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.

Value-Based Payment Reforms in Cardiovascular Care: Progress to Date and Next Steps.

In an effort to curb excessive health care spending and incentivize high-quality care, many payers have implemented value-based payment reforms designed to pay for the quality rather than the quantity of health care services. Medicare, the largest payer in the United States, has implemented numerous value-based payment policies over the past decade, many of which affect cardiovascular care. In this review, we discuss some of these major nationwide value-based payment reforms as they relate to cardiovascular care and what we may expect in the future from cardiovascular value-based policies.

Pediatric Cardiology Specialist's Opinions Toward the Acceptability of Comfort Care for Congenital Heart Disease.

In order to evaluate physicians' willingness to seek legal action to mandate surgery when parents refuse surgery for various congenital heart lesions, we surveyed pediatric cardiologists and cardiovascular surgeons at 4 children's hospitals. We asked whether physicians would support parental refusal of surgery for specific heart defects and, if not, whether they would seek legal action to mandate surgery. We then analyzed associations between physicians' willingness to mandate surgery and national operative mortality rates for each lesion. We surveyed 126 cardiologists and 9 cardiac surgeons at four tertiary referral centers. Overall response rate was 77%. Greater than 70% of physicians would seek legal action and mandate surgery for the following lesions: ventricular septal defect, coarctation of the aorta, complete atrioventricular canal, transposition of the great arteries, tetralogy of Fallot, and unobstructed total anomalous pulmonary venous return. Surgery for all of these lesions has reported mortality rates of < 5%. Physicians were less likely to seek legal action when parents refused surgery for Shone complex, any single ventricle lesion, or any congenital heart disease accompanied by Trisomy 13 or Trisomy 18. Among experts in pediatric cardiology, there is widespread agreement about the appropriate response to parental refusal of surgery for most congenital heart lesions, and these lesions tended to be heart defects with lower surgical mortality rates. Lesions for which there was greater consensus among experts were those with the best outcomes. There was less consensus for lesions with higher mortality rates. Such surveys, revealing disagreement among expert professionals, can provide an operational definition of the current professional "gray zone" in which parental preferences should determine treatment.

Industry Payment to Vascular Neurologists: A 6-Year Analysis of the Open Payments Program From 2013 Through 2018.

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

Border Medicine: The Pediatric Cardiology Perspective.

Pediatric cardiology and cardiovascular surgery have witnessed significant advancements over the last two decades. In spite of this progress, congenital heart disease (CHD) still remains as one of the major causes of death in infants and young children in the United States. Many patient-related and patient-independent factors influence the outcomes in patients with CHD, one of which is the geographical location. In the US-Mexico border, management and outcomes of patients with CHD are further complicated by additional problems stemming from complex interplay between two different health systems, and socioeconomic disparities. In this article, the authors evaluate the various interplaying factors and describe the difficulties facing the practicing pediatric cardiologists in a US-Mexico border city.

Medical Malpractice Claims Within Cardiology from 2006 to 2015.

With increasing healthcare costs and the high cost of spending driven by "defensive medicine," shedding light on recent litigation trends is critical for understanding current tort patterns, especially in the field of cardiology, a specialty with higher rates of malpractice suits than average. Understanding the characteristics of these liability claims and common types of patient injuries can aid cardiologists in mitigating malpractice risk and better patient care. Thus, the objective of this study was to characterize current malpractice trends in the field of cardiology and common sources of patient injury. An analysis of malpractice litigation claims from 2006 to 2015 in cardiology was performed on a database of nationwide professional liability insurers, health systems, and community hospitals. Both the total number of claims and annual indemnity payments in cardiology have seen an overall increase from 2006 to 2015. Of the 1,538 claims observed, the leading allegations were improper medical treatment and diagnostic error. However, despite the large number of claims, most cardiology claims during this decade were either decreased, denied, or dismissed (68%) and the plurality of the remainder was settled outside of court (30%). In conclusion, from 2006 to 2015, rates of cardiology malpractice claims and amount paid in compensation have increased substantially in the United States. Further understanding of the characteristics of these lawsuits can aid cardiologists in avoiding common sources of injury to improve patient care.

THE FUTURE OF CARDIOVASCULAR CARE: FROM AFFORDABLE CARE TO THE ACADEMIC MEDICAL CENTER.

We are presently seeing exponential advances in medical knowledge and development of therapeutic and diagnostic tools. We have also begun to experience an historic restructuring of our health care system. But health care costs continue to rise, disparities persist, and the chaotic, disjointed, and often thoughtless discourse in Washington threatens to roll back the prior advances. Improvement in patient care will be severely stymied if the threats to academic medical centers are not countered. This paper will explore our present state through the lens of cardiovascular care. It will 1) examine clinical trends; 2) dissect the value and challenges to the Patient Protection and Affordable Care Act; 3) highlight limitations and alternatives to relying on the federal government; and 4) present the Academic Medical System construct, as a structure designed to retain and advance the academic mission.

Cardiology consultation for non-cardiac surgery: Medical and legal explorations for clinicians.

Cardiologists performing preoperative cardiac evaluations for non-cardiac surgery have a unique opportunity to assess and optimize the patient's baseline and general health; determine the patient's inherent surgical risk based upon a comprehensive history, physical examination and pertinent laboratory data; ensure the patient has made an informed choice regarding surgery, and identify post-operative risks that must be considered to reduce the potential for major adverse cardiovascular events. There is always a small but inherent risk in surgical procedures. When an adverse outcome occurs there is potential for an allegation of negligence resulting in a detailed autopsy of the medical record. The best defense to an allegation of negligence is comprehensive documentation and a detailed rational for the cardiologist's management decisions.

The 2017 American College of Cardiology/American Heart Association hypertension guideline and opportunities for community pharmacists.

OBJECTIVES: To initiate a call to action for community pharmacists to maximize the opportunities to improve the management of hypertension (HTN) in light of the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) HTN guideline. SUMMARY: In November 2017, the ACC and the AHA, along with 9 other professional organizations, released a comprehensive guideline on the prevention, detection, evaluation, and management of high blood pressure (BP). Major changes included the reclassification of BP and redefinition of HTN to 130/80 mm Hg or above, significantly increasing the number of individuals with HTN. The 2017 ACC/AHA HTN guideline also emphasized out-of-office BP readings and recommended team-based care models that include pharmacists and other health professionals as one strategy to improve BP control rates and provide appropriate follow-up and monitoring. Community pharmacists are highly accessible health professionals that now have an even greater opportunity to improve the monitoring and management of patients with HTN. Monitoring of BP in pharmacies could be greatly improved if BP kiosks were replaced by automated BP monitors operated by appropriately trained personnel that would initiate a face-to-face consultation with a community pharmacist. Physicians and other prescribers should also refer patients directly to their community pharmacists to receive assistance in selecting a home BP monitor. Given recent expansion of collaborative practice legislation and prescriptive authority, health information exchanges, and reimbursement models, community pharmacists have a renewed opportunity to collaborate with medical practices and health systems to improve BP control. In addition, greater collaboration among pharmacists practicing in primary care and community pharmacy could improve care coordination. CONCLUSION: Community pharmacists have a significant opportunity to collaborate with patients, physicians, and the health care community at large to improve the monitoring and management of HTN and ensure that the 2017 ACC/AHA HTN guideline is successfully implemented.