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Cyanoacrylate Superglue to Treat Varicose Veins: Truly Office Based and Minimally Invasive?
EDITORIAL
Cyanoacrylate Superglue to Treat Varicose Veins: Truly Office Based and Minimally Invasive? One of the disadvantages of endovenous therapy for ablation of trunkal incompetence for patients with varicose veins is the requirement for tumescence anaesthesia, which may result in pain, swelling and bruising. The use of intravenous injection of cyanoacrylate glue for trunkal ablation is a recently developed concept. Cyanoacrylate glue is a liquid adhesive that has been used in humans to treat varicosities for more than 20 years and was first used in endoscopic intravenous injections of peptic varicosities.1, It has also been used in the treatment of arteriovenous malformations. The mechanism is simple: plasma and blood stimulates the polymerisation and leads to closure of the target vein.2, When used as endoscopic haemostatic or embolisation agents, it is generally very safe, but rare cases of bleeding and pulmonary embolisation after the use of cyanoacrylate have been reported after endoscopic-guided injection of a peptic varix.3,4 Wang et al. demonstrated that when cyanoacrylate mixed with lipiodol was injected into rabbit veins, the vessels were obliterated immediately. This was followed by a sub-acute vasculitis and a chronic granulomatous foreign body reaction, to be replaced by fibrotic tissue in 2e3 months.5, Min et al. reported that at 30 days’ post-injection, the treated swine veins were occluded with no evidence of recanalisation. Histological findings revealed that spindle cells with a dense eosinophilic matrix replaced the tunica intima and disrupted the tunica media.6, At 60 days, the histologic changes mainly consisted of segmental wall thickening and fibrosis.7 With regard to lower limb varicose veins, the use of a medical adhesive without thermal energy is novel.8 This commercially available VenaSealÔ Sapheon closure system is used in Europe following CE Mark approval in September 2012, and has now been extended to Southeast Asia. The procedure is performed under local anaesthesia at the puncture site of the long saphenous vein in the medial calf or thigh under ultrasound guidance, and the catheter is placed with the help of the intravenous guidewire with the tip at 5 cm from the saphenofemoral junction. There is no need for peri-venous tumescence anaesthesia during the intravenous injection of the cyanocrylate. The initial human pilot study was performed on eight patients, with a mean injected volume of 1.58 ml.9 All the veins were successfully obliterated at a 1-month follow-up. Proebstle et al. presented the preliminary results at the European Venous Forum in July 2011 and stated that this new method of treating varicose veins was safe and 1078-5884/$ e see front matter Ó 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejvs.2012.11.005
effective, without the need for peri-venous injection of anaesthesia or compression stockings.10, The results of 1year clinical follow-up on 38 patients who underwent treatment of their symptomatic varicose veins with cyanoacrylate glue injection into the long saphenous vein were published recently.11,12 All the treated veins were closed at 24e72 h, and at 30 days, 97% of the veins were completely closed. There were no significant side effects or complications. The patients did not have any deep vein thrombosis or pulmonary embolism, but Proebstle showed that the first 8 of 38 (21%) patients had post-ablation thrombus extension through the saphenofemoral junction.13 Further modification of their technique with the first cyanoacrylate injection located 5 cm from the saphenofemoral junction seemed to have eliminated any further post-ablation thrombus extension. These initial results showed that this new endovascular technique did not require any tumescence anaesthesia or post-procedure compression stockings. The results of the Sapheon Closure System Feasibility Study (SCSFS)14, and the European Sapheon Closure System Observational Prospective (eSCOPE) Trial15 are awaited to confirm these results. If confirmed, with this non-thermal ablative modality, endovenous varicose vein surgery may become even more minimally invasive. CONFLICT OF INTEREST None. REFERENCES 1 Labenz J, Börsch G. Bleeding gastric and duodenal varicose veins: endoscopic embolisation using tissue adhesives. Dtsch Med Wochenschr 1992;117:1274e7. 2 Brothers MF, Kaufmann JC, Fox AJ, Deveikis JP. N-butyl 2cyanoacrylate substitute for IBCA in interventional neuroradiology: histopathologic and polymerization time studies. AJNR Am J Neuroradiol 1989;10:777e86. 3 Tsokos M, White Jr RI. Fatal pulmonary embolism after endoscopic embolization of downhill esophageal varix. Dtsch Med Wochenschr 1998;123:691e5. 4 Kobilica N, Flis V, Sojar V. Major complication after Histoacryl injection for endoscopic treatment of bleeding peptic ulcer. Endoscopy 2012;44(Suppl. 2):E204e5. 5 Wang YM, Cheng LF, Li N. Histopathological study of vascular changes after intra-arterial and intravenous injection of Nbutyl-2-cyanoacrylate. Chin J Dig Dis 2006;7:175e9. 6 Min RJ, Almeida JI, McLean DJ, Madsen M, Raabe R. Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results. Phlebology 2012 Jan 19 [Epub ahead of print]. 7 Almeida JI, Min RJ, Raabe R, McLean DJ, Madsen M. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovasc Surg 2011;45:631e5.
Editorial 8 http://www.%20sapheoninc.com/pdfs/10VenousTimesapheon. pdf. 9 Almeida JI. Nonthermal ablation for the treatment of varicose veins: the evolving minimally invasive methods for saphenous vein ablation. Endovasc Today 2011 April:34e8. 10 Proebstle TM, Almeida JI, for the International Sapheon Clinical Study Group. Cyanocrylate superglue great saphenous vein ablation: preliminary results of a first-in-man feasibility study of a no-compression-no-local anaesthesia technique. In: Presented at the 12th annual meeting of the European Venous Forum. Ljubljana, Slovenia: July 2011. 11 Almeida J, Javier J, Mackay EG, Bautista C, Proebstle T. Cyanoacrylate glue great saphenous vein ablation: preliminary 180-day follow-up of a first-in-man feasibility study of a nocompression-no-local-anesthesia technique. In: Presented at the American Venous Forum 24th annual congress. Orlando, Florida, USA: February 2012.
177 12 One-year data support Sapheon’s closure system for varicose vein treatment. Endovasc Today 2012 August. 13 Proebstle T. Status of cyanoacrylate glue for saphenous ablation. In: Presented at the international vein congress. Miami, Florida, USA: June 2012. 14 http://clinicaltrials.gov/ct2/show/NCT01603433. 15 http://clinicaltrials.gov/ct2/show/NCT01570101.
Y.C. Chan*, A.C. Ting, W.K. Yiu, S.W. Cheng Division of Vascular & Endovascular Surgery, Department of Surgery, University of Hong Kong Medical Centre, South Wing, 14th Floor K Block, Queen Mary Hospital, Pokfulam Road, Hong Kong *Corresponding author. Tel.: þ852 2855 4962; fax: þ852 2855 4961. Email-addresses: [email protected] (Y.C. Chan)
Cyanoacrylate Superglue to Treat Varicose Veins: Truly Office Based and Minimally Invasive? One of the disadvantages of endovenous therapy for ablation of trunkal incompetence for patients with varicose veins is the requirement for tumescence anaesthesia, which may result in pain, swelling and bruising. The use of intravenous injection of cyanoacrylate glue for trunkal ablation is a recently developed concept. Cyanoacrylate glue is a liquid adhesive that has been used in humans to treat varicosities for more than 20 years and was first used in endoscopic intravenous injections of peptic varicosities.1, It has also been used in the treatment of arteriovenous malformations. The mechanism is simple: plasma and blood stimulates the polymerisation and leads to closure of the target vein.2, When used as endoscopic haemostatic or embolisation agents, it is generally very safe, but rare cases of bleeding and pulmonary embolisation after the use of cyanoacrylate have been reported after endoscopic-guided injection of a peptic varix.3,4 Wang et al. demonstrated that when cyanoacrylate mixed with lipiodol was injected into rabbit veins, the vessels were obliterated immediately. This was followed by a sub-acute vasculitis and a chronic granulomatous foreign body reaction, to be replaced by fibrotic tissue in 2e3 months.5, Min et al. reported that at 30 days’ post-injection, the treated swine veins were occluded with no evidence of recanalisation. Histological findings revealed that spindle cells with a dense eosinophilic matrix replaced the tunica intima and disrupted the tunica media.6, At 60 days, the histologic changes mainly consisted of segmental wall thickening and fibrosis.7 With regard to lower limb varicose veins, the use of a medical adhesive without thermal energy is novel.8 This commercially available VenaSealÔ Sapheon closure system is used in Europe following CE Mark approval in September 2012, and has now been extended to Southeast Asia. The procedure is performed under local anaesthesia at the puncture site of the long saphenous vein in the medial calf or thigh under ultrasound guidance, and the catheter is placed with the help of the intravenous guidewire with the tip at 5 cm from the saphenofemoral junction. There is no need for peri-venous tumescence anaesthesia during the intravenous injection of the cyanocrylate. The initial human pilot study was performed on eight patients, with a mean injected volume of 1.58 ml.9 All the veins were successfully obliterated at a 1-month follow-up. Proebstle et al. presented the preliminary results at the European Venous Forum in July 2011 and stated that this new method of treating varicose veins was safe and 1078-5884/$ e see front matter Ó 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejvs.2012.11.005
effective, without the need for peri-venous injection of anaesthesia or compression stockings.10, The results of 1year clinical follow-up on 38 patients who underwent treatment of their symptomatic varicose veins with cyanoacrylate glue injection into the long saphenous vein were published recently.11,12 All the treated veins were closed at 24e72 h, and at 30 days, 97% of the veins were completely closed. There were no significant side effects or complications. The patients did not have any deep vein thrombosis or pulmonary embolism, but Proebstle showed that the first 8 of 38 (21%) patients had post-ablation thrombus extension through the saphenofemoral junction.13 Further modification of their technique with the first cyanoacrylate injection located 5 cm from the saphenofemoral junction seemed to have eliminated any further post-ablation thrombus extension. These initial results showed that this new endovascular technique did not require any tumescence anaesthesia or post-procedure compression stockings. The results of the Sapheon Closure System Feasibility Study (SCSFS)14, and the European Sapheon Closure System Observational Prospective (eSCOPE) Trial15 are awaited to confirm these results. If confirmed, with this non-thermal ablative modality, endovenous varicose vein surgery may become even more minimally invasive. CONFLICT OF INTEREST None. REFERENCES 1 Labenz J, Börsch G. Bleeding gastric and duodenal varicose veins: endoscopic embolisation using tissue adhesives. Dtsch Med Wochenschr 1992;117:1274e7. 2 Brothers MF, Kaufmann JC, Fox AJ, Deveikis JP. N-butyl 2cyanoacrylate substitute for IBCA in interventional neuroradiology: histopathologic and polymerization time studies. AJNR Am J Neuroradiol 1989;10:777e86. 3 Tsokos M, White Jr RI. Fatal pulmonary embolism after endoscopic embolization of downhill esophageal varix. Dtsch Med Wochenschr 1998;123:691e5. 4 Kobilica N, Flis V, Sojar V. Major complication after Histoacryl injection for endoscopic treatment of bleeding peptic ulcer. Endoscopy 2012;44(Suppl. 2):E204e5. 5 Wang YM, Cheng LF, Li N. Histopathological study of vascular changes after intra-arterial and intravenous injection of Nbutyl-2-cyanoacrylate. Chin J Dig Dis 2006;7:175e9. 6 Min RJ, Almeida JI, McLean DJ, Madsen M, Raabe R. Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results. Phlebology 2012 Jan 19 [Epub ahead of print]. 7 Almeida JI, Min RJ, Raabe R, McLean DJ, Madsen M. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovasc Surg 2011;45:631e5.
Editorial 8 http://www.%20sapheoninc.com/pdfs/10VenousTimesapheon. pdf. 9 Almeida JI. Nonthermal ablation for the treatment of varicose veins: the evolving minimally invasive methods for saphenous vein ablation. Endovasc Today 2011 April:34e8. 10 Proebstle TM, Almeida JI, for the International Sapheon Clinical Study Group. Cyanocrylate superglue great saphenous vein ablation: preliminary results of a first-in-man feasibility study of a no-compression-no-local anaesthesia technique. In: Presented at the 12th annual meeting of the European Venous Forum. Ljubljana, Slovenia: July 2011. 11 Almeida J, Javier J, Mackay EG, Bautista C, Proebstle T. Cyanoacrylate glue great saphenous vein ablation: preliminary 180-day follow-up of a first-in-man feasibility study of a nocompression-no-local-anesthesia technique. In: Presented at the American Venous Forum 24th annual congress. Orlando, Florida, USA: February 2012.
177 12 One-year data support Sapheon’s closure system for varicose vein treatment. Endovasc Today 2012 August. 13 Proebstle T. Status of cyanoacrylate glue for saphenous ablation. In: Presented at the international vein congress. Miami, Florida, USA: June 2012. 14 http://clinicaltrials.gov/ct2/show/NCT01603433. 15 http://clinicaltrials.gov/ct2/show/NCT01570101.
Y.C. Chan*, A.C. Ting, W.K. Yiu, S.W. Cheng Division of Vascular & Endovascular Surgery, Department of Surgery, University of Hong Kong Medical Centre, South Wing, 14th Floor K Block, Queen Mary Hospital, Pokfulam Road, Hong Kong *Corresponding author. Tel.: þ852 2855 4962; fax: þ852 2855 4961. Email-addresses: [email protected] (Y.C. Chan)