CLINICAL RESEARCH: HEART FAILURE
Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias
Steven L. Higgins, MD, FACC*,*,
John D. Hummel, MD, FACC ,
Imran K. Niazi, MD, FACC ,
Michael C. Giudici, MD, FACC ,
Seth J. Worley, MD, FACC||,
Leslie A. Saxon, MD, FACC¶,
John P. Boehmer, MD, FACC#,
Michael B. Higginbotham, MD**,
Teresa De Marco, MD, FACC¶,
Elyse Foster, MD, FACC¶ and
Patrick G. Yong, MSEE
* Scripps Memorial Hospital, La Jolla, California, USA
Riverside Methodist Hospital, Columbus, Ohio, USA
St. Luke's Presbyterian Hospital, Milwaukee, Wisconsin, USA
Genesis Medical Center, Davenport, Iowa, USA
|| Lancaster General Hospital, Lancaster, Pennsylvania, USA
¶ University of California San Francisco Medical Center, San Francisco, California, USA
# The Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA
** Duke University School of Medicine, Durham, North Carolina, USA
Guidant Corporation, St. Paul, Minnesota, USA
* Reprint requests and correspondence: Dr. Steven L. Higgins, Scripps Regional Cardiac Arrhythmia Center, 9888 Genesee Ave., La Jolla, California 92038-0028, USA.
EPDocHiggins{at}msn.com
OBJECTIVES: This study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy (CRT) when combined with an implantable cardioverter defibrillator (ICD).
BACKGROUND: Long-term outcome of CRT was measured in patients with symptomatic heart failure (HF), intraventricular conduction delay, and malignant ventricular tachyarrhythmias (ventricular tachycardia/ventricular fibrillation [VT/VF]) requiring therapy from an ICD.
METHODS: Patients (n = 490) were implanted with a device capable of providing both CRT and ICD therapy and randomized to CRT (n = 245) or control (no CRT, n = 245) for up to six months. The primary end point was progression of HF, defined as all-cause mortality, hospitalization for HF, and VT/VF requiring device intervention. Secondary end points included peak oxygen consumption (VO2), 6-min walk (6 MW), New York Heart Association (NYHA) class, quality of life (QOL), and echocardiographic analysis.
RESULTS: A 15% reduction in HF progression was observed, but this was statistically insignificant (p = 0.35). The CRT, however, significantly improved peak VO2 (0.8 ml/kg/min vs. 0.0 ml/kg/min, p = 0.030) and 6 MW (35 m vs. 15 m, p = 0.043). Changes in NYHA class (p = 0.10) and QOL (p = 0.40) were not statistically significant. The CRT demonstrated significant reductions in ventricular dimensions (left ventricular internal diameter in diastole = –3.4 mm vs. –0.3 mm, p < 0.001 and left ventricular internal diameter in systole = –4.0 mm vs. –0.7 mm, p < 0.001) and improvement in left ventricular ejection fraction (5.1% vs. 2.8%, p = 0.020). A subgroup of patients with advanced HF (NYHA class III/IV) consistently demonstrated improvement across all functional status end points.
CONCLUSIONS: The CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay.
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Abbreviations and Acronyms
| | CRT | = cardiac resynchronization therapy | | HF | = heart failure | | HFEC | = Heart Failure Events Committee | | ICD | = implantable cardioverter defibrillator | | LV | = left ventricle/left ventricular | | LVEF | = left ventricular ejection fraction | | LVIDd | = left ventricular internal diameter in diastole | | LVIDs | = left ventricular internal diameter in systole | | NYHA | = New York Heart Association classification | | QOL | = quality of life | | VO2 | = oxygen consumption | | VT/VF | = ventricular tachycardia/ventricular fibrillation | | 6 MW | = 6-min walk |
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J. C. Daubert, C. Leclercq, and P. Mabo
There Is Plenty of Room for Cardiac Resynchronization Therapy Devices Without Back-Up Defibrillators in the Electrical Treatment of Heart Failure
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2204 - 2207.
[Abstract]
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G. M. Marcus, E. Rose, E. M. Viloria, J. Schafer, T. De Marco, L. A. Saxon, E. Foster, and for the VENTAK CHF/CONTAK-CD Biventricular Pacing
Septal to Posterior Wall Motion Delay Fails to Predict Reverse Remodeling or Clinical Improvement in Patients Undergoing Cardiac Resynchronization Therapy
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2208 - 2214.
[Abstract]
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C. Ermis, R. Seutter, A. X. Zhu, L. C. Benditt, L. VanHeel, S. Sakaguchi, K. G. Lurie, F. Lu, and D. G. Benditt
Impact of Upgrade to Cardiac Resynchronization Therapy on Ventricular Arrhythmia Frequency in Patients With Implantable Cardioverter-Defibrillators
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2258 - 2263.
[Abstract]
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A. M. Feldman, G. de Lissovoy, M. R. Bristow, L. A. Saxon, T. De Marco, D. A. Kass, J. Boehmer, S. Singh, D. J. Whellan, P. Carson, et al.
Cost Effectiveness of Cardiac Resynchronization Therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2311 - 2321.
[Abstract]
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M. A. Hlatky
Cost Effectiveness of Cardiac Resynchronization Therapy
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2322 - 2324.
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P. Carson, I. Anand, C. O'Connor, B. Jaski, J. Steinberg, A. Lwin, J. Lindenfeld, J. Ghali, J. H. Barnet, A. M. Feldman, et al.
Mode of Death in Advanced Heart Failure: The Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure (COMPANION) Trial
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2329 - 2334.
[Abstract]
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A. R. Leon, W. T. Abraham, A. B. Curtis, J. P. Daubert, W. G. Fisher, J. Gurley, D. L. Hayes, R. Lieberman, S. Petersen-Stejskal, K. Wheelan, et al.
Safety of Transvenous Cardiac Resynchronization System Implantation in Patients With Chronic Heart Failure: Combined Results of Over 2,000 Patients From a Multicenter Study Program
J. Am. Coll. Cardiol.,
December 20, 2005;
46(12):
2348 - 2356.
[Abstract]
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M. J. Calvert, N. Freemantle, G. Yao, J. G.F. Cleland, L. Billingham, J.-C. Daubert, S. Bryan, and on behalf of the CARE-HF Investigators
Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial
Eur. Heart J.,
December 2, 2005;
26(24):
2681 - 2688.
[Abstract]
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J. P. Singh, W. J. Hall, S. McNitt, H. Wang, J. P. Daubert, W. Zareba, J. N. Ruskin, A. J. Moss, and and the MADIT-II Investigators
Factors Influencing Appropriate Firing of the Implanted Defibrillator for Ventricular Tachycardia/Fibrillation: Findings From the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II)
J. Am. Coll. Cardiol.,
November 1, 2005;
46(9):
1712 - 1720.
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Developed in Collaboration With the American Colle, Endorsed by the Heart Rhythm Society, S. A. Hunt, W. T. Abraham, M. H. Chin, A. M. Feldman, G. S. Francis, T. G. Ganiats, M. Jessup, M. A. Konstam, et al.
ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult--Summary Article: 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)
J. Am. Coll. Cardiol.,
September 20, 2005;
46(6):
1116 - 1143.
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S. A. Hunt, W. T. Abraham, M. H. Chin, A. M. Feldman, G. S. Francis, T. G. Ganiats, M. Jessup, M. A. Konstam, D. M. Mancini, K. Michl, et al.
ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult--Summary Article: 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,
September 20, 2005;
112(12):
1825 - 1852.
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S. A. Strickberger, J. Conti, E. G. Daoud, E. Havranek, M. R. Mehra, I. L. Pina, J. Young, and Endorsed by the American College of Cardiology Fou
Patient Selection for Cardiac Resynchronization Therapy: From the Council on Clinical Cardiology Subcommittee on Electrocardiography and Arrhythmias and the Quality of Care and Outcomes Research Interdisciplinary Working Group, in Collaboration With the Heart Rhythm Society
Circulation,
April 26, 2005;
111(16):
2146 - 2150.
[Abstract]
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J. G.F. Cleland, J.-C. Daubert, E. Erdmann, N. Freemantle, D. Gras, L. Kappenberger, L. Tavazzi, and the Cardiac Resynchronization -- Heart Failure (CA
The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure
N. Engl. J. Med.,
April 14, 2005;
352(15):
1539 - 1549.
[Abstract]
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L. G. Olsson, K. Swedberg, A. L. Clark, K. K. Witte, and J. G.F. Cleland
Six minute corridor walk test as an outcome measure for the assessment of treatment in randomized, blinded intervention trials of chronic heart failure: a systematic review
Eur. Heart J.,
April 2, 2005;
26(8):
778 - 793.
[Abstract]
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C. Stellbrink
Heart rate, regularity, and synchronicity in heart failure: a tale of three brothers
Eur. Heart J.,
April 1, 2005;
26(7):
637 - 638.
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M. M. Scheinman and E. Keung
The year in clinical electrophysiology
J. Am. Coll. Cardiol.,
March 1, 2005;
45(5):
790 - 795.
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F. A. McAlister, N. Wiebe, and W. Abraham
Cardiac Resynchronization Therapy in Heart Failure
Ann Intern Med,
February 15, 2005;
142(4):
307 - 308.
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M. Calvert, N. Freemantle, and J. G.F. Cleland
Cardiac Resynchronization Therapy in Heart Failure
Ann Intern Med,
February 15, 2005;
142(4):
305 - 307.
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W. T. Abraham, J. B. Young, A. R. Leon, S. Adler, A. J. Bank, S. A. Hall, R. Lieberman, L. B. Liem, J. B. O'Connell, J. S. Schroeder, et al.
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,
November 2, 2004;
110(18):
2864 - 2868.
[Abstract]
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F. A. McAlister, J. A. Ezekowitz, N. Wiebe, B. Rowe, C. Spooner, E. Crumley, L. Hartling, T. Klassen, and W. Abraham
Systematic Review: Cardiac Resynchronization in Patients with Symptomatic Heart Failure
Ann Intern Med,
September 7, 2004;
141(5):
381 - 390.
[Abstract]
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C. Stellbrink, O.-A. Breithardt, A.-M. Sinha, and P. Hanrath
How to discriminate responders from non-responders to cardiac resynchronisation therapy
Eur. Heart J. Suppl.,
August 1, 2004;
6(suppl_D):
D101 - D105.
[Abstract]
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M. Josephson and H. J.J. Wellens
Implantable Defibrillators and Sudden Cardiac Death
Circulation,
June 8, 2004;
109(22):
2685 - 2691.
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M. R. Bristow, L. A. Saxon, J. Boehmer, S. Krueger, D. A. Kass, T. De Marco, P. Carson, L. DiCarlo, D. DeMets, B. G. White, et al.
Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure
N. Engl. J. Med.,
May 20, 2004;
350(21):
2140 - 2150.
[Abstract]
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