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Copyright ©The Author(s) 2023.
World J Clin Cases. Mar 16, 2023; 11(8): 1702-1711
Published online Mar 16, 2023. doi: 10.12998/wjcc.v11.i8.1702
Table 2 Ultrasound-assisted catheter-directed thrombolysis use in patients with intermediate or high-risk proximal pulmonary embolism
Study
Ultima[32]
Seattle II[33]
Optalyse[34]
Aim of the studyThe aim of the study was to investigate whether ultrasound-assisted catheter-directed thrombolysis (USAT) is superior to anticoagulation alone in the reversal of RV dilatation in intermediate-risk patientsTo evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysisTo determine the lowest optimal tissue plasminogen activator (tPA) dose and delivery duration using ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk (sub-massive) PE
Study designTwo armsSingle armSingle arm
Single-center/multi-centerMulti-centerMulti-centerMulti-center
Completed/ongoingCompletedCompletedCompleted
Year of publication201420152018
Primary endpointThe difference in the RV/LV ratio at 24 hThe difference in RV/LV ratio at 48 h and bleeding at 72 hreduction in RV/LV ratio on CT imaging at 48 h
Total number of patients59150101
Mean age of patients63 +/- 145960
% of males47%48.753
Drug usedUFH and USAT VS UFH alonet-PAt-PA and heparin
ResultsThe mean difference in RV/LV ratio from baseline to 24 h was 0.30 ± 0.20 vs 0.03 ± 0.16 (P < 0.001), respectivelyThe mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs 1.13; mean difference, -0.42; P < 0.0001)Improvements in RV/LV ratio were as follows: Arm 1 (4 mg/lung/2 h), 0.40 (24%; P = 0.0001); arm 2 (4 mg/lung/4 h), 0.35 (22.6%; P = 0.0001); arm 3 (6 mg/lung/6 h), 0.42 (26.3%; P = 0.0001); and arm 4 (12 mg/lung/6 h), 0.48 (25.5%; P = 0.0001)
Adverse effects4 minor bleedings. No major bleeding17 major bleeding events within 30 d of the procedure observed in 15 patients (10%). One of these major bleeding events was a GUSTO severe/life-threatening hemorrhage (a right groin vascular access site hematoma with transient hypotension requiring vasopressor support). The remainder (94%) were GUSTO moderate bleeds, 3 of which were related to vascular access4 patients had a total of 5 major bleeding events