Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- Incidence of NOP-LBBB (new onset of persistent left bundle branch block)
Study Overview
Brief Summary
This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.
It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •rapid-deployment aortic valve replacement (RD-AVR) with the Edwards Intuity™ bioprosthesis for severe aortic valve stenosis
- •between July 2012 and May 2018
Exclusion Criteria
- •preoperative permanent pacemaker or defibrillator,
- •complete intraventricular conductive disorder defined by a QRS width ≥ 120 ms.
- •absence of patient's authorization for anonymous publication of their clinical data for research purposes.
Outcomes
Primary Outcomes
Incidence of NOP-LBBB (new onset of persistent left bundle branch block)
Time Frame: at 1 year
QRS duration ≥ 120 ms with QS or rS patterns on the V1 lead, a large notched R wave in D1, aVL, V5 and V6 and the absence of Q wave in V5 and V6, according to the recommendations of the American Heart Association. NOP-LBBB was persistence of LBBB on the 12-lead recording electrocardiogram (ECG) at discharge from hospital.
Secondary Outcomes
No secondary outcomes reported