Evidence map›Paper›PMID 38639136›Full record

ReviewCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2024

Device regulation and surveillance in vascular care: Challenges and opportunities.

Alyssa J Pyun, Philip P Goodney, Jens Eldrup-Jorgensen, James Wadzinski, Eric A Secemsky, Joaquin E Cigarroa

Open access · bronzeAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Alyssa J PyunDivision of Vascular Surgery and Endovascular Therapy, Keck Medical Center of University of Southern California, Los Angeles, California, USA.
Philip P GoodneyHeart and Vascular Center, Dartmouth Health, Lebanon, New Hampshire, USA.ORCID 0000-0002-3973-3506
Jens Eldrup-JorgensenThe Society for Vascular Surgery's Patient Safety Organization (SVS-PSO) and Vascular Quality Initiative (VQI), Chicago, Illinois, USA.
James WadzinskiThe Society for Vascular Surgery's Patient Safety Organization (SVS-PSO) and Vascular Quality Initiative (VQI), Chicago, Illinois, USA.
Eric A SecemskyDivision of Vascular Interventions, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Joaquin E CigarroaDivision of Cardiovascular Medicine, Department of Medicine, Oregon Health Sciences University (OHSU), Portland, Oregon, USA.ORCID 0000-0003-1567-6006
Society for Vascular Surgery · USBeth Israel Deaconess Medical Center · USOregon Health & Science University · USUniversity of Southern California · US

Funding

Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment DecisionsK23HL150290 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SECEMSKY, ERIC ALEXANDER · 2020 to 2024
$851k
NHLBI NIH HHS K23 HL150290
6 · The paper itself

Abstract

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

Indexed as

Device ApprovalProduct Surveillance, PostmarketingCardiovascular DiseasesEndovascular ProceduresEquipment DesignHumansPatient SafetyRisk AssessmentRisk FactorsUnited StatesUnited States Food and Drug AdministrationVascular Access DevicesappropriatenessCenters for Medicare and Medicaid ServicesFood and Drug Administrationmedical devicenational coverage decision processpostmarket surveillanceregistries

Identifiers

PMID38639136
PMCPMC12702384
OpenAlexW4394962021

What Socratic 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 Socratic graph.