Ekos’ Ultrasound Shown to Treat Brain Hemorrhage
February 25, 2010—Ekos Corporation (Bothell, WA) announced that David W. Newell, MD, presented findings from the SLEUTH (Safety of Lysis With Ultrasound in the Treatment of Intracerebral [ICH] and Intraventricular Hemorrhage [IVH]) study at the International Stroke Conference 2010 in San Antonio, Texas. Dr. Newell is Co- Executive Director of the Swedish Neuroscience Institute in Seattle, Washington, which conducted SLEUTH. Ekos noted that ICH is a devastating form of stroke in which half of all patients die within 1 month of the event, and those who survive typically experience dramatic loss of brain function and motor skills.
According to Dr. Newell, the objective of SLEUTH was to evaluate the safety and efficacy of a novel therapy that combines ultrasound with recombinant tissue plasminogen activator (rt-PA) delivered through a microcatheter directly into spontaneous IVH or ICH patients, to facilitate evacuation of the hemorrhage. Thirty-five patients presented at the Swedish Neuroscience Institute with ICH and IVH and were screened between November 2008 and July 2009 for entry into the study. Entry criteria included the spontaneous onset of ICH ≥ 25 mL and or IVH producing ventricular obstruction. Nine patients (aged 38–83 years, average = 63; 6 men, 3 women) who met entry criteria were consented and entered into the trial. A ventricular drainage catheter and an ultrasound microcatheter were stereotactically delivered together directly into the IVH or ICH. The patients were treated with rt-PA and 24 hours of continuous ultrasound, and gravity drainage was performed. In patients with IVH, a total of 3 mg of rt-PA was injected, and in patients with intraparenchymal hemorrhages, a total of 0.9 mg of rt-PA was injected in three doses over 24 hours.
Dr. Newell reported that all patients had significant volume reductions of the treated hemorrhage. The mean percentage volume reduction after 24 hours of treatment, compared to the pretreatment stability scans, as determined by computed tomography were 59% ± 5% for ICH and 45.1% ± 13% for IVH (one ICH patient was excluded from analysis because of catheter breakage). There were no intracranial infections and no significant episodes of rebleeding by clinical or computed tomography assessment. There was one death by 30 days after admission. Clinical improvements, as determined by a decrease in the National Institutes of Health Stroke Score, were demonstrated at 30 days in seven of nine patients. The rate of thrombolysis was compared between eight patients who completed treatment to cohorts of patients treated using identical doses of tPA and catheter drainage without ultrasound for IVH and ICH (courtesy of MISTIE and CLEAR studies, which are large IVH/ICH studies sponsored by the National Institutes of Health that are already underway and do not use ultrasound acceleration). Compared to MISTIE and CLEAR data, SLEUTH investigators observed a faster rate of lysis during the first 24 hours of treatment for IVH (P = .046) and for ICH (P = .074) in the patients treated with sonolysis plus tPA.
“Lysis and drainage of spontaneous ICH and IVH with reduction of mass effect can be accomplished rapidly and safely by sonothrombolysis using stereotactically delivered drainage and ultrasound catheters through a burr hole,” commented Dr. Newell. “A larger clinical trial with catheters specifically designed for brain blood clot removal is warranted.”
Dr. Newell concluded, “The fastest, safest, and most complete way to remove a clot can make a difference between life and death. Ekos’s new therapy has clearly shown promising results, and we are excited to learn more.”