Temporal trends of device-related infection in de novo transvenous implantable cardioverter-defibrillator Medicare patients with underlying kidney disease.

BACKGROUND: Kidney disease is a risk factor for device infection in transvenous implantable cardioverter-defibrillator (TV-ICD) implants, with mechanisms that include immunodeficiency and a portal of entry for bacteria that can seed indwelling devices. OBJECTIVE: The purpose of this study was to examine the impact of both kidney disease and dialysis-dependence on the incidence of device-related infection after de novo TV-ICD implantation and how the incidence changes over time in. METHODS: Medicare 100% administrative and claims data were used to identify patients who underwent de novo TV-ICD implantation between July 1, 2016, and December 31, 2018. Baseline characteristics included underlying kidney disease (none, nondialysis, dialysis) plus device infection during follow-up. Patients were followed for TV-ICD infection up to 78 weeks after implantation. Piecewise Poisson regression was used to predict the incidence of and hazard ratios for infection over time. RESULTS: Overall, 809 of 42,200 patients (1.9%) had at least 1 device infection during mean follow-up of 66 weeks: 484 of 31,217 (1.6%) none; 202 of 9151 (2.2%) nondialysis; and 123 of 1832 (6.7%) dialysis (P <.001 via log-rank test). The incidence of infection increased during the first 8-12 weeks and declined thereafter. Hazard ratios increased over time (dialysis week 12 = 4.9/1000 patient-years; week 52 = 9.8; nondialysis week 12 = 1.4; week 52 = 2.5; all P <.05), as did the difference in cumulative incidence compared with none (dialysis week 12 = Δ11.8 and week 78 = Δ53.5; nondialysis week 12 = Δ1.4 and week 78 = Δ7.0). CONCLUSION: The incidence of infection after de novo TV-ICD implantation is higher when patients have kidney disease and is substantially higher when patients are dialysis-dependent.

Pathogen influence on epidemiology, diagnostic evaluation and management of infective endocarditis.

Infective endocarditis (IE) is uncommon and has, in the past, been most often caused by viridans group streptococci (VGS). Due to the indolent nature of these organisms, the phrase 'subacute bacterial endocarditis', so-called 'SBE', was routinely used as it characterised the clinical course of most patients that extended for weeks to months. However, in more recent years, there has been a significant shift in the microbiology of IE with the emergence of staphylococci as the most frequent pathogens, and for IE due to Staphylococcus aureus, the clinical course is acute and can be associated with sepsis. Moreover, increases in IE due to enterococci have occurred and have been characterised by treatment-related complications and worse outcomes. These changes in pathogen distribution have been attributed to a diversification in the target population at risk of IE. While prosthetic valve endocarditis and history of IE remain at highest risk of IE, the rise in prevalence of injection drug use, intracardiac device implantations and other healthcare exposures have heavily contributed to the existing pool of at-risk patients. This review focuses on common IE pathogens and their impact on the clinical profile of IE.

Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study.

Background: Previous studies support operational benefits when moving insertable cardiac monitor (ICM) insertions outside the cardiac catheterization/electrophysiology laboratories, but this has not been directly assessed in a randomized trial or when the procedure is specifically moved to the office setting. To gain insight, the RIO 2 US study collected resource utilization and procedure time intervals for ICM insertion in-office and in-hospital and these data were used to calculate costs associated with staff time and supply use in each setting.Methods and results: The Reveal LINQ In-Office 2 US study (randomized [1:1], multicenter, unblinded) included 482 patients to undergo insertion of the ICM in-hospital (in an operating room or CATH/EP laboratory) (n = 251) or in-office (n = 231). Detailed information on resource utilization was collected prospectively by the study and used to compare resource utilization and procedure time intervals during ICM insertion procedures performed in-office vs. in-hospital. In addition, costs associated with staff time and supply use in each setting were calculated retrospectively. Total visit duration (check-in to discharge) was 107 min shorter in-office vs. in-hospital (95% CI = 97-116 min; p < 0.001). Patient preparation and education in-office were more likely to occur in the same room as the procedure, compared with in-hospital (91.6% vs. 34.2%, p < 0.001 and 87.3% vs. 22.1%, p < 0.001, respectively). There was a reduction in registered nurse and cardiovascular/operating room technologist involvement in-office, accompanied by higher physician and medical assistant participation. Overall staff time spent per case was 75% higher in-hospital, leading to 50% higher staffing costs compared to in-office.Conclusions: ICM insertion in a physician's office vs. a hospital setting resulted in reduced patient visit time and reduced overall staff time, with a consequent reduction in staffing costs. Clinical trial registration: ClinicalTrials.gov NCT02395536.

Clinical and Economic Burden of Hospitalizations for Infective Endocarditis in the United States.

OBJECTIVE: To assess contemporary trends in the incidence, characteristics, and outcomes of hospital admissions for infective endocarditis (IE) in the United States. PATIENTS AND METHODS: Patients ≥18 years admitted with IE between January 1, 2003, and December 31, 2016, were identified in the National Inpatient Sample. We assessed the annual incidence, clinical characteristics, morbidity, mortality, and cost of IE-related hospitalizations. RESULTS: The incidence of IE-related hospitalizations increased from 34,488 (15.9; 95% confidence interval [CI], 15.73, 16.06) per 100,000 adults) in 2003 to 54,405 (21.8; 95% CI, 21.60-21.97) per 100,000 adults) in 2016 (P<.001). The prevalence of patients below 30 years of age, and those who inject drugs, increased from 7.3% to 14.5% and from 4.8% to 15.1%, respectively (P<.001). The annual volume of valve surgery for IE increased from 4049 in 2003 to 6460 in 2016 (P<.001), but the ratio of valve surgery to IE-hospitalizations did not decrease (11.7% in 2003; 11.8% in 2016). There was also a temporal increase in risk-adjusted rates of stroke (8.0% to 13.2%), septic shock (5.4% to 16.3%), and mechanical ventilation (7.7% to 16.5%; P<.001). However, risk-adjusted mortality decreased from 14.4% to 9.8% (P<.001). Median length-of-stay and mean inflation-adjusted cost decreased from 11 to 10 days and from $45,810±$61,787 to $43,020±$55,244, respectively, (P<.001). Nonetheless, the expenditure on IE hospitalizations increased ($1.58 billion in 2003 to $2.34 billion in 2016; P<.001). CONCLUSIONS: There is a substantial recent rise in endocarditis hospitalizations in the United States. Although the adjusted in-hospital mortality of endocarditis and the cost of admission decreased over time, the overall expenditure on in-hospital care for endocarditis increased.

Microbiology of Implant-Based Breast Reconstruction Infections: A Systematic Review.

BACKGROUND: Postsurgical complications have been an increasing concern for hospitals, particularly in light of payment reform. The costs to the health care system are increasing in light of Medicare penalties for readmissions for certain conditions. Surgical site infection following implant-based breast reconstruction (IBR) remains challenging. The rates of positive cultures and isolated microorganisms in IBR are unknown. This systematic review summarizes the reported microorganisms and positive culture rates in the existing literature. METHODS: A systematic review was performed using the guidelines outlined in Preferred Reporting Items for Systematic Reviews and Meta-analyses. Articles were included if breast implant infection rates and culture results were reported. Further subgroup analysis of culture positive infections was performed. RESULTS: A total of 25 studies were included, encompassing 25,177 IBR. Implant infections were reported in 1356 reconstructions (5.4%). Cultures were positive in 74.5% of infections. Gram-positive bacteria were the most common (68.6%), of which Staphylococcus species (51%) was the most isolated pathogen, followed by Pseudomonas. A subgroup analysis showed that early infections (63% vs 88%), radiotherapy (82% vs 93%), and acellular dermal matrix use (90% vs 100%) were associated with lower positive culture rates than their respective counterparts. Patients who received chemotherapy had higher positive culture results (94% vs 83%). Isolated microorganisms also varied among the subgroups. CONCLUSIONS: This systematic review outlines reported microorganisms in IBR. Staphylococcus species and Pseudomonas were the most frequently reported microorganism. Negative cultures were reported in up to 25.5% of infections. Patients with early infections, radiotherapy, and acellular dermal matrix demonstrated higher negative culture rates. This review can help guide the use of empirical antimicrobial therapy in IBR.

Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection.

BACKGROUND: Cardiac implantable electronic device (CIED) infection is a serious adverse event, but there are limited contemporary real-world data on treatment pathways and associated costs in the Medicare population following diagnosis of CIED infection. Hence, this study evaluates postinfection treatment pathways and associated healthcare expenditures and mortality among Medicare fee-for-service beneficiaries with CIED infection. METHODS: Retrospective cohort analysis of 5,401 beneficiaries who developed a device-related infection in the year following implantation/upgraded CIED (1/1/2010-12/31/2012). Patients were followed-up to 12 months/death following diagnosis of infection and were divided into mutually exclusive groups based on whether they underwent CIED system removal (Group I), or no CIED system intervention (Group II; IIA with or IIB without infection hospitalization). All-cause healthcare resource utilization/expenditures were also measured. RESULTS: In the year following infection, 64.1% of patients underwent device extraction, of who 2,109 (39.0%) had their device replaced (Group IA) and 1,355 (25.1%) had their device extracted without replacement (Group IB); 62.2% of patients were hospitalized and 25.3% of patients died. Mean Medicare payments-per-patient for facility-based services by group were: IA = $62,638 (standard deviation [SD]: $46,830), IB = $50,079 (SD: $45,006), IIA = $77,397 (SD: $79,130), and IIB = $22,856 (SD: $31,167). CONCLUSIONS: Hospitalizations were the largest cost driver; infection-related costs, including cost of extraction/replacement, accounted for >50% of expenditures for patients with surgical/hospital intervention. Management of CIED infection in Medicare beneficiaries is associated with high healthcare expenditures in the year following infection. Additional measures to prevent device infection are needed to improve the outcomes and reduce costs in these patients.

Cost-effectiveness of TYRX absorbable antibacterial envelope for prevention of cardiovascular implantable electronic device infection.

AIMS: Infection is a major complication of cardiovascular implantable electronic device (CIED) therapy that usually requires device extraction and is associated with increased morbidity and mortality. The TYRX Antibacterial Envelope is a polypropylene mesh that stabilizes the CIED and elutes minocycline and rifampin to reduce the risk of post-operative infection. METHODS: A decision tree was developed to assess the cost-effectiveness of TYRX vs standard of care (SOC) following implantation of four CIED device types. The model was parameterized for a UK National Health Service perspective. Probabilities were derived from the literature. Resource use included drug acquisition and administration, hospitalization, adverse events, device extraction, and replacement. Incremental cost-effectiveness ratios (ICERs) were calculated from costs and quality-adjusted life-years (QALYs). RESULTS: Over a 12-month time horizon, TYRX was less costly and more effective than SOC when utilized in patients with an ICD or CRT-D. TYRX was associated with ICERs of £46,548 and £21,768 per QALY gained in patients with an IPG or CRT-P, respectively. TYRX was cost-effective at a £30,000 threshold at baseline probabilities of infection exceeding 1.65% (CRT-D), 1.95% (CRT-P), 1.87% (IPG), and 1.38% (ICD). LIMITATIONS AND CONCLUSIONS: Device-specific infection rates for high-risk patients were not available in the literature and not used in this analysis, potentially under-estimating the impact of TYRX in certain devices. Nevertheless, TYRX is associated with a reduction in post-operative infection risk relative to SOC, resulting in reduced healthcare resource utilization at an initial cost. The ICERs are below the accepted willingness-to-pay thresholds used by UK decision-makers. TYRX, therefore, represents a cost-effective prevention option for CIED patients at high-risk of post-operative infection.

Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation.

BACKGROUND: Because of the increasing use of cardiac implantable electronic devices (CIEDs), it is important to estimate the incidence and annual healthcare expenditures associated with CIED infections. METHODS AND RESULTS: Patients with a record of an initial or replacement (full implant or generator only) CIED implant during the calendar years 2009 to 2012 in MarketScan Commercial Claims and Medicare Supplemental database were identified. CIED infections were classified into 4 categories: (1) infection not managed by inpatient admission nor implant removal, (2) infection managed by inpatient admission but no implant removal, (3) infection managed by an implant removal either in an inpatient or in an outpatient setting, and (4) infection with severe sepsis and managed in an inpatient setting with implant removal. Using separate models for initial and replacement cohorts, annualized incidence of infection and incremental annual expenditures by treatment intensity were estimated. Cumulative incidence of infection at 1 year post implant was 1.18% for initial CIED implants and 2.37% for replacement. Median time to infection was 35 days for initial and 23 days for replacement. Incremental healthcare expenditures by treatment intensity categories for initial implant patients at 1 year were $16 651, $104 077, $45 291, and $279 744. For replacement patients, incremental expenditures at 1 year by treatment intensity categories were $26 857, $43 541, $48 759, and $362 606. CONCLUSIONS: The management of CIED infections results in a substantial healthcare burden with a significant increase in annual expenditures the year after implant when device infection occurs.

Predictors of mortality in patients with cardiovascular implantable electronic device infections.

Infection reduces survival in cardiovascular implantable electronic device (CIED) recipients. However, the clinical predictors of short- and long-term mortality in patients with CIED infection are not well understood. We retrospectively reviewed all patients with CIED infection who were admitted to Mayo Clinic from January 1991 to December 2008. Survival data were obtained from the medical records and the United Sates Social Security Index. The purported risk factors for short-term (30-day) and long-term (>30-day) mortality were analyzed using univariate and multivariate models. Overall, 415 cases of CIED infection were identified during the study period. The mean follow-up duration for the 243 patients who were alive at the last follow-up visit was 6.9 years. In a multivariate model, heart failure (odds ratio 9.31, 95% confidence interval 2.08 to 41.67), corticosteroid therapy (odds ratio 4.04, 95% confidence interval 1.40 to 11.60), and presentation with CIED-related infective endocarditis (odds ratio 5.60, 95% confidence interval 2.25 to 13.92) were associated with increased short-term mortality. The factors associated with long-term mortality in the multivariate model included patient age (hazard ratio 1.20, 95% confidence interval 1.06 to 1.36), heart failure (hazard ratio 2.01, 95% confidence interval 1.42 to 2.86), metastatic malignancy (hazard ratio 5.99, 95% confidence interval 1.67 to 21.53), corticosteroid therapy (hazard ratio 1.97, 95% confidence interval 1.22 to 3.18), renal failure (hazard ratio 1.94, 95% confidence interval 1.37 to 2.74), and CIED-related infective endocarditis (hazard ratio 1.68, 95% confidence interval 1.17 to 2.41). In conclusion, these data suggest that the development of CIED-related infective endocarditis and the presence of co-morbid conditions are associated with increased short- and long-term mortality in patients with CIED infection.