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Observational Study
. 2019 Feb;6(1):182-193.
doi: 10.1002/ehf2.12367. Epub 2018 Oct 9.

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

Markus Zabel  1   2 , Christian Sticherling  3 , Rik Willems  4 , Andrzej Lubinski  5 , Axel Bauer  6 , Leonard Bergau  1 , Frieder Braunschweig  7 , Josep Brugada  8 , Sandro Brusich  9 , David Conen  3   10 , Iwona Cygankiewicz  11 , Panagiota Flevari  12 , Milos Taborsky  13 , Jim Hansen  14 , Gerd Hasenfuß  1   2 , Robert Hatala  15 , Heikki V Huikuri  16 , Svetoslav Iovev  17 , Stefan Kääb  6 , Gabriela Kaliska  18 , Jaroslaw D Kasprzak  19 , Lars Lüthje  1 , Marek Malik  20 , Tomas Novotny  21 , Nikola Pavlović  22 , Georg Schmidt  23 , Tchavdar Shalganov  24 , Rajeeva Sritharan  1 , Simon Schlögl  1 , Janko Szavits Nossan  25 , Vassil Traykov  26 , Anton E Tuinenburg  27 , Vasil Velchev  28 , Marc A Vos  29 , Stefan N Willich  30 , Tim Friede  2   31 , Jesper Hastrup Svendsen  32 , Béla Merkely  33 ; EU-CERT-ICD Study Investigators
Affiliations
Observational Study

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

Markus Zabel et al. ESC Heart Fail. 2019 Feb.

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] ESC Heart Fail. 2019 Aug;6(4):899. doi: 10.1002/ehf2.12444. Epub 2019 May 7. ESC Heart Fail. 2019. PMID: 31373446 Free PMC article. No abstract available.

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.

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Figures

Figure 1
Figure 1
Overview of the EU‐CERT‐ICD project structure. QoL, quality of life; WP, work package.
Figure 2
Figure 2
Clinical study sites in the European Union.
Figure 3
Figure 3
Study protocol. ICD, implantable cardioverter defibrillator.
See this image and copyright information in PMC

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