Implanted automatic defibrillators, known and described by several confounding names, have been in the market for a few years now. Essentially, just like all implanted devices, they have always been high risk devices. CRT is more riskier and expensive than implantable AF devices.
Every company involved in the manufacture of implantable defibrillators has been involved in expensive recalls and patient deaths:
1. Medtronic:
http://www.medtronic.com/product-advisories/
2. St. Jude: (I wasn't able to find any fatalities related to St. Jude's device)
http://www.schmidtandclark.com/St-Jude/
3. Boston Scientific/Guidant: (The most famous one)
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01185.html
Whither logic?
Given the very risky nature of defibrillators themselves, CRT should naturally only be recommended and restricted to patients severely afflicted with atrial fibrillation(AF). Of course, device makers have never concerned themselves with such aberrations one would call logical.
Why bother, especially when it can be claimed that because it is highly likely that patients with mild to moderate conditions of AF may progress to severity over the years, implanting them with the defibrillators is essential. This is why you see Medtronic's competitor, Boston Scientific prop its CEO Jim Tobin to "cautiously" suggest that MADIT-CRT will succeed.
After all, if it's good for the goose (and the officious FDA is easily pleased) then it will be good for the gander too...
It is in fact, quite true that patients with mild to moderate heart disease may progress in disease severity. But..., well, let's first look at the positives.
The Positives
While the study did not show progress in the first year, of the 262 patients carried over to the second year of MADIT-CRT (based on the assumption that one year wasn't sufficient because of the pace at which the disease spread), 180 had the device turned on in the second year. Of the 180 with the device turned on, only 19% had disease progression compared to the 82 in the other arm where a device was implemented but not turned on. In the second arm, 34% worsened in disease condition. This means that the device itself has a statistically significant chance at success in the patient group.
Why the rant?
1. For one, the devices are very risky, even for patients with severe disease conditions. These risks have not been mitigated to the extent that we can be confident that someone without a severe prognosis should risk having these implanted.
2. I haven't read the original study's details and I plan to do so, but I haven't seen the extent to which aggressive medical treatment was indeed pursued in this study. What about pursuing medical management aggressively in the future? Will that offset the need for a CRT device?
3. Is there a scientific technique by which the risks vs. benefits of CRT can be compared, and in turn, compared with respect to medical management? We don't know, and of course, no one is going to try hard.
4. Competition - No matter what the shiny press releases and the glossy pamphlets tell you, no one really understands AF and failure all too well to the extent of treating it, and none of the medical treatments/device treatments have had what can be termed "remarkable" success. Companies such as Hansen Medical are developing robotic mapping catheters that may have a better effect than implantable devices. If a procedure tends to work better (of course, we have no clue as of now) than an implantable device, then the patients who did have the devices implanted would be at an unfortunate and unnecessary risk...
5. Implantable Devices - With Implantable Devices, "Houston tenemos un problema"! It is always a high-risk option to consider implantable solutions. While, cardiac risk represents one of the highest echelons of risk, they have found in-roads much easier than with other diseases.
Remember all the apnea implantables? They competed with the ugly monstrosities that CPAP masks are! Easy to bring an implantable that gets rid of the CPAP mask to market, right?
Wrong!
Okay, so procedures and surgeries always win, right?
Wrong again! Years ago, I worked with a company on an RF procedure to treat migraines by closing the Patency of Foramen Ovale, shortly and sweetly abbreviated to PFO. Well, many other reasons aside, one big question never went answered - Hey, I get migraines, but will I let you poke around my heart with a catheter? Well, the device failed due to ineffectiveness, but once someone like NMT (if they can stop suing all the independent researchers who disagree with them, an excellent PR exercise by the way) has to actually answer that.
However, the point remains. If insulin pumps can deliver insulin shots from the outside into the inside, and can be easily removed and replaced in case of malfunction, then that is a good way to brainstorm the next AF device! So, yes, my doubts remain. I don't think any of Medtronic, Boston or St. Jude have a winner and probably ever will (innovation is different from market share grabbing), unless they buy someone out.
Really, can you have a wearable CRT device? Maybe, who knows? And in any case, if you are not afflicted with severe heart failure, would you really want something implanted? At this expense, given where our healthcare systems are?
What next?
I am predicting, if this is not carefully watched, and if the "big 3" (if you will) do not start forcing Doctors' arms and implant the patients willy-nilly, two things will happen:
1. Defibrillator style CRT tort suits:
Oh don't worry about Riegel and Pre-emption. It is going to go away, sooner than later. It won't be long before Congressional legislation finds a way to bring injury lawsuits back. Which means, the next time there is trouble with one of these implanted defibrillators, there is going to be a lot of unnecessary diversion.
2. NEJM, JAMA or some agent of sanity will come through, just like NEJM did in 2007, clearly demonstrating that Drug Eluting Stents are disappointing when compared to medical management of coronary disease. Since then, DES has only seen misery and collusion. Now, the drug manufacturers and the device makers have gotten together to perform a study to "prove" DES superiority. Hmm, Good Luck.
Oh yes, I know, HHS sponsored a study and proved that DES is better than bare metal stents - but, really, who cares? How do stents do by themselves?
A note on "Business Development and Medical Device Case Study Authoring"
All said and done, such
The end result?
You are stuck with heavy investments in technology, manufacturing, intellectual property and everything else, going in one direction. And now, it becomes your business to stifle and possibly shut down competition, compromising on patients and customers.
Once down this path, you have to keep going down, you cannot make turns and you will have to keep spending money on diminishing returns, both in profits and in PR. Of course, the solution is not to hire more MBAs to cover this up and muddle reality :). Leave that to the technology industry and Microsoft.
Medical Device Companies cannot stifle innovation and get away with it. Yes, it is difficult to start a company, do the trials and bring the device to market, but companies can and will do it.
What can you do?
To start with, cut down on the ppts, the seamless integrations, the fitting of the round pegs in the square holes, innovateuring, inventeuring - in short, BS! Don't limit strategies to "industry experts", and "Business Development" or "Marketing Driven Product Development".
"Marketing Driven Product Development"
I once had an amusing interview with a Marketing Director who asked me what my opinion towards "MDPD" was.
You want to know what happened right?
Well, I didn't take up the job and about a few million dollars later, the MDPD failed and the project was scrapped. A failed engineering student could have pointed them that, if they had developed the ability to listen.
Another MDPD situation I was involved in included sitting and making the shape of a device look "safe". And no, it didn't look unsafe to begin with. Moreover idiots and Joe Shmoes don't get to become coronary surgeons...
So, should engineering departments drive design?
Wrong Question. Competitiveness, Innovation and an undying flair for cutting-edge products that "save patients lives" and "do not, absolutely, do not compromise patient safety" should drive design.
Don't shut off your "strategy" and "business development" activities to Powerpoint experts. Let everyone play. Do constant reality checks. Make everyone go to the operating table and observe...Hey, you should really be paying me for this. :D
Conclusion
I think Madit-CRT is good news, but caution needs to be exercised in how it is introduced into standard treatment practices. I would also surmise that smaller start-ups designing the right CRT solutions can do with some extremely cost-effective marketing - "Hey, we have an indication for moderate to mild heart failure risk, and guess what, we don't leave anything in your body"..oops, did I say that out loud?
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