Predicting heart failure decompensation using cardiac implantable electronic devices: a review of practices and challenges

Cardiac implantable electronic devices include remote monitoring tools intended to guide heart failure management. The monitoring focus has been on averting hospitalizations by predicting worsening heart failure. However, although device measurements including intrathoracic impedance correlate with risk of decompensation, they individually predict hospitalizations with limited accuracy. Current ‘crisis detection’ methods involve repeatedly screening for impending decompensation, and do not adhere to the principles of diagnostic testing. Complex substrate, limited test performance, low outcome incidence, and long test to outcome times inevitably generate low positive and high negative predictive values. When combined with spectrum bias, the generalizability, incremental value, and cost‐effectiveness of device algorithms are questionable. To avoid these pitfalls, remote monitoring may need to shift from crisis detection to health maintenance, keeping the patient within an ideal physiological range through continuous ‘closed loop’ interaction and dynamic therapy adjustment. Test performance must also improve, possibly through combination with physiological sensors in different dimensions, static baseline characteristics, and biomarkers. Complex modelling may tailor monitoring to individual phenotypes, and thus realize a personalized medicine approach. Future randomized controlled trials should carefully consider these issues, and ensure that the interventions tested are generalizable to clinical practice.

[1]  J. Concato,et al.  Patterns of Weight Change Preceding Hospitalization for Heart Failure , 2007, Circulation.

[2]  R. Canby,et al.  Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). , 2011, Congestive heart failure.

[3]  E. Steyerberg,et al.  Prognosis Research Strategy (PROGRESS) 3: Prognostic Model Research , 2013, PLoS medicine.

[4]  Akshay S. Desai,et al.  Connecting the circle from home to heart-failure disease management. , 2010, The New England journal of medicine.

[5]  H. Krumholz,et al.  Telemonitoring in patients with heart failure. , 2010, The New England journal of medicine.

[6]  S. A. Christman,et al.  Heart failure decompensation and all-cause mortality in relation to percent biventricular pacing in patients with heart failure: is a goal of 100% biventricular pacing necessary? , 2009, Journal of the American College of Cardiology.

[7]  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.

[8]  R. Mahajan,et al.  Remote Monitoring of Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Clinical Outcomes. , 2015, Journal of the American College of Cardiology.

[9]  Mark Woodward,et al.  Risk prediction in patients with heart failure: a systematic review and analysis. , 2014, JACC. Heart failure.

[10]  B. Dimitrov,et al.  Rationale and study design of the REM‐HF study: remote management of heart failure using implanted devices and formalized follow‐up procedures , 2014, European journal of heart failure.

[11]  W. Abraham,et al.  Continuous Autonomic Assessment in Patients With Symptomatic Heart Failure: Prognostic Value of Heart Rate Variability Measured by an Implanted Cardiac Resynchronization Device , 2004, Circulation.

[12]  J. Cleland,et al.  It makes SENSE to take a safer road. , 2011, European heart journal.

[13]  Ja Wilson,et al.  Principles and practice of screening for disease , 1968 .

[14]  G. Huster,et al.  Characterization of the precipitants of hospitalization for heart failure decompensation. , 1998, American journal of critical care : an official publication, American Association of Critical-Care Nurses.

[15]  Ron Waksman,et al.  Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. , 2013, Journal of the American College of Cardiology.

[16]  A. Michalsen,et al.  Preventable causative factors leading to hospital admission with decompensated heart failure , 1998, Heart.

[17]  Harlan M Krumholz,et al.  Statistical models and patient predictors of readmission for heart failure: a systematic review. , 2008, Archives of internal medicine.

[18]  G. Hindricks,et al.  Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial , 2014, The Lancet.

[19]  M. Borggrefe,et al.  Intrathoracic Impedance Monitoring, Audible Patient Alerts, and Outcome in Patients With Heart Failure , 2011, Circulation.

[20]  E. Warman,et al.  Burden of atrial fibrillation and poor rate control detected by continuous monitoring and the risk for heart failure hospitalization. , 2012, American heart journal.

[21]  Patrick M M Bossuyt,et al.  Diagnostic test accuracy may vary with prevalence: implications for evidence-based diagnosis. , 2009, Journal of clinical epidemiology.

[22]  J. Cleland,et al.  Which components of heart failure programmes are effective? A systematic review and meta‐analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review , 2011, European journal of heart failure.

[23]  Ron Koymans,et al.  COST-EFFECTIVENESS OF TELEHEALTH INTERVENTIONS FOR CHRONIC HEART FAILURE PATIENTS: A LITERATURE REVIEW , 2014, International Journal of Technology Assessment in Health Care.

[24]  William T. Abraham,et al.  Trials of implantable monitoring devices in heart failure: which design is optimal? , 2014, Nature Reviews Cardiology.

[25]  Jeroen J. Bax,et al.  Intrathoracic impedance monitoring to predict decompensated heart failure. , 2007, The American journal of cardiology.

[26]  Michael Böhm,et al.  Impact of Remote Telemedical Management on Mortality and Hospitalizations in Ambulatory Patients With Chronic Heart Failure: The Telemedical Interventional Monitoring in Heart Failure Study , 2011, Circulation.

[27]  D. Altman,et al.  Statistics Notes: Diagnostic tests 2: predictive values , 1994, BMJ.

[28]  M. Zile,et al.  Transition From Chronic Compensated to Acute Decompensated Heart Failure: Pathophysiological Insights Obtained From Continuous Monitoring of Intracardiac Pressures , 2008, Circulation.

[29]  D. Mark,et al.  Prognostic importance of defibrillator shocks in patients with heart failure. , 2008, The New England journal of medicine.

[30]  N. Bayley,et al.  Failure , 1890, The Hospital.

[31]  P. Schauerte,et al.  European InSync Sentry Observational Study Investigators. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure , 2007 .

[32]  Sana M. Al-Khatib,et al.  Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. , 2010, Journal of the American College of Cardiology.

[33]  Jagmeet P. Singh,et al.  Rationale and Design of the Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF). , 2015, Journal of cardiac failure.

[34]  A. Hoes,et al.  Reducing hospitalizations for heart failure. , 2002, European heart journal.

[35]  William T. Abraham,et al.  Development and validation of an integrated diagnostic algorithm derived from parameters monitored in implantable devices for identifying patients at risk for heart failure hospitalization in an ambulatory setting , 2013, European heart journal.

[36]  M. Borggrefe,et al.  Intrathoracic Impedance Monitoring, Audible Patient Alerts, and Outcome in Patients With Heart Failure , 2011, Circulation.

[37]  Amanda H. Salanitro,et al.  Risk prediction models for hospital readmission: a systematic review. , 2011, JAMA.

[38]  T. Grodzicki,et al.  The costs of heart failure in Poland from the public payer's perspective. Polish programme assessing diagnostic procedures, treatment and costs in patients with heart failure in randomly selected outpatient clinics and hospitals at different levels of care: POLKARD. , 2013, Kardiologia polska.

[39]  A. Zwinderman,et al.  Factors influencing the predictive power of models for predicting mortality and/or heart failure hospitalization in patients with heart failure. , 2014, JACC. Heart failure.

[40]  H. Heidbuchel,et al.  EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring , 2014, European heart journal.

[41]  Andrew Boyle,et al.  Development of a method to risk stratify patients with heart failure for 30-day readmission using implantable device diagnostics. , 2013, The American journal of cardiology.

[42]  N. Schork,et al.  The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? , 2011, Personalized medicine.

[43]  John G F Cleland,et al.  Predicting hospitalization due to worsening heart failure using daily weight measurement: analysis of the Trans‐European Network‐Home‐Care Management System (TEN‐HMS) study , 2008, European journal of heart failure.

[44]  J. Cleland,et al.  Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis , 2013, Heart.

[45]  D. Altman,et al.  Diagnostic tests 4: likelihood ratios , 2004, BMJ : British Medical Journal.

[46]  A. de Silvestri,et al.  A meta-analysis of remote monitoring of heart failure patients. , 2009, Journal of the American College of Cardiology.

[47]  Hilary K. Wall,et al.  Costs of heart failure-related hospitalizations in patients aged 18 to 64 years. , 2010, The American journal of managed care.

[48]  Christian Butter,et al.  Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. , 2007, European heart journal.

[49]  J. Goldberger The coin toss: implications for risk stratification for sudden cardiac death. , 2010, American heart journal.

[50]  D. Hettrick,et al.  Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization , 2008, Journal of Interventional Cardiac Electrophysiology.

[51]  L. Stevenson,et al.  Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial , 2011, The Lancet.

[52]  D. Zenker,et al.  Intrathoracic impedance monitoring to detect chronic heart failure deterioration: Relationship to changes in NT‐proBNP , 2007, European journal of heart failure.

[53]  D. Hettrick,et al.  Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart failure: clinical utility of implanted device monitoring without a patient alert. , 2009, Journal of cardiac failure.

[54]  P. Thokala,et al.  Telemonitoring after discharge from hospital with heart failure: cost-effectiveness modelling of alternative service designs , 2013, BMJ Open.

[55]  L. Tavazzi,et al.  Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. , 2011, European heart journal.

[56]  C. O'connor,et al.  Factors identified as precipitating hospital admissions for heart failure and clinical outcomes: findings from OPTIMIZE-HF. , 2008, Archives of internal medicine.

[57]  Susan Mallett,et al.  Circulating MicroRNAs as a Novel Class of Diagnostic Biomarkers in Gastrointestinal Tumors Detection: A Meta-Analysis Based on 42 Articles , 2014, PloS one.

[58]  H. Burri,et al.  Cost–consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK , 2013, 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.