Medical interventions must be governed by the principles of biomedical ethics: autonomy, beneficence, nonmaleficence, and justice.1 Therefore, while we have a moral obligation to act for the benefit of others by promoting their wellbeing and legitimate interests, we must also uphold our commitment to the principle of justice. This principle is essentially understood as a cornerstone of health care policy based on equitable distribution and appropriate management of health care resources. Both regional health services and health professionals are thus morally obliged to analyze health care strategies that enhance patient care while integrating resource management within process-oriented care. This approach should also define clinical pathways with quality indicators to identify areas for improvement.2
Cardiology ranks high among the specialties with heavy resource utilization, not only because the procedures used are often expensive, but also because many conditions require urgent care.3 Together with acute coronary syndrome (ACS) and heart failure, bradyarrhythmia accounts for a large proportion of medical acts and health care expenditure, and demand is expected to rise with population aging.4 Therefore, it is time to structure the care process for severe bradyarrhythmia.
These are likely the considerations prompting Jiménez-Candil et al.5 to implement and a round-the-clock (24/7) pacemaker program and analyze its results. In their analysis, the authors compare patients undergoing pacemaker implantation in with a cohort of patients whose pacemaker implantation was scheduled for weekday mornings. We believe this analysis to be highly relevant, as it both highlights the potential to reduce hospital stays and free up beds for other patients and raises a series of questions, which the authors address in detail and which we discuss below.
First, given the context of an aging population, often with associated diseases (mean age of 81 years and a Charlson comorbidity index> 3 in 20% of the series by Jiménez-Candil et al.5), it is reasonable to assume that bradyarrhythmia can mask other conditions (eg, ACS, infection, advanced heart disease). If this were the case, early pacemaker implantation would not only fail to improve prognosis but would also violate the principle of nonmaleficence (primum non nocere). In this regard, the study by Jiménez-Candil et al.5 showed not only that this model did not increase the complication rate but also that it was associated with a reduction in the 180-day cumulative incidence of complications related to the index arrhythmia and device implantation (9% vs 17% for patients who underwent the procedure during working hours), mainly due to a lower frequency of preimplantation complications (2.5% vs 12%).
These results are consistent with our recently published experience with an emergency pacemaker implantation model on weekends and holidays, revealing a trend toward less frequent decompensated heart failure (5.5% vs 3.8%) and impaired kidney function (11% vs 4.6%).6 More pronounced differences might have been observed with a larger sample. Therefore, early implantation appears to be associated with a more favorable clinical course.
A second consideration concerns efficient resource management. A pertinent question is whether activating medical and nursing staff (€238 374 in staff costs5) truly saves health care resources. In the article by Jiménez-Candil et al.,5 implantation during working hours (8:00 to 15:00) was already efficient, with a 5- to 21-hour delay from diagnosis to implantation. In our series of weekend admissions,6 the delay was 60.22±26.77hours before implementation of the round-the-clock program. The authors report a total cost of €1 103 817 during the first period compared with €838 830 during the second (95% confidence interval [95%CI], €81 461-€418 227).5 In our series, the total cost of the 24/7 service was €479 052.59 vs €653 323.56 for the conventional program.6 Cost analysis of our program revealed it to be highly efficient, with an incremental cost-effectiveness ratio of €–5987.38, well below the acceptability threshold of €10 000 per life year gained. These results show that, in addition to their favorable clinical impact, these programs are associated with more effective resource management. We also believe that these models help to optimize the planning of day-to-day work in electrophysiology units, thus preventing the cancellation of scheduled procedures owing to care area overload.
Currently, there is a need to assess the feasibility of applying this model—and others—in implant centers in our setting. This will likely be challenging and will require the participation of regional health services for program approval and staff organization. Specifically, the 24/7 model potentially involves activity during the night shift, which may affect regular daily workload (more so during holiday periods), especially in departments with limited resources. Furthermore, both this and other models demand a high level of personal commitment, which not all health care professionals will be able to provide. Therefore, drawing from the example of ACS as a guide, we should aim to establish a unified model that can be adopted by all stakeholders to ensure widespread implementation of this approach, which appears to improve health outcomes and resource utilization.
Finally, let us not forget that some causes of severe bradyarrhythmia are reversible (eg, inflammatory diseases, infectious diseases, ischemia, hypothyroidism, collagen diseases), while others (e.g., sarcoidosis, myocarditis, channelopathy, familial myocardial heart disease, infiltrative disorders) may only require a standard stimulation system (defibrillator, physiological stimulator, or leadless pacemaker). Moreover, in the case of atrial fibrillation, persistence of the condition must be confirmed before implanting a single-chamber device, which may carry a subsequent risk of pacemaker syndrome (3 out of 664 cases in the series by Jiménez-Candil et al.,5 albeit with no differences between periods). Therefore, thorough clinical assessment is essential in these models to avoid unnecessary implants and ensure selection of the most appropriate device for each individual patient. It would also be a mistake to assume that bradyarrhythmia can always be managed simply by pacemaker placement. As noted by the authors, such an approach may not be suitable for younger patients or those showing even the slightest sign that their bradyarrhythmia is reversible. In addition, as detailed in the methods section,5 a previous echocardiogram is always required.
In conclusion, we congratulate the authors for the present initiative and their meticulous analysis of clinical issues and health costs. They offer a solution to a common condition in our setting, requiring the involvement of all health care personnel (nursing staff, implant specialists, and clinicians) and regional health services. Only through the participation of all the parties involved can we provide high-quality and equitable medical care to all our patients.
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