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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional: Posterior Pericardiotomy | Experimental | 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. |
|
| Control: Standard Care | Active Comparator | Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior Pericardiotomy | Procedure | A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Coronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismail S Al Shameri, MD | Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular & Kidney Transplantation Centre, Taiz University, Taiz, Yemen | Taiz | Muḩāfaz̧at Ta‘izz | Yemen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40603058 | Background | 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. |
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| ID | Term |
|---|---|
| D002305 | Cardiac Tamponade |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Outcome assessors were blinded to the treatment group; participants and care providers were aware of the intervention.
| Standard Care | Procedure | Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided. |
|
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 |