BACKGROUND:Infections following durable left ventricular assist device (dLVAD) implantation are common and associated with increased morbidity and mortality. Despite documented interhospital variability, few studies have identified strategies to mitigate their occurrence. This national study uses a multistage mixed methods design to develop a customizable and deployable toolkit of expert-guided recommendations to reduce infections post-dLVAD. METHODS:Using purposeful sampling, participants (eg, clinical and operational ventricular assist device [VAD] team members) from low, medium, and high-performance hospitals (based on their risk-adjusted, 90-day post-implantation infection rates) across the United States were interviewed to assess factors contributing to postdLVAD infections. Draft toolkit recommendations were iteratively developed after integrating thematically analyzed qualitative and quantitative data from a merged national registry with Medicare and hospital survey data. A national advisory team of VAD subject matter experts provided mixed methods input to refine the toolkit's content and structure. RESULTS:Seventy-three clinical and operational VAD team members across 8 US hospitals were interviewed, spanning low (n=4), medium (n=1) and high (n=3) performance groups. Fourteen subject matter experts provided stakeholder feedback to refine the toolkit. The resulting toolkit contains 39 infection prevention recommendations that address VAD program care processes (eg, real-time provider communication), clinicians (eg, multidisciplinary protocol development), patients and caregivers (eg, engaging patient advisors in patient education), and VAD leadership (eg, unit and service level data reporting). Accompanying resources (eg, team-based exercises, data collection worksheets) support implementing and evaluating site-specific strategies. CONCLUSIONS:Using mixed methods approaches, an infection prevention toolkit was developed to enhance care coordination among VAD team members and mitigate postdLVAD infections. Future work should evaluate the effectiveness of implementing this infection prevention toolkit within the dLVAD setting.

BACKGROUND: Left ventricular assist device (LVAD) implantation leads to substantial and sustained improvement in health-related quality of life (HRQOL) among patients. Infection following device implantation remains an important and frequent complication and adversely affects patient-reported HRQOL. METHODS: Patients in The Society of Thoracic Surgeons' Interagency Registry for Mechanically Assisted Circulatory Support receiving a primary LVAD between April 2012 to October 2016 were included. The primary exposure was one-year post-implant infection, characterized by: (1) any infection; (2) total number of infections and (3) type (LVAD-specific, LVAD-related, non-LVAD). The association between infection and the primary composite adverse outcome (defined as EuroQoL Visual Analog Scale < 65, too sick to complete the survey, or death at 1-year) was estimated using inverse probability weighting and Cox regression. RESULTS: The study cohort included 11,618 patients from 161 medical centers with 4,768 (41.0%) patients developing an infection, and 2,282 (19.6%) patients having > 1 infection during the follow up period. The adjusted odds ratio for the primary composite adverse outcome was 1.22 (95% CI, 1.19-1.24, p < 0.001) for each additional infection. Each additional infection was associated with a 3.49% greater probability of the primary composite outcome and was associated with worse performance across multiple dimensions of HRQOL as assessed by the EQ-5D for patients who survived to 1 year. CONCLUSIONS: For patients undergoing LVAD implantation, each additional infection within the first post-implantation year was associated with an incremental negative effect on survival free of impaired HRQOL. (c) 2023 International Society for Heart and Lung Transplantation. All rights reserved.

Infections are widely prevalent in left ventricular assist device (LVAD) recipients and associated with adverse events including mortality and rehospitalizations. Current evidence examining factors associated with infections in this setting predominantly comprises single-center observational data. We performed a scoping review to systematically summarize all existing studies examining patient-related factors associated with infections after LVAD implantation. Studies published between 01/06 and 02/ 19 were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of patient-related factors associated with infections among recipients of contemporary implantable, continuous flow LVADs. Key study characteristics were extracted by four independent reviewers and current literature described narratively. All analyses took place between February 2019 and May 2021. A total of 31 studies met inclusion criteria. All included studies were observational, and most commonly focused on driveline infections (n = 17). Factors studied most commonly included body composition (n = 8), diabetes and other comorbidities (n = 8), and psychosocial/socio-economic factors (n = 6). Studies were frequently single-center with heterogeneity in definition of infectious outcomes as well as exposure variables. Patient race and sex did not correlate with infection risk. There was no consistent association noted between obesity, diabetes, or psychosocial/socio-economic factors and infections in LVAD recipients. Two studies reported a significant association between malnutrition and hypoalbuminemia and post implant infections. This review summarizes 31 studies that described patient-related factors associated with infection after LVAD implantation. Patient related comorbidities, especially body composition and diabetes, were most commonly evaluated, but were not consistently associated with infections after (c) 2022 International Society for Heart and Lung Transplantation. All rights reserved.

BACKGROUND:Care fragmentation is associated with higher rates of infection after durable left ventricular assist device (LVAD) implant. Less is known about the relationship between care fragmentation and total spending, and whether this relationship is mediated by infections. METHODS:Total payments were captured from admission to 180 days post-discharge. Drawing on network theory, a measure of care fragmentation was developed based on the number of shared patients among providers (ie, anesthesiologists, cardiac surgeons, cardiologists, critical care specialists, nurse practitioners, physician assistants) caring for 4,987 Medicare beneficiaries undergoing LVAD implantation between July 2009 - April 2017. Care fragmentation was measured using average path length, which describes how efficiently information flows among network members; longer path length indicates greater fragmentation. Terciles based on the level of care fragmentation and multivariable regression were used to analyze the relationship between care fragmentation and LVAD payments and mediation analysis was used to evaluate the role of post-implant infections. RESULTS:The patient cohort was 81% male, 73% white, 11% Intermacs Profile 1 with mean (SD) age of 63.1 years (11.1). The mean (SD) level of care fragmentation in provider networks was 1.7 (0.2) and mean (SD) payment from admission to 180 days post-discharge was $246,905 ($109,872). Mean (SD) total payments at the lower, middle, and upper terciles of care fragmentation were $250,135 ($111,924), $243,288 ($109,376), and $247,290 ($108,241), respectively. In mediation analysis, the indirect effect of care fragmentation on total payments, through infections, was positive and statistically significant (β=16032.5, p=0.008). CONCLUSIONS:Greater care fragmentation in the delivery of care surrounding durable LVAD implantation is associated with a higher incidence of infections, and consequently, higher payments for Medicare beneficiaries. Interventions to reduce care fragmentation may reduce the incidence of infections and in turn enhance the value of care for patients undergoing durable LVAD implantation.

BACKGROUND: Infections are the most common complication in recipients of durable left ventricular assist devices (LVAD) and are associated with increased morbidity, mortality, and expenditures. The existing literature examining factors associated with infection in LVAD recipients is limited and principally comprises single-center studies. This scoping review synthesizes all available evidence related to identifying modifiable, non-patient factors associated with infections among LVAD recipients. METHODS: Published studies were identified through searching 5 bibliographic databases: PubMed, Scopus, EMBASE, CINAHL, and Web of Science Core Collection. Inclusion criteria required examination of factors associated with infections among recipients of contemporary, implantable, continuous flow LVADs. Key study characteristics were extracted by 4 independent reviewers and current literature described narratively. The Systems Engineering Initiative for Patient Safety (SEIPS) model was used to develop a taxonomy for non-patient related factors (e.g., tasks, tools, technologies, organization, and environment) associated with infections following LVAD implantation. All analyses took place between February 2019 and May 2021. FINDINGS: A total of 43 studies met inclusion criteria. The majority of included studies were observational (n = 37), single-center (n = 29), from the U.S. (n = 38), and focused on driveline infections (n = 40). Among the 22 evaluated sub-domains of non-patient related factors, only two: increasing center experience and establishing a silicone-skin interface at the driveline exit site, were identified as consistently being associated with a lower risk of infection. CONCLUSION: This review identified 43 studies that described non-patient related factors associated with infection in LVAD recipients. Only two factors were consistently associated with lower infection risk in LVAD recipients: increasing experience and establishing a silicone-skin interface at driveline exit site. The large variability in reporting across multiple studied interventions limited the ability to discern their effectiveness. (C) 2021 International Society for Heart and Lung Transplantation. All rights reserved.

Objective: Although infections are common after left ventricular assist device im-plantation, the relationship between timing and type of first infection with regard to mortality is less well understood. Methods: The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support patients receiving a primary left ventricular assist de-vice from April 2012 to May 2017 were included. The primary exposure was defined 3 ways: any infection, timing of first infection (early: <90 days; intermediate: 91-180 days; late: >180 days), and type (ventricular assist device specific, ventricular assist device related, non-ventricular assist device). The association between first infection and all-cause mortality was estimated using Cox regression.Results: The cohort included 12,957 patients at 166 centers (destination therapy: 47.4%, bridge-to-transplant: 41.2%). First infections were most often non- ventricular assist device (54.2%). Rates of first infection were highest in the early in-terval (10.7/100 person-months). Patients with any infection had a significantly higher adjusted hazard of death (hazard ratio, 2.63; 2.46-2.86). First infection in the interme-diate interval was associated with the largest increase in adjusted hazard of death (hazard ratio, 3.26; 2.82-3.78), followed by late (hazard ratio, 3.13; 2.77-3.53) and early intervals (hazard ratio, 2.37; 2.16-2.60). Ventricular assist device-related infections were associated with the largest increase in hazard of death (hazard ratio, 3.02; 2.69-3.40), followed by ventricular assist device specific (hazard ratio, 2.92; 2.57-3.32) and non-ventricular assist device (hazard ratio, 2.42; 2.20-2.65).Conclusions: Relative to those without infection, patients with any postimplanta-tion infection had an increased risk of death. Ventricular assist device-related infec-tions and infections occurring in the intermediate interval were associated with the largest increase in risk of death. After left ventricular assist device implantation, infection prevention strategies should target non-ventricular assist device infec-tions in the first 90 days, then shift to surveillance/prevention of driveline infections after 90 days.

Introduction: Patients receiving a durable left ventricular assist device (LVAD) implant for advanced heart failure require multidisciplinary care but integration of care delivery may vary among provider groups. Prior studies found that greater provider network connectivity may be associated with more integrated care and better clinical outcomes. Hypothesis: Greater connectedness in provider networks is associated with lower LVAD payments. Methods: Drawing on social network theory, a measure of connectedness was developed based on the number of shared patients among providers (e.g. primary care physicians, cardiologists, surgeons) caring for 4,985 Medicare beneficiaries, starting 180 days prior to LVAD admission until 180 days post-discharge, from July 2009-April 2017. Connectedness was measured as average network path length, with shorter path lengths indicating more connected networks. Total payments were captured from admission to 180 days post-discharge. Multivariable regression was used to analyze the relationship between connectedness and LVAD payments. Results: The patient cohort was 81% male, 73% white, 11% Intermacs Profile 1 with a mean age of 63.1 years (SD 11.1). The median path length (IQR) for a provider network was 1.7 (1.6, 1.8) and median (IQR) payments from admission to 180 days post-discharge was $162,774 ($151,279, $202,932). Median (IQR) payments at the lower, middle, and upper terciles of connectedness were $162,249 ($150,543, $198,709), $162,577 ($151,424, $199,471), and $163,922 ($152,263, $212,072), respectively. After adjusting for center, patient demographics, and clinical factors, greater connectedness was associated with lower payments (β=-22097.88, p<0.01), Figure. Conclusions: Greater provider network connectedness is associated with lower payments for Medicare beneficiaries receiving durable LVAD implants. Interventions to improve network connectedness may improve the value of care in this population.

ObjectiveThe objective of this study was to investigate variations across hospitals in infection rates and associated costs, the latter reflected in 90-day Medicare payments. Despite high rates and expenditures of health care--associated infections associated with durable ventricular assist device implantation, few studies have examined interhospital variation and associated costs.MethodsClinical data on 8688 patients who received primary durable ventricular assist devices from July 2008 to July 2017 from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) hospitals (n = 120) were merged with postimplantation 90-day Medicare claims. Terciles of hospital-specific, risk-adjusted infection rates per 100 patient-months were estimated using Intermacs and associated with Medicare payments (among 5440 Medicare beneficiaries). Primary outcomes included infections within 90 days of implantation and Medicare payments.ResultsThere were 3982 infections identified among 27.8% (2417/8688) of patients developing an infection. The median (25th, 75th percentile) adjusted incidence of infections (per 100 patient-months) across hospitals was 14.3 (9.3, 19.5) and varied according to hospital (range, 0.0-35.6). Total Medicare payments from implantation to 90 days were 9.0% (absolute difference: $13,652) greater in high versus low infection tercile hospitals (P < .0001). The period between implantation to discharge accounted for 73.1% of the difference in payments during the implantation to 90-day period across terciles.ConclusionsHealth care--associated infection rates post durable ventricular assist device implantation varied according to hospital and were associated with increased 90-day Medicare expenditures. Interventions targeting preventing infections could improve the value of durable ventricular assist device support from the societal and hospital perspectives.

[This corrects the article DOI: 10.2196/14701.].

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