What is the LifeVest?
How does the LifeVest work?
How does a patient know if he/she is a candidate for the LifeVest?
Are there patients for whom LifeVest is not recommended?
Are there any other devices like this on the market?
Is compliance an issue? How would physicians know if their patients are actually wearing the LifeVest?
Is LifeVest comfortable enough to wear and maintain a normal lifestyle?
Is the LifeVest noticeable to others?
Do those living with patients wearing LifeVest need to be trained on how to use the device?
Does the use of the LifeVest have any side effects?
How is the LifeVest different from an automatic external defibrillator (AED)?
Is there any clinical evidence that the LifeVest saves lives?
Is the LifeVest available outside the US?
Is the LifeVest covered by insurance? How much does it cost?
Are there currently any studies underway to provide further data on the LifeVest?
How can patients obtain the LifeVest?
What is the LifeVest?
The LifeVest®, manufactured by ZOLL Lifecor Corporation, is the first and only wearable defibrillator for patients at high risk of sudden cardiac arrest (SCA). The non-invasive device, approved by the FDA in 2002, has been worn by over 19,000 patients. LifeVest has a 98% first shock success rate for treating patients for SCA without requiring bystander intervention.
The LifeVest utilizes a soft garment worn under clothing that contains dry, non-adhesive therapy electrodes that detect your heart rhythm. When the garment is worn, these electrodes are placed against the skin and attached to a monitor that is worn around the waist or from a shoulder strap. The monitor constantly tracks the heart rhythm. It weighs about 1.8 pounds.
How does the LifeVest work?
The LifeVest wearable defibrillator, worn by patients at risk for SCA, continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device alerts the patient prior to delivering a shock. The device releases a conductive gel onto the therapy electrodes to protect the skin and then delivers a shock to restore normal heart rhythm. The entire event, from detecting a life-threatening arrhythmia to automatically delivering a defibrillation shock, usually occurs in less than a minute.
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How does a patient know if he/she is a candidate for the LifeVest?
The LifeVest is prescribed by a physician and is part of the continuum of care for patients at risk for sudden cardiac arrest. In many cases, the LifeVest can be used when SCA risk is changing or if implant surgery is not an option for at-risk patients. Specifically, the LifeVest is considered a solution for patients who have the following medical conditions or situation:
- Primary prevention (EF <=35% and either MI or NICM) including:
- Immediately after MI (Coverage during the 40-day waiting period)
- Before and immediately after CABG or PTCA (Coverage during the 90-day ICD waiting period)
- Listed for cardiac transplant
- Recently diagnosed nonischemic cardiomyopathy (Coverage during the 3-9 month ICD waiting period)
- NYHA Class IV heart failure
- Terminal disease with life expectancy of less than one year
- All ICD indications are covered
- Any ICD explantation
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Are there patients for whom LifeVest is not recommended?
Patients, who currently have an ICD or have a physical or mental deficit that would impair their interaction with the LifeVest, are probably not good candidates for the device.
Are there any other devices like this on the market?
No. The LifeVest is the first and only wearable defibrillator for patients at high risk of sudden cardiac arrest (SCA).
Is compliance an issue? How would physicians know if their patients are actually wearing the LifeVest?
Since the LifeVest is comfortable and practical to use, most patients are compliant. Additionally, the LifeVest monitor continuously records a patient’s ECG when he/she is wearing the device. These records, which indicate patient compliant, will be uploaded to a proprietary website where physicians can review their report. They are then able to tell from these reports how many hours/days a patient is wearing the LifeVest.
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Is LifeVest comfortable enough to wear and maintain a normal lifestyle?
The LifeVest is designed to allow patients to return to their normal daily activities. Patients may work, and even perform moderate exercise, with the LifeVest. Patients have to remove the LifeVest when showering or bathing, but otherwise they should wear it all the time.
Is the LifeVest noticeable to others?
The LifeVest is fit to a patient’s body and is worn under regular clothes. Other than the monitor, which is worn in a holster around the waist or on a shoulder strap, there is no evidence that a person is wearing the device.
Do those living with patients wearing LifeVest need to be trained on how to use the device?
Yes. Typically, caregivers are trained on the proper way to respond if a patient is about to receive a treatment by a LifeVest. However, a caregiver does not need to be present for the LifeVest to work. Unlike an AED, one benefit of the LifeVest is that it requires no bystander intervention or assistance.
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Does the use of the LifeVest have any side effects?
Because the LifeVest is worn outside the body, side effects are minimal. The most common physical problem noted during clinical trials was a minor temporary rash caused by the electrodes.
How is the LifeVest different from an automatic external defibrillator (AED)?
Use of an AED on a person who collapses because of a possible irregular heart rhythm (such as ventricular fibrillation) requires bystander assistance. The bystander operates the AED by applying the electrodes to the patient and following instructions. Ideally, this treatment should be delivered within ten minutes to reduce the risk of neurological damage, but could be effective after ten minutes, at least in restoring a pulse. However, the patient’s chances of survival drops ten percent each minute after the onset of fibrillation.
By contrast, the LifeVest requires no bystander intervention, and it protects patients when they are alone or sleeping. This level of protection provides constant monitoring, immediate protection, and offers peace of mind for patients and family members who worry about EMS personnel arriving or having to resuscitate a loved one themselves.
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Is there any clinical evidence that the LifeVest saves lives?
Yes. The following abstracts describe the results of the multi-center clinical trial which led to FDA approval of the LifeVest system. The clinical trials, which spanned three years and 17 hospitals throughout the US and Europe, included 289 patients who wore the wearable defibrillator for a collective 873 months. In the trials the LifeVest saved lives and incidents of false shocks were low (<2.3% per patient-month). The results confirmed that the LifeVest is safe and effective.
Abstracts
New Therapeutic Option for Patients With Time-Dependent Risk of Sudden Cardiac Arrest: Application of Novel Wearable Cardioverter-Defibrillator
Abstract of presentation made by Dr. Arthur Feldman at American College of Cardiology Meeting on March 18, 2002, in Atlanta, Georgia
The Wearable Defibrillator - A New Method to Prevent Sudden Death
Ulf Meltendorf, MD, Anke Wollbrueck, RN, Angelo Auricchio, MD, Sven Reek, MD, Christoph J. Geller, MD, Helmut U. Klein, MD, University Hospital Magdeburg, Germany
Clinical Efficacy of the Wearable Defibrillator in Acutely Terminating Episodes of Ventricular Fibrillation Using Biphasic Shocks
Abstract of presentation made by Dr. Sven Reek at the North American Society of Pacing and Electrophysiology Conference on May 10, 2002, in San Diego, California
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Is the LifeVest available outside the US?
Yes, the LifeVest has been available in the United States since receiving FDA approval in October, 2002. The device is also available in Europe. ZOLL Lifecor received the European CE mark certification for the LifeVest system. It received ISO registration in 1999, the latest in March, 2006 – ISO: 13485.
Is the LifeVest covered by insurance? How much does it cost?
For those living in the United States, the LifeVest is covered under many private insurance plans as Durable Medical Equipment (DME). Medicare and many Medicaid programs also cover the LifeVest. The LifeVest is rented on a monthly basis and is typically worn for 2-3 months. Costs for the device vary in other countries.
Are there currently any studies underway to provide further data on the LifeVest?
Yes, the National Heart, Lung and Blood Institute (NHLGBI) is sponsoring the VEST/PREDICTS trial. The study is composed of two parts: the VEST Prevention of Early Sudden Death Trial (VEST) and a follow-up study called Prediction of ICD Therapies Study (PREDICTS). The purpose of VEST is to evaluate the effectiveness of the LifeVest wearable defibrillator at preventing death caused by an abnormal heart rhythm in the two months after a heart attack. In PREDICTS, participants will be followed for several years after receiving an implantable cardioverter defibrillator), or an implantable monitor that helps physicians monitor heart rhythms. The purpose of PREDICTS is to improve the methods for determining which patients will benefit the most from receiving an ICD.
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How can patients obtain the LifeVest?
A LifeVest is prescribed by a physician. If a physician is not aware of the LifeVest, he/she should call 1-800-543-3267, or visit www.zoll.lifecor.com for more information.
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