Impella 5.5 as a bridge to heart transplantation: Waitlist outcomes in the United States.

OBJECTIVES: The 2018 United Network for Organ Sharing allocation policy change has led to a significant increase in the use of mechanical circulatory support devices in patients listed for orthotopic heart transplantation. However, there has been a paucity of data regarding the newest generation Impella 5.5, which received FDA approval in 2019. METHODS: The United Network for Organ Sharing registry was queried for all adults awaiting orthotopic heart transplantation who received Impella 5.5 support during their listing period. Waitlist, device, and early post-transplant outcomes were assessed. RESULTS: A total of 464 patients received Impella 5.5 support during their listing period with a median waitlist time of 19 days. Among them, 402 (87%) patients were ultimately transplanted, with 378 (81%) being directly bridged to transplant with the device. Waitlist death (7%) and clinical deterioration (5%) were the most common reasons for waitlist removal. Device complications and failure were uncommon (<5%). The most common post-transplant complication was acute kidney injury requiring dialysis (16%). Survival at 1-year post-transplant survival was 89.5%. CONCLUSION: Since its approval, the Impella 5.5 has been increasingly used as a bridge to transplant. This analysis demonstrates robust waitlist and post-transplant outcomes with minimal device-related and postoperative complications.

Sex Differences in Left Ventricular Assist Device-related Emergency Department Encounters in the United States.

BACKGROUND: There is a paucity of data regarding sex differences in the profiles and outcomes of ambulatory patients on left ventricular assist device (LVAD) support who present to the emergency department (ED). METHODS AND RESULTS: We performed a retrospective analysis of 57,200 LVAD-related ED patient encounters from the 2010 to 2018 Nationwide Emergency Department Sample. International Classification of Diseases Clinical Modification, Ninth Revision and Tenth Revision, codes identified patients aged 18 years or older with LVADs and associated primary and comorbidity diagnoses. Clinical characteristics and outcomes were stratified by sex and compared. Multivariable logistic regression was used to evaluate predictors of hospital admission and death. Female patient encounters comprised 27.2% of ED visits and occurred at younger ages and more frequently with obesity and depression (all P < .01). There were no sex differences in presentation for device complication, stroke, infection, or heart failure (all P > .05); however, female patient encounters were more often respiratory- and genitourinary or gynecological related (both P < .01). After adjustment for age group, diabetes, depression, and hypertension, male patient encounters had a 38% increased odds of hospital admission (95% confidence interval 1.20-1.58), but there was no sex difference in the adjusted odds of death (odds ratio 1.11, 95% confidence interval 0.86-1.45). CONCLUSIONS: Patient encounters of females on LVAD support have significantly different comorbidities and outcomes compared with males. Further inquiry into these sex differences is imperative to improve long-term outcomes.

Fontan-Associated Liver Disease: Screening, Management, and Transplant Considerations.

Surgical innovation and multidisciplinary management have allowed children born with univentricular physiology congenital heart disease to survive into adulthood. An estimated global population of 70 000 patients have undergone the Fontan procedure and are alive today, most of whom are <25 years of age. Several unexpected consequences of the Fontan circulation include Fontan-associated liver disease. Surveillance biopsies have demonstrated that virtually 100% of these patients develop clinically silent fibrosis by adolescence. As they mature, there are increasing reports of combined heart-liver transplantation resulting from advanced liver disease, including bridging fibrosis, cirrhosis, and hepatocellular carcinoma, in this population. In the absence of a transplantation option, these young patients face a poor quality of life and overall survival. Acknowledging that there are no consensus guidelines for diagnosing and monitoring Fontan-associated liver disease or when to consider heart transplantation versus combined heart-liver transplantation in these patients, a multidisciplinary working group reviewed the literature surrounding Fontan-associated liver disease, with a specific focus on considerations for transplantation.

Multiorgan procurement is associated with a survival benefit after heart transplantation.

We assessed the impact of donor multiorgan procurement on survival following orthotopic heart transplantation (OHT). From the UNOS STAR database, we included all adult (≥18 Y) heart transplants (OHT) performed since 2000 and used donor IDs to determine how many other organs were procured from the same donor as the recipient's heart allograft (regardless of recipient). The Kaplan-Meier survival functions and risk-adjusted Cox proportional hazards regression models were computed to assess the association of multiorgan procurement with post-heart transplantation mortality. We included 40 336 OHT patients. Including the heart, the median number of donor organs procured was 3 (IQR, 3-4). Heart donors underwent liver procurement in 89.7%; kidney(s) in 98.1% (single 95%, bilateral 5%); lung(s) in 38.0% (single 28%, bilateral 72%); pancreas in 10.4%; and intestine in 1.6%. Following risk adjustment across 16 recipient- and donor-specific variables, an increasing number of organs procured were independently associated with reduced post-OHT mortality (HR 0.98, 95% CI 0.96-0.99, P = .025). Though no significant associations were found examining specific organ types, double lung procurement trended toward a protective effect (HR 0.96, 0.92-1.01, P = .086), with counts of non-lung organs procured still bordering on significance (HR 0.97, 95% CI 0.95-1.00, P = .067). These results likely reflect improved multiorgan donor quality.

Brain-Type Natriuretic Peptide and Amino-Terminal Pro-Brain-Type Natriuretic Peptide Discharge Thresholds for Acute Decompensated Heart Failure: A Systematic Review.

BACKGROUND: Acute decompensated heart failure (ADHF) requiring hospitalization is associated with high postdischarge mortality and readmission rates. PURPOSE: To examine the association between achieving predischarge natriuretic peptide (NP) thresholds and mortality and readmission rates in adults hospitalized for ADHF. DATA SOURCES: Multiple databases from 1947 to October 2016 (English-language studies only). STUDY SELECTION: Trials and observational studies that compared mortality and readmission outcomes between patients with ADHF achieving a specific predischarge NP goal and those not achieving the goal. DATA EXTRACTION: Two investigators independently extracted study characteristics and assessed study risk of bias. One author graded the overall strength of evidence, with review by a second author. DATA SYNTHESIS: One randomized trial, 3 quasi-experimental studies, and 40 observational studies were identified. The most commonly used thresholds were a brain-type NP (BNP) level of 250 pg/mL or less or an amino-terminal pro-brain-type NP (NT-proBNP) decrease of at least 30%. Achievement of absolute BNP thresholds reduced postdischarge all-cause mortality (7 of 8 studies) and the composite outcome of mortality and readmission (12 of 14 studies). Achievement of percentage-change BNP thresholds reduced the composite outcome (5 of 6 studies), and achievement of percentage-change NT-proBNP thresholds reduced all-cause and cardiovascular mortality (2 of 4 studies) and the composite outcome (9 of 9 studies). All findings were low-strength. The randomized trial, assessed as having high risk of bias, suggested that a predischarge decrease in NT-proBNP level was associated with lower risk for the composite outcome. Two quasi-experimental studies and 5 observational studies had low risk of bias. Low-risk-of-bias studies had outcome estimates similar in magnitude and direction to estimates from high-risk-of-bias studies. LIMITATION: Most studies failed to adjust for critical confounders and had inadequate definition or assessment of exposures and outcomes. CONCLUSION: Low-strength evidence suggests an association between achieving NP predischarge thresholds and reduced ADHF mortality and readmission. PRIMARY FUNDING SOURCE: None.

Left Ventricular Dysfunction and Chemotherapeutic Agents.

PURPOSE OF REVIEW: We aim to summarize the effect of cancer therapy-related cardiotoxicity on the development of left ventricular (LV) dysfunction. RECENT FINDINGS: We discuss commonly used cancer therapeutics that have the potential for both acute and delayed cardiotoxicity. LV dysfunction from cancer therapies may be found by routine cardiac imaging prior to clinical manifestations of heart failure (HF) and we discuss the current multi-modality approaches for early detection of toxicity with the use of advanced echocardiographic parameters including strain techniques. Further, we discuss the role of biomarkers for detection of LV dysfunction from cancer therapies. Current approaches monitoring and treating LV dysfunction related to cancer therapy-related cardiotoxicity include addressing modifiable cardiovascular risk factors especially hypertension and early initiation of neurohormonal blockade (NHB) with disease-modifying beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors. Once LV dysfunction is identified, traditional ACC/AHA guideline-directed therapy is employed. Further, we highlight the use of advanced heart failure therapies including mechanical resynchronization devices, the use of durable ventricular assist devices, and cardiac transplantation as increasingly employed modalities for treatment of severe LV dysfunction and advanced heart failure in the cardio-oncology population. This review seeks to highlight the importance of early detection, treatment, and prevention of LV dysfunction from cancer therapy-related cardiotoxicity.

Access to durable LVAD therapy for patients with limited social support: Surveying program-specific approaches.

Racial and ethnic disparities in provision of left ventricular assist device (LVAD) therapy have been identified. These disparities may be at least partially related to socioeconomic factors, including social support networks and financial constraints. This study aimed to identify specific barriers, and variations in institutional approaches, to the provision of equitable care to underserved populations. A survey was administered to 237 LVAD program personnel, including physicians, LVAD coordinators, and social workers, at more than 100 LVAD centers across 7 countries. Three fourths of respondents reported that their program required a support person to live with the LVAD patient for some period of time following implantation. In addition, 31% of respondents reported that patients with the inability to pay for medications are turned down at their program. The most significant barriers to successful LVAD implantation were lack of social support, lack of insurance, and lack of timely referral. The most consistently identified supports needed from the hospital system for success in underserved populations were the provision of a solution for patient transportation to and from hospital visits and the provision of financial support. This survey highlights the challenges facing LVAD programs that care for underserved patient populations and sets the stage for specific interventions aimed at reducing disparities in access to care.

Health Coaching Improves Outcomes of Informal Caregivers of Adults With Chronic Heart Failure: A Randomized Controlled Trial.

BACKGROUND: Caring for someone with heart failure takes an emotional and physical toll. Engaging in self-care may decrease stress and improve the health of informal caregivers. We conducted a randomized controlled trial testing the efficacy of a virtual health coaching intervention, compared with health information alone, on the self-care, stress, coping, and health status of heart failure caregivers. METHODS: We enrolled 250 caregivers providing care at least 8 hours/week, reporting poor self-care, and able to use technology. All received a tablet device programmed with websites providing vetted information on heart failure and caregiving. Half were randomized to also receive 10 synchronous support sessions virtually with a health coach over 6 months. Data on self-care, stress, coping, and health status were collected at baseline and 3 and 6 months. Linear mixed-effects models were used to assess the interaction between time and treatment group. RESULTS: The sample was majority female (85.2%), White (62.2%), spouses (59.8%), and aged 55±13.6 years. Many were employed full time (41.8%). They had been caring for the patient 8 hours/day for a median of 3.25 years. In the intention-to-treat analysis, caregivers who received the health coach intervention had statistically and clinically greater improvement across 6 months compared with the control group in the primary outcome of self-care maintenance (5.05±1.99; P=0.01) and stress (-4.50±1.00; P<0.0001). Self-care neglect declined significantly (-0.65±0.32; P=0.04), but the difference between the treatment arms disappeared when the results were adjusted for multiple comparisons. Mental health status improved statistically but not clinically (3.35±1.61; P=0.04). Active coping improved in both groups but not significantly more in the intervention group (P=0.10). Physical health status was unchanged (P=0.27). CONCLUSIONS: This virtual health coaching intervention was effective in improving self-care and stress in heart failure caregivers.

Early Cardiopulmonary Fitness after Heart Transplantation as a Determinant of Post-Transplant Survival.

BACKGROUND: Decreased peak oxygen consumption during exercise (peak Vo2) is a well-established prognostic marker for mortality in ambulatory heart failure. After heart transplantation, the utility of peak Vo2 as a marker of post-transplant survival is not well established. METHODS AND RESULTS: We performed a retrospective analysis of adult heart transplant recipients at the Hospital of the University of Pennsylvania who underwent cardiopulmonary exercise testing within a year of transplant between the years 2000 to 2011. Using time-to-event models, we analyzed the hazard of mortality over nearly two decades of follow-up as a function of post-transplant percent predicted peak Vo2 (%Vo2). A total of 235 patients met inclusion criteria. The median post-transplant %Vo2 was 49% (IQR 42 to 60). Each standard deviation (±14%) increase in %Vo2 was associated with a 32% decrease in mortality in adjusted models (HR 0.68, 95% CI 0.53 to 0.87, p = 0.002). A %Vo2 below 29%, 64% and 88% predicted less than 80% survival at 5, 10, and 15 years, respectively. CONCLUSIONS: Post-transplant peak Vo2 is a highly significant prognostic marker for long-term post-transplant survival. It remains to be seen whether decreased peak Vo2 post-transplant is modifiable as a target to improve post-transplant longevity.

Left Ventricular Assist Device as a Bridge to Recovery: Single Center Experience of Successful Device Explantation.

Continuous-flow left ventricular assist devices (CF-LVAD) have been shown to enhance reverse remodeling and myocardial recovery in certain patients allowing for device removal. We sought to analyze the characteristics and describe outcomes of patients who underwent CF-LVAD explantation at a large academic center. We retrospectively identified all patients who underwent CF-LVAD explants due to recovery from 2006 to 2019. Patient baseline characteristics and data on pre- and postexplant evaluation were collected and analyzed. Of 421 patients who underwent CF-LVAD implantation, 13 underwent explantation (3.1%). Twelve HeartMate II and one HeartWare LVAD were explanted. All patients had nonischemic cardiomyopathy. Median time from heart failure diagnosis to LVAD implant was 12 months (interquartile range [IQR], 2-44) and the median time supported on LVAD was 22 months (IQR, 11-28). Two patients died within 30 days of explant. Three additional patients died during the follow-up period and all were noted to be nonadherent to medical therapy. After a mean follow-up duration of 5 years, overall survival was 52%. Mean pre-explant ejection fraction was 49%, which decreased at most recent follow-up to 32%. Mean pre-explant left ventricular internal diameter in diastole (LVIDD) was 4.37 cm and increased to 5.52 cm at most recent follow-up. Continuous-flow left ventricular assist device explantation is feasible and safe in select patients.

Ventricular Assist Device Driveline Infection and Development of Intracranial Hemorrhage: A Case Series.

Durable left ventricular assist devices (LVAD) are frequently complicated by driveline infection. The objective of this case series was to examine whether an association exists between driveline infection and intracranial hemorrhage. This retrospective case series included patients at a single tertiary care hospital on durable LVAD support who developed intracranial hemorrhage. Physical examination data, vital signs, and laboratory markers of sepsis including blood cultures and imaging of driveline sites were reviewed. A total of nine patients were included in the case series. At the time of hemorrhagic event, five patients had active driveline infection, and five patients were found to be bacteremic. All bacteremic patients were found to have supratherapeutic INR at the time of presentation. Although five patients experienced subarachnoid hemorrhage, only one patient was found to have a cerebral aneurysm. This case series highlights a possible association between LVAD driveline infection and intracranial hemorrhage, and the need for further research to better understand the pathophysiology driving this association.

Characteristics and Outcomes of COVID-19 in Patients on Left Ventricular Assist Device Support.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to afflict millions of people worldwide. Patients with end-stage heart failure and left ventricular assist devices (LVADs) may be at risk for severe COVID-19 given a high prevalence of complex comorbidities and functional impaired immunity. The objective of this study is to describe the clinical characteristics and outcomes of COVID-19 in patients with end-stage heart failure and durable LVADs. METHODS: The Trans-CoV-VAD registry is a multi-center registry of LVAD and cardiac transplant patients in the United States with confirmed COVID-19. Patient characteristics, exposure history, presentation, laboratory data, course, and clinical outcomes were collected by participating institutions and reviewed by a central data repository. This report represents the participation of the first 9 centers to report LVAD data into the registry. RESULTS: A total of 40 patients were included in this cohort. The median age was 56 years (interquartile range, 46-68), 14 (35%) were women, and 21 (52%) were Black. Among the most common presenting symptoms were cough (41%), fever, and fatigue (both 38%). A total of 18% were asymptomatic at diagnosis. Only 43% of the patients reported either subjective or measured fever during the entire course of illness. Over half (60%) required hospitalization, and 8 patients (20%) died, often after lengthy hospitalizations. CONCLUSIONS: We present the largest case series of LVAD patients with COVID-19 to date. Understanding these characteristics is essential in an effort to improve the outcome of this complex patient population.

Patterns of adherence to diuretics, dietary sodium and fluid intake recommendations in adults with heart failure.

BACKGROUND: Three behaviors advocated to minimize fluid-related hospitalizations in patients with heart failure (HF) are restricted sodium and fluid intake and consistent oral diuretic use. Adherence to behaviors intended to decrease risk of hospitalization is believed to vary over time, but surprisingly little research has addressed patterns of adherence in HF patients. OBJECTIVE: To describe patterns over time of 3 recommended self-care behaviors (i.e., diet, fluid intake, and diuretic dosing) in adults with HF and to determine how time and behavior influenced adherence rates. METHODS: We enrolled 24 adults hospitalized for a HF exacerbation and discharged on a loop diuretic into a descriptive, longitudinal pilot study. Over 3-months, diuretic use was measured using electronic event monitoring, and participants were telephoned regularly to assess sodium and fluid intake. Data were summarized for each 2-week intervals. RESULTS: The overall adherence rates were 42.4% for low sodium diet, 96.4% for fluid restriction, and 84.7% for the diuretic regimen. Early after hospital discharge, medication adherence was the highest, and dietary adherence was the lowest, but adherence to diet and diuretic use decreased significantly over time. CONCLUSION: Although participants were just discharged from the hospital after an acute exacerbation of HF, all three behavioral patterns decreased markedly over the 3-month follow-up period.

Health coaching to improve self-care of informal caregivers of adults with chronic heart failure - iCare4Me: Study protocol for a randomized controlled trial.

BACKGROUND: Persons with chronic heart failure are living longer. These patients typically live in the community and are cared for at home by informal caregivers. These caregivers are an understudied and stressed group. METHODS: We are conducting a two-arm, randomized controlled trial of 250 caregivers of persons with chronic heart failure to evaluate the efficacy of a health coaching intervention. A consecutive sample of participants is being enrolled from both clinic and hospital settings at a single institution affiliated with a large medical center in the northeastern US. Both the intervention and control groups receive tablets programmed to provide standardized health information. In addition, the intervention group receives 10 live coaching sessions delivered virtually by health coaches using the tablets. The intervention is evaluated at 6-months, with self-care as the primary outcome. Cost-effectiveness of the intervention is evaluated at 12-months. We are also enrolling heart failure patients (dyads) whenever possible to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on heart failure patient outcomes (number of hospitalizations and days in the hospital) at 12-months. DISCUSSION: We expect the proposed study to require 5 years for completion. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to. support millions of caregivers worldwide.

Managing heart failure care using an internet-based telemedicine system.

BACKGROUND: Managing patients with heart failure (HF) is labor intensive, and follow-up is often inadequate to detect day-to-day changes that ultimately lead to decompensation. We tested the effect of an Internet-based telemedicine (T) system that provides frequent surveillance and increased communicate between HF patients and their provider on frequency of hospitalization in a cohort of patients with advanced HF. METHODS AND RESULTS: HF patients in NYHA Class II-IV were randomized to usual care (UC, n = 24) or T (T plus UC, n = 24) and followed for 1 year. Office visits, emergency department visits, hospitalizations, telephone calls, and number of Internet communications were measured over the 1-year period. Left ventricular ejection fraction (EF) was assessed by echocardiography in both groups. For T, mean age was 53.2 +/- 2.0 years (72% male, 61% Caucasian, 39% African American). For UC, mean age was 54.1 +/- 2.6 years (76% male, 72% Caucasian, 14% African American, and 14% Hispanic). HF etiologies and EF were similar in both groups. During the 12-month period, UC had 74 total phone calls to the practice, whereas T had 88 telephone calls plus 1887 telemedicine data messages (6.5 messages/patient/month). ER visits were lower in the T group (T 5, UC 12; P < .05). Hospital admissions (T 24, C 40; P = .025) and total hospital days (T 84, UC 226 days; P < .005) were lower in T. Unscheduled clinic visits (T 13, UC 13; P = NS) and scheduled clinic visits (T 78, UC 94; P = NS) were similar in both groups. CONCLUSIONS: Frequent monitoring and patient management using a telemedicine system may help to reduce hospitalizations, hospital days, and emergency department visits.

Preoperative renal dysfunction does not affect outcomes of left ventricular assist device implantation.

OBJECTIVE: Selection criteria for durable left ventricular assist device (LVAD) implantation remain unclear. One such criterion is renal function. In this study we evaluated outcomes of LVAD implantation in patients with preoperative renal dysfunction. METHODS: Patients with implanted LVADs as destination therapy (DT) or bridge to transplantation (BTT) at a single institution between 2006 and 2015 were included. Primary stratification was according to pre-implantation glomerular filtration rate (GFR): >60 mL/min versus <60 mL/min or dialysis dependence. The primary outcome was post-LVAD implantation overall survival. RESULTS: Two hundred thirty-eight patients underwent LVAD implantation during the study period as DT (60%; n = 142) or BTT (40%; n = 96). Reduced GFR was present in 56% (n = 132), with 8% (n = 18) being dialysis-dependent. Normal versus reduced GFR cohorts were well matched except for a higher incidence of coronary artery disease in the patients with reduced GFR (61% vs 48%; P = .04). Mean follow-up was 13.5 ± 17.0 months. Unadjusted and risk-adjusted survival at 1, 3, 6, and 12 months after LVAD implantation were similar between the cohorts for DT and BTT. Rates of transplantation were comparable in BTT patients (61% normal vs 53% reduced GFR; P = .43). Recovery of renal function to a GFR >60 mL/min occurred in 43% (n = 17) and 57% (n = 42) of patients with reduced GFR in the BTT and DT cohorts, respectively, by 1 year post implantation. CONCLUSIONS: Well selected patients with preexisting renal dysfunction can undergo LVAD implantation with acceptable outcomes. Approximately half of LVAD recipients with preimplantation renal dysfunction will recover normal renal function within the first postoperative year. Renal dysfunction alone should not serve as an absolute contraindication to LVAD therapy.

A mixed methods study of symptom perception in patients with chronic heart failure.

BACKGROUND: Early heart failure (HF) symptoms are frequently unrecognized for reasons that are unclear. We explored symptom perception in patients with chronic HF. METHODS: We enrolled 36 HF out-patients into a longitudinal sequential explanatory mixed methods study. We used objectively measured thoracic fluid accumulation and daily reports of signs and symptoms to evaluate accuracy of detected changes in fluid retention. Patterns of symptom interpretation and response were explored in telephone interviews conducted every 2 weeks for 3-months. RESULTS: In this sample, 44% had a mismatch between objective and subjective fluid retention; younger persons were more likely to have mismatch. In interviews, two patterns were identified: those able to interpret and respond appropriately to symptoms were higher in decision-making skill and the quality of social support received. CONCLUSION: Many HF patients were poor at interpreting and managing their symptoms. These results suggest a subgroup of patients to target for intervention.

Lisinopril-Induced Alopecia: A Case Report.

The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines consider angiotensin-converting enzyme (ACE) inhibitors as one of the mainstay therapies in the management of heart failure. The widespread use of ACE inhibitors has been associated with several notable adverse effects such as hyperkalemia and an increased serum creatinine. There are no previous reports of alopecia associated with lisinopril use; however, a few previous cases of alopecia associated with other ACE inhibitors exist. This report discusses a case of lisinopril-induced alopecia of a 53-year-old male presenting to our outpatient heart failure clinic with a chief complaint of a new onset of alopecia. Upon evaluation, it was suspected that the patient's alopecia was likely medication induced by lisinopril; therefore, lisinopril was discontinued and switched to an angiotensin receptor blocker (ARB), losartan potassium. Alopecia resolved in 4 weeks after the therapeutic intervention. Our report suggests that the patient likely experienced a medication-induced alopecia, which was successfully resolved through proper identification and removal of the causative agent. Causality assessment between lisinopril and alopecia was determined using the Naranjo Adverse Drug Reaction Probability Scale-a total score of 6 was achieved and thus identified the adverse drug reaction as probable. Clinicians should be aware of the possibility that lisinopril may be an offending agent in a patient with unexplained alopecia.