Nighttime sleep and daytime sleepiness patterns among left ventricular assist device patients.

Despite the high prevalence of sleep disturbance in the heart failure population, information about its consequence on daytime function in patients with left-ventricular assist devices (LVADs) is limited. This study examined the nighttime and daytime sleep patterns and changes from pre-implant to 6 months post-implant. This study included 32 LVAD patients. Demographics, nighttime and daytime sleep variables were collected pre-implant and at 1, 3, and 6 months post-implant. Wrist actigraphy and self-report questionnaires measured objective and subjective sleep, respectively. Objective nighttime sleep data were sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and sleep fragmentation (SF). Objective daytime sleep data were nap times. Self-reported Subjective Sleep Quality Scale (SSQS) and Stanford Sleepiness Scale (SSS) were subjective measures. Increased SF and WASO scores and decreased TST and SE scores were found pre-LVAD implant, indicative of poor sleep quality. TST, SE, naptime and SSQS scores were higher at 3 and 6 months post-implant compared to baseline. Decreases in TST and SF scores were observed at 3 and 6 months post-implant along with increases in SSS scores. Increasing SSS scores and decreasing overall scores from pre- and up to 6 months post-implant suggest improvement in daytime function. This study provides information on sleep-daytime function in the LVAD patient population. Improvements in daytime sleepiness do not imply "good" sleep quality, consistent with the extant knowledge in LVAD literature. Future investigations should elucidate the mechanism by which sleep-daytime function influences quality of life.

Validity and reliability of the left ventricular assist device self-care behaviour scale.

BACKGROUND: Adequate self-care behaviour is essential for patients with a left ventricular assist device (LVAD) to prevent complications, prolong life, and optimise quality of life. However, there were no valid and reliable measurements available to assess self-care behaviour among patients with LVAD. We have previously developed the 33-item LVAD self-care behaviour scale. OBJECTIVES: To evaluate psychometric properties of the 33-item LVAD self-care behaviour scale. METHODS AND RESULTS: Data on 127 patients with a LVAD in Israel, Japan, and the USA were analysed (mean age 51±14.3, 81% male). Exploratory factor analysis extracted three factors, and 13 items were excluded from the scale. Internal consistency assessed by Cronbach's alpha was acceptable for the total scale (α = 0.80) and the three subscales: Factor 1: Monitoring (α = 0.81), Factor 2: Heart failure self-care (α = 0.67), and Factor 3: LVAD self-care (α = 0.63). The 20-item version of the LVAD self-care behaviour scale had sufficient convergent validity with another scale that assessed self-care related to the driveline of LVAD (r = 0.47, p<0.001). Test-retest reliability was adequate (intraclass correlation coefficient = 0.58). CONCLUSIONS: The 20-item version of the LVAD self-care behaviour scale showed adequate validity and reliability. The scale is ready for use in clinical practice and research. Additional testing might further optimise the scale.

Proposed Mechanism of Adherence in Caregivers Providing Care to Adults Living with a Left Ventricular Assist Device.

Introduction: The left ventricular assist device (VAD) is commonly used as the bridge-to-transplantation therapy for heart failure patients who are on waitlist of heart transplant. The caregivers' adherence to the homecare regimen plays a vital role in patient outcomes. There is little evidence about the factors related to the caregiver adherence. The purpose of this study was to determine the factors influencing adherence in caring for patients living with a left ventricular device. Methods: The data were collected from 4 online caregiver support groups. Multiple linear regression models were used to determine associations between key variables. The structure equation modeling was used to identify the mediators of caregiver adherence. Results: A total of 96 participants' data entered the final analysis. The average age of the participants was 49.8 (SD = 12.88) years, majority were white (84%), female (80%), and married (81%). Caregiver self-efficacy was positively related to their adherence (r = 0.460, P < 0.001). Caregiver knowledge did not mediate the effect of training on self-efficacy. Caregiver self-efficacy did not mediate the effect of knowledge on adherence. There was no interaction between practice hours and knowledge on adherence. Discussion: The findings suggest significant association between caregiver self-efficacy and adherence to left ventricular assist home-care regimens. Additional research is needed to identify factors influencing caregiver adherence, leading to the development of evidence-based practice guidelines and to improve the outcomes in advanced heart failure patients living with left VAD.

A pilot clinical trial of a self-management intervention in patients with a left ventricular assist device.

Self-management is a health behavior known to predict treatment outcomes in patients with multiple co-morbidities and/or chronic conditions. However, the self-management process and outcomes in the left-ventricular assist device (LVAD) population are understudied. This pilot randomized control trial (RCT) evaluated the feasibility of a novel "smartphone app-directed and nurse-supported self-management intervention" in patients implanted with durable LVADs. Assessments included behavioral (self-efficacy and adherence), clinical (complications), and healthcare utilization (unplanned clinic, emergency room (ER) visits, and re-hospitalization) outcomes, completed at baseline (pre-hospital discharge) and months 1, 3, and 6 post-hospital discharge. Intervention patients (n = 14) had favorable patterns/trends of results across study outcomes than control patients (n = 16). Notably, intervention patients had much lower complications and healthcare utilization rates than controls. For example, intervention patients had 2 (14.3%) driveline infections in 6 months while control patients had 3 (19.0%). Additionally, at month 3, intervention patients had 0% ER visits versus 36% of control patients. At month 6, the mean cumulative number of re-hospitalizations for the control group was higher (0.9 ± 0.93) than intervention (0.3 ± 0.61) group. Despite the small sample size and limitations of feasibility/pilot studies, our outcomes data appeared to favor the novel intervention. Lessons learned from this study suggest the intervention should be implemented for 6 months post-hospital discharge. Further research is needed including large and rigorous multi-center RCTs to generate knowledge explaining the mechanism of the effect of self-management on LVAD treatment outcomes.

Ambulatory Extracorporeal Membrane Oxygenation: Times Are Changing.

During the past century, medical technology has evolved to enhance quality and quantity of life. Medications, surgeries, and implantable devices have been developed and enhanced to reduce complications and improve patient outcomes. The use of extracorporeal membrane oxygenation is one of the most substantial advances in life-saving modalities. Extracorporeal membrane oxygenation has been widely used for patients with heart or lung failure across the lifespan. Expansion and simplifications of extracorporeal membrane oxygenation circuit designs have informed changes in patient treatment (from bed confinement to ambulatory) and shifted many clinical staffing structures (from cardiovascular perfusionist to nurse-managed care). Highly skilled registered nurses and advanced practice registered nurses are increasingly involved in managing extracorporeal membrane oxygenation in the critical care setting. The purpose of this article is to highlight the technological evolution of extracorporeal membrane oxygenation and the corresponding patient care that bedside registered nurses and advanced practice registered nurses provide.

Cognition predicts days-alive-out-of-hospital after LVAD implantation.

OBJECTIVE: Cognition influences hospitalization rates for a variety of patient groups but this association has not been examined in heart failure (HF) patients undergoing left ventricular assist device (LVAD) implantation. We used cognition to predict days-alive-out-of-hospital (DAOH) in patients after LVAD surgery. METHODS: We retrospectively identified 59 HF patients with cognitive assessment prior to LVAD. Cognitive tests of attention, memory, language, and visual motor speed were averaged into one score. DAOH was converted to a percentage based on total days from LVAD surgery to either heart transplant or 900 days post-LVAD. Variables significantly associated with DAOH in univariate analyses were included in a linear regression model to predict DAOH. RESULTS: A linear regression model including LVAD type (continuous or pulsatile flow) and cognition significantly predicted DAOH (F(2,54) = 6.44, p = 0.003, R2 = .19). Inspection of each variable revealed that cognition was a significant predictor in the model (ß = .11, SE = .04, p = 0.007) but LVAD type was not (p = 0.08). CONCLUSIONS: Cognitive performance assessed prior to LVAD implantation predicted how much time patients spent out of the hospital following surgery. Further studies are warranted to identify the impact of pre-LVAD cognition on post-LVAD hospitalization.

Patient-Reported Issues Following Left Ventricular Assist Device Implantation Hospitalization.

The purpose of this study was to explore the information reported by patients via a smartphone application (VAD Care App) used for left ventricular assist device (LVAD) self-care monitoring and reporting post hospital discharge. Specific aims were to examine the type and frequency of issues reported by patients through the app during months 1, 3, and 6 postdischarge. An exploratory-descriptive research design was used with 17 patients (12 males and 5 females) with durable LVADs, mean age of 48.6 ± 16 years. Data generated by the patients' daily smartphone app usage more than 6 months were extracted from the server. Data were coded and clustered according to issues reported by patients via the app and analyzed with descriptive statistics. Three clusters of issues were found: physiologic, behavioral (self-care), and signs and symptoms. LVAD flows and pulsatility indices, hypertension, driveline care, and heart failure symptoms were worse at month 1, and then appeared to improve at months 3-6. However, abnormal levels of the international normalization ratio were common at all assessment points. Further research is needed to understand the mechanism of the reported issues on treatment outcomes, then develop and test interventions to inform evidence-based practice and clinical guidelines for smartphone apps used in LVAD self-care monitoring.

Sleep quality and depression in adults with durable left-ventricular assist devices.

Poor sleep quality and depression remain understudied in patients implanted with a left-ventricular assist device (LVAD). This study aimed at describing sleep quality and depression pre and 6 months post LVAD implantation, examining the change in sleep quality and depression over time, and exploring the relationships among sleep quality and depression. An observational research design was used in this study involving 23 patients with LVADs. Patients' demographics, clinical characteristics, subjective and objective sleep data, and depression were collected pre and 6 months post-LVAD implantation hospitalization. Descriptive and inferential statistics were employed in data analysis. We found that poor sleep quality and depression were highly prevalent during pre and post LVAD. Comparing pre to post LVAD, there was a significant change in depression, sleep efficiency, and sleep quality. Differences between sleep quality and depression scores pre to post LVAD were negatively correlated, although there were positive correlations between depression sleep quality scores. These findings are fundamental to informing future research further to understand the sleep-depression phenomenon in the LVAD population. Research is needed to understand the mechanism of the phenomenon and identify.

Predicting post-LVAD outcome: Is there a role for cognition?

BACKGROUND: Cognition has been found to influence risk of stroke and death for a variety of patient groups but this association has not been examined in heart failure (HF) patients undergoing left ventricular assist device (LVAD) implant. We aimed to study the relationship between cognition, stroke, and death in a cohort of patients who received LVAD therapy. It was hypothesized that cognitive test results obtained prior to LVAD placement would predict stroke and death after surgery. METHODS: We retrospectively identified 59 HF patients who had cognitive assessment prior to LVAD placement. Cognitive assessment included measures of attention, memory, language, and visualmotor speed and were averaged to produce one z-score variable per patient. Survival analyses, censored for transplant, evaluated predictors for stroke and death within a follow-up period of 900 days. RESULTS: For patients with stroke or death during the follow up period, the average cognitive z-score predicted post-LVAD stroke (HR = 0.513, 95% CI = 0.31-0.86, p = 0.012) and death (HR = 0.166, 95% CI = 0.06-0.47, p = 0.001). Cognitive performances were worse in the patients who suffered stroke or died. No other variable predicted stroke and death within the follow up period when the cognitive variable was in the model. CONCLUSION: Cognitive performance was predictive of post-LVAD risk of stroke and death. Results are consistent with findings from other studies in non-LVAD samples and may reflect early signs of neurologic vulnerability. Further studies are needed to clarify the relationship between cognition and LVAD outcomes in order to optimize patient selection, management, and advanced care planning.

Development of an Instrument for Measuring Self-Care Behaviors After Left Ventricular Assist Device Implantation.

BACKGROUND: Successful long-term left ventricular assist device (LVAD) therapy necessitates a high degree of self-care. We aimed to develop an instrument that measures self-care behaviors in adult patients living with an LVAD. METHODS: We used the method to develop patient-reported outcomes recommended by the US Food and Drug Administration. Prior to developing the instrument, a literature review was conducted to generate items using the middle-range theory of self-care of chronic illness as a guiding framework. A 2-round Delphi method, involving 17 clinicians with expertise in heart failure and assist devices from the Netherlands, Israel, United States, Canada, and Japan, was used to generate and select items. In the first Delphi survey, the levels of importance, relevance, and clarity of items in the instrument were evaluated. The second Delphi survey was performed to gain consensus on the final selection of items. We also examined face validity. RESULTS: A preliminary 37-item version of the Self-Care Behavior Scale was produced. The first panel judged 33 items as important and relevant, taking out 4 items due to vague wording and duplication and adding in 4 items. In the final 33-item version, 19 items address self-care maintenance behaviors, 10 items address self-care monitoring behaviors, and 4 items address self-care management behaviors. Patients (N = 25) did not have any difficulties understanding items and report any missing items. CONCLUSION: The 33-item Self-Care Behavior Scale for patients with heart failure having an LVAD has been developed and is ready for further psychometric testing.