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

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No abstract – Letter to the Editor

Key words

aortic disease - heart valve surgery - transplantation

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