Effect of Ventricular Assist Device Self-care Simulation-Based Mastery Learning on Driveline Exit Site Infections: A Pilot Study.

BACKGROUND: Ventricular assist device simulation-based mastery learning (SBML) results in better patient and caregiver self-care skills compared with usual training. OBJECTIVE: The aim of this study was to evaluate the effect of SBML on driveline exit site infections. METHODS: We compared the probability of remaining infection free at 3 and 12 months between patients randomized to SBML or usual training. RESULTS: The SBML-training group had no infections at 3 months and 2 infections at 12 months, yielding a Kaplan-Meier estimate of the probability of remaining infection free of 0.857 (95% confidence interval [CI], 0.692-1.00) at 12 months. The usual-training group had 6 infections at 3 months with no additional infections by 12 months. Kaplan-Meier estimates of remaining infection free at 3 and 12 months were 0.878 (95% CI, 0.758-1.00) and 0.748 (95% CI, 0.591-0.946), respectively. Time-to-infection distributions for SBML versus usual training showed a difference in 12-month infection rates of 0.109 (P = .07). CONCLUSIONS: Ventricular assist device self-care SBML resulted in fewer 12-month infections.

Patient, Caregiver, and Clinician Perceptions of Ventricular Assist Device Self-care Education Inform the Development of a Simulation-based Mastery Learning Curriculum.

BACKGROUND: Patients who undergo ventricular assist device (VAD) implantation and their caregivers must rapidly learn a significant amount of self-care skills and knowledge. OBJECTIVE: The aim of this study was to explore patient, caregiver, VAD coordinator, and physician perspectives and perceptions of existing VAD self-care training to inform development of a simulation-based mastery learning (SBML) curriculum to teach patients and caregivers VAD self-care skills and knowledge. METHODS: We conducted semistructured, in-person interviews with patients with a VAD, their caregivers, VAD coordinators, and physicians (cardiac surgeons, an infectious disease physician, and advanced heart failure cardiologists). We used a 2-cycle team-based iterative inductive approach to coding and analysis. RESULTS: We interviewed 16 patients, 12 caregivers, 7 VAD coordinators, and 11 physicians. Seven major themes were derived from the interviews including (1) identification of critical curricular content, (2) need for standardization and assessment, (3) training modalities, (4) benefits of repetition, (5) piercing it all together, (6) need for refresher training, and (7) provision of training before implant. CONCLUSIONS: Findings from this study suggest that SBML is a natural fit for the high-risk tasks needed to save VAD self-care. The 7 unique training-related themes derived from the qualitative data informed the design and development of a VAD SBML self-care curriculum.

Race, substance use, and evaluation for heart transplantation: Insights from a large urban medical center.

It is unknown whether racial disparities in access to heart transplantation (HT) are amplified when coupled with substance use. We examined patients evaluated for HT over 8 years at an urban transplant center. We evaluated substance use and race/ethnicity as independent and interactive predictors of HT and left ventricular assist device (LVAD) implantation. Of 1,148 patients evaluated for HT, substance use was cited as an ineligibility factor in 151 (13%) patients, 16 (11%) of whom ultimately received HT. Significantly more non-Hispanic Black (NHB) patients were deemed ineligible due to substance use (n = 59, 19%) compared to other races/ethnicities (non-Hispanic white: n = 68, 12%; other race/ethnicity: n = 24, p = 0.002). No racial differences were observed in the likelihood of HT among patients initially excluded for substances, but more NHB patients ultimately received LVAD than the other racial groups. This study encourages greater awareness of the role of substance use and race in the HT evaluation.

Ventricular Assist Device Self-care Education at Tertiary Care Medical Centers.

Ventricular assist device (VAD) implantation requires patients and caregivers to attain self-care knowledge and skills before discharge from implant hospitalization. Inability to perform these skills can have devastating outcomes (i.e., death from pump malfunction, driveline site infections, and stroke). No standard-of-care guiding VAD self-care education exists. We sought to describe how select tertiary care VAD implant centers across the United States currently educate VAD patients and their caregivers. Using a multiple case studies design with a purposive sampling strategy, we conducted semistructured interviews of VAD coordinators responsible for VAD education at 18 centers. From audio recording of interviews, we used rapid qualitative analysis to organize and analyze the data. All centers spent significant time and effort educating patients and caregivers on VAD self-care. Although centers teach similar content, the rigor of assessments and follow-up education differed vastly. Only 3/18 (17%) centers performed competency-based assessments with a skills checklist and minimum passing standard assessing readiness to perform VAD self-care independently. Twelve of 18 (67%) centers provided formal follow-up education to address skills decay, yet wide variation existed in timing and content of education. Due to the diversity among centers regarding VAD self-care education, more prescriptive practice guidelines are needed.

Colonization with Multidrug-resistant Organisms in Patients with Ventricular Assist Devices.

Infection is a leading cause of morbidity and mortality in patients with ventricular assist devices (VAD). The impact of colonization with multidrug-resistant organisms (MDRO) on outcomes in this cohort is unknown. Patients on VAD support from July 2008 to September 2018 at a single site were evaluated for MDRO colonization after implantation. MDROs included methicillin-resistant Staphylococcus aureus , vancomycin-resistant Enterococcus species, and extended-spectrum beta-lactamase producing gram-negative bacteria. 378 patients with 433 VADs were included. 42.6% (n = 161) of patients were colonized with an MDRO throughout the duration of VAD support. Eighty-two VAD infections occurred, 74.4% (n = 61) of whom were MDRO colonized before infection. MDRO colonization was associated with an increased risk of a subsequent VAD infection (hazard ratio 3.704, p < 0.001). MDRO colonization is common after VAD implantation and is associated with future VAD infections. Further study is needed to determine best management strategies for VAD recipients with MDRO colonization given this increased risk.

Hyponatremia Is a Powerful Predictor of Poor Prognosis in Left Ventricular Assist Device Patients.

Serum sodium is an established prognostic marker in heart failure (HF) patients and is associated with an increased risk of morbidity and mortality. We sought to study the prognostic value of serum sodium in left ventricular assist device (LVAD) patients and whether hyponatremia reflects worsening HF or an alternative mechanism. We identified HF patients that underwent LVAD implantation between 2008 and 2019. Hyponatremia was defined as Na ≤134 mEq/L at 3 months after implantation. We assessed for differences in hyponatremia before and after LVAD implantation. We also evaluated the association of hyponatremia with all-cause mortality and recurrent HF hospitalizations. There were 342 eligible LVAD patients with a sodium value at 3 months. Among them, there was a significant improvement in serum sodium after LVAD implantation compared to preoperatively (137.2 vs. 134.7 mEq/L, P < 0.0001). Patients with and without hyponatremia had no significant differences in echocardiographic and hemodynamic measurements. In a multivariate analysis, hyponatremia was associated with a markedly increased risk of all-cause mortality (HR 3.69, 95% CI, 1.93-7.05, P < 0.001) when accounting for age, gender, co-morbidities, use of loop diuretics, and B-type natriuretic peptide levels. Hyponatremia was also significantly associated with recurrent HF hospitalizations (HR 2.11, 95% CI, 1.02-4.37, P = 0.04). Hyponatremia in LVAD patients is associated with significantly higher risk of all-cause mortality and recurrent HF hospitalizations. Hyponatremia may be a marker of ongoing neurohormonal activation that is more sensitive than other lab values, echocardiography parameters, and hemodynamic measurements.

Time Spent Engaging in Health Care Among Patients With Left Ventricular Assist Devices.

OBJECTIVES: This study aims to examine a novel patient-centered metric of time spent engaging in left ventricular assist device (LVAD)-related clinical care outside the home. BACKGROUND: Although LVAD implantation can improve survival and functional capacity in patients with advanced heart failure, this may occur at the expense of significant time spent engaging in LVAD-related health care activities. METHODS: The authors retrospectively assessed consecutive patients at a single center who received a continuous-flow LVAD between May 9, 2008, and December 31, 2019, and queried health care encounters after implantation, including all inpatient encounters and LVAD-related ambulatory encounters. Patient-level time metrics were determined, including the total number of days with any health care encounter, and the total estimated time spent receiving care. The primary outcome was the proportion (%) of days alive with an LVAD spent engaged in at least 1 health care encounter. The secondary outcome was the proportion (%) of total time alive with an LVAD spent receiving care. RESULTS: Among 373 patients, the median number of days alive with LVAD was 390 (IQR: 158-840 days). Patients had a median number of 88 (IQR: 45-161) days with ≥1 health care encounter, accounting for 23.2% (IQR: 16.3%-32.4%) of their days alive with an LVAD. A median 6.0% (IQR: 2.1%-14.1%) and 15.0% (IQR: 10.7%-20.0%) of total days alive were spent in inpatient and ambulatory encounters, respectively. Patients spent a median of 592 (IQR: 197-1,257) hours receiving care, accounting for 5.6% (IQR: 2.2%-12.7%) of their total time alive with an LVAD. CONCLUSIONS: LVAD patients spent more than 1 of every 5 days engaging in health care. Our findings may inform strategies to improve efficiency of postdischarge care delivery and expectations for post-treatment care.

Propensity Score-Matched Comparison of Right Ventricular Strain in Women and Men Before and After Left Ventricular Assist Device Implantation.

Objective: Adverse events following left ventricular assist device (LVAD) implantation are more common in women than in men, but the impact of gender differences on right ventricular (RV) failure is not well defined. Therefore, we calculated RV strain before and after LVAD implantation in matched groups of men and women to determine if gender differences in RV failure after LVAD might account for the gender differences in overall outcomes. Methods: RV free wall longitudinal strain (FWS) and fractional area change were calculated preoperatively and 3 months postoperatively using speckle-tracking echocardiography analysis. A total of 172 patients (86 women, 86 men) were then propensity score matched (1:1) for comparison. Results: Although women had higher preoperative CHA2DS2-VASc scores and more frequent moderate mitral regurgitation than men (P = 0.018), the preoperative hemodynamic parameters were similar. Preoperative RV-FWS was -6.7% in women and -6.0% in men (P = 0.65). Postoperatively, women had more progression to severe tricuspid regurgitation (TR) than men (15% vs 7%, P = 0.06). At 3 months the RV-FWS was -7.7% in women and -7.0% in men (P = 0.59). Postoperative TR was moderate-severe in 20% of women and in 9% of men (P = 0.001). Women had a higher incidence of venous thromboembolism, cardiac arrhythmias, and bleeding compared with men. Women also had higher mortality rates at discharge and 30 days after surgery, but the survival rates at 5 years were similar. Conclusions: RV strain measurements track standard hemodynamic and echocardiographic parameters and confirm that gender differences in outcomes following LVAD implantation are not related to gender differences in RV failure rates.

Short-term Retention of Patient and Caregiver Ventricular Assist Device Self-care Skills after Simulation-based Mastery Learning.

BACKGROUND: We developed a simulation-based mastery learning (SBML) curriculum that boosted self-care skills for patients with a ventricular assist device (VAD). In this study, we evaluated short-term skills retention. METHODS: We assessed skill retention among patients and caregivers who participated in VAD self-care SBML at a tertiary care center. We compared discharge skills tests (immediately after completing SBML) to 1- and 3-month follow-up tests to assess skill retention. RESULTS: Fifteen patients and 15 caregivers completed discharge and follow-up testing. Skills were largely retained at 1- and 3-months. CONCLUSIONS: SBML results in short-term retention of VAD self-care skills.

Association of cigarette smoking and adverse events in left ventricular assist device patients.

INTRODUCTION: Adverse events (AEs) associated with left ventricular assist devices (LVADs) cause significant morbidity and mortality. Little is known about patient-specific factors that contribute to rates of AEs. The purpose of this study was to assess the association of cigarette smoking history and AEs following LVAD implantation. METHODS: This study was a single-center, observational examination of 355 consecutive patients who underwent continuous-flow LVAD implantation from May 1, 2008 to July 1, 2018. Based on self-report, 348 patients with available data were categorized as never, former, or current smokers. Pre-LVAD implantation baseline characteristics were obtained, and summary characteristics were calculated. Hospitalizations for gastrointestinal bleeds, driveline infections, strokes, pump thromboses, and acute heart failure were evaluated. The Cox proportional hazard model was used to estimate the association of smoking and AE-related hospital admissions. The cumulative incidence competing risk method was used for survival analysis. RESULTS: Current (8.22%, p 0.006) and former (4.75%, p 0.026) smokers had a greater proportion of admissions for pump thrombosis compared to never smokers (2.22%). Former smoking was associated with admission for driveline infection (HR 2.43, CI 1.08-5.46, p 0.03) on multivariate analysis. There were no significant associations between smoking and the other AEs of interest. There was no difference in survival among the three groups. CONCLUSIONS: Smokers had a higher proportion of admissions for pump thrombosis compared to never smokers, and former smoking was associated with admission for driveline infections in patients with LVADs.

Outcome evaluation of a new model of critical care orientation.

BACKGROUND: The shortage of critical care nurses and the service expansion of 2 intensive care units provided a unique opportunity to create a new model of critical care orientation. The goal was to design a program that assessed critical thinking, validated competence, and provided learning pathways that accommodated diverse experience. OBJECTIVES: To determine the effect of a new model of critical care orientation on satisfaction, retention, turnover, vacancy, preparedness to manage patient care assignment, length of orientation, and cost of orientation. METHODS: A prospective, quasi-experimental design with both quantitative and qualitative methods. RESULTS: The new model improved satisfaction scores, retention rates, and recruitment of critical care nurses. Length of orientation was unchanged. Cost was increased, primarily because a full-time education consultant was added. CONCLUSIONS: A new model for nurse orientation that was focused on critical thinking and competence validation improved retention and satisfaction and serves as a template for orientation of nurses throughout the medical center.

The Effect of Judge Selection on Standard Setting Using the Mastery Angoff Method during Development of a Ventricular Assist Device Self-Care Curriculum.

BACKGROUND: Patients and caregivers need to perform ventricular assist device (VAD) self-care safely to help prevent complications (e.g., infection). We developed a VAD self-care simulation-based mastery learning (SBML) curriculum. We determined optimal minimum passing scores (MPSs) and evaluated effects of judge selection. METHODS: A multidisciplinary team created a VAD self-care SBML curriculum including simulated skills and knowledge examinations. Patients, caregivers, VAD coordinators, and physicians were expert judges who determined MPSs using the Mastery Angoff method. RESULTS: MPSs for the skills and knowledge examinations were high (range = 94-99% and 97% correct), respectively. Judges closely agreed on MPSs. CONCLUSIONS: Stakeholders set stringent MPSs for high-stakes VAD self-care.

Pre-Ventricular Assist Device Palliative Care Consultation: A Qualitative Analysis.

INTRODUCTION: In 2013, the Centers for Medicare and Medicaid Services issued a mandate requiring that all patients undergoing destination therapy ventricular assist device (DT VAD) implantation have access to a palliative care team before surgery. Subsequently, many VAD programs implemented a mandatory preimplantation palliative care consultation for patients considering DT VAD. However, little is known about the quality of these consults. METHODS: All patients undergoing DT VAD implantation at Northwestern Memorial Hospital from October 30, 2013 (the Centers for Medicare and Medicaid Services decision date), through March 1, 2018, were included. Palliative care consultation notes were qualitatively analyzed for elements of "palliative care assessment" and preparedness planning. RESULTS: Sixty-eight preimplantation palliative care consultations were analyzed. Fifty-six percent of the consults occurred in the intensive care unit, and the median time from consult to VAD implant was six days. General palliative care elements were infrequently discussed. Furthermore, the elements of preparedness planning-device failure, post-VAD health-related quality of life, device complications, and progressive comorbidities-were discussed in only 10%, 54%, 49%, and 12% of consultations, respectively. CONCLUSIONS: One-time preimplantation palliative care consultations at our institution do not lead to completion of preparedness planning or even general palliative care assessment. Further work is needed to determine the most effective way to integrate palliative care into preimplantation care.

Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial.

BACKGROUND: No recognized standards exist for teaching patients and their caregivers ventricular assist device (VAD) self-care skills. We compared the effectiveness of a VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training. METHODS AND RESULTS: VAD patients and their caregivers were randomized to SBML or usual training during their implant hospitalization. The SBML group completed a pretest on 3 VAD self-care skills (controller, power source, and dressing change), then viewed videos and participated in deliberate practice on a simulator. SBML participants took a posttest and were required to meet or exceed a minimum passing standard for each of the skills. The usual training group completed the existing institutional VAD self-care teaching protocol. Before hospital discharge, the SBML and usual training groups took the same 3 VAD self-care skills tests. We compared demographic and clinical information, self-confidence, total participant training time, and skills performance between groups. Forty participants completed the study in each group. There were no differences in demographic and clinical information, self-confidence, or training time between groups. More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%]; P=0.001), power source (36/40 [90%] versus 9/40 [23%]; P<0.001), and dressing change skills (19/20 [95%] versus 0/20; P<0.001). CONCLUSIONS: SBML provided superior VAD self-care skills learning outcomes compared with usual training. This study has important implications for patients due to the morbidity and mortality associated with improper VAD self-care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03073005.