Ethics and the Cardiac Pacemaker: More Than Just End-of-life Issues

Katrina Hutchison; Robert Sparrow


Europace. 2018;20(5):739-746. 

In This Article

Equitable Access to Care

The pacemaker is a relatively simple device compared to some implantable medical devices in common usage, such as the cochlear implant. Even so, implantation and follow-up can require interactions between interventional and non-interventional cardiologists, cardiac nurses, radiologists, and technicians. Effective communication between the different parties involved in clinical care is vital, as is the clear delineation of responsibilities.

In the context of scheduled implantations and follow-up it is relatively straightforward to bring together the appropriate personnel and equipment. However, the more people with different skills required to complete a task, the more risk of delays or unsatisfactory outcomes associated with absenteeism or intervening duties. There are no universal or generic pacemaker programmers on the market, despite the fact that such devices would be useful in remote and regional facilities where it is inefficient to maintain multiple programmers for a small number of patients. In emergency settings the risks posed by these features of the modern pacemaker are greater, particularly when non-specialist emergency staff need to keep a patient stable while waiting for specialists and (sometimes) an IEAP or the appropriate pacemaker programmer to arrive. Delays can result in temporary discomfort (e.g. external pacing) or non-optimal solutions to the problem, such as emergency staff cutting the leads of a 'runaway' pacemaker.[52]

The requirement for several specialist staff with different training to work together to treat a patient, the role of IEAPs, and the need to source the appropriate proprietary programmer for the patient's pacemaker are each likely to disadvantage patients who live in regional or remote areas, where services are more spread out and specialist care and equipment is not so readily available. In some cases, these areas have proportionally higher populations of individuals from disadvantaged groups, in which case existing social inequities may be compounded.[53]

These issues are partly an unavoidable consequence of implanting computerized medical devices into patients. They become ethical issues when exacerbated by the impact of commercial considerations (e.g. short commercial life cycles for pacemakers and proliferation of models). Dependence on proprietary programmers, with corresponding challenges for clinicians, hospitals, and patients, poses particular challenges in regional and remote areas where IEAPs are not accessible, and in these areas the availability of universal programmers would have the potential to benefit many patients. However, the ethical issues are complex. Even when driven by commercial considerations, there may be legitimate quality-related justification for the use of proprietary software. In particular, use of proprietary software gives the manufacturer unambiguous responsibility for the quality of the product, and for rectifying any faults. Manufacturers also retain greater control over the integrity of their software.

Another ethical issue arises when public health systems that aim for equity turn a blind eye, and do not take steps to mitigate geographical and social disadvantages in access to care.[54] Cardiologists should be aware of potential disadvantages experienced by pacemaker patients in regional or remote settings and take this into consideration when choosing a device for a patient. Table 5 provides a list of questions to guide reflection on access to care issues when selecting devices for patients who might be affected.