Ventricular Assist Device Utilization Research Articles

Impact of HeartWare ventricular assist device discontinuation on the pediatric population: An Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry analysis

BackgroundThe HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The aim of this study is to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device utilization and outcomes. MethodsThe Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry was queried for type of VAD utilization and outcomes/adverse event rates in patients with a body surface area of 0.7-1.4 m2. Results were compared from before and after July 2021. All patients in the registry implanted with a HVAD were reported to determine overall outcomes of these patients and define who remains on the device. ResultsThe HeartMate 3 (HM3) primarily replaced the HVAD in pediatric patients increasing from 29 of 258 (11%) of implants before July 2021 to 31 of 109 (29%) of implants after. A small increase in the use of the Berlin Heart EXCOR (40 of 258, 16% before to 20 of 109, 18% after) and paracorporeal continuous flow devices (116 of 258, 45% before to 58 of 109, 53% after) was also observed. The rate of ischemic stroke increased in the overall population and a decrease in bleeding complications in the EXCOR group was observed. Of the 187 pediatric patients implanted with a HVAD in the registry, 7 patients remain supported, one patient transitioned from the HVAD to a HM3, and 6 patients were lost to follow-up. ConclusionThe HM3 has been the primary replacement for the HVAD in the medium sized pediatric population. The rate of ischemic stroke was higher after July 2021.

Left Ventricular Assist Device Use in Minorities: An Analysis of the National Inpatient Sample.

Minorities are less likely to receive a left ventricular assist device (LVAD). This, however, is based on total implant data. By examining rates of LVAD implant among patients admitted with heart failure complicated by cardiogenic shock, we sought to further elucidate LVAD utilization rates and racial disparities. Utilizing the National Inpatient Sample from 2013 to 2019, all patients admitted with a primary diagnosis of heart failure complicated by cardiogenic shock were included for analysis. Those who then received an LVAD during that hospitalization defined the LVAD utilization which was examined for any racial disparities. Left ventricular assist device utilization was low across all racial groups with no significant difference noted in univariate analysis. Non-Hispanic Blacks had the highest length of stay (LOS), the highest proportion of discharge to home (71.52%), and the lowest inpatient mortality (6.33%). Multivariable modeling confirmed the relationship between race and LOS; however, no differences were noted in mortality. Non-Hispanic Blacks were found to be less likely to receive an LVAD; however, when controlling for payer, median household income, and comorbidities, this relationship was no longer seen. Left ventricular assist devices remain an underutilized therapy in cardiogenic shock. When using a multivariable model, race does not appear to affect LVAD utilization.

P46: Rationale and Design of a Patient Empowerment Pilot: Self-Administered 6MWT Improve to Outcomes and Timely Utilization of Ventricular Assist Devices

Background: Ventricular assist devices (VAD) are life-saving therapy for appropriately selected end-stage heart failure patients. Although life-prolonging, VAD implantation may accompany considerable lifestyle changes, need for caregiver support, and risk of complications. Furthermore, early evaluation of VAD therapy is important to minimize the exacerbation of cardiac dysfunction. Therefore, shared decision-making through a timely evaluation for VAD therapy is imperative to minimize discrepancies between patient goals and clinical outcomes. The 6-minute walk test (6MWT) is a validated measure to predict morbidity and mortality in advanced heart failure patients, but it can be costly and time-consuming to perform routinely in the clinic. The Timed Walk App is a smartphone application that allows patients to perform a self-directed 6MWT, providing clinicians and patients with opportunities for shared decision-making and a larger database of objective clinical data for VAD evaluation. This study aims to address whether the usage of the Timed Walk App by heart failure patients can improve the clinical outcomes and timely utilization of VAD therapy. Methods: Patients referred to the University of Florida Heart Failure Clinic with an ejection fraction of less than 30% will be considered for study inclusion. Eligible patients will be educated on using the Timed Walk App to self-administer the 6MWT. Patients will be instructed to perform the 6MWT every 15 days and at least once a month. The demographic information, heart failure etiology, and biomarkers of illness severity will be obtained from the electronic medical record. For enrolled patients with VAD implantation, the following data will be collected: time between referral and LAD implantation, hospital length of stay, and incidence of adverse events post-VAD. Quality of life (QOL) assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ-5D will be performed at one-, three-, six-, and twelve-month intervals post-VAD. Data collected will be compared to a retrospective propensity-matched cohort in a weighted 3:1 fashion [Figure]. Results: In comparison to standard clinical assessments, we will analyze whether the use of the Timed Walk App improves: 1) likelihood of implantation 2) time from referral to VAD 3) implant length of stay 4) incidence of post-implant adverse events and 5) patient-reported QOL and perception of care. Conclusion: This study aims to explore whether the patient-directed monitoring of heart failure progression using the Timed Walk App promotes timely and appropriate utilization of VAD therapy. Findings are expected to inform future studies exploring the usage of smartphone applications to facilitate shared decision-making in advanced heart failure patients to improve the quality of life and clinical outcomes of VAD therapy.

Contemporary Outcomes of Heart Transplantation in Children with Heterotaxy Syndrome: Sub-Optimal Pre-Transplant Optimization Translates into Early Post-Transplant Mortality.

Patients with heterotaxy syndrome and congenital heart disease (CHD) experience inferior cardiac surgical outcomes. Heart transplantation outcomes are understudied, however, particularly compared to non-CHD patients. Data from UNOS and PHIS were used to identify 4803 children (< 18years) undergoing first-time heart transplant between 2003 and 2022 with diagnoses of heterotaxy (n = 278), other-CHD (n = 2236), and non-CHD cardiomyopathy (n = 2289). Heterotaxy patients were older (median 5yr) and heavier (median 17kg) at transplant than other-CHD (median 2yr and 12kg), and younger and lighter than cardiomyopathy (median 7yr and 24kg) (all p < 0.001). UNOS status 1A/1 at listing was not different between groups (65-67%; p = 0.683). At transplant, heterotaxy and other-CHD patients had similar rates of renal dysfunction (12 and 17%), inotropes (10% and 11%), and ventilator-dependence (19 and 18%). Compared to cardiomyopathy, heterotaxy patients had comparable renal dysfunction (9%, p = 0.058) and inotropes (46%, p = 0.097) but more hepatic dysfunction (17%, p < 0.001) and ventilator-dependence (12%, p = 0.003). Rates of ventricular assist device (VAD) were: heterotaxy-10%, other-CHD-11% (p = 0.839 vs. heterotaxy), cardiomyopathy-37% (p < 0.001 vs. heterotaxy). The 1-year incidence of acute rejection post-transplant was comparable between heterotaxy and others (p > 0.05). While overall post-transplant survival was significantly worse for heterotaxy than others (p < 0.05 vs. both), conditional 1-year survival was comparable (p > 0.3 vs. both). Children with heterotaxy syndrome experience inferior post-heart transplant survival, although early mortality appears to influence this trend, with 1-year survivors having equivalent outcomes. Given similar pre-transplant clinical status to others, heterotaxy patients are potentially under risk-stratified. Increased VAD utilization and pre-transplant end-organ function optimization may portend improved outcomes.

Impact of 2016 UNOS pediatric heart allocation policy changes on VAD utilization, waitlist, and post-transplant survival outcomes in children with CHD versus Non-CHD.

We analyzed the impact of the revised pediatric heart allocation policy on types of ventricular assist device (VAD) utilization, and waitlist (WL) and post-heart transplant (HT) survival outcomes in congenital heart disease (CHD) versus non-CHD patients before (Era-1) and after (Era-2) pediatric heart allocation policy implementation. We retrospectively reviewed the UNOS database from December 16, 2011, through March 31, 2021, for patients<18 years old and listed for primary HT. We compared the differences observed between Era-1 and Era-2. 5551 patients were listed for HT, of whom 2447(44%) were in Era-1 and 3104(56%) were in Era-2. CHD patients were listed as status 1A unchanged, but the number of patients listed as status 1B decreased in Era-2, whereas the number of non-CHD patients listed as status 1A decreased, but status 1B increased. In Era-2 compared to Era-1, both temporary (1% to 4%, p<.001) and durable VAD (13.6% to 17.8%, p<.001) utilization increased, and the transplantation rate per 100-patient years increased in both groups. The median WL period for CHD patients increased marginally from 70 to 71 days (p=.06), whereas for non-CHD patients it decreased from 61 to 54 days (p<.001). Adjusted 90-day WL survival increased from 84% to 88%, p=.016 in CHD, but there was no significant change in non-CHD patients (p=.57). There was no significant difference in 1-year post-HT survival in CHD and non-CHD patients between Era-1 and Era-2. In summary, after the revised heart allocation policy implementation, temporary and durable VAD support increased, HT rate increased, waitlist duration marginally increased in the CHD cohort and decreased in the non-CHD cohort, and 90-day WL survival probability improved in children with CHD without significant change in 1-year post-HT outcomes. Future studies are needed to identify changes to the policy that may further improve the listing criteria to improve WL duration and post-HT survival.

Racial disparity exists in the utilization and post-transplant survival benefit of ventricular assist device support in children

Children of minority race and ethnicity experience inferior outcomes postheart transplantation (HTx). Studies have associated ventricular assist device (VAD) bridge-to-transplant (BTT) with similar-to-superior post-transplant-survival (PTS) compared to no mechanical circulatory support. It is unclear whether racial and ethnic discrepancies exist in VAD utilization and outcomes. The United Network for Organ Sharing (UNOS) database was used to identify 6,121 children (<18 years) listed for HTx between 2006 and 2021: black (B-22% of cohort), Hispanic (H-21%), and white (W-57%). VAD utilization, outcomes, and PTS were compared between race/ethnicity groups. Multivariable Cox proportional analyses were used to study the association of race and ethnicity on PTS with VAD BTT, using backward selection for covariates. Black children were most ill at listing, with greater proportions of UNOS status 1A/1 (p < 0.001 vs H & W), severe functional limitation (p < 0.001 vs H & W), and greater inotrope requirements (p < 0.05 vs H). Non-white children had higher proportions of public insurance. VAD utilization at listing was: B-11%, H-8%, W-8% (p=0.001 for B vs H & W). VAD at transplant was: B-24%, H-21%, W-19% (p=0.001 for B vs H). At transplant, all VAD patients had comparable clinical status (functional limitation, renal/hepatic dysfunction, inotropes, mechanical ventilation; all p > 0.05 between groups). Following VAD, hospital outcomes and one-year PTS were equivalent but long-term PTS was significantly worse among non-whites-(p < 0.01 for W vs B & H). On multivariable analysis, black race independently predicted mortality (hazard ratio 1.67 [95% confidence interval 1.22-2.28]) while white race was protective (0.54 [0.40-0.74]). Pediatric VAD use is, seemingly, equitable; the most ill patients receive the most VADs. Despite similar pretransplant and early post-transplant benefits, non-white children experience inferior overall PTS after VAD BTT.

Sex-related differences in left ventricular assist device utilization and outcomes: results from the PCHF-VAD registry.

Data on sex and left ventricular assist device (LVAD) utilization and outcomes have been conflicting and mostly confined to US studies incorporating older devices. This study aimed to investigate sex-related differences in LVAD utilization and outcomes in a contemporary European LVAD cohort. This analysis is part of the multicentre PCHF-VAD registry studying continuous-flow LVAD patients. The primary outcome was all-cause mortality. Secondary outcomes included ventricular arrhythmias, right ventricular failure, bleeding, thromboembolism, and the haemocompatibility score. Multivariable Cox regression models were used to assess associations between sex and outcomes. Overall, 457 men (81%) and 105 women (19%) were analysed. At LVAD implant, women were more often in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2 (55% vs. 41%, P=0.009) and more often required temporary mechanical circulatory support (39% vs. 23%, P=0.001). Mean age was comparable (52.1 vs. 53.4years, P=0.33), and median follow-up duration was 344 [range 147-823] days for women and 435 [range 190-816] days for men (P=0.40). No significant sex-related differences were found in all-cause mortality (hazard ratio [HR] 0.79 for female vs. male sex, 95% confidence interval [CI] [0.50-1.27]). Female LVAD patients had a lower risk of ventricular arrhythmias (HR 0.56, 95% CI [0.33-0.95]) but more often experienced right ventricular failure. No significant sex-related differences were found in other outcomes. In this contemporary European cohort of LVAD patients, far fewer women than men underwent LVAD implantation despite similar clinical outcomes. This is important as the proportion of female LVAD patients (19%) was lower than the proportion of females with advanced HF as reported in previous studies, suggesting underutilization. Also, female patients were remarkably more often in INTERMACS profile 1 or 2, suggesting later referral for LVAD therapy. Additional research in female patients is warranted.

Racial Disparity Exists in the Utilization of and Post-Transplant Survival Benefit from Ventricular Assist Device Support in Children

<h3>Purpose</h3> Despite advances in the field of pediatric heart failure, black patients continue to experience inferior outcomes. Studies have reported that ventricular assist device (VAD) bridge to transplant (BTT) is associated with similar or better post-transplant survival (PTS) versus no MCS, but whether race/ethnicity affect this is unclear. <h3>Methods</h3> UNOS was used to identify patients <18 years old at listing who received heart transplantation during or after 2006. Patients were grouped by race/ethnicity - black (B; n=1,294), Hispanic (H; n=1,218), and white (W; n=3,395) - and demographics, VAD utilization, clinical status, and PTS were compared. Multivariate (MV) Cox proportional analysis was performed to identify predictors of survival. <h3>Results</h3> Black patients were oldest and heaviest (p<0.01 for both). Dilated cardiomyopathy was more prevalent in non-whites (p<0.01) and congenital heart disease more prevalent in whites (p<0.01). Less consistent trends were seen in functional impairment and organ dysfunction (Table). VAD utilization at time of transplant was greatest in black patients (B-28%, H-23%, W-21%, p<0.01). Kaplan-Meier PTS was higher in whites than in blacks or Hispanics (W-B, p<0.01; W-H, p=0.01) (Figure). On MV analysis of PTS, white BTT with VAD was protective (HR 0.66 (95% CI 0.52-0.84), p<0.01). <h3>Conclusion</h3> VAD utilization is greatest in black children. The post-transplant survival benefit portended by VAD in whites is not seen in non-whites despite a greater percentage having a more favorable cardiac diagnosis and controlling for preoperative variables.

Pediatric VAD Growth in the US: What Factors May Be Driving Growth Jumps?

<h3>Purpose</h3> As the use of pediatric ventricular assist device (VAD) support has grown in the US, the rate of growth has not been linear. Instead, growth has occurred in spurts. We sought to analyze growth spurts in pediatric VAD use to determine what factors may be influencing increases in VAD utilization in the US. <h3>Methods</h3> OPTN data were used to identify all children ≤18 years listed for heart transplant between 2009 and 2019 including the proportion supported with a VAD at some point during the waiting period. VAD growth spurts were identified based on direct inspection of the annual implant volume trends. Factors independently associated with VAD growth spurts were identified using multivariable regression techniques. <h3>Results</h3> Among 6,940 children who met the inclusion criteria, 769 received a VAD. Annual VAD implant growth is depicted in the Figure. Two distinct periods of rapid growth were identified, the first between 2011 and 2012, where annual usage at listing jumped 75% and the second between 2016 and 2017, where annual usage at listing increased by 36% and was sustained. Regression analyses suggest that the 2011-12 jump was driven by increased implants among infants with the Berlin Heart while the 2016-2017 jump was observed in older children, especially ages 4-6 years, and associated with several factors including growth in use of the PediMag/CentriMag system, Heartmate III, introduction of bivalirudin anticoagulation, and UNOS revisions favoring VAD over milrinone to achieve 1A status in cardiomyopathy patients. Minimal change appears related to increase of VAD implants in children with congenital heart disease. <h3>Conclusion</h3> Over the past 10 years, pediatric VAD growth has been non-linear, accelerating more rapidly at specific time periods. The 2012 jump appears driven by Berlin Heart approval and use in infants, whereas the jump beyond 2016 appears related to a variety of factors including expansion of pump options, anticoagulation strategies and potentially the 2016 UNOS allocation revisions.

Patient and Device Selection in Pediatric MCS: A Review of Current Consensus and Unsettled Questions.

The field of pediatric ventricular assist device (VAD) support has expanded significantly over the past 20years, with one third of pediatric heart transplant recipients currently being bridged to transplant with a VAD. Despite increased pediatric VAD utilization, however, there remains little formalized guidance for patient or device selection. The population of children with advanced heart failure is quite heterogeneous, and the available data suggest that VAD outcomes vary significantly based upon patient size, anatomy, level of illness, and type of device implanted. In an effort to better understand current practice patterns and identify populations for whom there does not appear to be a consensus approach to achieving optimal VAD outcomes, the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has surveyed clinical decision-making among member sites and conducted a review of the available literature regarding patient population-specific VAD outcomes and center-specific practices related to patient and device selection. Rather than aiming to provide clinical guidelines, this document offers an overview of contemporary approaches to patient and device selection, highlighting specific populations for whom there is not a consensus approach to achieving reliably good VAD outcomes, as these populations may benefit most from future research and quality improvement efforts directed toward identifying best practice.

Recent Era Outcomes of Mechanical Circulatory Support in Children With Congenital Heart Disease as a Bridge to Heart Transplantation.

The objective of the study is to compare the clinical characteristics, risk factors, and overall survival (waitlist and posttransplant) outcomes in children with congenital heart disease (CHD) bridged to transplantation with either a ventricular assist device (VAD) versus extracorporeal membrane oxygenation (ECMO) versus no mechanical circulatory support (MCS) in the recent era. The study included 2,899 primary heart transplantations in patients <18 years with CHD between 2010 and 2019 from the United Network Organ Sharing database. Patients who had ECMO or VAD at listing or while listed were included, and their waitlist and posttransplant outcomes were compared with CHD patients who did not require MCS. Of all, 464 (16%) had ECMO and 200 (7%) VAD at the time of or during the listing. The VAD utilization increased over the last decade (4% in 2010 to 10% in 2019, p < 0.01). The 90 days post-MCS survival was better with VAD than ECMO (67 vs. 49%, p < 0.01). The transplantability rate at 90 days was decreased with younger age (odds ratio [OR], 0.91; 95% CI, 0.86-0.95), lower body mass index (BMI) (OR, 0.93; 95% CI, 0.89-0.98) and lower albumin <3g/dl (OR, 0.6; 95% CI, 0.53-0.7). The multivariate model predicted that lower BMI (OR, 1.12; 95% CI, 1.06-1.18), pretransplant ECMO (OR, 2.19; 95% CI, 1.39-3.45), and higher bilirubin (OR, 1.15; 95% CI, 0.97-1.36) decreased 1-year posttransplant survival. Patients transplanted with VAD had better 1-year survival than ECMO (88 vs. 70%, p = 0.01). Waiting list survival of children with CHD supported by VAD is better compared to ECMO. The 1-year posttransplantation outcome of CHD patients supported by VAD is similar to the no MCS patients and better than ECMO-supported patients. There is no significant difference in post-HT survival between patients transitioned from ECMO to VAD while listed and those with VAD-first.

Disparities in Implantable Ventricular Assist Device Utilization: Observation from Nationwide Inpatient Database

Introduction Implantable ventricular assist devices (IVADs) use is rising in the United-States as a heart transplant bridge or as destination therapy to improve survival in individuals with advanced heart failure. Previous studies have indicated gender, racial, geographic, and socioeconomic disparities in patients selected to receive IVADs. Methods This retrospective cohort study used the Nationwide Inpatient Sample to identify all patients above 18 years who underwent IVAD implantation from 2011 to 2017. All data was weight as recommended by Healthcare Cost and Utilization Project. Results A total of 25,503 patients had an IVAD implanted. Since 2011, there has been an average annual increase in implantation of IVADs of 9.6% per year (See Figure 1). Mean patient age was 57 ± 13 years, and the majority were men (77%). Most patients receiving IVADs self-identified as White (63%) or Black (24%), with fewer patients of Hispanic (6%), Asian or Pacific Islander (2%), or Native American ( Conclusion Although IVAD utilization in the US has substantially increased in the past decade, there still remains important disparities in various areas including gender, race, geographic location, and socioeconomic status. Further study is needed to evaluate the reasons for, and implications of, these disparities.

US Trends in Pediatric VAD Utilization - Where are We Now?

Pediatric ventricular assist device (VAD) therapy is a rapidly changing field where devices and applications are rapidly evolving. We sought to describe some of the most recent trends in pediatric VAD use and contemporary outcomes since UNOS began collecting VAD data on all listed patients regardless of whether they survived. All children ≤21 years of age listed for isolated HT between Jan 2004 and 2019 and underwent VAD placement were identified using OPTN data. Descriptive statistics were used to characterize recent trends in VAD utilization. Waitlist survival in children with cardiomyopathy, CHD and single-ventricle heart disease were estimated using the Kaplan-Meier method. Overall, 2059 children met the study inclusion criteria of whom the median age was 11 (IQR 1, 17), median weight 38 (11,66) kg, 26% were black; 18.3 had congenital heart disease (CHD) including 5.1% with single-ventricle (SV) HD. Forty-nine percent were supported with a VAD at listing, 72% at transplant and 13% received a VAD but was not supported at listing or transplant. Overall, 64% received LVADs, 31% BIVADs, 2.5% RVADs 1.7% total artificial hearts (TAH). Implants of the Berlin Heart fell dipped sharply to 34 in 2015 after a peak of 63 but have rebounded since in the era of bivalirudin. As of 2018, the Heartware HVAD was the most commonly implanted VAD in children (N=61) followed by the Berlin Heart (N=48), CentriMag/PediMag (N=18) and Heartmate III (N=11). The fastest growing segment of VAD patients are single-ventricle patients (Figure). The total number of pediatric VADs continues to grow at a brisk pace. The most recent era has seen growth of the Heartmate III and resurgence of the Berlin Heart EXCOR, after a brief decline in 2015. Single-ventricle and Heartmate III patients represent the fastest growing segment of the VAD population.

TCT-319 Impact of Percutaneous Ventricular Assist Device Utilization Volume During Percutaneous Coronary Intervention in Noncardiogenic Shock Patients on 30-Day Readmission Rate: A Nationwide Cohort Study

TCT-319 Impact of Percutaneous Ventricular Assist Device Utilization Volume During Percutaneous Coronary Intervention in Noncardiogenic Shock Patients on 30-Day Readmission Rate: A Nationwide Cohort Study

Sex-Based Differences in Left Ventricular Assist Device Utilization

Women comprise approximately one-third of the advanced heart failure population but may receive fewer advanced heart failure therapies including left ventricular assist devices (LVADs). During the early pulsatile-flow device era, women had higher post-LVAD mortality and increased complications. However, knowledge about these differences in the continuous-flow device era is limited. Therefore, we sought to explore temporal trends in LVAD utilization and post-LVAD mortality by sex. Patients with LVAD implantation from 2004 to 2016 were identified using the Nationwide Inpatient Sample. Trends in LVAD utilization and post-LVAD inpatient mortality were compared by sex and device era. Although LVADs are being increasingly utilized for patients with advanced systolic heart failure, women continue to represent a smaller proportion of LVAD recipients-25.8% in 2004 to 21.9% in 2016 (P for trend, 0.91). Women had increased inpatient mortality after LVAD implantation compared with men in the pulsatile-flow era (46.9% versus 31.1%, P<0.0001) but not in the continuous-flow era (13.3% versus 12.1%, P=0.27; P for interaction=0.0002). Inpatient mortality decreased for both sexes over time after LVAD, with a sharp fall in 2008 to 2009. Female sex was independently associated with increased post-LVAD inpatient mortality beyond adjustment for demographics and risk factors during the pulsatile-flow era (odds ratio, 2.13; 95% CI, 1.45-3.10; P<0.0001) but not during the continuous-flow era (1.18; 0.93-1.48; P=0.16). Although utilization of LVAD therapy increased over time for both sexes, LVAD implantation remains stably lower in women, which may suggest a potential underutilization of this potentially life-saving therapy. Prospective studies are needed to confirm these findings.

Organ Procurement and Transplantation in Italy

Organ Procurement and Transplantation in Italy

Gender Disparity in Left Ventricular Assist Device Utilization: Insights from Nationwide Inpatient Sample 2004-2016

Purpose Women comprise over half of the heart failure (HF) population but less commonly receive advanced HF therapies such as left ventricular assist devices (LVAD). Women had higher mortality rates and increased postoperative complications after LVADs during the early pulsatile flow (PF) era and in large registries in the continuous flow (CF) era. Whether these disparities and complication rates persist over time and how they may impact LVAD utilization in women in the CF era is unknown. Methods We utilized the National Inpatient Sample from 2004 to 2016 to identify patients with LVAD placement. Temporal trends in LVAD utilization and post-LVAD inpatient mortality were compared by gender and between PF (before 2009) and CF (2009 and after) era. Results The absolute number of LVAD implants increased for both genders (Fig 1A) over time but the percentage of women overall receiving LVAD remained stably low compared to men over time (less than 30% of total implants; Fig 1B&C). Baseline characteristics including comorbidity profiles, post-LVAD complications and inpatient outcomes are summarized (Table 1). Despite fewer comorbidities, women had higher mortality post LVAD in the PF era (p Conclusion Although overall LVAD implants increased for both genders from 2004 to 2016, LVAD utilization remained comparatively low in women. Disparately increased inpatient mortality in women post-LVAD during the PF era did not remain during the CF era. Prospective studies need to confirm our findings of post-LVAD outcomes between genders. However, our results suggest potential underutilization of LVAD in women with advanced HF in the CF LVAD era.

Readmission and resource utilization after orthotopic heart transplant versus ventricular assist device in the National Readmissions Database, 2010–2014

As the technology of ventricular assist devices continues to improve, the morbidity and mortality for patients with a ventricular assist device is expected to approach that of orthotopic heart transplantation. The present study was performed to compare perioperative outcomes, readmission, and resource utilization between ventricular assist device implantation and orthotopic heart transplantation, using a national cohort. Patients who underwent either orthotopic heart transplantation or ventricular assist device implantation from 2010 to 2014 in the National Readmission Database were selected. Of the 12,111 patients identified during the study period, 5,440 (45%) received orthotopic heart transplantation, while 6,671 (55%) received ventricular assist devices. Readmissions occurred frequently after ventricular assist device implantation and orthotopic heart transplantation, with greater rates at 30days (29% versus 24%, P=.005) and 6 months (62% versus 46%, P < .001) for the ventricular assist device cohort. Cost of readmission was greater among ventricular assist device patients at 30 days ($29,115 versus $21,586, P=.0002) and 6 months ($34,878 versus $20,144, P = .0106). Readmission rates and costs for patients with a ventricular assist device remain greater than their orthotopic heart transplantation counterparts. Given the projected increases in ventricular assist device utilization and limited transplant donor pool, further emphasis on cost containment and decreased readmissions for patients undergoing a ventricular assist device is essential to the viability of such therapy in the era of value-based health care delivery.

Effect of Hepatitis C Positivity on Survival in Adult Patients Undergoing Heart Transplantation (from the United Network for Organ Sharing Database)

Concerns exist regarding orthotropic heart transplantation in hepatitis C virus (HCV) seropositive recipients. Thus, a national registry was accessed to evaluate early and late outcome in HCV seropositive recipients undergoing heart transplant. Retrospective analysis of the United Network for Organ Sharing registry (1991 to 2014) was performed to evaluate recipient profile and clinical outcome of patients with HCV seropositive (HCV+ve) and seronegative (HCV-ve). Adjusted results of early mortality and late survival were compared between cohorts. From 23,507 patients (mean age 52years; 75% men), 481 (2%) were HCV+ve (mean age 52years; 77% men). Annual proportion of HCV+ve recipients was comparable over the study period (range 1.3% to 2.7%; p= 0.2). The HCV+ve cohort had more African-American (22% vs 17%; p= 0.01), previous left ventricular assist device utilization (21% vs 14%; p <0.01) and more hepatitis B core Ag+ve recipients (17% vs 5%; p <0.01). However, both cohorts were comparable in terms of extracorporeal membrane oxygenator usage (p= 0.7), inotropic support (p= 0.2), intraaortic balloon pump (p= 0.7) support, serum creatinine (p= 0.7), and serum bilirubin (p= 0.7). Proportion of status 1A patients was similar (24% HCV+ vs 21% HCV-); however, wait time for HCV+ve recipients were longer (mean 23 vs 19days; p <0.01). Among donor variables, age (p= 0.8), hepatitis B status (p= 0.4), and Center for Diseases Control high-risk status (p= 0.9) were comparable in both cohorts. At a median follow-up of 4years, 67% patients were alive, 28% died, and 1.1% were retransplanted (3.4% missing). Overall survival was worse in the HCV+ cohort (64.3% vs 72.9% and 43.2% vs 55% at 5 and 10 years; p <0.01), respectively. Late renal (odds ratio [OR] 1.2 [1 to 1.6]; p= 0.02) and liver dysfunction (odds ratio 4.5 [1.2 to 15.7]; p= 0.01) occurs more frequently in HCV+ve recipients. On adjusted analysis, HCV seropositivity is associated with poorer survival (hazard ratio for mortality 1.4 [1.1 to 1.6]; p <0.001). In conclusion, a small proportion of patients receiving a heart transplant in the United States have hepatitis C. Despite comparable preoperative hepatic function, hepatitis C seropositive recipients demonstrate poorer long-term survival.

Abstract 12276: The Changing Landscape of Ventricular Assist Device Utilization in Children Bridged to Transplant: The “Revolution” Begins

Introduction: Growing clinical experience and innovative implantation techniques have allowed individual pediatric centers to push the boundaries of VAD use. However, data describing the global trends in VAD utilization are lacking. We sought to assess temporal trends in the use of VADS as a bridge to transplant in children across the US. Methods: Children &lt;18 years listed for heart transplant 1/2006-6/2014 who were bridged with a VAD were identified in the UNOS database. Patients were stratified by era (Early: 2006-2010, Current: 2011-2014). Descriptive statistics were used to assess trends. Results: Of 3986 patients listed, 589 (15%) received a VAD as bridge to transplant during the study period. The percentage of patients bridged with a VAD increased in the current era (12% vs. 18%, p&lt;0.001), while both durable cfVAD use and waitlist times increased (Table). Children &lt; 25 kg continue to be bridged to transplant almost exclusively with pulsatile devices while 95% of patients ≥ 25 kg were bridged with a cfVAD in 2014 (Figure). Conclusions: The current era has seen a 1.5-fold increase in the percentage of children bridged to transplant with a VAD as well as a 3-fold increase in the percentage of patients bridged with a durable cfVAD in patients &gt; 25 kg. The emergence of cfVAD technology in an era of increasing waitlist times, raises the prospect of a dramatic increase in the number of children discharged from the hospital while supported with a cfVAD. This underscores the need to rapidly define pediatric specific best care practices in outpatient VAD management.