Left Bundle Branch Area Pacing in AVB Patients

Overview

Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.

Full Title of Study: “Permanent Left Bundle Branch Area Pacing for Atrioventricular Block”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Detailed Description

This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.

Interventions

  • Device: permanent left bundle branch area pacing
    • Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.

Arms, Groups and Cohorts

  • LBBAP group
    • patients received left bundle branch area pacing
  • traditional RVP group
    • Age and sex-matched patients received traditional right ventricular pacing

Clinical Trial Outcome Measures

Primary Measures

  • The synchronization status change at 3 months and 1 year as compared with baseline status.
    • Time Frame: 3 months and 1 year
    • Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.

Secondary Measures

  • Pacing threshold change at 3 months and 1 year as compared with baseline status.
    • Time Frame: 3 months and 1 year
    • The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status.
  • LBBAP related adverse events at 3 months and 1 year as compared with baseline status.
    • Time Frame: 3 months and 1 year
    • The adverse events includes perforation, acute myocardial infarction, loss of capture, increase of pacing threshold, et al. These events were evaluated at baseline, 3 months and 1 year after the procedure, respectively.
  • left ventricular ejection fraction change at 3 months and 1 year
    • Time Frame: 3 months and 1 year
    • Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.
  • Right ventricular ejection fraction change at 3 months and 1 year
    • Time Frame: 3 months and 1 year
    • Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.
  • Left ventricular end systolic diameter change at 3 months and 1 year
    • Time Frame: 3 months and 1 year
    • Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation.
  • Left ventricular end diastolic diameter change at 3 months and 1 year
    • Time Frame: 3 months and 1 year
    • Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation.

Participating in This Clinical Trial

Inclusion Criteria

1. Age over 18 years old; 2. Atrioventricular block patients with indication for permanent ventricular pacing; 3. LVEF> 40%; 4. With informed consent signed Exclusion Criteria:

1. Persistent atrial fibrillation; 2. Moderate or more severe valvular disease; 3. Hypertrophic cardiomyopathy; 4. Myocardial amyloidosis; 5. With indication for CRT or ICD implantation according to the current guideline; 6. Poor condition of the acoustic window because of emphysema or other reasons; 7. Patients refused postoperative follow-up.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fu Wai Hospital, Beijing, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fan Xiaohan, MD., PhD., Professor of Medicine, Deputy Director of Arrhythmia Center in Fuwai hospital – Chinese Academy of Medical Sciences, Fuwai Hospital

References

Vijayaraman P, Naperkowski A, Ellenbogen KA, Dandamudi G. Electrophysiologic Insights Into Site of Atrioventricular Block: Lessons From Permanent His Bundle Pacing. JACC Clin Electrophysiol. 2015 Dec;1(6):571-581. doi: 10.1016/j.jacep.2015.09.012. Epub 2015 Oct 17.

Citations Reporting on Results

Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.

Chen K, Li Y, Dai Y, Sun Q, Luo B, Li C, Zhang S. Comparison of electrocardiogram characteristics and pacing parameters between left bundle branch pacing and right ventricular pacing in patients receiving pacemaker therapy. Europace. 2019 Apr 1;21(4):673-680. doi: 10.1093/europace/euy252.

Guo XG, Liu X, Zhou GB, Sun Q, Yang JD, Luo B, Ouyang F, Ma J, Zhang S. Clinical, electrocardiographic, and electrophysiological characteristics of left upper septal fascicular ventricular tachycardia. Europace. 2018 Apr 1;20(4):673-681. doi: 10.1093/europace/euw429.

Upadhyay GA, Cherian T, Shatz DY, Beaser AD, Aziz Z, Ozcan C, Broman MT, Nayak HM, Tung R. Intracardiac Delineation of Septal Conduction in Left Bundle-Branch Block Patterns. Circulation. 2019 Apr 16;139(16):1876-1888. doi: 10.1161/CIRCULATIONAHA.118.038648.

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