Clinical trial NCT06070129: Surgery in Pulmonary Embolisms
Official title: Early Outcomes of Surgery in Patients With Massive and Sub Massive Pulmonary Embolism: ( a Single Center Experience)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 15
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: mortality
timeFrame: baseline
measure: NYHA Functional Classification.
timeFrame: baseline
measure: right ventricular dimension
timeFrame: baseline
measure: left ventricular ejection fraction (EF %)
timeFrame: baseline
Secondary outcomes:
measure: hospital stay days
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: professor of cardiothoracic surgery surgery department
name: Ahmed EL-Minshawy, professor
role: STUDY_DIRECTOR
affiliation: professor at cardiothoracic surgery department
name: Sameh Abdelrahman, professor
role: STUDY_DIRECTOR
affiliation: lecturer at pulmonary disease department
name: Alaa Salah, lecturer
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
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.
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.