Improving informed consent in percutaneous coronary revascularisation.

Informed consent is indispensable in contemporary medicine, especially in cases where the risks are high or there is true clinical equipoise, as in much invasive cardiology and cardiothoracic surgery practice. In this article we illustrate the principle of informed consent and describe how consent requirements have become more exacting in response to the rise of autonomy as the dominant principle in biomedical ethics. We outline some criticisms of informed consent, discuss why current requirements may never be achievable, and describe some of the vast literature aimed at "solving" the problem. We argue that respect for autonomy is just one of the principles of biomedical ethics and that the implementation of this principle must be weighed in the clinical context against the other principles, namely beneficence, non-maleficence and justice. The way we implement informed consent should be based on an ethical assessment of the clinical situation, including the invasiveness of the procedure, equipoise and the importance of patient values, and not on practical issues. We conclude that focusing on the whole decision-making process, effective communication, and a proportionate and individualised approach to consent could go some way to improve the experience of many patients in cardiology.

Informed consent for interventions in stable coronary artery disease: problems, etiologies, and solutions.

The objective of this review was to determine whether patients undergoing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) (1) understand the aims of the proposed intervention, and (2) whether they are offered alternative and potentially more effective therapies, as required for the process of informed consent. We performed a systematic review of Medline for observational studies of patient understanding and perceptions of coronary revascularization and of the consent process. Data extraction was of patient perceptions of expected symptomatic and prognostic benefits of PCI and CABG, and the proportion of patients offered potential alternative treatments. Eight studies were identified, of which seven were relevant to PCI and three to CABG. On average, 55% of patients correctly believed that PCI would improve symptoms, while 78% erroneously believed that PCI would extend life expectancy and 71% erroneously believed PCI would prevent future myocardial infarction. On average, over 80% of patients correctly identified that CABG would improve symptoms, reduce the risk of myocardial infarction and extend life expectancy. In the three studies that examined whether alternative therapies were discussed, 68% of PCI patients and 59% of CABG patients reported no such discussion. In conclusion, a large proportion of patients undergoing coronary interventions do not appear to understand the rationale for treatment and have erroneous perceptions regarding expected benefits. Moreover, patients are frequently not offered potentially more effective alternative therapies. This raises important questions about the adequacy of the current informed consent process. We recommend a multidisciplinary team approach as the most obvious way to remedy current practice.

Acute ischemic heart disease and interventional cardiology: a time for pause.

BACKGROUND: A major change has occurred in the last few years in the therapeutic approach to patients presenting with all forms of acute coronary syndromes. Whether or not these patients present initially to tertiary cardiac care centers, they are now routinely referred for early coronary angiography and increasingly undergo percutaneous revascularization. This practice is driven primarily by the angiographic image and technical feasibility. Concomitantly, there has been a decline in expectant or ischemia-guided medical management based on specific clinical presentation, response to initial treatment, and results of noninvasive stratification. This 'tertiarization' of acute coronary care has been fueled by the increasing sophistication of the cardiac armamentarium, the peer-reviewed publication of clinical studies purporting to show the superiority of invasive cardiac interventions, and predominantly supporting (non-peer-reviewed) editorials, newsletters, and opinion pieces. DISCUSSION: This review presents another perspective, based on a critical reexamination of the evidence. The topics addressed are: reperfusion treatment of ST-elevation myocardial infarction; the indications for invasive intervention following thrombolysis; the role of invasive management in non-ST-elevation myocardial infarction and unstable angina; and cost-effectiveness and real world considerations. A few cases encountered in recent practice in community and tertiary hospitals are presented for illustrative purposes The numerous and far-reaching scientific, economic, and philosophical implications that are a consequence of this marked change in clinical practice as well as healthcare, decisional and conflict of interest issues are explored. SUMMARY: The weight of evidence does not support the contemporary unfocused broad use of invasive interventional procedures across the spectrum of acute coronary clinical presentations. Excessive and unselective recourse to these procedures has deleterious implications for the organization of cardiac health care and undesirable economic, scientific and intellectual consequences. It is suggested that there is need for a new equilibrium based on more refined clinical risk stratification in the treatment of patients who present with acute coronary syndromes.