Quality of Anticoagulation With Phenprocoumon and Warfarin in Left Ventricular Assist Device Patients: A Multicenter Study.

VISUAL ABSTRACT: of key results. INR, international normalized ratio; TTR, time in therapeutic range; PTR, percentage of tests in range; HRAE, hemocompatibility-related adverse event; FFUV, first follow-up visit; GIB, gastrointestinal bleeding; HR, hazard ratio.http://links.lww.com/ASAIO/A961.

Postoperative tolvaptan use in left ventricular assist device patients: The TOLVAD randomized pilot study.

PURPOSE: Tolvaptan, a selective vasopressin type-2 antagonist, has been shown to increase serum sodium (Na) and urine output in hyponatremic left ventricular assist device (LVAD) patients in retrospective studies. In this prospective randomized pilot study, we aimed to assess the efficacy of tolvaptan in this population. METHODS: We conducted a prospective, randomized, non-blinded pilot study of LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L) (NCT05408104). Eligible participants were randomized to receive tolvaptan 15 mg daily in addition to usual care versus usual care alone. The primary outcome was a change in Na level and estimated glomerular filtration rate (eGFR), from the first post-operative day of hyponatremia (the day of randomization) to discharge. RESULTS: A total of 33 participants were enrolled, and 28 underwent randomization (median age 55 [IQR 50-62]), 21% women, 54% Black, 32% ischemic cardiomyopathy, median baseline Na 135 (IQR 134-138). Fifteen participants were randomized to tolvaptan (TLV) and 13 were randomized to usual care alone (No-TLV). Mean change in Na from randomization to discharge in the TLV group was 2.7 mEq/L (95%CI 0.7-4.7, p = 0.013) and 1.8 (95%CI 0.5-4.0, p = 0.11) in the No-TLV group, though baseline and final Na levels were similar between groups. The mean change in eGFR was 2.6 ml/min/1.73 m2 (95%CI 10.1-15.3, p = 0.59) in TLV versus 7.5 ml/min/1.73 m2 (95%CI 5.2-20.2, p = 0.15) in No-TLV. TLV participants had significantly more urine output than No-TLV patients during their first 24 h after randomization (3294 vs 2155 ml, p = 0.043). CONCLUSION: TLV significantly increases urine output, with nominal improvement in Na level, in hyponatremic post-operative LVAD patients without adversely impacting renal function.

Women's experiences when caring for relatives with mental illness in Northern Ireland: A qualitative study.

Care in the Community policies has led to people with mental illness receiving treatment and care at home; however, few studies have examined the impact on carers of providing care to a person with mental illness. This was a qualitative study of the experiences of 11 women who are informal carers of people with a long-term mental illness. The study aimed to gain an understanding of the characteristics of this particular caregiving context that contributes to the stress of the role, and to identify the ways in which services could support women in these roles to promote their wellbeing and support the recovery of those they care for. Two groups of themes emerged: the first was the sources of stress, which included how they became a carer, family obligations and relationships and engaging with services. The second was the impact on health and wellbeing, including emotional and mental health, the need for, and absence of support, and coping with stress. The study highlighted a number of unique features of mental illness that lead to additional stress for the carer and render the usual support structures and delivery mechanisms inappropriate. The results pose challenges for those tasked with supporting carers in this context and developing interventions to promote recovery in the community.

Psychological Journey of a Patient With a Ventricular Assist Device: A VAD Coordinator's Perspective.

BACKGROUND: A thorough psychosocial assessment is needed during the evaluation of candidacy for ventricular assist device placement to identify potential barriers that would limit success with the device. Ventricular assist device coordinators are generally involved in the psychosocial assessment of the patient, allowing them to provide a more holistic approach to ventricular assist device candidacy during discussions at multidisciplinary meetings. There is a gap in the literature describing the psychological journey of patients after ventricular assist device implantation and the challenges ventricular assist device coordinators face when caring for this complex population. OBJECTIVE: The psychological journey of 3 patients with a ventricular assist device was explored to determine if common themes exist and to describe the experiences faced by the ventricular assist device coordinators with each patient. METHODS: Three patient case scenarios are described, as are the interactions with the patients' ventricular assist device coordinator team members. RESULTS: All 3 case scenarios demonstrate similarities of younger ages, the need of family and social support, and ventricular assist device coordinators who went beyond the call of duty to assist in the successful heart transplantation for 2 cases and the successful decommission of the ventricular assist device in another case. CONCLUSION: The psychosocial needs of patients with a ventricular assist device and ventricular assist device coordinators require ongoing assessment because of the many physical and emotional challenges that arise during the time a patient has an implanted ventricular assist device.

Making community voices heard in a research-health service alliance, the evolving role of the Community Advisory Group: a case study from the members' perspective.

BACKGROUND: The Melbourne Genomics Health Alliance (the Alliance) is a collaboration of leading hospitals, research and academic organisations, supported by its member organisations and the Victorian Government. The Alliance was set up by its members in 2013 to steer the translation of genomics, making it an integral part of health care in Victoria, Australia. The Community Advisory Group (CAG) was formed soon after, to give input and advice across the program. This was to ensure consideration of community values, perspectives and priorities, and knowledge translation for patient care. The CAG was charged with providing a strong community voice for the duration of the program. Appointed members were experienced consumer advocates with developed connections to the community. MAIN BODY: The Alliance progressed from an initial Demonstration Project (2013-2015) to a multifaceted program (2016-2020). The CAG worked strategically to help address complex issues, for example, communication, privacy, informed consent, ethics, patient experience, measurement and evaluation standards and policies, data storage and re-use of genomic data. Many aspects of translating genomics into routine care have been tackled, such as communicating with patients invited to have genomic testing, or their caregivers, and obtaining informed consent, clinical questions across 16 areas of health care, training and education of health and laboratory professionals, genomic data management and data-sharing. Evidence generated around clinical utility and cost-effectiveness led to government funding of testing for complex genetic conditions in children. CONCLUSION: The CAG activities, recorded in a CAG-inspired Activity register, span the full spectrum of information sharing and consultation to co-design and partnership. The CAG were involved at multiple levels of participation and in all tiers of activity including governance, development of policies and procedures, program planning and evaluation. Working relationships were built up and a level of trust instilled to advance the Alliance work program in ensuring an effective patient-care model of delivery of genomics. CAG input into project deliverables has been tangible. Less tangible contributions included presentations at external meetings and conferences, direct interactions at meetings with Alliance members, interactions with visitors and external experts, taking part in consultations with experts, state and federal government.

Melbourne Genomics Health Alliance was established in 2013 to steer genomics into health care in Victoria, Australia. The Community Advisory Group (CAG) was formed soon after to provide advice and insights from the patient perspective. The CAG has added value to the Alliance's complex research-to-clinical service program of work over eight years to date. Following an explanation of the program, the CAG members identified priority areas and mechanisms for their involvement. Areas that members were involved in included: communication, visual identity and website, patient portal and its evaluation, information management, consent processes, laboratory requirements, tools for patient experience and quality of life measures, predictive health issues study, storage and sharing of data, databases, CAG Communication Plan, the Patient Guide, role with Victorian Government Department of Health and Human Services, implementation plan, workshop to upskill patient advocates, financial and strategic planning. Members also presented on the role of the CAG at conferences and symposia. The balanced, trusting relationship that developed between the CAG, the Program Team and its governance structure was of great value to and an achievement for the Alliance. CAG input into project deliverables and impact was recorded in a CAG inspired Activity Register and has been very tangible. Their less tangible contribution to the project is also important. Contributions included presentations at external meetings, direct interactions at annual meetings with Alliance members, interactions with visitors and external experts, taking part in consultations with experts, state and federal government. These provided opportunities to influence mindsets.

An International Study on Ventricular Assist Device Program Models.

BACKGROUND: Advanced technology and improved outcomes have led to rapid growth of ventricular assist devices (VADs) throughout the world, but little exists regarding their structure. We sought to study trends in VAD programs on a global level. METHODS: We distributed a 26-question online survey to 321 individuals who work within those programs. Four categories of questions were formed: patient management, coordinator role, multidisciplinary support, and leadership. RESULTS: Fifty-eight surveys (47 United States, 11 international) were analyzed. The majority of programs cared for 26 to 100 device-assisted patients (62%), 26% cared for ≤25 patients, and 12% cared for ≥100 patients. Advanced practice providers (APPs) were used in 69% of programs as a device coordinator. In-hospital rounding was performed equally among the APPs and registered nurses. Most programs used a social worker (90%), nutritionist (74%), pharmacist (72%), palliative care (66%), and finance coordinator (64%). Less than half (43%) included a case manager and only 33% used a pharmacist. The program leader was identified as a cardiologist (31%) or surgeon (26%) or both equally (43%). CONCLUSION: This study demonstrates differences and similarities between VAD program structures. Additional research is warranted to evaluate the effect of program structure on outcomes, job satisfaction, and retention regions.

Seven Key Themes in Physical Therapy Advice for Patients Living With Subacromial Shoulder Pain: A Scoping Review.

OBJECTIVE: To systematically scope the reported advice and education in physical therapy management of patients with subacromial shoulder pain, and to define key themes of the advice and education. DESIGN: Scoping review. LITERATURE SEARCH: We searched MEDLINE, Scopus, Web of Science, and CINAHL, with publication dates from 2007 to September 2019. STUDY SELECTION CRITERIA: We included quantitative and qualitative research that reported on physical therapy interventions for subacromial shoulder pain. DATA SYNTHESIS: We performed a qualitative synthesis that identified items included in patient advice and education. RESULTS: Of 89 original studies included, there were 61 randomized controlled trials; 5 prospective studies; 16 nonrandomized observational intervention studies or case series; and 7 surveys, audits of physical therapy patient records, and focus groups with physical therapists. We identified 7 key themes for advice and education: exercise intensity and pain response, activity modification advice, posture advice, pain self-management advice, pathoanatomical and diagnosis information, behavioral approaches, and pain biology advice. CONCLUSION: While advice focused predominantly on the local tissue pathology model, 10% of studies included information about pain neuroscience education, psychosocial factors, motor imagery, or behavior change. J Orthop Sports Phys Ther 2020;50(6):285-293. doi:10.2519/jospt.2020.9152.

Multicenter experience with durable biventricular assist devices.

BACKGROUND: Severe right ventricular failure necessitating a right ventricular assist device (RVAD) complicates 6% to 11% of left ventricular assist device (LVAD) implants. Patient outcomes for those receiving durable continuous-flow VADs in a biventricular configuration (i.e., BiVAD) have been reported in limited case series. METHODS: Data from United States centers with ≥ 6 BiVAD implants were collected. Characteristics and outcomes of patients receiving contemporaneous (i.e., same surgery) vs staged implantation of the HVAD as a BiVAD were compared. RESULTS: From 2011 to 2017, 46 patients received durable BiVADs and had the following characteristics: median age, 46 years (interquartile range [IQR], 19-67 years), non-ischemic cardiomyopathy (80%), bridge to transplant (83%), Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 or 2 (92%), use of temporary circulatory support (37%), right atrial pressure 19 mm Hg (IQR, 14-23 mm Hg), and cardiac index of 1.6 liters/min/m2 (IQR, 1.2-2.1 liters/min/m2). Operative mortality was 33%. Equal numbers of patients received a right atrial or right ventricular implant. Contemporaneous BiVAD implantation occurred in 31 patients (67%), and compared with 15 patients (33%) with staged implants, these patients had a shorter intensive care unit length of stay of 12 days (IQR, 7-23 days) vs 42 days (IQR, 28-48 days, p = 0.035) and were more likely to be discharged from the hospital on BiVAD support (61% vs 27%, p = 0.04). RVAD thrombosis developed in 17 patients (37%). Patients with contemporaneous BiVAD implants had a 1-year survival of 74% compared with 40% in staged BiVAD patients (p = 0.11). CONCLUSIONS: Patients receiving durable BiVADs represent a critically ill patient population with severe biventricular failure who have high operative mortality and RVAD thrombosis rates. The 1-year survival for patients receiving contemporaneous BiVADs in experienced centers mirrors other contemporary durable biventricular support strategies.

Complex HeartMate II infection treated with pump exchange to HeartWare HVAD.

Left ventricular assist device (LVAD) infections continue to present a serious challenge in both the destination therapy and the bridge to transplant patient populations. As devices are supporting patients longer due to increased durability, infections can evolve and worsen over time. Complex infections, resistant to standard pharmacologic management, require a more aggressive approach to treatment. A series of patients supported by HeartMate II (HMII) LVADs, treated for multidrug resistant complex driveline infections, failed antibiotic therapy and then underwent device exchange. In each case, the HMII device was exchanged for a HeartWare HVAD as we felt its small size and flexible driveline were advantageous properties when dealing with patients with a complex driveline or pump infection.

Impact of policy changes on infant feeding decisions among low-income women participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.

OBJECTIVES: We present infant feeding data before and after the 2009 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) food package change that supported and incentivized breastfeeding. We describe the key role of California WIC staff in supporting these policy changes. METHODS: We analyzed WIC data on more than 180,000 infants in Southern California. We employed the analysis of variance and Tukey (honestly significant difference) tests to compare issuance rates of postpartum and infant food packages before and after the changes. We used analysis of covariance to adjust for poverty status changes as a potential confounder. RESULTS: Issuance rates of the "fully breastfeeding" package at infant WIC enrollment increased by 86% with the package changes. Rates also increased significantly for 2- and 6-month-old infants. Issuance rates of packages that included formula decreased significantly. All outcomes remained highly significant in the adjusted model. CONCLUSIONS: Policy changes, training of front-line WIC staff, and participant education influenced issuance rates of WIC food packages. In California, the issuance rates of packages that include formula have significantly decreased and the rate for those that include no formula has significantly increased.

Advance directives: the clinical nurse specialist as a change agent.

The purpose of this article is to describe the impact the clinical nurse specialist (CNS) has on the advance directive process within the cardiac surgery patient population. As a change agent, the CNS needs to be able to increase the number of advance directives obtained and increase the provision of dignified, self-directed, quality patient care. With requirements from The Joint Commission and the Patient Self-determination Act, the change in process must take place to ensure that healthcare professionals are doing all they can do to carry out a patient's wishes. The 6-Source Influencer Model is applied to a case study to illustrate the role of the CNS as a change agent. Following this model, the CNS can facilitate lasting institutional change in the advance directive process. Based on the example, it is possible that a CNS can act as a change agent for other patient populations within the healthcare setting.

The association between an electric pump loan program and the timing of requests for formula by working mothers in WIC.

An electric pump loan program designed to facilitate breastfeeding for low-income mothers returning to full-time work was evaluated. All mothers were WIC participants in the Los Angeles area. Electric pump loans were made until the infant's first birthday or until the mother requested formula from WIC. Information was provided to employers on supporting breastfeeding in the workplace. A subsample of mothers who received an electric pump on return to full-time work was compared with counterparts in a wait list control group. Mothers who received an electric pump as soon as requested did not request formula until 8.8 months on average, whereas those who did not receive an electric pump requested formula on average at 4.8 months (P < .0001). Mothers who received an electric pump when requested were 5.5 (95% CI 2.0-15.1) times as likely as mothers who did not receive an electric pump to not request formula at 6 months.

Predictors of breastfeeding duration for employees of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

During the past decade there has been increasing breastfeeding support within the Women, Infants, and Children (WIC) program. For this study, it was hypothesized that employees at WIC would initiate and continue to breastfeed significantly longer than the National averages. Female employees, mostly paraprofessionals, from six Los Angeles County WIC agencies participated in the study to determine breastfeeding rates and predictors of breastfeeding success. As expected, 99% of WIC employees initiated breastfeeding and 68.6% continued to breastfeed to one year, significantly exceeding National averages. Four variables accounted for 30% of the variance in duration of breastfeeding: intent to exclusively breastfeed, delayed introduction of infant formula, attendance at breastfeeding support groups and availability of work-site breastpumps. Given that nearly 70% of the study participants reached the American Academy of Pediatrics goal of breastfeeding to 12 months or more, it is clear that full-time employment and breastfeeding can be compatible given appropriate work-site support.