Abstract
Purpose
The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients.
Methods
We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry.
Results
We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables.
Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3–3.8%).
Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31–10.7) to 6.53 (CI 1.52–28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models.
Conclusion
In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods.
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Availability of data and material
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Code availability
Not applicable.
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Acknowledgements
The authors gratefully acknowledge the valuable scientific input from Alessandro Capucci. The authors would like to thank Vincenzo Bombaci, Giusy Deblasi, Giulio Cannella, Gianluca Melino, and all field engineers of BIOTRONIK Italia for their continuous technical support.
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V.C. and C.B. conceived of the presented idea, wrote the original draft, and supervised the work. V.C., G.Z., A.DO., C.B., S.I., C.P., E.P., F.S., M.G., M.B., G.M., M.M., G.S., S.P., G.F., V.S., A.C., A.D.R., A.R., F.Q., P.B., F.C., M.M., D.S, D.O., M.S., G.B., and P.D.B. were responsible for data collection and contributed to results interpretation. D.G. and A.G. performed statistical analysis. All authors discussed the results and commented on the manuscript.
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D.G. and A.G. are employees of BIOTRONIK Italia. All the remaining authors have no major conflicts of interest to disclose.
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Calvi, V., Zanotto, G., D’Onofrio, A. et al. One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?. J Interv Card Electrophysiol 64, 607–619 (2022). https://doi.org/10.1007/s10840-021-01083-y
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DOI: https://doi.org/10.1007/s10840-021-01083-y