Differential multivariable risk prediction of appropriate shock versus competing mortality - A prospective cohort study to estimate benefits from ICD therapy

This data article features supplementary figures and tables related to the article “Differential Multivariable risk prediction of appropriate shock vs. competing mortality – a prospective cohort study to estimate benefits from implantable cardioverter defibrillator therapy” (Bergau et al., 2018) [1]. The figures show the clinical study CONSORT graph (data that show the number of patients not-analyzable as well as a distribution of patients by outcomes) and the correlation scatter plot for risk scores of appropriate shock vs. mortality (data that show the calculated score values of the two scores plotted against each other). The tables show the results for the univariate Cox regressions for prediction of mortality and appropriate shock. For further information, please see Bergau et al. (2018) [1].

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“…The data article features supplementary figures and tables related to [1]. See the abstract above for further details describing the data.…”

Section: Datamentioning

confidence: 99%

Data on differential multivariable risk prediction of appropriate shock vs. competing mortality

Bergau

Willems²,

Sprenkeler

et al. 2018

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“…34 Using multivariable regression statistics of the primary endpoint, we will be able to calculate an adequately powered hazard ratio of the ICD survival effect (as the primary measure of ICD benefit) in the overall cohort and predefined subgroups. 50,57,59,60 Cost-effectiveness in the overall trial population and in subgroups and the variation in EU countries can be analysed. Concerning these outcomes, the results will be able to confirm known independent risk factors and possibly detect new ones.…”

Section: Discussionmentioning

confidence: 99%

Section: Sample Size Calculationmentioning

confidence: 99%

“…In the Identification and Therapeutic Targeting of Common Arrhythmia Trigger Mechanisms clinical study, 50 an annual all-cause mortality of about 4% was observed for high-risk patients. In the EUTrigTreat clinical study, 50 an annual appropriate ICD shock rate of about 4.5% was observed for high-risk patients. From preliminary analyses of registry data in 1272 ICD patients 23 and from own prospective data from 282 ICD patients, 22 we inferred that independent binary or dichotomized risk stratifiers (electrophysiological parameters, biomarkers, and other patients' characteristics) provide hazard ratios between 1.5 and 2.5.…”

Section: Sample Size Calculationmentioning

confidence: 99%

“…We start here with the former. In the Identification and Therapeutic Targeting of Common Arrhythmia Trigger Mechanisms clinical study, 50 an annual all-cause mortality of about 4% was observed for high-risk patients. A similar mortality of 4.5% was observed by Smith et al 51 Assuming an annual all-cause mortality of 4.5% in the ICD patients, exponential survival times, and a hazard ratio of 0.7 as observed in Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II), 2 recruitment over 3 years, and total study duration of 4 years, a sample of 1500 ICD patients and 750 control patients yields a power of 80% at the usual two-sided significance level of 5%.…”

Section: Sample Size Calculationmentioning

confidence: 99%

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

et al. 2018

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AimsThe 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 resultsThe 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.ConclusionsThe 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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Nomogram predicting death and heart transplantation before appropriate ICD shock in dilated cardiomyopathy

et al. 2022

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Aims This study aimed to develop and validate a competing risk nomogram for predicting all‐cause mortality and heart transplantation (HT) before first appropriate shock in non‐ischaemic dilated cardiomyopathy (DCM) patients receiving implantable cardioverter‐defibrillators (ICD). Methods and results A total of 218 consecutive DCM patients implanted with ICD between 2010 and 2019 at our institution were retrospectively enrolled. Cox proportional hazards model was primarily built to identify variables associated with death and HT. Then, a Fine–Gray model, accounting for the appropriate shock as a competing risk, was constructed using these selected variables along with implantation indication (primary vs. secondary). Finally, a nomogram based on the Fine–Gray model was established to predict 1‐, 3‐, and 5‐year probabilities of all‐cause mortality and HT before first appropriate shock. The area under the receiver operating characteristic (ROC) curve (AUC), Harrell's C‐index, and calibration curves were used to evaluate and internally validate the performance of this model. The decision curve analysis was applied to assess its clinical utility. The 1‐, 3‐, and 5‐year cumulative incidence of all‐cause mortality and HT without former appropriate shock were 5.3% [95% confidence interval (CI) 2.9–9.9%], 16.6% (95% CI 11–25.0%), and 25.3% (95% CI 17.2–37.1%), respectively. Five variables including implantation indication, left ventricular end‐diastolic diameter, N‐terminal pro‐brain natriuretic peptide, angiotensin‐converting enzyme inhibitor/angiotensin receptor blocker, and amiodarone treatment were independently associated with it (all P < 0.05) and were used for constructing the nomogram. The 1‐, 3‐, and 5‐year AUC of the nomogram were 0.83 (95% CI 0.73–0.94, P < 0.001), 0.84 (95% CI 0.75–0.93, P < 0.001), and 0.85 (95% CI 0.77–0.94, P < 0.001), respectively. The Harrell's C‐index was 0.788 (95% CI 0.697–0.877, P < 0.001; 0.762 for the optimism‐corrected C‐index), showing the good discriminative ability of the model. The calibration was acceptable (optimism‐corrected slope 0.896). Decision curve analysis identified our model was clinically useful within the entire range of potential treatment thresholds for ICD implantation. Three risk groups stratified by scores were significantly different between cumulative incidence curves (P < 0.001). The identified high‐risk group composed 17.9% of our population and did not derive long‐term benefit from ICD. Conclusions The proposed nomogram is a simple, useful risk stratification tool for selecting potential ICD recipients in DCM patients. It might facilitate the shared decision‐making between patients and clinicians.

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Differential multivariable risk prediction of appropriate shock versus competing mortality - A prospective cohort study to estimate benefits from ICD therapy

Abstract: In a prospective ICD patient cohort, a very good approximation of mortality versus arrhythmic risk was possible using a multivariable diagnostic strategy. EP stimulation is the best test to assess risk of arrhythmias resulting in ICD shocks.

Cited by 23 publications

References 47 publications

Data on differential multivariable risk prediction of appropriate shock vs. competing mortality

Data on differential multivariable risk prediction of appropriate shock vs. competing mortality

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

Nomogram predicting death and heart transplantation before appropriate ICD shock in dilated cardiomyopathy

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