Industry Forum

CoreValve U.S. Trial to Continue Enrolling Patients in High Risk Study, and Will Maintain Therapy Access to Extreme Risk Patients via Continued Access Phase of Trial

Medtronic, Inc. announced it has completed patient enrollment in the extreme risk study in its CoreValve U.S. Pivotal Trial. The company also received approval from the U.S. Food and Drug Administration (FDA) for an extended investigation (under the FDA’s Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol. In the Trial’s second study evaluating high risk patients for aortic valve surgery, enrollment completion is anticipated later this year.

In this video interview Prof. Sievers discusses data that supports a survival benefit for the Ross procedure, referencing the German-Dutch Ross Registry of 1,500 patients, and Yacoub’s randomized trial. Presented are some of the advantages of the Ross procedure compared to a mechanical valve including freedom from micro-emboli to the brain, "unrestricted" quality of life without anticoagulants, near normal hemodynamics and better LV mass regression.  Prof. Sievers summarizes the spectrum of bicuspid aortic valve disease and concludes that, for him, the Type 0 true bicuspid valve (with only two sinuses) is the only absolute structural contraindication to the Ross procedure on the left side. However, he suggests that these various bicuspid valve categories form a continuum and the presence of annular dilatation and aortic regurgitation per se may be a risk factor for late reoperation.

The video interview with John W. Brown, MD and Paul E. Stelzer, MD, done during the Ross Summit III, is now available on the CryoLife Ross Summit page. Drs. Brown and Stelzer begins with a description of the development of the operation by Donald Ross and the two basic surgical approaches currently employed—the subcoronary and full root techniques. The issue of a complex double valve operation to treat single valve disease is discussed in some detail.