Surgery in Pulmonary Embolisms

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070129
• Other study ID #: surgery in pulmonary embolisms
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Mohamed Emad, assistant lecturer
• Phone: 01063067860
• Email: mohamed011374[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

- 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 1, 2026
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Procedure:
• surgical pulmonary embolectomy
open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Azari A, Beheshti AT, Moravvej Z, Bigdelu L, Salehi M. Surgical embolectomy versus thrombolytic therapy in the management of acute massive pulmonary embolism: Short and long-term prognosis. Heart Lung. 2015 Jul-Aug;44(4):335-9. doi: 10.1016/j.hrtlng.2015.04.008. — View Citation

Goldberg JB, Spevack DM, Ahsan S, Rochlani Y, Dutta T, Ohira S, Kai M, Spielvogel D, Lansman S, Malekan R. Survival and Right Ventricular Function After Surgical Management of Acute Pulmonary Embolism. J Am Coll Cardiol. 2020 Aug 25;76(8):903-911. doi: 10.1016/j.jacc.2020.06.065. — View Citation

Lin DS, Lin YS, Lee JK, Chen WJ. Short- and Long-Term Outcomes of Catheter-Directed Thrombolysis versus Pulmonary Artery Embolectomy in Pulmonary Embolism: A National Population-Based Study. J Endovasc Ther. 2022 Jun;29(3):409-419. doi: 10.1177/15266028211054763. Epub 2021 Oct 27. — View Citation

Loyalka P, Ansari MZ, Cheema FH, Miller CC 3rd, Rajagopal S, Rajagopal K. Surgical pulmonary embolectomy and catheter-based therapies for acute pulmonary embolism: A contemporary systematic review. J Thorac Cardiovasc Surg. 2018 Dec;156(6):2155-2167. doi: 10.1016/j.jtcvs.2018.05.085. Epub 2018 Jun 8. — View Citation

Martinez Licha CR, McCurdy CM, Maldonado SM, Lee LS. Current Management of Acute Pulmonary Embolism. Ann Thorac Cardiovasc Surg. 2020 Apr 20;26(2):65-71. doi: 10.5761/atcs.ra.19-00158. Epub 2019 Oct 5. — View Citation

Meneveau N. Therapy for acute high-risk pulmonary embolism: thrombolytic therapy and embolectomy. Curr Opin Cardiol. 2010 Nov;25(6):560-7. doi: 10.1097/HCO.0b013e32833f02c5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	number of patients died	baseline
Primary	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
Primary	right ventricular dimension	dimensions of right ventricle in centimeter by echocardiography	baseline
Primary	left ventricular ejection fraction (EF %)	left ventricular ejection fraction (EF ) percentage by echocardiography	baseline
Secondary	hospital stay days	number of days the patient stayed at hospital after the surgery	baseline