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

Markus Zabel; Christian Sticherling; Rik Willems; Andrzej Lubinski; Axel Bauer; Leonard Bergau; Frieder Braunschweig; Josep Brugada; Sandro Brusich; David Conen; Iwona Cygankiewicz; Panagiota Flevari; Milos Taborsky; Jim Hansen; Gerd Hasenfuß; Robert Hatala; Heikki V. Huikuri; Svetoslav Iovev; Stefan Kääb; Gabriela Kaliska; Jaroslaw D. Kasprzak; Lars Lüthje; Marek Malik; Tomas Novotny; Nikola Pavlović; Georg Schmidt; Tchavdar Shalganov; Rajeeva Sritharan; Simon Schlögl; Janko Szavits Nossan; Vassil Traykov; Anton E. Tuinenburg; Vasil Velchev; Marc A. Vos; Stefan N. Willich; Tim Friede; Jesper Hastrup Svendsen; Béla Merkely; for the EU-CERT-ICD Study Investigators

doi:10.1002/ehf2.12367

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

Markus Zabel^*, Christian Sticherling, Rik Willems, Andrzej Lubinski, Axel Bauer, Leonard Bergau, Frieder Braunschweig, Josep Brugada, Sandro Brusich, David Conen, Iwona Cygankiewicz, Panagiota Flevari, Milos Taborsky, Jim Hansen, Gerd Hasenfuß, Robert Hatala, Heikki V. Huikuri, Svetoslav Iovev, Stefan Kääb, Gabriela KaliskaJaroslaw D. Kasprzak, Lars Lüthje, Marek Malik, Tomas Novotny, Nikola Pavlović, Georg Schmidt, Tchavdar Shalganov, Rajeeva Sritharan, Simon Schlögl, Janko Szavits Nossan, Vassil Traykov, Anton E. Tuinenburg, Vasil Velchev, Marc A. Vos, Stefan N. Willich, Tim Friede, Jesper Hastrup Svendsen, Béla Merkely, for the EU-CERT-ICD Study Investigators

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

16 Citationer (Scopus)

20 Downloads (Pure)

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.

Originalsprog	Engelsk
Tidsskrift	ESC heart failure
Vol/bind	6
Udgave nummer	1
Sider (fra-til)	182-193
Antal sider	12
ISSN	2055-5822
DOI	https://doi.org/10.1002/ehf2.12367
Status	Udgivet - feb. 2019

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10.1002/ehf2.12367Licens: CC BY-NC-ND

Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantationForlagets udgivne version, 431 KBLicens: CC BY-NC-ND

Citationsformater

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., ... 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(1), 182-193. https://doi.org/10.1002/ehf2.12367

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, HV, Iovev, S, Kääb, S, Kaliska, G, Kasprzak, JD, Lüthje, L, Malik, M, Novotny, T, Pavlović, N, Schmidt, G, Shalganov, T, Sritharan, R, Schlögl, S, Szavits Nossan, J, Traykov, V, Tuinenburg, AE, Velchev, V, Vos, MA, Willich, SN, Friede, T, Svendsen, JH, Merkely, B & 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, bind 6, nr. 1, s. 182-193. https://doi.org/10.1002/ehf2.12367

@article{69e4f4e751854858af6861d03f2e7a2d,

title = "Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation",

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.",

keywords = "Implantable cardioverter defibrillator, Mortality, Risk factors, Sudden cardiac death",

author = "Markus Zabel and Christian Sticherling and Rik Willems and Andrzej Lubinski and Axel Bauer and Leonard Bergau and Frieder Braunschweig and Josep Brugada and Sandro Brusich and David Conen and Iwona Cygankiewicz and Panagiota Flevari and Milos Taborsky and Jim Hansen and Gerd Hasenfu{\ss} and Robert Hatala and Huikuri, {Heikki V.} and Svetoslav Iovev and Stefan K{\"a}{\"a}b and Gabriela Kaliska and Kasprzak, {Jaroslaw D.} and Lars L{\"u}thje and Marek Malik and Tomas Novotny and Nikola Pavlovi{\'c} and Georg Schmidt and Tchavdar Shalganov and Rajeeva Sritharan and Simon Schl{\"o}gl and {Szavits Nossan}, Janko and Vassil Traykov and Tuinenburg, {Anton E.} and Vasil Velchev and Vos, {Marc A.} and Willich, {Stefan N.} and Tim Friede and Svendsen, {Jesper Hastrup} and B{\'e}la Merkely and {for the EU-CERT-ICD Study Investigators}",

year = "2019",

month = feb,

doi = "10.1002/ehf2.12367",

language = "English",

volume = "6",

pages = "182--193",

journal = "E S C Heart Failure",

issn = "2055-5822",

publisher = "JohnWiley & Sons Ltd",

number = "1",

}

TY - JOUR

T1 - Rationale and design of the EU-CERT-ICD prospective study

T2 - comparative effectiveness of prophylactic ICD implantation

AU - Zabel, Markus

AU - Sticherling, Christian

AU - Willems, Rik

AU - Lubinski, Andrzej

AU - Bauer, Axel

AU - Bergau, Leonard

AU - Braunschweig, Frieder

AU - Brugada, Josep

AU - Brusich, Sandro

AU - Conen, David

AU - Cygankiewicz, Iwona

AU - Flevari, Panagiota

AU - Taborsky, Milos

AU - Hansen, Jim

AU - Hasenfuß, Gerd

AU - Hatala, Robert

AU - Huikuri, Heikki V.

AU - Iovev, Svetoslav

AU - Kääb, Stefan

AU - Kaliska, Gabriela

AU - Kasprzak, Jaroslaw D.

AU - Lüthje, Lars

AU - Malik, Marek

AU - Novotny, Tomas

AU - Pavlović, Nikola

AU - Schmidt, Georg

AU - Shalganov, Tchavdar

AU - Sritharan, Rajeeva

AU - Schlögl, Simon

AU - Szavits Nossan, Janko

AU - Traykov, Vassil

AU - Tuinenburg, Anton E.

AU - Velchev, Vasil

AU - Vos, Marc A.

AU - Willich, Stefan N.

AU - Friede, Tim

AU - Svendsen, Jesper Hastrup

AU - Merkely, Béla

AU - for the EU-CERT-ICD Study Investigators

PY - 2019/2

Y1 - 2019/2

N2 - 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.

AB - 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.

KW - Implantable cardioverter defibrillator

KW - Mortality

KW - Risk factors

KW - Sudden cardiac death

U2 - 10.1002/ehf2.12367

DO - 10.1002/ehf2.12367

M3 - Journal article

C2 - 30299600

AN - SCOPUS:85054621770

SN - 2055-5822

VL - 6

SP - 182

EP - 193

JO - E S C Heart Failure

JF - E S C Heart Failure

IS - 1

ER -

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

Abstract

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