Dataset Information

Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial. METHODS AND ANALYSIS:This study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ?35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates. ETHICS AND DISSEMINATION:This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists. TRIAL REGISTRATION NUMBER:Chinese Clinical Trial Registry (ChiCTR2000028726).

SUBMITTER: Cheng L

PROVIDER: S-EPMC7517551 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.

Cheng Liting L Zhang Junmeng J Wang Zefeng Z Zhou Mengge M Liang Zhuo Z Zhao Lin L Chen Jieruo J Wu Yongquan Y

BMJ open 20200924 9

<h4>Introduction</h4>Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.<h4>Methods and analysis</h4>This study ...[more]

PMID: 32973057

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Project description:Background: Little is known about the efficacy of permanent left bundle branch area pacing (LBBAP) in delivering cardiac resynchronization therapy (CRT). This study aimed to evaluate the effect of LBBAP on mechanical synchronization and myocardial work (MW) in heart failure (HF) patients and to compare LBBAP with biventricular pacing (BVP). Methods: This is a multicenter, prospective cohort study. From February 2018 to January 2021, 62 consecutive HF patients with reduced ejection fraction (LVEF ≤ 35%) and complete left bundle branch block (CLBBB) who underwent LBBAP or BVP were enrolled in this study. Echocardiograms and electrocardiograms and were conducted before and 3-6 months after implantation. Intra- and interventricular synchronization were assessed using two-dimensional speckle tracking imaging (2D-STI). The left ventricular pressure-strain loop was obtained by combining left ventricular strain with non-invasive blood pressure to evaluate mechanical efficiency. Results: The echocardiographic response rates were 68.6 and 88.9% in the BVP and LBBAP groups, respectively. Left bundle branch area pacing resulted in significant QRS narrowing (from 177.1 ± 16.7 to 113.0 ± 18.4 ms, P < 0.001) and improvement in LVEF (from 29.9 ± 4.8 to 47.1 ± 8.3%, P < 0.001). The global wasted work (GWW) (410.3 ± 166.6 vs. 283.0 ± 129.6 mmHg%, P = 0.001) and global work efficiency (GWE) (64.6 ± 7.8 vs. 80.5 ± 5.7%, P < 0.001) were significantly improved along with shorter peak strain dispersion (PSD) (143.4 ± 45.2 vs. 92.6 ± 35.1 ms, P < 0.001) and interventricular mechanical delay (IVMD) (56.4 ± 28.5 vs. 28.9 ± 19.0 ms, P < 0.001), indicating its efficiency in improving mechanical synchronization. In comparison with BVP, LBBAP delivered greater improvement of QRS narrowing (-64.1 ± 18.9 vs. -32.5 ± 22.3 ms, P < 0.001) and better mechanical synchronization and efficiency. Conclusions: Left bundle branch area pacing was effective in improving cardiac function, mechanical synchronization, and mechanical efficiency and may be a promising alternative cardiac resynchronization therapy.

Project description:Background: Left bundle branch area pacing (LBBAP) is a novel pacing modality with stable pacing parameters and a narrow-paced QRS duration. We compared heart failure (HF) hospitalization events and echocardiographic measures between LBBAP and right ventricular pacing (RVP) in patients with atrioventricular block (AVB). Methods and Results: This multicenter observational study prospectively recruited consecutive AVB patients requiring ventricular pacing in five centers if they received LBBAP or RVP and had left ventricular ejection fraction (LVEF) >50%. Data on electrocardiogram, pacing parameters, echocardiographic measurements, device complications, and clinical outcomes were collected at baseline and during follow-up. The primary outcome was first episode hospitalization for HF or upgrade to biventricular pacing. LBBAP was successful in 235 of 246 patients (95.5%), while 120 patients received RVP. During a mean of 11.4 ± 2.7 months of follow-up, the ventricular pacing burden was comparable (83.9 ± 35.1 vs. 85.7 ± 30.0%), while the mean LVEF differed significantly (62.6 ± 4.6 vs. 57.8 ± 11.4%) between the LBBAP and RVP groups. Patients with LBBAP had significantly lower occurrences of HF hospitalization and upgrading to biventricular pacing than patients with RVP (2.6 vs. 10.8%, P <0.001), and differences in primary outcome between LBBAP and RVP were mainly observed in patients with ventricular pacing >40% or with baseline LVEF <60%. The primary outcome was independently associated with LBBAP (adjusted HR 0.14, 95% CI: 0.04-0.55), previous myocardial infarction (adjusted HR 6.82, 95% CI: 1.23-37.5), and baseline LVEF (adjusted HR 0.91, 95% CI: 0.86-0.96). Conclusion: Permanent LBBAP might reduce the risk of HF hospitalization or upgrade to biventricular pacing compared with RVP in AVB patients requiring a high burden of ventricular pacing. Clinical Trial Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03851315; URL: http://www.chictr.org.cn; Unique Identifier: ChiCTR2100043296.

Dataset Information

Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.

Publications

Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.

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