Heart transplant donation after circulatory death: current status and implications.

PURPOSE OF REVIEW: The use of cardiac transplantation following circulatory death (DCD) has been limited worldwide. Concerns about cardiac function after warm ischemia and the potential for decreased graft function have been important considerations in this hesitancy. In addition, ethical and legal questions about the two widely used organ procurement methods have led to discussions and public education in many countries. RECENT FINDINGS: Publication of a US randomized trial of cardiac transplantation following DCD has shown that it is both feasible and has similar short-term outcomes compared with cardiac transplantation following brain death (DBD). These data support those from both Australia and the UK who have largest experience to date. SUMMARY: The adoption of cardiac transplantation following circulatory death has increased overall cardiac transplantation in those transplant centers who have incorporated these donors. Short term outcomes for DCD organ procurement methods are similar to those outcomes using DBD hearts. Continued study and standardization of warm ischemic times will allow for better comparisons of organ procurement techniques and organ optimization. The ethical concerns about procurement methods, in addition to a discussion of procurement costs and feasibility will need to be addressed further in the efforts to expand the organ pool and increase overall cardiac transplantation numbers.

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure" replaces the "2013 ACCF/AHA Guideline for the Management of Heart Failure" and the "2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure." The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. METHODS: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure" replaces the "2013 ACCF/AHA Guideline for the Management of Heart Failure" and the "2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure." The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. METHODS: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.

Socioeconomic status and in-hospital outcomes for patients undergoing heart transplantation or ventricular assist device implantation.

INTRODUCTION: Although lower socioeconomic status (SES) has been associated with worse in-hospital outcomes among patients with heart failure, the in-hospital outcomes for patients undergoing durable Left Ventricular Assist Device (LVAD) implantation or Heart Transplantation (HT) based on SES have not been well characterized. METHODS: We analyzed data from the National Inpatient Sample of hospitalizations between January 2016 and December 2020 of patients aged 18 and over who underwent a HT or newly implanted LVAD. Quartile classification of the median household income of the patient's residential zip code was used to estimate SES. Multivariable analyses with logistic and linear regression were used to evaluate the effects of SES on inpatient outcomes including inpatient mortality, length of stay, and key inpatient complications. RESULTS: A total of 16,265 weighted hospitalizations for new LVAD implantation and 14,320 weighted hospitalizations for HT were identified. In multivariable analysis, among patients undergoing HT or LVAD implantation respectively, there were no significant differences between the lowest and highest SES quartiles among important in-hospital outcomes including length of stay (adj B-coeff .56, (-3.59)-(4.71), p = .79 and adj B-coeff 2.40, (-.21)-(5.02), p = .07) and mortality (aOR 1.02, .61-1.70, p = .94 and aOR 1.08, .72-1.62, p = .73). There were also no differences based on SES quartile in important inpatient complications including stroke and cardiac arrest. CONCLUSION: In this analysis from the National Inpatient Sample, we demonstrate that SES, evaluated by median zip code income, was not associated with important in-hospital metrics including mortality and length of stay among patients undergoing LVAD or HT.

2022 American College of Cardiology/American Heart Association/Heart Failure Society of America Guideline for the Management of Heart Failure: Executive Summary.

BACKGROUND: The 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America (AHA/ACC/HFSA) Guideline for the Management of Heart Failure replaces the 2013 ACCF/AHA Guideline for the Management of Heart Failure and the 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose and manage patients with heart failure. METHODS: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews and other evidence conducted in human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies published through September 2021 were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. RESULTS AND CONCLUSIONS: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments that have high-quality published economic analyses.

SGLT-2 Inhibitors for Patients with Heart Failure: What Have We Learned Recently?

PURPOSE OF REVIEW: In this review, we discuss the mechanisms of action of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and the purported protective effects for mitigating heart failure (HF)-related outcomes. RECENT FINDINGS: Major randomized clinical trials have demonstrated the cardiovascular safety and efficacy of SGLT-2i among patients without known HF and those with established HF with reduced ejection fraction or preserved ejection fraction (HFrEF and HFpEF respectively). Recent HF guidelines have incorporated SGLT-2i in HF treatment algorithms. SGLT-2i have emerged as a novel treatment for both prevention of HF and reduction of cardiovascular morbidity and mortality among patients with existing HFrEF or HFpEF.

Telerehabilitation: Future of Phase II Cardiac Rehabilitation: Review of Preliminary Outcomes.

In this brief communication, we reported Telehealth Home-Based Cardiac Rehabilitation (CR) program structure and preliminary outcomes from patients that completed a 12-week program after coronary artery bypass graft surgery (CABG). We aim to advocate the use of Telerehabilitation as a Phase II CR in patients immediately after the CABG. This approach was innovative and encouraging because the patients were still in subacute phase. The program can serve as a continuation of care for the patients after being discharged from a hospital while regaining their functional ability at home. Our preliminary outcomes demonstrated improvements in resting heart rate, activity level, nutrition status, self-efficacy for managing cardiac diseases, muscle strength, endurance and depression. There were no adverse events during the virtual sessions. Patient satisfaction score was high.

An Open Discussion of the Impact of OpenNotes on Clinical Ethics: A Justification for Harm-Based Exclusions from Clinical Ethics Documentation.

The OpenNotes (ON) mandate in the 21st Century Cures Act requires that patients or their legally authorized representatives be able to access their medical information in their electronic medical record (EMR) in real time. Ethics notes fall under the domain of this policy. We argue that ethics notes are unique from other clinical documentation in a number of ways: they lack best-practice guidelines, are written in the context of common misconceptions surrounding the purpose of ethics consultation, and often answer questions of a different nature than other documentation. Thus, we believe the clinical ethics community would benefit from clarification on when the withholding of ethics notes is justified. We provide recommendations for excluding information from ethics documentation based on the likelihood and magnitude of harm that may occur with particular disclosures and suggest approaches to decrease the potential harms that may occur. We define and explain six types of reasons to exclude information from ethics notes based on significant harms that are not addressed in the ON policy: (1) harmful revelations from a protected chart note; (2) negative emotional effects on patients or families; (3) the purpose of the consultation is undermined by harmful consequences; (4) avoidable negative impact on interpersonal dynamics; (5) inappropriate labeling or disclosure of medical, social, or financial information; and (6) inclusion of biasing or otherwise unfair information. We also suggest approaches to mitigate harm when excluding, including, reframing, or delaying release of information that is perceived to be relevant to an ethics case. Overall, we hope our analysis and recommendations will initiate a much-needed discussion about the impact of the ON mandate on clinical ethics documentation.

Telehealth in Heart Failure.

Telehealth presents opportunities for enhanced care and benefits to patients with heart failure. As technology develops, telehealth is increasingly being integrated into the standard care of heart failure. Telehealth can help enhance timely access and follow-up, facilitate care coordination for diagnostic and management strategies, individualize management, increase opportunities for multidisciplinary care, help implement complementary management strategies, and improve outcomes. Telehealth commonly includes clinician-to-clinician communication; patient interaction with mobile health technologies including remote monitoring, and clinician-to-patient interaction modalities. Despite all the potential benefits of expanded access, telehealth may have limitations especially for vulnerable populations, who are at risk for less access to telehealth modalities and infrastructure. Clinicians and health networks should examine strategies to incorporate telehealth in the management of patients with heart failure. Health care systems should invest in technologies and provide equipment and connectivity to ensure that telehealth does not widen health disparities.

Consensus conference on heart-kidney transplantation.

Simultaneous heart-kidney transplant (sHK) has enabled the successful transplantation of patients with end-stage heart disease and concomitant kidney disease, with non-inferior outcomes to heart transplant (HT) alone. The decision for sHK is challenged by difficulties in differentiating those patients with a significant component of reversible kidney injury due to cardiorenal syndrome who may recover kidney function after HT, from those with intrinsic advanced kidney disease who would benefit most from sHK. A consensus conference on sHK took place on June 1, 2019 in Boston, Massachusetts. The conference represented a collaborative effort by experts in cardiothoracic and kidney transplantation from centers across the United States to explore the development of guidelines for the interdisciplinary criteria for kidney transplantation in the sHK candidate, to evaluate the current allocation of kidneys to follow the heart for sHK, and to recommend standardized care for the management of sHK recipients. The conference served as a forum to unify criteria between the different specialties and to forge a pathway for patients who may need dual organ transplantation. Due to the continuing shortage of available donor organs, ethical problems related to multi-organ transplantation were also debated. The findings and consensus statements are presented.

Etiology and pathophysiology of heart failure in people with HIV.

HIV-associated cardiomyopathy is a well-established sequela in people infected with HIV (PHIV). Despite significant advances in HIV management through the use of highly active anti-retroviral therapy (HAART), PHIV on HAART continue to have elevated risk of cardiomyopathy and heart failure, even when accounting for known cardiovascular risk factors. This review article will explore the proposed mechanisms by which chronic HIV infection induces cardiomyopathy and heart failure in the setting of HAART. Evaluation, work-up, and management of cardiomyopathy in PHIV will also be briefly discussed. The advent of HAART has altered the pathophysiology HIV-associated cardiomyopathy from a rapidly progressive cardiomyopathy, often with pericardial involvement, into a chronic process involving inflammation and persistent immune dysregulation. With the significant decrease in AIDS-related deaths, the prevalence of cardiomyopathy and the mortality associated with heart failure in PHIV have increased. Multiple immune-related and inflammatory mechanisms have been proposed, which may provide insight into evaluation and management of cardiomyopathy in PHIV.

Rethinking the Meaning of Palliation in Heart Failure.

PURPOSE OF REVIEW: Palliative care follows a philosophy of care that focuses upon the quality of life in patients with chronic or life-threatening illness. It also focuses upon the needs of their families which is a wider scope of care. Cardiovascular disease, and specifically heart failure, affects millions of patients and family members who have a symptom burden that exceeds that of many cancers and other chronic diseases. RECENTLY FINDINGS: Historically palliative care has been viewed as an alternative to curative therapies, but over time, it is now recognized that it should be implemented earlier in the course of chronic diseases. Although non-oncologic patients now comprise over half of the patient seen by palliative care, patients with cardiovascular disease are still not being referred to palliative care. Palliative care goes beyond advance directives and end of life planning. There is a need to continue to expand the view of palliative care to encompass interventions that help improve the overall health of these patients, including their psychosocial well-being and quality of life. The collection of papers in this journal provides insight into the breadth of palliative care for patients with heart failure and other cardiovascular diseases.

Acute Kidney Injury With Ventricular Assist Device Placement: National Estimates of Trends and Outcomes.

RATIONALE & OBJECTIVE: Ventricular assist devices (VADs) are used for end-stage heart failure not amenable to medical therapy. Acute kidney injury (AKI) in this setting is common due to heart failure decompensation, surgical stress, and other factors. Little is known about national trends in AKI diagnosis and AKI requiring dialysis (AKI-D) and associated outcomes with VAD implantation. We investigated national estimates and trends for diagnosed AKI, AKI-D, and associated patient and resource utilization outcomes in hospitalizations in which implantable VADs were placed. STUDY DESIGN: Cohort study of 20% stratified sample of US hospitalizations. SETTING & PARTICIPANTS: Patients who underwent implantable VAD placement in 2006 to 2015. EXPOSURE: No AKI diagnosis, AKI without dialysis, AKI-D. OUTCOMES: In-hospital mortality, length of stay, estimated hospitalization costs. ANALYTICAL APPROACH: Multivariate logistic and linear regression using survey design methods to account for stratification, clustering, and weighting. RESULTS: An estimated 24,140 implantable VADs were placed, increasing from 853 in 2006 to 3,945 in 2015. AKI was diagnosed in 56.1% of hospitalizations and AKI-D occurred in 6.5%. AKI diagnosis increased from 44.0% in 2006 to 2007 to 61.7% in 2014 to 2015; AKI-D declined from 9.3% in 2006 to 2007 to 5.2% in 2014 to 2015. Mortality declined in all AKI categories but this varied by category: those with AKI-D had the smallest decline. Adjusted hospitalization costs were 19.1% higher in those with diagnosed AKI and 39.6% higher in those with AKI-D, compared to no AKI. LIMITATIONS: Administrative data; timing of AKI with respect to VAD implantation cannot be determined; limited pre-existing chronic kidney disease ascertainment; discharge weights not derived for subpopulation of interest. CONCLUSIONS: A decreasing proportion of patients undergoing VAD implantation experience AKI-D, but mortality among these patients remains high. AKI diagnosis with VAD implantation is increasing, possibly reflecting changes in AKI surveillance, awareness, and coding.

Elevated Angiopoietin-2 Level in Patients With Continuous-Flow Left Ventricular Assist Devices Leads to Altered Angiogenesis and Is Associated With Higher Nonsurgical Bleeding.

BACKGROUND: Nonsurgical bleeding is the most common adverse event in patients with continuous-flow left ventricular assist devices (LVADs) and is caused by arteriovenous malformations. We hypothesized that deregulation of an angiogenic factor, angiopoietin-2 (Ang-2), in patients with LVADs leads to increased angiogenesis and higher nonsurgical bleeding. METHODS: Ang-2 and thrombin levels were measured by ELISA and Western blotting, respectively, in blood samples from 101 patients with heart failure, LVAD, or orthotopic heart transplantation. Ang-2 expression in endothelial biopsy was quantified by immunofluorescence. Angiogenesis was determined by in vitro tube formation from serum from each patient with or without Ang-2-blocking antibody. Ang-2 gene expression was measured by reverse transcription-polymerase chain reaction in endothelial cells incubated with plasma from each patient with or without the thrombin receptor blocker vorapaxar. RESULTS: Compared with patients with heart failure or those with orthotopic heart transplantation, serum levels and endothelial expression of Ang-2 were higher in LVAD patients (P=0.001 and P<0.001, respectively). This corresponded to an increased angiogenic potential of serum from patients with LVADs (P<0.001), which was normalized with Ang-2 blockade. Furthermore, plasma from LVAD patients contained higher amounts of thrombin (P=0.003), which was associated with activation of the contact coagulation system. Plasma from LVAD patients induced more Ang-2 gene expression in endothelial cells (P<0.001), which was reduced with thrombin receptor blockade (P=0.013). LVAD patients with Ang-2 levels above the mean (12.32 ng/mL) had more nonsurgical bleeding events compared with patients with Ang-2 levels below the mean (P=0.003). CONCLUSIONS: Our findings indicate that thrombin-induced Ang-2 expression in LVAD patients leads to increased angiogenesis in vitro and may be associated with higher nonsurgical bleeding events. Ang-2 therefore may contribute to arteriovenous malformation formation and subsequent bleeding in LVAD patients.

Screening for Outflow Cannula Malfunction of Left Ventricular Assist Devices (LVADs) With the Use of Doppler Echocardiography: New LVAD-Specific Reference Values for Contemporary Devices.

BACKGROUND: Echocardiographic assessment of left ventricular assist devices (LVADs) is used as a screening tool to evaluate the integrity and mechanics of the pump and circuit. We aimed to 1) establish the normal range and upper reference limit of peak velocity of the outflow cannula for the modern era of LVADs and 2) assess the clinical performance of the currently cited and newly proposed reference limits in patients with continuous-flow LVADs as a screening tool for cannula malfunction. METHODS: LVAD outflow peak CW velocities were measured with the use of Doppler transthoracic echocardiography (TTE) in 57 patients with LVADs (44 with Heartmate II (HM2), 13 with Heartware (HW)). The average velocity and the upper and lower normal reference limits (defined as ±2 standard deviations from the mean) for each LVAD type was calculated. The upper reference limit was then used as a screening threshold for cannula malfunction. RESULTS: The average outflow cannula peak velocity for the normal HM2 cohort was 1.86 ± 0.44 m/s with upper and lower reference limits of 2.73 m/s and 0.98 m/s, respectively. The average outflow cannula peak velocity for the normal HW cohort was 2.36 ± 0.53 m/s with upper and lower reference limits of 3.42 m/s and 1.3 m/s, respectively, which was significantly higher than the HM2 cohort (P = .004). CONCLUSIONS: In both HM2 and HW LVADs, the average peak outflow velocity and reference limit for the normal population, as measured by Doppler TTE, was markedly higher than the currently used LVAD reference limits of 2 m/s and are significantly different between devices. Patients with peak outflow velocities above our upper reference limits should be evaluated for LVAD outflow cannula malfunction.

Predictors of survival following trans-catheter aortic valve closure for left ventricular assist device associated aortic insufficiency.

OBJECTIVE: This study sought to assess the long-term clinical benefits and predictors of survival of trans-catheter aortic valve closure in left ventricular assist device (LVAD) patients. BACKGROUND: LVADs have been shown to increase survival and quality of life in patients with end-stage heart failure. However, severe aortic insufficiency (AI) can develop in up to 50% of patients at 12 months resulting in significant morbidity and mortality. Trans-catheter treatment of LVAD associated AI has emerged as a potential alternative to surgical treatment. METHODS: We conducted a retrospective analysis of all patients undergoing trans-catheter aortic valve closure using an Amplatzer Multi-Fenestrated Septal Occluder "Cribriform" device to assess potential clinical and procedural factors associated with survival. Student's t-tests were used to compare baseline patient demographics and procedural characteristics, as well as patient outcomes immediately post procedure and at 6 months. A P-value of less than 0.05 was considered statistically significant. RESULTS: A total of 10 patients (70% male, median age 59 years) were included. Technical success was accomplished in 100% of patients with a 6 month survival rate of 30% (3/10). Compared with survivors, non-survivors had a higher rate of pre-procedural clinical co-morbidities, an increased likelihood of right ventricular failure, and received larger occluder devices. CONCLUSIONS: Trans-catheter aortic valve closure successfully treats late severe AI in LVAD patients, however, the presence or development of right heart failure portends a worse prognosis. Further studies are needed to investigate the factors involved in the development of right ventricular failure, and potential treatment, in patients undergoing trans-catheter aortic valve closure.

Acute kidney injury and mortality following ventricular assist device implantation.

BACKGROUND: Ventricular assist devices (VADs) are increasingly common, and their surgical implantation predisposes patients to an increased risk of acute kidney injury (AKI). We sought to evaluate the incidence, risk factors and short- and long-term all-cause mortality of patients with AKI following VAD implantation. METHODS: We identified all patients who underwent VAD implantation at the University of Chicago between January 1, 2008, and January 31, 2012. We evaluated the incidence of AKI, defined as a ≥50% increase in serum creatinine over the first 7 postoperative days (RIFLE Risk-Creatinine). A logistic regression model was used to identify risk factors for the development of AKI, and a Cox proportional hazards model was used to examine factors associated with 30-day and 365-day all-cause mortality. RESULTS: A total of 157 eligible patients had VAD implantations with 44 (28%) developing postimplantation AKI. In a multivariate analysis, only diabetes mellitus [odds ratio = 2.25 (1.03-4.94), p = 0.04] was identified as a significant predictor of postoperative AKI. Using a multivariable model censored for heart transplantation, only AKI [hazard ratio, HR = 3.01 (1.15-7.92), p = 0.03] and cardiopulmonary bypass time [HR = 1.01 (1.001-1.02), p = 0.02] were independent predictors of 30-day mortality. Preoperative body mass index [HR = 0.95 (0.90-0.99), p = 0.03], preoperative diabetes mellitus [HR = 1.89 (1.07-3.35), p = 0.03] and postimplantation AKI [HR = 1.85 (1.06-3.21), p = 0.03] independently predicted 365-day mortality. CONCLUSION: AKI is common following VAD implantation and is an independent predictor of 30-day and 1-year all-cause mortality.

Ethical considerations in xenotransplantation of thoracic organs - a call for a debate on value based decisions.

Xenotransplant covers a broad ethical territory and there are several ethical questions that have arisen in parallel with the technological advances that have allowed the first porcine transplants to occur. This brief communication highlights ethical considerations regarding heart and lung xenotransplantation, with an emphasis on unresolved value-based concerns in the field. The aim of this text is therefore to encourage the readers to consider the vast potential of this emerging technique to do good, but also the risk of doing harm, and to participate in a discussion. The list of questions presented here is not exhaustive but hopefully represents some of the questions that appear to be most pressing as the field advances. The focus is on the value-based, or ethical questions, not the questions related to the practical medical procedures.

Deactivation of Left Ventricular Assist Devices at the End of Life: Narrative Review and Ethical Framework.

Left ventricular assist devices (LVADs) have become an increasingly common advanced therapy in patients with severe symptomatic heart failure. Their unique nature in prolonging life through incorporation into the circulatory system raises ethical questions regarding patient identity and values, device ontology, and treatment categorization; approaching requests for LVAD deactivation requires consideration of these factors, among others. To that end, clinicians would benefit from a deeper understanding of: 1) the history and nature of LVADs; 2) the wider context of device deactivation and associated ethical considerations; and 3) an introductory framework incorporating best practices in requests for LVAD deactivation (specifically in controversial situations without obvious medical or device-related complications). In such decisions, heart failure teams can safeguard patient preferences without compromising ethical practice through more explicit advance care planning before LVAD implantation, early integration of hospice and palliative medicine specialists (maintained throughout the disease process), and further research interrogating behaviors and attitudes related to LVAD deactivation.