Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
Conditions
Keywords
Transcatheter Aortic Valve Implantation, Left bundle branch pacing
Brief summary
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).
Detailed description
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.
Interventions
DEVICELeft bundle branch pacemaker
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.
DEVICEConventional pacing
Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization) * Left ventricular ejection fraction \< 50 %.
Exclusion criteria
* Unsuccessful TAVI procedure with life expectancy \< 1 year * Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis) * Severe kidney failure (glomerular filtration rate \< 30 ml/min) * Previous permanent pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular diastolic diameter | 12 months | — |
| Global work index | 12 months | Amount of myocardial work performed by the left ventricle during systole. |
| Global constructive work | 12 months | Positive work performed in systole + negative work performed in isovolumetric relaxation |
| Global wasted work | 12 months | Negative work performed in systole + positive work performed in isovolumetric relaxation |
| Global work efficiency | 12 months | Percentage of constructive work over total work = Constructive work/(constructive work + wasted work) |
| Signs of mechanical dyssynchrony | 12 months | Presence of at least one of the echocardiographic signs of mechanical dyssynchrony, such as apical rocking and septal flash. |
| Left ventricular systolic diameter | 12 months | — |
| NT-proBNP concentration | 6 and 12 months | — |
| NYHA status | 6 and 12 months | — |
| 6-minute walking test | 6 and 12 months | — |
| Hand grip test | 6 and 12 months | — |
| The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | 6 and 12 months | 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. |
| QRS duration | baseline, 6, and 12 months | — |
| Systolic pulmonary artery pressure (echocardiographic parameter) | 12 months | — |
Countries
Slovenia
Outcome results
None listed