Cardiovascular implantable electronic device selection based on clinical characteristics: A forgotten consideration on assumption that devices are all the same

This paper addresses an aspect of device selection that is very important but widely ignored or misunderstood. The last five decades have seen tremendous progress in evolution of cardiovascular implantable electronic devices. These advances have been possible by partnership between engineers and clinicians. Progress has been in increasing functionality, longevity, ease of implantation, minimizing complications and overall device function to address the patient's clinical needs. Many algorithms have been developed to increase device functionality and efficacy. Device and clinical advances have gone in parallel based on hemodynamics, and management of both tachyarrhythmias and bradyarrhythmias. These are examples of industry‐clinician partnership. In this field, there exists a healthy spirit of competition and collaboration constantly raising the bar to new heights to achieve better and more effective patient care. Additionally, when a clinically valuable advance has been made, manufacturers have tended to incorporate a similar algorithm using ingenious approaches to intellectual property, thereby, offering a wider choice to consumers. These rapid strides in device function have allowed Electrophysiologists to select the appropriate device and programmability for each patient based on their clinical characteristics. An implied assumption is that—devices are not equal, and each device may have a particular asset matching an individual patient's clinical requirement. It is, however, recognized that, in some instances, the difference between devices is too small to show statistically significant trial results and the final choice may be a compromise. The last decade has seen a dramatic shift in how devices are made available to clinicians. The driving factor remains cost, but the method of minimizing cost has changed. This is mediated by institutions either individually or under a corporate umbrella. Sales are by contracts negotiated with dominance of a demand for lower prices in exchange for almost exclusive use of the products of one or possibly two manufacturers. This approach is founded on an assumption that all devices are the same. The push from hospital corporations stems from ever‐pressing cost issues plus a lack of appreciation and involvement by physicians toward differences between devices. Physicians are thus disadvantaged in making the most appropriate choice of device leaving the patient ultimately, adversely affected. Furthermore, this trend deflects physicians and engineers from future collaborative development adding to patient disadvantage. These ill‐effects are examples of a very beneficial process being dumbed down by obsession with cost. The picture should be seen over a longer perspective where early advances such as the advent of “physiological” pacing and Lithium batteries in 1960s and 1970s, to name but two, were very expensive on their introduction. Physicians fought and won the expense issue for their patients. The opposite side of this coin is that recent benefits have perhaps been less dramatic than the two examples mentioned but the real penalty of dumbing down is that development stops. This would be a terrible error by physicians on behalf of their patients. Here is a new battle for physicians to win for their patients. No one else can fight it as in the earlier instances mentioned. Those who feel that all devices from different manufactures with different algorithms and design are the same may base this assumption on a lack of randomized controlled trials (RCTs) comparing one algorithm against another. Lead designs, device characteristics also do not have head‐to‐head comparisons. It is debated that the differences, if any, are too small to be demonstrated by RCTs. In some cases, this may be true but some evidence by registry or survey is necessary. Industry is reluctant to allow such comparisons often on the basis of huge cost of RCTs and other methods. Today, worryingly, most industry sponsored research is in testing the safety of an algorithm against its absence rather than proving superiority over alternatives. The process in this matter could possibly be aided by the Food and Drug Administration encouraging superiority studies of devices, something which appears to be better adopted in the pharmaceutical industry. A detailed discussion outlining the different algorithms and differences in technology between manufacturers is beyond the scope of this article. It may, however, be helpful to highlight a few examples. Rate response was extensively evaluated based on different sensor mechanisms including activity, minute ventilation and closed loop stimulation. Subtle differences, still carrying clinical benefit may have a role in patients based on the type and levels of activity required, and respiratory status. Surely, based on the mechanism of the rate response/sensor there could be an advantage of one sensor over another for some individuals.