Cardiac Implantable Electronic Device Infections; Long-Term Outcome after Extraction and Antibiotic Treatment

Background: The aim of the study was to examine the treatment outcome for patients with cardiovascular implantable electronic device (CIED) infections after extraction. Methods: Patients who underwent CIED extractions due to an infection at Karolinska University Hospital 2006–2015 were analyzed. Results: In total, 165 patients were reviewed, 104 (63%) with pocket infection and 61 (37%) with systemic infection. Of the patients with systemic infection, 34 and 25 patients fulfilled the criteria for definite and possible endocarditis, respectively. Complications after extraction occurred only in one patient. Reimplantation was made after a mean of 9.5 days and performed in 81% of those with pocket infection and 44.3% in systemic infection. Infection with the new device occurred in 4.6%. The mean length of hospital stay for patients with pocket infection was 5.7 days, compared to 38.6 days in systemic infection. One-year mortality was 7.7% and 22.2% in pocket infection and systemic infection, respectively. Patients with Staphylococcus aureus infection had a higher mortality. Conclusions: In this study, the majority of the patients had a pocket CIED infection, with a short hospital stay. Patients with a systemic infection, and S. aureus etiology, had a prolonged hospital stay and a higher mortality

Antibacterial Envelope to Prevent Cardiac Implantable Device Infection

Background Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections. Methods We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months. Results A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P=0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (+/- SD) duration of follow-up was 20.7 +/- 8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98). Conclusions Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications