My AAA-Stent FDA Adverse Event (Correctable Hypertension) Report, And The Role Of High Technology In My Life Recently

 

Hi folks,

Well! It was a busy week for me. I sent an adverse event report to the FDA for my AAA stent-induced hypertension and received a nice polite reply, which told me that if you want to use the FDA MedWatch Online Voluntary Reporting Form (3500) effectively, send data – which I did. In fact, here is their reply, just click on the image to see it more clearly, and use the back arrow on your browser to return to the post:

Polite FDA Reply To My AAA-Stent Adverse Event (Correctable Hypertension) Report

I was careful to point out that my stent saved my life, and all that I am asking them to do is to encourage endovascular surgeons to let people know that this is a real risk, based upon the data I sent (which is present in this blog under the category “hypertension”). Having this issue lost in a list of all things that might happen, and which generally cannot be fixed, is not so helpful, even if you do get to read the package insert. My BP is now in the normal range thanks to Lisinopril and regular exercise. The synergism between this ACE inhibitor and exercise was quite remarkable, in my case at least! Maybe I’ll tell Joe and Terry Graeden about it?

Next good thing was my follow-up CT scan this week, where I was entered into a research program to reduce the radiation dose during follow-up stent visits, whilst they are working to increase the use of ultrasound in place of radiation-heavy CT. My scan showed that my stent was happily in place, no issues, and my aneurysm had shrunk from 7 cm in diameter to just over 5 cm, so that was very encouraging. Here is a picture of Jo Fulton, my surgeon, showing me my scan (background screen), and holding up the kind of stent I have, Cook Zenith. What a great little invention that is!

Jo Fulton, The Author's Endovascular Surgeon. He deserved the hug I gave him. Thanks again, Jo!

Jo is now training for the Louisville Ironman, in fact, here he is on the participant list:

Fulton Joseph M 41 NC

I didn’t realize that Jo is the same age as my kids. I’ll buy you a nice dinner, Jo, if your August Louisville Ironman time beats my July Lake Placid Ironman time. I am doing the race this year (5th time!) with a real athlete, my son Nigel, shown here during our Lactate Threshold testing at the UNC Meadowmont Facility, with our coach Eric Bean, of Fast Forward Triathlon Training, and the great staff at UNC doing our testing work. Nigel’s LT is approximately 2x mine, wattage-wise!

My Lovely Son, Nigel, During Our Lactate Threshold Testing At UNC, Meadowmont, Chapel Hill

And finally, more high technology this week at the dentist, where my prosthodontist, Chez Ollie and his staff were checking my bite with a new pressure sensitive array system (bit-o-meter?), which really gets the bite right. Thanks to Jim I now have a full dentition up top, which stays in all the time for the first time since I was 16 years old (war is bad for children’s teeth!). Here is the output of Jim’s scanner:

Jim Hoke's Bit-o-Meter On The Author's Upper Dentition (All Implants And Magic Ironmongery!)

Basically, a great week for high technology which allowed me to (a) file my report with the FDA in minutes and from my home, (b) be alive and training, (c) to train safely within well-determined stress levels, and (d) to have a great smile.

Thanks to all those people, and remember that dinner, Jo!

Don’t tell me things were better in the old days!

Cheers,

Kevin

 

Comments

  1. Quite a story, Kevin. Will be interesting to see if FDA does anything. As for the old days, at least we were younger…

  2. Hi Kevin, I read here that you are taking Lisinopril. I am taking Losartan, as I understood it is from the same group of BP medications.
    I have been noticed the more active I am my BP is getting lower. It means being active is very important to me.
    Dacron Graft can have the same affects on BP level as Stent Graft. So the combination of BP drugs and exercise is very good to keep BP under control.

    Best,
    Masha

  3. Hi Masa, since writing that post I found that my blood pressure had self-corrected, which I kind of expected based upon the remarkable ability of the body to return key physiological variables to their inherent set points http://goo.gl/DY7CD and the likely underlying mechanism responsible for the hypertension (bounce back wave from the rigid stent confusing the baroreceptor system in the aortic arch and elsewhere). So I no longer take Lisinopril (ACE inhibitor), I just monitor my blood pressure intermittently. It generally sits around 135/80, which I consider to be within the normal range. Most cardiologists, based on my experience, would take this to be hypertension (rule of thumb for them is (135+80)/2 >2, therefore I am dangerously ill), in their weird opinion, and they’d put me on a dangerous drug (all drugs are dangerous), even a beta-blocker, which would screw up my sex life, amongst other things. I think that Lisinopril-induced hypotension contributed to my failure to finish the Lake Placid Ironman in 2012. So, I’m off the drug and watching events, but all seems fine. I continue to take aspirin, I hasten to add, due to concern about clots in my stent (not good). Yep, you have to learn, think, run a personal risk-benefit analysis, and decide for yourself, unless you decide to completely trust someone else with a god complex. It sure is a lovely day here, in North Carolina. -kevin (aka FitOldDog)

  4. Hi Kevin,
    I see you did “your homework”.
    All drugs are very dangerous.
    My case is diferencia specifica because I don’t know why my body developed such a terrible health problem in very young age. If it is genetics involved then It is good for me to continue taking low doses of BP drugs.
    In many cases I don’t trust people, especially people with God complex, and it goes on their nerves…but when I get advice from them I do what I think it is the best for me. They saved my life. No doubt, but now it is time for me to help my self to live the best possible hours of mine.
    I am glad you and your girl came back home safely.

    M.

    • Hi Masa, if I were you, I’d check my blood pressure, resting pulse, resting respiratory rate, and general feelings with respect to my body and mind health, and record it in a spread sheet. You can do it daily or less often, as you see fit. If things start to change you’ll notice when you graph the numerical data. Data is what you need to stay safe with your surgery. I follow mine pretty closely from time to time, plus I get a read out of wattage on my bike and clock times in the swim, all of which tell me how things are going. If my resting pulse goes up I’m either sick or overtraining, and I react accordingly. I also keep an eye on my feet for capillary perfusion rate (pressure and watch refill) just because of concern for reduced blood flow through my AAA stent graft. I don’t make a big performance of this, I just keep an eye on things. Your surgery was more extensive than mine, so you might want to do this for a while. I stop this when things all seem fine, but I return to greater vigilance as I approach an Ironman race or if I feel my heart thumping (almost always too much caffeine). Data can be very useful, but don’t expect the doctors to even look at it. Cheers, Kevin

      • Thank you for advice when it comes to my BP and everything else that can help me to follow my self better. Will start doing it, and see what will come from it.
        M.

  5. Oh yes Beta blockers are really out off question. You already explained why.:)

  6. This post of yours (BP issues should be in medical books!!!).
    Not joking!
    Everything you wrote is based on the facts.
    Finally somebody brave enough to write this!
    Thank you Kevin.
    Stay wild!!!
    M.

  7. How to trust anyone when I have never been seen my post surgical scan? Like it is top secret issue….stupid…
    This post of mine was inspired by the lovely photo of your surgeon, and your scan on the screen behind.
    :))))

    Nietzsche was right.
    God is dead. Only complex remains. :))))

    • Yes, the Gene Organizing Device might be dead (or never existed, my working hypothesis of life, as the universe is much more interesting than anything us little bugs-on-a-rock can dream up, just think about emergent behavior), but why did Nietzsche wear that silly mustache. No wonder he couldn’t find a girlfriend. Joe is a great guy, but he’s a surgeon with no interest beyond those mechanics, which makes sense given the complexity of stent insertion. I’ve did a lot of surgery as a veterinarian, but I have no idea how they do that without their patients bleeding out. Remarkable. -kevin

  8. I have to admit, I enjoyed your comments and the energy that drives them. Makes one feel less alone on this strange rock in space. -kevin (aka FitOldDog)

  9. Hi Kevin,
    yes Kevin the rock in space…:)))
    I am glad you enjoy my comments. I still don’t know what kind of energy drives me, but ever it is be sure it comes from my mind and hearth and it is not superficial invention of modern pharmaceutical industry…:)
    Nietzsche was and still is one of my favourite philosophers. I don’t think it was his look that was keeping girls away from him. :))))Bit it is interesting how guys can be critical when it comes to other guys look.:)))

    I have special surgeon my self. He is really “top dog in the business”(why you find it strange when I use this few words?), and he has talent and knowledge. He performed so many surgical repairs of aorta. Some which are very difficult,like mine for example. He has special something. Not ordinary man. I have to admit that he gave me few good advices, and one of the best was: ” If anything starts to go wrong it is not compatible with life, so don’t bather, go and live!!!!”
    It really helped me. If you think about it you will see that this advice is very good.
    According to what he and his team are capable to do in surgical room there is no way they can find time to work on other skills (but I heard he likes to ski…:)))))
    Your last question? Well, have no idea, I performed surgery on the frog, when I was young, much younger then I am now….so with the experience like that, I am not the right person who can answer you the question about bleeding. :))))
    Cheers,
    M.

  10. Paul Davidson says:

    Great article. Thanks for the info, it’s easy to understand. BTW, if anyone needs to fill out a FDA form 3500A, I found a blank form here http://goo.gl/ySiY4w. This site also has some tutorials on how to fill it out and a few related FDA forms just in case you need to fill out one.

    • Hi Paul,
      I appreciate the information. I did feel that my submission was going the way of the Ark, in Raiders of the Lost Ark, but at least it’s in the system. I suspect that my hypertension, and I’m clearly not alone, though I suspect that it is an uncommon side-effect, was due to a fluid dynamics issue related to relative aorta and stent lengths, combined with the non-compliant nature of the stent, sending a confusing bounce back pressure wave to the baroreceptor system. Of course, this is an educated guess, but my stent still keeping me alive and training – I’m one lucky guy, I must admit.
      Thanks for the info, and the link, which works fine.
      Cheers,
      Kevin

  11. Annette MacCord says:

    I have developed terrible hypertension since the repair of my AAA last February 2014 I am constantly exhausted, have a non stop headache and no follow up with the surgeon due to his office staff.
    I went to see my family Doctor and he put me on BP Medication last Friday.1-5-2014 .Valsartan. traimterene and atenolol. I want to add that I didn’t have High Blood Pressure until this surgery.
    I also have tremendous pain in my upper right thigh where I was cut and a thickening that feels abnormal.
    I have an Ultra Sound scheduled for 2-23-14 to make sure the graft is intact and the aneurysm is shrinking or at least not growing. I started walking about two miles a day to help with the legs and hopefully the hypertension.
    My kidneys are starting to return to normal but that took a while after the surgery. I went back to the hospital about 10 days after surgery without kidney function and they used Vancomycin for 9 days. This seemed to help and I was sent home. I knew from the radioactive isotopes used this might happen but was shocked when it happened and the extent of my illness.
    Back again two days later with my legs swollen about two times their normal size from the hips to my toes I was admitted but walked out when I was put in a room with a couple ( man and wife) . I would not share the room with a man when I had to walk past him to the restroom with an open back gown and a rear exposed. So I walked out and went home and have pretty much been on my own since.
    My concerns are of course the hypertension. Also to some extent the headaches. Sometimes I have to take aspirin and I know that is not good for the kidney damage from this surgery.
    I’m grateful that the aneurysm was repaired and that I am still here to be the grandmother I was intended to be but would like the energy to return and the pain to disappear.
    And FYI, I liked my surgeon. He is quite good and seemed to do a fairly decent surgery repair on me. Fighting his office to get an appointment has been a problem and frustrating. I drove for 2 1/2 hours to his office on the 5th and was there on time and they said I was late. They would not see me. Their office are the only vascular surgeons in this area and work in the hospital I use. Its kind of a no win for me and I cannot afford to pay for this on my own. Anyway. I just wanted you to know that the HBP is something I have and hope to get it under control.

    • HI Annette, what a story. I’m sorry you are going through this.
      Did you have an AAA stent placed?
      If so, you will be the third person I know of who has had stent-induced hypertension (mine jumped from normal to 220/120, and no one would believe it wasn’t renal dysfunction, which drove me nuts). Do you not have a home number for your surgeon. Be a pain in the ass, if necessary, as the squeaky wheel sometimes gets the oil. My hypertension corrected over a period of 18 months, with the help of exercise and Lisinopril an ACE inhibitor (I refused beta-blockers, as they make you tired all the time and it is impossible to train, and for a guy the can ruin your sex life). Have you tried an ACE inhibitor? Doctors love to give out beta-blockers, but it’s generally a bad idea in my opinion, unless you don’t want to have a life..
      What is your BP now?
      You can e-mail me if you like, at kevin.t.morgan@earthlink.net.
      Kindest regards, and hang in there.
      kevin

      • Kevin,
        I did indeed have the stent placed. The BP is at it’s lowest right now at 180/112. Not a decent reading at all. I take the medication daily at the same time with no results. I am going to tell my family Doctor about the Lisinopril. I work as a med tech in the hospital and have had many patients who have taken this drug with great success I see him again in one week and know he will listen.
        They too like to blame the kidney problems on the BP and everything including the exhaustion, headaches.
        Oddly enough my brother Paul passed away in May of 2013 with an aneurysm and now my twin sister Bonnie has an aneurysm much like mine but hers does include renal involvement. There certainly seems to be some kind of heredity in our gene pool with this illness.
        I don’t have the surgeons phone number or I would be on him to be honest. I almost feel like he is practicing Patient Abandonment since the surgery. In the hospital he and his hospital staff were most attentive but have since pretty much ignored my problems. I am going to call one more time but am not feeling hopeful right this moment.
        I almost forgot but I wonder if the stent is what is causing the actual pain in my upper right leg. It almost feels like there is something in there that doesn’t belong. It makes the groin area and thigh ache in the top and the leg is numb all the way to my knee. If it swells which it will after standing all day, the numbness grows. This is all so new to me that it kind of blows my mind.
        Kevin, thanks for starting this place to find information. I believe it will help me get my BP under control.
        Annette

        • Hi Annette, there really is nothing to be had from the hospitals or the surgeons once you survive the surgery. They are just too busy, and there is not money to be made. I wrote my last book, Aortic Disease From The Patient’s Perspective, in an attempt to reach these people. It is promoted at the Cleveland Clinic, but I can honestly say that they are not interested in our perspective. They saved our lives, and I’m grateful, and I’ve given up expecting their interest.

          There are some excellent Facebook Pages, where you can get support, encouragement, advice and information, such as this one: https://www.facebook.com/groups/2283898552/

          Plenty of people to talk to. The Marfan’s and dissection people have really hard time, and are amazingly stoic about it. If you want to talk, you can call me at (919) 357-3226. I’ll generally answer, and if you get voice mail send a text or e-mail.

          Yep! Genetic, absolutely.

          Kind Regards,

          Kevin

        • Hi Annette,
          I was worrying about you during the night, as I remember my blood pressure (BP) nightmare, when the surgeons showed no interest and wouldn’t listen. Don’t forget to tell your BP story on our Facebook page, as there may be others out there, who will be put on Beta Blockers and have their life messed up, too.
          Here’s the link again. I’m one of the managers of the page, so I can let you in when I see your request.
          https://www.facebook.com/groups/2283898552/
          My slow responses are because I’m in the final stages of finishing a book on planar fasciitis, and it takes considerable concentration to dot all the i’s and cross all the t’s.
          Kind Regards,
          Kevin

        • ADDIE LEE/Adrienne Lee says:

          I can emphasize with you, Annette. My surgeon abandoned me as well. Said come see me in 4 mos after surgery, triple A.. I had no post info, no meds, nothing. I had to use the ER 4 times for after care and treatment. He is primarily a weight loss surgeon. I was bleeding out inside so they couldn’t air lift me to Stanford(Palo Alto). They did it in my small town. Granted he saved my life, but I have no clue on follow up and my primary dr. is useless, in fact I just fired her. Good luck to you and keep on pushing. Your health is worth it.

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Disclaimer: As a veterinarian, I do not provide medical advice for human animals. If you undertake or modify an exercise program, consult your medical advisors before doing so. Undertaking activities pursued by the author does not mean that he endorses your undertaking such activities, which is clearly your decision and responsibility. Be careful and sensible, please.