Biventricular versus right ventricular pacing in patients with AV block (BLOCK HF): Clinical study design and rationale

Journal of Cardiovascular Electrophysiology

Volumn 18, Issue 9, 2007, Pages 965-971

  Curtis, Anne B ^a   Adamson, Philip B ^b   Chung, Eugene ^c   John Sutton, Martin St ^d   Tang, Feng ^e   Worley, Seth ^f  

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

^b Oklahoma Heart Hospital   (United States)

^c CHRIST HOSPITAL   (United States)

^d HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^e MEDTRONIC INC   (United States)

^f Lancaster Heart Foundation   (United States)

Author keywords

Bayesian; Cardiac pacing; Clinical trial; Congestive heart failure

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; SPIRONOLACTONE;

ADULT; ARTICLE; ATRIOVENTRICULAR BLOCK; CARDIAC RESYNCHRONIZATION THERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HEART LEFT VENTRICLE FAILURE; HEART PACING; HUMAN; IMPLANTATION; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CARDIAC PACING, ARTIFICIAL; FEMALE; HEART BLOCK; HEART FAILURE, CONGESTIVE; HUMANS; INTERNATIONALITY; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS; RESEARCH;

EID: 34548361849     PISSN: 10453873     EISSN: 15408167     Source Type: Journal    
DOI: 10.1111/j.1540-8167.2007.00907.x     Document Type: Article

References (34)

1. Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, Zheng ZJ, Flegal K, O'Donnell C, Kittner S, Lloyd-Jones D, Goff DC Jr., Hong Y : Heart disease and stroke statistics-2006 update: A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2006 113 : e85-151.
2. Manolis AS : The deleterious consequences of right ventricular apical pacing: Time to seek alternate site pacing. Pacing Clin Electrophysiol 2006 29 : 298 315.
3. Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA for the MOST Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker for sinus node dysfunction. Circulation 2003 107 : 2932 2937.
4. The DAVID Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator. JAMA 2002 288 : 3115 3123.
5. Prinzen FW, Augustijn CH, Arts T, Allessie MA, Reneman RS : Redistribution of myocardial fiber strain and blood flow by asynchronous activation. Am J Physiol 1990 259 : H300 H308.
6. Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jais P, Haissaguerre M, Clementy J, Jimenez M : Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Circulation 2004 110 : 3766 3772.
7. Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK : Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation 1998 97 : 987 995.
8. Maurer G, Torres MA, Corday E, Haendchen RV, Meerbaum S : Two-dimensional echocardiographic contrast assessment of pacing-induced mitral regurgitation: Relation to altered regional left ventricular function. J Am Coll Cardiol 1984 3 : 986 991.
9. Baker CM, Christopher TJ, Smith PF, Langberg JJ, Delurgio DB, Leon AR : Addition of a left ventricular lead to conventional pacing systems in patients with congestive heart failure: Feasibility, safety, and early results in 60 consecutive patients. Pacing Clin Electrophysiol 2002 25 : 1166 1171.
10. León AR, Greenberg JM, Kanuru N, Baker CM, Mera FV, Smith AL, Langberg JJ, DeLurgio DB : Cardiac resynchronization in patients with congestive heart failure and chronic atrial fibrillation; effect of upgrading to biventricular pacing after chronic right ventricular pacing. J Am Coll Cardiol 2002 39 : 1258 1263.
11. Abraham WT, Fisher WG, Smith AL, Delurgio DB, León AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Messenger J for the MIRACLE Study Group. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002 346 : 1845 1853.
12. Young JB, Abraham WT, Smith AL, León AR, Lieberman R, Wilkoff B, Canby RC, Schroeder JS, Liem LB, Hall S, Wheelan K for The Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioverter defibrillation in advanced chronic heart failure. The MIRACLE ICD Trial. JAMA 2003 289 : 2685 2694.
13. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, DeMarco T, Carson P, DeCarlo L, DeMets D, White BG, DeVries DW, Feldman AM for the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004 350 : 2140 2150.
14. Cleland JGF, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L for the Cardiac Resynchronization - Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N EngJ Med 2005 352 : 1539 1549.
15. Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL : 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). J Am Coll Cardiol 2002 40 : 1703 1719.
16. Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C : ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death-executive summary: 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). Circulation 2006 114 : 1088 1132.
17. Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr., Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B : ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). 2005. American College of Cardiology Web Site. Available at : http://www.acc.org/clinical/guidelines/failure/index.pdf.
18. Ritter P, Padeletti L, Gillio-Meina L, Gaggini G : Determination of the optimal atrioventricular delay in DDD pacing: Comparison between echo and peak endocardial acceleration measurements. Europace 1999 1 : 126 130.
19. White HD, Norris RM, Brown MA, Brandt PW, Whitlock RM, Wild CJ : Left ventricular end-systolic volume as the major determinant of survival after recovery from myocardial infarction. Circulation 1987 76 : 44 51.
20. Konstam MA, Udelson JE, Anand IS, Cohn JN : Ventricular remodeling in heart failure: A credible surrogate endpoint. J Card Fail 2003 9 : 350 353.
21. Carson P, Tognoni G, Cohn JN : Effect of valsartan on hospitalization: Results from the Val-HeFT Trial. J Card Fail 2003 9 : 164 171.
22. Wong M, Staszewsky L, Latini R, Barlera S, Glazer R, Aknay N, Hester A, Anand I, Cohn JN : Severity of left ventricular remodeling defines outcomes and response to therapy in heart failure: Valsartan Heart Failure Trial (Val-HeFT) echocardiographic data. J Am Coll Cardiol 2004 43 : 2022 2027.
23. Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, Ganiats TG, Goldstein S, Gregoratos G, Jessup ML, Noble RJ, Packer M, Silver MA, Stevenson LW : ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Review the 1995 Guidelines for the Evaluation and Management of Heart Failure). 2001. American College of Cardiology Web site. Available at : http://www.acc.org/clinical/guidelines/failure/hf_index.htm.
24. 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.
25. Murkofsky RL, Dangas G, Diamond JA, Mehta D, Schaffer A, Ambrose JA : A prolonged QRS duration on surface electrocardiogram is a specific indicator of left ventricular dysfunction. J Am Coll Cardiol 1998 32 : 476 482.
26. Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau CP, Newman DM : Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med 2000 342 : 1385 1391.
27. Skanes AC, Krahn AD, Yee R, Klein GJ, Connolly SJ, Kerr CR, Gent M, Thorpe KE, Roberts RS : Progression to chronic AF after pacing: The Canadian Trial of Physiologic Pacing, CTOPP Investigators. J Am Coll Cardiol 2001 38 : 167 172.
28. Yu C, Fung W, Lin H, Zhang Q, Sanderson JE, Lau C : Predictors of left ventricular reverse remodeling after cardiac resynchronization therapy for heart failure secondary to idiopathic dilated or ischemic cardiomyopathy. Am J Cardiol 2002 91 : 684 688.
29. Horwich T, Foster E, DeMarco T, Tseng Z, Saxon L : Effects of resynchronization therapy on cardiac function in pacemaker patients "pgraded" to biventricular devices. J Cardiovasc Electrophysiol 2004 15 : 1284 1289.
30. Valls-Bertault V, Fatemi M, Gilard M, Pennec PY, Etienne Y, Blanc JJ : Assessment of upgrading to biventricular pacing in patients with right ventricular pacing and congestive heart failure after atrioventricular junctional ablation for chronic atrial fibrillation. Europace 2004 6 : 438 443.
31. Kindermann M, Hennen B, Jung J, Geisel J, Bohm M, Frohlig G : Biventricular versus conventional right ventricular stimulation for patients with standard pacing indication and left ventricular dysfunction: The Homburg Biventricular Pacing Evaluation (HOBIPACE). J Am Coll Cardiol 2006 47 : 1946 1948.
32. Doshi RN, Daoud EG, Fellows C, Turk K, Duran A, Hamdan MH, Pires LA : Left ventricular-based cardiac stimulation Post AV nodal ablation Evaluation (The PAVE Study). J Cardiovasc Electrophysiol 2005 16 : 1160 1165.
33. Wang TJ, Levy D, Benjamin EJ, Vasan RS : The epidemiology of "symptomatic" left ventricular systolic dysfunction: Implications for screening. Ann Intern Med 2003 138 : 907 916.
34. Funck RC, Blanc JJ, Mueller HH, Schade-Brittinger C, Bailleul C, Maisch B for the BioPace Study Group : Biventricular stimulation to prevent cardiac desynchronization: Rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study. Europace 2006 8 : 629 635.