title: Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT/BIROAD.
abstract: The automatic ICD improves survival in patients with a history of sudden cardiac arrest. However, some patients do not meet the guidelines for ICD implantation or are unable to receive an implantable device. This study tested the hypothesis that these patients could benefit from a wearable cardioverter defibrillator. Patients with symptomatic heart failure and an ejection fraction of <0.30 (WEARIT Study) or patients having complications associated with high risk for sudden death after a myocardial infarction or bypass surgery not receiving an ICD for up to 4 months (BIROAD Study) were enrolled into two studies. After a total of 289 patients had been enrolled in the trial (177 in WEARIT and 112 in BIROAD), prespecified safety and effectiveness guidelines had been met. Six (75%) of eight defibrillation attempts were successful. Six inappropriate shock episodes occurred during 901 months of patient use (0.67% unnecessary shocks per month of use). Twelve deaths occurred during the study 6 sudden deaths: 5 not wearing and 1 incorrectly wearing the device). Most patients tolerated the device although 68 patients quit due to comfort issues or adverse reactions. The results of the present study suggest that a wearable defibrillator is beneficial in detecting and effectively treating ventricular tachyarrhythmias in patients at high risk for sudden death who are not clear candidates for an ICD and may be useful as a bridge to transplantation or ICD in some patients.
authors.affiliation: Department of Medicine, Jefferson Medical College, Philadelphia, Pennsylvania 19107-5083, USA. arthur.feldman@jefferson.edu
authors.forename: Arthur M
authors.initials: AM
authors.lastname: Feldman
authors.forename: Helmut
authors.initials: H
authors.lastname: Klein
authors.forename: Patrick
authors.initials: P
authors.lastname: Tchou
authors.forename: Srinivas
authors.initials: S
authors.lastname: Murali
authors.forename: W Jackson
authors.initials: WJ
authors.lastname: Hall
authors.forename: Donna
authors.initials: D
authors.lastname: Mancini
authors.forename: John
authors.initials: J
authors.lastname: Boehmer
authors.forename: Mark
authors.initials: M
authors.lastname: Harvey
authors.forename: M Stephen
authors.initials: MS
authors.lastname: Heilman
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Szymkiewicz
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Moss
mesh_terms: D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D004554:Electric Countershock; D004562:Electrocardiography; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D012307:Risk Factors; D013610:Tachycardia / Q000628:therapy*