Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

Maurizio Marzegalli, Maurizio Landolina, Maurizio Lunati, Giovanni B Perego, Alessia Pappone, Giuseppe Guenzati, Carlo Campana, Maria Frigerio, Gianfranco Parati, Antonio Curnis, Irene Colangelo, Sergio Valsecchi, Maurizio Marzegalli, Maurizio Landolina, Maurizio Lunati, Giovanni B Perego, Alessia Pappone, Giuseppe Guenzati, Carlo Campana, Maria Frigerio, Gianfranco Parati, Antonio Curnis, Irene Colangelo, Sergio Valsecchi

Abstract

Background: Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers. Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier.

Methods: The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively. Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations.

Trial registration: ClinicalTrials.gov: NCT00873899.

Figures

Figure 1
Figure 1
Trial design. Enrollment and follow-up schedule.
Figure 2
Figure 2
Management strategy requirements. Operative flowcharts for the management of device shocks and alerts in the standard arm.
Figure 3
Figure 3
Management strategy requirements. Operative flowcharts for the management of system performance alerts, device shocks and OptiVol alerts in the remote arm.
Figure 4
Figure 4
Management strategy requirements. Operative flowcharts for the management of atrial fibrillation alerts in the remote arm.

References

    1. Task Force for Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of European Society of Cardiology. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K, ESC Committee for Practice Guidelines. Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Document Reviewers ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM) Eur Heart J. 2008;29:2388–2442. doi: 10.1093/eurheartj/ehn309.
    1. Adamson PB, Smith AL, Abraham WT, Kleckner KJ, Stadler RW, Shih A, Rhodes MM, InSync III Model 8042 and Attain OTW Lead Model 4193 Clinical Trial Investigators Continuous autonomic assessment in patients with symptomatic heart failure: prognostic value of heart rate variability measured by an implanted cardiac resynchronization device. Circulation. 2004;110:2389–2394. doi: 10.1161/01.CIR.0000139841.42454.78.
    1. Kadhiresan VA, Pastore J, Auricchio A, Sack S, Doelger A, Girouard S, Spinelli JC, PATH-CHF Study Group Pacing therapies in congestive heart failure: A novel method – the activity log index – for monitoring physical activity of patients with heart failure. Am J Cardiol. 2002;89:1435–1437. doi: 10.1016/S0002-9149(02)02364-0.
    1. Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005;112:841–848. doi: 10.1161/CIRCULATIONAHA.104.492207.
    1. Capucci A, Santini M, Padeletti L, Gulizia M, Botto G, Boriani G, Ricci R, Favale S, Zolezzi F, Di Belardino N, Molon G, Drago F, Villani GQ, Mazzini E, Vimercati M, Grammatico A, Italian AT500 Registry Investigators Monitored atrial fibrillation duration predicts arterial embolic events in patients suffering from bradycardia and atrial fibrillation implanted with antitachycardia pacemakers. J Am Coll Cardiol. 2005;46:1913–1920. doi: 10.1016/j.jacc.2005.07.044.
    1. Gunderson BD, Patel AS, Bounds CA, Shepard RK, Wood MA, Ellenbogen KA. An algorithm to predict implantable cardioverter-defibrillator lead failure. J Am Coll Cardiol. 2004;44:1898–1902. doi: 10.1016/j.jacc.2004.07.042.
    1. Becker R, Ruf-Richter J, Senges-Becker JC, Bauer A, Weretka S, Voss F, Katus HA, Schoels W. Patient alert in implantable cardioverter defibrillators: toy or tool? J Am Coll Cardiol. 2004;44:95–98. doi: 10.1016/j.jacc.2004.03.051.
    1. Winters SL, Packer DL, Marchlinski FE, Lazzara R, Cannom DS, Breithardt GE, Wilber DA, Camm AJ, Ruskin JN, North American Society of Electrophysiology and Pacing Consensus statement on indications, guidelines for use, and recommendations for follow-up of implantable cardioverter defibrillators. North American Society of Electrophysiology and Pacing. Pacing Clin Electrophysiol. 2001;24:262–269. doi: 10.1046/j.1460-9592.2001.00262.x.
    1. Senges-Becker JC, Klostermann M, Becker R, Bauer A, Siegler KE, Katus HA, Schoels W. What is the "optimal" follow-up schedule for ICD patients? Europace. 2005;7:319–326. doi: 10.1016/j.eupc.2005.02.117.
    1. Lunati M, Gasparini M, Santini M, Landolina M, Perego GB, Pappone C, Marzegalli M, Argiolas C, Murthy A, Valsecchi S, InSync ICD Italian Registry Investigators Follow-up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD Italian Registry. Pacing Clin Electrophysiol. 2008;31:38–46.
    1. Schoenfeld MH, Compton SJ, Mead RH, Weiss DN, Sherfesee L, Englund J, Mongeon LR. Remote monitoring of implantable cardioverter defibrillators: a prospective analysis. Pacing Clin Electrophysiol. 2004;27:757–763. doi: 10.1111/j.1540-8159.2004.00524.x.
    1. Lazarus A. Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: analysis of a worldwide database. Pacing Clin Electrophysiol. 2007;30:S2–S12.
    1. Saxon LA, Boehmer JP, Neuman S, Mullin CM. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. J Card Fail. 2007;13:241–246. doi: 10.1016/j.cardfail.2006.12.004.
    1. Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail. 2001;7:176–182. doi: 10.1054/jcaf.2001.25652.
    1. Santini M, Ricci RP, Lunati M, Landolina M, Perego GB, Marzegalli M, Schirru M, Belvito C, Brambilla R, Guenzati G, Gilardi S, Valsecchi S. Remote Monitoring of Patients with Biventricular Defibrillators Through the CareLink System Improves Clinical Management of Arrhythmias and Heart Failure Episodes. J Interv Card Electrophysiol. 2009;24:53–61. doi: 10.1007/s10840-008-9321-3.
    1. Fauchier L, Sadoul N, Kouakam C, Briand F, Chauvin M, Babuty D, Clementy J. Potential cost savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2005;28:S255–9. doi: 10.1111/j.1540-8159.2005.00071.x.
    1. Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation – ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008;31:1259–1264. doi: 10.1111/j.1540-8159.2008.01175.x.
    1. Puglisi A, Gasparini M, Lunati M, Sassara M, Padeletti L, Landolina M, Botto GL, Vincenti A, Bianchi S, Denaro A, Grammatico A, Boriani G, InSync III Italian Registry Investigators Persistent atrial fibrillation worsens heart rate variability, activity and heart rate, as shown by a continuous monitoring by implantable biventricular pacemakers in heart failure patients. J Cardiovasc Electrophysiol. 2008;19:693–701. doi: 10.1111/j.1540-8167.2007.01093.x.
    1. Vollmann D, Nagele H, Schauerte P, Wiegand U, Butter C, Zanotto G, Quesada A, Guthmann A, Hill MR, Lamp B, European InSync Sentry Observational Study Investigators Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Eur Heart J. 2007;28:1835–1840. doi: 10.1093/eurheartj/ehl506.
    1. Perego GB, Landolina M, Vergara G, Lunati M, Zanotto G, Pappone A, Lonardi G, Speca G, Iacopino S, Varbaro A, Sarkar S, Hettrick DA, Denaro A, Optivol-CRT Clinical Service Observational Group Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol. 2008;23:235–242. doi: 10.1007/s10840-008-9303-5.
    1. Knackstedt C, Mischke K, Schimpf T, Waringer J, Fache K, Frechen D, Gramley F, Kelm M, Schauerte P. Integration of automatic intrathoracic fluid content measurement into clinical decision making in patients with congestive heart failure. Pacing Clin Electrophysiol. 2008;31:961–967. doi: 10.1111/j.1540-8159.2008.01122.x.
    1. Braunschweig F, Ford I, Conraads V, Cowie MR, Jondeau G, Kautzner J, Lunati M, Munoz Aguilera R, Man Yu C, Marijianowski M, Borggrefe M, van Veldhuisen DJ, on behalf of the DOT-HF steering committee and investigators 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) Eur J Heart Fail. 2008;10:907–916. doi: 10.1016/j.ejheart.2008.06.016.
    1. Chen J, Wilkoff BL, Choucair W, Cohen TJ, Crossley GH, Johnson WB, Mongeon LR, Serwer GA, Sherfesee L. Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients. Trials. 2008;9:18. doi: 10.1186/1745-6215-9-18.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다