Study on Heart Block Risks Using Outcome-Based Modeling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2025-06-26

Brief Summary

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This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis (AS). Analyzing 112 patients from Sun Yat-sen Memorial Hospital (2017-2024), the study incorporated clinical, electrocardiographic, and procedural variables to identify risk factors via logistic regression. A nomogram was constructed and validated internally (bootstrapping) and externally (temporal validation), with performance assessed using AUC, C-index, and calibration tests. The model aims to improve preoperative risk stratification and guide individualized management for TAVR-related conduction disturbances in this understudied population. Analyses were conducted in R 4.2.3 (significance: \*p\* \< 0.05).

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Detailed Description

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In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive surgical approach and has gradually become a standard treatment option for patients with moderate to severe aortic stenosis（AS), particularly those at high surgical risk or deemed ineligible for conventional surgery. TAVR has been widely adopted in clinical practice.

However, post-TAVR cardiac conduction disturbances are among the most frequently observed complications, particularly complete left bundle branch block (CLBBB) and high-degree atrioventricular block (AVB) requiring permanent pacemaker implantation (PPI). These complications are associated with an increased risk of heart failure and cardiac mortality. Identified risk factors include patient-specific characteristics, electrocardiographic features, intraoperative procedural techniques, and the type of device used.

Current research on post-TAVR conduction disorders predominantly focuses on Western populations. However, Chinese AS patients exhibit distinct clinical features-such as higher degrees of valve calcification and a higher prevalence of bicuspid aortic valves-which may lead to differences in risk factors for conduction abnormalities. Moreover, prior studies have largely focused on isolated risk factors rather than developing integrated models to quantify the risk of such complications. Against this backdrop, the purpose of this study is to address the knowledge gap in postoperative risk prediction for Chinese patients. By constructing a risk prediction model tailored to Chinese AS patients for post-TAVR cardiac conduction block, we aim to improve preoperative risk assessment and individualized clinical management, thereby providing actionable guidance for clinical decision-making.

This study included 112 aortic stenosis patients undergoing TAVR at Sun Yat-sen Memorial Hospital (2017-2024), divided into internal (2017-2022) and external (2023-2024) validation cohorts.

Data covered demographics, medical history, ECG, echocardiography, biomarkers, and valve parameters. Outcomes were permanent pacemaker implantation (PPI) ≤48h post-TAVR and complete left bundle branch block (CLBBB).

Univariate logistic regression (p\<0.20 threshold) and stepwise multivariate analysis (R "MASS" package, AIC-based) identified predictors for nomogram development. Model performance was assessed via AUC, C-index, ROC, and Hosmer-Lemeshow test. Internal validation used 1000 bootstrap resamples; external validation employed temporal validation. Analyses were performed in R 4.2.3 (significance: p\<0.05).

Conditions

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Left Bundle-Branch Block Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Permanent pacemaker implantation after TAVR surgery

The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Intervention Type OTHER

The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Complete left bundle branch block occurred after TAVR surgery

The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Intervention Type OTHER

The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Interventions

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The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years old) with severe symptomatic aortic stenosis (AS) meeting 2021 ESC/EACTS Guidelines and Chinese Expert Consensus criteria (AVA \<1.0 cm², or peak jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg)
* Scheduled to undergo transcatheter aortic valve replacement (TAVR) in Sun Yat-Sen Memorial Hospital

Exclusion Criteria

* Pre-existing complete left bundle branch block (CLBBB) on baseline ECG
* Patients with pre-existing permanent pacemaker implantation
* Inability to comply with follow-up protocol

Eligible Sex

ALL

Accepts Healthy Volunteers

No