This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).
Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.
Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %
University Medical Centre Ljubljana
Ljubljana, Slovenia
Left ventricular ejection fraction
Time frame: 12 months
Left ventricular systolic diameter
Time frame: 12 months
Left ventricular diastolic diameter
Time frame: 12 months
Global work index
Amount of myocardial work performed by the left ventricle during systole.
Time frame: 12 months
Global constructive work
Positive work performed in systole + negative work performed in isovolumetric relaxation
Time frame: 12 months
Global wasted work
Negative work performed in systole + positive work performed in isovolumetric relaxation
Time frame: 12 months
Global work efficiency
Percentage of constructive work over total work = Constructive work/(constructive work + wasted work)
Time frame: 12 months
Signs of mechanical dyssynchrony
Presence of at least one of the echocardiographic signs of mechanical dyssynchrony, such as apical rocking and septal flash.
Time frame: 12 months
Systolic pulmonary artery pressure (echocardiographic parameter)
Time frame: 12 months
NT-proBNP concentration
Time frame: 6 and 12 months
NYHA status
Time frame: 6 and 12 months
6-minute walking test
Time frame: 6 and 12 months
Hand grip test
Time frame: 6 and 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: 6 and 12 months
QRS duration
Time frame: baseline, 6, and 12 months
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