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

IntroductionLeft 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 analysisThis 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 disseminationThis 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 numberChinese Clinical Trial Registry (ChiCTR2000028726).

Left Bundle Branch Area Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy: A Meta-Analysis

“…Firstly, as a meta-analysis of non-randomized controlled studies, although key variables have been frequency-matched, we acknowledged that the potential imbalance of other clinical characteristic of the patients may confound the findings. Ongoing RCTs may validate our findings ( 27 ). Secondly, the number of studies and patients is quite limited, whereas the findings of the studies seemed very consistent.…”

Left bundle branch pacing for cardiac resynchronization therapy: A systematic literature review and meta‐analysis

“…The LBBP‐RESYNC (Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy, NCT04110431) study randomized 40 patients that need CRT in two centers to LBBP or BVP, and the therapeutic effects of LBBP and BVP on LV function and clinical endpoints may recently publish. Additionally, Cheng et al 18 reported a single‐center RCT. This study will consecutively enroll 180 patients with HF and LBBB into LBBP or BVP group (randomized at a 1:1 ratio) from January 2020 to December 2022.…”

“…LBBP is an innovation aimed at pacing the LBB conduction system, which could preserve satisfactory LV synchrony and lead to instantly favorable hemodynamic effects 19 . Moreover, LBBP could deliver similar LV electrical and mechanical synchrony compared with either native sinus rhythm or HBP, 18 and most importantly has a better sensing of R‐wave amplitude, a lower and stable pacing threshold and a further but physiological pacing site in case of developing conduction disease. Additionally, LBBP provide more anatomical space for atrioventricular node (AVN) ablation in patients with AF and cardiomyopathy.…”

The year in cardiovascular medicine 2020: arrhythmias

“…Trenutačno je u tijeku prospektivno randomizirano istraživanje u Kini. 49 Nasljedne bolesti srca, procjena rizika, implantabilni kardioverterski defibrilatori i iznenadna smrt…”

“…A prospective randomized study is currently performed in China. 49 inherited cardiac conditions, risk assessment, implantable defibrillators, and sudden death A novel approach to the diagnosis of Brugada syndrome (BrS) described the utilization of autoantibody screening for α-cardiac actin, α-skeletal actin, keratin, and connexin-43. In total, 18/18 BrS subjects demonstrated this autoantibody profile vs. 0/8 normal controls and 0/20 cardiomyopathy cases, which included arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM), and dilated cardiomyopathy (DCM) patients.…”