Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.
In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Implantation of a left bundle branch pacing lead via sheath
Active fixation lead (standard)
University Hospital of Patras
Pátrai, Rion, Greece
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Procedure Time (min)
The total time required for the completion of the procedure
Time frame: 1 Day of procedure
Fluoroscopy Time (min)
The total time of fluoroscopy
Time frame: 1 Day of procedure
Dose Area Product (DAP) (cGy/cm2)
Total Radiation Dose as expressed with DAP
Time frame: 1 Day of procedure
Implant success
Successful implantation with pacing threshold\<2 V
Time frame: 1 Day of procedure
Complications associated with pacemaker implantation
General device related complications: pneumothorax, hemothorax, infection, tamponade, hematoma, lead reoperation Specific complications associated with the left bundle branch pacing procedure: intraventricular septum rupture, septal perforator branch injury with subsequent myocardial infarction or lead displacement
Time frame: through study completion at 1 year post randomisation
B natriuretic peptide measurement (pg/ml)
Blood samples are extracted in all patients at baseline, 3 months, 6 months and one year after the procedure
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Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Stroke volume index (SVi) (ml/m2)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the SVi will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Ejection Fraction (EF) (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the EF will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Longitudinal Strain (GLS) (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the GLS will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain Rate (1/s)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain Rate will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Aortic Time- Velocity Integral (TVI) (cm)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the aortic TVI will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Work Index (GWI) (mmHg%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWI will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Constructive Work (GCW) (mmHg%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GCW will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Wasted Work (GWW) (mmHg%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWW will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the mid septal wall
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the mid septal wall will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the basal lateral wall
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the basal lateral wall will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Peak Strain Dispersion (PSD) (msec)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and PSD will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in capture threshold (V) in the ventricular lead
The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and the potential changes in capture threshold in the ventricular lead will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in sense (mV) in the ventricular lead
The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and potential changes in sense in the ventricular lead will be recorded
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure