Biotronik Enitra

I found this forum after looking for answers.

I had an Enitra 8 DR-T fitted 15 months ago and given an appointment for a year later to download the stored information. 

Doing my own research I found that there is a home monitoring device that wasn't offered to me by my NHS hospital. I have since discovered that the device is available in some NHS Trusts and find this unacceptable but not unexpected. 

Does NICE have any guidance on the use of home monitoring and can I get any feedback on the number of Trusts that use it? Looking at the Biotronik website the use of home monitoring is a better use of clinician's time  but "a clinically proven >60% reduction in all-cause mortality for patients with ICD and CRT-D devices."


7 Comments

Home monitoring - my experience

by Gemita - 2023-05-01 05:09:06

Sky9, firstly welcome.  I also live in the UK, have a Medtronic pacemaker and attend a main London hospital.  Home monitoring is certainly not in use “everywhere” and that includes other countries too but I am sure this will change.  As a matter of fact, my husband who has had a single lead pacemaker since 2018 has only recently received a home monitor due to a change in his condition.  Initially we were told that the hospital’s policy was to offer home monitoring only to those with ICD’s or a heart condition “that required close monitoring on a regular basis”.  This surprised me at the time, since my husband has right sided heart failure and was often unable to attend his appointments due to ill health.  

There is no doubt that home monitoring can save precious time and resources, gives early indication of any problems either with our heart or pacemaker, guides appropriate therapy speedily, gives peace of mind to the patient, is convenient and helpful for so many of us, and yet there are many members here who do not have and do not want home monitoring.

I have always had home monitoring because of my initial worrisome arrhythmias causing syncope but only download data on an as needed basis.  I used to have daily automatic monitoring, but this is no longer necessary since my arrhythmias are well controlled now.  However, fortunately I am still required to attend clinic regularly for pacemaker checks since I recently had several adjustments made to settings which are still in progress.  I am happy with this arrrangement since it gives me the opportunity to learn more about my pacemaker and heart condition because getting access to my data has proved so difficult.

I attach a link from the British Heart Rhythm Society on monitoring guidelines in case it is of help.  There will be NICE guidelines too, but I have to say it will so depend on your clinician, on your heart condition and on your hospital’s policy whether or not you receive a home monitor.  

https://bhrs.com/wp-content/uploads/2022/06/BHRS-CIED-FU-Standards-June22.pdf

Home monitoring

by piglet22 - 2023-05-01 07:48:10

Hello

I am a UK user as well as Gemita.

I am in two minds about having a home monitor. I have a Medtronic's MyCareLink (MCL) and have had it for about two years now.

Before that, I had regular 6-monthly or annual checkups firstly at a very local (over the fence) "cottage" hospital that had a well-equipped cardiology department with ECG, echo and pacemaker facilities. All the major pacemaker suppliers had their diagnostics equipment there and the physiologists used to come to the hospital on pacemaker days.

Out of the blue, maybe 8 years ago, the trust announced that these more local locations would shut and you had the choice of two very inconvenient regional hospitals. If you didn't have a car or someone who could take you, you faced a pretty poor day out on public transport. It was so bad, that I used to cycle the last few miles as car parking was awful.

Then two years ago, they said at the last hospital visit, that all routine checkups at the hospitals would stop, for me at least and probably others, and a home monitor would come through the post.

At first, I thought this was good, but I'm now not so sure. For starters, you don't get the full diagnostics, the full ECG and magnet test etc. You also don't get the familiar face to speak to if you have concerns. A "virtual device clinic" or data download followed by 10-minute conversation on the phone is no substitute for face to face.

GP surgeries have cut back face to face and cynically, I think Covid provided the opportunity to reorganise and introduce cut back services and probably the hospitals did the same.

Probably, the worst bit was not getting any contact from the hospital like "this is why we're doing this" or "how did you get on with setting it up?" It was box delivered by UPS, instruction book and get on with it. I would imagine that it could be a bit daunting for some, especially anyone who hadn’t a clue what 4G cellular phones are all about.

There's also a reliability issue. My MCL is a 2016 model or was. It failed within one year and came up with a load of error messages that needed a longish phone call to the Netherlands to resolve and then get a replacement. No involvement from the hospital.

If I thought it was a life saver, I might be pleased to have it, but I don't have that confidence. It certainly doesn't pick up my arrhythmia and if it does, it doesn't report it.

The hospital let my first pacemaker fail, an experience I don't want to repeat. I'm in the last two years of battery on this PM and am due to go onto 6-monthly downloads at the end of the year. PM batteries have a sharp voltage drop at end of life, and if the MCL isn't transmitting something like monthly battery status, then there's a good chance that an unforeseen failure could happen again.

My advice would be if this comes up in a conversation, make sure they tell you why they are or aren’t offering a home monitor, find out exactly what it does for you, does it protect you by alerting serious conditions and so on.

Self monitoring

by Gemita - 2023-05-01 08:37:49

Sky9, thank you for your private message which I will respond to.  You sound in complete control and that is reassuring.  

I agree with a lot of what Piglet writes, since there is nothing to beat face to face appointments when we have questions, difficult symptoms or need settings adjustments which cannot be done remotely.  

Because of my arrhythmias, I have been told that I will need to continue to attend clinic every 6 months or so, which suits me well because I am still mobile at 74 and prefer it this way.

A pacemaker is only as good as it is programmed by your EP or clinician.  If it is not programmed to store or trigger an alert say of a short run of a tachy arrhythmia, it won’t do so. There are clear parameters that have to be met before a rhythm disturbance is stored/recorded so we may still need to keep our own records during any periods of difficult symptoms and I see you are doing just this with success and reporting your findings. 

Home monitors - NICE

by Selwyn - 2023-05-01 16:35:34

https://www.nice.org.uk/advice/mib67

https://www.nice.org.uk/advice/mib64

I don't think you can get UK information as to which Trusts use home monitoring.

My latest PM is a Boston Scientific and came with home monitor device. 

As previously stated on the Club site, I have been in India for 3 weeks - do they think I have died in that time? Over Christmas I was in New Zealand for 4 weeks.  There appears to be no feedback as to what is going on. When I was getting PM checks at the hospital at least I knew what my parameters were. Now there is a black hole.

Personally, Sky9,  I would be happy to have hospital visits. 

 

Home monitors

by LondonAndy - 2023-05-01 18:48:01

Another Brit here, Sky9 - been paced 100% since a surgical complication in 2014, when I had my aorttc valve replaced. On my second device (since October last year), and never had a home monitor. My new pacemaker (Medtronic) is compatible with them, but my condition means they dont feel one is necessary. If it becomes necessary they will give me one. 

This article, from 2018 in the British Journal of Cardiology, has an interesting study which concludes the benefits of remote monitoring are not proven. https://bjcardio.co.uk/2018/10/remote-monitoring/#:~:text=Remote%20monitoring%2C%20generally%2C%20has%20yet%20to%20be%20proven%20to%20be%20a%20truly%20clinically%20and%20cost%2Deffective%20tool 

British Journal

by AgentX86 - 2023-05-01 22:16:39

I think that's a very one-dimensional summary of the article, particularly as it relates to pacemakers/ICDs.

"In contrast to single parameter monitoring, a combined multi-parameter heart failure diagnostic algorithm based on observational data showed that patients at higher risk of hospitalisation for heart failure could be identified within a 30-day window.18 Also, the Implant-based Multiparameter Telemonitoring of Patients with Heart Failure (IN-TIME) study19 used CIED monitoring of tachyarrhythmia, sub-optimal biventricular pacing, increased ventricular extrasystolic activity and decreased patient activity, with data sent daily to a central monitor. This approach was compared with usual care in 664 patients across 36 centres over 12 months and there was a reduction in a combined end point of death from any cause (an effect seen in patients with atrial fibrillation), with improved patient global self-assessment and New York Heart Association (NYHA) class change."

The article did answer the question of why not everyone is remotely monitored (shouldn't be new news to anyone):

"Mechanisms for reimbursement for remote monitoring services are highly variable, both within the UK, and more broadly across healthcare systems."

 

Home monitoring

by sky9 - 2023-05-03 03:33:38

Thank you all for the feedback,

I haven't been able to find any advice from Nice on the Biotronik Enitra but it is their claim of a clinically "proven >60% reduction in all-cause mortality for patients with ICD and CRT-D devices." that attracts my interest.

My Trust appears to be working on the basis of installing the device and see you in a year for your next appointment. I have been having issues that have required me to return for further investigation but it is initiated by me.

The game-changer for me was buying a Fourth Frontier X2 Heart Rate Monitor that records a single lead ECG but also gives you an analysis of normal and abnormal rhythms. It would be great if someone with more knowledge of pacemakers could review it. In my opinion, it is far better than the Karnia or any of the new ECG watches as it can record up to 24 hours. It isn't yet approved as a medical device but Athletics Weekly has done a recent review.

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