Abstract
Background
Isolation of the pulmonary veins (PVs) is the golden standard for atrial fibrillation (AF) ablation. To achieve a permanent PV isolation, the endoscopic guided HeartLight laser balloon system was invented. We analyzed the safety and efficacy of this laser balloon system.
Methods and results
Three hundred four patients from 21 investigational sites inside Japan were enrolled in this study. One thousand sixty-two out of 1175 PVs (90.4%) were isolated using the HeartLight laser balloon. The isolation rate of the left superior, left inferior, right superior, and right inferior PVs was 87.8%, 91.3%, 91.6%, and 92.1%, respectively. The procedure time, defined as the time from the venous access to taking out the balloon, was 155 ± 39 min. The fluoroscopic time was 44 ± 25 min. The mean follow-up period was 309 ± 125 days. The freedom from AF recurrence at 3 months was 89.0% and at 12 months 82.1%. Adverse events occurred in 22 patients (7.2%) including phrenic nerve injury lasting more than 3 months in 1.6% and strokes in 1.0% of the patients.
Conclusions
This initial experience demonstrated that the laser balloon ablation was feasible for PV isolation in Japanese AF patients.
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Data availability
The deidentified participant data will not be shared.
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Acknowledgements
The authors thank all of the investigators and site staff who participated in this clinical trial.
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IRB information: Ethical committee of Tokyo Medical and Dental University Hospital (M2020-099).
Conflict of interest
Masahiko Goya: speaker honorarium from Japan Lifeline, Medtronic Japan, Abbott Medical Japan, Johnson and Johnson, and Bayer, and research grant from Japan Lifeline.
Kazutaka Aonuma is a member of Circulation Journal’s editorial team.
Teiichi Yamane: speaker honoraria from Medtronic Japan.
Masaomi Kimura: speaker honorarium from Medtronic, Boston Scientific, Abbott, Toray, and Johnson & Johnson, and affiliation with the endowed department: Medtronic, Fukuda Denshi.
Kazuhiro Satomi: speaker honorarium from Japan Lifeline, Medtronic and Abbott Medical Japan.
Norishige Morita: speaker honoraria from Japan Lifeline.
Atsushi Kobori: speaker honoraria and consultant fee from Japan Lifeline.
Koichi Inoue: speaker honoraria from Medtronic Japan, and Johnson and Johnson.
Kenichi Hiroshima: speaker honoraria from Japan Lifeline.
Koichiro Kumagai: speaker honoraria from Japan Lifeline.
Ken Okumura: speaker honorarium from Daiichi Sankyo, Nippon Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Japan Lifeline, and Johnson & Johnson.
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Appendix
Appendix
The following persons participated in this trial.
Masahiko Goya, Kenzo Hirao, Yoshihide Takahashi, Mihoko Kawabata, Yasuhiro Shirai, Shingo Maeda, Susumu Tao, Atsuhiko Yagishita, Miki Amemiya, Kiko Akiyoshi, and Masahiro Sekigawa (Tokyo Medical and Dental University).
Akihiko Nogami, Kazutaka Aonuma, Hiro Yamasaki, Miyako Igarashi, and Yuki Komatsu (University of Tsukuba).
Teiichi Yamane, and Seigo Yamashita (The Jikei University School of Medicine).
Yasuteru Yamauchi, Kaoru Okishige, Rena Nakamura, Takuro Nishimura, and Takatoshi Shigeta (Japan Redcross Yokohama City Bay Hospital).
Akihiko Yotsukura (Hokko Memorial Hospital).
Masaomi Kimura (Hirosaki University).
Shigeto Naito, and Kohki Nakamura (Gunma Prefectural Cardiovascular Center).
Ritsushi Kato, Yoshifumi Ikeda, and Takahiko Nagase (Saitama Medical University International Medical Center).
Junichi Nitta, Osamu Inaba, Tomomasa Takamiya, Akira Sato, Yukihiro Inamura, Kazuya Murata, Takashi Ikenouchi, Toshikazu Kono, and Giichi Nitta (Japanese Red Cross Saitama Hospital).
Kazuhiro Satomi, Yoshinao Yazaki, Ken Takarada, Muryo Terasawa, Takahiro Kusume, and Yasuyuki Takada (Tokyo Medical University).
Norishige Morita, Yoshinori Kobayashi, Takayuki Iida, and Tomohisa Nanao (Tokai University Hachioji Hospital).
Yasuya Inden (Nagoya University Graduate School of Medicine).
Yukihiko Yoshida, Hirohiko Suzuki, and Yasuhiro Ogura (Japanese Red Cross Aichi Medical Center, Nagoya Daini Hospital).
Ken Kakita (Koseikai Takeda Hospital).
Atsushi Kobori, and Yasuhiro Sasaki (Kobe City Medical Center General Hospital).
Kengo Kusano, Koji Miyamoto, Takashi Noda, and Kenichiro Yamagata (National Cerebral and Cardiovascular Center).
Koichi Inoue (Sakurabashi Watanabe Hospital, National Hospital Organization Osaka National Hospital).
Masaharu Masuda, Takashi Kanda, and Yasuhiro Matsuda (Kansai Rosai Hospital Cardiovascular Center).
Kenichi Hiroshima, Michio Nagashima, and Masato Fukunaga (Kokura Memorial Hospital).
Junjiroh Koyama, Yasuaki Tanaka, and Ken Okumura (Saiseikai Kumamoto Hospital Cardiovascular Center).
Koichiro Kumagai, and Hideko Toyama (Heart Rhythm Center Fukuoka Sanno Hospital, International University of Health and Welfare).
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Goya, M., Hirao, K., Aonuma, K. et al. Initial multicenter clinical experience with the first-generation endoscopic guided laser balloon in Japan. J Interv Card Electrophysiol 66, 1713–1721 (2023). https://doi.org/10.1007/s10840-023-01493-0
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DOI: https://doi.org/10.1007/s10840-023-01493-0