- 著者
- Kenji Ando Kanki Inoue Tomoo Harada Satoshi Shizuta Yukihiko Yoshida Kengo Kusano Tatsuya Onuki Yuji Watari Akio Fukui Shingo Sasaki Morio Shoda Nobuhiro Nishii Akira Shiose Junya Hosoda Chie Okai Kurt Stromberg Jeffrey Murphy Thomas R Holmes Kyoko Soejima
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-23-0269, (Released:2023-08-02)
- 参考文献数
- 15
- 被引用文献数
- 2
Background: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61–6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria.Conclusions: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.
- 著者
- Yutaka Ogino Toshiyuki Ishikawa Tomoaki Ishigami Katsumi Matsumoto Junya Hosoda Kouhei Iguchi Hirooki Matsushita Yuka Taguchi Yoriko Horiguchi Kazuo Kimura
- 出版者
- 日本循環器学会
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-16-1018, (Released:2017-03-01)
- 参考文献数
- 21
- 被引用文献数
- 13
Background:The characteristics and prognosis of implanted pacemaker-identified new-onset atrial fibrillation (AF) in Japanese people has not been well evaluated.Methods and Results:A total of 395 consecutive patients with newly implanted pacemakers were retrospectively analyzed between January 2010 and December 2015 at Yokohama City University Hospital. Patients with a prior history of AF, VVI mode pacemaker, congenital heart disease, severe valvular heart disease, and cardiovascular surgery before pacemaker implantation were excluded. Among the remaining patients, 44 (21.3%) developed new AF during follow-up (mean follow-up, 1,115±651 days; range, 9–2,176 days). Patients with new-onset AF had a significantly higher CHADS2score (2.09±1.27 vs. 1.31±1.08, P<0.001) and CHA2DS2-VASc score (3.00±1.39 vs. 2.26±1.19, P<0.001) compared with those without new-onset AF. On Cox regression analysis only age at implantation was significantly correlated with new-onset AF. Interestingly, the incidence of hospitalization due to heart failure was significantly higher in the new-onset AF than in the without new-onset AF group.Conclusions:A total of 21.3% of pacemaker-implanted patients with high CHADS2and CHA2DS2-VASc scores developed new-onset AF during a mean follow-up of 3.1 years; and pacemaker-identified AF was associated with an increased risk of worsening heart failure.