Evidence map›Paper›PMID 38130257›Full record

ReviewLaryngoscope investigative otolaryngology2023

Complications of eustachian tube balloon dilation: Manufacturer and User Facility Device Experience (MAUDE) database analysis and literature review.

Paul F Chisolm, Amir A Hakimi, Jessica H Maxwell, Mark E Russo

Open access · goldAbstract readReview
In one paragraph

Review in Laryngoscope investigative otolaryngology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.7field-weighted citation impact, top 9% 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

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Paul F ChisolmDepartment of Otolaryngology-Head and Neck Surgery Medstar Georgetown University Hospital Washington DC USA.ORCID https://orcid.org/0000-0003-3428-7620
Amir A HakimiDepartment of Otolaryngology-Head and Neck Surgery Medstar Georgetown University Hospital Washington DC USA.ORCID https://orcid.org/0000-0002-5675-5758
Jessica H MaxwellDepartment of Otolaryngology-Head and Neck Surgery Medstar Georgetown University Hospital Washington DC USA.
Mark E RussoDepartment of Otolaryngology-Head and Neck Surgery Medstar Georgetown University Hospital Washington DC USA.
Georgetown University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To provide an analysis of complications following eustachian tube balloon dilation as well as their treatments and outcomes. Data Sources: PubMed, Ovid Embase, and MAUDE Database. Review Methods: A systematic approach following PRISMA guidelines was used to identify publications pertaining to balloon dilation of the eustachian tube from PubMed and Ovid Embase databases was used. Once these publications were critically reviewed, the primary outcome extracted were reported complications. Additional complications were collected in the Manufacturer and User Facility Device Experience (MAUDE) database using the product class "eustachian tube dilation device" and searching through relevant manufacturers. Complications and outcomes were compared between these sources. Results: Fifty five full-length manuscripts involving 7155 patients were included and 98 complications reported for a 1.4% complication rate. The most frequently reported adverse events were subcutaneous emphysema of the head and neck (19%), epistaxis (12%), and acute otitis media (11%). The MAUDE search returned 18 distinct patient entries, of which 12 (67%) reported complications. The most reported complications in the MAUDE database included subcutaneous emphysema (8, 67%) and pneumomediastinum (3, 25%). The most serious complication was a carotid artery dissection reported in one patient in the MAUDE database. Conclusion: Eustachian tube dilation is rarely associated with complications, which nevertheless may lead to morbidity and medical emergencies. Patients and providers should recognize potential risks associated with this intervention as well as methods to manage complications.

Indexed as

complicationscomprehensive otolaryngologyeustachian tube dilationMAUDE database

Identifiers

PMID38130257
PMCPMC10731503
OpenAlexW4388692183

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.