University of Oulu

Zabel, M., Sticherling, C., Willems, R., Lubinski, A., Bauer, A., Bergau, L., Braunschweig, F., Brugada, J., Brusich, S., Conen, D., Cygankiewicz, I., Flevari, P., Taborsky, M., Hansen, J., Hasenfuß, G., Hatala, R., Huikuri, H. V., Iovev, S., Kääb, S., Kaliska, G., Kasprzak, J. D., Lüthje, L., Malik, M., Novotny, T., Pavlović, N., Schmidt, G., Shalganov, T., Sritharan, R., Schlögl, S., Szavits Nossan, J., Traykov, V., Tuinenburg, A. E., Velchev, V., Vos, M. A., Willich, S. N., Friede, T., Svendsen, J. H., Merkely, B., and for the EU‐CERT‐ICD Study Investigators ( 2019) Rationale and design of the EU‐CERT‐ICD prospective study: comparative effectiveness of prophylactic ICD implantation. ESC Heart Failure, 6: 182– 193. https://doi.org/10.1002/ehf2.12367

Rationale and design of the EU‐CERT‐ICD prospective study : comparative effectiveness of prophylactic ICD implantation

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Author: Zabel, Markus1,2,3,4; Sticherling, Christian5; Willems, Rik6;
Lubinski, Andrzej7; Bauer, Axel8; Bergau, Leonard1,3,4; Braunschweig, Frieder9; Brugada, Josep10; Brusich, Sandro11; Conen, David5,12; Cygankiewicz, Iwona13; Flevari, Panagiota14,15,16; Taborsky, Milos17; Hansen, Jim18,19; Hasenfuss, Gerd1,2,3,4; Hatala, Robert20; Huikuri, Heikki V.21,22; Iovev, Svetoslav23; Kaeaeb, Stefan8,24; Kaliska, Gabriela25; Kasprzak, Jaroslaw D.26; Luethje, Lars1; Malik, Marek27,28; Novotny, Tomas29; Pavlovic, Nikola30; Schmidt, Georg31; Shalganov, Tchavdar32,33; Sritharan, Rajeeva1; Schloegl, Simon1,3,4; Nossan, Janko Szavits34; Traykov, Vassil35; Tuinenburg, Anton E.36; Velchev, Vasil37,38; Vos, Marc A.39,39,39; Willich, Stefan N.40,41; Friede, Tim2,42,43; Svendsen, Jesper Hastrup44,45,46; Merkely, Bela47; Seegers, J.3,48,49,4; Munoz-Exposito, P.3,4; Tichelbacker, T.3,4; Kirovo, A.3,4; Sritharan, R.1,3,4; Joerss, K.3,4; Macken, J.3,4; Misdaq, M.3,4; Rudolph, K.3,4; Schmidt, G.31,50,42; Mueller, A.50,42; Dommasch, M.50,42; Sinnecker, D.50,42; Sinner, M.24; Bauer, A.8,51,52; Dissmann, R.53; Burmester, U.53; Behrens, S.54; Gregor, M.54; Stefanow, S.55; Rueb, N.55; Wolpert, C.55; Bimmel, D.56; Lieberz, C.56; Seegers, J.3,48,49,4; Maier, L.48,49; Schwinger, R.57; Blaschke, F.58; Pieske, B.58; Groenefeld, G.59,60; Klein, G.61; Gardiwal, A.61; Merkely, B.47,62; Szeplaki, G.62; Perge, P.62; Nossan, J. Szavits63; Rotkvic, L.63; Pavlovic, N.30,64; Manola, S.64; Vinter, O.64; Benko, I.64; Brusic, S.65; Avdovic, E.65; Klasan, M.65; Bakotic, Z.66; Anic, A.3,66; Lubinski, A.7,67; Kowalczyk, E.67; Kucejko, T.67; Czechowska, A.67; Wybor, K.67; Cygankiewicz, I.13,68; Ptaszynski, P.68; Kasprzak, J.26,69,70; Qavoq, H.69,70; Guzik, P.71; Krauze, T.71; Sterlinski, M.72; Hatala, R.20,73; Svetlosak, M.73; Kaliska, G.25,74; Martinek, J.74; Thamsborg, K.46; Hansen, J.18,19,18; Schloett-Hyldelund, I. M.18; Laage-Petersen, J.18; Willems, R.6,6; Vandenberk, B.6; van Soest, S.6; Traykov, V.35,75; Iovev, S.23,76; Shalganov, T.32,33; Sticherling, C.5,77,78,79,5; Conen, D.5,12,77,5; Giesebart, S.77; Novotny, T.29,80; Kozak, M.80; Taborsky, M.17,81; Galuszka, J.81; Tuinenburg, A. E.36; Wijers, S.36,39,39; Wijers, S.36,39,39; Dunnink, A.39,39; Sprenkeler, D.39,39; Brugada, J.10,10,82; Arbelo, E.10,82; Trucco, E.10,82; Vidorreta, S.10; Huikuri, H.21,22,83,84; Kentta, T.83,84; Pelli, A.83,84; Huikuri, P.83; Koski, P.83; Braunschweig, F.9; Karlsson, H.85; Ersgaard, D.85; Platonov, P.86; Klingenheben, T.60; Scharfe, M.78,79; Reinhold, T.41; Cree, M.41; Hnatkova, K.28; Kentta, T.83,84; Gerhardt, J.42; Rizas, K.52; Hamm, W.52; Roever, C.; Harden, M.43; Kessel, B.43; Brugada, J.10,10,82; Berg, A.; Apel, S.; Walker, F.; Kirchhof, N.; Goerlitz, A.; Molitor, A.; Heinrich, J.; Annetzberger, S.; Fuchs, B.; Landwehr, A.; Merk, A.; Wilke, A.; Hennecke, C.; Mansch, R.
Organizations: 1Univ Med Ctr, Dept Cardiol & Pneumol, Heart Ctr, Gottingen, Germany.
2DZHK German Ctr Cardiovasc Res, Partner Site Gottingen, Gottingen, Germany.
3Univ Med Ctr Gottingen, Gottingen, Germany.
4Univ Med Ctr Gottingen, Dept Cardiol, Gottingen, Germany.
5Univ Hosp, Dept Cardiol, Basel, Switzerland.
6Univ Leuven, Dept Cardiovasc Sci, Leuven, Belgium.
7MUL, WAM Hosp, Dept Cardiol, Lodz, Poland.
8Ludwig Maximilians Univ Munchen, Klinikum Grosshadern, Dept Cardiol, Munich, Germany.
9Karolinska Inst, Dept Cardiol, Stockholm, Sweden.
10Hosp Clin Barcelona, Dept Cardiol, IDIBAPS, Barcelona, Spain.
11KBC Rijeka, Dept Cardiovasc Dis, Rijeka, Croatia.
12McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.
13MUL, Detp Electrocardiol, Lodz, Poland.
14Attikon Univ Hosp, Dept Cardiol 2, Athens, Greece.
15Univ Hosp Leuven KUL, Leuven, Belgium.
16Attikon Univ Hosp Athens, Athens, Greece.
17Univ Hosp, Dept Cardiol, Olomouc, Czech Republic.
18Gentofte Univ Hosp, Copenhagen, Denmark.
19KBC Split, Split, Croatia.
20Slovak Med Univ NUSCH, Bratislava, Slovakia.
21Oulu Univ Hosp, Med Res Ctr, Oulu, Finland.
22Univ Oulu, Oulu, Finland.
23St Ekaterina Univ Hosp, Dept Cardiol, Sofia, Bulgaria.
24Univ Med Ctr Gottingen, Staff Unit Clin Studies, Gottingen, Germany.
25SUSSCH, Dept Cardiol, Banska Bystr, Slovakia.
26MUL, Bieganski Hosp, Chair & Dept Cardiol, Lodz, Poland.
27Imperial Coll, Natl Heart & Lung Inst, London, England.
28Imperial Coll London, St Pauls Electrophysiol, London, England.
29Univ Hosp Brno, Dept Internal Med & Cardiol, Brno, Czech Republic.
30KBC Sestre Milosrdnice, Dept Cardiol, Zagreb, Croatia.
31Tech Univ Munich, Klinikum Rechts Isar, Med Klin & Poliklin 1, Munich, Germany.
32Natl Heart Hosp, Dept Cardiol, Sofia, Bulgaria.
33Natl Heart Hosp, Sofia, Bulgaria.
34Magdalena Klin, Dept Cardiol, Krapinske Toplice, Croatia.
35Tokuda Hosp, Dept Cardiol, Acibadem City Clin, Sofia, Bulgaria.
36Univ Med Ctr Utrecht, Dept Cardiol, Utrecht, Netherlands.
37St Anna Hosp, Dept Cardiol, Sofia, Bulgaria.
38St Anna Hosp, Sofia, Bulgaria.
39Univ Med Ctr Utrecht, Dept Med Physiol, Utrecht, Netherlands.
40Charite Univ Med Berlin, Inst Social Med Epidemiol & Hlth Econ, Berlin, Germany.
41Charite Inst Social Med Epidemiol & Hlth Econ, Berlin, Germany.
42Univ Med Ctr Gottingen, Dept Med Stat, Gottingen, Germany.
43Gabo Mi, Munich, Germany.
44Copenhagen Univ Hosp, Rigshosp, Heart Ctr, Dept Cardiol, Copenhagen, Denmark.
45Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark.
46Rigshosp Copenhagen, Copenhagen, Denmark.
47Semmelweis Univ, Dept Cardiol, Heart Ctr, Budapest, Hungary.
48Marienkrankenhaus Bonn, Bonn, Germany.
49Univ Hosp Regensburg, Regensburg, Germany.
50Tech Univ Munich, Klinikum Rechts Isar, Munich, Germany.
51Univ Hosp Tubingen, Tubingen, Germany.
52Univ Med Ctr Gottingen, Inst Clin Studies, Study Ctr, Clin Trial Unit IFS KSM, Gottingen, Germany.
53Ludwig Maximilians Univ Munchen, Klinikum Grosshadern & Innenstadt, Munich, Germany.
54Klinikum Reinkenheide Bremerhaven, Bremerhaven, Germany.
55Vivantes Humboldt Klinikum Berlin, Berlin, Germany.
56Klinikum Ludwigsburg, Ludwigsburg, Germany.
57Klinikum Weiden, Weiden, Germany.
58Charite Campus Virchow Klinikum, Berlin, Germany.
59Asklepios Klin Hamburg Barmbek, Hamburg, Germany.
60Endpoint Adjudicat Comm, Parma, Italy.
61Herz Zentrum Hannover, Hannover, Germany.
62Semmelweis Univ Hosp Budapest, Budapest, Hungary.
63Magdalena Klin Krapinske Toplice, Krapinske Toplice, Croatia.
64KBC Sestre Milosrdnice Zagreb, Zagreb, Croatia.
65KBC Rijeka, Rijeka, Croatia.
66Gen Hosp Zadar, Zadar, Croatia.
67MUL, WAM Hosp, Lodz, Poland.
68MUL, CKD Hosp, Lodz, Poland.
69MUL, Bieganski Hosp, Lodz, Poland.
70MUL, Bieganski Hosp, Dept Cardiol, Lodz, Poland.
71Poznan Med Univ, HSUH Hosp, Poznan, Poland.
72Inst Cardiol Warsaw, Warsaw, Poland.
73Slovak Med Univ, NUSCH Bratislava, Bratislava, Slovakia.
74SUSSCH Banska Bystrica, Banska Bystrica, Slovakia.
75Tokuda Hosp, Acibadem City Clin, Sofia, Bulgaria.
76St Ekaterina Univ Hosp, Sofia, Bulgaria.
77Univ Hosp Basel, Basel, Switzerland.
78Univ Hosp Basel, Dept Cardiol, Basel, Switzerland.
79Univ Hosp Basel, Clin Trial Unit, Basel, Switzerland.
80Univ Hosp Brno, Brno, Czech Republic.
81Univ Hosp Olomouc, Olomouc, Czech Republic.
82Univ Med Ctr Gottingen, EU Int Off, Gottingen, Germany.
83Univ Oulu, Med Ctr, Oulu, Finland.
84Univ Oulu, Med Ctr, Dept Cardiol, Oulu, Finland.
85Karolinska Inst Stockholm, Stockholm, Sweden.
86Lund Univ Hosp, Lund, Sweden.
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.4 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2020042822783
Language: English
Published: John Wiley & Sons, 2019
Publish Date: 2020-04-28
Description:

Abstract

Aims: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU‐CERT‐ICD) aims to assess its current clinical value.

Methods and results: The EU‐CERT‐ICD is a prospective investigator‐initiated non‐randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non‐randomized control group). The primary endpoint is all‐cause mortality; the co‐primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost‐effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12‐lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years.

Conclusions: The EU‐CERT‐ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.

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Series: ESC heart failure
ISSN: 2055-5822
ISSN-E: 2055-5822
ISSN-L: 2055-5822
Volume: 6
Issue: 1
Pages: 182 - 193
DOI: 10.1002/ehf2.12367
OADOI: https://oadoi.org/10.1002/ehf2.12367
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
Subjects:
Funding: The research leading to the results has received funding from the European Community's Seventh Framework Programme FP7/2007‐2013 under grant agreement n0 602299, EU‐CERT‐ICD (starting 1 October 2013).
Copyright information: © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
  https://creativecommons.org/licenses/by-nc-nd/4.0/