Variation in Post-Cardiac Arrest Care Within a Regional EMS System.

Objective: Within Emergency Medical Systems (EMS) regional systems, there may be significant differences in the approach to patient care despite efforts to promote standardization. Identifying hospital-level factors that contribute to variations in care can provide opportunities to improve patient outcomes. The purpose of this analysis was to evaluate variation in post-cardiac arrest care within a large EMS system and explore the contribution of hospital-level factors. Methods: This was a retrospective analysis from a regional cardiac system serving over 10 million persons. Patients with out-of-hospital cardiac arrest (OHCA) with return of spontaneous circulation (ROSC) are transported to 36 cardiac arrest centers with 24/7 emergent coronary angiography (CAG) capabilities and targeted temperature management (TTM) policies based on regional guidelines. We included adult patients ≥18 years with non-traumatic OHCA from 2016-2018. Patients with a Do-Not-Resuscitate order and those who died in the emergency department (ED) were excluded. For the TTM analysis, we also excluded patients who were alert in the ED. The primary outcome was receiving CAG or TTM after cardiac arrest. The secondary outcome was neurologic recovery (dichotomized to define a "good" outcome as cerebral performance category (CPC) 1 or 2). We used generalized estimating equations including patient-level factors (age, sex, witnessed arrest, initial rhythm) and hospital-level factors (academic status, hospital size based on licensed beds, annual OHCA patient volume) to estimate the odds ratios associated with these variables. Results: There were 7831 patients with OHCA during the study period; 4694 were analyzed for CAG and 3903 for TTM. The median and range for treatment with CAG and TTM after OHCA was 23% (12-49%) and 58% (17-92%) respectively. Hospital size was associated with increased likelihood of CAG, adjusted odds ratio 1.71, 95% CI 1.05-2.86, p = 0.03. Academic status approached significance in its association with TTM, adjusted odds ratio 1.69, 95% CI 0.98-2.91, p = 0.06. Overall, 28% of patients survived with good neurologic outcome, ranging from 17 to 43% across hospitals. Conclusion: Within this regional cardiac system, there was significant variation in use of CAG and TTM after OHCA, which was not fully explained by patient-level factors. Hospital size was associated with increased CAG.

Skill-Based Differences in the Detection and Utilization of Opponent Action Preferences Following Increasing Exposure and Changes in Tendencies.

We examined skill-based differences in the detection and utilization of contextual information over a period of increasing exposure to an opponent's action preferences in soccer. Moreover, we investigated the ability of athletes to adapt to changes in these action preferences over time. In an initial detection phase, the attacking opponent demonstrated a proclivity to either pass or dribble, with these preferences being reversed in a subsequent adaptation phase of the same length. Skilled soccer players showed superior anticipation accuracy across both phases compared with less-skilled counterparts. The skilled participants significantly enhanced their performance over both phases, despite a significant drop in performance immediately following the change in opponent action preferences. In contrast, the less-skilled group only improved over the detection phase. Gaze data revealed that the skilled participants fixated more on kinematically relevant areas, compared with the less-skilled group, and increased the time spent fixating the player "off the ball" following greater volumes of exposure. Our novel findings elaborate on how skilled performers use both action preferences and motion information to anticipate an opponent's impending actions in sport.

Minimizing radiographic contrast administration during coronary angiography using a novel contrast reduction system: A multicenter observational study of the DyeVert™ plus contrast reduction system.

OBJECTIVE: To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections. BACKGROUND: Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring. METHODS: We performed a multicenter, single-arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m2 . The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use. RESULTS: A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m2 . CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22-681) and mean CMV delivered was 67 ± 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased. CONCLUSIONS: These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.

Therapeutic Hypothermia After Resuscitation From a Non-Shockable Rhythm Improves Outcomes in a Regionalized System of Cardiac Arrest Care.

OBJECTIVE: Therapeutic hypothermia (TH) improves neurologic outcome in patients resuscitated from ventricular fibrillation. The purpose of this study was to evaluate TH effects on neurologic outcome in patients resuscitated from a non-shockable out-of-hospital cardiac arrest rhythm. DESIGN AND SETTING: This is a retrospective cohort study of data reported to a registry in an emergency medical system in a large metropolitan region. Patients achieving field return of spontaneous circulation are transported to designated hospitals with TH protocols. PATIENTS: Patients with an initial non-shockable rhythm were identified. Patients were excluded if awake in the Emergency Department or if TH was withheld due to preexisting coma or death prior to initiation. The decision to initiate TH was determined by the treating physician. MEASUREMENTS: The primary outcome was survival with good neurologic outcome defined by a cerebral performance category of 1 or 2. MAIN RESULTS: Of the 2772 patients treated for cardiac arrest during the study period, there were 1713 patients resuscitated from cardiac arrest with an initial non-shockable rhythm and 1432 patients met inclusion criteria. The median age was 69 years [IQR 59-82]; 802 (56%) male. TH was induced in 596 (42%) patients. Survival with good neurologic outcome was 14% in the group receiving TH, compared with 5% in those not treated with TH (risk difference = 8%, 95% CI 5-12%). The adjusted OR for a CPC 1 or 2 with TH was 2.9 (95% CI 1.9-4.4). CONCLUSION: Analyzing the data collected from the registry of the standard practice in a large metropolitan region, TH is associated with improved neurologic outcome in patients resuscitated from initial non-shockable rhythms in a regionalized system for post-resuscitation care.

Current State of ST-Segment Myocardial Infarction: Evidence-based Therapies and Optimal Patient Outcomes in Advanced Systems of Care.

Advances in reperfusion therapy for ST-segment elevation myocardial infarction (STEMI) provide optimal patient outcomes. Reperfusion therapies, including contemporary primary percutaneous coronary intervention, represent decades of clinical evidence development in large clinical trials and national databases. However, rapid identification of STEMI and guideline-directed management of patients across broad populations have been best achieved in advanced systems of care. Current outcomes in STEMI reflect the evolution of both clinical data and idealized health care delivery networks.

Survival and neurologic outcome after out-of-hospital cardiac arrest: results one year after regionalization of post-cardiac arrest care in a large metropolitan area.

BACKGROUND: Post-resuscitation care of cardiac arrest patients at specialized centers may improve outcome after out-of-hospital cardiac arrest (OOHCA). This study describes experience with regionalized care of resuscitated patients. METHODS: Los Angeles (LA) County established regionalized cardiac care in 2006. Since 2010, protocols mandate transport of nontraumatic OOHCA patients with field return of spontaneous circulation (ROSC) to a STEMI Receiving Center (SRC) with a hypothermia protocol. All SRC report outcomes to a registry maintained by the LA County Emergency Medical Services (EMS) Agency. We report the first year's data. The primary outcome was survival with good neurologic outcome, defined by a Cerebral Performance Category (CPC) score of 1 or 2. RESULTS: The SRC treated 927 patients from April 2011 through March 2012 with median age 67; 38% were female. There were 342 patients (37%) who survived to hospital discharge. CPC scores were unknown in 47 patients. Of the 880 patients with known CPC scores, 197 (22%) survived to hospital discharge with a CPC score of 1 or 2. The initial rhythm was VF/VT in 311 (34%) patients, of whom 275 (88%) were witnessed. For patients with an initial shockable rhythm, 183 (59%) survived to hospital discharge and 120 (41%) had survival with good neurologic outcome. Excluding patients who were alert or died in the ED, 165 (71%) patients with shockable rhythms received therapeutic hypothermia (TH), of whom 67 (42%) had survival with good neurologic outcome. Overall, 387 patients (42%) received TH. In the TH group, the adjusted OR for CPC 1 or 2 was 2.0 (95%CI 1.2-3.5, p = 0.01), compared with no TH. In contrast, the proportion of survival with good neurologic outcome in the City of LA in 2001 for all witnessed arrests (irrespective of field ROSC) with a shockable rhythm was 6%. CONCLUSION: We found higher rates of neurologically intact survival from OOHCA in our system after regionalization of post-resuscitation care as compared to historical data.

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.

Characteristic adverse events with intra-aortic balloon pumps: An analysis of the U.S. Food and Drug Administration MAUDE database from 2016 to 2021.

INTRODUCTION: The United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) dataset represents a unique source for post-market surveillance data on adverse events (AE). An analysis of AE with percutaneous mechanical circulatory support (pMCS) devices has previously been reported specifically for microaxial flow pumps. The characteristic AE for the intra-aortic balloon pump (IABP) have not been similarly analyzed or reported. MATERIAL AND METHODS: All events in the MAUDE dataset between January 1, 2016 and December 31, 2021 were reviewed involving the Linear, Mega and Sensation devices (Datascope/Getinge, Wayne New Jersey). Data was analyzed by two authors and categorized based on AE type, date, event type and device-related or patient-related AE. RESULTS: A total of 2795 AE were reported over five years. Device malfunction (91.4 %) was the most frequent classification followed by death (5.6 %) and injury (3.0 %). Catheter deformation/fracture/leak accounted for 37.9 % of total AEs. The most common patient event categorization was asymptomatic (90.8 %). Vessel damage/hemorrhage occurred in 1.4 % of reports. Death occurred in 5.6 % of reports and was associated with cardiac arrest in 110 of 156 events. Thrombus formation was described in 1.1 % of AEs. Device optic AE were common and unique to Sensation catheters. Calibration errors were also more common with Sensation (4.6 % versus 1.3 %) compared to other models. CONCLUSIONS: Publicly reported AE with IABPs are predominantly device malfunctions without clinical sequelae. Injury, vascular damage, bleeding and thrombosis AEs are not frequent amongst reported AEs. Emphasis should be placed on understanding mechanisms of device malfunction in order to improve both reliability and user experience.

Using error-estimation to probe the psychological processes underlying contextual interference effects.

Although the learning benefits of interleaved practice schedules relative to blocked schedules are well-reported, the mechanisms underlying these effects are not fully understood. Researchers have generally suggested that random schedules of practice increase task-related information processing which arises due to switching between variations of the same task (or switching between different tasks). Thus, one potentially useful way to both probe and manipulate contextual interference is to pair it with error estimation during practice. Forced error estimation increases task-related information processing and recording these estimates provides insight into learners' self-awareness of their errors. In the present study, 84 participants were randomly allocated to four groups. Participants practiced a timing task under blocked or random schedules, with and without error estimations prior to feedback. During the acquisition phase, three target times were trained (1500, 1700, 1900 ms), with feedback delivered after every trial. We used delayed post-tests (24 hrs later) to evaluate the retention of these target times and their transfer to two new target times (1600, 1800 ms). Participants who practiced with a random schedule performed worse (i.e., greater absolute error) than those with a blocked schedule during acquisition (p = .006); however, randomly scheduled participants also showed reduced error (p = .004) on the retention and transfer tests. Although prompting error estimations led to greater self-reported mental effort being invested on the task (p = .001), error estimation was not reliably associated with superior learning (p = .133). The accuracy of error estimations did not differ as a function of practice structure (p = .070), although the accuracy of error estimations improved during acquisition (p = .006). Findings highlight the robustness of the contextual interference effect, but we did not find evidence that error estimations moderated the effect on this task. It is in some ways surprising that we found an effect of contextual interference, as past-work suggests that interference effects are attenuated (or eliminated) when participants switch between different parameters of the same task. We speculate that this might be due to the difficulty of the task; even though participants switched between parametric variations of the same task, the distinction between parameters was subtle (i.e., tenths of a second).

Implementation of Targeted Temperature Management After Out-of-Hospital Cardiac Arrest: Observations From the Los Angeles County Regional System.

Background Despite the benefits of targeted temperature management (TTM) for out-of-hospital cardiac arrest), implementation within the United States remains low. The objective of this study was to evaluate the prevalence and factors associated with TTM use in a large, urban-suburban regional system of care. Methods and Results This was a retrospective analysis from the Los Angeles County regional cardiac system of care serving a population of >10 million residents. All adult patients aged ≥18 years with non-traumatic out-of-hospital cardiac arrest transported to a cardiac arrest center from April 2011 to August 2017 were included. Patients awake and alert in the emergency department and patients who died in the emergency department before consideration for TTM were excluded. The primary outcome measure was prevalence of TTM use. The secondary analysis were annual trends in TTM use over the study period and factors associated with TTM use. The study population included 8072 patients; 4154 patients (51.5%) received TTM and 3767 patients (46.7%) did not receive TTM. Median age was 67 years, 4780 patients (59.2%) were men, 4645 patients (57.5%) were non-White, and the most common arrest location was personal residence in 4841 patients (60.0%). In the adjusted analysis, younger age, male sex, an initial shockable rhythm, witnessed arrest, and receiving coronary angiography were associated with receiving TTM. Conclusions Within this regional system of care, use of TTM was higher than previously reported in the literature at just over 50%. Use of integrated systems of care may be a novel method to increase TTM use within the United States.

Seeing isn't necessarily believing: Misleading contextual information influences perceptual-cognitive bias in radiologists.

A substantial number of medical errors in radiology are attributed to failures of perception or decision making, although it is believed that experience (or expertise) might buffer diagnosticians from some types of perceptual-cognitive bias. We examined how the quality of contextual information influences decision making and how underlying perceptual-cognitive processes change as a function of experience and diagnostic accuracy. Twenty-one radiologists dictated their findings on 16 deidentified musculoskeletal radiographic cases while wearing a mobile-eye tracking system. Patient histories were mismatched on a subset of cases to be miscued relative to the correct diagnosis. Experienced radiologists outperformed less-experienced participants, but no systematic differences in gaze behaviors emerged between groups. Miscued case notes increased perceptual-cognitive bias in both groups, resulting in an approximate 40% decrease in diagnostic accuracy. Most errors were judgment errors, meaning participants visually fixated on the abnormality for longer than a second yet still failed to make the correct diagnosis. Findings suggest a physician's confidence in their diagnosis might be misplaced after spending insufficient time extracting relevant information from key areas of the visual display, or when decisions are based primarily on a priori expectations derived from patient histories. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

ST-Segment Elevation Myocardial Infarction and Out-of-Hospital Cardiac Arrest: Contemporary Management From the Multicenter START Registry.

BACKGROUND: Recent studies suggest that primary percutaneous coronary intervention (PCI) and targeted temperature management (TTM) improve outcome in ST-segment elevation myocardial infarction (STEMI) complicated by out-of-hospital cardiac arrest (OHCA). The objective of this study was to evaluate a contemporary series of patients with STEMI and OHCA to characterize treatment approaches and predictors of neurologic outcome. METHODS: From January 2009 through November 2012, a total of 239 patients who underwent emergent coronary angiography at 10 medical centers across the United States were enrolled. All patients suffered OHCA with STEMI on either the prehospital or post-resuscitation electrocardiogram. Neurologic outcome was assessed using the cerebral performance category (CPC) score. Predictors of neurologic outcome were determined using multivariate logistic regression analysis. The primary endpoint was in-hospital survival with good neurologic function (CPC score 1 or 2). RESULTS: Mean age was 60 ± 13 years, 72% were male, and the majority of patients had a history of cardiovascular event. Initial rhythm was ventricular fibrillation in 72%. At hospital presentation, 76% of patients were intubated, 37% were in cardiogenic shock, and 33% were receiving vasopressors. Primary PCI was performed in 74%, with an average door-to-balloon time of 95 ± 77 minutes, and TTM was used in 51%. Forty-four percent of patients had full neurologic recovery (CPC score 1) and 55% had good neurologic function. Overall in-hospital survival rate was 66%. Independent predictors of in-hospital survival with good neurologic function were: receiving bystander cardiopulmonary resuscitation, location of arrest, receiving drug-eluting stents, and not experiencing a recurrent cardiac arrest. CONCLUSIONS: Short-term survival for patients with STEMI and OHCA undergoing emergent coronary angiography and revascularization with TTM in this contemporary, multicenter registry was high and neurologic outcome was good in more than half of patients.

Racial and ethnic differences in outcomes after out-of-hospital cardiac arrest: Hispanics and Blacks may fare worse than non-Hispanic Whites.

BACKGROUND: This study evaluates differences in out-of-hospital cardiac arrest (OHCA) characteristics, interventions, and outcomes by race/ethnicity. METHODS: This is a retrospective analysis from a regionalized cardiac system. Outcomes for all adult patients treated for OHCA with return of spontaneous circulation (ROSC) were identified from 2011-2014. Stratifying by race/ethnicity with White as the reference group, patient characteristics, treatment, and outcomes were evaluated. The adjusted odds ratios (OR) for survival with good neurologic outcome (cerebral performance category 1 or 2) were calculated. RESULTS: There were 5178 patients with OHCA; 290 patients excluded for unknown race, leaving 4888 patients: 50% White, 14% Black, 12% Asian, 23% Hispanic. In univariate analysis, compared with Whites, Blacks had fewer witnessed arrests (83% vs 86%, p = 0.03) and less bystander CPR (37% vs 44%, p = 0.005), were less likely to undergo coronary angiography (14% vs 22%, p < 0.0001), and less likely to receive PCI (32% vs 54%, p < 0.0001). Asians presented less often with a shockable rhythm (27% vs 34%, p = 0.001) and were less likely to undergo angiography (15% vs 22%, p < 0.0001). Hispanics presented less often with a shockable rhythm (31% vs 34%, p = 0.03), had fewer witnessed arrests (82% vs 86%, p = 0.001) and less bystander CPR (37% vs 44%, p = 0.0001). In multivariable analysis, Hispanic ethnicity was associated with decreased favorable neurologic outcome (OR 0.78 [95%CI 0.63-0.96]). Outcomes for Asians and Blacks did not differ from Whites. When accounting for clustering by hospital, race was no longer statistically significantly associated with survival with good neurologic outcome. CONCLUSION: We identified important differences in patients with OHCA according to race/ethnicity. Such differences may have implications for interventions; for example, emphasis on bystander CPR instruction in Black and Hispanic communities.

Weekly Checks Improve Real-Time Prehospital ECG Transmission in Suspected STEMI.

IntroductionField identification of ST-elevation myocardial infarction (STEMI) and advanced hospital notification decreases first-medical-contact-to-balloon (FMC2B) time. A recent study in this system found that electrocardiogram (ECG) transmission following a STEMI alert was frequently unsuccessful.HypothesisInstituting weekly test ECG transmissions from paramedic units to the hospital would increase successful transmission of ECGs and decrease FMC2B and door-to-balloon (D2B) times. METHODS: This was a natural experiment of consecutive patients with field-identified STEMI transported to a single percutaneous coronary intervention (PCI)-capable hospital in a regional STEMI system before and after implementation of scheduled test ECG transmissions. In November 2014, paramedic units began weekly test transmissions. The mobile intensive care nurse (MICN) confirmed the transmission, or if not received, contacted the paramedic unit and the department's nurse educator to identify and resolve the problem. Per system-wide protocol, paramedics transmit all ECGs with interpretation of STEMI. Receiving hospitals submit patient data to a single registry as part of ongoing system quality improvement. The frequency of successful ECG transmission and time to intervention (FMC2B and D2B times) in the 18 months following implementation was compared to the 10 months prior. Post-implementation, the time the ECG transmission was received was also collected to determine the transmission gap time (time from ECG acquisition to ECG transmission received) and the advanced notification time (time from ECG transmission received to patient arrival). RESULTS: There were 388 patients with field ECG interpretations of STEMI, 131 pre-intervention and 257 post-intervention. The frequency of successful transmission post-intervention was 73% compared to 64% prior; risk difference (RD)=9%; 95% CI, 1-18%. In the post-intervention period, the median FMC2B time was 79 minutes (inter-quartile range [IQR]=68-102) versus 86 minutes (IQR=71-108) pre-intervention (P=.3) and the median D2B time was 59 minutes (IQR=44-74) versus 60 minutes (IQR=53-88) pre-intervention (P=.2). The median transmission gap was three minutes (IQR=1-8) and median advanced notification time was 16 minutes (IQR=10-25). CONCLUSION: Implementation of weekly test ECG transmissions was associated with improvement in successful real-time transmissions from field to hospital, which provided a median advanced notification time of 16 minutes, but no decrease in FMC2B or D2B times. D'ArcyNT, BossonN, KajiAH, BuiQT, FrenchWJ, ThomasJL, ElizarrarazY, GonzalezN, GarciaJ, NiemannJT. Weekly checks improve real-time prehospital ECG transmission in suspected STEMI. Prehosp Disaster Med. 2018;33(3):245-249.

The clinical evaluation of the CADence device in the acoustic detection of coronary artery disease.

The noninvasive detection of turbulent coronary flow may enable diagnosis of significant coronary artery disease (CAD) using novel sensor and analytic technology. Eligible patients (n = 1013) with chest pain and CAD risk factors undergoing nuclear stress testing were studied using the CADence (AUM Cardiovascular Inc., Northfield MN) acoustic detection (AD) system. The trial was designed to demonstrate non-inferiority of AD for diagnostic accuracy in detecting significant CAD as compared to an objective performance criteria (sensitivity 83% and specificity 80%, with 15% non-inferiority margins) for nuclear stress testing. AD analysis was blinded to clinical, core lab-adjudicated angiographic, and nuclear data. The presence of significant CAD was determined by computed tomographic (CCTA) or invasive angiography. A total of 1013 subjects without prior coronary revascularization or Q-wave myocardial infarction were enrolled. Primary analysis was performed on subjects with complete angiographic and AD data (n = 763) including 111 subjects (15%) with severe CAD based on CCTA (n = 34) and invasive angiography (n = 77). The sensitivity and specificity of AD were 78% (p = 0.012 for non-inferiority) and 35% (p < 0.001 for failure to demonstrate non-inferiority), respectively. AD results had a high 91% negative predictive value for the presence of significant CAD. AD testing failed to demonstrate non-inferior diagnostic accuracy as compared to the historical performance of a nuclear stress OPC due to low specificity. AD sensitivity was non-inferior in detecting significant CAD with a high negative predictive value supporting a potential value in excluding CAD.

A novel approach to diagnosing coronary artery disease: acoustic detection of coronary turbulence.

Atherosclerotic disease within coronary arteries causes disruption of normal, laminar flow and generates flow turbulence. The characteristic acoustic waves generated by coronary turbulence serve as a novel diagnostic target. The frequency range and timing of microbruits associated with obstructive coronary artery disease (CAD) have been characterized. Technological advancements in sensor, data filtering and analytic capabilities may allow use of intracoronary turbulence for diagnostic and risk stratification purposes. Acoustic detection (AD) systems are based on the premise that the faint auditory signature of obstructive CAD can be isolated and analyzed to provide a new approach to noninvasive testing. The cardiac sonospectrographic analyzer, CADence, and CADScore systems are early-stage, investigational and commercialized examples of AD systems, with the latter two currently undergoing clinical testing with validation of accuracy using computed tomography and invasive angiography. Noninvasive imaging accounts for a large percentage of healthcare expenditures for cardiovascular disease in the developed world, and the growing burden of CAD will disproportionately affect areas in the developing world. AD is a portable, radiation-free, cost-effective method with the potential to provide accurate diagnosis or exclusion of significant CAD. AD represents a model for digital, miniaturized, and internet-connected diagnostic technologies.

Diagnostic accuracy of Visipaque enhanced coronary computed tomographic angiography: a prospective multicenter trial.

BACKGROUND: Although several studies have shown promise for noninvasive angiography by coronary computed tomographic angiography (CCTA), few prospective multicenter trials have been conducted. This study evaluated the diagnostic accuracy of Visipaque enhanced CCTA to detect obstructive coronary stenosis compared with quantitative coronary angiography (QCA). PATIENTS AND METHODS: Three sites prospectively enrolled 77 patients (58.1% men, 54 years) with chest pain referred for invasive coronary angiography (ICA). Patients underwent CCTA (Lightspeed VCT/Visipaque 320) before ICA. CCTAs were graded on a 15-segment American Heart Association model by a CCTA core lab with blinded readers for the presence of obstructive stenosis (>50% or >70%); ICAs were independently graded for %stenosis by QCA, considered the reference standard. The efficacy of CCTA was assessed including all vessel segments for per-patient and per-vessel analyses. RESULTS: A total of 46 more than 50% stenoses in 27 (35%) patients, and 31 more than 70% stenoses in 20 (26%) patients, were identified by QCA. Per-patient and per-vessel efficacy of CCTA compared with QCA yielded sensitivities of 85% and specificities of 90 and 95%, respectively. CONCLUSION: This study shows the high accuracy of CCTA to reliably detect more than 50% and more than 70% stenoses in low-probability to intermediate-probability chest pain patients being referred for ICA. The high negative predictive values observed (92-100%) indicate that CCTA is also an effective noninvasive alternative to exclude obstructive coronary stenosis.