Surgery in Pulmonary Embolisms

NCT06070129 | Unknown

• 1 other identifier: surgery in pulmonary embolisms
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• hospital stay days

  baseline

Study Arms (2)

Patients 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.

Procedure: surgical pulmonary embolectomy

Patients with sub massive pulmonary embolism or intermediate -high risk

* 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

Interventions

surgical pulmonary embolectomy PROCEDURE

open heart surgery with cardiopulmonary bypass with opening of the pulmonary artery and its major branches and extraction of the embolus

Patients with massive pulmonary embolism or high-risk patients; Patients with sub massive pulmonary embolism or intermediate -high risk

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with massive and sub massive pulmonary embolism entering Assiut university hospital from October 2022 to November 2025 will be taken to be treated by surgical pulmonary embolectomy. patients will be divided according to type pulmonary embolism into two groups: massive pulmonary embolism group and sub massive pulmonary embolism group all of them will have the same inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 32819463 BACKGROUND

• 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.

  PMID: 30005883 BACKGROUND

• 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.

  PMID: 20852415 BACKGROUND

• 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.

  PMID: 26077690 BACKGROUND

• 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.

  PMID: 34706585 BACKGROUND

• 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.

  PMID: 31588070 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ahmed EL-Minshawy, professor

  professor of cardiothoracic surgery surgery department

  STUDY DIRECTOR

• Sameh Abdelrahman, professor

  professor at cardiothoracic surgery department

  STUDY DIRECTOR

• Alaa Salah, lecturer

  lecturer at pulmonary disease department

  STUDY DIRECTOR

Central Study Contacts

Mohamed Emad, assistant lecturer

CONTACT

01063067860; mohamed011374@med.au.edu.eg

Mohamed Farouk, lecturer

CONTACT

01014000469; mohammedfarouk@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 6, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share