ICD Education

I was due to have an ICD installed in March when the hospital stopped taking elective procedures because of COVID-19. I was rescheduled for June 8th. I postponed this procedure because I had some questions about the ICD model my doctor selected; the St. Jude Medical 2-wire.

During my research on ICDs, I came across a battery reliability study on the U.S. National Library of Medicine National Institute of Health's website; https://www.ncbi.nlm.nih.gov. This study is dated Oct/Dec 2016. This information along with the articles I found concerning faulty leads recalled by the FDA in 2014 (?) on St. Jude Medical devices was the basis for me to postpone my June 8th procedure date.

I can't find any current reports or studies on the reliability of the various manufacturer's many different models. I am skeptical of my doctor's selection at the moment because I am unsure of his decision process and if it has any monetary rebates from a manufacturer or its rep.

How can I educate myself to make an informed decision?

My neighbor's doctor chose the Boston Scientific model. Is the Boston Scientific model a better unit? Its batteries are rated as the best in the NIH study from 2016. I don't enjoy the idea of being cut open every 3 years for a battery change on a St. Jude model when I can go 6 years with a Boston Scientific.

 

 


3 Comments

It's as difficult a decision as you wish to make it

by crustyg - 2020-06-17 18:02:55

Being Cassandra for a moment: BostonSci had about 2900 devices recalled from Sep 2018 for short battery life due to hydrogen-induced accelerated battery depletion (FDA website), they also had a significant issue with third-party leads and noise problems causing pacing issues around the same time.  Medtronic have had a number of security issues with their devices and a lot of recalls for firmware updates.  No vendor is perfect, but they all try hard to make their implanted devices perform well: apparently more so than some of the implanted hip-replacements...

Switching to Polyanna mode: there are millions of implanted PMs/ICDs at any given moment, and the overwhelming majority perform well, delivering close to the lifespan projected at implantation - although I think ICD lifespan is heavily influenced by the number of times it delivers a shock - it's quite a big drain on the battery.

Sadly you are correct that *some* physicians are influenced in their choices by other factors - it might be as innocuous as they only have control/programming kit from one vendor (so implanting from another vendor would be crazy - no ability to control it), they may have a *lot* more experience with a particular vendor, or the hospital where they have admitting rights has done a solus deal with a vendor - free control/programming kit if they implant <x> devices pa.  Or they may just be accepting inducements - heaven forbid.

There has been adverse comment about the quality (thoroughness and duration of testing) by some medical device regulatory bodies, especially for some leadless devices.  But they are in a cleft stick: new device, promises great advances in ease of installation etc., and they say 'You can't put any in until we have a six year device reliability study done with 500 devices.  Great.  Thanks to some effective lobbying, the FDA never gave full approval for Thalidomide (one up to FDA), *BUT* they were so slow appoving metronidazole that Vets returning from Indo-China with amoebic dysentery were denied the most effective treatment (one down to FDA).  It's not an easy line to tread.

Choice of leads is really controlled by two factors: all kit from one vendor may give you a system that will enable an MRI - otherwise many imaging facilities will refuse.  Secondly, some leads are *much* easier to install than others - shape of curve, flexibility, ease of nudging them into tiny openings etc.  And if your EP doc is paid a fixed fee for the implantation then why waste time (and your time under the fluoroscope) with leads that are difficult - in their personal experience.

If you don't trust your physician enough to have a blunt conversation 'What factors have you considered regarding your choice of ICD for me' then you shouldn't trust them to implant *anything* in you.

Stop shopping...

by CyborgMike - 2020-06-17 20:41:02

Dhansen, I am like you. When I found out I was going to get an ICD I did a ton of research and talked to a lot of people. I only had about six days notice and when it came down to it, I didn't really have a choice anyway. I had been admitted and my pulse was dropping down to the 20's at night and they would have to keep waking me up. I was in over a three day weekend, so when the EP came in Tuesday morning I took what he suggested.

That said, I have a number of friends that are very senior at $10B Med Device companies. They connected me with their top analysts who work with the manufactures and my take away from the conversation (18 months ago) was "they are all about the same", as long as it is MRI safe and has rate response (almost all do now) then there is not a lot of difference in battery life, lead life, etc.  Things fail, but statistically it is a tiny percentage. I ended up with a St. Jude Assura ICD. I'm very happy with it and projections for me (pacing 95% / 5%) is about 9 years. My implant was done at Scripps where they do about 15 a day. So, I trust they know far better than I do what is going to have the least trouble. 

If you needed an ICD in March then every day that goes buy is a risk for you. You don't want to have an event while window shopping for the best ICD. 

Controlling ICD

by AgentX86 - 2020-06-17 22:33:21

It's not just a matter of the kit they use to control the PM.  Think about all the training the PM techs would have to go through for another manufacturer.  And then keeping them all straight.  It does make sense to specialize on one brand and perhaps even a limited number of models within that brand.  The EPs likely have favorite models of PMs and leads, even, for each sort of electrical problem.

IMO, if you can't trust your EP to do the right thing, find someone you can.  That includes the model of the PM.  I don't think it's a good idea to be telling specialists their business.  I wouldn't tell an electrician working in my house how to do his job, even though I know how to do it myself. I certainly can't implant a pacemaker.

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