Evidence map›Paper›PMID 35174572›Full record

ArticleJournal of cardiovascular electrophysiology2022

A wearable cardioverter defibrillator with a low false alarm rate.

Jeanne E Poole, Marye J Gleva, Ulrika Birgersdotter-Green, Kelley R H Branch, Rahul N Doshi, Tariq Salam, Thomas C Crawford, Mark E Willcox, Arun M Sridhar, Ghiath Mikdadi and 7 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of cardiovascular electrophysiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03887052 (ASSURE WCD Clinical Evaluation - Detection and Safety Study), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03887052 nacompletednot on this map

ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)

TypeinterventionalSponsorKestra Medical Technologies, Inc.Ran2019 to 2019Enrolled130ConditionsCardiac Arrest, SuddenArmsASSURE™ Wearable Cardioverter Defibrillator (WCD)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Trial
  2. Review
  3. Review
  4. Review
  5. A review on wearable cardioverter-defibrillators in clinical practice for sudden cardiac death prevention and heart failure management.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Review
  6. Article
  7. Review
  8. Article
  9. A wearable cardioverter defibrillator with a low false alarm rate.Journal of cardiovascular electrophysiology · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Jeanne E PooleUniversity of Washington, Seattle, Washington, USA.ORCID 0000-0002-8481-7389
Marye J GlevaWashington University in St. Louis, St. Louis, Missouri, USA.
Ulrika Birgersdotter-GreenUniversity of California San Diego, San Diego, California, USA.ORCID 0000-0002-0473-1826
Kelley R H BranchUniversity of Washington, Seattle, Washington, USA.
Rahul N DoshiHonor Health, Scottsdale, Arizona, USA.
Tariq SalamPulse Heart Institute, Tacoma, Washington, USA.ORCID 0000-0002-0829-8505
Thomas C CrawfordUniversity of Michigan, Ann Arbor, Michigan, USA.
Mark E WillcoxAlaska Heart and Vascular Institute, Anchorage, Alaska, USA.
Arun M SridharUniversity of Washington, Seattle, Washington, USA.
Ghiath MikdadiHeart Clinic of Hammond, Center for Cardiac and Vascular Research, Hammond, Louisiana, USA.
Sean C BeinartWashington Adventist Healthcare White Oak Medical Center, Silver Spring, Maryland, USA.
Yong-Mei ChaMayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0002-5897-9464
Andrea M RussoCooper Medical School of Rowan University, Camden, New Jersey, USA.
Ron K RowbothamKestra Medical Technologies, Inc., Kirkland, Washington, USA.
Joseph SullivanKestra Medical Technologies, Inc., Kirkland, Washington, USA.
Laura M GustavsonKestra Medical Technologies, Inc., Kirkland, Washington, USA.
Kaisa KivilaidLabcorp, Minneapolis, Minnesota, USA.

Funding

Kestra Medical Technologies, Inc.,
6 · The paper itself

Abstract

introductionA wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce the risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to electrocardiogram noise and wear discomfort. The objective of this study was to test a contemporary WCD designed for reduced false shock alarms and improved comfort.

methodsOne hundred and thirty patients with left ventricular ejection fraction ≤40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed for 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms were disabled. All WCD episodes and ICD ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were adjudicated. The primary endpoint was the false-positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day).

resultsOf 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only three false-positive shock alarm markers were recorded; one false-positive shock alarm every 1333 patient-days (0.00075 per patient-day, 95% confidence interval: 0.00015-0.00361; p < .001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥170 bpm for ≥20 s) were missed by the WCD during 3501 patient-days of use. Median wear was 31.0 days (interquartile range [IQR] 2.0) and median daily use 23.0 h (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%).

conclusionThe ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.

Indexed as

Defibrillators, ImplantableWearable Electronic DevicesArrhythmias, CardiacDeath, Sudden, CardiacDefibrillatorsElectric CountershockElectrocardiographyHumansStroke VolumeVentricular FibrillationVentricular Function, Leftdefibrillatorsudden cardiac deathventricular arrhythmia

Identifiers

PMID35174572
PMCPMC9305432

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.