INTRODUCTION
Each year, nearly one million cardiac implantable electronic devices (CIEDs) are implanted worldwide [
1]. CIEDs encompass a spectrum of technologies that deliver controlled electrical impulses to regulate cardiac rhythm or terminate life-threatening arrhythmias [
2]. Modern pacemakers, for instance, continuously monitor intrinsic cardiac activity and activate only when physiologic pacing fails, whereas implantable cardioverter-defibrillators (ICDs) incorporate both pacing and defibrillation capabilities [
3,
4]. These devices are more prevalent in older adults, who also make up the majority of patients undergoing elective orthopedic procedures such as total shoulder arthroplasty (TSA) [
5,
6].
These devices are typically implanted in prepectoral or subpectoral pockets in the infraclavicular region, with transvenous leads coursing through the subclavian or axillary veins into the cardiac chambers [
7-
9]. This anatomical positioning places them in close proximity to the operative field during upper extremity and shoulder surgeries, particularly those using the deltopectoral approach [
10,
11]. During such procedures, electrocautery or retraction near the device pocket may expose the CIED and its leads to electromagnetic interference (EMI), mechanical disruption, or thermal injury [
12]. The consequences of these interactions can be severe. Electrocautery-induced EMI can cause pacing inhibition, asynchronous firing, or inappropriate shocks in ICDs, potentially resulting in bradyarrhythmia, asystole, or ventricular arrhythmia [
12]. Furthermore, mechanical stress during exposure or retraction may dislodge leads or damage insulation, leading to post-operative device malfunction or infection [
13]. As a result, shoulder arthroplasty presents a particularly high-risk scenario for such complications [
7]. In particular, the early post-implantation period may represent a vulnerable window due to incomplete lead endothelialization, ongoing pocket healing, and heightened susceptibility to infection or mechanical disruption [
14]. These factors provide a biologically plausible basis to hypothesize that the initial months following device implantation are associated with higher perioperative complication risk in patients undergoing shoulder arthroplasty.
While anecdotal reports and small case series have described adverse complications after surgery, no large-scale studies have systematically examined how the presence of CIEDs affects complication rates following shoulder arthroplasty or evaluated the significance of time since device placement [
15,
16]. This represents a crucial knowledge gap given an aging, comorbidity-laden patient population undergoing arthroplasty and the potential for device-related perioperative complications. In the current study we use a large claims database to evaluate the associations between CIED presence on perioperative complications following shoulder arthroplasty.
DISCUSSION
In this large database analysis of patients undergoing shoulder arthroplasty with CIEDs, device presence was associated with significantly higher rates of systemic postoperative complications compared to matched controls. The most notable associations were observed for cardiac arrest, perioperative arrhythmia, myocardial ischemia, renal failure, sepsis, emergency department visits, readmission, wound complications, delirium, new pacing/ICD interventions, and mortality. Notably, many adverse outcomes were most pronounced when arthroplasty occurred soon after device implantation, indicating a period of heightened physiologic vulnerability. In contrast, differences in mechanical outcomes were less consistent.
Elevated perioperative rates of arrhythmia, cardiac arrest, and myocardial ischemia in CIED carriers remained significant after adjustment for cardiac disease, indicating a potential device-specific contribution. One proposed explanation involves electrocautery-related EMI, particularly with monopolar cautery, which has been reported to cause pacing inhibition or inappropriate sensing when electrical currents traverse the thorax or generator-lead complex [
12]. Using bipolar cautery reduces this risk [
17]. However, because surgical laterality and device position cannot be determined in an anonymized claims database, this mechanism remains speculative. Anesthetic factors, such as succinylcholine use, electrolyte shifts, and temperature changes, have also been described as contributors to transient pacing instability [
18]. Although atrial fibrillation subtypes remained slightly more prevalent in the CIED group after propensity matching (all P<0.05), the magnitude of difference was small and likely reflects underlying indications for device implantation rather than residual confounding. Thus, the European Heart Rhythm Association recommendations for preoperative interrogation, intraoperative reprogramming, and continuous electrocardiography monitoring, remain clinically relevant [
19].
Another key finding was the higher incidence of postoperative pacing or ICD interventions. In the previous literature, 8%–10% of CIED patients undergoing major surgery were observed to require postoperative reprogramming or lead evaluation, primarily due to transient sensing errors, lead dislodgement, or arrhythmia-related pacing changes [
20]. Notably, more recent CIED implantation was associated with higher rates of postoperative pacing or ICD interventions, suggesting that elective arthroplasty warrants consideration of delay beyond the early post-implantation period. These findings underscore the importance of coordinated perioperative management, including timely postoperative device interrogation, and highlight the need for further prospective investigation [
21].
Renal failure and sepsis were significantly more common in CIED patients, especially when arthroplasty occurred soon after implantation. This finding aligns with evidence that CIED-related infections and systemic complications peak within the first year post-implantation [
22]. Renal failure is also an independent infection risk factor due to immune impairment and delayed healing, while comorbidities such as diabetes, heart failure, and anticoagulation further increase sepsis risk [
23].
Wound complications were modestly higher in CIED carriers. Baddour et al. [
24] noted that hematoma formation after implantation can elevate readmission risk for up to a year, a factor likely contributing to our findings. This risk may also stem from the deltopectoral approach and prepectoral pocket placement used for CIED implantation, which can overlap with the shoulder surgical field. Violation of the existing pocket can increase the risk of mechanical damage or infection [
25]. Such interpretations remain speculative given lack of laterality data. Nonetheless, careful surgical planning, anticoagulation management, and adherence to infection-prevention strategies remain prudent in patients with CIEDs undergoing arthroplasty [
26]. Moreover, the higher rates of acute respiratory failure and prolonged ventilation in recently implanted CIED patients suggest transient vulnerability driven by recent implantation. This hypothesis aligns with studies indicating that early post-implant pneumothorax may be aggravated by the physiologic stress of arthroplasty [
20]. However, this link is not yet established and warrants further study.
Hospital readmissions and ED visits were significantly higher among CIED patients, even after controlling for cardiac disease, indicating an association with device presence. Westermann et al. [
27] found that pulmonary, cardiac, renal, septic, and neurologic complications accounted for over half of unplanned readmissions after shoulder arthroplasty, risks that were all elevated in our CIED cohort. Similarly, Fisher et al. [
28] reported that 16% of post-TJA ED visits were due to cardiovascular symptoms such as hypertension, which were also more frequent in our CIED cohort. Finally, the higher mortality observed among patients with recently implanted CIEDs parallels prior reports describing associations between early post-implant complications, such as pneumothorax, pocket hematoma, and device infection, and increased all-cause mortality [
14]. Readmission and mortality rates were significantly higher among patients who underwent arthroplasty within 6 months of CIED implantation compared with those whose procedures occurred more than 6 months after implantation. Although causality cannot be interpreted from our findings, deferring elective arthroplasty beyond this high-risk interval may reduce postoperative mortality and physiologic complications in patients with CIEDs.
Postoperative risks of MI, DVT, stroke, pneumonia, and transfusion requirements were higher in CIED patients but became insignificant after controlling for cardiac disease, implying these stem from underlying cardiovascular pathology rather than the device itself. CIEDs are typically implanted in older patients with advanced conduction abnormalities or ventricular dysfunction, such as sinus node dysfunction, atrioventricular block, or ventricular arrhythmias for sudden cardiac death prevention [
29]. Kurtz et al. [
23] reported increasing recipient age and comorbidity burden, with frequent heart failure, ischemic heart disease, diabetes, and chronic kidney disease. Similarly, Ajibawo et al. [
30] noted a high Charlson Comorbidity Index (mean, 4.3), reflecting substantial multimorbidity. This baseline frailty likely explains the elevated postoperative risks.
Our findings underscore the need for coordinated multidisciplinary perioperative care in patients with CIEDs undergoing shoulder arthroplasty, consistent with recent American Heart Association guidelines on perioperative CIED management. Future prospective studies incorporating operative laterality, device characteristics, and cause-of-death data are needed to better elucidate the pathways underlying the observed associations.
Our study has several limitations inherent to the use of the TriNetX real-world data network. TriNetX aggregates data from electronic health records and therefore depends on the accuracy of clinical documentation and coding. Misclassification bias, missing data, and residual confounding may persist despite validated outcome definitions and propensity score matching. TriNetX also provides de-identified aggregate data without access to individual-level charts, preventing detailed validation. Further, it does not stratify procedures by laterality, limiting laterality-specific interpretations and render the discussions of electrocautery interference or device pocket overlap hypothesis-generating rather than definitive. Lastly, while propensity score matching helps mitigate confounding, unmeasured variables, including socioeconomic status or provider preferences, could influence outcomes.