Persistent pocket-site pain after cardiac implantable electronic device implantation: a prospective observational study of prevalence, neuropathic characteristics, and quality of life

Abstract

Background

Although transvenous cardiac implantable electronic device (CIED) implantation is generally considered a minor procedure, long-lasting pocket-site pain may represent an underrecognized clinical problem. This study aimed to evaluate the prevalence, characteristics, and clinical impact of persistent pain after CIED implantation.

Methods

This prospective observational study included patients who underwent first-time CIED implantation and attended routine outpatient follow-up visits. Pain intensity was assessed using the Visual Analog Scale (VAS), and neuropathic pain characteristics were evaluated using the Douleur Neuropathique 4 Questions (DN-4) questionnaire. Health-related quality of life was assessed using the Short Form-12 (SF-12). Demographic and clinical data were also recorded.

Results

A total of 102 patients were included in the analysis. Persistent implantation-site pain (VAS ≥ 4) was reported by 22.5% of patients. Neuropathic pain characteristics (DN-4 ≥ 4) were identified in 26.5% of patients. A moderate positive correlation was observed between VAS and DN-4 scores (ρ = 0.473, p < 0.001). However, the association between VAS ≥ 4 and DN-4 ≥ 4 was not statistically significant and had a small effect size (p = 0.118; φ = 0.15). Pain intensity was moderately negatively correlated with the SF-12 physical component score, indicating reduced physical quality of life with increasing pain severity, while mental quality of life was not significantly affected.

Conclusions

Persistent pocket-site pain after CIED implantation affected a clinically meaningful proportion of patients despite generally low overall pain scores. Higher DN-4 scores were associated with poorer physical and mental quality of life and may provide additional clinical information in selected patients. However, because the categorical association between VAS-defined persistent pain and DN-4 positivity was not statistically significant, these findings should be interpreted cautiously and confirmed in larger prospective studies.

Introduction

Chronic postsurgical pain (CPP) is defined by the International Association for the Study of Pain (IASP) and ICD-11 as pain that develops or increases after a surgical procedure, persists or recurs for at least three months, is localized to the surgical field or a referred area, and cannot be better explained by other causes, such as infection, malignancy, or a pre-existing pain condition [1–3]. Reported prevalence in different surgical populations varies widely (approximately 5–85%), depending on the type of surgery and the assessment methods used [4, 5]. CPP is frequently accompanied by neuropathic pain features and has been associated with impaired physical function and reduced quality of life [6, 7]. Accordingly, in the present study, the term “persistent pocket-site pain” is used as the operational term for pain reported after transvenous cardiac implantable electronic devices (CIEDs) implantation, whereas the term “CPP” is reserved for pain fulfilling the ICD-11/IASP diagnostic criteria.

Longer life expectancy and an aging population have increased the use of cardiac implantable electronic devices (CIEDs) [8]. In these patients, fascial plane blocks supplement oral and intravenous treatments for acute pain management [9, 10]. However, postoperative pain management may not always follow international guidelines. Inadequate control of acute postoperative pain may contribute to the development of chronic pain after CIED implantation [11].

CPP can decrease patient satisfaction, raise stress levels, extend hospital stays, and lead to repeated visits. Patients may also use non-targeted medications, placing additional strain on them and the healthcare system [12, 13]. Drug use may complicate perioperative management due to drug interactions and systemic effects [14].

The primary objective of this study was to assess the presence, severity, and neuropathic characteristics of persistent pocket-site pain in patients undergoing outpatient follow-up after CIED implantation. The secondary objective was to evaluate its impact on health-related quality of life.

Methods

To ensure ethical standards, the study received approval from the Medical Research Ethics Committee (Approval number: E-24687260-604.01-1462042, 31.10.2025). Written informed consent was obtained from all patients for participation in the study and for the publication of their anonymized data in a scientific journal. The study was conducted in accordance with the STROBE guidelines [15] and adhered to the principles of Declaration of Helsinki.

Study population

A total of 216 patients presenting to the cardiac electrophysiology outpatient clinic during the study period were screened for eligibility.

Patients aged ≥ 18 years who had undergone first-time transvenous CIED implantation at our institution between June 2022 and June 2025 and had completed at least three months of follow-up were eligible for inclusion. The upper limit of three years after implantation was predefined as an eligibility criterion to reduce potential confounding related to long-term follow-up, including newly developed comorbidities, subsequent surgical procedures, or musculoskeletal disorders that might influence the assessment of persistent pocket-site pain. Eligible patients were identified consecutively during routine outpatient follow-up visits at the cardiac electrophysiology clinic. All eligible patients were invited to participate, and those who provided written informed consent were prospectively enrolled. Twenty-one eligible patients declined participation. Pain intensity, neuropathic pain characteristics, and quality of life were evaluated during the study visit using standardized questionnaires and assessment tools. Patients were excluded if they had conditions known to affect pain perception or neuropathic pain assessment, including diabetic neuropathy; neurodegenerative, vascular, or autoimmune diseases; active malignancy; recent trauma or infection; hereditary disorders; suspected or confirmed toxic exposure; or a history of CIED battery replacement. In addition, patients with chronic pain syndromes, those receiving antineuropathic medications, or those diagnosed with major psychiatric disorders were excluded.

All CIED implantations were performed by the same cardiology team to ensure procedural consistency. Intraoperative local anesthetic infiltration and postoperative analgesic management were provided according to the institution’s routine clinical practice.

Data collection

Data collection focused on evaluating the presence, severity, and neuropathic characteristics of persistent pain in the generator pocket site during outpatient follow-up visits in patients following CIED implantation. Data were also collected on the impact of reported pain on patients’ quality of life.

We recorded each patient’s age, gender, weight, height, education, and comorbidities (such as ischemic heart disease, heart failure, hypertension, chronic kidney disease, or thyroid disease). The use of antineuropathic and analgesic medications and their frequency of use were also recorded. Collected data included the onset of pain after implantation, the duration of pain (defined as the interval between the onset of persistent pocket-site pain and the study assessment), pain severity, indication for CIED implantation, use of antineuropathic medication for localized pocket pain, implant side (right/left), device type [pacemaker (PM), implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT-D)], number of leads, pocket location (subcutaneous, subfascial, subpectoral), and time since implantation. Patients with pain complaints identified during the evaluation were referred to the Pain Clinic at Istanbul University-Cerrahpasa, Faculty of Medicine.

Pain assessment

For the purposes of this study, persistent pocket-site pain was operationally defined as pain at the generator pocket site with a VAS score ≥ 4 that persisted for at least three months after CIED implantation. A VAS threshold of ≥ 4 was selected because it has been widely accepted as representing at least moderate pain intensity and clinically meaningful pain intensity that may warrant further clinical evaluation or treatment [16, 17]. Although this approach may underestimate milder but persistent pain, it was considered more appropriate for identifying patients with clinically important persistent symptoms during follow-up. This operational definition was used to identify patients with clinically relevant persistent pocket-site pain and should not be interpreted as a formal diagnosis of CPP according to the ICD-11/IASP criteria. Patients who met this criterion were referred to the pain clinic for further evaluation and management [18, 19]. Neuropathic pain characteristics were assessed using the Turkish-validated Douleur Neuropathique 4 (DN-4) questionnaire. The DN-4 questionnaire was used to evaluate both sensory descriptors and clinical examination findings, and a total score ≥ 4 indicated the presence of neuropathic pain [20].

Assessment of quality of life

The Short Form-12 (SF-12) test, validated in Turkish, was used to assess patients’ quality of life. The questionnaire consisted of 12 items divided into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). This allowed a rapid evaluation of both physical and mental health, providing insight into health-related quality of life [21, 22]. The SF-12 was standardized to a normative mean of 50 and a standard deviation of 10 [21]. Scores above 50 were interpreted as indicating better general health and quality of life. Results were calculated using a web-based calculator at https://orthotoolkit.com/sf-12/ [23].

Data analysis

Sample size (prevalence estimation)

The study included patients who underwent CIED implantation at our center and were at least 3 months post-implantation. The primary objective was to estimate the prevalence of persistent pain at the CIED generator pocket site. The sample size was calculated to estimate a single proportion with a specified margin of error. Goldthorpe [24] reported a 24% prevalence of prolonged pain after CIED implantation. This value was used as our expected prevalence (p = 0.24). The minimum sample size was calculated using the single-proportion formula, n = Z_(1-α/2)^2 p(1-p)/d^2. Using an expected prevalence of 0.24, a two-sided 95% confidence level, and a margin of error of 0.10, the required sample size was 70. No finite population correction was applied. After allowing for 10% potential data loss, the target sample size was 77. The final analysed sample of 102 patients exceeded this target, and no post hoc power calculation was performed.

Statistical method

IBM SPSS Statistics 31 (IBM Corp., Armonk, NY, USA) was used for all statistical analyses. Continuous variables were reported as mean ± standard deviation, median (minimum–maximum), and interquartile range (IQR). Categorical variables were shown as frequencies and percentages. We checked the normality of continuous data using the Shapiro–Wilk test.

The independent-samples t-test was used to compare two groups with normally distributed data, while the Mann–Whitney U test was used for non-normally distributed data. For comparisons among three or more groups, one-way ANOVA or the Kruskal–Wallis test was used as appropriate. Categorical variables were compared using the Pearson chi-square test or Fisher’s exact test.

Because VAS scores were not normally distributed, the median and interquartile range (IQR) were reported as the primary summary statistics. The crude odds ratio and its 95% confidence interval for the association between VAS-defined pain and DN-4 positivity were estimated from the corresponding 2 × 2 contingency table. Relationships between continuous variables were assessed using Spearman’s rank correlation coefficient. A two-tailed p value < 0.05 was considered statistically significant.

Results

A total of 216 patients screened between June 2022 and June 2025 were assessed for eligibility. After excluding those who were deceased, declined participation, did not meet the inclusion criteria, or were lost to follow-up, 102 patients were included in the final analysis (Fig. 1).

Fig. 1.

Flow diagram of patient selection and exclusion. CIED: Cardiac implantable electronic device

Baseline characteristics

The study population had a mean age of 68.43 ± 11.26 years, and 66.7% were male. The mean BMI was 27.86 ± 4.33 kg/m². The median time since implantation was 17.27 months (IQR: 8.13–35.50). At the time of study assessment, the mean frequency of self-reported analgesic use was 2.20 ± 2.05 times per week, and paracetamol was the only analgesic reported by patients.

Pain duration was defined as the interval between the onset of persistent pocket-site pain and the study assessment, rather than the interval since CIED implantation. Accordingly, pain duration was shorter than the time since implantation in many patients.

Detailed demographic and clinical characteristics are presented in Table 1.

Table 1.

Baseline demographic and clinical characteristics of the study population (n = 102)

Variable	Value*
Age, years	68.43 ± 11.26
Gender
Female  Male	34 (33.3%) 68 (66.7%)
Height, cm	165.98 ± 8.95
Weight, kg	75 [67–85]
Body mass index (BMI), kg/m²	27.86 ± 4.33
Comorbidities
HT	73 (71.6%)
IHD	43 (42.2%)
AF	25 (24.5%)
CHF	14 (13.7%)
CAD	13 (12.7%)
Hypothyroidism	11 (10.8%)
Education level
None  Literate (no formal schooling)  Primary school  Lower secondary / middle school  High school  Associate/Bachelor/Postgraduate	3 (2.9%) 8 (7.8%) 47 (46.1%) 15 (14.7%) 17 (16.7%) 12 (11.8%)
Analgesic use frequency, times/week	2.20 ± 2.05
Pain duration, months	6.00 [3.50–11.13]
Time since implantation, months	17.27 [8.13–35.50]
SF-12 Physical Component Summary (PCS)	39.29 ± 7.59
SF-12 Mental Component Summary (MCS)	42.65 ± 8.99
Neuropathic medication use frequency
0	102 (100.0%)
Clinically relevant pain (VAS-based)
No  Yes	79 (77.5%) 23 (22.5%)
Neuropathic pain (DN4-based)
No  Yes	75 (73.5%) 27 (26.5%)
CIED implantation side
Right  Left	1 (1.0%) 101 (99.0%)
CIED type (PM / ICD / CRT-D)
PM  ICD  CRT-D	42 (41.2%) 37 (36.3%) 23 (22.5%)
Number of leads
1  2  3	12 (11.8%) 67 (65.7%) 23 (22.5%)
Generator pocket location
Subpectoral  Subfascial  Intramuscular  Supramuscular  Suprafascial	45 (44.1%) 44 (43.1%) 5 (4.9%) 5 (4.9%) 3 (2.9%)

AF Atrial Fibrillation, BMI Body Mass Index, CAD Coronary Artery Disease, CHF Congestive Heart Failure, CIED Cardiac Implantable Electronic Device, CRT-D Cardiac Resynchronization Therapy Defibrillator, DN-4 Douleur Neuropathique 4 Questions, HT Hypertension, ICD Implantable Cardioverter-Defibrillator, IHD Ischemic Heart Disease, IQR Interquartile Range, MCS Mental Component Summary, PCS Physical Component Summary, PM Pacemaker, SD Standard Deviation, SF-12 12-Item Short Form Health Survey, VAS Visual Analog Scale

*Continuous variables were summarized using means ± SD (standard deviation) or medians (IQR), and categorical variables as n (%)

Clinically relevant pain (VAS ≥ 4) was reported by 23 patients (22.5%), while 79 (77.5%) reported no pain. Neuropathic pain features (DN-4 ≥ 4) were present in 27 patients (26.5%). The highest reported VAS score was 8 and was observed in 5.9% of patients. VAS scores were not normally distributed (Shapiro–Wilk p < 0.001). The median VAS score was 2.00 (IQR:1.00–3.00). The distribution showed marked clustering at low scores (predominantly 0–2), while a small number of patients reported higher pain scores.

Association between pain presence and neuropathic pain

The distribution of VAS scores is shown in Fig. 2.

Fig. 2.

Distribution of pain intensity per Visual Analog Scale (VAS) scores. The most frequent score was 1 (24.5%), then 0 (21.6%) and 2 (19.6%)

The distribution of DN-4 scores is shown in Fig. 3.

Fig. 3.

DN-4 total score distribution. Most frequent: 2 (26.5%), then 3 (17.6%) and 4 (17.6%)

Spearman correlation analysis demonstrated a moderate positive correlation between VAS and DN-4 scores (ρ = 0.473, p < 0.001). Pearson’s chi-square test did not show a statistically significant association between pain presence defined by VAS (VAS ≥ 4 vs. < 4) and DN-4 positivity (DN-4 ≥ 4) (χ²(1, N = 102) = 2.445, p = 0.118). Fisher’s exact test was likewise not statistically significant (two-sided p = 0.178). DN-4 positivity was observed in 9 of 23 patients (39.1%) with VAS-defined pain and in 18 of 79 patients (22.8%) without VAS-defined pain, corresponding to an odds ratio (OR) of 2.18 (95% CI: 0.81–5.86). This finding represented a non-significant trend with a small effect size (φ = 0.15). The observed agreement between the dichotomized VAS and DN-4 classifications was 68.6% (Table 2).

Table 2.

Association of pain presence (VAS ≥ 4) and neuropathic pain (DN-4 ≥ 4) (n = 102)

Pain presence (VAS)	DN-4 < 4, n (%)	DN-4 ≥ 4, n (%)	Total, n
VAS < 4 (no pain)	61 (77.2%)	18 (22.8%)	79
VAS ≥ 4 (pain present)	14 (60.9%)	9 (39.1%)	23
Total	75	27	102

Percentages are row percentages

VAS Visual Analog Scale, DN-4 Douleur neuropathique 4 questions

Pain and quality of life

Pain intensity showed a small-to-moderate negative correlation with the SF-12 Physical Component Summary (PCS) score (ρ = −0.382, p < 0.001), indicating worse physical quality of life with increasing pain severity. However, the correlation between VAS and SF-12 Mental Component Summary (MCS) score did not reach statistical significance (ρ = −0.186, p = 0.061). DN-4 scores showed small negative correlations with both PCS (ρ = −0.272, p = 0.006) and MCS (ρ = −0.288, p = 0.003) scores (Table 3).

Table 3.

Spearman rank-order correlations among pain intensity, neuropathic pain features, and health-related quality of life (n = 102)

Variable	VAS score	DN-4 score	SF-12 Physical (PCS)	SF-12 Mental (MCS)
VAS score	—
DN-4 score	0.473** (< 0.001)	—
PCS-12	−0.382**(< 0.001)	−0.272** (0.006)	—
MCS-12	−0.186 (0.061)	−0.288** (0.003)	0.270** (0.006)	—

Values are Spearman’s rho (ρ). Exact two-tailed p values are shown in parentheses

VAS Visual Analog Scale, DN-4 Douleur Neuropathique 4 Questions, PCS Physical Component Summary, MCS Mental Component Summary

** p < 0.01

Additional exploratory subgroup analyses were performed to examine whether pain outcomes varied according to follow-up duration, device type, or generator pocket location.

When patients were stratified according to follow-up duration (< 12 vs. ≥12 months after CIED implantation), 37 (36.3%) were in the < 12-month group and 65 (63.7%) in the ≥ 12-month group. The prevalence of VAS-defined persistent pocket site pain was 27.0% and 20.0%, respectively (χ² = 0.667, p = 0.414), while DN-4 positivity was observed in 29.7% and 24.6% of patients (χ² = 0.317, p = 0.573). No statistically significant differences were observed between the follow-up groups in continuous VAS scores (Mann–Whitney U = 1277.0, p = 0.598), DN-4 scores (U = 1121.5, p = 0.566), SF-12 PCS scores (U = 1354.0, p = 0.292), or SF-12 MCS scores (U = 1445.0, p = 0.091).

Further exploratory analyses according to device type and generator pocket location also showed no significant differences. The prevalence of VAS-defined persistent pocket-site pain was similar across device types, occurring in 21.4% of patients with a pacemaker, 21.4% of those with an ICD, and 27.8% of those with a CRT-D device (χ² = 0.342, p = 0.843). Consistent with this finding, neither continuous VAS scores (Kruskal–Wallis H = 1.019, p = 0.601) nor DN-4 scores (H = 2.985, p = 0.225) differed significantly among the three device groups. Similarly, direct comparison between pacemaker and ICD recipients showed no significant differences in either VAS scores (Mann–Whitney U = 794.0, p = 0.423) or DN-4 scores (U = 894.0, p = 0.913).

Neither VAS nor DN-4 scores differed significantly when the five original pocket-location categories (subpectoral, subfascial, intramuscular, supramuscular, and suprafascial) were analysed (VAS: H = 1.066, p = 0.900; DN-4: H = 6.879, p = 0.142). The results were unchanged after combining the smaller categories into subpectoral, subfascial, and other locations (VAS: H = 0.827, p = 0.661; DN-4: H = 4.333, p = 0.115).

Discussion

This study evaluated the prevalence and characteristics of persistent pocket-site pain in patients undergoing routine follow-up after first-time transvenous CIED implantation. Persistent pain was observed in 22.5% of patients, while neuropathic pain features were present in 26.5%. Higher pain intensity was significantly associated with poorer physical quality of life, whereas higher DN-4 scores showed small negative correlations with both PCS and MCS scores.

Although the overall pain intensity was generally low, the observed prevalence suggests that a notable proportion of patients experience persistent pain after implantation. In the context of chronic postsurgical pain, even low-intensity symptoms may have clinically meaningful consequences, particularly when they persist over time or exhibit neuropathic characteristics.

Chronic postsurgical pain (CPP) is a well-recognized and common clinical entity. In 6- to 12-month follow-ups of various surgical groups, the overall incidence of chronic pain after surgery has been reported to be 20–30%. It has been noted that this rate can reach up to 80% depending on the type of surgery and the assessment methodologies used [25].

In another study, Goldthorpe surveyed 310 patients who underwent CIED implantation to assess pain. 10% of the participants reported that their pain lasted longer than 6 months post-implantation. The mean pain score was 4.5 (95% CI: 4.2–4.8). More than one-third of the respondents (37.3%) rated the pain as severe (score > 5), and 2% described it as the worst possible pain (i.e., score 10). Although this research relied on survey data and cannot be considered a comprehensive prevalence study, it highlights the frequency of long-lasting pain after CIED implantation [24]. While CIED complications are typically attributed to pocket or device-lead issues, persistent pocket site pain is frequently overlooked as a formal complication [26–28].

In our cohort, 22.5% of patients reported clinically relevant persistent pocket-site pain at the implantation site based on the VAS ≥ 4 threshold. At the same time, the overall VAS distribution remained clustered around low scores (predominantly 0–2), indicating that many patients also experienced milder residual symptoms during follow-up. This pattern suggests that the burden of post-implantation pain cannot be fully characterized by dichotomous severity classification alone.

Notably, neuropathic pain features and reduced physical quality of life were observed alongside the broader spectrum of pain reporting. From a clinical perspective, these findings suggest that clinically relevant persistent pocket-site pain may affect a substantial minority of patients despite generally low overall pain scores. These observations support the view that post-implantation pain should be considered across its full clinical spectrum. Although perioperative pain management was not assessed in the present study, previous CPSP literature has suggested that optimizing perioperative analgesia may help reduce the risk of persistent postsurgical pain [29–31]. However, because perioperative analgesic strategies and acute postoperative pain intensity were not evaluated in this study, our findings should not be interpreted as demonstrating a causal relationship between perioperative pain management and persistent pain after CIED implantation.

Neuropathic pain is frequently associated with higher pain scores and typically presents a more severe, treatment-resistant clinical course. In our study, VAS and DN-4 scores showed a moderate positive correlation (ρ = 0.473, p < 0.001), consistent with previous reports suggesting that higher pain intensity may accompany neuropathic pain characteristics [32–34]. However, the categorical association between VAS-defined persistent pain (VAS ≥ 4) and DN-4 positivity (DN-4 ≥ 4) was not statistically significant according to either Pearson’s chi-square test (p = 0.118) or Fisher’s exact test (p = 0.178). Although DN-4 positivity was numerically more frequent among patients with VAS ≥ 4, the corresponding odds ratio of 2.18 (95% CI: 0.81–5.86) represents a non-significant trend rather than a statistically significant effect. The discrepancy between the significant correlation based on continuous scores and the non-significant categorical association may partly reflect the loss of information and statistical power resulting from dichotomization. These findings, together with the modest agreement between the dichotomized measures, suggest that pain intensity and neuropathic pain characteristics are related but capture different dimensions of the pain experience.

Furthermore, neuropathic mechanisms, such as nerve damage and central or peripheral sensitization, may contribute to persistent pocket-site pain after CIED implantation. Analyses using the continuous VAS and DN-4 scores suggest that neuropathic pain characteristics may be clinically relevant in patients with persistent pocket-site pain. At the same time, the absence of a statistically significant association between the predefined categorical measures of VAS-defined persistent pain and DN-4 positivity indicates that these findings should be regarded as exploratory and interpreted with appropriate caution. These observations require confirmation in larger prospective studies.

Neuropathic mechanisms have been proposed as a contributing factor in persistent postsurgical pain [35]. In the context of CIED implantation, potential mechanisms may include nerve fiber stretching or localized nerve injury during generator pocket formation.

These considerations suggest that assessment based solely on pain intensity may be insufficient, and that evaluation of pain characteristics is also warranted. From a clinical perspective, distinguishing between nociceptive and neuropathic pain components is relevant, as it may influence treatment strategies. While conventional management often includes simple analgesics such as paracetamol or non-steroidal anti-inflammatory drugs, the presence of neuropathic features may require alternative or adjunctive therapies, including gabapentinoids or certain antidepressants [34].

Although CIED implantation is generally considered a relatively minor procedure, postoperative pain may be underrecognized in this patient population. A large retrospective study reported that 20.2% of patients were discharged with an opioid prescription following CIED implantation, the majority of whom were opioid-naive. Among these patients, a subset required prescription renewals, suggesting that postoperative pain may persist beyond the immediate recovery period [36–38].

These findings underscore that clinically relevant pain following CIED implantation may be more common than traditionally assumed, supporting the need for careful postoperative pain assessment and follow-up.

An additional clinical implication of our findings relates to cardiac implantable electronic devices that do not require creation of a pectoral generator pocket. Because persistent pocket-site pain affected a clinically meaningful proportion of our cohort, pocketless technologies such as leadless pacemakers may theoretically reduce this complication in appropriately selected patients. Although leadless devices were not evaluated in the present study and no conclusions regarding comparative pain outcomes can therefore be drawn, previous evidence suggests that leadless pacing systems may be a safe option in certain patient populations [39]. Whether avoidance of a pectoral generator pocket translates into lower rates of persistent postoperative pain remains to be established in future comparative studies.

At the time of follow-up assessment, patients who reported analgesic use relied exclusively on paracetamol, with a mean self-reported frequency of 2.20 ± 2.05 times per week. This is likely attributable to clinicians’ reluctance to prescribe stronger analgesics given the advanced age and multiple comorbidities of the study population (mean age: 68.43 ± 11.26 years). Furthermore, national data suggests a high prevalence of ‘opiophobia’ among physicians, driven by concerns regarding addiction and adverse effects, which may further explain our findings [40, 41]. These findings may suggest that persistent pocket-site pain, particularly when accompanied by neuropathic characteristics, remains underrecognized and potentially undertreated in routine clinical practice.

Several studies have shown that cardiac function and symptoms may improve during the first year after CIED implantation, contributing to improvements in patients’ quality of life [42, 43]. However, alongside this improvement, postoperative pain may paradoxically persist and transition into a chronic condition. CPSP is a clinical problem that negatively affects patients’ psychological well-being, daily functioning, and overall quality of life [44]. In our study, a moderate negative correlation was found between pain intensity and the PCS-12 score, indicating that physical quality of life deteriorates as pain intensity increases. Conversely, no significant association was observed between pain intensity and mental quality of life (MCS-12).

A cohort study by Gatti et al., which evaluated overall quality of life after CIED implantation rather than pocket-site pain specifically, demonstrated early and sustained impairment in physical quality of life for up to one year after implantation, whereas mental quality of life remained largely preserved [45]. Similarly, Leosdottir et al. reported that pain and activity restrictions adversely affected physical quality of life in pacemaker and ICD recipients, regardless of device type, while mental quality of life remained relatively stable despite the presence of device-related concerns [46]. A subsequent review also concluded that physical quality of life is the domain most consistently affected following CIED implantation, whereas changes in mental quality of life appear to be more heterogeneous and influenced by individual patient characteristics [47, 48].

Although these studies focused on overall device-related quality of life rather than pocket-site pain, our results showed a similar pattern. Pain intensity was associated with poorer physical quality of life, whereas no significant relationship was observed with mental quality of life. This relative preservation of mental well-being may reflect patients’ perception of CIEDs as life-saving therapies, facilitating psychological adaptation despite persistent physical discomfort. In addition, higher DN-4 scores were associated with lower PCS-12 and MCS-12 scores, indicating that neuropathic pain characteristics may contribute to reduced quality of life beyond pain intensity alone.

Regardless of absolute pain severity, persistent discomfort at the implantation site appears to be associated with reduced well-being. Therefore, clinical evaluation of CIED patients may benefit from incorporating assessments of neuropathic pain features in addition to pain intensity.

This study has several limitations. First, although prospectively designed, it was conducted at a single center with a relatively small sample size. However, despite this limitation, the observed associations between pain intensity, neuropathic characteristics, and quality of life reached statistical significance, suggesting that the sample was sufficient to identify clinically relevant patterns in this patient population. Second, baseline (pre-implantation) pain and quality of life assessments were not available for comparison. Third, pain evaluation relied on self-reported scales (VAS and DN-4). While these are validated and widely used, they inherently reflect the subjective experience of pain; the absence of objective quantitative sensory testing represents a limitation. Fourth, although psychiatric and psychosocial factors (e.g., anxiety and depression) are known to influence chronic postoperative pain, these were not specifically quantified beyond the MCS-12 score. Fifth, the operational definition of persistent pocket-site pain using a VAS threshold of ≥ 4 may have underestimated the prevalence of milder but persistent symptoms. Nevertheless, this threshold was chosen to identify clinically meaningful pain, in keeping with previously proposed pain severity classifications, while minimizing the inclusion of very mild residual symptoms that are less likely to be clinically significant. Finally, information on acute postoperative analgesic management was not collected systematically. The reported use of paracetamol reflected analgesic use at follow-up rather than in the immediate postoperative period. Therefore, no conclusions can be drawn about the adequacy of early postoperative pain management or its potential contribution to persistent pocket-site pain. Despite these limitations, this study highlights the substantial frequency of chronic postoperative pain and its neuropathic components following CIED implantation, emphasizing their critical impact on quality of life.

Conclusion

Persistent pocket-site pain after CIED implantation affected a clinically meaningful proportion of patients, despite generally low overall pain scores. Higher DN-4 scores were modestly associated with poorer physical and mental quality of life, highlighting the potential value of careful pain assessment in this population. Assessment of neuropathic pain characteristics may also provide additional clinical information in selected patients. However, this observation was derived primarily from exploratory analyses of continuous VAS and DN-4 scores, whereas the predefined categorical association between VAS-defined persistent pain and DN-4 positivity was not statistically significant. Accordingly, these findings should be interpreted with caution and require confirmation in larger prospective studies. Further research is needed to improve strategies for the prevention and management of persistent pocket-site pain following CIED implantation.

Abbreviations

AF

Atrial Fibrillation

BMI

Body Mass Index

CAD

Coronary Artery Disease

CHF

Congestive Heart Failure

CIED

Cardiac Implantable Electronic Device

CPP

Chronic Postsurgical Pain

CRT-D

Cardiac Resynchronization Therapy (Defibrillator)

DN-4

Douleur Neuropathique 4 Questions

HT

Hypertension

ICD

Implantable Cardioverter-Defibrillator

ICD-11

International Classification of Diseases, 11th Revision

IHD

Ischemic Heart Disease

IQR

Interquartile Range

MCS

Mental Component Summary

OR

Odds Ratio

PCS

Physical Component Summary

PM

Pacemaker

SD

Standard Deviation

SF-12

12-Item Short Form Health Survey

STROBE

Strengthening the Reporting of Observational Studies in Epidemiology

VAS

Visual Analog Scale

Authors’ contributions

Authors’ contributions: G.A., K.E. have given substantial contributions to the conception or the design of the manuscript. G.A., S.A., Y.O.,A.E., A.S.B., B.S. to acquisition, analysis and interpretation of the data. All authors have participated to drafting the manuscript, Z.S. revised it critically. All authors read and approved the final version of the manuscript.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data availability

The datasets generates and/or analysed during the current study are not publicly available due to patient confidentiality but are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

This prospective research was conducted after obtaining ethical committee approval (Istanbul University-Cerrahpaşa Medical Research Ethics Committee, approval number: E-24687260-604.01-1462042, 31.10.2025). Written informed consent was obtained from all patients for participation in the study and for the publication of their anonymized data in a scientific journal. This manuscript adheres to the applicable STROBE guidelines and the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.