J Thorac Cardiovasc Surg 2006;131:760-761
© 2006 The American Association for Thoracic Surgery
St Jude Medical Regent valve
Robert W. Emery, MD
Cardiac Surgical Associates, PA, Minneapolis, MN 55407
To the Editor:
The recent publication by Øvrum and Tangen
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describes acute leaflet arrest with implantation of the St Jude Medical Regent valve (St Jude Medical, Inc, St Paul, Minn), specifically accumulation of subvalvular tissue into the leaflet and hinge mechanism. Several issues need to be raised with this brief report.
The St Jude Medical Regent valve, as noted, is implanted in the supra-annular position; only the pivot guards are intra-annular (Figure 1). My colleagues and I have described our technique for implanting all St Jude Medical valves utilizing everting mattress sutures and have used this technique in more than 5000 patients monitored for up to 25 years.
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We have not had issues of annular tissue impingement preventing the opening of the valve with any of the St Jude Medical models. Although leaflet opening has been impeded rarely by hypertrophic septa, turning the valve has provided relief. Utilizing ventricular-to-aortic suture (noneverting), particularly if the depth of the bite into aortic annulus is too great or the valve is not seated properly, can force annular tissue into the lumen of the prosthetic valve.
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Figure 1. The St. Jude Medical HP valve (left) is seated intra-annular while the Regent sewing ring supra-annular. The pivot guard on the Regent must be positioned properly intra-annular.
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The initial Regent valve implanted in these 3 cases was likely oversized and the pivot guard not seated properly. In each case, the Regent valve was replaced with a valve of a smaller effective tissue annulus diameter (ETAD) compared with the St Jude Medical standard model and a smaller effective orifice area (EOA) determined from industry-provided data.
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In case 1, a 25-mm tissue annulus diameter (TAD) St Jude Medical Regent valve (TAD 25 mm, ETAD 28 mm, EOA 2.6 cm2) was replaced with a 23 mm Regent valve (TAD 23 mm, ETAD 26 mm, EOA 2.5 cm2). In case 2, a 27-mm Regent valve (TAD 27 mm, ETAD 30 mm, EOA 3.5 cm2) was replaced with a 27-mm CarboMedics standard valve (Sulzer Carbomedics, Inc, Austin, Tex) (TAD 27 mm, ETAD 27 mm, EOA 2.2 cm2). In the third case, a 25-mm Regent valve was replaced with a 25-mm CarboMedics standard valve (TAD 25 mm, ETAD 25 mm, EOA 1.5 cm2); again a smaller valve by ETAD with a markedly smaller EOA. Suture technique may have compounded the oversizing. The high EOA in all Regent valves makes oversizing unnecessary.
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The calculations of Pibarot and associates
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for patient-prosthesis mismatch indicate only 1 patient (case 3), after a 25-mm CarboMedics valve implant was at risk for mismatch (EOA 1.5 cm2, EOAI 0.6 cm2/mm2).
In summary, the problems Øvrum and Tangen encountered can be explained by implantation techniques, depth of sutures, and oversizing of the Regent valve rather than by the valve itself.
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References
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- Øvrum E, Tangen G. Acute leaflet arrest in St Jude Medical Regent aortic valve. J Thorac Cardiovasc Surg 2005;129:1446.[Free Full Text]
- Nicoloff DM, Emery RW, Arom KV, et al. Clinical and hemodynamic results with the St Jude Medical cardiac valve prosthesis. J Thorac Cardiovasc Surg 1982;82:674-681.
- Emery RW, Krogh CC, Arom KV, et al. The St Jude Medical Cardiac valve prosthesis. a 25-year experience with single valve replacement. Ann Thorac Surg 2005;79:776-783.[Abstract/Free Full Text]
- St Jude Medical, Inc Pre-Market Approval Application—Supplement to Summary of Safety and Effectiveness, SJMN Regent Heart Valve. Washington (DC): US Food and Drug Administration; 2002P810002/S57.
- Carbomedics Inc Pre-Market Approval Application—Summary of Safety and Effectiveness. Washington (DC): US Food and Drug Administration; 1993P900060.
- Bach DS, Sakwa MP, Goldbach M, et al. Hemodynamics and early clinical performance of the St Jude Medical Regent mechanical aortic valve. Ann Thorac Surg 2002;74:2003-2009.[Abstract/Free Full Text]
- Pibarot P, Dumesnil JG, Cartier PC, et al. Patient-prosthesis mismatch can be predicted at the time of operation. Ann Thorac Surg 2001;71:S265-S268.[Medline]
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