Presence of cardiac implantable electronic devices is associated with increased risk of perioperative complications following shoulder arthroplasty
Article information
Abstract
Background
Patients with cardiac implantable electronic devices (CIEDs) increasingly present for elective orthopedic procedures. In this study we evaluate peri-operative complications associated with CIED presence using a large multicenter database.
Methods
Retrospective cohort analysis was performed using the TriNetX database. Adults undergoing primary total shoulder arthroplasty (TSA) between 2005 and 2025 were identified and stratified by CIED status. Four propensity score-matched (1:1) analyses were conducted: all TSA patients with versus without CIEDs, (2) patients with cardiac disease with CIED versus without CIEDs, and patients with recent device implantation (<6 months before TSA) versus patients with remote device implantation (>6 months before TSA). Matching balanced demographic factors and comorbidities. Outcomes included 90-day and 2-year complications. Relative risks, 95% CIs, and P-values were calculated using chi-square and t-tests; significance was set at P<0.05.
Results
After matching, 6,931 patients were included per cohort. CIED presence was associated with significantly higher 90-day rates of cardiac, renal, infectious, and neurologic complications, as well as increased mortality, readmissions, and emergency department visits. These associations persisted after controlling for underlying cardiac disease. Patients undergoing TSA within 6 months of device implantation experienced higher rates of complications. Revision rates were not significantly different between groups, and mechanical outcome associations were variable.
Conclusions
CIED presence was associated with increased systemic complications following TSA, particularly when surgery occurred within 6 months of device implantation. Mechanical outcome differences were less consistent. These findings indicate the necessity of multidisciplinary perioperative planning, thoughtful surgical timing, and prospective studies to better define underlying risk pathways.
Level of evidence
III.
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.
METHODS
Study Database
This retrospective cohort study utilized the TriNetX Research Network, a large, federated database that aggregates de-identified electronic health records from numerous healthcare organizations across the United States. TriNetX captures diagnostic, procedural, and demographic data for 195 million unique patients and enables longitudinal outcome assessment through continuously updated encounter information. Because all patient data were anonymized in accordance with the Health Insurance Portability and Accountability Act (HIPAA) regulations, this study met the criteria for exemption from institutional review board (IRB) review. A formal determination of exemption was obtained from the IRB.
Patient Selection
We performed a query on October 15, 2025 using relevant Current Procedural Terminology (CPT) and International Classification of Diseases codes to identify patients who underwent primary TSA. Each patient was evaluated for the presence of a cardiac device, defined as a pacemaker (Z95.0) or implantable cardiac defibrillator (Z95.810). Three cohort comparisons were performed. The first compared all TSA patients with a pacemaker or defibrillator to those without any device. The second included only patients with cardiac disease (I30-I52) and compared those with a cardiac device to those with cardiac disease but no device. The third examined the effect of device timing, comparing patients who received a pacemaker or defibrillator within 6 months before TSA to those with device implanted more than 6 months before TSA. Additionally, individuals without at least 2 years of postoperative follow-up were excluded from the final analysis.
1:1 Propensity Match
The TriNetX platform was used to conduct 1:1 propensity score matching employing logistic regression. The platform integrates nearest-neighbor matching with a tolerance level of 0.01 and ensures that the difference between propensity scores is P≤0.01 for each covariate after matching. Propensity matching was performed to balance demographic characteristics (age, sex, race) as well as relevant clinical factors, including body mass index, diabetes mellitus, chronic kidney disease, heart failure, tobacco use, hypertensive diseases, liver disease, atrial fibrillation, hyperlipidemia, ischemic heart diseases, acute myocardial infarction, and supraventricular tachycardia.
Outcomes
The primary outcomes included 90-day medical and surgical complications following TSA. Medical outcomes included myocardial infarction (MI), pulmonary embolism, deep vein thrombosis (DVT), stroke, pneumonia, transfusion, renal failure, sepsis, emergency department (ED) visits, hospital readmission, cardiac arrest, perioperative arrhythmia, new pacemaker or implantable defibrillator interventions, myocardial ischemia or unstable angina, anemia, delirium, and acute respiratory failure or prolonged mechanical ventilation. Surgical outcomes within 90 days included wound complications and postoperative infection. Secondary outcomes were evaluated at 2 years and included total implant-related mechanical complications, periprosthetic joint infection, loosening, dislocation, and revision arthroplasty. All outcomes were identified using standardized International Classification of Diseases and CPT codes available within the TriNetX platform (Supplementary Table 1).
Statistical Analysis
For all outcomes of interest, relative risks (RRs), 95% CIs and P-values were computed using the TriNetX system. Categorical variables were assessed using the chi-square test, while continuous variables were evaluated with Student t-tests. Statistical significance was defined as P<0.05.
RESULTS
Cohort Characteristics
A total of 6,970 (4.1%) patients who underwent a TSA were identified to have a CIED before surgery. Following matching, 6,931 patients remained in each group. Baseline characteristics were well balanced except for paroxysmal, persistent, and chronic atrial fibrillation (P<0.01 for each) (Table 1).
Primary Analysis
Among patients with underlying cardiac disease, the presence of a pacemaker or defibrillator was associated with significantly higher rates of several early postoperative complications following TSA (Table 2). At 90 days follow-up, the device group demonstrated increased risks of myocardial infarction (RR, 1.42; P<0.001), deep vein thrombosis (RR, 1.21; P=0.015), stroke (RR, 1.23; P=0.008), pneumonia (RR, 1.32; P<0.001), renal failure (RR, 1.51; P<0.001), transfusion (RR, 1.48; P<0.001), and sepsis (RR, 1.32; P<0.001). These patients also had greater rates of ED visits (RR, 1.45; P<0.001), hospital readmission (RR, 1.35; P<0.001), cardiac arrest (RR, 2.06; P<0.001), perioperative arrhythmia (RR, 1.45; P<0.001), new pacing or ICD interventions (RR, 18.15; P<0.001), myocardial ischemia or unstable angina (RR, 1.71; P<0.001), anemia (RR, 1.16; P=0.028), delirium (RR, 1.36; P=0.019), and acute respiratory failure (RR, 1.62; P<0.001). Mortality was also significantly higher among patients with a cardiac device (RR, 1.52; P<0.001). At 2 years, the device group showed elevated rates of mechanical complications (RR, 1.14; P=0.009) and component loosening (RR, 1.56; P=0.001), while rates of periprosthetic joint infection, dislocation, and revision did not differ significantly.
Pacemaker/Defibrillator Use in Patients with Cardiac Disease
To assess the differences among those with preexisting cardiac disease, a subgroup analysis was performed to determine whether postoperative outcomes were attributable to the presence of a CIED or the underlying cardiac condition. Among patients with preexisting cardiac disease, 6,390 were included in each cohort after matching, with all preoperative characteristics controlled (P>0.05). Those with a pacemaker or defibrillator had higher 90-day rates of renal failure (RR, 1.24; P=0.002), myocardial ischemia or unstable angina (RR, 1.42; P=0.011), perioperative arrhythmia (RR, 1.52; P<0.001), delirium (RR, 1.57; P=0.007), and new pacing or ICD interventions (RR, 18.81; P<0.001). They also had increased ED utilization (RR, 1.23; P=0.005) and readmission (RR, 1.12; P=0.005). Conversely, device recipients had lower risks of pulmonary embolism (RR, 0.70; P=0.021), sepsis (RR, 0.78; P=0.033), wound complications (RR, 0.77; P=0.004), postoperative infection (RR, 0.69; P=0.047), cardiac arrest (RR, 1.92; P<0.001), and death (RR, 0.57; P<0.001). Rates of other 90-day complications did not differ significantly. At 2 years, pacemaker or defibrillator recipients demonstrated higher rates of component loosening (RR, 1.60; P=0.004), while mechanical complications, periprosthetic joint infection, dislocation, and revision rates were comparable between cohorts (all P>0.05). These findings are summarized in Table 3.
Postoperative Outcomes by Device Implantation Interval
At 90 days, patients with cardiac devices placed within 6 months of surgery had higher rates of transfusion (RR, 1.32; P=0.039), renal failure (RR, 1.19; P=0.018), sepsis (RR, 1.36; P=0.037), readmission (RR, 1.22; P<0.001), acute respiratory failure (RR, 1.34; P=0.028), and mortality (RR, 3.50; P<0.001) compared with those with devices placed more than 6 months before surgery. Rates of other 90-day complications and all 2-year outcomes did not differ significantly. Ninety-day and 2-year outcomes by device implantation timing are summarized in Table 4.
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.
CONCLUSIONS
CIED presence was associated with higher rates of systemic complications, particularly cardiac, renal, respiratory, and infectious events, following TSA, with the strongest associations observed when surgery occurred <6 months after device implantation. Differences in mechanical outcomes were less consistent and should be interpreted cautiously given limitations in outcome ascertainment. These results underscore the importance of multidisciplinary perioperative planning, including consideration of surgical timing, electrophysiologic consultation, and postoperative monitoring. Future prospective studies incorporating operative laterality, device characteristics, and cause-of-death data are needed to better elucidate the pathways underlying the observed associations.
Notes
Author contributions
Conceptualization: TP. Data curation: TP. Formal Analysis: TP, AAA. Investigation: TP, AAA, FS. Methodology: TP, AAA, PB, FS. Project administration: TP. Resources: TP. Software: TP. Supervision: TP, MD, JAA. Validation: TP, AAA, PB, FS, MD. Visualization: TP, PB. Writing – original draft: TP, AAA. Writing – review & editing: TP, AAA, PB,, FS, MD, JAA. All authors read and agreed to the published version of the manuscript.
Conflict of interest
JAA would like to disclose the following Royalties from a company or supplier: DJO Global, Zimmer-Biomet, Smith and Nephew, Stryker, Globus Medical, Inc. Research support from a company or supplier as a PI: Lima Corporation, Italy, Orthofix, Arthrex, OREF. Royalties, financial or material support from publishers: Wolters Kluwer. Board member/committee appointments for a society: American Shoulder and Elbow Society, Pacira.
Funding
None.
Data availability
None.
Acknowledgments
None.
Supplementary materials
Supplementary materials can be found via https://doi.org/10.5397/cise.2025.01333.
International classification of diseases and current procedural terminology codes used in trinetX
