Long-Term Effectiveness of the Combined Minute Ventilation and Patient Activity Sensors as Predictor of Heart Failure Events in Patients Treated with Cardiac Resynchronization Therapy: Results of the Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device Trial (CLEPSYDRA) Study
Key result
The Physiological Diagnostic algorithm predicted 34% of heart failure events within a month, with a false positive rate of 2.4 alerts per patient-year.
Why the study?
Does the Physiological Diagnostic feature combining minute ventilation and physical activity sensors predict heart failure events in patients with CRT-D devices?
Population
521 patients with heart failure implanted with cardiac resynchronization therapy with defibrillation…
Design
Cohort, non-randomized, double-blind
Follow-up
mean 17.0 ± 8.7 months
Authors
Discussion
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Member takes
Implication
May inform remote monitoring in CRT-D recipients; leaves open whether alert-driven interventions improve outcomes in randomized trials.
Study Design
Type
Observational (n=521)
Blinding
Double-blind
Multicenter
Yes
Structured PICO
Does the Physiological Diagnostic feature combining minute ventilation and physical activity sensors predict heart failure events in patients with CRT-D devices?
P
Population
521 patients with heart failure (mean age 67.4 years, 82% male) implanted with CRT-D devices, followed for a mean of 17.0 months.
E
Exposure
Physiological Diagnostic feature (combining data from minute ventilation and physical activity sensors) in the PARADYM CRT device
O
Outcome
Sensitivity and false positive rate of the Physiological Diagnostic algorithm to predict heart failure events within the following monthsurrogate
The Physiological Diagnostic algorithm in CRT-D devices predicted 34% of heart failure events within a month, with a false positive rate of 2.4 alerts per patient-year.
Cite This Study
Auricchio et al. (2014) conducted an observational in heart failure (n=521). Physiological Diagnostic algorithm (combined minute ventilation and patient activity sensors) was evaluated on Sensitivity and false positive rate of the Physiological Diagnostic algorithm to predict heart failure events within the following month. The Physiological Diagnostic algorithm predicted 34% of heart failure events within a month, with a false positive rate of 2.4 alerts per patient-year.