Antibiotic prophylaxis based on individual infective risk stratification in cardiac implantable electronic device: the PRACTICE study

Michele Malagù, Francesco Vitali, Alessandro Brieda, Paolo Cimaglia, Martina De Raffele, Enea Tazzari, Cristina Musolino, Cristina Balla, Matteo Serenelli, Rosario Cultrera, Claudio Rapezzi, Matteo Bertini, Michele Malagù, Francesco Vitali, Alessandro Brieda, Paolo Cimaglia, Martina De Raffele, Enea Tazzari, Cristina Musolino, Cristina Balla, Matteo Serenelli, Rosario Cultrera, Claudio Rapezzi, Matteo Bertini

Abstract

Aims: In patients undergoing cardiac implantable electronic device (CIED) intervention, routine pre-procedure antibiotic prophylaxis is recommended. A more powerful antibiotic protocol has been suggested in patients at high risk of infection. Stratification of individual infective risk could guide the prophylaxis before CIED procedure.

Methods and results: Patients undergoing CIED surgery were stratified according to the Shariff score in low and high infective risk. Patients in the 'low-risk' group were treated with only two antibiotic administrations while patients in the 'high-risk' group were treated with a prolonged 9-day protocol, according to renal function and allergies. We followed-up patients for 250 days with clinical outpatient visit and electronic control of the CIED. As primary endpoint, we evaluated CIED-related infections. A total of 937 consecutive patients were enrolled, of whom 735 were stratified in the 'low-risk' group and 202 in the 'high-risk' group. Despite different risk profiles, CIED-related infection rate at 250 days was similar in the two groups (8/735 in 'low risk' vs. 4/202 in 'high risk', P = 0.32). At multivariate analysis, active neoplasia, haematoma, and reintervention were independently associated with CIED-related infection (HR 5.54, 10.77, and 12.15, respectively).

Conclusion: In a large cohort of patients undergoing CIED procedure, an antibiotic prophylaxis based on individual stratification of infective risk resulted in similar rate of infection between groups at high and low risk of CIED-related infection.

Keywords: Antibiotic prophylaxis; Cardiac implantable electronic device; Implantable cardioverter-defibrillator; Infection; Pacemaker; Shariff score.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Study protocol and results. bid, bis in die (two times a day); CIED, cardiac implantable electronic device; CrCl, creatinine clearance; iv, intravenous; po, per os (oral administration); tid, ter in die (three times a day).
Figure 2
Figure 2
Infective risk stratification according to Shariff score.
Figure 3
Figure 3
Freedom from CIED infection according to antibiotic prophylaxis based on individual infective risk stratification. Low risk, Shariff score

Figure 4

Kaplan–Meier curves of freedom from…

Figure 4

Kaplan–Meier curves of freedom from CIED infection according to the presence of CIED…

Figure 4
Kaplan–Meier curves of freedom from CIED infection according to the presence of CIED pocket haematoma and CIED surgical reintervention.
Figure 4
Figure 4
Kaplan–Meier curves of freedom from CIED infection according to the presence of CIED pocket haematoma and CIED surgical reintervention.

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