ON-X Valve?

[Elgato]

Of course they are impressive, it's a marketing statement not scientific results.

There are anomalies in the data as well.

Why in one table is it thromboemelism but in another it is thrombosis? Why is valve related death only given for one table? They cite the same references but present different data in the tables for the similar events.

Why does only one table give the number of subjects?

I certainly don't know the answers, but I would counsel to not judge any medical product by the manufacturer's marketing statements. The largest government fines in the history of the US are levied against drug manufacturers and one of the biggest problems is false claims of effectiveness...yes I know, that's drugs these are valves, but they are both made by people.

It lists them under the header of FDA Clinical Results. It gives the impression that they are just quoting FDA numbers.
I did look for "FDA Clinical Results" for some other valves and could not find anything.

Wouldn't it be nice if you could just see an apples to apples comparison for the valves?
Hard to believe something so important, controlled and studied is so hard to get clear comparisons.

Thanks

 

[tom in MO]

The health care system is designed to make money by treating disease. After FDA approval, for valves, their first priority is convincing your surgeon that their valve is the one to use. That's why Ony-X marketing efforts to patients are unusual.

You will never get apples to apples comparisons because it is not in the best interests of the companies making the valves. Ony-X newer valves have got to be compared by them to older ones for marketing purposes. If the new valve is not better but equivalent...this report will not be publicized.

 

[river-wear]

It would be nice if they could figure out a way to do standardized testing, but of course because every person is different (some calcify valves, some grow pannus, etc.) it isn't possible.

I'll have to read the threads Lynlw and ElectLive posted, because from where I sit, reducing the INR doesn't offer a whole lot of benefit. You're still taking warfarin, testing and monitoring; the newer valves aren't that much higher (0.5 INR higher, based on what my surgeon said). I have seen at least one limited study that said tissue calcification is greater for warfarin users, so there's one consideration. To me, the big plus of ON-X would be the better hemodynamics (not having a history of calcification or pannus). I'll definitely discuss it with my 2nd opinion doctor. But it looks like ANY valve is going to have better hemodynamics than the 75% regurgitant jet my native valve is shooting now. :eek2:

 

[Heart Of The Sunrise]

It was dramatic my improvement after surgery even though I was asymptomatic. My EF went from 45 pre-op to 60 post-op. My initial INR target was 2.5 to 3.0 set by my surgeon. My cardiologist has me in the 2.0 to 2.5. Last test was 2.3. 5mg per day. Even if ON-X gets approved in the 1.5 range in the US, I feel since I have no ill effects from Coumadin that I will stay where I am at in the 2.0 to 2.5. Per my surgeon I went with brand specific COUMADIN. I am fortunate to have good insurance so it only costs me $25.00 for a 3 month supply. Echo scheduled for 4/15.

 

[Mister_James]

The dream of lower INT on On-X is just a pipe dream. The main cause of thrombosis is platelet activation due to the impact of the mechanical leaflets and blood. It is not materials or how smooth the surface is. Why would a doctor who is comfortable administering INR range of 2.0 through 3.5 all of a sudden take chances with lower numbers and risk an event? This is more likely where the resistance is going to be.

 

[tom in MO]

My range went from 2-3 to 2-2.5 and my coumadin clinic supported the narrower range. It does mean a bit more frequent testing. Since I home test, this is not inconvenient but is expensive. The tighter range also gives me more piece of mind with my INR goes low (1.7 last week) or high (2.8 a month ago).