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
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