HFSA CRT Guideline Update
Indications for Cardiac Resynchronization Therapy: 2011 Update From the Heart Failure Society of America Guideline Committee

https://doi.org/10.1016/j.cardfail.2011.12.004Get rights and content

Abstract

Cardiac resynchronization therapy (CRT) improves survival, symptoms, quality of life, exercise capacity, and cardiac structure and function in patients with New York Heart Association (NYHA) functional class II or ambulatory class IV heart failure (HF) with wide QRS complex. The totality of evidence supports the use of CRT in patients with less severe HF symptoms. CRT is recommended for patients in sinus rhythm with a widened QRS interval (≥150 ms) not due to right bundle branch block (RBBB) who have severe left ventricular (LV) systolic dysfunction and persistent NYHA functional class II-III symptoms despite optimal medical therapy (strength of evidence A). CRT may be considered for several other patient groups for whom evidence of benefit is clinically significant but less substantial, including patients with a QRS interval of ≥120 to <150 ms and severe LV systolic dysfunction who have persistent mild to severe HF despite optimal medical therapy (strength of evidence B), some patients with atrial fibrillation, and some with ambulatory class IV HF. Several evidence gaps remain that need to be addressed, including the ideal threshold for QRS duration, QRS morphology, lead placement, degree of myocardial scarring, and the modality for evaluating dyssynchrony. Recommendations will evolve over time as additional data emerge from completed and ongoing clinical trials.

Section snippets

Pathophysiology of Dyssynchrony and Mechanism of Cardiac Resynchronization Therapy

Conduction delays occur commonly in patients with heart failure and lead to electrical and mechanical dyssynchrony. Electrical dyssynchrony is defined by a QRS duration of ≥120 ms. An estimated 20%–30% of patients with heart failure meet this criterion.1, 16, 17, 18

Inter- and intraventricular mechanical dyssynchrony lead to less efficient LV contractile performance, increased LV end-systolic volume (LVESV), increased left atrial pressure, and valvular dysfunction.1, 6, 7, 8, 19 By restoring

Review of the Evidence for Cardiac Resynchronization Therapy in Patients With Mild Heart Failure Symptoms and Reduced Ejection Fraction

CRT reduced mortality and morbidity among patients with NYHA functional class III-IV heart failure and dyssynchrony in several randomized controlled clinical trials.7, 8, 25 These data, in conjunction with evidence of reverse remodeling, led to the hypothesis that CRT may be effective at delaying or reversing disease progression in a heart failure population with mild symptoms through LV reverse remodeling. Three large randomized controlled trials of CRT in patients with mild heart failure

Impact of New Evidence on Guideline Recommendations and Clinical Practice

Guideline recommendations are based on the strength of evidence, which determines the strength of the recommendation.12 The HFSA uses 4 levels of strength in its guideline recommendations. These include “is recommended,” indicating that the therapy should be part of routine care and exceptions minimized; “should be considered,” indicating that the majority of patients should receive the intervention; “may be considered,” indicating that patient individualization is needed in the application of

Safety

Implementation of CRT requires an invasive procedure that carries risks. Upgrading an existing ICD or pacing system requires the addition of a new lead, which increases procedure risk. Replacing an existing ICD or pacemaker has also been associated with greater risk of infection. Lead dislodgment is generally the most commonly reported adverse event, and it occurred in 7% of RAFT patients, 4% of MADIT-CRT patients, and 10% of REVERSE patients (Table 4).13, 14, 15, 20 Reoperation for

Cost Effectiveness of CRT in Patients With Mild Heart Failure Symptoms

Among trials of CRT in patients with mild heart failure symptoms, the only cost-effectiveness analysis that has been published is from the REVERSE study.53 In that analysis, CRT was associated with a difference of 0.8 quality-adjusted life-years (QALY) over 10 years, corresponding to an incremental cost-effectiveness ratio of €14,278 per QALY gained (∼$19,529). The number needed to treat to prevent 1 death was 4.9 at 10 years, and CRT became cost-effective after 4.5 years. These data are

Remaining Evidence Gaps and Future Research Needs

Further research is needed to clarify optimal strategies for selection and implementation of CRT in heart failure patients, because of the potential for heterogeneity in risks and benefits.57 Optimal patient selection is an area of key interest. Current patient selection is based on clinical trial eligibility criteria and findings from subgroup analyses, but identification of patients who will and will not respond to CRT needs to be further refined by rigorous scientific data.57 The evidence

Conclusion

The totality of evidence supports the use of CRT in heart failure patients with reduced LVEF across the spectrum of mild to severe symptoms. The evidence is most compelling among patients with QRS duration ≥150 ms and without RBBB. The guidance for clinicians offered in this document is based on an analysis of available evidence. However, many gaps exist in the data. Because these gaps are filled by the completion of ongoing and future studies, it is anticipated that recommendations will evolve

Acknowledgments

The HFSA Guideline Committee acknowledges the administrative support of Cheryl Yano, Executive Director, HFSA, and Bart Galle, PhD. They also acknowledge the HFSA Executive Council for their careful review of this manuscript and their contributions to the document: Barry M. Massie, MD, Thomas Force, MD, Hani N. Sabbah, PhD, Mandeep R. Mehra, MD, Douglas L. Mann, MD, Inder S. Anand, MD, PhD, John C. Burnett, Jr, MD, John Chin, MD, Steven R. Houser, PhD, Sharon A. Hunt, MD, Mariell L. Jessup, MD,

Disclosures

Randall C. Starling, MD, MPH, has received consulting fees/honoraria from Biocontrol, Medtronic, Novartis, Novella, and Thoratec and research grants from Biotronik (paid to the Cleveland Clinic); has equity interests/stock/stock options with CardioMEMS; and is a board member of the United Network for Organ Sharing. James C. Fang, MD, has received consulting fees/honoraria from Boston Scientific and Medtronic and research grants from Medtronic (fellowship). Stuart D. Katz, MD, has received

References (62)

  • T.S. Rector et al.

    Validity of the Minnesota Living with Heart Failure Questionnaire as a measure of therapeutic response to enalapril or placebo

    Am J Cardiol

    (1993)
  • S.L. Normand et al.

    Clinical and analytical considerations in the study of health status in device trials for heart failure

    J Card Fail

    (2005)
  • A. Arshad et al.

    Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) trial

    J Am Coll Cardiol

    (2011)
  • J.P. Singh et al.

    Left ventricular lead electrical delay predicts response to cardiac resynchronization therapy

    Heart Rhythm

    (2006)
  • W. Mullens et al.

    Insights from a cardiac resynchronization optimization clinic as part of a heart failure disease management program

    J Am Coll Cardiol

    (2009)
  • A. Cheng et al.

    Acute lead dislodgements and in-hospital mortality in patients enrolled in the national cardiovascular data registry implantable cardioverter defibrillator registry

    J Am Coll Cardiol

    (2010)
  • A.M. Feldman 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

    (2005)
  • J.A. Bennett et al.

    Validity and reliability of the NYHA classes for measuring research outcomes in patients with cardiac disease

    Heart Lung

    (2002)
  • W.T. Abraham et al.

    Cardiac resynchronization in chronic heart failure

    N Engl J Med

    (2002)
  • J.B. Young et al.

    Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial

    JAMA

    (2003)
  • M.G. Sutton et al.

    Sustained reverse left ventricular structural remodeling with cardiac resynchronization at one year is a function of etiology: quantitative Doppler echocardiographic evidence from the Multicenter InSync Randomized Clinical Evaluation (MIRACLE)

    Circulation

    (2006)
  • S. Cazeau et al.

    Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay

    N Engl J Med

    (2001)
  • J.G. Cleland et al.

    The effect of cardiac resynchronization on morbidity and mortality in heart failure

    N Engl J Med

    (2005)
  • M.R. Bristow et al.

    Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure

    N Engl J Med

    (2004)
  • K. Dickstein et al.

    ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM)

    Eur Heart J

    (2008)
  • K. Dickstein et al.

    2010 Focused update of ESC guidelines on device therapy in heart failure: an update of the 2008 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association

    Eur Heart J

    (2010)
  • J. Lindenfeld et al.

    HFSA 2010 comprehensive heart failure practice guideline

    J Card Fail

    (2010)
  • A.S. Tang et al.

    Cardiac-resynchronization therapy for mild-to-moderate heart failure

    N Engl J Med

    (2010)
  • A.J. Moss et al.

    Cardiac-resynchronization therapy for the prevention of heart-failure events

    N Engl J Med

    (2009)
  • D. Farwell et al.

    How many people with heart failure are appropriate for biventricular resynchronization?

    Eur Heart J

    (2000)
  • G.C. Fonarow et al.

    Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)

    Circulation

    (2010)
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    This paper was reviewed and approved on December 9, 2011 by the Heart Failure Society of America Executive Council, whose members are listed in the Acknowledgment.

    See page 104 for disclosure information.

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