Electrophysiology: are there any ethical considerations to take into account?

Introduction

Modern electrophysiology is a complex and a rapidly expanding field with several interventions for the diagnosis and treatment of heart disorders. It uses procedures that not only resolve heart rhythm disorders, but also promote a change in the approach to heart diseases, prognosis, quality of life and life expectancy [1]. This incredible evolution allows us to perform more complex and riskier procedures with security and success; however, as with all interventional procedures, electrophysiology has inherent risks and potentially life-threatening consequences.

Any human decision, especially one that involves a cardiac procedure, is a complex undertaking that can have moral and ethical implications. That premise holds true for patients as well as physicians, since both moral values and past experience will certainly influence their decisions as well as the approach to an eletrophysiologic procedure [2]. Based on this statement, the physician has a moral duty to clarify, understand and help patients make their own decisions (without considering their own values), and to be objective and explain the potential consequences and benefits of any approach.

In clinical practice, physicians are confronted with several ethical problems, some of them concern the best therapeutic options to allow resolution of a disorder, but others involve answers regarding the best support and quality of life. In modern electrophysiology, we still attempt to achieve a complete procedure success, with a total electric and clinical resolution. Anything less than this is considered a failure. However, this paradigm has to change.

Clinical success should be measured not just by the total or partial resolution of a disorder but also in terms of clinical improvement or haemodynamic stabilisation. This is something that is lacking in electrophysiology today, which is still only focused on rhythm disorders and their complete control and suppression. This concept can cause some physicians not to refer patients for an electrophysiological procedure because they fear a partial procedure, which does not allow for some patients to have the best medical care and ethical consequences. We should accept some limitations on other acts, namely accept the electrophysiology procedure as a medical act with its limitations, and not limit our decisions simply based on the procedure’s complexity or success rates.

While taking into consideration that the present guidelines and indications are a powerful tool to be used in our defence, the patients remain our ultimate and unique goal. However, it is not possible to simply follow the guidelines in all cases; every case has its unique characteristics. For this reason, any intervention should be performed only if a real improvement can be obtained and with safe conditions and moderate risk. As electrophysiologists, we are responsible for our actions and should not try to escape them; however, we should avoid any futile or unnecessary action places at risk our ultimate goal, the patient.

Informed consent is an ethical obligation and a legal requirement for any medical act. This process safeguards the patient’s autonomy. It tries to ensure that patients have complete information about the procedure, and that they agree to and understand the procedure, its risks and benefits. Discussion about the procedure should be carried out before any technique. The common risks, even if not considered serious, should be discussed as serious risks that are potentially life-threating. Clear language should be used to allow patients to understand and interpret the information, if needed [1]. All aspects and doubts should be clarified and anticipated by the physician before any procedure or informed consent signature.

Without any doubt, the physician has substantial power to influence, and in some cases even to manipulate, their patients’ decisions. Because of this, the physician should be aware and recognise their power when establishing a discussion with the patient. Generally, patients consider the physician to be an expert and follow his/her recommendations without profound questions and doubts. Electrophysiologists should understand this concept, since their procedures have a higher risk (even if performed by experienced physicians) and their words will certainly influence the patient's decision. Supporting the ethical obligation to clarify the procedure, the physician should have a rational argument and indication to propose any intervention. Taking this into account, any communication regarding informed consent should be improved particularly as its implications can have legal and ethical concerns and consequences [1].

Another potential problem of electrophysiological procedures is that sometimes the plan for the procedure has to be altered or is inaccurate once mapping has been performed. Other techniques and procedures may have to be carried out in order to conclude the procedure and resolve the disorder. However, the patient would probably have been unaware of this modification and its implications when informed consent was signed. The procedure’s suspension and its replacement with another approach or/and technique should be considered, so that the patients can be made aware of the situation and have a new opportunity to discuss their concerns about the new procedure and have their questions answered satisfactorily.

As in any other specialised area, the learning curve is difficult and improves only with practical skills. Moreover, the teaching process allows the widespread dissemination of medical expertise which in the future may allow us to obtain better results and better healthcare professionals. However, as electrophysiology is an invasive procedure with some inherent risks, informing the patient that trainees will be involved in the procedure, is more than an ethical duty, and should be directly and clearly communicated to the patient [1]. This is something that is often neglected in the clinical practice. Yet curiously, for the majority of patients, this is not a problem since they allow trainees to practice their skills during the procedure without any limitation [3]. The participation of trainees is important and it is not questionable. However, some rules and concerns should be considered, since their participation implies some ethical dilemmas and potential implications for the planning and during the procedure. Trainees should participate in the procedure as an integral part of their training and according to their capacities, working with a supervising physician controlling all of the acts during the procedure [1].

Electrophysiology is a field that is expanding, with many more areas where we will have the choice of performing more interventional approaches and, as a consequence, an approach that entails a higher risk. For this reason, clinical research in electrophysiology is imperative in order to fully understand the clinical benefit of some of our actions. However, clinical research can expose patients to risks without benefit. As an operator, the physician’s responsibility lies first and foremost patient security, yet as a researcher his/her goals are knowledge and the meeting of research goals. For the physician, there is not an ethical dilemma with these two aspects, since the physician’s role is always more important.

The ethical challenge of electrophysiology regarding research is the physician’s guarantee that research protocol is followed, and that patients are not submitted to unreasonable risks that are disproportionate to the expected benefits of the research proposal. All research protocols performed should be reviewed and approved by an independent group to ensure that the study is ethically acceptable and the protocol has scientific merit and an adequate likelihood of success and a potential social benefit [1].

In the case of a medical complication due to a physician’s mistake or judgement, the physician is ethically required to inform the patient of all the facts necessary to ensure that the patient understands what has occurred [4]. Patients appreciate when a physician admits an error or an unexpected problem. In addition, this honest and true communication is associated with better risk management of problems, fewer litigation processes and more cost savings [5]. Moreover, communication with the truth is an ethical value recognised in medicine [6], that shows faithfulness to the patient. Mistakes are an inherent act. An error can happen in any medical process, and can occur independently of the standard of care followed [7]. Patients should be informed that an error has occurred, since in medicine not all errors are preventable, and the occurrence of an error is not the same as a negligent act or substandard care. This is something that should be clarified with the patient, prior to any intervention. Other important points are the clarification of errors and adverse outcomes, since their significance have different implications and ethical problems.

Conclusions

The objective of this paper was to discuss some of the physician’s responsibilities to patients and colleagues, as well as some of the ethical concerns that electrophysiologists encounter in everyday clinical practice. We have to improve our communication with patients to be able to accomplish our goal of providing the best clinical choices with the best results. Any ethical concerns or problems should focus on the patient as first priority and can be solved if the physician and patient relationship and dialogue remains.

Take-home messages

• Underpinning the ethical obligation to clarify the procedure, the physician should have a rational argument and indication to propose any intervention.
• Electrophysiologists should accept that there are some limitations to their acts and not limit their decisions just by the complexity or success rates of the procedures.