Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations

Aims To test recommended implantable cardioverter defibrillator (ICD) follow-up methods by ‘in-person evaluations’ (IPE) vs. ‘remote Home Monitoring’ (HM). Methods and results ICD patients were randomized 2:1 to automatic HM or to Conventional monitoring, with follow-up checks scheduled at 3, 6, 9, 12, and 15 months post-implant. Conventional patients were evaluated with IPE only. Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations. Adherence to follow-up was measured. HM and Conventional patients were similar (age 63 years, 72% male, left ventricular ejection fraction 29%, primary prevention 73%, DDD 57%). Conventional management suffered greater patient attrition during the trial (20.1 vs. 14.2% in HM, P = 0.007). Three month follow-up occurred in 84% in both groups. There was 100% adherence (5 of 5 checks) in 47.3% Conventional vs. 59.7% HM (P < 0.001). Between 3 and 15 months, HM exhibited superior (2.2×) adherence to scheduled follow-up [incidence of failed follow up was 146 of 2421 (6.0%) in HM vs. 145 of 1098 (13.2%) in Conventional, P < 0.001] and punctuality. In HM (daily transmission success rate median 91%), transmission loss caused only 22 of 2275 (0.97%) failed HM evaluations between 3 and 15 months; others resulted from clinic oversight. Overall IPE failure rate in Conventional [193 of 1841 (10.5%) exceeded that in HM [97 of 1484 (6.5%), P < 0.001] by 62%, i.e. HM patients remained more loyal to IPE when this was mandated. Conclusion Automatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE. Clinical trial registration NCT00336284.

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

[2]  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.

[3]  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.

[4]  N. Varma,et al.  Home monitored ICD patients are more loyal to follow up - the paradox of remote patient management in the Trust trial , 2013 .

[5]  B. Wilkoff,et al.  Follow-up of patients with new cardiovascular implantable electronic devices: is adherence to the experts' recommendations associated with improved outcomes? , 2013, Heart rhythm.

[6]  M. Nieuwdorp,et al.  Non-invasive assessment of microvascular dysfunction in families with premature coronary artery disease. , 2013, International journal of cardiology.

[7]  S. Chun,et al.  Detection of Atrial Fibrillation by Implanted Devices with Wireless Data Transmission Capability , 2005, Pacing and clinical electrophysiology : PACE.

[8]  Niraj Varma,et al.  Rationale and design of a prospective study of the efficacy of a remote monitoring system used in implantable cardioverter defibrillator follow-up: the Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) study. , 2007, American heart journal.

[9]  Niraj Varma,et al.  Remote monitoring of cardiovascular devices: a time and activity analysis. , 2012, Heart rhythm.

[10]  H. Burri Remote follow-up and continuous remote monitoring, distinguished. , 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.

[11]  G. Hindricks,et al.  Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial , 2013, European heart journal.

[12]  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.

[13]  Renato Pietro Ricci,et al.  Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry , 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.

[14]  Laura G. Qualls,et al.  Follow-up of Patients With New Cardiovascular Implantable Electronic Devices: Are Experts’ Recommendations Implemented in Routine Clinical Practice? , 2013, Circulation. Arrhythmia and electrophysiology.

[15]  B. Meier,et al.  Percutaneous repair of sinus venosus defect with anomalous pulmonary venous return. , 2014, European Heart Journal.

[16]  Renato Pietro Ricci,et al.  Long-term patient acceptance of and satisfaction with implanted device remote monitoring. , 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.

[17]  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.

[18]  Maria Grazia Bongiorni,et al.  Practices of cardiac implantable electronic device follow-up: results of the European Heart Rhythm Association survey. , 2012, 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.

[19]  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.