New Access Devices Create Gateway To Interventional Structural Heart Disease

With any new medical treatment, there are two types of risks: those that are known and anticipated from pre-commercial clinical work, and those that are unknown, can’t be predicted and only emerge once a device or procedure is exposed to real-world clinical practice. New products and procedures start out by being vetted in the protected, false security of clinical trials, involving small numbers of hand-picked patients often treated by leading physicians under ideal circumstances. Only as real-world clinical experience accumulates in large numbers of patients with a multitude of unpredictable co-morbidities and complications do the unanticipated problems begin to emerge.

That’s where TAVI (transcatheter aortic valve implantation) is today. Minimally invasive transcatheter treatments for the aortic valve as an alternative to surgical valve replacement have been available in Europe since 2007 (and in the US since November 2011), and in recent years the number of procedures in Europe has more than tripled, according to a presentation made at this year’s EuroPCR interventional cardiology meeting in Paris in May