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Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study

2020; Oxford University Press; Volume: 41; Issue: 36 Linguagem: Inglês

10.1093/eurheartj/ehaa226

1522-9645

Markus Zabel, Rik Willems, Andrzej Lubiński, Axel Bauer, Josép Brugada, David Conen, Panagiota Flevari, Gerd Hasenfuß, Martin Svetlošák, Heikki V. Huikuri, Marek Malík, Nikola Pavlović, Georg Schmidt, R. Sritharan, Simon Schlögl, Janko Szavits-Nossan, Vassil Traykov, Anton E. Tuinenburg, Stefan N. Willich, Markus Harden, Tim Friede, Jesper Hastrup Svendsen, Christian Sticherling, Béla Merkely, Béla Merkely, Péter Perge, Zoltán Salló, Gábor Széplaki, Nándor Szegedi, Klaudia Vivien Nagy, Markus Zabel, Lars Lüthje, Simon Schlögl, R. Sritharan, Helge Haarmann, Leonard Bergau, Joachim Seegers, Gerd Hasenfuß, Pascal Muñoz-Exposito, Tobias Tichelbäcker, Aleksandra Kirova, Gerd Hasenfuß, Tim Friede, Markus Zabel, Simon Schlögl, Tim Friede, Markus Harden, Marek Malík, Katerina Hnatkova, Marc A. Vos, Stefan N. Willich, Thomas Reinhold, Rik Willems, Bert Vandenberk, Magdalena Klinika, Janko Szavits-Nossan, Luka Rotkvić, Panayota Flevari, Ανδρέας Κατσιμάρδος, Dimitrios Katsaras, Róbert Hatala, Martin Svetlošák, Andrzej Lubiński, Tomasz Kuczejko, Jim Hansen, Christian Sticherling, David Conen, Nikola Pavlović, Šime Manola, Ozren Vinter, Ivica Benko, Anton E. Tuinenburg, David J. Sprenkeler, Agnieszka Smoczyńska, Marc A. Vos, Axel Bauer, Christine Meyer‐Zürn, Christian Eick, Jesper Hastrup Svendsen, Josép Brugada, Elena Arbelo, Gabriela Kaliská, Jozef Martinek, Georg Schmidt, Michael Dommasch, Alexander Steger, Stefan Kääb, Axel Bauer, Moritz F. Sinner, Konstantinos D. Rizas, Wolfgang Hamm, Vassil Traykov, Iwona Cygankiewicz, Paweł Ptaszyński, Krzysztof Kaczmarek, Izabela Poddębska, Svetoslav Iovev, Tomáš Novotný, Milan Kozák, Heikki V. Huikuri, Tuomas Kenttä, Ari Pelli, Jarosław D. Kasprzak, Dariusz Qavoq, Sandro Brusich, Ervin Avdović, Marina Klasan, Jan Gałuszka, Miloš Táborský, Vasil Velchev, Rüdiger Dißmann, Tchavdar Shalganov, Przemysław Guzik, Tomasz Krauze, Dieter Bimmel, Christiane Lieberz, Klinikum Ludwigsburg, Stefan Stefanow, Norman Rüb, Christian Wolpert, Joachim Seegers, Lars S Meier, Steffen Behrens, Zrinka Jurišić, Frieder Braunschweig, Florian Blaschke, Burkert Pieske, Zoran Bakotić, Ante Anić, Klinikum Weiden, Robert H. G. Schwinger, Pyotr G. Platonov, Gerian Grönefeld, Thomas Klingenheben,

Cardiomyopathy and Myosin Studies

The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy.We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537-0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class <III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569-0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902).In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.