Guidance
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 Major bleeding (retroperitoneal hematoma needing 4 units of blood) was reported in 1 patient in the ultrasound‑enhanced, catheter‑directed thrombolysis (UE‑CDT) group (n=24) in the randomised controlled trial of 48 patients. Minor bleeding at the site of catheter insertion (resolved by elevation of the limb or compressive banding) was reported in 12% (3/26) of patients in a case series of 26 patients.
5.2 Haematoma at the access site was reported in 1 patient in the UE‑CDT group (n=24) and 2 patients in the standard catheter‑directed thrombolysis group (n=24) in the RCT of 48 patients.
5.3 Pulmonary embolism (34 days after UE‑CDT) was reported in 1 patient in the case series of 87 patients (no further details available).
5.4 Haematuria (25 hours after minor bleeding during thrombolysis) was reported in 1 patient in the case series of 26 patients (further details were not reported).
5.5 Fever with positive cultures for staphylococcus aureus was reported in 6% (2/37) of patients in the case series of 37 patients. Both patients recovered after treatment with antibiotics for 6 weeks.
5.6 Transient foot drop was reported in 1 patient who had an access‑related popliteal haematoma in the case series of 87 patients (further details were not reported).
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 considered that the following were theoretical adverse events: thermal damage to surrounding structures, septic thrombophlebitis, vessel perforation and death.