Ethical and Equity Guidance for Transplant Programs Considering Thoracoabdominal Normothermic Regional Perfusion (TA-NRP) for Procurement of Hearts.

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical "authorization," for cadaveric organ donation using TA-NRP.

TAVR in Older Adults: Moving Toward a Comprehensive Geriatric Assessment and Away From Chronological Age: JACC Family Series.

Calcific aortic stenosis can be considered a model for geriatric cardiovascular conditions due to a confluence of factors. The remarkable technological development of transcatheter aortic valve replacement was studied initially on older adult populations with prohibitive or high-risk for surgical valve replacement. Through these trials, the cardiovascular community has recognized that stratification of these chronologically older adults can be improved incrementally by invoking the concept of frailty and other geriatric risks. Given the complexity of the aging process, stratification by chronological age should only be the initial step but is no longer sufficient to optimally quantify cardiovascular and noncardiovascular risk. In this review, we employ a geriatric cardiology lens to focus on the diagnosis and the comprehensive management of aortic stenosis in older adults to enhance shared decision-making with patients and their families and optimize patient-centered outcomes. Finally, we highlight knowledge gaps that are critical for future areas of study.

Assessment and Management of Older Adults Undergoing PCI, Part 1: A JACC: Advances Expert Panel.

As the population ages, older adults represent an increasing proportion of patients referred to the cardiac catheterization laboratory. Older adults are the highest-risk group for morbidity and mortality, particularly after complex, high-risk percutaneous coronary interventions. Structured risk assessment plays a key role in differentiating patients who are likely to derive net benefit vs those who have disproportionate risks for harm. Conventional risk assessment tools from national cardiovascular societies typically rely on 3 pillars: 1) cardiovascular risk; 2) physiologic and hemodynamic risk; and 3) anatomic and procedural risks. We propose adding a fourth pillar: geriatric syndromes, as geriatric domains can supersede all other aspects of risk.

Discharging to the Street: When Patients Refuse Medically Safer Options.

The ethical obligation to provide a reasonably safe discharge option from the inpatient setting is often confounded by the context of homelessness. Living without the security of stable housing is a known determinant of poor health, often complicating the safety of discharge and causing unnecessary readmission. But clinicians do not have significant control over unjust distributions of resources or inadequate societal investment in social services. While physicians may stretch inpatient stays beyond acute care need in the interest of their patients who are experiencing homelessness, they must also consider the implications of using an inpatient hospital bed for someone without the attendant level of medical need. Caring for patients in an inpatient setting when they no longer require acute care means fewer beds for acute care patients. And when a patient who is experiencing homelessness declines a medically safer option such as a skilled nursing facility, then clinicians may be faced with the sole option of discharge to the street, which raises troubling questions of nonmaleficence and social justice. Here we investigate the different forms of injustice that play out when patients are discharged to the street, and offer a map of the interwoven ethical responsibilities of clinicians, hospitals, and skilled nursing facilities.

Management of Atrial Fibrillation in Patients 75 Years and Older: JACC State-of-the-Art Review.

The prevalence of atrial fibrillation (AF) is increasing as the population ages. AF treatment-related complications also increase markedly in older adults (defined as ≥75 years of age for this review). The older AF population has a high risk of stroke, bleeding, and death. Syncope and fall-related injuries are the most common reasons for nonprescription of oral anticoagulation (OAC), and are more common in older adults when OACs are used with antiarrhythmic drugs. Digoxin may be useful for rate control, but associations with increased mortality limit its use. Beyond rate and rhythm control considerations, stroke prophylaxis is critical to AF management, and the benefits of direct OACs, compared with warfarin, extend to older adults. Invasive procedures such as AF catheter ablation, pacemaker implantation/atrioventricular junction ablation, and left atrial appendage occlusion may be useful in appropriately selected cases. However, older adults have generally been under-represented in clinical trials.

Scarce-Resource Allocation and Patient Triage During the COVID-19 Pandemic: JACC Review Topic of the Week.

The COVID-19 pandemic and its sequelae have created scenarios of scarce medical resources, leading to the prospect that health care systems have faced or will face difficult decisions about triage, allocation, and reallocation. These decisions should be guided by ethical principles and values, should not be made before crisis standards have been declared by authorities, and, in most cases, will not be made by bedside clinicians. Do not attempt resuscitation and withholding and withdrawing decisions should be made according to standard determination of medical appropriateness and futility, but there are unique considerations during a pandemic. Transparent and clear communication is crucial, coupled with dedication to provide the best possible care to patients, including palliative care. As medical knowledge about COVID-19 grows, more will be known about prognostic factors that can guide these difficult decisions.

Care Labor in VAD Therapy: Some Feminist Concerns.

Ventricular assist device (VAD) care offers a distinctive lens through which we can explore unjust gender norms. This is a resource-intensive intervention, one in which increasingly sophisticated technology brings with it the need for more long-term care. This care work is demanding, involving device maintenance, medication and appointment management, household work, and emotional support. Most patients eligible for receiving VADs are men, so it is not surprising that it is more often women who are responsible for the care of patients with VADs. Still, there is room to question why so much of this labor is expected of and taken on by female caregivers, when it could be shared with male caregivers and even patients themselves. To the extent that gender difference in the distribution of this labor is avoidable and inequitable, it becomes in part a disparity resulting from unjust social norms. In order to unpack some of this injustice, the authors utilize empiric data and theoretical work in feminist ethics to articulate some of the mechanisms of the gender disparity in VAD care labor and to offer communitarian decision-making and redistribution of care labor as potential routes toward greater justice for women with respect to VAD therapy.

Putting the "Informed" in the informed consent process for implantable cardioverter-defibrillators: Addressing the needs of the elderly patient.

Implantable cardioverter defibrillator (ICD) management complexities challenge the ethos of fully informed consent, particularly for the typically multimorbid elderly patient considering the device for primary prevention. The Heart Rhythm Society recommends providers include discussion on the potential need for later device deactivation or nonreplacement at the time of first implant, and to revisit this at appropriate intervals. The initial consent procedure could meet this standard by incorporating the future need to discuss further such issues when the recipient's clinical condition changes to such an extent that defibrillation would no longer be beneficial. At the time of obtaining consent, some patients may lack the will or capacity to make medically complex decisions when it would be necessary for healthcare surrogate decision-makers to contribute to this process. Ensuring an appropriate level of understanding and response may be enhanced by the use of information and decision aids. With improved communication regarding the nuances of ICD therapy, device eligible patients, and those close to them, will be empowered with a better understanding of the nature, benefits, and risks of ICD implantation, allowing them to make treatment decisions consistent with their values.

The Relationship Between Psychological Symptoms and Ventricular Assist Device Implantation.

CONTEXT: Ventricular assist devices (VADs) improve quality of life in advanced heart failure patients, but there are little data exploring psychological symptoms in this population. OBJECTIVE: This study examined the prevalence of psychiatric symptoms and disease over time in VAD patients. METHODS: This prospective multicenter cohort study enrolled patients immediately before or after VAD implant and followed them up to 48 weeks. Depression and anxiety were assessed with Patient-Reported Outcomes Measurement Information System Short Form 8a questionnaires. The panic disorder, acute stress disorder (ASD) and post-traumatic stress disorder (PTSD) modules of the Structured Clinical Interview for the DSM were used. RESULTS: Eighty-seven patients were enrolled. After implant, depression and anxiety scores decreased significantly over time (P = 0.03 and P < 0.001, respectively). Two patients met criteria for panic disorder early after implantation, but symptoms resolved over time. None met criteria for ASD or PTSD. CONCLUSIONS: Our study suggests VADs do not cause serious psychological harms and may have a positive impact on depression and anxiety. Furthermore, VADs did not induce PTSD, panic disorder, or ASD in this cohort.

Emerging Collaboration Between Palliative Care Specialists and Mechanical Circulatory Support Teams: A Qualitative Study.

CONTEXT: Despite national requirements mandating collaboration between palliative care specialists and mechanical circulatory support (MCS) teams at institutions that place destination therapy ventricular assist devices, little is known about the nature of those collaborations or outcomes for patients and families. OBJECTIVES: To assess how Centers for Medicare & Medicaid Services' regulations have changed collaboration between palliative care and MCS teams and how this collaboration is perceived by MCS team members. METHODS: After obtaining verbal consent, members of MCS teams were interviewed using semistructured telephone interviews. Interviews were transcribed, and content was coded and analyzed using qualitative methods. RESULTS: Models for collaboration varied widely between institutions. Several expected themes emerged from interviews: 1) improvements over time in the relationship between palliative care specialists and MCS teams, 2) palliative care specialists as facilitators of advance care planning, and 3) referral to hospice and ventricular assist device deactivation as specific areas for collaboration. Several unexpected themes also emerged: 4) the emergence of dedicated heart failure palliative care teams, 5) palliative care specialists as impartial voices in decision making, 6) palliative care specialists as extra support for MCS team members, and 7) the perception of improved patient and family experiences with palliative care team exposure. CONCLUSION: Although the structure of collaboration varies between institutions, collaboration between MCS teams and palliative care specialists is increasing and often preceded the Centers for Medicare & Medicaid Services requirement. Overall impressions of palliative care specialists are highly positive, with perceptions of improved patient and family experience and decreased burden on MCS team members.

Focused Cardiac Ultrasound in Place of Repeat Echocardiography: Reliability and Cost Implications.

BACKGROUND: Health care systems are increasingly moving toward models that emphasize the delivery of high-quality health care at lower costs. Rates of repeat echocardiography (two or more transthoracic echocardiographic studies performed within a short interval) are high and can contribute substantially to the cost of providing cardiovascular care. Certain findings from handheld ultrasound scans performed by echocardiographers have been shown to correlate well with findings on transthoracic echocardiography (TTE). It therefore may be feasible and cost effective to use expert focused cardiac ultrasound (eFCU) in place of repeat TTE for highly selected indications in certain settings. The aim of this study was to determine the reliability and cost implications of using eFCU in place of repeat TTE in selected inpatients. METHODS: Inpatients who underwent repeat TTE (prior TTE within 30 days) ordered for the assessment of ventricular function, pericardial effusion, or inferior vena cava collapse were prospectively enrolled. Subjects underwent eFCU in addition to TTE, and results were compared for correlation using the weighted κ statistic. The potential cost savings of using eFCU in place of TTE were modeled from the provider perspective (i.e., physicians and hospitals). RESULTS: Over 45 days, 105 patients were enrolled. The majority of scans were performed for assessment of left ventricular function and pericardial effusions. eFCU showed excellent correlation with TTE for most parameters, including left ventricular systolic function (κ = 0.80) and the presence and size of pericardial effusions (κ = 0.81) (P < .001 for both). Adoption of this eFCU protocol could save between $41 and $64 per study, or between $34,512 and $53,871 annually at the authors' institution. CONCLUSIONS: Findings from eFCU correlate well with those from TTE when used in the setting of repeat testing for assessment of ventricular function, pericardial effusion, and inferior vena cava collapse. The judicious use of eFCU in place of repeat inpatient TTE has the potential to deliver quality cardiac imaging at reduced cost.

Why should we care about ethical and policy challenges in congenital heart disease?

Congenital heart disease (CHD) affects 1% of infants worldwide, and approximately 90% of children with serious CHD who have access to surgery survive to adulthood. Particularly as this population ages, there are unique ethical and policy challenges pertaining to this diverse population of children and adults, which also serve as a paradigm for other chronic diseases. A unique forum to discuss these issues occurred at the University of Pennsylvania in Philadelphia on March 16 to 17, 2012, and was entitled "Ethics of the Heart: Ethical and Policy Challenges in Adult and Pediatric Congenital Heart Disease." The conference convened a multidisciplinary panel of nationally known experts in the fields of Pediatric Congenital Heart Disease, Adult Congenital Heart Disease, and Bioethics to identify and discuss the most important ethical issues in CHD through talks, panel discussions, and one-on-one interviews in six topic areas: genetic testing, transitions of care from pediatric to adult CHD, transplantation and mechanical circulatory support, research and development in CHD, the social and personal costs of success in treating CHD, and end-of-life considerations. This article is an introduction to the topics discussed.

Ethical challenges in advanced heart failure.

PURPOSE OF REVIEW: Advanced heart failure (AHF) is an increasingly important field. Both the population of AHF patients and the therapeutic and diagnostic interventions available are expanding, creating a host of difficult ethical challenges. This article discusses these important issues and proposes an approach to caring for AHF patients. RECENT FINDINGS: Recent guidelines and clinical trials describe the benefits of costly and invasive therapies for AHF, such as ventricular assist devices and cardiac resynchronization therapy which prolong life and improve symptoms but may create burdens and conflict over deactivation at the end of life. Prognostication, informed consent, and early involvement of palliative care are central to addressing the decision-making challenges raised by these devices. Societal concerns such as cost-effectiveness and distributive justice will play an increasingly important role in the dissemination of these devices. SUMMARY: More research, increased end-of-life education, emphasis on advance directives, a more comprehensive informed consent process, and a true multidisciplinary approach are needed to provide optimal care for patients with AHF.

Pacemaker reuse for patients in resource poor countries: is something always better than nothing?

Cardiovascular disease is the most common cause of death across the globe. Large disparities in access to cardiovascular care exist in the world. An estimated one million people die each year due to lack of access to life saving pacemaker therapy. We discuss the concept of justice in health and health care as it relates to the use of refurbished pacemakers in patients in low- and middle- income countries, where financial circumstances severely limit access to brand new devices. Egalitarianism, utilitarianism, and justice as fairness are examined, as they relate to provision of re-processed pacemakers. This practice, since it holds promise to improve human functioning and capabilities, can be morally justified with some conditions: transparency, further research in is its safety and efficacy, and its impact on other needs and priorities in those countries.

Assessment of ventricular remodeling in heart failure clinical trials.

Adverse remodeling involves a complicated process of structural and functional changes in the left ventricle (LV). LV remodeling is progressive and, if left unchecked, culminates in heart failure that portends a poor prognosis. Clinical trials in heart failure have employed various techniques to assess ventricular remodeling while focusing on therapeutic-specific strategies to halt or reverse remodeling. These strategies include (1) those designed to reduce wall stress by limiting LV dilatation and reducing LV loading conditions (nitrates and epicardial restraint), (2) those designed to block neurohormonal activation, including angiotensin converting enzyme inhibitors, angiotensin receptor blockers, ß-adrenergic receptor blockers, and aldosterone receptor blockers, (3) ionotropic agents/cardiac glycosides, and (4) cardiac resynchronization therapy. Strategies in development include mechanical assist devices and myocardial regeneration. To date, trials have demonstrated a linkage between indices of remodeling and clinical outcomes measures. Indices of remodeling have facilitated identification of targets for novel pharmaceutical agents and new device therapies.