The story of N-butyl cyanoacrylate saphenous vein ablation

Abstract

In 2009, our group was approached by an experienced radiologist who proposed to close refluxing saphenous veins with glue; an idea based on his experience with N-butyl cyanoacrylate (TRUFILL) embolization of cerebral arterial venous malformations. We henceforth began with a swine model, 1 Almeida J.I. Min R.J. Rabe R. McLean D.J. Madsen M. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovascular Surg. 2011; 45: 631-635 Crossref PubMed Scopus (74) Google Scholar and then moved to first-in-human studies 2 Almeida J.I. Javier J.J. Mackay E. Bautista C. Proebstle T. One-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphatic Disord. 2013; 1: 174-180 Abstract Full Text Full Text PDF PubMed Scopus (122) Google Scholar for nonthermal ablation of the saphenous vein with their proprietary N-butyl cyanoacrylate glue. Of interest, during the regulatory development pathway, this product was approved as a device, not a drug. It's efficacy has proved excellent, and during the past decade cyanoacrylate closure (CAC) has been adopted widely worldwide. However, reports of hypersensitivity-related adverse events, and granulomas, have begun to surface. It is timely that Dr Athavale and his team have recently published an excellent systematic review on CAC. Based on the available literature, the adverse events related to cyanoacrylate glue can be divided into the following: phlebitis, hypersensitivity (type I and type IV), foreign body granuloma, endovenous glue induced thrombosis and infection. These adverse events may require prolonged steroid use or vein excision. Cyanoacrylate glue reactions: A systematic review, cases, and proposed mechanismsJournal of Vascular Surgery: Venous and Lymphatic DisordersVol. 11Issue 4PreviewCyanoacrylate 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. Full-Text PDF