The prevalence, predictors and outcomes of guideline-directed medical therapy in patients with acute myocardial infarction undergoing PCI, an analysis from the PROMETHEUS registry.

OBJECTIVES: To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States. BACKGROUND: Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting. METHODS: PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year. RESULTS: Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58-0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46-0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61-0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56-1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47-1.34; P = 0.384) between the two groups. CONCLUSION: In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

Use of prasugrel and clinical outcomes in African-American patients treated with percutaneous coronary intervention for acute coronary syndromes.

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P < 0.0001). AA race was independently associated with a significantly higher risk of MI at 90-days and 1 year after PCI. CONCLUSIONS: Despite higher risk clinical presentation and worse 1-year ischemic outcomes, AA race was an independent predictor of lower prasugrel prescription in a contemporary population of ACS patients undergoing PCI.

Associations between use of prasugrel vs clopidogrel and outcomes by type of acute coronary syndrome: an analysis from the PROMETHEUS registry.

We sought to investigate the utilization of prasugrel and its association with outcomes relative to clopidogrel in three typical subgroups of ACS in a real-world setting. Prasugrel is superior to clopidogrel for reducing risk of ischemic events in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), but is associated with an increased risk of bleeding complications. PROMETHEUS was a retrospective multicenter observational study of 19,913 ACS patients undergoing PCI from 8 centers in the United States between 2010 and 2013. Major adverse cardiovascular events (MACE) were defined as a composite of all-cause mortality, myocardial infarction, stroke or unplanned revascularization. The study cohort included 3285 (16.5%) patients with ST-segment elevation myocardial infarction (STEMI), 5412 (27.2%) patients with NSTEMI and 11,216 (56.3%) patients with unstable angina (UA). The frequency of prasugrel use at discharge was highest in STEMI and lowest in UA patients, 27.3% versus 22.2% versus 18.9% (p < 0.001). Use of prasugrel vs clopidogrel was associated with a lower rate of MACE in STEMI, NSTEMI, or UA at 1 year, but the differences were attenuated for all groups except for patients with UA (adjusted HR 0.81, 95% CI 0.69-0.94, p = 0.006) after propensity adjusted analysis. After adjustment, there was no difference in bleeding risk between prasugrel and clopidogrel for all groups at 1 year. STEMI patients were more likely to receive prasugrel compared to NSTEMI and UA patients. Prasugrel was associated with reduced adverse outcomes compared with clopidogrel in unadjusted analyses, findings that were largely attenuated upon adjustment and suggest preferential use of prasugrel in low vs high risk patients.

Resource utilization and outcome among patients with selective versus nonselective troponin testing.

OBJECTIVE: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. Troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for resource utilization and outcome. Therefore, we examined selective versus nonselective troponin testing with respect to patient characteristics, resource utilization, and outcome. METHODS: This retrospective 1-year study included all patients with troponin testing at a U.S. emergency department. Testing was classified as selective (ACS) or nonselective (non-ACS) based on admission ICD-9 codes. Troponin upper reference limit (URL) was ≥99th percentile. RESULTS: Among 47,053 patients, troponin was measured in 9109 (19%) of whom 5764 were hospitalized. Admission diagnosis was non-ACS in 4427 (77%) and ACS in 1337 (23%). Non-ACS patients were older, 71±17 versus 65±16 years, with longer hospital stay, 77 versus 32 h, and greater 1-year mortality 22% versus 6.7%; P<.001. In patients with troponin ≥URL, revascularization was performed in 64 (4.7%) of non-ACS versus 213 (48%) of ACS; P<.001. In patients with troponin 80% of the non-ACS population CONCLUSIONS: Contemporary troponin testing is frequently nonselective. The non-ACS and ACS populations differ significantly regarding clinical characteristics, revascularization rates, and outcomes. Troponin elevation is a powerful predictor of 1-year mortality in non-ACS, this association reveals an opportunity for risk stratification and targeted therapy. KEY QUESTIONS: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. However, troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for hospital resource utilization and patient outcome. Our findings demonstrate contemporary troponin testing is largely nonselective (77% of testing was performed in patients without acute coronary syndrome). In comparison to patients with acute coronary syndrome, those with non-acute coronary syndrome are older, with longer hospital stay, lower revascularization rates, and greater 1-year mortality. Troponin elevation identifies a high-risk population in both acute coronary syndrome and non-acute coronary syndrome populations, yet effective treatment for the latter is lacking.

Use of prasugrel vs clopidogrel and outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention in contemporary clinical practice: Results from the PROMETHEUS study.

BACKGROUND AND OBJECTIVES: We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. METHODS: PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. RESULTS: Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders. CONCLUSIONS: In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.

Sex-related differences in outcomes among men and women under 55 years of age with acute coronary syndrome undergoing percutaneous coronary intervention: Results from the PROMETHEUS study.

BACKGROUND: Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under-treatment. We sought to compare the 1-year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort. METHODS: PROMETHEUS was a retrospective multicenter observational US study comparing outcomes in clopidogrel and prasugrel treated patients following ACS PCI. MACE was defined as a composite of death, myocardial infarction, stroke or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Hazard ratios were generated using multivariable Cox proportional hazards regression. RESULTS: The study cohort included 4,851 patients of which 1,162 (24.0%) were women and 3,689 (76.0%) were men. In this cohort, the prevalence of diabetes (41.0 vs. 27.9%) and chronic kidney disease (12.7 vs. 7.2%) was higher among women compared with men. Irrespective of sex, prasugrel was used in less than one-third of patients (31.8% in men vs. 28.1% in women, P = 0.01). Unadjusted, 1-year MACE (21.1% vs. 16.2%, P < 0.001) and bleeding (3.6% vs. 2.2%, P = 0.01) was significantly higher in women compared with men, but these results were no longer significant after adjustment for risk (HR 1.13, 95% CI 0.94-1.36 for MACE and HR 1.31, 95% CI 0.85-2.04 for bleeding). CONCLUSION: Women ≤ 55 years of age undergoing ACS PCI have significantly greater comorbidities than young men. Despite a higher risk clinical phenotype in women, prasugrel use was significantly lower in women than men. Female sex was associated with a significantly higher risk of 1-year MACE and bleeding than male sex, findings that are attributable to baseline differences. © 2016 Wiley Periodicals, Inc.

Chest Compression Injuries Detected via Routine Post-arrest Care in Patients Who Survive to Admission after Out-of-hospital Cardiac Arrest.

Abstract Objective. To examine injuries produced by chest compressions in out-of-hospital cardiac arrest (OHCA) patients who survive to hospital admission. Methods. A retrospective cohort study was conducted among 235 consecutive patients who were hospitalized after nontraumatic OHCA in Minnesota between January 2009 and May 2012 (117 survived to discharge; 118 died during hospitalization). Cases were eligible if the patient had received prehospital compressions from an emergency medical services (EMS) provider. One EMS provider in the area was using a mechanical compression device (LUCASTM) as standard equipment, so the association between injury and use of mechanical compression was also examined. Prehospital care information was abstracted from EMS run sheets, and hospital records were reviewed for injuries documented during the post-arrest hospitalization that likely resulted from compressions. Results. Injuries were identified in 31 patients (13%), the most common being rib fracture (9%) and intrathoracic hemorrhage (3%). Among those who survived to discharge, the mean length of stay was not statistically significantly different between those with injuries (13.5 days) and those without (10.8 days; p = 0.23). Crude injury prevalence was higher in those who died prior to discharge, had received compressions for >10 minutes (versus ≤10 minutes) and underwent computer tomography (CT) imaging, but did not differ by bystander compressions or use of mechanical compression. After multivariable adjustment, only compression time > 10 min and CT imaging during hospitalization were positively associated with detected injury (OR = 7.86 [95% CI = 1.7-35.9] and 6.30 [95% CI = 2.6-15.5], respectively). Conclusion. In patients who survived OHCA to admission, longer duration of compressions and use of CT during the post-arrest course were associated positively with documented compression injury. Compression-induced injuries detected via routine post-arrest care are likely to be largely insignificant in terms of length of recovery.

Thrombotic risk in patients with acute coronary syndromes discharged on prasugrel or clopidogrel: results from the PROMETHEUS study.

AIMS: Based on recent clinical data, the 2020 ESC guidelines on non-ST-elevation acute coronary syndrome (NSTE-ACS) suggest to tailor antithrombotic strategy on individual thrombotic risk. Nonetheless, prevalence and prognostic impact of the high thrombotic risk (HTR) criteria proposed are yet to be described. In this analysis from the PROMETHEUS registry, we assessed prevalence and prognostic impact of HTR, defined according to the 2020 ESC NSTE-ACS guidelines, and if the benefits associated with prasugrel vs. clopidogrel vary with thrombotic risk. METHODS AND RESULTS: PROMETHEUS was a multicentre prospective study comparing prasugrel vs. clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI). Patients were at HTR if presenting with one clinical plus one procedural risk feature. The primary endpoint was major adverse cardiac events (MACE), composite of death, myocardial infarction, stroke, or unplanned revascularization, at 1 year. Adjusted hazard ratio (adjHR) and 95% confidence intervals (CIs) were calculated with propensity score stratification and multivariable Cox regression. Among 16 065 patients, 4293 (26.7%) were at HTR and 11 772 (73.3%) at low-to-moderate thrombotic risk. The HTR conferred increased incidence of MACE (23.3 vs. 13.6%, HR 1.85, 95% CI 1.71-2.00, P < 0.001) and its single components. Prasugrel was prescribed in patients with less comorbidities and risk factors and was associated with reduced risk of MACE (HTR: adjHR 0.83, 95% CI 0.68-1.02; low-to-moderate risk: adjHR 0.75, 95% CI 0.64-0.88; pinteraction = 0.32). CONCLUSION: High thrombotic risk, as defined by the 2020 ESC NSTE-ACS guidelines, is highly prevalent among ACS patients undergoing PCI. The HTR definition had a strong prognostic impact, as it successfully identified patients at increased 1 year risk of ischaemic events.

Correlates of delayed recognition and treatment of acute type A aortic dissection: the International Registry of Acute Aortic Dissection (IRAD).

BACKGROUND: In acute aortic dissection, delays exist between presentation and diagnosis and, once diagnosed, definitive treatment. This study aimed to define the variables associated with these delays. METHODS AND RESULTS: Acute aortic dissection patients enrolled in the International Registry of Acute Aortic Dissection (IRAD) between 1996 and January 2007 were evaluated for factors contributing to delays in presentation to diagnosis and in diagnosis to surgery. Multiple linear regression was performed to determine relative delay time ratios (DTRs) for individual correlates. The median time from arrival at the emergency department to diagnosis was 4.3 hours (quartile 1-3, 1.5-24 hours; n=894 patients) and from diagnosis to surgery was 4.3 hours (quartile 1-3, 2.4-24 hours; n=751). Delays in acute aortic dissection diagnosis occurred in female patients; those with atypical symptoms that were not abrupt or did not include chest, back, or any pain; patients with an absence of pulse deficit or hypotension; or those who initially presented to a nontertiary care hospital (all P<0.05). The largest relative DTRs were for fever (DTR=5.11; P<0.001) and transfer from nontertiary hospital (DTR=3.34; P<0.001). Delay in time from diagnosis to surgery was associated with a history of previous cardiac surgery, presentation without abrupt or any pain, and initial presentation to a nontertiary care hospital (all P<0.001). The strongest factors associated with operative delay were prolonged time from presentation to diagnosis (DTR=1.35; P<0.001), race other than white (DTR=2.25; P<0.001), and history of coronary artery bypass surgery (DTR=2.81; P<0.001). CONCLUSIONS: Improved physician awareness of atypical presentations and prompt transport of acute aortic dissection patients could reduce crucial time variables.

Pharmacotherapy in the treatment of mitral regurgitation: a systematic review.

BACKGROUND AND AIM OF THE STUDY: Chronic mitral regurgitation (MR) causes volume overload on the left ventricle and, if uncorrected, will over time lead to left ventricular remodeling and heart failure. The benefits of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) in primary MR are not well defined. METHODS: MEDLINE was searched for studies in which the effects of ACE inhibitors and ARBs on chronic MR had been examined. The inclusion criteria required the patient population to have chronic MR, a normal left ventricular ejection fraction, and to report a quantitative measure of the change in MR severity. Studies in which patients had secondary MR were excluded. RESULTS: Nineteen studies met the inclusion criteria (13 daily therapy, five single-dose, and one combined study). The pooled mean decrease in regurgitant fraction (RF) was 7.7% [95% CI 4.9, 10.6] and 9.3% [95% CI 3.4, 15.2] for studies in patients with daily therapy and single-dose therapy, respectively. Among studies which reported changes in regurgitant volume (RV), the pooled mean decrease was 7.9 ml [95% CI 1.4, 14.5]. For patients with mitral valve prolapse (MVP), the pooled mean reduction in RF was 8.1% [95% CI 4.3, 11.9] and in rheumatic disease it was 3.4% [95% CI 13.2 - 7.0]. Across the seven studies of daily therapy which reported a change in left ventricular end-diastolic volume index (LVEDVI), the mean decrease was 11.5 ml/m2 [95% CI 2.4, 20.6]. CONCLUSION: ACE inhibitors and ARBs each reduced the RF, RV, and left ventricular size by a modest degree in chronic primary MR.

Is Compliance With Guideline Recommended Follow-Up After Aortic Dissection Associated With Survival?

BACKGROUND: Patients with acute aortic dissection (AD) remain at risk for long-term complications and thus are recommended to adhere closely to American College of Cardiology and American Heart Association aorta guideline-based follow-up imaging and clinic visits. The long-term outcomes of compliance with such a model are not well understood. METHODS: This was a retrospective cohort study of patients at a regional AD center who survived hospital discharge for AD and who were analyzed by compliance with initial follow-up at 3 months and long term after AD. The primary end point was death. RESULTS: A total of 172 (66% type A; 33% type B) patients survived hospitalization and were followed up over 48 months (interquartile range [IQR], 21, 88 months). Of these patients, 122 (71%) attended the first follow-up appointment, and 90 (52%) attended more than two-thirds of recommended appointments. Patients who attended the first follow-up visit had improved long-term follow-up compliance (75% [IQR, 50%, 91%]) compared with patients who did not attend the first visit (18% [IQR, 0%, 57%]). Noncompliance with the scheduled long-term follow-up was associated with a 50% increase in the risk of death (hazard ratio, 1.6; 95% confidence interval, 1.2, 2.1; P < .001). Furthermore, in patients with low compliance (consistently attending less than one-third of follow-up appointments), the lifetime risk of death after AD was more than double that of patients with high compliance (consistently attending more than two-thirds of appointments) (hazard ratio, 2.2; 95% confidence interval, 1.5, 3.1; P < .001). CONCLUSIONS: Nearly one-third of patients with AD do not attend the first recommended follow-up visit, and such failure was associated with later noncompliance with subsequent follow-up. Low-compliant patients have double the lifetime risk of death after AD than do high-compliant patients.

Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection.

Importance: Early data revealed a mortality rate of 1% to 2% per hour for type A acute aortic dissection (TAAAD) during the initial 48 hours. Despite advances in diagnostic testing and treatment, this mortality rate continues to be cited because of a lack of contemporary data characterizing early mortality and the effect of timely surgery. Objective: To examine early mortality rates for patients with TAAAD in the contemporary era. Design, Setting, and Participants: This cohort study examined data for patients with TAAAD in the International Registry of Acute Aortic Dissection between 1996 and 2018. Patients were grouped according to the mode of their intended treatment, surgical or medical. Exposure: Surgical treatment. Main Outcomes and Measures: Mortality was assessed in the initial 48 hours after hospital arrival using Kaplan-Meier curves. In-hospital complications were also evaluated. Results: A total of 5611 patients with TAAAD were identified based on intended treatment: 5131 (91.4%) in the surgical group (3442 [67.1%] male; mean [SD] age, 60.4 [14.1] years) and 480 (8.6%) in the medical group (480 [52.5%] male; mean [SD] age, 70.9 [14.7] years). Reasons for medical management included advanced age (n = 141), comorbidities (n = 281), and patient preference (n = 81). Over the first 48 hours, the mortality for all patients in the study was 5.8%. Among patients who were medically managed, mortality was 0.5% per hour (23.7% at 48 hours). For those whose intended treatment was surgical, 48-hour mortality was 4.4%. In the surgical group, 51 patients (1%) died before the operation. Conclusions and Relevance: In this study, the overall mortality rate for TAAAD was 5.8% at 48 hours. For patients in the medical group, TAAAD had a mortality rate of 0.5% per hour (23.7% at 48 hours). However, among those in the surgical group, 48-hour mortality decreased to 4.4%.

Overcoming gaps: regional collaborative to optimize capacity management and predict length of stay of patients admitted with COVID-19.

OBJECTIVE: Ensuring an efficient response to COVID-19 requires a degree of inter-system coordination and capacity management coupled with an accurate assessment of hospital utilization including length of stay (LOS). We aimed to establish optimal practices in inter-system data sharing and LOS modeling to support patient care and regional hospital operations. MATERIALS AND METHODS: We completed a retrospective observational study of patients admitted with COVID-19 followed by 12-week prospective validation, involving 36 hospitals covering the upper Midwest. We developed a method for sharing de-identified patient data across systems for analysis. From this, we compared 3 approaches, generalized linear model (GLM) and random forest (RF), and aggregated system level averages to identify features associated with LOS. We compared model performance by area under the ROC curve (AUROC). RESULTS: A total of 2068 patients were included and used for model derivation and 597 patients for validation. LOS overall had a median of 5.0 days and mean of 8.2 days. Consistent predictors of LOS included age, critical illness, oxygen requirement, weight loss, and nursing home admission. In the validation cohort, the RF model (AUROC 0.890) and GLM model (AUROC 0.864) achieved good to excellent prediction of LOS, but only marginally better than system averages in practice. CONCLUSION: Regional sharing of patient data allowed for effective prediction of LOS across systems; however, this only provided marginal improvement over hospital averages at the aggregate level. A federated approach of sharing aggregated system capacity and average LOS will likely allow for effective capacity management at the regional level.

The Cardiovascular Quality Improvement and Care Innovation Consortium: Inception of a Multicenter Collaborative to Improve Cardiovascular Care.

Despite decades of improvement in the quality and outcomes of cardiovascular care, significant gaps remain. Existing quality improvement strategies are often limited in scope to specific clinical conditions and episodic care. Health services and outcomes research is essential to inform gaps in care but rarely results in the development and implementation of care delivery solutions. Although individual health systems are engaged in projects to improve the quality of care delivery, these efforts often lack a robust study design or implementation evaluation that can inform generalizability and further dissemination. Aligning the work of health care systems and health services and outcomes researchers could serve as a strategy to overcome persisting gaps in cardiovascular quality and outcomes. We describe the inception of the Cardiovascular Quality Improvement and Care Innovation Consortium that seeks to rapidly improve cardiovascular care by (1) developing, implementing, and evaluating multicenter quality improvement projects using innovative care designs; (2) serving as a resource for quality improvement and care innovation partners; and (3) establishing a presence within existing quality improvement and care innovation structures. Success of the collaborative will be defined by projects that result in changes to care delivery with demonstrable impacts on the quality and outcomes of care across multiple health systems. Furthermore, insights gained from implementation of these projects across sites in Cardiovascular Quality Improvement and Care Innovation Consortium will inform and promote broad dissemination for greater impact.

Trends in prevalence of guideline-based use of lipid-lowering therapy in a large health system.

BACKGROUND: The 2013 ACC/AHA (American College of Cardiology/American Heart Association) cholesterol guidelines provided an evidence-based rationale for the allocation of lipid-lowering therapy based on risk for atherosclerotic cardiovascular disease (ASCVD). Adoption of these guidelines was initially suboptimal but whether this has improved over time remains unclear. HYPOTHESIS: Prevalence of guideline-based statin therapy will increase over time. METHODS: Electronic health record data were used to create two cross-sectional data sets of patients (age 40-75) served in 2013 and 2017 by a large health system. Data sets included demographics, clinical risk factors, lipid values, diagnostic codes, and active medication orders during each period. Prevalence of indications for statin therapy according to the ACC/AHA guidelines and statin prescriptions were compared between each time period. RESULTS: In 2013, of the 219 376 adults, 57.7% of patients met statin eligibility criteria, of which 61.3% were prescribed any statin and 19.0% a high intensity statin. Among those eligible, statin use was highest in those with established ASCVD (83.9%) and lowest in those with elevated ASCVD risk >7.5% (39.3%). In 2017, of the 256 074 adults, 62.3% were statin eligible, of which 62.3% were prescribed a statin and 24.3% a high intensity statin. In 2017, 66.4% of statin eligible men were prescribed a statin compared to 57.4% of statin eligible women (P < 0.001). The use of ezetimibe (3.6% in 2013, 2.4% in 2017) and protein convertase subtilisin/kexin type 9 inhibitors (<0.1% and 0.1%) was infrequent. CONCLUSION: In a large health system, guideline-based statin use has remained suboptimal. Improved strategies are needed to increase statin utilization in appropriate patients.

Impact of the Commercial Introduction of Transcatheter Mitral Valve Repair on Mitral Surgical Practice.

Background There has been uncertainty regarding the effect of transcatheter mitral valve repair (TMVr) with MitraClip on cardiac surgical practice. Our aim was to examine the impact of the commercial introduction of TMVr to a comprehensive mitral program. Methods and Results We evaluated 875 patients (aged 69±14 years; 58% men) who underwent transcatheter or mitral surgical procedures over a 6-year period at our institution. Main outcomes were changes in surgical procedural volume after TMVr introduction and short-term mortality for surgical and TMVr procedures. The numbers of patients treated with MitraClip, isolated mitral repair, and any mitral surgery were 249, 292, and 626 patients, respectively. Compared with surgery, patients with MitraClip were older (aged 82±8 versus 64±12 years; P<0.001) and had more severe morbidity. Following the introduction of MitraClip, surgical volumes steadily increased to a rate of 10 (95% CI, 3-7) procedures per year for isolated mitral procedures and 17 (95% CI, 13-20) procedures per year for all mitral surgeries. Both MitraClip and surgical volumes increased at the same rate (P=0.42). In-hospital mortality was 3.2% for MitraClip and 2.1% for all mitral surgeries (P=0.33). At 30 days, survival free of all mortality (P=0.17) and freedom from heart failure rehospitalization (P=0.75) were similar for transcatheter and surgical procedures. Conclusions The commercial introduction of TMVr may be associated with growth in cardiac surgery, without detracting from other therapies, and favorable clinical outcomes for all treated mitral regurgitation patients. These findings demonstrate the potential benefits of complementary therapies in the treatment of patients with mitral regurgitation.

CD34+ cell therapy significantly reduces adverse cardiac events, health care expenditures, and mortality in patients with refractory angina.

Patients with refractory angina who are suboptimal candidates for further revascularization have improved exercise time, decreased angina frequency, and reduced major adverse cardiac events with intramyocardial delivery of CD34+ cells. However, the effect of CD34+ cell therapy on health care expenditures before and after treatment is unknown. We determined the effect of CD34+ cell therapy on cardiac-related hospital visits and costs during the 12 months following stem cell injection compared with the 12 months prior to injection. Cardiac-related hospital admissions and procedures were retrospectively tabulated for patients enrolled at one site in one of three double-blinded, placebo-controlled CD34+ trials in the 12 months before and after intramyocardial injections of CD34+ cells vs placebo. Fifty-six patients were randomized to CD34+ cell therapy (n = 37) vs placebo (n = 19). Patients randomized to cell therapy experienced 1.57 ± 1.39 cardiac-related hospital visits 12 months before injection, compared with 0.78 ± 1.90 hospital visits 12 months after injection, which was associated with a 62% cost reduction translating to an average savings of $5500 per cell therapy patient. Patients in the placebo group also demonstrated a reduction in cardiac-related hospital events and costs, although to a lesser degree than the CD34+ group. Through 1 January 2019, 24% of CD34+ subjects died at an average of 6.5 ± 2.4 years after enrollment, whereas 47% of placebo patients died at an average of 3.7 ± 1.9 years after enrollment. In conclusion, CD34+ cell therapy for subjects with refractory angina is associated with improved mortality and a reduction in hospital visits and expenditures for cardiac procedures in the year following treatment.

Prasugrel use and clinical outcomes by age among patients undergoing PCI for acute coronary syndrome: from the PROMETHEUS study.

BACKGROUND: Prasugrel is a potent thienopyridine that may be preferentially used in younger patients with lower bleeding risk. OBJECTIVE: We compared prasugrel use and outcomes by age from the PROMETHEUS study. We also assessed age-related trends in treatment effects with prasugrel versus clopidogrel. METHODS: PROMETHEUS was a multicenter acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) registry. We compared patients in age tertiles (T1 < 60 years, T2 60-70 years, T3 > 70 years). Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke or unplanned revascularization. Data were adjusted using multivariable Cox regression for age-related risks and propensity score stratification for thienopyridine effects. RESULTS: The study included 19,914 patients: 7045 (35.0%) in T1, 6489 (33.0%) in T2 and 6380 (32.0%) in T3. Prasugrel use decreased from T1 to T3 (29.2% vs. 23.5% vs. 7.5%, p < 0.001). Crude 1-year MACE rates were highest in T3 (17.4% vs. 16.8% vs. 22.7%, p < 0.001), but adjusted risk was similar between the groups (p-trend 0.52). Conversely, crude incidence (2.8% vs. 3.8% vs. 6.9%, p < 0.001) and adjusted bleeding risk were highest in T3 (HR 1.24, 95% CI 0.99-1.55 in T2; HR 1.83, 95% CI 1.46-2.30 in T3; p-trend < 0.001; reference = T1). Treatment effects with prasugrel versus clopidogrel did not demonstrate age-related trends for MACE (p-trend = 0.91) or bleeding (p-trend = 0.28). CONCLUSIONS: Age is a strong determinant of clinical risk as well as prasugrel prescription in ACS PCI with much lower use among older patients. Prasugrel did not have a differential treatment effect by age for MACE or bleeding. Frequency of prasugrel use and age-related temporal risks of all-cause death and bleeding after ACS PCI.

Use of routinely captured echocardiographic data in the diagnosis of severe aortic stenosis.

OBJECTIVE: To determine the implications of applying guideline-recommended definitions of aortic stenosis to echocardiographic data captured in routine clinical care. METHODS: Retrospective observational study of 213 174 patients who underwent transthoracic echocardiographic imaging within Allina Health between January 2013 and October 2017. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of echocardiographic measures for severe aortic stenosis were determined relative to the documented interpretation of severe aortic stenosis. RESULTS: Among 77 067 patients with complete assessment of the aortic valve, 1219 (1.6%) patients were categorised as having severe aortic stenosis by the echocardiographic reader. Relative to the documented interpretation, aortic valve area (AVA) as a measure of severe aortic stenosis had the high sensitivity (94.1%) but a low positive predictive value (37.5%). Aortic valve peak velocity and mean gradient were specific (>99%), but less sensitive (<70%). A measure incorporating peak velocity, mean gradient and dimensionless index (either by velocity time integral or peak velocity ratio) achieved a balance of sensitivity (92%) and specificity (99%) with little detriment in accuracy relative to peak velocity and mean gradient alone (98.9% vs 99.3%). Using all available data, the proportion of patients whose echocardiogram could be assessed for aortic stenosis was 79.8% as compared with 52.7% by documented interpretation alone. CONCLUSION: A measure that used dimensionless index in place of AVA addressed discrepancies between quantitative echocardiographic data and the documented interpretation of severe aortic stenosis. These findings highlight the importance of understanding the limitations of clinical data as it relates to quality improvement efforts and pragmatic research design.