Optimal Self-Management Anticoagulation Therapy vs. Ross Procedure

[DJM 18]

In learning more about optimal self management of AC therapy I came across this piece of research. I am wondering what others think of this piece. I am sure there is some controversy here but it concludes that highly specialized (they seem to do a better job in Europe) Optimal Self Management may in fact make Mechanical Valves comparable to the 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."
[h=1]Survival Comparison of the Ross Procedure and Mechanical Valve Replacement With Optimal Self-Management Anticoagulation Therapy[/h] http://circ.ahajournals.org/content/123/1/31 [h=2]Propensity-Matched Cohort Study[/h]
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)."

 

[pellicle]

err ... was there a question?

If you were wondering what represented "Highly Specialized Optimal Self Management" means : basically in a nutshell it means "a group of people who aren't intellectually feeble , can follow directions and not fu(k up all the time"

it may be less people than you think in the usual "valve replacement" group (many of whom are elderly who are dippy, but not elderly like **** who is on the ball ...)

I am on good terms with a number of medical professionals (meaning like I went to school with them) who assure me that people who are "on the ball" are quite the outliers (statistically speaking) in their patients.

So, ask yourself how you rate yourself, then answer the question of "are you able to make the difference for yourself"

 

[DJM 18]

Thanks, the question was to get thoughts on this from people that have experience such as yourself. The data here is quite encouraging so I wanted to validate with people in this forum. I remain puzzled as to why the US seems to be so far behind with respect to Self Management of Anti-Coagulation therapy. There is another report from Italy that has similar results which I will post tomorrow once I get access.

And reading more on this topic it is interesting to note that there are other collateral benefits to self management which work to improve outcomes. And that is that in general they have found that people that self manage tend to take better care of themselves as it concerns diet and exercise.

 

[pellicle]

Hi

Thanks, the question was to get thoughts on this from people that have experience such as yourself.

ahh ... cos the study is one which I find few specific faults with ...

I remain puzzled as to why the US seems to be so far behind with respect to Self Management of Anti-Coagulation therapy.

well (and this if it was not obvious is my own opinion) the US system is a "for profit" industry which just happens to provide the "service" of health. So its primary motivation is (at the very best way of looking at this) a divided interest between providing best health care | giving returns to the shareholders.

There is very little profit in warfarin and not much more in self care consumables ... the benefits come when you consider how much the country pays ... assuming you have nationalised health care.

There is another report from Italy that has similar results which I will post tomorrow once I get access.

be keen to read it ...

And reading more on this topic it is interesting to note that there are other collateral benefits to self management which work to improve outcomes.

agreed ... such as being more "engaged with it". Weekly testing is like putting on your seatbelt; you don't expect an accident but you don't need to think about it. So (such as when you take new medications or eat something out of the ordinary (like drink gallons of grapefruit juice because it was cheap at the supermarket) you pick up INR variations which are "out side the norm" (and you learn what is norm over time) early (before they bite you).

And that is that in general they have found that people that self manage tend to take better care of themselves as it concerns diet and exercise.

myself I've not found specific "clinicaly significant" influences from either diet or food ...

Rather than assume you've found my blog, I'll just link to the posts which I think are related:

http://cjeastwd.blogspot.com/2014/01/heart-valve-information-for-choices.html
and
http://cjeastwd.blogspot.com/2014/09/managing-my-inr.html

 

[dick0236]

Self-management of INR in the USA only began a dozen or so years ago and many of our doctors still don't accept that patients can be trusted to self-test.......but times are slowly changing. Another factor in the US is that INR labs are simple to operate and very profitable.....hence the docs don't want to lose such a "profit center". We still cannot just buy the equipment and report results direct to the doc.......insurance will only cover these tests if we use a third party between the patient and doctor......really pretty silly and needlessly expensive.....another example as to why the US medical costs are so much more than the rest of the world.

PS Thanks Pellicle for not including me in the "dippy elderly" bunch.....but I do sense that my time is coming. I do self-test and pretty much self-manage with my docs blessing. I've had a number of conversations with doctors about warfarin and INR results and virtually all agree that patient non-compliance or ignorance is the main reason for warfarin mismanagement. However, they rarely accept any blame for poorly educating their patients. I have always found warfarin to be predicable. Take it as prescribe, test routinely and few problems arise......screw around with it and it probably will bite you hard..........been there, done that.

 

[DJM 18]

Thanks, very much enjoyed browsing your blog...will spend more time on it later. Here is the report I had referenced which I again found interesting as it generally deals with younger / healthier patients. In any case, I am not an advocate of lowering INR targets but I did find the results very encouraging, e.g. only 4 thromboembolic events in 2,198 patient years.

In any case, I am sure you will be able to better understand given your command of the subject matter.

Agreed with respect to your comments regarding the US healthcare system.


LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: Results from the "LOWERING-IT" Trial (PDF Download Available). Available from:

https://www.researchgate.net/public...eplacement_Results_from_the_LOWERING-IT_Trial [accessed Sep 25, 2017].


Background Moderate anticoagulation after mechanical heart valve replacement has been proposed to reduce the risk
of bleeding related to lifelong anticoagulation. However, the efficacy of such reduced antithrombotic regimens is still unknown.
The present prospective open-label, single-center, randomized controlled trial aimed to evaluate the safety and feasibility of
reduced oral anticoagulation after isolated mechanical aortic valve replacement.

Methods Low-risk patients undergoing bileaflet mechanical aortic valve replacement were randomized to a low
International normalized ratio (INR) target (1.5-2.5; LOW-INR group) or to the standard currently recommended INR (2.0-3.0;
CONVENTIONAL-INR group) through daily coumarine oral therapy. No aspirin was added. Median follow-up was 5.6 years.
The primary outcome was assessment of noninferiority of the low over the standard anticoagulation regimen on
thromboembolic events. Secondary end point was the superiority of the reduced INR target strategy on bleeding events.

Results We analyzed 396 patients (197 in the LOW-INR group and 199 in the CONVENTIONAL-INR group). The mean
of INR was 1.94 ± 0.21 and 2.61 ± 0.25 in the LOW-INR and CONVENTIONAL-INR groups, respectively (Pb.001). One
versus three thromboembolic events occurred in the LOW-INR and CONVENTIONAL-INR, respectively, meeting the
noninferiority criterion (P= .62). Total hemorrhagic events occurred in 6 patients in the LOW-INR group and in 16 patients in
the CONVENTIONAL-INR group (P= .04).

Conclusions LOWERING-IT trial established that the proposed LOW-INR target is safe and feasible in low-risk patients
after bileaflet aortic mechanical valve replacement. It results in similar thrombotic events and in a significant reduction of
bleeding occurrence when compared to the conventional anticoagulation regimen. (Am Heart J 2010;160:171-8.)

The patients were followed up for a total 2,198
patient-years (2,198 patient/years; 1,112 patient/years
in the CONVENTIONAL-INR group and 1086 patient/
years in the LOW-INR group). The median study follow-
up was 5.6 years (range 1.2-7.4). For all 396 patients, a
total of 46,245 measurements of the INR were obtained
during the follow-up period, with a median of 17
(range 15-24) measurements per year for each patient.
The mean INR in the LOW-INR group was 1.94 ± 0.21,
whereas in the CONVENTIONAL-INR group, it was
2.61 ± 0.25 (Pb.001).

Four patients had a thromboembolic event, which
occurred in 1 patient of the LOW-INR group (0.91 per
1,000 patient/year, 95% CI 0.02-5.09) and in 3 patients of
the CONVENTIONAL-INR group (2.73 per 1,000 patient/
year, 95% CI 0.56-7.99) (Tables III and IV). Comparison of
thromboembolic events between the 2 groups was not
significant (P= .62, OR 0.33, 95% CI 0.006-4.20). The
1-sided 97.5% exact CI for the difference in primary event
proportion was 1.45%, satisfying criteria for noninferior-
ity. There were no cases of valve thrombosis.
The incidence of bleeding events was significantly
different between the 2 groups (P= .04, OR 0.36, 95% CI
0.11-0.99). We observed 22 hemorrhagic events: 6 in the
LOW-INR group (5.62 per 1,000 patient/year, 95% CI
2.06-12.24) and 16 in the CONVENTIONAL-INR group
(15.69 per 1,000 patient/year, 95% CI 8.97-25.48). The
hemorrhagic events were divided as follows: 3 major
hemorrhages requiring hospitalization (in the CONVEN-
TIONAL-INR) and 19 minor hemorrhages (13 in the
CONVENTIONAL-INR and 6 in the LOW-INR group)
(Tables III and IV). Although there were no major
hemorrhages in the LOW-INR group, the significant
difference in the incidence of bleeding between the
2 groups was reached by the inclusion of both major and
nonmajor events.
Only 2 patients died: one because of a thrombotic event
and the other of a hemorrhagic cerebral event. Both were
in the CONVENTIONAL-INR group.
In the LOW-INR group, the thromboembolic events
occurred in 1 patient with an INR within the fixed target
value of 1.5 to 2.5. Of the 6 hemorrhagic events in the
LOW-INR group, 4 occurred in patients with an INR
higher of the target value, which were b3.5.
In the CONVENTIONAL-INR group, all but one of the
thromboembolic events occurred in patients with an INR
within the target range. In 1 patient, the thromboembolic
event occurred at the discontinuation of the coumarine
therapy because of a procedure of tooth extraction. In
this group, the 3 major hemorrhagic complications
occurred in patients with an INR above the target value.
In addition, in the CONVENTIONAL-INR group, 10 minor
hemorrhagic events occurred in patients with an INR
above the fixed target value, whereas the other 3 minor
hemorrhagic events occurred in patients with an INR
within the fixed target value. No case of endocarditis,
atrial fibrillation, and withdrawal from the oral anticoag-
ulant therapy occurred during follow-up.

 

[pellicle]

PS Thanks Pellicle for not including me in the "dippy elderly" bunch.....

Hey, no thanks needed. You are about the most on the ball over 70's I know, especially when it comes to management of INR

For clarification I do not think that anyone in the board group is dippy, (cos by definition they wouldn't be posting or otherwise literate in this area)

 

[dornole]

I'm totally dippy, Pellicle --absent-mindedness has little to do with literacy or even intelligence, unfortunately. For me, "Can I be trusted not to drop the ball on taking a dumb pill every day without fail, even with my life at stake?" is a question worthy of careful consideration. I'll need to figure out how much margin for error there is and carefully consider this question when my MVR time comes. All the more reason to hope for another repair.

 

[user 16827]

pellicle

Thanks for posting the 2 blog links...

Very informative & a good read

 

[pellicle]

Hi

I'm totally dippy, Pellicle --absent-mindedness has little to do with literacy or even intelligence, unfortunately. For me, "Can I be trusted not to drop the ball on taking a dumb pill every day without fail, even with my life at stake?" is a question worthy of careful consideration.

well firstly don't short sell yourself. Recognition of this is the first step towards creating systems which can compensate for you.

I can't tell you how many times I was angry at myself for forgetting my medications when going (even) on an overnight trip to stay at a friends for dinner (just across town). I would turn back and go home (for my pills) or get anxious and want to leave early the next morning to get back and take my missed warfarin.

Mostly that was anxiety driven by the clinics, who would then require "another" blood suck and my INR would be "all over the place" ... as they would say.

It was in the months after that surgery when I began investigating my INR using my coagucheck and doing readings and doing experiments (helped along by simply forgetting to take my warfarin) that I discovered that it really didn't matter.

I swear half the issue with this is the reactions from the clinics (and this is supported by my observations of others here too and their clinic responces).

You will find that (as I've written here so many times) a missed dose here or there will not harm at all ... even when its a missed dose within a few days of a missed dose. Two for starters

http://www.valvereplacement.org/foru...llicle-s-model

http://www.valvereplacement.org/foru...ps-missed-dose

I developed systems (such as setting alarms on my phones, such as pill boxes to check, such as habits I developed) over time to allow me to keep my medication regime while still being forgetful.


After all its the genius levels who are the most absent minded
:Smile:

:Tongue:

Remember, missing a dose (or even two) is not a significant issue for someone who is low risk (meaning not otherwise prone to strokes) ... it likely won't cause you a TIA or a stroke, and even dick0236 had to provoke it with a much longer period of missed doses ... a week if I recall. Perhaps he can clarify that?

Anwyway lastly don't be wishing for too many redo surgeries to allow you to "kick the can" on decisions. I would be hesitant to recommend a "repair" again over a VR (irrespective of it being tissue or pyro). As my surgeon said to me on the discussion of my third operation. It becomes more complex (due to scar tissue) with increased risks each time. Surgeons won't be lining up to do your operation for you on your 4th.

I suspect few people really grasp what scar tissue really is and why its a hassle.

Best Wishes

 

[dick0236]

Remember, missing a dose (or even two) is not a significant issue for someone who is low risk (meaning not otherwise prone to strokes) ... it likely won't cause you a TIA or a stroke, and even dick0236 had to provoke it with a much longer period of missed doses ... a week if I recall. Perhaps he can clarify that?

I was off warfarin for 4 or 5 days while on vacation...then resumed warfarin for 2 or 3 days....and then had the stroke. Recently, while doing some reading on the old PT system and the current INR system, I stumbled on an article that may shed some new light on the reasons for my stroke.

Prior to the INR system I had monthly blood draws to measure clotting time (PT). Back then (1970's), my PT was managed at about 1-1/2 times normal PT. An INR of 1.0 equals a normal PT of 12 seconds.......therefore, I was being managed at about a PT of 18 seconds which equals and INR of about 1.7. If my logic is correct I was being managed at a very low INR which, coupled with several days off warfarin, set me up for the stroke. It was a "perfect storm".

Hope this helps.

 

[pellicle]

**** somehow I can't reply using "quote" so ... my understanding of INR is that its a ratio of your time / normal time .. so 1.5 / 1 = 1.5 so you're correct your AC therapy was being managed low even by todays standards. I wonder if anyone was actually tracking that

 

[zee112]

Consuming Warfarin takes me 3-5 seconds a day. Testing takes me less than a minute per week. Do I want a third invasive surgery? - Considering my liver took a slight hit and I was bleeding slightly more than the average, I can definitely say I don't want to! And it's become such a routine now from taking 5 seconds out of my busy schedule to swallow some pills that I don't even think or worry about it. I've been self testing for a little over a year also, and have been able to keep my INR in range better than the clinics could! - I also eat anything I want and travel anywhere I want to. Thank you and goodnight.

 

[perico75]

Hi everybody, new in this forum. Need an AVR and Aoric root replacement. I am almost sure that I will go for the mechanical option but I am struggling with facts that shows that anticoagulated patients who manage to keep their INR within the safe zone still have a 1-2% annual risk of bleeding/having a stroke. I am 42 and this figure is a bit scary as the probability of being event free in the next 30-40 years is not that high. Is this reasoning correct? Thank you very much! Finding this very interesting. Can’t stop reading!

—

 

[pellicle]

Hi

... but I am struggling with facts that shows that anticoagulated patients who manage to keep their INR within the safe zone still have a 1-2% annual risk of bleeding/having a stroke

firstly, are you sure that is correct, is that 100% within the safe zone (and what are you defining as the safe zone). Next you need to understand that as you age (even without being "un normal") you have an increased risk of bleed / thrombosis. There are literally millions of patients who are on AC therapy because they had a stroke -> noone really knows why -> prevention is well known to be the better alternative -> and are on warfarin.

What I read suggests that if you are in range > 80% of the time that you are actually in the age related risk group.

A person who is mentally capable can manage their own INR (its called self management) with a device such as a Roche Coagucheck XS (its called Poing Of Care = POC) and be better than the so called "usual care" (which is usually crap) provided by the health "care" system.

Please feel free to browse my blog posts on this matter to assist also directing your readings:
Start with this one: http://cjeastwd.blogspot.com/2014/09...ng-my-inr.html

the full set (sadly I can not control the blog publication order) is here: http://cjeastwd.blogspot.com/search/label/INR

Happy to answer any other pointed questions ;-)

Best Wishes

PS focus your readings on Medical Journals not just fluff sites with the veracity of a supermarket scandal / mental chewing gum level. For instance:
https://academic.oup.com/icvts/article/14/3/253/647048

[h=2]Abstract[/h] In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions.
One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6 ± 2.1 years, representing 3612 patient-years.

During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P = 0.213) and 15.4% thromboembolic events (P = 0.064) in the Conv-T group.

Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P = 0.03); grade III thromboembolic events: 0.6 versus 5.0% (P = 0.011)].
Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P < 0.001).
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).

Univariate risk factors for mortality were age (P = 0.008), type of operation (P = 0.021) and conventional OA (P < 0.001). In multivariate analysis, only conventional OA reached significance (P < 0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.

 

[DachsieMom]

Perico, I was 42 when I had surgery 2 years ago. Went with mechanical. I am very drifty but use a pillbox and pill reminder app on my phone to ensure I take my coumadin. To me, the risk of another surgery was too much.

 

[perico75]

Hi, thanks for your answer!

Hi



firstly, are you sure that is correct, is that 100% within the safe zone (and what are you defining as the safe zone). Next you need to understand that as you age (even without being "un normal") you have an increased risk of bleed / thrombosis. There are literally millions of patients who are on AC therapy because they had a stroke -> noone really knows why -> prevention is well known to be the better alternative -> and are on warfarin.

What I read suggests that if you are in range > 80% of the time that you are actually in the age related risk group.

A person who is mentally capable can manage their own INR (its called self management) with a device such as a Roche Coagucheck XS (its called Poing Of Care = POC) and be better than the so called "usual care" (which is usually crap) provided by the health "care" system.

Please feel free to browse my blog posts on this matter to assist also directing your readings:
Start with this one: http://cjeastwd.blogspot.com/2014/09...ng-my-inr.html

the full set (sadly I can not control the blog publication order) is here: http://cjeastwd.blogspot.com/search/label/INR

Happy to answer any other pointed questions ;-)

Best Wishes

PS focus your readings on Medical Journals not just fluff sites with the veracity of a supermarket scandal / mental chewing gum level. For instance:
https://academic.oup.com/icvts/article/14/3/253/647048

Yes, I am trying to focus in good sources. In fact my 1-2% is from a chart from a journal that you mention in your blog! I will try to attach it for your reference. Hope it works! No, I don’t know what percentage of the year they were within range. Surely less than 100%. Best

 

[dick0236]

Perico, I have a mechanical valve......and I've had a stroke......and I would choose the mechanical again if I had to make the decision as a young man again.

PS. Welcome to the forum. You'll find a lot of info here that can help you with your decision.

 

[pellicle]

Hi

Hi, thanks for your answer!

totally welcome ...

Yes, I am trying to focus in good sources. In fact my 1-2% is from a chart from a journal that you mention in your blog! I will try to attach it for your reference.

LOL ... well I'm simultaneously flattered, pleased (that you've found my blog useful) and entertained by that ;-)

you can tell I don't memorize anything much (never was much of a wrote leaner) and refer to things to confirm (not trusting my own memory).

The link didn't work ... I've fished about a bit and can't seem to find a chart. I did find (for instance) this:

Studies have shown that Patient Self Testing reduced the bleed complications from 11% to 4.5% and Thromboembolic events from 3.6% to 0.9%.

but that of course is a reduction in events, not a comparison to the age related events or even the observed rate of events.

None the less one would also need to consider YOU ... not just "THE NORM" and depending on your own health (risk factors such as smoking...) what YOUR age related thrombo or bleed rate may be (it may be better than the norm). Its also important to consider the following points:

• we have more data on sick people than we do healthy people
• most of the data on warfarin is obtained from patients who are not on it simply because of Aortic Valve Replacement, so AVR patients (meaning being the only reason for them being on AC therapy) have lower levels of risk anyway

And ... as **** observed this is your first post, so Welcome Aboard

 

[perico75]

Thank you all!!
for some reason I can’t upload the picture of the chart I refer to. It seems I don’t have permission to upload pictures yet. It plots INR level (x axis) against events (y axis). It’s a U shape chart where the bottom of the U still shows events. ****: your case is really amazing and I am betting on your path but I am very analytical and wanted to understand the sort of risk that I will assume even if I am extremely careful and home test as Pellicle describes. Let’s say that this careful behavior results in being 80-90% of the time within a INR range of 2-3. I assume that this situation still has some risk which I’d like to understand to estimate the long term probability of being event free. Does this make sense?
Thanks again to you all!