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Background: Minorities and women are underrepresented in cardiovascular research. Whether their higher enrollment can be predicted or influences research site performance is unclear.Methods: We evaluated 104 sites that enrolled 4,184 patients in the U.S. Platinum Diversity (PD) and Promus Element Plus (PE Plus) studies (2012 to 2016). Research sites were ranked from lowest to highest minority and female enrollment, respectively. United States Census Bureau division and core-based statistical area (CBSA) populations were determined for each site and the following study performance metrics compared across quartiles of minority and female enrollment, respectively: (1) study subject enrollment rate (SER), (2) time to first patient enrolled, (3) rate of follow-up visits not done, (4) rate of follow-up visits out of window, and (5) protocol deviation rate (PDR). Multivariable regression was used to predict SER and PDR.Results: Minority enrollment varied by region (P = .025) and population (P = .024) with highest recruitment noted in the Pacific, West South Central, South Atlantic, Mid-Atlantic and East North Central divisions. Female enrollment bore no relationship to region (P = .67) or population (P = .40). Median SER was similar in sites withi the highest vs lowest quartile of minority enrollment (SER of 4 vs 5 patients per month, respectively, P =0.78) and highest vs. lowest female enrollment (SER of 4 vs 4, respectively, P = .21). Median PDR was lower in sites within the highest vs lowest minority enrollment (0.23 vs 0.50 PDs per patient per month, respectively, P = .01) and highest vs. lowest female enrollment (0.28 vs. 0.37 PDs per patient per month, respectively, P = .04). However, this relationship did not persist after multivariable adjustment. All other site performance metrics were comparable across quartiles of minority and female enrollment.Conclusions: Minority, but not female enrollment, correlated with research site geographic region and surrounding population. High enrollment of minorities and women did not influence study performance metrics. These findings help inform future strategies aimed at increasing clinical trial diversity.Trial Registration: The PD and PE Plus studies are registered at www.clinicaltrials.gov under identifiers NCT02240810 and NCT01589978, respectively.Key Points: Question: Does the enrollment of more Blacks, Hispanics and women in US cardiovascular research studies influence the overall rate of study subject enrollment and/or other key study site performance metrics and can diverse enrollment be predicted?Findings: In this pooled analysis of 104 sites that enrolled 4,184 patients in the Platinum Diversity and Promus Element Plus Post-Approval Studies, we found that the enrollment of higher proportions of underrepresented minorities and women was univariately associated with lower protocol deviation rates while having no effect on other site performance metrics. A site's geographic location and surrounding population predicted minority, but not female enrollment. Meaning: These findings suggest that cardiovascular research subject diversity may be predicted from site characteristics and enhanced without compromising key study performance metrics. These insights help inform future strategies aimed at improving clinical trial diversity. [ABSTRACT FROM AUTHOR]

• To recognize one of the major mechanical complications of late presenting acute myocardial infarction in the COVID-19 era. • To understand the role of mechanical circulatory support in acute myocardial infarction complicated by ventricular septal rupture • To outline the decision making process in the management of ventricular septal rupture with consequent cardiogenic shock. • To highlight the importance of a multidisciplinary cardiogenic shock team. The COVID 19 pandemic resulted in a total reduction in the number of hospitalizations for acute coronary syndromes. A consequence of the delay in coronary revascularization has been the resurgence of structural complications of myocardial infarctions. Ventricular septal rupture (VSR) complicating late presenting acute myocardial infarction (AMI) is associated with high mortality despite advances in both surgical repair and perioperative management. Current data suggests a declining mortality with delay in VSR repair; however, these patients may develop cardiogenic shock while waiting for surgery. Available options are limited for patients with VSR who develop right ventricular failure and cardiogenic shock. The survival rate is very low in patients with cardiogenic shock undergoing surgical or percutaneous VSR repair. In this study we present two late presenting ST elevation MI patients who were complicated by rapidly declining hemodynamics and impending organ failure. Both patients were bridged with venoarterial extracorporeal membrane oxygenation (ECMO) to cardiac transplant. [ABSTRACT FROM AUTHOR]

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Background: Dual antiplatelet therapy (DAPT) is recommended following transcatheter aortic valve replacement (TAVR); however, the optimal antiplatelet strategy is undefined, and little is known about practice patterns. We aimed to describe contemporary practice patterns of antiplatelet therapy and their relationship to outcomes post-TAVR.Methods: The population was derived from the National Cardiovascular Data Registry, Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry with Center for Medical Services linkage for 1-year outcomes from October 1, 2011 to June 30,2016. The primary outcome measured was DAPT use in patients without anticoagulation. Secondary outcomes included death, major bleeding, myocardial infarction (MI), and stroke at 1 year.Results: Overall, 16,694 patients underwent transfemoral TAVR at 444 hospitals and were discharged without anticoagulation. Among these, 13,546 (81.1%) patients were discharged on DAPT, whereas 3,148 patients (18.9%) were discharged on monotherapy. Patients discharged on DAPT versus monotherapy were similar in age, sex, and most comorbid illnesses but had higher rates of coronary artery disease (64.6% vs 52.3%; P < .01) and peripheral artery disease (25.2% vs 22.3%; P < .01). Hospital prescribing patterns varied significantly (median frequency of DAPT 85.7%, interquartile range 94.1%-74.2%). DAPT (vs monotherapy) patients had a similar mortality risk at 1 year (adjusted hazard ratio 0.92, 95% CI 0.81-1.05), significantly higher risk for major bleeding (1.48, 1.10-1.99), and similar hazard for stroke (1.04, 0.83-1.31) and MI (1.00, 0.72-1.39).Conclusions: In the United States, most patients were discharged on DAPT following TAVR. Practice patterns varied significantly among hospitals. Patients discharged with DAPT had a similar adjusted risk of mortality, stroke, and MI compared to antiplatelet monotherapy, although risk for bleeding was significantly higher. Future investigation is needed to define the optimal antiplatelet therapy for patients undergoing TAVR. [ABSTRACT FROM AUTHOR]

Background: We assessed antiplatelet therapy use and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ARISTOTLE trial.Methods: Patients were categorized based on the occurrence of PCI during follow-up (median 1.8 years); PCI details and outcomes post-PCI are reported. Of the 18,201 trial participants, 316 (1.7%) underwent PCI (152 in apixaban group, 164 in warfarin group).Results: At the time of PCI, 84% (267) were on study drug (either apixaban or warfarin). Of these, 19% did not stop study drug during PCI, 49% stopped and restarted <5 days post-PCI, and 30% stopped and restarted >5 days post-PCI. At 30 days post-PCI, 35% of patients received dual -antiplatelet therapy (DAPT), 23% received aspirin only, and 13% received a P2Y12 inhibitor only; 29% received no antiplatelet therapy. Triple therapy (DAPT + oral anticoagulant [OAC]) was used in 21% of patients, 23% received OAC only, 15% received OAC plus aspirin, and 9% received OAC plus a P2Y12 inhibitor; 32% received antiplatelet agents without OAC. Post-PCI, patients assigned to apixaban versus warfarin had numerically similar rates of major bleeding (5.93 vs 6.73 events/100 patient-years; P = .95) and stroke (2.74 vs 1.84 events/100 patient-years; P = .62).Conclusions: PCI occurred infrequently during follow-up. Most patients on study drug at the time of PCI remained on study drug in the peri-PCI period; 19% continued the study drug without interruption. Antiplatelet therapy use post-PCI was variable, although most patients received DAPT. Additional data are needed to guide the use of antithrombotics in patients undergoing PCI. [ABSTRACT FROM AUTHOR]

Background and Purpose: Patients with prior stroke are at greater risk for recurrent cardiovascular events post-acute coronary syndromes (ACS) and may have a different risk/benefit profile with antithrombotic therapy than patients without prior stroke.Methods: We studied 7391 patients with ACS from APPRAISE-2, stratified by the presence or absence of prior stroke. Baseline characteristics and outcomes of cardiovascular death, myocardial infarction (MI), or stroke were compared between groups. Interactions between prior stroke, treatment assignment (apixaban vs placebo), and outcomes were tested before and after multivariable adjustment with Cox proportional hazards models.Results: A total of 902 patients (12%) had prior stroke. Those with prior stroke were older (69 vs 67 years), had more hypertension (91% vs 77%), peripheral vascular disease (22% vs18%), and impaired renal function (38% vs 30%) but less diabetes (44% vs 48%) than those without prior stroke. Patients with prior stroke vs no prior stroke had higher unadjusted rates of cardiovascular death (4.8% vs 4.0%), MI (11.2% vs 7.1%), and ischemic stroke (3.2% vs 0.9%). Patients with prior stroke assigned to apixaban had similar rates of the composite of cardiovascular death, MI, or stroke compared with those assigned to placebo (HR 1.39; 95% CI 0.92-2.08). Patients without prior stroke assigned to apixaban had similar rates of cardiovascular death, MI, or ischemic stroke compared with those assigned to placebo (HR 0.87; 95% CI 0.73-1.04; P-interaction=.041). Median follow-up was 240 days.Conclusions: Patients with prior stroke are at higher risk for recurrent cardiovascular events post-ACS and had a differential risk/benefit profile with oral anticoagulation. [ABSTRACT FROM AUTHOR]

Objectives This study sought to determine variability and stability in risk-standardized mortality rates (RSMR) of percutaneous coronary intervention (PCI) operators meeting minimum case volume standards and identify differences in case mix and practice patterns that may account for RSMR variability. Background RSMR has been suggested as a metric to evaluate the performance of PCI operators; however, variability of operator-level RSMR and the stability of this metric over time among the same operator are unknown. Methods The authors calculated mean RSMRs for PCI operators with average annual volume of ≥50 cases in the National Cardiovascular Data Registry CathPCI Registry. Funnel plots were used to account for operator case volume. Demographic, clinical, and treatment variables of patients treated by operators with outlying high or low RSMRs (identified by RMSR greater than or less than 2 σ above or below the mean [analogous to 2 SD], respectively) were compared with nonoutlier operators. RMSR stability was assessed by calculating average annual operator RMSR during the study period and by determining if operators were consistently classified into RMSR categories in each year. Results Between October 1, 2009, and September 30, 2014, a total of 2,352,174 PCIs were performed at 1,373 hospitals by 3,760 operators. Of these, 242 operators (6.5%) had RSMR >2 σ above the mean and 156 operators (4.1%) had RSMR >2 σ below the mean. Both high and low RSMR outlier operators treated patients with lower expected mortality risk, compared with nonoutlier operators. There was significant instability in annual operator RMSR during the study period. Conclusions There is significant variability in risk-standardized PCI mortality among U.S. operators meeting minimum volume standards that is not explained by case mix or procedure characteristics. Operator RMSR was unstable from year to year, thus limiting its utility as a sole performance measure for PCI quality. [ABSTRACT FROM AUTHOR]

Objectives The authors assessed the use of dual antiplatelet therapy (DAPT) and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). Background The frequency, patterns, and outcomes when adding DAPT to non-vitamin K antagonist oral anticoagulants in the setting of PCI in patients with AF are largely unknown. Methods The study population included all patients in the treatment group of the ROCKET AF trial divided by the receipt of PCI during follow-up. Clinical characteristics, PCI frequency, and rates of DAPT were reported. Clinical outcomes were adjudicated independently as part of the trial. Results Among 14,171 patients, 153 (1.1%) underwent PCI during a median 806 days of follow-up. Patients treated with rivaroxaban were significantly less likely to undergo PCI compared with warfarin-treated patients (61 vs. 92; p = 0.01). Study drug was continued during PCI in 81% of patients. Long-term DAPT (≥30 days) was used in 37% and single antiplatelet therapy in 34%. A small number switched from DAPT to monotherapy within 30 days of PCI (n = 19 [12.3%]) and 15% of patients received no antiplatelet therapy after PCI. Rates of stroke/systemic embolism and major bleeding events were high in post-PCI patients (4.5/100 patient-years and 10.2/100 patient-years) in both treatment groups. Conclusions In patients with AF at moderate to high risk for stroke, PCI occurred in <1% per year. DAPT was used in a variable manner, with the majority of patients remaining on study drug after PCI. Rates of both thrombotic and bleeding events were high after PCI, highlighting the need for studies to determine the optimal antithrombotic therapy. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to assess usage patterns of transradial access in rescue percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) and associations between vascular access site choice and outcomes. Background Transradial access reduces bleeding and mortality in STEMI patients undergoing primary PCI. Little is known about access site choice and outcomes in patients undergoing rescue PCI after receiving full-dose fibrinolytic therapy for STEMI. Methods Patients in the National Cardiovascular Data Registry’s CathPCI Registry undergoing rescue PCI for STEMI between 2009 and 2013 were studied. Patients were divided on the basis of access site. Patterns of access use and baseline demographics were noted. Unadjusted and propensity-matched analyses were performed comparing in-hospital bleeding, vascular complications, and mortality outcomes among transradial and transfemoral access patients. The falsification endpoint of gastrointestinal bleeding was specified to assess for persistent unmeasured confounding. Results Transradial access was used in 14.2% of cases. In propensity-matched analyses, transradial rescue PCI was associated with significantly less bleeding than transfemoral access (odds ratio [OR]: 0.67; 95% confidence interval [CI]: 0.52 to 0.87; p = 0.003), but not mortality (OR: 0.81; 95% CI: 0.53 to 1.25; p = 0.35). Gastrointestinal bleeding was less frequent in the radial group (OR: 0.23; 95% CI: 0.05 to 0.98; p = 0.05). Conclusions In a large, “real-world” registry, transradial access was used in a minority of cases and was associated with significantly less bleeding than transfemoral access in patients undergoing rescue PCI. However, given persistent differences in a falsification endpoint, the influence of treatment-selection bias on these results cannot be ruled out. Further studies are needed to determine predictors of bleeding and mortality in this understudied high-risk group. [ABSTRACT FROM AUTHOR]

Background: Gastrointestinal (GI) bleeding is a common complication of oral anticoagulation.Objectives: This study evaluated GI bleeding in patients who received at least 1 dose of the study drug in the on-treatment arm of the ROCKET AF (Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial.Methods: The primary outcome was adjudicated GI bleeding reported from first to last drug dose + 2 days. Multivariable modeling was performed with pre-specified candidate predictors.Results: Of 14,236 patients, 684 experienced GI bleeding during follow-up. These patients were older (median age 75 years vs. 73 years) and less often female. GI bleeding events occurred in the upper GI tract (48%), lower GI tract (23%), and rectum (29%) without differences between treatment arms. There was a significantly higher rate of major or nonmajor clinical GI bleeding in rivaroxaban- versus warfarin-treated patients (3.61 events/100 patient-years vs. 2.60 events/100 patient-years; hazard ratio: 1.42; 95% confidence interval: 1.22 to 1.66). Severe GI bleeding rates were similar between treatment arms (0.47 events/100 patient-years vs. 0.41 events/100 patient-years; p = 0.39; 0.01 events/100 patient-years vs. 0.04 events/100 patient-years; p = 0.15, respectively), and fatal GI bleeding events were rare (0.01 events/100 patient-years vs. 0.04 events/100 patient-years; 1 fatal events vs. 5 fatal events total). Independent clinical factors most strongly associated with GI bleeding were baseline anemia, history of GI bleeding, and long-term aspirin use.Conclusions: In the ROCKET AF trial, rivaroxaban increased GI bleeding compared with warfarin. The absolute fatality rate from GI bleeding was low and similar in both treatment arms. Our results further illustrate the need for minimizing modifiable risk factors for GI bleeding in patients on oral anticoagulation. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This study sought to define the prevalence and prognostic impact of blood transfusions in contemporary percutaneous coronary intervention (PCI) practice. BACKGROUND: Although the presence of anemia is associated with adverse outcomes in patients undergoing PCI, the optimal use of blood products in patients undergoing PCI remains controversial. METHODS: A search of EMBASE and MEDLINE was conducted to identify PCI studies that evaluated blood transfusions and their association withmajor adverse cardiac events (MACE) andmortality. Two independent reviewers screened the studies for inclusion, and data were extracted from relevant studies. Random effects meta-analysis was used to estimate the risk of adverse outcomes with blood transfusions. Statistical heterogeneity was assessed by considering the I² statistic. RESULTS: Nineteen studies that included 2,258,711 patients with more than 54,000 transfusion events were identified (prevalence of blood transfusion 2.3%). Crude mortality rate was 6,435 of 50,979 (12.6%, 8 studies) in patients who received a blood transfusion and 27,061 of 2,266,111 (1.2%, 8 studies) in the remaining patients. Crude MACE rates were 17.4% (8,439 of 48,518) in patients who had a blood transfusion and 3.1% (68,062 of 2,212,730) in the remaining cohort. Meta-analysis demonstrated that blood transfusion was independently associated with an increase in mortality (odds ratio: 3.02, 95% confidence interval: 2.16 to 4.21, I² = 91%) and MACE (odds ratio: 3.15, 95% confidence interval: 2.59 to 3.82, I² = 81%). Similar observations were recorded in studies that adjusted for baseline hematocrit, anemia, and bleeding. CONCLUSIONS: Blood transfusion is independently associated with increased risk of mortality and MACE events. Clinicians should minimize the risk for periprocedural transfusion by using available bleeding-avoidance strategies and avoiding liberal transfusion practices. [ABSTRACT FROM AUTHOR]

The novel oral anticoagulants (NOACs) have rapidly emerged as an alternative therapy to warfarin. Several recent phase 3 randomized control trials have demonstrated the efficacy and safety of the NOACs in the treatment for patients with nonvalvular atrial fibrillation. As the NOACs are incorporated in clinical practice, questions have begun to arise concerning their optimal use in commonly encountered situations. In this review, we provide a summary of the available evidence from the phase 3 randomized control trials specifically with regard to 1 such scenario, the periprocedural management of NOACs, with a goal of providing guidance for practicing clinicians. [ABSTRACT FROM AUTHOR]

Objectives The goal of this study was to examine the calibration of a validated risk-adjustment model in very high-risk percutaneous coronary intervention (PCI) cases and assess whether sites' case mix affects their performance ratings. Background There are concerns that treating PCI patients with particularly high-risk features such as cardiogenic shock or prior cardiac arrest may adversely impact hospital performance ratings. However, there is little investigation on the validity of these concerns. Methods We examined 624,286 PCI procedures from 1,168 sites that participated in the CathPCI Registry in 2010. Procedural risk was estimated using the recently published Version 4 National Cardiovascular Data Registry (NCDR) PCI risk-adjusted mortality (RAM) model. We calculated observed/expected mortality using several risk classification methods, and simulated hospital performance after combining their highest risk cases over 2 years into a single year. Results In 2010, crude in-hospital PCI mortality was 1.4%. The NCDR model was generally well calibrated among high risk, however there was slight overprediction of risk in extreme cases. Hospitals treating the highest overall expected risk PCI patients or those treating the top 20% of high-risk cases had lower (better) RAM ratings than centers treating lower-risk cases (1.25% vs. 1.51%). The observed/expected ratio for top-risk quintile versus low-risk quintile was 0.91 (0.87 to 0.96) versus 1.10 (1.03 to 1.17). Combining all the high-risk patients over a 2-year period into a single year also did not negatively impact the site's RAM ratings. Conclusions Evaluation of a contemporary sample of PCI cases across the United States showed no evidence that treating high-risk PCI cases adversely affects hospital RAM rates. [ABSTRACT FROM AUTHOR]

Background Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals’ surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown. Methods We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality < 4%), intermediate-risk cases (4% to 8%), and high-risk cases (> 8%). A contemporary control was provided by non-TAVR centers. Results From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p < 0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p < 0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08). Conclusions Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve. [ABSTRACT FROM AUTHOR]

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Despite the ability to provide full pulmonary and biventricular support for severe or refractory cardiogenic shock (CS), a recognized limitation of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the increase in left ventricular afterload and its associated adverse effects on the myocardium. Limited data exists regarding the relative efficacy of typical left ventricular venting (LVV) strategies to address this issue. We retrospectively reviewed 31 consecutive patients at our institution initially treated for severe or refractory CS with VA-ECMO who then underwent LVV from 01/01/17 - 12/31/19. Patients with alternate MCS devices implanted prior to VA-ECMO and those with post-cardiotomy CS were excluded. Clinical characteristics, baseline risk stratification scores and serial hemodynamic assessments were collected at 0, 24 and 48 hours. Twenty-six (84%) patients underwent LVV with Impella (E-I) and 5 (16%) with atrial septostomy (E-S). Patients in the E-S cohort were younger (mean age 37 vs. 52, p =0.02).There were no significant differences between the E-S and E-I cohorts with regards to baseline CARDShock scores (5 vs. 4; p =0.06), SOFA scores (10 vs. 9; p =0.89), index hemodynamic assessments, and mean time to LVV (32 vs. 31 hours; p =0.60). We also did not detect a significant difference in total time on the mechanical ventilator between the E-S and E-I patients (19 vs. 10 days; p=0.19). At 48 hours following LVV, there was no significant difference in changes in mean lactate, pulmonary artery diastolic pressure (PA-D), right atrial pressure (RA), cardiac power output (CPO) or pulmonary arterial pulsatility index (PAPi) between the E-S and E-I cohorts. Thirty-day survival in the E-S and E-I cohorts were 80% (4/5) and 50% (13/26), respectively (p =0.35). Changes in hemo-metabolic profiles at 48 hours were similar between VA-ECMO patients who underwent LVV with E-S vs. E-I. There was a trend toward a greater reduction in PA-D with E-S vs. E-I. Larger prospective studies are needed to identify effective LVV strategies that optimize hemodynamics and improve long-term outcomes in these complex patients. [ABSTRACT FROM AUTHOR]

Background: Cardiogenic shock (CS) is a multifactorial, hemodynamically complex syndrome associated with high mortality. Despite advances in reperfusion and mechanical circulatory support, management remains highly variable and outcomes poor.Objectives: This study investigated whether a standardized team-based approach can improve outcomes in CS and whether a risk score can guide clinical decision making.Methods: A total of 204 consecutive patients with CS were identified. CS etiology, patient demographic characteristics, right heart catheterization, mechanical circulatory support use, and survival were determined. Cardiac power output (CPO) and pulmonary arterial pulsatility index (PAPi) were measured at baseline and 24 h after the CS diagnosis. Thresholds at 24 h for lactate (<3.0 mg/dl), CPO (>0.6 W), and PAPi (>1.0) were determined. Using logistic regression analysis, a validated risk stratification score was developed.Results: Compared with 30-day survival of 47% in 2016, 30-day survival in 2017 and 2018 increased to 57.9% and 76.6%, respectively (p < 0.01). Independent predictors of 30-day mortality were age ≥71 years, diabetes mellitus, dialysis, ≥36 h of vasopressor use at time of diagnosis, lactate levels ≥3.0 mg/dl, CPO <0.6 W, and PAPi <1.0 at 24 h after diagnosis and implementation of therapies. Either 1 or 2 points were assigned to each variable, and a 3-category risk score was determined: 0 to 1 (low), 2 to 4 (moderate), and ≥5 (high).Conclusions: This observational study suggests that a standardized team-based approach may improve CS outcomes. A score incorporating demographic, laboratory, and hemodynamic data may be used to quantify risk and guide clinical decision-making for all phenotypes of CS. [ABSTRACT FROM AUTHOR]

ST-segment elevation myocardial infarction (STEMI) systems of care have been associated with significant improvement in use and timeliness of reperfusion. Consequently, national guidelines recommend that each community should develop a regional STEMI care system. However, significant barriers continue to impede widespread establishment of regional STEMI care systems in the United States. We designed the Regional Systems of Care Demonstration Project: Mission: Lifeline STEMI Systems Accelerator, a national educational outcome research study in collaboration with the American Heart Association, to comprehensively accelerate the implementation of STEMI care systems in 17 major metropolitan regions encompassing >1,500 emergency medical service agencies and 450 hospitals across the United States. The goals of the program are to identify regional gaps, barriers, and inefficiencies in STEMI care and to devise strategies to implement proven recommendations to enhance the quality and consistency of care. The study interventions, facilitated by national faculty with expertise in regional STEMI system organization in partnership with American Heart Association representatives, draw upon specific resources with proven past effectiveness in augmenting regional organization. These include bringing together leading regional health care providers and institutions to establish common commitment to STEMI care improvement, developing consensus-based standardized protocols in accordance with national professional guidelines to address local needs, and collecting and regularly reviewing regional data to identify areas for improvement. Interventions focus on each component of the reperfusion process: the emergency medical service, the emergency department, the catheterization laboratory, and inter-hospital transfer. The impact of regionalization of STEMI care on clinical outcomes will be evaluated. [Copyright &y& Elsevier]

Background: Troponin is the preferred biomarker for risk stratification in non-ST elevation ACS. The incremental prognostic use of the initial magnitude of troponin elevation and its value in conjunction with ST-segment resolution (STRes) in ST elevation myocardial infarction (STEMI) is less well defined.Methods: Troponin T (TnT) was measured in 1,250 patients at presentation undergoing fibrinolysis for STEMI in CLARITY-TIMI 28. ST-segment resolution was measured at 90 minutes. Multivariable logistic regression was used to examine the independent association between TnT levels, STRes, and 30-day cardiovascular (CV) mortality.Results: Patients were classified into undetectable TnT at baseline (n = 594), detectable but below the median of 0.12 ng/mL (n = 330), and above the median (n = 326). Rates of 30-day CV death were 1.5%, 4.5%, and 9.5%, respectively (P < .0001). Compared with those with undetectable levels and adjusting for baseline factors, the odds ratios for 30-day CV death were 4.56 (1.72-12.08, P = .002) and 5.81 (2.29-14.73, P = .0002) for those below and above the median, respectively. When combined with STRes, there was a significant gradient of risk, and in a multivariable model both baseline TnT (P = .004) and STRes (P = .003) were significant predictors of 30-day CV death. The addition of TnT and STRes to clinical risk factors significantly improved the C-statistic (from 0.86 to 0.90, P = .02) and the integrated discriminative improvement (7.1% increase) (P = .0009).Conclusions: Baseline TnT and 90-minute STRes are independent predictors of 30-day CV death in patients with STEMI. Use of these 2 simple, readily available tools can aid clinicians in early risk stratification. [ABSTRACT FROM AUTHOR]

Background: Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown.Objectives: The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample.Methods: Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality.Results: The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding.Conclusions: Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). Background: The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. Methods: The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. Results: The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Conclusions: Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767) [Copyright &y& Elsevier]

Study Objective: To determine whether tracheoscopy is an accurate and quick method for verifying correct placement of the tracheal tube after intubation.Design: Prospective, randomized study.Setting: Operating rooms of a teaching hospital.Patients: 26 patients scheduled for surgery and general anesthesia.Interventions: 8.0-mm tracheal tubes were inserted into both the trachea and the esophagus. Tracheoscopy was performed consecutively through both tracheal tubes by a variety of clinicians.Measurements: The times taken to correctly identify the trachea and the esophagus were recorded.Main Results: Correct identification of either the esophagus or the trachea occurred with a 100% sensitivity and a 96% specificity. The mean time to recognize either the trachea or the esophagus was 22.0 seconds.Conclusions: Tracheoscopy is a reliable method for quickly verifying proper endotracheal placement of a tracheal tube. [ABSTRACT FROM AUTHOR]

: Study objectiveTo determine whether tracheoscopy is an accurate and quick method for verifying correct placement of the tracheal tube after intubation.: DesignProspective, randomized study.: SettingOperating rooms of a teaching hospital.: Patients26 patients scheduled for surgery and general anesthesia.: Interventions8.0-mm tracheal tubes were inserted into both the trachea and the esophagus. Tracheoscopy was performed consecutively through both tracheal tubes by a variety of clinicians.: MeasurementsThe times taken to correctly identify the trachea and the esophagus were recorded.: Main resultsCorrect identification of either the esophagus or the trachea occurred with a 100% sensitivity and a 96% specificity. The mean time to recognize either the trachea or the esophagus was 22.0 seconds.: ConclusionsTracheoscopy is a reliable method for quickly verifying proper endotracheal placement of a tracheal tube. [Copyright &y& Elsevier]