Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients

Study Overview
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Brief Summary
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Primary objective: to evaluate the success and mortality rates of catheter-directed reperfusion therapy in comparison to traditional use of systemic intravenous fibrinolytic therapy, will focus at safety of such management measured by in-hospital mortality and prevalence of severe adverse events. Secondary objective: to assess the feasibility of catheter-directed reperfusion in management of intermediate and high risk pulmonary embolism in Assiut University hospital and its reflection on pulmonary artery pressure

Detailed Description
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Venous thromboembolic disease represents one of the most important causes of cardiovascular death in the world. Symptomatic pulmonary embolism (PE) occurs in about 500,000 patients annually, with an estimated mortality as high as 30% in high-risk patients . High-risk pulmonary embolism clinically manifests with hemodynamic instability and systemic hypotension (systolic blood pressure < 90 mm Hg, pressure drop of more than 40 mm Hg or requiring administration of inotropic agents. In this form of PE (pulmonary embolism) imaging studies usually reveal a saddle embolus at the bifurcation of the pulmonary trunk, embolism of the main pulmonary artery, or embolic occlusion of at least two lobar arteries. Mortality in high-risk pulmonary embolism is at the level of 60%, and in 66% of these patients fatal outcomes take place during the first hours from the onset of clinical symptoms. The remaining patients with severe pulmonary embolism , those with intermediate risk of mortality, do not reveal hypotension, but present with clinical symptoms comprising dyspnea and/or tachycardia. Estimated 30-day mortality in patients with intermediate risk PE (pulmonary embolism) is at the level of 15-20%, and these patients are at a risk of developing pulmonary hypertension and right ventricle heart failure. Given the fact that 40% of patients with class 4 or 5 of the Pulmonary Embolism Severity Index present with contraindications for systemic fibrinolytic therapy, Catheter-directed reperfusion therapy seems to be a promising alternative treatment modality.

Official Title
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Catheter-Directed Pulmonary Re Perfusion in Treatment of Intermediate and High Risk Pulmonary Embolism Patients and Its Impact on Pulmonary Artery Pressure

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Procedure: mechanical fragmentation
* Procedure: In Situ thrombolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old. Both gender males and females. 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 dysfunction of the right ventricle and elevated troponin. patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis patients with high risk PE pulmonary embolism who cannot receive fibrinolysis patients with intermediate high risk PE pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis) Exclusion Criteria: patients with echocardiographically confirmed right sided thrombi. patients with low-risk PE pulmonary embolism or submassive acute PE pulmonary embolism with minor RV (right ventricle) dysfunction, minor myocardial necrosis, and no clinical worsening Anaphylactic reaction to contrast media. Acute renal failure or severe chronic non-dialysis dependent kidney disease. Uncooperative patient

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| No Intervention: systemic thrombolysis group<br>patients without any contraindications for systemic fibrinolytic therapy will be treated with traditional systemic thrombolysis (intravenous administration of streptokinase). | |
| Active Comparator: mechanical fragmentation group<br>patients will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy. | Procedure: mechanical fragmentation<br>* patients who will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy<br>|
| Active Comparator: In Situ thrombolysis group<br>patients will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC(Swan-Ganz pulmonary artery catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women). | Procedure: In Situ thrombolysis<br>* Group (C) will include the patients who will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC (Swan-Ganz catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality (mortality rate) | number of deaths from total number of patients in each arm | 30-day | 
| Rate of complications | as major and minor bleedings | 7 days | 
| Rate of Success | number of cases with clinical success which defined as stabilization of hemodynamic parameters, resolution of hypoxia, survival from PE(pulmonary embolism) and restoring of right ventricular function (improvement of ghit ventricle and pulmonary artery pressure and decrease troponin level) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Changes in mean blood pressure | the percent of change in mean arterial blood pressure | Baseline (measured at first admission) and compared with measurements the following second, eighth, and 24th hours of the intervention. | 
| Mean pulmonary artery pressure | Mean pulmonary artery pressure will be estimated by transthoracic echocardiography | Baseline (at addmission) and 24 hours after catheter-directed intervention | 
| Duration of ICU(intensive care unit) stay | the duration of ICU (intensive care unit) stay by days | through study completion, an average of 1 year. | 
| Duration of hospital stay | the duration of hospital stay by days | through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary embolism