This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (430)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Pacemakers/ Defibrillators  • Cardiovascular System  • Randomized Controlled Trial  • Arrhythmias  • Congestive Heart Failure/ Cardiomyopathy  • Cardiovascular Intervention  • Alert me on articles by topic  Social Bookmarking   What's this?

The MIRACLE ICD Trial

James B. Young, MD; William T. Abraham, MD; Andrew L. Smith, MD; Angel R. Leon, MD; Randy Lieberman, MD; Bruce Wilkoff, MD; Robert C. Canby, MD; John S. Schroeder, MD; L. Bing Liem, DO; Shelley Hall, MD; Kevin Wheelan, MD; for The Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators

JAMA. 2003;289:2685-2694.

Context  Cardiac resynchronization therapy (CRT) through biventricular pacing is an effective treatment for heart failure (HF) with a wide QRS; however, the outcomes of patients requiring CRT and implantable cardioverter defibrillator (ICD) therapy are unknown.

Objective  To examine the efficacy and safety of combined CRT and ICD therapy in patients with New York Heart Association (NYHA) class III or IV congestive HF despite appropriate medical management.

Design, Setting, and Participants  Randomized, double-blind, parallel-controlled trial conducted from October 1, 1999, to August 31, 2001, of 369 patients with left ventricular ejection fraction of 35% or less, QRS duration of 130 ms, at high risk of life-threatening ventricular arrhythmias, and in NYHA class III (n = 328) or IV (n = 41) despite optimized medical treatment.

Interventions  Of 369 randomized patients who received devices with combined CRT and ICD capabilities, 182 were controls (ICD activated, CRT off) and 187 were in the CRT group (ICD activated, CRT on).

Main Outcome Measures  The primary double-blind study end points were changes between baseline and 6 months in quality of life, functional class, and distance covered during a 6-minute walk. Additional outcome measures included changes in exercise capacity, plasma neurohormones, left ventricular function, and overall HF status. Survival, incidence of ventricular arrhythmias, and rates of hospitalization were also compared.

Results  At 6 months, patients assigned to CRT had a greater improvement in median (95% confidence interval) quality of life score (–17.5 [–21 to –14] vs –11.0 [–16 to –7], P = .02) and functional class (–1 [–1 to –1] vs 0 [–1 to 0], P = .007) than controls but were no different in the change in distance walked in 6 minutes (55 m [44-79] vs 53 m [43-75], P = .36). Peak oxygen consumption increased by 1.1 mL/kg per minute (0.7-1.6) in the CRT group vs 0.1 mL/kg per minute (–0.1 to 0.8) in controls (P = .04), although treadmill exercise duration increased by 56 seconds (30-79) in the CRT group and decreased by 11 seconds (–55 to 12) in controls (P<.001). No significant differences were observed in changes in left ventricular size or function, overall HF status, survival, and rates of hospitalization. No proarrhythmia was observed and arrhythmia termination capabilities were not impaired.

Conclusions  Cardiac resynchronization improved quality of life, functional status, and exercise capacity in patients with moderate to severe HF, a wide QRS interval, and life-threatening arrhythmias. These improvements occurred in the context of underlying appropriate medical management without proarrhythmia or compromised ICD function.

Author Affiliations: Cleveland Clinic Foundation, Cleveland, Ohio (Drs Young and Wilkoff); University of Kentucky, Lexington (Dr Abraham); Emory University School of Medicine, Atlanta, Ga (Drs Smith and Leon); Harper Hospital, Detroit, Mich (Dr Lieberman); Texas Cardiac Arrhythmia, Austin (Dr Canby); Stanford University Medical Center, Stanford, Calif (Drs Schroeder and Liem); and Baylor University Medical Center, Dallas, Tex (Drs Hall and Wheelan). Dr Abraham is now with Ohio State University, Columbus.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLE

Combining Resynchronization and Defibrillation Therapies for Heart Failure
David J. Bradley
JAMA. 2003;289(20):2719-2721.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Non-invasive cardiac output measurements based on bioreactance for optimization of atrio- and interventricular delays
Khan et al.
Europace 2009;11:1666-1674.
ABSTRACT | FULL TEXT  

Optimizing Hemodynamics in Heart Failure Patients by Systematic Screening of Left Ventricular Pacing Sites: The Lateral Left Ventricular Wall and the Coronary Sinus Are Rarely the Best Sites
Derval et al.
J Am Coll Cardiol 2009;0:j.jacc.2009.08.045v1-15236.
ABSTRACT | FULL TEXT  

Electrocardiographic patterns and long-term clinical outcome in cardiac resynchronization therapy
Kronborg et al.
Europace 2009;0:eup364v1-eup364.
ABSTRACT | FULL TEXT  

Prevention of Disease Progression by Cardiac Resynchronization Therapy in Patients With Asymptomatic or Mildly Symptomatic Left Ventricular Dysfunction: Insights From the European Cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) Trial
Daubert et al.
J Am Coll Cardiol 2009;54:1837-1846.
ABSTRACT | FULL TEXT  

Is it Time to Expand the Use of Cardiac Resynchronization Therapy to Patients With Mildly Symptomatic Heart Failure?
Exner
J Am Coll Cardiol 2009;54:1847-1849.
FULL TEXT  

Cardiac Resynchronization Induces Major Structural and Functional Reverse Remodeling in Patients With New York Heart Association Class I/II Heart Failure
St. John Sutton et al.
Circulation 2009;120:1858-1865.
ABSTRACT | FULL TEXT  

A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study
Gasparini et al.
Eur Heart J 2009;30:2758-2767.
ABSTRACT | FULL TEXT  

Effects and mechanisms of left ventricular false tendons on functional mitral regurgitation in patients with severe cardiomyopathy
Bhatt et al.
J. Thorac. Cardiovasc. Surg. 2009;138:1123-1128.
ABSTRACT | FULL TEXT  

Characterization of the suitability of coronary venous anatomy for targeting left ventricular lead placement in patients undergoing cardiac resynchronization therapy
Khan et al.
Europace 2009;11:1491-1495.
ABSTRACT | FULL TEXT  

Cardiac resynchronization therapy in combination with implantable cardioverter-defibrillator
Daubert et al.
Europace 2009;11:v87-v92.
ABSTRACT | FULL TEXT  

Association of electrostimulation with cell transplantation in ischemic heart disease
Shafy et al.
J. Thorac. Cardiovasc. Surg. 2009;138:994-1001.
ABSTRACT | FULL TEXT  

A prospective longitudinal evaluation of the benefits of epicardial lead placement for cardiac resynchronization therapy
Patwala et al.
Europace 2009;11:1323-1329.
ABSTRACT | FULL TEXT  

Real-Time 3-Dimensional Echocardiographic Assessment of Left Ventricular Dyssynchrony: Pitfalls in Patients With Dilated Cardiomyopathy
Sonne et al.
J Am Coll Cardiol Img 2009;2:802-812.
ABSTRACT | FULL TEXT  

Principles of heart failure
De Silva and Katbamna
InnovAiT 2009;2:423-429.
ABSTRACT | FULL TEXT  

Echocardiography and noninvasive imaging in cardiac resynchronization therapy: results of the PROSPECT (Predictors of Response to Cardiac Resynchronization Therapy) study in perspective.
Bax and Gorcsan
J Am Coll Cardiol 2009;53:1933-1943.
FULL TEXT  

Selecting patients for cardiac resynchronization therapy: the fallacy of echocardiographic dyssynchrony.
Hawkins et al.
J Am Coll Cardiol 2009;53:1944-1959.
ABSTRACT | FULL TEXT  

Effect of biventricular pacing on ventilatory and perceptual responses to exercise in patients with stable chronic heart failure
Laveneziana et al.
J. Appl. Physiol. 2009;106:1574-1583.
ABSTRACT | FULL TEXT  

Requirement for coronary sinus lead interventions and effectiveness of endovascular replacement during long-term follow-up after implantation of a resynchronization device
Borleffs et al.
Europace 2009;11:607-611.
ABSTRACT | FULL TEXT  

Left ventricular lead placement in cardiac resynchronization therapy: where and how?
Khan et al.
Europace 2009;11:554-561.
ABSTRACT | FULL TEXT  

Cardiac resynchronisation therapy for chronic heart failure and conduction delay
Cubbon and Witte
BMJ 2009;338:b1265-b1265.
FULL TEXT  

2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation
Hunt et al.
J Am Coll Cardiol 2009;53:e1-e90.
FULL TEXT  

2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation
Jessup et al.
J Am Coll Cardiol 2009;53:1343-1382.
FULL TEXT  

2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: Developed in Collaboration With the International Society for Heart and Lung Transplantation
2009 WRITING GROUP TO REVIEW NEW EVIDENCE AND UPDA et al.
Circulation 2009;119:1977-2016.
FULL TEXT  

2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: Developed in Collaboration With the International Society for Heart and Lung Transplantation
2005 WRITING COMMITTEE MEMBERS et al.
Circulation 2009;119:e391-e479.
FULL TEXT  

Effects of Exercise Training on Health Status in Patients With Chronic Heart Failure: HF-ACTION Randomized Controlled Trial
Flynn et al.
JAMA 2009;301:1451-1459.
ABSTRACT | FULL TEXT  

Imaging Cardiac Resynchronization Therapy
Abraham et al.
J Am Coll Cardiol Img 2009;2:486-497.
ABSTRACT | FULL TEXT  

Choosing pacemakers appropriately
Panicker et al.
Heart Asia 2009;2009:11-15.
ABSTRACT | FULL TEXT  

Long-term prognosis after cardiac resynchronization therapy is related to the extent of left ventricular reverse remodeling at midterm follow-up.
Ypenburg et al.
J Am Coll Cardiol 2009;53:483-490.
ABSTRACT | FULL TEXT  

Alternatives to transplantation in the surgical therapy for heart failure
Nicolini and Gherli
Eur. J. Cardiothorac. Surg. 2009;35:214-228.
ABSTRACT | FULL TEXT  

Utility of the Seattle heart failure model in patients with advanced heart failure.
Kalogeropoulos et al.
J Am Coll Cardiol 2009;53:334-342.
ABSTRACT | FULL TEXT  

Exercise stress echocardiography is superior to rest echocardiography in predicting left ventricular reverse remodelling and functional improvement after cardiac resynchronization therapy
Rocchi et al.
Eur Heart J 2009;30:89-97.
ABSTRACT | FULL TEXT  

Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms
Linde et al.
J Am Coll Cardiol 2008;52:1834-1843.
ABSTRACT | FULL TEXT  

Impact of interventricular lead distance and the decrease in septal-to-lateral delay on response to cardiac resynchronization therapy
Buck et al.
Europace 2008;10:1313-1319.
ABSTRACT | FULL TEXT  

Decreased connexin43 expression in the mouse heart potentiates pacing-induced remodeling of repolarizing currents
Kontogeorgis et al.
Am. J. Physiol. Heart Circ. Physiol. 2008;295:H1905-H1916.
ABSTRACT | FULL TEXT  

CRT and exercise capacity in heart failure: the impact of mitral valve regurgitation
Parthenakis et al.
Europace 2008;10:iii96-iii100.
ABSTRACT | FULL TEXT  

Pulmonary-Vein Isolation for Atrial Fibrillation in Patients with Heart Failure
Khan et al.
NEJM 2008;359:1778-1785.
ABSTRACT | FULL TEXT  

Cardiac Resynchronization in Patients With Atrial Fibrillation: A Meta-Analysis of Prospective Cohort Studies
Upadhyay et al.
J Am Coll Cardiol 2008;52:1239-1246.
ABSTRACT | FULL TEXT  

How should we optimize cardiac resynchronization therapy?
Stanton et al.
Eur Heart J 2008;29:2458-2472.
ABSTRACT | FULL TEXT  

Biventricular pacing for end-stage heart failure: early experience in surgical vs. transvenous left ventricular lead placement
Atoui et al.
ICVTS 2008;7:839-844.
ABSTRACT | FULL TEXT  

Contemporary Pacemakers: What the Primary Care Physician Needs to Know
Kaszala et al.
Mayo Clin Proc. 2008;83:1170-1186.
ABSTRACT | FULL TEXT  

Longitudinal Strain Delay Index by Speckle Tracking Imaging: A New Marker of Response to Cardiac Resynchronization Therapy
Lim et al.
Circulation 2008;118:1130-1137.
ABSTRACT | FULL TEXT  

Assessment of a remote monitoring system for implantable cardioverter defibrillators
Masella et al.
J Telemed Telecare 2008;14:290-294.
ABSTRACT | FULL TEXT  

Use of Cardiac Resynchronization Therapy in Patients Hospitalized With Heart Failure
Piccini et al.
Circulation 2008;118:926-933.
ABSTRACT | FULL TEXT  

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
Wilkoff et al.
J Am Coll Cardiol 2008;52:541-550.
ABSTRACT | FULL TEXT  

Interventricular interaction as a possible mechanism for the presence of a biphasic systolic velocity profile in normal left ventricular free walls
Marciniak et al.
Heart 2008;94:1058-1064.
ABSTRACT | FULL TEXT  

Heart Failure Care in the Outpatient Cardiology Practice Setting: Findings From IMPROVE HF
Fonarow et al.
Circ Heart Fail 2008;1:98-106.
ABSTRACT | FULL TEXT  

Benefit of cardiac resynchronization therapy in atrial fibrillation patients vs. patients in sinus rhythm: the role of atrioventricular junction ablation
Ferreira et al.
Europace 2008;10:809-815.
ABSTRACT | FULL TEXT  

Results of the Predictors of Response to CRT (PROSPECT) Trial
Chung et al.
Circulation 2008;117:2608-2616.
ABSTRACT | FULL TEXT  

Acute hemodynamic and functional effects of surgical ventricular restoration and heart transplantation in patients with ischemic dilated cardiomyopathy.
Cotrufo et al.
J. Thorac. Cardiovasc. Surg. 2008;135:1054-1060.
ABSTRACT | FULL TEXT  

Symptomatic heart failure is the most important clinical correlate of impaired quality of life, anxiety, and depression in implantable cardioverter-defibrillator patients: a single-centre, cross-sectional study in 610 patients
Johansen et al.
Europace 2008;10:545-551.
ABSTRACT | FULL TEXT  

Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure
Borggrefe et al.
Eur Heart J 2008;29:1019-1028.
ABSTRACT | FULL TEXT  

Improvement in cardiac sympathetic nerve activity in responders to resynchronization therapy
Burri et al.
Europace 2008;10:374-378.
ABSTRACT | FULL TEXT  

Cardiac resynchronisation as a rescue therapy in patients with catecholamine-dependent overt heart failure: Results from a short and mid-term study
Milliez et al.
Eur J Heart Fail 2008;10:291-297.
ABSTRACT | FULL TEXT  

Effect of cardiac resynchronisation therapy on occurrence of ventricular arrhythmia in patients with implantable cardioverter defibrillators undergoing upgrade to cardiac resynchronisation therapy devices
Lin et al.
Heart 2008;94:186-190.
ABSTRACT | FULL TEXT  

Instantaneous effects of resynchronisation therapy on exercise performance in heart failure patients: the mechanistic role and predictive power of total isovolumic time
Salukhe et al.
Heart 2008;94:59-64.
ABSTRACT | FULL TEXT  

Cardiac-Resynchronization Therapy in Heart Failure with Narrow QRS Complexes
Beshai et al.
NEJM 2007;357:2461-2471.
ABSTRACT | FULL TEXT  

Nuclear Imaging in Cardiac Resynchronization Therapy
Henneman et al.
JNM 2007;48:2001-2010.
ABSTRACT | FULL TEXT  

Cardiac resynchronization therapy: clinical results and evolution of candidate selection
Leclercq et al.
Eur Heart J Suppl 2007;9:I94-I106.
ABSTRACT | FULL TEXT  

Acute Effects of Initiation and Withdrawal of Cardiac Resynchronization Therapy on Papillary Muscle Dyssynchrony and Mitral Regurgitation
Ypenburg et al.
J Am Coll Cardiol 2007;50:2071-2077.
ABSTRACT | FULL TEXT  

Differential effects of left ventricular pacing sites in an acute canine model of contraction dyssynchrony
Johnson et al.
Am. J. Physiol. Heart Circ. Physiol. 2007;293:H3046-H3055.
ABSTRACT | FULL TEXT  

Diminished Left Ventricular Dyssynchrony and Impact of Resynchronization in Failing Hearts With Right Versus Left Bundle Branch Block
Byrne et al.
J Am Coll Cardiol 2007;50:1484-1490.
ABSTRACT | FULL TEXT  

The BRIGHT study: bifocal right ventricular resynchronization therapy: a randomized study
Res et al.
Europace 2007;9:857-861.
ABSTRACT | FULL TEXT  

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
Authors/Task Force Members et al.
Europace 2007;9:959-998.
FULL TEXT  

Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study
Becker et al.
Heart 2007;93:1197-1203.
ABSTRACT | FULL TEXT  

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
Authors/Task Force Members et al.
Eur Heart J 2007;28:2256-2295.
FULL TEXT  

Importance of contractile reserve for CRT
Lim et al.
Europace 2007;9:739-743.
ABSTRACT | FULL TEXT  

CRT-D use in heart failure: too little or too much?
Hohnloser and Prystowsky
Eur Heart J Suppl 2007;9:G9-G16.
ABSTRACT | FULL TEXT  

Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety
Gras et al.
Europace 2007;9:516-522.
ABSTRACT | FULL TEXT  

Cardiac Resynchronization Therapy for Patients With Left Ventricular Systolic Dysfunction: A Systematic Review
McAlister et al.
JAMA 2007;297:2502-2514.
ABSTRACT | FULL TEXT  

Mode of Death in Patients With Systolic Heart Failure
Patel and Heywood
J CARDIOVASC PHARMACOL THER 2007;12:127-136.
ABSTRACT  

Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography
Becker et al.
Eur Heart J 2007;28:1211-1220.
ABSTRACT | FULL TEXT  

Interventional Electrophysiology and Cardiac Resynchronization Therapy: Delivering Electrical Therapies for Heart Failure
Burkhardt and Wilkoff
Circulation 2007;115:2208-2220.
ABSTRACT | FULL TEXT