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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,000
IUCPQ
Québec, Quebec, Canada
RECRUITINGRate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm
Time frame: 1 year follow-up
Incidence of permanent pacemaker implantation
Time frame: At 30-day follow-up
Incidence of permanent pacemaker implantation
Time frame: At 1-year follow-up
Incidence of sudden death
Time frame: At 30-day follow-up
Incidence of sudden death
Time frame: At 1-year follow-up
Rate, timing of and reasons for permanent pacemaker implantation
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Time frame: Before hospital discharge (between 1 to 30 days)
Rate, timing of and reasons for permanent pacemaker implantation
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Time frame: At 30-day follow-up
Rate, timing of and reasons for permanent pacemaker implantation
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Time frame: At 1 year follow-up
Rate and timing of sudden death
Rate and timing of sudden death in each group of the pre-specified algorithm
Time frame: At 30-day follow-up
Rate and timing of sudden death
Rate and timing of sudden death in each group of the pre-specified algorithm
Time frame: At 1-year follow-up
Evaluation of arrhythmic events in patients with continuous ECG monitoring
Evaluation of arrhythmic events in patients with continuous ECG monitoring at hospital discharge
Time frame: After hospital discharge (up to 1-year)
Evaluation of the rate and timing of permanent pacemaker implantation
Time frame: After hospital discharge (up to 1-year)
Rate of PPI among valve types
Compare rate of permanent pacemaker implantation among different valve types
Time frame: At 30-day follow-up
Rate of PPI among valve types
Compare rate of permanent pacemaker implantation among different valve types
Time frame: At 1-year follow-up
Pace dependency and pacing rate
Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)
Time frame: At 30-day follow-up
Pace dependency and pacing rate
Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)
Time frame: At 1-year follow-up
Factors associated with sudden death or permanent pacemaker implantation
Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group
Time frame: At 30-day follow-up
Factors associated with sudden death or permanent pacemaker implantation
Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group
Time frame: At 1-year follow-up
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