Sex differences in outcomes of primary prevention implantable cardioverter-defibrillator therapy : combined registry data from eleven European countries
Sticherling, Christian; Arendacka, Barbora; Svendsen, Jesper Hastrup; Wijers, Sofieke; Friede, Tim; Stockinger, Jochem; Dommasch, Michael; Merkely, Bela; Willems, Rik; Lubinski, Andrzej; Scharfe, Michael; Braunschweig, Frieder; Svetlosak, Martin; Zürn, Christine S.; Huikuri, Heikki; Flevari, Panagiota; Lund-Andersen, Caspar; Schaer, Beat A.; Tuinenburg, Anton E.; Bergau, Leonard; Schmidt, Georg; Szeplaki, Gabor; Vandenberk, Bert; Kowalczyk, Emilia; Eick, Christian; Junttila, Juhani; Conen, David; Zabel, Markus (2017-06-28)
Christian Sticherling, Barbora Arendacka, Jesper Hastrup Svendsen, Sofieke Wijers, Tim Friede, Jochem Stockinger, Michael Dommasch, Bela Merkely, Rik Willems, Andrzej Lubinski, Michael Scharfe, Frieder Braunschweig, Martin Svetlosak, Christine S Zürn, Heikki Huikuri, Panagiota Flevari, Caspar Lund-Andersen, Beat A Schaer, Anton E Tuinenburg, Leonard Bergau, Georg Schmidt, Gabor Szeplaki, Bert Vandenberk, Emilia Kowalczyk, Christian Eick, Juhani Juntilla, David Conen, Markus Zabel, EU-CERT-ICD Investigators; Sex differences in outcomes of primary prevention implantable cardioverter-defibrillator therapy: combined registry data from eleven European countries, EP Europace, Volume 20, Issue 6, 1 June 2018, Pages 963–970, https://doi.org/10.1093/europace/eux176
© The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact firstname.lastname@example.org
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.
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