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aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.
Coronary artery bypass grafting (CABG) is a cornerstone in the management of advanced coronary artery disease, yet it carries a notable risk of postoperative complications. Among these, postoperative atrial fibrillation (POAF) is particularly common, affecting up to 40% of patients and contributing to increased morbidity, prolonged ICU and hospital stays, and elevated healthcare costs.
Pericardial effusion and tamponade are also frequent sequelae after CABG operation, often exacerbating the risk of POAF and necessitating re-intervention. Traditionally, retro-cardiac drains have been used to evacuate pericardial fluid, but their efficacy in preventing effusion-related complications is limited.
The posterior pericardial window (PPW) technique has emerged as a promising alternative, offering improved drainage and reduced incidence of POAF, early and late pericardial effusion, and tamponade. Studies have shown that PPW may also shorten ICU and hospital stays, reduce pleural effusion, and lower the need for revision surgery due to bleeding.
Despite encouraging data, randomized trials directly comparing PPW and retro-cardiac drains remain scarce. This study aims to fill that gap by evaluating the effectiveness of PPW versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, with secondary outcomes including pleural effusion, ICU/hospital stay duration, revision surgery, and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 61 patients undergoing CABG will have a posterior pericardial window created for drainage. | Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group).
| ||
| Group 2 : 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. | Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group).
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative atrial fibrillation and pericardial complications | Postoperative atrial fibrillation will be detected by continuous ECG monitoring during hospitalization. Pericardial complications, including early and late pericardial effusion, cardiac tamponade, and pleural effusion, will be assessed using echocardiography. The outcome will be reported as the number and percentage of participants experiencing any of these events. | During hospitalization and up to 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality) | Postoperative outcomes will include: Length of ICU stay and total hospital stay (measured in days from surgery until discharge). Requirement for revision surgery due to bleeding (documented from operative and postoperative records). All-cause in-hospital mortality (death from any cause during index hospitalization). These outcomes will be reported as duration in days and/or number and percentage of participants, as appropriate. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult patients scheduled to undergo elective, first-time, isolated coronary artery bypass grafting (CABG) surgery via median sternotomy. Eligible participants will be hemodynamically stable and able to provide informed consent prior to enrollment. Patients will be randomized intraoperatively to receive either a posterior pericardial window or a retro-cardiac drain for postoperative management.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed mohamed saad, Principal Investigator | Contact | +201014570052 | Ahmed.17289818@med.aun.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8759081 | Result | Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, VanderVliet M, Collins JJ Jr, Cohn LH, Burstin HR. Predictors of atrial fibrillation after coronary artery surgery. Current trends and impact on hospital resources. Circulation. 1996 Aug 1;94(3):390-7. doi: 10.1161/01.cir.94.3.390. | |
| 17356100 | Result | Kalavrouziotis D, Buth KJ, Ali IS. The impact of new-onset atrial fibrillation on in-hospital mortality following cardiac surgery. Chest. 2007 Mar;131(3):833-839. doi: 10.1378/chest.06-0735. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| From surgery until hospital discharge (up to 30 days) |
| 9351718 | Result | Almassi GH, Schowalter T, Nicolosi AC, Aggarwal A, Moritz TE, Henderson WG, Tarazi R, Shroyer AL, Sethi GK, Grover FL, Hammermeister KE. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997 Oct;226(4):501-11; discussion 511-3. doi: 10.1097/00000658-199710000-00011. |
| 15082699 | Result | Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720. |
| 11747385 | Result | Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010. |
| 34391454 | Result | Xiong T, Pu L, Ma YF, Zhu YL, Li H, Cui X, Li YX. Posterior pericardiotomy to prevent new-onset atrial fibrillation after coronary artery bypass grafting: a systematic review and meta-analysis of 10 randomized controlled trials. J Cardiothorac Surg. 2021 Aug 14;16(1):233. doi: 10.1186/s13019-021-01611-x. |
| 40255667 | Result | Ranjan R, Kapetanakis S, Chandrasekaran V, Kaba RA, Momin AU. Posterior Pericardial Window and a Single Pleural Drain: A Dual Defence Against Post-CABG Pericardial Effusion and Atrial Fibrillation. Ther Clin Risk Manag. 2025 Apr 15;21:481-487. doi: 10.2147/TCRM.S521874. eCollection 2025. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |