Evidence map›Paper›PMID 36586706›Full record

ArticleHeart rhythm2023

Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation.

Hope Caughron, Hilary Bowman, Merritt H Raitt, Mary A Whooley, Gary Tarasovsky, Hui Shen, Michael E Matheny, Kimberly A Selzman, Li Wang, Jacqueline Major and 2 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Heart rhythm, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Hope CaughronDepartment of Medicine, University of California San Francisco School of Medicine, San Francisco, California; Division of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, California.
Hilary BowmanDepartment of Medicine, University of California San Francisco School of Medicine, San Francisco, California.
Merritt H RaittKnight Cardiovascular Institute, Oregon Health and Sciences University, Portland, Oregon; Portland Veterans Affairs Health Care System, Portland, Oregon.
Mary A WhooleyDepartment of Medicine, University of California San Francisco School of Medicine, San Francisco, California; Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.
Gary TarasovskyDepartment of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.
Hui ShenDepartment of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.
Michael E MathenyGeriatrics Research, Education, and Clinical Service, Tennessee Valley Veterans Affairs Health Care System, Nashville, Tennessee; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee.
Kimberly A SelzmanDivision of Cardiology, Department of Medicine, University of Utah School of Medicine, Salt Lake City, Utah; Salt Lake City Veterans Affairs Health Care System, Salt Lake City, Utah.
Li WangCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jacqueline MajorCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Hetal OdobasicCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Sanket S DhruvaSection of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California. Electronic address: sanket.dhruva@ucsf.edu.
San Francisco VA Medical Center · USUnited States Food and Drug Administration · USUniversity of California, San Francisco · USOregon Health & Science University · USUniversity of Utah · USVA Tennessee Valley Healthcare System · US

Funding

UCSF-Stanford Center of Excellence in Regulatory Science and InnovationU01FD005978 · FDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ALTMAN, RUSS BIAGIO, GIACOMINI, KATHLEEN M · 2016 to 2025
$34.5M
Improving Safety of Cardiovascular Implantable Electronic Devices in VeteransIK2HX003357 · VA · VETERANS AFFAIRS MED CTR SAN FRANCISCO · PI Sanket S Dhruva · 2022 to 2026
–
FDA HHS U01 FD005978HSRD VA I50 HX002756HSRD VA I50 HX003266HSRD VA IK2 HX003357HSRD VA SDR 02-237
6 · The paper itself

Abstract

backgroundCurrent methods to identify cardiovascular implantable electronic device lead failure include postapproval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead.

objectiveThe purpose of this study was to determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation.

methodsAmong 48,191 actively monitored patients with a cardiovascular implantable electronic device, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between April 1, 2019, and April 1, 2021. We queried electronic health record and Medicare fee-for-service claims data to determine whether patients had administrative codes for lead failure. We verified lead failure through manual electronic health record review.

resultsOf the 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected by RM. Of these, 409 patients had administrative codes for lead failure, and 233 of these 409 patients (57.0%) had structural lead failure verified through chart review. Of the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 patients with RM transmissions suggestive of lead abnormalities (34.2%) had structural lead failure. In addition, 200 patients without preceding abnormal RM transmissions had leads abandoned or extracted for structural failure, making the total lead failure cohort 600 patients (66.7% with RM abnormalities, 33.3% without). Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure.

conclusionRM may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.

Indexed as

Defibrillators, ImplantableHeart FailureAgedHumansMedicareMonitoring, PhysiologicUnited StatesCardiovascular implantable electronic deviceLead failureLead replacementLead safetyRemote monitoringVeterans Affairs

Identifiers

PMID36586706
PMCPMC11687331
OpenAlexW4313379665

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.