1. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart rhythm 2017.
2. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. Revista espanola de cardiologia
(English ed) 2016; 69(12): 1167.
3. Wang CC, Chen JH, Yu WC, et al. 2012 Guidelines of the Taiwan Society of Cardiology (TSOC) for the Diagnosis and Treatment of Heart Failure. Acta
Cardiologica Sinica 2012; 28(2): 161-195.
4. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on Practice Guidelines. Journal of
the American College of Cardiology 2013; 62(16): e147-239.
5. Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). European heart journal 2015; 36(41): 2793-2867.
6. Hsi WL, Lai JS. Exercise test in acute myocardial infarction. American journal of
physical medicine & rehabilitation 1996; 75(4): 263-269.
7. Yip HK, Wu CJ, Yang CH, et al. Delayed post-myocardial infarction invasive measures, helpful or harmful? A subgroup analysis. Chest 2004; 126(1): 38-46.
8. Huang CH, Chang CC, Kuo CL, et al. Serum iron concentration, but not hemoglobin, correlates with TIMI risk score and 6-month left ventricular performance after primary angioplasty for acute myocardial infarction. PloS one 2014; 9(8): e104495.
9. Liu PY, Tsai WC, Lin LJ, et al. Time domain heart rate variability as a predictor of long-term prognosis after acute myocardial infarction. Journal of the Formosan
Medical Association = Taiwan yi zhi 2003; 102(7): 474-479.
10. Wang WH, Hsiao SH, Lin KL, Wu CJ, Kang PL, Chiou KR. Left atrial expansion index for predicting atrial fibrillation and in-hospital mortality after coronary artery bypass graft surgery. The Annals of thoracic surgery 2012; 93(3): 796-803.
11. Lai CC, Lin TH, Yip HK, et al. One-year cardiovascular outcomes of drug-eluting stent versus bare-metal stent implanted in diabetic patients with acute coronary
syndrome. Journal of the Chinese Medical Association : JCMA 2016; 79(5): 239-247.
醫療科技評估報告補充資料
12. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable
cardioverter-defibrillator for congestive heart failure. The New England journal of
medicine 2005; 352(3): 225-237.
13. Tang AS, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy for
mild-to-moderate heart failure. The New England journal of medicine 2010; 363(25):
2385-2395.
14. Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. The New England journal of medicine 2009; 361
(14): 1329-1338.
15. Society APHR. APHRS White Book 2017.
http://www.aphrs.org/publications/the-aphrs-white-book. Published 2017. Accessed July 17, 2018.
醫療科技評估報告補充資料
QT syndrome, short QT syndrome,Brugada syndrome, idiopathic ventricular fibrillation, arrhythmogenic rightventriculardysplasia,catecholaminergic polymorphic ventricular tachycardia 等, 且 合併心室快速不整脈或合併猝死症之家族 病,如 long QT syndrome, short QT
syndrome,Brugada syndrome, idiopathic ventricular fibrillation, arrhythmogenic right ventriculardysplasia,catecholaminergic polymorphic ventricular tachycardia 等,肥 厚性心肌症, 且臨床合併心室快速不整脈 或合併猝死症之家族史者。
(四)高危險性左心室收縮功能異常,符 合以下高危險條件:
1. 缺血或非缺血性心肌病變合併左心室 射出分率低於 35%及 NYHA Functional Class II or III。
2. 缺血性心肌病變合併左心室射出分率 低於 30%及 NYHA Functional Class I。
不宜列入項目:
醫療科技評估報告補充資料
附錄二、建議者歷次建議修訂之內容摘要
105 年申請修訂之內容摘要 本次(107 年)申請修訂之內容摘要 原高危險性心臟血管疾病(如曾經心肌梗
塞併左心室射出分率<=40%、肥厚性心肌 症、擴張性心肌症,且合併心室快速不整 脈者)改為:
1. 心肌梗塞後 40 天以上或擴張性心肌 症,左心室射出分率<=35%,NYHA Functional Class II, III 者。
2. 心肌梗塞後 40 天以上,左心室射出分 率<=30%,NYHA Functional Class I 者。
3. 心肌梗塞後 40 天以上,左心室射出分 率<=40%,有非持續性心室頻脈心律不 整,且心臟電生理學檢查可誘發心室顫 動或持續性心室頻脈者。
高危險性左心室收縮功能異常,符合以下 高危險條件:
1. 缺血或非缺血性心肌病變合併左心室 射出分率低於 35%及 NYHA Functional Class II or III。
2. 缺血性心肌病變合併左心室射出分率 低於 30%及 NYHA Functional Class I。
醫療科技評估報告補充資料
附錄三、各臨床指引對於 ICD 用於心因性猝死初段預防之建議
年份 臨床指引 建議使用 ICD 之條件 證據等級
中華民國心臟學會(Taiwan Society of Cardiology, TSOC) 2012 心衰竭診療指引[3] 心衰竭病人:
美國心臟學會(American Heart Association, AHA)
2013 心衰竭治療指引[4] Stage C1 低收縮分率心衰竭(heart failure with reduced ejection fraction, HFrEF):
非缺血性 DCM 或 IHD 病人。
醫療科技評估報告補充資料
歐洲心臟病學會(European Society of Cardiology, ESC) 2015 心室性心律不整和
醫療科技評估報告補充資料
有症狀之心衰竭:NYHA 功能分級第 二、三級。
預期存活期至少大於 1 年且功能狀態 良好。
ICD: implantable cardioverter defibrillator; MI: myocardial infarction; LVEF: left ventricular ejection fraction; NICM: nonischemic cardiomyopathy; NYHA: New York Heart Association; OMT: optimal medical therapy; HFrEF: heart failure with reduced ejection fraction; GDMT: guideline-directed management and therapy.