TY - JOUR
T1 - Sex differences in outcomes of primary prevention implantable cardioverter-defibrillator therapy
T2 - Combined registry data from eleven European countries
AU - Sticherling, Christian
AU - Arendacka, Barbora
AU - Svendsen, Jesper Hastrup
AU - Wijers, Sofieke
AU - Friede, Tim
AU - Stockinger, Jochem
AU - Dommasch, Michael
AU - Merkely, Bela
AU - Willems, Rik
AU - Lubinski, Andrzej
AU - Scharfe, Michael
AU - Braunschweig, Frieder
AU - Svetlosak, Martin
AU - Zürn, Christine S.
AU - Huikuri, Heikki
AU - Flevari, Panagiota
AU - Lund-Andersen, Caspar
AU - Schaer, Beat A.
AU - Tuinenburg, Anton E.
AU - Bergau, Leonard
AU - Schmidt, Georg
AU - Szeplaki, Gabor
AU - Vandenberk, Bert
AU - Kowalczyk, Emilia
AU - Eick, Christian
AU - Juntilla, Juhani
AU - Conen, David
AU - Zabel, Markus
N1 - Funding Information:
EU-CERT-ICD is funded by the European Commission within the 7th Framework Programme under Grant Agreement n°602299.
Funding Information:
The EU-CERT-ICD project is funded by the European Community’s 7th Framework Programme FP7/2007-2013 (grant agreement number 602299). The prospective arm will enrol 2500 patients with an indication for a primary prevention ICD implantation who will also undergo analysis of numerous candidate ECG markers from 12-lead Holter recordings as stratifiers for a higher risk of malignant arrhythmias. Our data stem from an associated work package 02, a retrospective compilation of 14 locally existing mostly prospective registries of primary prevention ICD implantations between 2002 and 2014.
Publisher Copyright:
© The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2018/6/1
Y1 - 2018/6/1
N2 - Aims: Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials.Methods and results: Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002).Conclusion: Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.
AB - Aims: Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials.Methods and results: Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002).Conclusion: Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.
KW - Cardiac resynchronization therapy
KW - Heart failure
KW - Implantable defibrillator
KW - Primary prevention
KW - Sex differences
KW - Sudden cardiac death
KW - Ventricular fibrillation
KW - Women
KW - Primary Prevention/methods
KW - Arrhythmias, Cardiac/complications
KW - Humans
KW - Middle Aged
KW - Mortality
KW - Death, Sudden, Cardiac/epidemiology
KW - Male
KW - Defibrillators, Implantable/adverse effects
KW - Electric Countershock/adverse effects
KW - Europe/epidemiology
KW - Registries/statistics & numerical data
KW - Sex Factors
KW - Female
KW - Aged
KW - Retrospective Studies
KW - Equipment Failure/statistics & numerical data
UR - http://www.scopus.com/inward/record.url?scp=85048048152&partnerID=8YFLogxK
U2 - 10.1093/europace/eux176
DO - 10.1093/europace/eux176
M3 - Article
C2 - 29016784
AN - SCOPUS:85048048152
SN - 1099-5129
VL - 20
SP - 963
EP - 970
JO - Europace
JF - Europace
IS - 6
ER -