Kit by AngioDynamics, Varithena foam sclerosant, the ClariVein Occlusion Catheter, and the VenaSeal Sapheon Closure System. Tables list perforating veins of the lower extremity, Clinical, Anatomic, Etiologic, Pathophysiologic classification, and the Venous Clinical Severity Score. This review contains 12 figures, 3 tables, and 103 references

Clarivein mechanochemical ablation of the great and small saphenous vein: Early treatment outcomes of two hospitals.

Mechanochemical endovenous ablation is a novel technique for the treatment of great saphenous vein and small saphenous vein incompetence which combines mechanical injury of the endothelium with simultaneous infusion of liquid sclerosant. The main objective of this study was to evaluate early occlusion. All consecutive patients who were eligible for the treatment with mechanochemical endovenous ablation were included. Inclusion period was from the introduction of the device in the hospitals (September 2011 and December 2011) until December 2012. A total of 449 patients were included representing 570 incompetent veins. In 506 treated veins, duplex ultrasonography was performed at follow-up: 457 veins (90%) were occluded at a follow-up of 6 to 12 weeks. In univariate and multivariate analysis, failure of treated great saphenous vein was associated with saphenofemoral junction incompetence (OR 4; 95% CI 1.0-17.1, P = 0.049). The Clarivein device proves to be safe and had a high short-term technical effectiveness.

Clarivein® mechano-chemical ablation an interim analysis of a randomized controlled trial dose-finding study.

The ClariVein® system is an endovenous technique that uses mechano-chemical ablation to treat incompetent truncal veins. This study was conducted to identify the ideal Polidocanol dosage and form for mechano-chemical ablation in order to occlude the great saphenous vein. When adhering to safe dosage levels, sclerosants with higher concentrations potentially limit the extent of treatment. It has been demonstrated that this problem may be overcome by using Polidocanol as a microfoam. This paper was established on findings of a preliminary analysis. The initial study was a single-blinded multicenter randomized controlled trial where patients are allocated to three treatment arms. Group 1 consisted of mechano-chemical ablation +2% Polidocanol liquid, group 2: mechano-chemical ablation +3% Polidocanol liquid and group 3: mechano-chemical ablation +1% Polidocanol foam Eighty-seven, 34 males and 53 females (60.9%), mean age 55 years s.d. 16.0 (range 24-84), were enrolled in the study. Treatment length was 30 cm (range 10-30) for 95.2% of the patients. Mean operating time was 16 minutes (range 5-70). The mean saphenofemoral junction diameter (7.7 mm) was similar in all three groups. At 6 weeks post-treatment duplex ultrasound showed that 25 out of 25 = 100%, 27 out of 28 = 96.4% and 13 out of 23 = 56.5% were occluded in the mechano-chemical ablation + 2% Polidocanol liquid, mechano-chemical ablation + 3% Polidocanol liquid and mechano-chemical ablation + 1% Polidocanol microfoam respectively (p < 0.001). However, stricter scrutiny showed that the anatomical success rate defined as occlusion of at least 85% of the treated length to be 88.0%, 85.7% and 30.4% respectively (p < 0.001). Mechano-chemical ablation using ClariVein® combined with 1% Polidocanol microfoam is significantly less effective and should not be considered as a treatment option of incompetent truncal veins. Further investigation to determine the ideal Polidocanol liquid dosage with mechano-chemical ablation is advocated and is being conducted accordingly.

The advent of non-thermal, non-tumescent techniques for treatment of varicose veins.

Varicose veins are common and their management has undergone a number of changes over the years. Surgery has been the traditional treatment option, but towards the 21st century, new endovenous thermal ablation techniques, namely, radiofrequency ablation and endovenous laser ablation, were introduced which have revolutionised the way varicose veins are treated. These minimally invasive techniques are associated with earlier return to normal activity and less pain, as well as enabling procedures to be carried out as day cases. They are, however, also known to cause a number of side-effects and involve infiltration of tumescent fluid which can cause discomfort. Non-thermal, non-tumescent methods are believed to be the answer to these unwelcome effects. Ultrasound-guided foam sclerotherapy is one such non-thermal, non-tumescent method and, despite a possible lower occlusion, has been shown to improve the quality of life of patients. The early results of two recently launched non-thermal, non-tumescent methods, mechanochemical ablation and cyanoacrylate glue, are promising and are discussed.

Serum endothelin 1 levels before, during and after mechanochemical endovenous ablation with foam and surgical correction of incompetent great saphenous veins

Serum endothelin 1 levels before, during and after mechanochemical endovenous ablation with foam and surgical correction of incompetent great saphenous veins

Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study

ENWEndNote BIBJabRef, Mendeley RISPapers, Reference Manager, RefWorks, Zotero AMA Ciostek P, Kowalski M, Woźniak W, Miłek T, Myrcha P, Migda B. Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study. Phlebological Review. 2015;23(3):72-77. doi:10.5114/pr.2015.57466. APA Ciostek, P., Kowalski, M., Woźniak, W., Miłek, T., Myrcha, P., & Migda, B. (2015). Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study. Phlebological Review, 23(3), 72-77. https://doi.org/10.5114/pr.2015.57466 Chicago Ciostek, Piotr, Marcin Kowalski, Witold Woźniak, Tomasz Miłek, Piotr Myrcha, and Bartosz Migda. 2015. "Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study". Phlebological Review 23 (3): 72-77. doi:10.5114/pr.2015.57466. Harvard Ciostek, P., Kowalski, M., Woźniak, W., Miłek, T., Myrcha, P., and Migda, B. (2015). Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study. Phlebological Review, 23(3), pp.72-77. https://doi.org/10.5114/pr.2015.57466 MLA Ciostek, Piotr et al. "Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study." Phlebological Review, vol. 23, no. 3, 2015, pp. 72-77. doi:10.5114/pr.2015.57466. Vancouver Ciostek P, Kowalski M, Woźniak W, Miłek T, Myrcha P, Migda B. Phlebogriffe – a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study. Phlebological Review. 2015;23(3):72-77. doi:10.5114/pr.2015.57466.

One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein

ENWEndNote BIBJabRef, Mendeley RISPapers, Reference Manager, RefWorks, Zotero AMA Stanisić M, Węgrzynowski A, Pawlaczyk-Gabriel K. One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein. Phlebological Review. 2015;23(4):102-105. doi:10.5114/pr.2015.59018. APA Stanisić, M., Węgrzynowski, A., & Pawlaczyk-Gabriel, K. (2015). One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein. Phlebological Review, 23(4), 102-105. https://doi.org/10.5114/pr.2015.59018 Chicago Stanisić, Michal-Goran, Adam Węgrzynowski, and Katarzyna Pawlaczyk-Gabriel. 2015. "One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein". Phlebological Review 23 (4): 102-105. doi:10.5114/pr.2015.59018. Harvard Stanisić, M., Węgrzynowski, A., and Pawlaczyk-Gabriel, K. (2015). One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein. Phlebological Review, 23(4), pp.102-105. https://doi.org/10.5114/pr.2015.59018 MLA Stanisić, Michal-Goran et al. "One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein." Phlebological Review, vol. 23, no. 4, 2015, pp. 102-105. doi:10.5114/pr.2015.59018. Vancouver Stanisić M, Węgrzynowski A, Pawlaczyk-Gabriel K. One-year results of fifty consecutive patients treated with mechanochemical ablation of great and small saphenous vein. Phlebological Review. 2015;23(4):102-105. doi:10.5114/pr.2015.59018.

Histologic findings after mechanochemical ablation in a caprine model with use of ClariVein.

The use of foam and liquid sclerotherapy for the treatment of varicose veins and underlying venous reflux is widespread. A novel device, the ClariVein Occlusion Catheter (Vascular Insights LLC, Madison, Conn), has been the subject of several clinical trials in humans. We report the initial histologic results obtained with use of the device in a caprine vein model. A total of 11 male goats (12 veins) underwent minimally invasive procedures. Unilateral mechanochemical ablation of the lateral saphenous vein by the ClariVein Occlusion Catheter with an E-140° tip was performed under fluoroscopic guidance in five veins with 5 mL of 1.5% sodium tetradecyl sulfate (STS) and in one vein with 5 mL of 0.9% saline. The remaining six received injection sclerotherapy with 5 mL of 1.5% STS or 0.9% saline. All subjects were assessed with ultrasound before the procedure and intermittently afterward during a period of 12 weeks. Subsequent termination was immediately followed by necropsy and histologic examination of the treated veins. Complete occlusion of the lateral saphenous vein was observed in all subjects treated with ClariVein and STS, whereas complete patency was noted in all other treatment modalities. Histologic staining with hematoxylin and eosin and Masson trichrome stain revealed total fibrotic sealing with extensive collagen production in all ClariVein/STS veins. A statistical significance was observed in the difference in the number of occluded veins between subjects treated with ClariVein/STS and those treated by injection sclerotherapy (Fisher exact test, P < .01). The ClariVein Occlusion Catheter with 1.5% STS can be used to achieve complete mechanochemical ablation of the lateral saphenous vein in a caprine model. The evidence in this report can be used to justify the device's use for the treatment of the great saphenous vein in subsequent human clinical trials.

Büyük Safen Ven Yetmezliklerinin Mekano-Kimyasal Endovenöz Ablasyonu: İki Yıllık Sonuçlar

Büyük Safen Ven Yetmezliklerinin Mekano-Kimyasal Endovenöz Ablasyonu: İki Yıllık Sonuçlar

Retrograde mechanochemical ablation of the small saphenous vein for the treatment of a venous ulcer

We present the first case of retrograde ablation of the small saphenous vein to treat active venous ulceration. A 73-year-old gentleman with complicated varicose veins of the left leg and a non-healing venous ulcer despite previous successful endovenous treatment to his left great saphenous vein underwent mechanochemical ablation of his small saphenous vein with the ClariVein® system, under local anaesthetic, using a retrograde cannulation technique. Post-operatively the patient had improved symptomatically and the ulcer size had reduced. This report highlights that patients with small saphenous vein incompetence and active ulceration can be treated successfully with retrograde mechanochemical ablation.

Mechanochemical ablation in patients with chronic venous disease: A prospective multicenter report

There are several endovenous methods to ablate the saphenous vein, all of which require tumescent anesthesia. This report was designed to evaluate the efficacy of a tumescent-free technique using mechanochemical ablation (MOCA). This was a prospective observational multicenter report on the efficacy of MOCA in selected patients with lower extremity chronic venous disease. Demographic information, clinical and procedural data were collected on a customized database. The distribution and extent of venous reflux and the closure rate of the treated veins were assessed with duplex ultrasound. Pain was evaluated during the procedure and postoperatively using an analog scale. The presence and severity of complications were recorded. Patient improvement was assessed by clinical-etiology-anatomy-pathophysiology (CEAP) class and venous clinical severity score (VCSS). There were 126 patients that were included at baseline, 81% females, with a mean age of 65.5 ± 14 years. The average BMI was 30.5 ± 6. The mean diameter of the great saphenous vein in the upper thigh was 7.3 mm and the mean treatment length was 38 cm. Adjunctive treatment of the varicosities was performed in 11% of patients during the procedure. Closure rates were 100% at one week, 98% at three months, and 94% at six months. Post-procedure complications included hematoma 1%, ecchymosis 9%, and thrombophlebitis 10%. There were no cases of venous thromboembolism. There was significant improvement in VCSS (p < 0.001) for all time intervals. MOCA of the saphenous veins has the advantage of endovenous ablation without tumescent anesthesia, making it an almost pain-free procedure. High occlusion rates with significant clinical improvement can be achieved with this method at short term.

Mechanochemical ablation: status and results

Mechanochemical ablation: status and results

SS21. Mechanochemical Ablation (MOCA) of the Great Saphenous Vein: Two-Year Results and Recommendations from the Initial Human Trial

SS21. Mechanochemical Ablation (MOCA) of the Great Saphenous Vein: Two-Year Results and Recommendations from the Initial Human Trial

Varicose vein surgery

Venous diseases are common in the general population. After a comprehensive diagnostic evaluation, an individual therapeutic approach should be selected on the basis of the findings, with the aim of treating the diseased vein segments and improving quality of life. Numerous therapeutic options are available for the treatment of varicose veins. In addition to conservative methods such as compression therapy, exercise or drugs, surgical procedures such as traditional surgery, thermal ablation techniques or sclerotherapy can be performed. Recent developments include the use of endoluminal water vapor or mechano-chemical endovenous ablation.

Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial

ObjectiveThe purpose of this study was to assess the safety and efficacy of the ClariVein® system that employs mechanochemical ablation of the great saphenous vein (GSV).MethodPatients eligible for ablation of the GSV underwent micropuncture access with only local anaesthesia to insert a 4 or 5 Fr sheath. The ClariVein® catheter was placed through the sheath, the wire was extruded, and the distal tip of the wire positioned 2 cm from the saphenofemoral junction under ultrasound guidance. Catheter wire rotation was then activated for 2–3 seconds at approximately 3500 rpm. With the wire rotating, infusion of the sclerosant was started simultaneously with catheter pullback. The sclerosant used was 1.5% liquid sodium tetradecyl sulphate (Sotradecol©, Bioniche Pharma Group, Geneva, Switzerland).ResultsThirty GSVs in 29 patients were treated. All patients have reached six-month follow-up; the average number of postoperative days is 260. No adverse events have been reported. The Primary Closure Rate is 96.7%.ConclusionMechanochemical ablation appears to be safe and efficacious. The ClariVein® technique eliminates the need for tumescent anaesthesia. The great majority of incompetent GSVs can be treated with this technique.