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