(HealthDay News) — Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis appears safe and efficacious for acute massive and submassive pulmonary embolism (PE), according to a study published in the August 24 issue of JACC: Cardiovascular Interventions.
Gregory Piazza, MD, from Brigham and Women’s Hospital in Boston, and colleagues conducted a prospective, single-arm, multicenter trial to examine the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis using the EkoSonic Endovascular System. One hundred fifty patients with acute massive or submassive (31 and 119, respectively) PE were included. Tissue-plasminogen activator (24mg) was administered as either 1mg/hour for 24 hours with a unilateral catheter or as 1mg/hour/catheter for 12 hours with bilateral catheters.
The researchers found that from baseline to 48 hours post-procedure, the mean right ventricular/left ventricular diameter ratio decreased (1.55 vs. 1.13; P<0.0001). Post-procedure there were also decreases in mean pulmonary artery systolic pressure and modified Miller Index score (both P<0.0001). In 15 patients, there was one Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO)-defined severe bleed and 16 GUSTO-defined moderate bleeding events. There were no cases of intracranial hemorrhage.
“Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased right ventricular dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE,” the authors write.
Several authors disclosed financial ties to pharmaceutical and medical device companies, including EKOS, which developed and manufactured the EkoSonic Endovascular System.