Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

Frailty and cardiovascular outcomes in the National Health and Aging Trends Study.

AIMS: Physical frailty is a commonly encountered geriatric syndrome among older adults without coronary heart disease (CHD). The impact of frailty on the incidence of long-term cardiovascular outcomes is not known.We aimed to evaluate the long-term association of frailty, measured by the Fried frailty phenotype, with all-cause-mortality and MACE among older adults without a history of CHD at baseline in the National Health and Aging Trends Study. METHODS AND RESULTS: We used the National Health and Aging Trends Study, a prospective cohort study linked to a Medicare sample. Participants with a prior history of CHD were excluded. Frailty was measured during the baseline visit using the Fried physical frailty phenotype. Cardiovascular outcomes were assessed during a 6-year follow-up.Of the 4656 study participants, 3259 (70%) had no history of CHD 1 year prior to their baseline visit. Compared to those without frailty, subjects with frailty were older (mean age 82.1 vs. 75.1 years, P < 0.001), more likely to be female (68.3% vs. 54.9%, P < 0.001), and belong to an ethnic minority. The prevalence of hypertension, falls, disability, anxiety/depression, and multimorbidity was much higher in the frail and pre-frail than the non-frail participants. In a Cox time-to-event multivariable model and during 6-year follow-up, the incidences of death and of each individual cardiovascular outcomes were all significantly higher in the frail than in the non-frail patients including major adverse cardiovascular event (MACE) [hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.53, 2.06], death (HR 2.70, 95% CI 2.16, 3.38), acute myocardial infarction (HR 1.95, 95% CI 1.31, 2.90), stroke (HR 1.71, 95% CI 1.34, 2.17), peripheral vascular disease (HR 1.80, 95% CI 1.44, 2.27), and coronary artery disease (HR 1.35, 95% CI 1.11, 1.65). CONCLUSION: In patients without CHD, frailty is a risk factor for the development of MACEs. Efforts to identify frailty in patients without CHD and interventions to limit or reverse frailty status are needed and, if successful, may limit subsequent adverse cardiovascular events.

Physical Frailty Phenotype and the Development of Geriatric Syndromes in Older Adults with Coronary Heart Disease.

BACKGROUND: Frailty, a clinical state of vulnerability, is associated with subsequent adverse geriatric syndromes in the general population. We examined the long-term impact of frailty on geriatric outcomes among older patients with coronary heart disease. METHODS: We used the National Health and Aging Trends Study, a prospective cohort study linked to a Medicare sample. Coronary heart disease was identified by self-report or International Classification of Diseases (ICD) codes 1-year prior to the baseline visit. Frailty was measured using the Fried physical frailty phenotype. Geriatric outcomes were assessed annually during a 6-year follow-up. RESULTS: Of the 4656 participants, 1213 (26%) had a history of coronary heart disease 1-year prior to their baseline visit. Compared to those without frailty, subjects with frailty were older (ages ≥75: 80.9% vs 68.9%, P < 0.001), more likely to be female, and belong to an ethnic minority. The prevalence of hypertension, stroke, falls, disability, anxiety/depression, and multimorbidity were much higher in the frail, than nonfrail, participants. In a discrete time survival model, the incidence of geriatric syndromes during 6-year follow-up including 1) dementia, 2) loss of independence, 3) activities of daily living disability, 4) instrumental activities of daily living disability, and 5) mobility disability were significantly higher in the frail than in the nonfrail older patients with coronary heart disease. CONCLUSION: In patients with coronary heart disease, frailty is a risk factor for the accelerated development of geriatric outcomes. Efforts to identify frailty in the context of coronary heart disease are needed, as well as interventions to limit or reverse frailty status for older patients with coronary heart disease.

Transcatheter Aortic Valve Replacement in Low-Population Density Areas: Assessing Healthcare Access for Older Adults With Severe Aortic Stenosis.

BACKGROUND: Restricting transcatheter aortic valve replacement (TAVR) to centers based on volume thresholds alone can potentially create unintended disparities in healthcare access. We aimed to compare the influence of population density in state of Florida in regard to access to TAVR, TAVR utilization rates, and in-hospital mortality. METHODS AND RESULTS: From 2011 to 2016, we used data from the Agency for Health Care Administration to calculate travel time and distance for each TAVR patient by comparing their home address to their TAVR facility ZIP code. Travel time and distance, TAVR rates, and mortality were compared across categories of low to high population density (population per square miles of land). Of the 6531 patients included, the mean (SD) age was 82 (9) years, 43% were female and 91% were White. Patients residing in the lowest category (<50/square miles) were younger, more likely to be men, and less likely to be a racial minority. Those residing in the lowest category density faced a longer unadjusted driving distances and times to their TAVR center (mean extra distance [miles]=43.5 [95% CI, 35.6-51.4]; P<0.001; mean extra time (minutes)=45.6 [95% CI, 38.3-52.9], P<0.001). This association persisted regardless of the methods used to determine population density. Excluding uninhabitable land, there was a 7-fold difference in TAVR utilization rates in the lowest versus highest population density regions (7 versus 45 per 100 000, P-for-pairwise-comparisons <0.001) and increase in TAVR in-hospital mortality (adjusted OR, 6.13 [95% CI, 1.97-19.1]; P<0.001). CONCLUSIONS: Older patients living in rural counties in Florida face (1) significantly longer travel distances and times for TAVR, (2) lower TAVR utilization rates, and (3) higher adjusted TAVR mortality. These findings suggest that there are trade-offs between access to TAVR, its rate of utilization, and procedural mortality, all of which are important considerations when defining institutional and operator requirements for TAVR across the country.

Frailty Among Older Adults With Acute Myocardial Infarction and Outcomes From Percutaneous Coronary Interventions.

Background Frailty is a predictor of adverse outcomes after acute myocardial infarction (AMI). Methods and Results We estimated the prevalence of frailty among adults age ≥75 years admitted with AMI and examined the relationship between frailty, interventions, and mortality. We used the Premier Healthcare Database to identify older adults with primary diagnoses of AMI. We classified individuals as frail or not using the validated Claims-based Frailty Index. We described patients' characteristics and receipt of percutaneous coronary intervention stratified by frailty status. The primary outcome was hospital mortality. From 2000 to 2016, we identified 469 390 encounters for older patients admitted with AMI. The median age was 82 years, 53% were women, and 75% were white. The prevalence of frailty was 19%. Frail patients were less likely to receive percutaneous coronary intervention than nonfrail (15% versus 33%, P<0.001) and much less likely to receive coronary artery bypass surgery (1% versus 9%, P<0.001). There were far fewer interventions in individuals over age 85 years. Frailty was associated with higher mortality during AMI admission (unadjusted odds ratio [OR] 1.43, CI 1.39-1.46). While there was a differential benefit of the interventions because of frailty, frail patients had reduced hospital mortality with percutaneous coronary intervention (frail: OR 0.59, CI 0.55-0.63; nonfrail: OR 0.49, CI 0.47-0.50, P for interaction <0.001) and with coronary artery bypass surgery (frail: OR 0.77, CI 0.65-0.93; nonfrail: OR 0.74, CI 0.71-0.77, P for interaction <0.001) relative to no intervention. Conclusions In the United States, frailty is common among older patients admitted with AMI. While these vulnerable patients are at an increased risk for mortality, judicial use of revascularization with percutaneous coronary intervention in frail older patients still confers immediate survival benefit.

Percutaneous Coronary Intervention in Older Patients With ST-Segment Elevation Myocardial Infarction and Cardiogenic Shock.

BACKGROUND: Older adults ≥75 years of age carry an increased risk of mortality after ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock. OBJECTIVES: The purpose of this study was to examine the use of percutaneous coronary intervention (PCI) in older adults with STEMI and shock and its influence on in-hospital mortality. METHODS: We used a large publicly available all-payer inpatient health care database sponsored by the Agency for Healthcare Research and Quality between 1999 and 2013. The primary outcome was in-hospital mortality. The influence of PCI on in-hospital mortality was assessed by quintiles of propensity score (PS). RESULTS: Of the 317,728 encounters with STEMI and shock in the United States, 111,901 (35%) were adults age ≥75 years. Of these, 53% were women and 83% were Caucasians. The median number of chronic conditions was 8 (interquartile range: 6 to 10). The diagnosis of STEMI and cardiogenic shock in older patients decreased significantly over time (proportion of older adults with STEMI and shock: 1999: 42% vs. 2013: 29%). Concomitantly, the rate of PCI utilization in older adults increased (1999: 27% vs. 2013: 56%, p < 0.001), with declining in-hospital mortality rates (1999: 64% vs. 2013: 46%; p < 0.001). Utilizing PS matching methods, PCI was associated with a lower risk of in-hospital mortality across quintiles of propensity score (Mantel-Haenszel odds ratio: 0.48; 95% confidence interval [CI]: 0.45 to 0.51). This reduction in hospital mortality risk was seen across the 4 different U.S. census bureau regions (adjusted odds ratio: Northeast: 0.41; 95% CI: 0.36 to 0.47; Midwest: 0.49; 95% CI: 0.42 to 0.57; South: 0.51; 95% CI: 0.46 to 0.56; West: 0.46; 95% CI: 0.41 to 0.53). CONCLUSIONS: This large and contemporary analysis shows that utilization of PCI in older adults with STEMI and cardiogenic shock is increasing and paralleled by a substantial reduction in mortality. Although clinical judgment is critical, older adults should not be excluded from early revascularization based on age in the absence of absolute contraindications.

Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.

BACKGROUND: We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques. METHODS AND RESULTS: This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques. CONCLUSION: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques.

Health Care Costs After Cardiac Arrest in the United States.

BACKGROUND: This study was designed to estimate the costs of index hospitalizations after cardiac arrest in the United States. METHODS AND RESULTS: We used the US Nationwide Inpatient Sample (2003-2012) to identify patients with cardiac arrest. Log transformation of inflation-adjusted cost was determined for care to patient outcomes. Overall, an estimated 1 387 396 patients were hospitalized after cardiac arrest. The mean age of the cohort was 66 years, 45% were women, and the majority were white. Inpatient procedures included coronary angiography (15%), percutaneous coronary intervention (7%), intra-aortic balloon pump (4.4%), therapeutic hypothermia (1.1%), and mechanical circulatory support (0.1%). The rates of therapeutic hypothermia increased from zero in 2003 to 2.7% in 2012 (P<0.001). Both hospital charges and inflation-adjusted cost increased linearly over time. In a multivariate analysis, predictors of inflation-adjusted cost included large hospital size, urban teaching hospital, and length of stay. Among comorbidities, atrial fibrillation or fluid and electrolytes imbalance was most associated with cost. Among selected interventions, the cost was significantly increased with automatic implantable cardioverter defibrillators (odds ratio, 1.83; P<0.001), intra-aortic balloon pump (odds ratio, 1.50; P<0.001), hypothermia (odds ratio, 1.28; P<0.001), and extracorporeal membrane oxygenation (odds ratio, 2.38; P<0.001). CONCLUSIONS: In the period between 2003 and 2012, postcardiac arrest hospitalizations resulted in a steady rise in associated health care cost, likely related to increased length of stay, medical procedures, and systems of care. Although targeted cost containment for postarrest interventions may reduce the finance burden, there is an increasing need for funding research into prediction and prevention of cardiac arrest, which offers greater societal benefit.

Influence of operator experience and PCI volume on transfemoral access techniques: A collaboration of international cardiovascular societies.

INTRODUCTION: Transfemoral access (TFA) is widely used for coronary angiography and percutaneous coronary intervention (PCI). The influence of operator age, gender, experience, and procedural volume on performance of femoral arterial access has not been studied. METHODS: A survey instrument was developed and distributed via e-mail from professional societies to interventional cardiologists worldwide from March to December 2016. RESULTS: A total of 988 physicians from 88 countries responded to the survey. TFA is the preferred approach for patients with cardiogenic shock, left main or bifurcation PCI, and procedures with mechanical circulatory support. Older (<50years: 56.4%; ≥50years: 66.8%, p<0.0039) and high PCI volume operators (<100 PCI: 57.3%; 100-299 PCI: 58.7%; ≥300 PCI: 64.3%, p<0.134) preferred palpation only without imaging (fluoroscopy or ultrasound (US)) for TFA. Most respondents preferred not to use micropuncture needle to puncture the femoral artery. Older (≥50years: 64.4%; <50years: 71.5%, p<0.04) and high PCI volume operators (≥300 PCI: 64.1%; 100-299 PCI: 72.6%; <100 PCI: 67.9%, p<0.072) tended not to perform femoral angiography (FA). Of those performing FA, the majority opted to do it at the end of the procedure. CONCLUSION: Despite best practice guideline recommendations, older and high PCI volume interventional cardiologists prefer not to use imaging for femoral access or perform femoral angiography during TF procedures. These data highlight opportunities to further reduce TFA complications.

Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: The acute coronary treatment and intervention outcomes network (ACTION) registry®-Get With The Guidelines (GWTG)®.

BACKGROUND: Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality. OBJECTIVE: To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality. METHODS: An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care. RESULTS: The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77-3.22]); presentation in cardiogenic shock (OR 2.22 [2.05-2.40]); STEMI (OR 1.72 [1.65-1.80]); presentation in heart failure (OR 1.55 [1.47-1.63]); baseline hemoglobin less than 12 g/dL (1.55 [1.48-1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12-1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11-1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07-1.08]). The model discriminated well in the derivation (C-statistic = 0.74) and validation (C-statistic = 0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%). CONCLUSION: The new ACTION Registry-GWTG inhospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models.

Why Aren't Our Digital Solutions Working for Everyone?

The article explores a digital injustice that is occurring across the country: that digital solutions intended to increase health care access and quality often neglect those that need them most. It further shows that when it comes to digital innovation, health care professionals and technology companies rarely have any incentives to focus on underserved populations. Nevertheless, we argue that the technologies that are leaving these communities behind are the same ones that can best support them. The key is in leveraging these technologies with: (a) design features that accommodate various levels of technological proficiency (e-literacy), (b) tech-enabled community health workers and navigators who can function as liaisons between patients and clinicians, and (c) analytics and customer relationship management tools that enable health care professionals and support networks to provide the right interventions to the right patients. Finally, we argue that community health care workers will need to be incentivized to play a larger role in building and adopting innovations targeting the underserved.

Transfemoral Approach for Coronary Angiography and Intervention: A Collaboration of International Cardiovascular Societies.

OBJECTIVES: The aim of this study was to examine the current practice and use of transfemoral approach (TFA) for coronary angiography and intervention. BACKGROUND: Wide variability exists in TFA techniques for coronary procedures. METHODS: The authors developed a survey instrument that was distributed via e-mail lists from professional societies to interventional cardiologists from 88 countries between March and December 2016. RESULTS: Of 987 operators, 18% were femoralists, 38% radialists, 42% both, and 2% neither. Access using femoral pulse palpation alone was preferred by 60% of operators, fluoroscopy guidance by 11%, and a combination of palpation, fluoroscopy, or ultrasound by 27%. Only 11% used micropuncture in >90% of their cases. Performing femoral angiography immediately after access was preferred by 23% and at the end of the procedure by 47%, and not done at all by 31% of operators. Hemostasis by manual compression was preferred by 50%, collagen plug vascular closure device by 31%, and suture-based vascular closure device by 11% of operators. Judkins left and right catheters were preferred for diagnostic angiography of the left (99%) and right (94%) coronary arteries. Extra backup curves (XB or EBU) were most commonly preferred for percutaneous coronary intervention of the left anterior descending (80%) and left circumflex (80%), whereas the Judkins right catheter was preferred for percutaneous coronary intervention of the right coronary artery (86%). CONCLUSIONS: There is significant variability in preferences for femoral access technique. Even though recommended best practices advocate for fluoroscopic and ultrasound guidance, most operators use palpation alone. Femoral angiography is also not consistently used despite guideline recommendations. The lack of adoption of imaging guidance for vascular access deserves further investigation.

Insulin provision therapy and mortality in older adults with diabetes mellitus and stable ischemic heart disease: Insights from BARI-2D trial.

IMPORTANCE: Optimal strategies for glucose control in very old adults with diabetes and stable ischemic heart disease (SIHD) are unclear. OBJECTIVE: To compare the effects of insulin provision (IP) therapy versus insulin sensitizing (IS) therapy for glycemic control in older (≥75years) and younger (<75years) adults with type II diabetes (DM) and SIHD. DESIGN, SETTING, AND PARTICIPANTS: Adults enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) were studied. The BARI 2D study population (all with type II DM and SIHD) was randomized twice: (1) between revascularization plus intensive medical therapy versus intensive medical therapy alone, and (2) between IP versus IS therapies. The primary endpoint was all-cause-mortality over five-year follow-up. In this substudy outcomes related to IP vs. IS are assessed in relation to age. Adults aged ≥75years who received IP versus IS are compared to those <75years who received IP versus IS. Multivariate Cox regression analysis was used to evaluate the effects of IP vs. IS on outcomes in the two age groups. RESULTS: 2368 subjects with SIHD and DM were enrolled in BARI 2D; 182 (8%) were ≥75years. Compared to younger subjects, the older cohort had lower BMI, higher diuretic use, worse kidney function, and increased history of heart failure. Within the older cohort, the IP and IS subgroups were similar in respect to baseline cardiovascular risk factors, medications, and coronary artery disease severity. During follow-up, the older subjects receiving IP therapy had higher cardiovascular mortality compared to those receiving IS therapy (16% vs. 11%, p=0.040). Using Cox proportional hazards analysis, the older IP subjects were at increased risk for all-cause-mortality (hazard ratio 1.89, CI 1.1-3.2, p=0.020). No mortality difference between IP and IS was observed in those <75years of age. CONCLUSION AND RELEVANCE: Among adults with diabetes and SIHD aged ≥75years, IP therapy may be associated with increased mortality compared to IS therapy. Additional studies are needed to further refine optimal treatment strategies for diabetes and SIHD in old age.

Venous Thromboembolism Prophylaxis: Inadequate and Overprophylaxis When Comparing Perceived Versus Calculated Risk.

Guidelines for venous thromboembolism (VTE) prophylaxis recommend appropriate risk stratification using risk estimation models as high risk or low risk followed by initiation of chemical or mechanical prophylaxis, respectively. We explored adherence to guidelines on the basis of the documentation of VTE prophylaxis. A retrospective medical record review of 437 consecutive adult patients (≥18 years) admitted to general medical wards under medicine service between January 1, 2015, and March 1, 2015, was performed. The primary outcome was appropriateness of risk stratification using the Padua Prediction Score. Secondary outcomes were appropriateness of type of prophylaxis (chemical vs mechanical) and cost-benefit analysis. We observed appropriate stratification based on the documented risk (compared with the calculated risk) in 54.9% of the patients (40.8% with low risk vs 72.1% with high risk; P<.001). Overall, 182 of 240 low-risk patients received unnecessary chemical prophylaxis, whereas 23 of 197 high-risk patients without contraindications for chemical prophylaxis received mechanical or no prophylaxis. No clinical VTE events were noted in the patients inappropriately assigned to mechanical or no prophylaxis. Also, 67.3% of patients with both low documented and low calculated risk and 74.5% of patients with low documented and high calculated risk received chemical prophylaxis, consistent with a tendency toward overtreatment. A total of 4068 annualized patient-days ($77,652/y) of inappropriate chemical prophylaxis were administered. In conclusion, estimation of the risk of VTE based on clinical impression was not congruent with the risk calculated using risk prediction models and was associated with a tendency toward overtreatment. These data support the inclusion of VTE risk calculators in electronic health record systems.

Predicting In-Hospital Mortality in Patients With Acute Myocardial Infarction.

BACKGROUND: As a foundation for quality improvement, assessing clinical outcomes across hospitals requires appropriate risk adjustment to account for differences in patient case mix, including presentation after cardiac arrest. OBJECTIVES: The aim of this study was to develop and validate a parsimonious patient-level clinical risk model of in-hospital mortality for contemporary patients with acute myocardial infarction. METHODS: Patient characteristics at the time of presentation in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-GWTG (Get With the Guidelines) database from January 2012 through December 2013 were used to develop a multivariate hierarchical logistic regression model predicting in-hospital mortality. The population (243,440 patients from 655 hospitals) was divided into a 60% sample for model derivation, with the remaining 40% used for model validation. A simplified risk score was created to enable prospective risk stratification in clinical care. RESULTS: The in-hospital mortality rate was 4.6%. Age, heart rate, systolic blood pressure, presentation after cardiac arrest, presentation in cardiogenic shock, presentation in heart failure, presentation with ST-segment elevation myocardial infarction, creatinine clearance, and troponin ratio were all independently associated with in-hospital mortality. The C statistic was 0.88, with good calibration. The model performed well in subgroups based on age; sex; race; transfer status; and the presence of diabetes mellitus, renal dysfunction, cardiac arrest, cardiogenic shock, and ST-segment elevation myocardial infarction. Observed mortality rates varied substantially across risk groups, ranging from 0.4% in the lowest risk group (score <30) to 49.5% in the highest risk group (score >59). CONCLUSIONS: This parsimonious risk model for in-hospital mortality is a valid instrument for risk adjustment and risk stratification in contemporary patients with acute myocardial infarction.

The association between in-hospital hemoglobin changes, cardiovascular events, and mortality in acute decompensated heart failure: Results from the ESCAPE trial.

INTRODUCTION: The effect of acute changes of hemoglobin during index heart failure admission on long-term outcomes remains unknown. METHODS: We examined 433 patients enrolled in the ESCAPE trial. RESULTS: Of the 433 patients, 324 (75%) had baseline and discharge hemoglobin available for analysis. Of those, 64 (20%) had at least 1g/dL drop of hemoglobin by time of discharge. Compared to patients without hemoglobin changes (g/dL), patients with hemoglobin drop were older (59 vs. 55, p=0.011), had lower systolic BP (mmHg) (99 vs. 106, p=0.017), lower sodium (mg/dL) (136 vs. 137 (mg/dL), p=0.025), higher BUN (mg/dL) (37 vs. 26, p<0.001), higher creatinine (mg/dL) (1.6 vs. 1.3, p<0.001) and higher hospital length of stay (10days vs. 6days, p=<0.001). Higher hemoglobin drop was observed in the pulmonary artery catheter (PACs) (vs. clinical care) randomized arm of the trial (2g/dL: 10% versus 3%, p=0.010; 3g/dL: 5% versus 0%, p=0.005). After adjustments, a drop of hemoglobin with at least 1g/dL was associated with increased mortality risk (Adjusted HR 2.38, p=0.003) and higher hemoglobin concentrations by the time of discharge was associated with lower mortality rate (Adjusted HR 0.79, p=0.003). PACs insertion was not associated with adverse clinical outcomes by quartiles of % change of hemoglobin. However, PACs use was an independent predictor of hemoglobin drop during heart failure admission (Adjusted OR: Hb Drop 1g/dL: 1.88, p=0.043; Hb Drop 2g/dL: 3.6 p=0.025). CONCLUSION: In-hospital decrease in hemoglobin is independently associated with increased long-term mortality and hospital length of stay in ADHF. The ideal hemoglobin levels in ADHF patients should be investigated and the insertion of PACs to direct therapy should be weighed against bleeding risks.

Influence of Total Coronary Occlusion on Clinical Outcomes (from the Bypass Angioplasty Revascularization Investigation 2 DiabetesTrial).

Our aim was to evaluate the influence of chronic total occlusions (CTOs) on long-term clinical outcomes of patients with coronary heart disease and diabetes mellitus. We evaluated patients with coronary heart disease and diabetes mellitus enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes, who underwent either prompt revascularization (PR) with intensive medical therapy (IMT) or IMT alone according to the presence or absence of CTO. Of 2,368 patients enrolled in the trial, 972 patients (41%) had CTO of coronary arteries. Of those, 482 (41%) and 490 (41%) were in the PR with IMT versus IMT only groups, respectively. In the PR group, patients with CTO were more likely to be selected for the coronary artery bypass grafting stratum (coronary artery bypass grafting 62% vs percutaneous coronary intervention 31%, p <0.001). Compared to the non-CTO group, patients with CTO had more abnormal Q wave, abnormal ST depression, and abnormal T waves. The myocardial jeopardy score was higher in the CTO versus non-CTO group (52 [36 to 69] vs 37 [21 to 53], p <0.001). After adjustment, 5-year mortality rate was significantly higher in the CTO group in the entire cohort (hazard ratio [HR] 1.35, p = 0.013) and in patients with CTO managed with IMT (HR 1.46, p = 0.031). However, the adjusted risk of death was not increased in patients managed with PR (HR 1.26, p = 0.180). In conclusion, CTO of coronary arteries is associated with increased mortality in patients treated medically. However, the presence of a CTO may not increase mortality in patients treated with revascularization. Larger randomized trials are needed to evaluate the effects of revascularization on long-term survival in patients with CTO.