We are delighted to hear of his great accomplishment and wish him continued success in his future endeavors!!

You can read about Mr. Minoru’s original story at: http://www.onxlti.com/2011/12/international-patients-concern-about-surgery-was-swept-away-with-the-on-x-heart-valve/

Last fall 6 weeks after a 100 miler and 2 weeks after a 15 mile mountain bike race, I suddenly had very labored breathing. Knowing it wasn’t right I went to the ER. Much to my surprise I found out I had a aortic valve regurgitation. I felt normal 2 weeks earlier. It didn’t seem possible as I ride 3500 miles a year, play basketball and cross country ski!

Well it was true. I was referred to a great surgeon and was immediately put at ease with his knowledge, personality and vast experience with this surgery. He understood my desire to stay active at my relatively young age of 52. He recommended the On X valve. He explained it’s benefits for an active person and the fact that I might not have to take warifin for the rest of my life.

The surgery went well and I was back on my bike in 7 weeks. Now its 6 months later and it’s working beautifully. I am gearing up for my first bike race of the season this Sunday. I basically live a normal life again plus  better improved blood flow. It’s a bonus that the valve is made of a special carbon and as a biker that owns a bike made with that material, I can appreciate it more!

Randy

AUSTIN, TX – April 30, 2012 – On-X^® Life Technologies, Inc. announced today that it is releasing the expected timelines for the initial submission to the FDA of modified “Instructions for Use” (IFU) of the On-X^® Prosthetic Heart Valve based on data from the PROACT Anticoagulation Trial. The expected timelines are being provided to attendees of the 92nd Annual Meeting of the American Association for Thoracic Surgery (AATS) in the On-X Life Technologies exhibition booth number 517.

The first On-X Heart Valve IFU submission is based on the results of the High-Risk Aortic Valve Replacement Patient Group. It is anticipated that the submission will be made in the fall of 2012. The interim results report for the Low-Risk Aortic Valve Replacement Patient Group submission will follow in late 2012. The low-risk patients are being maintained with aspirin and clopidogrel only; no warfarin.

“The results of the PROACT trial appear thus far to be very positive,” said Clyde Baker, On-X LTI’s president. “The submission to the FDA of the IFU changes and the interim report for the aspirin and clopidogrel patient group will provide significant benefit to patients looking for a life-long correction of their valve problems, without the fear of reoperation in the next 10-15 years. Further, these clinical results are expected to have a very positive effect on the market penetration of the On-X valve and the growth of the company.”

To obtain a copy of the expected timelines, contact On-X Life Technologies at onx@onxlti.com or (888) 339-8000.

More on the PROACT Trial

The preliminary report of PROACT (Prospective Randomized On-X Valve Anticoagulation Clinical Trial) data presented at the American College of Cardiology meeting in 2011 for the high-risk aortic patient test will provide the basis for modification of the IFU for the On-X Prosthetic Heart Valve. The modifications are expected to recommend that aortic valve replacement patients may be safely maintained at anticoagulation levels previously considered below professional society guidelines.

As had been hypothesized at the outset of the trial, patients in the test group with INRs between 1.5 and 2.0 are currently equal in composite thromboembolism and hemorrhage rates compared to the control group of patients. All patients received an On-X valve as a replacement for their aortic valve. High-risk aortic patients are those who have a higher potential for thrombotic or bleeding events. These were randomized into Test and Control groups for the trial. Both patient groups were maintained with standard anticoagulation therapy for the first three months after surgery and then randomized into their groups. The Test group was maintained with a daily dose of 81 milligrams of baby aspirin plus warfarin to achieve an INR target of 1.5 to 2.0. The Control group continued with standard anticoagulation therapy throughout the trial.

Present Guidelines (AHA/ACC) recommend patients with mechanical aortic valves be maintained at 2.0 to 2.5 INR. It is anticipated that with the lower levels of anticoagulation used during the PROACT trial that patients will experience fewer bleeding complications.

More about the On-X Prosthetic Heart Valve

The On-X valve is the result of a breakthrough in medical grade carbon technology—On-X^® pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X^® carbon enabled On-X LTI to make significant valve design changes that resulted in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and, therefore, significantly reduces the potential for life-threatening blood clots.

About On-X LTI

On-X^® Life Technologies, Inc. (On-X LTI) develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded On-X LTI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company has FDA, CE and Japanese approval for sale of the On-X^® valve. On-X LTI also provides contract-manufacturing services utilizing its patented pyrolytic carbon to manufacturers of other medical products, including orthopedic joint and spine prostheses. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.

# # #

On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.
 
Media Contact: Clyde Baker, On-X Life Technologies, Inc., 512-339-8000 ext. 269, cbaker@onxlti.com

I understand the designer of the On-X valve met with my surgical and recovery team during my hospital stay.  I certainly would have enjoyed meeting him.  

Thanks for everything, On-X!

Ken

My research led me to consider and choose between the SJM and On-X heart valves.  My decision to go with the On-X valve was influenced by the following:

1. The answer to the question I posed to On-X Life Technologies: “Why should I choose an On-X heart valve?” was met with politeness, professionalism and references to published literature and study reports with facts about the On-X valve as well as its design features.  There was great patience and understanding after numerous follow up questions from me.

2. The results of a ten week study by Flameng and Meuris (March 2002) referring to the results of SJM, On-X and CMI valves that were implanted in sheep without anticoagulation. The superiority of On-X heart valves was proven by longer living sheep having the On-X valve during the 10 weeks as compared with the other valves.

3. The preliminary and on-going results of a clinical trial in South Africa presented by Mervyn Williams in 2002. The On-X heart valve was implanted in patients who were observed for about 3 years and 42% were not properly anticoagulated but no major thrombotic events were present.

4. The hope that I might later be able to go without Coumadin (or Marcoumar in Europe) if aspirin only could be safe enough to be used as an anticoagulant for the On-X valve.

Since my operation in 2006, I have monitored the anticoagulant level (2-3 INR) via a ROCHe anticoagulant meter at home with the aim to use as low as possible anticoagulation level and as near as possible to the value of 2.

I have noticed that garlic therapy also enhances the anticoagulation level.  Before my operation a blood analysis indicated an INR of 1.8 using only raw garlic 3 times a day.  I have to ask why Garlic + aspirin is not considered as blood thiner but only trials with aspirin are done. Garlic also increases also the elasticity of the blood vessels which aspirin does not do and aspirin also absorbs vitamin C.

After my operation I had one month rehabilitation at the cost of the national health system of Austria. There they closely monitored my medical care, provided physical rehabilitation and gave us a diet plan to help lose weight.  I had a personal doctor allocated to follow my progress and had reference echocardiograms. Daily I had bicycle ergonomic measurements to see my progress regarding heart healing.

After the rehab, it took me half a year to be normal again and to go back to my daily routine which included the changes I learned to support my heart operation and avoid obesity and possible diabetes. I follow a low glycemic index diet after evaluating the number of Mediterranean foods I like (feta cheese, whole wheat grain bread with olive oil, tomatoes,  oregano, fish and red wine). Of course from time to time I go to extremes when I go out or we are invited, but afterwards I am aware if being” a marked man” as one of my doctors said.  Then I compensate with a bit more physical exercise and diet.

I have lowered my weight progressively and am now enjoying life. I do notice however the decay in my mental state. Instead of solving sudoku, I have a hobby involving electronic design and construction of gadgets, repairs etc, to keep my brain working and organizing and using methods to remember where I put things so that I can easily find them afterwards.  And now getting frustrated with Bill Gates decision to utilize stars in the place of letters when typing passwords making it impossible to check what you have inputted, so that you can correct it!

Thanks to the On-X valve ticking in me reminding me that I am alive, I can look forward to many happy years.

G.E.

Austria & Greece  

Painting from Japanese artist

In Japan, a 74-year-old gentleman who is a children’s artist began to feel short of breath in 2003—this is his story as translated by Professor Ono. 

Medical tests revealed severe aortic valve stenosis and regurgitation as well as mitral valve stenosis and atrial fibrillation.

Why the patient decided to have mechanical over tissue and why On-X over others

He obtained information about artificial heart valves from his surgeon. He chose to have a mechanical valve without hesitation, because he desired to live an active life to 100 years of age. Because he had been taking warfarin due to persistent atrial fibrillation, he was willing to continue taking warfarin after valve replacement. Also, he did not want to have repeat heart valve surgery which would be necessary if he had a failed tissue valve implanted. He also desired to avoid bleeding complications, one of the major side effects from warfarin. He finally chose to have an On-X heart valve because his research showed him it was possibly safer and because of its performance with low-dose warfarin.

Surgery and postoperative course

Both the aortic and mitral heart valves were replaced with On-X heart valves along with a Maze procedure–the patient went home on 13^th postoperative day.

Activity level and INR

The patient walked around his home every day without any limitation only a few weeks after surgery and began drawing his pictures–one of his beautiful art works is shown here. His INR level is around 2.0 with hopes this could be lowered after the results of the PROACT study are known.

Noise level of On-X valves

He never complained of noise from his On-X heart valves even at bed time when it is very quiet.

Future plans

He hopes to continue his artistry for children’s stories and has volunteered to instruct painting to children and to the disabled as his life work. His main theme for art is “to cheer people up.” He wants to keep on painting pictures to encourage as many people as he can until the age of 100 years.

Quotes from the artist about the valves and surgery

“I express my best gratitude for choosing the On-X heart valve for my heart surgery. I am greatly satisfied with the result of my heart surgery. I am very happy to have been operated upon by Professor Ono and to have On-X valves implanted.”

Will

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.

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 sizes^7-12 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}





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?

References

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: http://circ.ahajournal.org/content/early/2011/12/27/CIRCUALTIONAHA.111.025064
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

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.

Headquarters and Manufacturing Facilities:
1300 East Anderson Lane, Building B Austin, Texas 78752 U.S.A. – Telephone: (512) 339-8000 – Facsimile: (512) 339-3636 – www.onxlti.com – onx@onxlti.com
010006 202 012612 © 2012 On-X Life Technologies, Inc.

AUSTIN, TX – January 24, 2012 – On-X^® Life Technologies, Inc. (On-X LTI) announced today that it is highlighting the interim results of the potentially game-changing PROACT Anticoagulation Trial, two clinical studies completed during the first 15 years of the On-X® Prosthetic Heart Valve implant experience and several recent studies that indicate patients survive longer with mechanical rather than tissue valve prosthesis. The reports will be available to surgeons in the On-X Life Technologies, Inc. booth 508 at the 48^th Annual Meeting of The Society of Thoracic Surgeons, taking place January 29-31, 2012, in Fort Lauderdale, Florida.

The preliminary report of PROACT (Prospective Randomized On-X Clinical Trial) trial data presented at the American College of Cardiology meeting in 2011 for the high risk aortic patient test and control groups showed that as hypothesized, patients in the test group with INRs between 1.5 and 2.0 are currently equal in composite thromboembolism and hemorrhage rates compared to the control group of patients. All patients received an On-X valve as a replacement for their aortic valve. High-risk aortic patients are those who have a higher potential for thrombotic or bleeding events. These were randomized into Test and Control groups for the trial. Both patient groups were maintained with standard anticoagulation therapy for the first three months after surgery and then randomized into their groups. The Test group was maintained with a daily dose of 81milligrams of baby aspirin plus warfarin to achieve an INR target of 1.5 to 2.0. The Control group continued with standard anticoagulation therapy throughout the trial.

The recently presented South African study provides a stunning example of the On-X valve’s ability to reduce complications despite adverse anticoagulation compliance. For example, with an approximately 50 percent noncompliant patient group in this study, the thrombosis rate remains 0.2 percent per patient-year comparing favorably to competitive valves with 2.0 percent per patient-year to 6.0 percent per patient-year thrombosis rates in this same patient population.¹

Several recent studies, which provide evidence of durability, reoperation and mortality benefits received by mechanical valve recipients in comparison with matched patient groups receiving biologic valves, will available to participants of the meeting. These data provide new and compelling evidence that mechanical valve patients with equal disease severity and age to those with tissue valves can expect a survival advantage and an equivalent combined morbid event rate compared to their matched biological valve recipients.

“We are very pleased with the continuing record of clinical evidence demonstrating the benefit of the On-X valve’s unique design with many categories of patients in diverse geographic and clinical settings,” saidClyde Baker, On-X LTI’s president. “The results emphasize the ability of the On-X valve to tolerate an inconsistent INR level, to provide the lowest possible levels of clinical complications and to help heart valve replacement patients maintain an active life, without severe risk of reoperation at an advanced age.”

The On-X valve is the result of a breakthrough in medical grade carbon technology—On-X^® pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X Carbon^® enabled On-X LTI to make significant valve design changes that resulted in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and, therefore, significantly reduces the potential for life-threatening blood clots.

About On-X LTI

On-X^® Life Technologies, Inc. (On-X LTI) develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded On-X LTI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company has FDA, CE and Japanese approval for sale of the On-X^® valve. On-X LTI also provides contract-manufacturing services utilizing its patented pyrolytic carbon to manufacturers of other medical products, including orthopedic joint and spine prostheses. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.

1. Williams MA, Crause L, Van Riet S. A comparison of mechanical valve performance in a poorly anticoagulated community. J Card Surg 2004;19:410-14

# # #

On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.

Media Contact:  Clyde Baker, On-X Life Technologies, Inc., 512-339-8000 ext. 269, cbaker@onxlti.com