Clinical Outcome of Implantable Cardioverter Defibrillators With Recalled and Non-Recalled Leads in Japanese Patients:– Increased Failure Rate of The Sprint Fidelis Lead –

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概要

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• Background: In recent years, there has been a series of recalls of popular implantable cardioverter defibrillators leads, and several reports have demonstrated an increasing rate of failure of such leads over time in Caucasian patients. However, little is known about the performance of these leads in Asian patients. The aim of this study was to investigate the rate of failure of the recalled leads and the characteristics as compared with non-recalled leads in Japanese patients. Methods and Results: A retrospective chart review was conducted in 214 patients (75 Sprint Fidelis, 8 Riata, and 131 Sprint Quattro leads) who underwent implantation and follow-up at Nagoya University Hospital. During the follow-up period, 14 Sprint Fidelis leads (19%) and 1 Riata lead (13%) failed, but no abnormality was found in the Sprint Quattro, non-recalled leads. Five patients (4 Sprint Fidelis and 1 Riata, 33% of lead failure patients) received inappropriate shocks. The 3-, 4-, and 5-year lead survival rates in Sprint Fidelis leads were 95.1% (95% confidence interval [CI]: 89.6%–100%), 89.8% (95% CI: 82.1%–97.6%), and 88.0% (95% CI: 79.6%–96.4%), respectively. A previous device implantation before Sprint Fidelis lead was the only significant predictor for lead fracture (hazard ratio, 5.33; 95% CI: 1.55–18.4; P=0.008). Conclusions: The rate of Sprint Fidelis lead failure continues to increase over time in Japanese patients.

• 一般社団法人 日本循環器学会の論文

著者

• Hirai Makoto

  Department Of Circulation And Respiration Research Institute Of Environmental Medicine Nagoya Univer

• Inden Yasuya

  Department Of Cardiology Nagoya University Graduate School Of Medicine

• Shimano Masayuki

  Department Of Cardiology Nagoya University Graduate School Of Medicine

• Miyoshi Aya

  Department Of Forensic Medicine Fukuoka University School Of Medicine

• Yanagisawa Satoshi

  Department Of Agricultural Chemistry Faculty Of Agriculture Meiji University

• Fujita Masaya

  Department Of Biotechnology Faculty Of Engineering Fukuyama University

• Murohara Toyoaki

  Department Of Cardiology Nagoya Graduate School Of Medicine

• Okumura Satoshi

  Department Of Cardilogy Nippon Medical School

• Kato Hiroyuki

  Department Of Botany Faculty Of Science University Of Tokyo

• Yamamoto Toshihiko

  Department Of Architecture Faculty Of Engineering Daido Institute Of Technoligy

• YOSHIDA Naoki

  Department of Biomolecular Engineering, Tohoku University

• ISHIKAWA Shinji

  Department of Agricultural Chemistry, Faculty of Agriculture, Niigata University

• Ohguchi Shiou

  Department of Cardiology, Fukuroi Municipal Hospital

• Miyoshi Aya

  Departments of Cardiology, Nagoya University Graduate School of Medicine

• Yoshida Naoki

  Departments of Cardiology, Nagoya University Graduate School of Medicine

• Ichiyanagi Hiroshi

  Clinical Engineering, Nagoya University Graduate School of Medicine

• Nagao Tomoyuki

  Departments of Cardiology, Nagoya University Graduate School of Medicine

• Hirai Makoto

  Department of Cardiology, Nagoya University Graduate School of Health Science

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