Abstract
Background
The burden of mental disorders among patients with permanent pacemakers (PPMs) and their impact on long‐term outcomes remain poorly understood. We aimed to investigate the incidence of newly diagnosed mental disorders among PPM patients and to evaluate their prognostic implications.
Methods
From the Korean National Health Insurance Service database, we identified 19 746 patients who underwent PPM implantation and 58 642 propensity score–matched controls without a PPM between 2010 and 2020. Among PPM patients, long‐term clinical outcomes were compared according to the presence of newly diagnosed mental disorders.
Results
The 10‐year cumulative incidence of any newly diagnosed mental disorders among PPM patients was 45.1%. The most common mental disorders were depressive disorder (24.6%), insomnia (20.6%), and anxiety disorder (5.6%). The overall risk of detecting new mental disorders among PPM patients was similar to that of the matched general population (hazard ratio [HR], 0.98 [95% CI, 0.96–1.01]). However, male PPM patients showed a significantly higher risk, particularly those aged <50 years (HR, 1.42 [95% CI, 1.16–1.75]) and those aged 50 to 59 years (HR, 1.20 [95% CI, 1.04–1.38]). PPM patients diagnosed with any mental disorder had a significantly higher 10‐year cumulative all‐cause mortality compared with those without mental disorders (53.6% versus 31.3%; HR, 1.71 [95% CI, 1.61–1.82]), with the highest risk observed in patients with schizophrenia (HR, 3.23 [95% CI, 2.61–4.00]). Adverse outcomes were more pronounced in male patients and when mental disorders were diagnosed early after implantation (within 3.2 years).
Conclusions
Although the risk of detecting new mental disorders among PPM patients was comparable to that of the matched non‐PPM population, newly diagnosed mental disorders were associated with increased long‐term mortality in PPM patients, particularly in younger men and those with early‐onset mental disorders.
Keywords: mental disorder, mortality, permanent pacemaker, population‐based study
Subject Categories: Pacemaker
Nonstandard Abbreviations and Acronyms
- PPM
permanent pacemaker
Clinical Perspective.
What Is New?
Among patients with permanent pacemakers, male patients, particularly those aged <60 years, showed a higher incidence of newly diagnosed mental disorders compared with age‐matched controls without permanent pacemakers.
Newly diagnosed mental disorders among permanent pacemaker patients were associated with significantly higher mortality and adverse clinical outcomes, with the greatest risks observed in patients with schizophrenia spectrum disorders, those with early‐onset mental disorders after implantation, and male patients.
What Are the Clinical Implications?
Integrating mental health assessment and management into routine care for permanent pacemaker patients may improve long‐term clinical outcomes and quality of life, particularly in high‐risk subgroups.
Permanent pacemakers (PPMs) are essential for the management of symptomatic bradycardia, preventing symptoms such as syncope, fatigue, and life‐threatening arrhythmias. 1 , 2 Although most PPM recipients experience favorable outcomes, some report new or worsening mental health issues, highlighting an underexplored, yet clinically significant, aspect of pacemaker care. 3 Previous studies have predominantly documented psychiatric issues in patients with implantable cardioverter‐defibrillators (ICDs), noting increased anxiety and depression, and reduced quality of life. 4 , 5 , 6 , 7 However, few studies specifically address psychiatric problems in PPM patients. 8 , 9 , 10 , 11 , 12 , 13 Existing studies are often limited by small samples sizes, cross‐sectional designs, and reliance on self‐reported questionnaires, which may not adequately capture the extent of mental health issues in this patient population.
Despite these potential concerns, the current European guideline for PPM therapy only briefly acknowledges the potential need for psychosocial support, without providing in‐depth analysis, supporting evidence, or specific recommendations. 1 This absence reflects an important gap in the standard of care, where mental health may be as integral to patient outcomes as physical health, especially given the chronic, dependency‐driven nature of PPM therapy.
To address this gap, we analyzed data from a real‐world nationwide registry, selecting PPM patients with no prior psychiatric diagnoses to objectively evaluate the incidence of newly diagnosed mental disorders among PPM patients compared with a matched general population. We further aimed to identify subgroups at higher risk for psychiatric conditions and examined the prognostic implications of these mental health issues on long‐term clinical outcomes, including mortality.
METHODS
The data that support the findings of this study are available from the corresponding author on reasonable request.
Data Source
We conducted a retrospective, population‐based cohort study using the Korean National Health Insurance Service database, which serves as a single national insurer for ≈97% of the South Korean population (>52 million), with the remaining 3% covered by the Medical Aid Program. This database contains extensive population‐wide data, including sociodemographic details, health care utilization records coded with the International Classification of Diseases, Tenth Revision (ICD‐10), and mortality statistics. 14 Furthermore, the Korean National Health Insurance Service provides biennial health check‐ups for all adults, collecting clinical, biochemical, and lifestyle information. 15 Further details on the database and screenings are available in previous studies. 16
Study Population
All patients who underwent de novo implantation of cardiac implantable electronic devices, including PPMs, between 2010 and 2020 were included in the study (Figure 1). For the control group, a 10‐fold random sample of individuals without cardiac implantable electronic devices was selected, following data access restrictions imposed by the data‐sharing policy. Of the 2 791 753 total participants, those with preexisting mental disorders, a history of heart transplantation, or prior implantation of an ICD or cardiac resynchronization therapy before January 1, 2010, were excluded, leaving 2 468 155 participants for analysis. To minimize bias in comparisons between PPM recipients and the general (non‐PPM) population, we applied a sequential target trial emulation approach (Figure S1). 17 , 18 Participants were cloned every 6 months from January 1, 2010, to June 1, 2020, creating 20 time‐specific data sets. At each time point, cloned participants were reevaluated for eligibility. Those who had already received a PPM, had been diagnosed with a mental disorder, had undergone heart transplantation, or had received a left ventricular assist device, ICD, or cardiac resynchronization therapy were excluded. This approach ensured that PPM implantation or non‐PPM status was assigned at the start of follow‐up. As a result, 36 678 854 replicated entries remained. From this data set, we identified 19 746 patients who underwent PPM implantation based on specific procedural codes (O0203, O0204, O0230, O2003, and O2004) and a matched control group from the general (non‐PPM) population. The control group was matched to PPM recipients in a 1:3 ratio using propensity score matching, considering baseline demographic and clinical characteristics, as detailed in the Statistical Analysis section. This study complied with the Declaration of Helsinki, and the study protocol was approved by the Institutional Review Board of Samsung Medical Center, Seoul, Korea (Institutional Review Board number: SMC‐2024‐02‐035). Written informed consent was waived because of the retrospective nature of the study using deidentified administrative data.
Figure 1. Study flow.
From the K‐NHIS database between 2010 and 2020, all patients who underwent de novo implantation of CIEDs, including PPMs, and a 10‐fold random sample of men and women without CIEDs were included. Using the sequential target trial emulation and propensity score matching, 19 746 PPM patients and 58 642 individuals from the general population were selected. CIED indicates cardiac implantation electronic device; CRT, cardiac resynchronization therapy; ICD, implantable cardioverter‐defibrillator; K‐NHIS, Korean National Health Insurance Service; and PPM, permanent pacemaker.
Definition and Outcomes
Newly diagnosed mental disorders were identified on the basis of the assignment of a mental disorder code as the primary diagnosis, in line with previous studies. 19 , 20 , 21 , 22 , 23 The mental disorders included in the study were depressive disorder (F32 and F33), insomnia (G47.0 and F51.0), anxiety disorder (F40 and F41), schizophrenia spectrum disorders (F20–F29), substance use disorders (F10–F19), bipolar disorder (F30, F31, and F34.0), obsessive‐compulsive disorder (F42), and posttraumatic stress disorder (F43.1). Each mental disorder subtype was analyzed separately as an outcome. For analyses of “any mental disorder,” the earliest diagnosis date among all subtypes was used to define the event time.
Charlson comorbidity index and comorbidities were identified using ICD‐10 codes from insurance claims data, based on a 1‐year look‐back period from the index date (updated every 6 months). 24 Smoking status and body mass index were obtained from the most recent health screening examination conducted within 4 years before the index date. Data on age, residential area, and medication use at the time of PPM implantation were extracted from claims records. All baseline confounders were defined using data collected before the time of PPM implantation (index date).
The primary outcome was all‐cause death, with cause‐of‐death data obtained from death certificates compiled by Statistics Korea at the Ministry of Strategy and Finance. 25 Secondary outcomes included cardiovascular death, left ventricular assist device or heart transplantation, and any readmission. Cardiovascular death was defined using ICD‐10 codes for cardiovascular diseases (I00–I78), whereas left ventricular assist device implantation (O0881) and heart transplantation (Q8080) were defined by their respective ICD‐10 codes. Any readmission was determined on the basis of claim codes for admissions after PPM implantation. Although ICD‐10 codes for intentional self‐harm (X60–X84) are available in the national mortality registry, they are classified as sensitive causes of death and require separate approval for access. As such approval was not obtained for this study, suicide‐related death was defined using underlying causes coded as F00 to F99 (mental and behavioral disorders) as a proxy indicator.
Statistical Analysis
Baseline characteristics are reported as means (SDs) or numbers (percentages) as appropriate. The control group was selected through propensity score matching, with propensity scores estimated within each emulated cohort to reduce baseline differences between the PPM and control group. A logistic regression model was used to estimate the probability of receiving PPM based on covariates, including age, sex, residence area, Medical Aid care, body mass index, smoking status, Charlson comorbidity index, hypertension, and atrial fibrillation. We performed 1:3 propensity score nearest‐neighbor matching with a caliper of 0.2 on the propensity score scale. Baseline differences between the 2 groups were assessed before and after matching using absolute standardized mean differences. The 10‐year cumulative incidence of new‐onset mental disorders was estimated using the Kaplan–Meier method, and differences between PPM patients and the matched general population were evaluated using log‐rank tests. Hazard ratios (HRs) and 95% CIs for detecting new mental disorders in PPM patients were estimated by age group and sex, relative to the corresponding subgroup in the general population (non‐PPM), using Cox proportional hazards models. Interactions between PPM status and sex or age were tested by including corresponding interaction terms in the Cox models. For the target trial emulation comparing PPM and control groups, participants could contribute to multiple time‐specific emulated trials; thus, robust sandwich variance estimators clustered by individual were used.
We assessed the clinical impact of newly diagnosed mental disorders following PPM implantation. In this analysis, patients were followed up from the date of PPM implantation, treating the onset of newly diagnosed mental disorders as a time‐varying variable. In the main prognostic analysis restricted to PPM patients, each individual entered the cohort once, and the onset of mental disorder was treated as a time‐varying covariate, ensuring no duplication across analyses. PPM patients who diagnosed any new mental disorder contributed person‐time to the exposed group from the time of mental disorder onset. Unexposed person‐time was contributed by PPM patients without new mental disorders, as well as by those with or without clinical outcomes before the onset of mental disorders (Figure S2). The 10‐year cumulative incidences of each end point were estimated using an extended Kaplan–Meier Method for the time‐varying exposure. 26 Additionally, we analyzed the impact based on the type of first diagnosed mental disorder. Models were adjusted for age, sex, residence area, Medical Aid care, smoking, and preexisting comorbidities.
We also performed subgroup analyses to examine whether the relationship between newly diagnosed mental disorders after PPM implantation and the risk of all‐cause mortality varied based on factors such as age, sex, Medical Aid status, obesity, smoking status, atrioventricular block, and sick sinus syndrome. Additionally, to assess the prognostic impact of the timing of mental disorder diagnosis in relation to PPM implantation, we compared clinical outcomes between patients with early‐diagnosed mental disorders (within the mean interval from PPM implantation to mental disorder diagnosis) and those with delayed‐diagnosed mental disorders (beyond the mean interval). HRs and 95% CIs were estimated using conditional Cox regression models, with time since the index date serving as the underlying time scale.
All statistical analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC) and R version 4.0.3 (R Foundation for Statistical Computing, Vienna, Austria).
RESULTS
Incidence of Newly Diagnosed Mental Disorders After PPM: Comparison With Matched Controls
Among PPM patients, depressive disorder (24.6%) was the most frequent new diagnosis, followed by insomnia (20.6%) and anxiety disorder (5.6%). Because some patients had multiple disorders, 5853 developed at least 1 mental disorder during follow‐up, corresponding to a 10‐year cumulative incidence of 45.1% after accounting for censoring. The mean interval from implantation to diagnosis was 3.2 years (Table S1, Figure S3).
Propensity score matching ensured similar baseline characteristics between the matched general population and PPM patients at the index date, with all standardized mean differences below 0.2 (Table S2). The overall risk of detecting new mental disorders among PPM patients was comparable to that of the general population (HR, 0.98 [95% CI, 0.96–1.01]), with no significant differences observed across specific mental disorder subtypes (Table S3, Figure S3). However, significant interactions were found between PPM status and both sex (P for interaction <0.001) and age (P for interaction <0.001). Male PPM patients showed a notably higher risk of new mental disorders compared with the general population (HR, 1.10 [95% CI, 1.05–1.15]), especially among those aged <50 years (HR, 1.42 [95% CI, 1.16–1.75]) and 50 to 59 years (HR, 1.20 [95% CI, 1.04–1.38]). This elevated risk decreased progressively with age (Figure 2). In contrast, female PPM patients exhibited a lower risk of new mental disorders than the general population, particularly in those aged ≥60 years, with a similar age‐related trend of decreasing risk.
Figure 2. Age‐ and sex‐stratified risk of detecting newly diagnosed mental disorder among PPM patients compared with the general population (non‐PPM).
Hazard ratios (95% CIs) for detecting new mental disorders in PPM patients are shown by age group and sex, relative to the corresponding subgroup in the general population (non‐PPM), using Cox proportional hazards models. Black, blue, and red markers represent overall, male, and female hazard ratios, respectively, across age categories: overall and <50, 50 to 59, 60 to 69, 70 to 79, and >80 years. The reference group for each estimate is the non‐PPM population within the same age and sex stratum. PPM indicates permanent pacemaker.
Prognostic Impact of Newly Diagnosed Mental Disorders After PPM Implantation
No significant differences in baseline characteristics were observed between PPM patients who were newly diagnosed with mental disorders and those who were not, with all standardized mean differences below 0.2 (Table 1). During a median follow‐up of 5.6 years after implantation, 1759 deaths occurred among PPM patients with newly diagnosed mental disorders (incidence rate: 7.4 per 100 person‐years) and 3474 deaths occurred among those without (incidence rate: 3.6 per 100 person‐years). This corresponded to a significantly higher 10‐year cumulative all‐cause mortality in patients with newly diagnosed mental disorders compared with those without (53.6% versus 31.3%; HR, 1.71 [95% CI, 1.61–1.82]) (Table 2, Figure 3). Among the subtypes, schizophrenia spectrum disorder showed the strongest association with increased mortality (HR, 3.23 [95% CI, 2.61–4.00]), followed by insomnia (HR, 1.80 [95% CI, 1.66–1.76]) and depressive disorder (HR, 1.64 [95% CI, 1.59–2.63]). Anxiety disorders did not show a significant impact on mortality.
Table 1.
Baseline Characteristics According to the Newly Diagnosed Mental Disorders in Patients With PPM
| Characteristics | PPM patients without mental disorders (N=13 893) | PPM patients with mental disorders (N=5853) | SMD |
|---|---|---|---|
| Age, mean±SD, y | 70.1±14.5 | 71.4±12.4 | 0.098 |
| Sex, n (%) | −0.116 | ||
| Male | 7002 (50.4) | 2611 (44.6) | |
| Female | 6891 (49.6) | 3242 (55.4) | |
| Area, rural, n (%) | 5539 (39.9) | 2532 (43.3) | −0.069 |
| Medical Aid care, n (%) | 731 (5.3) | 348 (5.9) | 0.030 |
| Body mass index, n (%) | |||
| Underweight (<18.0 kg/m2) | 265 (1.9) | 126 (2.2) | 0.017 |
| Normal weight (18.0–23.0 kg/m2) | 3030 (21.8) | 1414 (24.2) | 0.056 |
| Overweight (23.0–25.0 kg/m2) | 2538 (18.3) | 1127 (19.3) | 0.025 |
| Obese (>25.0 kg/m2) | 4049 (29.1) | 1763 (30.1) | 0.021 |
| Unknown | 4011 (28.9) | 1425 (24.3) | −0.103 |
| Smoking status, n (%) | |||
| Never smoker | 6661 (47.9) | 3161 (54.0) | 0.121 |
| Past smoker | 2298 (16.5) | 876 (15.0) | −0.043 |
| Current smoker | 928 (6.7) | 393 (6.7) | 0.001 |
| Unknown | 4006 (28.8) | 1423 (24.3) | −0.103 |
| Charlson comorbidity index, mean±SD | 1.5±1.7 | 1.6±1.7 | 0.027 |
| Comorbidities, n (%) | |||
| Diabetes | 8121 (58.5) | 3399 (58.1) | −0.008 |
| Hypertension | 11 792 (84.9) | 5048 (86.2) | 0.039 |
| Dyslipidemia | 10 878 (78.3) | 4520 (77.2) | −0.026 |
| Chronic kidney disease | 1422 (10.2) | 483 (8.3) | −0.069 |
| Myocardial infarction | 1208 (8.7) | 480 (8.2) | −0.018 |
| Heart failure | 5381 (38.7) | 2083 (35.6) | −0.065 |
| Stroke | 430 (3.1) | 175 (3.0) | −0.006 |
| Peripheral arterial disease | 4996 (36.0) | 1988 (34.0) | −0.042 |
| Atrial fibrillation | 1322 (9.5) | 707 (12.1) | 0.083 |
| Congenital heart disease | 504 (3.6) | 151 (2.6) | −0.060 |
| Medications, n (%) | |||
| β‐Blocker | 4358 (31.4) | 1859 (31.8) | 0.008 |
| RAS blockade | 6896 (49.6) | 2997 (51.2) | 0.031 |
| ARNI | 18 (0.1) | 2 (0.0) | −0.033 |
| Spironolactone | 2485 (17.9) | 928 (15.9) | −0.054 |
| SGLT2 inhibitor | 139 (1.0) | 22 (0.4) | −0.076 |
| Calcium channel blocker | 6196 (44.6) | 2591 (44.3) | −0.007 |
| Thiazide | 1263 (9.1) | 565 (9.7) | 0.019 |
| Other diuretics | 5454 (39.3) | 2229 (38.1) | −0.024 |
| Aspirin | 5099 (36.7) | 2387 (40.8) | 0.084 |
| Clopidogrel | 549 (4.0) | 215 (3.7) | −0.015 |
| Potent P2Y12 inhibitor | 237 (1.7) | 69 (1.2) | −0.044 |
ARNI indicates angiotensin receptor neprilysin inhibitor; PPM, permanent pacemaker; RAS, renin‐angiotensin system; SGLT2, sodium‐glucose cotransporter 2; and SMD, standardized mean difference.
Table 2.
Risk of Clinical Outcomes According to the Newly Diagnosed Mental Disorders Among PPM Patients
| Variable | All‐cause death | Cardiac death | Suicide‐related death | LVAD or heart transplantation | Any readmission |
|---|---|---|---|---|---|
| Adjusted HR (95% CI)* | |||||
| Any mental disorder | 1.71 (1.61–1.82) | 1.48 (1.33–1.65) | 3.09 (1.28–7.48) | 3.84 (1.62–9.11) | 1.46 (1.39–1.53) |
| Early diagnosis† | 2.06 (1.86–2.28) | 2.09 (1.73–2.51) | 2.04 (0.60–7.14) | 1.86 (0.56–6.93) | 2.18 (2.00–2.38) |
| Late diagnosis | Reference | Reference | Reference | Reference | Reference |
| Type of mental disorder | |||||
| Depressive disorder | 1.64 (1.51–1.78) | 1.53 (1.33–1.76) | 2.63 (0.78–8.83) | 3.52 (1.20–10.25) | 1.43 (1.34–1.52) |
| Early diagnosis† | 2.04 (1.76–2.37) | 2.17 (1.67–2.82) | … | 2.29 (0.33–5.97) | 2.16 (1.90–2.45) |
| Late diagnosis | Reference | Reference | … | Reference | Reference |
| Insomnia | 1.80 (1.66–1.96) | 1.48 (1.27–1.73) | 2.69 (0.88–8.25) | 6.14 (2.09–18.19) | 1.46 (1.36–1.56) |
| Early diagnosis† | 2.09 (1.77–2.46) | 2.18 (1.60–2.97) | … | 1.76 (0.23–13.39) | 2.18 (1.90–2.39) |
| Late diagnosis | Reference | Reference | … | Reference | Reference |
| Anxiety disorder | 1.17 (0.97–1.40) | 0.82 (0.57–1.18) | 7.65 (1.98–29.55) | … | 1.44 (1.26–1.64) |
| Early diagnosis† | 1.82 (1.25–2.66) | 2.30 (1.05–5.08) | 2.19 (0.19–25.58) | … | 2.24 (1.70–2.96) |
| Late diagnosis | Reference | Reference | Reference | … | Reference |
| Schizophrenia spectrum disorder | 3.23 (2.61–4.00) | 2.58 (1.73–3.85) | … | … | 2.01 (1.54–2.63) |
| Early diagnosis† | 2.80 (1.72–4.58) | 4.92 (1.87–13.04) | … | … | 4.40 (2.07–9.38) |
| Late diagnosis | Reference | Reference | … | … | Reference |
HR indicates hazard ratio; LVAD, left ventricular assist device; and PPM, permanent pacemaker.
Adjusted for age, sex, residence area, Medical Aid care, smoking, Charlson comorbidity index, hypertension, and atrial fibrillation.
Early and late were divided by 3.2 years (mean duration from PPM implantation to the diagnosis of mental disorders).
Figure 3. Cumulative risk of clinical outcomes between PPM patients with newly diagnosed mental disorders and those without.
A, All‐cause death. B, Cardiac death. C, Heart transplantation or LVAD. D, Readmission at 10 years. All were compared between pacemaker patients who were newly diagnosed with mental disorders during follow‐up and those who were not. LVAD indicates left ventricular assist device; and PPM, permanent pacemaker.
Subgroup analysis consistently demonstrated that the presence of newly diagnosed mental disorders after PPM implantation was associated with increased all‐cause mortality (Figure 4). The impact was more significant in men and the patients without Medical Aid care.
Figure 4. Risks of all‐cause death among PPM patients with newly diagnosed mental disorders and those without across various subgroups.
AV indicates atrioventricular; HR, hazard ratio; PPM, permanent pacemaker; and SSS, sick sinus syndrome.
For secondary outcomes, newly diagnosed mental disorders after PPM implantation were significantly associated with higher risks of cardiac death, suicide‐related deaths, left ventricular assist device implantation or heart transplantation, and any readmission (Table 2, Figure 3). Depressive disorder and insomnia significantly increased the risk of all secondary outcomes.
Notably, patients with early‐diagnosed mental disorders (within 3.2 years after implant, mean onset time) had higher risks of all‐cause death, cardiac death, and any readmission compared with those with delayed‐diagnosed mental disorders (after 3.2 years after implant) (Table 2). These trends were consistently observed across all mental disorder subtypes. In contrast, the distribution of mental disorder subtypes among PPM patients was similar between early‐ and late‐diagnosed groups, with depressive disorder, insomnia, anxiety disorder, and schizophrenia spectrum disorder being the most common conditions in both groups (Table S1).
In the propensity score–matched general population, newly diagnosed mental disorders were also associated with increased all‐cause mortality (HR, 1.55 [95% CI, 1.49–1.61]); however, the association between newly diagnosed mental disorders and all‐cause mortality was significantly stronger in PPM patients (HR, 1.71 [95% CI, 1.61–1.82]) than in the matched general population (HR, 1.55 [95% CI, 1.49–1.61]; P for interaction=0.008) (Table S4).
DISCUSSION
This study represents the largest cohort to evaluate the incidence of newly diagnosed mental disorders among PPM patients compared with the matched general population and is the first to demonstrate the prognostic impact of these disorders on long‐term clinical outcomes.
Incidence of Newly Diagnosed Mental Disorders Among PPM Patients
Previous studies on psychological impact of cardiac implantable electronic device implantation have primarily focused on ICD patients, who often have more advanced cardiac diseases and experience additional psychological stress because of ICD shocks. 4 , 5 , 6 , 7 In contrast, research specifically addressing mental health outcomes in PPM patients remains extremely limited. The few available studies are constrained by small sample sizes, with even the largest including <200 patients. 8 , 9 , 10 , 11 , 12 , 13 Although some studies have reported that 5% to 40% of patients experience depression and anxiety after PPM implantation, 8 , 9 , 10 , 11 , 12 , 13 these studies mostly relied on cross‐sectional designs and patient‐reported, symptom‐based self‐assessment questionnaires, resulting in significant variability and inconsistency in incidence estimates. Given this sparse evidence base, the current European guideline for PPM patients does not offer specific recommendations but only briefly mentions the need for psychosocial support, without citing robust supporting evidence. 1 Similarly, the American and other national cardiology societies do not provide dedicated guidance on psychological issues in PPM patients. 2
To address these gaps, we analyzed a large‐scale, nationwide data set, providing a representative sample that enhances the generalizability of our findings. Additionally, unlike previous studies, our research used diagnostic codes, generally assigned by psychiatrists after thorough clinical assessments, to capture mental health outcomes more accurately. South Korea has a medical system in which most patients receive treatment by specialists from the beginning rather than being referred by primary care providers. Therefore, it is assumed that most of the codes for mental disorders used in the study were entered by psychiatrists, which increases the validity and reliability of the diagnosis. 19 , 20 , 21 , 22 , 23 Furthermore, the present study used new mental disorders after PPM implant as a time‐varying covariate, allowing for the inclusion of all mental disorders occurring throughout the entire follow‐up period, and addressing the issue of immortal time bias.
Our findings indicate that the overall incidence of new mental disorders among PPM patients is comparable to that in the general population, suggesting that PPM implantation per se is not a risk factor for the development of mental disorders in general. Rather, PPM implantation should be interpreted as a marker of underlying disease burden and exposure to major medical interventions. Notably, older female PPM patients exhibited a lower incidence of mental disorders than their matched general population, possibly because of increased health confidence and perceived stability after implantation. In contrast, younger male PPM patients, particularly those aged <50 years, had a higher incidence of mental disorders. Similar patterns in mental health outcomes following physical illness have been observed in prior research, with variations based on age and sex. For instance, a study on depression following spinal cord injury found a higher risk in men than in women. 27 Additionally, younger individuals often report greater psychological distress after physical illnesses. 20 , 28 , 29 This may be because younger people and men are more likely to experience greater perceived loss of autonomy, self‐mastery, and physical performance compared with older individuals and women.
Prognostic Impact of Newly Diagnosed Mental Disorders Among the PPM Population
This study is the first to assess the prognostic impact of newly diagnosed mental disorders in PPM patients, revealing that mental disorders among PPM patients are associated with increased long‐term risks of all‐cause death, cardiac death, severe heart failure–related events, and any readmission.
Among these, schizophrenia spectrum disorder had the most substantial impact on adverse outcomes, likely because of poor self‐care for cardiovascular conditions, delays in receiving timely device interrogation and appropriate interventions, and negative perceptions from health care providers. 30 In a similar context, PPM patients with depression may also neglect device optimization or fail to address PPM‐related complications, such as pacing‐induced cardiomyopathy, device‐detected subclinical atrial fibrillation, and pacing system malfunction or infection. 31 , 32 , 33 , 34 Previous studies indicate that patients with severe mental disorders, like schizophrenia and bipolar disorder, face higher risks of myocardial infarction and stroke but are less likely to receive necessary interventional treatments compared with the general population. 35 , 36
In addition to severe mental disorder, sleep disturbances also appear to contribute to adverse outcomes in PPM patients. Newly diagnosed insomnia among PPM patients was associated with an adverse prognosis. Sleep deprivation can lead to autonomic dysregulation, elevated cortisol levels, and inflammatory reaction, 37 , 38 , 39 which may have contributed to worse outcomes in vulnerable PPM patients. Conversely, patients with anxiety disorders may experience heightened health concerns or vigilance, potentially improving adherence to tests and treatments and resulting in a better prognosis than expected. Although poor sleep quality is known to increase the risks of ICD shocks and mortality, 40 , 41 the adverse effects of insomnia remain underrecognized in the clinical management of PPM patients, highlighting the need for effective management of sleep disturbances in these patients.
Beyond the type of mental disorder, the timing of its onset may further influence prognosis. Patients with early‐diagnosed mental disorders after PPM implantation showed worse outcomes than those with late‐diagnosed disorders. These patients may have latent vulnerabilities, such as a history of childhood trauma, heightened stress sensitivity, mood instability, limited social support, or inadequate coping mechanisms, that may have gone unrecognized before implantation. Such underlying predispositions can intensify responses to the psychological and physical stresses surrounding PPM implantation, leading to worse outcomes. This finding underscores the importance of understanding how preexisting psychological traits influence long‐term health risks, emphasizing the need for proactive mental health support in high‐risk patients.
Overall, these findings indicate that newly diagnosed mental disorders identify a particularly vulnerable subgroup within the PPM population, rather than implying a device‐specific causal effect of PPM implantation itself.
Clinical Implications
Our findings underscore the importance of age‐ and sex‐specific approaches in managing the psychological aspects of PPM patients. Early detection and intervention for mental disorders should be prioritized, given their strong association with adverse outcomes. Integrating mental health screening into routine follow‐up care could help identify at‐risk patients earlier, enabling timely intervention. Subgroups at higher mortality risk, including male patients, those with schizophrenia, and individuals with early‐onset mental disorders, may particularly benefit from regular psychological evaluations, potentially improving both survival rates and quality of life. Additionally, our findings indicate that latent vulnerabilities should be taken into account during preimplantation assessments. Routine psychological evaluations before PPM implantation may help identify patients with preexisting psychological vulnerabilities, allowing clinicians to proactively address these risks. Tailoring support to individual risk profiles may reduce mortality risks in PPM patients, with this study laying the groundwork for future guidelines on targeted mental health management.
Study Limitations
This study has several limitations. First, being observational in nature, it faces inherent challenges in controlling for confounding factors and immortal time bias. To address these issues, we used a target trial emulation approach, propensity score matching, and time‐varying methods to account for potential confounders and immortal time bias, as well as to enhance comparability between groups. However, patients requiring PPM implantation inherently differ from the general population; therefore, unmeasured factors, such as detailed disease severity or prior procedural history, may remain. PPM implantation should not be interpreted as a causal risk factor for mental disorders; rather, it may reflect underlying disease burden. Consistent with this interpretation, the overall risk of detecting new mental disorders was similar between PPM patients and the propensity score–matched general population, suggesting that PPM implantation itself is unlikely to be a primary driver of mental disorder incidence. Accordingly, the primary focus of this study was not to establish causality between PPM implantation and mental disorders, but to identify vulnerable subgroups among PPM patients and to evaluate the prognostic impact of newly diagnosed mental disorders within the PPM population. Second, mental disorder identification relied solely on diagnostic codes from Korean National Health Insurance Service claims data; as a result, individuals who did not seek care or were not given a mental disorder code may have been misclassified. Nevertheless, physician‐assigned diagnostic codes are generally considered more reliable than self‐reported questionnaires. 19 , 20 , 21 , 22 , 23 Third, the study did not analyze psychiatric medication use, which might have provided further insights into patients' mental health status.
CONCLUSIONS
Although the overall risk of detecting new mental disorders among PPM patients was comparable to that of the matched general population, newly diagnosed mental disorders are associated with a worse prognosis in PPM patients, particularly in younger male patients and those with early‐onset mental disorders. Further studies are warranted to determine whether tailored psychological support can improve outcomes in these high‐risk groups.
Sources of Funding
This research was supported by a grant from the National Institute of Medical Device Safety Information in 2024.
Disclosures
None.
Supporting information
Tables S1–S4
Figures S1–S3
STROBE Checklist
J. Kim and H. Kim contributed equally.
This manuscript was sent to Tazeen H. Jafar, MD, MPH, Associate Editor, for review by expert referees, editorial decision, and final disposition.
Supplemental Material is available at https://www.ahajournals.org/doi/suppl/10.1161/JAHA.125.046035
For Sources of Funding and Disclosures, see page 10.
Contributor Information
Danbee Kang, Email: dbee.kang@skku.edu.
Seung‐Jung Park, Email: orthovics@skku.edu, Email: orthovics@gmail.com.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Tables S1–S4
Figures S1–S3
STROBE Checklist