Clinical Update Forty-One: On-X Heart Valve

The On-X Heart Valve at 12 years

Long term follow-up of the On-X valve confirms its early performance of clinical excellence.1,2

 

European data establishes the On-X valve as market leader

A three center retrospective study of 691 patients from 1998 through 2009 inclusivley produced low complication rates.1 John Chambers of Guy’s and St. Thomas Hospital in London, Carlos Mestres and Jose Pomar of the University Hospital in Barcelona and George Palatianos of the Onassis Cardiac Center in Athens compiled data from their On-X patients. These patient demographics are seen in Table 1.

Table 1. Preoperative characteristics

AVR
n=214		 MVR
n=407		 DVR
n=70
Age 59.7 60.6 60.2
Gender % Male 74 50 60
Valve Stenosis % 44 21 –
Valve Regurgitation % 32 67 –
Mixed Disease % 22 16 –
NYHA III 33 50 54
NYHA IV 8 29 23
Previous Surgery % 10 28 26
Sinus Rhythm % 83 45 40
Atrial Fibrillation % 11 49 54

A population of predominantly mitral and double valve patients (69%) with a staggering 50% in atrial fibrillation and 70+% in NYHA classifications III and IV should have produced poor outcomes based on historical mechanical valve performance.4-8 Table 2 summarizes clinical event rates for the On-X valve from this latest publication. Predictably, the early and long term rates are similar.

Table 2. Comparison of early and long term complication rates

Event (%/pt.yr.) AVR
N (%/pt.yr.)		 MVR
N (%/pt.yr.)		 DVR
N (%/pt.yr.)		 Total
N (%/pt.yr.)		 FDA PMA3
(%/pt.yr.)
Total thromboembolism 8 (0.6) 19 (1.0) 6 (1.8) (33) 0.8 1.7
Major bleed 5 (0.4) 19 (1.0) 3 (0.9) (27) 0.9 0.7
Valve-related mortality 2 (0.2) 10 (0.5) 6 (1.8) (18) 0.5 0.2
Total 1.2 2.5 4.5 2.2 2.6

Startlingly low complication rates for a compromised population

These higher risk patients produced clinical event rates like those of a low risk population—more evidence that the advanced design of the On-X valve provides superior patient outcomes. Reduced blood damage from a less turbulent design contributes to these low rates.9

Stable low rates across cultures, time and varying compliance

Several other longer term studies of the On-X valve have produced similar results. These results are reviewed in Table 3. The South African population of young rheumatic patients is almost 50% noncompliant. The tertiary population of Taiwanese patients on low end anticoagulation also produced low complication rates. The German 10 year result is comparable.

Table 3. On-X Valve Complication Rates

South Africa2 Taiwan10 Germany11 12 Year Study1
Thromboembolism 1.9 0.7 1.5 0.8
Hemorrhage 1.2 1.6 1.1 0.9
Valve-related Mortality 1.3 0.7 1.9 0.5
Total 4.4 3.0 4.5 2.2

Twelve year results in a high risk population prove that the On-X valve will provide lower complication rates for your younger valve patient population versus conventional mechanical valves.

 

References

  1. Chambers JB, Pomar JL, Mestres CA, Palatianos GM. Clinical event rates with the On-X bileaflet mechanical heart valve: A multicenter experience with follow-up to 12 years. J Thorac Cardiovasc Surg 2012. (doi:10.101b / j.jtcvs.2011.12.059)
  2. Williams MA, Van Riet S. The On-X Heart Valve at 10 Years. Presented at the 6th Biennial Meeting of the Society for Heart Valve Disease.June 25-28, 2011 in Barcelona, Spain
  3. 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 March 6, 2002
  4. Bryan AJ, Rogers CA, Bayliss K, et al. Prospective randomized comparison of Carbomedics and St. Jude Medical bileaflet mechanical heart valve prostheses: Ten-year follow-up. J Thorac Cardiovasc Surg 2007;133:614-22
  5. Emery RW, Krough CC, Arom KV, et al. The St. Jude Medical cardiac valve prosthesis: A 25-year experience with single valve replacement. Ann Thorac Surg 2005; 79:776-83
  6. Toole JM, Stroud MR, Kratz JM, et al. Twenty-five year experience with the St. Jude Medical mechanical valve prosthesis. Ann Thorac Surg 2010;89:1402-09
  7. 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
  8. 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
  9. Birnbaum D, Laczkovics A, Heidt M, et al. Examination of hemolytic potential with the On-X® Prosthetic Heart Valve. J Heart Valve Dis 2000;9:142-45
  10. Tsai HW, Hsieh SR, Wei HJ, et al. Seven-year experience with On-X® Prosthetic Heart Valves in an Asian population with high risk cardiac status and reduced anticoagulation. Society for Heart Valve Disease 4th Biennial Meeting, New York, June 15-18, 2007. Poster 146 [Poster]
  11. Tossios P, Reber D, Oustria M, et al. Single-center experience with the On-X prosthetic heart valve between 1996 and 2005. J Heart Valve Dis 2007;16:551-57

On-X aortic and mitral valves are FDA approved. Not all On-X valve models are available in all markets.
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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