One of the most controversial posts I have ever written concerned Zoll corporation’s wearable cardiac defibrillator, which they have smartly branded the LifeVest. Here is the link to the 2013 post:
LifeVest: A Precarious and Unproven Bridge . . . to Somewhere
The less-than-glowing assessment brought me a great deal of criticism, both publicly and privately. I was proud of theHeart.org, which is now Medscape/ Cardiology, for publishing the piece without editing.
I bring this topic up again because of an email I received this week. It came from a patient who had been prescribed a LifeVest. Here is the email, which I post with permission:
I read your story about the Zoll Lifevest. I am currently wearing one due to having a 100% blockage and a stent put in and being told by the cardiologist that I was at risk for SCA. The thing is, this vest vibrates and goes off if I move around and quite frankly scares the hell out of me that it will shock me for no reason. I have been doing cardiac rehab and the heart monitors they have me on show no strange rhythms. I have always been an active person and anytime I wear this contraption, I tend to do less due to being afraid of having another alarm or beeping going off. I expressed this fear with my cardiologist and was told to contact Zoll about it, and they are no help. When I was discharged, I was not told that it was 100% necessary but was told of the risks and asked if I would agree to wear it. I have worn it for 30 days and am supposed to until my next appointment. It has been a huge psychological problem for me because I am scared to wear it and I am scared to not wear it in case I need it. I am sorry to bother you with this and I am not looking for you to tell me either way on what to do. I guess I am just reaching out because I am confused in what I should do. I have gone two days without wearing it but it is in the back of my mind with the “what if”. Your article was the only one I have seen online that didn’t sing the praises of this device. Thanks for your time.
Yes, this is an anecdote. And single cases do not tell the entire story.
But this experience speaks to one of the themes of my blog–namely, the notion of decision quality. This patient, who, by his writing is clearly a straight thinker, did not experience quality in the decision process.
He was told that he was at risk of sudden death, that he could die. It’s hard to know exactly what was said but it’s clear from his words that he was offered more fear than statistics.
He wasn’t told that the benefits of the LifeVest are completely unknowable–because there exists not a shred of randomized clinical trial evidence, despite its use for more than 12 years.
He wasn’t told that the only data that exists on the LifeVest comes from a manufacturer-controlled database. And that database teaches us that his percent same result (living) is greater than 98% with or without the device.
He wasn’t told that the inappropriate shock rate–aka…the wide-awake shock rate equaled the appropriate shock rate.
He wasn’t told that 1/3 of those patients who supposedly had their life saved by a shock went on to die in the coming weeks to months.
He wasn’t told that two randomized controlled trials (DINAMIT and IRIS) of internal cardiac defibrillators placed in high-risk post-MI patients failed to show mortality benefits. (If a real ICD, one that works while a patient takes a shower, did not show benefit in high-risk post-MI patients, one wonders how a wearable cardiac defibrillator would be any better.)
He wasn’t told that Zoll corporation still hosts educational symposium at places such as Ruth Chris Steakhouses. And that the unproven device brings thousands of dollars in reimbursements.
He wasn’t told a lot.
And that my friends is one of the problems with so much of medicine these days.
Decision quality. Absolute benefits. Absolute harms. Percent same result. Numbers needed to treat. Transparency. Goals of care.
These are words that doctors and patients should come to know.
JMM
Ashley D. Coleman says
March 23, 2014 at 11:38 amA clear example of the treatment being worse than the disease.
jane says
March 23, 2014 at 3:16 pmI think that’s one of the best and most important things you’ve ever written. Terrorizing people into believing they are likely to drop dead at any minute, even sitting on their couch, becomes a self-fulfilling prophecy as there’s no chance they will then dare to exercise enough to improve or even maintain their heart function. The *best* electro my husband saw once tried to push one of these things on him if he would not submit to a [NOT recommended by guidelines] ICD, and when I challenged him, he responded with death threats. (“Do you know what will happen to him if his heart stops?!?!” “A clean quick death?” “Yes, in about five minutes!!!” [Unspoken:] “A lot better than the death he’ll get if it’s up to you.”)
Well, hubby refused and proceeded to reverse his “irreversible” heart problems by lifestyle change. But it really made me bitterly angry to imagine how many people who could have done the same wound up quivering in their Barcaloungers because of that guy.
Dan Matlock, MD says
March 24, 2014 at 10:36 amJohn – another great post! The LifeVest has definitely caused some cognitive dissonance with many of the cardiologists I work with.
You hit on about 20 extremely important points in your very succinct post.
One in particular was the use of emotion and fear to drive decision making. I think this is one of the most powerful and dangerous forms of coercion that we physicians employ when we want a patient to do something.
Dan Kahneman (along with Amos Tversky) won the Nobel prize in economics for their work on decision making (aka “behaivoral economics”). Kahneman recently summarized this in his amazing book “Thinking Fast and Slow.” One of the central theories is the Dual Process Theory arguing that people make decisions either quickly – based on things like intuition or emotion (ie running from a bear) or slowly, based on cognitive information like facts, risks, and benefits.
When people prescribing the LifeVest use so much fear when they prescribe such a therapy, they are essentially employing patient’s quick, intuitive decision making. It is no wonder we never get decision quality when we clinicians use such tactics “you don’t want to die do you?”
In addition to communicating the risks and benefits in a way that patients will understand (which is essential), true decision quality also requires a physician to acknowledge the frightening situation that the patient may be experiencing in a gentle way that allows them to get to that second type of decision making so the patient can truly acheive decision quality. That would be true shared decision making.
Joe says
March 24, 2014 at 11:58 amShared decision making at some cardiology offices (no one here, of course!)
Device Rep: These things are fantastic, they save lives, and they will increase office revenue.
Doc: Insurance, will you reimburse for this
Insurance: Yes.
Doc: Patient, here’s your new device.
Decision made!
Dr John says
March 25, 2014 at 5:18 amDan…I am grateful that you take the time to comment. This site is about learning. Your words help accomplish that mission. I downloaded the award-winning book this morning.
Dan Matlock says
March 25, 2014 at 11:07 pmFrom what I know about you and from what you write on this blog – I suspect this will be right up your alley.
It turns out that we humans are complicated…
Anthony Pearson, MD, FACC says
March 24, 2014 at 11:43 amI couldn’t agree more with these observations. About a year ago I saw a patient with a fib who presented with CHF and EF<30%. I did a TEE/cardioversion and started him on BB/ACEI, oral AC and amiodarone. I planned to see him back , titrate his meds to optimize LV function and anticipated that his EF would rapidly normalize. The well-meaning CHF nurses prior to his discharge and unbeknownst to me brow beat him in to signing up for a Zoll Life Vest. He was told not to worry about the costs , that his insurance would certainly cover the device. Since then, at 3 months his EF was back to normal but for a year he has been fighting with his insurance company to cover the huge cost of the device. He asked me to write a letter supporting use of the LifeVest and when I reviewed the literature I realized that it really could not be justified. This is a case where ancillary medical personnel have been brainwashed by a device company and convinced my patient to wear an expensive, questionably effective, uncomfortable device for 3 months.
Dr John says
March 25, 2014 at 5:13 amThank you Anthony for sharing this experience. You might enjoy this thread. http://www.cafepharma.com/boards/showthread.php?t=527481&page=2