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Ann Thorac Surg 1996;62:1730
© 1996 The Society of Thoracic Surgeons
DR YARON BAR-EL (Haifa, Israel): I congratulate Dr Gabbay and his group for this excellent research and presentation. After a careful review of the preclinical data, we at the Rambam Medical Center in Israel have joined a few European and South American clinical centers to investigate the No-React bioprosthesis. We have been using the No-React bioprosthesis for the past year and have implanted various kinds of grafts in 8 patients. We have implanted two stentless mitral valves, five aortic stentless valves, one porcine internal mammary artery graft, and one femoropopliteal bypass below-knee graft using a bovine internal mammary artery graft. I would like to draw your attention to 2 patients who were youngsters, aged 12 and 13 years, at the time of operation.
The first is a girl who was flown in emergently with active bacterial endocarditis that destroyed her mitral and aortic valves, causing severe mitral and aortic insufficiency. We replaced both her valves with No-React stentless valves. The postoperative course was uneventful, and she was discharged in an excellent condition. Her last echocardiographic examination, performed less than a month ago, a year after the operation, revealed normal function of the valves and no signs whatsoever of calcification.
The second case is of a 13-year-old boy at the time of operation who was referred to our hospital approximately 2 months after the first girl and in a very similar condition, with severe aortic and mitral valve insufficiency due to active bacterial endocarditis. We replaced both his valves with No-React stentless valves, and he too underwent a smooth operative and postoperative course. His echocardiographic study done recently, about 9 months after the operation, shows no signs of calcification, and the valves are functioning normally.
This initial experience, however small, makes us optimistic about the further use of these valves, especially in young patients, where early calcification and valve deterioration is of great concern.
DR MARIO P. VRANDECIC (Belo Horizonte, Brazil): I congratulate Professor Gabbay for the excellent work in this very important field. I also wish to say a few words about our clinical experience. Although the longest follow-up will near 2 years only, the results from current multicenter trials will soon be available like the one you just heard from Dr Bar-El. I must add that all was not rosy in the beginning, as Professor Gabbay had stated; in the first few implants we experienced also some early explants. The analysis of these explants resulted in better understanding of the problem; thus those initial difficulties were fully corrected.
What is presented today are clinical results of a solid antimineralization treatment already subjected to the critical test of preliminary experience. From May 1994 to the present, 172 Biocor No-React heart valves were implanted in 158 patients, and it is worth noting that there were 40 patients less than 20 years of age and we have combined all the four model valve types. Thirty-two patients had these valves implanted at reoperation, and 5 had active endocarditis either in the native or in the prosthetic valve.
The hospital mortality was 5.7%, and none of the hospital deaths were related to the valve or the treatment itself. There were five reoperations: three due to early endocarditis and two due to paravalvular leak, again, not related to the valve itself. The patient follow-up was completed recently, and no other complications were recorded during this close to 2 years' follow-up.
Using postoperative echocardiography, as was shown earlier by the Rambam Hospital experience, we have observed the same cuspal mobility, leaflet function, and same thickness throughout this study. Even in patients less than 1 year of age, we have seen that the cusps stay soft and pliable. This process that renders tissue valve to be nontoxic is the only process I am aware of that has proved total cytocompatibility by each valve before clinical use. The current early follow-up has shown that the Biocor No-React tissue heart valve seems to be a very promising antimineralization process. The current clinical results should be confirmed by midterm and long-term follow-up, because this clinical experience included many patients younger than 20 years. The excellent midterm results might be very significant.
DR GABBAY: I thank the discussants for their comments and for presenting early clinical data of the No-React valves. Obviously only time will tell what is the final judgment of this process.
Related Article
Ann. Thorac. Surg. 1996 62: 1724-1730.
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