PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Association Between Caregiver Burden and Patient Recovery After Left Ventricular Assist Device Implantation: Insights From Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support.

INTRODUCTION: After left ventricular assist device (LVAD) implantation, caregivers may experience increasing burden because of new roles and responsibilities. We examined the association between caregiver burden at baseline and patient recovery after long-term LVAD implantation in patients ineligible for heart transplantation. METHODS: Between October 1, 2015, and December 31, 2018, data from 60 patients with a long-term LVAD (age, 60-80 years) and caregivers through 1 postoperative year were analyzed. Caregiver burden was measured using the Oberst Caregiving Burden Scale, a validated instrument used for measuring caregiver burden. Patient recovery post-LVAD implantation was defined by change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score and rehospitalizations over 1 year. Multivariable regression models (least-squares for change in KCCQ-12 and Fine-Gray cumulative incidence for rehospitalizations) were used to assess for association with caregiver burden. RESULTS: Patients were 69.4 ± 5.5 years old, 85% men, and 90% White. Over the first year post-LVAD implantation, there was a 32% cumulative probability of rehospitalization; 72% (43/60) of patients had an improvement of ≥5 points in KCCQ-12 scores. Caregivers were 61.2 ± 11.5 years old, 93% women, 81% White, and 85% married. Median Oberst Caregiving Burden Scale Difficulty and Time scores at baseline were 1.13 and 2.27, respectively. Higher caregiver burden was not significantly associated with hospitalizations or change in patient health-related quality of life during the first year post-LVAD implantation. CONCLUSIONS: Higher caregiver burden at baseline was not associated with patient recovery in the first year after LVAD implantation. Understanding the associations between caregiver burden and patient outcomes after LVAD implantation is important as excessive caregiver burden is a relative contraindication for LVAD implantation.

Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study.

PURPOSE: Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device [LVAD]-related self-care, adverse events) to research study enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL). METHODS: In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study. RESULTS: Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; "respondents") and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was "as expected." Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery. CONCLUSIONS: Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement. TRIAL REGISTRATION: NCT03044535 (accessible at https://clinicaltrials.gov/ct2/show/NCT03044535 ), registered February 7, 2017.

Longitudinal Effects of Left Ventricular Assist Device Implantation on Global and Domain-Specific Cognitive Function.

BACKGROUND: Left ventricular assist devices (LVADs) are a common treatment of advanced heart failure, but cognitive dysfunction, which is common in heart failure, could limit the ability to perform postimplantation LVAD care. Implantation of an LVAD has been associated with improved cerebral perfusion and may improve cognitive function post implantation. OBJECTIVE: The aim of this study was to quantify longitudinal change in cognitive function after LVAD implantation. METHODS: A secondary analysis of data on 101 adults was completed to evaluate cognitive function before implantation and again at 1, 3, and 6 months post implantation of an LVAD. Latent growth curve modeling was conducted to characterize change over time. Serial versions of the Montreal Cognitive Assessment were used to measure overall (total) cognitive function and function in 6 cognitive domains. RESULT: There was moderate, nonlinear improvement from preimplantation to 6 months post implantation in Montreal Cognitive Assessment total score (Hedges' g = 0.50) and in short-term memory (Hedges' g = 0.64). There also were small, nonlinear improvements in visuospatial ability, executive function, and attention from preimplantation to 6 months post implantation (Hedges' g = 0.20-0.28). The greatest improvements were observed in the first 3 months after implantation and were followed by smaller, sustained improvements or no additional significant change. CONCLUSIONS: Implantation of an LVAD is associated with significant, nonlinear improvement in short-term memory and global cognitive function, with the most significant improvements occurring in the first 3 months after implantation. Clinicians should anticipate improvements in cognitive function after LVAD implantation and modify postimplantation education to maximize effectiveness of LVAD self-care.

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.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial.

BACKGROUND: Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care. METHODS: Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models. RESULTS: Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups. CONCLUSIONS: The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.

The Approach to the Psychosocial Evaluation of Cardiac Transplant and Mechanical Circulatory Support Candidates.

PURPOSE OF REVIEW: We update evidence underlying the recommendations of a 2018 multi-society consensus report regarding the psychosocial evaluation of individuals for cardiothoracic transplantation and mechanical circulatory support (MCS). In the present review, we focus on heart transplantation and MCS. RECENT FINDINGS: Expert opinion and new evidence support the inclusion of ten core content areas in the psychosocial evaluation. Prospective data indicate that psychosocial factors can predict post-transplantation/post-implantation outcomes. Such factors include treatment adherence history, mental health and substance use history, cognitive impairment, knowledge about treatment options, and social factors such as socioeconomic status. For other factors (e.g., coping, social support), new evidence is weaker because it derives largely from cross-sectional studies. Concerning evaluation process issues, expert opinion remains consistent with consensus recommendations, but there is a dearth of empirical evidence. The psychosocial evaluation can identify factors relevant for candidacy for heart transplantation and MCS implantation. It enables the provision of interventions to improve patients' viability as candidates, and facilitates care planning.

Heart Failure Symptom Biology in Response to Ventricular Assist Device Implantation.

BACKGROUND: We have a limited understanding of the biological underpinnings of symptoms in heart failure (HF), particularly in response to left ventricular assist device (LVAD) implantation. OBJECTIVE: The aim of this study was to quantify the degree to which symptoms and biomarkers change in parallel from before implantation through the first 6 months after LVAD implantation in advanced HF. METHODS: This was a prospective cohort study of 101 patients receiving an LVAD for the management of advanced HF. Data on symptoms (dyspnea, early and subtle symptoms [HF Somatic Perception Scale], pain severity [Brief Pain Inventory], wake disturbance [Epworth Sleepiness Scale], depression [Patient Health Questionnaire], and anxiety [Brief Symptom Inventory]) and peripheral biomarkers of myocardial stretch, systemic inflammation, and hypervolumetric mechanical stress were measured before implantation with a commercially available LVAD and again at 30, 90, and 180 days after LVAD implantation. Latent growth curve and parallel process modeling were used to describe changes in symptoms and biomarkers and the degree to which they change in parallel in response to LVAD implantation. RESULTS: In response to LVAD implantation, changes in myocardial stretch were closely associated with changes in early and subtle physical symptoms as well as depression, and changes in hypervolumetric stress were closely associated with changes in pain severity and wake disturbances. Changes in systemic inflammation were not closely associated with changes in physical or affective symptoms in response to LVAD implantation. CONCLUSIONS: These findings provide new insights into the many ways in which symptoms and biomarkers provide concordant or discordant information about LVAD response.

The 2018 ISHLT/APM/AST/ICCAC/STSW Recommendations for the Psychosocial Evaluation of Adult Cardiothoracic Transplant Candidates and Candidates for Long-term Mechanical Circulatory Support.

The psychosocial evaluation is well-recognized as an important component of the multifaceted assessment process to determine candidacy for heart transplantation, lung transplantation, and long-term mechanical circulatory support (MCS). However, there is no consensus-based set of recommendations for either the full range of psychosocial domains to be assessed during the evaluation, or the set of processes and procedures to be used to conduct the evaluation, report its findings, and monitor patients' receipt of and response to interventions for any problems identified. This document provides recommendations on both evaluation content and process. It represents a collaborative effort of the International Society for Heart and Lung Transplantation (ISHLT) and the Academy of Psychosomatic Medicine, American Society of Transplantation, International Consortium of Circulatory Assist Clinicians, and Society for Transplant Social Workers. The Nursing, Health Science and Allied Health Council of the ISHLT organized a Writing Committee composed of international experts representing the ISHLT and the collaborating societies. This Committee synthesized expert opinion and conducted a comprehensive literature review to support the psychosocial evaluation content and process recommendations that were developed. The recommendations are intended to dovetail with current ISHLT guidelines and consensus statements for the selection of candidates for cardiothoracic transplantation and MCS implantation. Moreover, the recommendations are designed to promote consistency across programs in the performance of the psychosocial evaluation by proposing a core set of content domains and processes that can be expanded as needed to meet programs' unique needs and goals.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Baseline Findings.

Young adult solid organ transplant recipients who transfer from pediatric to adult care experience poor outcomes related to decreased adherence to the medical regimen. Our pilot trial for young adults who had heart transplant (HT) who transfer to adult care tests an intervention focused on increasing HT knowledge, self-management and self-advocacy skills, and enhancing support, as compared to usual care. We report baseline findings between groups regarding (1) patient-level outcomes and (2) components of the intervention. From 3/14 to 9/16, 88 subjects enrolled and randomized to intervention (n = 43) or usual care (n = 45) at six pediatric HT centers. Patient self-report questionnaires and medical records data were collected at baseline, and 3 and 6 months after transfer. For this report, baseline findings (at enrollment and prior to transfer to adult care) were analyzed using Chi-square and t-tests. Level of significance was p < 0.05. Baseline demographics were similar in the intervention and usual care arms: age 21.3 ± 3.2 vs 21.5 ± 3.3 years and female 44% vs 49%, respectively. At baseline, there were no differences between intervention and usual care for use of tacrolimus (70 vs 62%); tacrolimus level (mean ± SD = 6.5 ± 2.3 ng/ml vs 5.6 ± 2.3 ng/ml); average of the within patient standard deviation of the baseline mean tacrolimus levels (1.6 vs 1.3); and adherence to the medical regimen [3.6 ± 0.4 vs 3.5 ± 0.5 (1 = hardly ever to 4 = all of the time)], respectively. At baseline, both groups had a modest amount of HT knowledge, were learning self-management and self-advocacy, and perceived they were adequately supported. Baseline findings indicate that transitioning HT recipients lack essential knowledge about HT and have incomplete self-management and self-advocacy skills.

Implant Strategy-Specific Changes in Symptoms in Response to Left Ventricular Assist Devices.

BACKGROUND: Although we know that the quality of life generally improves after left ventricular assist device (LVAD) implantation, we know little about how symptoms change in response to LVAD. METHODS: The purpose of this study was to compare the changes in symptoms between bridge and destination therapy patients as part of a prospective cohort study. Physical (dyspnea and wake disturbances) and affective symptoms (depression and anxiety) were measured before LVAD and at 1, 3, and 6 months after LVAD. Multiphase growth modeling was used to capture the 2 major phases of change: initial improvements between preimplant and 1 month after LVAD and subsequent improvements between 1 and 6 months after LVAD. RESULTS: The sample included 64 bridge and 22 destination therapy patients as the preimplant strategy. Destination patients had worse preimplant dyspnea and wake disturbances, and they experienced greater initial improvements in these symptoms compared with bridge patients (all P < .05); subsequent change in both symptoms were similar between groups (both P > .05). Destination patients had worse preimplant depression (P = .042) but experienced similar initial and subsequent improvements in depression in response to LVAD compared with bridge patients (both P > .05). Destination patients had similar preimplant anxiety (P = .279) but experienced less initial and greater subsequent improvements in anxiety after LVAD compared with bridge patients (both P < .05). CONCLUSION: There are many differences in the magnitude and timing of change in symptom responses to LVAD between bridge and destination therapy patients. Detailed information on changes in specific symptoms may better inform shared decision-making regarding LVAD.

Social Support Moderates the Relationship Between Perceived Stress and Quality of Life in Patients With a Left Ventricular Assist Device.

BACKGROUND: Living with a left ventricular assist device has significant psychosocial sequelae that affect health-related quality of life (HRQOL). OBJECTIVE: The purpose of this study was to (1) describe psychosocial indicators of stress including perceived stress, depression, fatigue, and coping; (2) examine relationships among stress indicators by level of perceived stress; (3) examine relationships among indicators of stress and clinical outcomes; and (4) test the moderation of social support on the relationship between stress and clinical outcomes. METHODS: Participants were recruited from 2 outpatient clinics in a cross-sectional study design. Standardized measures were self-administered via survey. Descriptive statistics, correlation, and multiple linear regression analysis were conducted. RESULTS: The sample (N = 62) was mostly male (78%), black (47%), and married (66%), with a mean age of 56.5 ± 13 years. The overall sample had a moderate stress profile: moderate perceived stress (mean, 11.7 ± 7), few depressive symptoms (mean, 3.2 ± 3.9), and moderate fatigue (mean, 14.3 ± 9.1). Increased perceived stress was associated with fatigue, depressive symptoms, and maladaptive coping (P < .001). Regression analysis demonstrated that perceived stress and fatigue were significant correlates of overall HRQOL (adj. R = 0.41, P < .0001). Social support moderated the relationship between perceived stress and HRQOL, controlling for fatigue (R = 0.49, P < .001). CONCLUSIONS: Individuals living with left ventricular assist device with high perceived stress have worse depressive symptoms, fatigue, and coping. The influence of high social support to improve the relationship between stress and HRQOL underscores the importance of a comprehensive plan to address psychosocial factors.

Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement From the American Heart Association/American Stroke Association.

The mission of the American Heart Association/American Stroke Association includes increasing access to high-quality, evidence-based care that improves patient outcomes such as health-related quality of life and is consistent with the patients' values, preferences, and goals. Awareness of and access to palliative care interventions align with the American Heart Association/American Stroke Association mission. The purposes of this policy statement are to provide background on the importance of palliative care as it pertains to patients with advanced cardiovascular disease and stroke and their families and to make recommendations for policy decisions. Palliative care, defined as patient- and family-centered care that optimizes health-related quality of life by anticipating, preventing, and treating suffering, should be integrated into the care of all patients with advanced cardiovascular disease and stroke early in the disease trajectory. Palliative care focuses on communication, shared decision making about treatment options, advance care planning, and attention to physical, emotional, spiritual, and psychological distress with inclusion of the patient's family and care system. Our policy recommendations address the following: reimbursement for comprehensive delivery of palliative care services for patients with advanced cardiovascular disease and stroke; strong payer-provider relationships that involve data sharing to identify patients in need of palliative care, identification of better care and payment models, and establishment of quality standards and outcome measurements; healthcare system policies for the provision of comprehensive palliative care services during hospitalization, including goals of care, treatment decisions, needs of family caregivers, and transition to other care settings; and health professional education in palliative care as part of licensure requirements.

EVALUATION OF OUTCOMES AND COMPLICATIONS IN PATIENTS WHO EXPERIENCE HYPOGLYCEMIA AFTER CARDIAC SURGERY.

OBJECTIVE: The objective of the study was to elucidate 30-day and long-term outcomes in patients experiencing postoperative hypoglycemia. METHODS: We conducted a retrospective review of patients who underwent cardiac surgery between September 4, 2007, and April 30, 2011, at Northwestern Memorial Hospital who had intensive treatment of hyperglycemia postoperatively. Of 1,325 patients, 215 experienced a hypoglycemic episode (blood glucose <70 mg/dL) within the first 3 postoperative days. A total of 198 were propensity-score (PS) matched to 363 patients without hypoglycemia. The analysis consisted of a comparison of 30-day cardiac outcomes and long-term mortality between those who experienced a hypoglycemic event and those who did not. RESULTS: Between patients who experienced hypoglycemia compared to those that did not, there were no significant differences in mean glucose values while on insulin drips (119.8 ± 33.5 mg/dL vs. 120.9 ± 30.5 mg/dL; P = .69) or subcutaneous insulin (122.0 ± 38.0 mg/dL vs. 127.2 ± 35.5 mg/dL; P = .11) or postoperative surgical complication rates (30-day mortality: 3.5% vs. 1.7%; complications (any): 40% vs. 42%; 30-day re-admissions: 13% vs. 13%; all cardiac complications: 35% vs. 31%; and all infections: 8% vs. 5%). Over an average of 5.1 ± 2.2 years following index surgery, there was higher all-cause mortality among those PS-matched who had experienced hypoglycemia compared to those who had not (log-rank P = .031), primarily due to those (n = 32) experiencing more than one episode of hypoglycemia. CONCLUSION: Postoperative hypoglycemia did not negatively impact immediate surgical complication rates but was associated with a significant risk of increased postoperative morbidity and long-term all-cause mortality in patients experiencing multiple episodes of hypoglycemia. ABBREVIATIONS: BG = blood glucose BMI = body mass index CARD = Cardiovascular Research Database HR = hazard rate PS = propensity score.

Quality of Life, Depression, and Anxiety in Ventricular Assist Device Therapy: Longitudinal Outcomes for Patients and Family Caregivers.

BACKGROUND: Patients who receive ventricular assist device (VAD) therapy typically rely on informal caregivers (family members or friends) to assist them in managing their device. OBJECTIVE: The purpose of this study is to characterize changes in person-oriented outcomes (quality of life [QOL], depression, and anxiety) for VAD patients and their caregivers together from pre-implantation to 3 months post-implantation. METHODS: This was a formal interim analysis from an ongoing prospective study of VAD patients and caregivers (n = 41 dyads). Data on person-oriented outcomes (QOL: EuroQol 5 Dimensions Visual Analog Scale; depression: Patient Health Questionnaire-8; anxiety: Brief Symptom Inventory) were collected at 3 time points (just prior to implantation and at 1 and 3 months post-implantation). Trajectories of change for patients and caregivers on each measure were estimated using latent growth modeling with parallel processes. RESULTS: Patients' QOL improved significantly over time, whereas caregiver QOL worsened. Depression and anxiety also improved significantly among patients but did not change among caregivers. There was substantial variability in change on all outcomes for both patients and their caregivers. CONCLUSIONS: This is the first quantitative study of VAD patient-caregiver dyads in modern devices that describes change in person-oriented outcomes from pre-implantation to post-implantation. This work supports the need for future studies that account for the inherent relationships between patient and caregiver outcomes and examine variability in patient and caregiver responses to VAD therapy.

Variation of Quality of Life Data Collection Across INTERMACS Sites.

BACKGROUND: Given the importance of patients' health-related quality of life (HRQL) after mechanical circulatory support (MCS) device implantation, the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) collects the Kansas City Cardiomyopathy Questionnaire (KCCQ) before and after MCS. The success of data collection and potential implications of missing data on HRQL analyses are unknown. METHODS: We examined the frequency and reasons for not collecting baseline and 3-month KCCQ data across INTERMACS sites from May 2012 to December 2013. Hierarchical logistic regression was used to examine site variability (median odds ratios [MOR]) for not collecting KCCQ data to demonstrate the degree to which some sites can collect more complete data than others. RESULTS: Among 3960 and 3523 patients participating in INTERMACS before and 3 months after left ventricular assist device implantation, the KCCQ was not collected in 43.1% at baseline (range across sites, 0-100%) and 40.9% (range, 0-100%) at follow-up. The most common reasons for incomplete KCCQ data at baseline were that the patient was too sick (13.9%) and consent to participate in research was not obtained (12.4%). Significant variation across sites was observed for missingness because of patient (MOR, 2.8; P < .001) and administrative (MOR, 4.8; P < .001) reasons. The most variable patient reasons were that the patients were too stressed (MOR, 7.2; P < .001) and too busy (MOR, 10.6; P < .001). The most variable administrative reasons were that the coordinator was too busy/forgot (MOR, 7.1; P < .001) and miscellaneous reasons (MOR, 8.7; P < .001). At 3 months, significant variation persisted for both patient (MOR, 2.7; P < .001) and administrative (MOR, 3.5; P < .001) reasons. The most variability across sites was that the patient was too busy (MOR, 6.0, P < .001) and that the coordinator was too busy/forgot (MOR, 5.8; P < .001). CONCLUSIONS: Sites vary substantially in collecting KCCQ data, and many of these variations seem addressable. Improving the consistency of HRQL data collection can improve the value of INTERMACS in defining the patient-centered benefits of MCS treatment.

Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry.

OBJECTIVES: The aim of this analysis was to assess survival differences between men and women supported with Impella 2.5 (Abiomed Inc., Danvers) in the setting of acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). BACKGROUND: Data on sex differences in outcomes of CS with mechanical circulatory support are sparse. METHODS: Patients enrolled in the cVAD Registry who underwent percutaneous coronary intervention (PCI) and Impella 2.5 support for CS complicating an AMI were included. Differences between men and women were examined. RESULTS: In total, 180 patients were analyzed. Women (n = 49, 27.2%) were older (71.0 ± 12.8 years vs 63.8 ± 13.0, P = 0.001), smaller (BSA 1.82 ± 0.22 vs 2.04 ± 0.24 m(2) , P < 0.001), and had a higher STS mortality risk score than men (27.9 ± 17.0 vs. 20.8 ± 16.8 P = 0.01). There was no difference in survival to discharge (P = 0.3). Patients receiving the Impella 2.5 pre-PCI had significantly lower inpatient mortality than those who received support post-PCI (P = 0.003). However, the magnitude of the survival benefit was significantly greater in women who received the Impella pre-PCI as compared to men. Overall, 68.8% of women survived with pre-PCI Impella 2.5 versus 24.2% post-PCI (P = 0.005) whereas 54.2% of men survived with pre-PCI Impella 2.5 versus 40.3% post-PCI (P = 0.1, p-interaction = 0.07). No differences in timing to intervention were found between men and women. CONCLUSIONS: Early initiation of hemodynamic support prior to PCI with Impella 2.5, in the setting of AMI complicated by CS, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularization failure rate for women. (J Interven Cardiol 2016;29:248-256).

Visualization and dynamics of multidimensional health-related quality-of-life-adjusted overall survival: a new analytic approach.

BACKGROUND: Vesnarinone Trial (VesT) was a three-armed, placebo-controlled, randomized clinical trial designed to study the effects of 30 mg or 60 mg/day vesnarinone. Certain contradictory results involving patient health-related quality-of-life (HRQOL) and overall survival (OS) have made a definitive and unified conclusion difficult. METHODS: To reconcile these findings, we have focused on the HRQOL-adjusted OS, commonly known as quality-adjusted life years (QALYs). Currently, analyses of QALYs incorporate a single HRQOL subscale. However, the VesT HRQOL instrument had two subscales: physical (PHYS) and emotional (EMOT). We have developed new ways to visualize and compare EMOT- and PHYS-adjusted OS. RESULTS: In each VesT arm, there was an increased probability of superior EMOT-adjusted OS, compared to PHYS-adjusted OS. The magnitude of these findings was comparable across trial arms. Despite inferior survival and superior EMOT and PHYS scores, the 60-mg/day arm presents similar EMOT- and PHYS-adjusted OS compared to the placebo arm. CONCLUSIONS: We have provided a fresh perspective on the complex interactions between multiple HRQOL dimensions and OS. These novel methods address the burgeoning need for robust information on the interplay between OS and HRQOL from a patient, clinical care and public policy perspective.