Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance the lumos-T safely reduces routine office device follow-up (TRUST) Trial

Circulation: Arrhythmia and Electrophysiology

Volumn 3, Issue 5, 2010, Pages 428-436

  Varma, Niraj ^a   Michalski, Justin ^b   Epstein, Andrew E ^c   Schweikert, Robert ^d  

^a LERNER RESEARCH INSTITUTE   (United States)

^b Biotronik Inc   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d AKRON GENERAL MEDICAL CENTER   (United States)

Author keywords

Defibrillators; Follow up; Monitoring; Remote monitoring

Indexed keywords

AMIODARONE; ANTIARRHYTHMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CORONARY ARTERY DISEASE; DEFIBRILLATOR; FEMALE; FOLLOW UP; HEART FIBRILLATION; HEART LEFT VENTRICLE EJECTION FRACTION; HOME MONITORING; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PATIENT MONITORING; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SAFETY; AUTOMATION; COMPARATIVE STUDY; CONTROLLED STUDY; EQUIPMENT DESIGN; HEART ARRHYTHMIA; INSTRUMENTATION; MIDDLE AGED; PATHOPHYSIOLOGY; REPRODUCIBILITY; TELEMETRY; TIME;

ARRHYTHMIAS, CARDIAC; AUTOMATION; DEFIBRILLATORS, IMPLANTABLE; EQUIPMENT DESIGN; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; REPRODUCIBILITY OF RESULTS; TELEMETRY; TIME FACTORS;

EID: 78049502576     PISSN: 19413149     EISSN: 19413084     Source Type: Journal    
DOI: 10.1161/CIRCEP.110.951962     Document Type: Article

References (31)

1. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51:e1-e62. (Pubitemid 351689050)
2. Carlson MD, Wilkoff BL, Maisel WH, Carlson MD, Ellenbogen KA, Saxon LA, Prystowsky EN, Alpert JS, Cain ME, Ching EA, Curtis AB, Davies DW, Hammill SC, Hauser RG, Lampert R, Zipes DP. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm. 2006;3:1250-1273. (Pubitemid 44464165)
3. Maisel WH, Hauser RG, Hammill SC, Hauser RG, Ellenbogen KA, Epstein AE, Hayes DL, Alpert JS, Berger RD, Curtis AB, Dubin AM, Estes NA III, Gura MT, Krahn AD, Lampert R, Lindsay BD, Wilkoff BL. Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines: Developed in collaboration with the Am College of Cardiology (ACC) and the Am Heart Association (AHA). Heart Rhythm. 2009;6:869-885.
4. Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE. 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;5:907-925. (Pubitemid 351771251)
5. Joseph GK, Wilkoff BL, Dresing T, Burkhardt J, Khaykin Y. Remote interrogation and monitoring of implantable cardioverter defibrillators. J Interv Cardiol Electrophysiol. 2004;11:161-166. (Pubitemid 39273711)
6. 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. (Pubitemid 38758757)
7. Varma N, Stambler B, Chun S. Detection of atrial fibrillation by implanted devices with wireless data transmission capability. Pacing Clin Electrophysiol. 2005;28(Suppl 1):S133-S136. (Pubitemid 40171101)
8. Varma N. 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. Am Heart J. 2007;154:1029-1034. (Pubitemid 350116049)
9. Varma N. Remote monitoring for advisories: Automatic early detection of silent lead failure. Pacing Clin Electrophysiol. 2009;32:525-527.
10. Varma N, Epstein A, Irimpen A, Gibson L, Love CJ, Investigators T. Event notifications by remote monitoring systems performing automatic daily checks: Load, characteristics and clinical utility. Eur Heart J. 2009; 30:1909.
11. Medtronic. Physician Advisory Letter: Urgent Medical Device Information Sprint Fidelis Lead Patient Management Recommendations. Available at: Http://www.medtronic.com/product-advisories/physician/ sprint-fidelis/PROD-ADV- PHYS-OCT.htm 2007.
12. Varma N, Epstein A, Irimpen A, Schweikert R, Shah J, Love CJ, TRUST Investigators. Efficacy and safety of automatic remote monitoring for ICD follow-up: the TRUST trial. Circulation. 2010;122:325-332.
13. Varma N, Johnson MA. Prevalence of cancelled shock therapy and relationship to shock delivery in recipients of implantable cardioverterdefibrillators assessed by remote monitoring. Pacing Clin Electrophysiol. 2009;32(suppl 1):S42-S46.
14. Maisel WH. Pacemaker and ICD generator reliability: Meta-analysis of device registries. JAMA. 2006;295:1929-1934.
15. Borleffs CJ, van Erven L, van Bommel RJ, van der Velde ET, van der Wall EE, Bax JJ, Rosendaal FR, Schalij MJ. Risk of failure of transvenous implantable cardioverter-defibrillator leads. Circ Arrhythm Electrophysiol. 2009;2:411-416.
16. Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Saggau W, Weisse U, Seidl K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of > 10 years. Circulation. 2007;115:2474-2480. (Pubitemid 46763220)
17. Eckstein J, Koller MT, Zabel M, Kalusche D, Schaer BA, Osswald S, Sticherling C. Necessity for surgical revision of defibrillator leads implanted long-term: Causes and management. Circulation. 2008;117: 2727-2733. (Pubitemid 351770453)
18. Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6:605-610.
19. Hauser RG, Hayes DL, Epstein AE, Cannon DS, Vlay SC, Song SL, Tyers GF. Multicenter experience with failed and recalled implantable cardioverter- defibrillator pulse generators. Heart Rhythm. 2006;3: 640-644.
20. Crossley GH, Chen J, Choucair W, Cohen TJ, Gohn DC, Johnson WB, Kennedy EE, Mongeon LR, Serwer GA, Qiao H, Wilkoff BL. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol. 2009;54:2012-2019.
21. Brugada P. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up? Clin Res Cardiol. 2006;95(suppl 3): III3-III9.
22. 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. (Pubitemid 40790416)
23. Lee DS, Krahn AD, Healey JS, Birnie D, Crystal E, Dorian P, Simpson CS, Khaykin Y, Cameron D, Janmohamed A, Yee R, Austin PC, Chen Z, Hardy J, Tu JV. Evaluation of early complications related to de novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010;55:774-782.
24. Varma N, Cunningham D, Falk R. Central venous access resulting in selective failure of ICD defibrillation capacity. Pacing Clin Electrophysiol. 2001;24:394-395. (Pubitemid 32281520)
25. Hauser RG, Hayes DL, Almquist AK, Epstein AE, Parsonnet V, Tyers GF, Vlay SC, Schoenfeld MH. Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress. Pacing Clin Electrophysiol. 2001;24:1046-1054. (Pubitemid 32641725)
26. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 2001;286:793-799. (Pubitemid 33015572)
27. Maisel WH, Stevenson WG, Epstein LM. Changing trends in pacemaker and implantable cardioverter defibrillator generator advisories. Pacing Clin Electrophysiol. 2002;25:1670-1678. (Pubitemid 36026876)
28. Kallinen LM, Hauser RG, Lee KW, Almquist AK, Katsiyiannis WT, Tang CY, Melby DP, Gornick CC. Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled highvoltage implantable cardioverter-defibrillator lead. Heart Rhythm. 2008; 5:775-779.
29. Swerdlow CD, Gunderson BD, Ousdigian KT, Abeyratne A, Stadler RW, Gillberg JM, Patel AS, Ellenbogen KA. Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter- defibrillator leads. Circulation. 2008;118:2122-2129.
30. Varma N, Wilkoff BL. Device features for heart failure. Heart Fail Clin North Am. 2011;7.
31. Arya A, Block M, Kautzner J, Lewalter T, Mortel H, Sack S, Schumacher B, Sogaard P, Taborsky M, Husser D, Hindricks G. Influence of home monitoring on the clinical status of heart failure patients: Design and rationale of the IN-TIME study. Eur J Heart Fail. 2008;10:1143-1148.