Journal of Arrhythmia (Jun 2024)

Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN‐ICD/WCD study): Rationale and design of a prospective, multicenter, observational, comparative study

  • Yukitoshi Ikeya,
  • Yasuo Okumura,
  • Rikitake Kogawa,
  • Koichi Nagashima,
  • Toshiko Nakai,
  • Katsuaki Yokoyama,
  • Kazuki Iso,
  • Takeshi Kato,
  • Toyonobu Tsuda,
  • Eizo Tachibana,
  • Satoshi Hayashida,
  • Hidehira Fukaya,
  • Naruya Ishizue,
  • Hidemori Hayashi,
  • Shunsuke Kuroda,
  • Kazumasa Sonoda,
  • Shiro Nakahara,
  • Yuichi Hori,
  • Masahide Harada,
  • Masato Murakami,
  • Yu‐Ki Iwasaki,
  • Yoshiyasu Aizawa,
  • Wataru Shimizu,
  • Seiji Fukamizu,
  • Mitsuru Takami,
  • Kengo Kusano,
  • Kohei Ishibashi,
  • Tomoo Harada,
  • Ikutaro Nakajima,
  • Haruna Tabuchi,
  • Mitsuhiro Kunimoto,
  • Morio Shoda,
  • Satoshi Higuchi,
  • Itsuro Morishima,
  • Yasunori Kanzaki,
  • Ritsushi Kato,
  • Yoshifumi Ikeda,
  • Hisaki Makimoto,
  • Tomoyuki Kabutoya,
  • Kazuomi Kario,
  • Takanori Arimoto,
  • Yuichi Ninomiya,
  • Issei Yoshimoto,
  • Shingo Sasaki,
  • Yusuke Kondo,
  • Toshinori Chiba,
  • Kennosuke Yamashita,
  • Yosuke Mizuno,
  • Masaru Inoue,
  • Takeshi Ueyama,
  • Jyunjiro Koyama,
  • Takuo Tsurugi,
  • Yoshiya Orita,
  • Taku Asano,
  • Toshiro Shinke,
  • Kaoru Tanno,
  • Kenta Murotani,
  • For the TRANSITION JAPAN‐ICD/WCD study

DOI
https://doi.org/10.1002/joa3.13028
Journal volume & issue
Vol. 40, no. 3
pp. 423 – 433

Abstract

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Abstract Background Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients. Methods We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all‐cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints. Results Not applicable. Conclusion This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.

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