In order to bring you the best possible user experience, this site uses Javascript. If you are seeing this message, it is likely that the Javascript option in your browser is disabled. For optimal viewing of this site, please ensure that Javascript is enabled for your browser.
Did you know that your browser is out of date? To get the best experience using our website we recommend that you upgrade to a newer version. Learn more.

Ethical considerations in Electrophysiology: what should be taken into account?

The dilemma of ethics is “what can be done” versus “what should be done”. A number of issues are encountered in the electrophysiology field that might confuse the alignment of the decision-making process to the principles of ethics.

The first issue is about resource allocation. Challenges are found in dealing with complex procedures with limited resources or in incorporating new technologies for the “best interests” of our patients. The second is quality metrics. The infinite game in this context is in balancing efficiency and safety. The third issue is about evaluating the accuracy of communication with our patients.

Arrhythmias and Device Therapy


Introduction

Ethics is the key to standardising our medical practice to provide “beneficence” without “maleficence” with respect to patient’s autonomy and in a just manner [1].

Ethical dilemmas are found in the choices we make as practitioners and the reasons we provide to justify them. In cardiology in general, and in the electrophysiology (EP) field in particular, the challenge of aligning the decision-making process with the principles of ethics is not yet fully resolved. The “what can” versus “what should” be done is an infinite battle for each EP doctor nowadays, especially with the myriad of affordable gadgets on the market.

In this review, the discussion will be centred on three main issues: resource allocation, quality metrics and communication gaps that are specific to the EP field.

Resource allocation

The electrophysiology field is evolving exponentially and becoming ever more expansive, creating a large gap in practice between different institutions within the same country and around the world. Limited resources due to insurance coverage and healthcare systems (especially in low-and-middle income countries) are the main reason for healthcare inequity. From this, a number of ethical questions might be raised:

Do we really have the right to be selective when informing patients about the therapeutic options to manage their arrhythmia?

Is it an abuse of power or a rational use of resources when you offer catheter ablation for the first patient you see in the clinic but not for the second one because you lack funding?

Thus, resources might overly classify specific therapies in specific situations as a “pseudo-class III of recommendation”. For example, offering amiodarone to treat a drug-refractory atrial fibrillation in your 50-year-old patient because you don’t have access to an invasive EP option.

Another dilemma about resource allocation arises when choosing to incorporate new technologies for the “best interests” of our patients. What are the limiting or favourable factors? Is it crucial to offer the “best technology” to everyone if it’s affordable?

For example, do we all ask for the pulsed field ablation for atrial fibrillation (AF) as it is the emerging energy? Or perhaps send the patient for a hybrid convergent procedure when they have a persistent form of AF?

Quality metrics

Efficiency is crucial in the EP field but the metrics of qualification are not well defined because of the disparities in real-world cases. There is no “one-fits-all” approach and ethical considerations are sometimes blurred.

The burden of “harm”

In order to apply equity in access to standard healthcare, some institutions and some countries might adopt catheter reprocessing policies. In these instances, the dilemma is about the safety or the burden of “harm” of these reused materials. There are concerns about the vendor’s turnaround time, catheter collection logistics, and reprocessing success rate [2].

The clock challenge

In high-volume centres, many procedures are planned for a single day to keep up with metrics. This raises an efficiency issue.

A frequent challenge in this instance is, for example, having five AF catheter ablation procedures planned on the same day but the first one has taken more time than allotted. How ethical is it to spare the posterior wall isolation (as initially planned) for the next patient to remain on schedule?

Futile medical treatment or defensive approach to care

This question arises when you bring to the table, for the third time, the patient with a persistent AF and you get an “all red atria” with the voltage map. These patients have no more mappable substrate to target for ablation yet continue having symptoms from their AF. Do you then stop the procedure and call for a “pace-and-ablate approach” or do you bring out your ablation catheter and try blindly?

Ethical duties about communication to patient

The main dilemma in communication is about the “information given” versus the “hidden truth”.

Informed consent

Informed consent is an ethical obligation in medical practice but not a legal requirement in all countries. Especially in the EP field, it is crucial to obtain consent before making any decisions.  

Communication gaps might affect the clarity of the given information and thus the accuracy of the consent. Language is the first barrier in communication. The technical explanation of some EP procedures and details and the allocated time for discussing are also factors that influence the comprehensibility of the message [3].

For example, how much accuracy can we provide when explaining all the possible approaches for the left ventricular summit related PVCs ablation?

After a brain teaser of a session of informing our patients, how carefully could we  answer the justified or confused concerns they might express?

Additionally, manipulation within communication is of great concern in ethics. For example, when a new “gadget” is on the market, we usually tend to accelerate our learning curve and thus be a biased advocate.

Relationship to trainees

Teaching invasive procedural skills is a necessity to maintain the availability of a widespread medical expertise for patients [2].  Consent for trainees to perform procedures under the supervision of senior physicians is ethical and thus, concerned institutions should include such information in their chart. The remaining question is whether participation in the EP procedure should be part of the trainee’s program or just an option for the curious trainee?

Clinical research studies

Proof of concept studies in the EP world are very challenging to bioethics. As an example, Vein of Marshall ethanol infusion for persistent atrial fibrillation is a debatable concept. Although several operators are leaning towards this approach, especially after the results from the VENUS trial and the recent publication of Pambrun et al from the Bordeaux group [4,5], it is still a dilemma as there are crucial pitfalls that may lead to serious complications.

Relationship with industries

The goal of most EP specialised industries is advancing medical care and applying new concepts for better outcomes, especially in catheter ablation. However, there are ethical concerns about interactions potentially influencing the decision-making process. Conflicts of interest might lead some practitioners to manipulate communication whether intentionally or not.

Another issue with industries is the sponsored studies. The ethical challenge is first about the balance between ethical standards, biased inclusion and exclusion criteria. Second is the publication bias. The sponsored trials are usually bigger and thus preferentially published [­6].

The issue of truth-telling as an ethical value

Honesty about complications from a procedure is an uncomfortable situation for each EP doctor but is an ethical obligation. However, the unanswered question is about disclosing the truth when it concerns only a minor complication. Is it mandatory to report such truths, especially when there is no significant reason?

Problems in truth-telling might also arise when communications concerning all the affordable approaches for a certain procedure are intentionally avoided due to lack of physician expertise. For example, not offering an epicardial approach for ventricular tachycardia, although there is doubt about an epicardial substrate, but the concerned physician lacks the competency to go epicardial.  

Conclusion

In the evolving field of cardiac electrophysiology incorporating innovative technologies, bioethics is more and more challenging. Debates about when, why and how should be addressed individually. The decision-making process is affected not only by the many factors related to the patient’s status but also by local policies, resources, and doctors’ expertise.

It is all about ethical dilemmas, ethical debates, and ethical challenges.

Take-home message

  • Healthcare delivery should be tailored to each patient according to their beliefs and experience, the healthcare system and local resources.
  • Bioethics is a science in progress, mirroring the innovation and novelties in the electrophysiology field.

References


  1. Beauchamp TL, Childress JF. Principles of biomedical ethics. Oxford University Press. 2009
  2. Haines DE, Beheiry S, Akar JG, Baker JL, Beinborn D, Beshai JF, Brysiewicz N, Chiu-Man C, Collins KK, Dare M, Fetterly K, Fisher JD, Hongo R, Irefin S, Lopez J, Miller JM, Perry JC, Slotwiner DJ, Tomassoni GF, Weiss E. Heart Rhythm Society Expert Consensus Statement on Electrophysiology Laboratory Standards: Process, Protocols, Equipment, Personal, and Safety. Heart Rhythm. 2014;11:e9-e51. 
  3. Do the Right Thing But circumstances are making it much more difficult. CardioSource WorldNews Interventions. ACC News Story. Sep 22, 2014. 
  4. Valderrábano M, Peterson LE, Swarup V, Schurmann PA, Makkar A, Doshi RN, DeLurgio D, Athill CA, Ellenbogen KA, Natale A, Koneru J, Dave AS, Giorgberidze I, Afshar H, Guthrie ML, Bunge R, Morillo CA, Kleiman NS. Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation The VENUS Randomized Clinical Trial. JAMA. 2020;324():1620-8. 
  5. Kamakura T, Derval N, Duchateau J, Denis A, Nakashima T, Takagi T, Ramirez FD, André C, Krisai P, Nakatani Y, Tixier R, Chauvel R, Cheniti G, Kusano K, Cochet H, Sacher F, Hocini M, Jaïs P, Haïssaguerre M, Pambrun T. Vein of Marshall Ethanol Infusion: Feasibility, Pitfalls, and Complications in Over 700 Patients. Circ Arrhythm Electrophysiol. 2021;14:e010001. 
  6. Alfonso F, Timmis A, Pinto FJ, Ambrosio G, Ector H, Kulakowski P, Vardas P; Editor’s Network European Society of Cardiology Task Force. Conflict of interest policies and disclosure requirements among European Society of Cardiology national cardiovascular journals. Neth Heart J. 2012;20:279-87. 

Notes to editor


Author:

Zeynab Jebberi, MD
La Rabta Teaching Hospital of Tunis, Cardiology Department, Tunis, Tunisia

 

Address for correspondence:

Dr Zeynab Jebberi, BP 31 Bougatfa Bizerte, Tunisia

 

E-mail: zeynab.jebberi@gmail.com
Twitter handle: @zeynabjebberi

 

Author disclosures:

The author has no conflict of interest to declare.

 

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.