Surgery in Pulmonary Embolisms

Study Overview
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Brief Summary
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Measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.

Detailed Description
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Pulmonary embolism (PE) is one of the most important causes of mortality in cardiovascular diseases. It represents the third cause of mortality after myocardial infarction and stroke. Risk factors of pulmonary embolism include malignancy, recent operation, hypercoagulability, and deep venous thrombosis (DVT). DVT is the most common risk factor. Acute pulmonary embolism is classified into massive or high risk (characterized by evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm)) and sub massive type or intermediate-high risk (characterized by evidence of adverse effects on the RV (dysfunction and strain), with mild hypotension, tachycardia, and 1 or more of the following: RV systolic hypo kinesis, RV dilatation by echocardiogram , elevated cardiac biomarkers (troponin I), elevated serum N-terminal pro brain natriuretic peptide, or electrocardiogram changes suggestive of RV strain.). Treatment options of acute massive and sub massive PE include systemic thrombolytic therapy, catheter directed thrombolysis (CDT) and surgical pulmonary embolectomy (SBE). The outcomes of the surgical treatment to the catheter-based treatment is still a topic of interest in management of acute pulmonary embolism. This study aims to measure early out comes of surgical pulmonary embolectomy in patients with massive and sub massive pulmonary embolism.

Official Title
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Early Outcomes of Surgery in Patients With Massive and Sub Massive Pulmonary Embolism: ( a Single Center Experience)

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Procedure: surgical pulmonary embolectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with massive pulmonary embolism or high-risk patients characterized by : Evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm). CT pulmonary angiography demonstrating a thrombus which occludes greater than 50% of the pulmonary artery (PA) cross-sectional area or occludes two or more lobar arteries. Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view. Elevated cardiac troponin T and I above normal limits. Patients with sub massive pulmonary embolism or intermediate -high risk characterized by: Systolic blood pressure >90 mmHg and tachycardia (heart rate > 100 bpm). CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded. Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view. Elevated cardiac troponin T and I above normal limits Exclusion Criteria: Patients less than 18 years of age. Low risk acute pulmonary embolism (less than 30% occlusion of pulmonary vasculature by CT pulmonary angiography, no signs of Rt ventricular systolic dysfunction, RV dilation or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view by Echocardiography. Acute on top of chronic pulmonary embolism.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with massive pulmonary embolism or high-risk patients<br>Characterized by evidence of low-cardiac-output syndrome or clinical shock attributed to PE as the underlying cause, based on 1 or more of the following: systemic arterial systolic blood pressure<90 mm Hg, need for positive inotrope or systemic vasoconstrictor support, need for mechanical circulatory support, cardiac arrest, or profound bradycardia (heart rate<40 bpm). CT pulmonary angiography demonstrating a thrombus which occludes greater than 50% of the pulmonary artery (PA) cross-sectional area or occludes two or more lobar arteries. Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunction, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view. Elevated cardiac troponin T and I above normal limits. | Procedure: surgical pulmonary embolectomy<br>* open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus<br>|
| Patients with sub massive pulmonary embolism or intermediate -high risk<br>Systolic blood pressure >90 mmHg and tachycardia (heart rate > 100 bpm). CT pulmonary angiography shows that 30% to 50% of the pulmonary vasculature is occluded. Echocardiography both Trans thoracic and Trans esophageal shows right ventricular (RV) systolic dysfunctions, RV dilation, or a RV/left ventricular (LV) diameter ratio of >0.9 on four chamber view. Elevated cardiac troponin T and I above normal limits. | Procedure: surgical pulmonary embolectomy<br>* open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | number of patients died | baseline | 
| NYHA Functional Classification. | I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV Symptoms of heart failure at rest. Any physical activity causes further discomfort. | baseline | 
| right ventricular dimension | dimensions of right ventricle in centimeter by echocardiography | baseline | 
| left ventricular ejection fraction (EF %) | left ventricular ejection fraction (EF ) percentage by echocardiography | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay days | number of days the patient stayed at hospital after the surgery | baseline |