Comparison of infective complications with two different antibiotic prophylaxis at two-years follow up in patients undergoing cardiac implantable electronic device procedure: a prospective study

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Background Cardiac implantable electronic device (CIED) infective complications are associated with high morbidity and mortality. Selection of proper antibiotic prophylaxis therapy is mandatory, as it can decrease the infective risk. Purpose of the Study Aim of the present study was to compare two different antibiotic strategy in term of procedural-related infective complications in a two-years follow-up. Material and Methods Patients undergoing CIED procedure (implant, replacement, or revision), with cefuroxime antibiotic prophylaxis during 2009 were consecutively enrolled as study group, with the purpose to have a long follow-up available (10 years). Patients undergoing CIED procedure (implant, replacement, or revision), with cefazolin antibiotic prophylaxis during 2020 were consecutively enrolled as control group. Primary endpoint was the evaluation of infective complications in the first 2 years follow-up (pocket infection, endocarditis and infective complication requiring CIED complete extraction). Multivariate analysis was performed to evaluate association between covariates resulted significantly different between the two study groups and study endpoint. Long-term follow-up incidence of infective complications was evaluated in the cefuroxime group. Results 340 patients were enrolled in the cefuroxime prophylaxis group and 239 patients in the cefazolin prophylaxis group. There was no significative difference of median age between the two study groups. Patients in the cefazolin prophylaxis group compared to the cefuroxime group showed higher rate of diabetes (33.1% vs 22.1%, p=0.003), dyslipidemia (46.4% vs 36.5%, p=0.02) and higher rate of antiplatelet (45.2% vs 40.6%, p<0.001) and anticoagulation therapy (36.8% vs 31.8%, p<0.001) (Figure 1). ICD and CRT implant was more frequent in patients in the cefazolin group (33.3% vs 25.06%, p=0.05) (Figure 2). There was no significant difference of the primary endpoint in the two study groups: pocket infection (cefazolin group n=4, 1.7%, vs cefuroxime group n=5, 1.5%, p=0.85), endocarditis (cefazolin group n=1, 0.4%, vs cefuroxime group n=1, 0.3%, p=0.8) and infection requiring complete device extraction (cefazolin group n=2, 0.8%, vs cefuroxime group n=2, 0.6%, p=0.95). At multivariate analysis, there was an observed trend in reduction of infective complications in patients undergoing pacemaker (odds ratio 0.23) and CRT (odds ratio 0.82) implant. At 10 years follow-up, 11 (3.2%) infective procedure-related complications were recorded in the cefuroxime group, 5 pocket infection, 5 pocket infection with erosion and 1 endocarditis. Conclusion Cefazolin antibiotic prophylaxis is effective as cefuroxime prophilaxis in reducing CIED procedure-related infections, even if patients in the cefazolin group showed higher prevalence of comorbidities and more complex device procedure (ICD and CRT implant).