Report Published of First-In-Human Transcatheter Tricuspid Repair With Mitralign System

March 12, 2015—Mitralign Inc. announced that a detailed reporting of the first successful case of a direct transcatheter tricuspid repair (TTVR) for severe tricuspid regurgitation (TR) has been published online ahead of print by Prof. Joachim Schofer, MD, et al in Journal of the American College of Cardiology (JACC). In September 2014, Prof. Schofer and Rebecca Hahn, MD, first presented details of the procedure at the PCR London Valves Conference in the United Kingdom.

According to Mitralign, the patient was an 89-year-old woman with mild-to-moderate mitral and aortic regurgitation and severe TR. She underwent a transcatheter bicuspidization of the tricuspid valve, which successfully converted a regurgitating trileaflet valve into a functioning bileaflet valve. The patient was discharged 5 days later.

The Mitralign system is currently being evaluated in clinical trials for an indication in functional mitral regurgitation. The device is not approved for sale or distribution in Europe or the United States.

In the company’s press, Prof. Schofer commented, “We are pleased to see the development of the Mitralign system to not only treat mitral regurgitation but to potentially be the nonsurgical option for patients suffering from TR. These are challenging disease states. Surgery for TR suffers from high mortality rates and for those who do undergo surgery, reoccurrence is high as well. A transcatheter option is needed for this underserved patient population.” Prof. Schofer is from the Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease at Albertinen Heart Center in Hamburg, Germany.

Dr. Hahn added, “This is the first experience with a transcatheter tricuspid annuloplasty device, and we were able to immediately quantify dimensional changes and see significant reduction in TR. Imaging with two-dimensional and three-dimensional echocardiography is feasible and essential for the advancement of this technology.”

In an accompanying editorial published online in JACC, William W. O’Neill, MD, and Brian P. O’Neill, MD, commented, “TR remains an undertreated problem with substantial morbidity.” They noted, “Those patients who undergo surgery, recurrence of moderate or severe TR can be as high as 60% at 5 years.” They also stated that despite a 1-year mortality rate of 36.1% for patients with severe TR, only 16% of patients with isolated severe TR underwent surgery at 5 years.