A principal components analysis of factors associated with successful implementation of an LVAD decision support tool.

BACKGROUND: A central goal among researchers and policy makers seeking to implement clinical interventions is to identify key facilitators and barriers that contribute to implementation success. Despite calls from a number of scholars, empirical insights into the complex structural and cultural predictors of why decision aids (DAs) become routinely embedded in health care settings remains limited and highly variable across implementation contexts. METHODS: We examined associations between "reach", a widely used indicator (from the RE-AIM model) of implementation success, and multi-level site characteristics of nine LVAD clinics engaged over 18 months in implementation and dissemination of a decision aid for left ventricular assist device (LVAD) treatment. Based on data collected from nurse coordinators, we explored factors at the level of the organization (e.g. patient volume), patient population (e.g. health literacy; average sickness level), clinician characteristics (e.g. attitudes towards decision aid; readiness for change) and process (how the aid was administered). We generated descriptive statistics for each site and calculated zero-order correlations (Pearson's r) between all multi-level site variables including cumulative reach at 12 months and 18 months for all sites. We used principal components analysis (PCA) to examine any latent factors governing relationships between and among all site characteristics, including reach. RESULTS: We observed strongest inclines in reach of our decision aid across the first year, with uptake fluctuating over the second year. Average reach across sites was 63% (s.d. = 19.56) at 12 months and 66% (s.d. = 19.39) at 18 months. Our PCA revealed that site characteristics positively associated with reach on two distinct dimensions, including a first dimension reflecting greater organizational infrastructure and standardization (characteristic of larger, more established clinics) and a second dimension reflecting positive attitudinal orientations, specifically, openness and capacity to give and receive decision support among coordinators and patients. CONCLUSIONS: Successful implementation plans should incorporate specific efforts to promote supportive and mutually informative interactions between clinical staff members and to institute systematic and standardized protocols to enhance the availability, convenience and salience of intervention tool in routine practice. Further research is needed to understand whether "core predictors" of success vary across different intervention types.

The association between novel clinical factors and gastrointestinal bleeding among patients supported with continuous-flow left ventricular assist device therapy.

BACKGROUND: This study explores novel preimplantation risk factors associated with gastrointestinal bleeding (GIB) after continuous-flow left ventricular assist device (CF-LVAD) implantation. CF-LVAD therapy implantation for patients with advanced heart failure is associated with a 20% to 40% incidence of GIB. METHODS: This study includes patients receiving CF-LVAD at a quaternary medical center from 2006 to 2014 (n = 254). The primary endpoint was GIB within 12 months after implantation; the secondary outcome was 3-year all-cause mortality. The Student t test or the χ2 test compared continuous or categorical variables. Competing risks analysis calculated the cumulative incidence of GIB postimplantation. Cox proportional hazards model was used for univariate/multivariate models predicting GIB. RESULTS: Sixty-four patients had GIB, with incidence rates at 1, 3, and 12 months of 11.8%, 19.3%, and 25.2%, respectively. Endoscopy revealed no identified source of bleeding in 41%; 33% of lesions were localized in the upper gastrointestinal tract, with the bulk (39%) categorized as vascular. Patients with prior gastrointestinal abnormalities (n = 98) had a greater risk of GIB post-CF-LVAD (HR 1.85 [1.11-3.09]; P = 0.02) than those with normal gastrointestinal evaluation results (n = 45) and those without preimplantation gastrointestinal evaluation (n = 111). Baseline blood urea nitrogen, chronic obstructive pulmonary disease, and prior percutaneous coronary intervention were statistically associated with post-CF-LVAD GIB. The presence of GIB within 12 months of CF-LVAD implantation was associated with an increased risk of 3-year all-cause mortality (HR 2.57 [1.57-4.15]; P < 0.01). CONCLUSIONS: First-year GIB is associated with increased mortality post-CF-LVAD. We advocate a closer examination of several GIB risk factors when evaluating CF-LVAD candidates.

Does an intervention designed to improve self-management, social support and awareness of palliative-care address needs of persons with heart failure, family caregivers and clinicians?

AIMS AND OBJECTIVES: To conduct a formative evaluation of the iPad-Enhanced Shared Care Intervention for Partners (iSCIP) among persons with heart failure (HF), family caregivers and clinicians. Together, persons with HF and family caregivers are referred to as partners. BACKGROUND: There is growing awareness of the caregiver's contributions to HF self-management, social support and reciprocal benefits of interventions that involve both partners. The iSCIP engages both partners in a six-session psychosocial intervention to address three preventable causes of poor outcomes in a HF population: poor self-management skills, inadequate social support and underutilisation of palliative care. An iPad app is used to organise the intervention. The goals of the iSCIP are to engage partners in HF self-management, communication about the HF patient's care values and preferences, and future planning. DESIGN: A qualitative focus group design was used. METHODS: Seven clinicians and eight partners participated in focus groups to explore their experiences, needs and reaction to the iSCIP content and technologies employed. Open-ended questions and closed-ended surveys were used to collect data. Deductive content analysis was used to analyse the qualitative data. NVivo software was used for qualitative data analysis. Bayesian statistical models were used to analyse numeric data. RESULTS: The iSCIP met partners' and clinicians' needs to improve self-management, communicate about care values and preferences and plan for the future. Quantitative analysis of numeric data supported our qualitative findings, in that both groups rated the intervention components useful to very useful. IMPLICATIONS FOR PRACTICE: These findings add to the growing evidence of the feasibility and acceptability of programs that address care values and preferences, and care planning. The iSCIP can be used as a guide for developing interventions and software applications, which involve both partners in care and palliative-care discussions.

Role of Echocardiography in the Evaluation of Left Ventricular Assist Devices: the Importance of Emerging Technologies.

The role of left ventricular assist devices (LVAD) in patients with end-stage heart failure is well known, both as a temporary treatment before transplantation and as destination therapy, in a scenario of a relative shortage of donors to satisfy the increasing requests for transplantation. The increased population of LVAD patients needs careful imaging assessment before, during, and after LVAD implantation; echocardiography is the best tool for their evaluation and is considered the diagnostic technique of choice for the assessment before, during, and after device implantation. Although the conventional echocardiographic assessment is quite effective in evaluating the main critical issues, the role of new technologies like three-dimensional echocardiography and myocardial deformation measurements is still not properly clarified. In this review, we aim to provide an overview of the main elements that should be considered in the assessment of these patients, underlining the role that could be played by new techniques to improve the diagnostic and prognostic effectiveness of echocardiography in this setting.

Cardiac sarcoid: a chameleon masquerading as hypertrophic cardiomyopathy and dilated cardiomyopathy in the same patient.

Sarcoidosis is a multisystem, granulomatous disease of unknown etiology often seen in young adults, with cardiac involvement in more than one-quarter of sarcoid patients. The clinical presentation of cardiac sarcoid depends upon the location and extent of myocardium involved. Although cardiac sarcoid may produce asymmetrical septal hypertrophy, it is most commonly considered in the differential diagnosis of dilated cardiomyopathy. The hypertrophic stage of cardiac sarcoid is rarely seen. We describe a case of cardiac sarcoid in a young patient wherein a distinctive appearance of the cardiac sarcoid spectrum from "hypertrophic" stage to thinned/scarred stage, masquerading as hypertrophic cardiomyopathy followed by dilated cardiomyopathy, is demonstrated.

A mixed-methods landscape assessment of supportive care for heart failure.

Aim: Understanding factors that shape leading health systems' (LHS) perspectives around heart failure (HF) treatment. Patients & methods: First of its kind study using a cross-sectional, descriptive, mixed-method design (from executives and frontline healthcare providers) with quantitative survey (n = 35) and qualitative interview (n = 12) data from 47 participants (41 different LHS). Results: 97% of LHS had dedicated HF programs, but variations in maturity highlights opportunities for care standardization. Treatment innovations continue, though practitioners may struggle to keep pace amid provider/patient barriers. HF programs strive to co-locate supportive care services to optimize treatment, but access can prove challenging. Conclusion: Opportunities exist, with external partner support, for LHS to become more comprehensive HF care providers, increasing standardization of care across LHS and improved HF treatment.

What is this summary about? We interviewed frontline healthcare workers (such as doctors and nurses) as well as executives at large US health systems to understand how they treat people with heart failure. What were the results? We learned that healthcare workers as well as executives would like to provide many different services to help people with heart failure. However, many health systems do not have all of these services available and can only provide a few basic services. We also learned healthcare workers sometimes struggle to keep up to date with new scientific discoveries and heart failure treatments. What do the results mean? With support from external healthcare partners, health systems can improve their ability to treat people with heart failure.

Reduction in 90 day readmission rates utilizing ambulatory pulmonary pressure monitoring.

AIMS: In the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association Functional Class III Heart Failure Patients) trial, heart failure hospitalization (HFH) rates were lower in patients with ambulatory pulmonary artery pressure (PAP) monitoring guidance. We investigated the effect of ambulatory haemodynamic monitoring on 90 day readmission rates after HFH. METHODS AND RESULTS: We retrospectively analysed patients across the Advocate Aurora Health hospital network who had undergone PAP sensor implantation between 1 October 2015 and 31 October 2019. Patients with a ventricular assist device (VAD) or transplant prior to implantation were excluded. Rates of total HFH and 30 and 90 day all-cause readmission up to 12 months after implantation were collected, while censoring for an endpoint of heart transplantation, VAD, or death. Event rates were compared using Poisson regression. Of 459 patients included, there were 404 HFHs before and 179 after implantation. Compared with pre-implantation, 30 day all-cause readmission [incidence rate ratio (IRR): 0.55 (0.39-0.77), P = 0.0006] and 90 day all cause readmission rates were lower post-implantation [IRR: 0.45 (0.35-0.58), P < 0.0001]. The effect of PAP sensor implantation on 90 day all-cause readmission incidence rates was consistent across multiple subgroups. CONCLUSIONS: Across a large hospital network, ambulatory haemodynamic monitoring was associated with lower HFH rates, as well as 30 and 90 day all-cause readmission rates. This supports the utility of ambulatory PAP monitoring to improve HF management in the era of value-based medicine.

Survival Into the Seventh Decade of Life Following Mustard Repair.

Atrial switch procedures (Senning and Mustard) for transposition of the great arteries have largely been abandoned for arterial switch procedures. The number of surviving patients who have undergone atrial switch procedures is declining. We present a case of the oldest known survivor (aged 67 years) of the Mustard procedure. (Level of Difficulty: Beginner.).

Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices.

BACKGROUND: Hemodynamic-guided management with a pulmonary artery pressure sensor (CardioMEMS) is effective in reducing heart failure hospitalization in patients with chronic heart failure. This study aims to determine the feasibility and clinical utility of the CardioMEMS heart failure system to manage patients supported with left ventricular assist devices (LVADs). METHODS: In this multicenter prospective study, we followed patients with HeartMate II (n=52) or HeartMate 3 (n=49) LVADs and with CardioMEMS PA Sensors and measured pulmonary artery pressure, 6-minute walk distance, quality of life (EQ-5D-5 L scores), and heart failure hospitalization rates through 6 months. Patients were stratified as responders (R) and nonresponders to reductions in pulmonary artery diastolic pressure (PAD). RESULTS: There were significant reductions in PAD from baseline to 6 months in R (21.5-16.5 mm Hg; P<0.001), compared with an increase in NR (18.0-20.3; P=0.002), and there was a significant increase in 6-minute walk distance among R (266 versus 322 meters; P=0.025) compared with no change in nonresponder. Patients who maintained PAD <20 compared with PAD ≥20 mm Hg for more than half the time throughout the study (averaging 15.6 versus 23.3 mm Hg) had a statistically significant lower rate of heart failure hospitalization (12.0% versus 38.9%; P=0.005). CONCLUSIONS: Patients with LVAD managed with CardioMEMS with a significant reduction in PAD at 6 months showed improvements in 6-minute walk distance. Maintaining PAD <20 mm Hg was associated with fewer heart failure hospitalizations. Hemodynamic-guided management of patients with LVAD with CardioMEMS is feasible and may result in functional and clinical benefits. Prospective evaluation of ambulatory hemodynamic management in patients with LVAD is warranted. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03247829.

Benefits of Neurohormonal Therapy in Patients With Continuous-Flow Left Ventricular Assist Devices.

Left ventricular assist devices (LVADs) have dramatically improved short-term outcomes among patients with advanced heart failure. While neurohormonal blockade (NHB) is the cornerstone of treatment for patients with heart failure with reduced ejection fraction, its effect after LVAD placement has not been established. We reviewed medical records of 307 patients who underwent primary LVAD implantation from January 2006 to September 2015 at two institutions in the United States. Patients were followed for at least 2 years post-LVAD implantation or until explantation, heart transplantation, or death. Cox regression analysis stratifying on center was used to assess associations with mortality. Neurohormonal blockade use was treated as a time-dependent predictor. Stepwise selection indicated treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEIs/ARBs) (hazard ratio [HR] = 0.53 [0.30-0.95], p = 0.03), age at the time of implantation (HR = 1.28 [1.05-1.56] per decade, p = 0.02), length of stay postimplantation (HR = 1.16 [1.11-1.21] per week, p < 0.01) and INTERMACS profile of 1 or 2 (HR = 1.86 [1.17-2.97], p < 0.01) were independent predictors of mortality. In this large, retrospective study, treatment with ACEIs or ARBs was an independent factor associated with decreased mortality post-LVAD placement.

The first year post-heart transplantation: use of immunosuppressive drugs and early complications.

A large number of heart transplants are performed annually in different transplant centers in the United States. This is partly because of the improved survival of patients who undergo cardiac transplantation, thus making it a more viable option in the management of end-stage heart failure. The survival benefit after heart transplantation is a result of newer immunosuppressive drug regimens and a better understanding of their effects and interactions. Several studies, mostly involving a small number of patients, describe use and comparison of the many distinct immunosuppressive drugs available to date. Interestingly, many transplant centers perform in-house typical induction treatment regimens because of their own experience and intra-institutional preference. This review summarizes current practices of immunosuppressive drug therapy in the first year post-heart transplant based on the available clinical evidence and discusses future options of heart transplant immunosuppressive drug therapies.

Malignant cardiac phenotypic expression of Danon disease (LAMP2 cardiomyopathy).

INTRODUCTION: Danon disease is an X-linked lysosomal condition that causes a deficiency of lysosome-associated membrane protein 2 (LAMP2) gene. It is characterized clinically by a triad of skeletal myopathy, cardiomyopathy, and intellectual disability. METHODS: We examined clinical, echocardiographic, and genetic data on 5 patients with Danon disease, highlighting their clinical course and outcomes. RESULTS: All patients presented phenotypically with hypertrophic cardiomyopathy and later developed systolic dysfunction. The mean age at diagnosis was 19years (11-31years). All patients had diastolic dysfunction (mean e' of 5cm/s [3.5-6cm/s], mean E/e' of 17 [15-21]). Three patients required cardiac transplantation (ages 15, 27, and 42). Of the two deaths in this group, both were in women. CONCLUSION: We highlight the aggressive cardiac phenotype of Danon disease in our clinical experience with rapid progression to end-stage cardiomyopathy; this progression occurred in both men and women. A timely diagnosis and an early referral for cardiac transplantation is crucial for improved outcomes.

Administration of vascular endothelial growth factor adjunctive to fetal cardiomyocyte transplantation and improvement of cardiac function in the rat model.

BACKGROUND: The functional impact of cellular transplantation and the potential role of the addition of angiogenic factors for survival of engrafts remain controversial. METHODS: Vascular endothelial growth factor (VEGF) (25 ng/mL) was added to cultured fetal cardiomyocytes labeled with bromodeoxyuridine (BrDU), which was injected into the border zones of myocardial infarction 4 weeks after coronary occlusion in rat hearts. Group 1 (n = 12) received cells plus VEGF protein (100 ng), group 2 (n = 12) received cells without VEGF, group 3 (n = 10) received VEGF without cells, and group 4 (n = 12) received pure culture medium. Cardiac function was then assessed by transthoracic two-dimensional echocardiography and Langendorff perfusion system. In situ hybridization for Y chromosomes of transplanted cells, detection of BrDU-labeled cells, and platelet/endothelial cell adhesion molecule-1 (PECAM-1) staining for endothelial cells was performed. RESULTS: Echocardiography revealed smaller end-diastolic left ventricular dimensions in transplanted hearts in group 1 (0.83 +/- 0.13 cm 4 weeks after coronary occlusion before transplantation and 0.69 +/- 0.14 cm 2 months after transplantation, P < .05) and in group 2 (0.88 +/- 0.09 cm after coronary occlusion before transplantation and 0.76 +/- 0.08 cm 2 months after transplant), and increases in fractional shortening (34.2% +/- 8.53% before transplant and 45.3% +/- 10.9% after [P < .05] in group 1; 26.9% +/- 6.02% before transplant and 37.15% +/-8.08% after [P < .005] in group 2), whereas groups 3 and 4 showed a decrease in fractional shortening. Transplanted hearts developed higher pressures at rest (group 1, 96.8 +/- 20.8 mm Hg; group 2, 98.6 +/- 21.9 mm Hg) compared with controls (group 4, 70.9 +/- 25 mm Hg) (P < .05) and during inotropic stimulation (group 1, 111 +/- 19.5 mm Hg and group 2, 113.3 +/- 32.6 vs group 4, 80.7 +/- 31.6 mm Hg, P < .05). Histologic analysis demonstrated the presence of transplanted cells in border zones of infarcted host myocardium with neovascularization in all transplanted hearts. CONCLUSION: Transplantation of fetal cardiomyocytes results in improvement of left ventricular function. The addition of VEGF does not contribute to further improvement of left ventricular function and angiogenesis in the present model.

Monocyte chemoattractant protein 1-induced monocyte infiltration produces angiogenesis but not arteriogenesis in chronically infarcted myocardium.

BACKGROUND: Monocyte chemoattractant protein 1 (MCP-1) stimulates the invasion of monocytes into ischemic tissue with concomitant adhesion to endothelial cells. Monocyte stimulation has been shown to be involved in the induction of arteriogenesis, which is the development of functional arterioles resulting in improvement of perfusion. However, angiogenesis (newly developed capillaries contribute to improved tissue perfusion) in several models has not resulted in any improvement in blood flow. OBJECTIVE: The effects of MCP-1 on potential angiogenesis and arteriogenesis as well as changes in left ventricular function were tested in a chronic infarct model in rat hearts. METHODS: Anesthetized rats were subjected to open-chest ligation of the left coronary artery with subsequent myocardial infarction. After 6 weeks, animals were randomized to receive either MCP-1 (3 microL in 0.15 mL NaCl, group 1, n = 9) or saline (0.15 mL, group 2, n = 9), which was injected into the myocardium at the border zones of the infarcts. For assessment of left ventricular dimensions and global cardiac function, transthoracic two-dimensional echocardiography was performed at baseline, 6 weeks after myocardial infarction, and 4 weeks after MCP-1 or saline injection, by use of a 12-MHz pediatric transducer. For light microscopic analysis, myocardial tissue was stained with Elastica-van-Giesson and von Willebrand factor for blood vessels and endothelial cells, respectively. In a subset of animals, hearts were excised 24 hours after MCP-1 administration (n = 4) or saline administration (n = 4) for assessment of monocyte infiltration by immunohistologic staining of the CD31 antigen. RESULTS: Left ventricular dimensions and ejection fraction changed after coronary occlusion (from 60.4% +/- 2.85% to 24.8% +/- 5.01% ejection fraction in group 1, and from 58.4% +/-2.06% to 26.3% +/- 4.3% ejection fraction in group 2 at 6 weeks, P < .005) without any further change 4 weeks after treatment (ejection fraction in group 1, 26.3% +/- 2.7%, ejection fraction in group 2, 25.0% +/- 5.18%). The MCP-1 group resulted in 390.6 +/- 10.36 endothelial cells compared with 285.2 +/- 13.56 in group 2 (P < .005) at the injection site. Monocyte infiltration was observed at the MCP-1 injection site with an increase in capillary growth (angiogenesis). However, there was no difference in the number of arteriolar structures between animals treated with MCP-1 and saline animals (group 1, 19.0 +/- 1.52 vs group 2, 16.4 +/- 0.68, P > .05). CONCLUSION: A single intramyocardial injection of MCP-1 into the infarct border zone resulted in neo-angiogenesis and monocyte infiltration but not arteriogenesis in the rat heart. There was no functional change of chronically infarcted myocardium in the present model.

Practical value of identifying antibodies to cryptic HLA epitopes in cardiac transplantation.

BACKGROUND: Identification of antibodies to human leukocyte antigens (HLA) by single antigen bead arrays has led to the common practice of virtual crossmatching. However, inappropriate assignment of anti-HLA specificities can lead to false-positive virtual crossmatching, resulting in the decline of potentially crossmatch-negative organ offers. In this study we describe identification of antibodies to cryptic HLA present on denatured forms of HLA on single antigen bead array and provide a reassessment of calculated panel-reactive antibody (CPRA) based on elimination of false-positive reactions due to antibodies to cryptic HLA epitopes. METHODS: Sera from 96 patients with positive HLA antibodies detected on a standard single antigen bead platform were tested under denaturing conditions and with a new single antigen bead product (iBeads; One Lambda, Inc., Canoga Park, CA) to identify antibodies to cryptic HLA vs. native HLA. Flow cytometry crossmatching and complement-fixation assays were performed to assess clinical relevance. RESULTS: Antibodies to cryptic HLA were present in approximately 21% of patients on our waiting list for cardiac transplantation. These antibody responses were not associated with factors commonly thought to be associated with antibody responses to HLA such as age, gender, transfusions or presence of circulatory support. CONCLUSIONS: Antibodies to cryptic HLA can be reliably identified by iBeads technology, and usually do not fix complement nor produce positive flow cytometry crossmatches. Identification and removal of antibodies to cryptic HLA from the panel of unacceptable antigens may have dramatic and meaningful effects on CPRA and virtual crossmatch strategies.

The ABCs of left ventricular assist device echocardiography: a systematic approach.

Echocardiography is an important imaging modality used to determine the indication of left ventricular assist device (LVAD) implantation for patients with advanced heart failure (HF) and for serial follow-up to make management decisions in patient care post-implant. Continuous axial-flow LVAD therapy provides effective haemodynamic support for the failing left ventricle, improving both the clinical functional status and quality of life. Echocardiographers must develop a systematic approach to echocardiographic assessment of LVAD implantation and post-LVAD implant cardiac morphology and physiology. This approach must include the evaluation of left and right heart chamber morphology and physiology and the anatomy and physiology of the inflow and outflow cannulas and the rotor pump, and the determination of the degree of tricuspid regurgitation and the presence of interatrial shunts and aortic regurgitation. Collaboration among the echocardiography and HF/transplant teams is essential to obtain this comprehensive evaluation. We outline a systematic approach to evaluating patients with HF who have failed conventional therapy and require LVAD therapy as a bridge to cardiac transplantation or destination therapy.

Conivaptan: a selective vasopressin antagonist.

Complex neurohormonal interactions dictate the body's volume status in different disease states. Besides the known pathologic activation of the renin-angiotensin-aldosterone axis and the effect of the adrenergic system, arginine vasopressin (AVP) represents a key element that is responsible for volume homeostasis. Serum AVP levels have been shown to be chronically elevated in different pathologic conditions that exhibit an imbalance in volume status, particularly in congestive heart failure. Evidently, elevated levels of AVP play an important role in the pathogenesis and progression of these diseases. AVP has many other receptor-mediated deleterious effects on vascular smooth muscles and cardiomyocytes. These effects are an integral part of the neurohormonal milieu in patients with heart failure. This assumption has propelled agents that antagonize the effects of vasopressin receptors to the forefront of clinical research, especially in heart failure management. This paper reviews current knowledge on conivaptan, a novel dual V1a/V2 vasopressin receptor antagonist.