HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Antretter, H. Articles by Foster, J. G. Search for Related Content PubMed Articles by Antretter, H. Articles by Foster, J. G.

Ann Thorac Surg 1996;62:940-941
© 1996 The Society of Thoracic Surgeons

---

Correspondence

Medtronic Intact Porcine Bioprosthesis

Cardiac Surgery, University of Innsbruck, School of Medicine, Anichstr 35, 6020 Innsbruck, Austria

To the Editor:

Regarding the article by Lemieux and associates [1], I want to point out that there was a completely wrong citation of our brief report about an early, unexplainable degeneration of a Medtronic Intact porcine bioprosthesis [2]. My colleagues and I neither studied the hydrodynamic properties of this valve nor drew any conclusions regarding the zero-pressure fixation as mentioned in Lemieux and associates' article. We only described a potentially fatal complication of an Intact bioprosthesis 43 days after implantation-detected by transesophageal echocardiography-in which the valve had to be explanted some weeks later because of a jagged hole in the left cusp, approximately 8 x 5 mm (Fig 1). The noncoronary cusp also showed an area of abrasion/tear. As this valve was implanted by a surgeon with more than 20 years of experience in cardiac surgery, a mistake, as stated by Sir Brian G. Barratt-Boyes in a reply to the Editor, is impossible and must be refuted.

View larger version (26K): [in this window] [in a new window]   Fig 1. . Left cusp, inflow, showing an 8 x 5-mm jagged hole in the explanted 21-mm Medtronic Intact bioprosthesis (x3 before % reduction.)

As we cannot explain these early deteriorations, we think they are worth mentioning, because the more life-threatening a complication the clearer it has to be elucidated. Haverich and colleagues think that at this time the implantation of the Medtronic Intact bioprosthesis cannot be recommended unless the manufacturer can give a reasonable explanation for these potentially lethal complications, and I agree with them.

References

1. Lemieux MD, Jamieson WRE, Landymore RW, et al. Medtronic Intact porcine bioprosthesis: clinical performance to seven years. Ann Thorac Surg1995;60:S258–63.
2. Antretter H, Cottogni M, Mueller LC, Mair P, Furtwaengler W, Moes N. Medtronic Intact bioprosthesis in aortic position: unexplainable immediate degeneration. J Thorac Cardiovasc Surg1993;106:1218–9.
3. Haverich A, Cremer J, Hirt SW, Keutel J. Early degeneration of a Medtronic Intact bioprosthesis in aortic position. Eur J Cardiothorac Surg1995;9:172

Reply

Medtronic Cardiac Surgery, 7000 Central Ave Ne, Po Box 1350, Minneapolis, Mn 55440

To the Editor:

We appreciate the opportunity to respond to Dr Antretter's correspondence regarding the condition of two explanted Medtronic Intact aortic valves, one of which was explanted by Dr Antretter.

Medtronic has the highest level of commitment to product quality and patient safety. Thus, we take very seriously any issues raised by physicians concerning our products.

We value the feedback provided by Dr Antretter, as we do with all of our customers. With this feedback we have the opportunity to continually review and improve our products and processes. We will continue to carefully monitor the performance of the Intact valve, maintaining the highest standard of quality in the product and with patient safety as our first priority. An updated product performance report on the Intact valve will be published by Medtronic by the end of the summer.

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Antretter, H. Articles by Foster, J. G. Search for Related Content PubMed Articles by Antretter, H. Articles by Foster, J. G.