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A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital.
A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital. Patients aged at least 18 years with a diagnosis of submassive or massive acute PE were included. Patients were excluded if they either did not receive EKOS intervention or were presented with stable PE. The primary outcome was the change in RV/LV diameter ratio from baseline to first outpatient follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECOS group | ECOS |
| |
| Control group | IV infusion tpa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECOS | Drug | The EkoSonic Endovascular System, developed by EKOS Corporation, is a specialized CDT system that combines ultrasound technology with thrombolytic infusion to treat PE |
| Measure | Description | Time Frame |
|---|---|---|
| The change in RV/LV diameter ratio | The change in RV/LV diameter ratio from baseline to first outpatient follow-up as documented on an echocardiogram. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause 30-day readmission | All-cause 30-day readmission | one month |
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Inclusion Criteria:
Exclusion Criteria:
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Submassive PE was defined as having right ventricular (RV) dysfunction: detected via CT scan or echocardiography, with signs such as RV enlargement, RV hypokinesis, or RV/LV ratio >0.9 to 1.0), elevated cardiac biomarkers like troponin or BNP, which indicate strain or injury to the heart muscle with a maintained blood pressure (SBP equal to or > 90 mm Hg with no signs of shock.
Massive PE was defined as SBP <90 mm Hg for at least 15 minutes or require vasopressors to maintain adequate blood pressure with clinical signs of poor perfusion, including altered mental status, cool extremities, low urine output, or sudden loss of heart function due to obstructed blood flow from the pulmonary artery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saudi German Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Drug | Alteplase IV infusion |
|
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008722 | Methods |