Thorac Cardiovasc Surg 2008; 56(5): 314-315
DOI: 10.1055/s-2008-1038472
Letter to the Editor

© Georg Thieme Verlag KG Stuttgart · New York

Another Disastrous Outcome Following Aortic Root Replacement with the Shelhigh No-React Aortic Valved Tube

T. P. Carrel1
  • 1Department of Cardiovascular Surgery, University Hospital, Bern, Switzerland
Further Information

Publication History

received Feb. 12, 2008

Publication Date:
09 July 2008 (online)

No abstract – Letter to the Editor

References

  • 1 Tjan T D, Klotz S, Schmid C, Scheld H H. Creation of a self-made total artificial heart using combined components of available ventricular assist devices.  Thorac Cardiovasc Surg. 2008;  56 51-53
  • 2 Carrel T P, Berdat P, Englberger L, Eckstein F, Immer F, Seiler C, Kipfer B, Schmidli J. Aortic root replacement with a new stentless aortic valve xenograft conduit: preliminary hemodynamic and clinical results.  J Heart Valve Dis. 2003;  12 752-757
  • 3 Siniawski H, Lehmkuhl H, Weng Y, Pasic M, Yankah C, Hoffmann M, Behnke I, Hetzer R. Stentless aortic valves as an alternative to homografts for valve replacement in active infective endocarditis complicated by ring abscess.  Ann Thorac Surg. 2003;  75 803-808
  • 4 Albolhoda A, Yu S, Oyarzun J, McCormick J, Han S, Kemp F, Bogden J, Lu Q, Gabbay S. No-React® detoxification process: a superior anticalcification method for bioprostheses.  Ann Thorac Surg. 1996;  62 1724-1730
  • 5 CE 0318 Technical report. The NR-2000C stentless aortic valve conduit: a breakthrough in bioprosthetic design. Shelhigh, Inc., NJ, USA
  • 6 Carrel T, Schoenhoff F, Schmidli J, Stalder M, Eckstein F, Englberger L. Deleterious outcome of No-React treated stentless valved conduits following aortic root replacement.  J Thorac Cardiovasc Surg. 2008; 
  • 7 http://www.fda.gov/foi/warning_letters/archive/m3695n.pdf
  • 8 http://www.fda.gov/foi/warning_letters/archive/g5674d.pdf
  • 9 FDA preliminary public health notification: possible contamination and malfunction of heart valves and valved conduits, annuloplasty rings, surgical grafts, meshes and other devices manufactured by Shelhigh, Inc., April 18, 2007. http://www.fda.gov/cdrh/safety/041807-shelhigh.html

Prof. Thierry P. Carrel

Department of Cardiovascular Surgery
University Hospital

Freiburgstrasse

3010 Bern

Switzerland

Phone: + 41 3 16 32 23 75

Fax: + 41 3 16 32 44 43

Email: thierry.carrel@insel.ch