CoreValve Dislocation

The natural history of all substantial innovative medical procedures generally follows the same archetype. A new, potentially revolutionary treatment approach for a certain disease is introduced and initial first-in-men, feasibility, and safety studies are conducted by expert operators in highly specialized centers and selected patients. Given promising initial results, this triggers a wave of mounting enthusiasm and a flurry of activity in this field with transfer into the real world until previously unanticipated or not reported problems or complications are recognized that may act as wave-breakers, resulting in a deceleration or even decline in the stream of exuberance. Such complications usually lead to a change of mood and a state of reconsideration with calls for caution and for training programs, the enthusiasm settling down to a healthy, realistic steady state. Necessarily, problems are addressed and techniques refined, taking the procedure to the next, matured level.Article see p 531This archetype may be readily transferred to the setting of transcatheter aortic valve implantation (TAVI). Being a revolutionary approach for the treatment of severe aortic valve stenosis by offering—for the first time—a definite, catheter-based interventional treatment option for nonsurgical and high-risk patients, TAVI has jubilantly entered the clinical arena in an unprecedented fashion. Introduced only recently in 20021 in France with the first implantation in Germany in 2005,2 feasibility, safety, and efficacy of this novel technique have been demonstrated first for the balloon-expandable (Edwards Sapien, Edwards Lifesciences Inc, Irvine, Calif)3, 4 and a little later for the self-expandable (Medtronic CoreValve, Medtronic, Inc, Minneapolis, Minn)5–7 bioprosthesis. Meanwhile, both devices are commercially available in Europe, and an ever-increasing number of patients are being treated with these devices with remarkable clinical results. Just recently, the superiority of transfemoral TAVI over optimal medical therapy including adjunct balloon aortic …