Association of the COVID-19 Pandemic on Treatment Times for ST-Elevation Myocardial Infarction: Observations from the Los Angeles County Regional System.

Previous studies have documented longer treatment times and worse outcomes for patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) during the COVID-19 pandemic. The objective of the present study was to evaluate the impact of the COVID-19 pandemic on treatment times and outcomes for patients with STEMI who underwent primary PCI within a regional system of care. This was a retrospective study using data from the Los Angeles County Emergency Medical Services Agency. Data on the emergency medical service activations were abstracted for patients with STEMI from March 19, 2020 to January 31, 2021, during the COVID-19 pandemic and for the same interval the previous year. All adult patients (≥18 years) with STEMI who underwent emergent coronary angiography were included. The primary end point was the first medical contact (FMC) to device time. The secondary end points included treatment time intervals, vascular complications, need for emergent coronary artery bypass surgery, length of hospital stay, and in-hospital mortality. During the study period, 3,017 patients underwent coronary angiography for STEMI, 1,893 patients pre-COVID-19 and 1,124 patients during COVID-19 (40% lower). A total of 2,334 patients (77%) underwent PCI. During the COVID-19 period, rates of PCI were significantly lower compared with the control period (75.1% vs 78.7%, p = 0.02). FMC to device time was shorter during the COVID-19 period compared with the control period (median 77.0 vs 81.0 minutes, p = 0.004). For patients with STEMI complicated by out-of-hospital cardiac arrest, FMC to device time was similar during the COVID-19 period compared with the control period (median 95.0 [33.0] vs 100.0 [40.0] minutes, p = 0.34). Vascular complications, the need for emergent bypass surgery, length of hospital stay, and in-hospital mortality were similar between the periods. In conclusion, in this large regional system of care, we found a relatively small but significant decrease in treatment times, yet overall, similar clinical outcomes for patients with STEMI who underwent primary PCI and were treated during the COVID-19 period compared with a control period. These findings suggest that mature cardiac systems of care were able to maintain efficient care despite the challenges of the COVID-19 pandemic.

The Correlation between COVID-19 Hospitalizations and Emergency Medical Services Responses for Time-Sensitive Emergencies during the COVID-19 Pandemic.

OBJECTIVE: COVID-19 has had significant secondary effects on health care systems, including effects on emergency medical services (EMS) responses for time-sensitive emergencies. We evaluated the correlation between COVID-19 hospitalizations and EMS responses for time-sensitive emergencies in a large EMS system. METHODS: This was a retrospective study using data from the Los Angeles County EMS Agency. We abstracted data on EMS encounters for stroke, ST-elevation myocardial infarction (STEMI), out-of-hospital cardiac arrest (OHCA), and trauma from April 5, 2020 to March 6, 2021 and for the same time period in the preceding year. We also abstracted daily hospital admissions and censuses (total and intensive care unit [ICU]) for COVID-19 patients. We designated November 29, 2020 to February 27, 2021 as the period of surge. We calculated Spearman's correlations between the weekly averages of daily hospital admissions and census and EMS responses overall and for stroke, STEMI, OHCA, and trauma. RESULTS: During the study period, there were 70,616 patients admitted for confirmed COVID-19, including 12,467 (17.7%) patients admitted to the ICU. EMS responded to 899,794 calls, including 9,944 (1.1%) responses for stroke, 3,325 (0.4%) for STEMI, 11,207 (1.2%) for OHCA, and 114,846 (12.8%) for trauma. There was a significant correlation between total hospital COVID-19 positive patient admissions and EMS responses for all time-sensitive emergencies, including a positive correlation with stroke (0.41), STEMI (0.37), OHCA (0.78), and overall EMS responses (0.37); and a negative correlation with EMS responses for trauma (-0.48). ICU COVID-19 positive patient admissions also correlated with increases in EMS responses for stroke (0.39), STEMI (0.39), and OHCA (0.81); and decreased for trauma (-0.53). Similar though slightly weaker correlations were found when evaluating inpatient census. During the period of surge, the correlation with overall EMS responses increased substantially (0.88) and was very strong with OHCA (0.95). CONCLUSION: We found significant correlation between COVID-19 hospitalizations and the frequency of EMS responses for time-sensitive emergencies in this regional EMS system. EMS systems should consider the potential effects of this and future pandemics on EMS responses and prepare to meet non-pandemic resource needs during periods of surge, particularly for time-sensitive conditions.

Emergency Medical Services Responses to Out-of-Hospital Cardiac Arrest and Suspected ST-Segment-Elevation Myocardial Infarction During the COVID-19 Pandemic in Los Angeles County.

Background Public health emergencies may significantly impact emergency medical services responses to cardiovascular emergencies. We compared emergency medical services responses to out-of-hospital cardiac arrest (OHCA) and ST-segment‒elevation myocardial infarction (STEMI) during the 2020 COVID-19 pandemic to 2018 to 2019 and evaluated the impact of California's March 19, 2020 stay-at-home order. Methods and Results We conducted a population-based cross-sectional study using Los Angeles County emergency medical services registry data for adult patients with paramedic provider impression (PI) of OHCA or STEMI from February through May in 2018 to 2020. After March 19, 2020, weekly counts for PI-OHCA were higher (173 versus 135; incidence rate ratios, 1.28; 95% CI, 1.19‒1.37; P<0.001) while PI-STEMI were lower (57 versus 65; incidence rate ratios, 0.87; 95% CI, 0.78‒0.97; P=0.02) compared with 2018 and 2019. After adjusting for seasonal variation in PI-OHCA and decreased PI-STEMI, the increase in PI-OHCA observed after March 19, 2020 remained significant (P=0.02). The proportion of PI-OHCA who received defibrillation (16% versus 23%; risk difference [RD], -6.91%; 95% CI, -9.55% to -4.26%; P<0.001) and had return of spontaneous circulation (17% versus 29%; RD, -11.98%; 95% CI, -14.76% to -9.18%; P<0.001) were lower after March 19 in 2020 compared with 2018 and 2019. There was also a significant increase in dead on arrival emergency medical services responses in 2020 compared with 2018 and 2019, starting around the time of the stay-at-home order (P<0.001). Conclusions Paramedics in Los Angeles County, CA responded to increased PI-OHCA and decreased PI-STEMI following the stay-at-home order. The increased PI-OHCA was not fully explained by the reduction in PI-STEMI. Field defibrillation and return of spontaneous circulation were lower. It is critical that public health messaging stress that emergency care should not be delayed.

Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products.

IMPORTANCE: Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately. OBJECTIVES: To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments. DESIGN, SETTING, AND PARTICIPANTS: Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. EXPOSURE: A REMS program to reduce the risk of adverse outcomes, including misuse, abuse, addiction, and overdose, arising from use of TIRFs. MAIN OUTCOMES AND MEASURES: (1) Knowledge assessments of pharmacists, prescribers, and patients; (2) survey and claims-based prescribing assessments; (3) FDA and TIRF sponsor communications; (4) modifications to the REMS program; and (5) disenrollment of noncompliant prescribers. RESULTS: Twelve months after initiation of the program, 24 of 302 pharmacists (7.9%), 35 of 302 prescribers (11.6%), and 5 of 192 patients (2.6%) incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in the subsequent reports. At 60 months, product-specific analyses of claims data indicated that between 34.6% and 55.4% of patients prescribed TIRFs were opioid-nontolerant. In the 48-month survey, 106 of 310 prescribers (34.2%) reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 54 of 302 prescribers (18.4%) and 148 of 310 patients (47.7%) erroneously reported that TIRFs were FDA-approved for such use. Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing. CONCLUSIONS AND RELEVANCE: In this review of FDA documents pertaining to the TIRF REMS, surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge regarding proper TIRF prescribing, yet some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program.