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Purpose: We sought to characterize adaptive changes to the revised United Network for Organ Sharing donor heart allocation policy and estimate long-term survival trends for heart transplant (HTx) recipients., Methods: Patients listed for HTx between October 17, 2013 and September 30, 2021 were identified from the United Network for Organ Sharing database, and stratified into pre- and postpolicy revision groups. Subanalyses were performed to examine trends in device utilization for extracorporeal membranous oxygenation (ECMO), durable left ventricular assist device (LVAD), intra-aortic balloon pump (IABP), microaxial support (Impella), and no mechanical circulatory support (non-MCS). Survival data post-HTx were fitted to parametric distributions and extrapolated to 5 years., Results: We identified 27,523 HTx waitlist candidates during the study period, most of whom (n = 16,376) were waitlisted in the prepolicy change period. Overall, 19,554 patients underwent HTx during the study period (pre: 12,037 and post: 7517). Listings increased after the policy change for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients. Listings for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients decreased. HTx increased for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients after the policy change and decreased for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients. Waitlist survival increased for the overall ( P < 0.01), ECMO ( P < 0.01), IABP ( P < 0.01), and non-MCS ( P < 0.01) groups. Waitlist survival did not differ for the LVAD ( P = 0.8) and Impella ( P = 0.1) groups. Post-transplant survival decreased for the overall ( P < 0.01), LVAD ( P < 0.01), and non-MCS ( P < 0.01) populations., Conclusions: Allocation policy revisions have contributed to greater utilization of ECMO, Impella, and IABP, decreased utilization of LVADs and non-MCS, increased waitlist survival, and decreased post-HTx survival., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Venoarterial extracorporeal membrane oxygenation is a rescue therapy for patients in cardiogenic shock. We hypothesize that patients bridged to heart transplant with extracorporeal membrane oxygenation have decreased survival., Methods: The United Network of Organ Sharing database was retrospectively reviewed from January 1, 1999, to March 31, 2018, for heart transplant recipients. Recipients bridged with any form of mechanical support and those without support were compared with recipients bridged with extracorporeal membrane oxygenation. The primary end point was restricted mean survival time through 16.7 years., Results: Of 26,918 recipients, 15,076 required no pretransplant mechanical support (56.0%). Support patients included 9321 with left ventricular assist devices (34.6%), 53 with right ventricular assist devices (0.2%), 258 with total artificial hearts (1.0%), 686 with biventricular assist devices (2.6%), 1378 with intra-aortic balloon pumps (5.1%), and 146 who required extracorporeal membrane oxygenation (0.5%). In the first 16.7 years post-transplant, compared with recipients bridged with extracorporeal membrane oxygenation, estimated adjusted restricted mean survival time was higher in patients who required no mechanical support (16.6 months [14.0-19.4]) and patients with a left ventricular assist device (16.5 months [99% confidence interval, 13.9-19.2]), an intra-aortic balloon pump (11.2 months [8.3-14.7]), or a biventricular assist device (6.6 months [3.6-10.3]). Restricted mean survival time in patients with a right ventricular assist device or a total artificial heart was similar to patients with extracorporeal membrane oxygenation., Conclusions: Recipients bridged with extracorporeal membrane oxygenation were estimated to survive 16.6 months less than nonmechanical circulatory support recipients. Bridge to heart transplant with extracorporeal membrane oxygenation is a viable option, and these patients should be considered transplant candidates., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Left ventricular assist device (LVAD) implantation has been shown to increase allosensitization before orthotopic heart transplantation, but the influence of LVAD support on posttransplant rejection is controversial. This study examines the postoperative incidence of acute cellular rejection (ACR) in patients bridged with continuous flow LVAD (CF-LVAD) relative to primary transplant (Primary Tx)., Methods: All patients who underwent orthotopic heart transplantation at our institution between July 2006 and March 2019 were retrospectively reviewed (n = 395). Patients were classified into Primary Tx (n = 145) and CF-LVAD (n = 207) groups. Propensity score matching on 13 covariates implemented a 0.1 caliper logistic model with nearest neighbor 1:1 matching. Development of moderate to severe (ie, 2R/3R) rejection was evaluated using a competing risks model. Potential predictors of 2R/3R ACR were evaluated using Fine-Gray regression on the marginal subdistribution hazard., Results: Propensity score matching yielded 122 patients in each group (n = 244). At 12 and 24 months, the cumulative incidence of 2R/3R ACR was 17% and 23% for the CF-LVAD group and 26% and 31%, respectively, for the Primary Tx group (P = .170). CF-LVAD was not predictive of 2R/3R rejection on multivariable Fine-Gray regression (subdistribution hazard ratio, 0.73; 95% confidence interval, 0.40-1.33; P = .301). There was no difference in the 5-year incidence of antibody mediated rejection (10% [n = 12] vs 9% [n = 11]; P = .827)., Conclusions: After adjusting for covariates, CF-LVAD was not associated with an increased risk of moderate to severe ACR during the 24 months after cardiac transplantation. Further investigation is warranted with larger cohorts, but CF-LVAD may have minimal influence on posttransplant ACR., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) provides detailed information on pediatric patients supported with ventricular assist devices (VADs)., Methods: From September 19, 2012, to December 31, 2020, 1229 devices in 1011 patients were reported to the registry from 47 North American Hospitals in patients aged younger than 19 years., Results: Cardiomyopathy was the most common underlying etiology (58%), followed by congenital heart disease (CHD; 25%) and myocarditis (10%). The most common devices implanted were implantable continuous (IC; 419 [41%]), followed by paracorporeal pulsatile (PP; 269 [27%]), paracorporeal continuous (PC; 263 [26%]), and percutaneous (53 [5%]). Overall, at 6 months after VAD implantation, 83% had a positive outcome (transplant, explant, or alive on device). The freedom from stroke at 3 months was highest in IC VADs (93%), compared with PP VADs (84%) and with PC VADs (75%). There were differences in survival by device type, with patients on IC VADs having the best overall survival and those on PC having the lowest overall survival, though the patient populations being supported by each VAD type differed significantly from each other., Conclusions: This Fifth Pedimacs Report demonstrates the continued robust growth of VADs in the pediatric community, now with more than 1000 patients reported to the registry. The multiple available device types (PC, PP, IC) serve different populations with different pre-VAD risk profiles, which may account for differences in survival and adverse events between device types., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Survival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices., Objectives: This study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice., Methods: Adults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents "worst health" and 100 "best health"); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months)., Results: The cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups., Conclusions: In elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients., Competing Interests: Funding Support and Author Disclosures The Society of Thoracic Surgeons funded and designed the data analysis which was performed at the University of Alabama at Birmingham Data Coordinating Center, which had primary responsibility for collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. Dr Kirklin has received partial salary support, paid to his institution, from the Society of Thoracic Surgeons. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

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: Temporary mechanical circulatory support (MCS) devices are increasingly used in cardiogenic shock, but whether sociodemographic differences by sex, race and/or ethnicity, insurance status, and neighborhood poverty exist in the utilization of these devices is unknown., Methods: Retrospective cross-sectional study using the National Inpatient Sample for 2012-2017. Logistic regression models were used to examine predictors of use of temporary MCS devices and for in-hospital mortality, clustering by hospital-year., Results: Our study population included 109,327 admissions for cardiogenic shock. Overall, 14.3% of admissions received an intra-aortic balloon pump, 4.2% a percutaneous ventricular assist device, and 1.8% extracorporeal membranous oxygenation (ECMO). After adjusting for age, comorbidities, and hospital characteristics, use of temporary MCS was lower in women compared to men (adjusted odds ratio [aOR] = 0.76, P < .001), Black patients compared to white ones (aOR = 0.73, P < .001), those insured by Medicare (aOR = 0.75, P < .001), Medicaid (aOR = 0.74, P < .001), or uninsured (aOR = 0.90, P = .015) compared to privately insured, and those in the lowest income neighborhoods (aOR = 0.94, P = .003) versus other neighborhoods. Women, admissions covered by Medicare, Medicaid, or uninsured, and those from low-income neighborhoods also had higher mortality rates even after adjustment for MCS implantation., Conclusions: There are differences in the use of temporary MCS in the setting of cardiogenic shock among specific populations within the United States. The growing use of MCS for treating cardiogenic shock highlights the need to better understand its impact on outcomes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Adoption of implantable left ventricular assist devices has dramatically improved survival and quality of life in suitable patients with end-stage heart failure. In the era of value-based healthcare delivery, assessment of clinical outcomes and resource use associated with left ventricular assist devices is warranted., Methods: Adult patients undergoing left ventricular assist device implantation from 2008 to 2016 were identified using the National Inpatient Sample. Hospitals were designated as low-volume, medium-volume, or high-volume institutions based on annual institutional left ventricular assist device case volume. Multivariable logistic regression was used to evaluate adjusted odds of mortality across left ventricular assist device volume tertiles., Results: Over the study period, an estimated 23,972 patients underwent left ventricular assist device implantation with an approximately 3-fold increase in the number of annual left ventricular assist device implantations performed (P for trend <.001). In-hospital mortality in patients with left ventricular assist devices decreased from 19.6% in 2008 to 8.1% in 2016 (P for trend <.001) and was higher at low-volume institutions compared with high-volume institutions (12.0% vs 9.2%, P < .001). Although the overall adjusted mortality was higher at low-volume compared with high-volume institutions (adjusted odds ratio, 1.66; 95% confidence interval, 1.28-2.15), this discrepancy was only significant for 2008 and 2009 (low-volume 2008 adjusted odds ratio, 5.5; 95% confidence interval, 1.9-15.8; low-volume 2009 adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.8)., Conclusions: Left ventricular assist device use has rapidly increased in the United States with a concomitant reduction in mortality and morbidity. With maturation of left ventricular assist device technology and increasing experience, volume-related variation in mortality and resource use has diminished. Whether the apparent uniformity in outcomes is related to patient selection or hospital quality deserves further investigation., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Limited contemporary data exist regarding outcomes and resource use among adults with congenital heart disease and heart failure (ACHD-HF). This study compared outcomes, emergency department (ED) and hospital resource use, and advanced heart failure (HF) therapies in ACHD-HF versus non-ACHD with HF (HF-non-ACHD)., Methods: The Nationwide Emergency Department Sample and Nationwide Inpatient Sample were used to analyse outcomes and resource use among ACHD-HF ED visits and hospitalisations from 2006 to 2016. ACHD-HF was stratified by single-ventricle (SV) and two-ventricle (2V) disease., Results: A total of 76 557 ACHD-HF visits (3.6% SV physiology) and 31 137 414 HF-non-ACHD visits were analysed. ACHD-HFs were younger (SV 33 years (IQR 25-44), 2V 62 years (IQR 45-76); HF-non-ACHD 74 years (IQR 63-83); p<0.001). ACHD-HFs had higher ED admissions (78% vs 70%, p<0.001), longer hospital length of stay (5 days (IQR 2-8) vs 4 days (IQR 2-7), p<0.001) and greater hospital costs ($49K (IQR 2K-121K) vs $32K (17K-66K), p<0.001). Mortality was significantly higher among ACHD-HFs with SV physiology (6.6%; OR 1.6, 95% CI 1.1 to 2.3) or 2V physiology (6.3%; OR 1.4, 95% CI 1.3 to 1.5) versus HF-non-ACHD (5.5%). ACHF-HF hospitalisations increased more (46% vs 6% HF-non-ACHD) over a 10-year period, but the proportion receiving ventricular assist device (VAD) (ACHD-HF -2% vs HF-non-ACHD 294%) or transplant (ACHD-HF -37% vs HF-non-ACHD 73%) decreased., Conclusion: ACHD-HFs have significant ED and hospital resource use that has increased over the past 10 years. However, advanced HF therapies (VAD and transplantation) are less commonly used compared with those without adult congenital heart disease., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

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: Patients suffering an acute myocardial infarction complicated by cardiogenic shock (AMICS) may experience clinical deterioration with concomitant atrial fibrillation (AF). Recent data suggest that percutaneous ventricular assist devices (pVADs) provide superior hemodynamic support over intra-aortic balloon pump (IABP) in AMICS. In patients with AF+AMICS, however, outcomes data comparing these two devices remain limited., Methods: Using the National Inpatient Sample datasets (2008-2014) and a propensity-score matched analysis, we compared the outcomes of AMICS+AF hospitalized patients undergoing PCI with pVAD vs. IABP support., Results: A total of 12,842 AMICS+AF patients were identified (pVAD=468, IABP=12,374). The matched groups (pVAD=443, IABP=443) were comparable in terms of mean age (70.3 ± 12.0 vs. 70.4 ± 11.0yrs, p = 0.92). The utilization of pVAD was higher in whites but lower in Medicare/Medicaid beneficiaries as compared to IABP. The pVAD group demonstrated higher rates of obesity (13.6% vs. 7.8%, p = 0.006) and dyslipidemia (48.4% vs. 41.8%, p = 0.05). There was no difference in the in-hospital mortality (40.5% vs. 36.8%, p = 0.25); however, pVAD group had a lower incidence of post-procedural MI and higher incidences of stroke (7.8% vs. 4.4%, p = 0.03), hemorrhage (5.6% vs. 2.3%, p = 0.01), discharges to home health care (13.5% vs. 10.1%, p<0.001) and to other facilities (29.1% vs. 24.9%, p<0.001) as compared to IABP group. There was no difference between the groups in terms of mean length of stay or hospital charges., Conclusions: All-cause inpatient mortality was similar in AMICS+AF patients undergoing PCI who were treated with either pVAD or IABP. The pVAD group, however, experienced more complications while consuming greater healthcare resources., (Copyright © 2020 Southern Society for Clinical Investigation. All rights reserved.)

Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), originally a National Institutes of Health-sponsored U.S. database, provides a platform to understand the population of children supported with ventricular assist devices (VADs) during this time of increasing numbers, new devices, expanding indications, and improved outcomes., Methods: Between September 19, 2012, and December 31, 2019, 44 hospitals implanted 1031 devices in 856 patients under 19 years of age., Results: Overall, diagnosis was cardiomyopathy in 497 (58%) patients, congenital heart disease (CHD) in 216 (25%), myocarditis in 85 (10%), and other in 58 (7%). Positive outcome (alive on device or bridge to transplantation and recovery) occurred in 82% at 6 months. The patient cohort for implantable continuous (IC) pumps (n = 365) (age 13.2 ± 3.9 years, 18% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 23% intubated at implantation, 16% with CHD) was significantly different from the paracorporeal continuous (PC) pump cohort (n = 212) (age 3.6 ± 4.9 years, 46% Intermacs profile 1, 81% intubated, 42% CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 230) (age 2.7 ± 3.5 years, 31% Intermacs profile 1, 76% intubated, 26% CHD). Consistent with their cohort composition, positive outcomes at 6 months based on device type were the following: IC, 92%; PC, 68%; and PP, 81%. The incidence of cerebrovascular accidents in the IC, PC, and PP cohorts was 7%, 14%, and 15%, respectively., Conclusions: IC VADs, the most common VAD type placed in children, are associated with improved outcomes compared with PP and PC devices, though PP and PC devices are limited to supporting our most challenging patients. Noteworthy, the incidence of cerebrovascular accidents for pediatric VADs has significantly decreased and is now 11% overall. This report demonstrates again that although often attributed to age, size, or device type, much of the burden in mortality and adverse events is correlated to the patient's overall state at VAD implantation., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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.

Background: The objective of this study was to characterize practical use trends and outcomes for intraaortic balloon pump (IABP) and percutaneous left ventricular assist device (pVAD) use in cardiogenic shock at a national level., Methods: An analysis of all adult patients admitted nonelectively for cardiogenic shock from January 2008 through December 2017 was performed using the National Inpatient Sample. Trends of inpatient IABP and pVAD use were analyzed using survey-weighted estimates and the modified Cochran-Armitage test for significance. Multivariable regression models and inverse probability of treatment weights were used to perform risk-adjusted analyses of pVAD mortality, a composite of adverse events (AE), and resource use, with IABP as reference., Results: Of an estimated 774,310 patients admitted with cardiogenic shock, 143,051 received a device: IABP, 127,792 (16.5%); or pVAD, 15,259 (2.0%). IABP use decreased (23.8% to 12.7%; P for trend <.001), whereas pVAD implantation increased significantly during the study period (0.2% to 4.5%; P for trend <.001). Inverse probability of treatment weights demonstrated significantly higher odds of mortality with pVAD (odds ratio, 1.9; 95% confidence interval, 1.7 to 2.2), but not AE (odds ratio, 1.1; 95% confidence interval, 0.96 to 1.27), compared with IABP. After risk adjustment, pVAD use was associated with an additional $15,202 (P < .001) in cost for survivors and $29,643 for nonsurvivors (P < .001)., Conclusions: Over the study period, the rate of pVAD use for cardiogenic shock significantly increased. Compared with IABP, pVAD use was associated with increased mortality, higher costs, and several AEs. Multi-institutional clinical trials with rigorous inclusion criteria are warranted to evaluate the clinical utility of pVADs in the modern era., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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.)

Background Left ventricular assist devices (LVADs) improve outcomes in patients with end-stage heart failure and are increasingly implanted for destination therapy. We describe dynamic estimates of event-free survival with conditional survival probabilities in a destination therapy LVAD population. Methods and Results We studied 8245 adult patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) implanted with a continuous-flow destination therapy LVAD. The composite primary end point was death, device exchange or removal, or heart transplantation. Conditional survival probabilities were calculated and stratified by implantation characteristics and nonfatal adverse events experienced within the first year after implant. Probabilities of surviving an additional 1 to 3 years were numerically higher after longer prior event-free survival. INTERMACS profile 1, extracorporeal membrane oxygenation support, prior or concomitant surgery, and dialysis within 48 hours of implantation were associated with significantly lower event-free survival in the first year but did not impact event-free survival beyond then. For patients who experienced a nonfatal adverse event within the first year, subsequent 1-year conditional survival was lower than in the absence of that event for stroke (65% [95% CI, 57%-73%] versus 75% [95% CI, 73%-77%]; P <0.001), device-related infection (64% [95% CI 57%-71%] versus 76% [95% CI, 74%-78%]; P <0.001), and pump thrombosis or malfunction (64% [95% CI, 57%-70%] versus 76% [95% CI, 74%-78%]; P <0.001). Conclusions Conditional survival in patients with destination therapy LVADs improves over time, even for patients with unfavorable implantation characteristics. However, LVAD-related complications including stroke, device-related infection, and pump thrombosis or malfunction have an enduring negative influence on dynamic estimates of long-term prognosis.

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.)

There is limited data on regional differences in patient characteristics, practice patterns, and clinical outcomes in patients with ST elevation myocardial infarction (STEMI) with cardiogenic shock (CS) in the United States (US). We aimed to identify variations in treatment methods and clinical outcomes in patients with STEMI CS between the 4 US regions. Using the National Inpatient Sample database, we identified adult patients admitted with STEMI associated with CS between 2006 and 2015 using ICD-9-DM codes. Based on the US regions (Northeast, Midwest, South, and West), we divided patients in 4 cohorts and compared baseline patient characteristics, clinical outcomes and procedural outcomes. A total of 186,316 patients with STEMI CS were included; 32,303 (17.3%) were hospitalized in the Northeast, 43,634 (23.4%) in the Midwest, 70,036 (37.8%) in the South, and 40,043 (21.5%) in the West. Although nonstatistically significant, the in-hospital mortality was higher in Northeast region (37.7%), followed by the South (36.6%), West (35.7%), and Midwest (35.2%). Rates of percutaneous coronary intervention were higher in the Midwest (68.5%) and lower in the Northeast (56%). The use of percutaneous ventricular assist device and ECMO was higher in the Northeast (3.3% and 2.2%) and lower in the West (2.1% and 0.4%). The median length of stay was similar among all 4 cohorts (6 days) but median hospital costs were higher in the West ($36, 614) and lower in the South ($28,795). In conclusion, there are significant geographic variations in practice patterns, healthcare cost, and in-hospital outcomes in patients with STEMI complicated by CS between 4 US regions., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system., Methods: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices., Results: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001)., Conclusions: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Importance: Racial differences are recognized in multiple cardiovascular parameters, including left ventricular hypertrophy and heart failure, which are 2 major manifestations of hypertrophic cardiomyopathy. The association of race with disease expression and outcomes among patients with hypertrophic cardiomyopathy is not well characterized., Objective: To assess the association between race, disease expression, care provision, and clinical outcomes among patients with hypertrophic cardiomyopathy., Design, Setting, and Participants: This retrospective cohort study included data on black and white patients with hypertrophic cardiomyopathy from the US-based sites of the Sarcomeric Human Cardiomyopathy Registry from 1989 through 2018., Exposures: Self-identified race., Main Outcomes and Measures: Baseline characteristics; genetic architecture; adverse outcomes, including cardiac arrest, cardiac transplantation or left ventricular assist device implantation, implantable cardioverter-defibrillator therapy, all-cause mortality, atrial fibrillation, stroke, and New York Heart Association (NYHA) functional class III or IV heart failure; and septal reduction therapies. The overall composite outcome consists of the first occurrence of any component of the ventricular arrhythmic composite end point, cardiac transplantation, left ventricular assist device implantation, NYHA class III or IV heart failure, atrial fibrillation, stroke, or all-cause mortality., Results: Of 2467 patients with hypertrophic cardiomyopathy at the time of analysis, 205 (8.3%) were black (130 male [63.4%]; mean [SD] age, 40.0 [18.6] years) and 2262 (91.7%) were white (1351 male [59.7%]; mean [SD] age, 45.5 [20.5] years). Compared with white patients, black patients were younger at the time of diagnosis (mean [SD], 36.5 [18.2] vs 41.9 [20.2] years; P < .001), had higher prevalence of NYHA class III or IV heart failure at presentation (36 of 205 [22.6%] vs 174 of 2262 [15.8%]; P = .001), had lower rates of genetic testing (111 [54.1%] vs 1404 [62.1%]; P = .03), and were less likely to have sarcomeric mutations identified by genetic testing (29 [26.1%] vs 569 [40.5%]; P = .006). Implantation of implantable cardioverter-defibrillators did not vary by race; however, invasive septal reduction was less common among black patients (30 [14.6%] vs 521 [23.0%]; P = .007). Black patients had less incident atrial fibrillation (35 [17.1%] vs 608 [26.9%]; P < .001). Black race was associated with increased development of NYHA class III or IV heart failure (hazard ratio, 1.45; 95% CI, 1.08-1.94) which persisted on multivariable Cox proportional hazards regression (hazard ratio, 1.97; 95% CI, 1.34-2.88). There were no differences in the associations of race with stroke, ventricular arrhythmias, all-cause mortality, or the overall composite outcome., Conclusions and Relevance: The findings suggest that black patients with hypertrophic cardiomyopathy are diagnosed at a younger age, are less likely to carry a sarcomere mutation, have a higher burden of functionally limited heart failure, and experience inequities in care with lower use of invasive septal reduction therapy and genetic testing compared with white patients. Further study is needed to assess whether higher rates of heart failure may be associated with underlying ancestry-based disease pathways, clinical management, or structural inequities.

Acute circulatory collapse may rarely occur during transcatheter aortic valve implantation (TAVI). In such cases, immediate mechanical circulatory support (MCS) as a bridge to remedial interventions may be required. To define the rate of MCS utilization in TAVI patients and identify the predictors of MCS utilization in a cohort of TAVI patients. TAVI patients between January 2012 and September 2015 were identified in the National Inpatient Sample (NIS) by using the International Classification of Diseases, 9th Revision. Trend weights were used to generate the national estimates of MCS rate in TAVI. Multivariate regression analysis was done to identify predictors of MCS use. A total 60,985 patients underwent TAVI with 1,695 patients receiving MCS (2.8%) during index hospitalization. The most common type of MCS was intra-aortic balloon pump in 52%, followed by extra corporeal membrane oxygenator in 34%, then percutaneous ventricular assist device in 7.4%. Rate of MCS use declined over the study period from 3% in 2012 (Q1) to 1.8% in 2015 (Q3). The use of MCS during TAVI was associated with 10-fold increase in-hospital mortality (27.1% vs 2.8%, p <0.001). Predictors of MCS were congestive heart failure (OR = 2.58, p <0.001), transapical access (OR = 1.92, p <0.001), respiratory complication (OR = 5.19, p <0.001), acute myocardial infarction (OR = 4.21, p <0.001), cardiac arrest (OR = 10.65, p <0.001), and cardiogenic shock (OR = 19.09, p <0.001). In conclusion, the rate of MCS during TAVI hospitalization in the United States declined between 2012 and 2015. MCS during TAVI was associated with a 10-fold increase in in-hospital mortality., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Continuous-flow left ventricular assist device (LVAD) implantation is a payor sensitive procedure influenced by preoperative comorbidities and social factors. Whether expansion in insurance coverage will further influence device utilization is unknown. This study sought to assess the effects of Medicaid expansion on vulnerable populations (namely racial-ethnic minorities and those with low-income status) undergoing continuous-flow LVAD implantation after the enactment of the 2014 Affordable Care Act (ACA)., Methods: Data from the 2012 to Q3 2015 State Inpatient Database were used to examine a cohort of 624 nonelderly adults (aged 18-64 y) who were given a continuous-flow LVAD in three expansion states (Kentucky, New Jersey, and Maryland) and two nonexpansion states (North Carolina and Florida). The cohort excluded patients who had a heart transplant, heart-lung transplant, or noncontinuous-flow LVAD. Poisson Interrupted Time Series was used with three-way interactions and change of slope and intercept parameters at 2014 to determine the impact of the ACA expansion on utilization of continuous-flow LVAD by race and insurance strata., Results: Poisson Interrupted Time Series models show that within expansion states, the population of Medicaid and uninsured patients saw an increase in the utilization of LVAD's immediately after ACA expansion, from 2.8 in Q4 2013 to 9.83 Q1 2014 (incidence rate ratio [IRR] 5.26, P = 0.02). Utilization eventually declined to pre-ACA levels, however, ending with 3.04 LVADs in Q3 2015 (IRR 0.84, 95% confidence interval 0.58-1.20). Models testing for racial effect showed no statistically preferential or disparate effects (immediate effect IRR 1.608, P = 0.506; marginal effect IRR 0.897, P = 0.512)., Conclusions: These findings show that despite expanded insurance coverage, the utilization of continuous-flow LVADs was not increased in nonelderly racial and ethnic minorities following the ACA Medicaid expansion. Although these findings are preliminary and require further long-term evaluation, they suggest that insurance coverage alone does not play a significant role in increased utilization of continuous-flow LVAD. These findings point toward the importance of further exploring social, medical, and hospital drivers of these disparities., (Copyright © 2019. Published by Elsevier Inc.)

Background: 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., Methods and Results: 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)., Conclusions: 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.

The objectives were to study the overall and age-, sex-, and race-stratified incidence of cardiogenic shock (CS) during heart failure hospitalizations (HFHs) not complicated by acute coronary syndromes (ACS), utilization of short-term mechanical circulatory support (MCS) and in-hospital mortality with non-ACS-related CS, and respective temporal trends. Data are lacking regarding the epidemiology of non-ACS-related CS during HFHs., Methods: Retrospective observational analysis of the National Inpatient Sample 2005-2014 to identify all HFHs in adult patients without concomitant ACS., Results: Of 8,333,752 HFHs, incidence rate of non-ACS-related CS was 8.7 per thousand HFHs (N = 72,668), a 4-fold increase from 4.1 to 15.6 per thousand HFHs between 2005 and 2014 (P trend < .001). Among those with non-ACS-related CS, utilization rates of intra-aortic balloon pump, extracorporeal membrane oxygenation, and temporary ventricular assist devices were 12.8%, 1.4%, and 2.5%, respectively. Respective 2005 to 2014 trends were 14.2% to 10.7%, 0.6% to 1.8%, and 0.8% to 2.7% (P trend for all, <.001). In-hospital mortality rate was 27.1%, with a substantial decrease from 42.4% in 2005 to 23.3% in 2014 (P trend < .001). These temporal trends were largely consistent across age, sex, and race subgroups., Conclusion: During HFHs in the United States, non-ACS-related CS occurred infrequently but was associated with substantial mortality. Non-ACS-related CS incidence and certain MCS utilization rates increased, and in-hospital mortality rate decreased between 2005 and 2014. These trends were generally homogenous across the age, sex, and race groups. The observed trends in incidence and mortality may be a reflection of increased identification of CS during HFHs, although further study is needed to assess whether temporal changes in care may have influenced outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVADs) have revolutionized the treatment of advanced heart failure, but proliferation of device therapy has unmasked potential complications. Reports have emerged of outflow graft narrowing due to extrinsic compression., Methods and Results: The records of patients with LVADs that had been implanted at our institution were reviewed. Those who had postimplantation computed tomography angiographies sufficient to analyze the outflow graft lumen were identified, and the studies were analyzed to characterize the outflow graft lumen. We identified 241 patients; 110 (46%) had suitable computed tomography angiographies. Of those, 15 (14%) had evidence of outflow graft lumen narrowing, all in HeartMate devices and all within the portion covered by the bend relief. Of the 15, 3 underwent invasive examination, all without intraluminal thrombus but, rather, with biodebris between the bend relief and the outflow graft. Patients with HeartWare devices had a wide range of biodebris accumulation surrounding the outflow graft but no cases of lumen narrowing. On multivariable analysis, 1) time from device implant to scan, 2) nonischemic cardiomyopathy and 3) age at implant were significantly associated with higher risk of graft narrowing., Conclusion: Outflow graft narrowing can be seen in a number of patients with HeartMate LVADs within the portion covered by the bend relief. In the limited number of patients who underwent invasive evaluation, the narrowing was found to arise from extrinsic compression rather than intraluminal thrombus. The clinical significance of this requires further investigation., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The pulmonary artery catheter (PAC) has been used in a wide range of critically ill patients. It is not indicated for routine care of heart failure (HF), but its role in cardiogenic shock (CS) has not been clarified., Methods and Results: We conducted a retrospective cohort study with the use of the National Inpatient Sample and identified a total of 9,431,944 adult patients admitted from 2004 to 2014 with the primary diagnosis of HF (n = 8,516,528) or who developed CS (n = 915,416) during the index hospitalization. Overall, patients with PAC had increased hospital costs, length of stay, and mechanical circulatory support use. In patients with HF, PAC use was associated with higher mortality (9.9% vs 3.3%, OR 3.96; P < .001) but the excess of mortality declined over time. In those with CS, PAC was associated with lower mortality (35.1% vs 39.2%, OR 0.91; P < .001) and in-hospital cardiac arrest (14.9% vs 18.3%, OR 0.77; P < .001); this paradox persisted after propensity score matching., Conclusions: The use of PAC in CS has decreased from 2004 to 2014, although its use is now associated with improved outcomes, which may reflect better selection of patients or better use of the information to guide therapies. Our data provide reassurance that PAC use in this population is an appropriate strategy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Angiotensin II receptor activation may result in angiogenesis, and ultimately arteriovenous malformations (AVM), through transforming growth factor (TGF)-β and angiopoietin-2 pathway activation., Objectives: The goal of this study was to determine whether angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) were associated with lower risk of major gastrointestinal bleeds (GIB) and AVM-related GIBs in continuous-flow left ventricular assist device (CF-LVAD) patients., Methods: The authors reviewed HeartMate II CF-LVAD recipients between January 2009 and July 2016. Major GIBs were endoscopically confirmed requiring ≥2 U of packed red blood cells or resulting in death. ACE inhibitor/ARB dose was abstracted from medical records. ACE inhibitor/ARB exposure status was landmarked at 30 days post-operatively to avoid immortal time bias. Fine and Gray hazard models assessed the impact of ACE inhibitor/ARB therapy on major GIB and AVM-related GIB, whereas standard Cox regression assessed the impact on mortality, adjusting for baseline variables., Results: One-hundred and eleven patients were included with a mean 2.1 ± 1.4 years follow-up. Patients who received an ACE inhibitor/ARB within 30 days post-operatively had a 57% reduction in the risk of major GIB (adjusted hazard ratio [aHR]: 0.43; 95% confidence interval [CI]: 0.19 to 0.97; p = 0.042) and a 63% reduction in the risk of AVM-related GIB (aHR: 0.37; 95% CI: 0.16 to 0.84; p = 0.017). When the mean daily post-operative lisinopril-equivalent ACE inhibitor/ARB dose was >5 mg, the risk of major GIB decreased in a dose-threshold manner (aHR: 0.28; 95% CI: 0.09 to 0.85; p = 0.025)., Conclusions: ACE inhibitor/ARB therapy is associated with a protective effect of developing GIBs in CF-LVAD patients, with a dose threshold of >5 mg of daily lisinopril equivalence, possibly due to prevention of AVM formation., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The influence of ventricular assist device (VAD) use in the care of children with end-stage heart failure is growing rapidly through increasing numbers, new devices, expanding indications, and improving outcomes. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Institutes of Health-sponsored United States database, provides a platform to understand this emerging population., Methods: Between September 19, 2012, and December 31, 2017, 30 hospitals implanted 508 devices in 423 patients aged younger than 19 years. This past year was one of evolution for the database as its management was transitioned to The Society of Thoracic Surgery; therefore, this report does not include data from institutions not under contract by August 1, 2018., Results: Of the 423 patients, the diagnosis was cardiomyopathy in 261 (62%), myocarditis in 48 (11%), other in 28 (7%), and congenital heart disease (CHD) in 86 (20%), with 52 of these patients having single-ventricle physiology. The two most common support strategies included left VAD in 342 (81%) and biventricular assist device in 64 (15%). Positive outcome (alive on device or bridge to transplantation/recovery) was 80% at 6 months (overall mortality of 20%). The patient cohort for implantable continuous-flow (IC) pumps (n = 197; age at implant, 13.4 ± 3.8 years; 19% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 21% intubated at implant, and 12% with CHD) was significantly different from the paracorporeal continuous-flow (PC) pump cohort (n = 79; age, 3.9 ± 5.2 years; 49% Intermacs profile 1, 86% intubated at implant, and 38% with CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 121; age, 3.3 ± 3.9 years; 41% Intermacs profile 1, 77% intubated at implant, and 21% with CHD). Consistent with their cohort composition, device type positive outcomes at 6 months were PC, 63%; PP, 77%; and IC, 92%. Parametric hazard modeling showed an early hazard for death was associated with Intermacs profile 1, biventricular assist device, percutaneous devices, PC devices, small-volume institutions, low age, and low weight, whereas a constant hazard was associated with intubation and liver dysfunction at time of implant., Conclusions: IC VADs are the most common VAD type placed in children. The positive outcomes for the IC VADs exceed 90% at 6 months, which may represent our field's maturation in both patient selection and timing of implantation. The PP/PC devices are currently limited to supporting our most challenging patients, those weighing less than 20 kg and those with CHD. The introduction of new devices and our communities' commitment to shared learning and improvement will lead to more pediatric lives saved by VAD support and will also focus on improving the quality of life of children supported with VADs., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Heart failure is a widespread condition in the United States that is predicted to significantly increase in prevalence in the next decade. Many heart failure patients are given a left ventricular assist device (LVAD) while they wait for a heart transplant, while those that are not able to undergo a heart transplant may be given an LVAD permanently. However, past studies have observed a small subset of heart failure patients that recovered cardiac function of their native heart after being placed on an LVAD. As a result, some patients have been able to have their LVAD explanted and no longer needed a heart transplant. In this review, we analyzed the data of 15 studies that observed recovery of cardiac function in LVAD patients in order to investigate the effects that duration of LVAD support has on patient outcomes. From our review, we identified that there may be negative consequences of prolonged duration of mechanical support such as myocardial atrophy and abnormal calcium cycling as well as circumstances that may allow for a longer duration of LVAD support such as in patients using a continuous-flow LVAD, non-ischemic cardiomyopathy patients, and the specific pharmacological therapy.

Background: Medicaid insurance in Georgia provides limited reimbursement for heart transplant (HT) and left ventricular assist devices (LVAD). We examined whether insurance type affects eligibility for and survival after receipt of HT or LVAD., Methods and Results: We retrospectively identified patients evaluated for HT/LVAD from 2012 to 2016. We used multivariable logistic and Cox proportional hazards regression to examine the association of insurance type on treatment eligibility and 1-year survival. Of 569 patients evaluated, 282 (49.6%) had private, 222 (39.0%) had Medicare, and 65 (11.4%) had Medicaid insurance. Patients with Medicaid were younger, more likely to be Black, with fewer medical comorbidities. In adjusted models, Medicare and Medicaid insurance predicted lower odds of eligibility for HT, but did not affect survival after HT. Among those ineligible for HT, Medicaid patients were less likely to receive destination therapy (DT) LVAD (adj OR 0.08, 95% CI 0.01-0.66; P = .02) and had increased risk of death (adj HR = 2.03, 95% CI 1.13-3.63; P = .01)., Conclusions: Despite younger age and fewer comorbidities, patients with Medicaid insurance are less likely to receive DT LVAD and have an increased risk of death once deemed ineligible for HT. Medicaid patients in Georgia need improved access to DT LVAD., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: 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., Methods: Patients who underwent either orthotopic heart transplantation or ventricular assist device implantation from 2010 to 2014 in the National Readmission Database were selected., Results: 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 30 days (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)., Conclusion: 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., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: This study sought to examine the trends and predictors of mechanical circulatory support (MCS) use in patients hospitalized after out-of-hospital cardiac arrest (OHCA)., Background: There is a paucity of data regarding MCS use in patients hospitalized after OHCA., Methods: We conducted an observational analysis of MCS use in 960,428 patients hospitalized after OHCA between January 2008 and December 2014 in the Nationwide Inpatient Sample database. On multivariable analysis, we also assessed factors associated with MCS use and survival to discharge., Results: Among the 960,428 patients, 51,863 (5.4%) had MCS utilized. Intra-aortic balloon pump (IABP) was the most commonly used MCS after OHCA with frequency of 47,061 (4.9%), followed by extracorporeal membrane oxygenation (ECMO) 3650 (0.4%), and percutaneous ventricular assist devices (PVAD) 3265 (0.3%). From 2008 to 2014, there was an increase in the utilization of MCS from 5% in 2008 to 5.7% in 2014 (P trend  < 0.001). There was a non-significant decline in the use of IABP from 4.9% to 4.7% (P trend  = 0.95), whereas PVAD use increased from 0.04% to 0.7% (P trend  < 0.001), and ECMO use increased from 0.1% to 0.7% (P trend  < 0.001) during the study period. Younger, male patients with myocardial infarction, higher co-morbid conditions, VT/VF as initial rhythm, and presentation to a large urban hospital were more likely to receive percutaneous MCS implantation. Survival to discharge was significantly higher in patients who were selected to receive MCS (56.9% vs. 43.1%, OR: 1.16, 95% CI: (1.11-1.21), p < 0.001)., Conclusions: There is a steady increase in the use of MCS in OHCA, especially PVAD and ECMO, despite lack of randomized clinical trial data supporting an improvement in outcomes. More definitive randomized studies are needed to assess accurately the optimal role of MCS in this patient population., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a United States registry for adults receiving durable United States Food and Drug Administration-approved mechanical circulatory support devices (MCSDs). We merged INTERMACS records with Medicare claims to investigate the uncertainty of penetrance of Medicare beneficiaries within INTERMACS., Methods: INTERMACS records and Medicare claims (January 1, 2008, through December 31, 2013) from the Centers for Medicare and Medicaid (CMS) were linked using a deterministic matching methodology., Results: There was annual growth of CMS and INTERMACS centers performing durable MCSD implants among adults from 2008 through 2013 (54% and 87% increase, respectively). The number of CMS centers outnumbered INTERMACS centers throughout all years, with the 68% to 88% of CMS centers being represented in INTERMACS. Although annual patient volume was greatest for INTERMACS, the absolute number of patients significantly increased annually across both data sets from 2008 through 2013 (149% increase in CMS; 268% increase in INTERMACS). As a proportion of all INTERMACS registrants, Medicare beneficiary representation grew from 30% in 2008 to a high of 48% in 2010 and remained stable thereafter. Representation within INTERMACS of MCSDs implanted in Medicare beneficiaries more than doubled, from 36% in 2008 to 77% in 2013., Conclusions: Using a merged data set of MCSDs implanted between 2008 and 2013, we report that the vast majority of CMS centers and Medicare beneficiaries receiving MCSDs are increasingly captured in INTERMACS. Accordingly, contemporary studies in INTERMACS are relevant and generalizable to the Medicare population., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Pre-existing mitral pathology is common in patients undergoing continuous-flow left ventricular assist device implantation. We sought to investigate whether concurrent mitral repair confers any advantage., Methods: From March 2004 to October 2014, 374 patients received a continuous-flow left ventricular assist device. Of these, a total of 115 patients with pre-existing mitral regurgitation (MR) greater than moderate were identified and included in the analysis. Outcomes were compared between patients with concurrent mitral repair (n = 52 [45.2%]; Group A) and without repair (n = 63 [54.8%]; Group B)., Results: The mean age was 56.8 years and 25 (21.5%) were women. Patients in Group A were more likely to have undergone destination therapy (48.1% vs 11.1%; P < .001) and had a greater cardiopulmonary bypass time (125 vs 89 minutes; P < .001) than did patients in Group B. Longitudinal analysis using a generalized mixed-effects model demonstrated the odds of developing moderate or severe MR during device support were 86% lower for Group A patients (P < .001). Among those who were discharged alive, 9 (8.6%)-consisting of 1 (2.2%) in Group A and 8 (13.6%) in Group B (P = .039)-developed late right heart failure requiring a total of 13 readmissions (0.03 vs 0.15 readmissions per patient-year; P = .011). Multivariable competing risks regression revealed mitral repair to be a protective factor (hazard ratio, 0.16; 95% confidence interval, 0.03-0.94; P = .042) for late right heart failure occurrence., Conclusions: Concurrent mitral repair appears to be efficacious in controlling MR after device implant. The fact that repaired patients developed late right heart failure less frequently than did patients without repair challenges the notion that concurrent mitral repair is unwarranted., (Copyright © 2017. Published by Elsevier Inc.)

Background: Whether the routine use of continuous-flow left ventricular assist devices (LVAD) has affected gender differences in outcomes for patients listed for heart transplantation (HT) is unclear., Methods and Results: We identified 20,468 adults (25% women) listed as status 1A or 1B for HT from 2000 to 2014. Sex differences in removal from the wait list during the first 365 days due to death or deterioration was assessed with the use of Kaplan-Meier survival analysis. Patients were stratified according to listing before (era 1) or after (era 2) Food and Drug Administration approval of the Heartmate II LVAD on April 22, 2008. Freedom from death or deterioration on the wait list was higher for men than for women (70% vs 64%; P < .001). After adjusting for risk factors, women had a higher risk of removal from the wait list at 365 days during both era 1 (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.10-1.36; P < .001) and era 2 (HR 1.15, 95% CI 1.01-1.31; P = .029). Further adjustment for LVAD use eliminated the higher risk for women in era 2 (HR 1.14, 95% CI 0.99-1.29; P = .053) and not in era 1 (HR 1.22, 95% CI 1.10-1.36; P < .001)., Conclusions: The higher risk for death or deterioration in women waiting for HT has improved in the modern era., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Biventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival., Methods: All EXCOR Pediatric devices (Berlin Heart, Inc, The Woodlands, TX) placed in North America between May 2007 and December 2010 comprised the study cohort of 204 patients (128 [63%] LVADs and 76 [37%] BiVADs). The following patient cohorts were analyzed to determine the effect of BiVAD use on survival: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients, patients with abnormal bilirubin levels, patients who received previous extracorporeal membrane oxygenation (ECMO), and patients with a 10-mL pump size., Results: There were more patients with BiVADs in INTERMACS profile 1 (63% compared with 46%; p = 0.018). The incidence of major bleeding, neurologic and renal dysfunction, and infection was similar between BiVAD and LVAD groups. White race, abnormal glomerular filtration rate (GFR), sites with experience of less than 5 implantations, and use of 10-mL pumps were predictors of mortality in patients who received BiVADs. BiVADs were not associated with improved survival in any patient cohort; however, they were associated with increased mortality in patients who had undergone ECMO before receiving a VAD., Conclusions: BiVAD support was not associated with improved survival in any identified subset of patients. Although not randomized, these results (which were corrected for multiple possible risk factors) suggest that some children supported with BiVADs might have done better with LVADs alone. Further prospective studies will be needed to identify patient cohorts that will be better served with BIVAD support., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The prevalence of advanced heart failure (HF) is increasing because of the aging population and improvements in HF management strategies. Left ventricular assist device (LVAD) technology and management continue to advance rapidly, and it is anticipated that the number of LVAD implants will increase. LVADs have been demonstrated to extend life and improve outcomes in patients with advanced HF. The purpose of this article is to review and synthesize the evidence on impact of LVAD therapy on functional status. Significant functional gains were demonstrated in patients supported by LVAD throughout the 1st year, with most improvement in distance walked and peak oxygen consumption demonstrated in the 1st 6 months. Interventions to enhance exercise performance have had inconsistent effects on functional status. Poor exercise performance was associated with increased risk of adverse events. Functional status improved with LVAD therapy, although performance remained substantially reduced compared with age-adjusted norms. There is tremendous need to enhance our understanding of factors influencing functional outcomes in this high-risk population., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: The number of alternatives to intra-aortic balloon counterpulsation in the treatment of anticipated and established acute circulatory failure is growing. Despite the clinical importance and significant cost of short-term mechanical circulatory support (MCS) devices, the state of their present use has not been analyzed on a national scale., Objectives: The purpose of this study was to characterize the demographics, treatment practices, survival rates, and cost of short-term MCS., Methods: In this serial cross-sectional study, we analyzed all adult patients receiving short-term MCS in the United States from 2004 to 2011 by using the Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project., Results: From 2007 to 2011, use of percutaneous devices for short-term MCS increased by 1,511% compared with a 101% increase in nonpercutaneous devices. Mortality rates declined over this period (p for trend = 0.027) from 41.1% in 2004 to 2007 to 33.4% in 2008 to 2011. A similar trend was observed for the subset of patients with cardiogenic shock, decreasing from 51.6% to 43.1% (p for trend = 0.012). Hospital costs also declined over this period (p for trend = 0.011). Multivariable analysis revealed balloon pumps (odds ratio [OR]: 2.00; 95% confidence interval [CI]: 1.58 to 2.52), coagulopathy (OR: 2.35; 95% CI: 1.88 to 2.94), and cardiopulmonary resuscitation (OR: 3.50; 95% CI: 2.20 to 5.57) before short-term MCS were among the most significant predictors of mortality., Conclusions: Use of short-term MCS in the United States has increased rapidly, whereas rates of in-hospital mortality have decreased. These changes have taken place in the context of declining hospital costs associated with short-term MCS., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The sixth annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 8 years of patient enrollment. The analysis is based on data from >10,000 patients and updates demographics, survival, adverse events and risk factors. Among patients with continuous-flow pumps, actuarial survival continues to be 80% at 1 year and 70% at 2 years. The report features a comparison of two eras of continuous-flow durable devices in the USA in terms of device strategy, patient profiles, adverse event burden, survival and quality of life., (Copyright © 2014 International Society for Heart and Lung Transplantation. All rights reserved.)

Objectives: This study sought to examine trends in mortality, readmission, and costs among Medicare beneficiaries receiving ventricular assist devices (VADs) and associations between hospital-level procedure volume and outcomes., Background: VADs are an option for patients with advanced heart failure, but temporal changes in outcomes and associations between facility-level volume and outcomes are poorly understood., Methods: This is a population-based, retrospective cohort study of all fee-for-service Medicare beneficiaries with heart failure who received an implantable VAD between 2006 and 2011. We used Cox proportional hazards models to examine temporal changes in mortality, readmission, and hospital-level procedure volume., Results: Among 2,507 patients who received a VAD at 103 centers during the study period, the in-hospital mortality decreased from 30% to 10% (p < 0.001), the 1-year mortality decreased from 42% to 26% (p < 0.001), and the all-cause readmission was frequent (82% and 81%; p = 0.70). After covariate adjustment, in-hospital and 1-year mortality decreased (p < 0.001 for both), but the all-cause readmission did not change (p = 0.82). Hospitals with a low procedure volume had higher risks of in-hospital mortality (risk ratio: 1.72; 95% confidence interval [CI]: 1.28 to 2.33) and 1-year mortality (risk ratio: 1.55; 95% CI: 1.24 to 1.93) than high-volume hospitals. Procedure volume was not associated with risk of readmission. The greatest cost was from the index hospitalization and remained unchanged ($204,020 in 2006 and $201,026 in 2011; p = 0.21)., Conclusions: Short- and long-term mortality after VAD implantation among Medicare beneficiaries improved, but readmission remained similar over time. A higher volume of VAD implants was associated with lower risk of mortality but not readmission. Costs to Medicare have not changed in recent years., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the survival benefit from heart transplantation (HT), defined as reduction in the risks for 90-day and 1-year mortality on undergoing HT close to listing, in candidates stratified by their risk for waiting list mortality., Background: Among patients listed for HT, those at higher risk for death without transplantation are also at higher risk for early post-transplantation mortality., Methods: All patients age ≥18 years listed for HT in the United States from 2007 to 2010 were analyzed. A model was developed to predict the risk for waiting list mortality within 90 days, and listed patients were stratified into 10 risk groups (deciles). All groups were followed for 1 year to assess cumulative 1-year mortality while on the waiting list. Models of 90-day and 1-year post-transplantation mortality were developed using recipient data, and these risks were estimated at listing in all listed candidates., Results: Of 10,159 patients listed for HT, 596 (5.9%) died within 90 days and 1,054 (10.4%) within 1 year without undergoing transplantation. Of 5,720 recipients of transplants with 1-year follow-up, 576 (10.1%) died within 1 year. The risk for death while on the waiting list within 90 days increased from 1.6% to 19% across the 10 risk groups. The survival benefit from HT increased progressively with higher risk for death without transplantation (p < 0.001 for trend), but there was no benefit in the first 6 risk groups., Conclusions: The risk for waiting list mortality varies considerably among HT candidates. Although the survival benefit of HT generally increases with increasing risk for waiting list mortality, there is no measurable benefit in many candidates at the lower end of the risk spectrum., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Medication non-adherence (NA) can result in life-threatening illness in children after solid-organ transplantation. Little is known about the incidence, risk factors and outcomes of NA in large numbers of pediatric heart transplant (HT) recipients., Methods: Organ Procurement Transplant Network (OPTN) data were used to identify all children <18 years of age in the U.S.A. who underwent HT from October 1999 to January 2007. Cox proportional hazards analysis was used to identify risk factors for NA and the effect on graft survival., Results: Of 2,070 pediatric heart transplants performed the median age at transplant was 6 years (interquartile range [IQR] 0 to 13 years); 40% had congenital heart disease (CHD), 7% were re-transplants, 42% were non-white and 43% had Medicaid insurance. Overall, 186 (9%) children had a report of NA at a median age of 15 years with more than two-thirds of NA episodes occurring after 12 years of age. Factors independently associated with NA were: adolescent age at transplant (hazard ratio [HR] 7.0, 95% confidence interval [CI] 4.1 to 12, compared with infants); black race (HR 2.3, 95% CI 1.7 to 3.3, compared with white); Medicaid insurance (HR 2.0, 95% CI 1.5 to 2.7, compared with non-Medicaid insurance); and ventilator or ventricular assist device (VAD) support at transplant. The risk of mortality conditional upon report of NA was 26% at 1 year and 33% at 2 years., Conclusions: Medication NA is an important problem in pediatric HT recipients and is associated with high mortality. Adolescent age, black race, Medicaid insurance and invasive hemodynamic support at transplant were associated with NA, whereas time on the wait list and gender were not. Targeted interventions among at-risk populations may be warranted., (Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

The 5th annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes and analyzes the first 6 years of patient and data collection. The current analysis includes more than 6000 patients and updated risk factors for continuous flow pumps. Among continuous flow pumps, actuarial survival is 80% at 1 year and 70% at 2 years. Quality of life indicators are generally favorable and adverse event burden will likely influence patient selections of advanced heart failure therapies., (Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)