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Destination therapy (DT) is the indication to implant a left ventricular assist device (LVAD) in a patient with stage D heart failure who is not a candidate for heart transplantation. The implantable LVAD has been utilized in Japan since 2011 under the indication of bridge to transplant (BTT). After almost 10 year lag, DT has finally been approved and reimbursed in May 2021 in Japan. To initiate the DT program in Japan, revision of the LVAD indication from BTT is necessary. Also, in-depth discussion of caregiver issues as well as end-of-life care is indispensable. For that purpose, we assembled a DT committee of multidisciplinary members in August 2020, and started monthly discussions via web-based communication during the COVID-19 pandemic. This is a summary of the consensus reached after 6 months' discussion, and we have included as many relevant topics as possible. Clinical application of DT has just started, and we are willing to revise this consensus to meet the forthcoming issues raised during real-world clinical experience.

Advanced heart failure (HF) with persistent and progressive clinical decline despite maximal medical therapy portends a high mortality in the absence of advanced therapies, such as ventricular assist devices or heart transplantation. A subset of these advanced HF patients deteriorates into refractory cardiogenic shock, that is challenging to manage with vasoactive agents alone. Temporary mechanical circulatory support (MCS) device options have evolved over the years and provide a viable option to rescue and rest the myocardium of patients in cardiogenic shock. The goal of such therapy is to serve as bridge to recovery, or more often, a bridge to durable advanced therapies. For those patients with progressive advanced HF despite extensive medical therapy, durable MCS devices (ventricular assist devices) are available when heart transplantation is not feasible. In this article, we review currently available temporary and durable MCS devices, with a focus on their hemodynamic profiles, to inform optimal device selection for patients with advanced HF.

Left ventricular assist devices (LVADs) use in treatment of stage D heart failure (HF) has evolved and expanded in the past decade. There is paucity of data on LVAD utilization in patients with age ≥65 years with multiple co-morbidities. We aimed to investigate utilization trends, outcomes, and rates and predictors of readmissions in patients receiving LVADs with age ≥65 years (AO) and comparing them with patient age65 years (AY). We analyzed hospitalization data from the Nationwide Inpatient Sample from 2007 to 2015 to evaluate LVAD utilization trends and outcomes between the 2 patient cohorts. We also queried the Nationwide Readmission Database from 2014 to third quarter of 2015 to identify trends and compare etiologies of readmissions. Implants in AO patients increased from 20% (154) of the total LVADs implanted in 2007 to 33.2% (1,215) in 2014 and 31.8% (910) through September 2015 (p0.01). Over the study period there was a steady and significant increase in the mean Elixhauser scores in elderly patients who underwent LVAD implantation from 15.4 in 2007 to 24.54 in 2015 (p0.01). Despite this finding, the mean LOS in the AO cohort decreased from 56.0 days in 2007 to 33.8 days in 2015 (p0.001). Furthermore, the in-hospital mortality associated with LVAD implantation among the AO group gradually decreased over the study time period (39% in 2007 to 12.2% in 2015, p0.001). The overall readmission rate was not significantly different between AO versus AY group (28% vs 33%, p = 0.2). The most common cause in both groups was gastrointestinal bleed but it was significantly higher in AO group (24.3% vs 11.3%, p = 0.01). In conclusion, patients age ≥65 years with multiple co-morbidities are receiving increasing number of LVADs with improved survival outcomes. Their 30-day readmissions are comparable to the younger patients.

Patients with advanced heart failure (HF) symptoms constitute stage D heart failure with high mortality and less response to conventional guideline directed medical therapies. These patients are subjected to receive non-medical therapies including heart transplant or mechanical circulatory support for increasing survival. Considering the low availability and serious complications of these strategies,effective medical therapies for this group of patients would be pivotal for decreasing mortality and morbidity of them. Angiotensin receptor neprilysin inhibitor (ARNI) is a class of drugs approved for ambulatory heart failure patients. ARNI use like other groups of heart failure drugs has not been fully evaluated in end-stage heart failure patients. Herein, we describe four inotrope-dependent heart failure patients. Initiation of ARNI in these patients, lead to discontinuation of inotrope and reducing the need for inotrope in the follow-up period.

Although the growing use of continuous-flow left ventricular assist devices (LVADs) has improved the survival and quality of life of patients with stage D heart failure, ischemic and hemorrhagic cerebrovascular accidents remain one of the most-feared complications of this therapy and a significant source of disability, morbidity, and mortality. In this article, the authors aim to summarize the current data regarding the incidence/prevalence of both ischemic and hemorrhagic stroke in patients with continuous-flow LVADs, compare axial and centrifugal devices, and discuss the major risk factors for neurologic events that have been identified.

Though left ventricular assist devices (LVADs) are an increasingly common therapy for ACC/AHA Stage D heart failure, the optimal medical therapy for patients with LVADs is not known. We sought to evaluate the safety and efficacy of angiotensin receptor neprilysin inhibitor (ARNi) therapy in our single center LVAD patient experience. We evaluated patients implanted with LVADs at Columbia University Irving Medical Center between August 2010 and May 2019, and who were treated with an ARNi for at least 3 months. Thirty patients met this criteria. Eighteen (60%) patients transitioned to an ARNi from an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), while all were on a beta blocker (BB) at the time of ARNi initiation. The primary outcome, NT-proBNP levels at time of initiation and 3 and 6 month follow up, significantly decreased from a median of 1265 pg/mL at initiation to 750 pg/mL at 3 months and 764 pg/mL at 6 months ( p = 0.01). No significant change was seen in serum creatinine, BUN, or potassium levels.

Patients with Stage D heart failure can benefit from palliative care consultation to help them manage unpleasant symptoms and improve quality of life. Although guidelines describe how to manage symptoms, very little direction is provided on how to evaluate the effectiveness of those interventions.Numerous studies have used the measurement of symptoms, emotional distress, functional capacity and quality of life to evaluate the effectiveness of interventions in heart failure. There is limited evidence on the use of these instruments in heart failure palliative care. Four studies were identified that evaluate the effectiveness of palliative care consultation for patients with advanced heart failure. All four studies measured symptom severity, emotional distress, and quality of life. The application of appropriate instruments is discussed. Suggestions for scores that should trigger palliative care consultation are identified.The routine administration of standardized instruments to measure symptom severity and quality of life may improve the assessment and management of patients with Stage D heart failure. Ongoing discussion and research is needed to determine if these instruments are the best tools to use with heart failure palliative care patients.

Purpose Studies have shown that highly selected patients undergoing combined heart-kidney (HK) and heart-liver transplants (HL) have short- and long-term outcomes comparable to those observed in primary heart transplantation (HT). Methods Adults patients with stage D heart failure that underwent combined HK, HLv and heart-lung (HL) were identified in the United Network for Organ Sharing (UNOS) registry between 1991 and 2016, with follow-up through March 2018. We conducted inverse-probability weighted estimator (IPWE) survival analysis of long-term survival stratified by type of combined organ transplant, accounting for donor, recipient and operative characteristics. Results We identified 2300 patients who underwent combined organ transplant (HK: 1,257, HLv: 212, HL: 831). HL recipients were more likely white (77%), females (58%), with congenital heart disease (44.5%), and longer waiting list time (median 195 days). HK transplant increased significantly during the study period where as HL decreased significantly (Figure). Median survival was 12.2 years for HK (95% Confidence intervals [CI], 10.8-12.8), 12 for HLv (95% CI 8.6-17.6) but significantly lower at 4.5 years for HL (95% CI 3.6-5.8) (Figure). Conclusion Combined HK and HLv transplantation rates are increasing and long-term survival is comparable to primary HT, unlike HL which is associated with decreasing trends and significantly lower survival.

Improving outcomes with durable mechanical circulatory support have led to expanding interest in the earlier recognition of patients destined to develop refractory heart failure (HF). The recognition of advanced HF has received increasing attention. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry developed patient profiles of advanced HF to describe the spectrum of patients with refractory HF undergoing mechanical circulatory support. These patient profiles have been extended to advanced HF patients on medical therapy and used to align outcomes with medical and device therapy in the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) registries and the ROADMAP study. Shared decision-making about treatment options for advanced HF requires individualized consideration of risks and benefits beyond survival. Future studies, including the ongoing Registry for Vital Information for VADs in Ambulatory Life (REVIVAL) study, will provide prognostic information for patients transitioning from stage C to stage D HF to help patients, caregivers, and physicians navigate the increasingly complex terrain of HF care.

Left ventricular assist devices (LVADs) have revolutionized therapy for patients with Stage D heart failure (HF) with reduced systolic function providing not only improved survival benefits but also meaningful changes in quality of life and functional capacity. With technological advances and improved durability of devices, length of survival has significantly improved. With continued organ donor shortage, LVADs are frequently serving as a substitute for cardiac transplant as destination therapy, particularly among the elderly. Internists not only face the important challenge of identifying the patients in need referral for these advanced therapies, they are also faced with the challenges of taking care of these patients. This review will help the internists to better understand the present status, indications and advances in LVADs and also understand the complications and adverse effects associated with these devices.

Patients with symptomatic stage D heart failure who require left ventricular assist device (LVAD) support and suffer concomitant severe mitral regurgitation are often difficult to manage. One reason is due to cardiac anatomic constraints that limit optimization of the mechanical assist device. Typically, these patients are not candidates for repeat sternotomy with surgical mitral valve repair, and heart transplantation may not be feasible or timely. This case describes two patients with LVAD support who received transcatheter edge-to-edge mitral valve repair for severe, symptomatic mitral regurgitation. We believe this procedure may be a therapeutic option in stable patients with severe mitral regurgitation who require mechanical support.

An increasing number of stage D heart failure patients are supported with left ventricular assist devices (LVADs), and the management of LVAD patients who require noncardiac surgery (NCS) presents unique challenges. Using the 2010-2014 National Inpatient Sample, we identified all adult cases of

Purpose: This study examined life descriptions of persons with stage D heart failure (HF) comparing those newly diagnosed to those with chronic HF. Methods: A secondary analysis of interviews from 75 participants followed in a longitudinal study of persons with stage D HF was thematically analyzed. There were 24 participants who were recently diagnosed with stage D HF (less than 2 years) and 51 participants with HF longer than 2 years. Results: Both groups shared life descriptions along a continuum, where recently diagnosed participants described naive expectations with hope for improvement, while the chronic group appeared resigned to their fate and the reality of the limitations of living with HF. Four themes illustrated differences between the groups: outlook on life, activity adjustments, understanding of HF, and mood. Conclusions: Although persons with stage D HF share the same life descriptions, they have differing perspectives of life with HF. Findings from this study can help health-care providers tailor interventions based on the length of time from diagnosis.

An operational consensus definition of Stage D heart failure (HF) is currently lacking.We evaluated 512 outpatients (median age, 63 years; 35.0% women; 45.5% white and 45.9% black; median ejection fraction was 25%; 67.4% had coronary artery disease) with HF and reduced (≤40%) ejection fraction. We applied 3 hypothetical definitions for Stage D: (1) designation as "Stage D" or "advanced" HF by treating physician; (2) INTERMACS profiles, defining Stage D as profiles 2-6; and (3) European Society of Cardiology Heart Failure Association (ESC-HFA) criteria.Physicians, INTERMACS profiles, and ESC-HFA criteria identified 64 (12.5%), 93 (18.2%), and 67 (13.1%) patients, respectively, as Stage D, with modest concordance between definitions (κ = 0.37). After a median of 3.1 years, 97 patients died (3-year mortality 20.4%). Among patients identified as Stage D by physicians, 3-year mortality was 43.7% vs. 17.0% for non-Stage D patients (age-adjusted hazard ratio [HR] 3.17; 95%CI 1.94-5.18; P 0.001). The corresponding mortalities for the INTERMACS-based definition were 41.0% vs. 16.2% (HR 3.28; 95%CI 2.11-5.11; P 0.001) and for ESC-HFA criteria 33.5% vs. 18.6% (HR 2.02; 95%CI 1.22-3.33; P = 0.006); the INTERMACS-based definition provided the best prognostic separation. Results were similar with an alternative INTERMACS-based definition considering only profiles 2-5 as Stage D HF. The INTERMACS-based definition best separated all-cause and HF-specific hospitalization and composite endpoint risk between Stage D and non-Stage D patients also.INTERMACS profiles provide a practical alternative for the identification of Stage D HF in ambulatory populations with systolic HF. The ESC-HFA criteria offer limited prognostic information.

Recent progress and evolution in device engineering, surgical implantation practices, and periprocedural management have advanced the promise of durable support with left ventricular assist systems (LVAS) in patients with stage D heart failure. With greater uptake of LVAS globally, a growing population of LVAS recipients have pre-existing cardiac implantable electronic devices (CIEDs). Strategies for optimal clinical management of CIEDs in patients with durable LVAS are evolving, and clinicians will increasingly face complex decisions regarding implantation, programming, deactivation, and removal of CIEDs. Traditional decision-making pathways for CIEDs may not apply to LVAS-supported patients, as few patients die of arrhythmic causes and many arrhythmias may be well tolerated. Given limited data, treatment decisions must be individualized and made collaboratively among electrophysiologists, advanced heart failure specialists, and patients and their caregivers. Large, prospective, well-conducted studies are needed to better understand the contemporary utility of CIEDs in patients with newer-generation LVAS.

This study sought to estimate the rate of progression to Stage D heart failure (HF) among outpatients with Stage C HF and to identify risk factors for progression.The pool of patients who may be candidates for advanced HF therapies is growing.We estimated 3-year progression to clinically determined Stage D HF and competing mortality among 964 outpatients with Stage C heart failure with reduced ejection fraction (HFrEF), where ejection fraction is ≤40%.The mean age of patients was 62 ± 15 years; 35% were women; 47% were white; 46% were black, and 7% were of other races; median baseline ejection fraction was 28% (25th to 75th percentile: 20% to 35%); and 47% had ischemic heart disease. After 3.0 years (25th to 75th percentile: 1.7 to 3.2 years), 112 patients progressed to Stage D (3-year incidence: 12.2%; 95% confidence interval [CI]: 10.2% to 14.6%; annualized: 4.5%; 95% CI: 3.8% to 5.5%), and 116 patients died before progression (3-year competing mortality: 12.9%; annualized: 4.7%; 95% CI: 3.9% to 5.6%). By 3 years, 25.1% of patients (95% CI: 22.2% to 28.1%) had either progressed to Stage D or died (annualized: 9.2%; 95% CI: 8.1% to 10.5%). Annualized progression rates were higher in black versus white patients (6.3% vs. 2.7%, respectively; p 0.001), nonischemic versus ischemic patients (6.1% vs. 2.9%, respectively; p 0.001), and in New York Heart Association functional class III to IV versus I to II patients (7.5% vs. 1.9%, respectively; p 0.001) but were similar for men and women (4.7% vs. 4.2%, respectively; p = 0.53). Lower ejection fraction and blood pressure, renal and hepatic dysfunction, and chronic lung disease rates were additional predictors of progression. Predictors of competing mortality were different from those of disease progression.Among patients with Stage C HFrEF receiving care in a referral center, 4.5% progressed to Stage D HF each year, with earlier progression among black and nonischemic patients. These findings have implications for healthcare planning and resource allocation for these patients.

Introduction The number of patients with stage D heart failure (HF) requiring a left ventricular assist device (LVAD) is on the rise. The aim herein is to examine family medicine (FM), internal medicine (IM) faculty and house officers (HO) understanding and experience about LVAD. Methods A survey was distributed by email to FM, IM faculty and HO at the University of Michigan. The survey contained questions about LVAD survival and basic management of arresting LVAD patients. Results 111 completed the survey (23.8%). Respondents self-identified as HO (59.5%) and the rest were FM and IM faculty. Only 30.9% reported receiving education on LVADs during their training and 66.6% reported being somewhat familiar with LVAD therapy. However, only half felt that LVAD therapy is a good option for improving quality of life and only 32% felt that LVADs improved survival. Only 6% of respondents estimated correct 1-year survival post pump implant. 77% correctly identified the anticoagulation of choice and 47% reported the appropriate way to measure blood pressure. No respondents received instruction on how to run a code on LVAD patients during ACLS certification, only 6.3% were aware of the recent AHA scientific statement regarding unresponsive LVAD patient management, and only 9% felt comfortable running a code blue on an LVAD patient. 49% and 35%, respectively, report that chest compressions and defibrillation can be performed if indicated. HO had better knowledge than IM and FM faculty regarding arresting LVAD patient management (p Conclusions Substantial knowledge gaps about LVAD and basic LVAD management were identified among IM, FM faculty and HO at a large teaching hospital. Similar knowledge gaps may exist among the larger internal and family medicine communities as a whole.

Significant non-cardiac comorbidities can impact the care and change management of patients with stage D heart failure (HF). 41 year old African American male with non-ischemic cardiomyopathy (left ventricular ejection fraction < 20%) frequently admitted for cardiogenic shock and recurrent

Introduction: Care for patients with stage D heart failure (HF) is becoming increasingly complex in the era of mechanical circulatory support (MCS). However, an operational consensus definition of stage D HF is currently lacking. Hypothesis: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles better identify outpatients with stage D HF compared to European Society of Cardiology Heart Failure Association (ESC-HFA) criteria and physician assessment. Methods: We evaluated 474 outpatients with systolic HF (ejection fraction [EF] Results: INTERMACS profiles, ESC-HFA criteria, and physicians identified 50 (10.5%), 59 (12.4%), and 64 (13.5%) of 474 patients, respectively, as having stage D HF. Concordance between definitions was low, with κ =0.35 (optimal: 1.0). After a median of 3.1 years (1.6, 3.3), 95 patients died (3-year mortality: 21.4%). In addition, 24 patients received MCS and 11 received heart transplant. Mortality was 51.2%, 43.7%, and 34.5% for INTERMACS-, ESC-HFA-, and physician-identified stage D HF patients, respectively ( Figure 1 ). The INTERMACS definition provided the best prognostic separation between stage D and C HF patients, as measured by the Royston’s R 2 statistic ( Figure 1 ). Conclusions: INTERMACS profiles provide a reasonable alternative for the identification of stage D patients in ambulatory systolic HF populations and offer better prognostic information than the ESC-HFA criteria.

The new classification of heart failure in the American College of Cardiology/American Heart Association guidelines includes stage D, which is refractory severe heart failure that does not respond to medical or resynchronization therapy. Among the many treatment strategies for stage D heart failure, only heart transplantation and ventricular assist devices have been established as improving prognosis. With the evolution in the mechanics of ventricular assist devices in recent years, the postoperative prognosis has improved, and less sick patients can now be candidates for these devices. In Japan, 2 continuous flow devices have been approved since April 2011, and now is the best time to consider the indications for their use. (Circ J 2011; 75: 2038-2045)

Hypervolemic hyponatremia is often complicated with advanced heart failure together with increased excretion of sodium by diuretics. Tolvaptan, an oral vasopressin-2-receptor antagonist, has been previously reported to improve congestion and correct hyponatremia through increased excretion of free water. However, there is little evidence concerning the administration of tolvaptan in patients with stage D heart failure. We experienced 2 patients with stage D heart failure who received 3.75 mg/day of tolvaptan to correct hyponatremia before ventricular assist device implantation. It may be useful, even for patients with stage D heart failure, to administer a low dose of tolvaptan to treat hyponatremia before ventricular assist device implantation to avoid a drastic alteration in serum sodium concentration perioperatively.

Background: Continuous outpatient milrinone infusion is a proposed therapy for patients (pts) with NYHA-IV stage D HF, yet it is associated with an increase in ventricular dysrhythmias. As such, guidelines advise caution using milrinone in pts with a history of ventricular tachycardia (VT). As

Incidence rates and risk factors for transition to Stage D heart failure (HF) among patients with stable, Stage C HF with reduced ejection fraction (HFrEF) have not been reported. We evaluated 3-year transition to clinically determined Stage D HF, after accounting for competing mortality, in 919