International External Validation Study of the 2014 European Society of Cardiology Guidelines on Sudden Cardiac Death Prevention in Hypertrophic Cardiomyopathy (EVIDENCE-HCM),Circulation

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International External Validation Study of the 2014 European Society of Cardiology Guidelines on Sudden Cardiac Death Prevention in Hypertrophic Cardiomyopathy (EVIDENCE-HCM)
Circulation ( IF 37.8 ) Pub Date : 2018-03-06 , DOI: 10.1161/circulationaha.117.030437
Constantinos O’Mahony _{1,

2,

3} , Fatima Jichi ₄ , Steve R. Ommen ₅ , Imke Christiaans _{3,

6,

7} , Eloisa Arbustini ₈ , Pablo Garcia-Pavia _{3,

9,

10} , Franco Cecchi ₁₁ , Iacopo Olivotto ₁₁ , Hiroaki Kitaoka ₁₂ , Israel Gotsman ₁₃ , Gerald Carr-White ₁₄ , Jens Mogensen ₁₅ , Loizos Antoniades ₁₆ , Saidi A. Mohiddin _{1,

3,

15} , Mathew S. Maurer ₁₇ , Hak Chiaw Tang ₁₈ , Jeffrey B. Geske ₅ , Konstantinos C. Siontis _{5,

19} , Karim D. Mahmoud _{5,

20} , Alexa Vermeer _{3,

6,

7} , Arthur Wilde _{3,

6} , Valentina Favalli _{3,

8} , Oliver P. Guttmann _{1,

3,

21} , Maria Gallego-Delgado ₉ , Fernando Dominguez ₉ , Ilaria Tanini ₁₁ , Toru Kubo ₁₂ , Andre Keren _{13,

22} , Teofila Bueser _{15,

23} , Sarah Waters ₁₄ , Issa F. Issa ₂₄ , James Malcolmson _{1,

3,

24} , Tom Burns ₁₄ , Neha Sekhri _{1,

3,

15} , Christopher W. Hoeger ₁₇ , Rumana Z. Omar ₂₅ , Perry M. Elliott _{1,

2,

3,

21}

Affiliation

St. Bartholomew’s Centre for Inherited Cardiovascular Disease, St Bartholomew’s Hospital, West Smithfield, London, United Kingdom (C.O., S.A.M., O.P.G., J.M., N.S., P.M.E.).
Centre for Heart Muscle Disease, Institute of Cardiovascular Science (C.O., P.M.E.)
University College London, United Kingdom. European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART; http://guardheart.ern-net.eu) (C.O., I.C., P.G.-P., S.A.M., A.V., A.W., V.F., O.P.G., J.M., N.S., P.M.E.).
Biostatistics Group, University College London Hospitals/University College London Joint Research Office (F.J.)
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (S.R.O., J.B.G., K.C.S., K.D.M.).
Heart Center, Department of Clinical and Experimental Cardiology (I.C., A.V., A.W.)
Department of Clinical Genetics (I.C., A.V.)
Academic Medical Center, Amsterdam, Netherlands. Centre for Inherited Cardiovascular Diseases, Transplant Research Area, Istituto di Ricovero e Cura a Carattere Scientifico Foundation, Policlinico San Matteo, Pavia, Italy (E.A., V.F.).
Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain (P.G.-P., M.G.-D., F.D.).
Centro de Investigacion Biomedica en Red en Enfermedades Cardiovasculares, Madrid, Spain (P.G.-P.). University Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain (P.G.-P.).
Department of Cardiology, Careggi University Hospital, Florence, Italy (F.C., I.O., I.T.).
Department of Cardiology and Geriatrics, Kochi Medical School, Kochi University, Kohasu, Oko-cho, Nankoku-shi, Japan (H.K., T.K.).
Heart Institute, Hadassah University Hospital, Jerusalem, Israel (I.G., A.K.).
Guy’s and St. Thomas’ Hospital National Health Service Foundation Trust, London, United Kingdom (G.C.-W., T.B., S.W.).
London Chest Hospital, United Kingdom (S.A.M., J.M., T.B., N.S.).
Inherited Cardiovascular Disease Unit, Department of Cardiology, Nicosia General Hospital, Latsia, Cyprus (L.A.).
Columbia University Medical Center, New York, NY (M.S.M., C.W.H.).
Department of Cardiology, National Heart Centre Singapore (H.C.T.).
Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (K.C.S.).
Thorax Center, Department of Cardiology, Erasmus Medical Center, Rotterdam, Netherlands (K.D.M.).
The Inherited Cardiac Diseases Unit, The Heart Hospital (O.P.G., P.M.E.)
Clalit Health Services Beit Hadfus 20, Jerusalem, Israel (A.K.). Assuta Hospitals, Tel Aviv, Israel (A.K.).
King’s College London, United Kingdom (T.B.). St George’s, University of London, United Kingdom (T.B.).
Department of Cardiology, Odense University Hospital, Denmark (J.M., I.F.I.).
Department of Statistical Science (R.Z.O.)

Background: Identification of people with hypertrophic cardiomyopathy (HCM) who are at risk of sudden cardiac death (SCD) and require a prophylactic implantable cardioverter defibrillator is challenging. In 2014, the European Society of Cardiology proposed a new risk stratification method based on a risk prediction model (HCM Risk-SCD) that estimates the 5-year risk of SCD. The aim was to externally validate the 2014 European Society of Cardiology recommendations in a geographically diverse cohort of patients recruited from the United States, Europe, the Middle East, and Asia.

Methods: This was an observational, retrospective, longitudinal cohort study.

Results: The cohort consisted of 3703 patients. Seventy three (2%) patients reached the SCD end point within 5 years of follow-up (5-year incidence, 2.4% [95% confidence interval {CI}, 1.9–3.0]). The validation study revealed a calibration slope of 1.02 (95% CI, 0.93–1.12), C-index of 0.70 (95% CI, 0.68–0.72), and D-statistic of 1.17 (95% CI, 1.05–1.29). In a complete case analysis (n= 2147; 44 SCD end points at 5 years), patients with a predicted 5-year risk of <4% (n=1524; 71%) had an observed 5-year SCD incidence of 1.4% (95% CI, 0.8–2.2); patients with a predicted risk of ≥6% (n=297; 14%) had an observed SCD incidence of 8.9% (95% CI, 5.96–13.1) at 5 years. For every 13 (297/23) implantable cardioverter defibrillator implantations in patients with an estimated 5-year SCD risk ≥6%, 1 patient can potentially be saved from SCD.

Conclusions: This study confirms that the HCM Risk-SCD model provides accurate prognostic information that can be used to target implantable cardioverter defibrillator therapy in patients at the highest risk of SCD.

中文翻译：

2014年欧洲心脏病学会关于肥厚型心肌病中突然心脏死亡的预防指南的国际外部验证研究（EVIDENCE-HCM）

背景：识别患有肥厚型心肌病（HCM）并有心脏猝死（SCD）风险且需要预防性植入式心脏复律除颤器的人具有挑战性。2014年，欧洲心脏病学会提出了一种新的基于风险预测模型（HCM Risk-SCD）的风险分层方法，该模型可估计SCD的5年风险。目的是在从美国，欧洲，中东和亚洲招募的不同地理位置的患者队列中，从外部验证2014年欧洲心脏病学会的建议。

方法：这是一项观察性，回顾性，纵向队列研究。

结果：该队列包括3703名患者。73名（2％）患者在随访5年内达到SCD终点（5年发病率，为2.4％[95％置信区间{CI}，1.9-3.0]）。验证研究显示校正斜率为1.02（95％CI，0.93–1.12），C指数为0.70（95％CI，0.68–0.72）和D统计量为1.17（95％CI，1.05-1.29）。在完整的病例分析中（n = 2147； 5年时有44个SCD终点），预计5年风险<4％的患者（n = 1524； 71％）的5年SCD发生率是1.4％（95％CI，0.8-2.2）；预期风险≥6％（n = 297； 14％）的患者在5年时观察到的SCD发生率为8.9％（95％CI，5.96-13.1）。估计5年SCD风险≥6％的患者中，每进行13例（297/23）植入式心脏复律除颤器植入，就有1例患者可以从SCD中挽救。

结论：这项研究证实，HCM Risk-SCD模型可提供准确的预后信息，可用于靶向SCD最高风险患者的植入式心脏复律除颤器治疗。

更新日期：2018-03-06

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