When Edwards' INSPIRIS RESILIA Valve will be market available in US?

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hx77;n880481 said:
.......... BTW, what happen if you get a cut? Is it hard to stop the bleeding?

Thanks,
John

The bleeding issue has never been a concern to me. Over the years I have had many, many cuts, scrapes and gouges......none of which caused undue alarm or issues. Safety razor cuts while shaving have been the biggest nuisance. In the 50 years I've been on warfarin I've been lucky and have had only three occasions that caused significant bleeding:
1. in the 1980's I was building a lake cabin and got hit in the back of my head by an operating ceiling fan. I was installing ceiling tiles and backed into the fan. Required a bunch of stitches to stop bleeding and sew up wound in a country ER. No further issues.
2. in the early 2000's I fell off a ladder in my garage while hanging up a fishing kayak and busted up an elbow. Required another bunch of stitches at a local Immediate care center. No further issues.
3. a couple years ago I sliced the fatty part of my palm with a box cutter while regriping my golf clubs....again needed stitches to close the 1-1/2" long gash.

All of these cuts where closed with only stitches and all bleeding stopped. There was no interruption with my usual AC therapy after these incidents..

This "old wives tale" that you will bleed out if you get a nick is simply not true. A simple bandaid, stiptic(sp?) pencil or a piece of toilet paper will take care of most cuts. If you are ever in a serious auto accident and get your head split open you will have a problem.......with or without being on warfarin.
 
hx77;n880481 said:
.... The risk of getting stroke is a more important concern.
in which case, take your warfarin regularly and actually never worry about getting DVT on a flight as a bonus ;-)

BTW, what happen if you get a cut? Is it hard to stop the bleeding?

I have not observed any difference to bleeding or brusing since before warfarin. I suspect that the problem of "bleeds" comes from the so called "usual care" where people get slack and have their INR checked every month or two months ... ignorance may be bliss but I believe its a dangerous bliss.

Even my dentist remarks that if he didn't know I was on warfarin he'd not know any difference when I get any "scale and cleans" ... because I keep my INR in the 2 ~ 3 range ...

My view is that 90% of the "hype" you hear about warfain is from bad management.

You hear more "horror" from people who don't actually take it than who do

PS: I'm about to go for a colonoscopy next week and the management is quite simply "cease warfarin for 3 days prior (in case they need to snip some polyps) and then go back on it the day after the procedure ... I'll post about that when it is "live"
 
dick0236;n880486 said:
This "old wives tale" that you will bleed out if you get a nick is simply not true.

Sherlock Holmes investigates a paper cut to a person watching TV who was on warfarin ...
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:Face-Smirk:
A simple bandaid, stiptic(sp?) pencil or a piece of toilet paper will take care of most cuts

I use masking tape, paint with some betadine, and a bit of toilet paper (fresh from the roll, no expense spared) when I gash myself on a finger working or "micropore tape" instead (still with toilet paper) if cooking (thus closer to my first aid box in the bathroom).
 
hx77, have they told you why your arteries blocked? I'm interested in this stuff. There are a number of risk factors other than high cholesterol. Happy to share information; but if they've worked it out, no worries.

I haven't noticed any extra bleeding. Don't shave anymore. I gotta beard.

With an AVA of 1.1 I would change valve whilst he's in there.
 
hx - If they have told you that you have arterial blockage, have they evaluated your situation as to whether they recommend CABG or stenting? If stents would be appropriate, you could do that now and re-check for symptoms after the arterial issues are resolved. There is some risk to doing this, but it would isolate the cause of your symptoms.

Or, you could opt for the plan that I followed. When they did my pre-op angiogram they noted one artery blocked 50%. The surgeon told the interventional cardio not to stent me, as he "would fix that while he was in there" replacing my valve. So in one surgery, I had valve replacement and CABG. Only one recovery that way.

I would urge some caution on your part right now, though. You have symptoms. They may or may not be the result of your valve. Be aware that the prognosis for aortic stenosis patients is not great once they present symptoms. IIRC, the life expectancy of an aortic stenosis patient once symptoms develop is in low single-digit years (I've read something like 2-4 years). I am not trying to scare you, but you do need to get to the bottom of this. If your symptoms are related to arterial issues, I do not know how that would impact your lifespan. If, however, they are due to your valve and you don't act, you could put yourself in danger. I think this would be worth a very detailed discussion with your cardiologist.
 
Dick: Thank you for sharing your life stories! You are living a full life and some!

Pell: Thanks for the responses!

Agian: No, they did not tell me why my arteries were blocked. Me: BP 11/70, no diabetes, underweight, normal cholesterol. Maybe it's because of stress or genetics which are hard to quantify. I am happy to hear what you think might have caused my arteries be blocked.

Steve: My LAD is 100% blocked, and left circumflex 70% blocked. Fortunately some micro-circulation developed to flow blood to the blocked area so I avoided a heart attack. If I had done an angiogram 3 years ago, I might have been able to use stents.

My gut feeling is my symptoms are related to arteries blockage as my AV does not deteriorate that much in the past three years. 3 years ago i passed stress test (with HR 150) without any issue. Now whenever my HR goes above 90, i feel chest pain. Your profile said you had waited for 9 years, at what point (gradients, AVA etc) you decided to do AVR?

I just got my MRA report last night. The size of my ascending aorta is 4.0cm, the same as three years ago. Another evidence my AV has not changed that much except gradients.

Thanks everyone for your help!
 
Hx77, get your homocysteine and lipoprotein (a) checked out.
What are your triglycerides and HDL?
I've heard that people of Indian descent have reactive arteries, so CAD tends to be high there.
The vast majority of risk factors can be addressed.

CRP?
 
Nocturne;n880459 said:
The USA is probably the BEST place on Earth to get medical treatment/management -- if you are rich, famous, or both. Take a look at how many people who contracted HIV around the same time Magic Johnson did are still breathing. Now why do you suppose that is?

Or have good insurance. I'm not rich or famous and I had a great surgeon at a great hospital. I'm not saying the system isn't screwed up but it's not only the rich and famous.
 
Agian, Thanks for recommending additional blood tests. My HDL: 82, TRIG: 72, LDL: 88.
 
John,

The below piece is well worth reading as it demonstrates what can be accomplished with a good Self Managed AC protocol. The risk of Grade II/III TE complications with Self Managed AC therapy was about 1/3 of the risk with conventional AC therapy in patients with a mean age of about 60; (0.58%/patient-year versus 1.7%/patient-year).

And the survival curve is even more remarkable, 97% at 10 years for Self M vs 81% for conventional AC therapy. The difference is not entirely AC related in my opinion but it may have to do with the fact that patients who Self Managed tend to be more proactive about taking care of themselves.

I hope this is of some help as you gather good data to make the best decision possible.

And note that the Self M patients where in therapeutic range 73% of the time, while some here have had much better results.

David

Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions

https://academic.oup.com/icvts/article/14/3/253/647048

"Grade II + III thromboembolic events were reported significantly less frequently with Self-M than with Conv-T (0.58%/patient-year versus 1.7%/patient-year, respectively; P = 0.011)."

Survival

"Figure 3 illustrates the Kaplan–Meier survival. Event occurrence over the follow-up period was linear in both groups. Actuarial survival after 1, 5 and 10 years was 100, 99 and 97% with Self-M and 100, 95 and 81% with Conv-T, respectively (P < 0.001). In the follow-up period, 46 (11.0%) patients died (Self-M: 4 patients, Conv-T: 42 patients). There was no significant difference regarding the cause of death: in the Self-M group, 2 patients died from cardiac reasons and the other 2 from unknown reasons; in the Conv-T group, 15 patients died from cardiac reasons, 6 from bleeding complications, 1 from thromboembolic events, 8 from non-cardiac reasons and 12 from unknown reason."
 
hx77 - With the blockage you reported, I'm surprised they are not pressing you to schedule CABG soon. Yes, your heart developed alternative blood supply lines, but they are probably not fully sufficient or you would not have symptoms. True, the risk of heart events may be less for occluded arteries than it is for stenotic valves, but it is still higher than it would be in a healthy patient.

If they press for CABG, I would think that it would make sense for some "one-stop shopping" where you get the valve replaced in the same trip to the OR. Usually the same surgeon can do it, as mine did. That way there is only one set of cuts and one recovery for the patient. Just my layman's opinion, and how things worked out for me. I did it that way, and since my recovery was somewhat of a train wreck, I would not want to do it twice if I had a viable option.
 
John,

Some additional data that provides more perspective on results from optimal self managed AC therapy. In this case a comparison with the Ross Procedure with patients of a mean age of 48. It would be reasonable to assume that these were patients with lesser risk factors but still the outcomes are very good.

Sadly, the US has not been as proactive as Europe in embracing Self Management for AC therapy for patients considering a Mechanical Valve.

David

Optimal Self-Management Anticoagulation Therapy vs. Ross Procedure


"It is remarkable that for the duration of the follow-up period, survival after aortic valve replacement was comparable to that of the age-matched German population in both Ross patients and mechanical prosthesis patients. This observation supports the hypothesis that late mortality after aortic valve replacement is driven mainly by patient characteristics and that prosthesis selection plays only a minor role, if any."

Survival Comparison of the Ross Procedure and Mechanical Valve Replacement With Optimal Self-Management Anticoagulation Therapy

http://circ.ahajournals.org/content/123/1/31 Propensity-Matched Cohort Study

Conclusions—In comparable patients, there is no late survival difference in the first postoperative decade between the Ross procedure and mechanical aortic valve implantation with optimal anticoagulation self-management. Survival in these selected young adult patients closely resembles that of the general population, possibly as a result of highly specialized anticoagulation self-management, better timing of surgery, and improved patient selection in recent years. Methods and Results—We selected 918 Ross patients and 406 mechanical valve patients 18 to 60 years of age without dissection, aneurysm, or mitral valve replacement who survived an elective procedure (1994 to 2008). With the use of propensity score matching, late survival was compared between the 2 groups. Two hundred fifty-three patients with a mechanical valve (mean follow-up, 6.3 years) could be propensity matched to a Ross patient (mean follow-up, 5.1 years). Mean age of the matched cohort was 47.3 years in the Ross procedure group and 48.0 years in the mechanical valve group (P=0.17); the ratio of male to female patients was 3.2 in the Ross procedure group and 2.7 in the mechanical valve group (P=0.46). Linearized all-cause mortality rate was 0.53% per patient-year in the Ross procedure group compared with 0.30% per patient-year in the mechanical valve group (matched hazard ratio, 1.86; 95% confidence interval, 0.58 to 5.91; P=0.32). Late survival was comparable to that of the general German population.
RESULTS:

"In the cohort of 253 matched pairs, during 2899 patient-years of follow-up, 12 participants (2.4%) died (Table 3). Valve-related mortality was observed only in patients who underwent a Ross procedure. The 4 valve-related deaths were 2 sudden, unexplained, unexpected deaths without further clinical data or autopsy, 1 death resulting from a coronary embolus and subsequent myocardial infarction, and 1 death resulting from stroke.

During follow-up, 8 Ross patients in the matched cohort required an aortic valve replacement. None of the patients with a mechanical valve required reoperation in the matched cohort. Linearized all-cause reoperation rate was 0.61% per patient-year in the Ross procedure group compared with 0.00% per patient-year in the mechanical valve group (P=0.01). Two bleeding events were observed in the matched cohort of Ross patients, and 6 bleeding events were observed in the matched cohort of the patients with a mechanical valve. The linearized bleeding rate was 0.15% per patient-year in the Ross procedure group compared with 0.36% per patient-year in the mechanical valve group (P=0.15). During follow-up, 5 Ross patients and 1 patient with a mechanical valve experienced a thromboembolic event. The linearized thromboembolism rate was 0.38% per patient-year in the Ross procedure group compared with 0.06% per patient-year in the mechanical valve group (P=0.10). Endocarditis was diagnosed in 2 patients who underwent a Ross procedure and in none of the patients who underwent a mechanical aortic valve replacement. The linearized endocarditis rate was 0.15% per patient-year in the Ross procedure group compared with 0.00% per patient-year in the mechanical valve group (P=0.16).

All-cause mortality occurred in 0.54% per patient-year (n=7) in the Ross procedure group compared with 0.31% per patient-year (n=5) in the mechanical prosthesis group (matched hazard ratio, 1.86; 95% confidence interval, 0.58 to 5.91; P=0.32; Table 3). Cumulative survival is displayed in Figure 3. Age- and gender-matched late survival for young adult patients after aortic valve replacement was comparable to that of the general German population (96% versus 95% at 8 years)."
 
Today I met my surgeon and here are the main points of the meeting:

1. The symptoms I have are most likely related to coronary artery disease.
2. If not for CABG, I probably could wait for 5 years before doing AVR (I hate to part my native valve too early)
3. However American Heart Association recommends AVR when doing CABG during OHS in my case.
4. Fourth generation tissue valves, ie., Edward Inspiris valves, could only represent incremental improvement. Not worth to wait for it especially having to do a second OHS.
5. Second OHS is much riskier as Heart sticks to surrounding healing tissue.
6. Better to do second OHS in 15 years than in 5 years after first OHS. (I am thinking the other way around. Could someone explain to me the logic?)
7. Green vegetables work against anti-coagulation. So either taking more blood thinner or eat less vegetable (this is the first time i heard this. otherwise i was thinking i should open to mechanic valve to avoid a second OHS).
8. I am not eligible for off-pump minimal invasive CABG because i need two grafts.


Steve and all: I am ok with "one stop". but i need to make sure it does not require a second OHS down the road. If i have to do the second OHS,i prefer to do it when i am still young (contrary to point 6 above). If i choose a tissue valve today, it probably will only last for 8-10 years because of my "young" age. Then assuming a TAVR last another 8 years with the advance of technology, it only gives me 16-18 years. I am 53 now. So at an age of 69-71, i need another OHS to replace the worn down TV+TAVR. Alternatively, i could have CABG alone today. Wait for 3-5 years, then do OHS AVR. The new generation valve probably will last 15 years. After that another 8 years with TAVR. In total they will last 26-28 years. I would say this is longer than my expectancy.

Could someone comments on the risk of second OHS? Specifically is it riskier to do it early vs late?

Thanks!
John
 
hx77;n880531 said:
7. Green vegetables work against anti-coagulation. So either taking more blood thinner or eat less vegetable (this is the first time i heard this. otherwise i was thinking i should open to mechanic valve to avoid a second OHS).
I'm getting popcorn, does anyone else want some?
 
Hi

I think making a list is a good idea.

hx77;n880531 said:
7. Green vegetables work against anti-coagulation. So either taking more blood thinner or eat less vegetable (this is the first time i heard this...

Iys technically correct but only in such enormous quantity that you are unlikely to eat that much. Bu this I mean eating a weeks worth of spinach in a single sitting, and then doing that every meal...


Could someone comments on the risk of second OHS? Specifically is it riskier to do it early vs late?

Increased but not specifically significantly. I understood that it's a progression and that it roughly doubles each time. So I've had 3 OHS and was only really told that at the third to not seek a fourth, so I steered to mechanical.
 
Hi Pell,

My son has a friend who did both AVR and MVR with mechanic valves at an age of 20. He said he had changed his diet to eating more meat than vegetable. How much (weight) green vegetable do you eat each day?

Thanks,
John
 
Hi John
hx77;n880535 said:
My son has a friend who did both AVR and MVR with mechanic valves at an age of 20. He said he had changed his diet to eating more meat than vegetable.

ok, but did he change his diet because:
  • someone told him to (avoid greens)?
  • because he was actually making consistent and documented weekly readings and found an actual repeatable correlation of INR and greens?
  • some other reason
How much (weight) green vegetable do you eat each day?

I don't weigh my food ... Do you?

Ok, I'll assume that you don't know this but if you do forgive me ... there is no magic in greens ... the active ingredient is in Vitamin K ... and the quantity of Vit K in greens varies. Even wose, the quantity of Vit K in a specific green varies based on many factors.

Spinach is highest per gram in Vit K (sorry I hate imperial, so its metric), have you weighed your greens?

Next the amount of K needed implies a HUGE quantity of greens ....

Failing a mass assay, here is tonights dinner (I've not actually put the sausages on the grill yet). I'll fry the frozen veges (which is a blend of beans, capsicum and sweet potato with some olive oil and garlic) with the sausages and have a salad on the plate too. This is Spinach Rocket and grated carrots.

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As I said, I don't weigh this stuff because ... well lifes too bloody short for that nonsense and I've never ever seen a correlatable INR variance to greens and (in particular importantly) never seen a clinically significantly INR variation resulting from greens (meaning a variation which required action to rectify).

I'll have that glass of wine with dinner (or maybe after I type this if my beer runs out).

I would say without a doubt that EVERY long term warfarin user here on this forum will echo this sentiment:
dose the diet do not alter the diet to suite the dose.




This means eat what you want, and measure your INR and learn about how it works.

I've been managing this for 6 years now, and I can say that I'm 95% in range on average with weekly readings.

A good post to read:

http://www.valvereplacement.org/foru...561#post861561

and an oldie but a goodie:
http://www.valvereplacement.org/foru...et-and-no-no-s

ok ... I also eat quite a varied diet ... some days I eat a lot of spinach and other days not ... sometimes broccoli ... eat healthy ... it'll save your life.
 
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