Catheter Directed Interventions in Pulmonary Embolism

Study Overview
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Brief Summary
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Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism

Detailed Description
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Acute pulmonary embolism is common, but its presentation highly varies ranging from asymptomatic to massive pulmonary embolism. Massive pulmonary embolism is a common life-threatening condition and represents the most serious manifestation among venous thromboembolic disease. Acute pulmonary embolism is considered the third most common cause of death among hospitalized patients . The mortality rate can exceed 58% in patients with acute pulmonary embolism presenting with haemodynamic instability , mostly occur within 1 hour of presentation. In patients with high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk. The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited. Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by local thrombolytic therapy is accepted as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow. Several reports have shown that catheter-directed therapy is a safe and effective treatment for acute PE to restore pulmonary flow and decreasing Pulmonary artery systolic pressure , However, current knowledge on efficacy and safety of catheter-directed therapy in management of intermediate high risk pulmonary embolism is limited.

Official Title
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Safety and Efficacy of Catheter Directed Interventions in Acute High Risk Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Procedure: catheter directed fragmentation and thrombolysis
* Drug: Streptokinase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with angiographically confirmed acute high risk pulmonary embolism with shock index >1. Pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure >25 mmHg) Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis Patients with high risk pulmonary embolism who cannot receive fibrinolysis Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis) Exclusion Criteria: Patients with echocardiographically confirmed right sided thrombi. Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening Acute gastrointestinal bleeding. Anticoagulation with international normalized ratio >1.8 or severe coagulopathy. Anaphylactic reaction to contrast media. Acute stroke. Acute renal failure or severe chronic non-dialysis dependent kidney disease. Uncooperative patient
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: catheter directed interventions<br>Those patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase | Procedure: catheter directed fragmentation and thrombolysis<br>* A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours<br>|
| Active Comparator: systemic thrombolysis<br>Those patients will receive systemic streptokinase | Drug: Streptokinase<br>* intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure | systolic and diastolic blood pressure will be measured at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention | 24 hours | 
| oxygen saturation | oxygen saturation will be measured by arterial blood gases analysis at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention | 24 hours | 
| changes in right ventricular dysfunction | right ventricular dysfunction will be assessed by echocardiography and Mean pulmonary artery systolic pressure will be estimated by transthoracic echocardiography at first admission and 24 hours after catheter-directed intervention | 24 hours |