Research Appraisalobservational

Trends in cardiac implantable electronic device infections: 2015 to 2019

BMC cardiovascular disordersBaldauf, Benito, Bode, Kerstin, Lau, Ernest W et al.12 June 2026DOI

Clinical Snapshot

85CEBM
Evidence: Moderateobservational

PICO Framework

P — PopulationPatients undergoing cardiac implantable electronic device (CIED) procedures in Germany (n=282,205) from largest statutory health insurer covering >27 million beneficiaries
I — InterventionCIED procedures including initial implantations, upgrades/downgrades, generator replacements, early revisions, and device extractions
C — ComparatorInfected vs non-infected patients; temporal trends 2015-2019
O — OutcomesMajor CIED infections (generator pocket infections, lead-associated endocarditis), in-hospital mortality, healthcare utilization

Bottom Line

This large German administrative study of 282,205 CIED procedures reveals concerning infection rates of 2.33% within 90 days, higher than previously reported. Generator pocket infections (1.91%) were more common than lead-associated endocarditis (0.82%), but endocarditis carried higher mortality (15.0% vs 8.36%). The substantial healthcare burden and mortality associated with CIED infections highlight the critical importance of infection prevention strategies. Clinicians should counsel patients about these realistic infection risks and ensure optimal perioperative management. The findings support enhanced surveillance and quality improvement programs for CIED procedures, though the study's reliance on administrative data and limited confounder adjustment warrant cautious interpretation of absolute rates.

Evidence: Moderate

Key Findings

  • P Value: Not reported

  • Effect Size: Generator pocket infections 1.91%, lead-associated endocarditis 0.82%, combined infections 0.39%

  • Primary Outcome: Major CIED infections within 90 days: 2.33% overall rate

  • Nnt Or Sensitivity: In-hospital mortality: 8.36% for pocket infections, 15.0% for endocarditis

  • Confidence Interval: Not reported

Clinical Application

Results inform risk stratification and patient counselling for CIED procedures, support quality improvement initiatives Highly relevant to Australian cardiology practice; infection rates may inform TGA device surveillance and RACGP guidelines for CIED management Patients undergoing CIED procedures in developed healthcare systems with similar cardiac device practices

Abstract

BACKGROUND: Cardiovascular implantable electronic devices (CIEDs) improve survival in patients with cardiac rhythm disorders but carry risks of complications, most notably major infections. Reported infection rates vary internationally, and contemporary large-scale data from Germany are scarce. We aimed to determine nationwide rates of CIED infection-related hospitalizations and associated mortality over a five-year period. METHODS: We analyzed administrative claims from Germany's largest statutory health insurer covering more than 27 million beneficiaries. All CIED procedures performed between January 2015 and December 2019 were identified, including initial implantations, upgrades or downgrades, generator replacements, early revisions, and device extractions. Major infections were detected using International Classification of Diseases (ICD-10-GM) and procedural codes, and stratified as generator pocket infections or lead-associated endocarditis. In-hospital mortality was determined from discharge records. RESULTS: Among 282,205 patients (57.7% male) undergoing CIED procedures, 6,577 individuals (2.33%) experienced 7,704 major infections within three months. Generator pocket infections occurred in 5,396 cases (1.91%), lead-associated endocarditis in 2,308 (0.82%), and combined infections in 1,127 patients (0.39%) within the acute 90-day observation period. CIED infections substantially increased healthcare utilization: Infected patients required substantially more procedures than non-infected patients, despite correct treatment. In-hospital mortality reached 8.36% for pocket infections and 15.0% for endocarditis. Extended follow-up in the 2015 cohort revealed a 4.33% infection-related procedure rate over five years. CONCLUSIONS: Nationwide German data reveal higher acute CIED infection rates than previously reported, with considerable mortality and procedural burden. These findings highlight an urgent need for improved prevention and management strategies.

References

  1. 1.Baldauf, B., Bode, K., Lau, E. W., Giaccardi, M., Assadian, O., Chévalier, P., Haddad, C., Klöss, A., Cemin, R., Vonthein, R., & Bonnemeier, H. (2026). Trends in cardiac implantable electronic device infections: 2015 to 2019. BMC Cardiovascular Disorders. https://doi.org/10.1093/europace/euad224
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