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The ACCESS-EU study
Date:8/27/2012

Munich, Germany The percutaneous catheter-based treatment of mitral regurgitation with the MitraClip system improves symptoms and cardiac function at one-year, according to results of a prospective observational study presented here today at ESC Congress 2012.

ACCESS-EUROPE (ACCESS-EU) was a multicentre study of the MitraClip system in a commercial setting in 567 patients enrolled at 14 European sites, the largest group of patients evaluated to date. The results were presented by the study's co-principal investigator Professor Wolfgang Schillinger of the Universittsmedizin Gttingen in Germany.

"ACCESS-EU provides further confirmation of clinical and functional benefits of the MitraClip system in a real-world setting at one year," said Professor Schillinger. "The results are consistent with those from controlled clinical trials, although patients in ACCESS-EU were older and sicker."

Patients enrolled in ACCESS-EU were elderly (mean age 74 10 years) with significant baseline co-morbidities, including coronary artery disease in 63% and moderate to severe renal disease in 42%. At baseline, 85% were in NYHA Functional Class III/IV, and 53% had left ventricular ejection fraction less than 40%. Seventy-seven percent had functional mitral regurgitation, and many patients were considered at high risk for mitral valve surgery, with an average logistic EuroSCORE of 23 18%.

At one year 82% of patients treated with the MitraClip system were free from death, 79% free from mitral regurgitation grade above 2+, and 94% free from mitral valve surgery. Following treatment, the majority of patients showed significant clinical improvements, with 72% now classified in NYHA Class I/II. In addition, results reflected an improved functional capacity, with a median improvement of 60.5 meters for six-minute walk distance. Improvements in quality of life were also recorded, as shown in a median improvement of 14.0 points between baseline and one-year
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Contact: ESC Press Office
press@escardio.org
European Society of Cardiology
Source:Eurekalert

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