Left Bundle Branch Pacing Facilitated by Novel Surface Electrocardiography in Comparison with Electrophysiology Recording System

medRxiv (Cold Spring Harbor Laboratory)(2023)

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摘要
Background: Left bundle branch pacing (LBBP) had been proven to be feasible and safe in patients with a pacemaker indication. In this study, we assessed the feasibility and safety of LBBP procedure using simplified ECG monitoring and LBBP criteria in comparison with that by using the conventional EP system and currently adopted LBBP criteria. Methods: The single-center study included 143 consecutive patients from March 2021 to January 2022. The operator was single-blind to the electrophysiology recording system (EP system), and only observed the electrophysiological characteristics of the four-lead ECG monitor and the pacing system analyzer (PSA) by naked eye. Other researchers kept synchronized records of the EP system, and analyzed whether the data were correct and consistent after the operation. Intraoperative data were collected and the safety of 3-month follow-up after operation were evaluated. Results: Of 143 patients enrolled, 139 successfully performed LBBP, with a success rate of 97.2%, and the judgement concordance with EP system was 99.3%. The total operation time was 78.9±26.5min, the total fluoroscopy time was 9.5±6.1min, the fluoroscopy time of left bundle branch (LBB) lead deployment 3.0±2.6min, which had no significant difference with previous studies. Ventricular septal perforation occurred in 2 patients during the operation. Pacing parameters were stable and heart function improved during follow-up. Conclusions: The simplified LBBP implantation method without an EP system and only relying on a simplified ECG combined with an analyzer is clinically feasible and safe and can be promoted in clinical practice. Key Words: left bundle branch pacing, ECG monitoring, electrophysiology recording system ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov. [NCT05553431][1] ### Funding Statement This work was supported by the Key Research and Development Program of Zhejiang (grant no. 2019C03012) and University-Industry Collaborative Education Program (grant no.22097154062650). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The approval of the Ethics Committee of the first affiliated hospital of Wenzhou Medical University I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets used and analyzed during the current study available from the corresponding author on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05553431&atom=%2Fmedrxiv%2Fearly%2F2023%2F05%2F28%2F2023.05.22.23290368.atom
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novel surface electrocardiography
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