Early Clinical Experience with a New Tubular Equine Pericardial Stentless Aortic Valve


  • Friedrich S. Eckstein
  • Hendrik Tevaearai
  • Dorothee Keller
  • Jürg Schmidli
  • Franz F.
  • Christian Seiler
  • Hugo Saner
  • Thierry P. Carrel




Background: This study details a single-center experience with the 3F Therapeutics stentless aortic bioprosthesis (investigational device) and is part of a prospective, n o n r a n d o m i z e d w o r l d w i d e m u l t i c e n t e r s t u d y. We assessed the implantation procedure and the valve's efficacy in terms of early mortality and morbidity and early echocardiographic valve performance.

Methods: Between June 2001 and March 2004, 24 patients (14 men/10 women) underwent aortic valve replacement (AVR) with a 3F valve. Mean age was 72 ± 13 years (range, 31-88 years). Combined revascularization was performed in 12 patients; 1 patient received biatrial ablation therapy, 1 patient a myectomy, and 3 patients combined carotid endarterectomy. Echocardiographic systolic gradient and valve performance were investigated intra- and postoperatively by Doppler echocardiography.

Results: There were 2 perioperative deaths, 1 non-valve related, due to aortic rupture in an 83-year-old woman, and 1 fatal cerebral embolism in a 77-year-old woman 5 days postoperatively. Cardiopulmonary bypass time was 102 ± 32 minutes, aortic cross-clamp time was 79 ± 24 minutes. Sizes for implanted 3F valves were 5 ´ 23 mm, 6 ´ 25 mm, 7 ´ 27 mm, and 6 ´ 29 mm. Follow-up systolic gradient results were 11.5 ± 4.7 mm Hg at 30 days (n = 21), 11.4 ± 4.5 mm Hg at 6 months (n = 18), and 13.3 ± 4.4 mm Hg at 12 months (n = 13). During the follow-up period trivial central aortic valve regurgitation was found in 6 patients.

Conclusion: The 3F aortic valve shows favorable preliminary hemodynamic results. Owing to the new valve design, implantation technique is simplified compared with other stentless valves. Anticoagulation treatment is mandatory for the first 3 months postoperatively. Long-term observation is necessary to assess life span and durability.


Ando M, Imai Y, Takanashi Y, Hoshino S, Seo K, Terada M. 1997. Fate of trileaflet equine pericardial extracardiac conduit used for the correction of anomalies having pulmonic ventricle-pulmonary arterial discontinuity. Ann Thorac Surg 64(1):154-8.nBach DS, Goldman B, Verrier E, et al. 2004. Durability and prevalence of aortic regurgitation nine years after aortic valve replacement with the Toronto SPV stentless bioprosthesis. J Heart Valve Dis 13(1):64-72.nBonacchi M, Giunti G, Prifti E, et al. 2002. Early postoperative outcome and hemodynamic performance of the sorin pericarbon stentless aortic valve. J Heart Valve Dis 11(5):703-9.nDellgren G, Eriksson MJ, Brodin LA, Radegran K. 2002. Eleven years' experience with the Biocor stentless aortic bioprosthesis: clinical and hemodynamic follow-up with long-term relative survival rate. Eur J Cardiothorac Surg 22(6):912-21.nImai Y, Takanashi Y, Hoshino S, Nakata S. 1995. The equine pericardial valved conduit and current strategies for pulmonary reconstruction. Semin Thorac Cardiovasc Surg 7(3):157-61.nJin XY, Pepper JR. 2002. Do stentless valves make a difference? Eur J Cardiothorac Surg 22(1):95-100.nJin XY, Ratnatunga C, Pillai R. 2001. Performance of Edwards prima stentless aortic valve over eight years. Semin Thorac Cardiovasc Surg 13(4 suppl 1):163-7.nKon ND, Riley RD, Adair SM, Kitzman DW, Cordell AR. 2002. Eight-year results of aortic root replacement with the freestyle stentless porcine aortic root bioprosthesis. Ann Thorac Surg 73(6):1817-21.nLuciani GB, Auriemma S, Casali G, Barozzi L, Lamascese N, Mazzucco A. 2000. Experience with stentless aortic xenografts. J Heart Valve Dis 9(6):794-800.nMueller XM, von Segesser LK. 2003. A new equine pericardial stentless valve. J Thorac Cardiovasc Surg 125(6):1405-11.nNashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. 1999. European System for cardiac operative risk evaluation (Euroscore). Eur J Cardiothorac Surg 16(1):9-13.nSievers HH, Lange PE, Bernhard A. 1985. Implantation of a xenogeneic stentless aortic bioprosthesis. First experience. Thorac Cardiovasc Surg 33(4): 225-6.nSim EK, Muskawad S, Lim CS, et al. 2003. Comparison of human and porcine aortic valves. Clin Anat 16(3):193-6.nWestaby S, Jonson A, Payne N, et al. 2001. Does the use of a stentless bioprosthesis increase surgical risk? Semin Thorac Cardiovasc Surg 13(4 suppl 1):143-7.n



How to Cite

Eckstein, F. S., Tevaearai, H., Keller, D., Schmidli, J., F., F., Seiler, C., Saner, H., & Carrel, T. P. (2005). Early Clinical Experience with a New Tubular Equine Pericardial Stentless Aortic Valve. The Heart Surgery Forum, 7(5), E498-E502. https://doi.org/10.1532/HSF98.20041087




Most read articles by the same author(s)