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Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy
In high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk.
The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited.
Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by injection of 200 ml saline at high pressure using power injector can be used as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydro-mechanical pulmonary embolism fragmentation | Experimental | Those patients will undergo catheter directed fragmentation followed by injection of 100 ml of heparinized saline via power injector |
|
| thrombolytic treated arm | No Intervention | patients with high risk and intermediate high risk PE who received thrombolysis as only treatment modality |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter directed hydro-mechanical fragmentation of pulmonary embolism | Procedure | A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery , then 200 ml saline will be injected via power injector to aid fragmentation of thrombus |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| oxygen saturation | oxygen saturation will be measured by arterial blood gases analysis at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention | 24 hours |
| Changes in blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25173341 | Background | Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available. | |
| 11265879 |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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non randomized case control trial
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inclusion in each arm was made by pulmonary embolism response team not by the investigators . also at level of follow up assessment was done by blinded investigators.
|
systolic and diastolic blood pressure will be measured at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
| 24 hours |
| Background |
| Uflacker R. Interventional therapy for pulmonary embolism. J Vasc Interv Radiol. 2001 Feb;12(2):147-64. doi: 10.1016/s1051-0443(07)61821-1. |
| 29843174 | Background | Engelberger RP, Kucher N. Reperfusion Treatment for Acute Pulmonary Embolism. Hamostaseologie. 2018 May;38(2):98-105. doi: 10.1055/s-0038-1641717. Epub 2018 May 29. |
| 25856269 | Background | Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119. |
| 23710301 | Background | Mohan B, Chhabra ST, Aslam N, Wander GS, Sood NK, Verma S, Mehra AK, Sharma S. Mechanical breakdown and thrombolysis in subacute massive pulmonary embolism: A prospective trial. World J Cardiol. 2013 May 26;5(5):141-7. doi: 10.4330/wjc.v5.i5.141. |
| 27081754 | Background | Dilektasli AG, Demirdogen Cetinoglu E, Acet NA, Erdogan C, Ursavas A, Ozkaya G, Coskun F, Karadag M, Ege E. Catheter-Directed Therapy in Acute Pulmonary Embolism with Right Ventricular Dysfunction: A Promising Modality to Provide Early Hemodynamic Recovery. Med Sci Monit. 2016 Apr 15;22:1265-73. doi: 10.12659/msm.897617. |
| 34564780 | Derived | Hassan AKM, Ahmed H, Ahmed Y, Elfadl AA, Omar A. Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism. Egypt Heart J. 2021 Sep 25;73(1):84. doi: 10.1186/s43044-021-00204-2. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |