Cardiac Tamponade, Postoperative Atrial Fibrillation
Conditions
Keywords
Posterior pericardiotomy, Postoperative atrial fibrillation, Cardiac tamponade, Yemen
Brief summary
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.
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.
Interventions
PROCEDUREPosterior Pericardiotomy
A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.
PROCEDUREStandard Care
Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.
Sponsors
Taiz University - Faculty of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors were blinded to the treatment group; participants and care providers were aware of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge | During hospitalization, approximately 5-7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia | From surgery until hospital discharge (average 7-10 days) | Any anticoagulation therapy or cardioversion performed for arrhythmia management |
| Number of participants with cardiac tamponade requiring intervention | From date of surgery through 30 days postoperatively | Clinically diagnosed cardiac tamponade requiring intervention |
| Number of participants requiring surgical re-exploration for bleeding or tamponade | From date of surgery through 30 days postoperatively | Any return to surgery for bleeding or tamponade relief |
| Duration of Mechanical Ventilation (Hours) | From end of surgery until successful extubation (up to 72 hours postoperatively) | Total hours under mechanical ventilation until successful extubation |
| Number of participants requiring postoperative antiarrhythmic medications | From surgery until hospital discharge (average 7-10 days) | Any antiarrhythmic therapy administered postoperatively to manage POAF |
| Duration of total hospital stay (days) | From date of surgery until hospital discharge (average of 7-10 days) | Days from surgery to discharge |
| Number of participants with in-hospital mortality (any cause) | From date of surgery until hospital discharge (average of 7-10 days) | Death from any cause during hospital stay |
| Number of participants experiencing major adverse cardiovascular events (MACE: stroke, myocardial infarction, or death) | From date of surgery through 30 days postoperatively | Occurrence of stroke, myocardial infarction, or all-cause mortality |
| Duration of ICU stay (hours) | From ICU admission after surgery until transfer to ward (average of 1-4 days) | Total time in ICU from admission to transfer to ward |
Countries
Yemen
Outcome results
None listed