Spanish Rhythm Association member´s perspectives on cardiac implantable electronic device reuse in low- and middle-income countries

Of the 17.9 million reported deaths from cardiovascular diseases in 2019, it is estimated that approximately 75% occurred in LMIC [1]. The lack of prevention programmes and poor access to health care services, or their huge costs are some of the reasons for the high mortality from cardiovascular diseases in these countries [2].

Although CIED implantation is common in developed countries, it is not in many LMIC, partly because the cost of the devices often far exceeds the financial capacity of patients [3]. Thus, in the previous decade, the frequency of implantation in developed countries ranged from 200 to 1000, while in African countries ranged from 0.14 to 233 per million inhabitants. Due to this lack of access to CIEDs, it is estimated that approximately one million people die each year in LMIC [3].

Evidence on the reuse of CIEDs has increased in recent years and it is presented as a reasonable alternative to provide treatment when there is no possibility to access a new one [4]. Reusing CIEDs is not a new concept, as in countries such as Sweden was a common practice in the years prior to the 1990s [5]. As CIEDs must be removed from deceased patients who will be cremated, due to the risk of explosion of the devices when subjected to the high temperatures of the crematorium and approximately 21% of the explanted devices could be reusable, they could be an important resource for LMIC [6]. Furthermore, it has been stated that the reutilization of used devices is a safe practice, provided that they are reprocessed and sterilized appropriately [7]. For this reason, initiatives that recover used CIEDs in the USA and France, recondition and implant them on LMIC where national regulations allow device reutilization have emerged [8‐10].

There is no device donation initiative in Spain but presumably, used devices could be donated to LMIC for reuse. Previous studies have highlighted the importance that these reusable device donation initiatives must integrate a cooperation network between manufacturers, government agencies, patients, clinicians, and funeral directors [11]. It has been reported that the vast majority of patients, potential recipients, physicians, and funeral directors support the donation of reusable devices to LMIC [12]. However, since most of these studies have been carried out in the USA, no international data on these issues are currently available.

This study aims to describe the preferences of electrophysiologists and device implanting cardiologists in Spain regarding the management of explanted devices and their opinions and concerns about the donation and reutilization in LMIC.

The study consisted in an online self-administered form to be completed by physicians of the Rhythm Association (n = 832) based on similar previous studies by Hughey et al. and Logani et al. [11, 13]. The form contained 32 dichotomous, multiple choice or short answer questions. Demographic data such as gender, age, degree, professional speciality, years of experience, and type of institution of work were collected. The following questions collected data about the number of patients in follow-up, number of annual implantations of devices, number and usual handling of explanted devices, preferences about explanted devices, opinions about device advances directives, and concerns about reutilization. Finally, participants indicated their level of agreement with several positive statements on the reuse of cardiac devices by completing a Likert scale. Participants did not receive any financial compensation or benefits for completing the survey.

We obtained 43 responses. One response identified as a nursing professional was excluded because the aim of the study was to describe the preferences of specialist practitioners. Therefore, the response rate among physicians was 5%. Table 1 shows a summary of participant’s characteristics.

The most relevant contribution of this study is that the majority of Spanish Rhythm Association participants in the study support the concept of reusing CIEDs in patients who cannot afford new devices. As in the previous study by Hughey et al., there appears to be a widespread view that reimplantation of appropriately resterilized devices is a safe, reasonable and ethical alternative when a new device is not accessible [13].

Regarding the handling of explanted CIEDs, the majority of participants in our study reported either discarding the explanted devices (74.4%) or storing them in the surgery or extraction site (20.5%). These findings are partially consistent with those of the previous study by Logani et al. [11]. Devices explanted in hospitals in Spain are usually stored for didactic purposes, which may explain the differences in handling preferences of the older than average age group in our study. Moreover, the study pointed out the importance of returning explanted devices to manufacturers, so that they can be checked for possible inadvertent malfunctions [11]. However, remote monitoring is becoming increasingly common in Spain and with the integration of the National Pacemaker Registry, these defects can be detected in earlier stages [14]. Therefore, the need of returning all explanted devices to the manufacturers for malfunction detection has been minimized [11]. In addition, explanted devices are treated as biohazardous health care waste, which could explain these differences with the mentioned study [15].

Although explanted CIEDs are treated as hazardous waste, a considerable number could still have sufficient battery life and adequate function to be reconditioned and reused [16]. Although in Spain there is no legal framework on the ownership of implants, the ownership is considered to belong to the patients, so they or their relatives could claim them once they have been removed [17]. By this means, patients or relatives could recover and choose to donate their devices to a reutilization initiative, if the safe management of explanted CIEDs is ensured. Thus, on the basis of ethical and legal aspects, it has been stated the necessity to provide an advanced directive document for device donation [11]. Studies carried out in patients with CIEDs indicate that the most would be willing to sign this document [18]. In the previous study by Logani et al., only 33% of practitioners indicated that having a document for collecting these advanced directives would be beneficial, attributing the result largely to the increased time it would take for practitioners to inform and collect the advanced directives [11]. In our study, 57.1% of the participants responded that having this kind of document would be beneficial.

In our study, participants indicated their level of agreement with various positive statements on the reuse of CIEDs. As in the previous study by Hughey et al., the levels of agreement in terms of reuse and donation of devices were broadly positive [13]. Likewise, the most common concerns raised by participants surveyed about device reuse were malfunction and infection, as in the study of Hughey et al. [13]. The literature suggests that reuse of properly sterilized CIEDs in other patients is safe. In fact, the most recent meta-analysis found no significant differences in terms of infection (OR 0.98; 95% CI 0.60–1.60), malfunction (OR 1.58; 95% CI 0.56–4.48), premature battery depletion (OR 1.96; 95% CI 0.81–4.72), or device-related deaths comparing reused devices with new devices [7]. However, no randomized clinical trials have yet been conducted on this topic. So, the lack of higher quality research could be largely indicative of the data collected about these infection and malfunctioning concerns. The Project My Heart Your Heart (PMHYH), has a clinical trial underway that could shed light on these issues [19]. However, the results of this trial are not yet available. Therefore, device reutilization should only be considered in situations where a new device is not accessible, informing adequately potential recipients about the risks of reprocessed and getting the respective informed consent [20].

The vast majority of Spanish Rhythm Association participants (85.7%) stated they would support a program to donate CIEDs for reuse in LMIC, which could open the door to a national program similar to those in other countries. Taking into account the data on the advanced directives, implanting physicians could play a key role, informing patients and surrogates about potential device reuse and providing these advances directives for device donation after explant. Explanted devices could then be recovered from hospitals or funeral homes by a non-profit organization, maintaining patients’ wishes. In addition, the organization could then sterilize and recondition the devices for missions in LMIC or collaborate with PMHYH, shipping them the recovered devices, due to its expertise and larger network of professionals and hospitals involved.

Survey studies carried out in patients with devices have demonstrated a favorable view of CIED reuse [18]. It would be interesting to know the perspectives of patients with CIEDs in Spain, in order to describe if patients would be willing to donate their devices. In the most favorable scenario, a non-negligible number of devices could be recovered and provide a vital treatment for many patients unable to access a new one.

Study limitations.

The study has several limitations. First of all, the questionnaires were completed in a specific association and by email, supposing that we could not calculate how many physicians had really the chance to respond to the questionnaire. Secondly, the response rate was low (5%), so the applicability of the results at a broader level is limited. A low response rate is common in studies conducted in Heart Rhythm Association members or electrophysiologists (10–16%), but it could mean that the members who responded were more familiar and interested in CIED reuse and likely to have positive preferences on this topic [13, 21‐23]. Finally, this study was carried out using quantitative methodology, allowing us to identify opinions, but not to explore the processes that lead to the generation of these opinions. It would be interesting to explore these phenomena also with a qualitative methodology.

The donation of reusable CIEDs from developed countries to LMIC is an alternative that can provide vital therapy to many patients who currently lack other alternatives. A large majority of Spanish Rhythm Association respondents nationwide support the concept of donating reusable devices to patients without access to new devices. It would be interesting to describe device owners’ perspectives on potential donation, in order study the possibility of integrating a nationwide device donation initiative.