Boston Scientific Corporation today announced long-term data from the Prevention of Sudden Cardiac Death II registry (PreSCD II). The results found that implantable cardioverter defibrillators (ICDs) were associated with a 44 percent reduction in all cause mortality (p=0.053) when implanted in patients following myocardial infarction (heart attack). The mortality reduction trend was also observed in high-risk patients with severely reduced heart function. Analysis of the data was presented by Professor Heinz Voller, M.D., Klinikum am See, Ruedersdorf, Germany at the annual European Society of Cardiology (ESC) Congress in Barcelona.
Heart attack survivors have an increased risk for sudden cardiac death, and patients with impaired left ventricular function in particular benefit from protection by an ICD. Major clinical trials such as MADIT II suggest that ejection fraction — a measure of the heart’s pumping capacity — should be used to characterize risk and determine which patients should receive an ICD. Data from PreSCD II revealed that within the highest risk subgroup (ejection fraction <= 30%), only 22 percent of patients were prescribed ICD therapy.
“The PreSCD II data provide real-world confirmation of the findings of randomized clinical trials that have shown ICDs reduce mortality following a heart attack,” said Professor Voller. “In addition, PreSCD II confirms that actual ICD implantation rates for the highest risk subgroup were lower than those recommended by current guidelines and other study results. This is a significant concern because the mortality reduction associated with an ICD was greatest among these patients. We were also interested to observe a survival benefit that increased with the time interval between heart attack and ICD implantation.”
The PreSCD II registry enrolled 10,612 heart attack survivors between 2002 and 2005 in 19 centers in Germany. It has been endorsed by the German Society of Cardiology and the German Society for Prevention and Rehabilitation.
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Source: Boston Scientific
published: September 1, 2009 in: Boston Scientific, Cardio, Companies, News, Products, Specialty