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Comparison of ICD shock rates in Japanese and non‐Japanese patients in the PainFree SST study
Authors:Takashi Kurita MD  PhD  Kenji Ando MD  Marehiko Ueda MD  PhD  Satoshi Shizuta MD  Hideo Okamura MD  PhD  Naoki Matsumoto MD  PhD  Bart Gerritse PhD  Dedra H. Fagan PhD  Edward J. Schloss MD  Albert Meijer MD  Angelo Auricchio MD  PhD  Laurence D. Sterns MD  Ken Okumura MD  PhD
Affiliation:1. Cardiology, Kindai University School of Medicine, Osaka, Japan;2. Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan;3. Department of Cardiology, Eastern Chiba Medical Center, Chiba, Japan;4. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan;5. Department of Cardiovascular Medicine, National Hospital Organization Wakayama Hospital, Wakayama, Japan;6. Pharmacology, St. Marianna University School of Medicine, Kanagawa, Japan;7. Medtronic Bakken Research Center, Maastricht, Netherlands;8. Medtronic plc, Mounds View, MN, USA;9. The Christ Hospital, Cincinnati, OH, USA;10. Catharina Ziekenhuis, Eindhoven, Netherlands;11. Fondazione Cardiocentro Ticino, Lugano, Switzerland;12. Vancouver Island Arrhythmia Clinic, Victoria, BC, Canada;13. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan
Abstract:

Background

The PainFree Smart Shock Technology (SST) study showed a low implantable cardioverter‐defibrillator (ICD) inappropriate shock rate. However, the majority of patients were from Western countries with patient characteristics different from those in Japan. ICD shock rates using the novel SST algorithms in Japanese patients are still unknown.

Methods

All 2,770 patients in the PainFree SST study (Japan [JPN]: N = 181, other geographies [OJPN]: N = 2,589) were included in this analysis.

Results

Japanese patients had higher average left ventricular ejection fraction (P < 0.0001), higher prevalence of secondary prevention indications (P < 0.0001), nonischemic cardiomyopathy (P < 0.0001), and permanent atrial fibrillation (P < 0.0001). The appropriate shock rate at 12 months was not different between JPN and OJPN: 6.4% and 6.3%, respectively (P = 0.95). The inappropriate shock rate at 12 months was significantly higher in Japanese patients (2.9% vs 1.7%, P = 0.017). However, after propensity score matching to adjust for the difference in baseline characteristics, the difference in inappropriate shock rate was not statistically significant (P = 0.51).

Conclusions

There was no difference in the appropriate shock rate between Japan and other geographies. The inappropriate shock rate in Japan was low, although it was slightly higher compared to other geographies due to baseline characteristics, including a higher prevalence of permanent AF. There was not a statistically significant difference after adjusting for baseline characteristics.
Keywords:atrial fibrillation  cardiac resynchronization therapy  heart failure  implantable cardioverter‐defibrillator  inappropriate shock
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