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Left ventricular assist devices (LVADs) are increasingly implanted in patients with advanced heart failure. Currently, LVAD care is predominantly concentrated at specialized tertiary care hospitals. However, the increasing workload and logistical burden for implanting centres pose significant challenges to accessing care for individual patients in remote areas. An emerging approach to LVAD patient management is the use of a shared care model (SCM), which facilitates collaboration between implanting centres and local non-implanting hospitals. This scoping review explores and synthesizes the current scientific evidence on the use of SCMs in LVAD care management. Eligible studies were identified in EMBASE, PubMed MEDLINE, Web of Science, Cochrane and Google Scholar. Findings were synthesized in accordance with PRISMA-ScR guidelines. Of the 950 records screened, five articles met the inclusion criteria. Four review articles focused on the proposed benefits and challenges of using SCMs. Main benefits included improved patient satisfaction and continuity of care. Important challenges were initial education of non-implanting centre staff and maintaining competency. One prospective study showed that absence of LVAD-specific care was associated with impaired survival and higher rates of pump thrombosis and LVAD-related infections. The use of SCMs is a promising approach in the long-term management of LVAD patients. However, sufficient evidence about the impact of SCMs on patients and the healthcare system is not currently available. Standardized protocols based on prospective studies are needed to develop safe and effective shared care for LVAD patients. [ABSTRACT FROM AUTHOR]

In April 2021, destination therapy (DT) was finally approved in Japan. Since DT does not aim at heart transplantation (HT), our goal is to have a patient safely remain on an implantable ventricular assist device (VAD) for the rest of his/her life. To achieve this goal, similarly to bridge-to-transplant (BTT) patients, the authors believe the following six aspects are even more crucial in DT patients: (1) to appropriately assess risks before implantation, (2) to carefully determine the ability to manage the device by multidisciplinary discussions, (3) to prevent complications by improving the quality of care, (4) to expand the number of facilities that can take care of DT patients by improving collaboration among the facilities, (5) to reduce the burden of caregivers by utilizing social resources, and (6) to establish a home palliative care system based on advance care planning. In addition, for elderly DT patients to live happy and long lives, it is essential to help them to find a purpose of life and to keep activities of daily living, such as employment, schooling, and participation in social activities, just like the general elderly population. Our goals are not only to do our best for the patients just in front of us, but also to establish a system to follow up our DT cohort, same as BTT one, by all-Japan manner. In the present review, we discuss the current state of DT in Japan and what we need to focus on to maintain or improve its long-term performance. [ABSTRACT FROM AUTHOR]

Advance care planning (ACP) is essential in managing serious and chronic illnesses to ensure that patients receive care aligned with their personal values, goals, and preferences. This review focuses on integrating ACP in the treatment of patients receiving implantable left ventricular assist devices (VADs). The heart failure palliative care team developed a unique advance directive form and pamphlet to facilitate ACP discussions, emphasizing not only medical treatment preferences but also patients' values and life goals. The study highlights the distinction between bridge to transplantation (BTT) and destination therapy (DT) in VAD patients, with different goals and considerations for ACP. The use of decision aids developed especially for DT candidates as a communication tool helps in sharing patients' wishes and facilitates shared decision-making, particularly in the complex decisions surrounding DT therapy. Challenges in implementing ACP, such as time constraints due to urgent medical conditions, difficulties in patient communication, and the recent COVID-19 pandemic, are addressed. The need for a comprehensive healthcare system capable of supporting patients' ACP wishes, especially in the community setting, is also pointed out. Future directions include not only developing materials to ease ACP discussions and ensuring that ACP content is shared among healthcare providers to foster collaborative and detailed planning, but also a call for widespread adoption of ACP in Japan. This is a translation of a paper written in Japanese Journal of Artificial Organs (Vol. 52, No. 1, pp. 89–92) with additions and corrections. [ABSTRACT FROM AUTHOR]

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Left ventricular assist devices (LVADs) have been implanted as bridge to transplantation (BTT), bridge to candidacy (BTC) or destination therapy (DT) on the basis of relative and absolute contraindications to transplantation. Multiple factors may lead to changes in the strategy of support after LVAD implantation. Based on INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) 2012–2020 data, 11,262 patients survived to 3 months on continuous-flow LVADs with intent of BTT or DT. Preimplant characteristics and early events post-LVAD were analyzed in relation to changes in BTT or DT strategy during the next 12 months. Among 3216 BTT patients at 3 months, later transplant delisting or death without transplant occurred in 536 (16.7%) and was more common with age, profiles 1–2, renal dysfunction, and independently for prior cardiac surgery (HR 1.25, 95% CI 1.04–1.51; P = 0.02). Post-LVAD events of infections, gastrointestinal bleeding, stroke, and right heart failure as defined by inotropic therapy, predicted delisting and death, as did in-hospital location at 3 months (HR 1.67, 95% CI 1.20–2.33; P = 0.0024). Of 8046 patients surviving to 3 months with the intent of destination therapy, 750 (9.3%) subsequently underwent listing or transplantation, often with initial histories of acute HF (HR 1.70, 95% CI 1.27–2.27; P = 0.0012) or malnutrition-cachexia (1.73, 95% CI 1.14–2.63; P = 0.0099). Multiple gastrointestinal bleeding events (≥ 4) with LVAD increased transition from BTT to DT (HR 4.22, 95% CI 1.46–12.275; P = 0.0078) but also from DT to BTT (HR 5.17, 95% CI 1.92–13.9; P = 0.0011). Implant strategies change over time in relation to preimplant characteristics and adverse events post implant. Preimplant recognition of factors predicting later change in implant strategy will refine initial triage, whereas further reduction of post-LVAD complications will expand options, including eventual consideration of heart transplantation. [ABSTRACT FROM AUTHOR]

Background: Heart failure is a common life-limiting disease. A destination therapy for people who will not have a heart transplant is a left ventricular assist device. Aims: To discover how patients who have a left ventricular assist device for destination therapy make decisions about their healthcare after implantation of the device. Methods: A descriptive qualitative design with semi-structured, in-depth interviews with 11 participants who are living with a left ventricular assist device for destination therapy. Findings: People with a left ventricular assist device felt they had 'no choice' when making decisions about their healthcare. Conclusion: Engaging with patients to contemplate present and future healthcare decisions is a complex process that includes cognitive processes within the patient. Clinicians need to be aware that a gap may occur between what is said and what is heard in communication. [ABSTRACT FROM AUTHOR]

BACKGROUND: There are limited data to guide oncology and cardiology decision-making in patients with a left ventricular assist device (LVAD) and concurrent active malignancy. OBJECTIVES: The goal of this study was to describe cancer treatment approaches, complications, and survival among patients with active cancer on LVAD support in 2 tertiary heart failure and oncology programs. METHODS: In this retrospective cohort study, LVAD databases were reviewed to identify patients with a cancer diagnosis at the time of or after LVAD implantation. We created a 3:1 matched cohort based on age, sex, etiology of cardiomyopathy, LVAD implant strategy, and INTERMACS profile stratified by site. Kaplan-Meier analysis and Cox proportional hazards models were used to compare survival between patients with cancer and non-cancer comparators. RESULTS: Among 1,123 patients who underwent LVAD implantation between 2005 and 2019, 22 patients with LVADs with active cancer and 66 matched non-cancer comparators were identified. Median age was 62 years (range 41 to 73 years); 50% of patients with cancer were African-American, and 27% were women. Prostate cancer, followed by renal cell cancer and hematologic malignancies were the most common diagnoses. There was no significant difference in unadjusted Kaplan-Meier median survival estimates from the time of LVAD placement between patients with cancer (3.53 years; 95% confidence interval [CI]: 1.41 to 5.33) and non-cancer comparators (3.03 years; 95% CI: 1.83 to 5.26; log-rank P = 0.99). In Cox proportional hazard models, cancer diagnosis as a time-varying variable was associated with a statistically significant increase in death (hazard ratio: 2.05; 95% CI: 1.03 to 4.12; P = 0.04). Patients with cancer had less gastrointestinal bleeding compared with matched non-cancer comparators (P = 0.016). Other complications were not significantly different. CONCLUSIONS: Our study provides initial feasibility and safety data and set a framework for multidisciplinary team management of patients with cancer and LVADs.

Abstract Aims Use of left ventricular assist devices (LVADs) in older patients has increased, and assessing outcomes in older LVAD recipients is important. Therefore, this study aimed to investigate associations between age and outcomes after continuous‐flow LVAD (cf‐LVAD) implantation. Methods and results Cf‐LVAD patients from the multicentre European PCHF‐VAD registry were included and categorized into those

Driveline infection in patients with implantable left ventricular assist devices (LVAD) remains common and crucial. Once a driveline exit-site infection reaches the LVAD component, radical treatment such as LVAD exchange may become necessary, although the clinical results are unsatisfactory. The Jarvik 2000 device, which utilizes a postauricular cable, allows the driveline to exit the body behind the ear (postauricular) instead of through an abdominal site. Here, we report the case of a patient who had awaited heart transplantation for more than 6 years and had a critical driveline infection that almost reached the LVAD pump. The patient underwent a pump exchange using the Jarvik 2000 with a postauricular cable, with excellent results. It is a useful replacement option for patients with abdominal drive-line infections, owing to its small pump pocket and the availability of an alternative pathway for the driveline. [ABSTRACT FROM AUTHOR]

Advanced heart failure is a growing problem for which the best treatment is cardiac transplantation. However, the shortage of donors' hearts made left ventricular assist devices as destination therapy (DT-LVAD) a highly recommended alternative: they improved mid-term prognosis as well as patients' quality of life. Current intracorporeal pumps with a centrifugal continuous flow evolved in the last few years. Since 2003, when first LVAD was approved for long-term support, smaller device sizes with better survival and hemocompatibility profile were reached. The most important difficulty lies in the moment of the implant. Recent indications range from INTERMACS class 2 to 4, with close monitoring in intermediate cases. Moreover, a large multiparametric study is needed for considering the candidacy: basal situation, with a special interest in frailty, comorbidities, including renal and hepatic dysfunction, and medical background, considering every prior cardiac condition, must be evaluated. In addition, some clinical risk scores can be helpful to measure the possibility of right heart failure or morbi-mortality. With this review, we sought to summarize all the device improvements, with their updated clinical results, as well as to focus on all the patient selection criteria. [ABSTRACT FROM AUTHOR]

Aims: Use of left ventricular assist devices (LVADs) in older patients has increased, and assessing outcomes in older LVAD recipients is important. Therefore, this study aimed to investigate associations between age and outcomes after continuous‐flow LVAD (cf‐LVAD) implantation. Methods and results: Cf‐LVAD patients from the multicentre European PCHF‐VAD registry were included and categorized into those <50, 50–64, and ≥65 years old. The primary endpoint was all‐cause mortality. Among secondary outcomes were heart failure (HF) hospitalizations, right ventricular (RV) failure, haemocompatibility score, bleeding events, non‐fatal thromboembolic events, and device‐related infections. Of 562 patients, 184 (32.7%) were <50, 305 (54.3%) were aged 50–64, whereas 73 (13.0%) were ≥65 years old. Median follow‐up was 1.1 years. Patients in the oldest age group were significantly more often designated as destination therapy (DT) candidates (61%). A 10 year increase in age was associated with a significantly higher risk of mortality (hazard ratio [HR] 1.34, 95% confidence interval [CI] [1.15–1.57]), intracranial bleeding (HR 1.49, 95% CI [1.10–2.02]), and non‐intracranial bleeding (HR 1.30, 95% CI [1.09–1.56]), which was confirmed by a higher mean haemocompatibility score (1.37 vs. 0.77, oldest vs. youngest groups, respectively, P = 0.033). Older patients suffered from less device‐related infections requiring systemic antibiotics. No age‐related differences were observed in HF‐related hospitalizations, ventricular arrhythmias, pump thrombosis, non‐fatal thromboembolic events, or RV failure. Conclusions: In the PCHF‐VAD registry, higher age was associated with increased risk of mortality, and especially with increased risk of major bleeding, which is particularly relevant for the DT population. The risks of HF hospitalizations, pump thrombosis, ventricular arrhythmia, or RV failure were comparable. Strikingly, older patients had less device‐related infections. [ABSTRACT FROM AUTHOR]

Background: Peripartum cardiomyopathy (PPCM) is a rare cause of heart failure (HF), presenting with left ventricular (LV) systolic dysfunction either at the end of pregnancy or in the months following delivery. In rare cases, PPCM leads to severe impairment of LV function, refractory cardiogenic shock or advanced HF. LV assist devices (LVAD) have been shown to be a feasible treatment option in advanced HF. However, little is known about long‐term outcomes and prognosis of PPCM patients undergoing LVAD implantation. Methods: A retrospective analysis of data from PPCM patients undergoing LVAD implantation in two tertiary centers with respect to long‐term outcomes was performed. Results: Twelve patients of median age 30 (18–39) years were included. Eight patients were experiencing cardiogenic shock (INTERMACS 1) at implantation. Seven patients were implanted within 1 month of their PPCM diagnosis. Median duration of LVAD support was 19 (2–92) months with median follow up of 67 (18–136) months (100% complete). In‐hospital and 1‐year mortality were 0% and 8.3%, respectively. Two patients died on LVAD support, four patients were successfully bridged to transplantation, two patients are still on LVAD, and four were successfully weaned due to sufficient LV recovery (one died after LV function deteriorated again). Conclusion: LVAD treatment of decompensated end‐stage PPCM is feasible. Early LVAD provision led to hemodynamic stabilization in our cohort and facilitated safe LV recovery in one third of these young female patients. [ABSTRACT FROM AUTHOR]

At present, heart transplantation is the most effective treatment for end-stage heart failure. Nevertheless, the shortage of donors is becoming an increasingly severe challenge. In recent years, rapid development of mechanical circulatory support technologies has provided multiple therapeutic options for patients with end-stage heart failure. As an important mechanical circulatory support device, ventricular assist device (VAD) are divided into durable VAD (dVAD) and temporary VAD (tVAD) according to the duration of assistance. dVAD shows application potential in bridging heart transplantation, destination therapy and bridge to decision. With technological progress and experience accumulation in clinical application, VAD is evolving towards the direction of more biocompatible, lighter, more bionic and intelligent. In this article, the development of VAD, application status at home and abroad and the overall application of VAD in our hospital were reviewed, aiming to provide reference for promoting the clinical application of VAD in China. [ABSTRACT FROM AUTHOR]

Heart failure is the leading cause of morbidity and mortality in adults with congenital heart disease. However, for many in this population, heart transplantation is not possible or requires longer wait times, necessitating prolonged circulatory support. The medium to long-term durable ventricular assist device therapy provides a possible solution. We analyzed outcomes of 9 patients with congenital heart disease and at least 3 years of durable mechanical support, all age 18 or older at the time of ventricular assist device implantation at our affiliated pediatric and adult hospitals. Palliated congenital anatomies varied and included biventricular physiologies as well as single ventricles with Fontan circulation. The median duration of support was 4.2 years, including 3 patients successfully bridged to transplant, averaging 2.1 years on the waitlist. Device-related complications were infrequent with HeartMate 3, a feasible and sustainable option for either bridge to transplant or destination strategies in adults with congenital heart disease., Competing Interests: Disclosure statement C.R.B. reports a financial relationship with Abbott; H.T. reports a relationship with Abbott; I.A. serves as a consultant and proctor for Berlin Heart, Inc., Medtronic Inc., Jarvik Inc., BiVACOR Inc., and Sony-Olympus Medical Solutions Inc.; A.C. reports financial relationships with Medtronic Inc. and Abbott. The remaining authors have no conflicts of interest to report., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Myocardial recovery following left ventricular assist device (LVAD) implantation has been of interest in transplant candidates with non‐ischemic cardiomyopathy but is rare. Evidence suggests that a combination of left ventricular unloading and pharmacologic reverse remodeling is beneficial. Recovery in non‐transplant candidates (i.e., destination therapy [DT]) patients is believed to be even rarer. Methods: All DT LVADs between January 1, 2017 and November 23, 2020 were reviewed. All patients were subjected to an institutional protocol consisting of combined pharmacologic remodeling and mechanical unloading with proactive screening for recovery. The primary outcome of interest was the cumulative incidence of myocardial recovery. Baseline characteristics and operative outcomes were compared between recovered and non‐recovered DT patients using non‐parametric tests to identify predictive factors. Results: A total of 49 patients received DT LVADs. Nine patients were identified as myocardial recovery candidates using the protocol screening criteria. Overall, 11 patients underwent formal confirmatory testing for recovery, of which 10 were deemed recovered and underwent LVAD explant, defunctionalization, or transplantation. 37.5% of patients that had a concomitant coronary artery bypass during LVAD implantation achieved recovery. An equal proportion of ischemic and non‐ischemic cardiomyopathy patients achieved recovery. The cumulative incidence of myocardial recovery was 25.1% at 36 months. No factors were identified as being predictive of recovery. Conclusion: Myocardial recovery in DT LVAD patients can be achieved at a higher rate than previously reported. Revascularization at the time of LVAD is safe and may be beneficial. LVAD therapy may not be the final destination in these patients. [ABSTRACT FROM AUTHOR]

Background: Body mass index (BMI) is an important consideration for transplant‐eligible left ventricular assist device (LVAD) recipients. LVAD therapy's impact on BMI is unclear. We evaluated BMI changes in patients who underwent LVAD implantation. The association between these patients' BMI and the transplant was studied. Methods: This was a retrospective cohort study of patients who underwent LVAD implantation between January 1, 2012 and December 31, 2018 at our institution. Patients were stratified by preoperative BMI (kg/m2) into four groups: <30, 30–34.9, 34.9–39.9, and ≥40. BMI data were collected at 12 and 6 months prior to implantation, time of implantation, and 3‐ and 6‐ months postimplantation. Results: A total of 107 patients underwent LVAD implantation at our institution. Data were available for 80 patients. Baseline characteristics included a mean age of 56.0 years, 69% male, and a mean implant BMI of 29.9 ± 6.8 kg/m2. The mean BMI (kg/m2) for each of the BMI (kg/m2) groups <30, 30–34.9, 35–39.9, and ≥40 (n = 60, 25, 12, and 10, respectively) was 25.1, 32.5, 36.8, and 43.8, respectively. There was no consistent pattern with weight change across differing implant BMIs. No patient with a BMI of <30 gained sufficient weight to impact transplant candidacy. Twenty‐three percent of patients with a BMI of 30–34.9 kg/m2, 60% of patients with a BMI of 35–39.9 kg/m2, and 87.5% of patients with a BMI of ≥40 kg/m2 had a 6‐month BMI potentially affecting transplant. Conclusions: Associated weight changes during LVAD support may significantly impact transplant candidacy. Higher BMI groups may benefit from multimodal and multidisciplinary targeted weight‐loss interventions. [ABSTRACT FROM AUTHOR]

Abstract Aims Continuous‐flow left ventricular assist devices (LVADs) as destination therapy (DT) are a recommended treatment by National Institute for Health and Care Excellence England for end‐stage heart failure patients ineligible for cardiac transplantation. Despite the fact that DT is frequently used as an LVAD indication across other major European countries and the United States, with consistent improvements in quality‐of‐life and longevity, National Health Service (NHS) England does not currently fund DT, mainly due to concerns over cost‐effectiveness. On the basis of the recently published ENDURANCE Supplemental Trial studying DT patients, we assessed for the first time the cost‐effectiveness of DT LVADs compared with medical management (MM) in the NHS England. Methods and results We developed a Markov multiple‐state economic model using NHS cost data. LVAD survival and adverse event rates were derived from the ENDURANCE Supplemental Trial. MM survival was based on Seattle Heart Failure Model estimates in the absence of contemporary clinical trials for this population. Incremental cost‐effectiveness ratios (ICERs) were calculated over a lifetime horizon. A discount rate of 3.5% per year was applied to costs and benefits. Deterministic ICER was £46 207 per quality‐adjusted life year (QALY). Costs and utilities were £204 022 and 3.27 QALYs for the LVAD arm vs. £77 790 and 0.54 QALYs for the MM arm. Sensitivity analyses confirmed robustness of the primary analysis. Conclusions The implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost‐effective therapy in the NHS England healthcare system under the end‐of‐life willingness‐to‐pay threshold of £50 000/QALY, which applies for VAD patients.

Advanced heart failure is a growing problem for which the best treatment is cardiac transplantation. However, the shortage of donors’ hearts made left ventricular assist devices as destination therapy (DT-LVAD) a highly recommended alternative: they improved mid-term prognosis as well as patients’ quality of life. Current intracorporeal pumps with a centrifugal continuous flow evolved in the last few years. Since 2003, when first LVAD was approved for long-term support, smaller device sizes with better survival and hemocompatibility profile were reached. The most important difficulty lies in the moment of the implant. Recent indications range from INTERMACS class 2 to 4, with close monitoring in intermediate cases. Moreover, a large multiparametric study is needed for considering the candidacy: basal situation, with a special interest in frailty, comorbidities, including renal and hepatic dysfunction, and medical background, considering every prior cardiac condition, must be evaluated. In addition, some clinical risk scores can be helpful to measure the possibility of right heart failure or morbi-mortality. With this review, we sought to summarize all the device improvements, with their updated clinical results, as well as to focus on all the patient selection criteria.

Abstract Background In Switzerland, long-term circulatory support programs have been limited to heart transplant centers. In 2014, to improve the management of patients with end-stage heart failure not eligible for transplantation, we implemented a left ventricular assist device (LVAD) program for destination therapy at the University Hospital of Basel. Methods We described the program set-up with practical aspects. Patients aged 65 and above with therapy refractory end-stage heart failure without major contraindication for LVAD implantation were included. Younger patients with bridge-to-candidacy profile were also considered. Using the Kaplan-Meier estimate, we retrospectively analyzed the overall survival and freedom from major adverse events after LVAD implantation. We compared our results to internationally reported data. Results Between October 2014 and September 2019, 16 patients received an LVAD in our center. The mean age at implantation was 67.1 years. The mean EuroSCORE II was 24.4% and the median INTERMACS level was 4. Thirteen patients received an LVAD as destination therapy and three patients as bridge-to-candidacy. The overall survival was 87.5 and 70% at 1 and 2 years, respectively. Freedom from stroke was 81.3% at 1 and 2 years. Freedom from device infection was 67.7 and 58.7% at 1 and 2 years, respectively. Freedom from gastrointestinal bleeding was 75 and 56.3% at 1 and 2 years, respectively. Freedom from readmission was 50 and 31.3% and at 6 months and 1 year, respectively. Conclusions The Basel experience demonstrated the possible implementation of an LVAD program for destination therapy or bridge-to-candidacy in a non-transplant comprehensive heart-failure center with midterm survival results and freedom from major adverse events comparable to international registries. Patient selection remains crucial. Trial registration This study was registered on the ClinicalTrials.gov database ( NCT04263012 ).

The United Network for Organ Sharing (UNOS) recently revised its heart allocation policy to address numerous shortcomings of the previous system. Implemented in 2018, the changes sought to reduce waiting list mortality, clearly define urgency status based on objective physiologic variables, decrease exemption requests, and introduce geographic modifications to ensure organ distribution favors the highest urgency candidates. In large part, UNOS policy revisions were driven by the growing use of continuous flow left ventricular assist devices (CF-LVADs) and the relevant device complications that led to an unacceptably high number of status exemptions. The new 6-tiered system assigns a comparatively lower urgency status to patients supported on CF-LVADs and higher urgency to patients supported on short-term mechanical circulatory assist (MCA) such as extracorporeal membrane oxygenation (ECMO) and intraaortic balloon pump (IABP) counterpulsation. LVAD use as bridge to transplant (BTT) therapy increased steadily throughout the preceding decade due to technological improvements and increased physician familiarity, but the recent policy changes introduce incentives for physicians to withhold this life-saving therapy in order to achieve higher urgency status for their patients. This paper will explore the technological evolution of MCA and the pertinent clinical trials that have led to their FDA approval as BTT and destination therapy. A review of the inception and development of the donor allocation system will be provided before examining available post-policy outcome data. Finally, we will highlight successes and shortcomings of the implemented changes before commenting on areas to potentially expand upon the existing policy.

The clinical and cost-effectiveness of left ventricular assist device (LVAD) therapy for patients with advanced heart failure (HF) who are ineligible for heart transplantation is debated in the UK. This study develops an indirect comparison between the fully magnetically levitated HeartMate 3 (HM 3) LVAD and medical therapy (MT) to evaluate expected clinical and cost-effectiveness in the UK National Health Service (NHS) context. We performed an economic analysis comparing the HM3 pump against the HeartMate II LVAD (MOMENTUM 3), and then another analysis comparing MT with the first- and second-generation HeartMate XVE pump LVAD and HeartMate II LVAD for the same patient population (REMATCH and ROADMAP, respectively). By bridging those 2 analyses, an indirect comparison between HM3 and MT in the form of a network meta-analysis was developed. A literature search was performed to select the most appropriate pair of studies for this purpose. Outcomes were adjusted to produce Kaplan-Meier curves for the cost-effectiveness evaluation by using a decision-analytic model. Data were extrapolated linearly over a 5-year time horizon. Uncertainty and additional scenarios were addressed by one-way and probabilistic sensitivity analysis. Local costs and health utility were used from England, thereby representing the UK context. The incremental cost-effectiveness ratio (ICER) for LVAD vs MT in transplant ineligible patients with advanced HF was estimated to be £47,361 per quality-adjusted life year gained, with a 97.1% probability of being cost-effective at £50,000. In a subgroup of patients who are inotropic therapy dependent (INTERMACS 1-3 severity profile), the ICER was £45,616, while for a population with less-ill ambulatory HF (INTERMACS profile 4-7) the ICER changed to £64,051. This study provides evidence that HM3 LVAD therapy in advanced HF patients ineligible for heart transplantation may be cost-effective compared to MT in the NHS UK-England context. The ICER is lowest for patients dependent on inotropic support, but exceeds the willingness to pay threshold of £50,000 in ambulatory noninotropic therapy dependent advanced HF patients. [ABSTRACT FROM AUTHOR]

In April 2021, destination therapy (DT) was finally approved in Japan. Since DT does not aim at heart transplantation (HT), our goal is to have a patient safely remain on an implantable ventricular assist device (VAD) for the rest of his/her life. To achieve this goal, similarly to bridge-to-transplant (BTT) patients, the authors believe the following six aspects are even more crucial in DT patients: (1) to appropriately assess risks before implantation, (2) to carefully determine the ability to manage the device by multidisciplinary discussions, (3) to prevent complications by improving the quality of care, (4) to expand the number of facilities that can take care of DT patients by improving collaboration among the facilities, (5) to reduce the burden of caregivers by utilizing social resources, and (6) to establish a home palliative care system based on advance care planning. In addition, for elderly DT patients to live happy and long lives, it is essential to help them to find a purpose of life and to keep activities of daily living, such as employment, schooling, and participation in social activities, just like the general elderly population. Our goals are not only to do our best for the patients just in front of us, but also to establish a system to follow up our DT cohort, same as BTT one, by all-Japan manner. In the present review, we discuss the current state of DT in Japan and what we need to focus on to maintain or improve its long-term performance., (© 2024. The Author(s).)

Background: An increasing number of patients reach the final stage of heart failure with heart transplantation as the only curative treatment. Mechanical circulatory support, such as left ventricular assist devices (LVAD) are becoming increasingly more important at this stage of the disease. An LVAD improves the quality of life and prolongs the lifespan. The LVAD is used as a bridge to transplantation (BTT) for patients waiting for a donor heart or as a destination therapy (DT) with no transplantation intended; nevertheless, implantation is often associated with complications and the prognosis remains unfavorable in DT cases or after transition from BTT to DT. For patients the device may be a source of physical and psychological distress and can become a burden for families and caregivers. So far it remains unclear whether LVAD treatment is an indication for concurrent palliative care.Objective: The aim of this study was to collect the current data on the influence of palliative care in LVAD patients and to identify possible formats of palliative care in clinical practice.Material and Methods: In May 2020, a systematic literature search was performed using the PICOS instrument in six different databases, i.e. PubMed, Cochrane library, Google scholar, Scopus, Web of Science and Journals@Ovid. We included quantitative and qualitative studies in English and German. Case reports, comments and pediatric studies were excluded.Results: A total of 21 publications from an initial number of 491 were included in this review. The integration of palliative care in the context of LVAD implantation increased the number of advance directives and documented surrogate decision makers. Studies found a positive influence of palliative care on the conditions and place of death, family involvement and symptom and pain management. Involvement in the decision-making process may improve patient selection for LVAD treatment and helps patients to make the decision on informed consent. Various formats for the integration of palliative medical concepts into LVAD treatment are reported. It is not clear when palliative care involvement should start; however, most articles support an early and continuous integration in the LVAD process. We have aggregated possible topics for palliative care consultations from a number of publications. Mutual teaching of both LVAD and palliative care teams is recommended. Integration of a dedicated LVAD palliative care specialist as part of the LVAD team can support care for patients as well as clinicians.Conclusion: The role of palliative care in LVAD patients in clinical practice in the German-speaking area is not standardized. Early and continuous integration of palliative care into the course of LVAD treatment can improve the quality of care. Benefits for LVAD patients, caregivers and clinicians are described. For this purpose, recommendations as well as professional training for palliative care practitioners are useful. Further studies are needed to clarify the impact of palliative care in both DT and BTT patients. [ABSTRACT FROM AUTHOR]

BackgroundWe examined whether characteristics, implant strategy, and outcomes in patients who receive continuous-flow left ventricular assist devices (CF-LVAD) differ across geographic regions in the United States.MethodsA total of 7,404 CF-LVAD patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) from 134 participating institutions were analyzed from 4 distinct regions: Northeast, 2,605 (35%); Midwest, 2,210 (30%); West, 973 (13%); and South, 1,616 (22%).ResultsAt baseline, patients in the Northeast and South were more likely to have INTERMACS risk profiles 1 and 2. A bridge-to-transplant (BTT) strategy was more common in the Northeast (31.7%; West, 18.5%; South, 26.9%; Midwest, 25.5%; p < 0.0001). In contrast, destination therapy (DT) was more likely in the South (40.6%; Northeast, 32.3%; Midwest, 27.3%; West, 27.3%; p < 0.0001). Although all regions showed a high 1-year survival rate, some regional differences in long-term mortality were observed. Notably, survival beyond 1 year after LVAD implant was significantly lower in the South. However, when stratified by device strategy, no significant differences in survival for BTT or DT patients were found among the regions. Finally, with the exception of right ventricular failure, which was more common in the South, no other significant differences in causes of death were observed among the regions.ConclusionsRegional differences in clinical profile and LVAD strategy exist in the United States. Despite an overall high survival rate at 1 year, differences in mortality among the regions were noted. The lower survival rate in the South may be attributed to patient characteristics and higher use of LVAD as DT.

Aims: Continuous‐flow left ventricular assist devices (LVADs) as destination therapy (DT) are a recommended treatment by National Institute for Health and Care Excellence England for end‐stage heart failure patients ineligible for cardiac transplantation. Despite the fact that DT is frequently used as an LVAD indication across other major European countries and the United States, with consistent improvements in quality‐of‐life and longevity, National Health Service (NHS) England does not currently fund DT, mainly due to concerns over cost‐effectiveness. On the basis of the recently published ENDURANCE Supplemental Trial studying DT patients, we assessed for the first time the cost‐effectiveness of DT LVADs compared with medical management (MM) in the NHS England. Methods and results: We developed a Markov multiple‐state economic model using NHS cost data. LVAD survival and adverse event rates were derived from the ENDURANCE Supplemental Trial. MM survival was based on Seattle Heart Failure Model estimates in the absence of contemporary clinical trials for this population. Incremental cost‐effectiveness ratios (ICERs) were calculated over a lifetime horizon. A discount rate of 3.5% per year was applied to costs and benefits. Deterministic ICER was £46 207 per quality‐adjusted life year (QALY). Costs and utilities were £204 022 and 3.27 QALYs for the LVAD arm vs. £77 790 and 0.54 QALYs for the MM arm. Sensitivity analyses confirmed robustness of the primary analysis. Conclusions: The implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost‐effective therapy in the NHS England healthcare system under the end‐of‐life willingness‐to‐pay threshold of £50 000/QALY, which applies for VAD patients. [ABSTRACT FROM AUTHOR]

Purpose of Review: Heart failure is an important healthcare issue because of its high prevalence, mortality, and morbidity. Advanced heart failure therapies have improved significantly over the years with improved outcomes. Heart transplantation remains an elusive treatment option for most patients; hence, the need for alternative therapy has given rise to the use of mechanical circulatory support (MCS) devices, initially as bridge to transplantation, but with more recent use as destination therapy. This review focuses on the intricacies of establishing a successful left ventricular assist device (LVAD) program for destination therapy in the setting of a growing anticipated need for wider availability of such treatment options. Recent Findings: Guidelines have established the role of MCS in patients with advanced HF refractory to optimal guideline-directed medical therapy (GDMT) and cardiac device interventions. Multiple studies have shown generational improvement in the overall safety profile of MCS devices with the use of newer devices for destination therapy showing improved outcomes. Summary: Heart failure is a growing cardiovascular problem with an anticipated growing need for advanced HF therapies including MCS devices. A model of shared care LVAD to destination therapy implanting site should be considered as a strategy to start a successful LVAD program. [ABSTRACT FROM AUTHOR]

Background: In Switzerland, long-term circulatory support programs have been limited to heart transplant centers. In 2014, to improve the management of patients with end-stage heart failure not eligible for transplantation, we implemented a left ventricular assist device (LVAD) program for destination therapy at the University Hospital of Basel.Methods: We described the program set-up with practical aspects. Patients aged 65 and above with therapy refractory end-stage heart failure without major contraindication for LVAD implantation were included. Younger patients with bridge-to-candidacy profile were also considered. Using the Kaplan-Meier estimate, we retrospectively analyzed the overall survival and freedom from major adverse events after LVAD implantation. We compared our results to internationally reported data.Results: Between October 2014 and September 2019, 16 patients received an LVAD in our center. The mean age at implantation was 67.1 years. The mean EuroSCORE II was 24.4% and the median INTERMACS level was 4. Thirteen patients received an LVAD as destination therapy and three patients as bridge-to-candidacy. The overall survival was 87.5 and 70% at 1 and 2 years, respectively. Freedom from stroke was 81.3% at 1 and 2 years. Freedom from device infection was 67.7 and 58.7% at 1 and 2 years, respectively. Freedom from gastrointestinal bleeding was 75 and 56.3% at 1 and 2 years, respectively. Freedom from readmission was 50 and 31.3% and at 6 months and 1 year, respectively.Conclusions: The Basel experience demonstrated the possible implementation of an LVAD program for destination therapy or bridge-to-candidacy in a non-transplant comprehensive heart-failure center with midterm survival results and freedom from major adverse events comparable to international registries. Patient selection remains crucial.Trial Registration: This study was registered on the ClinicalTrials.gov database ( NCT04263012 ). [ABSTRACT FROM AUTHOR]

The United Network for Organ Sharing (UNOS) recently revised its heart allocation policy to address numerous shortcomings of the previous system. Implemented in 2018, the changes sought to reduce waiting list mortality, clearly define urgency status based on objective physiologic variables, decrease exemption requests, and introduce geographic modifications to ensure organ distribution favors the highest urgency candidates. In large part, UNOS policy revisions were driven by the growing use of continuous flow left ventricular assist devices (CF-LVADs) and the relevant device complications that led to an unacceptably high number of status exemptions. The new 6-tiered system assigns a comparatively lower urgency status to patients supported on CF-LVADs and higher urgency to patients supported on short-term mechanical circulatory assist (MCA) such as extracorporeal membrane oxygenation (ECMO) and intraaortic balloon pump (IABP) counterpulsation. LVAD use as bridge to transplant (BTT) therapy increased steadily throughout the preceding decade due to technological improvements and increased physician familiarity, but the recent policy changes introduce incentives for physicians to withhold this life-saving therapy in order to achieve higher urgency status for their patients. This paper will explore the technological evolution of MCA and the pertinent clinical trials that have led to their FDA approval as BTT and destination therapy. A review of the inception and development of the donor allocation system will be provided before examining available post-policy outcome data. Finally, we will highlight successes and shortcomings of the implemented changes before commenting on areas to potentially expand upon the existing policy. [ABSTRACT FROM AUTHOR]

Background Left ventricular assist devices (LVADs) improve outcomes in patients with end‐stage heart failure and are increasingly implanted for destination therapy. We describe dynamic estimates of event‐free survival with conditional survival probabilities in a destination therapy LVAD population. Methods and Results We studied 8245 adult patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) implanted with a continuous‐flow destination therapy LVAD. The composite primary end point was death, device exchange or removal, or heart transplantation. Conditional survival probabilities were calculated and stratified by implantation characteristics and nonfatal adverse events experienced within the first year after implant. Probabilities of surviving an additional 1 to 3 years were numerically higher after longer prior event‐free survival. INTERMACS profile 1, extracorporeal membrane oxygenation support, prior or concomitant surgery, and dialysis within 48 hours of implantation were associated with significantly lower event‐free survival in the first year but did not impact event‐free survival beyond then. For patients who experienced a nonfatal adverse event within the first year, subsequent 1‐year conditional survival was lower than in the absence of that event for stroke (65% [95% CI, 57%–73%] versus 75% [95% CI, 73%–77%]; P

Abstract Background Destination therapy (DT) is the permanent implantation of a left ventricular assist device (LVAD) in patients with end-stage, severe heart failure who are ineligible for heart transplantation. DT improves both the quality of life and prognosis of patients with end-stage heart failure. However, there are also downsides to DT such as life-threatening complications and the potential for the patient to live beyond their desired length of life following such major complications. Because of deeply ingrained cultural and religious beliefs regarding death and the sanctity of life, Japanese society may not be ready to make changes needed to enable patients to have LVADs deactivated under certain circumstances to avoid needless suffering. Main text Western ethical views that permit LVAD deactivation based mainly on respect for autonomy and dignity have not been accepted thus far in Japan and are unlikely to be accepted, given the current Japanese culture and traditional values. Some healthcare professionals might regard patients as ineligible for DT unless they have prepared advance directives. If this were to happen, the right to prepare an advance directive would instead become an obligation to do so. Furthermore, patient selection for DT poses another ethical issue. Given the predominant sanctity of life principle and lack of cost-consciousness regarding medical expenses, medically appropriate exclusion criteria would be ignored and DT could be applied to various patients, including very old patients, the demented, or even patients in persistent vegetative states, through on-site judgment. Conclusion There is an urgent need for Japan to establish and enact a basic act for patient rights. The act should include: respect for a patient’s right to self-determination; the right to refuse unwanted treatment; the right to prepare legally binding advance directives; the right to decline to prepare such directives; and access to nationally insured healthcare. It should enable those concerned with patient care involving DT to seek ethical advice from ethics committees. Furthermore, it should state that healthcare professionals involved in the discontinuation of life support in a proper manner are immune to any legal action and that they have the right to conscientiously object to LVAD deactivation.

This study aims to identify the major components of left ventricular assist device (LVAD)-related costs in a population on long-term mechanical circulatory support to gain insight into opportunities for improvements in quality, safety, and efficiency of care for end-stage heart failure patients. This was a single institution, retrospective cost analysis of patients who received a Heartmate II or HeartWare LVAD between November 2005 and October 2015. Payments for hospitalization for device implantation and subsequent readmissions were represented as the institution's 2015 Medicare reimbursement rate. The incidence, average Medicare reimbursement, and length of stay of readmissions were analyzed for the first year postimplant. A full year of LVAD-related hospitalizations in patients surviving ≥12 months, has a median Medicare reimbursement of $247,208. The most common complications related to ventricular assist devices were gastrointestinal bleeding, driveline infection, stroke, and pump thrombosis. Over 90% of total costs were incurred during the initial hospitalization. Seventy-five percent of first-time readmissions occurred within the first 4 months post discharge. Intensive care unit costs accounted for the single largest cost category during readmissions for all of the 4 most common complications. The trends demonstrated suggest that longer lengths of LVAD support in appropriately selected patients results in progressively decreasing cost-per-month up to 12 months, given the large upfront cost of device implantation and relatively modest additional costs of readmissions. This analysis emphasizes the importance of devices with improved complication profiles and clinical protocols to reduce unnecessary intensive care unit stays to increase the cost effectiveness of long-term ventricular assist device therapy. [ABSTRACT FROM AUTHOR]

Conventional long-term ventricular assist devices continue to be extremely problematic due to infections caused by percutaneous drivelines and thrombotic events associated with the use of blood-contacting surfaces. Here we describe a muscle-powered cardiac assist device that avoids both these problems by using an internal muscle energy converter to drive a non-blood-contacting extra-aortic balloon pump. The technology was developed previously in this lab and operates by converting the contractile energy of the latissimus dorsi muscle into hydraulic power that can be used, in principle, to drive any blood pump amenable to pulsatile actuation. The two main advantages of this implantable power source are that it 1) significantly reduces infection risk by avoiding a constant skin wound, and 2) improves patient quality-of-life by eliminating all external hardware components. The counterpulsatile balloon pumps, which compress the external surface of the ascending aorta during the diastolic phase of the cardiac cycle, offer another critical advantage in the setting of long-term circulatory support in that they increase cardiac output and improve coronary perfusion without touching the blood. The goal of this work is to combine these two technologies into a single circulatory support system that eliminates driveline complications and avoids surface-mediated thromboembolic events, thereby providing a safe, tether-free means to support the failing heart over extended – or even indefinite – periods of time. [ABSTRACT FROM AUTHOR]

Ventricular assist devices (VADs) are considered the standard of care for end‐stage heart failure (HF) patients. Despite increasing confidence in the technology, evidence data, endorsement by scientific societies and guidelines, the number of implants reached a steady state and is not increasing at the expected pace. This is most likely related to complications that are still burdening the technology and consequently excluding the most needy, ill, and fragile population. In this manuscript we are reporting a single‐center experience in a very fragile, elderly and end‐stage HF population, with a superficial, partial support device: the CircuLite Synergy. The patients were included in the pre‐CE mark clinical study and consequently the device underwent technical adjustment during the support, based on the complications recorded. At our institution were implanted 6 patients overall: 3 patients survived to discharge and 2 survived up to 5 years. Most of the complications recorded were due to patients' frailty and overall clinical conditions. The initial experience with the CircuLite Synergy device is proving that a more "superficial" device might be more tolerable in an elderly, frail population. Partial support has proven hemodynamically efficacious and efficient in relieving heart failure symptoms, improving medical therapy tolerability, and improving quality of life. Unfortunately, the technology was not made available due to financial uncertainty and poor management, but we hope that once the concept has been proved someone will collect the legacy. [ABSTRACT FROM AUTHOR]

Background: Patients considering a ventricular assist device for destination therapy (DT-VAD) face a complex decision. Patient decision aids (PDAs) facilitate informed, shared decision-making. Purpose: The primary purpose of our quality improvement (QI) initiative was to produce a revised/adapted version of a USA-developed DT-VAD-PDA for use in Ontario, Canada. Methods: Using mixed methods, we interviewed patients with DT-VADs, caregivers, and healthcare providers (HCPs; N = 18). Participants also completed an acceptability questionnaire on the USA-DT-VAD-PDA. Results: Participants (N = 3 patients; 2 caregivers; 13 HCPs) indicated that the USA-DT-VAD-PDA included critically important information for patients and caregivers, and was a valuable patient teaching tool for HCPs. The interviews also elicited insightful recommendations for content adaptions and implementation strategies. Conclusions: The outcome of this QI project was an evidence-informed DT-VAD-PDA that has the potential for HCPs to leverage when facilitating an informed, shared decision-making process for these patients within the Canadian context. [ABSTRACT FROM AUTHOR]

Current generation left ventricular assist devices (LVADs) are powered by a percutaneous driveline. The high prevalence of driveline infections has motivated the development of transcutaneous energy transfer (TET) systems which eliminate driveline associated complications by wirelessly delivering power across the skin. Destination therapy (DT) requires long‐term reliable operation of the TET electronics suggesting the use of hermetic packaging techniques as used in all other chronically implanted devices. TET coils dissipate heat during operation and in order for the technology to be suitable for patient use, sufficient power must be delivered while maintaining temperatures at levels deemed safe. The heating of a TET system designed for DT which uses hermetic packaging technology was evaluated in silico and in vivo. A numerical model was used to evaluate the temperature of the TET coils. The TET system was fabricated and assessed in vivo using an ovine model. The receiving coil was implanted subcutaneously in a sheep and the transmission coil placed in contact with the skin and concentric to the implanted coil. Temperatures of the system were measured using sensors fixed to the surface of the coils. Numerical modeling indicated that the maximum temperatures of the primary and secondary coil surfaces were 38.13°C and 38.41°C, respectively, when delivering 10 W continuously. Stable temperatures were observed in vivo after 70 minutes and the maximum skin and implant surface temperatures were 37.73°C and 38.31°C, respectively. This study showed that a hermetic, chronically implantable TET system is thermally safe when continuously delivering 10 W of power, sufficient to power modern LVADs. [ABSTRACT FROM AUTHOR]

• Much remains unknown or unexpected regarding life after LVAD-DT implantation. • A gap in the process of informing and supporting of LVAD-DT candidates exists. • Informed consent may be less than adequate for many LVAD-DT recipients. Left ventricular assist device-destination therapy (LVAD-DT) represents a powerful technology capable of prolonging and significantly altering recipients' lives. The objective of this systematic review is to analyze the experiences of LVAD-DT recipients and recommend directions of further study. This is a qualitative research project; a systematic review, using thematic meta-synthesis. Six studies were reviewed. Three over-arching themes supported by seven conceptual categories were recognized across the six studies. The three overarching themes are that LVAD-DT recipients continue to struggle with complex support needs post implantation; the motivations for accepting LVAD-DT is death avoidance, and symptom relief; and, that recipients often believe the device will reverse or fix their heart failure. Although elemental, these themes suggest LVAD-DT recipients' interests may not be well served by the informed consent process. The number of LVAD-DT recipients continues to grow and age, presenting significant implications for healthcare providers as a result of this finding. [ABSTRACT FROM AUTHOR]

The concept of a mechanical device to support failing hearts arose after the introduction of the heart lung bypass machine pioneered by Gibbon. The initial devices were the pulsatile paracorporeal and total artificial heart (TAH), driven by noisy chugging pneumatic pumps. Further development moved in three directions, namely short-term paracorporeal devices, left ventricular assist devices (LVADs), and TAH. The paracorporeal pumps moved in the direction of electrically driven continuous-flow pumps as well as catheter-mounted intracardiac pumps for short-term use. The LVAD became the silent durable electric, implantable continuous-flow pumps. The TAH remains a pneumatically driven pulsatile device with limited application, but newer technology is moving toward electrically operated TAH. The most successful pumps are the durable implantable continuous-flow pumps now taken over by the 3rd-generation pumps for the bridge to transplant and long-term use with significantly improved survival and quality of life. But bleeding including gastrointestinal bleeding, strokes, and percutaneous driveline infections exist as troublesome issues. Available data supports less adverse hemocompatibility of HeartMate 3 LVAD. Eliminations of the driveline will significantly improve the freedom from infections. Restoring physiological pulsatility to continuous-flow pumps is in the pipeline. Development of appropriate right VAD, miniaturization, and pediatric devices is awaited. Poor cost-effectiveness from the cost of LVAD needs to be resolved before mechanical cardiac support becomes universally available as a substitute for heart transplantation. [ABSTRACT FROM AUTHOR]

Despite the well‐established correlation between the tobacco use and cardiovascular disease, little is known about postoperative outcomes following the left ventricular assist device (LVAD) implantation. We aimed to elucidate the effect of tobacco smoking on post‐LVAD implant outcomes. Patients who received LVADs from 2013 to 2018 were retrospectively characterized as current, former, or never smokers at the time of implant. We examined 1‐year survival, total hospital readmissions, and specific hospital readmissions for LVAD‐related adverse events based on patient's smoking status. Of the enrolled patients (n = 292), 55% were former smokers, 33% were never smokers, and 11% were current smokers. The majority of patients were African‐American (48%) with a median age of 58 years. Never smokers were younger and less likely to be Caucasian compared to former or current smokers (P <.05, for both). The category of former smokers had statistically comparable total readmission rates with never smokers (2.49 vs. 2.13 event/year), whereas current smokers had significantly higher rates compared to never smokers (2.81 events/year, P <.05), with odds ratio 2.12 (95% CI = 1.35‐3.32) adjusted for age and Caucasian race for >5 times of total readmissions per year. The rates of driveline infection, stroke, and hemolysis were statistically comparable between the never smokers and former smokers, while current smokers had significantly higher rates compared to never smokers (P <.05 for all). [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Currently in Japan, a left ventricular assist device powered by an abdominal driveline is the only type of left ventricular assist device available. The driveline is vulnerable to infection secondary to inappropriate fixation and the traditional Japanese custom of bathing is prohibited in patients with an abdominal driveline. The Jarvik 2000 with postauricular cable is a left ventricular assist device in which the driveline exits the body behind the ear (postauricular) instead of exiting through an abdominal site. This case report is the first to describe the implantation of Jarvik 2000 with postauricular cable as destination therapy in a Japanese patient. This device enables patients to take a bath and may reduce the incidence of driveline infection. [ABSTRACT FROM AUTHOR]