Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation

PurposeGuidelines advocate remote monitoring (RM) in patients with a cardiac implantable electronic device (CIED). However, it is not known when RM should be initiated. We hypothesized that prompt initiation of RM (within 91 days of implant) is associated with improved survival compared to delayed initiation.MethodsThis retrospective, national, observational cohort study evaluated patients receiving new implants of market-released St. Jude Medical™ pacemakers (PM), implantable cardioverter defibrillators (ICD), and cardiac resynchronization therapy (CRT) devices. Patients were assigned to one of two groups: an “RM Prompt” group, in which RM was initiated within 91 days of implant; and an “RM Delayed” group, in which RM was initiated >91 days but ≤365 days of implant. The primary endpoint was all-cause mortality.ResultsThe cohort included 106,027 patients followed for a mean of 2.6 ± 0.9 years. Overall, 47,014 (44 %) patients had a PM, 31,889 (30 %) patients had an ICD, 24,005 (23 %) patients had a CRT-D, and 3119 (3 %) patients had a CRT-P. Remote monitoring was initiated promptly (median 4 weeks [IQR 2, 8 weeks]) in 66,070 (62 %) patients; in the other 39,957 (38 %) patients, RM initiation was delayed (median 24 weeks [IQR 18, 34 weeks]). In comparison to delayed initiation, prompt initiation of RM was associated with a lower mortality rate (4023 vs. 4679 per 100,000 patient-years, p < 0.001) and greater adjusted survival (HR 1.18 [95 % CI 1.13–1.22], p < 0.001).ConclusionsOur data, for the first time, show improved survival in patients enrolled promptly into RM following CIED implantation. This advantage was observed across all CIED device types.

[1]  S. Normand,et al.  Use of Remote Monitoring Is Associated With Lower Risk of Adverse Outcomes Among Patients With Implanted Cardiac Defibrillators , 2015, Circulation. Arrhythmia and electrophysiology.

[2]  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.

[3]  S. Chaudhry,et al.  Use of Remote Monitoring of Newly Implanted Cardioverter-Defibrillators: Insights From the Patient Related Determinants of ICD Remote Monitoring (PREDICT RM) Study , 2013, Circulation.

[4]  B. Whitcomb,et al.  Use of the Social Security Administration Death Master File for ascertainment of mortality status , 2004, Population health metrics.

[5]  Philippe Mabo,et al.  A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial) , 2011, European heart journal.

[6]  S. Priori,et al.  HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. , 2008, Heart rhythm.

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

[8]  R. Shaw,et al.  Remote Monitoring of Implantable Pacemakers: In‐Office Setup Significantly Improves Successful Data Transmission , 2013, Clinical cardiology.

[9]  P. Heidenreich,et al.  Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up: The ALTITUDE Survival Study , 2010, Circulation.

[10]  A. Waldo Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up , 2009 .

[11]  M. Linnaluoto,et al.  Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up , 2008, 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.

[12]  Niraj Varma,et al.  Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations , 2014, European heart journal.

[13]  M. Bloomston,et al.  The Social Security Death Index (SSDI) most accurately reflects true survival for older oncology patients. , 2013, American journal of cancer research.

[14]  Renato Pietro Ricci,et al.  HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. , 2015, Heart rhythm.

[15]  R. Schweikert,et al.  Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial , 2010, Circulation.

[16]  A. de Silvestri,et al.  Economic impact of remote patient monitoring: an integrated economic model derived from a meta‐analysis of randomized controlled trials in heart failure , 2011, European journal of heart failure.

[17]  S. Mittal,et al.  Remote patient management using implantable devices , 2011, Journal of Interventional Cardiac Electrophysiology.

[18]  R. Schweikert,et al.  Automatic Remote Monitoring of Implantable Cardioverter-Defibrillator Lead and Generator Performance: The Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) Trial , 2010, Circulation. Arrhythmia and electrophysiology.

[19]  Dominique Lacroix,et al.  Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study , 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.

[20]  J. Quinn,et al.  Validation of the Social Security Death Index (SSDI): An Important Readily-Available Outcomes Database for Researchers , 2008, The western journal of emergency medicine.

[21]  S. Schneeweiss,et al.  Repeated hospitalizations predict mortality in the community population with heart failure. , 2007, American heart journal.

[22]  Silvia G Priori,et al.  HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) , 2008, 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.

[23]  Dominique Lacroix,et al.  A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial , 2012, European heart journal.

[24]  J. Piccini,et al.  The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients. , 2015, Journal of the American College of Cardiology.

[25]  A. Boyle,et al.  The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. , 2011, Journal of the American College of Cardiology.

[26]  R. Schweikert,et al.  Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos‐T Reduces Routine Office Device Follow‐Up Study (TRUST) Trial , 2016, Journal of cardiovascular electrophysiology.

[27]  Daniel R. Frisch,et al.  16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. , 2011, Journal of the American College of Cardiology.