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Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed even on oral anticoagulants.
Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with heart failure in preventing thromboembolic events, bleeding and all-cause mortality.
Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
Patients selection All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.
Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.
Methods In this retrospective cohort study
Primary endpoint
- The primary endpoints of the study are procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up in both groups of patients with heart failure and without heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with atrial fibrillation and heart failure | Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study |
| |
| patients with atrial fibrillation without heart failure | Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial appendage closure | Device | The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel. |
| Measure | Description | Time Frame |
|---|---|---|
| procedural success | procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm) The study will assess the rate of procedural success in both groups of the study. | 6 weeks post procedure |
| the absence of any complication related to the intervention | Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups. | 6 months post intervention |
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Inclusion Criteria:
In this study,
Exclusion Criteria:
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All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.
In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants who were scheduled for transcatheter left atrial appendage closure are included
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed A Osman, Ass. lect. | Contact | 01061878040 | mosman87@gmail.com | |
| Hosam H Aly, Prof | Contact | 01223971327 | hosam_hasan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Osman, Ass. lect. | Assiut University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23325525 | Result | Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16. | |
| 26088300 |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Result |
| Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025. |
| 29104013 | Result | Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available. |
| 29103847 | Result | Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4. |
| 27567408 | Result | Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available. |
| 30926025 | Result | Ellis CR, Kanagasundram AN. Atrial Fibrillation in Heart Failure: Left Atrial Appendage Management. Cardiol Clin. 2019 May;37(2):241-249. doi: 10.1016/j.ccl.2019.01.009. Epub 2019 Feb 13. |