SmartDelay determined AV optimization: A comparison of AV delay methods used in cardiac resynchronization therapy (SMART-AV): Rationale and design

PACE - Pacing and Clinical Electrophysiology

Volumn 33, Issue 1, 2010, Pages 54-63

  Stein, Kenneth M ^a   Ellenbogen, Kenneth A ^b   Gold, Michael R ^c   Lemke, Bernd ^d   Lozano, Ignacio Fernández ^e   Mittal, Suneet ^f   Spinale, Francis G ^c   Van Eyk, Jennifer E ^g   Waggoner, Alan D ^h   Meyer, Timothy E ⁱ  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d Luedenscheid ^*  (Germany)

^e HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^f ST LUKE S ROOSEVELT HOSPITAL CENTER   (United States)

^g JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ Boston Scientific   (United States)

Author keywords

AV delay; Biomarkers; Cardiac resynchronization therapy; Optimization

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY; CHEMICAL ANALYSIS; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEFIBRILLATOR; DOUBLE BLIND PROCEDURE; ECHOCARDIOGRAPHY; ELECTROGRAPHY; HEART ATRIOVENTRICULAR NODE; HEART FAILURE; HEART LEFT VENTRICLE ENDDIASTOLIC VOLUME; HEART LEFT VENTRICLE FUNCTION; HEART LEFT VENTRICLE VOLUME; HEART RATE; HEART VENTRICLE CONDUCTION; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MEASUREMENT; MULTICENTER STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; THERAPY DELAY;

CARDIAC PACING, ARTIFICIAL; DOUBLE-BLIND METHOD; ECHOCARDIOGRAPHY; ELECTRIC COUNTERSHOCK; HEART FAILURE; HUMANS; RESEARCH DESIGN;

EID: 73649101348     PISSN: 01478389     EISSN: 15408159     Source Type: Journal    
DOI: 10.1111/j.1540-8159.2009.02581.x     Document Type: Article

References (57)

1. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd., Freedman RA, Gettes LS, Gillinov AM, et al. 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); American Association for Thoracic Surgery; Society of Thoracic Surgeons: 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 : 1 62.
2. Vardas PE, Auricchio A, Blanc JJ, Daubert JC, Drexler H, Ector H, Gasparini M, et al. European Society of Cardiology; European Heart Rhythm Association: Guidelines for cardiac pacing and cardiac resynchronization therapy: The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in collaboration with the European Heart Rhythm Association. Eur Heart J 2007 28 : 2256 2295.
3. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, et al. 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.
4. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L. Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators: The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005 352 : 1539 1549.
5. Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, et al. MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002 346 : 1845 1853.
6. Auricchio A, Stellbrink C, Sack S, Block M, Vogt J, Bakker P, Huth C, et al. Pacing Therapies in Congestive Heart Failure (PATH-CHF) Study Group. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am Coll Cardiol 2002 39 : 2026 2033. (Pubitemid 34628286)
7. Bakker PF, Meijburg HW, de Vries JW, Mower MM, Thomas AC, Hull ML, Robles De Medina EO, et al. Biventricular pacing in end-stage heart failure improves functional capacity and left ventricular function. J Interv Card Electrophysiol 2000 4 : 395 404.
8. Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, et al. Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med 2001 344 : 873 880.
9. Gras D, Leclercq C, Tang AS, Bucknall C, Luttikhuis HO, Kirstein-Pedersen A. Cardiac resynchronization therapy in advanced heart failure the multicenter InSync clinical study. Eur J Heart Fail 2002 4 : 311 320.
10. Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, 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 1459.
11. Linde C, Leclercq C, Rex S, Garrigue S, Lavergne T, Cazeau S, McKenna W, et al. Long-term benefits of biventricular pacing in congestive heart failure: Results from the MUltisite STimulation in cardiomyopathy (MUSTIC) study. J Am Coll Cardiol 2002 40 : 111 118.
12. Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, Canby RC, 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. JAMA. 2003 289 : 2685 2694.
13. Erol-Yilmaz A, Verberne HJ, Schrama TA, Hrudova J, De Winter RJ, Van Eck-Smit BL, De Bruin R, et al. Cardiac resynchronization induces favorable neurohumoral changes. Pacing Clin Electrophysiol 2005 28 : 304 310.
14. Lappegard KT, Bjornstad H. Anti-inflammatory effect of cardiac resynchronization therapy. Pacing Clin Electrophysiol 2006 29 : 753 758.
15. Sinha AM, Filzmaier K, Breithardt OA, Kunz D, Graf J, Markus KU, Hanrath P, et al. Usefulness of brain natriuretic peptide release as a surrogate marker of the efficacy of long-term cardiac resynchronization therapy in patients with heart failure. Am J Cardiol 2003 91 : 755 758.
16. Theodorakis GN, Flevari P, Kroupis C, Adamopoulos S, Livanis EG, Kostopoulou A, Kolokathis F, et al. Antiinflammatory effects of cardiac resynchronization therapy in patients with chronic heart failure. Pacing Clin Electrophysiol 2006 29 : 255 261.
17. Yu CM, Fung JW, Zhang Q, Chan CK, Chan I, Chan YS, Kong SL, et al. Improvement of serum NT-ProBNP predicts improvement in cardiac function and favorable prognosis after cardiac resynchronization therapy for heart failure. J Card Fail 2005 11 : S42 S46.
18. Michelucci A, Ricciardi G, Sofi F, Gori AM, Pirolo F, Pieragnoli P, Giaccardi M, et al. Relation of inflammatory status to major adverse cardiac events and reverse remodeling in patients undergoing cardiac resynchronization therapy. J Card Fail 2007 13 : 207 210.
19. Yan AT, Yan RT, Spinale FG, Afzal R, Gunasinghe HR, Arnold M, Demers C, et al. Plasma matrix metalloproteinase-9 level is correlated with left ventricular volumes and ejection fraction in patients with heart failure. J Card Fail 2006 12 : 514 519.
20. Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, et al. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation 1999 99 : 2993 3001.
21. Auricchio A, Ding J, Spinelli JC, Kramer AP, Salo RW, Hoersch W, KenKnight BH, et al. Cardiac resynchronization therapy restores optimal atrioventricular mechanical timing in heart failure patients with ventricular conduction delay. J Am Coll Cardiol 2002 39 : 1163 1169. (Pubitemid 34267420)
22. Inoue N, Ishikawa T, Sumita S, Nakagawa T, Kobayashi T, Matsushita K, Matsumoto K, et al. Long-term follow-up of atrioventricular delay optimization in patients with biventricular pacing. Circ J 2005 69 : 201 204.
23. Meisner JS, McQueen DM, Ishida Y, Vetter HO, Bortolotti U, Strom JA, Frater RW, et al. Effects of timing of atrial systole on LV filling and mitral valve closure: Computer and dog studies. Am J Physiol 1985 249 : H604 H619.
24. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Klein W, et al. CARE-HF study Steering Committee and Investigators. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): Rationale, design and end-points. Eur J Heart Fail 2001 3 : 481 489.
25. Gorcsan J 3rd., Abraham T, Agler DA, Bax JJ, Derumeaux G, Grimm RA, Martin R, et al. American Society of Echocardiography Dyssynchrony Writing Group. Echocardiography for cardiac resynchronization therapy: Recommendations for performance and reporting - a report from the American Society of Echocardiography Dyssynchrony Writing Group endorsed by the Heart Rhythm Society. J Am Soc Echocardiogr 2008 21 : 191 213.
26. Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, Ganiats TG, et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure); International Society for Heart and Lung Transplantation; Heart Failure Society of America: ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure): Developed in Collaboration With the International Society for Heart and Lung Transplantation; Endorsed by the Heart Failure Society of America. Circulation 2001 104 : 2996 3007.
27. Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, et al. American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society: 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): Developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: Endorsed by the Heart Rhythm Society. Circulation 2005 112 : 154 235.
28. Stellbrink C, Breithardt OA, Franke A, Sack S, Bakker P, Auricchio A, Pochet T, et al. PATH-CHF (PAcing THerapies in Congestive Heart Failure) Investigators; CPI Guidant Congestive Heart Failure Research Group: Impact of cardiac resynchronization therapy using hemodynamically optimized pacing on left ventricular remodeling in patients with congestive heart failure and ventricular conduction disturbances. J Am Coll Cardiol 2001 38 : 1957 1965.
29. Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail 2000 6 : 276 285.
30. Guidant Corporation. VENTAK CHF/CONTAK CD. Final Clinical Report Update to US Food and Drug Administration. 2001 9-6-2001.
31. St. John Sutton MG, Plappert T, Abraham WT, Smith AL, DeLurgio DB, Leon AR, Loh E, et al. Multicenter InSync Randomized Clinical Evaluation (MIRACLE) Study Group: Effect of cardiac resynchronization therapy on left ventricular size and function in chronic heart failure. Circulation 2003 107 : 1985 1990.
32. Rao RK, Kumar UN, Schafer J, Viloria E, De Lurgio D, Foster E. Reduced ventricular volumes and improved systolic function with cardiac resynchronization therapy: A randomized trial comparing simultaneous biventricular pacing, sequential biventricular pacing, and left ventricular pacing. Circulation 2007 115 : 2136 2144.
33. US Food and Drug Administration. Summary of Safety and Effectiveness Data, Medtronic, P010031. 2008. Accessed from http://www.fda.gov. 6-26-2002.
34. US Food and Drug Administration. Summary of Safety and Effectiveness Data, St. Jude Medical, P030054. 2008. Accessed from http://www.fda.gov on June 30, 2004.
35. Abraham WT, Young JB, León AR, Adler S, Bank AJ, Hall SA, Lieberman R, et al. Multicenter InSync ICD II Study Group: Effects of cardiac resynchronization on disease progression in patients with left ventricular systolic dysfunction, an indication for an implantable cardioverter- defibrillator, and mildly symptomatic chronic heart failure. Circulation 2004 110 : 2864 2868.
36. Sawhney NS, Waggoner AD, Garhwal S, Chawla MK, Osborn J, Faddis MN. Randomized prospective trial of atrioventricular delay programming for cardiac resynchronization therapy. Heart Rhythm 2004 1 : 562 567.
37. Vidal B, Sitges M, Marigliano A, Delgado V, Díaz-Infante E, Azqueta M, Tamborero D, et al. Optimizing the programation of cardiac resynchronization therapy devices in patients with heart failure and left bundle branch block. Am J Cardiol 2007 100 : 1002 1006. (Pubitemid 47368109)
38. Proschan MA, Lan KK, Wittes JT. Statistical Monitoring of Clinical Trials: A Unified Approach, New York, Springer, 2006.
39. Stein KM. Clinical trials and response to CRT therapy. In : Ellenbogen KA, Aurrichio, A (eds. Pacing to Support the Failing Heart. Hoboken, NJ, Wiley-Blackwell, 2008, pp. 130 155.
40. Gold MR, Niazi I, Giudici M, Leman RB, Sturdivant JL, Kim MH, Yu Y, et al. A prospective comparison of AV delay programming methods for hemodynamic optimization during cardiac resynchronization therapy. J Cardiovasc Electrophysiol 2007 18 : 490 496.
41. Morales MA, Startari U, Panchetti L, Rossi A, Piacenti M. Atrioventricular delay optimization by doppler-derived left ventricular dP/dt improves 6-month outcome of resynchronized patients. Pacing Clin Electrophysiol 2006 29 : 564 568.
42. Steendijk P, Tulner SA, Bax JJ, Oemrawsingh PV, Bleeker GB, van Erven L, Putter H, et al. Hemodynamic effects of long-term cardiac resynchronization therapy: Analysis by pressure-volume loops. Circulation 2006 113 : 1295 1304.
43. Hardt SE, Yazdi SH, Bauer A, Filusch A, Korosoglou G, Hansen A, Bekeredjian R, et al. Immediate and chronic effects of AV-delay optimization in patients with cardiac resynchronization therapy. Int J Cardiol 2007 115 : 318 32g5.
44. Tournoux FB, Alabiad C, Fan D, Chen AA, Chaput M, Heist EK, Mela T, et al. Echocardiographic measures of acute haemodynamic response after cardiac resynchronization therapy predict long-term clinical outcome. Eur Heart J 2007 28 : 1143 1148.
45. Kedia N, Ng K, Apperson-Hansen C, Wang C, Tchou P, Wilkoff BL, Grimm RA. Usefulness of atrioventricular delay optimization using Doppler assessment of mitral inflow in patients undergoing cardiac resynchronization therapy. Am J Cardiol 2006 98 : 780 785.
46. Whinnett ZI, Briscoe C, Davies JE, Willson K, Manisty CH, Davies DW, Peters NS, et al. The atrioventricular delay of cardiac resynchronization can be optimized hemodynamically during exercise and predicted from resting measurements. Heart Rhythm 2008 5 : 378 386.
47. Valzania C, Eriksson MJ, Boriani G, Gadler F. Cardiac resynchronization therapy during rest and exercise: Comparison of two optimization methods. Europace 2008 10 : 1161 1169.
48. Zuber M, Toggweiler S, Quinn-Tate L, Brown L, Amkieh A, Erne P. A comparison of acoustic cardiography and echocardiography for optimizing pacemaker settings in cardiac resynchronization therapy. Pacing Clin Electrophysiol 2008 31 : 802 811.
49. Jansen AH, Bracke FA, van Dantzig JM, Meijer A, Van Der Voort PH, Aarnoudse W, van Gelder BM, et al. Correlation of echo-Doppler optimization of atrioventricular delay in cardiac resynchronization therapy with invasive hemodynamics in patients with heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol 2006 97 : 552 557.
50. Kerlan JE, Sawhney NS, Waggoner AD, Chawla MK, Garhwal S, Osborn JL, Faddis MN. Prospective comparison of echocardiographic atrioventricular delay optimization methods for cardiac resynchronization therapy. Heart Rhythm 2006 3 : 148 154.
51. Auricchio A, Stellbrink C, Butter C, Sack S, Vogt J, Misier AR, Böcker D, et al. Pacing Therapies in Congestive Heart Failure II Study Group; Guidant Heart Failure Research Group: Clinical efficacy of cardiac resynchronization therapy using left ventricular pacing in heart failure patients stratified by severity of ventricular conduction delay. J Am Coll Cardiol 2003 42 : 2109 2116.
52. Di Pede F, Gasparini G, De Piccoli B, Yu Y, Cuesta F, Raviele A. Hemodynamic effects of atrial septal pacing in cardiac resynchronization therapy patients. J Cardiovasc Electrophysiol 2005 16 : 1273 1278.
53. Sogaard P, Egeblad H, Pedersen AK, Kim WY, Kristensen BO, Hansen PS, Mortensen PT. Sequential versus simultaneous biventricular resynchronization for severe heart failure: Evaluation by tissue Doppler imaging. Circulation 2002 106 : 2078 2084.
54. van Gelder BM, Bracke FA, Meijer A, Lakerveld LJ, Pijls NH. Effect of optimizing the VV interval on left ventricular contractility in cardiac resynchronization therapy. Am J Cardiol 2004 93 : 1500 1503.
55. Boriani G, Muller CP, Seidl KH, Grove R, Vogt J, Danschel W, Schuchert A, et al. Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy: The Resynchronization for the Hemodynamic Treatment for Heart Failure Management II Implantable Cardioverter Defibrillator (RHYTHM II ICD) study. Am Heart J 2006 151 : 1050 1058.
56. O'Donnell D, Nadurata V, Hamer A, Kertes P, Mohammed W. Long-term variations in optimal programming of cardiac resynchronization therapy devices. Pacing Clin Electrophysiol 2005 28 : S24 S26.
57. Valzania C, Biffi M, Martignani C, Diemberger I, Bertini M, Ziacchi M, Bacchi L, et al. Cardiac resynchronization therapy: Variations in echo-guided optimized atrioventricular and interventricular delays during follow-up. Echocardiography 2007 24 : 933 939.