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

AU - EU-CERT-ICD Investigators

PY - 2018

Y1 - 2018

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 - Aged

KW - Arrhythmias, Cardiac/complications

KW - Death, Sudden, Cardiac/epidemiology

KW - Defibrillators, Implantable/adverse effects

KW - Electric Countershock/adverse effects

KW - Equipment Failure/statistics & numerical data

KW - Europe/epidemiology

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Mortality

KW - Primary Prevention/methods

KW - Registries/statistics & numerical data

KW - Retrospective Studies

KW - Sex Factors

U2 - 10.1093/europace/eux176

DO - 10.1093/europace/eux176

M3 - Journal article

C2 - 29016784

VL - 20

SP - 963

EP - 970

JO - Europace

JF - Europace

SN - 1099-5129

IS - 6

ER -