Citations

Introduction: Device-related infection is estimated to occur in 1.9% of the Medicare patients with de novo transvenous (TV) implantable cardioverter-defibrillators (ICD) within 2 years post-implant. TV-ICD infection is a serious complication that frequently requires complete device removal for attempted cure, which can be associated with patient morbidity and mortality. The objective of this study is to expand on limited published data and assess mortality risk associated with TV-ICD infection in a large Medicare population with de novo TV-ICD implants. Methods: A survival analysis was conducted using 100% fee-for-service Medicare facility-level claims data to identify patients who underwent de novo TV-ICD implantation between 7/2016 and 1/2018. TV-ICD infection within 2 years of implantation was identified using ICD-10 and CPT codes. Baseline patient risk factors associated with mortality were identified using the Charlson Comorbidity Index categories. Infection was treated as a time-dependent variable in a multivariate Cox proportional hazards model to account for immortal time bias. Results: Among 26,742 Medicare patients with de novo TV-ICD, 518 (1.9%) had a device-related infection. The overall number of decedents was 4,721 (17.7%) over 2 years, with 4,555 (17%) in the non-infection group and 166 (32%) in the infection group. After adjusting for baseline patient demographic characteristics and various comorbidities, the presence of TV-ICD infection was associated with an increase of 2.4 [95% CI: 2.08-2.85] times in the mortality hazard ratio (see attached Figure). Most of the baseline patient risk factors were also associated with higher risk of mortality in the Cox model. Conclusion: The rate of de novo TV-ICD infection and associated mortality in a large, real-world Medicare population is noteworthy. The positive association between device-related infection and risk of mortality further highlights the need to reduce infections.

Abstract Background Population-based studies of Staphylococcus aureus bacteremia (SAB) in the United States are limited. We provide a contemporary evaluation of SAB incidence in Olmsted County, Minnesota, from 2006 to 2020. Methods This was a retrospective population-based study of all adult patients with SAB residing in Olmsted County from 1 January 2006 through 31 December 2020. Initial episodes of SAB were identified using the microbiology laboratory databases at both Olmsted Medical Center and Mayo Clinic Rochester. Results Overall, 541 incident SAB cases were identified with a median age of 66.8 (interquartile range, 54.4–78.5) years, and 60.4% were male. Among these cases, 298 (56.2%) were due to methicillin-susceptible S aureus (MSSA) and 232 (43.8%) cases of methicillin-resistant S aureus (MRSA). The overall age- and sex-adjusted SAB incidence rate (IR) was 33.9 (95% confidence interval [CI], 31.0–36.8) cases/100 000 person-years (PY). Males had a higher age-adjusted IR of 46.0 (95% CI, 41.0–51.0) cases/100 000 PY compared to females (IR, 24.4 [95% CI, 21.1–27.7] cases/100 000 PY). Age- and sex-adjusted SAB IRs due to MSSA and MRSA were 18.7 and 14.6 cases/100 000 PY, respectively, and the percentage of incident SAB cases due to MRSA fluctuated across the study period. There was no apparent temporal trend in SAB incidence over the study period (P = .093). Conclusions Our investigation represents the only contemporary population-based study in the United States. Despite the impression that SAB incidence may have increased based on Centers for Disease Control and Prevention surveillance data, our finding of no change in SAB incidence was somewhat unanticipated.

Background: The rate of cardiovascular implantable electronic device infection (CIEDI) has increased, despite the use of preoperative antibiotics at the time of device placement or revision. Cefazolin, a beta-lactam antibiotic, is used as standard preoperative prophylaxis in the bulk of patients. Vancomycin is used in the small minority of patients who have IgE-mediated allergies to beta-lactams or have a history of colonization/infection with MRSA. As compared to cefazolin, vancomycin is less effective against methicillin-susceptible Staphylococcus aureus, has no gram-negative coverage, and has nephrotoxicity risk. Methods: A retrospective cohort study was performed to assess whether vancomycin use increased the risk of CIEDI in comparison to the standard preoperative prophylaxis. The VA Informatics and Computing Infrastructure (VINCI) database, which includes all veterans who underwent CIED placement or revision between 2008 and 2015, was used. A logistic regression model was constructed to estimate the adjusted risk of CIEDI among patients who received vancomycin after adjusting for confounding factors. Results: Overall, 10,454 CIED procedures were included, and 98% of them were performed in men with a mean age of 71 ± 12 years. Vancomycin was given in 40.6% of these procedures. The rate of diabetes mellitus, heart failure, and advanced chronic kidney diseases were 20.5%, 13.5%, and 2.3%, respectively. The logistic regression analysis showed that vancomycin increased the risk of CIEDI three-fold (OR 2.99 [1.76-5.06], P-value <0.001) as compared to the standard preoperative prophylaxis, after controlling for other effects including MRSA colonization. Conclusions: Our study revealed that among patients who received vancomycin as preoperative for CIED placement or revision, there was a three-fold increase in the risk of subsequent CIEDI.

AbstractIntroductionTransvenous implantable cardioverter‐defibrillators (TV‐ICD) infection is a serious complication that frequently requires complete device removal for attempted cure, which can be associated with patient morbidity and mortality. The objective of this study is to assess mortality risk associated with TV‐ICD infection in a large Medicare population with de novo TV‐ICD implants.MethodsA survival analysis was conducted using 100% fee‐for‐service Medicare facility‐level claims data to identify patients who underwent de novo TV‐ICD implantation between 7/2016 and 1/2018. TV‐ICD infection within 2 years of implantation was identified using International Classification of Disease, 10th Edition and current procedural terminology codes. Baseline patient risk factors associated with mortality were identified using the Charlson Comorbidity Index categories. Infection was treated as a time‐dependent variable in a multivariate Cox proportional hazards model to account for immortal time bias.ResultsAmong 26,742 Medicare patients with de novo TV‐ICD, 518 (1.9%) had a device‐related infection. The overall number of decedents was 4721 (17.7%) over 2 years, with 4555 (17%) in the noninfection group and 166 (32%) in the infection group. After adjusting for baseline patient demographic characteristics and various comorbidities, the presence of TV‐ICD infection was associated with an increase of 2.4 (95% CI: 2.08–2.85) times in the mortality hazard ratio.ConclusionThe rate of TV‐ICD infection and associated mortality in a large, real‐world Medicare population is noteworthy. The positive association between device‐related infection and risk of mortality further highlights the need to reduce infections

Background: Infection remains a major complication of cardiac implantable electronic devices (CIEDs) and can lead to significant morbidity and mortality. Extrathoracic devices that avoid epicardial or transvenous leads, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD), can reduce the risk of serious infection-related complications, such as bloodstream infection and infective endocarditis. While the 2017 AHA/ACC/HRS guidelines include recommendations for S-ICD use for patients at high risk of infection, currently, there are no clinical trial data that address best practices for the prevention of S-ICD infections. Therefore, an expert panel was convened to develop consensus on these topics. Methods: An expert process mapping methodology was used to achieve consensus on the appropriate steps to minimize or prevent S-ICD infections. Two face-to-face meetings of high-volume S-ICD implanters and an infectious diseases specialist, with expertise on cardiovascular implantable electronic device infections, were conducted to develop consensus on useful strategies pre-, peri-, and post-implant to reduce S-ICD infection risk. Results: Expert panel consensus of recommended steps for patient preparation, S-ICD implantation, and post-operative management were developed to provide guidance in individual patient management. Conclusion: Achieving expert panel consensus by process mapping methodology for S-ICD infection prevention was attainable, and the results should be helpful to clinicians in adopting interventions to minimize risks of S-ICD infection.

Abstract Clinical significance of a single positive blood culture bottle (SPBCB) with Staphylococcus aureus is unclear. We aimed to assess the significance of an SPBCB by looking at the associated outcomes. We performed a retrospective, multicenter study of patients with an SPBCB with S aureus using data collected from both electronic health records and the clinical microbiology laboratory. Overall, 534 patients with S aureus bacteremia were identified and 118 (22.1%) had an SPBCB. Among cases with an SPBCB, 106 (89.8%) were classified as clinically significant whereas 12 (10.2%) were considered contaminated or of unclear significance. A majority (92.4%) of patients received antibiotic therapy, but patients with clinically significant bacteremia were treated with longer courses (25.9 vs 5.7 days, P &lt; .001). Significant differences in both frequency of echocardiography (65.1% vs 84.6%, P &lt; .001) and infective endocarditis diagnosis (3.8% vs 14.2%, P = .002) were seen in those with an SPBCB compared to those with multiple positive bottles. A longer hospital length of stay and higher 90-day, 6-month, and 1-year mortality rates were seen in patients with multiple positive blood culture bottles. An SPBCB with S aureus was common among our patients. While this syndrome has a more favorable prognosis as compared to those with multiple positive blood cultures, clinicians should remain concerned as it portends a risk of infective endocarditis and mortality.

Abstract Background Cardiovascular implantable electronic device (CIED) implantation has markedly increased over the past two decades. Staphylococcus aureus bacteremia (SAB) occurs in patients with CIED and determination of device infection among patients without clinical findings of pocket site infection is often difficult. Our study examines the characteristics, management, and outcomes of SAB in patients living with CIED using 2019 international criteria to define CIED infection. Methods We conducted a retrospective study of patients with CIED who were hospitalized at Mayo Clinic, Rochester, with SAB from January 1, 2012 to December 31, 2019. Patients who met CIED infection criteria following SAB based on the 2019 European Heart Rhythm Association International Concensus Document were identified. A time-to-event analysis was used to determine the impact, if any, of complete device extraction on outcomes. Results Overall, 110 patients with CIED developed SAB and 92 (83.6%) of them underwent transesophageal echocardiogram (TEE). Eighty-eight (80%) had CIED infection with 57 (51.8%) and 31 (28.2%) patients meeeting criteria for definite and possible CIED infections, respectively. Forty-three (75.4%) patients with definite CIED infection underwent complete device extraction. For possible and rejected CIED infection, the rates of complete device extraction were 35.5% and 27.3%, respectively (p&lt; .001 for each). The primary endpoint of a composite of one-year mortality and SAB relapse had a rate that was significantly lower in patients with CIED infection who underwent complete device extraction as compared to that of patients who did not undergo device extraction (25.9% vs. 76.5%, p&lt; .001). No significant difference in outcomes was seen in the rejected CIED infection group (33.3% vs. 62.5%, p =.27). Conclusion The rate of CIED infections following SAB was higher than that reported previously. Increased use of TEE and a novel case definition with broader diagnostic criteria were likely operative, in part, in accounting for the the higher rate of CIED infections complicating SAB. Complete device removal is critical in patients with either definite or possible CIED infection as defined by the 2019 consensus document to improve one-year mortality and SAB relapse rates. Disclosures Larry M. Baddour, MD, Boston Scientific (Individual(s) Involved: Self): Consultant; Botanix Pharmaceuticals (Individual(s) Involved: Self): Consultant; Roivant Sciences (Individual(s) Involved: Self): Consultant Muhammad R. Sohail, MD, Medtronic (Consultant)Philips (Consultant)

Abstract Background Serial blood cultures are integral in managing Staphylococcus aureus bacteremia (SAB) as clinicians rely on the results to determine infectious complication risks and antibiotic duration. Current IDSA guidelines suggest a single set of negative blood cultures is adequate evidence of SAB clearance. Several studies, however, have identified the skip phenomenon (SP), which is the occurrence of intermittent negative blood cultures, and have recommended obtaining additional blood cultures to document bacterial clearance (Table 1). We therefore examined patients who manifested the SP to determine its clinical significance and to study this, associations were tested for SP in relation to various baseline factors as well as clinical outcomes. Methods We performed a retrospective, multicenter study of all patients with a positive blood culture for S. aureus from January 2019 to December 2019 using data collected from electronic health records and the clinical microbiology laboratory. Results A total of 602 patients with SAB were identified and 495 patients were included in the investigation (Figure 1). Overall, 25 (5.1%) patients had the SP. Significant differences between those who did and did not manifest the SP included higher rates of injection drug use, automatic implantable cardioverter defibrillator, and community onset of infection in the SP cohort (Table 2). Moreover, the median duration of SAB was longer (3.2 [2.3-5.4] vs 1.90 [1.2-2.9] days, p=0.002), and high-grade SAB, (88.0% vs 58.7%, p=0.004), complicated bacteremia (92.0% vs 67.9%, p=0.011) and IE diagnosis (28.0% vs 11.3%, p=0.013) were all more common in the SP group. In unadjusted outcome analyses, association of SP with hospital length of stay was not significant, although a higher risk of in-hospital mortality among SP patients approached statistical significance (p=0.055). Analysis of 435 hospital survivors revealed no significant differences in rates of 1-year mortality or 90-day relapse between the two groups (Table 3). Conclusion Findings of the current investigation demonstrates an increased risk of SAB complications in patients with the SP and support the notion that serial negative blood cultures are needed to document clearance of SAB. Disclosures Larry M. Baddour, MD, Boston Scientific (Individual(s) Involved: Self): Consultant; Botanix Pharmaceuticals (Individual(s) Involved: Self): Consultant; Roivant Sciences (Individual(s) Involved: Self): Consultant Muhammad R. Sohail, MD, Medtronic (Consultant)Philips (Consultant)