Favourable MitraClip trial data from initial presented at ACC 2015

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Favourable outcomes from the initial commercial experience of transcatheter mitral valve repair with MitraClip in the USA were presented during the late-breaking clinical trial session at the American College of Cardiology (ACC)’s 64th Annual Meeting (14–16 March, San Diego, USA).

MitraClip is a treatment option for degenerative mitral regurgitation patients who are not good candidates for surgery—the current standard of care—because of their advanced age, frailty or other complicating factors. In the USA, mitral regurgitation is the most common valve disease, affecting nearly one in 10 people age 75 and older. People with mitral regurgitation often have difficulty with everyday activities, such as climbing stairs, and may require long periods of rest due to fatigue.

In the study, a transcatheter valve therapy registry formed from a partnership with the Society of Thoracic Surgeons and ACC, researchers evaluated data from 564 people with TMVR who were treated with MitraClip following FDA approval of the device in October 2013 through August 2014. The data continue to support the use of MitraClip, with successful treatment for 93% of people in the study. The treated group’s median age was 83-years-old, and they were not candidates for surgery because they were too frail or had other complicating factors. Sorajja, the lead investigator for this study, shared the data at the ACC event.

“The results of this MitraClip study are very favourable and consistent with the results we saw in studies prior to the therapy’s US approval,” Sorajja said. “The results show clinically meaningful reduction in the severity of mitral regurgitation and improvement in the overall health of very sick people with prohibitive risk degenerative mitral regurgitation who have no other meaningful options to improve their lives.”

In the presentation, Sorajja concluded that treatment with MitraClip for prohibitive risk patients with symptomatic mitral regurgitation is durable in a real-world commercial setting. Key findings from the 564 patients treated with the MitraClip device demonstrated the following:

  • Prior to treatment, more than 90% of patients had a mitral regurgitation grade of 3 or 4, indicating significant leakage of the mitral valve. After treatment with MitraClip, 93% of patients achieved a mitral regurgitation grade of less than or equal to 2, with 63.6% at a grade of less than or equal to 1, demonstrating a significant decrease in leakage.
  • Average length of stay in the hospital was three days, with 82% discharged home.
  • Adverse events and procedural complications were low, consistent with clinical trial experience.