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

Katrina Hutchison; Robert Sparrow

Disclosures

Europace. 2018;20(5):739-746. 

In This Article

The Impacts of Competition for Market Share on the Product Improvement Cycle

Pacemakers are a highly successful treatment for arrhythmias, and are implanted into hundreds of thousands of patients worldwide each year. As a consequence of their effectiveness and the high demand, a competitive market has emerged. In the context of this market, manufacturers have been driven to iteratively improve the devices they sell to build market share. These improvements are often in the interest of patients. However, the number of manufacturers and devices, as well as the dynamics of the market, also give rise to ethical issues which can have ramifications for clinicians and patients.

Device Compatibility and Obsolescence

Until the late 1980s incompatibility between new pacemakers and implanted leads was common both when switching manufacturers (cross-platform compatibility) and when switching from an older to a newer device of the same brand (backwards compatibility), with safety implications for patients. The adoption of an ISO standard for pacemaker leads has at least partially addressed this issue. Most pulse generators will now connect to most leads either directly or with adapters that meet the ISO standard.[30–32]

While these particular issues have been largely resolved, there will always be tension between benefit to patients from incremental improvement to medical devices and the impact of improvements on the standard of care available to those with older devices.[33,34] Moreover, manufacturers are likely to continue to have opportunities to attempt to shape the market for their products via design choices that may not necessarily be in the best interests of all patients. Built in obsolescence is a recognised issue with computer systems, where manufacturers can render hardware and software obsolete by releasing new systems that are not compatible with previous releases. Given that pacemakers run on software, the same tactics are possible. Indeed, in contrast with efforts to standardise leads, the use of proprietary software is rarely questioned. Incremental upgrades could work to encourage—or even force—patients and physicians to purchase new and more expensive devices.

Companies release new pacemaker models approximately every 6–12 months.[35] whereas patients have their pacemakers replaced much less often—usually after 8–14 years due to depleted battery.[36] The striking difference between the commercial and clinical life cycles of pacemakers suggests that manufacturers might be driven in part by the desire to encourage more frequent device upgrades. In fact it has recently been suggested that manufacturer indifference to battery life when improving pacemakers and other cardiac implants is an example of this: despite the desire of both patients and clinicians to minimize the number of procedures, battery performance (the most common reason for pacemaker replacement) has not improved for decades.[37]

Product Familiarity and Continuing Education

The frequent release of new pacemakers makes it challenging to stay current while also retaining an awareness of legacy devices previously implanted in patients. There are reports of both lithium ion and plutonium pacemakers that have functioned in patients for over 25 years.[38–40] Thus cardiologists might need to have adequate knowledge of a device manufactured over 25 years ago, while also needing to stay up-to-date on newly released devices. The very short commercial life cycle of pacemakers invites ethical critique if it does not provide benefit to patients and adversely impacts clinicians' ability to stay familiar with the various models they will encounter.

Limitations of the Evidence Recommending Specific Pacemakers

The short production life-cycle of pacemakers and the practice of iteratively changing existing devices means that it is not economical for companies to undertake clinical trials on each device. This is compounded by the fact that there has been no requirement by regulatory bodies such as the FDA for independent testing of new models that are judged to be substantially similar to earlier models.[41] Companies rarely undertake trials or collect data that can allow comparison of the effectiveness of new devices in patients (or, indeed, demonstrate that the 'improvements' associated with incremental device change actually deliver improved effectiveness to patients). There has been some concern in the literature about the lack of comparative effectiveness data for high risk cardiovascular devices such as pacemakers and selective publication of trials.[34,42,43] The regulatory context, however, does appear to be changing, with the European Union recently moving to increase the clinical evidence requirements for high risk implantable devices.[44] Meanwhile clinicians and purchasing bodies should prefer devices for which there is good clinical evidence.

The Role of Clinicians in a Rapidly Changing Environment

In the clinical context, the main thing for cardiologists to be aware of is the way market competition influences the product improvement cycle in ways that may not result in better outcomes for patients. Table 3 lists some key questions that clinicians can ask when deciding whether to recommend a new device to a patient. There is also a political dimension to these issues, and cardiologists are in a unique position to observe the impacts of commercial competition on the evolution of pacemakers. They have an obvious interest in the impacts of this dynamic on their training workload and clinical practice. Through professional bodies it may be possible to advocate for changes to the regulatory environment that make it less attractive for device manufacturers to release new products that do not meaningfully improve upon existing devices, and to tighten requirements for evidence of comparative effectiveness.

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