Drainage Technique in CABG

Official title

A Prospective Randomized Trial Comparing the Posterior Pericardial Window Versus Retro-Cardiac Drain for the Prevention of Postoperative Atrial Fibrillation and Pericardial Complications Following CABG

Overview

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.

Detailed description

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.

Primary outcome measures

• Incidence of postoperative atrial fibrillation and pericardial complications [Time frame: During hospitalization and up to 3 months after surgery]

Secondary outcome measures (1)

• Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality) [Time frame: From surgery until hospital discharge (up to 30 days)]

Eligibility criteria

Inclusion criteria

• Adult patients (aged 18 and above) scheduled for elective, first-time coronary artery bypass grafting (CABG).
• Patients with preserved left ventricular function (ejection fraction ≥ 35%).
• Ability to provide informed consent and comply with follow-up protocols.
• No prior history of atrial fibrillation or other significant arrhythmias.

Exclusion criteria

• Patients undergoing combined cardiac procedures (e.g., valve repair or replacement).
• Emergency CABG cases or re-operations.
• Known bleeding disorders or ongoing anticoagulation therapy that cannot be paused.
• Severe pericardial adhesions or anatomical abnormalities preventing safe creation of a posterior pericardial window.
• Chronic pulmonary disease or pleural pathology that may interfere with drainage assessment.
• Patients with active infections or systemic inflammatory conditions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 8759081
• 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. PMID 17356100
• 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. PMID 9351718
• 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. PMID 15082699
• 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. PMID 11747385
• 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. PMID 34391454
• 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. PMID 40255667

Identifiers

NCT: NCT07194798 · Drainage technique in CABG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗