Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk.

BACKGROUND: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turnaround times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid point-of-care (POC) whole-blood hs-cTnI assay at presentation with potential early patient discharge. METHODS: Consecutive patients presenting to the emergency department from 2 prospective observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica VTLi) threshold using whole blood at presentation, which resulted in a negative predictive value of ≥99.5% and sensitivity of >99% for index MI, was derived (SEIGE [Safe Emergency Department Discharge Rate]) and validated with plasma (SAMIE [Suspected Acute Myocardial Infarction in Emergency]). Event adjudications were established with hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30 days. RESULTS: A total of 1086 patients (8.1% with MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole-blood POC hs-cTnI concentration of <4 ng/L provided a sensitivity of 98.9% (95% CI, 93.8%-100%) and negative predictive value of 99.5% (95% CI, 97.2%-100%) for ruling out MI. In the validation cohort, the sensitivity was 98.8% (95% CI, 93.3%-100%), and negative predictive value was 99.8% (95% CI, 99.1%-100%); 17.8% and 41.8%, respectively, were defined as low risk for discharge. The 30-day adverse cardiac events were 0.1% (n=1) for SEIGE and 0.8% (n=5) for SAMIE. CONCLUSIONS: A POC whole-blood hs-cTnI assay permits accessible, rapid, and safe exclusion of MI and may expedite discharge from the emergency department. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04772157. URL: https://www.australianclinicaltrials.gov.au/anzctr_feed/form; Unique identifier: 12621000053820.

Rapid Rule-Out of Myocardial Infarction Using a Single High-Sensitivity Cardiac Troponin I Measurement Strategy at Presentation to the Emergency Department: The SAFETY Study.

BACKGROUND: Our study addressed the diagnostic performance of the Atellica® IM High-Sensitivity Troponin I (hs-cTnI) assay for the rapid rule-out of myocardial infarction (MI) using a single hs-cTnI measurement at presentation in patients presenting to a US emergency department (ED). METHODS: This was a prospective, observational, cohort study of consecutive ED patients with suspected acute coronary syndrome, using 12-lead electrocardiogram and serial hs-cTnI measurements ordered on clinical indication (SAFETY, NCT04280926). ST-segment elevation MI patients were excluded. The optimal threshold required a sensitivity ≥99% and a negative predictive value (NPV) ≥99.5% for MI during index hospitalization as primary outcome. Type 1 MI (T1MI), myocardial injury, and 30-day adverse events were considered secondary outcomes. Event adjudications were established using the hs-cTnI assay used in clinical care. RESULTS: In 1171 patients, MI occurred in 97 patients (8.3%), 78.3% of which were type 2 MI. The optimal rule out hs-cTnI threshold was <10 ng/L, which identified 519 (44.3%) patients as low risk at presentation, with sensitivity of 99.0% (95% CI, 94.4-100) and NPV of 99.8% (95% CI, 98.9-100). For T1MI, sensitivity was 100% (95% CI, 83.9-100) and NPV 100% (95% CI, 99.3-100). Regarding myocardial injury, the sensitivity and NPV were 99.5% (95% CI, 97.9-100) and 99.8% (95% CI, 98.9-100), respectively. For 30-day adverse events, sensitivity was 96.8% (95% CI, 94.3-98.4) and NPV 97.9% (95% CI, 96.2-98.9). CONCLUSIONS: A single hs-cTnI measurement strategy enabled the rapid identification of patients at low risk of MI and 30-day adverse events, allowing potential discharge early after ED presentation. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT04280926.

Renal impairment and mortality in patients with STEMI and cardiogenic shock/cardiac arrest.

OBJECTIVES: We sought to study the association of renal impairment (RI) with mortality in ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock and/or cardiac arrest (CS/CA). METHODS: Patients with RI (estimated glomerular filtration rate <60 mL/min/1.73 m2 ) were identified from the Midwest STEMI consortium, a prospective registry of four large regional programs comprising consecutive patients over 17 years. Primary outcome was in-hospital and 1-year mortality stratified by RI status and presence of CS/CA among patients with STEMI referred for coronary angiography. RESULTS: In a cohort of 13,463 STEMI patients, 13% (n = 1754) had CS/CA, 30% (n = 4085) had RI. Overall, in-hospital mortality was 5% (12% RI vs. 2% no-RI, p < 0.001) and 1-year mortality 9% (21% RI vs. 4% no-RI, p < 0.001). Among uncomplicated STEMI, in-hospital mortality was 2% (4% RI vs. 1% no-RI, p < 0.001) and 1-year mortality 6% (13% RI vs. 3% no-RI, p < 0.001). In STEMI with CS/CA, in-hospital mortality was 29% (43% RI vs. 15% no-RI, p < 0.001) and 1-year mortality 33% (50% RI vs. 16% no-RI, p < 0.001). Using Cox proportional hazards, RI was an independent predictor of in-hospital mortality in STEMI with CS/CA (odds ratio [OR]: 3.86; confidence interval [CI]: 2.6, 5.8). CONCLUSIONS: The association of RI with in-hospital and 1-year mortality is disproportionately greater in those with CS/CA compared to uncomplicated STEMI presentations. Factors predisposing RI patients to higher risk STEMI presentations and pathways to promote earlier recognition in the chain of survival need further investigation.

Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire.

BACKGROUND: Ventricular assist device (VAD) implantation has become an alternative treatment for patients with end-stage heart failure. In Germany, valid and reliable instruments to assess health-related quality of life in patients with VAD are lacking. OBJECTIVE: The aim of this study was to present the psychometric validation of the German version of the Quality of Life with a Ventricular Assist Device questionnaire. METHODS: In a multicenter, cross-sectional study, 393 participants (mean age, 58.3 years; 85.8% male, 60.3% bridge to transplant, and 72.8% living with VAD for ≤2 years) completed the German Quality of Life with a Ventricular Assist Device questionnaire of physical, emotional, social, cognitive, and meaning/spiritual domains. Item and confirmatory factor analyses were conducted to test item difficulty and discrimination and the underlying structure, respectively. To examine internal consistency, Cronbach α was assessed. Convergent construct validity was tested using the Kansas City Cardiomyopathy Questionnaire and the Patient Health Questionnaire-9. Readability was examined using Flesch Reading Ease index and Vienna Factual Text Formula. RESULTS: The Quality of Life with a Ventricular Assist Device showed reasonable item difficulty (Ptotal = .67) and mostly moderate to high discriminatory power (rit > 0.30). In confirmatory factor analysis, root-mean-square error of approximation (0.07) was acceptable for model fit, but no other indices. Acceptable internal consistency was found (α ≥ 0.79), with the exception of the cognitive domain (α = 0.58). The overall questionnaire and single domains demonstrated convergent validity (r ≥ 0.45, P < .001). The questionnaire showed adequate readability (Flesch Reading Ease, 64.11; Vienna Factual Text Formula, 6.91). CONCLUSION: Findings indicate a promising standardized clinical instrument to assess health-related quality of life in patients with VAD.

Leadless pacemaker perforations: Clinical consequences and related device and user problems.

BACKGROUND: Cardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA). METHODS: FDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems. RESULTS: Between 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and 146 patients (26%) required emergency surgery. Half of perforations were associated with 139 (25%) device problems, 78 (14%) operator use problems, and 62 (11%) combined device and operator use problems. Inadequate electrical measurements or difficult positioning were the most frequent device problems (n = 129); non-septal implants and perforation of other structures were the most frequent operator use problems (n = 69); a combined operator use and device problem resulted in 62 delivery system perforations. No device or operator use problem was identified for 282 perforations (50%), but they were associated with 78 deaths, 245 tamponades, and 57 emergency surgeries. CONCLUSION: The Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.

Revascularization and long-term outcomes in high-acuity spontaneous coronary artery dissection.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is often treated conservatively due to revascularization risks. Yet, an important number of SCAD patients have high acuity characteristics necessitating revascularization, with uncertain long-term outcomes. OBJECTIVES: Document revascularization utilization and long-term outcomes in high acuity SCAD. METHODS: Prospective/retrospective analysis of consecutive patients with acute myocardial infarction (AMI) due to first SCAD event presenting directly to the Minneapolis Heart Institute 2002-2021, median follow-up 3.8 years. RESULTS: Among 139 patients (age 49 ± 12 years, 96% female), revascularization was performed in 60 (43%), utilizing percutaneous coronary intervention (PCI) (n = 56, successful in 80%) or coronary artery bypass graft (n = 4). In the entire cohort, 90 (65%) unique patients had one or more high acuity characteristic: ST-elevation (38%), proximal dissection (38%), cardiogenic shock (6.5%), cardiac arrest (9.4%), left main dissection (6.5%), peripartum dissection (7.2%). High acuity patients accounted for 51 of 60 (85%) revascularizations. Revascularization rates were: ST-elevation (60%), proximal dissection (62%), cardiogenic shock (89%), cardiac arrest (62%), left main dissection (100%), peripartum dissection (70%). Survival was 97% (revascularized) vs 100% (nonrevascularized); p = 0.2. Adverse outcomes (revascularized vs. nonrevascularized) included recurrent AMI:16.7% versus 8.9%; p = 0.2, SCAD recurrence: 13.3% versus 6.3%; p = 0.1, stroke: 5% versus 2.5%; p = 0.44, implantable cardioverter-defibrillator: 6.7% versus 6.3%; p > 0.9. Reintervention was necessary in 21% of PCI-treated patients. CONCLUSIONS: High-acuity characteristics were present in nearly two-thirds of this SCAD cohort; the vast majority of revascularizations were performed in high-acuity patients. Despite high acuity, long-term survival was favorable in revascularized patients.

The changing landscape of cardiac co-morbidities and in-hospital cardiac complications mediating Covid-19 mortality between 2020 and 2021.

Background: Cardiac co-morbidities and in-hospital cardiac complications significantly contribute to COVID-19 mortality. However, their influence on mortality between 2021 and 2020 may differ due to the availability of vaccines, different viral strains, and therapeutic advancements. Methods: We performed a retrospective chart review and individual patient analysis of all COVID-19 associated in-patient deaths in 2020 (n = 346) and 2021(n = 527) in a large Minneapolis health system. Cause of death was adjudicated by at least two health care providers, including one cardiologist. Results: Patients who died in 2021 were younger, of similar race/ethnicity, and body mass index compared to 2020. In 2021, 24 % of the cohort was full or partially vaccinated, while none were vaccinated in 2020. Patients who died in 2021 had significantly fewer cardiovascular co-morbidities and major adverse cardiovascular events prior to COVID-19 infection, resulting in significantly fewer in-hospital cardiac adverse events compared to patients who died in 2020, including myocardial infarction, stroke, and atrial fibrillation. In contrast, patients in 2021 had significantly higher rates of venous thromboembolic events. Conclusion: Patients who died from COVID-19 in 2021 had significantly fewer cardiovascular co-morbidities and in-hospital cardiovascular complications compared to patients who died in 2020. Sixteen percent of patients stipulated as dying from COVID-19 actually die from other causes.

Reach and effectiveness of a non-university cardio-obstetrics program.

BACKGROUND: Current guidelines recommend multidisciplinary cardiovascular obstetric programs (CVOB) to manage complex pregnant patients with cardiovascular disease. Minimal evaluation of these programs exists, with most of these programs offered at university-based centers. METHODS: A cohort of 113 patients managed by a CVOB team at a non-university health system (2018-2019) were compared to 338 patients seen by cardiology prior to the program (2016-2017). CVOB patients were matched with comparison patients (controls) on modified World Health Organization (mWHO) category classification, yielding a cohort of 102 CVOB and 102 controls. RESULTS: CVOB patients were more ethnically diverse and cardiovascular risk was higher compared to controls based on mWHO ≥ II-III (57% vs 17%) and. After matching, CVOB patients had more cardiology tests during pregnancy (median of 8 tests vs 5, p < .001) and were more likely to receive telemetry care (32% vs 19%, p = .025). The median number of perinatology visits was significantly higher in the CVOB group (8 vs 2, p < .001). Length of stay was a half day longer for vaginal delivery patients in the CVOB group (median 2.66 vs 2.13, p = .006). CONCLUSION: Implementation of a CVOB program resulted in a more diverse patient population than previously referred to cardiology. The CVOB program participants also experienced a higher level of care in terms of increased cardiovascular testing, monitoring, care from specialists, and appropriate use of medications during pregnancy.

Iso-osmolar vs low-osmolar contrast agents for coronary optical coherence tomography: a blinded prospective randomized controlled study.

BACKGROUND: The impact of contrast type on coronary optical coherence tomography (OCT) imaging has received limited research. METHODS: We conducted a blinded, prospective, single-center, randomized, controlled crossover study comparing iso-osmolar contrast media (IOCM) with low-osmolar contrast media (LOCM) in patients undergoing clinically indicated coronary OCT imaging. Patients were randomly assigned to undergo OCT imaging with either IOCM or LOCM as the initial contrast medium. Following a washout period, a second run of OCT imaging of the same coronary vessel was performed using the other contrast medium. RESULTS: A total of 62 patients were randomized to IOCM first (n = 31) or LOCM first (n = 31). Mean patient age was 65.9 ± 11.2 years and 74.2% were male, with high prevalence of dyslipidemia (82.3%) and prior myocardial infarction (41.9%). Percutaneous coronary intervention was performed in 60 cases (96.8%) and the left anterior descending artery was the most common target vessel (53.3%). The contrast volume used for OCT imaging was similar for IOCM and LOCM (8.0 [6.9, 9.0] mL vs 8.0 [6.7, 9.0] mL; P = .89), as was the length of clear OCT images (70.0 [62.8, 74.0] mm for IOCM vs 70.0 [64.0, 74.0] mm for LOCM; P = .65). Electrocardiographic changes were observed in 11 runs with IOCM (ventricular repolarization changes in 9 runs and premature ventricular contractions [PVCs] in 2 runs) vs 12 runs with LOCM (ventricular repolarization changes in 9 runs and PVCs in 3 runs). CONCLUSIONS: The use of IOCM in coronary OCT is associated with similar contrast volume and clear imaging length when compared with LOCM.

Association of triglyceride levels with adverse cardiovascular events in patients with ST-segment elevation myocardial infarction.

Although there is an established association between elevated triglyceride (eTG, ≥175 mg/dl) levels and adverse cardiovascular events, some studies have suggested that eTG levels may be linked to neutral or even improved clinical outcomes, particularly among patients with acute myocardial infarction. However, these studies had certain limitations, including small sample sizes, heterogeneous study populations, and inadequate statistical adjustments. To address these limitations, we conducted an analysis of 5347 patients with ST-segment elevation myocardial infarction (STEMI) between March 2003 and December 2020, using a prospective registry-based cohort from two large, regional STEMI centers. We used a triglyceride level of 175 mg/dl as the cutoff point for eTG levels. Of the study participants, 24.5% (n = 1312) had eTG levels. These patients were more likely to be younger, male, and have a higher number of cardiovascular risk factors compared to those with low TG levels. Despite these unfavorable cardiovascular risk profiles, patients with eTG levels had lower unadjusted risks of 1-year major adverse cardiac events (MACE) -a composite of myocardial infarction, stroke, and death- than those with low TG levels (8.8% vs. 11%, p = 0.034). However, after adjusting for certain clinical factors and lipid profile, eTG levels were not associated with a lower 1-year MACE (aHR: 1.10 (0.71-1.70), p = 0.7). In conclusion, a quarter of STEMI patients had eTG levels and these patients had comparable long-term cardiovascular outcomes compared to those with low TG levels after controlling for clinical factors and lipid profile.

Coronary Angiography Within 30 Days From Coronary Artery Bypass Graft Surgery: Indications, Findings, and Outcomes.

BACKGROUND: The incidence, indications, and outcomes of coronary angiography (CAG) performed within 30 days following coronary artery bypass graft surgery (CABG) have received limited study. METHODS: We reviewed patients who underwent CAG within 30 days following CABG between April 2018 and September 2021 at a large quaternary healthcare system. RESULTS: Of 2209 patients who underwent CABG during the study, 111 (5%) underwent CAG within 30 days following CABG. Mean age was 65 ± 10 years and they had high prevalence of comorbidities. Graft utilization was as follows: left internal mammary artery (LIMA) (84%); saphenous vein graft(s) (SVG) (81%); and right internal mammary artery (RIMA) (22%). The most common presentations/indications for angiography were cardiogenic shock (41%), ST-segment-elevation myocardial infarction (32%), and achieving complete revascularization by percutaneous coronary intervention (PCI) (16%). The LIMA, RIMA, and SVGs were completely/partially occluded in 41 (44%), 10 (42%), and 11 (50%) of patients, respectively. Of the 111 patients who underwent CAG, 55 (50%) underwent PCI, including 47 (85%) to the native vessel and 8 (15%) to the bypass graft, and 19 (17%) underwent repeat sternotomy. Overall, 29 patients (26%) required 30-day readmission following CAG and 19 (17%) died. CONCLUSION: The incidence of CAG within 30 days following CABG is approximately 5%. Patients who need CAG following CABG have high complication rates (26% readmission and 17% mortality, respectively, at 30 days).

Characteristics and Long-term Mortality in Patients with ST-Segment Elevation Myocardial Infarction with Non-Obstructive Coronary Arteries (STE-MINOCA): A High Risk Cohort.

Background: The prognosis of ST-segment elevation myocardial infarction with non-obstructive coronaries (STE-MINOCA) is largely unknown. Methods: The objective of this study is to evaluate the prevalence, characteristics, and 5-year mortality of patients with STE-MINOCA compared to STEMI with coronary artery obstruction (STEMI-Obstruction) using a multicenter cohort of consecutive STEMI patients at 3 regional Midwest STEMI programs from 2003 to 2020. STE-MINOCA was defined based on (1) coronary stenosis < 60% by visual estimation, (2) ischemia with elevated troponin, and (3) no alternative diagnosis. STE-MINOCA was further classified based on American Heart Association (AHA) definition as AHA STE-MINOCA and AHA STE-MINOCA Mimicker. Results: 8,566 STEMI patients, including 420 (4.9%) STE-MINOCA (26.9% AHA STE-MINOCA and 73.1% AHA STE-MINOCA Mimicker) were followed for a median of 7.1 years. Compared to STEMI-Obstruction, STE-MINOCA were younger, more often female, had fewer cardiovascular risk factors, and were less likely to be discharged on cardiac medications. At five years, mortality was higher in STE-MINOCA compared with STEMI-Obstruction (18% vs. 15%, p=0.033). In propensity score-matched analysis, STE-MINOCA had a 1.4-fold (95% CI: 1.04-1.89, p=0.028) higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Furthermore, 5-year mortality risk was significantly higher in AHA STE-MINOCA Mimicker (19% vs. 15%, p=0.043) but similar in AHA STE-MINOCA (17% vs. 15%, p=0.42) compared with STEMI-Obstruction. Conclusions: In this large multicenter STEMI cohort, nearly 5% of patients presented with STE-MINOCA. At five years, mortality approached 20% among patients with STE-MINOCA. Despite the lower risk profile, STE-MINOCA patients were at 40% higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Additionally, 5-year all-cause mortality risk was higher in AHA STE-MINOCA Mimicker but similar in AHA STE-MINOCA compared to STEMI-Obstruction.

Use of Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

The use of mechanical circulatory support (MCS) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We analyzed the clinical and angiographic characteristics, and procedural outcomes of 7,171 CTO PCIs performed between 2012 and 2021 at 35 international centers. Mean age was 64.5 ± 10 years, mean left ventricular ejection fraction was 50 ± 13%. MCS was used in 4.5%, prophylactically in 78.7%, and urgently in 21.3%. The most common type of MCS overall was Impella CP (Abiomed) (55.5%), followed by intra-aortic balloon pump (14.8%) and TandemHeart (LivaNova Inc.) (10.0%). Prophylactic MCS patients were more likely to have diabetes mellitus (55% vs 42%, p <0.001) and had more complex lesions compared with cases without prophylactic MCS (Japan-CTO score: 2.80 ± 1.22 vs 2.39 ± 1.27, p <0.001). Cases with prophylactic MCS had similar technical (86% vs 87%, p = 0.643) but lower procedural (80% vs 86%, p = 0.028) success rates and higher rates of periprocedural major cardiac adverse events compared with no prophylactic MCS use (6.55% vs 1.68%, p <0.001). Urgent MCS use was associated with lower technical (68% vs 87%, p <0.001) and procedural (39% vs 86%, p <0.001) success rates and higher major cardiac adverse events compared with no-MCS use (32.26% vs 1.68%, p <0.001). The differences persisted in multivariable analyses. In summary, in this contemporary multicenter registry, MCS was used in 4.5% of CTO PCIs, mostly prophylactically (78.7%). Elective MCS cases had similar technical success but a higher risk of complications. Urgent MCS cases had lower technical and procedural success and higher periprocedural major complication rates.

Development of a Novel Score to Predict Urgent Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

Estimating the likelihood of urgent mechanical circulatory support (MCS) can facilitate procedural planning and clinical decision-making in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,784 CTO PCIs performed between 2012 and 2021 at 12 centers. The variable importance was estimated by a bootstrap applying a random forest algorithm to a propensity-matched sample (a ratio of 1:5 matching cases with controls on center). The identified variables were used to predict the risk of urgent MCS. The performance of the risk model was assessed in-sample and on 2,411 out-of-sample procedures that did not require urgent MCS. Urgent MCS was used in 62 (2.2%) of cases. Patients who required urgent MCS were older (70 [63 to 77] vs 66 [58 to 73] years, p = 0.003) compared with those who did not require urgent MCS. Technical (68% vs 87%, p <0.001) and procedural success (40% vs 85%, p <0.001) was lower in the urgent MCS group compared with cases that did not require urgent MCS. The risk model for urgent MCS use included retrograde crossing strategy, left ventricular ejection fraction, and lesion length. The resulting model demonstrated good calibration and discriminatory capacity with the area under the curve (95% confidence interval) of 0.79 (0.73 to 0.86) and specificity and sensitivity of 86% and 52%, respectively. In the out-of-sample set, the specificity of the model was 87%. The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention CTO MCS score can help estimate the risk of urgent MCS use during CTO PCI.

Diagnostic performance of a rapid, novel, whole blood, point of care high-sensitivity cardiac troponin I assay for myocardial infarction.

BACKGROUND: We evaluated the diagnostic performance of a whole blood, point of care (POC) high-sensitivity cardiac troponin I (hs-cTnI) assay for myocardial infarction (MI) compared to central laboratory assays. METHODS: Consecutive patients presenting to the emergency department with symptoms of ischemia were studied. Serial hs-cTnI testing was based on clinical indication at presentation. Parallel measurements were made using fresh whole blood on Siemens Atellica VTLi POC assay, EDTA plasma on Abbott ARCHITECT i2000 used in practice, and heparin plasma on Siemens Atellica. MI was determined according to the Fourth Universal Definition of MI using 99th percentiles. Sensitivities and negative predictive values (NPV) were calculated using 99th percentile URLs. RESULTS: 1089 Patients, 418 females and 671 males, were enrolled. There were 91 (8.4%) MIs. At baseline (0 h), POC hs-cTnI assay had a sensitivity of 65.7% (95% CI 47.8-80.9) for females and 67.9% (54.0-79.7) for males and NPV of 96.4% (93.9-98.1) for females and 96.7% (94.9-98.0) for males. At 2 h, sensitivity improved to 82.9% (66.4-93.4) for females and 80.4% (67.6-89.8) for males, while NPV improved to 98.2% (96.1-99.3) and 97.9% (96.3-99.0), respectively. For central laboratory assays, comparable diagnostics were observed at 2 h: females - sensitivity 94.3% (80.8-99.3) for ARCHITECT and 79.4% (62.1-91.3) for Atellica, and NPV 99.3% (97.6-99.9) and 98.0% (95.8-99.2), respectively; males - sensitivity 87.5% (75.9-94.8) for ARCHITECT and 80.4% (67.6-89.8) for Atellica, NPVs of 98.7% (97.3-99.5) and 97.9% (96.3-99.0), respectively. CONCLUSIONS: The POC, whole blood Atellica VTLi hs-cTnI assay demonstrated comparable diagnostic accuracy for MI to central laboratory assays using 99th percentiles.

Circadian dependence of microvascular obstruction during ST-segment elevation myocardial infarction.

BACKGROUND: Microvascular obstruction (MVO) contributes significantly to adverse left-ventricular remodeling and mortality following ST-segment elevation myocardial infarction (STEMI). Because circadian processes contribute significantly to the timing and degree of ischemic injury in STEMI we hypothesized that the occurrence of MVO may also exhibit circadian behavior. METHODS AND RESULTS: A single center cohort trial of 336 STEMI patients (273 M 63 F) with their first STEMI who were reperfused with primary percutaneous coronary intervention (PCI) and referred for cardiac MRI prior to discharge. The time of onset of chest pain was recorded from the patients chart and used to stratify patients with MVO over a 24-h cycle to analyze for circadian behavior. Subjects with MVO (n = 200) had greater infarct size by cMRI (45 vs. 20 g; p < 0.001), had reduced ejection fraction (LVEF = 50 vs 45%; p = 0.008) and significantly greater LV end-diastolic (LVEDVI) and end-systolic (LVESVI) volume index compared to subject without MVO (n = 136). The frequency of patients with MVO was compared against the frequency of patients without MVO at each 1-h and 3-h period over a 24-h cycle. A clear peak in patients with MVO (MVO + / MVO -) was seen at the 0700 h interval where 26 out of 27 patients had MVO (p = 0.0038) although MVO mass was not increased. This observation remained significant at the 06-09 time interval when 3-h segments were analyzed. Through 2021, mortality in patients with MVO was significantly greater compared to patients without MVO (n = 20 vs. 5, p < 0.03). CONCLUSIONS: This analysis reveals for the first time a circadian dependence of the frequency of MVO in the setting of STEMI which could explain in part, the wide variation in MVO seen in STEMI patients with similar ischemic times and infarct size.

Observational Study of Receptor Binding Domain Spike Antibody Responses to 3 SARS-CoV-2 Vaccinations in Noninfected Subjects: Parallel Neutralizing Antibody and Cardiac Troponin I and T Observations.

BACKGROUND: Our goals were to demonstrate receptor binding domain spike 1 (RBD S1) protein antibody (Ab) kinetic responses to multiple vaccines over approximately 180 days, neutralizing Ab effectiveness, and high-sensitivity cardiac troponin I (hs-cTnI) and T (hs-cTnT) responses in postvaccinated, non-SARS-CoV-2-infected subjects. METHODS: Blood specimens were collected pre- and postvaccinations from seronegative subjects. RDB S1 Abs were measured by the novel Qorvo Biotechnologies Omnia platform. Neutralizing Abs and hs-cTnI and hs-cTnT were measured on the ET Healthcare Pylon 3D. RESULTS: Two-dose vaccines (Pfizer, Moderna) had peak RBD S1 Ab concentrations about 45 to 55 days after both doses and showed declines over the next 50 to 70 days. The Janssen vaccine showed lower RBD S1 Ab peak concentrations, continued to increase over time, and plateaued after 60 days. There was strong neutralizing Ab response post vaccinations, with only 3 specimens, shortly before and shortly after vaccination, not showing a response. Specimens showed no hs-cTnI (all < 3 ng/L) and hs-cTnT (all < 6 ng/L) increases or changes over time. CONCLUSIONS: We demonstrate in seronegative SARS-CoV-2 subjects that Pfizer and Moderna vaccinations provide strong, neutralizing RBD S1 Ab effectiveness, based on 2 different assays after 2 doses, with the Janssen single-dose vaccine showing a lower RBD S1 Ab response over 4 to 6 months. No myocardial injury was associated with the Pfizer postvaccination. The Qorvo Biotechnologies RBD S1 Ab assay measured on the Omnia platform has potential as a point-of-care platform.

Clinical Impact of Hypoattenuating Leaflet Thickening After Transcatheter Aortic Valve Replacement.

BACKGROUND: Hypoattenuated leaflet thickening (HALT), identified on functional cardiac computed tomography (CTA), can affect valve function and clinical outcomes. The objective of this study was to assess the impact of HALT on clinical outcomes in patients treated with transcatheter aortic valve replacement (TAVR). METHODS: In July 2015, Minneapolis Heart Institute implemented prospective screening of HALT at 30-day post-TAVR with CTA. Patients with evidence of HALT were recommended to initiate anticoagulation for 3 to 6 months with warfarin. Echocardiographic, ischemic, and bleeding outcomes were compared between HALT+ and HALT- patients. Survival rates were compared between HALT+ and HALT- patients using log-rank test, with Cox regression analysis used to identify variables independently associated with long-term death landmarked at time of CTA. This analysis included patients treated from July 1, 2015 to October 31, 2019. RESULTS: Of 856 patients undergoing TAVR during the study period, 638 (75%) underwent CTA post-TAVR (median time 31 [30-37] days). HALT+ was evident in 79 (12.3%). HALT+ patients were more likely prescribed warfarin at 1, 3, and 12 months (all P<0.001) and had similar gradients compared with HALT- patients. After a median follow-up of 2.2 years (1.5-3.2), HALT+ patients had increased mortality (30% versus 20%; P=0.001). In Cox regression analysis, presence of HALT (hazard ratio, 1.83 [95% CI, 1.13-2.97]; P=0.014) remained independently associated with long-term mortality. CONCLUSIONS: In a large, real-world cohort of patients receiving TAVR followed by systematic screening with CTA 30-days post-procedure, HALT was found in 12% of patients and independently associated with long-term mortality. Findings of this nonrandomized, observational cohort study require independent validation.

Frequency, Etiology, and Impact of Unplanned Repeat Coronary Angiography After ST-Elevation Myocardial Infarction.

Unplanned repeat coronary angiography (CAG) after balloon angioplasty for ST-elevation myocardial infarction (STEMI) was common before the advent of coronary stenting. Limited data are available regarding the role of unplanned repeat CAG in contemporary percutaneous coronary intervention (PCI) for STEMI. Therefore, we analyzed a large, 2-center prospective STEMI registry (January 2011 to June 2020) stratified by the presence or absence of unplanned repeat CAG during index hospitalization. Patients with planned CAG for staged PCI or experimental drug administration were excluded. Among 3,637 patients with STEMI, 130 underwent unplanned repeat CAG (3.6%) during index hospitalization. These patients were more likely to have cardiogenic shock (16% vs 9.8%, p = 0.021), left anterior descending culprit (44% vs 31%, p <0.001), lower left ventricular ejection fraction (45% vs 52%, p <0.001), and higher peak troponin levels (22 vs 8 ng/ml, p <0.001) than those without repeat CAG. At repeat CAG, 80 patients had a patent stent (62%) including 65 requiring no further intervention (50%) and 15 who underwent intervention on a nonculprit lesion (12%). Only 32 patients had stent thrombosis (25%). Repeat CAG was associated with a higher incidence of recurrent MI (19% vs 0%, p <0.001) and major bleeding (12% vs 4.5%, p <0.001), yet similar in-hospital mortality (7% vs 6.4%, p = 0.93) than those without repeat CAG. In conclusion, in the era of contemporary PCI for STEMI, unplanned repeat CAG during index hospitalization was infrequent and more commonly observed in patients with left anterior descending culprit in the presence of significant left ventricular dysfunction or shock and was associated with higher in-hospital recurrent myocardial infarction and major bleeding complications.

Trends in Clinical Presentation, Management, and Outcomes of STEMI in Patients With COVID-19.

BACKGROUND: We previously reported high in-hospital mortality for ST-segment elevation myocardial infarction (STEMI) patients with COVID-19 treated in the early phase of the pandemic. OBJECTIVES: The purpose of this study was to describe trends of COVID-19 patients with STEMI during the course of the pandemic. METHODS: The NACMI (North American COVID-19 STEMI) registry is a prospective, investigator-initiated, multicenter, observational registry of hospitalized STEMI patients with confirmed or suspected COVID-19 infection in North America. We compared trends in clinical characteristics, management, and outcomes of patients treated in the first year of the pandemic (January 2020 to December 2020) vs those treated in the second year (January 2021 to December 2021). RESULTS: A total of 586 COVID-19-positive patients with STEMI were included in the present analysis; 227 treated in Y2020 and 359 treated in Y2021. Patients' characteristics changed over time. Relative to Y2020, the proportion of Caucasian patients was higher (58% vs 39%; P < 0.001), patients presented more frequently with typical ischemic symptoms (59% vs 51%; P = 0.04), and patients were less likely to have shock pre-PCI (13% vs 18%; P = 0.07) or pulmonary manifestations (33% vs. 47%; P = 0.001) in Y2021. In-hospital mortality decreased from 33% (Y2020) to 23% (Y2021) (P = 0.008). In Y2021, none of the 22 vaccinated patients expired in hospital, whereas in-hospital death was recorded in 37 (22%) unvaccinated patients (P = 0.009). CONCLUSIONS: Significant changes have occurred in the clinical characteristics and outcomes of STEMI patients with COVID-19 infection during the course of the pandemic.