AbstractBackgroundData are limited regarding the association of race and outcomes for patients requiring temporary mechanical circulatory support (tMCS) after acute myocardial infarction (AMI).MethodsUtilizing the TriNetX US collaborative network, we included adults with tMCS post-AMI from 01/2009-12/2023 and created two cohorts: non-Hispanic Black (NHB) and non-Hispanic White (NHW) participants. 1:1 Propensity score matching (PSM) was performed for age, sex, comorbid conditions, coronary artery procedures, and medications. Primary outcomes were bleeding or ischemic stroke within 7 days, 30 days, 90 days, and 1-year follow-up. Secondary outcomes included all-cause mortality, cardiac arrest, ventricular tachycardia (VT), ventricular fibrillation (VF), mechanical complications of AMI, intracardiac thrombus, severe sepsis, and acute kidney injury (AKI).ResultsOur study analyzed 2,808 patients in the NHB and 18,956 in the NHW cohorts. After PSM, both cohorts had 2,794 patients each. There was no statistically significant difference in bleeding risk across all timepoints when comparing NHB with NHW patients. However, NHB patients had statistically significant increased risk of ischemic stroke at 90 days (HR 1.28; 95% CI: 1.01-1.64) and 1 year (HR 1.43; 95% CI: 1.15-1.78). NHB patients also had a significantly increased risk of AKI at 7 days (HR 1.20; 95% CI: 1.06-1.36), 30 days (HR 1.20; 95% CI: 1.06-1.35), 90 days (HR 1.19; 95% CI: 1.06-1.34) and 1 year (HR 1.21; 95% CI: 1.08-1.36). NHB individuals also had an increased risk of all-cause mortality (HR 1.13; 95% CI: 1.03-1.24), cardiac arrest (HR 1.18; 95% CI: 1.04-1.34) and VF (HR 1.20; 95% CI: 1.02-1.41) at 1 year, but reduced risk of mechanical complications of AMI at 7 days (HR 0.47; 95% CI: 0.25-0.86), 30 days (HR 0.49; 95% CI: 0.28-0.84), 90 days (HR 0.52; 95% CI: 0.31-0.89) and 1 year (HR 0.48; 95% CI: 0.28-0.81). No significant differences were observed in other outcomes at each evaluated timepoint.ConclusionsCompared to NHW patients requiring tMCS after AMI, NHB individuals had similar risk of bleeding but increased risk of ischemic stroke and cardiovascular events at longer term. For all follow-up times, NHB patients were more likely to develop AKI, but less likely to suffer from a mechanical complication of AMI.Clinical PerspectiveWhat is New?This study highlights the presence of significant variations in immediate, short, and longer-term patient outcomes following placement of a temporary mechanical circulatory support (tMCS) device after acute myocardial infarction (AMI) in non-Hispanic Black (NHB) patients compared to non-Hispanic White (NHW) patients.Relative to NHW patients, NHB patients had an increased risk of cardiovascular events at long term follow-up but had similar risk of bleeding. NHB patients were more likely to develop acute kidney injury (AKI) at each evaluated time period and had decreased all-cause survival at 1 year.What are the Clinical Implications?This study provides a framework that can be used in modifying treatment initiatives among underrepresented groups. Recognizing the distinctions in outcomes of tMCS procedures following AMI may help to ensure that personalized care can be developed and leveraged where indicated, in unique racial cohorts.
Despite advances in noninvasive imaging modalities to identify atrial fibrillation (AF) risk in Hypertrophic Cardiomyopathy (HCM), there is a paucity of evidence concerning the impact of low Left Atrial strain (LAS) on AF and major adverse cardiac events (MACE) incidence in these patients. This study investigated the diagnostic and prognostic significance of LAS in predicting AF and MACE in HCM. Findings revealed lower LA reservoir (MD:-11.79, 95% CI-14.83,-8.74; p<0.00001), booster (MD:-4.10, 95% CI-6.29,-1.91; p=0.0002), and conduit (MD:-7.52, 95% CI-9.39,-5.65; p<0.00001) strains in HCM patients versus healthy controls, and also indicated a significant association between low LA reservoir/conduit/booster strain and the development of new AF as well as MACE prevalence in HCM patients. The results from this study suggest the valuable role of LA strain in HCM and its utility in predicting the development of new AF and cardiac events in HCM patients.
Background Prevention strategies targeting standard modifiable cardiovascular risk factors (SMuRFs; diabetes, hypertension, smoking, hypercholesterolemia) are critical to improving cardiovascular disease outcomes. However, acute myocardial infarction (AMI) among individuals who lack 1 or more SMuRFs is not uncommon. Moreover, the clinical characteristics and prognosis of SMuRFless individuals are not well characterized. Methods and Results We analyzed AMI hospitalizations from 2000 to 2014 captured by the ARIC (Atherosclerosis Risk in Community) study community surveillance. AMI was classified by physician review using a validated algorithm. Clinical data, medications, and procedures were abstracted from the medical record. Main study outcomes included short‐ and long‐term mortality within 28 days and 1 year of AMI hospitalization. Between 2000 and 2014, a total of 742 (3.6%) of 20 569 patients with AMI were identified with no documented SMuRFs. Patients without SMuRFs were less likely to receive aspirin, nonaspirin antiplatelet therapy, or beta blockers and less often underwent angiography and revascularization. Compared with those with one or more SMuRFs, patients without SMuRFs had significantly higher 28‐day (odds ratio, 3.23 [95% CI, 1.78–5.88]) and 1‐year (hazard ratio, 2.09 [95% CI, 1.29–3.37]) adjusted mortality. When examined across 5‐year intervals from 2000 to 2014, the incidence of 28‐day mortality significantly increased for patients without SMuRFs (7% to 15% to 27%), whereas it declined for those with 1 or more SMuRFs (7% to 5% to 5%). Conclusions Individuals without SMuRFs presenting with AMI have an increased risk of all‐cause mortality with an overall lower prescription rate for guideline‐directed medical therapy. These findings highlight the need for evidence‐based pharmacotherapy during hospitalization and the need to discover new markers and mechanisms for early risk identification in this population.
Point-of-care ultrasonography (POCUS) augments physical examination and expedites diagnostic care and clinical decision-making. The use of POCUS in internal medicine (IM) appears inconsistent despite its commendable benefits. It is not fully incorporated into the IM residency core competency skills or academic curriculum. This narrative literature review explores the benefits of POCUS and evaluates the need for an IM-focused POCUS curriculum. The obstacles and a proposed curriculum are also described.
Data on utilization and safety of mitral Transcatheter Edge-to-Edge Repair (TEER) among hypertrophic cardiomyopathy (HCM) patients is limited. Our study aimed to assess the national utilization, safety, and clinical outcomes of TEER procedures among HCM patients using a nationwide real-world cohort. HCM patients undergoing TEER hospitalizations between 2015-2020 were identified using ICD-10 (International Classification of Diseases, (ICD-10-CM/ PCS). HCM-TEER and HCM No-TEER formed the two comparison groups. Demographic characteristics, baseline comorbidities, procedural complications, inpatient mortality, length of stay (LOS), and cost of hospitalization were compared between the propensity-matched cohorts. Numeric values of 10 or less were not reported per NIS data use agreements. A total of 39,625 weighted cases of TEER were identified from 2015-2020. Of the included patients, 335 patients had the HCM diagnosis. The median age of the HCM-TEER group was 74 (70-79) vs. 79 (72-85) for the no-TEER cohort. The TEER procedure was more frequently performed among Caucasians (86.57%) and females (53.73%). The TEER procedure among HCM patients had similar inhospital mortality (Adjusted odds ratio: aOR 1.50, 95% CI [0.68-3.29]; p = 0.30) and net adverse cardiac events (NACE) (aOR 1.16, 95% CI [0.73-1.85]; p = 0.51). TEER among HCM was associated with higher odds of gastrointestinal/hematological (aOR 2.33, 95% CI [1.29-4.19]; p = 0.003) complications. However, the odds of cardiac complications (aOR 0.57, 95% CI [0.33-0.96]; p = 0.03) were not higher. The median length of stay was similar in both the groups (median: 2 vs. 2, p = 0.74), although TEER among HCM was associated with higher costs of hospitalization ($44729.36 vs. $40513.82, p < 0.01). TEER is a minimally invasive procedure and could be a safe option for symptomatic HCM patients with significant MR who are poor surgical candidates. Mitral TEER among HCM has been increasingly utilized in recent years in the United States more commonly in obstructive HCM and is associated with no difference in mortality and net adverse cardiac events but higher odds for gastrointestinal/hematological complications than non-HCM patients.
Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM). The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution on HF patients at NorthShore University HealthSystem (NSUHS). This study is a feasibility study and will use a wearable biosensor to continuously, remotely monitor HF patients for 30 days post discharge. Eligible patients admitted with a HF exacerbation at NSUHS will be recruited and the wearable biosensor will be placed prior to discharge. The biosensor will collect physiological ambulatory data, which will be analyzed for signs of patient deterioration. Participants will also complete a daily survey through a dedicated study phone. If prespecified criteria from the physiological data and survey results are met a notification will be triggered and a predetermined EHR-based pathway of telephonic management will be completed. In phase I, which has already been completed, five patients were enrolled and monitored for 30 days post-discharge. The results of phase I were analyzed and modifications to the program were made to optimize it. Following analysis of the results from phase I, 15 patients are being enrolled for phase II, which is a calibration and testing period to enable further adjustments to be made. Following phase II, 45 patients will be enrolled for phase III. These results will be analyzed to determine the feasibility of a CRPM program in HF patients. Semi-structured interviews will also be conducted with key stakeholders, including patients, and these results will be analyzed using the Affective Adaptation of the Technology Acceptance Model (A/TAM). Phase I has been completed and results have been published. Phase II and phase III results will be available by the end of 2022. A CRPM program may offer a low-risk solution to improve care of HF patients post hospital discharge and may help decrease readmission of HF patients to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other high risk patient groups. NCT04738279
Changes in cardiac size, myocardial mass, cardiomyocyte appearance, and, ultimately, the function of the entire organ are interrelated features of cardiac remodeling that profoundly affect patient outcomes.This study proposes that the application of radiomics for extracting cardiac ultrasonic textural features (ultrasomics) can aid rapid, automated assessment of left ventricular (LV) structure and function without requiring manual measurements.This study developed machine-learning models using cardiac ultrasound images from 1,915 subjects in 3 clinical cohorts: 1) an expert-annotated cardiac point-of-care-ultrasound (POCUS) registry (n = 943, 80% training/testing and 20% internal validation); 2) a prospective POCUS cohort for external validation (n = 275); and 3) a prospective external validation on high-end ultrasound systems (n = 484). In a type 2 diabetes murine model, echocardiography of wild-type (n = 10) and Leptr−/− (n = 8) mice were assessed longitudinally at 3 and 25 weeks, and ultrasomics features were correlated with histopathological features of hypertrophy.The ultrasomics model predicted LV remodeling in the POCUS and high-end ultrasound external validation studies (area under the curve: 0.78 [95% CI: 0.68-0.88] and 0.79 [95% CI: 0.73-0.86], respectively). Similarly, the ultrasomics model predicted LV remodeling was significantly associated with major adverse cardiovascular events in both cohorts (P < 0.0001 and P = 0.0008, respectively). Moreover, on multivariate analysis, the ultrasomics probability score was an independent echocardiographic predictor of major adverse cardiovascular events in the high-end ultrasound cohort (HR: 8.53; 95% CI: 4.75-32.1; P = 0.0003). In the murine model, cardiomyocyte hypertrophy positively correlated with 2 ultrasomics biomarkers (R2 = 0.57 and 0.52, Q < 0.05).Cardiac ultrasomics-based biomarkers may aid development of machine-learning models that provide an expert-level assessment of LV structure and function.
HomeCirculationVol. 143, No. 252020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessReview ArticlePDF/EPUB2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference Report Ivor J. Benjamin, MD, FAHA, FACC, Conference Co-Chair, AHA C. Michael Valentine, MD, MACC, FAHA, Conference Co-Chair, ACC William J. Oetgen, MD, MBA, MACC, Executive Committee Author Task Force 2 Author, ACC Katherine A. Sheehan, PhD, Executive Committee Author, AHA Ralph G. Brindis, MD, MPH, MACC, FAHA, Task Force Co-Chair, ACC William H. Roach Jr, MS, JD, Task Force Co-Chair, AHA Robert A. Harrington, MD, FAHA, MACC, Author Glenn N. Levine, MD, FACC, FAHA, Author Rita F. Redberg, MS, MD, FACC, FAHA, Author Bernadette M. Broccolo, JD, Discussant Adrian F. Hernandez, MD, MHS, FAHA, Discussant Pamela S. Douglas, MD, MACC, FAHA, Task Force Co-Chair, ACC Ileana L. Piña, MD, MPH, FAHA, FACC, Task Force Co-Chair, AHA Emelia J. Benjamin, MD, ScM, FAHA, FACC, Author Megan J. Coylewright, MD, MPH, FACC, Author Jorge F. Saucedo, MD, MBA, FACC, FAHA, Author Keith C. Ferdinand, MD, FACC, FAHA, Discussant Sharonne N. Hayes, MD, FACC, FAHA, Discussant Athena Poppas, MD, FACC, FAHA, Discussant Karen L. Furie, MD, MPH, FAHA, Task Force Co-Chair, AHA Laxmi S. Mehta, MD, FACC, FAHA, Task Force Co-Chair, ACC John P. Erwin III, MD, FACC, FAHA, Author Jennifer H. Mieres, MD, FACC, FAHA, Author Daniel J. Murphy Jr, MD, FACC, Author Gaby Weissman, MD, FACC, Author and Discussant Colin P. West, MD, PhD, Author and Discussant Willie E. Lawrence Jr, MD, FACC, FAHA, Task Force Co-Chair, AHA Frederick A. Masoudi, MD, MSPH, FACC, FAHA, Task Force Co-Chair, ACC Camara P. Jones, MD, MPH, PhD, Author Daniel D. Matlock, MD, MPH, Author Jennifer E. Miller, PhD, Author John A. Spertus, MD, MPH, FACC, FAHA, Discussant Lynn Todman, PhD, Discussant Cathleen Biga, MSN, FACC, Task Force Co-Chair, ACC Richard A. Chazal, MD, FAHA, MACC, Task Force Co-Chair, AHA Mark A. Creager, MD, FAHA, FACC, Author Edward T. Fry, MD, FACC, Author Michael J. Mack, MD, MACC, Author Clyde W. Yancy, MD, MSc, MACC, FAHA, Author and Discussant Richard E. AndersonMD, Discussant Ivor J. BenjaminIvor J. Benjamin , C. Michael ValentineC. Michael Valentine , William J. OetgenWilliam J. Oetgen , Katherine A. SheehanKatherine A. Sheehan , Ralph G. BrindisRalph G. Brindis , William H. Roach JrWilliam H. Roach Jr , Robert A. HarringtonRobert A. Harrington , Glenn N. LevineGlenn N. Levine , Rita F. RedbergRita F. Redberg , Bernadette M. BroccoloBernadette M. Broccolo , Adrian F. HernandezAdrian F. Hernandez , Pamela S. DouglasPamela S. Douglas , Ileana L. PiñaIleana L. Piña , Emelia J. BenjaminEmelia J. Benjamin , Megan J. CoylewrightMegan J. Coylewright , Jorge F. SaucedoJorge F. Saucedo , Keith C. FerdinandKeith C. Ferdinand , Sharonne N. HayesSharonne N. Hayes , Athena PoppasAthena Poppas , Karen L. FurieKaren L. Furie , Laxmi S. MehtaLaxmi S. Mehta , John P. Erwin IIIJohn P. Erwin III , Jennifer H. MieresJennifer H. Mieres , Daniel J. Murphy JrDaniel J. Murphy Jr , Gaby WeissmanGaby Weissman , Colin P. WestColin P. West , Willie E. Lawrence JrWillie E. Lawrence Jr , Frederick A. MasoudiFrederick A. Masoudi , Camara P. JonesCamara P. Jones , Daniel D. MatlockDaniel D. Matlock , Jennifer E. MillerJennifer E. Miller , John A. SpertusJohn A. Spertus , Lynn TodmanLynn Todman , Cathleen BigaCathleen Biga , Richard A. ChazalRichard A. Chazal , Mark A. CreagerMark A. Creager , Edward T. FryEdward T. Fry , Michael J. MackMichael J. Mack , Clyde W. YancyClyde W. Yancy , and Richard E. AndersonRichard E. Anderson Originally published11 May 2021https://doi.org/10.1161/CIR.0000000000000963Circulation. 2021;143:e1035–e1087is corrected byCorrection to: 2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics: A Consensus Conference ReportTable of Contents1. Introduction e10361.1. Historical Perspective and Current Plan e10371.2. Context Framing e10381.3. The Tenets of Medical Ethics e10391.4. The Principles and Commitments of Medical Professionalism e10391.4.1. Principles of Professionalism e10391.4.2. Commitments of Professionalism e10391.5. The Obligations of Medicine's Social Contract e10401.5.1. Medical Practitioners Agree to:e10401.5.2. Society Agrees to:e10411.6. Organization of Writing Committee e10421.7. Document Review and Publication Approval e10421.8. Abbreviations e10422. Task Force Reports e10422.1. Task Force 1: Navigating Conflicts: RWIs and COIs in Teaching and Publications, Peer Review, Research Data, Technology, and Expert Testimony e10422.1.1. Recommendations Related to Disclosure of RWIs in Educational Activities and Scientific Publications e10432.1.2. Recommendations Related to Associational and Intellectual Interests e10442.1.3. Recommendations Related to External Assessments of Interests e10452.1.4. Recommendations Related to Research, Publication, Educational Activities, and Implementation Ethics e10462.1.5. Recommendations Related to Peer Review and Grant Study Sections e10472.1.6. Recommendations Related to Expert Testimony and Opinions e10482.2. Task Force 2: Diversity, Equity, Inclusion, and Belonging: Optimizing Cardiovascular Health Care, Research, and Education Through Equity and Respect and Eliminating Bias, Discrimination, Harassment, and Racism e10492.2.1. DEIB: General Concepts e10512.2.2. Specific Accountabilities and Special Groups e10522.2.3. Eradicating Bias, Harassment, Structural Racism, and Structural Sexism, Including Sexual Harassment e10542.2.4. Achieving Equity, Inclusion, and Belonging: A Road Map e10552.2.5. Coda e10562.3. Task Force 3: Enhancing the Well-Being of Clinicians e10562.3.1. Organizational Strategies to Promote Well-Being e10592.3.2. Addressing Well-Being Among Trainees and Researchers e10602.3.3. Well-Being Strategies Focused on Health Information Technology e10612.3.4. Identifying Symptoms of the Disruptive Physician e10622.3.5. Identifying and Assisting the Impaired Clinician e10632.3.6. Additional Considerations and Caveats e10642.4. Task Force 4: Patient Autonomy, Privacy, and Social Justice in Health Care e10642.4.1. Patient Autonomy e10652.4.2. Data Privacy, Transparency, and Access e10652.4.3. Social Justice e10652.4.4. Recommendations: Patient Autonomy e10662.4.5. Recommendations: Data Privacy, Transparency, and Access e10672.4.6. Recommendations: Social Justice and Racism e10692.4.7. Caveats e10702.5. Task Force 5: Modern Healthcare Delivery: Challenges Related to New Care Delivery Systems e10712.5.1. Addressing Potential COIs When Designing and Engaging in New Models and Venues of Cardiovascular Care Delivery e10722.5.2. Medical Professionalism for the Employed Clinician e10732.5.3. Ethical Challenges and Professionalism Related to Billing, Coding, Documentation, and EHRs e10752.5.4. Quadruple Aim: Does an Ethical and Professional Perspective Enhance or Obstruct Patient Satisfaction, Outcomes and Quality, Cost, and Clinician Satisfaction? e10762.5.5. Conclusions e1076References e1077Appendix 1. Author Relationships With Industry and Other Entities (Comprehensive) e1082Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive) e10871. INTRODUCTIONIvor J. Benjamin, MD, FAHA, FACCWilliam J. Oetgen, MD, MBA, MACCKatherine A. Sheehan, PhDC. Michael Valentine, MD, MACC, FAHAThe 2020 American Heart Association and American College of Cardiology Consensus Conference on Professionalism and Ethics (2020 Consensus Conference) comes at a time even more fraught than the eras of the 3 previous meetings on the same topics. A virulent pathogen has challenged the physical and economic health of the entire country; a series of tragedies have awakened a sense of social justice previously unexpressed nationally; and the political climate rivals the divisiveness seen at the birth of the nation.1 Arguably, there could be no better time to review and take a fresh perspective on medical ethics and professionalism in the light of established norms and current stressors. In addition, the American Heart Association (AHA) and the American College of Cardiology (ACC) recognize that this important assessment should be undertaken on a more regular basis. There should be no more 16-year gaps.Building on a solid understanding of previous similar efforts and with a firm appreciation of the obligations of medicine's social contract, the tenets of medical ethics, and the principles and commitments of medical professionalism, the ACC and the AHA sponsored a conference on medical professionalism and ethics on October 19 to 20, 2020. Multiple medical professional organizations provided valuable input. The purpose of the present 2020 Consensus Conference is to address the practical management of professional and ethical behavior of cardiovascular clinicians and scientists and to make specific recommendations in light of contemporary issues of professionalism and ethics. The consensus committee reviewed previously published documents and current materials to formulate their recommendations.1.1. Historical Perspective and Current PlanThe AHA and the ACC have long individual and collective histories of formally addressing issues of medical ethics and medical professionalism. The 21st Bethesda Conference (Ethics in Cardiovascular Medicine) was held in October 19892; the 29th Bethesda Conference (Ethics in Cardiovascular Medicine [1997]) was held in October 19973; and the collaborative effort (ACC/AHA Consensus Conference on Professionalism and Ethics) was held in June 2004.4 The specific major topics and subtopics discussed in these conferences reflect the ethical and professional issues extant at the time of the assemblies.The 21st Bethesda Conference2 was devoted to discussions of ethical decision making in medicine; the relation of cardiovascular specialists to patients, other physicians, and physician-owned organizations; the allocation of limited resources in cardiovascular medicine; scientific responsibility and integrity in medical research; and the relation of cardiovascular specialists to industry, institutions, and organizations.Subtopics included in the 21st Bethesda Conference discussion were the following: acting in the patient's interest; respecting the patient's preferences; distributive justice; physician responsibilities to society; medical decision making; end-of-life decisions; AIDS and the cardiovascular physician; conflicts of interest (COIs) and ethics in medical education; resource limitations and distribution; end-of-life care; cost and efficacy of medical technology; the welfare of the individual patient and the welfare of society; responsibilities of clinical investigators, research objectivity, credibility, and COIs; specific physician relationships with industry (RWIs); physician ownership of healthcare facilities; and physicians' relationships to institutions and organizations.The 29th Bethesda Conference3 discussed external influences on the practice of cardiology, application of medical and surgical intervention near the end of life, and clinical research in a molecular era and the need to expand its ethical imperatives.Subtopics discussed in the 29th Bethesda Conference included managed care and the reinterpretations of ethical standards and the concept of professionalism; the relationship of medical ethics and business ethics; the application of medical and surgical interventions in elderly patients; palliative care; futile care; forgoing treatment and advance care planning; physician-assisted suicide; ethical considerations in the conduct of clinical trials; the ethical, legal, and social implications of the Human Genome Project; data confidentiality; and genetic information and its implications for medical insurance.The ACC/AHA Consensus Conference4 dwelt on codes of conduct in human subjects research (HSR); investigator participation in clinical research; disclosure of relationships with commercial interests and policies for educational activities and publications; appropriate clinical care and issues of self-referral; expert testimony and opinions; and a code of conduct for organizational staff and volunteer leadership.Subtopics treated in the ACC/AHA Consensus Conference were COIs and proper disclosure; formal scrutiny of research involving human subjects; confidentiality in research activities; indemnification of research activities; avoidance of bias in clinical trials; physician self-referral; direct-to-consumer advertising; cardiovascular specialty hospitals and physician financial COIs; antikickback statutes; Stark laws; expert testimony in professional liability, class action litigation, and patent issues; and nonprofit organizational governance, management, and potential COIs.For the 3 prior ACC or ACC/AHA ethics and professionalism conferences, there were 164 unique attendees; 11.6% were identified as women, and 2.4% were identified as Black. Twenty of the 164 attendees were present at 2 or 3 of the conferences. Of the 164 attendees, 20 were past, present, or future ACC presidents, and 13 were past, present, or future AHA presidents. No attendees were identified as early career or fellows-in-training.In the 2020 Consensus Conference, of the 61 participating attendees, 41.2% were women, 7.9% were Black, and 4.8% were Hispanic. Three of the 61 were present at the prior conference in 2004; 6 were past, present, or future ACC presidents; and 4 were past, present, or future AHA presidents. Two 2020 Consensus Conference attendees were identified as early career, and 4 were fellows-in-training. Figure 1 shows comparative attendee demographic data for the combined earlier conferences and for the 2020 Consensus Conference.Download figureDownload PowerPointFigure 1. American Heart Association (AHA)/American College of Cardiology (ACC) conferences on professionalism and ethics: attendee demographics.Figure 2 shows the academic degrees and professional representations of the attendees at the current conference and at each of the 3 previous conferences. It is important to note that for the purpose of the current conference, the ascendancy of the team care paradigm in 21st century cardiovascular medicine is recognized, and references to physicians in prior publications, by extension, include all members of the healthcare team. In this document, the terms clinician, practitioner, and medical professional will be used in lieu of the term provider.Download figureDownload PowerPointFigure 2. American Heart Association (AHA)/American College of Cardiology (ACC) Conferences on Professionalism and Ethics: attendee academic and professional representation. Mean conference attendance=63.This document is a comprehensive summary of the deliberations of the 5 task forces that made up the 2020 Consensus Conference. Throughout the preparation of this report, efforts were made to be as concise as reasonably possible; however, because this is envisioned to be a reference document, essential detail was deliberately not euthanized for the sake of brevity.1.2. Context FramingThese conferences have reinforced the notion that the operative underpinning for the practice of medicine in the United States is a set of principles of medical ethics. These principles also form the basis for medical professionalism and what has become known in more recent years as medicine's social contract. Ethical medical practice is an a priori assumption of medicine's social contract, and the principles of ethics shape that contract, giving rise to the concept of professionalism and the rules by which that contract is implemented from the perspective of the medical professional.5,6The American College of Physicians7 and the American Medical Association (AMA)8 have codes of ethics for physicians. The American College of Physicians' Ethics Manual provides context, for example, in reviewing the principles of medical ethics and reminding us thatMedicine is not, as Francis Peabody said, "a trade to be learned, but a profession to be entered." A profession is characterized by a specialized body of knowledge that its members must teach and expand; by a code of ethics and a duty of service that, in medicine, puts patient care above self-interest; and by the privilege of self-regulation granted by society. Physicians must individually and collectively fulfill the duties of the profession.7The tenets of medical ethics, the principles and commitments of medical professionalism, and the specific obligations of medicine's social contract form the basis of this joint AHA/ACC study of medical ethics and professionalism in the 21st century. By way of creating a common ground of understanding, in this introduction, each of these 3 sets of elements is reviewed.1.3. The Tenets of Medical EthicsThe classic ethical principles of medical practice are duties based in respect for autonomy, beneficence, nonmaleficence, and justice.7,9Respect for autonomy. The duty to protect and foster a patient's free, uncoerced choices.Beneficence. The duty to promote good and to act in the best interest of the patient.Nonmaleficence. The duty to do no harm in every interaction with patients.Justice. There should be fairness and equity in health care.1.4. The Principles and Commitments of Medical ProfessionalismThe Physician Charter on Medical Professionalism was published in 2002 as a collaboration between the American Board of Internal Medicine Foundation, the American College of Physicians–American Society of Internal Medicine Foundation, and the European Federation of Internal Medicine.10 Both the ACC and the AHA have officially endorsed the charter, as have >100 other medical professional organizations across the world.11 The charter contains eloquent, succinct, and actionable expressions of the principles and commitments of medical professionalism. Its descriptors are reproduced here with permission.101.4.1. Principles of ProfessionalismPrimacy of patient welfare. This principle is based on a dedication to serving the interest of the patient. Altruism contributes to the trust that is central to the physician-patient relationship. Market forces, societal pressures, and administrative exigencies must not compromise this principle.Patient autonomy. Physicians must have respect for patient autonomy. Physicians must be honest with their patients and empower them to make informed decisions about their treatment. Patients' decisions about their care must be paramount, as long as those decisions are in keeping with ethical practice and do not lead to demands for inappropriate care.Social justice. The medical profession must promote justice in the healthcare system, including the fair distribution of healthcare resources. Physicians should work actively to eliminate discrimination in health care, whether based on race, sex, socioeconomic status, ethnicity, religion, or any other social category.1.4.2. Commitments of ProfessionalismProfessional competence. Physicians must be committed to lifelong learning and be responsible for maintaining the medical knowledge and clinical and team skills necessary for the provision of quality care. More broadly, the profession as a whole must strive to see that all of its members are competent and must ensure that appropriate mechanisms are available for physicians to accomplish this goal.Honesty with patients. Physicians must ensure that patients are completely and honestly informed before the patient has consented to treatment and after treatment has occurred. This expectation does not mean that patients should be involved in every minute decision about medical care; rather, they must be empowered to decide on the course of therapy. Physicians should also acknowledge that in health care, medical errors that injure patients sometimes do occur. Whenever patients are injured as a consequence of medical care, patients should be informed promptly because failure to do so seriously compromises patient and societal trust. Reporting and analyzing medical mistakes provide the basis for appropriate prevention and improvement strategies and for appropriate compensation to injured parties.Patient confidentiality. Earning the trust and confidence of patients requires that appropriate confidentiality safeguards be applied to disclosure of patient information. This commitment extends to discussions with individuals acting on a patient's behalf when obtaining the patient's own consent is not feasible. Fulfilling the commitment to confidentiality is more pressing now than ever before, given the widespread use of electronic information systems for compiling patient data and an increasing availability of genetic information. Physicians recognize, however, that their commitment to patient confidentiality must occasionally yield to overriding considerations in the public interest (for example, when patients endanger others).Maintaining appropriate relations with patients. Given the inherent vulnerability and dependency of patients, certain relationships between physicians and patients must be avoided. In particular, physicians should never exploit patients for any sexual advantage, personal financial gain, or other private purpose.Improving quality of care. Physicians must be dedicated to continuous improvement in the quality of health care. This commitment entails not only maintaining clinical competence but also working collaboratively with other professionals to reduce medical error, to increase patient safety, to minimize overuse of healthcare resources, and to optimize the outcomes of care. Physicians must actively participate in the development of better measures of quality of care and the application of quality measures to routinely assess the performance of all individuals, institutions, and systems responsible for healthcare delivery. Physicians, both individually and through their professional associations, must take responsibility for assisting in the creation and implementation of mechanisms designed to encourage continuous improvement in the quality of care.Improving access to care. Medical professionalism demands that the objective of all healthcare systems be the availability of a uniform and adequate standard of care. Physicians must individually and collectively strive to reduce barriers to equitable health care. Within each system, the physician should work to eliminate barriers to access based on education, laws, finances, geography, and social discrimination. A commitment to equity entails the promotion of public health and preventive medicine, as well as public advocacy on the part of each physician, without concern for the self-interest of the physician or the profession.A just distribution of limited finite resources. While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care.Scientific knowledge. Much of medicine's contract with society is based on the integrity and appropriate use of scientific knowledge and technology. Physicians have a duty to uphold scientific standards, to promote research, and to create new knowledge and ensure its appropriate use. The profession is responsible for the integrity of this knowledge, which is based on scientific evidence and physician experience.Maintaining trust by managing COIs. Medical professionals and their organizations have many opportunities to compromise their professional responsibilities by pursuing private gain or personal advantage. Such compromises are especially threatening in the pursuit of personal or organizational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. Physicians have an obligation to recognize, to disclose to the general public, and to deal with COIs that arise in the course of their professional duties and activities. Relationships between industry and opinion leaders should be disclosed, especially when the latter determine the criteria for conducting and reporting clinical trials, writing editorials or therapeutic guidelines, or serving as editors of scientific journals.Professional responsibilities. As members of a profession, physicians are expected to work collaboratively to maximize patient care, to be respectful of one another, and to participate in the processes of self-regulation, including remediation and discipline of members who have failed to meet professional standards. The profession should also define and organize the educational and standard-setting process for current and future members. Physicians have both individual and collective obligations to participate in these processes. These obligations include engaging in internal assessment and accepting external scrutiny of all aspects of their professional performance.1.5. The Obligations of Medicine's Social ContractMedicine's social contract is an agreement between 2 parties: society as a whole and medical practitioners.12,13 Some elements of the contract are tacit, and some are codified in the laws and regulations governing the practice of medicine. Examples of the latter are laws establishing the healthcare system, educational requirements, and licensure. The tacit elements are behaviors and attitudes expressed by practitioners such as honesty, commitment, compassion, and altruism, none of which are concepts suitable for legislative or regulatory actions. Contracts—tacit or written—document the obligations agreed to by the parties involved. The obligations of the healthcare social contract, as delineated by Cruess and Cruess,14 are as follows:1.5.1. Medical Practitioners Agree to:Fulfill the role of the healer. The healer is an elemental and well-defined role in all human societies. Attributes of the healer include caring and compassion; insight and self-awareness; openness; respect for the healing function; respect for patient dignity and autonomy; being fully present and without distraction for the patient; and accompanying the patient through the journey of healing.15Achieve and maintain proficiency in the knowledge of their area of practice. At the basic level for initial licensure, all US states require an allopathic or osteopathic medical degree, successful completion of a licensure examination, and between 1 and 3 years of postgraduate training.16 For license renewal, all US states except Colorado and South Dakota require continuing medical education.17 At the higher clinical functioning level, all boards require postgraduate training in an approved program and successful completion of a comprehensive examination for specialty certification. All specialty boards provide time-limited certification, and all require participation in a maintenance of certification program for recent diplomates.18Achieve and maintain a high level of skill in their area of practice. At the level of the medical student, clinical skills are assessed by Step 2 (Clinical Skills) of the United States Medical Licensing Examination process.19 The Accreditation Council for Graduate Medical Education (ACGME) sets skill standards for residents and fellows-in-training.20 For the practicing physician, fulfillment of this obligation of the social contract is aspirational. There is no formal organization or process for assessing and documenting clinical skills beyond clinical training, although hospital medical staff quality committees have the responsibility of monitoring procedural outcomes across a variety of specialties.Provide for the patient's needs ahead of their own. This is the fundamental expression of altruism, which is a basic tenet of all descriptions of professionalism. The modern concept of altruism is that it is not an inherent, fixed personality trait; rather, it can be objectively measured and increased by education, practice, role modeling, and reinforcement.21Provide access to needed care. Five steps have recently been highlighted with which physicians can advocate or act to improve access to care for the most vulnerable of our fellow Americans:– Ensure adequate funding of the Children's Health Insurance Program and retain Medicaid expansion and implement expansion in more states.– Stabilize individual insurance marketplaces and retain Affordable Care Act market reforms.– Address physician clinical workforce shortages.– Expand telehealth and remote patient monitoring.– Increase the efficiency of the existing workforce by instituting common-sense medical liability reforms and reducing government and insurance industry regulatory burdens such as prior authorization that detract from patient care and increase costs.22Behave with morality, integrity, and honesty within a delineated code of ethics. Both the ACC23 and the AHA24 have established codes of ethics that define the values and behaviors required of their respective members.Be trustworthy. Patients must be confident that physicians will act not in self-interest but in the interests of their patients. Avoidance of even the appearance of a COI is the responsibility of each physician and is a corollary to the fundamental altruistic obligation to put the patient's needs ahead of the physician's own needs.25Show respect for patient dignity and autonomy. Respect for the dignity and autonomy of the patient is foundational to the pract
OBJECTIVE:We report on our experience of deploying a continuous remote patient monitoring (CRPM) study soft launch with structured cascading and escalation pathways on heart failure (HF) patients post-discharge. The lessons learned from the soft launch are used to modify and fine-tune the workflow process and study protocol.METHODS:This soft launch was conducted at NorthShore University HealthSystem's Evanston Hospital from December 2020 to March 2021. Patients were provided with non-invasive wearable biosensors that continuously collect ambulatory physiological data, and a study phone that collects patient-reported outcomes. The physiological data are analyzed by machine learning algorithms, potentially identifying physiological perturbation in HF patients. Alerts from this algorithm may be cascaded with other patient status data to inform home health nurses' (HHNs') management via a structured protocol. HHNs review the monitoring platform daily. If the patient's status meets specific criteria, HHNs perform assessments and escalate patient cases to the HF team for further guidance on early intervention.RESULTS:We enrolled five patients into the soft launch. Four participants adhered to study activities. Two out of five patients were readmitted, one due to HF, one due to infection. Observed miscommunication and protocol gaps were noted for protocol amendment. The study team adopted an organizational development method from change management theory to reconfigure the study protocol.CONCLUSION:We sought to automate the monitoring aspects of post-discharge care by aligning a new technology that generates streaming data from a wearable device with a complex, multi-provider workflow into a novel protocol using iterative design, implementation, and evaluation methods to monitor post-discharge HF patients. CRPM with structured escalation and telemonitoring protocol shows potential to maintain patients in their home environment and reduce HF-related readmissions. Our results suggest that further education to engage and empower frontline workers using advanced technology is essential to scale up the approach.
James A. Arrighi, MD, FACC, Chair Lisa A. Mendes, MD, FACC, Co-Chair Jesse E. Adams III, MD, FACC[‡][1] John E. Brush, Jr, MD, FACC[‡][1] G. William Dec, Jr, MD, FACC Ali Denktas, MD, FACC Susan Fernandes, LPD, PA-C Rosario Freeman, MD, MS, FACC[‡][1] Sanjeev A. Francis, MD, FACC