Benito Baldauf, Kerstin Bode, Ernest W. Lau, Marzia Giaccardi, Ojan Assadian, Philippe Chévalier, Christelle Haddad, Andreas Klöss, Roberto Cemin, Reinhard Vonthein, Hendrik Bonnemeier
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.