Key result
Diabetes and CKD linked to up to ~650% higher risk of CIED pocket swelling.
Why the study?
The rise in CIED procedures requires timely management of pocket-site complications, prompting an assessment of their incidence and associated risk factors in clinical practice.
Observational (n=119)
No
Odds Ratio: 4.9 (95% CI 1.1–21.3)
p-value: p=0.0331
Major complications following CIED procedures are infrequent, but younger age, diabetes, and chronic kidney disease are significant risk factors for pocket swelling.
Low CIED complication rates support current protocols; diabetes and CKD associations with swelling are hypothesis-generating and need prospective validation.
Background The rise in cardiac implantable electronic device (CIED) procedures necessitates timely management of pocket–site complications, where nursing care is crucial. This study assessed the incidence of major surgical site complications and identified their associated risk factors within our center’s clinical practice. Methods We conducted a retrospective observational study of patients undergoing CIED implantation, revision, or generator replacement at our institution from January to May 2024. The study assessed the incidence of post–operative pain, infection signs, allergic reactions, and pocket swelling. Logistic regression explored associations between clinical/procedural factors and complication risks. Results A total of 119 patients were included in our analysis (median age 74 years, 71% male). Most patients underwent a primary CIED implantation (n=75), 35 generator replacements, 3 upgrades, and 6 revisions. Cefazolin prophylaxis and skin antisepsis with chlorhexidine were standardized. Post–operative management involved a 5 kg weight and ice application in 115 patients (96.6%) while 3.4% were treated with a pneumatic dressing. The initial flat dressing was maintained for 10 days by 87.4% of patients; 12.6% replaced it earlier (primarily due to accidental detachment or soiling). Surgical site pain was reported by 16.8% (3.4% with NRS › 5). Other findings included erythema (5.9%), fever (0.8%), and pruritus (17.6%). Pocket swelling occurred in 9 patients (7.6%); 8 were managed conservatively. The patient whose swelling did not resolve was the only one with a confirmed diagnosis of infection (0,8%), necessitating surgical revision and device extraction. Anticoagulant therapy was never interrupted. No factors were significantly associated with pain or pruritus. However, the risk of pocket swelling decreased with age (OR 0.95; 95% CI 0.91–0.99; p=0.0322) and increased in patients with diabetes (OR 4.9; 95% CI 1.1–21.3; p=0.0331) and chronic kidney disease (OR 7.5; 95% CI 1.7–33.7; p=0.0086). Conclusions Our study confirms a low incidence of major complications following CIED procedures, supporting current standardized nurse–centered protocols. Younger age, diabetes, and chronic kidney disease are significant risk factors for pocket swelling, requiring targeted nursing surveillance to optimize patient safety.
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Sois et al. (2026) conducted an observational in Cardiac implantable electronic device (CIED) procedures (n=119). Diabetes vs. No diabetes was evaluated on Pocket swelling (OR 4.9, 95% CI 1.1-21.3, p=0.0331). Following CIED procedures, the risk of pocket swelling was significantly increased in patients with diabetes (OR 4.9; 95% CI 1.1-21.3) and chronic kidney disease (OR 7.5; 95% CI 1.7-33.7).
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