Monday, August 20, 2007

Cardiac Resynchronization Therapy (CRT) in heart failure (HF)

UK NICE guidance for CRT published

By Caroline Price
20 August 2007

Heart 2007; 93: 1134-1135

MedWire News: A summary of the UK National Institute for Health and Clinical Excellence (NICE) guidance on the use of cardiac resynchronization therapy (CRT) in heart failure (HF) has been published by the journal Heart.

The “technology appraisal guidance” provides additional treatment options for some patient subgroups covered in the earlier NICE guidance on implantable cardioverter defibrillators (ICDs).

It recommends CRT with a pacing device (CRT-P) for HF patients who have New York Heart Association (NYHA) Class III or IV symptoms despite optimal medical therapy, are in sinus rhythm, have a left ventricular ejection fraction (LVEF) of 35% or less, and have ventricular dyssynchrony.

Ventricular dyssnchrony is indicated by either QRS duration of 150 ms or longer as estimated by standard electrocardiogram (ECG) or QRS duration 120-149 ms as estimated by ECG and mechanical dyssynchrony confirmed by echocardiography.

CRT with a defibrillator (CRT-D) may be considered for patients meeting the above criteria who separately also fulfill criteria for use of an ICD as previously recommended.

The guidance was based on evidence from four randomized controlled trials, with particular attention placed on the largest of these, the COMPANION and CARE-HF trials. Pooled analysis of these studies demonstrated a significant reduction in death from HF for CRT-P compared with optimal medical treatment alone.

These studies also indicated that CRT-P significantly reduced the risk for worsening HF, improved NYHA Class and quality of life, and reduced admissions to hospital for HF, explain David Barnett and colleagues from the University of Leicester.

Similar results were reported for CRT-D, they say. Noting that only COMPANION provided the basis for a direct comparison of CRT-P and CRT-D, and that this was not powered to detect differences, they point out that only CRT-D produced a significant reduction in death from all cardiac causes and sudden cardiac death in this trial.

The team reports that the cost of both CRT-P and CRT-D, at a cost per quality-adjusted life year (QALY) of £16,000 (US$31,700) and £23,000 ($45,600), respectively, is considered to be a cost-effective use of resources in comparison with medical therapy alone.

Using all available evidence in the absence of a head-to-head trial comparison, the NICE guidance committee found that implanting a CRT-D rather than CRT-P would have a cost per QALY of £40,000 ($79,300), and would not normally be deemed cost-effective.

But Barnett et al explain that “the committee accepted that the cost effectiveness of CRT-D is likely to be considerably improved in people with additional risk factors for sudden cardiac death over and above those associated with cardiac dyssynchrony.”

In an accompanying editorial, Christophe Leclercq, from Hôpital Pontchaillou in Rennes, France, commented that the inclusion of echocardiographic criteria “seems logical but is not yet clearly supported by the results of clinical trials.”

He wrote: “Echocardiography is an attractive tool for selecting and, especially, for optimizing the selection of patients as candidates for CRT, but it has also to be validated.”

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