Considerations on the Management of Acute Postoperative Ischemia After Cardiac Surgery: A Scientific Statement From the American Heart Association.

Acute postoperative myocardial ischemia (PMI) after cardiac surgery is an infrequent event that can evolve rapidly and become a potentially life-threatening complication. Multiple factors are associated with acute PMI after cardiac surgery and may vary by the type of surgical procedure performed. Although the criteria defining nonprocedural myocardial ischemia are well established, there are no universally accepted criteria for the diagnosis of acute PMI. In addition, current evidence on the management of acute PMI after cardiac surgery is sparse and generally of low methodological quality. Once acute PMI is suspected, prompt diagnosis and treatment are imperative, and options range from conservative strategies to percutaneous coronary intervention and redo coronary artery bypass grafting. In this document, a multidisciplinary group including experts in cardiac surgery, cardiology, anesthesiology, and postoperative care summarizes the existing evidence on diagnosis and treatment of acute PMI and provides clinical guidance.

The Current State of Coronary Revascularization: Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Interventions.

PURPOSE OF REVIEW: The optimal revascularization strategy for coronary artery disease depends on various factors, such as disease complexity, patient characteristics, and preferences. Including a heart team in complex cases is crucial to ensure optimal outcomes. Decision-making between percutaneous coronary intervention and coronary artery bypass grafting must consider each patient's clinical profile and coronary anatomy. While current practice guidelines offer some insight into the optimal revascularization approach for the various phenotypes of coronary artery disease, the evidence to support either strategy continues to evolve and grow. Given the large amount of contemporary data on revascularization, this review aims to comprehensively summarize the literature on coronary artery bypass grafting and percutaneous coronary intervention in patients across the spectrum of coronary artery disease phenotypes. RECENT FINDINGS: Contemporary evidence suggests that for patients with triple vessel disease, coronary artery bypass grafting is preferred over percutaneous coronary intervention due to better long-term outcomes, including lower rates of death, myocardial infarction, and target vessel revascularization. Similarly, for patients with left main coronary artery disease, both percutaneous coronary intervention and coronary artery bypass grafting can be considered, as they have shown similar efficacy in terms of major adverse cardiac events, but there may be a slightly higher risk of death with percutaneous coronary intervention. For proximal left anterior descending artery disease, both percutaneous coronary intervention and coronary artery bypass grafting are viable options, but coronary artery bypass grafting has shown lower rates of repeat revascularization and better relief from angina. The Synergy Between PCI with Taxus and Cardiac Surgery score can help in decision-making by predicting the risk of adverse events and guiding the choice between percutaneous coronary intervention and coronary artery bypass grafting. European and American guidelines both agree with including a heart team that can develop and lay out individualized, optimal treatment options with respect for patient preferences. The debate between coronary artery bypass grafting versus percutaneous coronary intervention in multiple different scenarios will continue to develop as technology and techniques improve for both procedures. Risk factors, pre, peri, and post-procedural complications involved in both revascularization strategies will continue to be mitigated to optimize outcomes for those patients for which coronary artery bypass grafting or percutaneous coronary intervention provide ultimate benefit. Methods to avoid unnecessary revascularization continue to develop as well as percutaneous technology that may allow patients to avoid surgical intervention when possible. With such changes, revascularization guidelines for specific patient populations may change in the coming years, which can serve as a limitation of this time-dated review.

2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use. METHODS: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.

Temporal trends in transcatheter aortic valve replacement use and outcomes by race, ethnicity, and sex.

OBJECTIVES: To identify trends in transcatheter aortic valve replacement (TAVR) use and outcomes by race (non-Hispanic White, Black), ethnicity (Hispanic), and sex over time. BACKGROUND: Despite rapid growth in TAVR use over time, our understanding of its use and outcomes among males and females of underrepresented racial/ethnic groups remains limited. METHODS: A retrospective analysis of hospitalizations from 2013 to 2017 from the Healthcare Cost and Utilization Project database was performed. RESULTS: White patients comprised 65% (n = 2.16 × 107 ) of all hospitalizations, yet they comprised 83% (n = 176,887) of the admissions for aortic stenosis (p < 0.0001). Among 91,693 hospitalizations for aortic valve replacement, 64,069 were surgical (34.0% female, 7.0% Hispanic, and 5.9% Black) and 27,624 were transcatheter (46.6% female, 4.5% Hispanic, and 4.4% Black). Growth in TAVR volumes was the slowest among minorities and females. Hispanic males, Hispanic females, and White females had the highest in-hospital mortality (2.7%-3.3%; compared to White males, adjusted odds ratio: Hispanic males 1.9 [1.2-3.0], Hispanic females 1.9 [1.2-3.1], and White females 1.4 [1.2-1.7]). Despite less baseline vascular disease, females of all races/ethnicities had more vascular complications than men (female 5% vs. male 3.5%, p ≤ 0.001). Further adjustment for vascular complications only partially attenuated mortality differences. Black and Hispanic patients had a longer mean length of hospital stay than White patients, which was most pronounced among females. Pacemaker requirements were consistently low among all groups. CONCLUSION: Differences in TAVR growth and outcomes by race, ethnicity, and sex over time highlight areas for focused efforts to close gaps in minimally invasive structural heart disease care.

Cardiovascular procedural deferral and outcomes over COVID-19 pandemic phases: A multi-center study.

BACKGROUND: The COVID-19 pandemic has disrupted routine cardiovascular care, with unclear impact on procedural deferrals and associated outcomes across diverse patient populations. METHODS: Cardiovascular procedures performed at 30 hospitals across 6 Western states in 2 large, non-profit healthcare systems (Providence St. Joseph Health and Stanford Healthcare) from December 2018-June 2020 were analyzed for changes over time. Risk-adjusted in-hospital mortality was compared across pandemic phases with multivariate logistic regression. RESULTS: Among 36,125 procedures (69% percutaneous coronary intervention, 13% coronary artery bypass graft surgery, 10% transcatheter aortic valve replacement, and 8% surgical aortic valve replacement), weekly volumes changed in 2 distinct phases after the initial inflection point on February 23, 2020: an initial period of significant deferral (COVID I: March 15-April 11) followed by recovery (COVID II: April 12 onwards). Compared to pre-COVID, COVID I patients were less likely to be female (P = .0003), older (P < .0001), Asian or Black (P = .02), or Medicare insured (P < .0001), and COVID I procedures were higher acuity (P < .0001), but not higher complexity. In COVID II, there was a trend toward more procedural deferral in regions with a higher COVID-19 burden (P = .05). Compared to pre-COVID, there were no differences in risk-adjusted in-hospital mortality during both COVID phases. CONCLUSIONS: Significant decreases in cardiovascular procedural volumes occurred early in the COVID-19 pandemic, with disproportionate impacts by race, gender, and age. These findings should inform our approach to future healthcare disruptions.

Cardiac procedural deferral during the coronavirus (COVID-19) pandemic.

We aimed to examine factors impacting variability in cardiac procedural deferral during the COVID-19 pandemic and assess cardiologists' perspectives regarding its implications. Unprecedented cardiac procedural deferral was implemented nationwide during the COVID-19 pandemic. A web-based survey was administered by Society for Cardiovascular Angiography and Interventions and the American College of Cardiology Interventional Council to cardiac catheterization laboratory (CCL) directors and interventional cardiologists across the United States during the COVID-19 pandemic. Among 414 total responses, 48 states and 360 unique cardiac catheterization laboratories were represented, with mean inpatient COVID-19 burden 16.4 ± 21.9%. There was a spectrum of deferral by procedure type, varying by both severity of COVID-19 burden and procedural urgency (p < .001). Percutaneous coronary intervention volumes dropped by 55% (p < .0001) and transcatheter aortic valve replacement volumes dropped by 64% (p = .004), with cardiologists reporting an increase in late presenting ST-elevation myocardial infarctions and deaths among patients waiting for transcatheter aortic valve replacement. Almost 1/3 of catheterization laboratories had at least one interventionalist testing positive for COVID-19. Salary reductions did not influence procedural deferral or speed of reinstituting normal volumes. Pandemic preparedness improved significantly over time, with the most pressing current problems focused on inadequate testing and staff health risks. During the COVID-19 pandemic, cardiac procedural deferrals were associated with procedural urgency and severity of hospital COVID-19 burden. Yet patients did not appear to be similarly influenced, with cardiologists reporting increases in late presenting ST-elevation myocardial infarctions independent of local COVID-19 burden. The safety and importance of seeking healthcare during this pandemic deserves emphasis.

Association of insurance type with receipt of oral anticoagulation in insured patients with atrial fibrillation: A report from the American College of Cardiology NCDR PINNACLE registry.

BACKGROUND: It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs). METHODS: We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC). RESULTS: In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, P<.001; NOAC: Military 24%, Private 19%, Medicare 17%, Other 17%, Medicaid 8%, P<.001). After adjustment for patient characteristics and facility, private, Medicaid, and other insurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription. CONCLUSIONS: In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies.

Sedentary Behavior and Cardiovascular Morbidity and Mortality: A Science Advisory From the American Heart Association.

Epidemiological evidence is accumulating that indicates greater time spent in sedentary behavior is associated with all-cause and cardiovascular morbidity and mortality in adults such that some countries have disseminated broad guidelines that recommend minimizing sedentary behaviors. Research examining the possible deleterious consequences of excess sedentary behavior is rapidly evolving, with the epidemiology-based literature ahead of potential biological mechanisms that might explain the observed associations. This American Heart Association science advisory reviews the current evidence on sedentary behavior in terms of assessment methods, population prevalence, determinants, associations with cardiovascular disease incidence and mortality, potential underlying mechanisms, and interventions. Recommendations for future research on this emerging cardiovascular health topic are included. Further evidence is required to better inform public health interventions and future quantitative guidelines on sedentary behavior and cardiovascular health outcomes.

Cangrelor reduces the risk of ischemic complications in patients with single-vessel and multi-vessel disease undergoing percutaneous coronary intervention: Insights from the CHAMPION PHOENIX trial.

OBJECTIVE: To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). BACKGROUND: Cangrelor, an intravenous, rapidly acting P2Y12 inhibitor, is superior to clopidogrel in reducing ischemic events among patients receiving percutaneous coronary intervention (PCI). METHODS: We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non-coronary artery bypass grafting GUSTO severe bleeding at 48hours. RESULTS: Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P=.67) compared with SVD patients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. CONCLUSION: In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. CLINICAL PERSPECTIVES.

Patterns and prognosis of all components of the J-wave pattern in multiethnic athletes and ambulatory patients.

BACKGROUND: Despite recent concern about the significance of the J-wave pattern (also often referred to as early repolarization) and the importance of screening in athletes, there are limited rigorous prognostic data characterizing the 3 components of the J-wave pattern (ST elevation, J waves, and QRS slurs). We aim to assess the prevalence, patterns, and prognosis of the J-wave pattern among both stable clinical and athlete populations. METHODS: We retrospectively studied 4,041 electrocardiograms from a multiethnic clinical population from 1997 to 1999 at the Veterans Affairs Palo Alto Health Care System. We also examined preparticipation electrocardiograms of 1,114 Stanford University varsity athletes from 2007 to 2008. Strictly defined criteria for components of the J-wave pattern were examined. In clinical subjects, prognosis was assessed using the end point of cardiovascular death after 7 years of follow-up. RESULTS: Components of the J-wave pattern were most prevalent in males; African Americans; and, particularly, athletes, with the greatest variations demonstrated in the lateral leads. ST elevation was the most common. Inferior J waves and slurs, previously linked to cardiovascular risk, were observed in 9.6% of clinical subjects and 12.3% of athletes. J waves, slurs, or ST elevation was not associated with time to cardiovascular death in clinical subjects, and ST-segment slope abnormalities were not prevalent enough in conjunction with them to reach significance. CONCLUSIONS: J waves, slurs, or ST elevation was not associated with increased hazard of cardiovascular death in our large multiethnic, ambulatory population. Even subsets of J-wave patterns, recently proposed to pose a risk of arrhythmic death, occurred at such a high prevalence as to negate their utility in screening.

Temporal Trends in Cardiovascular Disease Prevalence Among Asian American Subgroups.

BACKGROUND: Asian and multiracial individuals represent the 2 fastest growing racial and ethnic groups in the United States, yet most prior studies report Asian American and Native Hawaiian or Other Pacific Islander as a single racial group, with limited data on cardiovascular disease (CVD) prevalence among subgroups. We sought to evaluate temporal trends in CVD burden among disaggregated Asian subgroups. METHODS AND RESULTS: Patients with CVD based on International Classification of Diseases, Ninth Revision and Tenth Revision (ICD-9 and ICD-10) coding who received care from a mixed-payer health care organization in California between 2008 and 2018 were classified into self-identified racial and ethnic subgroups (non-Hispanic White [NHW], Asian Indian, Chinese, Filipino, Japanese, Korean, Native Hawaiian or Other Pacific Islander, and multiracial groups). Adjusted trends in CVD prevalence over time by subgroup were compared using logistic regression. Among 3 494 071 patient-years, prevalence of CVD increased faster among all subgroups except Japanese and Native Hawaiian or Other Pacific Islander patients (P<0.01 for each, reference: NHW). Filipino patients had the highest overall CVD prevalence, which increased from 34.3% to 45.1% over 11 years (increase from 17.3%-21.9%, P<0.0001, reference: NHW). Asian Indian patients had the fastest increase in CVD prevalence over time (16.9%-23.7%, P<0.0001, reference: NHW). Among subcategories of disease, hypertension increased faster among Asian Indian, Chinese, Filipino, Korean, and multiracial groups (P<0.01 for all, reference: NHW), and coronary artery disease increased faster among Asian Indian, Chinese, Filipino, and Japanese groups (P<0.05 for each, reference: NHW). CONCLUSIONS: The increasing prevalence of CVD among disaggregated Asian, Native Hawaiian or Other Pacific Islander, and multiracial subgroups over time highlights the importance of tailored approaches to addressing CVD in these diverse subpopulations.

Racial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019.

PURPOSE: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis. METHODS: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality. RESULTS: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity. CONCLUSIONS: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations.

Variability in quantitative and qualitative analysis of intravascular ultrasound and frequency domain optical coherence tomography.

BACKGROUND: Frequency-domain optical coherence tomography (FD-OCT) is an intravascular imaging technique now available in the United States. However, the importance of level of training required for analysis using intravascular ultrasound (IVUS) and FD-OCT is unclear. The aim of this study was to evaluate inter- and intra-observer variability between expert and beginner analysts interpreting IVUS and FD-OCT images. METHODS AND RESULTS: Two independent expert analysts and two independent beginner analysts evaluated a total of 226 ± 2 stent cross-sections with IVUS and 232 ± 2 stent cross-sections with FD-OCT in 14 patients after stenting. Inter- and intra-observer variability for determining stent volume index (VI), as well as identifying incomplete stent apposition and dissection were assessed. The inter- and intra-observer variability of stent VI was minimal for both beginner and expert analysts regardless of imaging technology (random variability: 0.38 vs. 0.05 mm(3) /mm for IVUS, 0.26 vs. 0.08 mm(3) /mm for FD-OCT). Although qualitative IVUS analysis at the patient level revealed no significant difference between beginners and experts, this was not the case for FD-OCT. The number of overall qualitative findings noted by beginner and expert analysts were more variable (overestimated or underestimated) with FD-OCT. CONCLUSION: Despite varying levels of training, the increased resolution of FD-OCT compared to IVUS provides better detection and less variability in quantitative image analysis. On the contrary, this increased resolution not only increases the rate but also the variability of detection of qualitative image analysis, especially for beginner analysts.

Myocardial Infarction Across COVID-19 Pandemic Phases: Insights From the Veterans Health Affairs System.

Background Cardiovascular procedural treatments were deferred at scale during the COVID-19 pandemic, with unclear impact on patients presenting with non-ST-segment-elevation myocardial infarction (NSTEMI). Methods and Results In a retrospective cohort study of all patients diagnosed with NSTEMI in the US Veterans Affairs Healthcare System from January 1, 2019 to October 30, 2022 (n=67 125), procedural treatments and outcomes were compared between the prepandemic period and 6 unique pandemic phases: (1) acute phase, (2) community spread, (3) first peak, (4) post vaccine, (5) second peak, and (6) recovery. Multivariable regression analysis was performed to assess the association between pandemic phases and 30-day mortality. NSTEMI volumes dropped significantly with the pandemic onset (62.7% of prepandemic peak) and did not revert to prepandemic levels in subsequent phases, even after vaccine availability. Percutaneous coronary intervention and coronary artery bypass grafting volumes declined proportionally. Compared with the prepandemic period, patients with NSTEMI experienced higher 30-day mortality during Phases 2 and 3, even after adjustment for COVID-19-positive status, demographics, baseline comorbidities, and receipt of procedural treatment (adjusted odds ratio for Phases 2 and 3 combined, 1.26 [95% CI, 1.13-1.43], P<0.01). Patients receiving Veterans Affairs-paid community care had a higher adjusted risk of 30-day mortality compared with those at Veterans Affairs hospitals across all 6 pandemic phases. Conclusions Higher mortality after NSTEMI occurred during the initial spread and first peak of the pandemic but resolved before the second, higher peak-suggesting effective adaptation of care delivery but a costly delay to implementation. Investigation into the vulnerabilities of the early pandemic spread are vital to informing future resource-constrained practices.

Coronary Artery Bypass Surgery After Transradial Catheterization: Implementing 2021 ACC/AHA/SCAI Revascularization Guidelines Into Clinical Practice.

The 2021 ACC/AHA/SCAI coronary artery disease revascularization guideline recommends radial artery (RA) access for coronary angiography and RA grafting over saphenous vein grafting in patients referred for coronary artery bypass grafting. We present a case of a patient who underwent coronary angiography via both RAs and therefore could not receive RA bypass grafts. (Level of Difficulty: Advanced.).

2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention guidelines, providing a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization as well as the supporting documentation to encourage their use. METHODS: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. STRUCTURE: Coronary artery disease remains a leading cause of morbidity and mortality globally. Coronary revascularization is an important therapeutic option when managing patients with coronary artery disease. The 2021 coronary artery revascularization guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with coronary artery disease who are being considered for coronary revascularization, with the intent to improve quality of care and align with patients' interests.