Judicialización en cardiología y cirugía cardiovascular: estudio observacional transversal en materia de responsabilidad patrimonial en la sanidad pública española / Litigation in cardiology and cardiovascular surgery: A cross-sectional observational study of liability in the spanish public healthcare system

Introducción: la sobrestimación por los facultativos del riesgo a una demanda judicial tiene, entre otras consecuencias, la intensificación de la medicina defensiva. El objetivo del trabajo fue analizar las características de las sentencias sobre la responsabilidad médica en España en la asistencia sanitaria pública en las especialidades de cardiología y cirugía cardiovascular.Material y métodos: estudio observacional transversal cuyo objetivo fue analizar las sentencias dictadas en la jurisdicción contencioso-administrativa por los Tribunales Superiores de Justicia entre el período 2008-2020, en las especialidades de cardiología y cirugía cardiovascular. Las variables fueron administrativas, clínicas, judiciales e indemnizatorias.Resultados: se analizaron 1.015 sentencias, de las cuales 47 (4,63%) se refirieron a las especialidades de cardiología y cirugía cardiovascular. Ambas obtuvieron porcentajes de frecuencia similares, cardiología 22 (2,16%) y cirugía cardiovascular 25 (2,46%). El 74,1% de las sentencias fueron desestimatorias en primera instancia y el 75% en segunda instancia. Los 2 motivos de sentencia estimatoria más frecuentes fueron la pérdida de oportunidad 6 (42,85%) y la mala praxis diagnóstica y/o terapéutica 5 (35,71%). Los daños reclamados fueron: fallecimiento 21 (44,68%) y secuelas 26 (55,32%). La mediana de las indemnizaciones fue 30.000 euros.Conclusiones: la baja frecuencia de las demandas en cardiología y cirugía cardiovascular indica que se trata de especialidades de «bajo riesgo» de litigiosidad. La inmensa mayoría de las sentencias son, además, desestimatorias de la pretensión de los pacientes. Los datos contribuyen a estructurar el papel de las demandas judiciales y a aumentar el conocimiento de los profesionales en la dimensión médico-legal de la asistencia sanitaria. (AU)

Introduction: The overestimation by physicians of the risk of a lawsuit has, among other consequences, the stepped-up of defensive medicine. To analyze the characteristics of medical liability rulings in Spain in public health care in the specialties of cardiology and cardiovascular surgery.Materials and methods: Cross-sectional observational study analyzing the rulings handed down in the contentious-administrative jurisdiction by the High Courts of Justice in the period 2008-2020, in the specialties of cardiology and cardiovascular surgery. The variables were administrative, clinical, judicial, and compensatory.Results: A total of 1015 rulings were analyzed; 47 (4.63%) involved to the specialties of cardiology and cardiovascular surgery. Both obtained similar frequency percentages, cardiology 22 (2.2%) and cardiovascular surgery 25 (2.5 %). A total of 74.1 % of the rulings were dismissed in the first instance and 75% in the second instance. The two grounds for finding against the defendent were loss of chance 6 (42.85%) and diagnostic and/or therapeutic malpractice 5 (35.71%). Damages were usually claimed: death 21 (44.68%) and sequelae 26 (55.32%). The median award was 30,000 euros.Conclusions: The low frequency of claims in cardiology and cardiovascular surgery indicates that these are “low risk” specialties for litigation. The vast majority of the rulings are, moreover, dismissive of the patients' claims. The data help to structure the role of lawsuits and to increase professionals' knowledge of the medical-legal dimension of health care. (AU)

Artificial Intelligence in Cardiovascular Imaging: "Unexplainable" Legal and Ethical Challenges?

Nowhere is the influence of artificial intelligence (AI) likely to be more profoundly felt than in health care, from patient triage and diagnosis to surgery and follow-up. Over the medium-term, these effects will be more acute in the cardiovascular imaging context, in which AI models are already successfully performing at approximately human levels of accuracy and efficiency in certain applications. Yet, the adoption of unexplainable AI systems for cardiovascular imaging still raises significant legal and ethical challenges. We focus in particular on challenges posed by the unexplainable character of deep learning and other forms of sophisticated AI modelling used for cardiovascular imaging by briefly outlining the systems being developed in this space, describing how they work, and considering how they might generate outputs that are not reviewable by physicians or system programmers. We suggest that an unexplainable tendency presents 2 specific ethico-legal concerns: (1) difficulty for health regulators; and (2) confusion about the assignment of liability for error or fault in the use of AI systems. We suggest that addressing these concerns is critical for ensuring AI's successful implementation in cardiovascular imaging.

Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic.

Introduction: Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our goal was to develop an electronic self-consenting workflow that mimicked clinical services. Specifically, we tested a research consent process for the biobanking of remnant clinical samples that relies solely on clinical resources in a busy outpatient practice. Materials and Methods: The Biorepositories Core Resource (BCR) unit initiated a new enterprise-wide biobanking infrastructure for consenting patients, termed Biospecimen Use for Research-Related Investigations and Translational Objectives (BURRITO). BURRITO is modeled after an established clinical process called Terms and Conditions of Service (TACOS). The TACOS requires patients to annually review printed documentation and self-consent electronically for clinical services. BURRITO also requires patients to review printed documentation and self-consent with eSign to opt-in for remnant biospecimen banking, but patients must complete this process only once. We captured eSign for consents directly into the EMR without research staff. Results: Patients reviewed the IRB-approved documents and self-consented during their cardiology clinic visit. At checkout, their participation preferences were electronically documented by clinic staff. During a 6-month period, 123 patients agreed to donate. After a review of process, a second 3-month period identified 202 patients agreeing to donate. BURRITO did not require face-to-face interactions with research staff, used a "no-paper" eSign for consent, and created discrete fields in the clinical EMR of the patient's preference. Conclusions: BURRITO electronically documents informed consent using an EMR functionality and the least amount of clinical and research resources. Our results show promise for developing institutionally adopted processes, which could leverage existing clinical workflows for universal research consenting and scalability.

SCAI/ACVP expert consensus statement on cardiovascular catheterization laboratory economics: If the cath lab is your home you should understand its finances: This statement was endorsed by the Alliance of Cardiovascular Professionals (ACVP) in April 2019.

This article is intended for any physician, administrator, or cardiovascular catheterization laboratory (CCL) staff member who desires a fundamental understanding of finances and economics of CCLs in the United States. The authors' goal is to illuminate general economic principles of CCL operations and provide details that can be used immediately by CCL leaders. Any article on economics in medicine should start by acknowledging the primacy of the principles of medical ethics. While physicians have been trained to act in the best interests of their patients and avoid actions that would harm patients it is vitally important that all professionals in the CCL focus on patients' needs. Caregivers both at the bedside and in the office must consider how their actions will affect not only the patient they are treating at the time, but others as well. If the best interests of a patient were to conflict with any recommendation in this article, the former should prevail. KEY POINTS: To be successful and financially viable under current payment systems, CCL physicians, and managers must optimize the outcomes and efficiency of care by aligning CCL leadership, strategy, organization, processes, personnel, and culture. Optimizing a CCL's operating margin (profitability) requires maximizing revenues and minimizing expenses. CCL managers often focus on expense reduction; they should also pay attention to revenue generation. Expense reduction depends on efficiency (on-time starts, short turn-over time, smooth day-to-day schedules), identifying cost-effective materials, and negotiating their price downward. Revenue optimization requires accurate documentation and coding of procedures, comorbidities, and complications. In fee-for-service and bundled payment reimbursement systems, higher volumes of procedures yield higher revenues. New procedures that improve patient care but are expensive can usually be justified by negotiating with vendors for lower prices and including the "halo effect" of collateral services that accompany the new procedure. Fiscal considerations should never eclipse quality concerns. High quality CCL care that prevents complications, increases efficiency, reduces waste, and eliminates unnecessary procedures represents a win for patients, physicians, and CCL administrators.

The Burdens of Offering: Ethical and Practical Considerations.

We reflect upon highlights of a facilitated panel discussion from the 2016 Pediatric Cardiac Intensive Care Society Meeting. The session was designed to explore challenges, share practical clinical experiences, and review ethical underpinnings surrounding decisions to offer intensive, invasive therapies to patients who have a poor prognosis for survival or are likely to be burdened with multiple residual comorbidities if survival is achieved. The discussion panel was representative of a variety of disciplines including pediatric cardiology, cardiac intensive care, nursing, and cardiovascular surgery as well as different health-care delivery systems. Key issues discussed included patient's best interests, physician obligations, moral distress, and communication in the context of decisions about providing therapy for patients with a poor prognosis.