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Comparison of His–Purkinje Conduction System Pacing with Atrial–Ventricular Node Ablation and Pharmacotherapy in HFpEF Patients with Recurrent Persistent Atrial Fibrillation (HPP-AF study)

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Abstract

Background

There is currently no particularly effective strategy for patients with persistent atrial fibrillation accompanying heart failure with preserved ejection fraction (HFpEF), especially with recurrent atrial fibrillation after ablation. In this study, we will evaluate a new treatment strategy for patients with persistent atrial fibrillation who had at least two attempts (≧2 times) of radio-frequency catheter ablation but experienced recurrence, and physiologic conduction was reconstructed after atrioventricular node ablation or drug therapy, to control the patient's ventricular rate to maintain a regular heart rhythm, which is called His–Purkinje conduction system pacing (HPCSP) with atrioventricular node ablation.

Methods and results

This investigator-initiated, multicenter prospective randomized controlled trial aimed to recruit 296 randomized HFpEF patients with recurrent atrial fibrillation. All the enrolled patients were randomly assigned to the pacing group or the drug treatment group. The primary endpoint is differences in cardiovascular events and clinical composite endpoints (all-cause mortality) between patients in the HPCSP and drug-treated groups. Secondary endpoints included heart failure hospitalization, exercise capacity assessed by cardiopulmonary exercise tests, quality of life, echocardiogram parameters, 6-minute walk distance, NT-ProBNP, daily patient activity levels, and heart failure management report recorded by the CIED. It is planned to compete recruitment by the end of 2023 and report in 2025.

Conclusions

The study aims to determine whether His–Purkinje conduction system pacing with atrioventricular node ablation can better improve patients' symptoms and quality of life, postpone the progression of heart failure, and reduce the rate of rehospitalization and mortality of patients with heart failure.

Clinical trial registration number: ChiCTR1900027723, URL:http://www.chictr.org.cn/edit.aspx?pid=46128&htm=4

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Data Availability (Data Transparency)

The clinical trial registration number is ChiCTR1900027723, the data can be tracked at the following website, Chinese Clinical Trial Registry. URL:http://www.chictr.org.cn/edit.aspx?pid=46128&htm=4.

Code Availability (Software Application or Custom Code)

Not applicable.

Abbreviations

AF:

Atrial fibrillation

HF:

Heart failure

HFpEF:

Heart failure with preserved ejection fraction

HFrEF:

Heart failure with reduced ejection fraction

LV:

Left ventricle

CA:

Catheter ablation

MRA:

Mineralocorticoid receptor antagonist

RFCA:

Radio-frequency catheter ablation

AAD:

Antiarrhythmic drugs

AVNA:

Atrioventricular node ablation

SGLT2:

Sodium-dependent glucose cotransporter 2

ODT:

Optimized drug therapy

RVP:

Right ventricular pacing

CRT:

Cardiac resynchronization therapy

HPCSP:

His–Purkinje conduction system pacing

HBP:

His-bundle pacing

LBBB:

Left bundle branch block

LVEDD:

Left ventricular end diastolic diameter

LVEF:

Left ventricular ejection fraction

NDHP-CCB:

Non dihydropyridine-calcium blocker

LBBP:

Left bundle branch pacing

QOL:

Quality of life

BNP:

B-type natriuretic protein

NT-proBNP:

N-terminal pro-B-type natriuretic peptide

LVH:

Left ventricular hypertrophy

LAE:

Left atrial enlargement

HR:

Heart rate

INR:

International normalized ratio

ECG:

Electrocardiogram;

RAO:

Right anterior oblique

Stim-LVAT:

Stimulus to left ventricular activation time

LBB:

Left bundle branch

AVB:

Atrioventricular block

CPET:

Cardiopulmonary exercise test

OUES:

Oxygen uptake efficiency slope

VE/VCO2:

Ventilation/volume of carbon dioxide released

CIED:

Cardiovascular implantable electronic device

MLHFQ:

Minnesota Living with Heart Failure Questionnaire

GLM:

Generalized linear model

RBBB:

Right bundle branch block

AVD:

AV delay

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Acknowledgements

We would like to thank Dr. Xiaohong Zhou (Department of Cardiac Rhythm and Heart Failure, Medtronic, Minneapolis, MN, USA) for his diligent review of our manuscript.

Funding

This work was supported by the Medical and health science program of Zhejiang Province (No.2018KY467, 2019KY416) and the Medical Health Science and Technology Project of Zhejiang Provincial Health Commission (2020KY596).

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Authors and Affiliations

  1. Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University of Medicine, 3 East Qingchun Road, Hangzhou, 310016, Zhejiang Province, People’s Republic of China

    J. F. Zhang, Y. W. Pan, X. G. Kong, M. Wang, Z. M. Xue, J. Gao & G. S. Fu

  2. Department of Cardiology, Jinhua Wenrong Hospital, Jinhua, 3121000, Zhejiang, People’s Republic of China

    J. Li

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  1. J. F. Zhang
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Jiefang Zhang, Yiwen Pan and Jing Gao. The first draft of the manuscript was written by Jiefang Zhang, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to J. F. Zhang.

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Ethics Approval

The study conforms to the guiding principles of the Declaration of Helsinki, and the patients will provide informed consent of the procedure and publication that was approved by the Institutional Committee on Human Research.

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Informed consent was obtained from all individual participants included in the study.

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The authors affirm that human research participants provided informed consent for the publication of the images in Figs. 1 and 2.

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Zhang, J.F., Pan, Y.W., Li, J. et al. Comparison of His–Purkinje Conduction System Pacing with Atrial–Ventricular Node Ablation and Pharmacotherapy in HFpEF Patients with Recurrent Persistent Atrial Fibrillation (HPP-AF study). Cardiovasc Drugs Ther (2023). https://doi.org/10.1007/s10557-023-07435-2

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