Conduction Disturbances, Permanent Pacemaker Implantation, Transcatheter Aortic Valve Replacement
Conditions
Keywords
atrioventricular block, complete heart block, high-degree atrioventricular block, intraventricular conduction delay, left bundle branch block, Permanent pacemaker implantation, Right bundle branch block
Brief summary
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. The implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-TAVR applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. This may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with TAVR. In the end, the final objective of a pre-specified strategy for managing conduction disturbances post-TAVR should be to obtain a low rate of PPM without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the TAVR procedure.
Detailed description
The objectives of the study are: * Feasibility: to validate and determine the applicability of a pre-specified algorithm for managing conduction disturbances in consecutive patients undergoing TAVR, also evaluating the percentage of patients included in each group of the algorithm strategy. * Efficacy: (i) to evaluate the rate of permanent pacemaker implantation in-hospital and at 30 days compared to that of the year prior to the implementation of the protocol, (ii) to determine the incidence of sudden death at 30 days and at 1-year follow-up.
Interventions
None listed
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Patients with aortic valve disease undergoing transcatheter aortic valve replacement
Exclusion criteria
* Prior permanent pacemaker * Failure to provide signed informed consent for data collection * Impossibility for a follow-up * Unwillingness to follow the pre-specified strategy for the management of conduction disturbances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm | 1 year follow-up |
| Incidence of permanent pacemaker implantation | At 30-day follow-up |
| Incidence of sudden death | At 30-day follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate, timing of and reasons for permanent pacemaker implantation | Before hospital discharge (between 1 to 30 days) | Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm |
| Rate and timing of sudden death | At 30-day follow-up | Rate and timing of sudden death in each group of the pre-specified algorithm |
| Evaluation of arrhythmic events in patients with continuous ECG monitoring | After hospital discharge (up to 1-year) | Evaluation of arrhythmic events in patients with continuous ECG monitoring at hospital discharge |
| Evaluation of the rate and timing of permanent pacemaker implantation | After hospital discharge (up to 1-year) | — |
| Rate of PPI among valve types | At 30-day follow-up | Compare rate of permanent pacemaker implantation among different valve types |
| Pace dependency and pacing rate | At 30-day follow-up | Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm) |
| Factors associated with sudden death or permanent pacemaker implantation | At 30-day follow-up | Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group |
Countries
Canada
Contacts
CONTACTJosep Rodes-Cabau, MD
CONTACTMelanie Cote, MSc
Outcome results
None listed