Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter- defibrillator therapy

American Heart Journal

Volumn 163, Issue 5, 2012, Pages

  Olde Nordkamp, Louise R A ^a   Knops, Reinoud E ^a   Bardy, Gust H ^b   Blaauw, Yuri ^c   Boersma, Lucas V A ^d   Bos, Johannes S ^e   Delnoy, Peter Paul H M ^f   Van Dessel, Pascal F H M ^a   Driessen, Antoine H G ^a   De Groot, Joris R ^a   Herrman, Jean Paul R ^g   Jordaens, Luc J L M ^h   Kooiman, Kirsten M ^a   Maass, Alexander H ⁱ   Meine, Mathias ^j   Mizusawa, Yuka ^a   Molhoek, Sander G ^k   Van Opstal, Jurjen ^l   Tijssen, Jan G P ^a   Wilde, Arthur A M ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b UNIVERSITY OF WASHINGTON   (United States)

^c MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^d ST ANTONIUS HOSPITAL   (Netherlands)

^e RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^f ISALA HOSPITAL   (Netherlands)

^g ONZE LIEVE VROUWE GASTHUIS   (Netherlands)

^h ERASMUS MEDICAL CENTER   (Netherlands)

ⁱ UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^j UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^k AMPHIA HOSPITAL   (Netherlands)

^l MEDISCH SPECTRUM TWENTE   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; BLEEDING; CONTROLLED STUDY; DEFIBRILLATOR; DEVICE INFECTION; ELECTRIC SHOCK; FEMALE; HEMATOTHORAX; HUMAN; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; PERFORATION; PHASE 2 CLINICAL TRIAL; PNEUMOTHORAX; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; STATISTICAL ANALYSIS; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; THROMBOSIS; TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR;

EID: 84861302619     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2012.02.012     Document Type: Article

References (30)

1. R. Yee, G.J. Klein, and G.M. Guiraudon Initial clinical experience with the pacemaker-cardioverter-defibrillator Can J Cardiol 6 1990 147 156 (Pubitemid 20204768)
2. G.H. Bardy, W.M. Smith, and M.A. Hood An entirely subcutaneous implantable cardioverter-defibrillator N Engl J Med 363 2010 36 44
3. A.L. Dabiri, D.A. Theuns, and S.D. Valk Clinical experience with a novel subcutaneous implantable defibrillator system in a single center Clin Res Cardiol 100 2011 737 744
4. J.C. Lee, L.M. Epstein, and L.L. Huffer ICD lead proarrhythmia cured by lead extraction Heart Rhythm 6 2009 613 618
5. G. Lin, R.A. Nishimura, and H.M. Connolly Severe symptomatic tricuspid valve regurgitation due to permanent pacemaker or implantable cardioverter-defibrillator leads J Am Coll Cardiol 45 2005 1672 1675 (Pubitemid 40704505)
6. O.J. van, G. Geskes, and L. Debie A completely subcutaneous implantable cardioverter defibrillator system functioning simultaneously with an endocardial implantable cardioverter defibrillator programmed as pacemaker Europace 13 2011 141 142
7. M.V. Sherrid, and J.P. Daubert Risks and challenges of implantable cardioverter-defibrillators in young adults Prog Cardiovasc Dis 51 2008 237 263
8. T. Kleemann, T. Becker, and K. Doenges Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years Circulation 115 2007 2474 2480 (Pubitemid 46763220)
9. W.H. Maisel, and D.B. Kramer Implantable cardioverter-defibrillator lead performance Circulation 117 2008 2721 2723 (Pubitemid 351770451)
10. M.R. Gold, D.A. Theuns, and B.P. Knight Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: The START Study J Cardiovasc Electrophysiol 2011
11. J.P. Daubert, W. Zareba, and D.S. Cannom Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact J Am Coll Cardiol 51 2008 1357 1365 (Pubitemid 351443082)
12. E.B. Schron, D.V. Exner, and Q. Yao Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks Circulation 105 2002 589 594 (Pubitemid 34123433)
13. F.D. Murgatroyd, A.K. Slade, and S.M. Sopher Efficacy and tolerability of transvenous low energy cardioversion of paroxysmal atrial fibrillation in humans J Am Coll Cardiol 25 1995 1347 1353
14. N.S. Lok, C.P. Lau, and H.F. Tse Clinical shock tolerability and effect of different right atrial electrode locations on efficacy of low energy human transvenous atrial defibrillation using an implantable lead system J Am Coll Cardiol 30 1997 1324 1330
15. C.R. Killingsworth, S.H. Litovsky, and S.B. Melnick Shocks delivered via a subcutaneous defibrillation system cause less acute injury than transvenous leads in swine Heart Rhythm 7 2010 S186
16. D.P. Zipes, A.J. Camm, and M. Borggrefe ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society Circulation 114 2006 e385 e484
17. A.E. Epstein, J.P. DiMarco, and K.A. Ellenbogen 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 Circulation 117 2008 e350 e408
18. B.L. Wilkoff, B.D. Williamson, and R.S. Stern Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study J Am Coll Cardiol 52 2008 541 550
19. G.H. Bardy, K.L. Lee, and D.B. Mark Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure N Engl J Med 352 2005 225 237 (Pubitemid 40110811)
20. T.A. Dewland, C.N. Pellegrini, and Y. Wang Dual-chamber implantable cardioverter-defibrillator selection is associated with increased complication rates and mortality among patients enrolled in the NCDR implantable cardioverter-defibrillator registry J Am Coll Cardiol 58 2011 1007 1013
21. J.D. Fisher, R. Mehra, and S. Furman Termination of ventricular tachycardia with bursts of rapid ventricular pacing Am J Cardiol 41 1978 94 102 (Pubitemid 8259979)
22. A.M. Gillis, J.W. Leitch, and R.S. Sheldon A prospective randomized comparison of autodecremental pacing to burst pacing in device therapy for chronic ventricular tachycardia secondary to coronary artery disease Am J Cardiol 72 1993 1146 1151 (Pubitemid 24050052)
23. A. Schaumann, M.F. von zur, and B. Herse Empirical versus tested antitachycardia pacing in implantable cardioverter defibrillators: a prospective study including 200 patients Circulation 97 1998 66 74 (Pubitemid 28036156)
24. M.S. Wathen, M.O. Sweeney, and P.J. DeGroot Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease Circulation 104 2001 796 801 (Pubitemid 32762678)
25. M.S. Wathen, P.J. DeGroot, and M.O. Sweeney Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results Circulation 110 2004 2591 2596 (Pubitemid 39453007)
26. S.C. Hammill, D.L. Packer, and M.S. Stanton Termination and acceleration of ventricular tachycardia with autodecremental pacing, burst pacing, and cardioversion in patients with an implantable cardioverter defibrillator. Multicenter PCD Investigator Group Pacing Clin Electrophysiol 18 1995 3 10
27. M.J. Kantoch, M.S. Green, and A.S. Tang Randomized cross-over evaluation of two adaptive pacing algorithms for the termination of ventricular tachycardia Pacing Clin Electrophysiol 16 1993 1664 1672 (Pubitemid 23239364)
28. H. Calkins, R. el-Atassi, and S. Kalbfleisch Comparison of fixed burst versus decremental burst pacing for termination of ventricular tachycardia Pacing Clin Electrophysiol 16 1993 26 32 (Pubitemid 23062002)
29. L.A. Cobb, C.E. Fahrenbruch, and M. Olsufka Changing incidence of out-of-hospital ventricular fibrillation, 1980-2000 JAMA 288 2002 3008 3013 (Pubitemid 35471162)
30. P. Neuzil, J. Petru, and V.Y. Reddy Subcutaneous ICD implantation in the setting of an occluded superior vena cava J Cardiovasc Electrophysiol 22 2011 475 476