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The Miracle Money Making Vest

January 28, 2016
By

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.

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5 Responses to The Miracle Money Making Vest

  1. Michael McMillan on December 28, 2016 at 5:07 am

    My experience with Zoll and the Zoll Lifevest has been very poor.

    Pros: It might? save your life

    List of Cons:

    Con: When the company representative firsts fits you with the device there is no mention that it is over $36,000 a year cost that the patient may be responsible for.

    Con: Poor customer service. When requesting information on airline travel with the lifevest I had to make multiple calls. I would be told they were emailing information and then never received promised info forcing me to call back.

    Con: Poor customer service. When I spoke to the billing department that is supposed to answer billing and insurance information the Zoll representative refused to provide me with any billing information, costs etc. I was told that if I wanted any information to contact my insurance company. What kind of company refuses to tell a customer How Much?

    Con: Very expensive. Insurance coverage on device is limited and cost to the insurance company is over $3000 a month. My out of pocket after 3 months is over $1800 and next month the out of pocket would be the full $3000+. Claims made by Zoll on insurance coverage for the device may not be true. I recommend patients check with their insurance carrier for specific coverage.

    Con: Zoll appears to be making false claims to doctors. Zoll representatives are telling doctors that Zoll is working with patients and offering payment plans to those in financial need. That is not true. Due to money issues and new insurance I cannot afford the Zoll vest in 2017. I have no past due amount and no late payments. When I called and had to discuss returning the vest because of financial concerns all the Zoll representative does is instruct you on returning the equipment. There is no offer of assistance or payment plan.

    Con: Causes significant skin irritation and sores if used for more than a month or two. I began to develop open sores where the sensors are in contact with the skin. Similar to bedsores and inevitable when you have something pressing against the skin 24 hours a day.

    Con: False alarms – I have to unplug the unit wait 15 seconds and plug it back in. It then works OK for a while. Constant fear that it may go off inadvertently. The alarm is loud, but not loud enough in all circumstances. I sometimes work in a loud environment and have had the alarm go off and not hear it. There is a real danger the unit can discharge when there is no heart issue. If it goes off at the incorrect time it can stop a beating heart. According to a letter from the FDA to Zoll in 2014 “approximately half of all treatments delivered to patients are inappropriate shocks”

    For those with very low EF numbers it may be worth the cost and pain. It also may be the only way a hospital will release you after being diagnosed with a heart medical issue. However at over $3000 a month, a billing department that will not discuss billing, questionable statements on insurance coverage for the device, Zoll making false claims to doctors about assisting patients in financial need, and very poor customer service I cannot recommend this device or company. Company appears to only be concerned about $$$$ and not patients.

    I had to return mine because I cannot afford $$$$$ month after month. I would have been at $5000 out of pocket after only 4 months if I had not returned the equipment.

  2. John Wright on October 18, 2016 at 11:05 am

    I had the vest prescribed for me in November 2014. I had “A Flutter”. I agreed to meet with the Zoll representative in my hospital room. I did not want to wear the vest. I made it clear that if I did wear the vest I was not in a position to even pay a copay. I was assured by her that it would not even been offered if my insurance company was not going to pay.
    I wore the vest for three miserable months. The alarm went off multiple times a day and when I called Zoll I was told there were no warnings sent to them.
    Here it is October 2016 and I received a bill from Zoll for $10,110.00 because the insurance company refused to pay. I called Zoll and got no satisfaction, I was told I am ultimately responsible no matter what the sales person told me. Now it looks like I have a fight on my hands.

  3. Gary Jackson on July 16, 2016 at 1:55 pm

    My experience with Zoll was disappointing to say the least. The Zoll Lifevest was prescribed during my hospital stay after a heart attack at the end of October 2015, where a second stent was implanted. We would never have taken it if not covered by insurance. The device never worked properly and would go off at any moment, many times a day, even when doing something as simple as tying my shoes. I am athletic and in good shape, but have hereditary plumbing problems and was back to working out, albeit a bit lighter at the beginning, within a week of the heart attack. The data transfer never worked, even after repeated phone calls to the company, and sitting by my modem for hours to get the best signal in the house. Their suggestion was to go to a public library or local fire station for a better data transfer connection. Talk about ineffectual. The end result was that no data was ever transferred to the company, or my cardiologist. In mid-December, after less than two months I took it off and returned the device to the company. I had concluded that, for me, it was a piece of junk and not meaningfully supported by Zoll. Fast forward to June 2016 when we received a bill for $880 dollars from Zoll. We are fighting this money-grubbing from a company that is not upfront about its product or service, a service it never delivered upon.

  4. heartdude on February 13, 2016 at 8:21 am

    Clean up the waste and you can fund healthcare. You cannot elect a president who accepts funds from big business and big Pharma.

  5. liberalvoice on February 8, 2016 at 4:02 pm

    There are various estimates for just how much of our healthcare system wastes on unjustified treatments, bogus application of medical devices, ineffective drugs and CYA. It’s in the 800 billion dollar range. How many people are denied health care because so much money is merely lining the pockets of the corporate players? You can buy healthcare for a country for what Americans are wasting and getting ripped-off for. France, which is the gold standard for national healthcare, spends less than 2/3 (as percentage of GDP) of what the US does. Why is congress so uninterested in why? Because it’s about profit for the campaign donors. The Republicans aren’t going to look into that, now are they?

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