The Carpentier-Edwards aortic pericardial valve portfolio is built upon the PERIMOUNT bioprosthesis design.

Magna Ease valve

Carpentier-Edwards PERIMOUNT Magna Ease aortic heart valve

Magna Ease aortic valve

Clinical communiqué

20 year results
Carpentier-Edwards PERIMOUNT pericardial aortic bioprosthesis

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‡ No clinical data are available that evaluate the long-term impact of the Edwards Lifesciences tissue treatments in patients.
* Freedom from explant / prosthesis replacement / reoperation due to SVD.
† Freedom from valve reoperation for prosthesis dysfunction and all other causes.

 

References:

  1. Dalmau M, et al. The Carpentier-Edwards Perimount Magna aortic xenograft: a new design with an improved hemodynamic performance. Interactive Cardiovasc and Thoracic Surgery 2006;5:263–267.
  2. Ruzicka D, et al. The Complete Supraannular Concept, In Vivo Hemodynamics of Bovine and Porcine Aortic Bioprostheses. Circulation 2009;120(11 Suppl):S139-45.
  3. Wendt D, et al. The new St Jude Trifecta versus Carpentier-Edwards Magna and Magna Ease aortic bioprosthesis: Is there a hemodynamic superiority? J Thorac Cardiovasc Surg. 2014;147(5):1553-1560.
  4. Banbury MK et al. Hemodynamic Stability During 17 Years of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg 2002;73:1460-65. (Cohort size = 267, mean age = 65 yrs.)
  5. Pelletier LC, Carrier M, Leclerc Y, et al. The Carpentier-Edwards Pericardial Bioprosthesis: Clinical Experience with 600 Patients. Ann Thorac Surg. 1995;60:S297-302. (Cohort size = 416, mean age = 63 yrs. Number at risk for Primary Valve Dysfunction at last follow-up = 18)
  6. Cosgrove DM, Lytle BW, Taylor PC, et al. The Carpentier-Edwards Pericardial Aortic Valve. Ten-year results. J Thorac Cardiovasc Surg. 1995;110(3):651 662. (Cohort size = 310; mean age = 64.2 ± 10. 8 yrs. Number at risk for Structural Valve Deterioration at last follow-up = 63)
  7. Carrier M, Pellerin M, Perrault LP, et al. Aortic Valve Replacement with Mechanical and Biologic Prosthesis in Middle-aged Patients. Ann Thorac Surg. 2001;71:S253-256. (Cohort size = 158, mean age = 61 ± 3 yrs. Number at risk for Valve Dysfunction at last follow-up not reported)
  8. Murakami T, et al. Aortic and Mitral Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: 10-year Results. J Heart Valve Dis. 1996 Jan;5(1):45-9. (Cohort size = 49, mean age = 58.6 ± 15.1 yrs. Number at risk for SVD at last follow-up = 1)
  9. Aupart MR, Babuty DG, Guesnier L, et al. Double Valve Replacement with the Carpentier-Edwards Pericardial Valve: 10-year Results. J Heart Valve Dis. 1996;5(3):312-316. (Cohort size = 71, mean age = 63.4 yrs. Number at risk for Valve Structural Failure at last follow-up not reported)
  10. Aupart MR, Sirinelli AL, Diemont FF, et al. The Last Generation of Pericardial Valves in the Aortic Position: Ten-year Follow-up in 589 Patients. Ann Thorac Surg. 1996;61(2):615-620. (Cohort size = 589, mean age = 67.5 ± 11.2 yrs. Number at risk for Structural Valve Failure at last follow-up not reported)
  11. Aupart M, Simonnot I, Sirinelli A, et al. Pericardial Valves in Small Aortic Annuli: Ten Years’ Results. Eur J Cardiothorac Surg. 1996;10(10):879-883. (Cohort size = 90, mean age = 72.2 ± 10.1 yrs. Number at risk for Valve Failure at last follow-up not reported)
  12. Gao G, Wu Y, Grunkemeier GL, et al. Durability of Pericardial Versus Porcine Aortic Valves. J Am Coll Cardiol. 2004;44(2):384-388. (Cohort size = 1,021, mean age = 74 yrs. Number at risk for Explant for SVD at last follow-up = 6)
  13. Le Tourneau T, Vincentelli A, Fayad G, et al. Ten-year Echocardiographic and Clinical Follow-up of Aortic Carpentier-Edwards Pericardial and Supraannular Prosthesis: a Case-match Study. Ann Thorac Surg. 2002;74(6):2010-2015. (Cohort size = 75, mean age = 72 ± 9 yrs. Number at risk for SVD or reoperation at last follow-up = 18)
  14. Banbury MK, Cosgrove DM III, Lytle BW, Smedira NG, Sabik JF, Saunders CR. Long-term Results of the Carpentier-Edwards Pericardial Aortic valve: A 12-year Follow-up.Ann Thorac Surg 1998;66:S73–6. (Cohort size = 310, mean age = 64.2 ± 10.8 yrs. Number at risk for Structural Deterioration at last followup = 111)
  15. Dellgren G, David TE, Raanani E, Armstrong S, Ivanov J, Rakowski H. Late Hemodynamic and Clinical Outcomes of Aortic Valve Replacement with the Carpentier-Edwards Perimount Pericardial Bioprosthesis. J Thorac Cardiovasc Surg 2002;124:146-54. (Cohort size = 254, mean age = 71 yrs. Number at risk for Structural Valve Dysfunction at last follow-up = 6)
  16. Nakajima H, Aupart MR, Neville PH, Sirinelli AL, Meurisse YA, Marchand MA. Twelve-year Experience with the 19 mm Carpentier-Edwards Pericardial Aortic Valve. J Heart Valve Dis 1998;7:534-539. (Cohort size = 121, mean age = 73.2 ± 9.4 yrs. Number at risk for Structural Valve Deterioration at last follow-up = 4)
  17. Neville PH, et al. Carpentier-Edwards Pericardial Bioprosthesis in Aortic or Mitral Position: a 12-year Experience. Ann Thorac Surg. 1998;66(6 Suppl):S143-7. (Cohort size = 787, mean age = 68.83± 10.8` yrs. Number at risk for Structural Deterioration at last follow-up = 13)
  18. Pellerin M, Mihaileanu S, Couetil JP, Relland JYM, Deloche A, Fabiani JN, Jindani A, Carpentier AF. Carpentier-Edwards Pericardial Bioprosthesis in Aortic Position: Long-term Follow-up 1980 to 1994. Ann Thorac Surg. 1995;60:S292-6. (Cohort size = 124, mean age = 65 yrs. Number at risk for Structural Valve Deterioration at last follow-up = 8)
  19. Frater RWM, Furlong P, Cosgrove DM, Okies JE, Colburn LQ, Katz AS, Lowe NL, Ryba EA. Long-term Durability and Patient Functional Status of the Carpentier-Edwards Perimount Pericardial Bioprosthesis in the Aortic Position. J Heart Valve Dis. 1998;7:48-53. (Cohort size = 267, mean age = 64.9 ± 11.8 yrs. Number at risk for Valve Dysfunction at last follow-up = 28)
  20. Poirier NC, et al. 15-year Experience with the Carpentier-Edwards Pericardial Bioprosthesis. Ann Thorac Surg. 1998;66:S57-61. (Cohort size = 598, mean age = 65 yrs. Number at risk for Structural Deterioration at last follow-up = 8)
  21. Banbury MK, Cosgrove DM III, White JA, et al. Age and Valve Size Effect on the Long-term Durability of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg. 2001;72(3):753-757. (Cohort size = 267, mean age = 65 ± 12 yrs. Number at risk for Explant for SVD at last follow-up not reported)
  22. McClure RS, Narayanasamy N, Wiegerinck E, et al. Late Outcomes for Aortic Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: Up to 17-year Follow-up in 1,000 Patients. Ann Thorac Surg. 2010;89(5):1410-1416. (Cohort size = 1,000, mean age = 74.1 ± 0.29 yrs. Number at risk for SVD at last follow-up not reported)
  23. Minakata K et al. Long-Term Outcome of the Carpentier-Edwards Pericardial Valve in the Aortic Position in Japanese Patients. Circulation Journal 2014;78:882-889. (Cohort size = 574, mean age = 71.9 yrs. Number at risk for Structural Deterioration at 15-year follow-up = 54)
  24. Jamieson WR, Germann E, Aupart MR, et al. 15-year Comparison of Supra-annular Porcine and PERIMOUNT Aortic Bioprostheses. Asian Cardiovasc Thorac Ann. 2006;14(3):200-205. (Cohort size = 1,430, mean age = 69.5 ± 10.4 yrs. Number at risk for SVD at last follow-up = 33)
  25. Biglioli P, Spampinato N, Cannata A, et al. Long-term outcomes of the Carpentier-Edwards pericardial valve prosthesis in the aortic position: effect of patient age. J Heart Valve Dis. 2004;13(1):S49-51. (Cohort size = 327, mean age = 67.2 ± 10.6 yrs. Number at risk for Prosthesis Replacement at last follow-up not reported)
  26. Bergoënd E, Aupart MR, Mirza A, et al. 20 years’ durability of Carpentier-Edwards Perimount stented pericardial aortic valve. In: Yankah CA, Weng Y, Hetzer R, eds. Aortic Root Surgery The Biological Solution. Berlin: Springer; 2010:441-451. (Cohort size = 1,857, mean age = 69.8 yrs, Number at risk for Structural Valve Deterioration at last follow-up not reported)
  27. Aupart MR, Mirza A, Meurisse YA, et al. Perimount Pericardial Bioprosthesis for Aortic Calcified Stenosis: 18-year Experience with 1133 Patients. J Heart Valve Dis. 2006;15(6):768-775. (Cohort size = 1,133, mean age = 72.6 yrs. Number at risk for SVD at last follow-up = 2)
  28. Forcillo J et al. Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience. Ann Thorac Surg 2013;96:486-93. (Cohort size = 2,405, mean age = 71 yrs. Number at risk for Structural Deterioration at last follow-up = 30)
  29. Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis 20-year Results. Data on file at Edwards Lifesciences, 2003. (Cohort size = 267, mean age = 65 ± 12 yrs. For patients ≥65, number at risk for explant due to SVD at last follow-up = 2)