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This is a prospective, randomized study to compare the effects of Bachmann bundle pacing (BBP) versus conventional right atrial appendage (RAA) pacing on atrial electromechanical synchrony in patients with sick sinus syndrome (SSS). The study utilizes two-dimensional speckle tracking imaging (2D-STI) to assess improvements in cardiac function and synchrony, aiming to determine a more optimal pacing site for SSS patients.
Sick sinus syndrome (SSS) is a common indication for permanent pacemaker implantation. Conventional right atrial appendage (RAA) pacing, however, is non-physiological and may lead to atrial conduction delays, atrial remodeling, and an increased risk of atrial fibrillation. Bachmann bundle pacing (BBP) is emerging as a more physiological pacing strategy that may correct atrial conduction delays and improve electromechanical synchronization. This study prospectively enrolled and randomized 72 patients with SSS to receive either BBP or RAA pacing. The primary objective is to evaluate the differences in atrial synchrony, cardiac function, and pacing parameters between the two groups at baseline, 1-month, and 3-month follow-ups, using electrocardiography and two-dimensional speckle tracking imaging (2D-STI). The study aims to provide evidence for BBP as a superior treatment option for improving long-term outcomes in SSS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bachmann Bundle Pacing (BBP) Group | Experimental | Patients were randomized to receive a permanent pacemaker with the atrial lead placed in the Bachmann bundle region. They were followed up at 1 month and 3 months post-procedure. |
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| Right Atrial Appendage (RAA) Pacing Group | Active Comparator | Patients were randomized to receive a permanent pacemaker with the atrial lead placed in the conventional right atrial appendage. They were followed up at 1 month and 3 months post-procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bachmann Bundle Pacing | Device | Implantation of a permanent pacemaker system. The atrial lead (Medtronic 3830 active electrode) is surgically positioned and fixed in the Bachmann bundle region, located at the angle between the superior vena cava and the atrium in the mid-posterior position of the high atrial septum. Successful placement is confirmed by achieving a P-wave width shortening of at least 30ms compared to the preoperative P-wave. The ventricular lead is positioned in the mid-to-lower portion of the ventricular septum. Pacing parameters are measured and confirmed to be good. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inter-atrial Electromechanical Delay (Inter AEMD) | Measured by two-dimensional speckle tracking imaging (2D-STI) as the time difference between the onset of the P-wave on the electrocardiogram (ECG) and the peak longitudinal strain of the lateral walls of the right and left atria. A smaller value indicates better inter-atrial synchrony. | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Intra-atrial Mechanical Delay (IAMD) | Measured by 2D-STI as the standard deviation of the time-to-peak longitudinal strain of six segments of the left atrium. A smaller value indicates better intra-atrial synchrony. | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Intra-right Atrial Electromechanical Delay (Intra-right AEMD) | Measured by 2D-STI as the time difference between the earliest and latest peak longitudinal strain within the right atrium segments. | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in P-wave Duration (PWD) and Morphology | Measured from the 12-lead surface ECG, including P-wave duration (P-AT, P-Am) and P-wave axis (P-aI, P-aL). | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Change in QRS Duration and Axis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongquan Wu | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Shiyan | Hubei | 442000 | China |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Right Atrial Appendage Pacing | Device | Implantation of a permanent pacemaker system using the conventional technique. The atrial active electrode is surgically positioned and fixed in the right atrial appendage. The ventricular lead is placed in the mid-to-lower portion of the ventricular septum. Pacing parameters (sensing > 2.0mV; impedance between 300 to 1000Ω; threshold < 1.5mV) are confirmed to be good. |
|
Measured from the 12-lead surface ECG.
| Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Left Atrial (LA) and Right Atrial (RA) Dimensions | Measured by standard 2D echocardiography. | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Left Ventricular End-Systolic Diameter (LVESD) and End-Diastolic Diameter (LVEDD) | Measured by standard 2D echocardiography. | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Left Atrial Strain Parameters | Includes left atrial reservoir strain (LASr), conduit strain (LAScd), and contraction strain (LASct), measured by 2D-STI. | Baseline, 1 Month Post-procedure, 3 Months Post-procedure |
| Recurrence of Atrial Arrhythmia | Number of patients experiencing newly developed or recurrent atrial fibrillation or atrial tachycardia. | Up to 1 year |
| Change in Atrial Pacing Threshold | Measured via pacemaker programmer interrogation. Unit: millivolts (mV). | 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Atrial Sensing (P-wave amplitude) | Measured via pacemaker programmer interrogation. Unit: millivolts (mV). | 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Atrial Pacing Impedance | Measured via pacemaker programmer interrogation. Unit: Ohms (Ω). | 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Ventricular Pacing Threshold | Measured via pacemaker programmer interrogation. Unit: millivolts (mV). | 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Ventricular Sensing (R-wave amplitude) | Measured via pacemaker programmer interrogation. Unit: millivolts (mV). | 1 Month Post-procedure, 3 Months Post-procedure |
| Change in Ventricular Pacing Impedance | Measured via pacemaker programmer interrogation. Unit: Ohms (Ω). | 1 Month Post-procedure, 3 Months Post-procedure |
| Percentage of Ventricular Pacing | Measured via pacemaker programmer interrogation. Unit: Percentage (%). | 1 Month Post-procedure, 3 Months Post-procedure |
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |