1. Safety threshold of R-wave amplitudes in patients with implantable cardioverter defibrillator.
- Author
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Lillo-Castellano JM, Marina-Breysse M, Gómez-Gallanti A, Martínez-Ferrer JB, Alzueta J, Pérez-Álvarez L, Alberola A, Fernández-Lozano I, Rodríguez A, Porro R, Anguera I, Fontenla A, González-Ferrer JJ, Cañadas-Godoy V, Pérez-Castellano N, Garófalo D, Salvador-Montañés Ó, Calvo CJ, Quintanilla JG, Peinado R, Mora-Jiménez I, Pérez-Villacastín J, Rojo-Álvarez JL, and Filgueiras-Rama D
- Subjects
- Action Potentials, Adult, Aged, Delayed Diagnosis, Electric Countershock adverse effects, Electrocardiography methods, Female, Heart Rate, Humans, Male, Middle Aged, Patient Safety, Predictive Value of Tests, Prosthesis Design, Registries, Remote Sensing Technology methods, Risk Factors, Signal Processing, Computer-Assisted, Spain, Telemetry methods, Time Factors, Treatment Outcome, Ventricular Fibrillation diagnosis, Ventricular Fibrillation physiopathology, Defibrillators, Implantable, Electric Countershock instrumentation, Heart Conduction System physiopathology, Ventricular Fibrillation therapy
- Abstract
Objective: A safety threshold for baseline rhythm R-wave amplitudes during follow-up of implantable cardioverter defibrillators (ICD) has not been established. We aimed to analyse the amplitude distribution and undersensing rate during spontaneous episodes of ventricular fibrillation (VF), and define a safety amplitude threshold for baseline R-waves., Methods: Data were obtained from an observational multicentre registry conducted at 48 centres in Spain. Baseline R-wave amplitudes and VF events were prospectively registered by remote monitoring. Signal processing algorithms were used to compare amplitudes of baseline R-waves with VF R-waves. All undersensed R-waves after the blanking period (120 ms) were manually marked., Results: We studied 2507 patients from August 2011 to September 2014, which yielded 229 VF episodes (cycle length 189.6±29.1 ms) from 83 patients that were suitable for R-wave comparisons (follow-up 2.7±2.6 years). The majority (77.6%) of VF R-waves (n=13953) showed lower amplitudes than the reference baseline R-wave. The decrease in VF amplitude was progressively attenuated among subgroups of baseline R-wave amplitude (≥17; ≥12 to <17; ≥7 to <12; ≥2.2 to <7 mV) from the highest to the lowest: median deviations -51.2% to +22.4%, respectively (p=0.027). There were no significant differences in undersensing rates of VF R-waves among subgroups. Both the normalised histogram distribution and the undersensing risk function obtained from the ≥2.2 to <7 mV subgroup enabled the prediction that baseline R-wave amplitudes ≤2.5 mV (interquartile range: 2.3-2.8 mV) may lead to ≥25% of undersensed VF R-waves., Conclusions: Baseline R-wave amplitudes ≤2.5 mV during follow-up of patients with ICDs may lead to high risk of delayed detection of VF., Trial Registration Number: NCT01561144; results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
- Published
- 2016
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