Percutaneous interventional cardiovascular medicine: The PCR-EAPCI Textbook

Summary

Moral teaching concerns decisions about right and wrong based on shared values and norms in a given society. Ethics is a study of morality in a given context. Finally, law represents a set of rules of conduct systematized and enforced by society. Thus, in a nutshell, ethics addresses moral obligations often outlined in moral teaching while the law defines legal duties. To follow the principles of Good Medical Practice all three domains need to inform decision-making, and their respective missions should be clearly understood by all professionals and organizations involved in health care.

This chapter provides a brief overview of medical ethics with a focus on the practice of cardiovascular interventions.

"Be ethical." It's a stress.

Dr. Jordan Cohen, The "Crisis" in the Ethics and Profession of Medicine, 2007

“Personal moral failure is the best teacher of sympathy for the mistakes of others, and life brings us many opportunities to acquire such magnanimity”

(Richard Holloway, How to read the Bible)

1. Introduction

Ethics is the branch of philosophy concerned with morality. Morality addresses issues of the rights and wrongs in human decisions and actions. Western moral philosophy commences with the teachings of Plato (428-348 BC) and Aristotle (384-322 BC) expressing the ideals of eudaimonia (happiness, well-being, flow). Traditionally, three main concepts of ethics can be distinguished; teleology (telos; Greek for end, purpose, goal; consequentialism), deontology (deon; obligation, duty; and logia; teaching, body of knowledge) and virtue ethics. The first derives its authority from the primacy of ends over intentions; the second puts the intentions of actions first while the third emphasizes the ethical expertise of the decision maker. Philosophers working both on meta-ethics and normative ethics dispute the underpinnings and the codification - if one is possible (particularists deny this, principlists affirm it) - of moral or ethical judgements. Consequentialists think, roughly, that acts are good if they produce good outcomes. Deontologists think that their goodness depends on the right intentions of the actor, behaving in accord with duty coded as principles. Virtue ethicists think that actions are good if they are the actions of a virtuous agent balancing competing factors in a way that may resist codification. At present within each main branch number of schools of ethics have emerged emphasizing distinct interpretations and justifications of morality [Appendix A, Appendix B] [1, 2].

Medical ethics relies largely on deontology; but also includes consequentialist and virtue ethics based considerations. Once considered rather straight forward, the increasing complexity of the practice of modern medicine, the departure from traditional paternalism guiding patients-doctors relationships (PDR) for millennia and the growing emphasis on patients’ rights and the possibility of legal actions [3, 4] have made medical ethics far more intricate. Thus, casual acquaintance with medical ethics is no longer sufficient; rather, ample understanding of the principles of medical ethics and their application in clinical practice is required. In addition, the increasing importance of transparency, communication, media etc. have resulted in empowering a number of stakeholders including patients, public and society. Thus, the doctors need to be keenly aware of these changes and should be acquainted with the relevant legal consequences as far as they concern medical practice. In interventional cardiovascular medicine (ICM), relevant procedural risks born by the patient [5] make operators’ knowledge and understanding of ethical responsibilities for patients’ well-being and safety, based on fair risk-benefit accounting, imperative.

This chapter briefly reviews some of the key ethical considerations and legal implications with relevance to the practice of ICM. For more extensive treatment, the specialised literature should be consulted [6, 7].

2. Ethics

Ethics explores questions of morality; goodness of decisions and actions. Metaethics examines the nature of or principles governing goodness and wrongness. Normative ethics strives to develop a comprehensive system of rules of ethical conduct free of contradictions and inconsistencies. However, there are also theoretical normative perspectives that deny the possibility of congruous, conflict-free and comprehensive narratives of moral conduct. Facing countless dilemmas resulting from human frailty and fallibility in combat with the sea of uncertainties characterizing the human condition, applied ethics is concerned with moral right and wrong in pragmatic decisions. To make ethical judgments in real-life conflicts, a close examination of facts, weighting of arguments, trading-off between interests of different stakeholders and readiness to concession and compromise are required. Applied professional ethics introduces contingent features of the roles of professions as extra premises to whatever normative approach one might adopt. Typically, it is summarized in codes of professional conduct regulating professional duties and obligations. The written codes and policies are expected to be read, understood and followed by the professionals. Applied professional ethics in medicine essentially recapitulates the principles of normative ethics, adapted to the needs of the current medical practice, by codifying the rules of conduct for health care professionals. While the main doctrine is based on deontology, consequentialist and virtue ethical perspectives are also adopted in practice. Personalized professional medical ethics (PPME) refers to the actual state of ethics as practiced by individual doctors. Thus, by reflecting the ethical integrity of individual doctors and mirroring the ethical standing of the medical community PPME represents the ethics that matter to the patients, public and society the most. [Appendix C]. Figure 1 provides overview of ethical categories.

FOCUS BOX 1

Ethics represents philosophical inquiry into the morality of rights and wrongs of human actions. Three major schools of ethics are teleology (consequentialism), deontology and virtue ethics. Medical ethics which relies largely on deontology also includes, depending on context, teleological and virtue ethical views. Doctors’ professionalism depends on understanding and attending to the principle maxims of ethics in daily clinical practice; preserving patient safety and well-being is the first of the promises to keep.

3. Medical ethics

In the Western moral tradition, ethical principles such as justice and fairness have become elements of constitutional human rights, and thus increasingly also elements of common sense. Health care, formerly considered mostly a matter of private and not necessarily of public concern, has now become in the countries of the European Union increasingly subject to endorsable patients’ rights for health, autonomy, safety and well-being [8]. However, the legal implications of these new developments have not yet been fully born out and remain controversial matter of ongoing debates.

While the main mission of medicine is the prevention of disease, and restoration and maintenance of health, the main objective of medical ethics is to assure that this mission is accomplished by confirming with ethical standards.

Medical ethics is bound by the maxims of theoretical ethics considering the fairness, goodness and justice of human actions. To capture the essence of the maxims of theoretical ethics relevant to bioethics, Beauchamp and Childress have famously formulated Four Principles to govern biomedicine and medical practice ( Table 1) [9].

These Four Principles, also termed ‘principlism’, are supposed to capture the essence of medical ethical reasoning. Nevertheless, even this small number of principles may conflict. Because each of the Four Principles is axiomatic and not derived from a single “first” principle they need both ‘balancing’ and further ‘specification’ when applied to particular real-life cases. Classically, in medicine, beneficence and non-maleficence are always in tension due to the possibility of harm. To determine which principle should dominate in any particular context requires patient- and situation-specific judgment suggesting that, ultimately, the Four Principles approach collapses into particularism. Thus the ‘principles’ are not really principles governing a judgment but rather maxims and helpful reminders for what is wise to consider in a particular case.

While broadening the scope of ethical consideration by the inclusion of a multiplicity of principles such as people’s rights and claims, different sorts of interests and their relative strength, human well-being , loss of life, what would be good or bad for people, democratic acceptance, consultation, sensitive moments, benefits and harms, grief and distress, an obligation to make sacrifices for the community, an entitlement of the community to deny autonomy and even to violate bodily integrity in the public interest, the system of justice, public safety, public policy considerations, danger, civil liberties, individual autonomy, and saving and protecting the lives and liberties of citizens [10] may not be necessarily practical in resolving particular ethical conflicts. On the contrary, with the increasing number of potentially, but not necessarily, relevant issues to be considered, the complexity of decision making may seriously impede due process.

In economically advanced nations, bioethics has gradually developed into an arbiter between the interests of patients and other medical and non-medical stakeholders involved in health care. In addition, rapid progress in medicine has swayed the focus of bioethical considerations from the more basic issues concerning the social mission of health care towards the most visible and hype issues such as organ donation, human enhancement, technical manipulation of human genome, stem cell therapy etc. Thus, the bioethics of day-to-day medical practice has been taken for granted escaping further scrutiny. In contrast, the boethics of medical practice in poor and less advanced countries has remained primarily concerned with isssues related to managing health care in a state of poverty, destitution, famine and scarcity.

The recent coronavirus SARS-CoV-2 pandemic seems to narrow the gap between the two perspectives. Experiences of humanitarian hardships and economic shortages have forced numerous doctors in wealthy nations to re-examine their own ethics in real-life practice. Sudden need to triage resources, conduct treatments at personal risk, weighing tough choices etc. have made self-scrutiny in PPME imperative. Thus, while pressing medical issues related to the medical progress will remain on the agenda of bioethical considerations, clearly a more balanced and more inclusive approach to bioethics, including considerations of health care under the conditions of economic shortages and arising social conflicts related to the day-to-day medical practice is needed.

To deliver optimum health care, medical and bioethical expertise is required. Such expertise requires thorough understanding of patients’ and doctors’ views of means and aims of the intended treatments. Although doctors and patients will likely agree in principle, unanimity is unlikely to be reached. While doctors care for multiple patients and carry multiple patients’ related and unrelated responsibilities, including those to their professional careers, families, employers, public and society, patients focus on their own health issues and impact on their families. To harmonize these two perspectives the informed consent (IC) has become the key instrument formalizing doctor-patient relationships (DPR) and authorizing doctors to take medical actions on behalf of patients. Patients’ and doctors’ conceptions of medical ethics will be briefly outlined; DPR will be reviewed more extensively.

3.1. Ethics; patients’ view.

As a well-known adage aptly states health is not everything, but without health nothing counts where health, for the current purpose rather simplistically defined as the state of well-being and absence of ills, is fundamental to what is general considered good living. Thus, patients’ outmost interest in keeping healthy is fully understandable. Some patients do assume responsibilities for their own health while others prefer to delegate those responsibilities to others, mainly health care professionals. By prioritizing one’s own health, other considerations including restrictions implemented in systems of managed care; limits of expenditures defined by the society etc. usually receive low, if any, consideration.

Undergoing treatments, patients have typically two main expectations; delivery of the best possible care and the best possible outcome. These pragmatic expectations appear natural and fully appropriate. Thus, a good outcome of treatment is what really counts to the patients; the good intentions of doctors are considered as given. If treatments fail or the outcomes do not meet patients’ expectations, doctors’ expertise is questioned. Although blame on doctors may be justified in some cases, even well-educated and thoroughly informed patients may underestimate or even fail to understand the often uncertain and essentially probabilistic nature of treatment outcomes and consequently the limits of healing powers. Thus, while individual patients’ ethical attitudes may be fairly complex, the adoption of the teleological point of view based on the utilitarian self-interest is common, if not universal.

3.2. Ethics; doctors’ view.

On resuming their profession, doctors pledge to conform to the mandates of medical ethics. The conduct of treatments in good faith preceding the outcomes corresponds to the deontological take on ethics. Consequently, successful treatment is morally acceptable only if achieved in good faith – that is with the forthright intention to serve the best interests of the patient. On the contrary, successful treatments conducted in any other but good faith are unsound and ethically inacceptable regardless of outcome.

In clinical practice, however, the issues are more complex and concessions to the ideal state of deontological ethics may be required. For example, while the need to make ethically hard decisions is natural to doctors practicing outside the fringes of wealth, it has recently become also a bare necessity to numerous doctors working on the frontlines in wealthy nations suddenly facing shortages in medical supplies and available facilities (intensive care beds, respirators, personal protection equipment etc.) during the Coronavirus SARS-CoV-2 pandemic. In contemporary Western ethics, the needs for triaging of patients and the distribution of scarce resources have been addressed thus far only in the military and partly also in emergency medicine. With the current pandemic and resulting worldwide repercussions the time has come to develop and to teach ethical standards for decision making ethics under conditions of constraints, limited resources and personal threats.

Furthermore, the growing patients’ expectation of a quasi-guarantee of good outcomes and the power of modern medicine suggests that a balance between the virtual and the real must be restored. To bring about accord between expectations and reality, greater transparency and public education regarding the nature and limits of medical services is needed. In the course of this process, doctors will need to reaffirm their grasp of ethics with many of those multiple real-life ramifications. However, regardless of these efforts, making consistent sound ethical judgments in the best interest of patients in complex environments will not be an easy task. To meet these challenges, doctors will need not only to review, and if needed, refurbish their personal conversance with the claims of professional ethics but also pay close attention to the new trends and demands in changing and rapidly transforming society. However, the exercise of professional ethics in daily practice in accord with patients’ needs will remain a lifelong challenge requiring persistence and dedication.

ILLUSTRATIVE CASE

Consider the case of young patient scheduled for elective Transcatheter Aortic Valve Implantation (TAVI). A new valve that is marketed for excellent short-term outcomes becomes available, yet the long-term durability of the device is unknown. The operator is keen to gain experience with the new technology and wants to implant the device, yet, acknowledging the incompleteness of evidence, the operator does not know what is in the best interest of the patient. Yet, nevertheless, ultimately a decision must be made. Involving the team in the decision process and detailed education of the patient are the typical steps to resolve the doctor’s dilemma. Nonetheless, the validity of the recommendation and the soundness of the decision will remain uncertain.

3.3. Doctor-patient relationships.

DPR is based on the professional ethical responsibility of doctors towards their patients. Formerly based on an idealized form of unfailing altruism and patients’ inferior knowledge of medicine, in DPR the doctrine of paternalism prevailed and a virtually unlimited trust by patients towards their doctors was granted. More recently, as a result of the numerous changes in medical practice and society (e.g. impact of information technology, digitalization, artificial intelligence etc. on communication and human preferences), paternalism has been questioned and patients’ emancipation encouraged. As a result, unconditional trust has been replaced by trust with strings attached.

When patients authorize doctors to act on their behalf, they trust in the doctors’ professional knowledge, skills and ethical integrity. Considering the worth of health in human affairs, such authorization expresses the ultimate trust. When patients ask Can I trust this doctor? how do they decide? It depends on personal preferences. However, trustworthiness of verbal and non-verbal communication and personal rapport with the patient will likely dominate. Charisma, frankness, clarity, gentleness, confidence, empathy but also reputation, track record, professional standing, reputation, titles etc. and increasingly also information via media and internet affect patients’ trust and determine the quality of the DPR.

Upholding fairness and justice in dealing with all patients all the time exposes doctors to multitudes of moral and ethical challenges. Adherence to firm professional and ethical principles helps but given the pace of changes in medical practice it may not suffice. It is therefore hardly surprising that doctors working at bed-side may lack the sufficient ethical expertise and time to cope successfully with emerging new and potentially unprecedented conflicts. While resort to the ethical committees or professional clinical ethicists may provide a reasonable option in some cases [11] in the long run doctors require professional education in ethics. The objectives of such education is not necessarily learning to provide all the right answers but learning how to cope with ethical dilemmas by developing a greater sense of accountability, sensitivity to patients’ and other stakeholder interests, reasoning and clear-headedness.

Legally DPR expresses a fiduciary relation acknowledging mutual dependence based on trust. In dealing with patients, doctors (fiduciaries) are expected to uphold professionalism by delivering treatments in good faith according to the accepted medical standards in the best interest of the patient. While the law does not explicitly question the essentially trust-based DPR format the doctors must know that abuse of trust may have legal implications [12].

ILLUSTRATIVE CASE

Consider the case of an elderly patient with stable ischemic coronary artery disease and a moderate cardiovascular risk profile including type 2 diabetes with known three-vessel coronary disease with no exertional angina on the medication recommended by current guidelines with 20% left ventricular mass myocardial ischemia on Thallium-201 myocardial scintigraphy. The patient consults his/her cardiologist and wishes to have the best treatment based on available evidence. Given the available data (status April 2020; DOI: 10.1056/NEJMoa1915922; DOI: 10.1056/NEJMoa1916370) no conclusive evidence in definite favour of either conservative or invasive management in regard to the primary and secondary endpoints is available. Further, given the sensitivity of outcomes in respect to the definition of myocardial infarction in the studies further complicating the results’ interpretation, advice to the patient will likely be equivocal, if strictly evidence-based. To reach consensus and to make a decision fulfilling the criteria of professional ethics, the patient`s education requires an explanation of data ambiguity preventing any straight forward recommendation. The doctor’s task will be to explore with the patients the factors present in a given context. These factors may include such as: potential relevance of absence of angina in patients with diabetes, potential long-term impact of ischemia on myocardial function, procedural risks and risk factors related specifically to this patient including left ventricular function, presence of panvascular status, co-morbidities, experience of the operator performing the procedure etc. depending on the context and patients’ expectations and preferences. Clearly, fully objective and bias free communication represents the ideal, not the real case, scenario. While cardiologist may lean towards the conservative option, an interventional cardiologist may more likely recommend coronary revascularization. Professional ethics requires awareness and control of personal biases. Decisions should be based on careful weighing of pros and cons in the best interest of each individual patient. Realistic and austere presentation and close rapport with the patient characterize fair and truly personalized medical practice.

3.3.1. Informed consent and patients’ education

Informed consent based on patients’ education formalizes DPR and legalizes medical actions. Based on the current jurisdiction, medical treatment is considered an injury representing criminal offense unless explicit informed consent (IC) has been obtained; only valid IC legalizes treatments. Correspondingly, the current format of IC has been designed to assure patients’ rights and to legalize the intended and fully described medical actions.

The steps of obtaining valid IC are summarized in Table 2 [13].

Prior to consenting, patients must be educated concerning the rationale, necessity, urgency, suitability and effectiveness of the intended treatment. Effective and valid Patient Education (PE) should allow the patient to make informed decisions concerning all intended medical actions based on the explanations provided. These explanations should include all relevant procedural steps including diagnostics, treatments, risks, and also any alternatives to the suggested treatment [14].

PE in diagnostics should include description of all intended diagnostic measures. The patient is entitled to receive a full disclosure of all findings. PE in treatments should include a justification of the recommended medical action, the pros and cons of this and alternative treatment options, particularly in regard to benefit and risk evaluation. The probability and magnitude of the risk of harm and the plan of the intended procedure should be explained to, and understood by, the patient. Full risk education is considered the most essential step to ascertain the patient’s right of self-determination. PE about alternatives should include fair information about other therapy options supported by evidence. Fair weighing of the pros and cons of each of the relevant alternatives is also required.

Educated judgments about the expected risks and benefits of intended treatments require extensive PE. However, due to the probabilistic nature of risks and benefits and due to the complexity of procedural details, the necessary depth and extent of PE may, in clinical practice, be difficult to define. Complete PE has to be understood as a maxim to be pursued, not as an ultimate all-inclusive explanation of all procedural details.

Furthermore, the patient’s mental capabilities should allow her/him to understand the proposed treatments’ principles and implications and to ensure responsible decision-making. The test of mental capability codified by law is that the patient is able to understand and retain the information to arrive at an informed decision, to believe it and to weigh it to arrive at his or her own choice, and to communicate the decision [15]. Even for patients with marked cognitive limitations, basic PE must be performed. In urgent and emergency interventions life-saving procedures are usually prioritized over detailed education. In contrast, detailed education is required when procedures deviate from established standards and when new medical treatments are involved.

The physician performing the intervention can delegate PE to another physician sufficiently knowledgeable about the scope of the intended treatment. However, ultimate responsibility rests with the operator. Delegation to non-medical personnel, such as nurses, is not permissible.

PE should allow sufficient time to guarantee the right for self-determination; commonly ‘over-night’ or 24 hours is considered adequate. Prior to minor procedures, shorter time periods are acceptable. The consenting patient should be mentally capable of comprehending the meaning of the intended medical action. PE should be conducted in an understandable form and manner. Technical medical terms should be translated into lay language and must be, as far as possible, adequately explained. Paternalism in speech overriding the patient’s wishes and preferences is misplaced and out of the question. Dating and signing are necessary to validate any written IC. For standard procedures, printed IC forms are available and should be used.

Providing medical treatment with a limited, or even without a specific, IC can be considered only in narrowly defined medical emergencies. In such cases, three requirements must usually apply: the patient is incapable of giving consent and no lawful surrogate is available, the condition of the patient is life-threatening, or the patient is in danger of a serious impairment of health and immediate treatment is necessary to avoid this danger [16]. The Biomedicine Convention of the European Union states When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned. § 19 of the Health Act 2005 stipulates that if a patient who is temporarily or permanently unable to provide informed consent or is under the age of 15, is in a situation where immediate treatment is essential for his survival or long term improvement of the chances for survival or significantly improved result of treatment, a health care provider may initiate or proceed with treatment without consent from the patient or the custodian, closest relative or guardian. Details on IC can be found in this EU document [17]. Information on consenting minors has been provided in the literature [18].

In the European Union, patients’ rights of self-determination, safety and protection from harms are regulated and apply to all citizens [4, 17]. Thus, medical professionals acting upon incomplete IC are guilty of negligence. Those acting upon an invalid IC are considered guilty of trespasses against medical ethics and may be subject to legal prosecution. It should also be understood that mere availability of signed IC is only an evidence of legal consent. Full consent requires sufficient and appropriate PE and, as far as possible, evidence of comprehension. In summary, legally valid IC must be a clear expression of the free will of the patient. Undue influence, emotional blackmail, mock explanations and partisanship are against the law and invalidate IC [14].

3.3.2. Informed consent in interventional procedures

To undertake an invasive procedure without obtaining consent exposes the operator to the criminal charge of battery. For example, in the United Kingdom (UK), the standard of acceptable medical care has been derived from case law and in particular that of Bolam (Bolam v Friern Barnet Hospital Management Committee [14] 2All ER 118). In that Landmark case the judge held that a doctor ‘… Is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’.

While this standard is used to judge the quality of clinical care provided (such as the type of treatment given or the technical aspects of an operative procedure), it no longer applies to the process of obtaining consent. This comprises the provision of sufficient information with which to make an informed decision and the comprehension of that information in order to make a decision. Such decisions should be characterized by the absence of pressure, undue influence or coercion, and there should be evidence that a clear decision has been reached.

There should be evidence that a process of consenting has occurred and that this was supported by written - as well as verbal – information. There should be up-to-date documentation in the medical records, in the letter to the patient’s general practitioner or on the consent form itself. The language on the consent form should be clear and in non-specialist language, where possible, avoiding or at least clarifying any abbreviations (e.g. CABG, MI or PE). Importantly, there should be evidence that time was provided to allow consideration and discussion – a “cooling-off period”. It follows that consenting to a planned procedure on the day of the procedure itself represents substandard practice and is to be avoided.

Traditionally the disclosure of risks or side effects inherent in any planned procedure has been decided by the operator and based largely upon their likelihood. Thus, for example, a complication such as life-threatening contrast allergy that might be considered to occur in less than one case in every thousand was felt rare enough to justify non-disclosure. This operator-based decision, previously considered as ‘Bolam-defensible’, no longer applies. In the UK Supreme Court, a pivotal judgment of 2015 ruled that the disclosure of risks should be patient- rather than doctor-centered and should include all material risks (Montgomery v Lanarkshire Health Board [14] UKSC 11). Material risks are defined as those to which a reasonable person in the patient’s position would be likely to attach significance, or those risks to which the doctor should be reasonably aware that the patient would likely attach significance.

Information should also be provided about any alternatives with their own risks and benefits, including the option of doing nothing. Should patients decline to receive such information, every reasonable attempt should still be made to inform them fully. Information may be withheld, however, if it is felt that providing it would be ‘seriously detrimental to the patient's health’.

Any discussion prior to an urgent procedure, e.g. angiogram proceeds or ‘follow-on’ cases, will understandably present problems with the consenting process. It is clear that fully informed patient choice is not possible, as the exact nature and extent of the procedural risk cannot be known prior to the diagnostic angiogram. Therefore, the patient’s understanding of all treatment options will be limited and no formal multidisciplinary team (MDT) discussion with a surgical team can occur. Advising the patient about possible treatment options once the angiographic information is available cannot be accepted as sufficient. A patient on the catheter laboratory table, monitored and already instrumented, is understandably anxious and may also have been sedated. This makes his or her full comprehension of the possible management options limited and consent obtained in that setting cannot be seen as valid.

In such situations – which are becoming increasingly common in interventional practice – discussion prior to the procedure should be thorough and well-considered. The patient should be advised that there will be a degree of uncertainty and that the operator will proceed to percutaneous coronary intervention (PCI) in defined circumstances, acting in the patient’s best interest. He or she should be advised that the procedure can be stopped in order to allow further discussion with other colleagues. The nature and extent of that discussion should immediately be documented.

Emergency PCI in the context of ST- segment elevation myocardial infarction (STEMI) presents similar but more intense challenges in terms of the consenting process. Predictably, this arises from the clear need to undertake PCI with a minimum of time delay; accordingly, any discussion of risk will be by necessity brief. This clinical scenario also brings to bear the issue of mental capacity and the extent to which a patient in the throes of an acute STEMI can be considered to have capacity.

In the UK, an adult is presumed to have capacity. This assumes that the patient is able to understand the information relevant to any decision to be made, to retain that information, use and weigh it in the process of decision-making and to be able to communicate his or her decision. There will be circumstances when a patient is deemed to lack capacity, defined as the result of impairment of, or disturbance in, the functioning of the mind or brain which may be temporary. This should not be generalised across different patients such as to assume that any patient presenting with a STEMI must lack capacity. Similarly, any lack of capacity cannot be generalised to all decisions a patient may make and should relate to the particular issue in question. Importantly, a person is not to be treated as unable to make a decision merely because he makes an unwise decision (Re C [Adult: Refusal of Treatment]: FD 1994, 1 WLR 290).

It is the responsibility of a PCI operator, faced with such a pressing clinical situation, to decide whether the patient before him or her has the capacity to understand the nature and risks of the proposed emergency treatment. If so, such a discussion should be brief, but must still be documented.

If the patient is deemed to lack capacity, there is a sequence of possible options to consider before proceeding further. One option is to ascertain whether the patient has an “advanced decision” in place (made while the patient still had capacity); another is to check whether there is a person with power of attorney who may take decisions on behalf of the patient. In the absence of these possibilities, a court-appointed deputy might be sought if there is sufficient time to apply for one. In practice, of course, a PCI operator will quite reasonably be entitled to act in the patient’s best interests, and this forms the basis of the vast majority of emergency PCI procedures that are undertaken.

Occasionally, PCI may be considered for patients for whom a ceiling of care has been defined because of significant comorbidity or frailty. This might include a clear wish, made by the patient, not to have treatment escalated to intensive care or assisted ventilation. Commonly, this comprises a so-called ‘Do Not Attempt Cardiopulmonary Resuscitation’ (DNACPR) order.

An operator considering PCI in such a setting should discuss the procedure fully with the patient and his or her family in order to ascertain the defined ceiling of care. There needs to be an agreement to distinguish between clinical deterioration, as a direct complication of the PCI procedure itself – e.g. an episode of ventricular fibrillation resulting from transient peri-procedural ischaemia that the operator is obliged to rectify – and inexorable progression of the underlying condition (e.g. refractory cardiogenic shock). This discussion should define under what circumstances resuscitation will be undertaken. The nature of that discussion should be documented contemporaneously.

In summary, the consenting process is required to recognise a patient’s autonomy and his or her inherent right to decide what is to happen to their body. As with any other medical treatment or procedure, cardiovascular intervention must also comply with this principle – accepting that the clinical circumstances in which this is undertaken poses particular challenges to the operator. Elective cases should be consented to prior to the day of the procedure and all material risks relevant to the particular patient should be disclosed. More urgent cases should be preceded by a discussion and agreement that allows for a degree of uncertainty and clarifies under what conditions the intervention will proceed. In emergencies, consideration should be given as to whether the patient has capacity and, if not, whether it is permissible to proceed on the basis of ‘best interest’. Consent given prior to intervention, when a ceiling of care is in place, should define beforehand in what circumstances resuscitation is to be undertaken. In all these settings, the nature of any discussion should be documented in the medical records.

Regulations concerning PCI and applicable in the United Kingdom provide an example of similar regulations relevant to other catheter-based cardiovascular interventions and applicable across Europe.

The purpose of IC is fulfilled when firstly, patients understand and retain the information, and secondly are able to use this information to make informed decisions. Nevertheless, experiences show that even detailed information provided in plain language may fail the intended purpose. Gaining appropriate consent from a patient requires good communication skills, sensitivity to patient needs, sufficient knowledge of the course and complications of the intended intervention and importantly a good measure of common sense. Yet, doctors and patients need to be aware of fallibilities inherent to human judgments and decision making, even if all critical information has been provided. Other limits to the efficacy of IC process have been discussed elsewhere [19].

FOCUS BOX 2

Medical ethics primarily reflecting the tenets of deontology follows the maxims of the established rules of normative ethics. In the Four Principles approach (Autonomy, Beneficience, Non-maleficience, Justice) the basic ethical obligations of doctors towards their patients have been summarized. While ethics is far more inclusive than the Four Principles approach, it represents a useful point of departure and commentary. Medical ethics underwrites doctor-patient relationships, based on fairness and mutual trust, formalized and legalized by thorough patients’ education and with signed written Informed Consent.

3.4. Confidentiality

Spelled out in the Hippocratic Oath “Whatever, in connection with my professional practice or not, in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.” [Appendix C] confidentiality was traditionally fundamental to DPR. With the emergence of information technologies, formerly strictly confidential personal medical data stored in on-site or virtual digital databases have become vulnerable to breaches of confidence by technical accidents or hostile hacking. Thus, protection of patients’ privacy is no longer fully controlled by health care providers requiring medico-legal protection. Since 2012, the European Union has stepped up the effort to retain control over privacy and patients’ data by passing a series of recommendations [20, 21].

The confidential nature of the relationship between the doctor and patient is a cornerstone of the foundation of medical practice. In The General Medical Council (GMC) licenses and regulates the practice of doctors registered in the UK. It has provided guidance on this important issue (Confidentiality: good practice in handling patient information, published in January 2017 and available at www.gmc-uk.org/guidance).

This guidance specifies those circumstances in which patient information may be disclosed without breaching confidentiality. In most cases, the patient will have consented, whether implicitly for the sake of their own care or for local clinical audit, or explicitly for other purposes.

Similarly, disclosure is justified if it is deemed to be of overall benefit to a patient who lacks the capacity to consent.

Doctors owe a duty of confidentiality to their patients, but they also have a wider duty to protect and promote the health of patients and the public. There will therefore also be occasional instances when disclosure of patient information is required by law.

There is a large number of laws that require disclosure of patient information – for purposes as diverse as the notification of infectious diseases, the provision of health- and social-care services, the prevention of terrorism and the investigation of road accidents.

Disclosure may also be justified if it is deemed to be in the interests of the wider public. Confidential medical care is recognised in law as being in the public interest. The fact that people are encouraged to seek advice and treatment benefits society as a whole, as well as the individual. But there can be a public interest in disclosing information if the benefits to an individual or society outweigh both the public and the patient’s interest in keeping the information confidential. For example, disclosure may be justified to protect individuals or society from risks of serious harm, such as from serious communicable diseases or serious crime.

In the era of universal electronic communication, the management of confidential information requires particular attention and care. Health and care records can include a wide range of material, including handwritten notes, electronic records, correspondence between health professionals, visual and audio recordings, laboratory reports and communications with patients (including texts and emails).

Many improper disclosures of patient information are unintentional. Conversations in reception areas, at a patient’s bedside and in public places may be overheard. Notes and records may be seen by other patients, unauthorised staff, or the public if they are not managed securely. Patient details can be lost if handover lists are misplaced, or when patient notes are in transit.

Healthcare organisations have well-established information governance structures, and familiarity with such processes is now part of the mandatory training of healthcare staff. They should develop and maintain an understanding of information governance that is appropriate to their role. They should be satisfied that any members of staff that they manage are trained and understand their information governance responsibilities. If they are responsible for employment contracts, they must make sure they contain obligations to protect confidentiality and to process information in line with data protection law.

In the UK, the Data Protection Act 1998 sets out the responsibilities of data controllers when processing personal data, as well as a number of rights of individuals (known as data subjects). If you are a data controller, you must understand and meet your obligations under data protection law. This includes responsibilities to make sure that all patients’ personal information that you hold is handled in ways that are transparent and that patients would reasonably expect, and appropriate technical and organisational measures are in place to guard against data loss.

You must also make sure information is readily available to patients which explain how their information is processed. This includes who has access to information you hold that might identify them and for what purposes, their options for restricting access to some or all of their records, and their rights to complain about how their information is processed, and how to make a complaint.

Whether or not you are a data controller, you must be familiar with, and follow, the confidentiality, data protection and record management policies and procedures where you work and know where to get advice on these issues. This includes policies on the use of laptops and mobile devices.

In summary, even in the digital era, the role of the doctor in his or her relationship with the patient continues to adhere to the basic foundations of medical practice. Confidentiality is at the root of that relationship and should always be respected. There are specific instances, however, when patient information may be disclosed without consent; in such cases, and if in any doubt, the practitioner would be wise to consult with his or her organization’s information legal adviser.

Unintentional disclosure of confidential information is of particular concern in the era of widespread digital communications. It is therefore essential that healthcare workers are trained -and continuously updated - in all aspects of information governance.

4. Medico-legal concepts

Doctors are more used to dealing with professional ethics than with laws. Yet, given the increasing complexity of medical care and also widely publicized illegal medical practices [22, 23, 24] a basic knowledge of the regulations of medical practice by the law is useful. By definition, the laws are there to uphold justice and order in a particular country by regulating the actions of citizens and public in ways that can be enforced by the imposition of penalties. Public law consists of all the rules of law relating to the organisation and functioning of the State and to relations between public authorities and individuals; private law is constituted by all the rules of law that govern the relationships between individuals. It deals with relations between individuals, placed on an equal footing and free from any interference by public authority. These two basic types of domestic law are subdivided into several branches concerned with specific domains of the public and private life [25].

Medical law is not a specific law; rather, it borrows and applies the rules from other legal branches; articles of the civil law (branch of the private law) and criminal law (part of the public law) are mainly employed. Tort law, a division of the civil law, determines whether a person should be held legally accountable for injury to other persons. Medical law attempts to define, however crudely, the permissible limits of medical practice; upholding the right to autonomy, the right to dignity and the right to life are the fundamental claims. Medical laws differ among nations in the European Union and consequently different legislations concerning physicians’ liability apply. Rectifying legal actions concern civil or criminal prosecutions [7]. Professional disciplinary proceedings pertain to self-governance and are implemented by responsible regulatory professional bodies. Besides professional medical bodies and boards, there also other stakeholders in health care such as medical corporations, the pharmaceutical industry and publishers of medical or scientific journals, which also implement their own rules and which impact on practice of medicine.

The practice of doctors is based on science and humanity; scientific knowledge and charity provide equal guidance. Sterile knowledge and technical ability must never make doctors forget patients’ rights and the irreplaceable value of each individual human life. In this context, the DPR is understood as an interaction between two reasonable people in which the physician helps the patient based on mutual understanding, yet it also represents a legally binding document required in all cases to justify and legalize medical actions.

The relationship between ethics and law is not straight forward. One way to think of this relation is that where we agree strongly on an ethical judgement, we sometimes frame it as a legal requirement. Thus, the law seems to encode a moral judgement we all agree with. The law sets standards of conduct while ethics states the ideals of conduct. While the law deals only with punishable transgressions of rules, duties and obligations, ethics, in the attempt to provide guidance, covers the entire domain of health care provision. While unethical actions are not necessarily illegal, illegal actions might not be necessarily unethical. The breadth of the spectrum of human relations, motifs, responsibilities, duties etc. explains the need for careful and thorough evaluation of actions that become of legal and/or ethical concern. Medical ethics takes on special significance in the field of end-of-life decisions, organ and tissue transplantation, transfusion medicine etc. Questions and problems here are caused by a social plurality of moral and value concepts and the right of self-determination of the individual. Here and elsewhere ethicists, and in legal cases lawyers, are asked to gather and evaluate facts provided by the involved parties, and weigh different stakeholders’ interests. While ethicists do not necessarily need to come to conclusions regarding the rightness or wrongness of actions and may provide (only) suggestions and recommendations, the lawyers are expected to make judicial decisions. In most cases, recourse to the legal proceedings should be reserved for conflicts not accessible to reasoning by other means (e.g. ethics) or those representing reprehensible transgressions.

In medicine, the civil law, largely the tort law, deals with claims of negligence addressing the rights for compensations for damages suffered. The criminal law is concerned with the questions of gross negligence and manslaughter.

4.1. Litigations.

Litigation is a process of taking a case to a court of law so that a judgment can be made (Cambridge dictionary).Treatments resulting from errors (unintentional wrong conduct) and wilful (intentional) breaches of standards may be subject to legal queries. Depending on the magnitude of harm to the patient, not only financial compensations but possibly also litigations and prosecutions may follow. Civil law proceedings result when culpable treatment error is proven or treatment was conducted without the patient's consent. Both instances constitute a violation of obligations (see e.g. in Germany Sec. 280 BGB) or violation of the health of another person (see e.g. in Germany Sec. 823 BGB; torts – liability in damages: (1) A person who, intentionally or negligently, unlawfully injures the life, body, health, freedom, property or another right of another person is liable to make compensation to the other party for the damage arising from this.(2) The same duty is held by a person who commits a breach of a statute that is intended to protect another person. If, according to the contents of the statute, it may also be breached without fault, then liability to compensation only exists in the case of fault. Sanctions can also be considered under criminal law depending on the case’s scenario. Thus, in treatments resulting in the death of the patient, criminal law prosecution for gross negligence, manslaughter and offences related to ill-treatment and wilful neglect is possible.

Doctors involved in litigations should provide full and honest accounts of the case in question. However, such an account does not require self-incrimination based on the principle nemo tenetur se ipsum accusare (no person is to be compelled to accuse himself). In cases of pending litigation, legal counselling is strongly recommended.

4.2. Medical negligence.

Medical malpractice is defined as any act, or omission, by a physician, during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient. Medical malpractice is a specific subset of tort law that deals with professional negligence. Medical negligence is defined as the negligent, improper, or unskilled treatment of a patient by a health care professional (LegalMatch).

The concepts of liability, defined as the fact that someone is legally responsible for something (Cambridge dictionary), and medical negligence are internationally diverse and range from strict liability for fault, to liability for accidental damage, to liability completely independent of fault. What these concepts have in common is that the cause of liability lies in the judgement of increased risk of a certain state or behaviour for the rights of third parties such as a basic right for safety, equal treatment and freedom from harm guaranteed by the constitution. These basic principles are an essential characteristic of social coexistence in democratic systems.

Negligence as a civil law concept addresses the claims of malpractice related to the conduct of improper treatments. Claims of gross negligence are subject to criminal law. The confirmation of negligence requires proof that an accused doctor owed the claimant a duty of care, that the doctor breached that duty and that the breach caused the damage [7].

Thus, following the legal definition, any doctor acts negligently if he or she disregards the established and expected standards of reasonable medical care to which he or she is obliged to excercise and is able according to the specific circumstances including his or her personal medical knowledge and skills. Yet, the definition of standards of medical care is far from straight forward. Courts define standard care mostly as the care delivered by a reasonable doctor following the established standards of medical care. For example, in Great Britain, Bolam’s case definition applies; a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art [7]. However, the required standard of skills has been disputed; in some Europeans countries the term experienced specialist is used instead. Nevertheless, either term implies definite performative expertise and ethical responsibility. It is then up to the court’s proceedings to decide whether the criteria of negligence have been met. To assist the courts to decide the case expert witness opinion is usually required.

Negligence can be attested when evidence can be found that inappropriate medical actions were taken and could not be justified in a given case scenario. Once negligence has been attested, the severity of infraction and damages must also be considered. Examples of negligent (substandard) treatments include provision of treatments without valid IC, disclosure of confidential data, sidestepping the duty to obtain informed consent, fudging data, manipulating patients’ charts etc. Examples of gross negligence include performing high risk treatments without sufficient expertise, particularly if resulting in relevant harm or death of the patient, trafficking in drugs, cover-ups of medical disasters, refusal of emergency medical assistance, conduct of unlicensed treatments, sexual abuse etc. However, allegations of negligence always require detailed and thorough evaluations; in most cases written expert opinion is required. Assessment of damages and compensation is based on considerations of fairness and reasonableness; the claims may include such damages as injuries, pains and sufferings, loss of amenities, incurred expenses, loss of earnings and future losses [7].

In clinical practice, when complications occur, negligence may be assumed or considered by the party bearing the harm. If an operator is sued for negligence, he or she is asked to provide a detailed account of the case; frequently, external expertise is brought in. The issues to be clarified include the availability of the required expertise and legitimacy of the ctreatment, compliance with procedural standards, reasonableness of actions taken, proportionality of means and outcomes etc. Operators are expected to provide a full account of the procedure in question; transparency is the best strategy to assure just and fair proceedings. In all cases of alleged gross negligence, legal counselling is required.

4.3. No fault concepts; medical mishaps.

Given the complexity of some treatments, the difficulties of definition of unequivocal norms or standards and perhaps even greater difficulties of determining causal relations between actions taken and harms, the proof of negligence may be difficult in some cases. Thus, to avoid lengthy legal proceedings, system paralysis as well as possible uncertainties of verdicts, in some countries (e.g. Sweden, New Zealand) the no fault concept medical liability compensation system has been adopted. Arguments in favour of and against no fault schemes have been discussed elsewhere [7]. However, this concept is not legally recognized in all Europe. For example, a legal definition of the term medical mishap does not exist in German law. In legal terms, a complication caused by an error is considered violation of the recognized rules of medical science, while taking into account the abilities of the individual physician. The recognized rules of medical science are those medical methods that are generally known, accepted, and constantly practiced. Errors may concern diagnosis and therapy, consulting and organizational procedural steps, but also faulty assumptions. In some cases errors as defined in legal terms can be found, in other cases complications may occur without culpable negligence or error of the doctor. The law of damages does not exempt the individual from any unforeseen events and, in particular, does not impose personal risk on third parties. Only negative consequences of a treatment based on a breach of duty by physicians (but which do not present themselves as a general fate) are therefore punishable in the sense of a treatment error.

When harm occurs, the question of responsibility and compensation arises. While it is widely agreed that patients’ compensation is justified in cases with complications causing harm due to errors, the question of patients’ compensation in cases with unproven causality and unclear accountability remains unsettled. At present, liability insurances in health care in the majority of European countries are not designed to provide compensations in cases of damages where the causes remained unproven, an exception being the countries with no-fault compensation principle. However, the issue of compensation is far from settled elsewhere and remains, along with disputes about the level of financial compensation, a matter of debate with, as yet, varied court rulings.

ILLUSTRATIVE CASE

A 70 year old male patient is admitted with Non-ST Segment Elevation Myocardial Infarction (NSTEMI). Coronary angiography reveals multi-vessel coronary artery disease characterized by three high grade coronary artery stenosis in different coronary arteries. After discussing the findings, the patient agrees to proceed with PCI. The operator decides for a staged procedure and treats the most severe lesion first. Following the treatment, the patient is transferred to the Intensive Care Unit (ICU). One hour after PCI, ventricular fibrillation occurs. Following resuscitation, coronary angiography reveals occlusion of one of the other concurrent coronary artery lesions and good results after PCI. Successful complete revascularization is performed resulting in extensive myocardial infarction. Retrospective analysis of the coronary angiograms does not reveal any morphologic findings of unstable culprit lesions. Is the poor outcome the result of an unidentified error or simply bad luck?

ILLUSTRATIVE CASE

A 78 years old female undergoes emergency carotid artery stenting (CAS) for acutely symptomatic high grade (NASCET 80%) ulcerated left internal carotid artery (LICA) stenosis. During the placement of the thromboembolic device (TED), the basket jams and cannot be released. In the attempt to overcome the resistance, the 8F Neuromax catheter becomes dislocated into the aortic arch, pulling the TED behind. The patient becomes unconscious and occlusion of the LICA and/or distal embolization is suspected. After restoring the Neuromax catheter into the LICA, a normal cerebral angiogram is obtained and using a different TED stent is securely placed. Following post-dilatation using 5.0x15mm balloon catheter therapy and subsequently all-out resuscitation resistant hypotension develops and the patient dies. The combination of technical difficulties (jamming device), operator error (dislocation of the catheter) and patient idiosyncrasy (resuscitation resistant hypersensitive carotid syndrome) leads to a tragic scenario with three interlinked critical factors. Retrospectively, correct procedural actions can be easily identified; the removal and replacement of TED with another device, no manipulation; prevention of the dislocation of the catheter, if possible; indication for carotid endatherectomy rather than CAS. A detailed and transparent review of all consequential steps will help to make future procedures safer, yet the question of the legal and ethical responsibility remains open for discussion.

4.4. Are there specific legal considerations in interventional cardiology?

There is no specific legal framework for interventional cardiology. However, it must be taken into account that the more dangerous and risky intervention, the greater the liability. This applies both to the potential problem of medical malpractice as well as to the question of (informed) consent. The more risky and dangerous the intervention, the more comprehensively the patient must be informed, otherwise there is no effective consent. The liability of other parties involved (manufacturers, service providers, etc.) for medical devices or drugs, for example, is also becoming increasingly important and is particularly relevant if the intervention is associated with potentially great risks due to the use of devices and instruments. Nevertheless, the basic considerations under liability law are not different in interventional cardiology from those in other medical fields.

FOCUS BOX 3

Medical law provides a legal framework for medical practice. Medical ethics defines the ideals for the conduct of medical professionals, emphasizing the ethical foundation of doctor-patient relationships based on mutual trust between two rational human beings.

Knowledge of legal aspects of patients’ education and consent as well as a thorough understanding of basic legal principles should complement the cognitive and other competencies of operators.

5. Components of ethics in interventional cardiovascular medicine

While medical ethics borrows from numerous schools of ethics, those from virtue ethics are rare. This is different in Interventional Cardiovascular Medicine (ICM). Here, the operators bear personally the full responsibility for the conduct and outcomes of procedures carrying relevant risk of harm to the patients. To bear and to account for this responsibility, a number of specific “virtues” is required.

Virtues are considered good habits leading people towards good actions. Health care professionals are expected to act with compassion, honesty, fairness and diligence [7] and Beauchamp and Childress list five representative virtues: compassion, discernment, trustworthiness, integrity and conscientiousness [9]. However, ICM is characterized by specifics such as the risk of iatrogenic harm needing comprehensive assessment – with relevant factors including benefit accounting, imperfect visualization of the target sites, limited control of the instrumentation and the probabilistic nature of outcomes as well as a number of other factors such as a high load of emergency cases and dealing with highly competitive, high-pressure environment – which place serious demands not only on cognitive and psychomotor skills but also importantly on ethical competence and integrity.

Thus, the importance of ethics at the PPME level in ICM cannot be overestimated. Operators should not be only familiar with but should also embody “virtues”, including those specific to ICM. Some of these “virtues” will be discussed below.

5.1. Operators

5.1. Operators

Operators are primarily responsible for the safety and well-being of patients in their care. This noble responsibility is based on interventional excellence and ethical integrity. To meet these challenges, operators need to possess a number of competencies and attributes; some of the key attributes have been captured in Table 3.

Fellowships in ICM are designed to teach procedural skills using traditional means (textbooks, seminaries, lectures, conferences, live-case demonstrations etc.), practical clinical training (assisting in cases) and increasingly also virtual and simulation devices [26, 27]. However, interventional ethics are not as yet a defined part of these curricula. Due to the growing importance of the medico-legal considerations in ICM, inclusion of dedicated courses on medical ethics into fellowship curricula and operators’ education appears justified. Some of the topics relevant to professional ethics in ICM will be discussed below.

5.1.1. Professionalism and professional honesty.

Professions are occupations requiring specialized qualification and expertise. Professionals apply specialized knowledge and/or technical skills in service to the community. To justify professional services, communities decide on their importance, acceptable costs and privileges granted. In return, professional bodies provide the expected services and establish codes of professional standards of conduct, and in the case of medicine, moral responsibilities [28].

In medicine, which was originally considered an art, some of the axioms of ethics such as primacy of patients’ well-being, sanctity of life, importance of moral purity, and discretion are contained already in the Hippocratic Oath [29] and the famous no harm diction [30] have survived millennia. Since the end of 19th century, when medicine has come to be considered science rather than art and more recently even as part of business services, other issues such as patient autonomy and self-determination have been emphasized.

While traditionally the DPR has been the main concern of medical ethics, more recently numerous other issues, often not directly related to patient care, have achieved prominence. Thus, economic needs, commercial pressures and other public forces emergent in modern societies have transformed health care into an externally regulated business of managed care and financial motivated enterprise. In this new climate, the altruistic fundamentals of the medical profession need to be explicated, taught and fortified. The Ethics Manual issued by the American College of Physicians aptly reviews the contemporary principles of medical ethics [31]. As stated by the authors: pursuit of ethics is timely, pertinent and enduring and will help physicians avert future problems.

Medicine, law, and social values are not static. Re-examining the ethical tenets of medicine and their application in new circumstances is a necessary exercise. The seventh edition of the American College of Physicians (ACP) Ethics Manual covers emerging issues in medical ethics and revisits older ones that are still very pertinent. It reflects on many of the ethical tensions in medicine and attempts to shed light on how existing principles extend to emerging concerns. In addition, by reiterating ethical principles that have provided guidance in resolving past ethical problems, the Manual may help physicians avert future problems. The Manual is not a substitute for the experience and integrity of individual physicians, but it may serve as a reminder of the shared duties of the medical profession.

‘Honesty’, one of the moral maxims, means truthfulness. Full transparency and openness implied in this context, however, may not be always possible and in some cases even not called for in medical practice. While doctors should not lie to or for the patient in certain circumstances white lies may be appropriate. However, defensible deceptions and concealments remain controversial [32] and a case-to-case approach should be adopted.

IlLUSTRATIVE CASE

A 70-years-old female presented with a left hemispheric ischemic stroke and high grade stenosis of the left internal carotid artery (LICA) by color duplex ultrasound examination. Following clinical stabilization, extensive patient education and after signing informed consent papers, the patient was scheduled for elective carotid artery stenting (CAS). Four-vessel cerebral angiography revealed NASCET 95% stenosis of the LICA and a heavily calcified type III arch as the main findings. Despite multiple attempts using various combinations of different introducing catheters and 0.035” guidewires, the sheath could not be introduced into the common carotid artery (CCA). At this point the operator decided to employ the 8F Simmons II catheter. In the aortic root the attempts to reform the catheter failed. Multiple failures prompted the operator to attempt the reformation of the catheter by placing the stiff end of the guidewire first. Suddenly, the patient experienced severe chest pain. Angiography of the aorta revealed focal dissection of the ascending aorta. The patient was transferred to cardiac surgery for aortic repair. The post-operative course was uneventful. Following recovery, the patient was informed that emergency surgery was required to treat CAS- related complications; the presumed cause of the complications were not stated.

The likely cause of the aortic dissection complicating the CAS procedure was the use of the stiff end of the 0.035” guidewire inside the vascular system; clearly, a breach of interventional rules. The operator reported that in this case the use was deliberate. The operator said that the reason to resort to this approach was the worry about the increasing risk of stroke complication and frustration about the course of the lengthy and difficult procedure. The operator said that it was the first time that that approach had been implemented. The operator said that the choice of other technical options or referring the patient to surgery was not considered at the time.

The intervention resulted in a serious harm to the patient. The reason for the aortic dissection has been suggested as likely but not definitely proven. If confirmed, a breach of interventional rules would have been proven.

The benefits and harms of full disclosure of the truth for patients and operators have been discussed in the literature but remain inconclusive. Some of the issues of concern include; firstly; the full disclosure of an error could imply prosecution for bodily injury or manslaughter by negligence; secondly, the law observes the legal maxim that no one is bound to incriminate himself; thirdly, financial and capital responsibilities remain poorly defined [33].

In the illustrative case of the 70 years old female patient, the operator applied the policy of incomplete disclosure. Was the operator obliged to disclose the full technical details of the procedure to the patient? Was the patient entitled to full disclosure? Does the policy of ‘don’t ask don’t tell’ apply? What should have been the answer, if the patient were directly to ask about the technical details? Would a full technical disclosure have been imperative in the case of legal proceedings or of the patient’s death?

Possible and tentative answers include; firstly, the operator is not principally obliged to provide full disclosure, if not directly asked by the patient; secondly, the operator is principally obliged to provide full disclosure, if questioned by the law; thirdly, if directly asked by the patient the operator should provide the true answer. If the doctor decides against full disclosure, he or she still must remain fully accountable; if not asked than to his or her own conscience. Self-scrutiny represents the last, and in a long run the most important instance of ethical responsibility and judgments.

ICM operators should develop a firm sense of accountability that includes assuming full responsibility for one’s own actions; avoiding evasions and belittling failures, accepting deserved criticism and dealing equitably with errors are indispensable traits. Habitual professional accountability is safe harbour; dishonesty is not and courts disaster.

5.1.2. Solecism.

Solecism means behavior that ranges in severity from a social error to a serious breach: it includes corruption. Transparency International defines corruption as the abuse of entrusted power for private gain [34]. Corruption comes in numerous forms; opaqueness, bribery, clientelism, collusion, conflict of interests, false disclosure, embezzlement, lobbying and patronage are some of them. Moral corruption does not represent a special category; it is betrayal of moral pledges. Thus, in medicine, acts of moral corruption negate duties and obligations towards patients. Reliable counter-measures to corruption include transparency, accountability, audits etc.

In the past, cases of doctors’ corruption surfaced from time to time mostly resulting in disciplinary measures and reprimands by professional responsible bodies. However, more recently, gross breaches of professional duties have been widely publicized. In ICM particularly, the lures of financial profits derived from possible overtreatments, overcharging and fraudulent billing surfaced and have been evidenced in recent trials [35, 36, 37] calling into question the ability of self-governance to stop doctors’ abuses. In consequence, increasingly strict anti-corruption legislations and regulations have been inaugurated [38, 39]. Doctors should review critically the potential conflicts of interest of a wide range of professional activities such as collection of fees, fee splitting, and fee – based collaborations with industry, patenting, ownership and advertising. Adherence to the professional moral standards and lawful conduct save troubles and avoid belated regrets.

5.1.3. Decision making and risk – benefit accounting.

The guidelines of the European Society of Cardiology (ESC) and the recommendations of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) formulate standards of patient care in ICM. These documents capture theoretical knowledge; practice, including the means of the acquisition of the required technical skills, and ethics are tacitly assumed but not explicated. To transfer guidelines into clinical practice requires operators to possess a wide range of capabilities (see Table 3). However, the guidelines do not explicate the cognitive aspects and ethical dispositions required for guideline compliance.

Decision making, including risk – benefit accounting, in ICM is a highly complex cognitive process described elsewhere [40]. Due to the risk involved in ICM, a thorough understanding of the risk-benefit assessments for individual patients represents an important hallmark of operators’ professional competence. Understanding how to balance risks and benefits in patients’ best interests requires knowledge of the risk and benefit scales. Ethical risk – benefit decisions require comprehensive knowledge of current medical evidence and self-knowledge concerning the ability to provide a service in the best interest of the patient. [Appendix D]

5.1.4. Coping with errors.

Errors are unintentional professional lapses, whereas breaches represent wilful transgressions of established professional rules. Errors may be inconsequential or they may cause variable degrees of harm to the patient. The typology and nomenclature of errors can be reviewed in the literature [41] [Appendix E].

Management of errors and breaches arguably represents the most important and perhaps the most sensitive task to establish and to maintain transparency and accountability in catheterization laboratories. The prevention of errors represents by far the best approach. Nevertheless, errors happen and need to be addressed. Written standard operating procedures (SOP) dedicated to the management of errors are good means to cultivate and preserve fairness and transparency. Such SOP define steps to be followed and the rules to be obeyed when errors or breaches occur; they are equally binding for all members of team. Table 4 summarizes typical contents of SOP dedicated to error management.

The first and most important step is the acknowledgment of possible error. This step requires personal courage and trust in teams’ fairness and benevolence. Distrust and blaming attitudes make the admission of error difficult and even unlikely. Admission of the possibility of an error should be shared first with the team leader or with the most senior member of staff. If a putative error has been recognized and shared, a written protocol should provide procedural details including the action that could have been an error. Sometimes, the evolution and possible escalation of the procedure may provide a rationale for the origin of the error. While the putative culprit action should be stated, the labelling of that action as an error is not called for; a case analysis may later reveal other plausible explanations (e.g. occlusion of a non-target lesion rather than complications at the site of the intervention).

Learning from the experience, and prevention of error in the future, should be based on a thorough analysis of the case with the team leader in an attempt to reveal the potential causes of the error. This is a fundamental step in deliberate practice [42]. Awareness and understanding of the nature of risks associated with ICM treatments may help to handle the emotional upset that may follow making an error. It is important, however, to recognize that identification of errors may not be straightforward. Thus, the probabilistic nature of interventional actions and the multiplicity of different trajectories leading through the vast ‘decision space’ may impede rationalization. Sometimes, even thorough case analysis may not allow the clear-cut identification of an error. Particularly in these cases, premature ‘jumping to conclusions’ is not called for and should be avoided. Sharing the results of case analysis with other members of the team helps to raise awareness of the risk of errors in similar scenarios.

While technical error (e.g. treating a non-target lesion by error) may be admitted unconditionally, admission of errors due to moral failings (e.g. the evasion of treatment of a patient with acute myocardial infarction on a night call duty) is emotionally demanding [43]. The appropriate handling of errors needs to be based on transparency; trust and even-handed treatment of all team members, which is an important prerequisite. Blaming, reproaching, chiding, contempt, derogation and exploiting must be avoided. However, in cases of repetitive and serious offences, firm and fair disciplinary measures are required; turning a blind eye to the habitual offender may become an expensive error. It should be noted that making errors is not limited to novices; complacency might become an ‘error trap’ for experienced operators. To reduce the risk of error, sustained vigilance, including in so-called routine cases, is required.

Being face-to-face with a patient in the aftermath of a harmful procedure can be a troubling and difficult experience. In severe cases, the resulting emotional distress may even undermine professional self-esteem and confidence. In dealing with a difficult situation the operator has to accept from the outset that the best and also the only approach is to convey compassion, solidarity and empathy and to acknowledge squarely responsibility for the outcome. It is important to establish honest rapport with the patient and his/her relatives and to deal with the consequences in a fair and efficient manner. Uprightness in all dealings carries the whole way; attempts to evade or even to cover-up are doomed to fail. Seasoned operators have learned to adopt openness from the onset; less experienced operators might need to learn to overcome uncertainties, fears and doubts before setting the right course. Retaining confidence and professional self-esteem in the high sea of adversities belongs to a virtue of experience. However, confidence and professional self-esteem will survive stormy times only if they are based on sound professionalism.

Breaches, defined as deliberate infractions of established medical standards, may be rationalized by the operator in some exceptional cases (e.g. taking prohibited measures as the last resort in desperate settings, yet, in vast majority of cases, breaches represent severe reprehensible violations of the established professional standards. Breaches performed in bad faith require disciplinary measures; in severe cases they may result in license revocation. If breaches cause harm to the patient, they must be reported to the hospital authorities; in severe cases legal authorities must be notified.

5.1.5. Debiasing.

Biases are systematic cognitive errors caused by subjective preferences resulting from false or incomplete evidence or misguided perceptions [44]. Personal biases are likely to compromise the validity of decision-making. Table 5 provides examples of cognitive biases relevant to decision making in ICM.

The detrimental impact of biases on decision-making in cardiology has been reported [45], yet systematic studies of their impact on decision making in clinical medicine are not available [46]. Similarly, no data on the role of biases in ICM is available. Nevertheless, due to the ubiquity of cognitive biases in mental activities, their presence and precarious impact on decision making in ICM is highly probable. Awareness of the presence of biases and adoption of anti-bias strategies (debiasing) are the key steps to bias control [47]. Closer attention and teaching to control biases in ICM will likely improve cognitive performance in interventional therapy in the future.

5.1.6. Resilience.

The practice of ICM imposes high demands on the mental, emotional and physical resources of its operators. Particularly, complex, long, high-risk, emergency or escalating cases, as well as long working hours, may push operators to their mental and physical limits. The successful conduct and conclusion of tough cases depends on operators’ ability to sustain attention in all procedural steps. As the going gets tough, operators need to mobilize all their cognitive skills to a single cause: the resolution of crisis, often in life and death scenarios. The absolute concentration and focused attention required in these cases may be compared to the mental state of the soccer player performing a penalty kick in an important match. He or she, too, must eliminate all outside and potentially disturbing factors to assure the best performance. The pressure to succeed and the need to focus all resources towards a single aim appear to be similar. The need to stay in control and to persevere in the ups and downs of demanding procedures, however, may be unique to ICM operators. While in more “routine” cases operators’ mental and physical resources may be divided, to attend to other aspects of procedures in difficult escalating cases, all their cognitive resources must be dedicated to the conduct of the procedure. Under such circumstances, the operator must fully rely on the team to take over those other responsibilities.

Resilience, variously defined as the ability to persevere in adverse circumstances [48], becomes an important attribute in the conduct of ICM. Persistent long-term training is required to develop the means to overcome fatigue, to control mental upheaval and to follow the set course. Resilience eventually becomes the distinguishing hallmark of high-level operators.

5.1.7. Courage.

Falstaff's ‘discretion is the better part of valour’ in Shakespeare’s Henry IV and Hemingway’s ‘grace under pressure’ are literary expressions applicable to characterize the sort of courage required in ICM. Thus, courage in ICM stands for the equanimity, steadiness and unwavering resolution to achieve the best achievable outcome for every patient under all circumstances. It is controlled and rational. Following the principle of proportionality of means, it weighs carefully the expected risks against the presumed benefits while keeping in mind the optimum outcome and, most importantly, patient’s safety. The development of controlled and measured courage in ICM is a complex skill important to all operators. Dedicated and deliberate interventional practice is the best means to achieve this aim.

Recklessness mistaken for courage is dangerous and reprehensible. Equally, however, timidity hampering the flow of the decision – action processes is unwanted and should be avoided. Recklessness courts disasters. Timidity and hesitancy, however, are also deficient inviting long procedures and increasing procedural risk resulting in poor outcomes; both of these extremes should be avoided.

5.1.8. Leadership.

The conduct of ICM procedures requires teamwork. Catheterization laboratory teams are fully involved in the organization and performance of procedures. Team members attend to the patients. Sensible and caring rapport with patients and close attendance to their needs assure patients’ comfort, allay fears and facilitate the course of interventions. Vigil in the form of watchful and sensible participation of team members is always helpful but becomes essential in escalating and emergency procedures. The quality of verbal and tacit communication between team members become key determinants of success or failure. Thus, team – play should be practiced; SOP assigning the role of each team member in emergency cases facilitates workflow and fluency.

Team coherence is also important in times of crisis. To deal with critical situations effectively, strict and consistent adherence to the established standards is required. In most critical cases: the command stick to the protocol may represent the last resort option. Team spirit based on shared responsibilities is always important; in situations when ‘thumbs are down’ and the odds dwindle, it is priceless.

Team leadership requires professional and moral authority. The first among equals, the leader is a role model for others ideally living up to the virtues of professional competence, honesty and fairness that he/she is expected to project. However, only authentic leaders may expect the respect of their teams. Authentic leaders build up trust by providing sufficient opportunities to express appreciation and to voice concerns by calling regularly staff meetings with set and open agendas. Encouraging transparency and the demonstration of abilities to absorb, to take seriously and to respond adequately to criticisms are also important traits of authentic team leaders. Consistent fair treatment of all team members prevents discord and rancour. Approaching all members of the team with respect is a recipe for trust; favouritism is recipe for discord. A firm stance in cases of infractions of duties and the adoption of decisive measures in cases of offences and transgressions certify to the resolve of the leader to hold the course. Establishing and maintaining an orderly yet easy going working climate, along with the ability to navigate conflicts efficiently and fairly, are the trademarks of master leaders and the important aim for the development of future leaders.

Only authentic leaders who do what they preach are convincing. Only such leaders are able to develop the appropriate and maintain team culture to master adversities. Failure to lead invites mess. Disrespect, disloyalty, bad-mouthing, scapegoating, and whistle-blowing, discord and revolt are typical signs of poor or missing leadership.

FOCUS BOX 4

The practice of ethics in Interventional Cardiovascular Medicine is highly dependent on ethical integrity of operators. While the general virtues expected from all medical professionals also apply, operators, due to their exposed status, need to acquire a number of ICM specific professional virtues. The practice of virtues assures ethical integrity and long-term capacity in a highly competitive and demanding profession.

6. Related issues

Operators work and need to master a complex working environment. Besides having to focus on the main task - patient care - they also need to attend to multiple other responsibilities towards the community, public, employers and, not least, their families. Some of these issues may distract, impede or even conflict with patient care. In the context of this chapter only some of the topics will be reviewed.

6.1. Triage and Limited resources.

Health care (see Appendix F) is driven by the principles of need and availability.Only about 12 months ago, while we were writing this section, the need for triage due to limited resources has concerned developing countries given their low budgets and under financed health care systems [Appendix F].

The corona virus SARS-CoV-2 pandemic has brought home the issues related to triage under the conditions of limited resources to all concerned countries. The enormous surge in the need for personal protection equipment, medical supplies including infusion pumps, respirators, intensive care beds etc. has raised number of issues concerning ethics not commponly dealt with in advanced countries’ health care systems.

These shortages requiring triaging and the immediacy of needs to deal with their professional and private responsibilities and individual anxieties challenged relentlessly health care providers’ ethics. Although interventionists have not been the typical primary care providers in the pandemic, they too became increasingly involved in frontline care for Covid-19 patients due to the high incidence of cardiovascular complications.

Witnesses’ testimony best represents the scale of the threats:

In a pandemic, patient-centered care is inadequate and must be replaced by community- centered care. Solutions for Covid-19 are required for the entire population, not only for hospitals. The catastrophe unfolding in wealthy Lombardy could happen anywhere.

Clinicians at a hospital at the epicenter call for a long-term plan for the next pandemic.

Our own hospital is highly contaminated, and we are far beyond the tipping point: 300 beds out of 900 are occupied by Covid-19 patients. Fully 70% of ICU beds in our hospital are reserved for critically ill Covid-19 patients with a reasonable chance to survive. The situation here is dismal as we operate well below our normal standard of care. Wait times for an intensive care bed are hours long. Older patients are not being resuscitated and die alone without appropriate palliative care, while the family is notified over the phone, often by a well-intentioned, exhausted, and emotionally depleted physician with no prior contact.

But the situation in the surrounding area is even worse. Most hospitals are overcrowded, nearing collapse while medications, mechanical ventilators, oxygen, and personal protective equipment are not available. Patients lay on floor mattresses. The health care system struggles to deliver regular services — even pregnancy care and child delivery — while cemeteries are overwhelmed, which will create another public health problem. In hospitals, health care workers and ancillary staff are alone, trying to keep the system operational. Outside the hospitals, communities are neglected, vaccination programs are on standby, and the situation in prisons is becoming explosive with no social distancing. We have been in quarantine since March 10. Unfortunately, the outside world seems unaware that in Bergamo, this outbreak is out of control.

Western health care systems have been built around the concept of patient-centered care, but an epidemic requires a change of perspective toward a concept of community-centered care. What we are painfully learning is that we need experts in public health and epidemics, yet this has not been the focus of decision makers at the national, regional, and hospital levels. We lack expertise on epidemic conditions, guiding us to adopt special measures to reduce epidemiologically negative behaviors.

This outbreak is more than an intensive care phenomenon, rather it is a public health and humanitarian crisis. [49].

Some of the ethical issues emerging in the spreading pandemic, such as those concerning the limitations of materials (personal protection, Corona virus test sets, respirators etc.) and triage logistics, have been addressed [50, 51, 52]. Yet, major weaknesses of systems of health care, even in affluent countries, have dramatically surfaced. Frequently, lacking legal or ethical guidance, the community of doctors and other health care providers has been forced to provide ethically defendable answers and to organize medical practices accordingly, immediately.

While the need for elective ICM procedures has been temporarily reduced, the need to reorganize the delivery of patient services has become pressing. The issues that have been addressed early on have largely concerned spatial separation of infected and non-infected patients, education in handling infected patients and materials, measures of personal protection, staff reorganization into small units sharing the workload, protection of colleagues with high risk of a severe course of the disease if infected etc. Other issues such as possible modification of strategies of percutaneous coronary interventions (PCI) (staged vs. single stage procedures, risk of complications limiting measures - highly experienced operators performing the Covid-19 cases, postponing stable highly complex cases, avoiding escalating procedures e.g. associated with complete revascularizations etc.), reconsidering indications for structural heart disease interventions and other practice relevant topics may need to be addressed in the future. It appears likely that different ICM groups will reach different conclusions regarding proper management of care, depending on the local conditions. Due to the heterogeneity of conditions, universally valid solutions to emerging challenges are unlikely. However, the pandemic forces development of ethically defensible rules designed to establish logistics required to combat large scale medical emergencies. Addressing material and ethical preparedness for catastrophic events should bring about the close collaboration of experts in both high- and low income countries.

6.2. Conduct of research.

Research is a critical driver of progress and innovation in medicine. As a fallout of historical experiences [53, 54], research on human beings has been strictly regulated [55, 56] conditioned upon the freely given, informed consent of the patient, extensive education, moral justification and written authorization by patients, as codified in the Handbook for Good Clinical Research Practice issued by the World Health Organization [57] and endorsed worldwide.

While the quality of research has been raised, at the same time increasing numbers of breaches against research standards and ethics have surfaced. Entering fraud research showed 323.000.000 hits into a search engine (April 10, 2020). The Retraction Watch Leaderboard is led by 183 retractions for a single author (April 10, 2020) [58]. Thus, much has been written about scientific misconduct and doubtful practices that include fraud, data manipulations, shoddy interpretations, overstatements, lack of reproducibility of results, poor study designs, conflicts of interest, corruption, plagiarism and other transgressions.

To restore the credibility of clinical research, European regulatory boards, public sponsors, and medical companies, have adopted strict rules regulating the conduct of clinical studies [59, 60, 61, 62]. Furthermore, in proven cases of abuse such as fabrication and falsification of data, plagiarism, and fraud, disciplinary measures reinforced by legal sanctions have been introduced [e.g. 63- 65]. In addition, the leading medical and scientific journals including the European Heart Journal and Nature have introduced strict policies regarding the transparency of data submitted for publication. Thus, for example, access to log books, presentation of the source data, disclosure of technical details etc. are increasingly a matter of established policies. Recently, attention has been drawn to damage to science related to emerging cases of systematic fraud and data fabrication [66]. As the last resort, in extreme cases of research misconduct, legal prosecution may be considered [67].

From a legal point of view, there are wide-ranging regulatory frameworks addressing the questions of basic rules of clinical research and consequences resulting from violations of these rules. If a patient gets injured in the course of improper clinical research, general civil and criminal sanctions apply. If breaches of duty have been also proven (see for example in Germany in accordance with the provisions of the German Medicines Act, the Medical Devices Act, or similar regulations), sanctions ranging from the initiation of administrative offence proceedings to allegations of conduct relevant to criminal law and civil law sanctions may also become effective. In addition to civil, criminal, and public law sanctions, professional sanctions including the withdrawal of a doctor’s licensure are conceivable.

Understandably, ICM research is mostly clinical and far less frequently comprises basic research. Consequently, most research focuses on clinical practices concerning new drugs, devices, and novel techniques and technologies. To assure accountability and compliance with the existing codes of conduct and ethics, a number of measures such as transparency of data storage, open access analysis review of data, use of core laboratories, direct accountability of individual authors etc. have been introduced. To stop unsound and unethical practices, a helpful overview of relevant topics is available in the literature [68].

Decisions concerning the conduct of device studies commissioned by the industry should be based on the clinical value and scientific merits of the intended studies. A recent example warns against abuse of clinical science for commercial profit, self-promotion and commercial hype [69]. Clearly, the ethical integrity of all researchers is not a given; the development of courses dedicated to ethics in research are long overdue and should become a basic component of MD, PhD curricula.

6.3. Relationships with industry.

Medical companies are important partners and stakeholders in ICM. Highly successful professional relationships between Charles Dotter and William Cook in the 1960s [70] and between Andreas Grüntzig and Schneider Medintang Company in the 1970s [71] have become legendary. Nevertheless, in the 1980s concerns regarding potential conflicts of interest in the emerging medical-industrial complex were raised [72, 73].

A number of cases of wide spread corruption [74] and dilemmas resulting from “walking the borderlines” [75] have confirmed the early concerns, seriously undermining trust in self-governance. Besides the self-regulatory measures of individual stakeholders, extensive measures were taken by regulatory bodies targeting bribery in medical service delivery, procurement corruption, improper marketing, abuse of leadership positions and undue reimbursement claims [76].

In addition, legal measures addressing the corruption associated with the medical-industrial complex have been put in place. However, due to differences in the legal systems among countries, legal terms are nation specific with different codes of application and reach. For example, in Germany, traditionally only the regulations according to Sec. 299 StGB (Strafgesetzbuch) – bribery and corruption in business transactions – as well as the regulations in Sec. 331–58 StGB (concerning civil service officials) apply to the German Health Care System. After a long dispute about the extent to which even physicians in private practice could make themselves liable to prosecution for bribery offences (this was ultimately negated by the courts), the legislative created a special element of offense in Sec. 299a and 299b, so that corruption in private practice is now also liable to prosecution. Four principles are decisive for all compliance rules, which are to be considered independently of the specific offence:

documentation
transparency
equivalence
separation of regulatory decision and financial contribution.

The current regulations do not prohibit, but clearly regulate, the partnerships between medical companies and health care providers. All relationships must have the same footing: fairness, accountability and transparency. Disclosure of all financial relations is mandatory. Doctors involved in collaborations with industry are obliged to provide full disclosure of the nature of their relationships. Ethical considerations include assurance of authenticity of declarations and soundness of business relations. Purely pro-profit relationships clearly collide with the key mission of the medical profession, which is in service to patient well-being and safety.

6.4. Teaching and Life cases.

Life case demonstration in interventional medicine is associated with Andreas R. Grüntzig and his early work at the University Hospital Zürich. In order to preserve controlled conditions in catheterization laboratory while facing increasing number of visitors keen to learn the new technique of percutaneous transluminal coronary angioplasty (PTCA) Dr. Grüntzig decided to set up direct video transmissions from the laboratory to the audience in the auditorium duringthe teaching courses [77]. Eventually, life case presentations have become a fixed feature of teaching and interventional conferences.

More recently, ethical concerns regarding life case presentations have been voiced [78]. Patient safety and privacy and the impact on operators’ performance, related to possible distractions by the presence of media teams, have been discussed. Later studies have not confirmed these concerns [79, 80]. Other objections included the potentially commercial character and abuse for private marketing. Industrial sponsorships, particularly if novel products were utilized, were also criticized.

To mitigate criticism, live-in-the-box cases were introduced as a possible alternative. However, by comparison, in live-in-the-box cases the atmosphere, immediacy, and drama of unfiltered procedural actions is clearly missing; the air of artificial, mute, sterile and pre-arranged presentation is difficult to avoid. Witnessing real-life procedures in real time provides the observer full access to the intricacies of evolving case scenarios he or she experiences in in own ICM practice. In addition, the ability to ask questions, make suggestions, and discuss operators’ decision on-line represents an important teaching experience. The immediacy of the actual “drama” encountered in the real life of laboratories, and the identification of viewers with the team actually performing the cases, provide for an important emotional experience which is useful in coping with the stress experienced in their own catheterization laboratories. The need to respond to unexpected courses of action and the real-time decision-making by experienced operators provide a unique opportunity for professionals to learn how to master similar scenarios in their practice.

Clearly, concerns regarding the practice and presentation of life cases need to be addressed and rules of conduct should be set. First of all, these rules should provide for extensive and detailed patient education as to the nature and purpose of the transmission. In addition, strict regulations are needed concerning the potential issues of abuse concerning product- or self- promotion and other lures of public relations which should be prohibited. To minimize the procedural risk, the interventions should be performed by experienced operators and high-risk cases should be excluded. Finally, the audience should be restricted to ICM professionals.

6.5. Team approach.

The increasing technical sophistication of interventional treatments, the availability of alternative treatment options and increasing co-morbidities of patients, all contribute to the complexity of decision making. While, in standard cases, individual experienced operators are well equipped to make decisions on treatments, in all elective non-standard cases and in some selected emergency cases interdisciplinary teams’ decisions are required. In such cases, only expert teams are well positioned to provide a sufficiently broad and balanced perspective to weigh options, decide accordingly and inform patients objectively. The establishment of heart teams in the past decade as a tool to assure the best available treatments to the greatest possible number of patients is one of the most significant advances in the delivery of quality care and patient education. While, early on, operators were mostly competent soloists, they are now better part of teams. To become a good team player, operators have to learn to examine their own performance and the performance of others critically and fairly. The transparency required to discuss cases represents the best exercise in ethics there is. Only a defensible position can be presented and accepted by the team. Honesty and openness work; concealments and power play don’t. The concept of interdisciplinary heart teams not only assures adherence to the best clinical practice but also guarantees ethically sound decision-making [80]; see also this volume, section Heart Teams].

6.6. Whistleblowing.

Based on the EU whistleblower protection directive, whistleblowing broadly means disclosure of wrongdoing such as money-laundering and breaches of corporate taxation, data, environmental, food and product safety. Whistleblowers are protected from recriminations [82]. The Encyclopedia Britannica defines whistleblowing by stating It covers the activity of any employee or officer of a public or private organization who alerts a wider group to setbacks to their interests as a result of waste, corruption, fraud, or profit seeking. Whistleblower is an individual who, without authorization, reveals private or classified information about an organization, usually related to wrongdoing or misconduct [83]. Despite the noble and ethically responsible intentions of whistleblowing, it is well known since antiquity that no one loves the messenger who brings bad news [Sophocles, Antigone]. Although ‘whistle blowers’ are protected in the EU and in the USA [82, 84), the laws and regulations are complex and their interpretation may be uneven. In Germany, for example, there is still no general (legal) protection of whistleblowers. However, special regulations for leniency to witnesses in criminal law or in finance exist. In addition, on 21 March 2019, the long-awaited Law for the Protection of Business Secrets (GeschGehG) was passed, transposing European Union (EU) Directive 2016/943 into German law. It can be assumed however, that the privileges provided by the GeschGehG will conflict with the future EU Whistleblower Directive. In this regard, certain minimum standards were set on 12 March 2019, although the new EU directive is only at the draft stage and is the subject of a controversial debate.

In interventional medicine, whistleblowing is a measure of last resort to rectify deficiencies or, in rare cases, however, it may become an act of revenge or sabotage. Leadership of interventional teams characterized by fairness and openness makes whistleblowing redundant. If justified, it may lead to amendments. Nevertheless,in most cases the disruption of the teams and the departure of the whistleblower may result.

Conclusion

Ethics represent an integral part of professionalism and excellence in interventional cardiovascular medicine. The assurance of patients’ well-being and safety as well as preservation of autonomy and self-determination is the primary concern of interventional practice. This chapter provides a brief introduction into the increasingly complex and ever more relevant domain of ethics in interventional practice. Achievement of consistent ethical integrity is a lifelong endeavour and important hallmark of top operators.

Personal perspective

Ethics has come to be considered an intellectual activity rather than practical one in modern Western societies. Why? One important reason appears to be the transformation of key ethical issues into constitutional rights; inscribed in the law, these issues have become common sense rather than results of individual ethical growth based on self-scrutiny. Thus, most of us consider ourselves naturally ethical. This may be an error. The ethical complacency may be misleading providing a false impression of the impeccability of one’s own ethical standing and integrity. It may be a truly disappointing experience one day to realize that this self-image has been inaccurate and possibly even wrong. Professional ethics in medicine is not a high ground of philosophical deliberation; it is a matter of critical practice. As human fellowship may be on the decline, advocacy and practice of ethics represent the best antidote. Although never fully reached, ethics is one of the most worthy and deserving targets to be strived for by all medical professionals including interventionists.

Acknowledgment

I would like to thank Professor Tim Thornton, professional philosopher and expert in ethics, for his most valuable advice in the advanced stages of the preparation of this manuscript.

Supplementary data

The appendices below are to be read in conjunction with the main text of the manuscript.

Ethics in cardiovascular interventions

Summary

1. Introduction

2. Ethics

3. Medical ethics

3.1. Ethics; patients’ view.

3.2. Ethics; doctors’ view.

ILLUSTRATIVE CASE

3.3. Doctor-patient relationships.

ILLUSTRATIVE CASE

3.3.1. Informed consent and patients’ education

3.4. Confidentiality

4. Medico-legal concepts

4.1. Litigations.

4.2. Medical negligence.

4.3. No fault concepts; medical mishaps.

ILLUSTRATIVE CASE

ILLUSTRATIVE CASE

4.4. Are there specific legal considerations in interventional cardiology?

5. Components of ethics in interventional cardiovascular medicine

5.1. Operators

5.1.1. Professionalism and professional honesty.

IlLUSTRATIVE CASE

5.1.2. Solecism.

5.1.3. Decision making and risk – benefit accounting.

5.1.4. Coping with errors.

5.1.5. Debiasing.

5.1.6. Resilience.

5.1.7. Courage.

5.1.8. Leadership.

6. Related issues

6.1. Triage and Limited resources.

6.2. Conduct of research.

6.3. Relationships with industry.

6.4. Teaching and Life cases.

6.5. Team approach.

6.6. Whistleblowing.

Conclusion

Personal perspective

Acknowledgment

Supplementary data

RELATED MEDIA

REFERENCES

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