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AHA releases first scientific advisory on wearable cardioverter defibrillators
In the first scientific statement on the wearable cardioverter defibrillators, the American Heart Association recommends the use of the external device in certain patients as an alternative to an implantable cardioverter defibrillator, but cautions that more research is needed.
While more than 300,000 deaths from sudden cardiac arrest occur in the United States each year, an ICD is not suitable for all at-risk patients, according to the statement.
The authors wrote that patients who might benefit from the wearable cardioverter defibrillator include those who had an ICD extracted due to infection as well as patients with contraindications for surgery. It also can be used as a bridge therapy for patients who are in the first 40 to 90 days after MI, CABG or PCI when the ICD is not recommended or for patients with HF who are waiting for a heart transplant. The external device also may benefit those with an unknown cardiac prognosis, according to the scientific statement.
“For many of these patients, the risk for life-threatening rhythm abnormalities may be temporary, so the wearable cardiac defibrillator could be a short-term alternative to an ICD, which is permanently implanted in patient’s chest,” Jonathan P. Piccini Sr., MD, MHS, FACC, FAHA, FHRS, a cardiac electrophysiologist at Duke University Medical Center in Durham, North Carolina, said in a press release.
Although there are no surgery-related risks with a wearable cardioverter defibrillator, there are certain limitations with the device, the authors wrote. It can only deliver up to five shocks before it must be replaced, and there is no pacing capability. In addition, patients often find the devices uncomfortable to wear, which can reduce patient adherence.
The major concern, however, according to the authors, is that little data are available on whether these external devices actually improve patient outcomes.
“Although a growing number of patients are being prescribed wearable cardiac defibrillators by their doctors, there have been very few well-designed and completed studies of these devices. Widespread use of the wearable defibrillator is not advisable because there isn’t enough clinical evidence to support its use, except in a small number of patients with known life-threatening arrhythmias, but for whom surgery to implant an ICD is not advised in the short term,” Piccini said in the release.
The advisory committee’s recommendations included a caveat that a wearable cardioverter defibrillator should not be used when nonarrhythmic risk outweighs arrhythmic risk in patients with an expected survival of less than 6 months.
Piccini said in the release that larger randomized controlled trials are needed to better weigh the risks vs. benefits of the wearable cardioverter defibrillator. Currently, researchers in the VEST trial are assessing the external device’s ability to improve 12-month survival after MI. – by Tracey Romero
Disclosure: Piccini reports no relevant financial disclosures. Please see the full statement for a list of all the other authors’ relevant financial disclosures.
Perspective
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I agree with the recommendations made, but I am unsure how big of an impact they will make on clinical practice. It will depend on how this is disseminated and promoted to physicians. Future studies should focus on the problem of compliance.