Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicentre prospective study including 1,025 patients.

OBJECTIVES Increasing interest in foam sclerotherapy (FS) for saphenous insufficiency has highlighted the need to study the side-effects and complications of this treatment. The aim of this study is to better assess their nature and incidence. METHODS A multicentre, prospective and controlled study was carried out in which patients treated with FS for great (GSV) and small saphenous veins (SSV) trunk incompetence were included. Immediate untoward events were reported. Duplex ultrasound (DUS) examination was carried out to assess all patients between the eighth and 30th day. In addition, 20% of patients were called by an external auditor. RESULTS In total, 818 GSV and 207 SSV were treated in 1025 patients in 20 phlebology clinics. Ninety-nine percent of patients were controlled with DUS and non-duplex-checked patients were all called. The saphenous trunk was occluded in 90.3% of patients. Twenty-seven (2.6%) side-effects were reported: migraine (n = 8, 4 with visual disturbance); visual disturbance alone (n = 7); chest pressure alone (n = 7); and chest pressure associated with visual disturbance (n = 5). Eleven thrombo-embolic events occurred: 10 deep vein thrombosis (DVT) but only five in symptomatic patients, and one pulmonary embolism that occurred 19 days following the FS without DVT identified by DUS. One transient ischaemic stroke, with complete clinical recovery in 30 minutes, and one septicaemia with satisfactory outcome were reported as well. CONCLUSION This study demonstrates in a large sample of patients a low rate of adverse reactions after FS of great and small saphenous trunks. However, but the eventuality of exceptional but more serious complications has to be taken into account in the management of patients. A multicentre study like this one takes into account different practices and reports all possible complications, thus demonstrating the need for a common validated protocol.