BACKGROUND AND AIMS: Risk stratification of sudden cardiac death after myocardial infarction and prevention by defibrillator rely on left ventricular ejection fraction (LVEF). Improved risk stratification across the whole LVEF range is required for decision-making on defibrillator implantation. METHODS: The analysis pooled 20 data sets with 140 204 post-myocardial infarction patients containing information on demographics, medical history, clinical characteristics, biomarkers, electrocardiography, echocardiography, and cardiac magnetic resonance imaging. Separate analyses were performed in patients (i) carrying a primary prevention cardioverter-defibrillator with LVEF ≤ 35% [implantable cardioverter-defibrillator (ICD) patients], (ii) without cardioverter-defibrillator with LVEF ≤ 35% (non-ICD patients ≤ 35%), and (iii) without cardioverter-defibrillator with LVEF > 35% (non-ICD patients >35%). Primary outcome was sudden cardiac death or, in defibrillator carriers, appropriate defibrillator therapy. Using a competing risk framework and systematic internal-external cross-validation, a model using LVEF only, a multivariable flexible parametric survival model, and a multivariable random forest survival model were developed and externally validated. Predictive performance was assessed by random effect meta-analysis. RESULTS: There were 1326 primary outcomes in 7543 ICD patients, 1193 in 25 058 non-ICD patients ≤35%, and 1567 in 107 603 non-ICD patients >35% during mean follow-up of 30.0, 46.5, and 57.6 months, respectively. In these three subgroups, LVEF poorly predicted sudden cardiac death (c-statistics between 0.50 and 0.56). Considering additional parameters did not improve calibration and discrimination, and model generalizability was poor. CONCLUSIONS: More accurate risk stratification for sudden cardiac death and identification of low-risk individuals with severely reduced LVEF or of high-risk individuals with preserved LVEF was not feasible, neither using LVEF nor using other predictors.
- MeSH
- defibrilátory implantabilní * MeSH
- elektrokardiografie MeSH
- hodnocení rizik metody MeSH
- infarkt myokardu * mortalita komplikace MeSH
- lidé MeSH
- náhlá srdeční smrt * prevence a kontrola epidemiologie etiologie MeSH
- tepový objem * fyziologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
Objective: Safety data on Do-It-Yourself Artificial Pancreas Systems are missing. The most widespread in Europe is the AndroidAPS implementation of the OpenAPS algorithm. We used the UVA/Padova Type 1 Diabetes Simulator to in silico test safety and efficacy of this algorithm in different scenarios. Methods: We tested five configurations of the AndroidAPS algorithm differing in aggressiveness and patient's interaction with the system. All configurations were tested with insulin sensitivity variation of ±30%. The most promising configurations were tested in real-life scenarios: over- and underestimated bolus by 50%, bolus delivered 15 min before meal, and late bolus delivered 15 min after meal. Continuous Glucose Monitoring (CGM) time in ranges (TIRs) metrics were used to assess the glycemic control. Results: In silico testing showed that open-source closed-loop system AndroidAPS works effectively and safely. The best results were reached if AndroidAPS algorithm worked with microboluses and when half of calculated bolus was issued (mean glycemia 131 mg/dL, SD 27 mg/dL, TIR 91%, time between 54 and 70 mg/dL <1%, and low blood glucose index even <1). The meal bolus over- and underestimation as well as late bolus did not affect the TIR and, importantly, the time between 54 and 70 mg/dL. Conclusion: In silico testing proved that AndroidAPS implementation of the OpenAPS algorithm is safe and effective, and it showed a great potential to be tested in prospective home setting study.
- MeSH
- algoritmy MeSH
- bezpečnost vybavení MeSH
- časové faktory MeSH
- diabetes mellitus 1. typu krev farmakoterapie MeSH
- inzulinová rezistence MeSH
- inzulinové infuzní systémy MeSH
- jídla MeSH
- krevní glukóza analýza MeSH
- lidé MeSH
- pankreas umělý * MeSH
- počítačová simulace * MeSH
- testování materiálů metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
