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Key Clinical Message: A patient presented with cardiogenic shock, requiring the implantation of a left ventricular assist device (LVAD), and acute myeloblastic leukemia. This necessitated total body irradiation (TBI) while balancing dose reduction to the LVAD components to avoid potential radiation damage. Here we outline our treatment approach and dose estimates to the LVAD. This case report discusses the delivery of TBI to a patient with an LVAD. This treatment required radiation‐dose determinations and consequential reductions for the heart, LVAD, and an external controller connected to the LVAD. The patient was treated using a traditional 16MV anterior posterior (AP)/posterior anterior (PA) technique at a source‐to‐surface‐distance of 515 cm for 400 cGy in two fractions. A 3 cm thick Cerrobend block was placed on the beam spoiler to reduce dose to the heart and LVAD to 150 cGy. The external controller was placed in a 1 cm thick acrylic box to reduce neutron dose and positioned as far from the treatment fields as achievable. In vivo measurements were made using optically stimulated luminescence dosimeters (OSLDs) placed inside the box at distances of 2 cm, 8.5 cm, and 14 cm from the field edge, and on the patient along the central axis and centered behind the LVAD block. Further ion chamber measurements were made using a solid water phantom to more accurately estimate the dose delivered to the LVAD. Neutron dose measurements were also conducted. The total estimated dose to the controller ranged from 135.3 cGy to 91.5 cGy. The LVAD block reduced the surface dose to the patient to 271.6 cGy (68.1%). The block transmission factors of the 3 cm Cerrobend block measured in the phantom were 45% at 1 cm depth and decreased asymptotically to around 30% at 3 cm depth. Applying these transmission factors to the in vivo measurements yielded a dose of 120 cGy to the implanted device. The neutron dose the LVAD region is estimated around 0.46 cGy. Physical limitations of the controller made it impossible to completely avoid dose. Shielding is recommended. The block had limited dose reduction to the surface, due to secondary particles, but appropriately reduced the dose at 3 cm and beyond. More research on LVADs dose limits would be beneficial. [ABSTRACT FROM AUTHOR]

Several patients requiring biventricular mechanical circulatory support in the acute setting will not be candidates for less invasive advanced heart failure therapies not requiring median sternotomy. Temporary biventricular assist device may provide reliable short term support bridging patients to recovery or further advanced treatments. However, this exposes patients to increased risk of reoperation due to bleeding and further exposure to blood products. This article outlines the practical details necessary in performing this technique while minimizing potential complications. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

With the growing number of patients undergoing left ventricular assist device (LVAD) implantation and improved survival in this population, more patients with LVADs are presenting for various types of non-cardiac surgery. Therefore, anesthesiologists need to understand the physiology and adequately prepare for the perioperative management of this unique patient population. This review addresses perioperative considerations and intraoperative management for the safe and successful management of patients with an LVAD undergoing non-cardiac surgery. Understanding the basic physiology of preload dependency and afterload sensitivity in these patients is essential. The main considerations include a collaborative preoperative multidisciplinary approach, perioperative care aimed at optimizing the intravascular volume and right ventricular function, and maintaining the afterload within recommended ranges for optimal LVAD function. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

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.

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

Left ventricular assist devices (LVAD) implantation is an effective treatment for end ⁃ stage heart failure in addition to heart transplantation. Neurological complications, especially ischemic stroke and hemorrhagic stroke, are the most common complications in patients after LVAD. This paper reviews the common neurological complications and its risk factors in patients after LVAD, and proposes early prevention and management strategies to provide guidance for the perioperative and long ⁃ term management of LVAD implantation in end⁃stage heart failure.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

• Daily living with an LVAD is complex and candidates may have barriers to independence. • Occupational therapists developed a pre-operative functional assessment battery. • The protocol was feasible to deliver as standard care over a four-year period. • Assessments revealed the multifactorial functional needs of LVAD candidates. 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. 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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

Aim: Life-threatening complications such as intra-device thrombus, infection, bleeding, kidney and liver failure are frequently encountered due to the use of left ventricular assist devices (LVADs). We aimed to determine the incidence of hemolysis in patients implanted with LVAD, the mechanical complications detected in patients with hemolysis, and whether hemolysis can be used as a predictor of complications. Material and Methods: In this single-center, retrospective clinical research study, we evaluated 40 patients with HeartWare (HeartWare International, Inc., MA, USA) LVAD implants to assess the incidence of hemolysis and its association with mechanical complications. Hemolysis parameters, including lactate dehydrogenase (LDH), bilirubin, serum-free hemoglobin (sfHg), corrected reticulocyte count (CRC), and haptoglobin, were measured in venous blood samples obtained from patients attending cardiovascular outpatient clinics. Patients were divided into two groups(group 1:without hemolysis, n=32; group 2: with hemolysis, n=8) based on the presence or absence of hemolysis, and demographic data, comorbidities, and laboratory results were compared. The time elapsed after implantation of the patients was min: 90 days, max: 3147 days. Results: Hemolysis was detected in 20% (8 out of 40) of the patients included in the study. Patients with hemolysis demonstrated higher CRC, LDH, and total bilirubin levels(p<0,005), and lower haptoglobin levels compared to those without hemolysis(p<0,001). Intra-device thrombus was detected as a mechanical complication in 2 patients with hemolysis. One patient died and the other was discharged after medical treatment. Conclusion: Our findings suggest that routine monitoring of hemolysis parameters in LVAD recipients may aid in the early detection of mechanical complications, such as pump thrombosis, before symptomatic manifestation, thus potentially reducing mortality. Assessing multiple parameters, including LDH, bilirubin, sfHg, CRC, and haptoglobin, is crucial for accurate hemolysis diagnosis and its association with mechanical complications. It should be supported by large series of studies with longer and similar follow-up periods and a larger number of patients. [ABSTRACT FROM AUTHOR]

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This paper presents the results of a study on the effect of vascular lumen reduction on the performance of an innovative implantable LVAD (left ventricular assist device). It details the pressures in the individual cardiac chambers as a function of device frequency. In addition, mass flow rates and energy consumption of the device are examined, varying with lumen reduction and operating frequency. While the lumen reduction of the vessels has little effect on energy consumption, the mass flow rates vary considerably, i.e., above 140 cyc/min, the mass flow rate increment is no longer achieved for specified initial conditions. There are also differences regarding the pressures in the heart; namely, it was found that the pressure plots look similar in all cases, leading to the conclusion that the reduction of the vessel lumen does not affect their shape, but does affect the maximum values of the left ventricular and aortic pressures. Importantly, the innovative device in the form of an intra-cardiac balloon assembly for circulatory support is based on a pulsatile flow strategy and is synchronized with the ECG signal. Other advantages of the proposed solution include a minimally invasive method of implantation, which is important for patients with end-stage heart failure. The design of the device is portable and the device itself is battery-powered, allowing for shorter hospitalization times and faster recovery, even in patients with end-stage heart failure associated with mitral regurgitation and pulmonary hypertension. [ABSTRACT FROM AUTHOR]

BackgroundA better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care.MethodsAdults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes.ResultsParticipants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p

Identification of patients who are at a high risk for right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation is of critical importance. Conventional tools for predicting RVF, including two-dimensional echocardiography, right heart catheterization (RHC), and clinical parameters, generally have limited sensitivity and specificity. We retrospectively examined the ability of computed tomography (CT) ventricular volume measures to identify patients who experienced RVF after LVAD implantation. Between September 2017 and November 2021, 92 patients underwent LVAD surgery at our institution. Preoperative CT-derived ventricular volumes were obtained in 20 patients. Patients who underwent CT evaluation had a similar demographics and rate of RVF after LVAD as patients who did not undergo cardiac CT imaging. In the study cohort, seven of 20 (35%) patients experienced RVF (2 unplanned biventricular assist device, 5 prolonged inotropic support). Computed tomography-derived right ventricular end-diastolic and end-systolic volume indices were the strongest predictors of RVF compared with demographic, echocardiographic, and RHC data with areas under the receiver operating curve of 0.79 and 0.76, respectively. Computed tomography volumetric assessment of RV size can be performed in patients evaluated for LVAD treatment. RV measures of size provide a promising means of pre-LVAD assessment for postoperative RV failure.

Key Clinical Message A patient presented with cardiogenic shock, requiring the implantation of a left ventricular assist device (LVAD), and acute myeloblastic leukemia. This necessitated total body irradiation (TBI) while balancing dose reduction to the LVAD components to avoid potential radiation damage. Here we outline our treatment approach and dose estimates to the LVAD. Abstract This case report discusses the delivery of TBI to a patient with an LVAD. This treatment required radiation‐dose determinations and consequential reductions for the heart, LVAD, and an external controller connected to the LVAD. The patient was treated using a traditional 16MV anterior posterior (AP)/posterior anterior (PA) technique at a source‐to‐surface‐distance of 515 cm for 400 cGy in two fractions. A 3 cm thick Cerrobend block was placed on the beam spoiler to reduce dose to the heart and LVAD to 150 cGy. The external controller was placed in a 1 cm thick acrylic box to reduce neutron dose and positioned as far from the treatment fields as achievable. In vivo measurements were made using optically stimulated luminescence dosimeters (OSLDs) placed inside the box at distances of 2 cm, 8.5 cm, and 14 cm from the field edge, and on the patient along the central axis and centered behind the LVAD block. Further ion chamber measurements were made using a solid water phantom to more accurately estimate the dose delivered to the LVAD. Neutron dose measurements were also conducted. The total estimated dose to the controller ranged from 135.3 cGy to 91.5 cGy. The LVAD block reduced the surface dose to the patient to 271.6 cGy (68.1%). The block transmission factors of the 3 cm Cerrobend block measured in the phantom were 45% at 1 cm depth and decreased asymptotically to around 30% at 3 cm depth. Applying these transmission factors to the in vivo measurements yielded a dose of 120 cGy to the implanted device. The neutron dose the LVAD region is estimated around 0.46 cGy. Physical limitations of the controller made it impossible to completely avoid dose. Shielding is recommended. The block had limited dose reduction to the surface, due to secondary particles, but appropriately reduced the dose at 3 cm and beyond. More research on LVADs dose limits would be beneficial.

ObjectivesTo evaluate characteristics and outcomes of patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) during the coronavirus disease 2019 (COVID-19) pandemic.BackgroundThe COVID-19 pandemic has created challenges in delivering acute cardiovascular care. Quality measures and outcomes of patients presenting with AMICS during COVID-19 in the United States have not been well described.MethodsWe identified 406 patients from the National Cardiogenic Shock Initiative (NCSI) with AMICS and divided them into those presenting before (N = 346, 5/9/2016-2/29/2020) and those presenting during the COVID-19 pandemic (N = 60, 3/1/2020-11/10/2020). We compared baseline clinical data, admission characteristics, and outcomes.ResultsThe median age of the cohort was 64 years, and 23.7% of the group was female. There were no significant differences in age, sex, and medical comorbidities between the two groups. Patients presenting during the pandemic were less likely to be Black compared to those presenting prior. Median door to balloon (90 vs. 88 min, p = 0.38), door to support (88 vs. 78 min, p = 0.13), and the onset of shock to support (74 vs. 62 min, p = 0.15) times were not significantly different between the two groups. Patients presented with ST-elevation myocardial infarction more often during the COVID-19 period (95.0% vs. 80.0%, p = 0.005). In adjusted logistic regression models, COVID-19 period did not significantly associate with survival to discharge (odds ratio [OR] 1.09, 95% confidence interval [CI] 0.54-2.19, p = 0.81) or with 1-month survival (OR 0.82, 95% CI 0.42-1.61, p = 0.56).ConclusionsCare of patients presenting with AMICS has remained robust among hospitals participating in the NCSI during the COVID-19 pandemic.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

• There is a high variation in the dressings used in the driveline exit-site of patients using heartmate. • The frequency of change not being standardised. • Infection was the complication of the driveline with highest incidence density. • Possibility of standardizing the dressing with the use of chlorhexidine, absorbent foam impregnated with silver, transparent film, and anchoring devices. 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. 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. 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. 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%). 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. [ABSTRACT FROM AUTHOR]

BACKGROUND: Right ventricular failure (RVF) is a leading driver of morbidity and death after major cardiac surgery for advanced heart failure, including orthotopic heart transplantation and left ventricular assist device implantation. Inhaled pulmonary-selective vasodilators, such as inhaled epoprostenol (iEPO) and nitric oxide (iNO), are essential therapeutics for the prevention and medical management of postoperative RVF. However, there is limited evidence from clinical trials to guide agent selection despite the significant cost considerations of iNO therapy. METHODS: In this double-blind trial, participants were stratified by assigned surgery and key preoperative prognostic features, then randomized to continuously receive either iEPO or iNO beginning at the time of separation from cardiopulmonary bypass with the continuation of treatment into the intensive care unit stay. The primary outcome was the composite RVF rate after both operations, defined after transplantation by the initiation of mechanical circulatory support for isolated RVF, and defined after left ventricular assist device implantation by moderate or severe right heart failure according to criteria from the Interagency Registry for Mechanically Assisted Circulatory Support. An equivalence margin of 15 percentage points was prespecified for between-group RVF risk difference. Secondary postoperative outcomes were assessed for treatment differences and included: mechanical ventilation duration; hospital and intensive care unit length of stay during the index hospitalization; acute kidney injury development including renal replacement therapy initiation; and death at 30 days, 90 days, and 1 year after surgery. RESULTS: Of 231 randomized participants who met eligibility at the time of surgery, 120 received iEPO, and 111 received iNO. Primary outcome occurred in 30 participants (25.0%) in the iEPO group and 25 participants (22.5%) in the iNO group, for a risk difference of 2.5 percentage points (two one-sided test 90% CI, -6.6% to 11.6%) in support of equivalence. There were no significant between-group differences for any of the measured postoperative secondary outcomes. CONCLUSIONS: Among patients undergoing major cardiac surgery for advanced heart failure, inhaled pulmonary-selective vasodilator treatment using iEPO was associated with similar risks for RVF development and development of other postoperative secondary outcomes compared with treatment using iNO. [ABSTRACT FROM AUTHOR]

Abstract 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.

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. [ABSTRACT FROM AUTHOR]

BACKGROUND: Information about health-related quality of life (HRQOL) among caregivers of older patients with heart failure who receive heart transplantation (HT) and mechanical circulatory support (MCS) is sparse. We describe differences and factors associated with change in HRQOL before and early post-surgery among caregivers of older heart failure patients who underwent 3 surgical therapies: HT with pretransplant MCS (HT MCS), HT without pretransplant MCS (HT non-MCS), and long-term MCS. METHODS: Caregivers of older patients (60-80 years) from 13 US sites completed the EQ-5D-3 L visual analog scale (0 [worst]-100 [best] imaginable health state) and dimensions before and 3 and 6 months post-surgery. Analyses included linear regression, t tests, and nonparametric tests. RESULTS: Among 227 caregivers (HT MCS=54, HT non-MCS=76, long-term MCS=97; median age 62.7 years, 30% male, 84% White, 83% spouse/partner), EQ-5D visual analog scale scores were high before (84.8±14.1) and at 3 (84.7±13.0) and 6 (83.9±14.7) months post-surgery, without significant differences among groups or changes over time. Patient pulmonary hypertension presurgery (β=-13.72 [95% CI, -21.07 to -6.36]; P<0.001) and arrhythmia from 3 to 6 months post-operatively (β=-14.22 [95% CI, -27.41 to -1.02]; P=0.035) were associated with the largest decrements in caregiver HRQOL; patient marital/partner status (β=6.21 [95% CI, 1.34-11.08]; P=0.013) and presurgery coronary disease (β=8.98 [95% CI, 4.07-13.89]; P<0.001) were associated with the largest improvements. CONCLUSIONS: Caregivers of older patients undergoing heart failure surgeries reported overall high HRQOL before and early post-surgery. Understanding factors associated with caregiver HRQOL may inform decision-making and support needs. [ABSTRACT FROM AUTHOR]

BackgroundAcute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with significant morbidity and mortality.MethodsWe provide an overview of previously conducted studies on the use of mechanical circulatory support (MCS) devices in the treatment of AMI-CS and difficulties which may be encountered in conducting such trials in the United States.ResultsWell powered randomized control trials are difficult to conduct in a critically ill patient population due to physician preferences, perceived lack of equipoise and challenges obtaining informed consent.ConclusionsWith growth in utilization of MCS devices in patients with AMI-CS, efforts to perform well-powered, randomized control trials must be undertaken.

AimsCaregivers of persons living with ventricular assist devices (VADs) are integrally involved in both medical and non-medical care. We sought to understand tasks caregivers perform after surgical recovery, ways the home is adapted for those tasks, and presence of home safety hazards.Methods and resultsWe conducted semi-structured interviews with persons living with a VAD and their caregivers. Pictures were taken of areas in the home where: (i) caregiving activities occurred, (ii) VAD or medical supplies were kept, and (iii) home adaptations were made for VAD care. Pictures were described in written detail and analysed. A qualitative descriptive approach was used for analysis. The sample consisted of 10 dyads, with mostly spousal relationships (60%) between male patients (60%) and female caregivers (80%). Three themes were identified: (i) Evolution of Caregiving and Support: Patients gain independence, but caregivers are still needed, (ii) Adapting the Home Environment: Changes are focused on functional needs, and (iii) Hidden Dangers: Illumination of safety concerns by photographs. Assistance with bathing, driveline care, and medication management were common caregiving tasks. Most home adaptations occurred in the bathroom and bedroom including sleeping recliners, shower chairs, removable shower heads, and hanging hooks to hold VAD equipment. Safety hazards included minimal space for safe ambulation, infection risk, and home-made adaptations to the environment.ConclusionsThese findings describe key home caregiving tasks, home adaptations, and safety concerns that require further education and support. Utilizing pictures may be a feasible method for assessing VAD teaching, caregiving needs, and identifying potential risks.

ObjectiveTo test the hypothesis that factor eight inhibitor bypassing activity (FEIBA) can be used to control bleeding following left ventricular assist device (LVAD) implantation without increasing the 14-day composite thrombotic outcome of pump thrombus, ischemic cerebrovascular accidents, pulmonary embolism, and deep venous thrombosis.DesignRetrospective cohort study.SettingAcademic hospital.ParticipantsThree hundred nineteen consecutive patients who underwent LVAD implantation (December 1, 2009 to December 30, 2018).InterventionFEIBA administered to control perioperative hemorrhage.Measurements and main resultsThe 82 patients (25.7%) in the FEIBA cohort had more risk factors for perioperative hemorrhage, such as lower preoperative platelet count (169 ± 66 v 194 ± 68 × 103/mL, p = 0.004), prior cardiac surgery (36.6% v 21.9%, p = 0.008), and longer cardiopulmonary bypass (CPB) time (100.3 v 75.2 minutes, p = 0.001) than the 237 controls. After 16.6 units (95% CI: 14.3-18.9) of blood products were given, 992 units (95% CI: 821-1163) of FEIBA were required to control bleeding in the FEIBA cohort. Compared to the controls, there were no differences in the 14-day composite thrombotic outcome (11.0% v 7.6%, p = 0.343) or mortality rate (3.7% v 1.3%, p = 0.179). Multivariate logistical regression identified preoperative international normalized ratio (odds ratio [OR]: 1.30, 95% CI: 1.04-1.62) and CPB time (OR: 1.11, 95% CI: 1.02-1.20) as risk factors for 14-day thrombotic events, but FEIBA usage was not associated with an increased risk.ConclusionsIn this retrospective cohort study, the use of FEIBA (∼1,000 units, ∼13 units/kg) to control perioperative hemorrhage following LVAD implantation was not associated with increases in mortality or composite thrombotic outcome.

BACKGROUND: Vital components of communicating goals of care and preferences include eliciting the patient and caregivers definition of quality of life, understanding meaningful activities and relationships, and exploring wishes for care at the end of life. Although current literature suggests framing conversations regarding end of life through the lens of meaning and quality of life, there is limited literature exploring dyadic congruence surrounding these important constructs among patients with ventricular assist devices (VADs) and their caregivers. OBJECTIVES: The purpose of this study was to explore congruence of VAD patient and caregiver perspectives regarding end of life, definitions of quality of life, and meaning in life while managing the uncertainty of living with a VAD. METHODS: We used thematic analysis to analyze semistructured qualitative interviews of 10 patient-caregiver dyads 3 to 12 months after VAD implantation. RESULTS: Three major themes were identified: (1) differing trajectories of uncertainty and worry, (2) a spectrum of end-of-life perspectives, and (3) enjoying everyday moments and independence. Overall, patients and caregivers had differing perspectives regarding uncertainty and end of life. Within-dyad congruence was most evident as dyads discussed definitions of meaning or quality of life. CONCLUSIONS: Dyadic perspectives on end of life, meaning in life, and quality of life can inform how palliative care and VAD teams approach conversations about planning for the end of life. Findings from this study can inform future shared decision-making interventions for patients living with VADs and their caregivers.

Background Prior studies have shown that women have worse 3-month survival after receiving a left ventricular assist device compared with men. Currently used prognostic scores, including the Heartmate II Risk Score, do not account for the increased residual risk in women. We used the IMACS (International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support) registry to create and validate a sex-specific risk score for early mortality in left ventricular assist device recipients. Methods and Results Adult patients with a continuous-flow LVAD from the IMACS registry were randomly divided into a derivation cohort (DC; n=9113; 21% female) and a validation cohort (VC; n=6074; 21% female). The IMACS Risk Score was developed in the DC to predict 3-month mortality, from preoperative candidate predictors selected using the Akaike information criterion, or significant sex × variable interaction. In the DC, age, cardiogenic shock at implantation, body mass index, blood urea nitrogen, bilirubin, hemoglobin, albumin, platelet count, left ventricular end-diastolic diameter, tricuspid regurgitation, dialysis, and major infection before implantation were retained as significant predictors of 3-month mortality. There was significant ischemic heart failure × sex and platelet count × sex interaction. For each quartile increase in IMACS risk score, men (odds ratio [OR], 1.86; 95% CI, 1.74-2.00; P

BackgroundThe LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system.MethodsAEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year.ResultsDuring 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of

Background: Children with heart failure have the highest mortality while awaiting transplantation. Ex situ heart perfusion (ESHP), a method for continuous perfusion of the donor heart, has the potential to improve access to transplant by increasing travel distance between donor and recipient. An adult ESHP device is currently available, but as of yet there is no pediatric device. The aim of this study was to evaluate current knowledge of ESHP among pediatric heart transplant practitioners, define potential barriers, and identify uses of this novel technology. Methods: An electronic survey was developed to assess perspectives of international pediatric heart transplant stakeholders (n = 68) on ESHP. Select questions were analyzed to evaluate for associations between groups of respondents and patterns of response. Results: Most respondents were familiar but <10% had clinically utilized ESHP. There was optimism that ESHP could decrease waitlist mortality. Respondents were concerned about potential device malfunction and lack of long‐term outcomes. There were no differences found in terms of ESHP familiarity among age groups, practitioner center volume, country of work, or discipline. Conclusions: ESHP has the potential to expand the pediatric heart donor pool and decrease waitlist mortality. More education on outcomes and risks/benefits is needed in order to promote widespread adoption. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the caregiver burden and quality of life of family members who care for patients with ventricular assisted devices. Material and Methods: This cross-sectional and descriptive study was conducted in the cardiovascular surgery clinic of a university hospital with 90 caregivers caring for patients who implanted ventricular assist device at least 3 months ago. A questionnaire prepared by the researchers was used to collect data. The questionnaire comprised 2 sections. The first section included questions on sociodemographic and clinical characteristics of patients and caregivers, whereas the second section included the Family Caregiver Quality of Life Scale in Heart Failure (FAMQOL) and Zarit Caregiver Burden Scale (ZCBS). Research data were collected by face-to-face interview method. Descriptive statistics, independent samples t-test and one-way analysis of variance, and Pearson’s correlation were used for data analysis. Results: The mean FAMQOL Scale score of caregivers was 47.24±14.57 and the mean ZCBS score was 58.87±19.55. Statistically significant negative correlation was determined between the mean FAMQOL Scale and ZCBS scores. Conclusion: Caregiver burden and quality of life of caregivers of patients with ventricular assist was moderate. Increase in caregiver burden decreases the caregiver’s quality of life. [ABSTRACT FROM AUTHOR]

Venoarterial extracorporeal membrane oxygenation provides cardiorespiratory support to patients in cardiogenic shock. This comes at the cost of increased left ventricle (LV) afterload that can be partly ascribed to retrograde aortic flow, causing LV distension, and leads to complications including cardiac thrombi, arrhythmias, and pulmonary edema. LV unloading can be achieved by using an additional circulatory support device to mitigate the adverse effects of mechanical overload that may increase the likelihood of myocardial recovery. Observational data suggest that these strategies may improve outcomes, but in whom, when, and how LV unloading should be employed is unclear; all techniques require balancing presumed benefits against known risks of device-related complications. This review summarizes the current evidence related to LV unloading with venoarterial extracorporeal membrane oxygenation. [ABSTRACT FROM AUTHOR]

Impella devices are increasingly utilized for hemodynamic support in high-risk percutaneous coronary intervention or cardiogenic shock despite a lack of randomized clinical trial data showing clinical benefit and newer observational data suggesting harm. In this retrospective analysis, our aim was to determine the most common adverse events associated with Impella usage reported annually to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and to estimate via the National Inpatient Sample (NIS) database the number of percutaneous ventricular assist devices utilized and associated with inpatient mortality since introduction of the Impella. Among the 885 complete reports submitted to the MAUDE database from 2008 to 2019 related to Impella usage, there were 1,206 complications coded; 88.2% of reports occurred from 2016 to 2019. Among patients with adverse events reported, bleeding (32.8%), device deployment or retrieval issues (18.2%), vascular complications (15.8%), and death (12.4%) were the most common, and 7.9% of all complications were attributable to operator decision-making or technique. From 2007 to 2017 there was a >100-fold increase in percutaneous ventricular assist devices use with an increase and plateau in in-hospital mortality to 31% from 2012 to 2016 based on NIS data. In conclusion, Impella use has increased substantially over the last decade but remains associated with high inpatient mortality and serious complications based on data from the NIS and MAUDE databases. These findings emphasize the need for high quality randomized controlled trials to determine the clinical utility of Impella in high-risk percutaneous coronary intervention and cardiogenic shock.

BACKGROUND: The objective of this study was to characterize practical use trends and outcomes for intraaortic balloon pump (IABP) and percutaneous left ventricular assist device (pVAD) use in cardiogenic shock at a national level. METHODS: An analysis of all adult patients admitted nonelectively for cardiogenic shock from January 2008 through December 2017 was performed using the National Inpatient Sample. Trends of inpatient IABP and pVAD use were analyzed using survey-weighted estimates and the modified Cochran-Armitage test for significance. Multivariable regression models and inverse probability of treatment weights were used to perform risk-adjusted analyses of pVAD mortality, a composite of adverse events (AE), and resource use, with IABP as reference. RESULTS: Of an estimated 774,310 patients admitted with cardiogenic shock, 143,051 received a device: IABP, 127,792 (16.5%); or pVAD, 15,259 (2.0%). IABP use decreased (23.8% to 12.7%; P for trend

Background : The year 2022 marks the 30th anniversary of heart transplant service in Hong Kong (HK). In this study, we describe prevailing trends and outcomes of advanced heart failure (AHF), including heart transplantations (HTx), in HK over the past 30 years. Methods : Trends in heart failure prevalence in HK from 1993 to 2021 were analyzed based on data from the Hospital Authority Clinical Data and Reporting System. All AHF patients referred for HTx consideration between 1992 and 2021 were reviewed. The bridge-to-transplant (BTT) utilization of short-term mechanical circulatory support (ST-MCS) devices, including venoarterial extracorporeal membrane oxygenation (VA-ECMO) and durable left ventricular assist devices (LVADs), from 2010 to 2021 was reviewed. Results : Overall, 237 heart transplants were performed in HK, with 10-year posttransplant and median survival of 68.1% and 18.7 years, respectively. An increase in AHF clinic referrals was correlated with increasing heart failure prevalence (R2=0.635, P

Resumen: Introducción y objetivo: Evaluar el resultado del uso de dispositivos de asistencia ventricular de corta-media duración, tipo Centrimag e Impella, en pacientes en INTERMACS 1-3, como puente al trasplante cardiaco. Material y método: Del 2015 al 2021 se implantaron 60 dispositivos de asistencia ventricular como puente a trasplante cardiaco: 53 Centrimag (8 fueron biventricular y 1 derecho, siendo el resto izquierdo) y 7 Impella para asistencia izquierda. De ellos, 20 casos estaban asistidos con ECMO previamente y se implantó el dispositivo como puente-al-puente (eran pacientes que se encontraban en INTERMACS 1, estando el resto en 2-3). La edad media fue de 50,8 años. La mayoría eran hombres (86,7%). La etiología de la insuficiencia cardiaca predominante fue isquémica (43,3%), seguida de idiopática (30%). Resultados: De los pacientes asistidos previamente con ECMO y posteriormente con dispositivo como puente-al-puente, llegaron al trasplante cardiaco 5 de 20 (éxito de la estrategia del 25%). En cambio, de los pacientes asistidos directamente con Centrimag o Impella llegaron al trasplante cardiaco 31 de 40 pacientes (éxito de la estrategia del 77,5%). La mortalidad global de los pacientes que se trasplantaron fue del 16,7% (siendo la mortalidad del total de la serie del 50%). Conclusión: La escasez de donantes y el tiempo en lista de espera está aumentando el número de candidatos a trasplante cardiaco asistidos con dispositivos de asistencia ventricular. Encontramos unos resultados aceptables en los pacientes asistidos con dispositivos directamente, en INTERMACS 2-3. En cambio, la asistencia previa con ECMO conlleva mayor mortalidad hospitalaria. Abstract: Introduction and objective: To evaluate the results of the use of short-medium duration ventricular assist devices, such as Centrimag and Impella, in patients in INTERMACS 1-3, as a bridge to heart transplantation. Material and method: From 2015 to 2021, 60 ventricular assist devices were implanted as a bridge to heart transplantation: 53 Centrimag (8 were biventricular and 1 right, the rest being left) and 7 Impella for left assist. Of these, 20 cases were previously assisted with ECMO and the device was implanted as a bridge-to-bridge (these were patients who were in INTERMACS 1, while the rest were in 2-3). The mean age was 50.8 years. Most were men (86.7%). The predominant aetiology of heart failure was ischemic (43.3%), followed by idiopathic (30%). Results: Of the patients previously assisted with ECMO and subsequently with a bridge-to-bridge device, 5 out of 20 underwent heart transplantation (25% strategy success). In contrast, of the patients directly assisted with Centrimag or Impella, 31 out of 40 patients underwent heart transplantation (77,5% success of the strategy). The overall mortality of the patients who underwent transplantation was 16.7% (with the mortality of the total series being 50%). Conclusion: The shortage of donors and the time on the waiting list is increasing the number of heart transplant candidates assisted with ventricular assist devices. We found acceptable results in patients directly assisted with devices, in INTERMACS 2-3. In contrast, previous assistance with ECMO carries a higher risk.

PURPOSE: Ventricular arrhythmias (VAs) are common in patients after left ventricular assist device (LVAD) implant and are associated with worse outcomes. However, the prevalence and impact of VA in patients with durable biventricular assist device (BIVAD) is unknown. We performed a retrospective cohort study of patients with BIVADs to evaluate the prevalence of VA and their clinical outcomes. METHODS: Consecutive patients who received a BIVAD between June 2014 and July 2017 at our medical center were included. The prevalence of VA, defined as sustained ventricular tachycardia or fibrillation requiring defibrillation or ICD therapy, was compared between BIVAD patients and a propensity-matched population of patients with LVAD from our center. The occurrence of adverse clinical events was compared between BIVAD patients with and without VA. RESULTS: Of the 13 patients with BIVADs, 6 patients (46%) experienced clinically significant VA, similar to a propensity-matched LVAD population (38%, p = 1.00). There were no differences in baseline characteristics between the two cohorts, except patients in the non-VA group who had worse hemodynamics (mitral regurgitation and right-sided indices), had less history of VA, and were younger. BIVAD patients with VA had a higher incidence of major bleeding (MR 3.05 (1.07-8.66), p = 0.036) and worse composite outcomes (log-rank test, p = 0.046). The presence of VA was associated with worse outcomes in both LVAD and BIVAD groups. CONCLUSIONS: Ventricular arrhythmias are common in patients with BIVADs and are associated with worse outcomes. Future work should assess whether therapies such as ablation improve the outcome of BIVAD patients with VA.

ObjectiveLeft ventricular assist devices (LVADs) fail in up to 10% of patients due to the development of pump thrombosis. Remote monitoring of patients with LVADs can enable early detection and, subsequently, treatment and prevention of pump thrombosis. We assessed whether acoustical signals measured on the chest of patients with LVADs, combined with machine learning algorithms, can be used for detecting pump thrombosis.Methods13 centrifugal pump (HVAD) recipients were enrolled in the study. When hospitalized for suspected pump thrombosis, clinical data and acoustical recordings were obtained at admission, prior to and after administration of thrombolytic therapy, and every 24 hours until laboratory and pump parameters normalized. First, we selected the most important features among our feature set using LDH-based correlation analysis. Then using these features, we trained a logistic regression model and determined our decision threshold to differentiate between thrombosis and non-thrombosis episodes.ResultsAccuracy, sensitivity and precision were calculated to be 88.9%, 90.9% and 83.3%, respectively. When tested on the post-thrombolysis data, our algorithm suggested possible pump abnormalities that were not identified by the reference pump power or biomarker abnormalities.SignificanceWe showed that the acoustical signatures of LVADs can be an index of mechanical deterioration and, when combined with machine learning algorithms, provide clinical decision support regarding the presence of pump thrombosis.

Open in new tab Download slide OBJECTIVES To describe the use of ventricular assist devices (VAD) in children in Spain and to identify variables related to survival. METHODS This is an observational cohort study of all children younger than 18 years of age who underwent an initial implantation of a VAD at any of the 6 paediatric heart transplant centres from May 2006 to December 2020. Subjects were identified retrospectively from each hospital's database. RESULTS Paracorporeal VADs were implanted in 118 children [pulsatile (63%), continuous (30.5%) or both types (5.9%)]. Small children (<0.7 m2 of body surface area) comprised the majority of this cohort (63.3%). Overall, 67% survived to VAD explantation, and 64.9% survived to hospital discharge. Non-central nervous system haemorrhage (39%) and stroke (38.1%) were the most common complications. Body weight <5 kg, congenital heart disease, pre-implantation bilirubin >34 μmol/l and bridge to decision strategy were associated with a higher mortality at hospital discharge and in the long-term. Interagency registry for mechanically assisted circulatory support (INTERMACS) status 1 and cardiac arrest prior to VAD implantation were related to long-term mortality, whereas pre-implantation renal replacement therapy and extracorporeal membrane oxygenation were not related to mortality. CONCLUSIONS In Spain, 67% of the VAD-supported children have been bridged to heart transplantation or to recovery. Body weight lower than 5 kg, congenital heart disease diagnosis, cholestatic liver dysfunction, bridge to decision as VAD strategy, INTERMACS-1 status and cardiac arrest were pre-implantation variables related to mortality, whereas pre-implantation renal replacement therapy and extracorporeal membrane oxygenation were not. [ABSTRACT FROM AUTHOR]

Objective: To describe characteristics of patients admitted with refractory cardiac arrest for possible extracorporeal cardiopulmonary resuscitation (ECPR) and gain insight into the reasons for refraining from treatment in some.Methods: Nationwide retrospective cohort study involving all tertiary centres providing ECPR in Denmark. Consecutive patients admitted with ongoing chest compression for evaluation for ECPR treatment were enrolled. Presenting characteristics, duration of no-flow and low-flow time, end-tidal carbon dioxide (ETCO2), lactate and pH, and recording of reasons for refraining from ECPR documented by the treating team were recorded. Outcomes were survival to intensive care unit admission and survival to hospital discharge.Results: Of 579 patients admitted with refractory cardiac arrest for possible ECPR, 221 patients (38%) proceeded to ECPR and 358 patients (62%) were not considered candidates. Median prehospital low-flow time was 70 min (IQR 56 to 85) in ECPR patients and 62 min (48 to 81) in no-ECPR patients, p<0.001. Intra-arrest transport was more than 50 km in 92 (42%) ECPR patients and 135 in no-ECPR patients (38%), p=0.25. The leading causes for not initiating ECPR stated by the treating team were duration of low-flow time in 39%, severe metabolic derangement in 35%, and in 31% low ETCO2. The prevailing combination of contributing factors were non-shockable rhythm, low ETCO2, and metabolic derangement or prehospital low-flow time combined with low ETCO2. Survival to discharge was only achieved in six patients (1.7%) in the no-ECPR group.Conclusions: In this large nationwide study of patients admitted for possible ECPR, two-thirds of patients were not treated with ECPR. The most frequent reasons to abstain from ECPR were long duration of prehospital low-flow time, metabolic derangement and low ETCO2. [ABSTRACT FROM AUTHOR]

Background: Extensive evidence from single-center studies indicates that a subset of patients with chronic advanced heart failure (HF) undergoing left ventricular assist device (LVAD) support show significantly improved heart function and reverse structural remodeling (ie, termed "responders"). Furthermore, we recently published a multicenter prospective study, RESTAGE-HF (Remission from Stage D Heart Failure), demonstrating that LVAD support combined with standard HF medications induced remarkable cardiac structural and functional improvement, leading to high rates of LVAD weaning and excellent long-term outcomes. This intriguing phenomenon provides great translational and clinical promise, although the underlying molecular mechanisms driving this recovery are largely unknown.Methods: To identify changes in signaling pathways operative in the normal and failing human heart and to molecularly characterize patients who respond favorably to LVAD unloading, we performed global RNA sequencing and phosphopeptide profiling of left ventricular tissue from 93 patients with HF undergoing LVAD implantation (25 responders and 68 nonresponders) and 12 nonfailing donor hearts. Patients were prospectively monitored through echocardiography to characterize their myocardial structure and function and identify responders and nonresponders.Results: These analyses identified 1341 transcripts and 288 phosphopeptides that are differentially regulated in cardiac tissue from nonfailing control samples and patients with HF. In addition, these unbiased molecular profiles identified a unique signature of 29 transcripts and 93 phosphopeptides in patients with HF that distinguished responders after LVAD unloading. Further analyses of these macromolecules highlighted differential regulation in 2 key pathways: cell cycle regulation and extracellular matrix/focal adhesions.Conclusions: This is the first study to characterize changes in the nonfailing and failing human heart by integrating multiple -omics platforms to identify molecular indices defining patients capable of myocardial recovery. These findings may guide patient selection for advanced HF therapies and identify new HF therapeutic targets. [ABSTRACT FROM AUTHOR]

Background: It is often difficult for patients with advanced heart failure (HF) to decide whether to live with a left ventricular assist device (LVAD) or not. Little is known about their decisional needs prior to LVAD implantation and if these needs were met in the Asian cultural setting. Aims: We aimed to explore the influences, concerns, and needs surrounding the decision-making process of the LVAD implantation among multi-ethnic Asian patients with HF. Methods: Semi-structured interviews with HF patients and caregivers were conducted, based upon the grounded theory approach. Participants were purposively recruited from the inpatient and outpatient setting of the National Heart Centre Singapore. Results: A total of 31 patients and 11 caregivers participated. Mindsets that shaped decision-making ranged from "having no choice," "being reflective," "taking a gamble," and "fighting on." Instead of making a sole decision, many patients reported that decisions were shared with the family or medical team. Current LVAD patients who acted as patient ambassadors were also strong influences. Spiritual support was pivotal to decision-making for some participants. Goals influencing decision-making including protecting the family and life prolongation improving quality of life. Values held close included sanctity of life, trusting in a higher power, believing in pre-destination or karma, and preserving family harmony. Participants had concerns about cost, employment, and health outcomes. Conclusions: Asian LVAD patients and caregivers had culturally specific mindsets, goals, and values and concerns around decision-making. Our findings have implications for the design of interventions and supportive care models. [ABSTRACT FROM AUTHOR]

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.

Giant cell myocarditis is a rare but often devastating diagnosis. Advances in cardiac imaging and mechanical circulatory support have led to earlier and more frequent diagnoses and successful management. This disease state has wide variation in acuity of presentation, and consequently, optimal treatment ranging from intensity and type of immunosuppression to mechanical circulatory support is not well defined. The following case describes the management of a patient with an unusual presentation of giant cell myocarditis over a 10 year course of advanced heart failure therapies and immunomodulatory support. This case highlights emerging concepts in the management of giant cell myocarditis including sub-acute presentations, challenges in diagnosis, and treatment modalities in the modern era.