Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques. Patients receiving cardiac implantable electronic devices (CIEDs)-including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs)-constitute a unique population with high rates of multimorbidity, psychological vulnerability, and limited analgesic options due to cardiovascular comorbidities. Insufficient postoperative pain management in this group may lead to persistent pain at the generator site, neuropathic pain features, reduced quality of life, and increased healthcare utilization.
The present study aims to evaluate the prevalence, risk factors, and clinical predictors of CPSP following CIED implantation using both subjective and objective pain assessments. Pain intensity will be measured using validated self-report scales (Visual Analog Scale and DN-4 questionnaire), and objective pain thresholds will be determined using a calibrated digital pressure algometer. Quality of life will be assessed with the validated Turkish version of the Short Form-12 (SF-12) instrument.
This prospective observational study will include 180 adult patients who underwent first-time CIED implantation at Istanbul University-Cerrahpaşa, Cardiology Institute. Participants will be evaluated at 3, 6, and 12 months post-implantation. Collected data will include preoperative, intraoperative, and postoperative variables such as demographics, comorbidities, anesthesia type, surgical duration, and acute postoperative pain control.
Using the obtained data, an artificial intelligence-based clinical decision support system will be developed to predict individual CPSP risk before implantation. The model will integrate subjective scales, objective algometric data, and clinical factors to generate personalized risk estimates. Ultimately, this system aims to improve early detection and prevention of CPSP, optimize postoperative pain management strategies, and enhance patient quality of life.
Adults aged ≥18 years.
Patients who have undergone first-time implantation of a cardiac implantable electronic device (CIED), including pacemaker (PM), implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT).
Device implantation performed within the past 12 months at Istanbul University-Cerrahpaşa Cardiology Institute.
Ability to attend scheduled follow-up visits at 3, 6, and 12 months post-implantation.
History of neuropathic or chronic pain syndromes prior to implantation (e.g., fibromyalgia, diabetic neuropathy).
Presence of neurodegenerative, autoimmune, or vascular disorders affecting peripheral or central pain pathways.
Known malignancy, active infection, or recent trauma in the chest or upper extremities.
Prior CIED replacement or battery exchange procedures.
Patients who meet the inclusion criteria and have undergone CIED implantation will constitute the study population.
Cohort
Prospective
Not listed
Incidence of Chronic Postsurgical Pain (CPSP) Based on Subjective VAS Assessments
CPSP is defined as persistent or newly occurring pain at or near the device pocket (or corresponding dermatomes) lasting ≥3 months after surgery and not explained by other causes. Pain intensity and neuropathic features will be measured using the Visual Analog Scale (VAS) and DN-4; Pressure Pain Threshold (PPT) by digital algometry provides objective corroboration. The primary outcome is the proportion of patients meeting CPSP criteria at 12 months, with intermediate assessments at 3 and 6 months used for longitudinal description and sensitivity analyses. Type of Measure: Clinical assessment (subjective scales + objective PPT). VAS\> 4 means positive result.
Incidence of Chronic Postsurgical Pain (CPSP) Based on DN-4 Assessments
CPSP is defined as persistent or newly occurring pain at or near the device pocket (or corresponding dermatomes) lasting ≥3 months after surgery and not explained by other causes. Pain intensity and neuropathic features will be measured using the Visual Analog Scale (VAS) and DN-4; Pressure Pain Threshold (PPT) by digital algometry provides objective corroboration. The primary outcome is the proportion of patients meeting CPSP criteria at 12 months, with intermediate assessments at 3 and 6 months used for longitudinal description and sensitivity analyses. Type of Measure: Clinical assessment (subjective scales + objective PPT). DN4 ≥ 4 means positive result.
Incidence of Chronic Postsurgical Pain (CPSP) Based on Pressure Pain Threshold Assessments
CPSP is defined as persistent or newly occurring pain at or near the device pocket (or corresponding dermatomes) lasting ≥3 months after surgery and not explained by other causes. Pain intensity and neuropathic features will be measured using the Visual Analog Scale (VAS) and DN-4; Pressure Pain Threshold (PPT) by digital algometry provides objective corroboration. The primary outcome is the proportion of patients meeting CPSP criteria at 12 months, with intermediate assessments at 3 and 6 months used for longitudinal description and sensitivity analyses. Type of Measure: Clinical assessment (subjective scales + objective PPT).There is no known cut-off value for the pain threshold in this patient group. One of the aims of this study is to determine a threshold value for chronic pain in this patient population using algometry, in correlation with clinical examination findings. We will evaluate the association between lower values and increased pain sensitivity in patients.
Change in Health-Related Quality of Life (SF-12 PCS/MCS)
The SF-12 is a validated measure of health-related quality of life and provides two summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). Higher PCS-12 and MCS-12 scores indicate better physical and mental health status, respectively, whereas lower scores reflect greater physical limitation, higher pain burden, and poorer psychological well-being. In patients with chronic pain, lower PCS-12 scores are associated with increased pain-related functional impairment, while lower MCS-12 scores suggest a greater psychological impact of pain. SF-12 scores are normalized to a population mean of 50 with a standard deviation of 10; scores below 50 indicate below-average health status, and scores above 50 indicate better-than-average health-related quality of life.
Determination of Pressure Pain Threshold (PPT) Cut-off for CPSP
The primary outcome is the identification of a pressure pain threshold (PPT) cut-off that best discriminates chronic postsurgical pain (CPSP) in patients with cardiac implantable electronic devices (CIEDs). PPT will be measured using a handheld algometer on the device pocket and contralateral sides, with three measurements obtained in four predefined quadrants per side and averaged to derive side-specific mean values. Side-to-side PPT differences (ΔPPT) will be calculated for each patient. Discriminatory performance of ΔPPT for CPSP will be assessed using receiver operating characteristic (ROC) analysis, with the optimal cut-off determined by the Youden index and reported as area under the curve (AUC), sensitivity, and specificity.
Performance of the AI-Based CPSP Risk Prediction Model
Diagnostic/predictive performance of the AI-based clinical decision support model integrating clinical, subjective, and PPT features. Metrics: ROC-AUC, sensitivity, specificity, accuracy, F1-score (with internal validation via cross-validation/bootstrapping). The diagnostic and predictive performance of an AI-based clinical decision support model for identifying chronic postsurgical pain (CPSP) in patients with cardiac implantable electronic devices (CIEDs). The model integrates clinical variables, patient-reported subjective measures, and pressure pain threshold (PPT) features derived from side-to-side (pocket vs. contralateral) algometric assessments. Model performance will be evaluated against the clinical diagnosis of CPSP using receiver operating characteristic area under the curve (ROC-AUC), sensitivity, specificity, accuracy, and F1-score. Internal validation will be performed using cross-validation and/or bootstrapping techniques.
Prevalence of Neuropathic Pain Features (DN-4)
Prevalence and trajectory of neuropathic pain features defined as DN-4 ≥ 4, reported at each visit and cumulatively at 12 months; evaluated in relation to CPSP status. Type of Measure: Clinical classification (screening instrument threshold)
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