Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen

Taiz University - Faculty of Medicine210 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

210

Conditions

Postoperative Atrial Fibrillation

Interventions

Posterior PericardiotomyPROCEDURE

A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.

Standard CarePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiovascular & Kidney Transplantation Centre, Taiz University, Taiz, Yemen

Taiz, Muḩāfaz̧at Ta‘izz, Yemen

Outcomes

Primary Outcomes

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.

Time frame: During hospitalization, approximately 5-7 days

Secondary Outcomes

Number of participants requiring postoperative antiarrhythmic medications

Any antiarrhythmic therapy administered postoperatively to manage POAF

Time frame: 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

Time frame: From surgery until hospital discharge (average 7-10 days)

Number of participants with cardiac tamponade requiring intervention

Clinically diagnosed cardiac tamponade requiring intervention

Time frame: 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

Time frame: From date of surgery through 30 days postoperatively

Duration of Mechanical Ventilation (Hours)

Total hours under mechanical ventilation until successful extubation

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From date of surgery through 30 days postoperatively

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.