Why should I consider the LifeVest System as a treatment option for my patients?
What do I need to do to be able to prescribe this for my patients? (How do I get a LifeVest for a patient?)
How much research has been conducted?
Has the FDA approved use of the LifeVest?
What training tools are available for me if I prescribe this to my patient?
Who will train my patient on how to use the LifeVest?
How long does it take to fit and train a patient?
How complicated is it to learn how to use, for both my patient and me?
What are the applications for use; how are other physicians using it?
Is the LifeVest covered under insurance?
How long is the battery life?
How can I tell if my patient is really wearing the device?
What happens if my patient has an arrhythmic event?
How does it detect VT/VF?
What is the specificity and sensitivity of the VT/VF detection algorithm?
How frequent are unnecessary shocks?
Are there any adverse reactions?
Are there any restrictions when wearing the LifeVest?
How much does it cost? Is the LifeVest covered under my insurance?
How do I bill insurance for patient follow-up/training/monitoring?
Why should I consider the LifeVest System as a treatment option for my patients?
The LifeVest was designed to fill a therapeutic gap in the treatment of SCA. There are many patients who are at a temporary, but high risk for SCA. Until now, these patients were either sent home unprotected, kept in the hospital in a monitored bed, or in rare cases purchased an AED that family members had to learn to use. Now there is a safe, cost effective way to protect at-risk patients and gather important clinical data from the clinical event recorder to help provide even better treatment for patients.
What do I need to do to be able to prescribe this for my patients? (How do I get a LifeVest for a patient?)
Call 1-800-543-3267 and a customer service representative can help you obtain a LifeVest for your patient.
How much research has been conducted?
The LifeVest has been extensively tested and researched throughout Europe and the US. The US trials were comprised of 17 major medical centers throughout the country, 289 patients and were conducted over a three-year time span. For more information, read our Clinical Trials.
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Has the FDA approved use of the LifeVest?
Yes. The Food and Drug Administration approved the use of the LifeVest WCD 2000 for the US in December of 2001 and approved for the next generation LifeVest WCD 3000 for the US in October of 2002.
What training tools are available for me if I prescribe this to my patient?
A ZOLL Lifecor representative will train and fit your patient and can also teach your staff to train and fit LifeVest patients. The training tools available include an Operator's Manual, Patient's Manual, Patient Training Video, and an online training tool that can serve as a refresher course for your staff.
Who will train my patient on how to use the LifeVest?
A ZOLL Lifecor representative will train your patient or, if you prefer, the representative can train your staff to do this as well.
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How long does it take to fit and train a patient?
This depends greatly on the condition of the patient. Very weak patients who have been hospitalized for a long period or had a very rough course may take longer than patients who are in better condition. On average, we allow about 2 hours to train and fit a patient. We also remain on-call to answer questions patients may have when they go home.
How complicated is it to learn how to use, for both my patient and me?
The LifeVest is easy to use. The most time consuming part is learning to thread the electrode belt into the garment, but this is not complicated. Most people understand how to do it easily after doing it a couple of times. The voice prompts, audible alarms, and visual messages on the monitor make it easy to understand and use. Most patients are able to learn to use the LifeVest without problems.
What are the applications for use; how are other physicians using it?
There are many applications for use of the LifeVest. Some of the most common include:
Patients who need ICDs but have infections
Patients waiting for heart transplant
Patients waiting for an EP study or waiting for an ICD
CHF patients at discharge or MADIT II candidates on discharge from the hospital
Post-MI patients with a complicated course
Post-CABG patients with a complicated course
Patients who can not receive an ICD for some reason
Patients who refuse an ICD
Patients on anticoagulation medications who can not undergo surgery at that time
The LifeVest is indicated for use by patients who have a significant risk of sudden cardiac arrest due to ventricular tachyarrhythmias, but are not clear candidates for an implantable defibrillator. This includes, but is not limited to, patients having a temporary risk of sudden cardiac death, patients having a condition preventing or delaying implantable defibrillator use, or patients having a risk of sudden cardiac death not high enough to justify an implantable defibrillator. See Who Can Benefit From the LifeVest for examples of the patient groups who can use the device.
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How long is the battery life?
The battery pack is a three-cell lithium ion battery pack, generally referred to as "smart batteries." It has a life expectancy of 1 year (or approximately 200 charge/discharge cycles in use every other day). One battery pack should be worn while the other is charging. Patients are to switch battery packs at the same time every day.
How can I tell if my patient is really wearing the device?
The LifeVest monitor continuously records your patient's ECG when he/she is wearing the device. These records, which also indicate patient compliance, will be uploaded to our proprietary Web site where you can review them. You will be able to tell from these reports how many hours/day your patient is wearing the LifeVest.
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What happens if my patient has an arrhythmic event?
The LifeVest continuously monitors the patient's heart with dry, non-adhesive sensing electrodes to detect life-threatening abnormal heart rhythms. If a life-threatening rhythm is detected, the device alerts the patient prior to delivering a shock, and thus allows a conscious patient to disarm the shock. If the patient is unconscious, the device automatically releases a conductive gel over the therapy electrodes and delivers an electrical shock to restore normal rhythm. The LifeVest monitor continually records ECG readings and you will thus be able to use that data for diagnostic purposes.
How does it detect VT/VF?
It detects with rate and morphology using a baseline template of the patient's own vector-cardiogram baseline ECG.
What is the specificity and sensitivity of the VT/VF detection algorithm?
The LifeVest meets the applicable portions of the AAMI standards for Automatic External Cardioverter Defibrillators "AECDs" (ANSI/AAMI DF2-1989 and AAMI DF39-1/93), which specify that the sensitivity for detecting VF should be greater than 90% and the sensitivity for detecting VT should be greater than 75%. It also meets the AAMI standard for specificity which states that the specificity for AECDs should be greater than 95% (without artifacts).
ZOLL Lifecor bench testing demonstrated 100% detection sensitivity for VF and 95% detection sensitivity for treatable VT. Bench testing for specificity of the algorithm was 100%.
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How frequent are unnecessary shocks?
During the clinical study, there was less than one false shock for every 100 months of use. As a result of clinical experience, ZOLL Lifecor modified the device to further reduce the rate of false shocks.
Are there any adverse reactions?
In clinical studies, the most frequent side effect reported was a temporary rash, which was experienced by 5.9% of those studied. So there is a small possibility that your patient will experience some minor skin irritation. Also, if your patient actually receives a defibrillating shock, there is the possibility of minor burns.
Are there any restrictions when wearing the LifeVest?
The LifeVest was designed to allow patients to return to their normal activities. Some of our patients work, golf, or even perform moderate exercise with the LifeVest (see our Patient Stories). Your patient will have to remove the LifeVest to shower, bathe, and wash the garment, but otherwise can wear it all the time. The LifeVest is lightweight and comfortable and won't limit most daily activities.
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How much does it cost?
Most patients wear the LifeVest temporarily or for a defined period of time and rent the device. This price varies from country to country. If in the United States, call 1-800-543-3267 for more information. For use outside of the United States, contact us and tell us where you live. We can refer you to the ZOLL Lifecor representative in your country.
Is the LifeVest covered under insurance?
Most insurance companies in the United States cover the LifeVest. Contact 1-800-543-3267 and we can help you determine if your patient's insurance company covers the use of the LifeVest.
How do I bill insurance for patient follow-up/training/monitoring?
Physicians are provided with a packet of information that can help with billing codes in the United States for treatment of LifeVest patients. Ask your ZOLL Lifecor representative for this packet or call 1-800-543-3267.
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