Clinical Update Forty-Five: Tissue Valve Failure

Factors leading to premature tissue valve failure

Accelerated failure of biological valve replacements due to diabetes, atherosclerosis, metabolic syndrome, hypercholesterolemia and patient-prosthesis mismatch puts patients at risk.1-5


Recently published studies describe a variety of conditions common in patients with heart valve disease that can cause early tissue valve failure.

Diabetes is a 3X higher risk factor for biological valve failure

In a twelve center study in Italy of 6184 bioprosthetic patients, 1731 (27.9%) exhibited type II diabetes mellitus (DM).1 1113 pairs of patients with and without diabetes were propensity matched and compared after a median follow-up of 7 years.

“Patients with type II DM showed higher 30-day mortality, longer intensive care unit stay, longer assisted ventilation time and higher incidence of early postoperative complications. . . . One-hundred-twenty-one patients (10.8%) in the type II DM group, and 43 (3.8%) patients in the no DM group had reoperation as a result of primary tissue valve failure.”1

Metabolic syndrome accelerates bioprosthetic valve failure

Briand and associates of Quebec after finding that the presence of metabolic syndrome was a predictor of disease progression in patients with aortic valve stenosis, hypothesized that it would also influence bioprosthetic valve deterioration.2 Thirty three per cent of their aortic patients exhibited metabolic syndrome—a grouping of inflammatory abnormalities associated with abdominal obesity and insulin resistance. Their findings:

  • Progression of valve regurgitation was twice as high in the group with metabolic syndrome compared to those that did not have it, and
  • Deterioration of hemodynamic function was higher in patients with metabolic syndrome.

Young patients with high cholesterol are at risk for early valve failure

A study from Munich, Germany, showed that a cholesterol level greater than 240 mg/dL in patients less than 57 years old was associated with faster valve degeneration and failure prior to 10 years after implant.3 This study also showed that young women experienced early valve failure more frequently than younger men. Smoking and diabetes were also risk factors in younger valve patients.

A Harvard study found increasing serum cholesterol levels are associated with implanted bioprosthetic valve calcification and that patients who had their valves explanted exhibited higher cholesterol levels than a matched group of valve patients who did not have their valves explanted.4 These authors also found a link to younger age and increased calcification.

Factors leading to premature tissue valve failure

Patient-prosthesis mismatch and poor hemodynamics as risk factors

A study of patient-prosthesis mismatch5 in biological valve patients showed that those who were mismatched experienced stenotic valve failure more often than those who were not mismatched. 50% of 564 biological implants were mismatched in this study. These authors state:

“Because it is obvious that only patients prone to P-PtM develop stenosis-type SVD over time, there must be a link between disturbed hemodynamics and this kind of pathology.”5

With poor effective orifice areas and gradients typically displayed by biological valves in small sizes7-12 it is probable that patient-prosthesis mismatch, i.e.,“disturbed hemodynamics” and early failure of the implanted valves would be more frequent. This would contribute to the increased mortality seen in several matched or randomized studies between biological and mechanical valve patients.6, 13-17

Factors associated with early degeneration and
reoperation of tissue valves
Type II diabetes mellitus
Cholesterol levels
Metabolic syndrome
Young age

With the common occurrence of these risk factors for bioprosthetic valve failure especially in younger patients needing replacement, shouldn’t these risks be factored into valve choice favoring the mechanical option in patients younger than 65?



  1. Lorusso R, Gelsomino S, Lucá F, et al. Type II diabetes mellitus is associated with faster degeneration of bioprosthetic valve: Results from a propensity score-matched Italian multicenter study. Circulation 2011;on-line publication available at:
  2. Briand M, Pibarot P, Despres JP, et al. Metabolic syndrome is associated with faster degeneration of bioprosthetic valves. Circulation 2006;114:I-512-I-517
  3. Nollert G, Miksch J, Kreuzer E, et al. Risk factors for atherosclerosis and the degeneration fo pericardial valves after aortic valve replacement. J Thorac Cardiovasc Surg 2003;126:965-68
  4. Farivar RS, Cohn LH. Hypercholesterolemia is a risk factor for bioprosthetic valve calcification and explantation. J Thorac Cardiovasc Surg 2003;126:969-75
  5. Flameng W, Herregods M, Vercalsteren M, et al. Prosthesis-patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation 2010;121:2123-29
  6. Weber A, Noureddine H, Englberger L, et al. Ten-year comparison of pericardial bioprostheses and mechanical aortic valve replacement in patients less than 60 years of age. The Society of Thoracic Surgeons 47th Annual Meeting Program Book, Abstract 47, page 182
  7. Edwards Life Sciences Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis. Instructions for Use. © 2003
  8. Mitroflow Aortic Pericardial Heart Valve. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P060038. Approval date October 23, 2007
  9. SJM Biocor® Valve and SJM Biocor® Supra Valve. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P040021. Approval date August 5, 2005
  10. Medtronic Freestyle® Aortic Root Prosthesis. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P970031 Approval date November 26, 1997
  11. Mosaic Heart Valve. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P990064. Approval date July 14, 2000
  12. ATS 3f® Aortic Bioprosthesis, Model 1000. Instructions for Use
  13. Brown ML, Schaff HV, Lahr BD, et al. Aortic valve replacement in patients aged 50 to 70 years: Improved outcome with mechanical versus biologic prostheses. J Thorac Cardiovasc Surg 2008;135:878-84
  14. Daneshmand MA, Milano CA, Rankin JS, et al. Influence of patient age on procedural selection in mitral valve surgery. Ann Thorac Surg 2010;90:1479-86
  15. Badhwar V. Ofenloch J, Rovin J, et al. Equivalency of closely monitored mechanical valves to bioprostheses overshadowed by early mortality benefit in younger patients. The Society of Thoracic Surgeons 47th Annual Meeting Program Book, Poster Abstract 12, page 359
  16. Vicchio M, Della Corte A, De Santo LS, et al. Tissue versus mechanical prostheses: Quality of life in octogenarians. Ann Thorac Surg 2008;85:1290-95
  17. de Vincentiis C, Kunkl AB, Trimarchi S, et al. Aortic valve replacement in octogenarians: Is biologic valve the unique solution? Ann Thorac Surg 2008;85:1296-302

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