Incidence and Predictors of Infections and All-Cause Death in Patients with Cardiac Implantable Electronic Devices: The Italian Nationwide RI-AIAC Registry

Abstract

Background: The incidence of infections associated with cardiac implantable electronic devices (CIEDs) and patient outcomes are not fully known. Aim: To provide a contemporary assessment of the risk of CIEDs infection and associated clinical outcomes. Methods: In Italy, 18 centres enrolled all consecutive patients undergoing a CIED procedure and entered a 12-months follow-up. CIED infections, as well as a composite clinical event of infection or all-cause death were recorded. Results: A total of 2675 patients (64.3% male, age 78 (70–84)) were enrolled. During follow up 28 (1.1%) CIED infections and 132 (5%) deaths, with 152 (5.7%) composite clinical events were observed. At a multivariate analysis, the type of procedure (revision/upgrading/reimplantation) (OR: 4.08, 95% CI: 1.38–12.08) and diabetes (OR: 2.22, 95% CI: 1.02–4.84) were found as main clinical factors associated to CIED infection. Both the PADIT score and the RI-AIAC Infection score were significantly associated with CIED infections, with the RI-AIAC infection score showing the strongest association (OR: 2.38, 95% CI: 1.60–3.55 for each point), with a c-index = 0.64 (0.52–0.75), p = 0.015. Regarding the occurrence of composite clinical events, the Kolek score, the Shariff score and the RI-AIAC Event score all predicted the outcome, with an AUC for the RI-AIAC Event score equal to 0.67 (0.63−0.71) p < 0.001. Conclusions: In this Italian nationwide cohort of patients, while the incidence of CIED infections was substantially low, the rate of the composite clinical outcome of infection or all-cause death was quite high and associated with several clinical factors depicting a more impaired clinical status.

Antibiotic-Eluting Envelopes for the Prevention of Cardiac Implantable Electronic Device Infections: Rationale, Efficacy, and Cost-Effectiveness

“…This contrasts with recent randomized studies reporting much lower infection rates in the range of 0.6–1.3% ( 3 , 9 , 11 ). In addition, very recent real-life, nonrandomized data demonstrates infection rates comparable to that reported in the randomized trials ( 12 , 13 ). A study by Lee et al reported 7.2% in-hospital mortality and 25.3% mortality at 1 year ( 3 ) among 387 patients following lead extraction for CIED infection.…”

“…The predictive value of the PADIT risk score has recently been validated in a large real-world dataset comprising 54,042 procedures where each unit increase in PADIT risk score was associated with 28% increase in infection risk ( 35 ). Very recently Boriani et al have also introduced a scoring system (RI-AIAC score) based on real-life registry data including 2,675 patients ( 13 ). They have identified three major clinical characteristics associated with increased CIED infection risk and have created a 5-point scoring system.…”

Risk Scores for Cardiac Implantable Electronic Device Infection: Which One to Believe In?

“…Moreover, the PADIT risk score showed a significant association with CIED infections, with overall modest prediction performance when tested in the RI-AIAC registry population [ 27 ]. There was no association with the occurrence of the composite clinical event of infection or all-cause death.…”

“…In 2022, two different scores were developed with the purpose of providing an assessment of both the risk of CIED infection and risk of CIED infection + all-cause mortality [ 27 ]. Eighteen Italian centers enrolled a total of 2675 patients, which were followed up for 12 months.…”

“…The original studies proposing the different scores presented noteworthy differences ( Table 2 ). First of all, the PADIT trial enrolled 19,603 patients, a number much higher than all the other studies, which ranged from 899 (KOLEK) to 2675 (RI-AIAC) and 2880 (MITALL) [ 25 , 27 , 30 , 32 ]. The PADIT, SHARIFF, and RI-AIAC scores have been validated in external cohorts.…”