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

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Harvard

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 & 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, vol. 6, no. 1, pp. 182-193. https://doi.org/10.1002/ehf2.12367

APA

Zabel, M., Sticherling, C., Willems, R., Lubinski, A., Bauer, A., Bergau, L., ... 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

CBE

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, 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

MLA

Vancouver

Author

Zabel, Markus ; Sticherling, Christian ; Willems, Rik ; Lubinski, Andrzej ; Bauer, Axel ; Bergau, Leonard ; Braunschweig, Frieder ; Brugada, Josep ; Brusich, Sandro ; Conen, David ; Cygankiewicz, Iwona ; Flevari, Panagiota ; Taborsky, Milos ; Hansen, Jim ; Hasenfuß, Gerd ; Hatala, Robert ; Huikuri, Heikki V ; Iovev, Svetoslav ; Kääb, Stefan ; Kaliska, Gabriela ; Kasprzak, Jaroslaw D ; Lüthje, Lars ; Malik, Marek ; Novotny, Tomas ; Pavlović, Nikola ; Schmidt, Georg ; Shalganov, Tchavdar ; Sritharan, Rajeeva ; Schlögl, Simon ; Szavits Nossan, Janko ; Traykov, Vassil ; Tuinenburg, Anton E ; Velchev, Vasil ; Vos, Marc A ; Willich, Stefan N ; Friede, Tim ; Svendsen, Jesper Hastrup ; Merkely, Béla ; EU-CERT-ICD Study Investigators. / Rationale and design of the EU-CERT-ICD prospective study : comparative effectiveness of prophylactic ICD implantation. In: ESC Heart Failure. 2019 ; Vol. 6, No. 1. pp. 182-193.

Bibtex

@article{fb15357275ed48b0a685b640a1cf1999,
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 = "Cardiomyopathy, Dilated/complications, Death, Sudden, Cardiac/epidemiology, Defibrillators, Implantable, Electrocardiography, Europe/epidemiology, Follow-Up Studies, Humans, Patient Selection, Primary Prevention/methods, Prospective Studies, Quality of Life, Risk Assessment, Survival Rate/trends, Treatment Outcome, Mortality, Implantable cardioverter defibrillator, Sudden cardiac death, Risk factors",
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 Pavlović 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 {EU-CERT-ICD Study Investigators}",
note = "{\circledC} 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.",
year = "2019",
month = "2",
day = "1",
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",

}

RIS

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 - EU-CERT-ICD Study Investigators

N1 - © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

PY - 2019/2/1

Y1 - 2019/2/1

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 - Cardiomyopathy, Dilated/complications

KW - Death, Sudden, Cardiac/epidemiology

KW - Defibrillators, Implantable

KW - Electrocardiography

KW - Europe/epidemiology

KW - Follow-Up Studies

KW - Humans

KW - Patient Selection

KW - Primary Prevention/methods

KW - Prospective Studies

KW - Quality of Life

KW - Risk Assessment

KW - Survival Rate/trends

KW - Treatment Outcome

KW - Mortality

KW - Implantable cardioverter defibrillator

KW - Sudden cardiac death

KW - Risk factors

UR - http://www.scopus.com/inward/record.url?scp=85054621770&partnerID=8YFLogxK

U2 - 10.1002/ehf2.12367

DO - 10.1002/ehf2.12367

M3 - Journal article

VL - 6

SP - 182

EP - 193

JO - E S C Heart Failure

JF - E S C Heart Failure

SN - 2055-5822

IS - 1

ER -

ID: 56979200