Contemporary Safety of Ultrasound Enhancing Agents in a Nationwide Analysis
Abstract Body (Do not enter title and authors here): Background: Ultrasound enhancing agents (UEAs) are an important diagnostic tool for transthoracic or stress echocardiography (TTE/SE) but recent concerns have been raised about their safety in reports from individual health systems.
Objectives: To identify if UEAs for TTE/SE are associated with serious adverse events within 48 hours of receipt in nationwide claims data.
Methods: All-payor nationwide claims from 320 million insured individuals across the US, 2018-2022 from the Komodo Health database were used to evaluate rates of death or the composite of death, anaphylaxis, MI, coronary angiography, PCI, CABG, ventricular tachycardia or cardiac arrest within 48 hours of UEA receipt for TTE/SE among adults. Propensity score matching (PSM) was used to account for baseline imbalances.
Results: Of the 11,421,463 individuals included (mean age 57.5 ± 16.2, 54.0% female, 46.2% White), a total of 500,073 (4.4%) received TTE/SE with UEAs. Individuals receiving Lumason™ or Definity™ more frequently had TTEs/SEs performed in the emergency department/inpatient setting and had more comorbidities than those receiving Optison™. After PSM, the odds of death were lower in those receiving UEAs (receipt vs. non-receipt, 0.02% vs. 0.14%, OR 0.23, 95% CI 0.19-0.28, p < 0.001) and were similar across agents (Table; Definity™: 0.02%, OR 0.22, 95% CI 0.18-0.28; Lumason™: 0.03%, OR 0.33, 95% CI 0.18-0.28; Optison™: 0.01%, OR 0.17, 95% CI 0.08-0.38; all p < 0.001). Rates of the composite outcome were essentially unchanged after excluding claims for anaphylaxis. Rates of all outcomes were stable across study years, including considering pre-COVID (2018-2019) and post-COVID (2020-2022) periods.
Conclusions: In this large nationwide claims analysis from 2018-2022, serious adverse events from UEAs for TTE/SE were uncommon and overall similar across agents and years of study. Receipt of UEAs was associated with a lower odds of death at 48 hours.
Strom, Jordan
( Beth Israel Deaconess Medical Center
, Milton
, Massachusetts
, United States
)
Main, Michael
( ST LUKES CARDIOVASC CONSULTANTS
, Kansas City
, Missouri
, United States
)
Wei, Kevin
( Oregon Health Sciences University
, Portland
, Oregon
, United States
)
Feinstein, Steven
( Rush University
, Chicago
, Illinois
, United States
)
Fiano, Ryan
( Cencora
, Conshohocken
, Pennsylvania
, United States
)
Gennarelli, Renee
( Cencora
, Conshohocken
, Pennsylvania
, United States
)
Author Disclosures:
Jordan Strom:DO have relevant financial relationships
;
Research Funding (PI or named investigator):NIH:Active (exists now)
; Consultant:Bristol Myers Squibb:Active (exists now)
; Consultant:EVERSANA:Active (exists now)
; Other (please indicate in the box next to the company name):Pfizer (clinical endpoint committee):Active (exists now)
; Advisor:EchoIQ:Active (exists now)
; Research Funding (PI or named investigator):Philips Healthcare:Active (exists now)
; Consultant:GE Healthcare:Active (exists now)
; Research Funding (PI or named investigator):Anumana:Active (exists now)
; Consultant:Bracco Diagnostics:Active (exists now)
; Advisor:HeartSciences:Active (exists now)
; Consultant:Edwards Lifesciences:Active (exists now)
| Michael Main:DO NOT have relevant financial relationships
| Kevin Wei:DO NOT have relevant financial relationships
| Steven Feinstein:No Answer
| Ryan Fiano:DO NOT have relevant financial relationships
| Renee Gennarelli:No Answer
Oliveira Izadora, Graner Moreira Humberto, De Sousa Andre, Paiva Arthur, Ferreira Vitor, De Sá Carlos Eduardo, Alves Alencar Joao Victor, Alves Alencar Pedro Lucas, Duarte Lima Ana Paula, Oliveira Vinicius
