Background: The treatment of saphenous vein reflux has evolved over the years with the development of thermal ablation techniques. This study was designed to analyze the complications of endovenous ablation (EVA) using data from an open, voluntary national database.
Methods: We analyzed 349 adverse events of endovenous laser (EVLT) and radiofrequency ablation (RFA) reported in the Manufacturer and User Facility Device Experience (MAUDE) database from January 2000 to June 2012. Outcomes of interest were pulmonary embolism (PE), deep vein thrombosis (DVT), death, and device failures (i.e. broken laser tip, broken sheath).
Results: Two hundred and three (58%) reports were patient-related injuries and the other 146 (42%) device-related failures. More complications were related to RFA compared to EVLT (216 vs. 133 procedures). Thirty (8%) non-fatal PEs and 123 (35%) DVTs were described. There were 7 (2%) periprocedural deaths, all from PE. Of the 135 device failure reports, 41(30%) required surgical intervention. Despite an increasing number of procedures, reported events peaked around 2008 and stabilized since then. Over the past 5 years, the incidence of adverse events reported for EVLT and RFA were 1 and 2 per 10,000 procedures. The complication ratio over the years was <1:2500 for DVT, <1:10,000 for PE, <1:50,000 for death.
Conclusion: EVA has gained high acceptance worldwide but the risks tend to be overlooked. Despite a very low complication rate, mortality has been reported. The complications found in MAUDE represent only a fraction as the majority of the practitioners are not aware of this database. Further investigation by a large national registry is warranted to better define the real magnitude of EVA complications.