5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Thread‑like thrombus extensions across the saphenofemoral junction were reported in 21% (8/38) of patients in a case series of 38 patients (seen on ultrasound imaging at 48‑hour follow‑up). At 6‑month follow‑up, all thrombus extensions had resolved without clinical sequelae. Thrombus extension into the common femoral vein was reported in 1 patient in a case series of 70 patients; this resolved without progression.

5.2 Phlebitis was reported in 16% (6/38) of patients in the case series of 38 patients; the patients had mild pain and erythema, which persisted for an average of 5 days. Superficial thrombophlebitis that resolved spontaneously was reported in 1 patient in the same case series. A mild phlebitic reaction was reported in 11% (8/70) of patients in the case series of 70 patients, with a median duration of 6.5 days. Self‑limited thrombophlebitis was reported after 40% (4/10) of procedures in a case series of 10 veins. 'Mild' phlebitis in the treatment zone was reported in 6% (6/108) of patients treated by cyanoacrylate glue occlusion in a randomised controlled trial of 222 patients. 'Moderate' phlebitis not in the treatment zone was reported in 1 patient treated by cyanoacrylate glue occlusion in the same study and 'mild' superficial vein thrombophlebitis was reported in 3% (3/108) of patients.

5.3 Low‑grade cellulitis that resolved with oral antibiotics was reported in 1 patient in the case series of 38 patients. Moderate access site infection was reported in 1 patient treated by cyanoacrylate glue occlusion in the randomised controlled trial of 222 patients.

5.4 A postoperative erysipeloid‑phlebitic skin reaction was reported after 15% (10/65) of procedures in the case series of 65 patients; all resolved quickly after conservative compression therapy. A hypersensitivity reaction was reported in 1 patient in the case series of 10 veins; the patient had simultaneous occlusion of both incompetent anterior accessory saphenous veins and the reaction was thought to be caused by subcutaneous delivery of the adhesive.

5.5 Hyperpigmentation was reported in 1 patient in the case series of 38 patients: this was still visible at 24‑month follow‑up.

5.6 Moderate and mild paraesthesia were each reported in 1 patient treated by cyanoacrylate glue occlusion in the randomised controlled trial of 222 patients.

5.7 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers described the following anecdotal adverse events: nerve injury (no other details provided) and inadvertent injection into the subcutaneous space, muscle or perivenous space. They considered that the following were theoretical adverse events: embolisation of glue to the lungs; cerebrovascular complications giving rise to transient or permanent neurological sequelae; deep vein thrombosis; scarring; ulceration; haematoma; and pain.

  • National Institute for Health and Care Excellence (NICE)