Left Bundle-Branch Block, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Transcatheter Aortic Valve Implantation
Conditions
Keywords
algorithm to predict delayed high-grade conduction disturbances after transcatheter aortic valve implantation, Right Bundle-Branch Block, Left Bundle-Branch Block, transcatheter aortic valve implantation
Brief summary
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited. The research team hypothesized that a rationalized strategy combining ECG findings with simple pre-procedural computed tomography (CT), derived criteria and implantation depth of the device, could improve risk stratification, reduce unnecessary pacemaker implantation (PPI) and preserve patient safety. The investigator conducted a retrospective, multicenter study including 209 consecutive participants who underwent TAVR between February 2023 and September 2024 who were free from permanent pacemaker implantation at discharge. The investigator evaluated the performance of an ECG-based risk stratification algorithm previously described associated with pre-procedural CT parameters, including (membranous septum length, extent of valvular and subvalvular calcifications) and implantation depth. The primary endpoint was the incidence of severe delayed conduction disturbances (including high-grade or complete atrioventricular block, severe or symptomatic bradycardia requiring Permanent Pacemaker Implantation (PPI)) occurring at 3 months in patients according to the presence or absence of risk criteria defined by the algorithm. Secondary endpoints included the algorithm's positive and negative predictive values, assessment of non-syncopal conduction disorders, impact on post-procedural intensive care admission, timing of delayed conduction disturbances, delayed elective pacemaker indications, all-cause and cardiovascular mortality, and cardiac-related rehospitalizations.
Interventions
OTHERretrospective health data collection
Data collected from the medical records of patients followed in the participating centers Pre- and post-TAVI conduction disturbances that did not warrant in-hospital permanent pacemaker implantation, including: age, sex, key care dates (procedure, discharge, follow-up visits). Cardiac CT anatomy: membranous septum length; location/extent of valvular and LVOT calcifications Procedural details: annular perimeter/area; device implantation depth; device oversizing vs annulus. Clinical course \& outcomes: non-syncopal conduction disturbances; ICU stay (need and impact); timing of delayed conduction disturbances; delayed/elective PPI indications (e.g., persistent left bundle branch block (LBBB) with heart failure); mortality (all-cause and cardiovascular); cardiac rehospitalizations; survival status at follow-up. 12-lead ECGs, cardiac CT, medical reports, medical history.
Sponsors
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any patient aged over 18 years * underwent TAVI, regardless of the access route and valve type * discharged from the hospital without a pacemaker
Exclusion criteria
* Patients with a pre-existing pacemaker prior to TAVI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe delayed conduction disturbances occurring at 3 months in patients according to the presence or absence of risk criteria | From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024 | Percentage of participants discharged without a permanent pacemaker who develop a severe delayed conduction disturbance within 3 months, defined as high-grade AV (atrioventricular) block or severe/symptomatic bradyarrhythmia (e.g., sinus node dysfunction or atrial fibrillation (AF) with ventricular rate \<40 bpm) requiring therapeutic intervention (medication change, unplanned hospitalization, temporary or permanent pacemaker). Events are ascertained from ECGs/clinical assessments/records at routine \~1- and \~3-month follow-up and reported overall and stratified by the protocol-defined risk algorithm (ECG, cardiac CT anatomy-including membranous septum length and valvular/LVOT calcifications-and implantation depth). |
Countries
France
Outcome results
None listed