12/07/2006 • Medical tech

CRT Show Significant Benefit

Further analysis of data from the CARE-HF (Cardiac Resynchronization in Heart Failure) study presented at the ESC/WCC demonstrate that Cardiac Resynchronization Therapy (CRT) significantly reduces mortality in heart failure (HF) patients. Each year more than two million patients worldwide are diagnosed with heart failure, a condition in which the heart cannot meet the energy demands of the body.

The data show that CRT reduced all-cause mortality including significant reduction in heart failure death as well as sudden cardiac death, which together account for one-third of overall deaths in patients with heart failure. Additionally, CRT also reduced all-cause mortality in patients with moderate to severe heart failure and diabetes to a similar extent of that in patients without concomitant diabetes.

CARE-HF Sudden Cardiac Death (SCD) Analysis

An analysis of the CARE-HF study was performed to determine the causes of death and the predictors of sudden cardiac death (SCD) in heart failure patients. The results of the analysis presented today show that the use of CRT decreased this risk of HF death by 45% and SCD by 53% and supports the concept that it is the improvement in cardiac function with CRT that leads to the reduction in SCD. Hundreds of thousands of people worldwide are at risk of sudden cardiac death every year.

The patients in the CARE-HF study were analysed to determine factors predicting SCD during long-term follow-up. The CARE-HF study showed that CRT reduced mortality in HF patients with ventricular dyssynchrony by 36% during a mean follow-up of 29.4 months, but without significant decrease in SCD; however, in the planned extension phase, mean follow-up of 36.4 months, with an all-cause mortality reduction of 40%, SCD was significantly reduced.

CARE-HF Diabetes Mellitus (Dm) Analysis

The other analysis presented today showed that patients with diabetes and heart failure seem to benefit equally from CRT as patients with heart failure and without diabetes. CRT reduced the mortality rate in patients with diabetes by 39%; comparably, CRT reduced the mortality rate in patients without diabetes by 40%. Diabetes mellitus and heart failure often coexist patients with diabetes have an up to five-fold increased risk of developing cardiovascular disease.

For this analysis, the impact of diabetes mellitus was studied by distribution of the patients (207 participants, 25.9%) between the CRT group and the medical therapy group. The relative benefits of CRT were similar in patients with and without diabetes for a number of outcomes. In patients with diabetes, CRT also reduced the risk for all predefined combined endpoints, such as death or unplanned hospitalisation for a cardiovascular event or death from any cause or unplanned hospitalisation with worsening heart failure, and improved New York Heart Association (NYHA) class and quality of life. In addition, no interaction between diabetes and CRT was observed for any outcome.

Cost-Effectiveness Of CRT

Long-term treatment with Cardiac Resynchronisation Therapy (CRT) or CRT-D (with an implantable cardioverter defibrillator or ICD) is a cost-effective way to improve survival in patients with heart failure.

The cost-effectiveness of CRT is based on the proven clinical evidence of improvements in quality of life, morbidity, mortality, and reduction in costs associated with hospitalisation for heart failure. The cost-effectiveness of CRT-D is based on similar benefits with the additional advantage of preventing a high proportion of sudden cardiac deaths.

The results demonstrate that the incremental cost-effectiveness is
7,614 (£5,128/US-$9,798) for CRT and
18,199 (£12,257/US-$23,419) for CRT-D when compared with optimal medical therapy per quality adjusted life year (QALY), which is substantially lower than the threshold of
44,542 (£30,000/US-$57,305) per QALY estimate that is widely considered to be acceptable value for cost effectiveness.

The analysis was conducted from a life-time perspective and based on cost data obtained from the UK, data from the CARE-HF trial, and by making the assumption that adding a defibrillator to CRT would reduce the risk of sudden, presumed arrhythmic death by a similar amount observed in the COMPANION study.

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