Bergau, Leonard

[["dc.bibliographiccitation.firstpage","3437"],["dc.bibliographiccitation.issue","36"],["dc.bibliographiccitation.journal","European Heart Journal"],["dc.bibliographiccitation.lastpage","3447"],["dc.bibliographiccitation.volume","41"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Willems, Rik"],["dc.contributor.author","Lubinski, Andrzej"],["dc.contributor.author","Bauer, Axel"],["dc.contributor.author","Brugada, Josep"],["dc.contributor.author","Conen, David"],["dc.contributor.author","Flevari, Panagiota"],["dc.contributor.author","Hasenfuß, Gerd"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Lüthje, Lars"],["dc.contributor.author","Haarmann, Helge"],["dc.contributor.author","Bergau, Leonard"],["dc.contributor.author","Tichelbäcker, Tobias"],["dc.contributor.author","Hasenfuß, Gerd"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Harden, Markus"],["dc.contributor.author","Pieske, Burkert"],["dc.contributor.authorgroup","EU-CERT-ICD Study Investigators"],["dc.date.accessioned","2020-05-07T07:50:46Z"],["dc.date.accessioned","2021-10-27T13:22:10Z"],["dc.date.available","2020-05-07T07:50:46Z"],["dc.date.available","2021-10-27T13:22:10Z"],["dc.date.issued","2020"],["dc.description.abstract","Aims: The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. Methods and results: We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class

[["dc.bibliographiccitation.firstpage","182"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","ESC Heart Failure"],["dc.bibliographiccitation.lastpage","193"],["dc.bibliographiccitation.volume","6"],["dc.contributor.author","Zabel, Markus"],["dc.contributor.author","Sticherling, Christian"],["dc.contributor.author","Willems, Rik"],["dc.contributor.author","Lubinski, Andrzej"],["dc.contributor.author","Bauer, Axel"],["dc.contributor.author","Bergau, Leonard"],["dc.contributor.author","Braunschweig, Frieder"],["dc.contributor.author","Brugada, Josep"],["dc.contributor.author","Brusich, Sandro"],["dc.contributor.author","Conen, David"],["dc.contributor.author","Cygankiewicz, Iwona"],["dc.contributor.author","Flevari, Panagiota"],["dc.contributor.author","Taborsky, Milos"],["dc.contributor.author","Hansen, Jim"],["dc.contributor.author","Hasenfuß, Gerd"],["dc.contributor.author","Hatala, Robert"],["dc.contributor.author","Huikuri, Heikki V"],["dc.contributor.author","Iovev, Svetoslav"],["dc.contributor.author","Kääb, Stefan"],["dc.contributor.author","Kaliska, Gabriela"],["dc.contributor.author","Kasprzak, Jaroslaw D"],["dc.contributor.author","Lüthje, Lars"],["dc.contributor.author","Malik, Marek"],["dc.contributor.author","Novotny, Tomas"],["dc.contributor.author","Pavlović, Nikola"],["dc.contributor.author","Schmidt, Georg"],["dc.contributor.author","Shalganov, Tchavdar"],["dc.contributor.author","Sritharan, Rajeeva"],["dc.contributor.author","Schlögl, Simon"],["dc.contributor.author","Szavits Nossan, Janko"],["dc.contributor.author","Traykov, Vassil"],["dc.contributor.author","Tuinenburg, Anton E"],["dc.contributor.author","Velchev, Vasil"],["dc.contributor.author","Vos, Marc A"],["dc.contributor.author","Willich, Stefan N"],["dc.contributor.author","Friede, Tim"],["dc.contributor.author","Svendsen, Jesper Hastrup"],["dc.contributor.author","Merkely, Béla"],["dc.date.accessioned","2019-07-09T11:50:28Z"],["dc.date.available","2019-07-09T11:50:28Z"],["dc.date.issued","2019"],["dc.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."],["dc.identifier.doi","10.1002/ehf2.12367"],["dc.identifier.pmid","30299600"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/15947"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59780"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.relation","info:eu-repo/grantAgreement/EC/FP7/602299/EU//EU-CERT-ICD"],["dc.relation.issn","2055-5822"],["dc.rights","CC BY-NC-ND 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by-nc-nd/4.0"],["dc.subject.ddc","610"],["dc.subject.mesh","Cardiomyopathy, Dilated"],["dc.subject.mesh","Death, Sudden, Cardiac"],["dc.subject.mesh","Defibrillators, Implantable"],["dc.subject.mesh","Electrocardiography"],["dc.subject.mesh","Europe"],["dc.subject.mesh","Follow-Up Studies"],["dc.subject.mesh","Humans"],["dc.subject.mesh","Patient Selection"],["dc.subject.mesh","Primary Prevention"],["dc.subject.mesh","Prospective Studies"],["dc.subject.mesh","Quality of Life"],["dc.subject.mesh","Risk Assessment"],["dc.subject.mesh","Survival Rate"],["dc.subject.mesh","Treatment Outcome"],["dc.title","Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]