Clinical Update Thirty-Three: On-X Pure Carbon Valve

Does the On-X Pure Carbon Valve behave like a mechanical or tissue valve?

Results of an intermediate term study of 737 Canadian patients show decreased risk with the On-X® Prosthetic Heart Valve.1

 

A study published in the November 2010 issue of The Journal of Thoracic and Cardiovascular Surgery found approximately 30% improvement in aortic valve morbid event rates for the On-X valve and approximately 50% improvement in mitral valve morbid even rates compared with other mechanical valves’ rates. The most stunning difference is the low level of hemorrhagic events for the On-X valve compared with other mechanical valve studies—an indication that On-X patients were being maintained at very moderate levels of anticoagulation. The low level of anticoagulation and reduced hemorrhagic events for On-X patients did not lead to increased thromboembolic (TE) events. These findings for On-X patients emulate those for tissue valves.

The authors of this paper from two prestigious academic Canadian centers studied 737 patients implanted with the On-X valve from 2003 to 2008. Average intermediate follow-up for the study was 2.8 years. Their findings confirm the previous trend for the On-X valve to produce the lowest complication rates seen to date for mechanical valve technology.

The comparison in this publication reflects a similar advantageous finding for the On-X valve in studies conducted for mechanical valves for FDA market approval in the USA. Comparison to tissue valve studies conducted for the FDA further reveals the similarity to On-X valve results (Tables 1 and 2).

Comparison Tables

Studies conducted under protocols approved by the FDA for market approval in the United States are closely monitored, international multi-center studies that yield the best possible comparison of clinical values next to randomized trials because:

  • Randomized trials which are theoretically better are difficult to conduct with different prostheses due to unwillingness of participants to randomize in lieu of surgeon choice/patient condition and/or patient choice.
  • Single center comparisons can fall short of objectivity since patients may be selected to give the “best results”.

When a “mechanical valve” is indicated, choose the valve “designed for life” – the On-X® Pure Carbon Valve!

 

References

  1. Chan V, Jamieson WRE, Lam BK, et al. Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: A prospective multicenter study. J Thorac Cardiovasc Surg 2010;140:1053-58
  2. On-X On-X® Prosthetic Heart Valve. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P000037. Approval date May 30, 2001 and October 11,2002
  3. SJM Regent® Valve. Clinical Study Summary (package insert)
  4. CarboMedics® Prosthetic Heart Valve. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P900060. Approval date April 13, 1993
  5. ATS Open Pivot® Bileaflet Heart Valve. Summary of Safety and Effectiveness Data submitted to the United States Food and Drug Administration. PMA P990046. Approval date October 13, 2000
  6. Edwards Life Sciences Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis. Instructions for Use. Copyright 2003
  7. 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
  8. ATS 3f® Aortic Bioprosthesis, Model 1000. Instructions for Use
  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. 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.

On-X aortic and mitral valves are FDA approved. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use that accompany each valve for indications, contraindications, warnings, precautions and possible complications. For further information, visit www.onxlti.com.

 

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