Artificial Intelligence in Cardiovascular Care - Part 2: Applications: JACC Review Topic of the Week.

Recent Artificial Intelligence (AI) advancements in cardiovascular care offer potential enhancements in effective diagnosis, treatment, and outcomes. Over 600 Food and Drug Administration (FDA)-approved clinical AI algorithms now exist, with 10% focusing on cardiovascular applications, highlighting the growing opportunities for AI to augment care. This review discusses the latest advancements in the field of AI, with a particular focus on the utilization of multimodal inputs and the field of generative AI. Further discussions in this review involve an approach to understanding the larger context in which AI-augmented care may exist, and include a discussion of the need for rigorous evaluation, appropriate infrastructure for deployment, ethics and equity assessments, regulatory oversight, and viable business cases for deployment. Embracing this rapidly evolving technology while setting an appropriately high evaluation benchmark with careful and patient-centered implementation will be crucial for cardiology to leverage AI to enhance patient care and the provider experience.

Artificial Intelligence for Cardiovascular Care - Part 1: Advances: JACC Review Topic of the Week.

Recent AI advancements in cardiovascular care offer potential enhancements in diagnosis, treatment, and outcomes. Innovations to date focus on automating measurements, enhancing image quality, and detecting diseases using novel methods. Applications span wearables, electrocardiograms, echocardiography, angiography, genetics, and more. AI models detect diseases from electrocardiograms at accuracy not previously achieved by technology or human experts, including reduced ejection fraction, valvular heart disease, and other cardiomyopathies. However, AI's unique characteristics necessitates rigorous validation by addressing training methods, real-world efficacy, equity concerns, and long-term reliability. Despite an exponentially growing number of studies in cardiovascular AI, trials showing improvement in outcomes remain lacking. A number are currently underway. Embracing this rapidly evolving technology while setting a high evaluation benchmark will be crucial for cardiology to leverage AI to enhance patient care and the provider experience.

Post-hospitalization remote monitoring for patients with heart failure or chronic obstructive pulmonary disease in an accountable care organization.

BACKGROUND: Post-hospitalization remote patient monitoring (RPM) has potential to improve health outcomes for high-risk patients with chronic medical conditions. The purpose of this study is to determine the extent to which RPM for patients with congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) is associated with reductions in post-hospitalization mortality, hospital readmission, and ED visits within an Accountable Care Organization (ACO). METHODS: Nonrandomized prospective study of patients in an ACO offered enrollment in RPM upon hospital discharge between February 2021 and December 2021. RPM comprised of vital sign monitoring equipment (blood pressure monitor, scale, pulse oximeter), tablet device with symptom tracking software and educational material, and nurse-provided oversight and triage. Expected enrollment was for at least 30-days of monitoring, and outcomes were followed for 6 months following enrollment. The co-primary outcomes were (a) the composite of death, hospital admission, or emergency care visit within 180 days of eligibility, and (b) time to occurrence of this composite. Secondary outcomes were each component individually, the composite of death or hospital admission, and outpatient office visits. Adjusted analyses involved doubly robust estimation to address confounding by indication. RESULTS: Of 361 patients offered remote monitoring (251 with CHF and 110 with COPD), 140 elected to enroll (106 with CHF and 34 with COPD). The median duration of RPM-enrollment was 54 days (IQR 34-85). Neither the 6-month frequency of the co-primary composite outcome (59% vs 66%, FDR p-value = 0.47) nor the time to this composite (median 29 vs 38 days, FDR p-value = 0.60) differed between the groups, but 6-month mortality was lower in the RPM group (6.4% vs 17%, FDR p-value = 0.02). After adjustment for confounders, RPM enrollment was associated with nonsignificantly decreased odds for the composite outcome (adjusted OR [aOR] 0.68, 99% CI 0.25-1.34, FDR p-value 0.30) and lower 6-month mortality (aOR 0.41, 99% CI 0.00-0.86, FDR p-value 0.20). CONCLUSIONS: RPM enrollment may be associated with improved health outcomes, including 6-month mortality, for selected patient populations.

CYP2C19 Polymorphisms and Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) in the Million Veterans Program.

Background: CYP2C19 loss-of-function (LOF) alleles decrease the antiplatelet effect of clopidogrel following percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndrome (ACS). The impact of genotype in stable ischemic heart disease (SIHD) is unclear. Objectives: Determine the association of CYP2C19 genotype with major adverse cardiac events (MACE) after PCI for ACS or SIHD. Methods: Million Veterans Program (MVP) participants age <65 years with a PCI documented in the VA Clinical Assessment, Reporting and Tracking (CART) Program between 1/1/2009 to 9/30/2017, treated with clopidogrel were included. Time to MACE defined as the composite of all-cause death, stroke or myocardial infarction within 12 months following PCI. Results: Among 4,461 Veterans (mean age 59.1 ± 5.1 years, 18% Black); 44% had ACS, 56% had SIHD and 29% carried a CYP2C19 LOF allele. 301 patients (6.7%) experienced MACE while being treated with clopidogrel, 155 (7.9%) in the ACS group and 146 (5.9%) in the SIHD group. Overall, MACE was not significantly different between LOF carriers vs. noncarriers (adjusted hazard ratio [HR] 1.18, confidence interval [95%CI] 0.97-1.45, p=0.096). Among patients presenting with ACS, MACE risk in LOF carriers versus non-carriers was numerically higher (HR 1.30, 95%CI 0.98-1.73, p=0.067). There was no difference in MACE risk in patients with SIHD (HR 1.09, 95%CI 0.82-1.44; p=0.565). Conclusions: CYP2C19 LOF carriers presenting with ACS treated with clopidogrel following PCI experienced a numerically greater elevated risk of MACE events. CYP2C19 LOF genotype is not associated with MACE among patients presenting with SIHD.

ACC/AHA Hypertension Guidelines and CHA2DS2-VASc Up-Scoring in Patients With Atrial Fibrillation.

This cohort study compares rates of hypertension among nonhypertensive patients with atrial fibrillation using JNC 8 vs ACC/AHA thresholds.

Clinician Perspectives on Barriers and Enablers to Implementing an Inpatient Oncology Early Warning System: A Mixed-Methods Study.

PURPOSE: To elicit end-user and stakeholder perceptions regarding design and implementation of an inpatient clinical deterioration early warning system (EWS) for oncology patients to better fit routine clinical practices and enhance clinical impact. METHODS: In an explanatory-sequential mixed-methods study, we evaluated a stakeholder-informed oncology early warning system (OncEWS) using surveys and semistructured interviews. Stakeholders were physicians, advanced practice providers (APPs), and nurses. For qualitative data, we used grounded theory and thematic content analysis via the constant comparative method to identify determinants of OncEWS implementation. RESULTS: Survey respondents generally agreed that an oncology-focused EWS could add value beyond clinical judgment, with nurses endorsing this notion significantly more strongly than other clinicians (nurse: median 5 on a 6-point scale [6 = strongly agree], interquartile range 4-5; doctors/advanced practice providers: 4 [4-5]; P = .005). However, some respondents would not trust an EWS to identify risk accurately (n = 36 [42%] somewhat or very concerned), while others were concerned that institutional culture would not embrace such an EWS (n = 17 [28%]).Interviews highlighted important aspects of the EWS and the local context that might facilitate implementation, including (1) a model tailored to the subtleties of oncology patients, (2) transparent model information, and (3) nursing-centric workflows. Interviewees raised the importance of sepsis as a common and high-risk deterioration syndrome. CONCLUSION: Stakeholders prioritized maximizing the degree to which the OncEWS is understandable, informative, actionable, and workflow-complementary, and perceived these factors to be key for translation into clinical benefit.

Comparison of Characteristics and Outcomes of Veterans With Stable Ischemic Heart Disease Enrolled in the COURAGE Trial Versus the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Randomized clinical trials have not demonstrated a survival benefit with percutaneous coronary intervention in stable ischemic heart disease (SIHD). We evaluated the generalizability of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial findings to the broader population of veterans with SIHD. Veterans who underwent coronary angiography between 2005 and 2013 for SIHD were identified from the Veterans Affairs Clinical Assessment, Reporting and Tracking Program (VA CART). Patient-level comparisons were made between patients from VA CART who met the eligibility criteria for COURAGE and veterans enrolled in COURAGE between 1999 and 2004. All-cause mortality over long-term follow-up was assessed using Cox proportional hazards models. COURAGE-eligible patients from VA CART (n = 59,758) were older, had a higher body mass index, a greater prevalence of co-morbidities, but fewer diseased vessels on index coronary angiography, and were less likely to be on optimal medical therapy at baseline and on 1-year follow-up compared with VA COURAGE participants (n = 968). Patients from VA CART (median follow-up 6.5 years) had higher all-cause mortality (adjusted hazard ratio [aHR] 1.98 [1.61 to 2.43]) than participants from VA COURAGE (median follow-up: 4.6 years). Risks of mortality were greater in the 56.4% patients from CART who were medically managed (aHR 1.94 [1.49 to 2.53]) and in the 43.6% who underwent percutaneous coronary intervention (aHR 1.99 [1.45 to 2.74]), compared with their respective VA COURAGE arms. In conclusion, in this noncontemporaneous patient-level analysis, veterans in the randomized COURAGE trial had more favorable outcomes than the population of veterans with SIHD at large.

Large-scale genome-wide association study of coronary artery disease in genetically diverse populations.

We report a genome-wide association study (GWAS) of coronary artery disease (CAD) incorporating nearly a quarter of a million cases, in which existing studies are integrated with data from cohorts of white, Black and Hispanic individuals from the Million Veteran Program. We document near equivalent heritability of CAD across multiple ancestral groups, identify 95 novel loci, including nine on the X chromosome, detect eight loci of genome-wide significance in Black and Hispanic individuals, and demonstrate that two common haplotypes at the 9p21 locus are responsible for risk stratification in all populations except those of African origin, in which these haplotypes are virtually absent. Moreover, in the largest GWAS for angiographically derived coronary atherosclerosis performed to date, we find 15 loci of genome-wide significance that robustly overlap with established loci for clinical CAD. Phenome-wide association analyses of novel loci and polygenic risk scores (PRSs) augment signals related to insulin resistance, extend pleiotropic associations of these loci to include smoking and family history, and precisely document the markedly reduced transferability of existing PRSs to Black individuals. Downstream integrative analyses reinforce the critical roles of vascular endothelial, fibroblast, and smooth muscle cells in CAD susceptibility, but also point to a shared biology between atherosclerosis and oncogenesis. This study highlights the value of diverse populations in further characterizing the genetic architecture of CAD.

FAST: A Framework to Assess Speed of Translation of Health Innovations to Practice and Policy.

The 17-year time span between discovery and application of evidence in practice has become a unifying challenge for implementation science and translational science more broadly. Further, global pandemics and social crises demand timely implementation of rapidly accruing evidence to reduce morbidity and mortality. Yet speed remains an understudied metric in implementation science. Prevailing evaluations of implementation lack a temporal aspect, and current approaches have not yielded rapid implementation. In this paper, we address speed as an important conceptual and methodological gap in implementation science. We aim to untangle the complexities of studying implementation speed, offer a framework to assess speed of translation (FAST), and provide guidance to measure speed in evaluating implementation. To facilitate specification and reporting on metrics of speed, we encourage consideration of stakeholder perspectives (e.g., comparison of varying priorities), referents (e.g., speed in attaining outcomes, transitioning between implementation phases), and observation windows (e.g., time from intervention development to first patient treated) in its measurement. The FAST framework identifies factors that may influence speed of implementation and potential effects of implementation speed. We propose a research agenda to advance understanding of the pace of implementation, including identifying accelerators and inhibitors to speed.

Potential Impact of 2017 American College of Cardiology/American Heart Association Hypertension Guideline on Contemporary Practice: A Cross-Sectional Analysis From NCDR PINNACLE Registry.

Background Clinical implications of change in the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) guideline on the diagnosis and management of hypertension, compared with recommendations by 2014 expert panel and Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7), are not known. Methods and Results Using data from the NCDR (National Cardiovascular Data Registry) PINNACLE (Practice Innovation and Clinical Excellence) Registry (January 2013-Decemver 2016), we compared the proportion and clinical characteristics of patients seen in cardiology practices diagnosed with hypertension, recommended antihypertensive treatment, and achieving blood pressure (BP) goals per each guideline document. In addition, we evaluated the proportion of patients at the level of practices meeting BP targets defined by each guideline. Of 6 042 630 patients evaluated, 5 027 961 (83.2%) were diagnosed with hypertension per the 2017 ACC/AHA guideline, compared with 4 521 272 (74.8%) per the 2014 panel and 4 545 976 (75.2%) per JNC7. The largest increase in hypertension prevalence was seen in younger ages, women, and those with lower cardiovascular risk. Antihypertensive medication was recommended to 70.6% of patients per the ACC/AHA guideline compared with 61.8% and 65.9% per the 2014 panel and JNC7, respectively. Among those on antihypertensive agents, 41.2% achieved BP targets per the ACC/AHA guideline, compared with 79.4% per the 2014 panel and 64.3% per JNC7. Lower proportions of women, non-White (Black and "other") races, and those at higher cardiovascular risk achieved BP goals. Median practice-level proportion of patients meeting BP targets per the 2014 panel but not the ACC/AHA guideline was 37.8% (interquartile range, 34.8%-40.7%) and per JNC7 but not the ACC/AHA guideline was 22.9% (interquartile range, 19.8%-25.9%). Conclusions Following publication of the 2017 guideline, significantly more people, particularly younger people and those with lower cardiovascular risk, will be diagnosed with hypertension and need antihypertensive treatment compared with previous recommendations. Significant practice-level variation in BP control also exists. Efforts are needed to improve guideline-concordant hypertension management in an effort to improve outcomes.

Outcomes of in-hospital cardiac arrest among hospitals with and without telemedicine critical care.

BACKGROUND: Survival rates following in-hospital cardiac arrest (IHCA) are lower during nights and weekends (off-hours), as compared to daytime on weekdays (on-hours). Telemedicine Critical Care (TCC) may provide clinical support to improve IHCA outcomes, particularly during off-hours. OBJECTIVE: To evaluate the association between hospital availability of TCC and IHCA survival. METHODS: We identified 44,585 adults at 280 U.S. hospitals in the Get With The Guidelines® - Resuscitation registry who suffered IHCA in an Intensive Care Unit (ICU) or hospital ward between July 2017 and December 2019. We used 2-level hierarchical multivariable logistic regression to investigate whether TCC availability was associated with better survival, overall, and during on-hours (Monday-Friday 7:00 a.m.-10:59p.m.) vs. off-hours (Monday-Friday 11:00p.m.-6:59 a.m., and Saturday-Sunday, all day, and US national holidays). RESULTS: 14,373 (32.2%) participants suffered IHCA at hospitals with TCC, and 27,032 (60.6%) occurred in an ICU. There was no difference between TCC and non-TCC hospitals in acute resuscitation survival rate or survival to discharge rates for either IHCA occurring in the ICU (acute survival odds ratio [OR] 1.02, 95% CI 0.92-1.15; survival to discharge OR 0.94 [0.83-1.07]) or outside of the ICU (acute survival OR 1.03 [0.91-1.17]; survival to discharge OR 0.99 [0.86-1.12]. Timing of cardiac arrest did not modify the association between TCC availability and acute resuscitation survival (P =.37 for interaction) or survival to discharge (P =.39 for interaction). CONCLUSIONS: Hospital availability of TCC was not associated with improved outcomes for in-hospital cardiac arrest.

Reducing Cardiovascular Risk in the Medicare Million Hearts Risk Reduction Model: Insights From the National Cardiovascular Data Registry PINNACLE Registry.

BACKGROUND: The Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high-risk (ASCVD ≥30%) Medicare patients. To estimate average practice-level ASCVD risk reduction, we applied optimal trial outcomes to a real-world population with high ASCVD risk. METHODS: This study uses observational registry data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence Registry from January 2013 to June 2016. We modeled ASCVD risk reductions using historical clinical trial data (reducing cholesterol by 26.5%, reducing systolic blood pressure by 10.9%, reducing smoking rates by 21.8%) the average reduction in ASCVD risk associated with individual and combined risk factor modifications, and then percentage of practices achieving the various incentive thresholds for the Million Hearts Model. RESULTS: The final study population included 135 166 patients, with 16 248 (12.0%) with 10-year ASCVD risk of ≥30%, but without existing ASCVD. The mean 10-year ASCVD risk was 41.9% (±1 SD of 11.6). Using risk factor reductions from clinical trials, lowering cholesterol, blood pressure, and smoking rates reduced 10-year ASCVD risk by 3.3% (±3.1), 6.3% (±1.1) and 0.5% (±1.3), respectively. Combining all 3 reductions resulted in a 9.7% (±3.6) reduction, with 67 (27.0%) of practices achieving a patient-level average 10-year ASCVD risk reduction of ≥10%, 181 (73.0%) achieving a 2 to 10% reduction, and no practice achieving <2% reduction. CONCLUSIONS: In cardiology practices, about 1 out of 8 patients have a 10-year ASCVD risk ≥30% and qualify as high risk in the Million Hearts Model. If practices target the three main modifiable risk factors and achieve reductions similar to clinical trial results, ASCVD risk could be substantially lowered and all practices could receive incentive payments. These findings support the potential benefit of the Million Hearts Model and provide guidance to participating practices.

Impact of the COVID-19 Pandemic on Patients Without COVID-19 With Acute Myocardial Infarction and Heart Failure.

Background Excess mortality from cardiovascular disease during the COVID-19 pandemic has been reported. The mechanism is unclear but may include delay or deferral of care, or differential treatment during hospitalization because of strains on hospital capacity. Methods and Results We used emergency department and inpatient data from a 12-hospital health system to examine changes in volume, patient age and comorbidities, treatment (right- and left-heart catheterization), and outcomes for patients with acute myocardial infarction (AMI) and heart failure (HF) during the COVID-19 pandemic compared with pre-COVID-19 (2018 and 2019), controlling for seasonal variation. We analyzed 27 427 emergency department visits or hospitalizations. Patient volume decreased during COVID-19 for both HF and AMI, but age, race, sex, and medical comorbidities were similar before and during COVID-19 for both groups. Acuity increased for AMI as measured by the proportion of patients with ST-segment elevation. There were no differences in right-heart catheterization for patients with HF or in left heart catheterization for patients with AMI. In-hospital mortality increased for AMI during COVID-19 (odds ratio [OR], 1.46; 95% CI, 1.21-1.76), particularly among the ST-segment-elevation myocardial infarction subgroup (OR, 2.57; 95% CI, 2.24-2.96), but was unchanged for HF (OR, 1.02; 95% CI, 0.89-1.16). Conclusions Cardiovascular volume decreased during COVID-19. Despite similar patient age and comorbidities and in-hospital treatments during COVID-19, mortality increased for patients with AMI but not patients with HF. Given that AMI is a time-sensitive condition, delay or deferral of care rather than changes in hospital care delivery may have led to worse cardiovascular outcomes during COVID-19.

Potential Impact of the 2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease Recommendations on the Inappropriate Routine Use of Aspirin and Aspirin Use Without a Recommended Indication for Primary Prevention of Cardiovascular Disease in Cardiology Practices: Insights From the NCDR PINNACLE Registry.

BACKGROUND: Aspirin is recommended in patients with atherosclerotic cardiovascular disease for secondary prevention. In patients without atherosclerotic cardiovascular disease and not at high 10-year risk, there is no evidence aspirin reduces adverse cardiovascular events and it could increase bleeding. The 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease state that aspirin may be considered for primary prevention (class IIb) in patients 40 to 70 years that are at higher risk of atherosclerotic cardiovascular disease and that routine use of aspirin should be avoided (class III:Harm) for patients >70 years. We examined the frequency of patients on aspirin for primary prevention that would have been considered unindicated or potentially harmful per the recent guideline where aspirin discontinuation may be beneficial. METHODS: To assess the potential impact, within the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence Registry, we assessed 855 366 patients from 400 practices with encounters between January 1, 2018 and March 31, 2019, that were receiving aspirin for primary prevention. We defined inappropriate use as the use of aspirin in patients <40 or >70 years and use without a recommended indication as use of aspirin in patients 40 to 70 years with low, borderline, or intermediate 10-year atherosclerotic cardiovascular disease risk. Frequency of inappropriate use and use without a recommended indication were calculated and practice-level variation was evaluated using the median rate ratio. RESULTS: Inappropriate use occurred in 27.6% (193 674/701 975) and use without a recommended indication in 26.0% (31 810/122 507) with significant practice-level variation in inappropriate use (predicted median practice-level rate 33.5%, interquartile range, 24.1% to 40.8%; median rate ratio, 1.71 [95% CI, 1.67-1.76]). CONCLUSIONS: Immediately before the 2019 American College of Cardiology/American Heart Association Guidelines on Primary Prevention of Cardiovascular Disease, over one-fourth of patients in this national registry were receiving aspirin for primary prevention inappropriately or without a recommended indication with significant practice-level variation. These findings help to determine the potential impact of guideline recommendations on contemporary use of aspirin for primary prevention.

Association of Race and Neighborhood Disadvantage with Patient Engagement in a Home-Based COVID-19 Remote Monitoring Program.

BACKGROUND: COVID-positive outpatients may benefit from remote monitoring, but such a program often relies on smartphone apps. This may introduce racial and socio-economic barriers to participation. Offering multiple methods for participation may address these barriers. OBJECTIVES: (1) To examine associations of race and neighborhood disadvantage with patient retention in a monitoring program offering two participation methods. (2) To measure the association of the program with emergency department visits and hospital admissions. DESIGN: Retrospective propensity-matched cohort study. PARTICIPANTS: COVID-positive outpatients at a single university-affiliated healthcare system and propensity-matched controls. INTERVENTIONS: A home monitoring program providing daily symptom tracking via patient portal app or telephone calls. MAIN MEASURES: Among program enrollees, retention (until 14 days, symptom resolution, or hospital admission) by race and neighborhood disadvantage, with stratification by program arm. In enrollees versus matched controls, emergency department utilization and hospital admission within 30 days. KEY RESULTS: There were 7592 enrolled patients and 9710 matched controls. Black enrollees chose the telephone arm more frequently than White enrollees (68% versus 44%, p = 0.009), as did those from more versus less disadvantaged neighborhoods (59% versus 43%, p = 0.02). Retention was similar in Black enrollees and White enrollees (63% versus 62%, p = 0.76) and in more versus less disadvantaged neighborhoods (63% versus 62%, p = 0.44). When stratified by program arm, Black enrollees had lower retention than White enrollees in the app arm (49% versus 55%, p = 0.01), but not in the telephone arm (69% versus 71%, p = 0.12). Compared to controls, enrollees more frequently visited the emergency department (HR 1.71 [95% CI 1.56-1.87]) and were admitted to the hospital (HR 1.16 [95% CI 1.02-1.31]). CONCLUSIONS: In a COVID-19 remote patient monitoring program, Black enrollees preferentially selected, and had higher retention in, telephone- over app-based monitoring. As a result, overall retention was similar between races. Remote monitoring programs with multiple modes may reduce barriers to participation.

Cost and Value in Contemporary Heart Failure Clinical Guidance Documents.

OBJECTIVES: This study sought to evaluate the frequency and nature of cost/value statements in contemporary heart failure (HF) clinical guidance documents (CGDs). BACKGROUND: In an era of rising health care costs and expanding therapeutic options, there is an increasing need for formal consideration of cost and value in the development of HF CGDs. METHODS: HF CGDs published by major professional cardiovascular organizations between January 2010 and February 2021 were reviewed for the inclusion of cost/value statements. RESULTS: Overall, 33 documents were identified, including 5 (15%) appropriate use criteria, 7 (21%) clinical practice guidelines, and 21 (64%) expert consensus documents. Most CGDs (27 of 33; 82%) included at least 1 cost/value statement, and 20 (61%) CGDs included at least 1 cost/value-related citation. Most of these statements were found in expert consensus documents (77.7%). Three (9%) documents reported estimated costs of recommended interventions, but only 1 estimated out-of-pocket cost. Of 179 cost/value-related statements observed, 116 (64.8%) highlighted the economic impact of HF or HF-related care, 6 (3.4%) advocated for cost/value issues, 15 (8.4%) reported gaps in cost/value evidence, and 42 (23.5%) supported clinical guidance recommendations. Over time, patterns of inclusion of statements and citations of cost/value have been largely stable. CONCLUSIONS: Although most contemporary HF CGDs contain at least 1 cost/value statement, most CGDs focus on the high economic impact of HF and its related care; explicit inclusion of cost/value to support clinical guidance recommendations remains infrequent. These results highlight key opportunities for the integration of formalized cost/value considerations in future HF-focused CGDs.

Comparison of Patients Undergoing Percutaneous Coronary Intervention in Contemporary U.S. Practice With ISCHEMIA Trial Population.

OBJECTIVES: The study sought to assess the proportion of patients in modern U.S. interventional practice that fulfilled criteria for enrollment in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial. BACKGROUND: The ISCHEMIA trial, which enrolled patients with stable ischemic heart disease (SIHD), showed that revascularization improved angina symptoms with little effect on death or myocardial infarction. METHODS: A cross-sectional analysis of the National Cardiovascular Data Registry CathPCI Registry (v5.0), including 1,662 hospitals, was performed. Patients undergoing percutaneous coronary intervention (PCI) for SIHD in routine clinical practice meeting ISCHEMIA trial inclusion criteria and those that did not were evaluated. RESULTS: During the study period, 388,212 patients underwent PCI for SIHD, comprising 41.88% of all patients undergoing PCI during the study period. Of these, 125,302 (32.28%; 13.52% of all patients undergoing PCI) met criteria for enrollment in the ISCHEMIA trial. Among SIHD patients that did not meet criteria, 71,852 (18.51%) had SIHD with high-risk features (35.2% left main disease, 43.7% left ventricular systolic dysfunction, 16.8% end-stage renal disease), 67,159 (17.3%) had SIHD with negative or low-risk functional testing, and 123,899 (31.92%) either had no stress testing or did not have ischemic burden reported. At the median hospital, 32.1% (interquartile range: 23.5%-40.6%) of SIHD patients met criteria for enrollment in the ISCHEMIA trial, with these patients experiencing lower unadjusted in-hospital mortality rate than comparator groups who met exclusion criteria for the trial (0.11%) (P < 0.01 for all comparisons). CONCLUSIONS: Among contemporary U.S. patients undergoing PCI for SIHD, 32.28% clearly met enrollment criteria for the ISCHEMIA trial. There was significant variation among individual centers in the proportion of SIHD patients meeting criteria for the ISCHEMIA trial.