Abstract
Background
Cardiac implantable electronic devices (CIEDs) substantially improve outcomes in cardiac patients, but device-related infection can negate these benefits. Data on the epidemiology of CIED infections in Saudi Arabia are limited.
Methods
We performed a multicenter retrospective cohort study of consecutive patients receiving CIEDs (pacemakers [PPM], implantable cardioverter-defibrillators [ICD], and cardiac resynchronization devices [CRT]) at three tertiary hospitals in Riyadh, Saudi Arabia, from January 2017 through December 2021. Patients were followed for at least one year post-implantation. Data collected included patient demographics, device type (new implant, replacement, revision), infection timing and microbiology, management (device extraction vs conservative treatment), and outcomes.
Results
Of 4080 CIED recipients, 114 (2.8 %) developed device infections (incidence 98.8 per 10,000 person-years). CRT-P (cardiac resynchronization therapy pacemaker) devices had the highest infection rate (7.7 %). Revision procedures carried higher infection rates than initial implants or generator replacements (10.0 % vs 2.1 % vs 2.7 %; P < 0.001). The most common pathogens were Staphylococcus aureus (30.1 %), coagulase-negative staphylococci (10.6 %), and Pseudomonas aeruginosa (8.8 %); 38.9 % of infections were culture-negative. Systemic infections and patients managed without device removal had significantly higher mortality (32.3 % vs 8.2 % for systemic vs pocket; 48.4 % vs 12.0 % for no extraction vs extraction; P < 0.001 for both).
Conclusions
In this large Saudi cohort, CIED infection occurred in 2.8 % of patients, particularly following revision procedures and in CRT-P recipients. Infections were often culture-negative and associated with substantial mortality, especially in systemic cases or when devices were not removed. These findings highlight the importance of strict infection-prevention protocols, early recognition, and prompt complete device extraction to improve patient outcomes.
Keywors: Cardiac implantable electronic device, Infection, Incidence, Saudi Arabia, Outcomes
1. Introduction
Cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices have greatly improved survival and quality of life for patients with heart failure and arrhythmias. However, device-related infections represent a serious complication that can negate these benefits. The incidence of CIED infections has risen along with the growing volume and complexity of device implantation [1]. Observational cohorts report infection rates on the order of 1–5% among recipients [2], but detailed data from Saudi Arabia are scarce.
While CIED therapy confers clear survival advantages, any infection can offset these gains [10]. Gram-positive bacteria, particularly staphylococci, account for the majority of CIED infections [3]. In fact, Staphylococcus aureus and coagulase-negative staphylococci are the most frequently isolated pathogens, whereas up to 40–50 % of symptomatic infections may have negative cultures, reflecting prior antibiotic exposure or difficult-to-culture organisms [4,5]. CIED infections are broadly classified as pocket infections or systemic infections. Pocket infections involve local erythema, discharge, or inflammation at the generator site in the absence of systemic illness [11]. In contrast, systemic infections feature bacteremia, fever, or echocardiographic evidence of lead or valvular vegetations [12].
The main aim of this study was to determine the incidence, timing, causative organisms, and clinical outcomes of CIED infections in patients treated at three major centers in Riyadh, Saudi Arabia, over a five-year period.
2. Methods
We conducted a retrospective cohort study of all patients aged ≥18 years who underwent CIED implantation (initial implant, generator replacement, or lead revision) at King Fahad Medical City, Prince Sultan Military Medical City, or Ministry of National Guard Health Affairs in Riyadh from January 2017 through December 2021. Device types included single- and dual-chamber pacemakers (PPMs), ICDs, CRT pacemakers (CRT-P), CRT defibrillators (CRT-D), subcutaneous ICDs, and leadless pacemakers. We collected demographic data (age, sex, comorbidities), device characteristics (type, number of leads, use of antibacterial envelope), and procedural details (date and type of procedure) from electronic medical records. All patients had at least one year of follow-up via clinic visits or telephone contacts to identify device infections or mortality.
CIED infection was defined as clinical evidence of pocket infection (local erythema, tenderness, or purulent discharge at the device site) or systemic infection (positive blood cultures or lead/valve vegetation on echocardiography) in the presence of an implanted CIED. In patients with suspected infection, cultures were obtained from the device pocket, blood, and, if explanted, the device or leads. Data on infection timing (early ≤3 months vs late >3 months after implantation), microbiological findings, management strategy (device extraction vs conservative antibiotic therapy), and outcomes (readmission, mortality) were recorded.
Statistical analysis: We calculated infection incidence per person-year of follow-up. Categorical variables are reported as counts (percentages) and were compared using chi-square or Fisher’s exact tests, while continuous variables are reported as mean (SD) and compared using t-tests. Kaplan–Meier curves with log-rank tests compared survival between groups. A Cox proportional hazards model was constructed to identify independent predictors of infection risk, including hospital site, patient age, sex, device type, and procedure type, with significance set at P < 0.05. Analyses were performed with appropriate software (e.g., SAS or SPSS).
It’s a descriptive study without any intervention. However, confidentiality of patients’ identity will be secure and not published. The patients’ confidentiality, autonomy and beneficence are emphasized as part of this study.
3. Results
3.1. Study cohort
Of 4649 patients screened, 4080 met inclusion criteria. The main exclusions were loss to follow-up (9.1 %) and age <18 years (3.1 %). The study cohort’s devices were 40.3 % ICDs, 30.0 % pacemakers (PPMs), 25.4 % CRT-D, 2.5 % leadless pacemakers, 1.3 % CRT-P, and 0.4 % subcutaneous ICDs. Mean (SD) age was 63.5 (16.1) years, and 68.3 % were male. The median follow-up duration was 34.7 months (Table 1).
Table 1.
Baseline characteristics of the study population by hospital.
| Characteristic | KFMC (n = 1159) | PSCC (n = 1822) | NGHA (n = 1099) | Total (n = 4080) | p-value |
|---|---|---|---|---|---|
| Survival status | <0.001 | ||||
| Surviving, n (%) | 913 (78.9) | 1577 (86.6) | 896 (81.5) | 3386 (83.0) | |
| Died, n (%) | 244 (21.1) | 245 (13.4) | 203 (18.5) | 692 (17.0) | |
| Device type | <0.001 | ||||
| ICD | 512 (44.2) | 623 (34.2) | 510 (46.4) | 1645 (40.3) | |
| CRT-D | 270 (23.3) | 537 (29.5) | 229 (20.8) | 1036 (25.4) | |
| CRT-P | 2 (0.2) | 46 (2.5) | 4 (0.4) | 52 (1.3) | |
| PPM | 286 (24.7) | 586 (32.2) | 353 (32.1) | 1225 (30.0) | |
| Leadless PPM | 82 (7.1) | 20 (1.1) | 2 (0.2) | 104 (2.5) | |
| Subcutaneous ICD | 6 (0.5) | 10 (0.5) | 1 (0.1) | 17 (0.4) | |
| Procedure type | <0.001 | ||||
| Initial implantation | 871 (75.2) | 1231 (67.6) | 901 (82.0) | 3003 (73.6) | |
| Replacement | 264 (22.8) | 528 (29.0) | 166 (15.1) | 958 (23.5) | |
| Revision | 24 (2.1) | 63 (3.5) | 32 (2.9) | 119 (2.9) | |
| Age, years | <0.001 | ||||
| Mean ± SD | 65.6 ± 15.2 | 62.0 ± 17.1 | 63.7 ± 15.0 | 63.5 ± 16.1 |
Bold p-values indicate statistical significance (p < 0.05).
3.2. Infection incidence and risk factors
During follow-up, 114 patients (2.8 %) developed CIED infections, corresponding to an incidence of 98.8 per 10,000 person-years. Infections occurred a mean 20 months after implantation (interquartile range 6–36 months). Patients with infection were younger (mean age 57 vs 63 years, P < 0.001); with no significant sex difference (2.8 % of men vs 2.9 % of women, P = 0.86). CRT-P recipients had the highest infection rate among device types (7.7 %, p = .083). Revision procedures had significantly higher infection rates than initial implants or generator replacements (10.0 % vs 2.1 % and 2.7 %, respectively; P < 0.001).(Table 2).
Table 2.
Device-related infection according to patient and device characteristics.
| Characteristic | Infection Yes (n = 114) | Infection No (n = 3960) | p-value |
|---|---|---|---|
| Male sex, n (%) | 77 (67.5) | 2705 (68.3) | 0.86 |
| CRT-P device, n (%) | 4 (7.7) | 48 (92.3) | 0.083 |
| Revision procedure, n (%) | 12 (10.1) | 107 (2.9) | <0.001 |
| Device extraction, n (%) | 83 (72.8) | — | <0.001 |
3.3. Infection timing and microbiology
CIED infections were evenly split between pocket-localized and systemic infections. Forty-two percent occurred within 3 months of a procedure. Among systemic infections, 67.7 % had echocardiographic evidence of lead or valve vegetations. The most common pathogens identified were Staphylococcus aureus (30.1 %), coagulase-negative staphylococci (10.6 %), and Pseudomonas aeruginosa (8.8 %). Notably, 38.9 % of infections were culture-negative despite clinical evidence of device infection (Fig. 1).
Fig. 1.
Distribution of causative organisms in cardiac implantable electronic device infections.
3.4. Management and outcomes
Device extraction was performed in 72.8 % of patients with CIED infection, typically within 7 days of diagnosis; the remaining patients received antibiotic therapy without complete extraction. The overall mortality rate in the cohort was 17 %. Mortality was higher among infected patients than those without infection (21.9 % vs 16.8 %), though this difference did not reach statistical significance (P = 0.15). Systemic infections carried significantly higher mortality than pocket infections (32.3 % vs 8.2 %, P = 0.007) (Table 3 and Fig. 2). Patients whose devices were not removed had markedly higher mortality than those who underwent extraction (48.4 % vs 12.0 %, P < 0.001). Among infected patients, there was a non-significant trend toward higher mortality with delayed extraction (>7 days) compared to early extraction (20.6 % vs 6.1 %, P = 0.083) (Table 4).
Table 3.
Survival according to type of CIED infection (n = 114).
| Infection type | Surviving n (%) | Died n (%) | Survival rate (%) | Mean survival time (95% CI) | p-value |
|---|---|---|---|---|---|
| Systemic | 44 (67.7) | 21 (32.3) | 60.0 54.7 | (47.3–62.2) | 0.007 |
| 45 (91.8) | 4 (8.2) | 90.2 | 69.8 (63.9–75.6) |
Fig. 2.
Survival status with respect to infection type in the CIEDs.
Table 4.
Survival status across infection occurrence after procedure and device removal.
| Characteristic | Description | Surviving | Died | Total | p value |
|---|---|---|---|---|---|
| Device extraction | Yes | 75 (87.2) | 11 (12.8) | 86 (2.1) | 0.297 |
| No | 3311 (82.9) | 681 (17.1) | 3992 (97.9) | ||
| Device extraction in the Infected cases | Yes | 73 (88.0) | 10 (12.0) | 83 (72.8) | <0.001 |
| No | 16 (51.6) | 15 (48.4) | 31 (27.2) | ||
| Timing of Infection after Procedure (month) | 0–3 month | 39 (81.3) | 9 (18.8) | 48 (42.1) | 0.379 |
| >3 month | 49 (74.2) | 17 (25.8) | 66 (57.9) | ||
| Time between Infection date and Device removal date (day) | ≤7 | 46 (93.9) | 3 (6.1) | 3 (6.1) 49 | 0.083 |
| >7 | 27 (79.4) | 7 (20.6) | 7 (20.6) 34 |
3.5. Cox proportional hazard analysis
The final Cox proportional hazard model identified several significant predictors of CIED infection risk. Patients from Hospital B (PSCC) had a significantly lower risk of infection compared to Hospital C (NGHA) (RR: 0.75, 95 % CI: 0.62–0.91, p = .003), while there was no significant difference between Hospital A (KFMC) and Hospital C (NGHA) (RR: 1.05, 95 % CI: 0.87–1.28, p = .605). Increasing age was associated with a higher risk of infection (RR: 1.04 per year, 95 % CI: 1.04–1.05, p < .001). Male patients had a higher risk compared to female patients (RR: 1.21, 95 % CI: 1.02–1.45, p = .031). There were no significant differences in infection risk associated with different device types (ICD, CRT-D, CRT-P), device status (replacement or revision), or the number of leads (Table 5).
Table 5.
Cox proportional hazards analysis for predictors of CIED infection.
| Variable | Reference | RR (95% CI) | p-value |
|---|---|---|---|
| Hospital – KFMC | NGHA | 1.05 (0.87–1.28) | 0.605 |
| Hospital – PSCC | NGHA | 0.75 (0.62–0.91) | 0.003 |
| Age (per year) | ― | 1.04 (1.04–1.05) | <0.001 |
| Male sex | Female | 1.21 (1.02–1.45) | 0.031 |
Discussion
This multicenter Saudi cohort study found a CIED infection incidence of 2.8%, comparable to the 1–4% reported in large international series [1,2]. This burden is also consistent with previous reports of healthcare-associated infections from tertiary-care hospitals in Saudi Arabia [6,8].
Infections typically presented early after device implantation or revision, consistent with prior observations that acute post-procedural infections occur within weeks to months [17]. About half of the infections were pocket infections and half systemic, reflecting the known clinical spectrum. The microbiology was in line with global experience. Grampositive cocci, especially staphylococci, predominated [4,5]. Staphylococcus aureus was the most frequent pathogen, and coagulase-negative staphylococci were also common.
The 39% rate of culture-negative infections is consistent with previous reports [4,5].
These culture-negative cases highlight the diagnostic challenge of CIED infections, as a substantial proportion remain microbiologically unconfirmed despite extensive culturing. This underscores the need for high clinical suspicion and supportive imaging, such as echocardiography. Furthermore, advances in molecular diagnostic techniques could potentially improve pathogen detection rates in the future, helping to guide more targeted therapy.
We identified several important risk factors. Revision procedures were associated with significantly higher infection rates than new implants, reflecting the cumulative risk of repeat interventions, as consistently demonstrated in prior large cohort studies [14]. Similarly, patients with CRT-P devices had the highest infection rate (7.7%), consistent with previous studies showing that more complex systems involving multiple leads and larger generator pockets carry a greater infection risk [15,20]. The association of younger age and male sex with infection risk in our cohort is also supported by prior reports, with male sex recognized as an independent risk factor for CIED infection [7]. The underlying mechanisms for the increased risk in males may relate to differences in skin flora, hormonal influences, or health-seeking behaviors, but remain speculative. Regarding age, younger patients may undergo more repeat procedures over their longer expected lifespans, thereby accumulating procedural exposure and infection risk, although the precise mechanisms are not fully understood.
Outcome analysis underscores the critical importance of complete device extraction. We observed an overall mortality of 17%, which exceeded 30% in systemic infections and reached 48% when the infected device was not removed. In contrast, patients undergoing prompt extraction experienced substantially lower mortality. These findings are consistent with prior studies demonstrating high mortality and healthcare costs associated with CIED infections, particularly when infected hardware is retained [13,16]. Accordingly, current guidelines emphasize that complete hardware removal is essential for cure [10]. This recommendation is further supported by evidence showing significant long-term complications related to retained or abandoned pacemaker leads, including recurrent infection and venous obstruction [9,19]. Delayed or incomplete device removal has been repeatedly associated with treatment failure and death.
Our results have important practical implications. Although the infection rate observed in Riyadh aligns with international reports, the severe outcomes emphasize the need for rigorous prevention strategies. Clinicians should adhere strictly to sterile implantation techniques, ensure appropriate antibiotic prophylaxis, and consider the use of antibacterial envelopes in high-risk patients, as supported by large randomized trials such as PADIT and WRAP-IT [7,18,19].
Additionally, the involvement of multidisciplinary teams―including infectious disease specialists, cardiologists, and cardiac surgeons―may enhance the management of complex CIED infections and optimize patient outcomes.
Early recognition of infection and prompt referral for device extraction are critical to improving survival. In addition, patient-centered strategies, including education, follow-up engagement, and structured monitoring, may facilitate earlier detection and improved outcomes in patients with CIED-related complications [20].
The strengths of this study include its multicenter design and large sample size, providing a comprehensive and contemporary overview of CIED practice in Saudi Arabia. Inclusion of all device types and systematic follow-up for at least one year allowed capture of the majority of post-implant infections. Nevertheless, several limitations should be acknowledged.
The retrospective design may have led to under-detection of subclinical infections or incomplete documentation of management details. Infections treated at other centers may not have been captured, and data on certain variables, such as perioperative antibiotic regimens and lead dwell time, were incomplete. Where possible, we attempted to minimize bias by using standardized data collection forms and performing sensitivity analyses; however, some degree of missing data is unavoidable in retrospective studies. Finally, as the study was limited to tertiary centers in Riyadh, the findings may not be fully generalizable to other regions.
Conclusion
In this multicenter Saudi cohort, CIED infections occurred in 2.8 % of device recipients, with particularly high incidence after revision procedures and in CRT-P recipients. Staphylococcus aureus was the most common causative organism, and a substantial proportion of infections were culture-negative. Infection was associated with markedly increased mortality, especially in systemic cases and when the device was not removed. These findings underscore the necessity of strict infection-prevention protocols and prompt, complete device extraction to optimize patient outcomes.
Abbreviation list
- CIED
Cardiac implantable electronic device
- CRT
Cardiac resynchronization therapy
- CRT-D
Cardiac resynchronization therapy defibrillator
- CRT-P
Cardiac resynchronization therapy pacemaker
- ICD
Implantable cardioverter-defibrillator
- PPM
Permanent pacemaker
Footnotes
Ethics information: This study was approved by the institutional review boards of King Fahad Medical City, Prince Sultan Military Medical City, and Ministry of National Guard Health Affairs. Due to the retrospective nature of the study, informed consent was waived. Patient confidentiality was strictly maintained.
Author contributions: Saad Albogami and Wael Alqarawi conceived the study. Data collection was performed by Ahmed Alfagih, Hiatham Alenzi, Mohammad Alshehri, Mossab Aljuaid, Saeed Alqahtani, Norah Alswaidan, Mohammad Alharbi, Norah Alkaltham, Lama Alasmri, Rghd Sadkh, Muna Albashari, and Nour Alhouda. Data analysis was conducted by Saad Albogami and Imad Tleyjeh. All authors contributed to manuscript drafting and approved the final version.
Artificial Intelligence (AI) or Large Language Model (LLM) Use Declaration: The author(s) declare that no AI-assisted technologies were used in the writing, research, or content creation of this manuscript.
Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Conflicts of interest: None declared.
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