Abstract
Background
The patient’s right to refuse pacemaker therapy is mentioned in the relevant European consensus statement but additional information is only available on deactivation of implantable cardioverter deactivator and not on other cardiac implantable electronic devices such as pacemakers. Therefore, we were interested in opinions, concerns and attitudes of cardiologists, who are the primary contact persons for such requests, since the number of patients asking for withdrawal of pacemaker therapy is likely to increase leaving cardiologists and healthcare professionals with a difficult medical but also ethical problem.
Methods
An anonymous questionnaire was sent to all German cardiology departments (N = 288).
Results
48% of cardiology departments responded by sending back 247 completed questionnaires. Most participating cardiologists were experienced when considering the duration of their professional activity. Almost all of the respondents regularly perform check-ups of pacemakers. The majority of cardiologists answering our questionnaire were prepared to deactivate a pacemaker upon patients’ request, and have done so. In pacemaker dependency, however, the willingness to withdraw decreases, even if death is imminent, for fear of causing distressing symptoms, sense of being responsible for patients possible immediate death, or fear of legal consequences.
Conclusions
The survey could clearly show that uncertainties remain among cardiologists dealing with a patient's wish for withdrawal, especially in cases of pacemaker dependency. We suggest that official statements of cardiologic societies in Europe are issued to clarify ethical, legal and practical aspects of pacemaker withdrawal.
Trial registration
Registered in the German Clinical Trials Register (DRKS00026168) on 30.08.2021.
Graphical Abstract
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Introduction
The US American Heart Rhythm Association issued expert consensus statements affirming the ethical and legal permissibility of cardiac implantable electronic devices (CIED) deactivation, even if the patient is not terminally ill [1]. This statement was developed in collaboration with members of the European Heart Rhythm Association (EHRA). The equivalent European consensus statement focuses on the deactivation of implantable cardioverter defibrillators (ICDs) in dying patients [2]. It points out, that less agreement exists in Europe for PM deactivation. In Germany, an equivalent statement was published in 2017 regarding the withdrawal of ICD but not pacemaker (PM) therapy [3]. The legal situation regarding PM withdrawal in Germany is still a matter of debate and has not been finally clarified [4].
The consequences of withdrawal of PM therapy vary depending on indication: Sinunodal disease (SND) and higher degree atrioventricular block (AVB) are the most common forms of bradyarrhythmia, where permanent PMs provide effective treatment [5, 6]. SND is not a life-threatening condition, the benefit of PM therapy is essentially to alleviate symptoms (syncope leading to injuries from falls, breathlessness, or fatigue) [7]. By deactivation of PM therapy an effective treatment will be discontinued. In high-grade AVB, PM therapy is known to prevent sudden cardiac death in addition to the aforementioned improvement of quality of life (reviewed in [6]). In these cases, deactivation of PM therapy will probably lead to worsening of symptoms and sudden cardiac death may occur.
In some patients, PM dependency can be detected. In PM dependency an intrinsic rhythm ≥ 30 bpm is absent after lowering the pacing rate to 30 bpm for at least 10 s or after transient inhibition of pacing therapy. It must be noted, that a number of definitions for PM dependency exist and several authors have called for standardization of the term [8]. In PM dependency, PM therapy is thought to prolong life [1] and may prolong the dying process. After the withdrawal of PM therapy in PM-dependent patients an escape rhythm normally ensues. Depending on how quickly this happens, death, loss of conscience, organ failure due to prolonged asystole e.g. hypoxic ischemic encephalopathy, or (severe) symptoms of heart failure may follow [2, 9].
PM dependency is believed to occur only rarely. In a recent study, follow-up examinations of patients with PM could show, that 16% (131 out of 802) were found to be pacing-dependent [10]. Along with increasing numbers of PM implantations, PM dependency seems to occur more frequently in an aging population [10].
Management of PM therapy is at least in Germany usually in the hand of cardiologists. For the withdrawal of PM therapy, reprogramming of PM using special equipment is needed where each company has its own device. Apart from these technical issues, the request for termination of PM therapy, particularly in PM dependency, are part of end of life (EOL) decisions. Therefore, cardiologists are not only confronted with a difficult medical but also ethical problem.
Most healthcare professionals regard device deactivation in dying patients as allowing natural death, especially when intended to alleviate symptoms and not to hasten death [11,12,13,14,15]. However, in PM-dependent patients a number of physicians object to deactivating PMs, arguing that it can either lead to symptoms of heart failure or death [1, 16, 17].
The question of whether and how PM therapy can and should be withdrawn at the request of an actively dying patient can be a challenge. It can be even more difficult if the patient who requests discontinuation of PM therapy, is nearing EOL, but yet not actively dying, or not even terminally ill (these terms are used according to [18, 19]). Health care professionals including those without cardiologic expertise will in the future have to deal with these questions. We have therefore conducted a survey in Germany among cardiologists working in hospitals to learn more about their opinions, concerns, and attitudes towards withdrawal of PM therapy.
Methods
In January 2022 paper versions of an anonymous questionnaire were sent to heads of all cardiology departments of hospitals (N = 288) listed in the German hospital registry allowing more than one questionnaire to be returned (physician-based analysis).
Our survey was conducted using a questionnaire with close-ended questions to capture participants’ experience with PM deactivation. In addition, three case vignettes were included. The respondents were asked to decide if they would deactivate the PM in the situation given and to indicate the reasons for their decision.
The items of the questionnaire were developed for this survey using a two-step methodology. First, a multidisciplinary research team drafted items that were based on scientific knowledge, a literature survey, and own experiences from clinical practice through an iterative consensus procedure. During the discussions, the research team agreed on items inquiring about the general perception of PM deactivation and secondly on items regarding experiences with, attitudes towards and knowledge of issues in relation to decisions about deactivation of PM. The team focused on clinical problems and omitted differences in dealing with deactivation depending on whether or not the dying process had already started. In addition, three case vignettes were included describing situations where patients with PM dependence ask for withdrawal.
Second, prior to the final application of the questionnaire, cognitive interviews were undertaken with two experienced cardiologists that helped to test problems in feasibility, e.g. comprehensibility of the questions or acceptance. Minor changes in wording were made to the questionnaire according to the results obtained.
Our study targeted cardiologists with experience in pacing and arrhythmia, in particular those who care for patients carrying PMs. We tried for a representative survey by sending our questionnaires to all hospitals in Germany with a cardiology department having experience with PM implantation and follow-up examinations. Questionnaires were sent along with pre-stamped return envelopes to ensure anonymity.
The investigation conforms with the principles outlined in the ‘Declaration of Helsinki’. The study was approved by the local Ethics Committee for Human Research at Philipps-University Marburg, Germany (161–20) and was registered in the German Clinical Trials Register (DRKS00026168).
Statistical analysis was carried out descriptively with SPSS (version 29, 2022).
Results
Over a period of 4 months out of 288 hospitals 137 (47.6%) responded by sending back at least one questionnaire. In total, we received 247 questionnaires, where 62 hospitals sent one questionnaire, 37 two, 34 three, one four and another five questionnaires.
All of the respondents were cardiologists. Table 1 summarizes sociodemographic data collected.
Figure 1 shows that most cardiologists have experience with PM withdrawal and consider the issue of PM withdrawal to be important.
When asked under what circumstances the respondent would deactivate a PM upon the patient’s request only 27 (11%) answered that they cannot imagine a situation in which they would withdraw. 189 (77%) answered, that the patient’s EOL should be foreseeable in the near future, and 121 (48%) require the patient to suffer in some way comprehensible. 81 (33%) would ask experienced colleagues for advice. 101 (41%) need a trusting relationship with their patient, and 148 (60%) require there to be a constant wish for deactivation.
When asked, whether the respondents believe that it is possible and correct to fulfil the patient’s wish for withdrawal, 207 (84%) agreed. 141 (57%) argue, that physicians have to respect the patient’s wish for withdrawal and 155 (63%) want to know that the patient is well cared for should problems arise after deactivation.
Amongst the remaining approximately 16%, who would not deactivate the PM, various reasons have been put forward. 31 (13%) fear legal consequences, in 21 (9%) conscience forbids it, 19 (8%) argue, that the PM cannot be deactivated, 3 (1%) don’t as a cardiologist feel responsible for deactivating a PM, 3 (1%) have religious reasons, and 1 (0.4%) believe that the PM is an integral part of the patient’s body.
A few were undecided in that they ticked both ‘yes’ and ‘no’-answers (mainly fearing legal consequences).
Interestingly, about a third—although in principle ready to—are also critical of PM deactivation, arguing that the consequences of withdrawal are often not foreseeable. Also, most PMs would help to lessen symptoms without prolonging life and ask why one should withdraw from a useful therapy. 105 (43%) argue that in the case of pacemaker dependency, deactivation of the pacemaker can lead directly to death, thus providing inadmissible medical assistance in dying.
Case vignettes
We then asked the respondents to decide whether they would withdraw PM therapy in three case vignettes (see info box).
In the first case, 150 (61%) of respondents would withdraw from PM therapy, in the second 70 (28%) and in the third 34 (14%) (Fig. 2a). Reasons given for or against the cardiologists’ decision are listed in Table 2.
When correlating reasons given for each decision in the case vignettes with sociodemographic data or cardiologists’ general views on PM deactivation the following was found: Cardiologists who believe that the patient should be allowed to decide whether a therapy is terminated, or who have experience with deactivating a PM, are significantly more likely to withdraw PM therapy in all cases and significantly less likely to refuse withdrawal (Fig. 2b).
Most interestingly, one (case 1), four (case 2), and eight (case 3) cardiologists saw patients suffer after deactivation of PM in a comparable situation.
Info Box on case vignettes used in the questionnaire
We ask you to consider whether you would withdraw the PM in the following cases: | |
---|---|
In all three cases, the patients’ wish for withdrawal is deliberate. The patients have been informed about and have understood the possible consequences. An advance directive exists including the request for withdrawal, which family and friends support | |
1st case vignette: You are called to the palliative care unit because an 85-year-old patient is dying and urgently requests that his pacemaker be turned off. He is convinced that the PM is keeping him alive unnecessarily. The PM was implanted 20 years ago due to AV block III. The patient is pacemaker dependent *. Life expectancy is believed to be hours, or at most very few days | |
2nd case vignette: A 60-yr-old patient has recently been diagnosed with metastatic pancreatic cancer. A pacemaker was implanted 2 years ago due to AV block III°. She is pacemaker dependent *. Prognosis is considered to be poor (about 3 months). In this situation, she would like the PM to be deactivated as soon as possible so that she is not kept alive unnecessarily | |
3rd case vignette: A 75-year-old patient received a pacemaker 5 years ago due to AV block III°. He is pacemaker dependent *. Apart from orthopedic complaints, there are no relevant comorbidities. In his living will he states that he no longer wishes to be kept alive by technical devices when he reaches the age of 75 | |
Would you withdraw PM therapy at the patient's request? | |
*The last 3 routine pacemaker checks showed a ventricular pacing requirement of 100% without junctional or ventricular replacement rhythm during temporary inhibition of ventricular pacing so that complete pacemaker dependence must be assumed. |
Discussion
Our study provides insights into cardiologists’ views in Germany regarding the withdrawal of PM therapy in general and in PM dependency in particular. Our survey could show that the majority of cardiologists answering our questionnaire are prepared to deactivate a PM upon patients’ request and have done so. But in PM dependency, the willingness to withdraw decreases considerably for fear of causing distressing symptoms, a sense of being responsible for patients possible immediate death, or fear of legal consequences.
In the case vignettes (where patients were PM dependent) the number of respondents ready to withdraw therapy was around 60% in the first case, where the patient is ‘actively dying’, and about 30% in the second, where the patient is terminally ill but has a prognosis of about 3 months. Reasons for refusal given, are either medical (fear of causing distressing symptoms) or personal ones (sense of being responsible for patients’ possible immediate death or fear of legal consequences). In the first case, the patient’s death is imminent due to a terminal illness. If death follows a patient’s competent refusal, withdrawal of an ICD as well as other medical devices such as mechanical ventilation, hemodialysis, intravenous therapy, and percutaneous endoscopic gastrotomy (PEG) feeding is in most western societies ethically and legally permissible [1, 2, 20]. Where withdrawal of PM therapy is concerned, cardiologists have expressed uneasiness for fear of performing medical assistance in dying or assisted suicide [21]. Ethically there is no apparent difference in withdrawal of treatment other than PM [17, 22]. A Heart Rhythm Society (HRS) expert consensus statement [1] has suggested the ethical and legal permissibility of PM deactivation upon patient’s request for the United States of America, emphasizing the patient’s right to decide for him- or herself whether to agree to a therapy or to request it’s discontinuation. In Europe, legal issues regarding the withdrawal of PM therapy are not finally resolved, as is highlighted by the expert consensus statement published by the European Society of Cardiology (ESC) [5].
It can be argued that in the first case vignette PM therapy is futile and that health-related burdens are prolonged unnecessarily. The patient was in a palliative care unit, where unpleasant symptoms could be dealt with should they occur after PM withdrawal. Still, in our survey amongst German cardiologists only 60% of the respondents would deactivate the PM in such a situation. We believe that this finding reflects the need for an official statement resolving legal and practical issues.
In the second case, the patient is terminally ill with a prognosis of 3 months. However, ethical issues apply as stated above. The patient needs to assess the treatment’s value against discomfort and inconveniences associated with his/her illness and its treatment [23]. Clinicians should not overrule patients’ wishes [22] but need to inform patients on possible consequences of withdrawal and have to consider legal issues. The consequences of PM deactivation cannot always be foreseen [1] and data on outcome after withdrawal of PM therapy are rare [24, 25]. In PM dependency, PM therapy may well prolong the dying process in the terminally ill and the patient may ask for withdrawal. In the HRS expert consensus statement mentioned above [1], ethical principles regarding the withdrawal of PM therapy in such a case are discussed based on an algorithm described by Pellegrino [23]. It is emphasized, that only the patient can determine whether the perceived burden of the therapy outweighs the benefit. It is concluded that PM deactivation can be justifiable in the given situation.
The authors concede that the wording in the second case vignette may have been equivocal, as it was not made clear enough that the request for pacemaker deactivation was a consequence of the high disease burden due to the underlying disease.
We believe, that the respondents’ decisions reflect uneasiness regarding the withdrawal of PM therapy in PM-dependent patients as has been reported by others before [11, 16, 26]. This uneasiness might be overcome, should recommendations be issued by professional societies responsible for how to proceed in cases where competent patients ask for the withdrawal of PM therapy. Such detailed recommendations are currently lacking in Europe. The 2021 European guidelines on PM therapy include one sentence, only, saying that competent patients have the right to refuse PM therapy [5]. An older guideline from 2010 focuses on the deactivation of ICDs in patients with an irreversible or terminal illness [1, 2, 23], but not PM withdrawal.
In the third case, where the patient is apparently healthy apart from carrying a PM, only a few of the respondents would deactivate the PM: On principle, the same arguments apply as mentioned above. The patient’s reasons for withdrawal have to be heard and discussed, especially as patients with a PM wish to do so [27, 28]. In the case vignette, no such reasons are given. It is not known if the patient wants to remove a futile treatment or to hasten death, in that he requests a form of physician-assisted suicide. If the latter is the case, the patient should be counselled regarding the legal possibility of assisted suicide, since the imponderabilites of PM withdrawal are such that it cannot be recommended, and alternative methods are available. Only if the reasons behind the request for withdrawal are given a solution can be sought. It is therefore understandable, that most of the respondents refuse to deactivate the PM in the case vignette given.
Interestingly, one (case 1), four (case 2), and eight (case 3) cardiologists saw patients suffer after deactivation of PM in a comparable situation and would therefore deny withdrawal in the case vignettes presented. These experiences again call for a consensus statement by cardiologic societies of each European country comprising ethical, legal and practical issues of PM withdrawal to support cardiologists in these difficult situations. Not surprisingly, the majority of respondents in our survey opted for an official statement of the German cardiologic society.
The discrepancy between the willingness to deactivate in principle and actual deactivation in individual cases, as shown in the case vignettes, was reported by others as well [15, 16, 30]. The same applies to the recommendation of conversations regarding the withdrawal of ICD therapy. When a terminal illness is diagnosed, information on the possibility of ICD withdrawal should be offered to avoid unnecessary painful shocks in the dying process [15, 16, 29, 30, 31]. As has been mentioned before, PM withdrawal should be treated accordingly.
Our survey could also show, that cardiologists faced with a patient’s desire to withdraw PM therapy, have practical issues in mind. The HRS consensus statement [1] clearly states that it must be clarified beforehand how device deactivation can effectively be put into practice. In the said statement, cardiology departments implanting CIEDs are required to ensure that personnel and facilities are provided to enable patients to have their CIEDs deactivated at their request.
Limitations
Apart from the known general limitations of surveys, such as deductive assumptions in the conception of the questions, the study has several additional limitations. The group under study is not representative for cardiologists in general. Cardiologists were recruited by sending the questionnaire to all hospitals in Germany with a cardiologic department registered for PM implantations, almost half (47.6%) of them responded. Cardiologists working in outpatient clinics or practices were not included. Cardiologists were recruited during the COVID-19 pandemic. Since the questionnaire was sent in paper form, the impact of the pandemic will not have been relevant.
Conclusion
Our survey shows that the majority of cardiologists answering our questionnaire are prepared to deactivate a PM upon patients’ request and have done so. In PM dependency the willingness to withdraw decreases for fear of causing distressing symptoms, sense of being responsible for the patients possible immediate death, or fear of legal consequences. The results of the survey suggest that official statements of the cardiologic societies in Europe are warranted to clarify ethical, legal, and practical aspects of PM withdrawal. Especially because in an aging population the number of patients with PMs and subsequently requests for withdrawal will increase in number.
Availability of data and materials
The datasets used are available from the corresponding author upon reasonable request.
Abbreviations
- AVB:
-
Atrioventricular block
- EOL:
-
End of life
- ESC:
-
European Society of Cardiology
- EHRA:
-
European Heart Rhythm Association
- HRS:
-
Heart Rhythm Society
- ICD:
-
Implantable cardioverter defibrillator
- PM:
-
Pacemaker
- SND:
-
Sinunodal disease
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Acknowledgements
We would like to thank all the participants for their willingness to share their experiences and taking part in this survey.
Funding
Open Access funding enabled and organized by Projekt DEAL. None.
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Contributions
IP, CS, PS and CV conceptualized this project. IP and CV conducted the data collection. IP and EH performed the data analysis. IP, EH, CV and CS discussed and interpreted the results. IP wrote the manuscript, which all authors revised. All authors approved the final version.
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The authors have no conflict of interest to declare.
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Not applicable due to the anonymous nature of the survey. Each participant was informed in the invitation letter that taking part in the anonymous survey and returning the questionnaire to the study team included consent for publication.
Ethical approval and consent to participate
The ethics committee of the medical faculty of the University of Marburg (161/20) authorized the conduct of the study and the study was registered in the German Clinical Trials Register (DRKS00026168). According to German law, a signed declaration is not required, as the data is collected anonymously. Participation and return of the questionnaire imply the willingness to process the data, about which participants were informed in the cover letter. Research was conducted in accordance with the Declaration of Helsinki.
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Portig, I., Hofacker, E., Sommer, P. et al. Cardiologists' perspective on termination of pacemaker therapy–an anonymous survey among cardiologists in Germany. Clin Res Cardiol (2024). https://doi.org/10.1007/s00392-024-02525-z
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DOI: https://doi.org/10.1007/s00392-024-02525-z