Early Outcomes in Patients With LVAD Undergoing Heart Transplant via Use of the SherpaPak Cardiac Transport System.

BACKGROUND: Heart transplant (HT) in recipients with left ventricular assist devices (LVADs) is associated with poor early post-HT outcomes, including primary graft dysfunction (PGD). As complicated heart explants in recipients with LVADs may produce longer ischemic times, innovations in donor heart preservation may yield improved post-HT outcomes. The SherpaPak Cardiac Transport System is an organ preservation technology that maintains donor heart temperatures between 4 °C and 8 °C, which may minimize ischemic and cold-induced graft injuries. This analysis sought to identify whether the use of SherpaPak versus traditional cold storage was associated with differential outcomes among patients with durable LVAD undergoing HT. METHODS: Global Utilization and Registry Database for Improved Heart Preservation-Heart (NCT04141605) is a multicenter registry assessing post-HT outcomes comparing 2 methods of donor heart preservation: SherpaPak versus traditional cold storage. A retrospective review of all patients with durable LVAD who underwent HT was performed. Outcomes assessed included rates of PGD, post-HT mechanical circulatory support use, and 30-day and 1-year survival. RESULTS: SherpaPak (n=149) and traditional cold storage (n=178) patients had similar baseline characteristics. SherpaPak use was associated with reduced PGD (adjusted odds ratio, 0.56 [95% CI, 0.32-0.99]; P=0.045) and severe PGD (adjusted odds ratio, 0.31 [95% CI, 0.13-0.75]; P=0.009), despite an increased total ischemic time in the SherpaPak group. Propensity matched analysis also noted a trend toward reduced intensive care unit (SherpaPak 7.5±6.4 days versus traditional cold storage 11.3±18.8 days; P=0.09) and hospital (SherpaPak 20.5±11.9 days versus traditional cold storage 28.7±37.0 days; P=0.06) lengths of stay. The 30-day and 1-year survival was similar between groups. CONCLUSIONS: SherpaPak use was associated with improved early post-HT outcomes among patients with LVAD undergoing HT. This innovation in preservation technology may be an option for HT candidates at increased risk for PGD. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04141605.

Noncardiac Surgery in Patients with Left Ventricular Assist Devices: A 11-Year Institutional Experience.

INTRODUCTION: Limited options in the end-stage treatment of heart failure have led to increased use of left ventricular assist devices. For this reason, the rate of non-cardiac surgeries in patients with left ventricular assist devices is also increasing. Our study aims to analyze surgical rate, anesthesia management, and results by reviewing our 11-year experience with patients who underwent non-cardiac surgery receiving left ventricular assist devices support. METHODS: We retrospectively evaluated 57 patients who underwent non-cardiac surgery and 67 non-cardiac surgical procedures among 274 patients who applied between January 2011 and December 2022 and underwent left ventricular assist devices implantation with end-stage heart failure. RESULTS: Fifty (74.6%) patients with left ventricular assist devices admitted to the hospital for non-cardiac surgery were emergency interventions. The most common reasons for admission were general surgery (52.2%), driveline wound revision (22.3%), and neurological surgery (14.9%). This patient group has the highest in-hospital mortality rate (12.8%) and the highest rate of neurological surgery (8.7%). While 70% of the patients who underwent neurosurgery were taken to surgery urgently, the International Normalized Ratio values of these patients were between 3.5 and 4.5 at the time of admission to the emergency department. CONCLUSION: With a perioperative multidisciplinary approach, higher morbidity and mortality risks can be reduced during emergencies and major surgical procedures.

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

AIMS: To evaluate the validity and reliability of the self-care behaviour scale for patients with left ventricular assist devices. DESIGN: Methodological study. METHODS: The English version of the scale was translated into Korean, and it was then back-translated into English. Survey data were collected from 32 patients with left ventricular assist device in South Korea, and construct validity, content validity and reliability were analysed. RESULTS: The original self-care behaviour scale comprises three domains and 33 items, whereas the Korean self-care behaviour scale comprises 27 items and five domains: device management, wound management, symptom monitoring, activated healthcare system and self-care management. Cronbach's alpha for the overall scale was 0.94, and that for the five domains ranged from 0.36 to 0.90. The intraclass correlation coefficient for the overall scale was 0.89, and the five domains ranged from 0.71 to 0.88. CONCLUSION: The newly evaluated scale would be valid and reliable in measure self-care behaviour for patients with a left ventricular assist device. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Patients can manage the left ventricular assist device on their own based on evidence and use it as a tool for effective communication with medical professionals.

Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial.

INTRODUCTION: Percutaneous coronary intervention for complex coronary disease is associated with a high risk of cardiogenic shock. This can cause harm and limit the quality of revascularization achieved, especially when left ventricular function is impaired at the outset. Elective percutaneous left ventricular unloading is increasingly used to mitigate adverse events in patients undergoing high-risk percutaneous coronary intervention, but this strategy has fiscal and clinical costs and is not supported by robust evidence. METHODS: CHIP-BCIS3 (Controlled Trial of High-Risk Coronary Intervention With Percutaneous Left Ventricular Unloading) is a prospective, multicenter, open-label randomized controlled trial that aims to determine whether a strategy of elective percutaneous left ventricular unloading is superior to standard care (no planned mechanical circulatory support) in patients undergoing nonemergent high-risk percutaneous coronary intervention. Patients are eligible for recruitment if they have severe left ventricular systolic dysfunction, extensive coronary artery disease, and are due to undergo complex percutaneous coronary intervention (to the left main stem with calcium modification or to a chronic total occlusion with a retrograde approach). Cardiogenic shock and acute ST-segment-elevation myocardial infarction are exclusions. The primary outcome is a hierarchical composite of all-cause death, stroke, spontaneous myocardial infarction, cardiovascular hospitalization, and periprocedural myocardial infarction, analyzed using the win ratio. Secondary outcomes include completeness of revascularization, major bleeding, vascular complications, health economic analyses, and health-related quality of life. A sample size of 250 patients will have in excess of 80% power to detect a hazard ratio of 0.62 at a minimum of 12 months, assuming 150 patients experience an event across all follow-up. CONCLUSIONS: To date, 169 patients have been recruited from 21 National Health Service hospitals in the United Kingdom, with recruitment expected to complete in 2024. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05003817.

Clinical implications of pleural effusion following left ventricular assist device implantation.

BACKGROUND: Studies on the association between pleural effusion (PE) and left ventricular assist devices (LVADs) are limited. This study aimed to examine the characteristics and the clinical impact of PE following LVAD implantation. METHODS: This study is a prospective analysis of patients who underwent LVAD implantation from June 2015 to December 2022. We investigated the prognostic impact of therapeutic drainage (TD) on clinical outcomes. We also compared the characteristics and clinical outcomes between early and late PE and examined the factors related to the development of late PE. RESULTS: A total of 71 patients was analyzed. The TD group (n=45) had a longer ward stay (days; median [interquartile range]: 31.0 [23.0-46.0] vs. 21.0 [16.0-34.0], P=0.006) and total hospital stay (47.0 [36.0-82.0] vs. 31.0 [22.0-48.0], P=0.002) compared to the no TD group (n=26). Early PE was mostly exudate, left-sided, and neutrophil-dominant even though predominance of lymphocytes was the most common finding in late PE. Patients with late PE had a higher rate of reintubation within 14 days (31.8% vs. 4.1%, P=0.004) and longer hospital stays than those without late PE (67.0 [43.0-104.0] vs. 36.0 [28.0-48.0], P<0.001). Subgroup analysis indicated that female sex, low body mass index, cardiac resynchronization therapy, and hypoalbuminemia were associated with late PE. CONCLUSIONS: Compared to patients not undergoing TD, those undergoing TD had a longer hospital stay but not a higher 90-day mortality. Patients with late PE had poor clinical outcomes. Therefore, the correction of risk factors, like hypoalbuminemia, may be required.

Cardiogenic Shock in Older Adults: A Focus on Age-Associated Risks and Approach to Management: A Scientific Statement From the American Heart Association.

Cardiogenic shock continues to portend poor outcomes, conferring short-term mortality rates of 30% to 50% despite recent scientific advances. Age is a nonmodifiable risk factor for mortality in patients with cardiogenic shock and is often considered in the decision-making process for eligibility for various therapies. Older adults have been largely excluded from analyses of therapeutic options in patients with cardiogenic shock. As a result, despite the association of advanced age with worse outcomes, focused strategies in the assessment and management of cardiogenic shock in this high-risk and growing population are lacking. Individual programs oftentimes develop upper age limits for various interventional strategies for their patients, including heart transplantation and durable left ventricular assist devices. However, age as a lone parameter should not be used to guide individual patient management decisions in cardiogenic shock. In the assessment of risk in older adults with cardiogenic shock, a comprehensive, interdisciplinary approach is central to developing best practices. In this American Heart Association scientific statement, we aim to summarize our contemporary understanding of the epidemiology, risk assessment, and in-hospital approach to management of cardiogenic shock, with a unique focus on older adults.

Addressing the functional needs of left ventricular assist device candidates: Development and feasibility of an occupational therapy pre-operative evaluation.

BACKGROUND: Everyday living with a left ventricular assist device (LVAD) is complex, particularly for people with physical or cognitive impairments or limited social supports. There is a need for standardized pre-operative functional evaluations. OBJECTIVES: Our objectives were to describe a pre-operative occupational therapy (OT) evaluation for LVAD candidates, assess its feasibility in routine care, and characterize functional needs. METHODS: We retrospectively reviewed electronic medical records of pre-operative OT consultations for LVAD candidates over four years (n = 209). Occupational profile, vision, and sensation were operationalized from documentation narratives. Daily functioning was measured with Activity Measure for Post-Acute Care, grip strength with dynamometer, cognition with Montreal Cognitive Assessment and Allen Cognitive Level Screen-5, and LVAD self-management with a performance-based ordinal scale. RESULTS: 89.5 % of consultations were completed, averaging 61.2 min (n = 187): 79.1 % (148/187) inpatient and 20.9 % (39/187) outpatient. Patients completed 87.7 % (164/187) to 100.0 % (187/187) of evaluation components. 21.9 % (41/187) of candidates lived alone. 6.4 % (12/187) and 7.0 % (13/185) had visual and sensory dysfunction. 57.4 % were independent with daily activities (104/181). 17.7 % (32/181) had impaired grip strength. 69.3 % (124/179) had impaired cognition, 29.7 % (51/172) with impaired functional cognition for everyday activities. 88.4 % (145/164) required physical or cueing assistance while practicing LVAD batteries management. OTs interpreted that 20.9 % (39/187) would likely require 24/7 post-operative support with LVAD self-care. CONCLUSION: Pre-operative OT evaluations were feasible and emphasized complex functional needs. Assessing LVAD self-care abilities may inform candidacy and facilitate early interventions to optimize functioning. OT should be consulted within interprofessional teams for all LVAD candidates.

Unexpected Restart Failure of Durable Left Ventricular Assist Devices: A Report of Two Cases.

The HeartWare Ventricular Assist Device (HVAD) was widely used for mechanical circulatory support in patients with end-stage heart failure. However, there have been reports of a critical issue with HVAD pumps failing to restart, or experiencing delays in restarting, after being stopped. This case report describes 2 instances of HVAD failure-to-restart during heart transplantation surgery and routine outpatient care. Despite multiple attempts to restart the pump using various controllers and extensions, the HVAD failed to restart, triggering a hazard alarm for pump stoppage. In one case, the patient survived after receiving a heart transplantation, while in the other, the patient died immediately following the controller exchange. These cases highlight the rare but life-threatening complication of HVAD failure-to-restart, underscoring the importance of awareness among clinicians, patients, and caregivers, and adherence to the manufacturer's guidelines and recommendations for HVAD management.

The Complex Ethical and Moral Experience of Left Ventricular Assist Device Deactivation.

The left ventricular assist device (LVAD) is a fully implantable cardiac replacement device that can complicate the process of dying. We present a case of a patient who attempted to deactivate the LVAD without the support of his medical team. This action was understood as a "suicide attempt" though when the patient was later felt to be dying, LVAD deactivation proceeded without reference to psychiatric illness. To understand this case, we discuss the ethics of LVAD deactivation in the dying process. We then explore the experience of clinicians and the public encountering this unique technology across clinical contexts. We herein present a novel and possibly controversial analysis of the moral complexities of LVAD deactivation and suggest that clinicians be transparent about these complexities with patients and families.

Facility-based approach for the management of acute ST segment elevation myocardial infarction with cardiogenic shock in a rural medical centre: the Durango model.

INTRODUCTION: Cardiogenic shock (CS) complicates 5%-15% of cases of acute myocardial infarction (AMI) with inpatient mortality greater than 40%. The implementation of standardised protocols may improve clinical outcomes in patients with AMI-CS. METHODS AND ANALYSIS: The Durango model is a prospective single-centre registry designed to enable early identification of patients with STEMI-CS to facilitate primary reperfusion therapy with a shock team management algorithm in a rural level II heart attack centre. This prospective registry includes all patients >18 years of age presenting with STEMI with or without CS beginning on 1 February 2023. The primary outcome measures are adherence to model-based documentation of SCAI shock Classification prehospital and in the ED with appropriate STEMI shock alert for AMI and stages C, D, E shock; use of mechanical circulatory support Pre-PCI and door to support time <90 min. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board with a waiver of informed consent. The findings will be submitted for publication in a peer-review open access journal on completion of the study. CONCLUSIONS: The Durango model will demonstrate that the implementation of a STEMI shock team can be feasible in a rural medical centre through comprehensive education of a diverse group providers with different levels of experience, continuous model/device proficiency training and performance feedback.

Delaying reperfusion plus left ventricular unloading reduces infarct size: Sub-analysis of DTU-STEMI pilot study.

INTRODUCTION: The STEMI-DTU pilot study tested the early safety and practical feasibility of left ventricular (LV) unloading with a trans-valvular pump before reperfusion. In the intent-to-treat cohort, no difference was observed for microvascular obstruction (MVO) or infarct size (IS) normalized to either the area at risk (AAR) at 3-5 days or total LV mass (TLVM) at 3-5 days We now report a per protocol analysis of the STEMI-DTU pilot study. METHODS: In STEMI-DTU STUDY 50 adult patients (25 in each arm) with anterior STEMI [sum of precordial ST-segment elevation (ΣSTE) ≥4 mm] requiring primary percutaneous coronary intervention (PCI) were enrolled. Only patients who met all inclusion and exclusion criteria were included in this analysis. Cardiac magnetic resonance (CMR) imaging 3-5 days after PCI quantified IS/AAR and IS/TLVM and MVO. Group differences were assessed using Student's t-tests and linear regression (SAS Version-9.4). RESULTS: Of the 50 patients enrolled, 2 died before CMR imaging. Of the remaining 48 patients those without CMR at 3-5 days (n = 8), without PCI of a culprit left anterior descending artery lesion (n = 2), with OHCA (n = 1) and with ΣSTE < 4 mm (n = 5) were removed from this analysis leaving 32/50 (64 %) patients meeting all inclusion and exclusion criteria (U-IR, n = 15; U-DR, n = 17) as per protocol. Despite longer symptom-to-balloon times in the U-DR arm (228 ± 80 vs 174 ± 59 min, p < 0.01), IS/AAR was significantly lower with 30 min of delay to reperfusion in the presence of active LV unloading (47 ± 16 % vs 60 ± 15 %, p = 0.02) and remained lower irrespective of the magnitude of precordial ΣSTE. MVO was not significantly different between groups (1.5 ± 2.8 % vs 3.5 ± 4.8 %, p = 0.15). Among patients who received LV unloading within 180 min of symptom onset, IS/AAR was significantly lower in the U-DR group. CONCLUSION: In this per-protocol analysis of the STEMI-DTU pilot study we observed that LV unloading for 30 min before reperfusion significantly reduced IS/AAR compared to LV unloading and immediate reperfusion, whereas in the ITT cohort no difference was observed between groups. This observation supports the design of the STEMI-DTU pivotal trial and suggests that strict adherence to the study protocol can significantly influence the outcome.

The Role of Palliative Care in Heart Failure, Part 1: Referring Provider Perspectives About Opportunities in Advanced Cardiac Therapies.

Background: There are many ways that palliative care can support patients with heart failure, but the role of palliative care in supporting patients who are considering or are already using advanced cardiac therapies is less clear. Objective: To understand referring providers' perspectives about the role of palliative care in the treatment of patients with heart failure considering or using advanced cardiac therapies. Design: Qualitative study using a semistructured interview guide. Setting/Subjects: This study was conducted at an academic medical center in the United States with an integrated cardiac palliative care program. Interviews were conducted with cardiology providers, including cardiologists, cardiac surgeons, and nurse practitioners who care for patients with heart failure and who are considering or receiving advanced cardiac therapies. Measurements: Interview transcripts were analyzed deductively and inductively to reveal themes in providers' perspectives. Results: Five themes were identified about the role of palliative care when advanced therapies were considered or being used: (1) educating patients; (2) supporting goal-concordant care; (3) managing symptoms; (4) addressing psychosocial needs; and (5) managing end-of-life care. Providers suggested palliative care could be a facilitator of advanced therapies, rather than merely something to add to end-of-life care. Conclusions: Cardiology providers recognize the value of integrating palliative care across the heart failure disease trajectory to provide therapy options, support decision-making processes, and provide goal-concordant care for patients considering or receiving advanced therapies. Increasing awareness of opportunities to integrate palliative care throughout the treatment of these patients may help cardiology providers better coordinate with palliative care specialists to improve patient care.

Balancing the ventricular outputs of pulsatile total artificial hearts.

BACKGROUND: Maintaining balanced left and right cardiac outputs in a total artificial heart (TAH) is challenging due to the need for continuous adaptation to changing hemodynamic conditions. Proper balance in ventricular outputs of the left and right ventricles requires a preload-sensitive response and mechanisms to address the higher volumetric efficiency of the right ventricle. METHODS: This review provides a comprehensive overview of various methods used to balance left and right ventricular outputs in pulsatile total artificial hearts, categorized based on their actuation mechanism. RESULTS: Reported strategies include incorporating compliant materials and/or air cushions inside the ventricles, employing active control mechanisms to regulate ventricular filling state, and utilizing various shunts (such as hydraulic or intra-atrial shunts). Furthermore, reducing right ventricular stroke volume compared to the left often serves to balance the ventricular outputs. Individually controlled actuation of both ventricles in a pulsatile TAH seems to be the simplest and most effective way to achieve proper preload sensitivity and left-right output balance. Pneumatically actuated TAHs have the advantage to respond passively to preload changes. CONCLUSION: Therefore, a pneumatic TAH that comprises two individually actuated ventricles appears to be a more desirable option-both in terms of simplicity and efficacy-to respond to changing hemodynamic conditions.

Treatment of fungal infection on left ventricle assist device driveline exit site: a case report and systematic review.

OBJECTIVE: The use of ventricular assist devices (VAD) is increasing; however, diagnosis and management of device complications, such as the driveline exit site (DES) being the portal of entry for fungal infection, is not well known. METHOD: A systematic review involving searching PubMed (2005 to July 2020) was conducted. The case of a 43-year-old female patient who had a left VAD (LVAD) (HeartMate 3, Abbott, US) is also reported. RESULTS: The patient was successfully treated with ketoconazole cream and oral fluconazole for likely superficial DES fungal infections. We included 36 studies that met our inclusion criteria; however, only one was included in our review. In the literature, five cases of DES fungal infection were reported, with Candida being the only fungal pathogen. CONCLUSION: LVAD fungal infections are uncommon but can be responsible for high mortality rates, require a prolonged period of treatment, and can present a huge problem when surgical alternatives are not available. However, Candida species are most common. Fungal infections can only produce clear discharge, and so the classic definition of driveline infection based on purulent secretion can vary. Negative skin culture does not exclude the diagnosis of infection of the DES, and so empirical diagnosis may only be clinically based.

Korean Society of Heart Failure Guidelines for the Management of Heart Failure: Advanced and Acute Heart Failure.

The Korean Society of Heart Failure (KSHF) Guidelines provide evidence-based recommendations based on Korean and international data to guide adequate diagnosis and management of heart failure (HF). Since introduction of 2017 edition of the guidelines, management of advanced HF has considerably improved, especially with advances in mechanical circulatory support and devices. The current guidelines addressed these improvements. In addition, we have included recently updated evidence-based recommendations regarding acute HF in these guidelines. In summary, Part IV of the KSHF Guidelines covers the appropriate diagnosis and optimized management of advanced and acute HF.

Driveline dressings used in heartmate patients and local complications: A retrospective cohort.

BACKGROUND: Patients with long-term ventricular assist devices (VAD) are predisposed to infection, bleeding, and pressure injuries at the insertion of the driveline. There is no consensus on a driveline dressing protocol. Chlorhexidine is often used to clean the driveline exit site and has been associated with lower rates of infection. For driveline coverage, bacteriostatic agents and transparent film have shown good results, but are costly. The same issue was associated with anchorage devices. OBJECTIVES: The purpose of this study was to evaluate the types of dressings used in the driveline of patients using HeartMate (HM) and to describe the incidence density of local complications (infection, bleeding, and pressure injury) within 30 days postoperatively. METHODS: A retrospective cohort study was conducted and included 22 patients admitted to the Intensive Care Unit after implantation of HM II and III in a Brazilian private hospital. RESULTS: Several types of dressings were used in the drivelines. There were 22 different types of dressings. Dressing type 6 (Chlorhexidine, Excilon, Gauze and IV3000) were the most used (45.4%). Subjects using the Flexi-Trak anchoring device had a higher rate of local bleeding (50.0%) and those who used the Hollister device had more infection (61.1%) and pressure injury associated with a medical device (11.1%), compared to others. Infection was the primary complication (45.4%), followed by local bleeding (27.7%). CONCLUSION: Despite the high variability of products used in the driveline of patients using HeartMate, the dressing made with chlorhexidine, silver-impregnated absorbent foam and transparent film, and the use of anchoring devices was the most frequently used. Infection was the most common complication.

Left ventricular assist devices for treatment of refractory advanced heart failure: the Western Australian experience.

BACKGROUND: Left ventricular (LV) assist devices (LVADs) can prolong survival and improve quality of life in end-stage heart failure. AIMS: Review outcomes of the Western Australian LVAD programme. METHODS: Retrospective database and medical record review. RESULTS: One hundred forty-seven LVADs have been implanted in 23 years, of which 95 were newer-generation devices (HeartWare HVAD [HW], HeartMate II and HeartMate 3). Presented data refer to these devices only. Most patients (94%) were classed as bridge-to-transplant or -candidacy/decision, with the remainder classed as 'destination therapy' (DT). Mean LV ejection fraction was 20%, and 36% had severe right ventricular dysfunction. Sixty-two percent of patients had a nonischaemic cardiomyopathy. Following LVAD implant, the median length of stay in intensive care was 2 days, and in the hospital overall was 23 days. Ninety-six percent of patients survived to hospital discharge, and, following discharge, 98% of days with LVAD were spent as an outpatient. The median number of hospital readmissions was 1.5 per patient per year. LVAD-associated infection requiring admission or intravenous antibiotics at any time after implant occurred in 36%, significant gastrointestinal bleeding in 19% and stroke in 11%. The percentage of patients alive with LVAD still in situ at 1, 2 and 5 years was 94%, 88% and 62% respectively, which exceeds current international registry outcomes. All DT patients survived at least 4 years, spending 97% of days with LVAD as an outpatient. The two longest-surviving HW DT patients worldwide (11.3 and 10.5 years) are among this cohort. CONCLUSIONS: Excellent outcomes can be achieved with LVADs in appropriately selected patients.