FDA Approves ZOLL's Wearable Defibrillator For Kids

According to Zoll, the WEARIT-II registry includes more than 2,000 patients prescribed the LifeVest wearable defibrillator. Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver therapy appropriately when needed” according to an FDA press release.
A study last summer showed that use of the vests by patients who had previously had a heart attack reduced all-cause mortality but not mortality Wearable Defibrillator from sudden cardiac death Investigators, however, speculated that misclassification of some deaths could be responsible for the odd result.



39. Unknown Cardiac Prognosis  Use of WCDs may be reasonable when there is concern about a heightened risk of SCD that may resolve over time or treatment of left ventricular dysfunction, for example, in ischemic heart disease with recent revascularization, newly diagnosed nonischemic dilated cardiomyopathy in a patient starting guideline-directed medical therapy, or secondary cardiomyopathy (tachycardia mediated, thyroid mediated, etc) in which the underlying cause is potentially treatable (Class IIb; Level of Evidence C) 39 Piccini JP, Allen LA, Kudenchuk PJ, Page RL, Patel MR, Turakhia MP. Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death.
24. Clinical Experience With WCDs  United States between 2002 and 2006, a 3569 patients wore a WCD for at least 1 day (mean duration, 53±70 days)  Discontinuation 14%  Longer duration of use associated with higher rates of compliance  Indications for WCD use included ICD explantation (23%), ventricular arrhythmia before planned ICD implantation (16%), recent MI (16%), post- CABG status (9%), and recent diagnosis of cardiomyopathy with an LVEF ≤0.35 (28%) 24 Piccini JP, Allen LA, Kudenchuk PJ, Page RL, Patel MR, Turakhia MP. Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death.

Others have told Olgin that worrying about an accidental shock makes them anxious; in the study, nine people were shocked when they didn't need to be. And patients sometimes reported their vests emitting alarms when they felt fine — another potential source of stress.
The Centers for Medicare and Medicaid Services guidelines stress that for patients to be considered for an implantable cardioverter-defibrillator (ICD) patients must not have had angioplasty such as a coronary artery bypass graftwithin the past three months.

15 The overall survival was not different largely because patients in the ICD group had a higher risk of non-arrhythmic death (hazard ratio 1.72; P = 0.05) suggesting that patients with risk factors for SCD are also at high risk of death from other causes.
During a total of 1,765,772 hours of wearable cardioverter-defibrillator wear time, participants received 57,451 alarms for possible arrhythmias (as determined by the device algorithms); the average rate (number of alarms÷total wear time in hours) was 0.033 alarms per hour.

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