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Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator: a prospective, controlled, multicentre cohort study

2019; Elsevier BV; Volume: 394; Issue: 10206 Linguagem: Inglês

10.1016/s0140-6736(19)31996-8

1474-547X

Axel Bauer, Mathias Klemm, Konstantinos D. Rizas, Wolfgang Hamm, Lukas von Stülpnagel, Michael Dommasch, Alexander Steger, Andrezej Lubinski, Panagiota Flevari, Markus Harden, Tim Friede, Stefan Kääb, Béla Merkely, Christian Sticherling, Rik Willems, Heikki V. Huikuri, Marek Malík, Georg Schmidt, Markus Zabel, Béla Merkely, Péter Perge, Zoltán Salló, Gábor Széplaki, Markus Zabel, Lars Lüthje, Simon Schlögl, Helge Haarmann, Leonard Bergau, Joachim Seegers, Gerd Hasenfuß, Pascal Muñoz-Exposito, Tobias Tichelbäcker, Aleksandra Kirova, Tim Friede, Markus Harden, Marek Malík, Katerina Hnatkova, Marc A. Vos, Stefan N. Willich, Thomas Reinhold, Rik Willems, Bert Vandenberk, Magdalena Klinika, Krapinske Toplice, Panayota Flevari, Ανδρέας Κατσιμάρδος, Dimitrios Katsaras, Róbert Hatala, Martin Svetlošák, Andrzej Lubiński, Tomasz Kuczejko, Jim Hansen, Christian Sticherling, David Conen, Sestre Milosrdnice, Nikola Pavlović, Šime Manola, Ozren Vinter, Ivica Benko, Anton E. Tuinenburg, Axel Bauer, Christine Meyer‐Zürn, Christian Eick, J Hastrup, Josép Brugada, Elena Arbelo, Gabriela Kaliská, Jozef Martinek, Michael Dommasch, Alexander Steger, Stefan Kääb, Moritz F. Sinner, Konstantinos D. Rizas, Wolfgang Hamm, Nikolay Vdovin, Mathias Klemm, Lukas von Stülpnagel, 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, Przemysław Guzik, Dieter Bimmel, Christiane Lieberz, Stefan Stefanow, Norman Rüb, Christian Wolpert, Lars S. Maier, Steffen Behrens, Zrinka Jurišić, Frieder Braunschweig, Florian Blaschke, Burkert Pieske, Zoran Bakotić, Ante Anić, Robert H. G. Schwinger, Pyotr G. Platonov,

Cardiac Imaging and Diagnostics

A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality.We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (≤35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality.Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2·7 years [IQR 2·0-3·3] in the ICD group and 1·2 years [0·8-2·7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0·57 [95% CI 0·41-0·79]; p=0·0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0·0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7·5 deg or higher (n=199; adjusted HR 0·25 [95% CI 0·13-0·47] for the ICD group vs the control group; p<0·0001) than in those with periodic repolarisation dynamics less than 7·5 deg (n=1166; adjusted HR 0·69 [95% CI 0·47-1·00]; p=0·0492; pinteraction=0·0056). The number needed to treat was 18·3 (95% CI 10·6-4895·3) in patients with periodic repolarisation dynamics less than 7·5 deg and 3·1 (2·6-4·8) in those with periodic repolarisation dynamics of 7·5 deg or higher.Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation.The European Community's 7th Framework Programme.