Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patients at High Risk for Sudden Death: Results of WEARIT/BIROAD

Arthur M. Feldman, Helmut Klein, Patrick Tchou, Srinivas Murali, W. Jackson Hall, Donna Mancini, John Boehmer, Mark Harvey, M. Stephen Heilman, Steven J. Szymkiewicz, Arthur J. Moss

Research output: Contribution to journalArticle

145 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)4-9
Number of pages6
JournalPACE - Pacing and Clinical Electrophysiology
Volume27
Issue number1
DOIs
StatePublished - Jan 1 2004

Fingerprint

Defibrillators
Sudden Death
Tachycardia
Equipment and Supplies
Shock
Guidelines
Sudden Cardiac Death
Heart Failure
Transplantation
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Feldman, Arthur M. ; Klein, Helmut ; Tchou, Patrick ; Murali, Srinivas ; Hall, W. Jackson ; Mancini, Donna ; Boehmer, John ; Harvey, Mark ; Heilman, M. Stephen ; Szymkiewicz, Steven J. ; Moss, Arthur J. / Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patients at High Risk for Sudden Death : Results of WEARIT/BIROAD. In: PACE - Pacing and Clinical Electrophysiology. 2004 ; Vol. 27, No. 1. pp. 4-9.
@article{7c0a72dd9f144c0abc6caa6bc2fab8bc,
title = "Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patients at High Risk for Sudden Death: Results of 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.",
author = "Feldman, {Arthur M.} and Helmut Klein and Patrick Tchou and Srinivas Murali and Hall, {W. Jackson} and Donna Mancini and John Boehmer and Mark Harvey and Heilman, {M. Stephen} and Szymkiewicz, {Steven J.} and Moss, {Arthur J.}",
year = "2004",
month = "1",
day = "1",
doi = "10.1111/j.1540-8159.2004.00378.x",
language = "English (US)",
volume = "27",
pages = "4--9",
journal = "PACE - Pacing and Clinical Electrophysiology",
issn = "0147-8389",
publisher = "Wiley-Blackwell",
number = "1",

}

Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patients at High Risk for Sudden Death : Results of WEARIT/BIROAD. / Feldman, Arthur M.; Klein, Helmut; Tchou, Patrick; Murali, Srinivas; Hall, W. Jackson; Mancini, Donna; Boehmer, John; Harvey, Mark; Heilman, M. Stephen; Szymkiewicz, Steven J.; Moss, Arthur J.

In: PACE - Pacing and Clinical Electrophysiology, Vol. 27, No. 1, 01.01.2004, p. 4-9.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patients at High Risk for Sudden Death

T2 - Results of WEARIT/BIROAD

AU - Feldman, Arthur M.

AU - Klein, Helmut

AU - Tchou, Patrick

AU - Murali, Srinivas

AU - Hall, W. Jackson

AU - Mancini, Donna

AU - Boehmer, John

AU - Harvey, Mark

AU - Heilman, M. Stephen

AU - Szymkiewicz, Steven J.

AU - Moss, Arthur J.

PY - 2004/1/1

Y1 - 2004/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=9144235414&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=9144235414&partnerID=8YFLogxK

U2 - 10.1111/j.1540-8159.2004.00378.x

DO - 10.1111/j.1540-8159.2004.00378.x

M3 - Article

C2 - 14720148

AN - SCOPUS:9144235414

VL - 27

SP - 4

EP - 9

JO - PACE - Pacing and Clinical Electrophysiology

JF - PACE - Pacing and Clinical Electrophysiology

SN - 0147-8389

IS - 1

ER -