The American Heart Association at 100: A Century of Scientific Progress and the Future of Cardiovascular Science: A Presidential Advisory From the American Heart Association.

In 1924, the founders of the American Heart Association (AHA) envisioned an international society focused on the heart and aimed at facilitating research, disseminating information, increasing public awareness, and developing public health policy related to heart disease. This presidential advisory provides a comprehensive review of the past century of cardiovascular and stroke science, with a focus on the AHA's contributions, as well as informed speculation about the future of cardiovascular science into the next century of the organization's history. The AHA is a leader in fundamental, translational, clinical, and population science, and it promotes the concept of the "learning health system," in which a continuous cycle of evidence-based practice leads to practice-based evidence, permitting an iterative refinement in clinical evidence and care. This advisory presents the AHA's journey over the past century from instituting professional membership to establishing extraordinary research funding programs; translating evidence to practice through clinical practice guidelines; affecting systems of care through quality programs, certification, and implementation; leading important advocacy efforts at the federal, state and local levels; and building global coalitions around cardiovascular and stroke science and public health. Recognizing an exciting potential future for science and medicine, the advisory offers a vision for even greater impact for the AHA's second century in its continued mission to be a relentless force for longer, healthier lives.

Coronary artery bypass surgery versus percutaneous interventions for women with multivessel coronary artery disease.

OBJECTIVE: To compare outcomes in women undergoing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery. DESIGN: This retrospective, propensity-score matched cohort study from the New York State cardiac registry (2012-2018) included all women with multivessel coronary artery disease undergoing PCI with everolimus-eluting stents (EES) and CABG surgery. The primary outcome was all-cause mortality. The key secondary outcome was major adverse cardiac events, defined as the composite of all-cause mortality, myocardial infarction, and stroke. RESULTS: PCI with EES was associated with a higher 6-year risk of mortality (25.75% vs 23.57%; adjusted hazard ratio [AHR], 1.29; 95% confidence interval [CI], 1.14-1.45). PCI also was associated with a higher rate of the composite outcome of death, myocardial infarction, and stroke (36.58% vs 32.89%; AHR, 1.28; 95% CI, 1.17-1.41), as well as myocardial infarction (14.94% vs 9.12%; AHR, 1.84; 95% CI, 1.56-2.17), but not stroke (7.07% vs 7.62%; AHR, 0.83; 95% CI, 0.67-1.03). Repeat revascularization rates also were higher for women undergoing PCI (21.53% vs 11.57%; AHR, 1.88; 95% CI, 1.63-2.17). There was no difference in mortality between the 2 interventions when PCI patients received complete revascularization or had noncomplex lesions and for women without diabetes. CONCLUSIONS: For women with multivessel coronary artery disease, CABG surgery is associated with lower 6-year mortality, myocardial infarction, and repeat revascularization rates compared to PCI with EES.

New York Risk Model and Simplified Risk Score for In-Hospital/30-Day Mortality for Percutaneous Coronary Intervention.

Risk models and risk scores derived from those models require periodic updating to account for changes in procedural performance, patient mix, and new risk factors added to existing systems. No risk model or risk score exists for predicting in-hospital/30-day mortality for percutaneous coronary interventions (PCIs) using contemporary data. This study develops an updated risk model and simplified risk score for in-hospital/30-day mortality following PCI. To accomplish this, New York's Percutaneous Coronary Intervention Reporting System was used to develop a logistic regression model and a simplified risk score model for predicting in-hospital/30-day mortality and to validate both models based on New York data from the previous year. A total of 54,770 PCI patients from 2019 were used to develop the models. Twelve different risk factors and 27 risk factor categories were used in the models. Both models displayed excellent discrimination for the development and validation samples (range from 0.894 to 0.896) and acceptable calibration, but the full logistic model had superior calibration, particularly among higher-risk patients. In conclusion, both the PCI risk model and its simplified risk score model provide excellent discrimination and although the full risk model requires the use of a hand-held device for estimating individual patient risk, it provides somewhat better calibration, especially among higher-risk patients.

Race-Based Differences in ST-Segment-Elevation Myocardial Infarction Process Metrics and Mortality From 2015 Through 2021: An Analysis of 178 062 Patients From the American Heart Association Get With The Guidelines-Coronary Artery Disease Registry.

BACKGROUND: Systems of care have been developed across the United States to standardize care processes and improve outcomes in patients with ST-segment-elevation myocardial infarction (STEMI). The effect of contemporary STEMI systems of care on racial and ethnic disparities in achievement of time-to-treatment goals and mortality in STEMI is uncertain. METHODS: We analyzed 178 062 patients with STEMI (52 293 women and 125 769 men) enrolled in the American Heart Association Get With The Guidelines-Coronary Artery Disease registry between January 1, 2015, and December 31, 2021. Patients were stratified into and outcomes compared among 3 racial and ethnic groups: non-Hispanic White, Hispanic White, and Black. The primary outcomes were the proportions of patients achieving the following STEMI process metrics: prehospital ECG obtained by emergency medical services; hospital arrival to ECG obtained within 10 minutes for patients not transported by emergency medical services; arrival-to-percutaneous coronary intervention time within 90 minutes; and first medical contact-to-device time within 90 minutes. A secondary outcome was in-hospital mortality. Analyses were performed separately in women and men, and all outcomes were adjusted for age, comorbidities, acuity of presentation, insurance status, and socioeconomic status measured by social vulnerability index based on patients' county of residence. RESULTS: Compared with non-Hispanic White patients with STEMI, Hispanic White patients and Black patients had lower odds of receiving a prehospital ECG and achieving targets for door-to-ECG, door-to-device, and first medical contact-to-device times. These racial disparities in treatment goals were observed in both women and men, and persisted in most cases after multivariable adjustment. Compared with non-Hispanic White women, Hispanic White women had higher adjusted in-hospital mortality (odds ratio, 1.39 [95% CI, 1.12-1.72]), whereas Black women did not (odds ratio, 0.88 [95% CI, 0.74-1.03]). Compared with non-Hispanic White men, adjusted in-hospital mortality was similar in Hispanic White men (odds ratio, 0.99 [95% CI, 0.82-1.18]) and Black men (odds ratio, 0.96 [95% CI, 0.85-1.09]). CONCLUSIONS: Race- or ethnicity-based disparities persist in STEMI process metrics in both women and men, and mortality differences are observed in Hispanic White compared with non-Hispanic White women. Further research is essential to evolve systems of care to mitigate racial differences in STEMI outcomes.

Ad Hoc Percutaneous Coronary Intervention in Stable Patients With Multivessel or Unprotected Left Main Disease.

BACKGROUND: There is very little information about the use of ad hoc percutaneous coronary intervention (PCI) in stable patients with multivessel (MV) disease or unprotected left main (LM) disease patients for whom a heart team approach is recommended. OBJECTIVE: To identify the extent of ad hoc PCI utilization for patients with multivessel disease or left main disease, and to explore the inter-hospital variation in ad hoc PCI utilization for those patients. METHODS: New York State's cardiac registries were used to examine the use and variation in use of ad hoc PCI for MV/LM disease as a percentage of all MV/LM PCIs and revascularizations (PCIs plus coronary artery bypass graft procedures) during 2018 to 2019 in New York. RESULTS: After exclusions, 6,425 of the 8,196 stable PCI patients with MV/LM disease (78.4%) underwent ad hoc PCI, ranging from 58.7% for patients with unprotected LM disease to 85.4% for patients with 2-vessel proximal left anterior descending (PLAD) disease. Ad hoc PCIs comprised 35.1% of all revascularizations, ranging from 11.5% for patients with unprotected LM disease to 63.9% for patients with 2-vessel PLAD disease. The risk-adjusted utilization of ad hoc PCI as a percentage of all revascularizations varied widely among hospitals (eg, from 15% in the first quartile to 46% in the last quartile for 3-vessel disease). CONCLUSIONS: Ad hoc PCIs occur frequently even among patients with MV/LM disease. This is particularly true among patients with 2-vessel PLAD disease. The frequency of ad hoc PCIs is lower but still high among patients with diabetes and low ejection fraction and higher in hospitals without surgery on-site (SOS). Given the magnitude of hospital- and physician-level variation in the use of ad hoc PCIs for such patients, consideration should be given to a systems approach to achieving heart team consultation and shared decision making that is consistent for SOS and non-SOS hospitals.

Impact of COVID-19 on percutaneous coronary intervention utilization and mortality in New York.

BACKGROUND: COVID-19 has disrupted the care of all patients, and little is known about its impact on the utilization and short-term mortality of percutaneous coronary intervention (PCI) patients, particularly nonemergency patients. METHODS: New York State's PCI registry was used to study the utilization of PCI and the presence of COVID-19 in four patient subgroups ranging in severity from ST-elevation myocardial infarction (STEMI) to elective patients before (December 01, 2018-February 29, 2020) and during the COVID-19 era (March 01, 2020-May 31, 2021), as well as to examine the impact of different COVID severity levels on the mortality of different types of PCI patients. RESULTS: Decreases in the mean quarterly PCI volume from the prepandemic period to the first quarter of the pandemic ranged from 20% for STEMI patients to 61% for elective patients, with the other two subgroups having decreases in between these values. PCI quarterly volume rebounds from the prepandemic period to the second quarter of 2021 were in excess of 90% for all patient subgroups, and 99.7% for elective patients. Existing COVID-19 was rare among PCI patients, ranging from 1.74% for STEMI patients to 3.66% for elective patients. PCI patients with COVID-19 and acute respiratory distress syndrome (ARDS) who were not intubated, and PCI patients with COVID-19 and ARDS who were either intubated or were not intubated because of Do Not Resuscitate//Do Not Intubate status had higher risk-adjusted mortality ([adjusted ORs = 10.81 [4.39, 26.63] and 24.53 [12.06, 49.88], respectively]) than patients who never had COVID-19. CONCLUSIONS: There were large decreases in the utilization of PCI during COVID-19, with the percentage of decrease being highly sensitive to patient acuity. By the second quarter of 2021, prepandemic volumes were nearly restored for all patient subgroups. Very few PCI patients had current COVID-19 throughout the pandemic period, but the number of PCI patients with a COVID-19 history increased steadily during the pandemic. PCI patients with COVID-19 accompanied by ARDS were at much higher risk of short-term mortality than patients who never had COVID-19. COVID-19 without ARDS and history of COVID-19 were not associated with higher mortality for PCI patients as of the second quarter of 2021.

Treatment Time and In-Hospital Mortality Among Patients With ST-Segment Elevation Myocardial Infarction, 2018-2021.

Importance: Recognizing the association between timely treatment and less myocardial injury for patients with ST-segment elevation myocardial infarction (STEMI), US national guidelines recommend specific treatment-time goals. Objective: To describe these process measures and outcomes for a recent cohort of patients. Design, Setting, and Participants: Cross-sectional study of a diagnosis-based registry between the second quarter of 2018 and the third quarter of 2021 for 114 871 patients with STEMI treated at 648 hospitals in the Get With The Guidelines-Coronary Artery Disease registry. Exposures: STEMI or STEMI equivalent. Main Outcomes and Measures: Treatment times, in-hospital mortality, and adherence to system goals (75% treated ≤90 minutes of first medical contact if the first hospital is percutaneous coronary intervention [PCI]-capable and ≤120 minutes if patients require transfer to a PCI-capable hospital). Results: In the study population, median age was 63 (IQR, 54-72) years, 71% were men, and 29% were women. Median time from symptom onset to PCI was 148 minutes (IQR, 111-226) for patients presenting to PCI-capable hospitals by emergency medical service, 195 minutes (IQR, 127-349) for patients walking in, and 240 minutes (IQR, 166-402) for patients transferred from another hospital. Adjusted in-hospital mortality was lower for those treated within target times vs beyond time goals for patients transported via emergency medical services (first medical contact to laboratory activation ≤20 minutes [in-hospital mortality, 3.6 vs 9.2] adjusted OR, 0.54 [95% CI, 0.48-0.60], and first medical contact to device ≤90 minutes [in-hospital mortality, 3.3 vs 12.1] adjusted OR, 0.40 [95% CI, 0.36-0.44]), walk-in patients (hospital arrival to device ≤90 minutes [in-hospital mortality, 1.8 vs 4.7] adjusted OR, 0.47 [95% CI, 0.40-0.55]), and transferred patients (door-in to door-out time <30 minutes [in-hospital mortality, 2.9 vs 6.4] adjusted OR, 0.51 [95% CI, 0.32-0.78], and first hospital arrival to device ≤120 minutes [in-hospital mortality, 4.3 vs 14.2] adjusted OR, 0.44 [95% CI, 0.26-0.71]). Regardless of mode of presentation, system goals were not met in most quarters, with the most delayed system performance among patients requiring interhospital transfer (17% treated ≤120 minutes). Conclusions and Relevance: This study of patients with STEMI included in a US national registry provides information on changes in process and outcomes between 2018 and 2021.

Emergency Interhospital Transfer of Patients With ST-Segment-Elevation Myocardial Infarction: Call 9-1-1-The American Heart Association Mission: Lifeline Program.

The American Heart Association Mission: Lifeline program objectives are to improve the quality of care and outcomes for patients with ST-segment-elevation myocardial infarction. Every minute of delay in treatment adversely affects 1-year mortality. Transfer of patients safely and timely to hospitals with primary percutaneous coronary intervention capability is needed to improve outcomes. But treatment times continue to show delays, especially during interhospital transfers. A simple 3-step process of an interhospital "Call 9-1-1" protocol may expedite this process. This STAT TRANSFER process uses a systems approach that considers diverse ways in which patients access care, how EMS responds and determines destinations, how referring hospital transfers are performed, urban and rural differences, and how receiving hospitals prepare for an incoming patient with ST-segment-elevation myocardial infarction. This initiative suggests a strategy to reduce variability in interhospital transfer times using a STAT TRANSFER and a Call 9-1-1 process in a system of care that involves all stakeholders.

Percutaneous Coronary Intervention With and Without Intravascular Ultrasound for Patients With Complex Lesions: Utilization, Mortality, and Target Vessel Revascularization.

BACKGROUND: Intravascular ultrasound (IVUS) has several benefits during percutaneous coronary interventions (PCIs), including more accurate vessel sizing, improved stent expansion, and better strut apposition. Prior clinical trials have demonstrated a reduction in cardiac events when IVUS is used. However, there is limited information about the utilization of IVUS and the outcomes of IVUS-guided versus angiography-guided PCI in patients with complex lesions in a contemporary population-based setting. METHODS: New York's PCI registry was used to identify 44 305 patients with complex lesions (lesions that complicate stenting or that require multiple stents) undergoing PCI with and without IVUS guidance and discharged between December 1, 2013 and November 30, 2018. Trends and inter-hospital variation in IVUS use were examined. Risk-adjusted mortality and target vessel revascularization were compared. RESULTS: A total of 6174 (13.9%) PCI patients underwent IVUS-guided PCI. The median follow-up period was 2.5 years. The percent of patients with complex lesions who underwent IVUS-guided PCI rose from 13.4% in 2014 to 16.5% in 2018 (P<0.0001 for trend), with the main increases occurring in the last 2 years of the period. Only 31 of 66 hospitals in the study used IVUS for >5% of their study patients. IVUS-guided PCI patients experienced significantly lower mortality (adjusted hazard ratio=0.89 [0.79-0.98] after adjustment using a Cox proportional hazards model, and HR=0.88 [0.78-0.99] for propensity-matched patients). We also found that IVUS-guided PCI patients had a lower rate of target vessel revascularization (adjusted hazard ratio=0.88 [0.80-0.97]) after adjusting using Cox proportional hazards with competing risk of mortality and after propensity matching (0.88 [0.79-0.99]). CONCLUSIONS: Utilization of IVUS for complex lesions has increased but contemporary rates remain low, and there are large inter-hospital variations. The use of IVUS for complex lesions was associated with lower risk of medium-term mortality and target vessel revascularization.

Relation of Operator Volume and Access Site to Short-Term Mortality in Radial Versus Femoral Access for Primary Percutaneous Coronary Intervention.

The relation between operator volume and mortality of primary percutaneous coronary intervention (PPCI) procedures for ST-elevation myocardial infarction has not been studied comprehensively. This study included patients who underwent PPCI between 2010 and 2017 in all nonfederal hospitals approved to perform PCI in New York State. We compared risk-adjusted in-hospital/30-day mortality for radial access (RA) and femoral access (FA) and the relation between risk-adjusted mortality and procedure volume for each access site. In 44,540 patients in the study period, the use of RA rose from 8% in 2,010% to 43% in 2017 (p <0.0001). There was no significant change in PPCI risk-adjusted mortality during the period (p=0.27 for trend). RA was associated with lower mortality when imposing operator exclusion criteria used in recent trials. There was a significant operator inverse volume-mortality relation for FA procedures but not for RA procedures. FA procedures performed by lower volume FA operators (lowest quartile) were associated with higher risk-adjusted mortality compared with RA procedures (3.71% vs 3.06%, p = 0.01) or compared with FA procedures performed by higher volume FA operators (3.71% vs 3.16%, p = 0.01). In conclusion, in patients with ST-elevation myocardial infarction referred for primary PCI in New York State, there was a significant uptake in the use of RA along with relatively constant in-hospital/30-day mortality. There was a significant inverse operator volume-mortality relation for FA procedures accompanied by higher mortality for FA procedures performed by low volume FA operators than for all other primary PCI procedures. In conclusion, this information underscores the need for operators to remain vigilant in maintaining FA skills and monitoring FA outcomes.

The challenges of data safety monitoring for a pragmatic study: Lessons from the ADAPTABLE study.

Data monitoring committees (DMCs) play a critical role in protecting the safety of participants and integrity of clinical studies. While there are well-established DMC guidelines for traditional, randomized controlled trials, the clinical trial community is still in the search for best practices in data and safety monitoring in pragmatic clinical trials. ADAPTABLE was a large, open label, pragmatic, randomized controlled trial, harnessing real world data from multiple sources and studying the comparative effectiveness of the two most common dosages of aspirin in patients with atherosclerotic cardiovascular disease. Specific issues arose in ADAPTABLE such as data quality, information latency, and protocol adherence, and these issues were both expected and unexpected features of the pragmatic study design. These issues imposed great challenges to the DMC members who were tasked to make critical decisions during the study. This article summarizes the unique experience of the ADAPTABLE DMC, including the internal debates and concerns, the concerted efforts to accomplish its mission, and the special contribution of the patient representatives. We also offer recommendations on data and safety monitoring for future pragmatic trials.

The Association of Socioeconomic Factors With Percutaneous Coronary Intervention Outcomes.

BACKGROUND: Numerous studies have identified the association of socioeconomic factors with outcomes of cardiac surgical procedures. Most have focused on easily measured demographic factors or on socioeconomic characteristics of patients' 5-digit zip codes. The impact of socioeconomic information that is derived from smaller geographic regions has rarely been studied. METHODS: The association of the Area Deprivation Index (ADI) with short-term mortality and readmissions was tested for patients undergoing percutaneous coronary intervention (PCI) in New York while adjusting for numerous patient risk factors, including race, ethnicity, and payer. Changes in hospitals' risk-adjusted outcomes and outlier status with the addition of socioeconomic factors were examined. RESULTS: After adjustment, patients in the 2 most deprived ADI quintiles were more likely to experience in-hospital and 30-day mortality after PCI (adjusted odds ratios [95% confidence intervals] 1.39 [1.18-1.65] and 1.24 [1.03-1.49], respectively), than patients in the first quintile (least deprived). Also, patients in the second and fifth ADI quintiles had higher 30-day readmissions rates than patients in the first quintile (1.12 [1.01-1.25] and 1.17 [1.04-1.32], respectively). Medicare patients had higher mortality and readmission rates, Hispanics had lower mortality, and Medicaid patients had higher readmission rates. CONCLUSIONS: Patients with the most deprived ADIs are more likely to experience short-term mortality and readmissions after PCI. Ethnicity and payer are significantly associated with adverse outcomes even after adjusting for ADI. This information should be considered when identifying patients who are at the highest risk for adverse events after PCI and when risk-adjusting hospital outcomes and assessing quality of care.

Systems of Care for ST-Segment-Elevation Myocardial Infarction: A Policy Statement From the American Heart Association.

The introduction of Mission: Lifeline significantly increased timely access to percutaneous coronary intervention for patients with ST-segment-elevation myocardial infarction (STEMI). In the years since, morbidity and mortality rates have declined, and research has led to significant developments that have broadened our concept of the STEMI system of care. However, significant barriers and opportunities remain. From community education to 9-1-1 activation and emergency medical services triage and from emergency department and interfacility transfer protocols to postacute care, each critical juncture presents unique challenges for the optimal care of patients with STEMI. This policy statement sets forth recommendations for how the ideal STEMI system of care should be designed and implemented to ensure that patients with STEMI receive the best evidence-based care at each stage in their illness.

Hybrid coronary revascularization vs. percutaneous coronary interventions for multivessel coronary artery disease.

OBJECTIVE: Hybrid coronary revascularization (HCR) combines a minimally invasive surgical approach to the left anterior descending (LAD) artery with percutaneous coronary intervention (PCI) for non-LAD diseased coronary arteries. It is associated with shorter hospital lengths of stay and recovery times than conventional coronary artery bypass surgery, but there is little information comparing it to isolated PCI for multivessel disease. Our objective is to compare long-term outcomes of HCR and PCI for patients with multivessel disease. METHODS: This cohort study used data from New York's cardiac surgery and PCI registries in 2010-2016 to examine mortality and repeat revascularization rates for patients with multivessel coronary artery disease who underwent HCR and PCI. Cox proportional hazards methods were used to reduce selection bias. Patients were followed for a median of four years. RESULTS: There was a total of 335 HCR patients (1.2%) and 25,557 PCI patients (98.8%) after exclusions. There was no difference in 6-year risk adjusted survival between HCR and PCI patients (83.17% vs. 81.65%, adjusted hazard ratio (aHR) = 0.90 (95% CI: 0.67-1.20). However, HCR patients were more likely to be free from repeat revascularization in the LAD artery (91.13% vs. 83.59%, aHR = 0.51 (95% CI: 0.34-0.77)). CONCLUSIONS: For patients with multi-vessel coronary artery disease, HCR is rarely performed. There are no differences in mortality rates after four years, but HCR is associated with lower repeat revascularization rates in the LAD artery, presumably due to better longevity in left arterial mammary grafts.

Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction Before and During COVID in New York.

Little is known about regional differences in volume, treatment, and outcomes of STEMI patients undergoing PCI during the pandemic. The objectives of this study were to compare COVID-19 pandemic and prepandemic periods with respect to regional volumes, outcomes, and treatment of patients undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) between January 1, 2019 and March 14, 2020 (pre-COVID period) and between March 15, 2020 and April 4, 2020 (COVID period) in 51 New York State hospitals certified to perform PCI. The hospitals were classified as being in either high-density or low-density COVID-19 counties on the basis of deaths/10,000 population. There was a decrease of 43% in procedures/week in high-density COVID-19 counties (p <0.0001) and only 4% in low-density counties (p = 0.64). There was no difference in the change in risk-adjusted in-hospital mortality rates in either type of county, but STEMI PCI patients in high-density counties had longer times from symptom onset to hospital arrival and lower cardiac arrest rates in the pandemic period. In conclusion, the decrease in STEMI PCIs during the pandemic was mainly limited to counties with a high density of COVID-19 deaths. The decrease appears to be primarily related to patients not presenting to hospitals in high-density COVID regions, rather than PCI being avoided in STEMI patients or a reduction in the incidence of STEMI. Also, high-density COVID-19 counties experienced delayed admissions and less severely ill STEMI PCI patients during the pandemic. This information can serve to focus efforts on convincing STEMI patients to seek life-saving hospital care during the pandemic.