Aortic Valve Disease Clinical Trial
Official title:
Long-Term Follow-up After the Autograft Aortic Valve Procedure (Ross Operation)-the German-Dutch- Ross Registry
With the current knowledge of aortic valve replacement modalities, no specific recommendations can be given and the decision for a particular prosthesis or procedure is rather arbitrarily. The investigators hypothesize that the autograft procedure according to Ross is superior in terms of hemodynamic (especially regression of left ventricular hypertrophy) and major adverse valve related events even in a long-term course
For patients with aortic valve disease requiring surgical treatment several options are
available. In some instances the valve can be repaired, however replacement of the valve is
usually necessary. The choice for a particular aortic valve replacement procedure is
influenced by several inter-related factors (e.g. prosthesis, procedure itself, patient age,
concomitant disease, atrial fibrillation, center`s experience, and preference of the
referring cardiologist, the attending surgeon and the patient). Often, more than one type of
prosthesis seems suitable for the individual patient, whereby the decision for a particular
prosthesis is made rather arbitrarily.
With the current knowledge on outcome of patients after aortic valve replacement with
different types of prosthesis (pulmonary autograft according to Ross, bioprosthesis,
mechanical heart valve), no specific recommendation can be given. This is especially true
for the autograft, since no long-term outcome is yet available from clinical practice.
In 2001 the German Ross Registry was established by our working group. Although the Ross
procedure was expected to be a lifelong solution for aortic valve disease, it seemed
appropriate to make a collaborative effort to establish a multicenter long term follow-up
study to examine longitudinal clinical outcomes associated with the procedure, as well as,
attempt to resolve and identify the many technical considerations necessary for successful
execution of the procedure. With these issues in mind, we have already included about 1400
Ross operated patients from nine participating centers into the registry with up to fourteen
years follow-up. The first release of an annual report was presented in February 2004. The
main limitation of this Registry is the limited maximal time span of follow-up keeping in
mind that the next years of the follow-up are most important for evaluating the Ross
procedure because possible degeneration of the aortic valve substitute may occur.
Therefore long-term observation is required.
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Time Perspective: Prospective
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