Biotronik Evia Pacemaker for Vasovagal Syncope?

I'm not sure which category to post this in, but this one seems the most appropriate.

I am looking for people who have been treated for vasovagal or neurcardiogenic syncope with the Biotronik Evia Pacemaker.

I received my first pacemaker almost 10 years ago for this problem, coupled with postural orthostatic tachycardia syndrome. The PM was replaced at the end of 2009, so my new medtronic adapta is still completely functional. However, I recently started passing out again for the first time in five years and when I am not passing out, I am almost passing out. Of course, this has some serious impact on my very active life.

A specialist I saw last week said that I have "the wrong pacemaker" and suggested a Biotronik Evia replacement, even though my current PM is new. I've read through a number of studies on the use of this PM for vasovagal syncope and it looks pretty promising, and I know it was FDA approved for this dx just last year, but I'd like to hear from a patient's perspective too. Surgery, no matter how minor, is always quite complicated for me, so I want to make sure I make this decision with as much information as possible.

Any suggestions or insight you can provide on your experiences with this PM would be greatly appreciated.

20 Comments

Vasovagal

by pezzypooh - 2011-06-27 02:06:16

Hi there...I also have a Medtronic Adapta. I am diagnosed with other things on top of the Vasovagal Syncope...are you? I found that the pacemaker did not fix the entire dizzy/passing out issue - that was more related to my blood pressure - Orthostatic Hypotension. I also have to take a medication - Midodrine - to keep my blood pressure from dropping. Have they checked your blood pressure - such as with a Tilt Table Test? Just a thought...especially since you already have a orthostatic issue...maybe it's connected? I just know that there are days that if I don't take my mediation, the world spins and I barely can stay on my feet....just a thought....I hope they come up with a solution soon! I know that horrible passing out feeling!!! Good luck! Keep me posted on what they find!

Thanks!

by jenny97 - 2011-06-28 09:06:32

Thanks, Pezzypooh!

I guess there aren't a lot of people out there who have this pacemaker for this purpose. I was pretty excited about it after reading the clinical study results, but I'm a little more nervous now. I mean, even in the last five years of not passing out, I still had significant symptoms on a regular basis and curtailed some activities to prevent passing out. So anything that has the potential to get rid of the pre-syncopal episodes too is definitely appealing. But I would really like to hear from patients and understand better the difference between closed loop stimulation technology which is what propels the Evia and the accelerator technology that runs the Adapta. (If I've even got that right.)

For now, I guess, I'll continue my research and wait and see if I pass out any more with my current settings, which were recently readjusted. Being on coumadin, though, makes the whole specter of randomly passing out a bit more frightening.

Pezzypooh, how do you do on Midodrine? Does it make your blood pressure too high sometimes? What side effects have you experienced?

I have taken and failed (or passed, I guess, depending on how you look at it) a Tilt Table Test about 11 years ago. Bps are normally low, 90/60 is pretty typical for me. Heart rates periodically go over 200, especially during exercise. But even at rest they frequently run in the low hundreds on a bad day. In bad episodes, bp often drops to 80/30 and heart rate falls to the 30s. For the last couple of months since everything started up again, I've felt serious pre-syncopal episodes 4-5 times a day. And have passed out numerous times.

My current pm is set for rate drop response, which has worked pretty well for me, provided they allow sufficient ventricular pacing at the same time. But since I'm young (was in my early 20s at initial implantation, now mid-30s), they are worried about the ventricular pacing and they say the rate drop response is over-pacing me. However, I also have 2nd degree heart block, so I really need it and, again, I have presyncopal episodes all the time.

To further complicate things, I have a small aortic root aneurysm and a blood clotting disorder (autoimmune).

So, I guess for me, I just want my life back. Between Feb 3 and April 23, I ran 300 miles and felt pretty great most of the time. Since April 23, I've run 40 miles, had to sit on the side of the road numerous times to prevent myself from losing consciousness, can barely walk up stairs some days, and often have to rest on my 3 minute walk from my house to public transportation. I want to at least return to status quo, but I don't feel like I know enough to make the best medical decisions sometimes. So any input is ALWAYS welcome.

Evia

by shockbox340 - 2011-06-30 09:06:20

Jenny,

IMHO, there is no better device for your particular problem. You are right, there aren't that many out there that have it, partly because it is new and partly because it doesn't come from one of the BIG companies (no names mentioned). The few specialists out there that do advocate this device for vasovagal symptoms do so partly because of the research behind it but mostly because they have seen the difference it can make first-hand.

Evia is new, but the technology that makes it perfect for you has been around for almost a decade: Closed Loop Stimulation (or CLS). Without getting too technical, CLS combats this issue completely differently than any other PM on the market. It can actually 'sense' when your brain is trying to increase cardiac output and begins pacing faster immediately. Others wait for the "pause" and respond by pacing faster. CLS allows pacing faster before the pause even happens.

Please keep this board posted if you do have the device changed and, if so, what differences you experience. Patients who get this technology after another company's device are my best salespeople with the doctor, because the doctor listens to you! Obviously, I work for the company, but not in your area so I'm not saying this for financial reasons. I promise you will feel a difference!

Thanks, shockbox

by jenny97 - 2011-07-01 09:07:42

I'm trying to get in at a major educational hospital for a second opinion. I'll definitely post my experience one way or the other. I know I was a great walking commercial for medtronic because my first pacemaker absolutely changed my life! I got so much quality of life back, it was amazing. So if I get the new one and it makes a similar difference, I will definitely share.

Plus, as a patient, I know I would prefer to hear about the impact of the device from someone who's experienced it. It's good to talk to someone who knows what it "feels" like in addition to knowing about it from reading and studying it.

Thx crdismom!

by jenny97 - 2011-08-31 12:08:44

I have an appointment at Mayo in November and am just trying to hold on until then. Currently, I'm fainting a few times a week (always in the most inopportune places) and nearly fainting several times a day. I hope it works for you and look forward to hearing more about your journey.

evia

by crdismom - 2011-08-31 12:08:58

I currently have the Evia for cardioinhibitory reflux syncope. Its been in two weeks. I am still having the near pass out episodes. Lots to still work out on it but dr was really confident that this is the correct one for me. I'll let you know more I go.

MAYO

by crdismom - 2011-09-12 05:09:45

Jenny97--
funny that you are headed to the Mayo. I couldn't stand the answer of just give it time and it will get better. I was having the pre-syncopal epsidoes once or twice a day. I am still exhusted and having episodes where my heart feels like it will beat right out of my chest, without doing exercise. I had the PM tweeked so it was at the most sensitive and it was only set to pace +50. The DR said give it time and I will see you in a year....seriously?!?! I put in for an appointment to Mayo and got in with in the week. So last week I spent time with a regular cardiologist and then they put me thru the paces. I passed the tilt table ( couldn't get me to go out) they did see my pacemaker pace during those but didn't see my BP drop too greatly. Plus a litney of other tests. I will be back the first week of Oct to see the Cardio EPs. Since I got in so fast they couldn't get that one on the same trip. So glad I live close to Rochester.

Loved all the the attention and thoughtfulness that their staff gives. They too were worried about ventrical pacing. so the put it up to the highest time setting between pacing. I never knew that I had to know all of the terms with this bugger. They do think they can help me figure it out but it will be a long process.

Good luck...bring a book and really good walking shoes as they have you run all over the place.

Thanks, Crdismom

by jenny97 - 2011-09-12 06:09:00

I am very scared for Mayo since I have been so unstable, even on meds, and I have to go off of them for the testing. I've had two tilt table tests and the first one was absolutely horrifically painful, with a feeling like my heart was literally ripping in two. The second was supposedly not positive. But, it depends on what you are testing for, as I understand it. Vasovagal syncope will cause a drop in blood pressure, while postural orthostatic tachycardia syndrome will cause an increase in pulse that just keeps climbing. In my "negative" tilt, my heart rate was 160 standing, which signals autonomic nervous system dysfunction, as I understand it.

I'm with you though. I'm sick of being told this is not a life-threatening condition, while I watch my life fall to pieces all around me. I'm passing out a lot these days and feel sick most of the time.

Do you have rate drop response on your PM? Did they turn it off for the tilt table? Mine is set to help when the hr drops suddenly, which often happens when standing (but not always). So I'm curious if they will turn it off temporarily.

As for the ventricular pacing, I feel better when there's less of a pause. I know there's so much concern about it, but I only have passed out since my pm was implanted when they've messed with that setting. I would rather live another 10 years and have some decent quality of life, than live another 30 where I am passing out all the time and unable to support and care for myself. I don't want to be a burden. And I don't want to suffer.

Had you been to Mayo before? I'm surprised they got you in so quickly. I was wait-listed and they gave me a 12 week lead time. Maybe because I'm an out of towner. It's hard to wait, especially when you are as unstable as I currently am.

Also, how did insurance work?

Anyway, thanks for your response. It's good to hear from someone who's been through it.

Mayo Follow Up

by crdismom - 2011-10-06 08:10:14

Well my appointments have come and gone. I think I got in because I was a former patient and my case was so suddent and without any warning. I passed out one day and had the PM the next. My patient number starts with 03 to give you an idea how long I have been there.

My Holter and oxometer showed all normal along with the blood work.

Yes I do have the rate response turned on. They left the pacemaker on during the tilt table. They are able to see when it starts pacing. They did confirm that it is vessovegal syncope with the cardio inhibitory side.

The doc did say that the PM is a controversial way to treat syncope but with how long my pauses were it made sense to put it in. They did talk about Beta-blockers and Midodrine. I really don't want any drugs. I wasn't on anything before this. They did reiterate that I need to more salt, drink more water, work on getting my leg muscles tone, drop weight, wear support hose and Spanx. And to raise my bed so all the autonomic nerves have to work harder. And to avoid the known triggers--for me that is a small environment that is warm, like my car. I have had pre episode getting into a warm car....glad I live in MN

The description that I got of the vegas nerve made me understand it more. Apparently it is nerve from when we were less developed and never evolved so it is not well insultated and has fiber that can cross so it if it goes hay wire it is toough to pin point where it is wrong. For example our skin nerves can tell us exactly where we burned ourselves but the vegas nerve just tells us there is pain in the tummy--not that the left lobe of the liver is hurt. I guess that helped me get it.

I am still not okay with all of this especially the excercise component but if it will keep me up I guess I will do it. Grudenly.

Good luck!

Recently diagnosed

by jfuhring - 2012-01-18 01:01:22

I've been recently diagnosed with vasovagal syncope. The first through fourth cardiologists recommended a Boston scientific or Medtronic pacemaker. I went to see an electro physiologist. He stated that the biotronik pacemaker was the only one that would work for me. My operation is scheduled for jan24.

Headed to Mayo Clinic

by JustKrs - 2012-02-02 07:02:17

I'm currently unpaced with vasovagal syncope.

My EP Cardiologist here in Chicago at Northwestern has worked with me the last two years to try to imporove my symptoms, but they are still troublesome.

I'm already on high salt, high fluids, midodrine, and fludrocortisone. So last week he explained that the next step would be on of these Biotronik CLS pacemakers, but he is hesistant because I have an odd presentation of syncope.

Apparenly most people are AOK shortly after they come to after blacking out. I on the other hand will have a pulse in the 30s or low 40s afterwards for DAYS on end. In November I was hospitalized for a part of a 10 day spell of this sort. And they couldn't do anything other than monitor me.
Because im an odd presentation he said he cannot know for sure if the pacemaker would solve the problem. He has put 5 of them into syncope patients previously with good success in 4/5 though.

So off to Mayo for a second opinion before we put the pacemaker in.
I''ve never been to Mayo so I'm a little nervous but I've heard its the right place to go for complex syncope issues. I'll be seeing Dr. Michael J. Osborn in cardiology there.

Good luck at Mayo!

by jenny97 - 2012-02-04 01:02:45

I don't know if you'll see this message, but I wanted to wish you the best at Mayo. I was there recently and they have quite a good set up with lots of specialists. I hope they will be able to help you out.

My own presentation of syncope is unusual too, although very different from yours. Like you said, most people recover from blacking out ok. But although my heart rate will return to normal and blood pressure will be ok, I am sick to my stomach, dizzy, and fatigued to the point of paralysis anywhere from 20 minutes to 1.5 hours after an episode. Once I regain the ability to move my limbs, I must sleep before I will be able to resume normal activities and not suffer spikes in my pulse with every movement.

Anyway, I wish you the best at Mayo and hope they are able to help you regain your quality of life!

Mayo's Verdict

by JustKrs - 2012-03-03 05:03:28

Well... went to Mayo a couple of weeks ago. The EP Cardiologist says she does NOT recommend pacemaker for vasovagal syncope because she doesnt think the research proves it would help.
On the other hand... Mayo had nothing better/different to offer. They said they had no other treatment ideas, recommendations or plans.

sooo.... i know that when it comes to syncope there is no guarantee that the Biotronik Evia pacemaker will reduce or get rid of symptoms. But I also know that for some people it does. And if there is no OTHER things to try.....
pacemakers seem like a pretty safe thing to try

thought anyone?

surgery scheduled

by JustKrs - 2012-04-20 07:04:24

Getting my Biotronik Evia Pacemaker for Vasovagal Syncope on April 30th

Good luck!

by jenny97 - 2012-04-20 07:04:35

I hope it does the trick for you! Keep us posted.

New Biotronik Evia Settings

by JustKrs - 2012-05-05 10:05:26

Got mine on April 30th, yesterday was my first day not on vicodin. Mostly so far I've been sleeping. I guess the procedure is tougher on my body than I expected.

Thankfully I work from home - so my laptop and I can work from bed next week :D

The first few days my pacemaker triggered the algorithm and it jumped my pulse up to the 120 line...
it kinda freaked out the nurses in recovery who are not used to seeing that in regular pacemaker patients - but my doc explained that the pacemaker may have some "false positives" where it paces when not needed as it is learning me.

I've been told my settings are "Aggressive" to try to make sure we catch as much as possible.

My settings are (they gave me the print out after interrogating my device the day after surgery):
Biotronik Evia DR-T
Symptom: B1 Syncope
A Lead: Biotronik setrox s53
V Lead: Biotronik setrox s60

Mode:DDD-CLS
Basic rate: 50
CLS: 120
CLS response High
CLS resting rate control OFF
CLS VP required: No

Sensor rate fading: 120
sensor gain 4
automatic gain ON
sensor threshold Medium
rate increase 4ppm/cycle
rate decrease 0.5 ppm/cycle

upper rate response 140/2:1
2:1 rate 129
upper rate atrium 240

Mode switching 160/DDIR
Intervention rate 160
Switch to DDIR
Onset criterion 5/8
Resolution criterion 5/8
Crhange of basic rate +10
Rate stabilization during mode switching OFF
2:1 lock in proctection ON

Vv suppression OFF


AV delay after pace all rates: 215ms
AV delay after pace sense compensation OFF
AV hysteresis I-Opt
AC delay after pace AV hysteresis @ 60: 400ms
AC delay after pace AV hysteresis @ 80: 400ms
AC delay after pace AV hysteresis @ 100: 400ms
AC delay after pace AV hysteresis @ 120: 380ms
AC delay after pace AV hysteresis @ 140: 300ms
AC delay after pace AV repetitive cycles: AUTO
AC delay after pace AV scan cycles AUTO

Atrium Pulse Amplitude: 3.0V
Atrium Pulse Width 0.4ms
Atrium Capture control: OFF
Atrium Sensitivity: AUTO

Ventricle Pulse Amplitude: 3.0V
Ventricle Pulse Width 0.4ms
Ventricle Capture control: OFF
Ventricle Sensitivity: AUTO

Regractory period/Blanking: Individual
Atr refract period: AUTO
Auto PVARP OFF
PVARP 250ms
PVARP after PVC 400ms
Ven refractory period 250ms
Far-field protection after Vs 100ms
Far-field protection after Vp 150ms
Ven. blanking after Ap 30ms
PMT protection ON
VA criterion 350ms

Home MOnitoring ON
Time of transmission AUTO
Periodic IEGM 30days
High atrial rate AT
Ongoing atrial episode 12:00
High ventricular rate ON

symptom free

by JustKrs - 2012-09-15 10:09:41

I've been symptom free since my pacemaker was put in back in late April.

This was the answer in my case!

After 4 months had to have a lead revision (ventricular lead wasnt sensing right) and a pocket revision (the pacemaker was flipping when i laid on my side).

But otherwise I've been very happy with things!

how's everyone doing??

by JustKrs - 2012-10-22 07:10:28

So ive had my pacemaker for syncope for 6 months now and im symptom free. I dont even get the pre-syncope symptoms. It's pretty awesome.

now i just have to get off my butt and get working out back into my lifestyle (docs had me on NO ACTIVITY for about 3 years it took to figure this all out)

Biotronik

by mohammedalo - 2013-03-21 12:03:49

I'm a cardiologist in Toledo, Ohio that has been treating vasovagal syncope with Biotronik Evia pacers. I have had tremendous success with this device. Every one of my patients has had complete resolution of their vasodepressor syncope. The Mayo clinic has started referring patients to me for treatment after they give up trying to treat them with medications. Google "Dr. Blair Grubb syncope". You will find tons of research on this. Unfortunately people at big name places like mayo clinic sometimes haven't heard of the latest technology or they are stuck in the old way of doing things. If a cardiologist is telling you that pacers don't treat vasovagal syncope, you should find a new doctor. Most patients end up never having to take pills again. This thing is a miracle and will change your life. I've had patients fly in from all over the country to get this done, their lives are completely back to normal.

Yup!!

by JustKrs - 2013-05-22 12:05:55

Yes, since getting my pacemaker the ONLY time I've had symptoms is when i caught norovirus and was SOO dehydrated that there wasnt enough blood volume for the pacer to work with :D

I'm off ALL the meds I had been on before (midodrine, fludro, etc)

I LOVE my Biotronik pacer!

Mohammedalo - do you know anyone in/near Austin, TX that works with Biotronik pacers? I'm considering moving back down there for work... but want a doc that knows my device!

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