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J Thorac Cardiovasc Surg 2003;125:1563
© 2003 The American Association for Thoracic Surgery

Letters to the Editor

Prosthetic cardiac valve replacement

Bram D. Zuckerman, MD, Wolf Sapirstein, MD

Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Division of Cardiovascular Devices, Rockville, MD 20850

To the Editor:

The US Food and Drug Administration (FDA) has become aware of a problem associated with cardiac valve prosthetic replacement arising from mismatch between annulus sizing devices and the labeled dimension of prostheses. Anecdotal reports suggest that discrepancies between the labeled size of prostheses and the dimensions of the specific sizer may have compromised seating of selected valve prostheses.Go 1 Christakis and colleaguesGo 2 documented discrepancies of as much as 8 mm between the labeled size of a particular prosthesis and the external diameter of the sewing cuff. Considerable variation was also found between the diameters of sewing cuffs for valves labeled as similar in size by different manufacturers. Although these discrepancies may not in themselves be relevant to the implantation procedure when the appropriately matched device-specific sizer is used, the use of generic or so-called universal sizers or of sizers designed for other prostheses, even if from the same manufacturer, may result in selection of an oversized valve. At best such an occurrence will require discarding a device before suture attachment because of body fluid contamination. A more serious consequence occurs when the mismatch is not recognized until the attempt to seat the prosthesis after suture placement.

To assess the pervasiveness of this problem with valve sizers, the Society of Thoracic Surgeons, in cooperation with the FDA, surveyed a cohort of 200 cardiac surgeons. One hundred six responders to a mailed questionnaire identified problems with manufacturer-supplied sizers in 31 instances and with universal sizers in 7 cases. The responders also indicated knowledge of similar problems experienced by other surgeons in 52 instances.

The intention of this communication is to alert surgeons to the FDA's concerns regarding the problem of valve and sizer mismatch. The frequency of occurrence suggests a need for remedial prosthetic labeling that accurately and uniformly across devices describes both sewing cuff external dimensions and orifice area. Tight manufacturing controls should ensure that the prosthetic sewing cuff dimension matches the labeled size within specified tolerances that provide confidence that they are accurately reflected by the sizers used to measure the cardiac valve annulus.

Because of the FDA's concerns, surgeons are cautioned to use only sizers labeled for use with the specific prosthetic valve to be implanted. In addition, it is advised that selection of a satisfactory device fit be confirmed by testing the prosthesis within the annulus before insertion of sewing cuff sutures.

References

  1. Bartels C, Leyh RG, Bechtel MJ, Joubert-Hubner E, Sievers HH. Discrepancies between sizer and valve dimensions: implications for small aortic root. Ann Thorac Surg. 1998;65:1631-3.[Abstract/Free Full Text]
  2. Christakis GT, Buth KJ, Goldman BS, Fremes SE, Rao V, Cohen G, et al. Inaccurate and misleading valve sizing: a proposed standard for valve size nomenclature. Ann Thorac Surg. 1998;66:1198-203.[Abstract/Free Full Text]




This Article
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Right arrow Articles by Zuckerman, B. D.
Right arrow Articles by Sapirstein, W.

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