Use Of Ventricular Assist Devices Research Articles

(1037) What to Do with a Squeaky Wheel? Ventricular Assist Device Use in Children with Mechanical Valves in the Action Database

(1037) What to Do with a Squeaky Wheel? Ventricular Assist Device Use in Children with Mechanical Valves in the Action Database

(1181) Successful Use of Percutaneous Right Ventricular Assist Device with Oxygentaor (Oxyrvad) as a Bridge to Lung Transplantation

(1181) Successful Use of Percutaneous Right Ventricular Assist Device with Oxygentaor (Oxyrvad) as a Bridge to Lung Transplantation

(73) Successful Use of Right Ventricular Assist Device after Pulmonary Endarterectomy

(73) Successful Use of Right Ventricular Assist Device after Pulmonary Endarterectomy

Efficacy of Prolonged Impella 5.5 Support as Bridge to Heart Transplantation: Current Concepts and Future Direction.

To the Editor: Zaky et al.1 recently published an interesting article titled, “Impella 5.5 Support beyond 50 Days as Bridge to Heart Transplant in End-Stage Heart Failure Patients” that demonstrated efficacy of the Impella 5.5 regarding its ability to provide adequate prolonged hemodynamic support and maintain durability in four cases. The four patients presented in cardiogenic shock with a history of heart failure with or without chronic kidney disease. Due to contraindications to left ventricular assist device use, they received Impella 5.5 support for a mean duration of 70 days (range 54–83). All patients were able to ambulate by day 6, with the only device malfunction being loss of placement signal in one patient and the only complication being bilateral posterior cerebral artery infarcts of unknown cause in another patient. All four patients had devices with intact pump function on explantation and underwent successful heart transplantation. The authors note only one other report in the literature of prolonged Impella 5.5 support as bridge to heart transplantation and no reports in the existing literature of malfunctions or complications in patients with prolonged use (>50 days). Adding on to their discussion of the relevant literature, we wanted to note our published experience with a patient on prolonged Impella support beyond 50 days.2 The patient was a 51-year-old male with decompensated heart failure, chronic kidney disease, and cirrhosis who was sequentially supported with axillary intra-aortic balloon pump, Impella 5.5, and venoarterial extracorporeal membrane oxygenation (V-A ECMO) prior to triple organ, heart-liver-kidney transplantation. The patient was supported on Impella 5.5 for 79 days, comparable to the mean duration of support in the case series published by Zaky et al.1 Total length of temporary mechanical circulatory support (MCS) was 95 days prior to successful transplantation. During the period of Impella support in our patient, he had an episode of heparin-induced thrombocytopenia (HIT) at 30 days treated with argatroban and, subsequently, sepsis at 78 days, prompting Impella explant and initiation of V-A ECMO. Studies have evaluated the risk of these patterns of complications in patients supported with Impella and have shown an association between Impella support and HIT and sepsis.3–5 Our case report corroborates the findings of the reported case series.1 While our collective findings do demonstrate the efficacy of Impella 5.5 support for prolonged temporary MCS as a bridge to heart transplantation beyond the duration of less than or equal to 14 days as approved by the Food and Drug Administration, rates of complications during prolonged support have not been fully delineated. These potential complications do appear to be significant; however, they have not affected survival to transplantation based on our single-center experience. Multicenter, longitudinal studies are warranted to examine the risk and significance of complications of prolonged Impella support before prolonged use of this device becomes an established and widely applied bridging strategy.

The Growing Use of Ventricular Assist Devices in Children: Addressing Evolving Challenges with a Multidisciplinary Collaboration Between Palliative Care and Heart Failure (SA310A)

The Growing Use of Ventricular Assist Devices in Children: Addressing Evolving Challenges with a Multidisciplinary Collaboration Between Palliative Care and Heart Failure (SA310A)

OPTN/SRTR 2021 Annual Data Report: Heart

The past 5 years have posed challenges to the field of heart transplantation. The 2018 heart allocation policy revision was accompanied by anticipated practice adjustments and increased use of short-term circulatory support, changes that may ultimately serve to advance the field. The COVID-19 pandemic also had an impact on heart transplantation. While the number of heart transplants in the United States continued to increase, the number of new candidates decreased slightly during the pandemic. There were slightly more deaths following removal from the waiting list for reasons other than transplant during 2020, and a decline in transplants among candidates listed as status 1, 2, or 3 compared with the other statuses. Heart transplant rates decreased among pediatric candidates, most notably among those younger than 1 year. Despite this, pretransplant mortality has declined for both pediatric and adult candidates, particularly candidates younger than 1 year. Transplant rates have increased in adults. The prevalence of ventricular assist device use has increased among pediatric heart transplant recipients, while the prevalence of short-term mechanical circulatory support, particularly intra-aortic balloon pump and extracorporeal membrane oxygenation, has increased among adult recipients.

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.

Time to Expand Use of Left Ventricular Assist Devices

Time to Expand Use of Left Ventricular Assist Devices

Abstract 9709: Impact of Ventricular Assist Device Use on Pediatric Heart Transplant Waitlist Mortality: Analysis of the SRTR Database

Introduction: Children in need of heart transplant (Tx) have a high risk of death on the Tx waitlist due to scarcity of donor organs. Studies of previous eras have shown that ventricular assist devices (VADs) reduce waitlist mortality. We sought to determine whether a survival benefit for VAD patients persists in the current Tx allocation system. Methods: Using the Scientific Registry of Transplant Recipients database, we identified patients listed for primary Tx between 3/22/2016-9/1/2020. Characteristics at time of Tx listing were compared between VAD and non-VAD groups. Cox proportional hazards models were used to identify risk factors for one-year Tx waitlist mortality. Results: Among 5,054 total patients, 764 (15%) had a VAD at time of Tx listing. The VAD group was older, heavier, and had higher prevalence of cardiomyopathy, mechanical ventilation (MV), and impaired renal function. Unadjusted waitlist mortality was similar between the VAD and non-VAD groups (p=0.55, Figure), with the curves crossing ~90 days after listing. A multivariable Cox model showed infant age (HR 2.94, 95% CI 2.26-3.81), Black race (HR 1.59, 95% CI 1.33-1.90), congenital heart disease (HR 1.37, 95% CI 1.56-1.62), renal impairment (HR 2.62 95% CI 2.15-3.19), IV inotropes (HR 1.19, 95% CI 1.01-1.40) and MV (HR 2.58, 95% CI 2.13-3.13), were associated with one-year waitlist mortality. VAD use was not associated with mortality in the first 90 days after Tx listing (HR 0.87, 95% CI 0.65-1.18) but was protective for those waiting ≥90 days (HR 0.40, 95% CI 0.24-0.66). Conclusions: VADs reduce waitlist mortality in the current era, but only for those waiting ≥90 days after Tx listing. Potentially modifiable risk factors, including MV and renal impairment, are associated with mortality. These findings suggest that Tx listing without VAD may be a reasonable option if a short waitlist time is anticipated. However, VAD use may confer benefits, particularly for those expected to wait more than 90 days.

Rising Use of Percutaneous Ventricular Assist Devices: What Can Be Learned From the Data?

Rising Use of Percutaneous Ventricular Assist Devices: What Can Be Learned From the Data?

Ventricular Assist Device Use in Patients With Single-Ventricle Circulation.

Ventricular assist devices (VADs) are being increasingly used to support patients with congenital heart disease and single-ventricle physiology. Because of their unique anatomy and physiology, special consideration must be used to provide effective mechanical circulatory support for each individual patient. This can include alternative cannulation techniques, strategies to balance cardiac output to the systemic and pulmonary circulations from a single ventricle, or the use of continuous vs pulsatile VADs for better ventricular offloading. In this article we review the etiology of single-ventricle failure, VAD options for support, cannulation strategies, post-VAD management considerations, and outcomes at each of the 3 stages of palliation.

Long-Term Ventricular Assist Devices – Main Complications in Contemporary Clinical Practice

Advanced heart failure (HF) is associated with reduced quality of life and high hospitalization and mortality rates. Ventricular assist devices (VADs) promote an increase in cardiac output, and consequently improvements in body functions, functional capacity and patient survival. However, the use of VAD may be associated with complications and require systematic and specialized care. Ischemic and hemorrhagic stroke is among the most feared complications and its occurrence is related to thrombus formation in the pump. The connection between the [...]

Ventricular assist device for advanced heart failure

&lt;p&gt;Heart failure (HF) continues to be a highly prevalent disease, affecting 1–2% of the population in developed countries, therefore constitutes a health problem due to its high cost. Despite the progress made in drug treatment and implantation devices, the prognosis is poor. About 5% of patients diagnosed with heart failure are in advanced stage or stage D. Heart transplantation (HT) has become the preferred treatment for this high-risk group in the past 30 years. Unfortunately, in addition to the limitation of the current shortage of donors, there is only a limited number of patients meet the appropriate age and with the absence of comorbidities necessary to access this treatment. Due to this and the long waiting lists worldwide, the development and use of ventricular assist devices (VAD) are increasing. In view of the quality of life of patients with this serious disease, these devices improve the short-term and long-term survival rate and gradually reduce the complication rate. These benefits not only provide a choice for patients waiting for HT, but also give those with reversible contraindications the time and opportunity to become suitable candidates or, if impossible, eventually use it as a target treatment. However, these devices have many limitations: their cost, durability, incidence of complications and their limited application. Technological advances in mitigating complications, increased experience in management centers and their promotion to reduce costs are strategies that will continue to strengthen the use of VAD in patients with advanced heart failure.&lt;/p&gt;

‘A new normal’? Ventricular Assist Device implantation and subsequent heart transplant in children and adolescents: A family experience

Ventricular Assist Devices (VAD) are enabling children experiencing severe heart failure, who would have otherwise died, to be bridged to transplant or recovery. Donated Paediatric hearts are in short supply, so the use of VAD is likely to continue to support paediatric patients for the foreseeable future. This study explored the experiences of children and young people (CYP) being supported by VAD and their families. Semi-structured interviews were undertaken with 24 families after transplant (either parents only, parents and CYP together, or CYP only), and two participant observations with families currently living with a child on VAD. This study was conducted at one of two UK Paediatric Heart Transplantation Centres. The data suggest that families adjust to a ‘new normal’ that the heart failure and subsequent medical intervention brings. This involves adjusting to the initial diagnosis and need for VAD implantation; establishing a new life on VAD; the emotional roller coaster that comes with this highly invasive treatment option; and, adapting to a new way of life following transplant. This research adds to the limited available research on the experience of families with a CYP being supported by VAD. The family viewpoint raises important issues about highly invasive treatment, the lived realities of VAD implantation and subsequent transplant, and the forever changed lives post discharge. These perspectives are of great importance when considering the growth of both VAD implantation and paediatric heart transplantations as established therapeutic treatment options.

Waitlist and posttransplant outcomes of critically ill infants awaiting heart transplantation managed without ventricular assist device support.

Infants listed for heart transplant are at high risk for waitlist mortality. While waitlist mortality for children has decreased in the current era of increased ventricular assist device use, outcomes for small infants supported by ventricular assist device remain suboptimal. We evaluated morbidity and survival in critically ill infants listed for heart transplant and managed without ventricular assist device support. Critically ill infants (requiring ≥1 inotrope and mechanical ventilation or ≥2 inotropes without mechanical ventilation) listed between 2008 and 2019 were included. During the study period, infants were managed primarily medically. Mechanical circulatory support, specifically extracorporeal membrane oxygenation, was utilized as "rescue therapy" for decompensating patients. Thirty-two infants were listed 1A, 66% with congenital heart disease. Median age and weight at listing were 2.2months and 4.4kg, with 69% weighing <5kg. At listing, 97% were mechanically ventilated, 41% on ≥2 inotropes, and 25% under neuromuscular blockade. Five patients were supported by ECMO after listing. A favorable outcome (transplant or recovery) was observed in 84%. One-year posttransplant survival was 92%. Infection was the most common waitlist complication occurring in 75%. Stroke was rare, occurring in one patient who was supported on ECMO. Renal function improved from listing to transplant, death, or recovery (eGFR 70 vs 87 ml/min/1.73m2 , p=.001). A strategy incorporating a high threshold for mechanical circulatory support and acceptance of prolonged mechanical ventilation and neuromuscular blockade can achieve good survival and morbidity outcomes for critically ill infants listed for heart transplant.

Trends in Contemporary Use of Ventricular Assist Devices in Children Awaiting Heart Transplantation and Their Outcomes by Race/Ethnicity.

This retrospective study included children aged ≤18 years who had durable ventricular assist devices (VADs) as a bridge to transplantation from the United Network Organ Sharing (UNOS) database between 2011 and 2020. We evaluated 90 day waitlist mortality and 1 year posttransplant mortality after VAD implantation in children stratified by race/ethnicity: Black, White, and Others. The VAD was used in a higher proportion of Black children listed for heart transplantation (HT) (26%) versus Other (25%) versus White (22%); p < 0.01. Black children had Medicaid health insurance coverage (67%) predominantly at the time of listing for HT. There was no significant overall difference in waitlist survival among the three groups supported with VAD at the time of listing (log-rank p = 0.4). On the other hand, the 90 day waitlist mortality after the VAD implantation at listing and while listed was the lowest among Black (6%) compared with White (13%) and Other (14%) ( p < 0.01). The multivariate regression analysis showed that Other race (hazard ratio [HR], 2.29; p < 0.01), Black race (HR, 2.13; p < 0.01), use of mechanical ventilation (HR, 1.72; p = 0.01), and Medicaid insurance (HR, 1.54; p = 0.04) were independently associated with increased 1 year posttransplant mortality. In conclusion, Black children had more access to durable VAD support than White children. The 90 day waitlist mortality was significantly lower in Black children compared with White and Other after VAD implantation. However, Black and Other racial/ethnic children with VAD at transplant had higher 1 year posttransplant mortality than White children. Future studies to elucidate the reasons for these disparities are needed.

C-reactive protein predicts early clinical outcomes and long-term mortality after left ventricular assisted device.

Left ventricular assist device (LVAD) implantation has become a reliable therapeutic strategy in patients with advanced heart failure. C-reactive protein (CRP) is a well-established biomarker of inflammation. This study aims to determine the prognostic effect of CRP level on clinical outcomes of patients who undergo LVAD implantation. This is a single-center, observational, retrospective study. One hundred fifty-three patients who received continuous-flow LVAD implantation were included and were divided into two groups of high (>3.9 mg/dL) versus low CRP (⩽3.9 mg/dL). Patients with high pre-implant CRP levels were prone to severe preoperative clinical conditions and complicated intraoperative procedures. Compared with patients in the low CRP group, elevated pre-implant CRP was associated with increased hospital mortality (31.4% vs 8.4%, p < 0.001), postoperative right ventricular failure (47.1% vs 30.1%, p = 0.031), right ventricular assist device use (34.3% vs 16.9%, p = 0.013), AKI (70% vs 51.8%, p = 0.022) and significantly prolonged duration of postoperative mechanical ventilation and intensive care unit length of stay. Univariate Cox regression showed that high pre-implant CRP was significantly associated with increased risk of long-term mortality (Hazard ratio (HR) 2.632 95%; CI: 1.657-4.183, p < 0.001), and multivariable Cox regression also revealed the higher risk of long-term mortality in patients with elevated pre-implant CRP (HR, 2.848 95%CI: 1.659-4.888, p < 0.001). These results remained stable when treating pre-implant CRP as a continuous variable. Besides, the prognostic effect of post-implant CRP was also observed. CRP is a reliable risk-stratification biomarker in patients receiving continuous-flow -LVAD and can be used as a predictor for short- and long-term outcomes.

Impact of the 2016 Organ Procurement and Transplantation Network (OPTN) Pediatric Heart Allocation Policy Change on Use of Durable Ventricular Assist Devices and Heart Transplantation Rates in Children with Congenital Heart Disease versus Cardiomyopathy

<h3>Purpose</h3> In March 2016, the OPTN changed the pediatric heart allocation policy to prioritize congenital heart disease (CHD) patients on high inotropes for 1A listing to increase their heart transplantation (HT) rates than those with cardiomyopathy (CM). This study evaluates the use of durable ventricular assist devices (VADs) and HT in CHD versus CM patients before and after the policy change in the USA. <h3>Methods</h3> All patients ≤18-yrs-old listed for HT between December 2011 and November 2020 were included in the study. The cohort was stratified into those listed before (Era-1) and after (Era-2) the policy change. We analyzed demographics, listing status, ECMO, VADs use, waitlist duration and HT rates between CHD and CM patients. <h3>Results</h3> During the study period, 5,667 patients were listed for HT, with 3108 (55%) in Era-1 and 2559 (45%) in Era-2. Between Era-1 and Era-2, CHD patients were listed 1A in 67% vs 66% and 1B in 17% vs 12% whereas CM patients were listed 1A in 73% vs 49% and 1B in 8% vs 33% (p<0.01) (Table). In Era-2 compared to Era-1, ECMO use decreased in both CHD (5% vs 8%, p<0.01) and CM (6% vs 8%, p<0.01), conversely, durable VADs use increased significantly in both CHD (10% vs 5%, p<0.01) and CM (34% vs 25%, p <0.01) patients. Furthermore, the HT rate within 180 days of listing was unchanged in CHD (<b>53 % vs 51%, p=0.3</b>) and CM patients (<b>63% vs 64%, p=0.4</b>) in Era-2 compared to Era-1 (Figure). The waitlist duration for CHD patients increased from 73 to 83 days (p<0.01), but no significant change in CM patients (66 days). <h3>Conclusion</h3> The current allocation policy has positive impact on the use of VADs in both CHD and CM. However, there was no change in HT rates, no increase in listing as status 1A, and an increase in the waitlist duration among CHD patients. Future studies are needed to analyze the factors for the failure of the intended benefits of pediatric heart allocation policy changes.

Cell-Free DNA in the Early Course After Heart Transplantation

<h3>Purpose</h3> Cell-free DNA (cfDNA) has been used as a marker of rejection after heart transplantation (HTx). The commonly reported outcome is donor fraction (DF). However, cfDNA from donor (dd-cfDNA) and recipient (rd-cfDNA) can be quantified separately. We aimed to investigate the influence of donor and recipient-derived factors as well as intraoperative measures on levels of cfDNA. <h3>Methods</h3> Blood samples were collected in parallel to the first endomyocardial biopsy in 45 patients (8 children, 37 adults) after HTx. Levels of rd- and dd-cfDNA and DF were determined using digital PCR. Regression analyses were performed with respect to the influence of donor- (age, body surface area (BSA), gender) and recipient-derived factors (age, BSA, gender, kidney function pre-HTx, ventricular assist device (VAD) pre-HTx, previous heart operation) as well as perioperative measures (operation time, ischemic graft time, early rejection, presence of acute kidney injury). <h3>Results</h3> The first biopsy was taken on a mean of 11 days after HTx (median 10, range 5-14, IQR 9-12). Mean ischemic time was 180 min (median 180, range 62-394, IQR 118-215), mean operation time was 376 min (median 333, range 174-745, IQR 239-510). Mean rd-cf-DNA levels were 190,000 copies/μl (median 140,000, range 33,000-1,400,000, IQR 83,000-200,000), mean dd-cfDNA-levels 700 copies/μl (median 400, range 150-7000, IQR 270-620). Mean DF was 0.48 (median 0.33, range 0.09-5.3, IQR 0.2-0.5). In a multiple regression model, ischemic graft time was the only factor with a statistically significant impact on levels of dd-cfDNA, but not on DF. The biggest influence on rd-cfDNA-levels was the use of a VAD pre-HTx, but this was not statistically significant. Strong correlations were seen between age and BSA of donor and recipient. <h3>Conclusion</h3> The separate quantification of both rd- and dd-cfDNA, in contrast to solely reporting DF, allows for the distinction of factors mainly influencing the recipient (such as the pre-HTx use of VAD) and the donor (such as ischemic graft time). In this proof-of-concept study, most of the investigated measures did not reach statistical significance. The correlation of ischemic graft time and dd-cfDNA (but not DF), however, shows the possibility of precisely detecting graft injury

Ventricular Assist Devices Are a Viable Method to Support Patients to Multi-Organ Transplant

<h3>Purpose</h3> While ventricular assist devices (VADs) are known to improve survival in patients awaiting heart transplant, there are limited data describing the use of VADs in patients listed for multi-organ transplant or evaluating these patients' outcomes. <h3>Methods</h3> This retrospective cohort study identified patients from the UNOS database listed for heart transplant in combination with another solid organ from 2004-2019 and identified those with VADs at the time of listing and at transplant. Mortality was compared between patients with and without VAD using χ2 tests. Linear regression was used to assess changes in VAD use over time. <h3>Results</h3> Over 15 years, 22% (n=700) of heart-kidney (HK), 4% (n=20) of heart-liver (HLi), and 3% (n=25) of heart of heart-lung (HLu) patients were on VADs at listing. The median age of HK-VAD was 55y (IQR 47, 62), of HLi-VAD 52y (IQR 43, 55), and HLu-VAD 47y (IQR 33, 58). The majority of multi-organ VAD patients survived to transplant; 64% of HK-VAD, 70% of HLi-VAD, and 44% of HLu-VAD. Survival to transplant was higher in HK-VAD compared to HK-no VAD (72% vs 67%, p<0.05), while there was no difference between HLi-VAD and HLi-no VAD (80% vs 71%, p=0.38) or HLu-VAD and HLu-no VAD (52% vs 61%, p=0.37). One year post-transplant survival did not differ based on the presence of a VAD; HK-VAD (86.0%) vs HK-no VAD (88.9%) <i>p=0.11,</i> HLi-VAD (85.0%) vs HLi-no VAD (89.1%) <i>p=0.48</i>, and HLu-VAD (82.7%) vs HLu-no VAD (79.1%) <i>p=0.71.</i> <b>Figure</b> HK-VAD increased from 4 in 2004 to 94 in 2019 (<i>p for trend<0.001).</i> There were no changes over time in HLi-VAD or HLu-VAD <i>(p for both>0.05)</i>. <h3>Conclusion</h3> VADs are being used to support a substantial proportion of multi-organ patients, with an increase in patients waiting for heart-kidney transplant. The majority of these patients survive to transplant, and waitlist survival is higher in HK-VAD vs HK-no VAD. There is no difference in 1 year mortality when compared to patients without VADs, suggesting that this may be an effective support strategy for certain patients with multi-organ failure.