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Ann Thorac Surg 2001;71:1065
© 2001 The Society of Thoracic Surgeons

Correspondence

Thrombogenicity of the St. Jude Medical prosthesis with and without silzone-coated sewing cuffs

Dieter Horstkotte, MD, PhD, FESCa, Rito Bergemann, MDa, The GELIA Study Group

a Heart Center North Rhine-Westphalia, Ruhr University, Department of Cardiology, Bad Oeynhausen, Germany

e-mail: akohlstaedt{at}hdz-nrw.ruhr-uni-bochum.de

To the Editor

A small sample-sized observation study recently claimed a high incidence of embolic complications with the St. Jude Medical Silzone valve [1, 2]. Silzone coating by an ion beam–assisted deposition process, resulting in a layer of metallic silver bonded to each strand of the cuff fabric, was introduced to prevent bacterial colonization and consequent prosthetic valve endocarditis. Such a coating however may not only reduce bacterial colonization but may influence endothelialization of the sewing ring, which potentially increases the frequency of periprosthetic leaks and the thrombogenicity of the device [3]. As the 40-year history of valve replacement surgery is full of unexpected setbacks in expected "improved versions" of valve substitutes, there is an urgent need to discover any adverse effect related to silver coating—all the more as an interim analysis of data gathered for the AVERT study [4] discovered a significantly increased risk for periprosthetic leaks [3].

We used the German Experience with Low-Intensity Anticoagulation (GELIA) database to retrospectively discover potential differences in the thromboembolic risk of patients with St. Jude Medical prosthesis with either the Silzone or the conventional cuff implanted in the mitral or the aortic position. GELIA is a prospective randomized, controlled clinical trial with more than 2,800 patients enrolled to evaluate the optimal target intensity of oral anticoagulation [5]. To compare the risk for thromboembolic as well as bleeding complications, a matched pair analysis was performed using standard biostatistical methods [6]. The stepwise matching process resulted in an exact match of the following parameters: site of implantation, intent-to-treat intensity for oral anticoagulation, hemodynamic and myocardial function parameters at the time of surgery, valve diameter, patient age, and gender. Fisher’s exact test gave a one-side p value of 0.38 and a power of 77% with respect to differences between the Silzone group (n = 81) and the matched controls (n = 81). In neither of the two groups was a thrombotic or a thromboembolic event documented, although one serious bleeding event occurred in a patient with a St. Jude Medical Silzone valve.

From this analysis of a subgroup of patients participating in the GELIA study it may be concluded that the overall thromboembolic and bleeding complication rate in patients who receive St. Jude Medical Silzone-coated cuffs are similar to those with conventional cuffs and that there are no arguments to change the standard antithrombotic treatment regimen established for patients with St. Jude Medical prostheses in patients with Silzone or conventional cuffs.

References

  1. Ionescu A.A., Fraser A.G. High incidence of embolism after St. Jude Silzone prosthetic valve implantation. Circulation 1999;100:I524.
  2. Ionescu A.A., Fraser A.G., Butchart E.G. Unexpected high incidence of embolic events with the St. Jude Silzone® valve. Eur Heart J 1999;20(Suppl):558.
  3. Bodnar E. The Silzone dilemma—what did we learn?. J Heart Valve Dis 2000;9:170-173.[Medline]
  4. Schaff H., Carrel T., Steckeberg J.M., Grunkemeier G.L., Holubkov R., AVERT Investigators. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis 1999;8:131-139.[Medline]
  5. Horstkotte D., Bergemann R., Althaus U., et al. German experience with low intensity anticoagulation (GELIA) study: protocol of a multi-center randomized prospective study with the St. Jude Medical valve. J Heart Valve Dis 1993;2:411-419.[Medline]
  6. Ingelfinger J.A., Mosteller F., Thibodeau L.A., Ware J.H. Biostatistics in clinical medicine. New York: McGraw-Hill, 1994:312-315.



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