Evaluation of an Integrated Device Diagnostics Algorithm to Risk Stratify Heart Failure Patients　― Results From the SCAN-HF Study ―

Ken Okumura; Shingo Sasaki; Kengo Kusano; Takanao Mine; Kenshi Fujii; Atsushi Iwasa; Osahiko Sunagawa; Hiroshige Yamabe; Naohiko Takahashi; Shunsuke Ishii; Yasuchika Takeishi; Naoya Tsuboi; Satoshi Shizuta; Kazutaka Aonuma; Akira Shimane; Hiroshi Tada; Toshiyuki Ishikawa; Ryusuke Tsunoda; Tetsuya Numata; Yasushi Mukai; Yasuki Kihara; Jodi Koehler; Kazuhiro Hidaka; Vinod Sharma

doi:10.1253/circj.CJ-19-1143

Heart Failure

Evaluation of an Integrated Device Diagnostics Algorithm to Risk Stratify Heart Failure Patients　― Results From the SCAN-HF Study ―

Ken Okumura, Shingo Sasaki, Kengo Kusano, Takanao Mine, Kenshi Fujii, Atsushi Iwasa, Osahiko Sunagawa, Hiroshige Yamabe, Naohiko Takahashi, Shunsuke Ishii, Yasuchika Takeishi, Naoya Tsuboi, Satoshi Shizuta, Kazutaka Aonuma, Akira Shimane, Hiroshi Tada, Toshiyuki Ishikawa, Ryusuke Tsunoda, Tetsuya Numata, Yasushi Mukai, Yasuki Kihara, Jodi Koehler, Kazuhiro Hidaka, Vinod Sharma

Author information

Ken Okumura
Division of Cardiology, Saiseikai Kumamoto Hospital [Japan]
Department of Cardiology, Hirosaki University Graduate School of Medicine [Japan]
Shingo Sasaki
Department of Cardiology, Hirosaki University Graduate School of Medicine [Japan]
Kengo Kusano
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center [Japan]
Takanao Mine
Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine [Japan]
Kenshi Fujii
Division of Cardiology, Sakurabashi-Watanabe Hospital [Japan]
Atsushi Iwasa
Department of Cardiology, New Tokyo Hospital [Japan]
Osahiko Sunagawa
Department of Cardiology, Okinawa Prefectural Nanbu Medical Center and Children’s Medical Center [Japan]
Hiroshige Yamabe
Department of Cardiology, Cardiovascular Center, Shin-Koga Hospital [Japan]
Naohiko Takahashi
Department of Cardiology and Clinical Examination and Diagnosis, Faculty of Medicine, Oita University [Japan]
Shunsuke Ishii
Department of Cardiovascular Medicine, Kitasato University School of Medicine [Japan]
Yasuchika Takeishi
Department of Cardiovascular Medicine, Fukushima Medical University [Japan]
Naoya Tsuboi
Division of Cardiology, Japan Community Health Care Organization (JCHO) Chukyo Hospital [Japan]
Satoshi Shizuta
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University [Japan]
Kazutaka Aonuma
Department of Cardiology, Faculty of Medicine, University of Tsukuba [Japan]
Akira Shimane
Department of Cardiology, Himeji Cardiovascular Center [Japan]
Hiroshi Tada
Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui [Japan]
Toshiyuki Ishikawa
Department of Cardiology, Yokohama City University Hospital [Japan]
Ryusuke Tsunoda
Department of Cardiology, Japanese Red Cross Kumamoto Hospital [Japan]
Tetsuya Numata
Department of Cardiovascular Medicine, Itabashi Chuo Medical Center [Japan]
Yasushi Mukai
Department of Cardiology, Japanese Red Cross Fukuoka Hospital [Japan]
Yasuki Kihara
Department of Cardiovascular Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University [Japan]
Jodi Koehler
Medtronic Inc [United States]
Kazuhiro Hidaka
Medtronic Japan Co., Ltd. [Japan]
Vinod Sharma
Medtronic Inc [United States]

Keywords: Heart failure, Hospitalization, Implantable device diagnostics, Risk stratification

JOURNAL FREE ACCESS FULL-TEXT HTML

2020 Volume 84 Issue 7 Pages 1118-1123

DOI https://doi.org/10.1253/circj.CJ-19-1143

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Abstract

Background:Integrated device diagnostics, Triage-HF, is useful in risk stratifying patients with heart failure (HF), but its performance for Japanese patients remains unknown. This is a prospective study of Japanese patients treated with a cardiac resynchronization therapy defibrillator (CRT-D), with a Medtronic OptiVol 2.0 feature.

Methods and Results:A total of 320 CRT-D patients were enrolled from 2013 to 2017. All received HF treatment in the prior 12 months. Following enrollment, they were followed every 6 months for 48 months (mean, 22 months). Triage-HF-stratified patients at low, medium and high risk statuses at every 30-day period, and HF-related hospitalization occurring for the subsequent 30 days, were evaluated and repeated. The primary endpoint was to assess Triage-HF performance in predicting HF-related hospitalization risk. All device data were available for 279 of 320 patients (NYHA class II or III in 93%; mean left ventricular ejection fraction, 31%). During a total of 5,977 patient-month follow-ups, 89 HF-related hospitalization occurred in 72 patients. The unadjusted event numbers for Low, Medium and High statuses were 19 (0.7%), 42 (1.6%) and 28 (4.1%), respectively. Relative risk of Medium to Low status was 2.18 (95% CI 1.23–3.85) and 5.78 (95% CI 3.34–10.01) for High to Low status. Common contributing factors among the diagnostics included low activity, OptiVol threshold crossing, and elevated night heart rate.

Conclusions:Triage-HF effectively stratified Japanese patients at risk of HF-related hospitalization.

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