Another disastrous outcome following aortic root replacement with the shelhigh no-react aortic valved tube

Thoracic and Cardiovascular Surgeon

Volumn 56, Issue 5, 2008, Pages 314-315

  Carrel, Thierry P ^a  

^a BERN UNIVERSITY HOSPITAL   (Switzerland)

Author keywords

Aortic disease; Heart valve surgery; Transplantation

Indexed keywords

AORTA DISSECTION; AORTA GRAFT; AORTA ROOT; AORTA RUPTURE; AORTA STENOSIS; AUTOPSY; BLOOD CULTURE; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; COMPUTER ASSISTED TOMOGRAPHY; ENDOCARDITIS; ENDOPROSTHESIS; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEART ASSIST DEVICE; HUMAN; LETTER; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSTHESIS FAILURE; STANDARDIZATION; SUDDEN DEATH;

AORTA; AORTIC VALVE; BIOPROSTHESIS; BLOOD VESSEL PROSTHESIS; BLOOD VESSEL PROSTHESIS IMPLANTATION; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; PROSTHESIS DESIGN; PROSTHESIS FAILURE; REOPERATION;

EID: 50849119089     PISSN: 01716425     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2008-1038472     Document Type: Letter

References (9)

1. Tjan TD, Klotz S, Schmid C, Scheld HH. 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 TP, 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, in press
7. http://www.fda.gov/foi/warning_matters/archive/m3695n.pdf
8. http://www.fda.gov/foi/warning_matters/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 Shel-high, Inc., April 18, 2007. www.fda.gov/cdrh/safety/041807-shel-high.html