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Background: Limited research exists on the influence of social determinants of health (SDOH) on outcomes in pediatric patients with advanced heart failure receiving mechanical circulatory support., Methods: Linkage of the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) and Society of Thoracic Surgeon's Congenital Heart Surgery Database (STS-CHSD) identified pediatric patients who underwent ventricular assist device (VAD) implantation from 2012 to 2022 with available residential zip codes. Utilizing the available zip codes, each patient was assigned a Childhood Opportunity Index (COI) score. Level of childhood opportunity, race, and insurance type were used as proxies for SDOH. Major outcomes included death, transplant, alive with device, and recovery. Secondary outcomes were adverse events. Statistical analyses were performed using the Kaplan-Meier survival, competing risk analyses, and multivariable Cox proportional hazards model., Results: Three hundred seventeen patients were included in the study. Childhood opportunity level and insurance status did not significantly impact morbidity or mortality after VAD implantation. White race was associated with reduced 1-year survival (71% in White vs. 87% in non-White patients, p = 0.05) and increased risk of pump thrombosis (p = 0.02)., Conclusion: Childhood opportunity level and insurance status were not linked to morbidity and mortality in pediatric patients after VAD implantation. Notably, White race was associated with higher mortality rates. The study underscores the importance of considering SDOH in evaluating advanced therapies for pediatric heart failure and emphasizes the need for accurate socioeconomic data collection in future studies and national registries., (© 2024 Wiley Periodicals LLC.)

Background: Children awaiting heart transplant (Tx) have a high risk of death due to donor organ scarcity. Historically, ventricular assist devices (VADs) reduced waitlist mortality, prompting increased VAD use. We sought to determine whether the VAD survival benefit persists in the current era., Methods: Using the Scientific Registry of Transplant Recipients, we identified patients listed for Tx between 3/22/2016 and 9/1/2020. We compared characteristics of VAD and non-VAD groups at Tx listing. Cox proportional hazards models were used to identify risk factors for 1-year waitlist mortality., Results: Among 5054 patients, 764 (15%) had a VAD at Tx listing. The VAD group was older with more mechanical ventilation and renal impairment. Unadjusted waitlist mortality was similar between groups; the curves crossed ~90 days after listing (p = .55). In multivariable analysis, infant age (HR 2.77, 95%CI 2.13-3.60), Black race (HR 1.57, 95%CI 1.31-1.88), congenital heart disease (HR 1.23, 95%CI 1.04-1.46), renal impairment (HR 2.67, 95%CI 2.19-3.26), inotropes (HR 1.28, 95%CI 1.09-1.52), and mechanical ventilation (HR 2.23, 95%CI 1.84-2.70) were associated with 1-year waitlist mortality. VADs were not associated with mortality in the first 90 waitlist days but were protective for those waiting ≥90 days (HR 0.43, 95%CI 0.26-0.71)., Conclusions: In the current era, VADs reduce waitlist mortality, but only for those waitlisted ≥90 days. The differential effect by race, size, and VAD type is less clear. These findings suggest that Tx listing without VAD may be reasonable if a short waitlist time is anticipated, but VADs may benefit those expected to wait >90 days., (© 2024 Wiley Periodicals LLC.)

Background: Advanced technology and improved outcomes have led to rapid growth of ventricular assist devices (VADs) throughout the world, but little exists regarding their structure. We sought to study trends in VAD programs on a global level. Methods: We distributed a 26-question online survey to 321 individuals who work within those programs. Four categories of questions were formed: patient management, coordinator role, multidisciplinary support, and leadership. Results: Fifty-eight surveys (47 United States, 11 international) were analyzed. The majority of programs cared for 26 to 100 device-assisted patients (62%), 26% cared for ≤25 patients, and 12% cared for ≥100 patients. Advanced practice providers (APPs) were used in 69% of programs as a device coordinator. In-hospital rounding was performed equally among the APPs and registered nurses. Most programs used a social worker (90%), nutritionist (74%), pharmacist (72%), palliative care (66%), and finance coordinator (64%). Less than half (43%) included a case manager and only 33% used a pharmacist. The program leader was identified as a cardiologist (31%) or surgeon (26%) or both equally (43%). Conclusion: This study demonstrates differences and similarities between VAD program structures. Additional research is warranted to evaluate the effect of program structure on outcomes, job satisfaction, and retention regions. [ABSTRACT FROM AUTHOR]

Background: To date, no pediatric studies have highlighted the impact of center's ventricular assist device (VAD) volumes on post implant outcomes., Methods: Children (age <19) enrolled in Pedimacs undergoing initial left ventricular assist device implantation from 2012 to 2020 were included. Center volume was analyzed as a continuous and categorical variable. For categorical analysis, center volumes were divided as: low volume (1-15 implants), medium volume (15-30 implants), and high volume (>30 implants) during our study period. Patient characteristics and outcomes were compared by center's VAD volumes., Results: Of 44 centers, 16 (36.4%) were low, 11 (25%) were medium, and 17 (38.6%) were high-volume centers. Children at high-volume centers were least likely intubated, sedated, or paralyzed, and most likely ambulating preimplant (p < 0.05 for all). Center's VAD volumes were not a significant risk factor for mortality post implant when treated as a continuous or a categorical variable (p > 0.05). Compared to low volume, children at high-volume centers had fewer early neurological events. Compared to medium volume, those at high-volume centers had fewer late bleeding events (p < 0.05 for all). There were no significant differences in survival after an adverse event by hospital volumes (p > 0.05)., Conclusions: Although hospital volume does not affect post-VAD implant mortality, pediatric centers with higher VAD volumes have fewer patients intubated, sedated, paralyzed pre implant, and have lower adverse events. Failure to rescue was not significantly different between low, medium, and high-volume VAD centers., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background/Aim : Pediatric cardiac intensive care physicians practicing at centers that implant ventricular assist devices (VAD's) are exposed to increasing numbers of VAD patients, with a significant number of VAD-days. We aimed to delineate pediatric cardiac critical care practices surrounding routine and emergency management of VADs. Methodology : We administered a multicenter cross-sectional survey of pediatric cardiac intensive care unit (CICU) physicians in the United States and Canada. Survey distribution occurred between August 31st and October 26th 2021. Results : A total of 254 CICU physicians received a formal invitation to participate, with 108 returning completed surveys (42.5% response rate). Responses came from CICU attending physicians at 26 separate institutions. Respondents' level of experience was well distributed across junior, mid-level, and senior staff: less than 5 years (38%), 5-9 years (25%), and >/= 10 years (37%). Most respondents had received formal training in the management of VAD patients (n = 93, 86.1%), with training format including fellowship (61%), simulation (36%), and national/international conferences (26.5%). Dedicated advanced cardiac therapies teams were available at the institutions of 97.2% of respondents. A total of 78/108 (72.2%) described themselves as "comfortable" or "very comfortable" in pediatric VAD management. While 63% (68/108) of respondents reported that they had never performed (or overseen the performance of) chest compressions in a pediatric patient with a VAD, 37% (40/108) reported performing CPR at least once in a VAD patient. Conclusion : With no existing international guidelines for emergency cardiovascular care in the pediatric VAD population, our survey identifies an important gap in resuscitation recommendations., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background/Objectives Frailty, characterized by low physiological reserves, is strongly associated with vulnerability to adverse outcomes. Features of frailty overlap with those of advanced heart failure, making a distinction between them difficult. We sought to determine whether implantation of a left ventricular assist device ( LVAD) would decrease frailty. Design Prospective, cohort study. Setting Five academic medical centers. Participants Frail individuals (N = 29; mean age 70.6 ± 5.5, 72.4% male). Measurements Frailty, defined as having 3 or more of the Fried frailty criteria, was assessed before LVAD implantation and 1, 3, and 6 months after implantation. Other domains assessed included quality of life, using the Kansas City Cardiomyopathy Questionnaire; mood, using the Patient Health Questionnaire; and cognitive function, using the Trail-Making Test Part B. Results After 6 months, three subjects had died, and one had undergone a heart transplant; of 19 subjects with serial frailty measures, the average number of frailty criteria decreased from 3.9 ± 0.9 at baseline to 2.8 ± 1.4 at 6 months ( P = .003). Improvements were observed after 3 to 6 months of LVAD support, although 10 (52.6%) participants still had 3 or more Fried criteria, and all subjects had at least one at 6 months. Changes in frailty were associated with improvement in QOL but not with changes in mood or cognition. Higher estimated glomerular filtration rate at baseline was independently associated with a decrease in frailty. Conclusion Frailty decreased in approximately half of older adults with advanced heart failure after 6 months of LVAD support. Strategies to enhance frailty reversal in this population are worthy of additional study. [ABSTRACT FROM AUTHOR]

Left ventricular assist device therapy for advanced heart failure is contraindicated if a patient lives in an unsafe environment and recent guidelines declare that "legal history is pertinent for determining personal constraints or financial responsibilities due to parole requirements, pending charges, and possible imprisonment," implying that incarceration would be a contraindication. International guidelines and precedent in the United States establish that medical care for incarcerated persons should match access in the community. We present a case example and practical considerations for advanced heart failure programs faced with the challenge of partnering with patients with heart failure who may be incarcerated and their correctional health systems in the care of their chronic condition. We encourage the heart failure community to not let incarceration be a contraindication to left ventricular assist device therapy., Competing Interests: Conflict of Interest The authors have no relevant conflicts of interest to report., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Sex-associated differences in clinical outcomes among left ventricular assist device recipients in the United States have been recognized. However, an investigation of the social and clinical determinants of sex-associated differences is lacking., Methods: Left ventricular assist device receiving patients enrolled in Interagency Registry for Mechanically Assisted Circulatory Support between 2005 and 2017 were included. The primary outcome was all-cause mortality. Secondary outcomes included heart transplantation and postimplantation adverse event rates. The cohort was stratified by the social subgroup of race and ethnicity (non-Hispanic White, non-Hispanic Black, non-Hispanic Asian, and Hispanic), and clinical subgroups of device strategy (destination therapy, bridge to transplant, and bridge to candidacy), and implantation center volume (low [≤20 implants/y], medium [21-30 implants/y], and high [>30 implants/y]). A multivariable-adjusted Cox proportional hazard model was used to assess the risk of death and heart transplantation with prespecified interaction testing. Poisson regression was used to estimate adverse events by sex across the various subgroups., Results: Among 18 525 patients, there were 3968 (21.4%) females. Compared with their male counterparts, Hispanic (adjusted hazard ratio [HR adj ], 1.75 [1.23-2.47]) females had the highest risk of death followed by non-Hispanic White females (HR adj , 1.15 [1.07-1.25]; P interaction =0.02). Hispanic (HR adj , 0.60 [0.40-0.89]) females had the lowest cumulative incidence of heart transplantation followed by non-Hispanic Black females (HR adj , 0.76 [0.67-0.86]), and non-Hispanic White females (HR adj , 0.88 [0.80-0.96]) compared with their male counterparts ( P interaction <0.001). Compared with their male counterparts, females on the bridge to candidacy strategy (HR adj , 1.32 [1.18-1.48]) had the highest risk of death ( P =0.40) did not vary by sex in the center volume subgroup. A higher incidence rate of adverse events after left ventricular assist device implantation was also seen in females compared with the males, overall, and across all subgroups.interaction =0.01). The risk of death ( P interaction =0.44) and cumulative incidence of heart transplantation ( P interaction =0.40) did not vary by sex in the center volume subgroup. A higher incidence rate of adverse events after left ventricular assist device implantation was also seen in females compared with the males, overall, and across all subgroups., Conclusions: Among left ventricular assist device recipients, the risk of death, the cumulative incidence of heart transplantation, and adverse events differ by sex across the social and clinical subgroups., Competing Interests: Disclosures None.

Background Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80% in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) Methods PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. Results This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy ( n = 146, 73%), myocarditis ( n = 17, 9%), congenital heart disease ( n = 35, 18%) and other ( n = 2, 1%). Pulsatile-flow devices were used in 91 patients (45%) and continuous-flow devices in 109 patients (55%). Actuarial survival was 86% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction ( n = 79), infection ( n = 78), neurologic dysfunction ( n = 52) and bleeding ( n = 68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event and 16% of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population. Conclusions In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar. [ABSTRACT FROM AUTHOR]

Heart failure is epidemic in the United States with a prevalence of over 5 million. The diagnosis carries a mortality risk of 50% at 5 years rivaling many diagnoses of cancer. Heart transplantation, long the “gold standard” treatment for end stage heart failure unresponsive to maximal medical therapy falls way short of meeting the need with only about 2,000 transplants performed annually in the United States due to donor limitation. Left ventricular devices have emerged as a viable option for patients as both a “bridge to transplantation” and as a final “destination therapy”. [ABSTRACT FROM AUTHOR]

Objective: The HeartMate II (HMII; Thoratec, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) is an established treatment modality for advanced heart failure in adults. The objective of this study was to evaluate outcomes of pediatric patients supported by the HMII LVAD. Methods: This was a retrospective review of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) of patients supported with a HMII from April 2008 to September 2011. The primary cohort comprised pediatric patients aged 11 to 18 years. Outcomes were compared with a group of young adults aged 19 to 39 years who underwent HMII implant during the same period. Ischemic etiologies for heart failure were excluded. Results: There were 28 pediatric patients, of whom 19 (68%) were males, 14 (46%) were African American, and 7 (25%) underwent device placement in a pediatric hospital. Competing outcomes analysis showed that at 6 months of follow-up, the composite of survival to transplantation, ongoing support, or recovery was 96% for the pediatric group, which was not significantly different from the young adult group (96%, p = 0.330). The 2 groups had similar INTERMACS profiles but differed in diagnosis, weight, and morbidities. Bleeding complications requiring surgical intervention were more common in the pediatric group. Conclusions: Pediatric outcomes with a HMII LVAD are comparable to that of young adults. As we continue to monitor this growing group, more sophisticated characterization and comparisons will be possible. Also, as technology progress and second- and third-generation devices are introduced, the number of children who will benefit from mechanical support will continue to grow. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to investigate variations across hospitals in infection rates and associated costs, the latter reflected in 90-day Medicare payments. Despite high rates and expenditures of health care--associated infections associated with durable ventricular assist device implantation, few studies have examined interhospital variation and associated costs., Methods: Clinical data on 8688 patients who received primary durable ventricular assist devices from July 2008 to July 2017 from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) hospitals (n = 120) were merged with postimplantation 90-day Medicare claims. Terciles of hospital-specific, risk-adjusted infection rates per 100 patient-months were estimated using Intermacs and associated with Medicare payments (among 5440 Medicare beneficiaries). Primary outcomes included infections within 90 days of implantation and Medicare payments., Results: There were 3982 infections identified among 27.8% (2417/8688) of patients developing an infection. The median (25th, 75th percentile) adjusted incidence of infections (per 100 patient-months) across hospitals was 14.3 (9.3, 19.5) and varied according to hospital (range, 0.0-35.6). Total Medicare payments from implantation to 90 days were 9.0% (absolute difference: $13,652) greater in high versus low infection tercile hospitals (P < .0001). The period between implantation to discharge accounted for 73.1% of the difference in payments during the implantation to 90-day period across terciles., Conclusions: Health care--associated infection rates post durable ventricular assist device implantation varied according to hospital and were associated with increased 90-day Medicare expenditures. Interventions targeting preventing infections could improve the value of durable ventricular assist device support from the societal and hospital perspectives., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of Competing Interest A.T.O. reports consulting for Cytokinetics and Myokardia/Bristol Myers Squibb and has received research support from Cytokinetics, Myokardia/Bristol Myers Squibb, and Pfizer. J.W.R. has received paid consulting fees from Abiomed, Amgen, Myokardia/Bristol Myers Squibb, Cytokinetics, Bayer, and Novartis. E.Y.B. reports research support paid to the University of Pennsylvania by Medtronic Inc. and Impulse Dynamics Ltd. The remaining authors report no disclosures., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. Background: After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. Methods: The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Results: Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. Conclusions: The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results. [Copyright &y& Elsevier]

In many adult cardiac programs, intracorporeal mechanical circulatory support has become a routine treatment for end-stage cardiac failure. For the pediatric population, options are often limited by a small body habitus. Even when an adolescent's weight may suggest adequate space for device implant, most intracorporeal adult devices remain too large for adolescents. The Thoratec HeartMate II (HM II) (approved by the FDA in April of 2008) is a small, noiseless device that is easily operated and monitored. By having an uncomplicated operating system and small percutaneous drive line, the HM II provides an opportunity for these patients to aggressively rehabilitate to become a better transplant candidate and also provides the potential to be discharged home. The two youngest patients ever to utilize the HM II are also the first two cases of using the HM II at a freestanding pediatric hospital. A 12-year-old, 53 kg, girl with dilated cardiomyopathy was supported for 85 days before receiving her heart transplant. The second patient, a 13-year-old, 149 kg, Hispanic male suffering from morbid obesity and dilated cardiomyopathy, was supported for 128 days. The HM II allowed for rehabilitation and nutritional education, resulting in this patient losing 50 kg before heart transplant. Despite both of these patients' size, their thoracic cavities were that of a preadolescent and thus techniques were developed to avoid morbidities like chest wall abrasion and bleeding. Because of differences between adult and pediatric patients and institutions, these cases provided unique challenges. However, as pediatric device therapy is now maturing, pediatric programs such as Texas Children's Hospital have begun to develop strategies for mechanical support that factor in patient's size and need for long-term or temporary support, utilizing the growing number of devices (i.e., Jostra Rotoflow, Tandem Heart PTVA, Thoratec CentriMag, Berlin Heart EXCOR, etc.) that are now available to children. [ABSTRACT FROM AUTHOR]

Among elderly adults, the most common reason for hospitalization is heart failure. Understanding the treatment options for this complex syndrome is vital to the practice of contemporary medicine. Early recognition of patients at risk for developing heart failure and the stage-appropriate management of patients with established heart failure is paramount for optimal patient care. However, the vast array of therapeutic options currently available can seem daunting. It is the aim of this review to describe the framework for approaching heart failure patients so that the physician can provide the most appropriate therapies at each stage of the disease. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to determine the relationship between pre-transplant ventricular assist device (VAD) support and mortality after heart transplantation. Background: Increasingly, VADs are being used to bridge patients to heart transplantation. The effect of these devices on post-transplant mortality is unclear. Methods: Patients 18 years or older who underwent first-time, single-organ heart transplantation in the U.S. between 1995 and 2004 were included in the analyses. This study compared 1,433 patients bridged with intracorporeal and 448 patients bridged with extracorporeal VADs with 9,455 United Network for Organ Sharing status 1 patients not bridged with a VAD with respect to post-transplant mortality. Because the proportional hazards assumption was not met, hazard ratios (HRs) for different time periods were estimated. Results: Intracorporeal VADs were associated with an HR of 1.20 (95% confidence interval [CI]: 1.02 to 1.43; p = 0.03) for mortality in the first 6 months after transplant and an HR of 1.99 (95% CI: 1.44 to 2.75; p < 0.0001) beyond 5 years. Between 6 months and 5 years, the HRs were not significantly different from 1. Extracorporeal VADs were associated with an HR of 1.91 (95% CI: 1.53 to 2.37; p < 0.0001) for mortality in the first 6 months and an HR of 2.93 (95% CI: 1.19 to 7.25; p = 0.02) beyond 5 years. The HRs were not significantly different from 1 between 6 months and 5 years, except for an HR of 0.23 (95% CI: 0.06 to 0.91; p = 0.04) between 24 and 36 months. Conclusions: Extracorporeal VADs are associated with higher mortality within 6 months and again beyond 5 years after transplantation. Intracorporeal VADs are associated with a small increase in mortality in the first 6 months and a clinically significant increase in mortality beyond 5 years. These data do not provide evidence supporting VAD implantation in stable United Network for Organ Sharing status I patients awaiting heart transplantation. [Copyright &y& Elsevier]

The article provides an update on ventricular assist devices (VADs) that are available in the U.S. VADs are part of the mechanical cardiac support therapies for the failing heart. The author offers reviews clinical aspects of patient care where VADs are deployed, such as common complications, psychosocial concerns and ethical considerations.

Given the stalling improvement in vaccine hesitancy rates in the United States (US), it is important to understand why a chronically ill group, patients with left-ventricular assist devices (LVADs), might not get vaccinated and to delineate the barriers they may face in seeking care. We conducted an online survey to characterize the attitudes of patients with LVADs toward COVID-19 vaccination, identify their willingness to seek care during the pandemic, and characterize barriers to doing so. Our survey showed that the rate of vaccine hesitancy among LVAD patients is similar to that of the general population in the US. This rate is higher than expected for a chronically ill group at risk of severe COVID-19 infection. We also found that LVAD patients perceive barriers to seeking care during the pandemic. We recommend that LVAD care teams emphasize that patients should seek care for emergency medical conditions despite their fears of contracting COVID-19. Based on our results, we also recommend vaccine uptake education for this population focused on patients' concerns about serious side effects and not enough research done on the vaccine.

As we enter the third year of the new adult heart allocation policy, we are faced with the new challenges of the COVID-19 pandemic. In 2020, new listings (adult and pediatric) decreased slightly, with 4000 new listings in 2020, compared with 4087 in 2019; however, the number of adult heart transplants performed continued to increase, to 3715 in 2020. The number of pediatric heart transplants declined from 509 in 2019 to 465 in 2020. One-year and six-month posttransplant mortality rates in adult recipients have increased slightly since 2015 but have not significantly changed over the past decade. Overall, posttransplant mortality rates for adult recipients were 7.4% at six months and 9.4% at one year for transplants in 2019, 14.0% at three years for transplants in 2017, and 19.1% at five years for transplants in 2015. Although shorter-term posttransplant mortality rates have slightly increased, there has been a steady downward trend in longer-term mortality. Mortality rates for pediatric recipients were 5.7% at six months and 8.1% at one year for transplants in 2019, 11.6% at three years for transplants in 2017, and 15.2% at five years for transplants in 2015., (.)

Background: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches., Methods: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique., Results: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively., Conclusions: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background Patients with left ventricular assist devices (LVADs) implanted as destination therapy may receive suboptimal preparation for and care at the end of life, but there is limited understanding of the reasons for these shortcomings. Exploring perceptions of individuals (caregivers and clinicians) who are closely involved in the end-of-life experience with patients with destination therapy LVADs can help identify key opportunities for improving care. Methods and Results We conducted semistructured qualitative interviews with 7 bereaved caregivers of patients with destination therapy LVADs and 10 interdisciplinary LVAD clinicians. Interviews explored perceptions of preparing for end of life, communicating about end of life, and providing and receiving end-of-life care, and were analyzed using a 2-step team-based inductive approach to coding and analysis. Six themes pertaining to end-of-life experiences were derived: (1) timing end-of-life discussions in the setting of unpredictable illness trajectories, (2) prioritizing end-of-life preparation and decision-making, (3) communicating uncertainty while providing support and hope, (4) lack of consensus on responsibility for end-of-life discussions, (5) perception of the LVAD team as invincible, and (6) divergent perceptions of LVAD withdrawal. Conclusions This study revealed 6 unique aspects of end-of-life care for patients with destination therapy LVADs as reported by clinicians and caregivers. Themes coalesced around communication, team-based care, and challenges unique to patients with LVADs at end of life. Programmatic changes may address some aspects, including training clinicians in LVAD-specific communication skills. Other aspects, such as standardizing the role of the palliative care team and developing practical interventions that enable timely advance care planning during LVAD care, will require multifaceted interventions.

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., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Cerebralvascular accidents (CVA) are common complications of pediatric ventricular assist devices (VADs). We employed the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) to investigate rates, risk factors, and outcomes of CVA in pediatric patients supported on VAD., Methods: Analysis of Pedimacs (September 2012-June 2019) data to determine rates of all neurologic events and specifically CVA. Risk factors were determined by a multiphase parametric hazard model. Outcomes of patients with CVA were compared with patients without CVA., Results: We included 662 patients in our analysis. In total, 87 CVA events occurred in 71 patients (10.7%). The proportion of patients with CVA was highest in the paracorporeal pulsatile group (16.9%) followed by the paracorporeal continuous group (10.4%). However, the rate of CVA was lower in the paracorporeal pulsatile group compared to the paracorporeal continuous group (6.4 vs 11.1 events/100 patient months), which reflects differences in support duration. Ascites, higher patient profile groups, and implants within small volume centers were associated with the occurrence of CVA. Our analysis found that the recent era (i.e., June 2017), and intracorporeal continuous implants were protective. Mortality was higher in patients following a CVA diagnosis compared to those without a CVA diagnosis., Conclusions: CVA continues to be a problem in pediatric VAD support, though the overall percent is now <11%. Data from the most recent era are encouraging, but CVA is still significantly associated with mortality. Future efforts should focus on pre-implant and early support periods., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Paracorporeal continuous-flow ventricular assist devices (PCF VAD) are increasingly used in pediatrics, yet PCF VAD resource utilization has not been reported to date., Methods: Pediatric Interagency Registry for Mechanically Assisted Circulatory Support (PediMACS), a national registry of VADs in children, and Pediatric Health Information System (PHIS), an administrative database of children's hospitals, were merged to assess VAD implants from 19 centers between 2012 and 2016. Resource utilization, including hospital and intensive care unit length of stay (LOS), and costs are analyzed for PCF VAD, durable VAD (DVAD), and combined PCF-DVAD support., Results: Of 177 children (20% PCF VAD, 14% PCF-DVAD, 66% DVAD), those with PCF VAD or PCF-DVAD are younger (median age 4 [IQR 0-10] years and 3 [IQR 0-9] years, respectively) and more often have congenital heart disease (44%; 28%, respectively) compared to DVAD (11 [IQR 3-17] years; 14% CHD); p < 0.01 for both. Median post-VAD LOS is prolonged ranging from 43 (IQR 15-82) days in PCF VAD to 72 (IQR 55-107) days in PCF-DVAD, with significant hospitalization costs (PCF VAD $450,000 [IQR $210,000-$780,000]; PCF-DVAD $770,000 [IQR $510,000-$1,000,000]). After adjusting for patient-level factors, greater post-VAD hospital costs are associated with LOS, ECMO pre-VAD, greater chronic complex conditions, and major adverse events (p < 0.05 for all). VAD strategy and underlying cardiac disease are not associated with LOS or overall costs, although PCF VAD is associated with higher daily-level costs driven by increased pharmacy, laboratory, imaging, and clinical services costs., Conclusion: Pediatric PCF VAD resource utilization is staggeringly high with costs primarily driven by pre-implantation patient illness, hospital LOS, and clinical care costs., Competing Interests: Conflict of interest disclosure The PediMACS database is funded by a contract grant (HHSN268201100025C) from the National Heart, Lung, and Blood Institute. JWR has served as a consultant for Novartis, Abiomed, Bayer, Amgen. DLSM has served as a consultant for Abbott, Syncardia, and Berlin Heart. The other authors have no relevant disclosures to report., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: In a stable, inotrope-dependent pediatric patient with dilated cardiomyopathy, we evaluated the cost-effectiveness of continuous-flow VAD implantation compared to a watchful waiting approach using chronic inotropic therapy., Methods: We used a state-transition model to estimate the costs and outcomes of 14-year-old (INTERMACS profile 3) patients receiving either VAD or watchful waiting. We measured benefits in terms of lifetime QALYs gained. Model inputs were taken from the literature. We calculated the ICER, or the cost per additional QALY gained, of VADs and performed multiple sensitivity analyses to test how our assumptions influenced the results., Results: Compared to watchful waiting, VADs produce 0.97 more QALYs for an additional $156 639, leading to an ICER of $162 123 per QALY gained from a healthcare perspective. VADs have 17% chance of being cost-effective given a cost-effectiveness threshold of $100 000 per QALY gained. Sensitivity analyses suggest that VADs can be cost-effective if the costs of implantation decrease or if hospitalization costs or mortality among watchful waiting patients is higher., Conclusions: As a bridge to transplant, VADs provide a health benefit to children who develop stable, inotrope-dependent heart failure, but immediate implantation is not yet a cost-effective strategy compared to watchful waiting based on commonly used cost-effectiveness thresholds. Early VAD support can be cost-effective in sicker patients and if device implantation is cheaper. In complex conditions such as pediatric heart failure, cost-effectiveness should be just one of many factors that inform clinical decision-making., (© 2021 Wiley Periodicals LLC.)

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.

The use of ventricular assist devices (VADs) as a bridge to heart transplant (HT) is increasing, while HT volume remains stagnant. This may portend longer waiting times and an otherwise more competitive environment for all patients on the HT waiting list. A retrospective analysis of patients who were listed for HT in the United Network for Organ Sharing (UNOS) database from 2000 to 2015 was conducted. Mean waiting time, proportion of HT reception (%HT), proportion of death (%death), and proportion of waiting list removal (%removal) were calculated across three eras: Era 1 (2000-2007), Era 2 (2008-2011), and Era 3 (2012-2015). During the study period, 29 728 patients successfully underwent HT. 19 127 (64.3%) were directly transplanted (direct HT); 4491 (15.1%) received VADs prior to listing as a bridge to decision (BTD); and 4593 (15.5%) received VADs after listing as a bridge to transplant (BTT). Across the three eras, the average number of registrants per year grew. Among all groups, waiting time increased across the eras. %HT generally decreased in the BTD and BTT groups but remained constant in the direct HT group. %removal increased, while %death decreased in all group across the eras. Waiting time for HT increased from 2000 to 2015. Patients with VADs as a bridge strategy experienced decreasing %HT and increasing %removal but stable survival. Improvements in VAD safety and durability will ensure their success as part of a bridge strategy to HT under the new UNOS allocation policy., (© 2021 International Center for Artificial Organs and Transplantation and Wiley Periodicals LLC.)

Background With a growing population of patients supported by ventricular assist devices (VADs) and the improvement in survival of this patient population, understanding the healthcare system burden is critical to improving outcomes. Thus, we sought to examine national estimates of VAD-related emergency department (ED) visits and characterize their demographic, clinical, and outcomes profile. Additionally, we tested the hypotheses that resource use increased and mortality improved over time. Methods and Results This retrospective database analysis uses encounter-level data from the 2010 to 2017 Nationwide Emergency Department Sample. The primary outcome was mortality. From 2010 to 2017, >880 million ED visits were evaluated, with 44 042 VAD-related ED visits identified. The annual mean visits were 5505 (SD 4258), but increased 16-fold from 2010 to 2017 (824 versus 13 155). VAD-related ED visits frequently resulted in admission (72%) and/or death (3.0%). Median inflation-adjusted charges were $25 679 (interquartile range, $7450, $63 119) per encounter. The most common primary diagnoses were cardiac (22%), and almost 30% of encounters were because of bleeding, stroke, or device complications. From 2010 to 2017, admission and mortality decreased from 82% to 71% and 3.4% to 2.4%, respectively ( P for trends <0.001, both). Conclusions We present the first study using national-level data to characterize the growing ED resource use and financial burden of patients supported by VAD. During the past decade, admission and mortality rates decreased but remain substantial; in 2017 ≈1 in every 40 VAD ED encounters resulted in death, making it critical that clinical decision-making be optimized for patients with VAD to maximize good outcomes.

The new adult heart allocation policy was approved in 2016 and implemented in October 2018. This year's Annual Data Report provides early insight into the effects of this policy. In 2019, new listings continued to increase, with 4086 new candidates. Also in 2019, 3597 heart transplants were performed, an increase of 157 (4.6%) from 2018; 509 transplants occurred in children and 3088 in adults. Short- and long-term posttransplant mortality rates improved. Overall, Mortality rates for adult recipients were 6.4% at 6 months and 7.9% at 1 year for transplants in 2018, 14.4% at 3 years for transplants in 2016, and 20.1% at 5 years for transplants in 2014. Mortality rates for pediatric recipients were 6.3% at 6 months and 8.2% at 1 year for transplants in 2018, 10.3% at 3 years for transplants in 2016, and 17.8% at 5 years for transplants in 2014., (.)

Left ventricular assist devices (LVADs) have revolutionized the care of patients with advanced heart failure, yet still require concomitant medications in order to achieve the best possible clinical outcomes. Since the outset of routine placement of durable, continuous-flow LVADs, much of the medication management of these patients to date has been based on International Society of Heart and Lung Transplantation (ISHLT) guidance, most recently published in 2013. Since 2013, numerous multidisciplinary pharmacotherapy publications have increased the LVAD community's understanding of best practices with respect to medications. We identified the major domains of LVAD medication management and conducted a comprehensive search of US National Library of Medicine MEDLINE ® database using keywords chosen to identify medication-related publications of significance dated 2013 or later. Trials pertaining to the HeartMate II™ and the HeartMate™ 3 LVADs (Abbott, Chicago, IL) and the HeartWare™ HVAD™ System (Medtronic, Minneapolis, MN) were chosen for inclusion. Highest priority for inclusion was given to prospective, randomized, controlled studies. Absent these, controlled trials (retrospective or prospective observational) were given next-highest consideration, followed by retrospective uncontrolled studies, and finally case series. Reference lists of qualified publications were reviewed to find any other publications of interest that were not discovered on initial search. Case reports were generally excluded, except where the insight gained was deemed to be uniquely pertinent. This document serves to provide a comprehensive review of the current understanding of optimal medication management in patients with durable, continuous-flow LVADs., (© 2020 Pharmacotherapy Publications, Inc.)

Background: Ventricular assist device (VAD) patients are at high risk for morbidities and mortality. One potentially beneficial component of the Joint Commission VAD Certification process is the requirement that individual VAD programs select 4 performance measures to improve and optimize patients' clinical outcomes., Problem Statement: Review of patient data after our program's first certification visit in 2008 showed that, compared to national recommendations and published reports, our patients had suboptimal outcomes in 4 areas after device implantation: length of hospital stay, receipt of early (<48 hours) postsurgical physical therapy, driveline infection incidence, and adequacy of nutritional status (prealbumin ≥18 mg/dL)., Methods: Plan-Do-Study-Act processes were implemented to shorten length of stay, increase patient receipt of early physical therapy, decrease driveline infection incidence, and improve nutritional status. With 2008 as our baseline, we deployed interventions for each outcome area across 2009 to 2017. Performance improvement activities included staff, patient, and family didactic, one-on-one, and hands-on education; procedural changes; and outcomes monitoring with feedback to staff on progress. Descriptive and inferential statistics were examined to document change in the outcomes., Outcomes: Across the performance improvement period, length of stay decreased from 40 to 23 days; physical therapy consults increased from 87% to 100% of patients; 1-year driveline infection incidence went from 38% to 23.5%; and the percentage of patients with prealbumin within the normal range increased from 84% to 90%., Implications: Performance improvement interventions may enhance ventricular assist device patient outcomes. Interventions' sustainability should be evaluated to ensure that gains are not lost over time.

Background: The new heart transplant allocation criteria prioritize inpatients who require temporary mechanical circulatory support and give lower urgency to candidates on a durable left ventricular assist device (LVAD) who require a device exchange. This study explores whether the latter group should warrant higher priority to reduce wait-list mortality., Methods: This is a retrospective observational study of 13,113 adult heart transplant candidates in the Organ Procurement and Transplantation Network database who underwent LVAD implantation between 2007 and 2017. It evaluates the impact of LVAD exchange on the composite endpoint of death or removal from the wait list owing to worsening medical condition 1 y after device implantation., Results: There were 1085 pump exchanges in 954 patients (7% of candidates), of which 22% were women. The pump exchange rate was 5.92 events per 100 patient-years. One-year survival was lower for those who required a pump exchange (76.3% versus 88.5%, logrank P < 0.001). This was congruent with the risk-adjusted mortality 1-y after implantation (hazards ratio: 2.56, 95% confidence interval: 2.18-3.00, P < 0.001)., Conclusions: These findings indicate that among candidates awaiting heart transplantation with a durable LVAD, undergoing pump exchange doubles the risk of 1-y mortality. Giving priority to these candidates may reduce wait-list mortality., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To assess the outcomes of the use of the percutaneous Impella RP device (Abiomed, Danvers, MA) in adolescents and young adults., Background: Results of the Impella RP device have been reported in adults, but a multicenter experience in adolescents and young adults has yet to be reported., Methods: Patients ≤21 years of age who underwent implantation of an Impella RP device for refractory right heart failure from June, 2016 to April, 2018 at nine U.S. Centers were included., Results: A total of 12 adolescents, median age of 18 (14-21) years and median weight 74.4 (49-112.4) kg underwent Impella RP implantation (INTERMACS Profile 1 in nine and Profile 2 in three patients. The central venous pressure decreased from 20 (16-35) to 12 (7-17) mmHg, (p = .001). One patient was concomitantly supported with an intra-aortic balloon pump (IABP) and the rest with a percutaneous/surgically placed left ventricular assist device. There was one adverse event related to the Impella RP device (thrombosis requiring explant). The support duration was 6.5 days (4.8 hr-18.4 days) and survival to hospital discharge was 83%. At a median follow-up of 11 months (5 days-2.5 years), 8 of 12 (67%) patients are alive., Conclusions: In this multicenter experience, the Impella RP device was found to be efficacious and safe when used in adolescents and young adults. Further studies are warranted to identify suitable young/pediatric candidates for Impella RP therapy for right heart failure., (© 2020 Wiley Periodicals, Inc.)

Background: Psychiatric comorbidities play a key role in patient selection for left ventricular assist devices (LVADs), but their impact on clinical outcomes is unknown., Objectives: The goal of this study was to examine the clinical impact of psychiatric illness on outcomes in patients receiving LVADs for end-stage heart failure (HF)., Methods: The study identified adults in the Interagency Registry for Mechanically Assisted Circulatory Support with psychiatric comorbidities (history of alcohol abuse, drug use, narcotic dependence, depression, and other major psychiatric diagnoses) receiving continuous-flow LVADs from 2008 to 2017. Demographic characteristics, survival, adverse events, and quality of life scores were compared for patients with and without each psychiatric comorbidity., Results: Over the study period, the prevalence of psychiatric comorbidities was low: alcohol abuse, n = 1,093 (5.5%); drug use, n = 1,077 (5.4%); narcotic dependence, n = 96 (0.5%); depression, n = 401 (2.0%); and other major psychiatric illnesses, n = 265 (1.4%). Narcotic dependence (adjusted hazard ratio: 1.9; 95% confidence interval: 1.2 to 3.0; p = 0.004) and other major psychiatric illnesses (adjusted hazard ratio: 1.4; 95% confidence interval: 1.0 to 1.9; p = 0.02) were associated with increased risk of mortality, whereas alcohol abuse, drug use, and depression were not. All comorbidities except narcotic dependence were associated with increased risk of rehospitalization and device-related infection (both p < 0.05). Kansas City Cardiomyopathy Questionnaire scores were lower from 6 to 24 months' post-implantation among patients with psychiatric comorbidities (p < 0.05)., Conclusions: Despite a low prevalence of psychiatric comorbidities among LVAD recipients, these conditions were associated with mortality risk, adverse events, and poorer quality of life. Further study is needed to understand how specific psychiatric conditions affect outcomes and how to best manage this vulnerable patient population., (Copyright © 2020. Published by Elsevier Inc.)

Background: The United Network of Organ Sharing (UNOS) heart allocation policy designates patients on ECMO or with nondischargeable, surgically implanted, nonendovascular support devices (TCS-VAD) to higher listing statuses., Objectives: This study aimed to explore whether temporary circulatory support-ventricular assist devices (TCS-VAD) have a survival advantage over extracorporeal membrane oxygenation (ECMO) as a bridge to transplant., Methods: The UNOS database was used to conduct a retrospective analysis of adult heart transplants performed in the United States between 2005 and 2017. Survival analysis was performed to compare patients bridged to transplant with different modalities., Results: Of the 24,905 adult transplants performed, 7,904 (32%) were bridged with durable left ventricular assist devices (LVADs), 177 (0.7%) with ECMO, 203 (0.8%) with TCS-VAD, 44 (0.2%) with percutaneous endovascular devices, and 8 (0.03%) with TandemHeart (LivaNova, London, United Kingdom). Unadjusted survival at 1 and 5 years post-transplant was 90 ± 0.4% and 77 ± 0.7% for durable LVAD, 84 ± 3% and 71 ± 4% for all TCS-VAD types, 79 ± 9% and 73 ± 14% for biventricular TCS-VAD, and 68 ± 3% and 61 ± 8% for ECMO. After propensity-matched pairwise comparisons were made, survival after all TCS-VAD types continued to be superior to ECMO (p = 0.019) and similar to LVAD (p = 0.380). ECMO was a predictor of post-transplant mortality in the Cox analysis compared with TCS-VAD (hazard ratio 2.40; 95% confidence interval: 1.44 to 4.01; p = 0.001)., Conclusions: Post-transplant survival with TCS-VAD is superior to ECMO and similar to LVAD in a national database., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The new adult heart allocation policy was approved in 2016 and implemented in October 2018, so its effect was not yet evident in 2018 data. However, the more granular data being collected are anticipated to allow for improved analyses. In 2018, new listings continued to increase; 3883 new adult and 685 new pediatric candidates were added. In 2018, 3440 heart transplants were performed, an increase of 167 over 2017; 473 transplants occurred in pediatric recipients and 2967 in adult recipients. Short-term and long-term posttransplant mortality improved. Overall 1-year survival for adults who underwent heart transplant in 2011-2013 was 90.3%, 3-year survival was 84.7%, and 5-year survival was 79.6%. Mortality rates for pediatric recipients were 4.5% at 6 months and in 5.9% at 1 year posttransplant, 12.5% at 3 years for transplants in 2014-2015, 14.8% at 5 years for transplants in 2012-2013, and 29.8% at 10 years for transplants performed in 2008-2009., (.)

Objectives: The purpose of this study was to examine outcomes after left ventricular assist device (LVAD) implantation in older adults (>75 years of age)., Background: An aging heart failure population together with improvements in mechanical circulatory support (MCS) technology have led to increasing LVAD implantations in older adults. However, data presenting age-specific outcomes are limited., Methods: Adult patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) who required durable MCS between 2008 and 2017 were included. Patients were stratified by 4 age groups: <55 years of age, 55 to 64 years of age, and >75 years of age. Kaplan-Meier survival estimates were used to assess post-LVAD outcomes, with log-rank testing used to compare groups. Univariate and multivariate cox proportional hazard regression models were used to determine predictors of survival and complications., Results: A total of 20,939 individuals received an LVAD during the study period: 7,743 (37.0%) were <55 years of age, 6,755 (32.3%) were 55 to 64 years of age, 5,418 (25.9%) were 65 to 74 years of age, and 1,023 (4.9%) were ≥75 years of age or older. After multivariate adjustment, adults ≥75 years of age had increased mortality post-LVAD implantation. Elderly patients with LVADs had a higher incidence of gastrointestinal bleeding but lower rates of device thrombosis. Compared to 84.5% of patients <55 years of age who were discharged home, only 46.8% of adults ≥75 years of age were discharged home following implantation (p < 0.001). Use of a RVAD, serum albumin level, and 6-min walk test distances were identified as predictors of outcomes in the oldest cohort., Conclusions: Despite careful selection of older adults for LVAD implantation, age remains a significant predictor of mortality. Higher bleeding and lower clotting risk in elderly patients with LVADs support the use of a less intense antithrombotic regimen in this unique population., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There are no published data on post-transplant outcomes in durable ventricular assist device (VAD)-supported adult congenital heart disease (ACHD) patients., Methods: We compared post-transplant outcomes in VAD-supported vs non-VAD-supported ACHD patients using the Scientific Registry of Transplant Recipients., Results: At 1 year, there was no difference in post-transplant mortality between VAD-supported (12 patients) and non-VAD-supported (671 patients) ACHD patients., Conclusions: In appropriate ACHD patients, VAD use as a bridge to transplant is a reasonable strategy., (© 2019 Wiley Periodicals, Inc.)

Aim: Preoperatively elevated pulmonary vascular resistance (PVR) is a contraindication to heart transplantation (HT). Transpulmonary pressure gradient (TPG) is one of the main variables used in PVR determination (ie, PVR = TPG/cardiac output). Unlike PVR, which is subject to the shortcoming of cardiac output estimation, TPG is directly measured. We aimed to evaluate the relationship of TPG obtained before left ventricular assist device (LVAD) implantation on post-HT survival., Methods and Results: A total of 490 patients were implanted with Heartmate II LVADs in the multicenter Heartmate II Bridge-to-Transplantation clinical trial, and 416/490 had pre-LVAD TPG data available. Outcomes during LVAD support and after HT stratified by both PVR and TPG were studied. The median pre-LVAD TPG was 10 mm Hg. Baseline demographic and clinical characteristics were similar for patients with and without TPG >10 mm Hg. Outcomes during LVAD support (ie, recovery to LVAD explantation, HT, or ongoing device support) for patients below and above the median TPG were similar. However, post-HT 1-year survival rate was significantly higher for patients with TPG ≤10 mm Hg compared with those with TPG >10 mm Hg (91% vs 80%; P = .016). Analysis based on the median PVR of 2.68 Wood units did not stratify post-HTx 1-year survival rates between the groups (89% vs 83%; P = .25)., Conclusions: Elevated TPG, rather than high PVR, before LVAD implantation was associated with increased mortality following HT. Pre-LVAD TPG may be useful to identify a cohort that requires close follow-up with serial hemodynamic monitoring before HT., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The HeartMate II (HMII) left ventricular assist device can be exchanged to HeartMate 3 (HM3) to reduce the risk of device thrombosis and stroke. However, data of this procedure are still limited. We reviewed early and mid-term outcomes of 9 patients who received a HMII to HM3 exchange at our institution. The median age of the cohort was 58 years [interquartile range (IQR) 53-61], and 7 (78%) patients were men. The median duration of HMII support was 608 days (IQR 493-1116). Indications for device exchange include device thrombosis (n = 8.89%) and driveline injury (n = 1.11%). Procedures were performed through a lateral thoracotomy in all patients. The median cardiopulmonary bypass time was 117 min (IQR 97-133). In-hospital mortality was 0%. One patient required repositioning of the HM3 pump through full sternotomy due to inflow malposition. During 486 days (IQR 235-712) of follow-up, 3 patients (33%) developed late HMII pump pocket infection after discharge. Five patients had a successful heart transplant and 1 patient died due to unknown reason. HMII to HM3 exchange can be performed via lateral thoracotomy. However, there is a risk of inflow malposition and previous pump pocket infection., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: To assess baseline patient characteristics and identify factors associated with in-hospital mortality after ventricular assist device (VAD) placement., Methods: Cross-sectional study using the National Inpatient Sample database from January 2010 to December 2014. Analyses were performed with sample weights provided by the National Inpatient Sample, which are reported ± the standard error of the mean., Results: Weighted samples yielded 15,021 ± 1111 patients who received a VAD. The mean age at time of implantation was 56.6 years. Most recipients were white (59.9%) and male (75.0%). Among older patients, in-hospital mortality increased from 17.2% to 48.2% when 1 or more high-risk interventions (cardiac surgery, prolonged mechanical ventilation, hemodialysis, or extracorporeal membrane oxygenation) preceded VAD placement (P < .001). In comparison, in-hospital mortality in younger patients increased from 11.1% to 29.4% when 1 or more of these same procedures preceded VAD placement. The mortality difference associated with these procedures was 19% greater in older patients compared with younger patients (95% confidence interval [CI], 9%-28%). In-hospital mortality among VAD recipients was associated with age older than 65 years (odds ratio [OR], 1.76; 95% CI, 1.29-2.40), female sex (OR, 1.27; 95% CI, 0.97-1.67), and at least 1 high-risk intervention preceding VAD (OR, 5.52; 95% CI, 4.27-7.13)., Conclusions: Older patients who underwent 1 or more intensive treatments before VAD placement had a nearly 50% inpatient mortality and were unlikely to receive a cardiac transplantation. Refining patient selection might help better align VAD with those most likely to benefit., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Ventricular assist device (VAD) patients often experience infections, which increase the risk of stroke and mortality. Using the definitions of the International Society for Heart and Lung Transplantation (ISHLT), we have characterized differences in clinical outcomes for categories of infection: VAD-specific (e.g., pump component related); VAD-related (e.g., bloodstream infection, BSI); and non-VAD infections (e.g., pneumonia)., Methods: Querying of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) identified 16,597 continuous-flow VAD recipients. Categories of infection were tested in multivariate models to determine the risk of stroke and death., Results: After implant, 7,046 patients (42%) developed an infection at a median of 69 (interquartile range 12 to 272) days. A majority were non-VAD infections (49%), followed by VAD-related (26%) and VAD-specific infections (25%). BSIs were the most common form of VAD-related infection (92%), and the majority (59%) had no associated infection, that is, idiopathic bacteremia. Internal pump component infections were rare (0.003 event per patient-year [EPPY]). Infected VAD patients had a higher prevalence of stroke compared to patients without an infection (18% vs 11%, p < 0.001). The lowest stroke rate occurred after a VAD-specific infection (0.11 EPPY) compared with VAD-related (0.17 EPPY) and non-VAD infections (0.15 EPPY, p < 0.001). Hemorrhagic strokes were more common than ischemic strokes in all infection groups and highest after a VAD-related infection (0.13 EPPY). One-year survival after an infection was 87% in VAD-specific infections, as compared with VAD-related (71%) and non-VAD infections (72%, p < 0.001)., Conclusions: The ISHLT categorization of VAD infections unveils notable differences in associated risk of stroke and mortality. A re-assessment of transplant prioritization for eligible infected VAD patients may be useful to increase transplant-related survival benefit., (Copyright © 2019 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study's objective was to investigate compassionate ventricular assist device deactivation (VADdeact) in children from the perspective of the pediatric heart failure provider., Background: Pediatric VAD use is a standard therapy for advanced heart failure. Serious adverse events may affect relative benefit of continued support, leading to consideration of VADdeact. Perspectives and practices regarding VADdeact have been studied in adults but not in children., Methods: A web-based anonymous survey of clinicians for pediatric VAD patients (<18 years) was sent to list-serves for the ISHLT Pediatric Council, the International Consortium of Circulatory Assist Clinicians Pediatric Taskforce, and the Pediatric Cardiac Intensivist Society., Results: A total of 106 respondents met inclusion criteria of caring for pediatric VAD patients. Annual VAD volume per clinician ranged from <4 (33%) to >9 (20%). Seventy percent of respondents had performed VADdeact of a child. Response varied to VADdeact requests by parent or patient and was influenced by professional degree and region of practice. Except for the scenario of intractable suffering, no consensus on VADdeact appropriateness was reported. Age of child thought capable of making informed requests for VADdeact varied by subspecialty. The majority of respondents (62%) do not feel fully informed of relevant legal issues; 84% reported that professional society supported guidelines for VADdeact in children had utility., Conclusion: There is limited consensus regarding indications for VADdeact in children reported by pediatric VAD provider survey respondents. Knowledge gaps related to legal issues are evident; therefore, professional guidelines and educational resources related to pediatric VADdeact are needed., (© 2019 Wiley Periodicals, Inc.)

In 2017, 3273 heart transplants were performed in the United States. New listings continued to increase, and 3769 new adults were listed for heart transplant in 2017. Over the past decade, posttransplant mortality has declined. The number of new pediatric listings increased over the past decade, as did the number of pediatric heart transplants, although some fluctuation has occurred more recently. New listings for pediatric heart transplants increased from 481 in 2007 to 623 in 2017. The number of pediatric heart transplants performed each year increased from 330 in 2007 to 432 in 2017, slightly fewer than in 2016. Short-term and long-term mortality improved. Among pediatric patients who underwent transplant between 2015-2016, 4.8% had died by 6 months and 6.2% by 1 year., (.)

Background: People with end-stage renal disease (ESRD) are at risk for advanced heart failure, but little is known about use and outcomes of durable mechanical circulatory support in this setting. We examined use and outcomes of implantable ventricular assist devices (VADs) in a national ESRD cohort., Methods and Results: We performed a retrospective cohort study of Medicare beneficiaries with ESRD who underwent implantable VAD placement from 2006 to 2014. We examined in-hospital and 1-year mortality, all-cause and cause-specific hospitalizations, and heart/kidney transplantation outcomes. We investigated as predictors demographic factors, time-period of VAD implantation, primary or post-cardiotomy implantation, and duration of ESRD before VAD implantation. We identified 96 people with ESRD who underwent implantable VAD placement. At time of VAD implantation, 74 (77.1%) were receiving hemodialysis, 10 (10.4%) were receiving peritoneal dialysis and 12 (12.5%) had renal transplant. Time from incident ESRD to VAD implantation was median 4.0 (interquartile range 1.1, 8.2) years. Mortality during the implantation hospitalization was 40.6%. Within 1 year of implantation 61.5% of people had died. On multivariable analysis, males had half the mortality risk of females. Lower mortality risk was also seen with VAD implantation in a primary setting, and with more recent year of implantation, but these results did not reach statistical significance., Conclusions: Medicare beneficiaries with ESRD are undergoing durable VAD implantation, often several years after incident ESRD, although in low numbers. Mortality is high among these patients, highlighting the need for investigations to improve treatment selection and management., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Few data exist on resource utilization with pediatric ventricular assist devices (VADs). We tested the hypothesis that device type and adverse events are associated with increased resource utilization in pediatric patients supported with VADs., Methods and Results: The Pediatric Interagency Registry for Mechanically Assisted Circulatory Support, a national registry of VADs in patients <19 years old, and the Pediatric Health Information System, an administrative database, were merged. Univariate analysis was performed assessing the association of all factors with the total cost and length of stay first. Significant variables ( P <0.05) were subjected to multivariable analysis. The study included 142 patients from 19 centers with VAD implants from October 2012 to June 2016. The median age was 9 years (interquartile range [IQR] 2-15), 84 (59%) supported with a continuous-flow VAD. Overall median hospital costs were $750 000 (IQR $539 000 to $1 100 000) with a median hospital length of stay of 81 days (IQR 54-128). On multivariable analysis, device type and postoperative complications were not associated with resource utilization. Factors associated with increased costs included patient age, lower-volume VAD center, being intubated, being on extracorporeal membrane oxygenation, number of complex chronic medical conditions, and length of stay. Among continuous-flow VAD patients, discharge to home before transplant versus remaining hospitalized was associated with lower hospital costs (median $600 000 [IQR $400 000 to $820 000] versus median $680 000 [IQR $500 000 to $970 000], P =0.03)., Conclusion: VADs in pediatric patients are associated with high resource utilization. Increased resource utilization was associated with lower-volume VAD centers, disease severity at VAD implantation, and the presence of complex chronic medical conditions. Further study is needed to develop cost-effective strategies in this complex population., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Pediatric ventricular assist device (VAD) support as bridge to transplant has improved waitlist survival, but the effects of pre-implant status and VAD-related events on post-transplant outcomes have not been assessed. This study is a linkage analysis between the PediMACS and Pediatric Heart Transplant Study databases to determine the effects of VAD course on post-transplant outcomes., Methods: Database linkage between October 1, 2012 and December 31, 2015 identified 147 transplanted VAD patients, the primary study group. The comparison cohort was composed of 630 PHTS patients without pre-transplant VAD support. The primary outcome was post-transplant survival, with secondary outcomes of post-transplant length of stay, freedom from infection and freedom from rejection., Results: At implant, the VAD cohort was INTERMACS Profile 1 in 33 (23%), Profile 2 in 89 (63%) and Profile 3 in 14 (10%) patients. The VAD cohort was older, larger, and less likely to have congenital heart disease (p < 0.0001). However, they had greater requirements for inotrope and ventilator support and increased liver and renal dysfunction (p < 0.0001), both of which normalized at transplant after device support. Importantly, there were no differences in 1-year post-transplant survival (96% vs 93%, p = 0.3), freedom from infection (81% vs 79%, p = 0.9) or freedom from rejection (71% vs 74%, p = 0.87) between cohorts., Conclusions: Pediatric VAD patients have post-transplant outcomes equal to that of medically supported patients, despite greater pre-implant illness severity. Post-transplant survival, hospital length of stay, infection and rejection were not affected by patient acuity at VAD implantation or VAD-related complications. Therefore, VAD as bridge to transplant mitigates severity of illness in children., (Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to compare trends of use, in-hospital mortality, and annual expenditures associated with orthotopic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation. In view of the changing health care landscape, we assessed the impact of federal funding cuts on Medicare and Medicaid beneficiaries seeking these procedures., Background: Use and cost trends associated with OHT and LVAD are not well defined. Moreover, little is known about the economic contribution of Medicare and Medicaid for these procedures., Methods: Using the National Inpatient Sample from 2009 through 2014, the study identified index hospitalizations for OHT and LVAD. The aforementioned trends and inflation-adjusted cost analyses were performed., Results: A total of 28,765 hospitalizations associated with OHT or LVAD were identified. The number of index hospitalizations for OHT increased from 1,795 to 2,140, whereas the number of LVAD implants increased from 2,205 to 3,645 (p trend  <0.001 for both). Unadjusted in-hospital mortality declined significantly from 17% to 12% (p trend  = 0.013) but remained unchanged for OHT (4.5% and 6.6%, respectively; p trend  = 0.30). The annual expenditure increased from ∼$288 to $451 million for OHT and from ∼$400 to $800 million for LVAD during the study period. Overall, Medicare and Medicaid contributed to more than 50% of the costs associated with these hospitalizations., Conclusions: With increasing use and annual expenditure, OHT and LVAD account for more than 1 billion dollars of the health care budget. In-hospital mortality associated with LVAD has continued to decline but has remained higher than that with OHT. Medicare and Medicaid beneficiaries seeking these procedures would be adversely affected by the proposed cuts., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)