Cost-consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK

Europace

Volumn 15, Issue 11, 2013, Pages 1601-1608

  Burri, Haran ^a   Sticherling, Christian ^b   Wright, David ^c   Makino, Koji ^d   Smala, Antje ^e   Tilden, Dominic ^d  

^a GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

^c LIVERPOOL HEART AND CHEST HOSPITAL   (United Kingdom)

^d THEMA CONSULTING PTY LTD   (Australia)

^e Biotronik SE and Co KG   (Germany)

Author keywords

Cardiac resynchronization therapy; Cost effectiveness analysis; Health care costs; Implantable defibrillator; Markov chain; Remote monitoring

Indexed keywords

AGED; ARTICLE; COHORT ANALYSIS; COST BENEFIT ANALYSIS; COST CONTROL; ECONOMIC MODEL; FOLLOW UP; HOME MONITORING; HUMAN; INVESTMENT; PRIORITY JOURNAL; REMOTE SENSING; AMBULATORY CARE; AMBULATORY MONITORING; CARDIAC RESYNCHRONIZATION THERAPY; CARDIAC RESYNCHRONIZATION THERAPY DEVICE; COMPARATIVE STUDY; COST; COST-EFFECTIVENESS ANALYSIS; ECONOMICS; EQUIPMENT; EVALUATION STUDY; FEMALE; HEALTH-CARE COSTS; HEART FAILURE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; MALE; NATIONAL HEALTH SERVICE; PHYSIOLOGIC MONITORING; PROBABILITY; REVIEW; STATISTICAL MODEL; TELEMEDICINE; UNITED KINGDOM;

CARDIAC RESYNCHRONIZATION THERAPY; COST-EFFECTIVENESS ANALYSIS; HEALTH-CARE COSTS; IMPLANTABLE DEFIBRILLATOR; MARKOV CHAIN; REMOTE MONITORING;

AGED; CARDIAC RESYNCHRONIZATION THERAPY DEVICES; COSTS AND COST ANALYSIS; DEFIBRILLATORS, IMPLANTABLE; FEMALE; GREAT BRITAIN; HEART FAILURE; HUMANS; MALE; MARKOV CHAINS; MODELS, ECONOMIC; MONITORING, AMBULATORY; MONITORING, PHYSIOLOGIC; OFFICE VISITS; STATE MEDICINE; TELEMEDICINE;

EID: 84901834727     PISSN: 10995129     EISSN: 15322092     Source Type: Journal    
DOI: 10.1093/europace/eut070     Document Type: Article

References (38)

1. Wilkoff B. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): Description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm 2008;5:907-25.
2. Varma N, Epstein AE, Irimpen A, Schweikert R, Love C. 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. Circulation 2010;122:325-32.
3. Stoepel C, Boland J, Busca R, Saal G, Oliveira M. Usefulness of remote monitoring in cardiac implantable device follow-up. Telemed J E Health 2009;15:1026-30.
4. Smala A, Gessler M, Stoepel C. Demand for routine in office follow-up visits for cardiac implantable electric devices (CIED) in Germany and the United Kingdom. Value Health 2011;14:A256.
5. Fuhrer J, Babotai I, Bauersfeld U, Burri H, Gloor H, Schläpfer J et al. Richtlinien für die Fernüberwachung (Remote Monitoring) implantierter Geräte zur Diagnostik und Therapie von Rhythmusstörungen und Herzinsuffizienz. Cardiovasc Med 2011;14:13-5.
6. Vogtmann T, Stiller S, Marek A, Kespohl S, Gomer M, Kühlkamp V et al.Workload and usefulness of daily centralised Home Monitoring for patients treated with implantable cardiac pacing devices: Results of the MoniC (Model Project Monitor Centre) prospective multicentre study. Europace 2013;15:219-26.
7. Boriani G, Burri H, Mantovani LG, Maniadakis N, Leyva F, Kautzner J et al. Device therapy and hospital reimbursement practices across European countries: A heterogeneous scenario. Europace 2011;13:ii59-65.
8. Burri H, Heidbüchel H, Jung W, Brugada P. Remote monitoring: A cost or an investment? Europace 2011;13:ii44-48.
9. Burri H, Senouf D. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators. Europace 2009;11:701-9.
10. National Institute for Health and Clinical Excellence (NICE). Guide to the methods of technology appraisal. 2008. Ref No N1618. http://www.nice.org.uk/media/B52/A7/TAMethodsGuideUpdatedJune2008.pdf (April 2011, date last accessed).
11. Sonnenberg FA, Beck JR. Markov models on medical decision making: A practical guide. Med Decis Making 1993;13:322-39.
12. Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A et al. A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial). Eur Heart J 2011;33:1105-11.
13. Saxon LA, Hayes DL, Gilliam FR, Heidenreich PA, Day J, Seth M et al. Long-term outcome after ICD and CRT implantation and influence of remote device followup: The ALTITUDE survival study. Circulation 2010;122:2359-67.
14. Guédon-Moreau L, Lacroix D, Sadoul N, Clémenty J, Kouakam C, Hermida JS et al.A randomized study of remote follow-up of implantable cardioverter defibrillators. Safety and efficacy report of the ECOST trial. Eur Heart J 2013;34:605-14.
15. BIOTRONIK GmbH & Co KG. LUMAX 500/540 Technical Specifications, Doc ID TKD-118-047 Rev E, 2010;19.
16. BIOTRONIK GmbH & Co KG. LUMAX 540 Function Manual, Doc ID 363 986-B, 2008;232-233.
17. Brugada P. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up? Clin Res Cardiol 2006;9:III/3-III/9.
18. Halimi F, Clémenty J, Attuel P, Dessenne X, Amara W. Optimised post-operative surveillance of permanent pacemakers by home monitoring: The OEDIPE trial. Europace 2008;10:1392-9.
19. Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: The Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol 2010;3:428-36.
20. Guédon-Moreau L, Chevalier P, Marquié C, Kouakam C, Klug D, Lacroix D et al. ECOST trial Investigators. Contributions of remote monitoring to the follow-up of implantable cardioverter-defibrillator leads under advisory. Eur Heart J 2010;31: 2246-52.
21. Fauchier L, Sadoul N, Kouakam C, Briand F, Chauvin M, Babuty D et al. Potential cost savings by telemedicine-Assisted long-term care of implantable cardioverter defibrillator recipients. PACE 28:S255-9.
22. Centre for Evidence-based Purchasing (CEP). Evidence review: Implantable cardiac devices with remote monitoring facilities. CEP08047 report. April 2007. http://www.parliament.uk/deposits/depositedpapers/2009/DEP2009-3160.pdf (January 2011, date last accessed).
23. Ricci R, Morichelli L, Gargaro A, Laudadio MT, Santini M. Home Monitoring in patients with implantable cardiac devices: Is there a potential reduction of stroke risk? Results from a computer model tested through Monte Carlo simulations. J Cardiovasc Electrophysiol 2009;20:1244-51.
24. Eckstein J, Koller MT, Zabel M, Kalusche D, Schaer BA, Osswald S et al. Necessity for surgical revision of defibrillator leads implanted long-term-Causes and Management. Circulation 2008;117:2727-33.
25. Cronin EM, Ching EA, Varma N, Martin DO, Wilkoff BL, Lindsay BD. Remote monitoring of cardiovascular devices: A time and activity analysis. Heart Rhythm 2012. Article in press.
26. Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH. The CONNECT (Clinical Evaluation of remote notification to reduce time to clinical decision) trial. The value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol 2011;57:1181-9.
27. BIOTRONIK Inc. The TRUST Study. Final clinical report. 30 November 30 2009:53.
28. Fox M, Mealing S, Anderson R, Dean J, Stein K, Price A et al. The clinical effectiveness and cost-effectiveness of cardiac resynchronisation (biventricular pacing) for heart failure: Systematic reviewand economicmodel. Health Technol Assess 2007;11:1-264.
29. National Institute for Health and Clinical Excellence (NICE). Atrial fibrillation: The management of atrial fibrillation, Costing Report. Implementing NICE guidance in England. (NICE clinical guideline No 36), 2006. http://www.nice.org.uk/nicemedia/pdf/CG036costingreport.pdf (January 2011, date last accessed).
30. Department of Health (UK). Appendix NSRC04: NHS trust and PCT combined reference cost schedule, 2011. http://www.dh.gov.uk/prod-consum-dh/groups/dh-digitalassets/documents/digitalasset/dh-123458.xls (February 2011, date last accessed).
31. Ward S, Lloyd Jones M, Pandor A, Holmes M, Ara R, Ryan A et al. A systematic review and economic evaluation of statins for the prevention of coronary events. Health Technol Assess 2007;11:1-166.
32. Luengo-Fernandez R, Gray AM, Rothwell PM. Population-based study of determinants of initial secondary care costs of acute stroke in the United Kingdom. Stroke 2006;37:2579-87.
33. Goldenberg I, Moss AJ, Hall WJ, McNitt S, Zareba W, Andrews ML et al. Multicenter Automatic Defibrillator Implantation Trial (MADIT) II Investigators. Causes and consequences of heart failure after prophylactic implantation of a defibrillator in the multicenter automatic defibrillator implantation trial II. Circulation 2006;113:2810-7.
34. Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA et al. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol 2003;42:1454-9.
35. Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B et al. Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: The MIRACLE ICD Trial. J Am Coll Cardiol 2003;289:2685-94.
36. Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP et al. MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med 2009;361:1329-38.
37. Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S et al. Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med 2010;363:2385-95.
38. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED): Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds). Application by Guidant Corp. 2004. Report No.: P010012/S026. http://www. accessdata.fda.gov/cdrh-docs/pdf/P010012S026b.pdf (May 2011, date last accessed).