The DATAS rationale and design: A controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator

Europace

Volumn 6, Issue 2, 2004, Pages 142-150

  Quesada, Aurelio ^a,i   Almendral, Jesús ^b   Arribas, Fernando ^c   Ricci, Renato ^d   Wolpert, Christian ^e   Adragao, Pedro ^f   Cobo, Eric ^g   Navarro, Xavier ^h  

^a HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA   (Spain)

^b HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^c HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^d SAN FILIPPO NERI HOSPITAL   (Italy)

^e UNIVERSITY OF HEIDELBERG   (Germany)

^f HOSPITAL DE SANTA CRUZ   (Portugal)

^g UNIVERSITAT POLITÈCNICA DE CATALUNYA   (Spain)

^h Scientific/Clinical Department   (Spain)

ⁱ NONE   (Spain)

Author keywords

Atrial fibrillation; Clinical trial; Implantable cardioverter defibrillators; Ventricular tachyarrhythmias

Indexed keywords

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEFIBRILLATOR; HEALTH STATUS; HEART ATRIUM ARRHYTHMIA; HEART VENTRICLE ARRHYTHMIA; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; OPEN STUDY; PARALLEL DESIGN; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SCREENING TEST; SHOCK; SIMULATION; STATISTICAL ANALYSIS; SUPRAVENTRICULAR TACHYCARDIA; SYMPTOMATOLOGY; EQUIPMENT DESIGN; HEART ARRHYTHMIA; HEART BLOCK; HEART PACING; METHODOLOGY; SINUS ARRHYTHMIA; TIME;

ARRHYTHMIA; ARRHYTHMIA, SINUS; CARDIAC PACING, ARTIFICIAL; CROSS-OVER STUDIES; DEFIBRILLATORS, IMPLANTABLE; EQUIPMENT DESIGN; HEART BLOCK; HUMANS; PROSPECTIVE STUDIES; RESEARCH DESIGN; TIME FACTORS;

EID: 3042803759     PISSN: 10995129     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eupc.2003.11.011     Document Type: Article

References (54)

1. The AVID investigators A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias N Engl J Med 337 1997 1576-1583
2. Moss A.J. Hall J. Cannom D.S. et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmias N Engl J Med 335 1996 1933-1940
3. Buxton A.E. Lee K.L. Fisher J.D. et al. A randomized study of the prevention of sudden death in patients with coronary artery disease N Engl J Med 341 1999 1882-1890
4. Connolly S.J. Hallstrom A. Cappato R. et al. on behalf of the investigators or the AVID, CASH and CIDS studies Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials Eur Heart J 21 2000 2071-2078
5. Santini M. Ansalone G. Auriti A. Magris B. Pandozi C. Altamura G. Indications for dual chamber (DDD) pacing in ICD patients Am J Cardiol 78 1996 116-118
6. Best P.J. Hayes D.L. Stanton M.S. The potential usage of dual chamber pacing in patients with implantable cardioverter defibrillators Pacing Clin Electrophysiol 22 1999 79-85
7. Grimm W. Flores B. Marchlinski F.E. Electrocardiographically documented unnecessary, spontaneous shocks in 241 patients with implantable cardioverter defibrillators Pacing Clin Electrophysiol 15 1992 1667-1673
8. Ryan S. Siemon G. Drogemuller A. et al. 2 year follow-up of 321 patients with an implantable cardioverter-defibrillator: comparison of patients with and without atrial fibrillation Z Kardiol 90 2001 906-915
9. Nunain S.O. Roelke M.D. Trouton T. et al. Limitations and late complications of third generation automatic cardioverter defibrillators Circulation 91 1995 2204-2213
10. Schmitt C. Montero M. Melichercik J. Significance of supraventricular tachyarrhythmias in patients with implanted pacing cardioverter defibrillators Pacing Clin Electrophysiol 17 1994 295-302
11. Neuzner J. Petschner H.F. Managing the problem of atrial tachyarrhythmias in patients with ICDs. Practice and progress in cardiac pacing and electrophysiology 1996 353-360 Kluwer Academic Publishers
12. Neuzner J. Pitschner H.F. Konig S. Stohring R. Schlepper M. Stored electrogram in cardioverter-defibrillator therapy: accuracy of rhythm diagnosis in 335 spontaneous arrhythmia episodes J Ambulatory Monit 8 1995 1-9
13. Marchlinski F.E. Callans D.J. Gottlieb C.D. Schwartzman D. Preminger M. Benefits and lessons learned from stored electrogram information in implantable defibrillators J Cardiovasc Electrophysiol 1995 832-851
14. Epstein A.E. Kay G.N. Plumb V.J. Shepard R.B. Kirklin J.K. Combined automatic implantable cardioverter defibrillator and pacemaker systems: implantation techniques and follow-up J Am Coll Cardiol 13 1989 121-131
15. Calkins H. Brinker J. Veltri E. Levine J.H. Clinical interactions between pacemakers and automatic implantable cardioverter-defibrillators J Am Coll Cardiol 16 1990 666-673
16. Hook B.G. Callans D.J. Kleiman R.B. Flores B. Marchlinski F.E. Implantable cardioverter defibrillators therapy in the absence of significant symptoms. Rhythm diagnosis and management aided by stored electrogram analysis Circulation 87 1993 1897-1906
17. Trappe H. Achtelik M. Pfitzner P. Voigt B. Weismuller P. Single-chamber versus dual-chamber implantable cardioverter defibrillator: indications and clinical results Am J Cardiol 83 1999 8D-16D
18. Osswald S. Cron T.A. Sterns L. Alt E. Stotts L. Coenen M. New ICD-technologies: First clinical experience with dual-chamber sensing for differentiation of supraventricular tachyarrhythmias Pacing Clin Electrophysiol 21 1998 292-295
19. Olson W. Dual chamber sensing and detection for implantable cardioverter defibrillators, In: Singer I. Barold S.S. Camm A.J. (Eds.). Nonpharmacological therapy of arrhythmias for the 21st century: the state of the art 1998 385-395 Futura Publishing Co, Inc Armonk, NY
20. Sticherling C. Schaumann A. Klingenheben T. Hohnloser S. for the Ventak AV II DR investigators First worldwide clinical experience with a new dual chamber implantable cardioverter defibrillator Europace 1 1999 96-99
21. Deisenhofer I. Kolb Ch. Ndrepepa G. et al. Do current dual chamber cardioverter defibrillators have advantages over conventional single chamber cardioverter defibrillators in reducing inappropriate therapies? A randomized, prospective study J Cardiovasc Electrophysiol 12 2001 134-142
22. The dual chamber and VVI implantable defibrillator (DAVID) trial. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator J Am Med Assoc 288 2002 3115-3123
23. Gregoratos G. Abrams J. Epstein A.E. et al. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines) Circulation 106 2002 2145-2161
24. Bernstein A.D. Camm A.J. Fisher J.D. et al. The North American Society of Pacing and Electrophysiology policy statement. The NASPE/BPEG Defibrillation Code Pacing Clin Electrophysiol 16 1993 1776-1780
25. Geelen P. Lorga A. Chauvin M. Wellens F. Brugada P. The value of DDD pacing in patients with an implantable cardioverter defibrillator Pacing Clin Electrophysiol 20 1997 177-181
26. Mattke S. Markewitz A. Muller D. et al. The combined transvenous implantation of cardioverter defibrillators and permanent pacemakers Pacing Clin Electrophysiol 20 1997 2775-2782
27. Higgins S.L. Williams S.K. Pak J.P. Meyer D.B. Indications for implantation of a dual chamber pacemaker combined with an implantable cardioverter-defibrillator Am J Cardiol 81 1998 1360-1362
28. Sutandar A. Solimon S. Kaddaha R. Vloka M. Steinberg J. Should all patients receive a dual chamber device? Unanticipated use of the implantable defibrillator as a pacemaker J Am Coll Cardiol 35 Suppl A 2000 127
29. Proclemer A. Della Bella P. Facchin D. et al. Indications for dual-chamber cardioverter defibrillators at implant and at 1 year follow-up: a retrospective analysis in the single-chamber defibrillator era Europace 3 2001 132-135
30. Paćfico A. Hohnloser S. Williams J. Tao B. Saksena S. Henry P. et al. Prevention of implantable-defibrillator shocks by treatment with sotalol N Engl J Med 340 1999 1855-1862
31. Packer M. Coats A. Fowler M. et al. Effect of carvedilol on survival in patients with severe chronic heart failure N Engl J Med 344 2001 1651-1658
32. Reiter M.J. Hindman M.C. Hemodynamic effects of acute atrioventricular sequential pacing in patients with sick sinus syndrome: the hidden benefits of dual-chamber pacing J Am Coll Cardiol 19 1992 1542-1549
33. Andersen H.R. Nielsen J.C. Thomsen P.E.B. Thuesen L. Mortensen P.T. Vesterlund T. et al. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome Lancet 350 1997 1210-1216
34. Lüderitz B. Jung W. Deister A. Marneros A. Manz A. Patient acceptance of the implantable cardioverter defibrillator in ventricular tachyarrhythmias Pacing Clin Electrophysiol 16 1993 1815-1821
35. Jones G. Johnson G. Troutman C. et al. Incidence of atrial fibrillation following ventricular defibrillation with transvenous lead systems in man J Cardiovasc Electrophysiol 1992 411-417
36. Birgersdotter-Green U. Rosenqvist M. Lindemans F. Rydén L. Rådegran K. Holter documented sudden death in a patient with an implanted defibrillator Pacing Clin Electrophysiol 15 1992 1008-1014
37. Neuzner J. Pitschner H.F. Schlepper M. Programmable detection enhancements in implantable cardioverter defibrillator therapy Pacing Clin Electrophysiol 18 1995 539-547
38. Unterberg C. Stevens J. Vollmann D. Hasenfuss G. Buchwald A.B. Long term clinical experience with the EGM width detection criterion for differentiation of supraventricular and ventricular tachycardia in patients with implantable cardioverter defibrillators Pacing Clin Electrophysiol 23 2000 1611-1617
39. Brugada J. Is inappropriate therapy a resolved issue with current implantable cardioverter defibrillators? Am J Cardiol 83 1999 40D-44D
40. Roelke M. Garan H. McGovern B.A. Ruskin J. Analysis of the initiation of spontaneous ventricular tachycardia by stored electrograms J Am Coll Cardiol 23 1994 117-122
41. Dijkman B. Wellens H.J. Importance of the atrial channel for ventricular arrhythmia therapy in the dual chamber implantable cardioverter defibrillator J Cardiovasc Electrophysiol 11 2000 1309-1319
42. Stein K.M. Euler D.E. Mehra R. et al. Jewel AF Worldwide Investigators Do atrial tachyarrhythmias beget ventricular tachyarrhythmias in defibrillator recipients? J Am Coll Cardiol 40 2002 335-340
43. Dries D.L. Exner D.V. Gersh B.J. Domanski M.J. Waclawiw M.A. Stevenson L.W. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of left ventricular dysfunction J Am Coll Cardiol 32 1998 695-703
44. Wellens H.J.J. Lau C.P. Lüderitz B. Akhart M. Waldo A.L. Camm A.J. et al. Atrioverter: an implantable device for treatment of atrial fibrillation Circulation 98 1998 1651-1656
45. Schoels W. Swerdlow C.D. Jung W. Stein K.M. Seidl K. Haffajee C.J. The Worldwide Jewel AF Investigators Worldwide clinical experience with a new dual-chamber implantable cardioverter defibrillator system J Cardiovasc Electrophysiol 12 2001 521-528
46. Ricci R. Pignalberi C. Disertori M. et al. Efficacy of a dual chamber defibrillator with atrial antitachycardia functions in treating spontaneous atrial tachyarrhythmias in patients with life-threatening ventricular tachyarrhythmias Eur Heart J 23 2002 1471
47. Josephson M.E. New approaches to the management of atrial fibrillation: the role of the atrial defibrillator Circulation 98 1998 1594-1596
48. Adler S.W. Wolpert C. Warman E.N. Musley S.K. Koehler J.L. Euler D.E. for the Worldwide Jewel AF Investigators Efficacy of pacing therapies for treating atrial tachyarrhythmias in patients with ventricular arrhythmias receiving a dual-chamber implantable cardioverter defibrillator Circulation 104 2001 887-892
49. Shenasa H. Shenasa M. Conversion of atrial fibrillation to sinus rhythm during implantable cardioverter-defibrillator discharges: incidence and implications Eur Heart J 17 Abstr Suppl 1996 479
50. Kosar E. Nademance K. Complications in the implantation of dual chamber ICD Cardiac Electrophysiol Rev 5 2001 108-109
51. Kühlkamp V. Dörnberger V. Mewis C. Suchalla R. Bosch R. Seipel L. Clinical experience with the new detection algorithms for atrial fibrillation of a defibrillator with dual chamber sensing and pacing J Cardiovasc Electrophysiol 10 1999 905-915
52. Swerdlow C.D. Schsls W. Dijkman B. Jung W. Sheth N.V. Olson W.H. et al. for the Worldwide Jewel AF Investigators Detection of atrial fibrillation and flutter by a dual-chamber implantable cardioverter-defibrillator Circulation 101 2000 878-885
53. Rahlfs V. Zimmermann H. H scores: ordinal data with few categories-how should they be analyzed? Drug Information J 27 1993 1227-1240
54. Moss A.J. Zareba W. Hall W.J. et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction N Engl J Med 346 2002 877-883