Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen (PP-POAF)

Taiz University - Faculty of Medicine

Status: Completed

Conditions: Postoperative Atrial Fibrillation; Cardiac Tamponade

Treatments: Procedure: Standard Care; Procedure: Posterior Pericardiotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07266935

TaizU-PP-AF-2022

Details and patient eligibility

About

A single-center, randomized controlled trial in Yemen evaluating whether posterior pericardiotomy (PP) reduces postoperative atrial fibrillation (POAF) after open-heart surgery. 210 patients undergoing CABG, aortic valve replacement, ascending aortic surgery, or combined procedures were randomized 1:1 to receive either posterior pericardiotomy (PP group, n = 106) or standard care (control group, n = 104). Outcomes assessed included POAF incidence, pericardial effusion, cardiac tamponade, ICU stay, mechanical ventilation, in-hospital mortality, and re-exploration for bleeding or tamponade.

Full description

This single-center, prospective randomized controlled trial was conducted at the Cardiovascular and Kidney Transplantation Centre, Taiz University, Yemen. Adult patients undergoing elective open-heart surgery were randomized to receive either posterior pericardiotomy or standard care. The intervention involved creating a longitudinal posterior pericardiotomy incision parallel to the left phrenic nerve to facilitate pericardial drainage into the left pleural cavity.

The study evaluated the impact of posterior pericardiotomy on postoperative atrial fibrillation and related complications, including pericardial effusion and cardiac tamponade, compared with standard surgical management. Participants were monitored during hospitalization and followed for 30 days after surgery to assess clinical outcomes, resource utilization, and mortality.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years.
• Elective open-heart surgery:

Coronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)

Exclusion criteria

• Previous cardiac or thoracic surgery
• Left-sided pleural adhesions
• Preoperative atrial fibrillation or other rhythm disorders
• Hyperthyroidism
• Renal failure with plasma creatinine >2.0 mg/dL
• Off-pump CABG
• Mitral or tricuspid valve surgery (excluded due to distinct pathophysiology and POAF risk)
• Refusal to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Interventional: Posterior Pericardiotomy

Experimental group

Description:

A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery. This intervention aims to reduce postoperative atrial fibrillation, pericardial effusion, and cardiac tamponade.

Treatment:

Procedure: Posterior Pericardiotomy

Control: Standard Care

Active Comparator group

Description:

Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided.

Treatment:

Procedure: Standard Care