St Jude Medical Regent valve

Abstract

The recent publication by Øvrum and Tangen1Øvrum E. Tangen G. Acute leaflet arrest in St Jude Medical Regent aortic valve.J Thorac Cardiovasc Surg. 2005; 129: 1446Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar 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.2Nicoloff D.M. Emery R.W. Arom K.V. et al.Clinical and hemodynamic results with the St Jude Medical cardiac valve prosthesis.J Thorac Cardiovasc Surg. 1982; 82: 674-681Google Scholar, 3Emery R.W. Krogh C.C. Arom K.V. et al.The St Jude Medical Cardiac valve prosthesis a 25-year experience with single valve replacement.Ann Thorac Surg. 2005; 79: 776-783Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar 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. 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.4St Jude Medical, IncPre-Market Approval Application—Supplement to Summary of Safety and Effectiveness, SJMN Regent Heart Valve. US Food and Drug Administration, Washington (DC)2002Google Scholar, 5Carbomedics IncPre-Market Approval Application—Summary of Safety and Effectiveness. US Food and Drug Administration, Washington (DC)1993Google Scholar 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.6Bach D.S. Sakwa M.P. Goldbach M. et al.Hemodynamics and early clinical performance of the St Jude Medical Regent mechanical aortic valve.Ann Thorac Surg. 2002; 74: 2003-2009Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar The calculations of Pibarot and associates7Pibarot P. Dumesnil J.G. Cartier P.C. et al.Patient-prosthesis mismatch can be predicted at the time of operation.Ann Thorac Surg. 2001; 71: S265-S268Abstract Full Text Full Text PDF PubMed Scopus (128) Google Scholar 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. Reply to the EditorThe Journal of Thoracic and Cardiovascular SurgeryVol. 131Issue 3PreviewWe appreciate the interest in our brief report1 regarding acute leaflet arrest in the St Jude Medical (SJM) Regent aortic valve (St Jude Medical, Inc, St Paul, Minn). The remarks forwarded by Dr Emery clearly indicate that specific precautions must be taken regarding the technique of implantation. His figure 1 demonstrates the shorter distance from the subvalvular tissue to the hinges. He proposes everting mattress sutures for inserting all the types of SJM valves, and this is certainly a safe technique. Full-Text PDF