Clinical outcomes of patients with acute myeloid leukemia and cardiovascular disease.

Incidence of both acute myeloid leukemia (AML) and cardiovascular disease (CVD) increases with age. We evaluated whether pre-existing CVD impacts clinical outcomes in AML. We retrospectively evaluated 291 consecutive adult AML patients treated at our institution, 2014-2020. Pretreatment comorbidities were identified by chart review. Outcomes included complete remission (CR) and CR with incomplete count recovery (CRi) rates, disease-free survival (DFS), overall survival (OS) and incidence of cardiovascular adverse events. CVD was present in 34% of patients at AML diagnosis. CVD patients had worse performance status (p=0.03) and more commonly had secondary AML (p=0.03) and received hypomethylating (HMA) agent-based therapy (72% vs 38%, p< 0.001). CVD (0.45 vs 0.71, p<0.001) and diabetes mellitus (HR= 0.24, 95% CI: 0.08 - 0.8, p= 0.01) were associated with lower probability of achieving CR/CRi. Accounting for age, performance status (PS), complex karyotype, secondary disease and treatment, CVD patients had shorter OS (HR=1.5, 95% CI: 1.1-2.2, p=0.002), with 1- and 3-year OS 44% vs 67% and 25% vs 40%, respectively, but there was no difference in cumulative incidence of relapse between patients with vs without CVD. Thus, CVD is an independent risk factor for lower response rate and shorter survival in AML patients.

Robert Veatch's transplantation ethics: obtaining and allocating organs from deceased persons.

This essay appreciatively and critically engages the late Robert Veatch's extensive and important contributions to transplantation ethics, in the context of his overall ethical theory and his methods for resolving conflicts among ethical principles. It focuses mainly on ways to obtain and allocate organs from deceased persons, with particular attention to express donation, mandated choice, and presumed consent/routine salvaging in organ procurement and to conflicts between medical utility and egalitarian justice in organ allocation. It concludes by examining the unclear relations between Veatch's ideal moral theory and his nonideal moral theory, especially in organ allocation.

Recent temporal trends in hospital costs for non-surgical patients receiving implantable cardioverter defibrillators.

PURPOSE: Many studies have analyzed the cost-effectiveness of implantable cardioverter defibrillators (ICDs), but hospital costs have not been as thoroughly reported. This study reviewed the associated hospital costs for non-surgical patients who received ICDs from 2015 to 2019. METHODS: We performed a retrospective single-center analysis of patients who received an ICD between 2015 and 2019. ICD cost was analyzed with respect to time using linear regression t-test analysis. RESULTS: For 304 patients, we trended cost of the devices over time. 168 (55.2%) cases were single-chamber devices, 53 (17.4%) were dual-chamber, 59 (19.4%) were cardiac resynchronization therapy-defibrillators (CRT-D), and 24 (7.9%) were subcutaneous devices. The cost of all ICDs decreased by -$1.82/day (p<0.001), R2 = 0.056. By type, cost of single-chamber devices decreased by -$2.56/day (p<0.001), R2 = 0.47, dual-chamber ICD by -$3.50/day (p<0.001), R2 = 0.51, CRT-D by -$4.07/day (p<0.001), R2 = 0.47, and subcutaneous by -$3.33/day (p<0.001), R2 = 0.83. CONCLUSION: This is the first detailed analysis of ICD costs that we are aware of. The cost of all ICDs decreased modestly and became much greater when categorized by type. Overall hospital cost associated with ICD implantation did not show a significant trend, but total supply cost showed a significant decrease over time.

Anatomical characteristics of the membranous septum are predictive of pacemaker requirement in patients undergoing transcatheter aortic valve replacement.

PURPOSE: We aimed to study the characteristics of the membranous septum (MS) and its relationship with the aortic valve (AoV) and aortic annulus (AA) in patients who required PPM post-TAVR. METHODS: We performed a retrospective case-control study of 144 patients undergoing TAVR from 2016 to 2018. Thirty-four patients, requiring PPM implantation, were compared with 34 matched controls who did not require pacing. The total MS length, supra-annular MS (SA-MS) length, infra-annular MS (IA-MS) length, angle between the plane of the AA and MS (AA-MS), and degree of AoV calcifications (AVC) were obtained from preoperative CT. AoV prosthesis implantation depth was obtained from intra-operative fluoroscopy. RESULTS: There were no significant differences in valve type (self-expandable: 23 cases vs 25 controls, and balloon-expandable: 11 vs 9, p = 0.79), degree of AVC (0.65 cm3 vs 0.82 cm3, p = 0.62), or implantation depth (7.76 mm vs 7.28 mm, p = 0.83). Compared to controls, there was no difference in total MS length (6.68 mm vs 6.06 mm, p = 0.97), but the IA-MS was significantly shorter (3.64 mm vs 4.56 mm, p = 0.02) and the SA-MS was significantly longer (2.73 mm vs 1.67 mm, p = 0.02) in patients requiring PPM. Patients requiring PPM also had a larger AA-MS angle (103.5° vs 96.7°, p = 0.01). CONCLUSION: The position of the MS with respect to the AA and MS distance below the annular plane were more closely associated with post-TAVR conduction abnormalities requiring PPM than the absolute length of the MS. Patients undergoing TAVR with such anatomy have a higher risk of requiring PPM and should be monitored for developing these complications.

Common Morality Principles in Biomedical Ethics: Responses to Critics.

After briefly sketching common-morality principlism, as presented in Principles of Biomedical Ethics, this paper responds to two recent sets of challenges to this framework. The first challenge claims that medical ethics is autonomous and unique and thus not a form of, or justified or guided by, a common morality or by any external morality or moral theory. The second challenge denies that there is a common morality and insists that futile efforts to develop common-morality approaches to bioethics limit diversity and prevent needed moral change. This paper argues that these two critiques fundamentally fail because they significantly misunderstand their target and because their proposed alternatives have major deficiencies and encounter insurmountable problems.

Isolated Antineutrophil Cytoplasmic Antibody-Associated Coronary Vasculitis and Valvulitis.

A 30-year-old woman presented with angina pectoris. Coronary angiography revealed severe stenosis in the left main and right coronary arteries that did not improve with intracoronary nitroglycerin. Coronary computed tomography angiography and positron emission tomography revealed coronary ostia inflammation and aortic root fat stranding. She was diagnosed with vasculitis and valvulitis and received immunotherapy and coronary bypass. (Level of Difficulty: Advanced.).

Electric cigarette-related lung injury and cardiovascular insult.

The cardiovascular effects of electronic cigarette use are unknown. Here we present a case describing a young, previously healthy patient without prior cardiopulmonary comorbidities who developed severe, acute cardiac dysfunction in the setting of e-cigarette use, in addition to the more commonly encountered respiratory symptoms. While pulmonary manifestations are characteristic of e-cigarette or vaping product use-associated lung injury (EVALI), the acute and reversible cardiomyopathy seen here has not been previously described in association with either EVALI or e-cigarette use.

COVID-19 and Religious Ethics.

The editors of the JRE solicited short essays on the COVID-19 pandemic from a group of scholars of religious ethics that reflected on how the field might help them make sense of the complex religious, cultural, ethical, and political implications of the pandemic, and on how the pandemic might shape the future of religious ethics.

Response to Commentaries.

After expressing our gratitude to the commentators for their valuable analyses and assessments of Principles of Biomedical Ethics, we respond to several particular critiques raised by the commentators under the following rubrics: the compatibility of different sets of principles and rules; challenges to the principle of respect for autonomy; connecting principles to cases and resolving their conflicts; the value of and compatibility of virtues and principles; common morality theory; and moral status. We point to areas where we see common agreement with our commentators and respond to their critical evaluations.

Never Solo: Gratitude for My Academic Journey.

Tom Beauchamp and I were asked by the editors of The Journal of Medicine and Philosophy to prepare "intellectual autobiographies," with particular attention to sources and influences on our work, including but not limited to Principles of Biomedical Ethics. Of course, it is artificial and even impossible to try fully to separate the "intellectual" from other aspects of our lives. So, while emphasizing the "intellectual" aspects of my autobiography, I have attended to other aspects, too. The huge debts of gratitude I owe also mix the "intellectual" and other aspects of life.

What Does the Evolution From Informed Consent to Shared Decision Making Teach Us About Authority in Health Care?

This article examines the legal doctrine and ethical norm of informed consent and its deficiencies, particularly its concentration on physician disclosure of information rather than on patient understanding, which led to the development of shared decision making as a way to enhance informed consent. As a vague and imprecise rubric, shared decision making encompasses several different approaches. Narrower approaches presuppose an individualistic account of autonomy, while broader approaches view autonomy as relational and hold that clinician-patient relationships grounded in good communication can assist decision making and foster autonomous choices. Shared decision making faces conceptual, normative, and practical challenges, but, with its goal of respecting, protecting, and promoting patients' autonomous choices, it represents an important cultural change in medicine.

Reflections on the National Bioethics Advisory Commission and Models of Public Bioethics.

The National Bioethics Advisory Commission, of which I was a member, was established by a 1995 executive order that identified its "first priority" as "the protection of the rights and welfare of human research subjects." Not surprisingly, then, most of NBAC's work focused on research involving human subjects or participants. A second priority concerned "issues in the management and use of genetics information, including but not limited to, human gene patenting." NBAC's charter (in contrast to the executive order) listed this charge as "part B" of the "first priority." Nonetheless, NBAC never fully developed it. In addition to responding to requests and recommendations from the National Science and Technology Council, NBAC could accept suggestions from Congress and the public for bioethical issues it should consider, and it could also identify other issues to consider and set priorities among them. From its first meeting on October 4, 1996, until its charter expired on October 3, 2001, NBAC produced six reports, with 120 recommendations. In this essay, I make a few observations about principles and moral reasoning in NBAC's deliberations and about NBAC's attention to religious beliefs in the context of two bioethical controversies, provide a rough evaluation of NBAC's impact, and consider three possible models for future public bioethics directed at federal public policy.

The circulatory-respiratory determination of death in organ donation.

OBJECTIVE: Death statutes permit physicians to declare death on the basis of irreversible cessation of circulatory-respiratory or brain functions. The growing practice of organ donation after circulatory determination of death now requires physicians to exercise greater specificity in circulatory-respiratory death determination. We studied circulatory-respiratory death determination to clarify its concept, practice, and application to innovative circulatory determination of death protocols. RESULTS: It is ethically and legally appropriate to procure organs when permanent cessation (will not return) of circulation and respiration has occurred but before irreversible cessation (cannot return) has occurred because permanent cessation: 1) is an established medical practice standard for determining death; 2) is the meaning of "irreversible" in the Uniform Determination of Death Act; and 3) does not violate the "Dead Donor Rule." CONCLUSIONS: The use of unmodified extracorporeal membrane oxygenation in the circulatory determination of death donor after death is declared should be abandoned because, by restoring brain circulation, it retroactively negates the previous death determination. Modifications of extracorporeal membrane oxygenation that avoid this problem by excluding brain circulation are contrived, invasive, and, if used, should require consent of surrogates. Heart donation in circulatory determination of death is acceptable if proper standards are followed to declare donor death after establishing the permanent cessation of circulation. Pending additional data on "auto-resuscitation," we recommend that all circulatory determination of death programs should utilize the prevailing standard of 2 to 5 mins of demonstrated mechanical asystole before declaring death.

Organ donation after circulatory determination of death: lessons and unresolved controversies.

This article responds to the four pieces in this special symposium of the Journal of Law, Medicine & Ethics on uncontrolled organ donation following circulatory death (uDCD). The response will focus on lessons and debates about the kinds of consent necessary and sufficient for temporary organ preservation in the context of DCD and for organ donation itself; on conflicts of obligation, loyalty, and interest in DCD and ways to address those conflicts; and on benefit, cost, risk assessments of uDCD programs, including measures to achieve a more favorable balance of benefits, costs, and risks.