St. Jude Regent AV user satisfaction

[bdryer]

Hi

Those who have the St. Jude Regent installed in the aorta position, what is your level of satisfaction?

How is the noise?

How is your energy?

Bleeding after installation?

Comments?

I spoke with a St. Jude rep and found out that this valve is very comparable with the On-X AV. Like the On-X the Regent also holds back pannus.This is a function of the pivot arms. The rep said pannus is more likely to develop if you are lethargic and poorly manage warfarin.

Also found out that silicone carbon composite is stronger then pure carbon, this is why St. Jude uses this composite. Note that silicone composite is significantly more expensive for Dupont to MFG, yet St. Jude incorporates it into the design.

Thanks

 

[Lynlw]

Hi

Those who have the St. Jude Regent installed in the aorta position, what is your level of satisfaction?

How is the noise?

How is your energy?

Bleeding after installation?

Comments?

I spoke with a St. Jude rep and found out that this valve is very comparable with the On-X AV. Like the On-X the Regent also holds back pannus.This is a function of the pivot arms. The rep said pannus is more likely to develop if you are lethargic and poorly manage warfarin.

Also found out that silicone carbon composite is stronger then pure carbon, this is why St. Jude uses this composite. Note that silicone composite is significantly more expensive for Dupont to MFG, yet St. Jude incorporates it into the design.

Thanks

From what I know, Regent is a very good valve and several members here have them and are very happy.

But I found statement this very interesting, and kind of hard to believe "The rep said pannus is more likely to develop if you are lethargic.."
Where they able to list any studies where you could confirm this?

 

[Luana]

Yeah, Lyn, that is an important statement. Glad you asked for more about it!

I have a St. Jude Regent. I rarely hear it. The only time I am aware of it is when I get in bed as I sleep on my side, but it's not bothersome to me at all.

My energy level is quite poor, though it does not appear to be related to the valve as I have other things going on. I had no bleeding problems after surgery and have had easy success in keeping INR stable and I freely eat vegetables and salads. I do not restrict intake of veggies at all. Warfarin, for me, is no problem.

 

[bdryer]

My bad, not lethargic, rather not active

My bad, not lethargic, rather not active

Hi Lynn

I should have written, "pannus is more likely to develop if you do not manage warfarin and are inactive", NOT lethargic.

Lyndsay Hartmann the St. Jude rep, gave me this info during a phone conversation last week.

 

[Lynlw]

Hi Lynn

I should have written, "pannus is more likely to develop if you do not manage warfarin and are inactive", NOT lethargic.

Lyndsay Hartmann the St. Jude rep, gave me this info during a phone conversation last week.

I took it to mean if you weren't very active, but have never heard or seen anything that says, pannus or excess scar tissue growth is affected by how active you are or aren't. I have seen a few articles/studies saying that unstable INRs could play a role in pannus, but not how active you are, it doesn't really make sense to me at least.

 

[bigsidster]

I got a 23 St jude Regent installed in the aortic position on nov22/2010 along with a coupke of bypasses for good measure.I have not heard this valve yet.Everyone talks about ticking etc but I have heard nothing.No bleeding either.INR pretty stable at 2.1 or 2.2 on 5 mg coumadin and I eat what i want . Pretty happy so far.

 

[Bina]

No ticking noise now, just a mild thump thump--- but I'm on BBs also.
Standing very close to a glass door gives me a sense of the valve working, could be cuz I am also very thin.
Not very active, eating well including salad and veggies, stable INR.

 

[ALCapshaw2]

I sent these questions to my contact at On-X.

Here is the reply I received.

---------------------------

Quote (from Ox-X rep):

Silicone was initially used to control the carbon deposition process according to Jack Bokros, originator of the process. It is not advantageous in any way--and is known to be more thrombogenic (clot producing) in testing. I can send you that slide. It probably causes a rougher surface which could lead to more blood cell damage. The SJM valve produces more blood damage as evidenced by documented higher LDH levels. ST. Jude is stuck with silicon because they do not have the expertise to produce valves with pure carbon. On-X Carbon is patented and more difficult to produce as a coating on valves. Silicon Carbon has to be machined to fit up parts and this produces far more surface flaws than those seen on the surface of OnX valve parts that are coated to size with little machining required.

Pure Carbon is stronger and I have the slide I can send you on that.

The ST. Jude ears are manufacturing necessities from the 70's when Jack's people did not have the capability to machine inside the orifice as they do now--Jack Bokros and his team made the SJM valve for many years because they were the only ones with carbon manufacturing capability at the time. . Those ears may actually irritate the annulus and cause excess pannus to grow as we have read about many times with the SJM valve--that is a theory we have heard from surgeons.

There is laboratory testing from Japan to show that the On-X valve is one Decibel quieter than the SJM valve and I can send you that. This difference is logarithmic not linear -- there have been no definitive sound tests in patients--there is not a best way to test this yet but the vast majority of our patients report very little noise with On-X. Not the same for SJM no matter what the rep says.

On-X has a fourteen year history with No documented pannus, no structural failure (there are documented ones for SJM and I can send you those), evidence of lowered blood damage and turbulence against SJM.

The complication rates for the On-X valve were 50% less than those of the SJM valve in recent FDA trials, more evidence of the advantage in the more natural design and better carbon of the On-X valve.

End Quote
------------

VR.org members have had issues with pannus growth (RobThatsMe just had his St. Jude Master's Series Aortic Valve replaced at Cleveland Clinic because of pannus tissue growth after 10 years).

Another member wrote that her blood was "blenderized" (i.e. blood cell damage) by her SJM valve.
I'm thinking this was a Regent. Do a VR Search for keyword "blenderized" to find the original post.

'AL'

 

[bdryer]

Thx for the notes Al. I have e-mailed them to my surgeon.

 

[Duff Man]

it's hard to get a surgeon behind the newer valve when they didn't come up with the idea to use it. Surgeons I've talked to are extremely skeptical about it despite some positive data. I'm not sure how many years they'll need on the market or how many lives statistically are saved before they make the switch.

Sometimes, i think maybe the surgeons are hesitant because of things like the bjork shively. Maybe that's not a fair comparison, I don't know.

 

[Bina]

it's hard to get a surgeon behind the newer valve when they didn't come up with the idea to use it. Surgeons I've talked to are extremely skeptical about it despite some positive data. I'm not sure how many years they'll need on the market or how many lives statistically are saved before they make the switch.

Sometimes, it reminds me of the bjork shively valve and I imagine the surgeons are thinking along the same lines. Maybe that's not a fair comparison, I don't know.

Maybe giving out gas coupons with every valve ordered would help ?

 

[Duff Man]

Maybe giving out gas coupons with every valve ordered would help ?

lol.... seriously.

I just hope that by the time it really is time for me to have it done, the on-x valve is as common as the bigger names. By then, too, it should be more proven via the low ACT study they have going. I wish it were more like sports equipment, where the athlete has his choice of what wrap or pads or brace he wants to wear and maybe the doc gives them a strong suggestion.

 

[Luana]

I was supposed to get an On-X valve, but it would not fit right, so I would assume this has probably happened to others.

 

[Duff Man]

Large Canadian Heart Valve Study Supplies Evidence of On-X Heart Valve Superior Performance:

http://www.tradingmarkets.com/news/...idence-of-on-x-heart-valve-super-1374566.html

 

[bdryer]

Hey Duffy

Thanks for the read. I'll be 50/50 On-X verses St. Jude. I will get this report to my surgeon and HOPE that he reads it. Even St. Jude is anticipating that warfarin will be a thing of the past in 5 years.

St Jude folks feeling slanted by On-X propeganda, do a google search of the following, you will be pleasantly surprised.

Small aortic annulus: The hydrodynamic performances of 5
commercially available bileaflet mechanical valves

I have copied some of the finding below:

Small aortic annulus: The hydrodynamic performances of 5
commercially available bileaflet mechanical valves
Tomaso Bottio, MD
Luca Caprili, MD
Dino Casarotto, MD
Gino Gerosa, MD
The Journal of Thoracic and Cardiovascular Surgery ● Volume 128, Number 3

Results: The SJM Regent valve and the Sorin Bicarbon Slimline prosthesis showed
the lowest mean and peak gradients at increasing cardiac outputs. The closure
volume was higher for the SJM Regent and Sorin Bicarbon Slimline prostheses,
unlike with the ATS prosthesis at 7 L/min of cardiac output. The ATS and SJM
Regent prostheses showed the largest regurgitant volume, whereas the Sorin Bicar-
bon Slimline prosthesis showed the lowest regurgitant volume. The calculated
effective orifice area and stroke work loss were significantly better with the SJM
Regent and Sorin Bicarbon Slimline prostheses.

Conclusion: Assuming that the 21-mm valve holder in which all the tested pros-
theses were accommodated is comparable with a defined aortic valve size, this
hydrodynamic evaluation model allowed us to compare the efficiency of currently
available valve prostheses, and among these, the SJM Regent and the Sorin
Bicarbon Slimline exhibited the best performances.

These results are well explained for the SJM Regent
valve by using the evidence of the larger EOA, greater
geometric orifice area, and valve clear area when compared
with those values in the others prostheses. As previously
published, at 5 L/min of CO, the SJM Regent valve showed
the greatest closing volume, becoming comparable with the
others at 7 L/min. Nevertheless, among all tested valves, we
observed the lowest stroke work loss with the SJM Regent
valve. With the small valve size, the cause of energy loss
was largely the result of the forward flow transvalve pres-
sure difference, with less than 10% being the result of the
regurgitant flow,15 and these satisfactory results with the
SJM Regent depend mostly on the improved design and
increased geometric orifice area.

On the other hand, the results obtained with the On-X
valve are controversial and difficult to explain. In fact, the
On-X valve, which was designed to improve hydrodynamic
performance, unlike accredited of the largest clear orifice
area, the largest calculated EOA at lower CO, and the
greater opening angle (90°), showed results in terms of
regurgitant volumes, transprosthetic gradients, and stroke
work loss comparable with those of the Carbomedics Top
Hat and ATS valves and significantly inferior to those
obtained with the Sorin Bicarbon Slimline and SJM Regent
prostheses. Therefore further explanations, probably related
to the peculiar On-X prosthesis design (higher profile) or to
an incomplete valve opening, might be inferred.
In conclusion, according to our experimental model,
each of the tested valves could be accommodated on a
21-mm aortic annulus, but in the light of these in vitro
results, the best hemodynamic performances should be ob-
tained mostly with the SJM Regent and Sorin Bicarbon
Slimline prostheses.

This is for you Bina

 

[Lynlw]

Large Canadian Heart Valve Study Supplies Evidence of On-X Heart Valve Superior Performance:

http://www.tradingmarkets.com/news/...idence-of-on-x-heart-valve-super-1374566.html

It surprised me when I realised this "Large" study is the the 5 year study w/ 737 patients I posted a couple of weeks ago in another thread, http://www.valvereplacement.org/forums/showthread.php?36869-AVR-selection&p=479463#post479463

I did read a midterm 5 year study on On-X the other day http://www.ncbi.nlm.nih.gov/pubmed/20546795

RESULTS: Early mortality was 2.5% (n = 10) for aortic valve replacement and 3.2% (n = 9) for mitral valve replacement. Late mortality for aortic valve replacement was 4.8% per patient-year and 6.0% per patient-year for mitral valve replacement. Five-year freedom from major thromboembolism was 96.5% ± 1.2% for aortic valve replacement and 97.7% ± 0.9% for mitral valve replacement. Five-year freedom from hemorrhage was 93.6% ± 1.8% for aortic valve replacement and 95.7% ± 1.5% for mitral valve replacement. Concomitant coronary artery bypass grafting was predictive of major thromboembolism after aortic valve replacement (hazard ratio, 5.3; P = .02) and antithrombotic hemorrhage after mitral valve replacement (hazard ratio, 4.7; P = .03). No other independent predictors of major thromboembolism or hemorrhage were identified. One thrombosed mitral prosthesis was observed after deliberate discontinuation of anticoagulation. The major thromboembolic events occurred with variation of international normalized ratio levels inclusive of subtherapeutic levels. The majority of hemorrhagic events occurred with high international normalized ratio levels.

CONCLUSIONS: The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism and hemorrhage"

 

[Duff Man]

that's sobering, Bdryer... here's the link to the study just posted

http://jtcs.ctsnetjournals.org/cgi/content/full/128/3/457

I mean, I find it hard to allow one not so positive study tarnish my view of the valve...

 

[Lily]

I sent these questions to my contact at On-X.

Here is the reply I received.

---------------------------

Quote (from Ox-X rep):

Silicone was initially used to control the carbon deposition process according to Jack Bokros, originator of the process. It is not advantageous in any way--and is known to be more thrombogenic (clot producing) in testing. I can send you that slide. It probably causes a rougher surface which could lead to more blood cell damage. The SJM valve produces more blood damage as evidenced by documented higher LDH levels. ST. Jude is stuck with silicon because they do not have the expertise to produce valves with pure carbon. On-X Carbon is patented and more difficult to produce as a coating on valves. Silicon Carbon has to be machined to fit up parts and this produces far more surface flaws than those seen on the surface of OnX valve parts that are coated to size with little machining required.

Pure Carbon is stronger and I have the slide I can send you on that.

The ST. Jude ears are manufacturing necessities from the 70's when Jack's people did not have the capability to machine inside the orifice as they do now--Jack Bokros and his team made the SJM valve for many years because they were the only ones with carbon manufacturing capability at the time. . Those ears may actually irritate the annulus and cause excess pannus to grow as we have read about many times with the SJM valve--that is a theory we have heard from surgeons.

There is laboratory testing from Japan to show that the On-X valve is one Decibel quieter than the SJM valve and I can send you that. This difference is logarithmic not linear -- there have been no definitive sound tests in patients--there is not a best way to test this yet but the vast majority of our patients report very little noise with On-X. Not the same for SJM no matter what the rep says.

On-X has a fourteen year history with No documented pannus, no structural failure (there are documented ones for SJM and I can send you those), evidence of lowered blood damage and turbulence against SJM.

The complication rates for the On-X valve were 50% less than those of the SJM valve in recent FDA trials, more evidence of the advantage in the more natural design and better carbon of the On-X valve.

End Quote
------------

VR.org members have had issues with pannus growth (RobThatsMe just had his St. Jude Master's Series Aortic Valve replaced at Cleveland Clinic because of pannus tissue growth after 10 years).

Another member wrote that her blood was "blenderized" (i.e. blood cell damage) by her SJM valve.
I'm thinking this was a Regent. Do a VR Search for keyword "blenderized" to find the original post.

'AL'

But if I'm remembering correctly, don't you have a St. Jude valve, AL? Which one do you have? Is it working well for you?

 

[soccerdad]

I've got a St. Jude 23mm aortic. Installed 12/29/2009. I hear it always. I'm a light sleeper anyway. Wish it was quieter. No bleeding or cause for concern. Better energy that what I had but still not what I'd like.

 

[ALCapshaw2]

I've got a St. Jude 23mm aortic. Installed 12/29/2009. I hear it always. I'm a light sleeper anyway. Wish it was quieter. No bleeding or cause for concern. Better energy that what I had but still not what I'd like.

Did you receive a St. Jude Regent Valve (approved in late 1990's)
or a St. Jude Master's series (evolved from original St. Jude BiLeaflet Design from the early 1980's)?