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Ann Thorac Surg 2003;76:337
© 2003 The Society of Thoracic Surgeons

Correspondence

Mismatching of annular sizers and cardiac prosthetic valve sewing cuff sizes

Bram D. Zuckerman, MDa, Wolf Sapirstein, MDa

a U.S. Food and Drug Administration, Division of Cardiovascular Devices, U.S. Food and Drug Administration/Center for Devices and Radiological Health, 9200 Corporate Blvd, HFZ-450 Rockville, MD, USA 20850

To the Editor:

The 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 [1]. Christakis and associates documented discrepancies of as much as 8 mm between the labeled size of a particular prosthesis and the external diameter of the sewing cuff [2]. Considerable variation was also found between the diameters of sewing cuffs for valves labeled as similar in size by different manufacturers. While these discrepancies may not in themselves be relevant to the implantation procedure when the appropriately matched device-specific sizer is employed, the use of generic, or so-called Universal Sizers, or 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 attempting to seat the prosthesis after suture placement.

In order 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 and six responders to a mailed questionnaire identified problems with manufacturer-supplied sizers in 31 instances and with universal sizers in seven 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 of the FDA’s concerns regarding the problem of valve/sizer mismatch. The frequency of occurrence suggests 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 provides confidence that they are accurately reflected by the sizers used to measure the cardiac valve annulus.

Surgeons are cautioned to employ only sizers labeled for use with the 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 R.G., Bechtel M.J.F., Joubert-Hubner E., Sievers H.H. Discrepancies between sizer and valve dimensions: implications for small aortic root. Ann Thorac Surg 1998;65:1631-1633.[Abstract/Free Full Text]
  2. Christakis G.T., Buth K.J., Goldman B.S., et al. Inaccurate and misleading valve sizing: a proposed standard for valve size nomenclature. Ann Thorac Surg 1998;66:1198-1203.[Abstract/Free Full Text]




This Article
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