BACKGROUND: Cardiac implantable electronic device (CIED) infection is associated with morbidity and mortality. OBJECTIVES: To determine the incidence and risk factors for CIED infection, to develop a scoring index for risk stratification, and to analyze the effect of the AIGISRx envelope on infection rates. METHODS: Consecutive patients who underwent a CIED procedure were identified and surveyed for 6 months for the development of an infection necessitating removal of all implanted hardware. RESULTS: In the pre-envelope era, an infection occurred in 25 (1.5%) of 1651 patients. After its availability, an envelope was used in 275 (22%) of 1240 patients; an infection occurred in 8 (0.6%) patients in this era (P = .029 vs pre-envelope). In the overall cohort of 2891 patients, the infection rate was 1.2% and 3.5% in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device, respectively (P = .018); in these patients, 7 independent risk factors predicted infection: early pocket re-exploration, male sex, diabetes, upgrade procedure, heart failure, hypertension, and glomerular filtration rate < 60 mL/min. A composite risk score (0-25; C index 0.72; 95% confidence interval 0.61-0.83) was created by weight, adjusting these 7 factors: 3 groups emerged-low risk (score 0-7; 1% infection), medium risk (score 8-14; 3.4% infection), and high risk (score ≥15; 11.1% infection). The envelope reduced infections by 79% and 100% in the medium- and high-risk groups, respectively. CONCLUSIONS: CIED infection most commonly occurred in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device. A composite score based on clinical variables appeared feasible for infection risk stratification. The AIGISRx envelope significantly lowered the risk of CIED infection. Randomized clinical data are warranted.
BACKGROUND: Cardiac implantable electronic device (CIED) infection is associated with morbidity and mortality. OBJECTIVES: To determine the incidence and risk factors for CIED infection, to develop a scoring index for risk stratification, and to analyze the effect of the AIGISRx envelope on infection rates. METHODS: Consecutive patients who underwent a CIED procedure were identified and surveyed for 6 months for the development of an infection necessitating removal of all implanted hardware. RESULTS: In the pre-envelope era, an infection occurred in 25 (1.5%) of 1651 patients. After its availability, an envelope was used in 275 (22%) of 1240 patients; an infection occurred in 8 (0.6%) patients in this era (P = .029 vs pre-envelope). In the overall cohort of 2891 patients, the infection rate was 1.2% and 3.5% in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device, respectively (P = .018); in these patients, 7 independent risk factors predicted infection: early pocket re-exploration, male sex, diabetes, upgrade procedure, heart failure, hypertension, and glomerular filtration rate < 60 mL/min. A composite risk score (0-25; C index 0.72; 95% confidence interval 0.61-0.83) was created by weight, adjusting these 7 factors: 3 groups emerged-low risk (score 0-7; 1% infection), medium risk (score 8-14; 3.4% infection), and high risk (score ≥15; 11.1% infection). The envelope reduced infections by 79% and 100% in the medium- and high-risk groups, respectively. CONCLUSIONS:CIED infection most commonly occurred in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device. A composite score based on clinical variables appeared feasible for infection risk stratification. The AIGISRx envelope significantly lowered the risk of CIED infection. Randomized clinical data are warranted.
Authors: Alyssa G Ashbaugh; Xuesong Jiang; Jesse Zheng; Andrew S Tsai; Woo-Shin Kim; John M Thompson; Robert J Miller; Jonathan H Shahbazian; Yu Wang; Carly A Dillen; Alvaro A Ordonez; Yong S Chang; Sanjay K Jain; Lynne C Jones; Robert S Sterling; Hai-Quan Mao; Lloyd S Miller Journal: Proc Natl Acad Sci U S A Date: 2016-10-24 Impact factor: 11.205
Authors: Matthew J Kolek; Neel J Patel; Walter K Clair; S Patrick Whalen; Jeffrey N Rottman; Arvindh Kanagasundram; Sharon T Shen; Pablo J Saavedra; Juan C Estrada; Robert L Abraham; Christopher R Ellis Journal: J Cardiovasc Electrophysiol Date: 2015-09-06