For the past fifteen years Zoll Medical has done a remarkable job selling their wearable defibrillator and has certainly created a perfect name for it: The LifeVest. Too many local news agencies, who commonly neglect performing adequate research into their stories, have in essence promoted Zoll’s product as a lifesaver – and too often by using phrases that appear to come directly from Zoll’s own PR handbook.
In my review of the literature I noticed that most news agencies failed to mention the price tag for this vest — $10,000 for a three-month rental.
Welcome to mobile medical technology. The LifeVest is a wearable defibrillator that beeps when things go wrong, squirts gel onto your chest and then, if you fail to disarm it, shocks you with up to 150 joules of electrical energy, apparently, sometimes by mistake and when you are wide awake!
Approved by the Food and Drug Administration (FDA) in 2001, the LifeVest, also known as the wearable cardioverter defibrillator (WCD) and manufactured by ZOLL Lifecore Corp, a subsidiery of Zoll Medical, is a very innovative device that was approved for use by patients “who could not receive the standard implantable cardioverter defibrillator (ICD) for a relatively short period of time.”
In Fact Zoll cleverly markets their vest to doctors and patients with statements like this:
The LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess their long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their common activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk.
In the clinical setting some patients have suggested that they feel they are wearing something more akin to a suicide vest and are troubled that they may receive that “treatment shock,” a jolt of 150 Joules of electrical energy, in error while they are awake and quite alert .
Clearly this device appears to have its own particular drawbacks and risks, as well as lacking any randomized trial data to support its use. And yet, the FDA did not provide any specific guidelines or instruct doctors about which specific patients might benefit from the wearable defibrillator. Instead they approved the device for certain patients who are at risk of sudden cardiac arrest but because of certain medical conditions were not candidates for the implantable defibrillator – somewhat unclear indications to many cardiologists. We have a device available in the market, never studied in a prospective randomized trial (one study known as the VEST trial is still ongoing) where the manufacturer and the physicians, some of whom work for ZOLL, are discovering indications for its use and then touting the benefits to their colleagues and the insurance companies by reinterpreting the FDA indications for their device.
To be fair to Zoll there is quite a bit of data showing that if a patient does develop a lethal ventricular arrhythmia the device is quite successful in correcting it, but–and I must continue to repeat this–there remains NO randomized data showing which type of patient might benefit from the device. None!
There does appear to be some niche populations that certainly seemed to be candidates for this device: Patients who had an infection where the ICD needed to be explanted (removed from the body), as part of their treatment to eradicate any foreign bodies where bacteria could survive, and who clearly remained at risk for a life-threatening arrhythmia; patients with some transient type of viral heart infection who are likely to get better but who demonstrate high risk for sudden death.
But even at a cost of $10,000 for each patient such niche populations were not going to make ZOLL rich. Sure, everyone agreed these patients could benefit from such an external device but ZOLL’s board likely calculated that they needed a much broader customer base—they needed to pull that $10,000 cash register handle many more times.
In an almost Catch-22 paradox, Zoll would find their cash cow in the most ironic of circumstances. Large randomized controlled trials, the ones that Zoll had failed to supply, showed that the real implantable ICDs offered no mortality benefit to patients who received these implantable devices within 42 days for clogged arteries (ischemic cardiomyopathy) or within 90 days for patients with a damaged heart muscle without clogged arteries (non-ischemic myopathy) or a procedure to revascularize the heart.
So published guidelines as well as CMS and other insurers, who carefully reviewed these studies, decided not to allow or pay for the implantable defibrillators until that waiting period had expired.
Zoll clearly knew what the FDA approved their LifeVest device for: “patients who could not receive the standard implantable cardioverter defibrillator for a relatively short time” and to Zoll, and the physicians who help market their product, that same FDA indication would fit for the thousands of patients who needed to wait for a real ICD. Why not suggest that patients who must wait to get the implantable ICD, even if the studies show there is no benefit, wear their $10,000 vest for those three months? Why not offer patients who could not get the real ICD–because it doesn’t prevent sudden death if it’s implanted in that time period — the LifeVest? It’s a doublespeak bonanza!
Zoll has aggressively marketed this device through paid speaking engagements to doctors who promote and use their product, and by also confronting physicians with the ultimate fear, the ultimate what if! What if your patient dies from sudden death doctor, and you didn’t even offer your patient the device? With their classic quid pro quo paid speaking arrangements and the necessity of some physicians to practice defensive medicine, Zoll is indeed selling/renting their device.
Their further cunning calculation, I believe, is to slowly, oh very slowly, conduct that randomized trial to see if the thing works. Even though the LifeVest has been available for almost 15 years, Zoll has managed to drag out their trial, the VEST Trial, which will follow patients randomly assigned to get the vest or not. By the time the trial results are in, it might be 20 years –longer than a branded prescription drug manages to keeps its patent. So whatever the trial results — favorable or not — Zoll will have already made a fortune. And Zoll conveniently excluded patients with the non-ischemic variety of heart failure, so for these patients there may never be a trial showing if the device helps anyone.
Looking at some of the most recent data published on their LifeVest, a retrospective review of ICD implants at the University of Pittsburgh, and published in the December edition of Journal of the American College of Cardiology, we find the following:
In the ischemic cardiomyopathy group, the patients with coronary blockages, there were a total of 8 patients who received a shock. Two of the shocks were incorrectly given, one patient died immediately, one patient died at the hospital, and 4 survived to leave the hospital. Unfortunately the authors did not report on the further outcomes of these four patients but did mention that they were all men, with a specific ECG abnormality.
In the other group of patients, those with the non-ischemic cardiomyopathy, the patients that apparently will never be studied, no one received an appropriate shock therapy and 3 patients (1.2%) got shocked inappropriately. Getting shocked inappropriately with a 150 joules of electrical energy without sedation might even be considered inhumane to the likes of Dick Cheney.
Until 2012, Zoll was a public traded company, listed on the Nasdaq under Zoll, and provided sales data that included publishing the number of times the Vest device was prescribed, reaching over 50,000 prescriptions at the end of 2011. But since being purchased by Ashai Kasei Group, of Japan, Zoll is now part of that group, and I have been unable to find any sales figures for their LifeVest since the takeover.
I suspect that Zoll, now part of Asahi Kasei Group, has continued to record revenue. I am a clinical cardiologist and I notice more and more physicians prescribing the vest, especially by physicians who accept paid speaking engagements. I believe that the FDA was foolish to allow this device into the healthcare market without restrictive use, until a randomized trial might show some reasonable and cost-effective benefit. For now Zoll has even eclipsed Versace in pricing their vest.
About the author: Evan S. Levine, MD FACC, is Director of the Cardiovascular Center at Saint Joseph’s Hospital and a Clinical Assistant Professor of Medicine at Montefiore Medical Center – Albert Einstein College of Medicine. He is also the author of the book “What Your Doctor Won’t (or can’t) Tell You”. He lives in Connecticut with his wife and children.