ACCESS-EU 1-Year Data Show Benefits of Abbott Vascular's MitraClip

August 27, 2012—Percutaneous catheter-based treatment of mitral regurgitation with the MitraClip system (Abbott Vascular, Santa Clara, CA) improves symptoms and cardiac function at 1 year, according to results of a prospective observational study presented at the European Society of Cardiology’s Congress 2012 in Munich, Germany.

As stated in the ESC press release, ACCESS-EUROPE (ACCESS-EU) was a multicenter study of the MitraClip system in a commercial setting of 567 patients enrolled at 14 European sites. The results were presented by the study’s Coprincipal Investigator Professor Wolfgang Schillinger, MD, of the Universitätsmedizin Göttingen in Germany.

The study was summarized in the ESC press release. Patients enrolled in ACCESS-EU were elderly (mean age, 74 ± 10 years) with significant baseline comorbidities, including coronary artery disease in 63% and moderate-to-severe renal disease in 42%. At baseline, 85% were in New York Heart Association (NYHA) Functional Class III/IV; 53% had left ventricular ejection fraction < 40%; 77% had functional mitral regurgitation; and many patients were considered at high risk for mitral valve surgery, with an average logistic EuroSCORE of 23 ± 18%.

The investigators found that at 1 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. After 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 6-minute walk distance. Improvements in quality of life were also recorded, as shown in a median improvement of 14 points between baseline and 1-year scores on the Minnesota Living With Heart Failure Questionnaire.

“ACCESS-EU provides further confirmation of clinical and functional benefits of the MitraClip system in a real-world setting at 1 year," commented Prof. Schillinger. “The results are consistent with those from controlled clinical trials, although patients in ACCESS-EU were older and sicker.”

“Where the benefits of surgery do not outweigh the surgical risks, the MitraClip treatment is an important alternative for patients with mitral regurgitation,” concluded Prof. Schillinger in the ESC announcement.