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

A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of Posterior Pericardiotomy in Preventing Postoperative Atrial Fibrillation Among Yemeni Cardiac Surgical Patients

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Atrial Fibrillation; Cardiac Tamponade
• Intervention / Treatment: Procedure: Posterior Pericardiotomy; Procedure: Standard Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Yemen
  • Muḩāfaz̧at Ta‘izz
    • Taiz, Muḩāfaz̧at Ta‘izz, Yemen
      • Cardiovascular & Kidney Transplantation Centre, Taiz University, Taiz, Yemen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional: Posterior Pericardiotomy; 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.	Procedure: Posterior Pericardiotomy; A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.
Active Comparator: Control: Standard Care; Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided.	Procedure: Standard Care; Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge	Occurrence of atrial fibrillation documented by 12-lead ECG or continuous telemetry monitoring, lasting >30 seconds, and occurring after cardiac surgery in patients with no prior history of atrial fibrillation.	During hospitalization, approximately 5-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants requiring postoperative antiarrhythmic medications	Any antiarrhythmic therapy administered postoperatively to manage POAF	From surgery until hospital discharge (average 7-10 days)
Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia	Any anticoagulation therapy or cardioversion performed for arrhythmia management	From surgery until hospital discharge (average 7-10 days)
Number of participants with cardiac tamponade requiring intervention	Clinically diagnosed cardiac tamponade requiring intervention	From date of surgery through 30 days postoperatively
Number of participants requiring surgical re-exploration for bleeding or tamponade	Any return to surgery for bleeding or tamponade relief	From date of surgery through 30 days postoperatively
Duration of Mechanical Ventilation (Hours)	Total hours under mechanical ventilation until successful extubation	From end of surgery until successful extubation (up to 72 hours postoperatively)
Duration of ICU stay (hours)	Total time in ICU from admission to transfer to ward	From ICU admission after surgery until transfer to ward (average of 1-4 days)
Duration of total hospital stay (days)	Days from surgery to discharge	From date of surgery until hospital discharge (average of 7-10 days)
Number of participants with in-hospital mortality (any cause)	Death from any cause during hospital stay	From date of surgery until hospital discharge (average of 7-10 days)
Number of participants experiencing major adverse cardiovascular events (MACE: stroke, myocardial infarction, or death)	Occurrence of stroke, myocardial infarction, or all-cause mortality	From date of surgery through 30 days postoperatively

Collaborators and Investigators

• Sponsor: Taiz University - Faculty of Medicine
• Investigators: Principal Investigator: Ismail S Al Shameri, MD, Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen

Publications and helpful links

General Publications

• Al-Shameri I, Al-Ganadi AA, Noman T, Kadry MA, Elsharkawy IM, Al-Wsabi N, Mohammed AA. Posterior Pericardiotomy and Its Impact on Cardiac Tamponade and Pericardial Effusion after Cardiac Surgery. Ann Thorac Cardiovasc Surg. 2025;31(1):25-00075. doi: 10.5761/atcs.oa.25-00075.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative atrial fibrillation; Yemen; Posterior pericardiotomy; Cardiac tamponade
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiac Tamponade; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: TaizU-PP-AF-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No