Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn whether temporary atrial pacing improves heart function after cardiac surgery under cardiopulmonary bypass (CPB). It will also help determine the best pacing rate during the first 24 hours after surgery. The main questions it aims to answer are:
Cardiac surgery under cardiopulmonary bypass (CPB) frequently leads to immediate postoperative rhythm or conduction disturbances, especially atrial fibrillation or atrioventricular block (AV Block), along with hemodynamic instability and transient reduction in cardiac output due to myocardial contractility impairment.
Temporary pacing wires are placed in the operating room and have been used since the 1960s to manage cardiac conduction disorders in these patients, allowing for atrial (AAI) or dual-chamber (DDD) pacing if necessary. Atrial pacing, by restoring synchronized atrial contraction with ventricular filling, helps maintain optimal cardiac output.
Cardiac output is defined as the product of heart rate (HR) and stroke volume (SV). To optimize cardiac output, increasing heart rate is possible, hence the need for atrial pacing.
A pacing rate slightly higher than spontaneous sinus rhythm appears to prevent pauses, limit rhythm instability, and reduce the risk of atrial fibrillation. However, the optimal pacing rate postoperatively has not been clearly defined, and data comparing different rates (70, 80, or 90 bpm) are scarce.
In our center, postoperative atrial pacing is nearly routine and commonly set at 90 bpm, a rate we consider optimal due to its alignment with the Frank-Starling curve. This rate maximizes venous return and stroke volume, thereby optimizing postoperative cardiac output.
Nevertheless, several studies have suggested that routine postoperative temporary pacing wire insertion may not always be necessary and should be reserved for patients identified as high-risk for postoperative rhythm disturbances.
Nowadays, in many international centers, the absence of routine temporary pacing has become the norm. Although 90 bpm is theoretically the optimal rate for atrial pacing, important questions remain: Is postoperative pacing absolutely necessary? If so, could a rate lower than 90 bpm suffice to maintain adequate hemodynamic profile (HDP)?
This study aims at determining whether routine temporary pacing is necessary during the first 24 hours after cardiac surgery under CPB, and what the optimal pacing rate is (AAI or DDD: 70 bpm vs. 80 bpm vs. 90 bpm) in terms of its impact on the HDP.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacing Group | Placebo Comparator | Patients in this group receive continuous atrial pacing at 90 bpm during the first 24 postoperative hours (outside of evaluation sequences). |
|
| Non-Pacing Group | Active Comparator | Patients in this group remain in their spontaneous sinus rhythm outside of the evaluation sequences. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing Protocol for Pacing Group | Procedure | At four standardized time points (H0: arrival in the ICU, H6, H12, H24), a transient pacing sequence at 70, 80, and 90 bpm is conducted, with each rate applied for 10 minutes to allow stabilization, followed by recording of the hemodynamic profile and blood pressure, as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the impact of different pacing rates on cardiac index measured by Swan-Ganz catheter in the postoperative period following cardiac surgery under cardiopulmonary bypass at H0, H6, H12, and H24. | To evaluate the impact of different pacing rates (50-69 bpm [Category 1], 70-79 bpm [Category 2], 80-89 bpm [Category 3], ≥ 90 bpm [Category 4]) on cardiac index measured by Swan-Ganz catheter in the postoperative period following cardiac surgery under cardiopulmonary bypass (CPB), at H0, H6, H12, and H24. | 24 hours after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether atrial pacing reduces the incidence of atrial fibrillation in the pacing group compared to the non-pacing group in the postoperative period after cardiac surgery under CPB | 24 hours after the surgery | |
| To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on cardiac index measured by Swan-Ganz catheter in patients with heart failure following cardiac surgery under CPB |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rhea Mattar | Contact | +96171464840 | rhea.mattar@net.usj.edu.lb | |
| Joanna Tohme | Contact | +96170492735 | joanna.tohme1@usj.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Samia Jebara | Saint Joseph University of Beirut | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia and Critical Care, Hôtel-Dieu de France Hospital | Recruiting | Beirut | Lebanon |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, randomized, controlled, comparative, single-center study
Not provided
Not provided
Not provided
|
| Pacing Protocol for Non-pacing Group | Procedure | At H0, H6, H12, and H24, they will undergo transient pacing at 70, 80, and 90 bpm, following the same measurement protocol (10 minutes per rate), followed by recording of the hemodynamic profile and blood pressure, as follows:
Outside the pacing periods at different rates, patients in the non-pacing group will remain on their spontaneous sinus rhythm. |
|
| 24 hours after the surgery |
| To assess the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on mean arterial pressure in the postoperative period after cardiac surgery under CPB | 24 hours after the surgery |
| To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on systemic vascular resistance measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB | 24 hours after the surgery |
| To assess the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on stroke volume measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB | 24 hours after the surgery |
| To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on left and right ventricular work measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB | 24 hours after the surgery |