Tag Archives: stroke

Reversal Agent for Eliquis and Xarelto Receives FDA “Fast-track” Approval

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This is great news for people with atrial fibrillation (AF) who take the newer anticoagulants Eliquis or Xarelto. According to a recent article in Cardiology News the FDA, in early May 2018, approved Andexxa (Portola Pharmaceuticals), the first reversal agent for the popular newer anticoagulants Eliquis and Xarelto.

I think runners and mountain bikers, correctly, worry about problems with excessive bleeding while on anticoagulants because we are certainly at increased risk of falls or of being hit by a car, and many have hesitated to transition from warfarin (Coumadin) because of the lack of a reliable reversal agent.

Pradaxa (dabigatran) and warfarin both already have reversal available reversal agents.

Andexxa acts as a decoy molecule and essentially binds to the drug preventing it from interacting with clotting factors.

Terrific news, right?

According to drugs.com “In the U.S. alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month.” 

But wait – there’s catch!

Andexxa has been approved but as the writing of this blog post (May 23, 2018) it is not yet available. It exists, but you can’t get it!

I called one of the pharmacists at our hospital (Sky Lakes Medical Center) and asked if it was going to be readily available at our hospital – that’s when I discovered that it wasn’t yet being distributed – but she told me that our hospital plans to have it in stock and available for use.

She also said that once Andexxa is actually available our hospital would then develop guidelines for usage of the new drug. These have not yet been declared but she expects that it will be similar for guidelines pertaining to the reversal agents for Pradaxa and warfarin which are 1.) Patients with serious, life threatening bleeding and 2.) Patients who need emergency surgery.

I think that means that people having elective surgery (like a knee replacement) will not be eligible and will have to taper off their anticoagulant and bridge with Lovenox, just like they do now. I imagine that emergency surgery refers to surgery that is necessary to save your life, not necessarily surgeries like fracture repair, where it would be possible to wait a few days.

As far as my personal experience – I take warfarin and don’t intend to change. I had taken Pradaxa for several years and was very happy with it until I had a mini-stroke and a trans-esophageal echocardiogram revealed that I had a blood clot in my left atrium.

The next big question, of course, is how much will Andexxa cost? I have no idea and I can’t find any information about cost – but I’m guessing it will be really expensive. But then again – people who are anti coagulated and have life threatening bleeding or need emergency life-saving surgery can just go ahead and get Andexxa and worry about how to pay for it later.

 

Any comments are appreciated! Thanks for reading.

Watchman Device Update

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A little one a year ago I wrote about the Watchman device. People with atrial fibrillation often develop a blood clot in the part of the left atrium called the left atrial appendage. This Watchman device basically closes off this area to prevent clot formation.

Last time I wrote the device was relatively new (long term data wasn’t yet available), and based on my research it didn’t seem like a great choice. I would refer you to this excellent article on John Mandrola, MD’s blog: Say No to Watchman.

As a person who has already had a ministroke and a verified blood clot in my left atrial appendage, well yes, I am very interested in a device that would prevent me from having a stroke which, at this point, for me, seems pretty much inevitable. Technology improves over time, right?

So what is going on with the Watchman now?

Well, Boston Scientific released its final five year outcome data from the PREVAIL study, along with five year outcome data from the PROTECT-AF trial. I would refer you to an excellent article in Cardiac Rhythm News (link).

At first look I was fairly optimistic:

In the PREVAIL and PROTECT-AF randomized clinical trials, LAAC with the WATCHMAN device was compared to warfarin for stroke prevention in high-risk patients with non-valvular AF. In addition to stroke prevention comparable to warfarin, the analysis concluded the WATCHMAN device also effectively reduced non-procedure related major bleeding, disabling or fatal stroke, and mortality.

Source Cardiac Rhythm News

I had been thinking the best course of action would be to, perhaps, have a Watchman implant and just remain anti coagulated. After researching this, however, that doesn’t seem like a good plan. The Watchman device has been shown to protect from strokes with an outcome similar to warfarin; but it turns out most of the additional benefit of the Watchman is basically related to the fact that those patients didn’t suffer as many warfarin related side effects/deaths from strokes caused by bleeding or from other major bleeds:

The analysis confirmed a 55% reduction in disabling or fatal stroke, largely driven by an 80% statistically significant reduction in hemorrhagic stroke. Further, the combined data demonstrated a 52% decrease in non-procedure related major bleeding and 27% reduction in all-cause mortality when compared to long-term warfarin therapy

Source Cardiac Rhythm News

At best, regrettably, the Watchman device might be equivalent to warfarin as far as stroke prevention is concerned, but not necessarily better. At best, I think, it would be a good choice for people who have had problems (such as bleeding) with warfarin; but it hasn’t been tested on people who are not eligible for anticoagulation (who are generally less healthy patients). And the Watchman hasn’t been tested against the newer anticoagulants (Pradaxa, Eliquis, Xarelto) which may actually be more effective than warfarin.

So I’m just going to keep watching and hoping for a better option than the Watchman device. I’d be interested in your opinions, and especially in the opinions of anybody reading this who has had a Watchman implant. Please comment below.

Runners with Atrial Fibrillation – Considering the Watchman?

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Are you considering the Watchman device?

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Ever since having a TIA/stroke, I certainly have thought a lot about it.

What is it? The Watchman, by Boston Scientific is a little device, sort of like a basket, that can be inserted into the left atrial appendage, theoretically blocking it off and preventing clot formation. As you probably know already, clot formation may lead to Stroke. The device was FDA approved in the US in March, 2015, and has been used in Europe since 2005.

It’s placed in the left atrial appendage via a catheter through an artery in the groin, and if all goes well the patient can discontinue their blood thinner (warfarin, etc.) within six months.

Sounds great, doesn’t it?

I know I’d love to be protected from having another TIA or stroke and not have to take a blood thinner – I’m currently on warfarin + aspirin which makes bicycling, especially mountain biking, quite hazardous. But truthfully, it’s not that I necessarily want to be off the warfarin: I just don’t want to ever have another TIA/stroke. Recall that I had my event while I was already taking Pradaxa (and I never missed a dose). I just want a treatment that is going to work.

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But there is some evidence to suggest the Watchman might not be as terrific as it sounds.

A recent study showed that the risk of a major bleed over the course of three years is the same with the Watchman compared to just staying on warfarin. Huh?

This is an excerpt from a Medscape article:

Patients with atrial fibrillation (AF) who received a left atrial appendage closure device (Watchman, Boston Scientific) or stayed on long-term warfarin therapy had similar rates of major bleeding during a mean follow-up of 3.1 years, in pooled analysis of two randomized clinical trials[1]. However, patients who received the device and were able to stop taking warfarin and clopidogrel at 6 months had lower rates of major bleeding from then onward, compared with patients receiving long-term warfarin.

Furthermore, in a very thoughtful, somewhat technical, article CMS Proposal on Watchman Is the Right Decision, Dr John Mandrola, a thought leader in Cardiology and Electrophysiology, agrees with the CMS proposal that “the evidence is sufficient to determine percutaneous left atrial appendage closure therapy using an implanted device is not reasonable and necessary.”

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There are two major studies in the US regarding the Watchman. According to Dr Mandrola in the PREVAIL study, “Due to an excess of ischemic strokes, Watchman did not reach noninferiority in this category in the updated analysis presented to the FDA.” In PROTECT-AF study, “ischemic strokes were numerically higher in the Watchman group.” Which, ultimately, “leads one to conclude that the device is not effective.”

As for me, personally, as much as I’d like to believe the Watchman is a solution for me, the evidence, so far, is not convincing. I’m going to wait.

By the way, if any readers have experience with the Watchman PLEASE leave a comment below. We would love to hear from you!

Adverse effects of the Watchman:

“The main adverse events related to this procedure are pericardial effusion, incomplete LAA closure, dislodgement of the device, blood clot formation on the device requiring prolonged oral anticoagulation, and the general risks of catheter-based techniques (such as air embolism). The left atrium anatomy can also preclude use of the device in some patients.”

By the way – I linked a couple of articles from Medscape. I’m not certain but I think you need to be registered for that sight. Sorry.

Runners with Atrial Fibrillation – Thinking About Having a Cardioversion? “Look Before You Shock”

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sunsetbackyard

This is, so far, the most discouraging article about atrial fibrillation I have ever read:

Left Atrial Appendage Thrombus When Least Expected: Look Before You Shock, Evaluate Before You Ablate | EP Lab Digest

As a distance runner with atrial fibrillation, who never missed a single dose of my anti-coagulant, and who has already had a blood clot in my left atrial appendage, and has already had a “mini-stroke” – this one leaves me feeling a bit hopeless.

Feel free to read the article; but I will go over a few key points here. One of the dreaded consequences of atrial fibrillation is having a stroke. Because the top chambers of the heart, the atria (plural of atrium) are beating so fast that they are basically just sitting there vibrating, the blood pools and becomes sluggish, and is prone to forming blood clots. Combine this with an enlarged left atrium and the likelihood is even higher. The blood clot forms in a little corner of the heart called the “left atrial appendage” (LAA).

appendage

That’s where I formed a clot. If the blood clot, or a piece of the clot, breaks off it can quickly travel to the brain, get caught and cut off the circulation to part of the brain. This is a type of stroke, and is a huge problem for people with atrial fibrillation.

There are people who like to refer to a stroke as a “brain attack” because that’s what it is – like a heart attack in the brain. And like heart attacks there are big ones and small ones. I had a small one (TIA – tangent ischemia episode) that fortunately only lasted a minute or so. A big stroke, of course, can be fatal.

Important point: if a person is in atrial fibrillation and has blood clot in the LAA, it might be very stable. It might be just sitting there, hanging out, because the atria isn’t doing any beating. Everything is pretty tranquil in there. But then the person has a cardioversion (shock to reset the beating heart) or an ablation and the atrium begins to beat again, the blood starts moving through more quickly – well – now there’s a problem. Now the clot can break loose and BLAM!! – you’ve had a stroke!

The problem: it’s difficult to tell whether or not a patient has a clot prior to having a procedure. A regular echocardiogram doesn’t even show a small clot; there’s not enough detail. The best way to determine if a clot is present is to do a transesophageal echocardiogram (TEE).

teeTransesophageal Echocardiogram

I’ve had three TEEs – it’s not fun – sort of like swallowing a telephone. Thankfully the last two that I had involved an anesthesiologist who put me to sleep for the procedure.

As far as I know it is fairly common to have a TEE prior to having an ablation procedure; but less common before a cardioversion (the shock!), especially for people who presumably have a low risk of a LAA blot clot – like people who are appropriately anti-coagulated, or people who have had atrial fibrillation for less that 48 hours.

In this article five interesting cases are reviewed.

Case #1 – a patient who was effectively anti-coagulated but turned out to have a LAA clot anyway (sounds familiar).

Case #2 – a patient who was actually more anti-coagulated than thought necessary, and was in atrial flutter for less than 48 hours, but turned out to have a LAA clot anyway.

Case #3 – an appropriately anti-coagulated person with a low risk of clot (CHADS2 score=1), but turned out to have a LAA clot anyway.

Cases #4 and #5 were high risk patients who would be expected to have a high risk of a clot. Case #5 actually had three clots in her heart – yikes!

How does all this apply to athletes with atrial fibrillation? Well, apparently healthy, athletic patients, who are appropriately anti-coagulated, and either undergoing a planned or emergency cardioversion, still have a certain risk of having a LAA clot and subsequent stroke.

Should everybody have a TEE before having a cardioversion? Probably not. TEE is expensive, unpleasant, and if anesthesia is involved it basically takes up an entire day out of your schedule. It might be a good idea to talk it over with your cardiologist, however.

mooreparkrun
Happy Trails

Update Part 2 – Atrial Fibrillation, Pradaxa Fail, Transient Ischemic Episode, Blood Clot in Left Atrial Appendage

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Jimi Hendrix sang, “manic depression’s a frustrating mess.” Well, I think the same can be said of atrial fibrillation!

mountainbikingwringoRingo and Me – Photo by Ben Vallejos

It’s been a while since I have written and I have to say the last couple of months have been nerve-wracking. As I posted in a previous entry I had a TIA (transient ischemic attack) while running a couple of months ago, had a normal carotid scan, but a TEE (trans-esophageal echocardiogram) showed that I had a small blood clot in my left atrial appendage.

In other words I had a “mini-stroke” and was at risk of having a full on stroke.

pradaxa

This TIA occurred while I was on Pradaxa, a newer, novel anticoagulant. At that point I was taken off Pradaxa, started on Lovenox (low molecular weight heparin) injections, and warfarin (Coumadin), and also aspirin. I was instructed to discontinue running, and bicycling, and limit my activity to easy walks, and a repeat TEE was scheduled two months after the initial one.

I won’t hold back any longer regarding the surprise ending – I never had a second TIA “mini-stroke” (that I know of) or stroke and the follow-up TEE (trans-esophageal echocardiogram) showed that the blood clot inside my heart is now gone. Hooray!

appendagePhoto – The little cul-de-sac is the LA appendage

Just to review how this happens: when you are in atrial fibrillation your atria is beating so fast it’s like it isn’t beating at all, just sort of vibrating. There is a part of the left atrium (the “appendage”) where the blow flow is extra sluggish, and this is where clots can form. When a tiny piece of clot breaks of and goes into the brain that’s a TIA. If a big clot is present and breaks of into the brain that’s a stroke, which of course can be disabling and even fatal.

It goes without saying that I am disappointed that this occurred while I was on Pradaxa. I figured that as long as I was taking it I was safe, and I liked not having to watch my diet or have blood tests constantly. Taking Pradaxa is easy – “set it and forget it.” Now I’m on warfarin (Coumadin), a royal pain in the butt, and have to micromanage my diet constantly – this drug is not an easy choice for a vegetarian! Eating too many greens (think kale) is dangerous as is not eating enough greens. Imagine trying to eat about the same amount of kale or broccoli or spinach each day.

zaPhoto – vegan pizza

My target INR is between 2.0 and 3.0, but seeing as I have had a TIA while on an anticoagulant I am trying to keep it nearer to 3.0 or even higher (3.0 – 3.5).

The two months between echocardiograms was an era of angst – anxiety and fear – for me, especially the first several weeks. Every symptom, no matter how minor, seemed like stroke. For example – lie in bed trying to get to sleep and your hand becomes numb – normal, right? Not when you know you have a blood clot in your heart – that seems like a stroke! Jump up from bed, start testing the muscle strength in each arm and leg, recite the alphabet, smile, frown, move eyebrows up and down checking for asymmetry. Do you think I’m exaggerating?

Every once in a while a person stammers or mispronounces a word. Normal? Maybe, but not when you are obsessed with a gigantic blood clot lodging in your brain.

As far as exercise was concerned at first I was limiting myself to short, easy walks more appropriate for a non-athlete. Eventually I became a bit bolder and started doing longer (but slow, especially up hills) hikes of an hour or two. It took me three weeks (!) to bridge to a therapeutic INR, so I was on warfarin and Lovenox for all that time. Once I was off the injections I started doing bike rides – but they were on non-technical trails and were slow, especially while going uphill.

My brain never got the memo that I was no longer a long distance runner/cyclist so I still ate like I was, and consequently I’ve gained some weight.

At this point, after finding out the clot is no longer present, I have started increasing the intensity of my bike rides, but mostly I’m still doing bike rides. I haven’t yet started running again – but I will.

I am mountain biking again, but not on any trails that would be considered challenging. Well, that’s not 100% true, I guess.

awol-1-2Photo – “Adventure Without Limits?”

As far as mountain biking is concerned I am phasing out technical trails (gradually). I made a deal with my self that if I didn’t have the blood clot on the second TEE I would get a new bike – and I did. I got a Specialized AWOL, which is a “gravel grinder.” That’s sort of a cross between cyclocross bike and a loaded touring road bike – basically a bike designed for gravel or dirt roads – we have an infinite supply of these around here so I have a lot of exploring ahead of me.

As far as that blood clot is concerned I’m very pleased it has gone away – but I am not fooling myself that it is gone forever. It could return at any time. It wasn’t there when I had my second TEE, but it could actually be there right now – how would I know? How long had it been there and how many times have I had a clot in that area? There’s no telling without doing a ridiculously expensive, somewhat invasive test over and over. I guess all I can do is stay vigilant, take my meds, watch the diet, and keep on trying to run, hike, and ride, even if it is at a reduced level.

Atrial Fibrillation News Update

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Here are a few internet news stories related to atrial fibrillation. In the future I’ll try to update more frequently so I don’t end up with four topics in one blog entry.

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Overall, the increase in risk of heart attack was about 70% in AF patients, even after accounting for other cardiovascular disease risk factors, such as hypertension, high cholesterol, body mass index, and history of stroke and vascular disease. However, when the researchers looked at subgroups, they found that increased risk of heart attack was more than doubled in women and African Americans with AF—but less than 50% for men and whites with AF.

I’m not sure what to say about this – hopefully runners with atrial fibrillation (who hopefully also have other heart healthy lifestyle choices – like a healthy diet, not smoking, reasonable body weight) will do better than the general population. One bit of good news – the blood thinners a fib patients take to prevent stroke also seem to help prevent heart attacks.

pradaxasmall

“Novel” anticoagulants refers to the newer prescription anticoagulants that are used as an alternative to Coumadin (warfarin). Specifically: Pradaxa (which is the one I currently take), Xarelto, and Eliquis.

I can tell you that as a clinician there are not many things more frustrating than prescribing medications for people who are on Coumadin – it seems like it interacts with everything! One of the great things about the newer anticoagulants is that they have less drug interactions – but they still do have potential drug interactions.

Please click on the link to see tables for drug interactions involving Pradaxa (Dabigatran), Xarelto (Rivaroxaban), and Eliquis (Apixaban).

Obviously all of the novel anticoagulants can interact with any other drug that is *ALSO* an anticoagulant – like Plavix or aspirin. Keep in mind that this includes NSAIDs like Alleve (naproxen), Motrin (ibuprofen), etc.

Personally, I completely avoid taking ibuprofen and naproxen – but every once in a while (like after a brutal long run) I will take a Celebrex. Tylenol (Acetaminophen) is fine – no interactions with the anticoagulants (although it has its own issues).

By the way – if you read the article and see a possible drug interaction please don’t stop taking any of your meds – but contact your own doctor immediately for advice.

neautral milk

A recent study has shown that Coumadin (warfarin) actually increases the risk of stroke for people in atrial fibrillation during the FIRST THIRTY DAYS of warfarin therapy. That’s just the first thirty days – the idea is to prevent having a stroke, and that’s what taking Coumadin does.

This finding does not suggest that anything will change – doctors are still going to put people on warfarin to prevent stroke. They just have to get through the first thirty days!

If you are on warfarin and you read this article – please do not stop taking your medication.

Watchman_2

Finally – the FDA has not yet approved the Watchman left atrial appendage closure device by Boston Scientific – but it has given a “vote of confidence.” It appears that this gadget, which is implanted in the left atrium to prevent the formation of the clots that cause strokes, may be approved by the FDA for the US market late this year. The majority of the panel agreed that the Watchman was equivalent to standard treatment with warfarin, but it hasn’t been compared to the new novel anticoagulants (see above).

ryespur

Atrial Fibrillation Stroke Calculator

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Atrial Fibrillation Stroke Calculator

I saw this link today on Facebook and thought I would share it – it is an AF Stroke Risk Calculator, and was posted by the Atrial Fibrillation Association – a great resource for people with atrial fibrillation. As you probably know one of the greatest risks of being afflicted with atrial fibrillation is that it can lead to you having a stroke. Blood clots can form in the malfunctioning atrium, break loose, travel to the brain and – BOOM!!!! – you’ve had a stroke. Prevention is the best approach.

This calculator is basically a clever automated version of the CHADS2 score. I was delighted to find my risk is 0%.

But if course my risk is definitely higher than zero percent – even if my CHADS2 score is zero.

My heart is abnormal in more ways than the atrial fibrillation. I have hypertrophy of my left ventricle (from running – not a risk factor) but I also have “severe hypertrophy” of my left atrium (the top chamber of the heart) which my cardiologist assures me is a risk factor for stroke and although my CHADS2 remains zero I am on an anticoagulant (Pradaxa).

My question has been: Why not include left atrial hypertrophy in the CHADS2 calculation?

Answer: I dunno.

lillianandmargo
Lillian and Lolawanda ready for another trail run

My other question has been: What else can I do to reduce my risk of a stroke?

I understand my risk is NOT zero, regardless of what this calculator says.

Obviously one thing I know I can do is to remember to take my Pradaxa twice daily. Believe me, for somebody who is only taking one medication it isn’t as easy to remember as you might think. I have considered switching to Xarelto simply because of the once a day dosing.

pradaxasmall
My Pradaxa

But other than that what else can I do? One more thing (I think) – stay well hydrated.

As a large, slow, long distance runner (who is often on the trail for several hours at a time) I sweat more than smaller runners, and I have to be very careful not to become dehydrated. I spoke with a friend of mine who is an Internists/hospitalist and he agreed – don’t become dehydrated. Being dehydrated can literally thicken the blood and increase the chance on a clot, and therefore increase the chance of a stroke.

becareful
Be Careful Out There!

How much water should a person drink? I have no specific prescription but what I do is try to drink enough so that my urine is relatively clear once per day. Also there is such a thing as too much water and big, middle-aged distance runners are at relatively high risk of hyponatremia (too much water – not enough sodium) so be careful out there!

We talked about other risk factors are there? Risk factors for blood clots in the legs include being inactive, obesity, and smoking – probably less likely for the readers of this blog.

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Sedentary after a LONG RUN

What about alcohol? Does that increase the risk? He said probably not and in moderation might even decrease the risk – but remember – alcohol clearly increases your risk of atrial fibrillation – and if you drink enough alcohol you will become dehydrated – so there you go!

By the way – don’t expect this this risk calculator or this blog to advise you as to whether or not you should take your aspirin, your warfarin (Coumadin), your Xarelto, or your Pradaxa. It is important that you make this decision with your doctor.