What is the clinical evidence from this study?

Study design: Observational. Population: Cardiac implantable electronic device (CIED) procedures (n=282205). Intervention: Cardiac implantable electronic device (CIED) procedures. Primary outcome: Major CIED infections requiring hospitalization within 3 months (95% CI 2.28%-2.39%).

What question did this study set out to answer?

This research aimed to evaluate the rates of infections related to cardiac implantable electronic devices (CIEDs) and their impact on mortality throughout Germany between 2015 and 2019.

June 12, 2026BMC Cardiovascular Disorders0 citationsOpen Access

Trends in cardiac implantable electronic device infections: 2015 to 2019

BBBenito BaldaufKiel University KBKerstin BodeDeutsches Herzzentrum der Charité ELErnest W. LauUniversity of Ulster

Key Result

Among patients undergoing CIED procedures, 2.33% experienced major infections within three months, with in-hospital mortality reaching 8.4% for pocket infections and 15.0% for endocarditis.

Key Points

This research aimed to evaluate the rates of infections related to cardiac implantable electronic devices (CIEDs) and their impact on mortality throughout Germany between 2015 and 2019.
Analyzed administrative claims from Germany’s largest statutory health insurer covering over 27 million beneficiaries.
Identified all CIED procedures from January 2015 to December 2019, including various procedures and detected infections via ICD-10-GM and procedural codes.
Determined in-hospital mortality from discharge records.
Among 282,205 patients, 6,577 (2.33%) had 7,704 major infections within three months.
In-hospital mortality was 8.36% for pocket infections and 15.0% for lead-associated endocarditis.
Infections led to significantly increased healthcare utilization, necessitating more procedures than in non-infected patients.

Study Design

Type

Observational (n=282,205)

Multicenter

Yes

Structured PICO

Population

282,205 patients undergoing 403,936 cardiac implantable electronic device procedures in Germany between 2015 and 2019, evaluated for acute and long-term infection rates.

Exposure

Cardiac implantable electronic device (CIED) procedures including de novo implantation of permanent pacemakers (PPM) or implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT), cardiac contractility modulation (CCM), subcutaneous ICD (S-ICD), generator replacements, revisions, and extractions

Outcome

Major CIED infections (generator pocket infections or lead-associated endocarditis) occurring during the index hospitalization or within 90 days after the index proceduresafety

Nationwide German claims data reveal that acute CIED infections occur in 2.33% of patients within 90 days, representing a higher rate than previously reported, and are associated with substantial in-hospital mortality and procedural burden.

Limitations

Relies on de-identified billing data primarily designed for reimbursement purposes rather than epidemiological research
Potential underestimation of CIED infections treated exclusively in outpatient settings
Coding ambiguity of ICD-10-GM code T82.7, which encompasses various hardware infections
Analyses were not adjusted for potential confounders such as diabetes mellitus, chronic kidney disease, heart failure, or device type
Structure of the anonymized claims dataset did not permit robust time-to-event analyses or multivariable survival analyses

Abstract

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.

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