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Ann Thorac Surg 1995;59:857-862
© 1995 The Society of Thoracic Surgeons
DR RONALD C. ELKINS (Oklahoma City, OK): Doctor Kon asked if I would make a few comments about his presentation. I have enjoyed reading his manuscript, and I think the last two presentations point out two very significant points that we all must recognize. Number one, for the replacement of tissue valves with either an allograft, a xenograft as a Freestyle xenograft, or an autograft, the results now are graded in a significantly different way than they were before the past 10 years. We now have to perform surgical repair of these valves or implantation of the valves in which we have an echographically satisfactory result. They are not dependent on auscultation or the hemodynamics; they are dependent on an echocardiographic measurement of the effectiveness of a valve replacement. Evaluation clearly has changed and, as was identified at one of our previous meetings, the standard for surgical correction of many diseases is now the echocardiographic evaluation of the correction.
The second is that our knowledge base has changed over the last few years in terms of what are the essential components of maintenance of a competent aortic valve. Initially we thought annulus size was extremely important. We also thought that we could place a freehand valve and, if we made the symmetry of the leaflets appropriate, it would remain competent. We now know that it is not only the size of the annulus, it is the size of the sinotubular ridge and the symmetry of leaflets and commissural height that are important in maintaining leaflet coaptation and prevention of aortic insufficiency, and this is certainly true long-term, not only at the time of operation.
Doctor Kon, this is a very nice study. I think it again demonstrates that for the vast majority of us, as we use tissue valves we probably are going to move in the direction of root replacement techniques; the question is, are you really surprised, in an operation in which you place something inside the aorta and you have a significant amount of hematoma formation related to the suture line, that it would have a somewhat higher gradient, which actually is a relatively trivial echocardiographic gradient? I think it is not surprising that it would decrease over time. I certainly think the present incidence of aortic insufficiency is not different than what we would anticipate. We have used the technique of an inclusion cylinder using this valve and have been very pleased with it, and our echocardiographic evaluation of the technique as an inclusion cylinder, which is a relatively easy operation, is identical to what you have demonstrated with your root replacements, although it is in a smaller series of patients.
DR JOHN M. KRATZ (Charleston, SC): To turn in a slightly different direction, most of us who are involved in investigational devices now know that because of some legal action by the Health Care Financing Administration it has become in doubt whether investigational devices implanted previously, such as this in a Medicare patient, or in the future will be compensated and whether hospitals can go broke because of this. You have been a leader in the development of this technique, and this valve is not currently released. Most of your patients look like they are Medicare patients based on mean age. What are you doing about the problem of the Health Care Financing Administration and the laws?
DR KON: I thank Dr Elkins for his comments. He is one of the pioneers, as you all know, in implantation of stentless valves. I am not sure I can answer Dr Kratz's question without a lawyer present, but I will try. Medtronic has not told us to stop implanting this valve in Medicare patients; therefore, we have not. Hopefully, Congress will be smart enough to make an amendment to this law soon so that Medicare patients will be able to benefit equally from new technology.
DR ELKINS: I might answer with my own personal thought. I have not used this valve in Medicare patients, for just that reason, which does limit our ability to enroll patients.
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Ann. Thorac. Surg. 1995 59: 857-862.
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