Assessment of long-term prognosis and mechanism of conduction system in patients with His-bundle pacing implantation in a multi-center study

• Project/Area Number: 19K17558
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 53020:Cardiology-related
• Research Institution: Nagoya University
• Principal Investigator: Yanagisawa Satoshi 名古屋大学, 医学系研究科, 特任講師 (30768578)
• Project Period (FY): 2019-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000); Fiscal Year 2022: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2021: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2020: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000); Fiscal Year 2019: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
• Keywords: ペースメーカ / ヒス束 / 房室ブロック

Outline of Research at the Start

本研究は、新しいペーシングシステムであるヒス束ペーシングの有効性と安全性、さらにその長期的な予後について多施設で検討を行うものである。日本では、ヒス束ペースメーカは臨床診療に導入されてから間もないため、各施設ともまだ症例数が少なく、その適応や効果について模索している段階である。本研究の目的は、ヒス束ペースメーカを対象として前向きに多施設の症例登録・共同研究を行い、多くのヒス束ペースメーカの症例を収集して長期の追跡を行うことで、その有効性と安全性だけでなく、心機能への影響や長期的な予後について検証を行うものである。

Outline of Final Research Achievements

This prospective multi-center study was aimed to evaluate the efficacy and long-term prognosis in patients who underwent His-bundle pacing implantation. Approximately 70% of the patients had successful His-bundle pacing. After a follow-up period of 6-12 months, mean left ventricular ejection function and brain natriuretic peptide levels were improved from baseline. Most patients had a good clinical course with stable His-bundle pacing threshold and no clinical adverse events at the follow-up. Some population could not continue His-bundle pacing owing to an increased His pacing threshold.

Academic Significance and Societal Importance of the Research Achievements

本研究は、ヒス束ペースメーカを植え込んだ症例を前向きに多施設共同で検討を行い、長期にわたり観察を行ったものである。ヒス束ペースメーカの急性期の成功率や植え込み後の効果については、既存の報告と比較して遜色ない結果であることが示された。本研究の成果により、本邦でのヒス束ペースメーカの植え込みの実情と成績（安全性、効果）について示すことができた貴重な報告であると考える。

Research Products

• [Journal Article] Worldwide survey on implantation of and outcomes for conduction system pacing with His bundle and left bundle branch area pacing leads (2023)
  • Author(s): Perino Alexander C.、Wang Paul J.、Masahide Harada, et al.
  • Journal Title: Journal of Interventional Cardiac Electrophysiology Volume: In press. Issue: 7 Pages: 1589-1600
  • DOI: 10.1007/s10840-022-01417-4
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Depolarization and repolarization dynamics after His‐bundle pacing: Comparison with right ventricular pacing and native ventricular conduction (2022)
  • Author(s): Yanagisawa Satoshi、Inden Yasuya、Watanabe Ryo、Tsurumi Naoki、Suzuki Noriyuki、Nakagomi Toshifumi、Shimojo Masafumi、Okajima Takashi、Riku Shuro、Furui Koichi、Suga Kazumasa、Shibata Rei、Murohara Toyoaki
  • Journal Title: Annals of Noninvasive Electrocardiology Volume: 27 Issue: 5
  • DOI: 10.1111/anec.12991
  • Peer Reviewed / Open Access
• [Journal Article] Efficacy of His Bundle Pacing on LV Relaxation and Clinical Improvement in HF and LBBB (2022)
  • Author(s): Kato Hiroyuki、Yanagisawa Satoshi、Sakurai Taku、Mizuno Chiaki、Ota Ryusuke、Watanabe Ryo、Suga Kazumasa、Okada Takuya、Murakami Hisashi、Kada Kenji、Inden Yasuya、Tsuboi Naoya、Murohara Toyoaki
  • Journal Title: JACC: Clinical Electrophysiology Volume: 8 Issue: 1 Pages: 59-69
  • DOI: 10.1016/j.jacep.2021.06.011
  • Peer Reviewed
• [Journal Article] Permanent His‐bundle pacing using distal His‐bundle electrogram‐guided approach in patients with atrioventricular block (2021)
  • Author(s): Suga Kazumasa、Kato Hiroyuki、Inden Yasuya、Yanagisawa Satoshi、Murakami Hisashi、Kada Kenji、Tsuboi Naoya、Murohara Toyoaki
  • Journal Title: Pacing and Clinical Electrophysiology Volume: 44 Issue: 11 Pages: 1907-1917
  • DOI: 10.1111/pace.14363
  • Peer Reviewed
• [Journal Article] Autopsy evaluation of the implantation site of a His bundle pacing lead demonstrating selective capture (2020)
  • Author(s): Kato Hiroyuki、Igawa Osamu、Suga Kazumasa、Murakami Hisashi、Kada Kenji、Tsuboi Naoya、Yanagisawa Satoshi、Inden Yasuya、Murohara Toyoaki
  • Journal Title: Pacing and Clinical Electrophysiology Volume: 43 Issue: 11 Pages: 1412-1416
  • DOI: 10.1111/pace.13989
  • Peer Reviewed
• [Journal Article] His bundle pacing with unusual automaticity (2019)
  • Author(s): Yanagisawa Satoshi、Inden Yasuya、Shibata Rei、Murohara Toyoaki
  • Journal Title: Journal of Cardiovascular Electrophysiology Volume: 30 Issue: 6 Pages: 966-968
  • DOI: 10.1111/jce.13904
  • Peer Reviewed
• [Journal Article] Study design and protocol for evaluating the long‐term prognosis of patients receiving his bundle pacing: A multicenter observational study (2019)
  • Author(s): Yanagisawa Satoshi、Inden Yasuya、Kato Hiroyuki、Suzuki Hirohiko、Fujita Masaya、Ishikawa Shinji、Kanzaki Yasunori、Kamikubo Yosuke、Murase Yosuke、Murohara Toyoaki、Shibata Rei
  • Journal Title: Journal of Arrhythmia Volume: 35 Issue: 5 Pages: 760-765
  • DOI: 10.1002/joa3.12229
• [Presentation] Depolarization and Repolarization Dynamics After His-Bundle Pacing: Comparison with Different Pacing Modes (2022)
  • Author(s): Yanagisawa S, Inden Y, Watanabe R, Suzuki N, Tsurumi N, Okajima T, Nakagomi T, Suga K, Shimojo M, Shibata R, Murohara T.
  • Organizer: 第68回 日本不整脈心電学会学術大会
• [Presentation] Changes in Electrocardiographic Dyssynchrony Parameters after CRT Implantation and Correlation with Echocardiographic Desynchrony: Comparison with His-Bundle Pacing and RV pacing (2021)
  • Author(s): Yanagisawa S, Inden Y, Suga K, Furui K, Riku S, Nakagomi, T, Shimojo, M, Okajima, T, Shibata R, Murohara T
  • Organizer: 第85回日本循環器学会学術集会
• [Presentation] Comparison of the Intrinsicoid Deflection on the Electrocardiogram among the Different Pacing Morphologies in Patients with His Bundle Pacing (2020)
  • Author(s): Yanagisawa S, Inden Y, Fujii A, Tomomatsu T, Mamiya K, Okamoto H, Suga K, Furui K, Riku S, Nakagomi, T, Shibata R, Murohara T
  • Organizer: 第84回日本循環器学会学術集会
• [Presentation] ヒス束ペーシングにおける異なるペーシング波形でのIntrinsicoid Deflection指標の比較検討 (2020)
  • Author(s): 柳澤 哲、因田恭也、藤井亜弥、間宮慶太、岡本均弥、友松敏郎、 須賀一将、古井宏一、陸 脩郎、中込敏文、柴田 玲、室原豊明
  • Organizer: 第12回日本不整脈心電学会 植込みデバイス関連冬季大会
• [Presentation] His Bundle Pacing but His Bundle Stimulation: A Rare Clinical Feature (2019)
  • Author(s): Yanagisawa S, Inden Y, Fujii A, Sakamoto Y, Mamiya K, Okamoto H, Tomomatsu T, Shibata R, Murohara T
  • Organizer: 第66回 日本不整脈心電学会学術総会
• [Presentation] ヒス束ペースメーカ植え込み後にAccelerated junctional rhythmが持続した房室ブロックの一例 (2019)
  • Author(s): 柳澤 哲、因田恭也、藤井亜弥、間宮慶太、岡本均弥、友松敏郎、須賀一将、古井宏一、陸 脩郎、中込敏文、柴田 玲、室原豊明
  • Organizer: 第152回 日本循環器学会東海地方会