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Ann Thorac Surg 2001;71:S282-S284
© 2001 The Society of Thoracic Surgeons

Bioprosthetic valves and conduits: new developments

Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement

W.R. Eric Jamieson, MDa, Michael T. Janusz, MDa, Joan MacNaba, Charmaine Hendersona

a Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, British Columbia, Vancouver, Canada

Address reprint requests to Dr Jamieson, St. Paul’s Hospital, 331-332 Burrard Building, 1081 Burrard St, Vancouver, BC V6Z 1Y6, Canada
e-mail: wrej{at}interchange.ubc.ca

Presented at the VIII International Symposium on Cardiac Bioprostheses, Cancun, Mexico, Nov 3–5, 2000.


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
Background. The hemodynamic performance of aortic replacement prostheses is of extreme importance. There is renewed interest in hemodynamics because of the influence of prosthesis–patient mismatch on left ventricular mass regression and the potential influence on survival.

Methods. The hemodynamic performance of the second-generation Carpentier-Edwards supraannular porcine and pericardial (Perimount) bioprostheses and the third-generation Medtronic Mosaic porcine bioprosthesis were compared for mean gradient and effective orifice area index. The effective orifice area index of at least 0.85 cm2/M2 was considered as lack of prosthesis–patient mismatch. The study group included included 53 patients with Carpentier-Edwards supraannular porcine, 48 with pericardial, and 98 with Medtronic Mosaic porcine bioprostheses.

Results. The mean gradients were not different between the prostheses by prosthesis size. The Medtronic Mosaic was not provided in size 19. The mean gradients for the prostheses, except in the very large sizes, were all double-digit values. The effective orifice area index was not different between the prostheses but there was a trend toward prosthesis-patient mismatch in smaller size prostheses.

Conclusions. There was no apparent hemodynamic advantage between porcine and pericardial bioprostheses in the aortic position.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 Acknowledgments
 References
 
The hemodynamic performance of replacement aortic substitutes is receiving renewed interest because of the influence of prosthesis–patient mismatch on left ventricular mass regression and the potential influence on intermediate and long-term survival. Prosthesis–patient mismatch has been defined by Pibarot and coworkers [1] as an effective orifice area indexed as less than or equal to 0.85 cm2/M2.

The second-generation porcine bioprostheses, the Carpentier-Edwards and Hancock II, are designed as supraannular prostheses to alleviate the obstructive properties of the first-generation standard intraannular porcine bioprostheses. The second-generation Carpentier-Edwards pericardial (Perimount) bioprosthesis has been shown to have hemodynamics superior to those of the Carpentier-Edwards standard porcine bioprosthesis [2]. It is generally considered that the Perimount prosthesis is indicated in small aortic sizes to alleviate the need for annular enlarging procedures.

The study was performed to compare the second-generation Carpentier-Edwards porcine (CE-SAV) (Edwards Lifesciences, Irvine, CA) and pericardial (CE-P) bioprostheses (Edwards Lifesciences, Irvine, CA) and the third-generation Medtronic Mosaic (MM) (Medtronic Inc, Irvine, CA) supraannular porcine bioprosthesis. The study was also conducted to determine whether prosthesis–patient mismatch was evident, especially in small annular sizes.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 Acknowledgments
 References
 
The patients evaluated were 53 with CE-SAV, 48 with Carpentier-Edwards CE-P, and 98 with MM porcine bioprostheses. The echocardiograms were not performed concurrently and were not randomized. The echocardiograms were performed between 1 and 2 years after valve replacement. The CE-SAV study was conducted as a prospective evaluation during 1991 and 1992. The MM evaluations were conducted between 1994 and 1998 as part of the Food and Drug Authority-Investigational Device Exemption (FDA-IDE) international trial. The echocardiographic examinations of the CE-P were performed between 1995 and 1999 as routine practice, and reports were collected retrospectively. The echocardiograms were performed for all three prostheses by the cardiac echocardiographic laboratories of Vancouver General Hospital and St. Paul’s Hospital, affiliated teaching hospitals of the University of British Columbia.

The number of patients and echocardiograms by prosthesis size and type are detailed in Table 1. The internal diameters of the prosthesis type by prosthesis size as reported by the manufacturers is shown in Table 2.


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  		Table 1. Numbers of Patients and Echocardiograms by Prosthesis Size and Type

 

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  		Table 2. Internal Diameters of the Prosthesis Types by Prosthesis Size

 
The comparisons were made for mean gradient (mm Hg) and in vivo effective orifice area (EOAI) indexed to body surface area (cm2/m2). The comparisons were done on the number of echocardiograms using analysis of variance to compare the three prosthesis types. Multiple range tests were used to evaluate differences for prosthesis pairs comparisons.


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 Acknowledgments
 References
 
The mean gradients for the prostheses by valve size are shown in Table 3. The MM was not provided in size 19. Our center did not use the size 27 and 29 CE-P bioprostheses. The mean gradients for the prostheses, except for the very large sizes, were all double-digit values. There were no significant differences between the prostheses.


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  		Table 3. Mean Gradients for Prostheses, by Size

 
The EOAI are shown in Table 4. The comparisons were all nonsignificant except for size 19, for which the EOAI was larger for CE-P than for CE-SAV; however, there were only four CE-SAV echocardiograms compared with 17 studies for CE-P. There was a trend, to a degree, of prosthesis–patient mismatch in size 19 CE-SAV, sizes 19 to 23 CE-P, and sizes 21 and 23 MM bioprostheses.


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  		Table 4. Effective Orifice Area Indices for Prostheses, by Prosthesis Size

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
Acknowledgments
 References
 
The hemodynamic performance of aortic prostheses is of extreme importance because too high a level of gradients across the valve may have an influence on intermediate and long-term survival. When the prosthesis used produces excessive gradient in a particular patient, there is said to be prosthesis–patient mismatch. In 1996, Pibarot and colleagues [1] determined clinically that 0.85 cm2/m2 or less was the level indicating mismatch.

There is inadequate knowledge of the hemodynamic performance of second-generation porcine and pericardial prostheses. There is also a need for comparison of these with third-generation porcine prostheses. In 1986 Cosgrove and associates [2] reported on an intraoperative evaluation of Carpentier-Edwards (CE) standard and supraannular porcine and pericardial bioprostheses. They found that the mean gradients decreased with increasing size of prosthesis. They also showed that the effective orifice area of the CE pericardial prosthesis was greater than that of the CE-SAV, but that the CE-SAV was superior to the first-generation intraannular CE standard porcine bioprosthesis. On the other hand, McDonald and colleagues [3] identified the relationship between valve size, gradient, and effective orifice area but failed to define the specific hemodynamic effects of the CE pericardial, CE standard, and Medtronic Intact bioprostheses.

The current study has revealed no difference between the CE-SAV porcine, CE Perimount pericardial and Medtronic Mosaic porcine bioprostheses with regard to mean gradients by prosthesis size and also indexed effective orifice area by prosthesis size. There was a tendency for an element of prosthesis-patient mismatch in sizes 19 to 23, with mean gradients between 12 to 17 mm Hg. The findings correlated with those of other investigators. Thomson and the Canadian investigators [4] of the Medtronic Mosaic have identified mean gradients of 10 to 13 mm Hg throughout the various prosthesis sizes. Pibarot and associates [5–7] and Dumesnil and colleagues [8] documented mismatch with stented prostheses. In a specific evaluation of the intraannular Medtronic Intact porcine bioprosthesis, Pibarot and associates [5] reported that mismatch increased as gradients ranged from 15 to 22 mm Hg.

There is considered opinion that hemodynamics of stentless porcine bioprostheses are superior to that of stented bioprostheses [6–12]. Yun and investigators [13] identified this phenomenon in a comparison of the Medtronic Mosaic stented and Freestyle stentless porcine bioprostheses. The stentless prostheses have lower gradients and better EOAI in small prostheses. Rao and colleagues [14] reported an interesting finding that the CE-Perimount size 21 had an internal diameter similar to that of the Toronto SPV stentless size 25; in addition, when comparisons were made, the hemodynamics were similar when matched to internal diameters.

A relationship has been identified between left ventricular mass and prosthesis–patient mismatch [12, 15]. Jin and coauthors [12] reported that homografts and stentless bioprostheses have mass regression superior to that of stented bioprostheses and mechanical prostheses. Del Rizzo and colleagues [15] have shown that mass regression correlates with mismatch, and that EOAI less than or equal to 0.85 cm2/m2 resulted in minimal regression over 3 years after valve replacement.

There is growing information that prosthesis size, prosthesis–patient mismatch, and left ventricular mass are likely related to survival [16, 17]. David and colleagues [16] first reported on a matched-pairs cohort analysis, showing that at 8 years the survival with the Toronto SPV stentless was 91% and that the Hancock II stented porcine was 69%. Del Rizzo and colleagues [17] compared the Medtronic Freestyle stentless porcine to the Hancock II and found a significant survival advantage at 5 years for the stentless bioprosthesis. Prosthesis size and design has been evaluated for influence on survival [18]. Rao and associates [18] found that size alone influenced valve-related mortality in a combined evaluation of the Hancock II and CE-S and SAV porcine bioprostheses.

In conclusion, this study shows that hemodynamic performance is similar for the second-generation Carpentier-Edwards supraannular porcine and Carpentier-Edwards Perimount pericardial and the Medtronic Mosaic third-generation porcine bioprostheses. There is a tendency for higher mean gradients and potential prosthesis–patient mismatch in smaller size prostheses. There is a need to study prosthesis performance with intraoperative annular sizing as a more realistic indicator of left ventricular outflow tract performance. There is also a need to compare stentless and stented prostheses for all prostheses sizes to determine indicators for implantation, so as to avoid prosthesis–patient mismatch, to optimize ventricular mass regression, and, likely, to optimize intermediate and long-term survival.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
References
 
We thank Judy Maxwell for her assistance in the preparation of the manuscript.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Pibarot P., Honos G.N., Durand L.G., Dumesnil J.G. The effect of prosthesis-patient mismatch on aortic bioprosthetic valve hemodynamic performance and patient clinical status. Can J Cardiol 1996;12:379-387.[Medline]
  2. Cosgrove D.M., Lytle B.W., Gill C.C., et al. In vivo hemodynamic comparison of porcine, and pericardial valves. J Thorac Cardiovasc Surg 1985;89:358-368.[Abstract]
  3. McDonald M.L., Daly R.C., Schaff H.V., et al. Hemodynamic performance of small aortic valve bioprostheses: is there a difference?. Ann Thorac Surg 1997;63:362-366.[Abstract/Free Full Text]
  4. Thomson D.J., Jamieson W.R.E., Dumesnil J.G., et al. Medtronic Mosaic porcine bioprosthesis satisfactory early clinical performance. Ann Thorac Surg 1998;66:S122-S125.
  5. Pibarot P., Dumesmil J.G., Lemieux M., Cartier P., Métras J., Durand L.G. Impact of prosthesis-patient mismatch on hemodynamic and symptomatic status, morbidity and mortality after aortic valve replacement with a bioprosthetic heart valve. J Heart Valve Dis 1998;7:211-218.[Medline]
  6. Pibarot P., Dumesnil J.G., Jobin J., Cartier P., Honos G., Durand L.G. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. J Am Coll Cardiol 1999;34:1609-1617.[Abstract/Free Full Text]
  7. Pibarot P., Dumesnil J.G., LeBlanc M.H., Cartier P., Métras J. Changes in left ventricular mass and function after aortic valve replacement: a comparison between stentless and stented bioprosthetic valves. J Am Soc Echocardiogr 1999;12:981-987.[Medline]
  8. Dumesnil J.G., LeBlanc M.H., Cartier P.C., et al. Hemodynamic features of the freestyle aortic bioprosthesis compared with stented bioprosthesis. Ann Thorac Surg 1998;66:S130-S133.
  9. Walther T., Falk V., Autschbach R., et al. Hemodynamic assessment of the stentless Toronto SPV bioprosthesis by echocardiography. J Heart Dis 1994;3:657-665.
  10. Del Rizzo D.F., Goldman B.S., Christakis G.T., David T.E. Hemodynamic benefits of the Toronto stentless valve. J Thorac Cardiovasc Surg 1996;112:1431-1445.[Abstract/Free Full Text]
  11. Del Rizzo D.F., Abdoh A. Clinical and hemodynamic comparison of the Medtronic Freestyle and Toronto SPV stentless valves. J Card Surg 1998;13:398-407.[Medline]
  12. Jin X.Y., Zhang Z.M., Gibson D.G., Yacoub M.H., Pepper J.R. Effects of valve substitute on changes in left ventricular function and hypertrophy after aortic valve replacement. Ann Thorac Surg 1996;62:683-690.[Abstract/Free Full Text]
  13. Yun K.L., Jamieson W.R.E., Khonsari S., Burr L.H., Munro A.I., Sintek C.F. Prosthesis-patient mismatch: hemodynamic comparison of stented and stentless aortic valves. Semin Thor Cardiovasc Surg 1999;11(4 Suppl 1):98-102.
  14. Rao V., Christakis G.T., Sever J., et al. A novel comparison of stentless versus stented valves in the small aortic root. J Thorac Cardiovasc Surg 1999;117:431-436.[Abstract/Free Full Text]
  15. Del Rizzo D.F., Abdoh A., Cartier P., Doty D., Westaby S. Factors affecting left ventricular mass regression after aortic valve replacement with stentless valves. Semin Thorac Cardiovasc Surg 1999;11(4 Suppl 1):114-120.[Medline]
  16. David T.E., Puschmann R., Ivanov J., et al. Aortic valve replacement with stentless and stented porcine valves: a case-match study. J Thorac Cardiovasc Surg 1998;116:236-241.[Abstract/Free Full Text]
  17. Del Rizzo D.F., Abdoh A., Cartier P., Doty D., Westaby S. The effect of prosthetic valve type on survival after aortic valve surgery. Semin Thorac Cardiovasc Surg 1999;11:1-8.[Medline]
  18. Rao V., Jamieson W.R.E., Ivanov J., Armstrong S., David T.E. Patient-prosthesis mismatch affects survival after aortic valve replacement. Circulation 2000;102(Suppl III):III5-III9.[Abstract/Free Full Text]



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