TY - JOUR
T1 - International external validation study of the 2014 European society of cardiology guidelines on sudden cardiac death prevention in hypertrophic cardiomyopathy (EVIDENCE-HCM)
AU - O'Mahony, Constantinos
AU - Jichi, Fatima
AU - Ommen, Steve R.
AU - Christiaans, Imke
AU - Arbustini, Eloisa
AU - Garcia-Pavia, Pablo
AU - Cecchi, Franco
AU - Olivotto, Iacopo
AU - Kitaoka, Hiroaki
AU - Gotsman, Israel
AU - Carr-White, Gerald
AU - Mogensen, Jens
AU - Antoniades, Loizos
AU - Mohiddin, Saidi A.
AU - Maurer, Mathew S.
AU - Tang, Hak Chiaw
AU - Geske, Jeffrey B.
AU - Siontis, Konstantinos C.
AU - Mahmoud, Karim D.
AU - Vermeer, Alexa
AU - Wilde, Arthur
AU - Favalli, Valentina
AU - Guttmann, Oliver P.
AU - Gallego-Delgado, Maria
AU - Dominguez, Fernando
AU - Tanini, Ilaria
AU - Kubo, Toru
AU - Keren, Andre
AU - Bueser, Teofila
AU - Waters, Sarah
AU - Issa, Issa F.
AU - Malcolmson, James
AU - Burns, Tom
AU - Sekhri, Neha
AU - Hoeger, Christopher W.
AU - Omar, Rumana Z.
AU - Elliott, Perry M.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85051017534&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29191938
U2 - https://doi.org/10.1161/CIRCULATIONAHA.117.030437
DO - https://doi.org/10.1161/CIRCULATIONAHA.117.030437
M3 - Article
C2 - 29191938
SN - 0009-7322
VL - 137
SP - 1015
EP - 1023
JO - Circulation
JF - Circulation
IS - 10
ER -