Assessment of a novel device‐based diagnostic algorithm to monitor patient status in moderate‐to‐severe heart failure: rationale and design of the CLEPSYDRA study

Monitoring systems integrated into electronic implantable devices for heart failure (HF) have significantly expanded the possibility of obtaining diagnostic information and can be used to enhance patient follow‐up. The ability to obtain advance warning of worsening HF is currently being explored using a variety of diagnostic parameters. A novel device‐based algorithm, physiological diagnostic (PhD), combines data from minute ventilation and accelerometer sensors to provide an indicator of the overall status of HF patients and detect clinically relevant acute HF events. The objective of this study was to evaluate the effectiveness of the PhD algorithm for detecting HF events in patients with HF.

[1]  Karl Swedberg,et al.  Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure , 2007, Circulation.

[2]  Michael Böhm,et al.  Kommentar zu den ESC-Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 , 2008, European journal of heart failure.

[3]  Y Wang,et al.  Readmission after hospitalization for congestive heart failure among Medicare beneficiaries. , 1997, Archives of internal medicine.

[4]  Simon Capewell,et al.  The current cost of heart failure to the National Health Service in the UK , 2002, European journal of heart failure.

[5]  Mary Ann Peberdy,et al.  The minute ventilation/carbon dioxide production slope is prognostically superior to the oxygen uptake efficiency slope. , 2007, Journal of cardiac failure.

[6]  Roger Willems,et al.  Comparison of Impedance Minute Ventilation and Direct Measured Minute Ventilation in a Rate Adaptive Pacemaker , 2003, Pacing and clinical electrophysiology : PACE.

[7]  H. Tsutsui.  [Candesartan in heart failure: assessment of reduction in mortality and morbidity]. , 2007, Nihon rinsho. Japanese journal of clinical medicine.

[8]  Philippe Ritter,et al.  Physiological approach to monitor patients in congestive heart failure: application of a new implantable device-based system to monitor daily life activity and ventilation. , 2007, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[9]  M. Zile,et al.  Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. , 2008, Journal of the American College of Cardiology.

[10]  R. Arena,et al.  The clinical and research applications of aerobic capacity and ventilatory efficiency in heart failure: an evidence-based review , 2008, Heart Failure Reviews.

[11]  N Freemantle,et al.  The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. , 2003, European heart journal.

[12]  L. Tavazzi,et al.  Rationale and design of a prospective trial to assess the sensitivity and positive predictive value of implantable intrathoracic impedance monitoring in the prediction of heart failure hospitalizations: the SENSE-HF study. , 2009, Journal of cardiac failure.

[13]  J. Daubert,et al.  The effect of cardiac resynchronization on morbidity and mortality in heart failure. , 2005, The New England journal of medicine.

[14]  C. Lau,et al.  Intrathoracic Impedance Monitoring in Patients With Heart Failure: Correlation With Fluid Status and Feasibility of Early Warning Preceding Hospitalization , 2005, Circulation.

[15]  P. Vardas,et al.  Tracing the European course of cardiac resynchronization therapy from 2006 to 2008. , 2010, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[16]  K. Dickstein,et al.  Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: changes from 2004 to 2008 , 2009, European journal of heart failure.

[17]  D. J. Veldhuisen,et al.  Can monitoring of intrathoracic impedance reduce morbidity and mortality in patients with chronic heart failure? Rationale and design of the Diagnostic Outcome Trial in Heart Failure (DOT‐HF) ☆ , 2008, European journal of heart failure.