UVA-Led Study Spurs FDA Approval of MitraClip Device

In a recent study published in the Journal of the American College of Cardiology, University of Virginia Health System interventional cardiologist Scott Lim, MD, and colleagues reveal that a minimally invasive procedure using the Abbot MitraClip® device is effective treatment for patients with severe degenerative mitral regurgitation who are at prohibitive risk for open heart surgery. “Patients whose health would not allow them to undergo surgery haven’t previously had a treatment option for their mitral regurgitation,” says Lim. “This study demonstrated that the MitraClip is a viable treatment for this life-threatening condition.”

UVA was a leading enroller for the national study, in which 95 percent of participating subjects had a MitraClip successfully inserted utilizing a percutaneous femoral approach. The subjects were high risk for open-heart surgery to replace their mitral valve due to one or more risk factors, such as frailty or additional severe medical conditions. Overall, after one year, patients experienced:

  • An improvement in their mitral regurgitation
  • Reduction in hospitalizations for heart failure
  • Improved heart function
  • Improved quality of life as measured by pre- and postprocedural surveys.

These positive study results led to the recent approval by the U.S. Food and Drug Administration for the use of the MitraClip device in this high-risk patient population. UVA is among the first hospitals in the country to offer the MitraClip and it is the first international training center, educating cardiologists and surgeons worldwide on the nuances of placing the device.

More Options for Valve Repair and Replacement

The MitraClip is one more promising addition to the arsenal of advanced procedures offered at UVA for those with MR. “We are experienced in all types of valve surgery at UVA, including high-risk open surgery and minimally invasive, port-access surgery,” says cardiac surgeon Gorav Ailawadi, MD. “With the approval of MitraClip, we can now treat a majority of patients with degenerative MR. Our cardiologists and surgeons work together to determine the best approach. No matter what the cause of the leaky valve, we have options for treatment.”

Read more about which patients are eligible to receive the MitraClip.

Watch a 3D animation of the MitraClip procedure.

Learn more about the UVA Advanced Cardiac Valve Center by watching the video below: