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pulmonary embolism
Medical College of Georgia
WASHINGTON, DC—Results of the SEATTLE II trial indicate that ultrasound-facilitated, catheter-directed, low-dose fibrinolysis can improve outcomes in patients with acute, massive or submassive pulmonary embolism (PE).
Overall, the treatment appeared to improve right ventricle function, minimize the risk of intracranial hemorrhage, and decrease the risk of death in this cohort of 150 patients.
However, some patients experienced major bleeding following treatment. There were 17 major bleeding events, including 1 severe event.
Gregory Piazza, MD, of Brigham and Women’s Hospital in Boston, presented these results at the American College of Cardiology’s 63rd Annual Scientific Session & Expo (presentation 407-04).
SEATTLE II is a prospective, single-arm, multicenter trial designed to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose thrombolysis using the EkoSonic Endovascular System. The study was sponsored by the system’s makers, EKOS Corporation.
Researchers enrolled 150 patients with acute massive (N=31) or submassive (N=119) PE. Chest CT had to demonstrate proximal PE and a dilated right ventricle (RV/LV ratio ≥ 0.9) for patients to be eligible to participate.
Patients received 24 mg of tissue plasminogen activator (tPA), administered either as 1 mg/hour for 24 hours with a unilateral catheter or 1 mg/hour/catheter for 12 hours with bilateral catheters.
The treatment appeared to confer an improvement in right ventricle function. Overall, the mean RV/LV ratio decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure, a difference of 0.42 (P<0.0001).
Previous research has suggested that massive PE has a mortality rate of about 52% at 90 days. In this study, there were 31 patients presenting with massive PE manifested by syncope and hypotension.
None of these patients died within the 30 day follow-up period. Of the 150 patients in the overall study, 1 death was directly attributed to PE.
There were no intracranial hemorrhages and no fatal bleeding events. Major bleeds occurred in 17 patients, including 1 severe bleed and 16 moderate bleeds.
Six of the major bleeds occurred in patients with comorbidities known to be associated with an increased risk of bleeding during thrombolytic therapy.
“This trial represents a breakthrough in demonstrating the safety and efficacy of thrombolytic therapy for acute PE,” said Samuel Z. Goldhaber, MD, a professor at Harvard Medical School and principal investigator for SEATTLE II.
“The reduction of the RV/LV ratio by 0.42 is substantial and clinically significant, without any intracranial hemorrhage and using a much-reduced lytic dose. These findings establish a new rationale for considering thrombolysis in both massive and submassive PE.”
About the EkoSonic Endovascular System
The EkoSonic Endovascular device is approved by the US Food and Drug Administration for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EkoSonic System is cleared for the infusion of solutions into the pulmonary arteries, but it is not designed for peripheral vasculature dilation purposes.
EkoSonic and MicroSonic products have earned the CE mark for the following indications. The EkoSonic Endovascular Device, consisting of the Intelligent Drug Delivery Catheter and the MicroSonic Device, is intended for controlled and selective infusion of physician-specified fluids into the peripheral vasculature.
The EkoSonic Endovascular System is intended for the treatment of PE patients with a 50% or greater clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation. 
pulmonary embolism
Medical College of Georgia
WASHINGTON, DC—Results of the SEATTLE II trial indicate that ultrasound-facilitated, catheter-directed, low-dose fibrinolysis can improve outcomes in patients with acute, massive or submassive pulmonary embolism (PE).
Overall, the treatment appeared to improve right ventricle function, minimize the risk of intracranial hemorrhage, and decrease the risk of death in this cohort of 150 patients.
However, some patients experienced major bleeding following treatment. There were 17 major bleeding events, including 1 severe event.
Gregory Piazza, MD, of Brigham and Women’s Hospital in Boston, presented these results at the American College of Cardiology’s 63rd Annual Scientific Session & Expo (presentation 407-04).
SEATTLE II is a prospective, single-arm, multicenter trial designed to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose thrombolysis using the EkoSonic Endovascular System. The study was sponsored by the system’s makers, EKOS Corporation.
Researchers enrolled 150 patients with acute massive (N=31) or submassive (N=119) PE. Chest CT had to demonstrate proximal PE and a dilated right ventricle (RV/LV ratio ≥ 0.9) for patients to be eligible to participate.
Patients received 24 mg of tissue plasminogen activator (tPA), administered either as 1 mg/hour for 24 hours with a unilateral catheter or 1 mg/hour/catheter for 12 hours with bilateral catheters.
The treatment appeared to confer an improvement in right ventricle function. Overall, the mean RV/LV ratio decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure, a difference of 0.42 (P<0.0001).
Previous research has suggested that massive PE has a mortality rate of about 52% at 90 days. In this study, there were 31 patients presenting with massive PE manifested by syncope and hypotension.
None of these patients died within the 30 day follow-up period. Of the 150 patients in the overall study, 1 death was directly attributed to PE.
There were no intracranial hemorrhages and no fatal bleeding events. Major bleeds occurred in 17 patients, including 1 severe bleed and 16 moderate bleeds.
Six of the major bleeds occurred in patients with comorbidities known to be associated with an increased risk of bleeding during thrombolytic therapy.
“This trial represents a breakthrough in demonstrating the safety and efficacy of thrombolytic therapy for acute PE,” said Samuel Z. Goldhaber, MD, a professor at Harvard Medical School and principal investigator for SEATTLE II.
“The reduction of the RV/LV ratio by 0.42 is substantial and clinically significant, without any intracranial hemorrhage and using a much-reduced lytic dose. These findings establish a new rationale for considering thrombolysis in both massive and submassive PE.”
About the EkoSonic Endovascular System
The EkoSonic Endovascular device is approved by the US Food and Drug Administration for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EkoSonic System is cleared for the infusion of solutions into the pulmonary arteries, but it is not designed for peripheral vasculature dilation purposes.
EkoSonic and MicroSonic products have earned the CE mark for the following indications. The EkoSonic Endovascular Device, consisting of the Intelligent Drug Delivery Catheter and the MicroSonic Device, is intended for controlled and selective infusion of physician-specified fluids into the peripheral vasculature.
The EkoSonic Endovascular System is intended for the treatment of PE patients with a 50% or greater clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation.
pulmonary embolism
Medical College of Georgia
WASHINGTON, DC—Results of the SEATTLE II trial indicate that ultrasound-facilitated, catheter-directed, low-dose fibrinolysis can improve outcomes in patients with acute, massive or submassive pulmonary embolism (PE).
Overall, the treatment appeared to improve right ventricle function, minimize the risk of intracranial hemorrhage, and decrease the risk of death in this cohort of 150 patients.
However, some patients experienced major bleeding following treatment. There were 17 major bleeding events, including 1 severe event.
Gregory Piazza, MD, of Brigham and Women’s Hospital in Boston, presented these results at the American College of Cardiology’s 63rd Annual Scientific Session & Expo (presentation 407-04).
SEATTLE II is a prospective, single-arm, multicenter trial designed to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose thrombolysis using the EkoSonic Endovascular System. The study was sponsored by the system’s makers, EKOS Corporation.
Researchers enrolled 150 patients with acute massive (N=31) or submassive (N=119) PE. Chest CT had to demonstrate proximal PE and a dilated right ventricle (RV/LV ratio ≥ 0.9) for patients to be eligible to participate.
Patients received 24 mg of tissue plasminogen activator (tPA), administered either as 1 mg/hour for 24 hours with a unilateral catheter or 1 mg/hour/catheter for 12 hours with bilateral catheters.
The treatment appeared to confer an improvement in right ventricle function. Overall, the mean RV/LV ratio decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure, a difference of 0.42 (P<0.0001).
Previous research has suggested that massive PE has a mortality rate of about 52% at 90 days. In this study, there were 31 patients presenting with massive PE manifested by syncope and hypotension.
None of these patients died within the 30 day follow-up period. Of the 150 patients in the overall study, 1 death was directly attributed to PE.
There were no intracranial hemorrhages and no fatal bleeding events. Major bleeds occurred in 17 patients, including 1 severe bleed and 16 moderate bleeds.
Six of the major bleeds occurred in patients with comorbidities known to be associated with an increased risk of bleeding during thrombolytic therapy.
“This trial represents a breakthrough in demonstrating the safety and efficacy of thrombolytic therapy for acute PE,” said Samuel Z. Goldhaber, MD, a professor at Harvard Medical School and principal investigator for SEATTLE II.
“The reduction of the RV/LV ratio by 0.42 is substantial and clinically significant, without any intracranial hemorrhage and using a much-reduced lytic dose. These findings establish a new rationale for considering thrombolysis in both massive and submassive PE.”
About the EkoSonic Endovascular System
The EkoSonic Endovascular device is approved by the US Food and Drug Administration for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EkoSonic System is cleared for the infusion of solutions into the pulmonary arteries, but it is not designed for peripheral vasculature dilation purposes.
EkoSonic and MicroSonic products have earned the CE mark for the following indications. The EkoSonic Endovascular Device, consisting of the Intelligent Drug Delivery Catheter and the MicroSonic Device, is intended for controlled and selective infusion of physician-specified fluids into the peripheral vasculature.
The EkoSonic Endovascular System is intended for the treatment of PE patients with a 50% or greater clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation.