Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice.

OBJECTIVES: Prior data indicate a very rare risk of serious adverse drug reaction (ADR) to ultrasound enhancement agents (UEAs). We sought to evaluate the frequency of ADR to UEA administration in contemporary practice. METHODS: We retrospectively reviewed 4 US health systems to characterize the frequency and severity of ADR to UEA. Adverse drug reactions were considered severe when cardiopulmonary involvement was present and critical when there was loss of consciousness, loss of pulse, or ST-segment elevation. Rates of isolated back pain and headache were derived from the Mayo Clinic Rochester stress echocardiography database where systematic prospective reporting of ADR was performed. RESULTS: Among 26,539 Definity and 11,579 Lumason administrations in the Mayo Clinic Rochester stress echocardiography database, isolated back pain or headache was more frequent with Definity (0.49% vs 0.04%, P < .0001) but less common with Definity infusion versus bolus (0.08% vs 0.53%, P = .007). Among all sites there were 201,834 Definity and 84,943 Lumason administrations. Severe and critical ADR were more frequent with Lumason than with Definity (0.0848% vs 0.0114% and 0.0330% vs 0.0010%, respectively; P < .001 for each). Among the 3 health systems with >2,000 Lumason administrations, the frequency of severe ADR with Lumason ranged from 0.0755% to 0.1093% and the frequency of critical ADR ranged from 0.0293% to 0.0525%. Severe ADR rates with Definity were stable over time but increased in more recent years with Lumason (P = .02). Patients with an ADR to Lumason since the beginning of 2021 were more likely to have received a COVID-19 vaccination compared with matched controls (88% vs 75%; P = .05) and more likely to have received Moderna than Pfizer-Biotech (71% vs 26%, P < .001). CONCLUSION: Severe and critical ADR, while rare, were more frequent with Lumason, and the frequency has increased in more recent years. Additional work is needed to better understand factors, including associations with recently developed mRNA vaccines, which may be contributing to the increased rates of ADR to UEA since 2021.

Impact of an Emergency Department Observation Unit Management Algorithm for Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is a common, growing, and costly medical condition. We aimed to evaluate the impact of a management algorithm for symptomatic AF that used an emergency department observation unit on hospital admission rates and patient outcomes. METHODS AND RESULTS: This retrospective cohort study compared 563 patients who presented consecutively in the year after implementation of the algorithm, from July 2013 through June 2014 (intervention group), with 627 patients in a historical cohort (preintervention group) who presented consecutively from July 2011 through June 2012. All patients who consented to have their records used for chart review were included if they had a primary final emergency department diagnosis of AF. We observed no significant differences in age, sex, vital signs, body mass index, or CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke or transient ischemic attack) score between the preintervention and intervention groups. The rate of inpatient admission was significantly lower in the intervention group (from 45% to 36%; P<0.001). The groups were not significantly different with regard to rates of return emergency department visits (19% versus 17%; P=0.48), hospitalization (18% versus 16%; P=0.22), or adverse events (2% versus 2%; P=0.95) within 30 days. Emergency department observation unit admissions were 40% (P<0.001) less costly than inpatient hospital admissions of ≤1 day's duration. CONCLUSIONS: Implementation of an emergency department observation unit AF algorithm was associated with significantly decreased hospital admissions without increasing the rates of return emergency department visits, hospitalization, or adverse events within 30 days.

Relationship of Sonographer Credentialing to Intersocietal Accreditation Commission Echocardiography Case Study Image Quality.

BACKGROUND: Cardiac sonographer credentialing may guarantee baseline content knowledge but does not directly evaluate clinical scanning skills. The aim of this study was to determine the relationship of sonographer credentialing status to clinical competence, as defined by image quality of case studies submitted for Intersocietal Accreditation Commission (IAC) adult transthoracic echocardiography laboratory accreditation. METHODS: In this study, data were retrieved retrospectively from the IAC Echocardiography application database for all adult echocardiography laboratories applying online from August 10, 2011, to December 12, 2013. Aortic stenosis (AS) and left ventricular (LV) regional dysfunction case studies were analyzed separately. Sonographers submitting case studies were coded as credentialed or noncredentialed. An image quality score (IQS) was calculated for each case study, reflecting review scores for examination components directly related to image quality and acquisition. The group of sonographers was divided into quartiles on the basis of annual procedure volume; mean case study IQS was compared between credentialed and noncredentialed sonographers. RESULTS: For all four quartiles of the LV cases and the lowest three volume quartiles of the AS cases, mean IQS was significantly higher for credentialed than noncredentialed sonographers. Mean IQS in the highest volume quartile for AS studies was not significantly different by credential status. CONCLUSIONS: In the setting of IAC Echocardiography accreditation, credentialed sonographers achieved higher mean IQSs than noncredentialed sonographers in seven of eight comparisons. However, further research will be required to expand the scope of this inference beyond AS and LV regional dysfunction cases submitted for IAC adult transthoracic echocardiography laboratory accreditation.

Predictors of Delayed Accreditation of Echocardiography Laboratories: An Analysis of the Intersocietal Accreditation Commission Database.

BACKGROUND: Intersocietal Accreditation Commission Echocardiography accreditation involves a broad-based evaluation of a given echocardiography facility's daily operation. An in-depth analysis of the most frequent noncompliant accreditation items provides learning opportunities for improvement of echocardiographic practice and facilities. METHODS: Data from 3,260 facilities applying for accreditation from 2011 to 2013 were analyzed to assess five key elements, each including multiple variables. The key elements included staff qualifications, imaging protocols, image quality, reporting, and documentation of quality improvement activities. Site characteristics for each facility were also analyzed. RESULTS: Sixty-two percent of facilities (n = 2,020) demonstrated deficiencies resulting in delayed accreditation. Deficiencies were less frequently observed at hospital-based facilities, facilities applying for reaccreditation, and facilities with credentialed sonographers. The most frequent deficiencies were related to reports (48%), followed by staff qualifications (46%), quality improvement (45%), image quality (44%), and protocols (43%). Both reports and image quality had the highest average numbers of deficiencies per facility, with 2.0 ± 1.0 and 1.83 ± 0.82, respectively. The most common deficient variables were lack of documented continuing medical education (25%), incomplete protocols (36%), incomplete interrogation of aortic stenosis from multiple views (34%), incomplete reports (36%), and insufficient annual summary of quality improvement activities (45%). CONCLUSIONS: Accreditation is delayed for a majority of facilities seeking Intersocietal Accreditation Commission Echocardiography accreditation because of major deficiencies or noncompliance. By focusing on staff continuing medical education, adoption and implementation of standard imaging protocols, ensuring acceptable image quality, using standards in reporting, and implementing quality improvement programs, echocardiography facility performance and quality as compared with the Intersocietal Accreditation Commission Echocardiography standards may be improved.

Advanced Cardiovascular Sonographer: a proposal of the American Society of Echocardiography Advanced Practice Sonographer Task Force.

Echocardiographic examinations require a well-trained and competent sonographer to obtain proper anatomic and physiologic data to establish an accurate diagnosis for clinical decision-making and patient management. Although the formal education and training of cardiovascular sonographers are evolving, many entry-level and staff sonographers may not have sufficient practical or clinical knowledge of the necessary components of the echocardiographic study for the individual patient's clinical presentation. In many clinical settings, echocardiograms are read after the patient has left the laboratory. Thus, there is a role for a sonographer who can practice at an advanced level in a cardiovascular ultrasound laboratory to ensure a proper echocardiographic examination is performed on every patient. In this setting, an Advanced Cardiovascular Sonographer (ACS) would be able to review the indication for and quality of the examination. If additional images were needed, the ACS would assist the sonographer in obtaining these images, which would lead to the performance of a complete and fully diagnostic examination before the patient had left the echocardiography laboratory. In clinical practice, the quality of the examinations performed would improve, advancements in echocardiographic methods could be taught and incorporated into daily practice, and patients would be better served. The present report is a proposal from the American Society of Echocardiography Advanced Practice Task Force that identifies the potential of cardiac sonographers to achieve the ACS level.