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

Posted on May 23, 2018 by michaelpmccullough

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.

Runners with Atrial Fibrillation – Considering the Watchman?

Posted on March 31, 2016 by michaelpmccullough

Are you considering the Watchman device?

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.

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.”

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.

Warfarin Withdrawal in Patient’s Awaiting Surgery Increases the Risk for Stroke

Posted on November 22, 2015 by michaelpmccullough

Last April Dr. Adnan I. Qureshi reported on research, at the 67th Annual Meeting of the American Academy of Neurology, that has shown that atrial fibrillation patient’s who are taken off of warfarin for surgical procedures have an increased likelihood of having a stroke.

Subjects included in the analysis had atrial fibrillation plus at least one additional risk factor for stroke or death: age >65 years, systemic hypertension, diabetes, congestive heart failure, transient ischemic attack, prior stroke, left atrium diameter 50+ mm, left ventricular fractional shortening <25%, or left ventricular ejection fraction <40%.

Specifically atrial fibrillation patients who discontinued warfarin for surgical procedures had a 1.1% rate of stroke while atrial fibrillation patients who remained on warfarin had a 0.2% rate of stroke.

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

Posted on July 11, 2015 by michaelpmccullough

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

Ringo 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.

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!

Photo – 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.

Photo – 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.

Photo – “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.

Update: Atrial Fibrillation, Pradaxa Fail, Transient Ischemic Episode, Blood Clot in Left Atrial Appendage

Posted on April 12, 2015 by michaelpmccullough

Ridgeview Trail – Moore Park

About two weeks ago I was out for my typical Saturday two hour trail run on Moore Mountain with my dogs. It was a fine day and I felt great, and with about ten minutes left in the run I ran into three of my friends who were out mountain biking. My friend Linda, a Physician Assistant, was trying out her fancy new mountain bike and we stopped to talk for a while. She showed me her new bike and I introduced her to my new dog. I noticed, and commented, that I was having a little trouble getting my mouth working properly. I didn’t have any trouble finding words, or even saying the words, but my tongue just felt sort of thick – especially with consonants like “R” that seem to be made in the back of the mouth. I immediately did my self inventory for asymmetry and muscle weakness and found none. I attributed it to having had one of those little, annoying white sores in my mouth, accompanied by some swollen glands and thought nothing of it.

Linda Cyclecross racing

I finished my run, which involved a fairly technical descent, ate my post-run Clif Bar, and went home where I noticed nothing amiss. I forgot about it until Linda texted me the following day asking how I was doing and saying she was worried about me. I assured her – I was fine!

The next Monday, at work, I thought I’d ask my friend and co-worker, Dr Zakir Ali, if he thought the incident was any reason for concern. Dr Ali is a neurologist who works a couple of days a week at the orthopedic clinic, where I work as a podiatrist.

He wasn’t as dismissive as I was about the incident and said that that was very suspicious for a TIE (transient ischemic episode). A TIE is basically a small, brief stroke, in this case likely caused by a small blood clot that resolves fairly quickly. Dr Ali said I should, at the very least, get an echocardiogram to see if there is a clot in my left atrium, and possibly a carotid artery scan as well.

I have been in permanent atrial fibrillation and on Pradaxa, a potent anticoagulant (blood thinner) for two years and had never missed a dose. I thought he may have been over reacting – and I had had an echocardiogram just two months ago.

But Dr Ali had told me, “You will never regret checking.”

And I agreed.

Okay.

So I called the on call cardiologist, explained what had happened, and he told me a standard echocardiogram would be useless as it won’t show a clot, and recommended a trans-esophageal echocardiogram, and also a carotid scan (ultrasound).

I mentioned that I had had a trans-esophageal echocardiogram before (in 1994!) and it was like swallowing a telephone. He said he’d get anesthesia involved and we set up both procedures not expecting to find anything.

So the carotid scan came first and was normal, as expected.

Last Wednesday I went to the hospital and checked in to Day Surgery – which was a peculiar and strange experience for me. I’ve been working there, as a surgeon, for the past twenty-five years, but this was my first time being there as a patient. It’s a little disorienting, and oddly embarrassing, to be on “the other side of the door.”

Anyway – Dr Vince Herr, the anesthesiologist, gave me some propofol so I don’t remember a thing; but when I woke up I was told that I had a small clot in my left atrial appendage, and turbulence in my left atrium as well. This was a surprise for everybody involved. Judging from my lab work and the bruises on my arms the Pradaxa seemed to be working – but evidently not well enough! And that “small clot” looked pretty big to me – downright dangerous.

Trail Running on the PCT

At that point I was immediately started on Lovenox injections twice daily (for six weeks!), the Pradaxa was discontinued, and I am beginning to take warfarin (Coumadin); and of course I stay on the beta blocker (carvedilol). My cardiologist gave me the first Lovenox injection right in the post-op area.

Also it looks like no running or bicycling for six weeks – which of course is devastating to me, emotionally, but – shit! – blood clot / stroke / potential death – yes, I am definitely sticking with the program!

The injections are easy to do, they burn a bit but don’t really hurt, and every injection leaves a bruise. Believe it or not I enjoy and look forward to each injection because I’m hopeful that they will be helpful.

I’m disappointed that the Pradaxa failed – it is much easier to take that warfarin. Remember that I am a vegetarian and one of my passions is eating healthy food, especially kale. Also everyday, up until now, I eat a little square of nori (seaweed – like the wrapper on sushi) thinking that it would be a good source of iodine as I don’t eat any seafood or use table salt. Kale and nori are probably the two worst foods to eat if you’re taking warfarin!

Taking warfarin is going to be a real challenge – changes will be made, changes that actually seem sort of unhealthy. The one advantage is that warfarin is, unlike Pradaxa, reversible, which is a true benefit in the case of a bike or auto crash, a GI bleed, a head injury, and so on.

Moore Park Trails

In six weeks the trans-esophageal echocardiogram will be repeated and hopefully the clot will be gone. If not some sort of procedure (by the electrophysiologist) is in store for me. Hopefully I will 1.) not die and 2.) get back to trail running. Until then my nerves are wracked worrying about having a major stroke!

I need to say that I feel incredibly blessed – if I hadn’t met my friends and stopped to chat I never would have known I was having a TIE. And if Linda hadn’t have texted me the next day I wouldn’t have ever pursued it, because I had, in my mind, completely dismissed it. And also – how many people actually have a neurologist right in their office who is willing to talk at any time?

Clearly I’m not through this yet – but in a way I feel I have already dodged a bullet. Really, if it weren’t for Linda that blood clot would have just kept getting bigger and who knows what would happen next? I might be dead by now. Even as it is now – who knows? But at least now I know I have a problem and the treatment plan has been changed.

So thanks, Linda!

Me and Linda in Costa Rica

I would appreciate any comments, especially shared experiences, you might have.

To be continued. Wish me luck.

Bicycling the Rim Drive Crater Lake National Park and Atrial Fibrillation

Posted on October 1, 2014 by michaelpmccullough

I haven’t blogged for a while because we’ve been on vacation in Croatia for two and a half weeks, and of course after being gone for that long I’ve been incredibly busy at work. I am working on along blog entry (actually it’ll be a separate blog) about Croatia, so stay tuned.

Me During a Brief Rest Stop

In my opinion bicycling around Crater Lake is one of the finest bike rides in the entire United States, and Crater Lake National Park will, from time to time, close of twenty-four of the thirty-three miles of the Rim Drive to allow bicyclists, hikers, and runners to have a relatively car free day. This year they had vehicle free days on two Saturdays: September 20 and 27, and I made time to be there for both days.

Since I live near Crater Lake N. P. I’ve had the opportunity to ride the rim several times, but this year was my first time doing it in permanent atrial fibrillation (and while on a beta blocker). Always a challenging ride under any circumstances, adding a fib and a beta blocker to mix changes things a bit.

Most riders start at the Steel Visitors Center (Park Headquarters) and ride clockwise. The first thing on the agenda is a three mile climb with 650 feet of elevation gain up to the Rim Village. This is actually the steepest hill along the route, but not the most difficult, in my opinion, mostly because the legs are still fresh. It is quite odd to pedal up a climb like that and find a lake at the top. There are several climbs and descents along the thirty-three mile route, and rarely is there any flat road, and the two toughest climbs, in my experience, are in the second half of the ride – the long easy climb to Cloud Cap (where most people stop to sigh and eat their Clif Bar) and the last grind up to Dutton Ridge. I might even say that you only need two gears to ride the rim – whatever you use as your easiest climbing gear and a big gear for coasting downhill.

Elevation varies from 6700 to 7700 above sea level. Personally I don’t have an issue with the elevation at Crater Lake because I’m used to living at higher elevation, but people coming from sea level might feel it.

Bicycling in Croatia with Margo

To be honest, none of the climbs (going clockwise) are particularly steep, and there is only a total of about 3500 feet of climbing, but the climbs are so long and persistent that it seems like more. The descents can be fast and one could easily go 50 mph down the descent from Cloud Cap, but don’t. The speed limit is 35 mph and there are often surprising potholes encountered once you get up above 40 mph. The vehicle free days are great because you don’t have to worry about cars behind you. One day I was descending at 45 mph, a speed at which the wind in my ears prevents hearing anything, riding right down the middle of the lane, and was passed by a van. I thought, “What’s your hurry, bro? I’m already going 10 mph over the speed limit!”

The scenery is world class and seeing it slowly, up close on a bike, complete with the sounds and the smells is unimaginably beautiful. Being there on a vehicle free day with hundreds of bicyclists from all over Oregon is even better – there is an amazing energy in the air on the vehicle free days.

Snowshoeing with Libo April 2013

If you are going to ride the rim, especially on a vehicle free day, keep in mind that once you are past the Visitor Center and the Rim Village (basically once you are past the first three miles) there is no water. I’m a heavy sweater so I’ll take three liters on a hot day. Actually along the last big climb there are some little “waterfalls” right along the roadside and I have seen people filling their water bottles there and it is probably fine; but it is definitely not tested and designated as potable water. Also keep in mind that there will be no SAG wagon trailing you so make sure you have the proper gear and tools for changing flat tubes and minor repairs.

As far as riding the rim in a fib while on a beta blocker, well, it is much slower. I was able to ride it but it took me at least an extra hour. I had a triple chainring on my old road bike, and I used to be able to do the entire ride in the middle chainring (except for part of the first climb); but now I am using my easiest gear for most of the climbing (my new bike has compact double, but the gearing is similar). I think I need to be happy with being able to complete the ride without falling to pieces, and quit lamenting my slower speed.

Photo by Margo

My personal preference, now that I am in a fib, is to keep going and minimize rest stops. It seems every time I stop it’s like starting over again. On the first Saturday I was riding with a group of friends, including my wife Margo (her first time doing the rim ride) and I told them I wouldn’t be stopping much and that they could catch up to me. The last I saw them was at the top of the first climb, and I actually completed the ride a half hour or so ahead of them – they had fun, stopped at the many overlooks, stopped for lunch. I was the tortoise to their hare; slogging up the hills and only stopping a few times.

Another difference is that now that I am on an anticoagulant I brake a lot on the descents. I’m usually the biggest rider in whatever group I’m riding in and consequently the slowest climber that makes up for that by being the fastest descender. No more. Now I think about how descending slowly will help me keep my blood inside my body and I was passed by dozens of riders on each hill. As a matter of fact I kept getting passed by the same groups over and over. They’d pass me on the climb, then I’d pass them at the top of each hill where they’d stop to look at the stunning view of the lake, then they’d pass me on the descent and I’d pass them again at the bottom of the hill where they’d evidently stop to chat. Over and over – sort of fun.

Skiing with Jan (evidently I’m relying on old photos because I only took one photo for two days of riding around Crater Lake – like I said I don’t stop enough!)

I returned and rode the Rim Drive again the following weekend as well but my friends didn’t accompany me. It was a much cooler, windier day and looked like rain, and they had other plans. I ended up doing the first half and deciding to make it an out and back. I was thinking about the big descent down the other side of Cloud Cap in the heavy wind and thought that might not be the best idea on account of my being anti-coagulated. I learned that riding the rim counter-clockwise is not as safe as riding clockwise. When riding clockwise the lake is to your right; but when riding counterclockwise there was quite often a steep drop off and no shoulder and no guard rail. The drop offs weren’t a thousand feet or anything like that but they were certainly much further than I wanted to go over on my bike so I did the long descents towards the middle of the lane although I pissed off a few drivers I will live to ride again. There is no way I will ever ride the entire rim counterclockwise. Keep in mind that most drivers are looking toward the lake (why wouldn’t they) and if you are between the driver and the lake they are likely to see you. But when riding the other direction there is more risk of being unseen.

Carter Lake Century 2011 (not my video)

Another good time to ride around Crater Lake in the Crater Lake Century. I have never ridden with the organized century (I’ve always been training for something at that time – it’s held in August) but I have been told it is a blast. As far as I know the Rim Drive isn’t closed during the century but there are about 300 riders up there that day. The number of applicants is limited so register early if you want to get in. The century, obviously, involves more than the thirty-three mile Rim Drive and in addition to more climbing from Fort Klamath up to the Park Headquarters, there is some routing around the local farmlands near Fort Klamath to make it an even one hundred miles.

I would love to hear from other bicyclists, especially cyclists dealing with atrial fibrillation. Please feel free to comment below.

SOB Trail Run 15K Race Report: Atrial Fibrillation, Running, Beta Blockers – My First Impression

Posted on August 13, 2014 by michaelpmccullough

SOB Trail Run

I have been in permanent atrial fibrillation for a couple of years now, but only been taking an anticoagulant (Pradaxa). But things have changed and for the past month I have been on a beta blocker, carvedilol.

Prior to starting the carvedilol, while in permanent atrial fibrillation, I had been able to run two marathons and one ultramarathon (50K) without any more trouble than the normal marathon type suffering, but over the past six months I have noticed things have been changing. I’ve slowed down, even for me, and distances are getting harder. My last half marathon was a joke and I was at the end of the pack within the first two miles. After a run or mountain bike ride of an hour or more I would have problems afterwards – my blood pressure would drop and my pulse would stay high. After a long run, especially if it was a hot day (which they all are, recently) I would get so light-headed after standing up I sometimes had to grip onto something to remain standing.

A visit to the cardiologist, and a subsequent echocardiogram, revealed that my heart rate was increasing and my ejection fraction was decreasing, and for that reason the cardiologist wanted me to start on a beta blocker.

A beta blocker, in this case carvedilol, is a drug that reduces stress on the heart by slowing the heart rate, decreasing the force with which the heart beats, and reduces the tone of the arteries throughout the body. The end result is that blood pressure is reduced, as is heart rate. The heart needn’t work so hard.

SOB 50 Mile Course – tough!

Some non-endurance athletes actually use beta blockers as performance enhancing drugs – it is said that it calms a person, reduces performance anxiety, and is commonly used in less endurance specific sports such as golf, target shooting, archery, and even in music performance.

Clearly these drugs are performance diminishing for endurance sports like distance running and mountain biking. We like to stress the heart, raise the heart rate, and we don’t have very much stress – we’re long distance runners after all – the mellowest people around.

I generally am in at least half marathon shape year round. Even if I’m not training for anything my weekend long run is going to be between nine and twelve trail miles. Prior to starting the beta blocker I had signed up for the 15K at the SOB Trail Run at Mount Ashland (Oregon) – one of my favorite races. This relatively high altitude run is basically all up and down trails and fire roads (zero flat sections) and I have done it at least six times in the past, including completing it twice in atrial fibrillation. I was curious to see how being on the beta blocker would affect my race.

DNF

The answer was I DNFed (did not finish) and dropped out fairly early in the race. That was terrible – most of my friends were running the 50K or the 50 mile and I DNFed the little 15K???

The course at the SOB is brilliant, really. A lot of trail races start out right away on singletrack, but the SOB has about a mile(?) of fire road at the start so everybody has plenty of time to figure out whether they are going to be running with the fast people or the slow people before they hit narrow Pacific Crest Trail. I ended up at the very back of the group that was running, but I was still in front of the few people who were walking the 15K.

I found that as soon as the course headed up hill I was unable to run. My chest felt funny – not chest pain, just felt weak, not right, and my legs felt dead. I wasn’t short of breath, I was just unable to do it. I decided, in my typical OCD mode, to continue running for five more songs on my iPod shuffle, and then turn around and drop out, thinking that I should at least get a little bit of a work out in, and that I could justify keeping the T-shirt I had paid extra for. I knew I could have walked the course, but that is not what I went there to do.

I was delighted that the fifth song on my iPod turned out to be an oldie from my high school days: Yours is No Disgrace by Yes. Not actually I song I still like very much, but in this context it seemed like a cosmic pat on the back.

http://youtu.be/Vd4jeeu90Rk
A Cosmic Pat on the Back

On the way back I met a woman who was also DNFing (sprained ankle) and we walked the last section of the race together, commiserated, and removed our numbers so they wouldn’t mistake us for the top finishers. At the finish line we informed the race officials that we had dropped out so they didn’t need to send a search and rescue team to find us.

DNFing and commiserating together as we remove our race numbers

So this article is, basically, my first impression of being on a beta blocker, in addition to the atrial fibrillation, and trying to remain an endurance athlete.

So far I feel that the beta blocker is more of a hindrance to my running and cycling than the atrial fibrillation alone had been – but then again, because of the atrial fibrillation my heart function is gradually diminishing.

I should say, on a positive note, that the beta blocker is working, and is doing what it is supposed to do. I check my heart rate and blood pressure at least once per day and since I started the carvedilol I am right where the cardiologist wants me to be. And I can understand why people who aren’t trying to be athletes might like the med – it seems to have a mild calming effect. Furthermore I no longer feel like my heart is a fish flopping around in my chest, and my post work out blood pressure and heart rate has stabilized.

I am optimistic that the carvedilol will be worthwhile and will help me preserve and regain my ejection fraction. But really, what choice do I have?

So here is how things have changed so far (compared to just permanent a fib without the beta blocker):

1.) As far as mountain and road biking is concerned I have been able to ride all the hills that I used to be able to ride, although I am much slower. My wife now has to wait for me at the top of a climb, and that’s fine. I am delighted I can still ride and don’t have to get off and walk my bike.

2.) Running is more negatively influenced. My previous slow pace is even worse, and hills are quite difficult. Not surprisingly I do not like this one bit. A slow jog feels like a 5K effort. But I am still able to run – Yay!

3.) Long runs in heat are not possible. I am just not able to do a long run in heat, and lately every day has been warm. Understand that I am a big red-faced Irish-American who considers anything over sixty degrees to be hot running weather; plus I live in a very sunny place, a high desert climate without a lot of shade. It is not surprising that this is happening. A normal person running in heat will have a higher heart rate for a given pace, and will need to slow down. If you are on a beta blocker that reduces the maximum heart rate by a significant amount, well: “game over.”

My goal is to continue running and mountain biking on trails like this: Brown Mountain Trail

4.) I suspect that the beta blocker might be making me lazy. I don’t know if that is the right word, but I had a full day off in the middle of the week a while ago and I had planned on, among other things, writing this article and going for a trail run, and next thing I knew it was late afternoon and I hadn’t done a thing. What? By that time there was a thunderstorm so I was not going out for a run – but the article still hadn’t been started. I hope this is not going to be the case from now on. Being lazy and depressed is far from my idea of fun.

I am going to wait until I have had more experience with the beta blocker and write a better informed article. I’m going to sign up for a relatively flat (downhill, actually) trail half marathon and try to redeem myself.

In the meantime I would love hear about other people’s experiences with the dreaded beta blockers. Please post a comment below.

Emergency Pack for Trail Running or Mountain Biking While on Anticoagulants (Coumadin, Xarelto, Pradaxa, Plavix)

Posted on May 30, 2014 by michaelpmccullough

This article is a work in progress and is only a description of my strategy for the time being. I hope to learn from readers of this blog about how to better plan for a trail debacle.

Heading out for a trail run on the Pacific Crest Trail

What kinds of things should a person like me, who is dealing with atrial fibrillation and is taking an anticoagulant (I take Pradaxa), carry on a long run in the wilderness? Or during a long mountain bike ride in remote areas?

When the high country in our local wildernesses is not covered with snow, I will generally do runs, nearly every weekend, of anywhere between six to twenty miles. I almost always run alone (except for my trail buddy – Ringo).

Dangerous and a bad idea? Possibly. But this is what I enjoy in life so I don’t plan on stopping any time soon.

The most important piece of equipment is a phone. People complain that everybody is always on their smartphone, and they should NOT be talking on their phones on mountain summits when everybody else is trying to get all Zen-like and self-actualized, and whatever – that’s a different discussion. You certainly don’t even need to have your phone on; but you absolutely should take it with you, and it should be fully charged. The days of getting hopelessly lost and spelling out SOS with rocks hoping a search plane will find you are fading into the past. A smartphone is a GPS and a direct link to help.

I always carry my iPhone in a baggie with my ID and a sheet of paper towel (which I use for unrelated toilet purposes).

Fully charged and protected from water

Even if there is poor cell phone coverage in your local high mountain or deep canyon wilderness, and a phone call isn’t always possible, I find that a text message can often still be sent. It might take a while but it eventually will be sent, especially if I am moving along a trail.

There is the standard emergency gear that most people take, often called the “ten essentials” which most people carry while in the wilderness. Of course there is truly no such thing as a standard ten essentials and the list of things you carry will vary depending on the season, your skill set, your location, and your past experience.

My generic survival gear

I got out my little survival kit that I typically carry in the wilderness, and of course not everything is pictured here, and I might not even have all of this stuff with me on any given trip. Naturally I will also have other things like food, gels, electrolytes, a jacket, and plenty of water.

What I found in my default wilderness pack is:

Two knives – a mini-leatherman tool and a standard knife. I will only actually carry one of these.

Two lights – a headlamp and a tiny LED flashlight (one is plenty).

Fire starter – a cigarette lighter, birthday candles, a tampon, and hand sanitizer (which I discovered has completely evaporated).

A space blanket, a compass.

Repair gear (Shoe laces, tenacious tape, dental floss)

Pain pills: Vicoprofen samples – okay they expired in 2000 but I’m guessing they are still good (at least for a placebo effect). Missing: Benadryl for allergies or yellow jacket stings, and I probably should have some of my Pradaxa in case I end up unexpectedly staying out overnight. Also missing: small roll of duct tape, safety pins, and my whistle!

Saint Christopher Medal

Oh, and there is a Saint Christopher medal. This one belonged to my grandfather. Well it probably won’t change anything, but it certainly couldn’t hurt. Feel free to substitute your own personal good luck charm.

But what about specific items for the runner on an anticoagulant? Is there anything else beyond the “ten essentials”?

Other stuff: Map with reading glasses (if needed) and some rope

Obviously having a major bleed while running alone in the wilderness would be a disaster. Death is certainly a possibility. How can a trail runner prepare to increase the odds of a good outcome?

I always make sure to let somebody know (usually my wife) where I’m going and I also send her a text (I text “OOTW” short for “out of the woods”) when I get back to my vehicle.

I also wear a Road ID. This way if somebody finds me they will know I am on an anticoagulant. Maybe this won’t help, but it certainly is worth wearing. At least they will be able to figure out why I bled out so quickly (I know – not funny).

My Road ID

Another item I always carry is a bandanna. This can be used for a number of purposes, such as making a field dressing; but I want to have it in case I need a tourniquet. Plus – I have an extra one because my trail dog always has one draped around his neck.

Bandanna

My bandanna came in handy a week ago when my wife Margo (not on an anticoagulant) crashed her mountain bike and punctured her left thigh with her brake lever. I used it to make a compressive dressing before we road our bikes back to where we could get a ride to the hospital.

One item I do not currently have but definitely need to obtain is a Quickclot field dressing. Evidently these things really work and are routinely used in combat situations. It is a topical coagulant (an anti-anti-coagulant?) which helps clot blood and also serves as a physical barrier to bleeding. I’ve been meaning to obtain one of these for a long time. They are available online via amazon.com, and I just ordered one.

Quickclot

Question: Will the Quickclot sponge even work on bleeding in an individual who is on a direct thrombin inhibitor like Pradaxa? Answer: I have no idea. I’ll let you know if I ever get a chance to find out.

In case of bleeding the most important first step is to apply direct pressure. As a surgeon I have a lot of experience with this. Usually sixty seconds of direct thumb pressure will stop or slow most bleeding, but of course if you take an anticoagulant it will take longer. Apply direct pressure as long as necessary. Elevate the wound if possible. Don’t try to clean out major wounds as this will restart bleeding – that can be done later at the hospital.

A tourniquet is a last resort, but the bandanna can be used as a compressive dressing if needed.

Please understand that an anticoagulant doesn’t completely stop clotting of blood, it just makes it take longer. Eventually bleeding will stop. Hopefully before all the blood leaves your body!

Ringo always has a spare bandanna for me

Bonus – How to stop a nosebleed:

I have been plagued by frequent nosebleeds since I was a child but, oddly enough, I haven’t had a single nosebleed since I started Pradaxa a couple of years ago. The best method I have found is to pinch the nose, fairly tightly, just above the nostrils, and lean forward. Don’t lie with your head back – that doesn’t work. Hold for a full sixty seconds. Repeat as necessary.

If you are, like me, a trail runner or mountain biker on an anticoagulant, I would love to hear from you. Please leave comments and suggestions in the comments area below.

Thanks.

Atrial Fibrillation News Update

Posted on January 19, 2014 by michaelpmccullough

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.

AFib Doubles Risk of Heart Attack in Women and African Americans

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.

Drug Interactions with Novel Oral Anticoagulants

“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.

Warfarin May Up Stroke Risk in Those With Irregular Heartbeat: Study

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.

FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific

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).

Atrial Fibrillation Stroke Calculator

Posted on January 9, 2014 by michaelpmccullough

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.

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.

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.

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.

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.

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A Fib Runner – Distance Running and Mountain Biking With Atrial Fibrillation

A blog about atrial fibrillation and trail running, ultra running, mountain biking, and other endurance sports.

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