Ventricular Assist Device In Children Research Articles

(128) - Long Term Ventricular Assist Devices in Children

(128) - Long Term Ventricular Assist Devices in Children

Abstract 17254: Myocardial Functional Recovery Following Durable Ventricular Assist Device in Children

Introduction: Ventricular Assist Device (VAD) explantation following myocardial functional recovery (MFR) for heart failure (HF) is uncommon and associated with a risk of recurrence of HF. Research Question: What are the patient characteristics and outcomes for VAD explantation in children following MFR? Methods: Retrospective, single centre study of patients who were supported with durable VADs, both intracorporeal continuous flow devices (CFD) and paracorporeal pulsatile flow devices (PFD) between 2004 to 2022. Results: A total of 75 children, of which 43 were female, underwent VAD implantation (PFD = 61 and CFD = 14) at a median (IQR) age of 5.6 (0.8, 13.5) years and with a weight of 16.2 (7.5, 40.7) kg. From this cohort, we identified 8/75 (11%) children who underwent VAD explantation for MFR after a median duration of 56 (22, 115) days. All were supported with durable PFD. Five were listed for transplantation as a part of their HF management strategy following VAD implantation and four patients had dilated cardiomyopathy (DCM). Of those, 7/8 (88%) children with MFR were under 2 years of age and 5/8 (63%) were supported for > 90 days. The pathological findings on the LV core samples were variable in severity and no patient had any evidence of active inflammation (see Table). After explant, 7/8 patients remained in HF remission with no symptoms and stable LV function. One patient had a recurrence of HF following explantation after demonstrating MFR while on VAD support. This patient was 5 years old at implant and was in HF remission for ~9 months following explant before HF recurrence, requiring VAD re-implantation and eventual heart transplantation. Conclusions: MFR resulting in VAD explantation is feasible in children with chronic HF especially for those < 2 years of age. Further work is needed to help better identify the features that promote MFR and maintain it after explant.

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)

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.

Current status of pediatric mechanical circulatory support

The field of pediatric mechanical circulatory support has experienced exponential evolution in recent decades. With favorable complication profiles, implantable continuous-flow ventricular assist devices (VADs) have become a standard option in children, as has been seen in the adult counterpart. Nevertheless, there still exists room for further advances, not just for survival, but throughout the whole trajectory of treatment courses. With reviewing the current state of pediatric VAD support, including existing challenges, we aim to highlight the targets clinicians should focus on for further improvement of pediatric VAD support. The field of pediatric VAD has been steadily growing, as evidenced by an increasing number of total VAD implants, particularly with continuous-flow VAD. Currently, HeartWare HVAD (Medtronic Inc., Mounds View, MN) is the most widely used continuous-flow VAD in children with excellent performance. However, only half of the children with HVAD are discharged home, which is drastically different from adult patients, suggesting that the pediatric field is still in the process of maturation. Additionally, outcomes of VAD support for complex congenital heart defect, particularly single ventricle physiology, remain suboptimal, despite an increasing number of such patients. With the ongoing advancement, the field of pediatric VAD support is undergoing a rapid maturation process. This will eventually lead to further paradigm changes, including the use of VAD as permanent therapy.

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

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

Early experience with the HeartMate 3 continuous-flow ventricular assist device in pediatric patients and patients with congenital heart disease: A multicenter registry analysis

The HeartMate 3 ventricular assist device (VAD) is a newer centrifugal continuous-flow VAD used for bridge-to-transplant and destination therapy in adults. However, there is limited experience regarding its use in children and adults with complex congenital heart disease (CHD). The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) is a multicenter learning network comprised of pediatric hospitals implanting VADs in children and adults with complex CHD. We examined the outcomes of patients undergoing HeartMate 3 implantation at an ACTION center between December 2017 and September 2019. The HeartMate 3 was implanted in 35 patients at 9 ACTION centers, with a median age of 15.7 (8.8-47.3) years, median weight of 65.7 (19.1-114.1) kg, and median body surface area (BSA) of 1.74 (0.78-2.36) m2. Of the cohort, 14 patients (40%) weighed <60 kg. Diagnoses included dilated cardiomyopathy (63%), dilated cardiomyopathy in neuromuscular disease (20%), and CHD (17%). Of those with CHD, most had a Fontan circulation. With a median 78 days of follow-up, there was 1 death on device (97% survival); 20 out of 35 (57%) underwent transplantation with no post-transplantation mortality. There were no episodes of stroke or pump thrombosis. Use of the HeartMate 3 in ACTION centers was associated with a low incidence of mortality and adverse events. Patients as small as 19 kg (BSA 0.78 m2) were successfully implanted and supported, indicating that this device may be appropriate for older children and small adults.

Outcomes of children with congenital heart disease implanted with ventricular assist devices: An analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs).

The reported ventricular assist device (VAD) experience in the pediatric congenital heart disease (CHD) population is limited. We sought to describe contemporary use and outcomes of VADs in children with CHD and compare these outcomes to those of non-CHD children. Patients enrolled in the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) between September 19, 2012 through June 30, 2017 were included. CHD was classified as biventricular vs single ventricle (Stages 1, 2, or 3). Outcomes were compared between groups and multivariable analysis was used to identify factors associated with mortality on the device. Among the 471 patients enrolled, 108 (24%) had CHD (45 biventricular and 63 single ventricle). CHD patients were younger (5.7 ± 5.7 years vs 9.8 ± 6.5 years; p < 0.0001) and smaller (0.8 ± 0.5 m2 vs 1.2 ± 0.7 m2; p < 0.0001) compared with non-CHD patients. CHD patients were more likely to receive a paracorporeal continuous-flow VAD (36.1% vs 12.9%; p < 0.0001) and less likely to receive an implantable continuous-flow VAD (27.8% vs 55.0%; p < 0.0001) compared with non-CHD patients. After 6 months on a VAD, CHD patients had higher mortality (36.4% vs 12.1%) and a lower transplantation rate (29.1% vs 59.9%) than non-CHD patients (p < 0.0001). In the multivariable analysis, CHD was the factor most strongly associated with mortality on VAD (hazard ratio [HR] = 2.9; p < 0.0001), whereas the factors implantable continuous-flow device and high-volume center were protective (HR = 0.3, p < 0.0001, and HR = 0.6, respectively; p = 0.02). VAD use in children with CHD is associated with increased mortality and decreased transplant rates compared to children without CHD. For the subgroup of children with CHD who received implantable continuous-flow VADs, survival rates were higher and comparable to those of children without CHD. Increased experience correlated with better survival in pediatric VADs.

Extracorporeal membrane oxygenation, Berlin, and ventricular assist devices: a primer for the cardiologist.

Mechanical circulatory support (MCS) has become an indispensable tool in the management of children with impending respiratory and cardiac failure. Though extracorporeal membrane oxygenation (ECMO) was classically the only form of support available to pediatric patients, considerable advances have allowed ventricular assist devices (VADs) to become increasingly utilized in children. This review provides an update of recent advances in ECMO and VAD management in children. The options for mechanical support in infants and small children with end-stage heart failure are limited. As such, the greatest advances in the past decade have come in the successful adoption of the Berlin Heart EXCOR device, with a marked improvement in survival to transplant over ECMO. Further advances have been made in the use of adult VADs in children. For instance, the HeartWare HVAD has been utilized in children as young as 3 years of age, despite being designed for use in adult patients. The availability of mechanical support options for children remains limited to ECMO and a small number of VADs. While outcomes of VAD support in pediatric patients have been promising, further study in smaller and more complex pediatric patients is necessary.

Pneumatic paracorporeal ventricular assist device as bridge to transplant in children ≤ 20 kg: Krakow experience

Pulsatile mechanical ventricular assist devices (VADs) of various designs and functional principles have been in use in adult patients for long-term support of the failing heart. Despite the remarkable advances with the use of VAD, its support in children is still limited. We report on our experience in the paediatric population. The aim is either recovery of the heart or, more often, to keep the patient alive until later transplantation. We retrospectively study of children ≤ 20 kg, who were mechanically bridged to heart transplantation using the Berlin Heart (BH) Excor VAD at our hospital. The period of review was from November 2009 to March 2017. A total eight patients were included in this analysis, with these patients weighing < 20 kg. The study included three boys and five girls, with a mean weight of 10.55 kg (5.30–20 kg) and mean age of 20.69 months (4.5 to 60 months). Eight patients were supported with the Berlin Excor VAD, and six patients were supported with a left-sided ventricular assist device (LVAD) and two patients were supported with biventricular assist device (BVAD). Three of eight patients (38%) have been successfully bridged to heart transplant. Insertion of pulsatile paracorporeal VADs in children with end-stage heart failure is an effective strategy as a bridge to heart transplantation. This study demonstrates VAD support had serious ceribrovascular complications, and implantation BVAD support results were not satisfactory.

Impact of a modified anti-thrombotic guideline on stroke in children supported with a pediatric ventricular assist device

Stroke is the most feared complication associated with the Berlin Heart EXCOR pediatric ventricular assist device (VAD), the most commonly used VAD in children, and affects 1 in 3 children. We sought to determine whether a modified anti-thrombotic guideline, involving more intense platelet inhibition and less reliance on platelet function testing, is associated with a lower incidence of stroke. All children supported with the EXCOR at Stanford from 2009 to 2014 were divided into 2 cohorts based on the primary anti-thrombotic guideline used to prevent pump thrombosis: (1) the Edmonton Anti-thrombotic Guideline (EG) cohort, which included children implanted before September 2012 when dual anti-platelet therapy was used with doses titrated to Thromboelastrography/PlateletMapping (TEG/PM); and (2) the Stanford Modified Anti-thrombotic Guideline (SG) cohort, which included children implanted on or after September 2012 when triple anti-platelet therapy was used routinely and where doses were uptitrated to high, weight-based dosing targets, with low-dose steroids administered as needed for inflammation. At baseline, the EG (N = 16) and SG (N = 11) cohorts were similar. The incidence rate of stroke in the SG cohort was 84% lower than in the EG cohort (0.8 vs 4.9 events per 1,000 days of support, p = 0.031), and 86% lower than in the previous Investigational Device Exemption trial (p = 0.006). The bleeding rate was also lower in the SG cohort (p = 0.015). Target doses of aspirin, clopidogrel and dipyridamole were higher (all p < 0.003), with less dosing variability in the SG cohort than in the EG cohort. There was no difference in adenosine diphosphate inhibition by TEG/PM, but arachidonic acid inhibition was higher in the SG cohort (median 75% vs 39%, p = 0.008). Stroke was significantly less common in pediatric patients supported with the Berlin Heart EXCOR VAD using a triple anti-platelet regimen uptitrated to high, weight-based dosing targets as compared with the dual anti-platelet regimen titrated to PM, and without a higher risk of bleeding. Larger studies are needed to confirm these findings.

(74) - Compassionate Deactivation of Ventricular Assist Devices in Children: A Survey of Pediatric VAD Clinicians’ Perspectives and Practices

(74) - Compassionate Deactivation of Ventricular Assist Devices in Children: A Survey of Pediatric VAD Clinicians’ Perspectives and Practices

(69) - Reverse Remodeling After Placement of Pulsatile and Continuous Flow Left Ventricular Assist Device in Children with End-Stage Idiopathic Dilated Cardiomyopathy

(69) - Reverse Remodeling After Placement of Pulsatile and Continuous Flow Left Ventricular Assist Device in Children with End-Stage Idiopathic Dilated Cardiomyopathy

(414) - Weaning from Ventricular Assist Devices in Children: Predictors for Recovery and Long-Term Follow Up

(414) - Weaning from Ventricular Assist Devices in Children: Predictors for Recovery and Long-Term Follow Up

(99) - Utilization and Outcomes of Temporary Ventricular Assist Devices in Children: A Report from the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs)

(99) - Utilization and Outcomes of Temporary Ventricular Assist Devices in Children: A Report from the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs)

Single-Center Experience of Mechanical Circulatory Support with Berlin Heart EXCOR Pediatric Ventricular Assist Device in Children with Severe Myocarditis

Objective: Fulminant myocarditis with cardiogenic shock is a life-threatening disease with failure to aggressive medical treatment. In these cases, mechanical circulatory support represents a lifesaving measure to allow for myocardial recovery.

Ventricular Assist Device in Children with Cardiac Graft Failure.

We sought to determine whether ventricular assist device (VAD) support is an effective therapy in children with cardiac graft dysfunction. We conducted a retrospective review of VAD usage in this scenario at our institution. Although short-term VAD support was highly successful (89% [eight out of nine] were bridged to recovery), only 29% (2 out of 7) with long-term VAD survived to retransplant. Of note, three out of five mortalities with long-term VAD were related to sepsis (two fungal and one Gram-negative bacterial). Infectious risk imposed by ongoing immunosuppressive therapy limits the role of long-term VAD in this population.

Children Are Not Small Adults: Options for Pediatric Ventricular Assist Devices

The number of children supported with ventricular assist devices (VADs) has grown rapidly over the last few years. VAD use in children holds the promise of improving the outcomes in pediatric end-stage heart failure; however, the risk–benefit profile inherent to VAD use is not uniform across all ages, sizes, and diagnoses. Device use in children has underscored a number of issues that distinguish pediatric and adult heart failure such as the high prevalence of complex congenital heart disease and the challenges inherent to supporting infants and small children. The use of VADs in children also raises a range of social, emotional, and logistic changes unique to children across the age spectrum.

The Use of Pediatric Ventricular Assist Devices in Children's Hospitals From 2000 to 2010: Morbidity, Mortality, and Hospital Charges.

The use of ventricular assist devices has increased dramatically in adult heart failure patients. However, the overall use, outcome, comorbidities, and resource utilization of ventricular assist devices in pediatric patients have not been well described. We sought to demonstrate that the use of ventricular assist devices in pediatric patients has increased over time and that mortality has decreased. A retrospective study of the Pediatric Health Information System database was performed for patients 20 years old or younger undergoing ventricular assist device placement from 2000 to 2010. None. Four hundred seventy-five pediatric patients were implanted with ventricular assist devices during the study period: 69 in 2000-2003 (era 1), 135 in 2004-2006 (era 2), and 271 in 2007-2010 (era 3). Median age at ventricular assist device implantation was 6.0 years (interquartile range, 0.5-13.8), and the proportion of children who were 1-12 years old increased from 29% in era 1 to 47% in era 3 (p = 0.002). The majority of patients had a diagnosis of cardiomyopathy; this increased from 52% in era 1 to 72% in era 3 (p = 0.003). Comorbidities included arrhythmias (48%), pulmonary hypertension (16%), acute renal failure (34%), cerebrovascular disease (28%), and sepsis/systemic inflammatory response syndrome (34%). Two hundred forty-seven patients (52%) underwent heart transplantation and 327 (69%) survived to hospital discharge. Hospital mortality decreased from 42% in era 1 to 25% in era 3 (p = 0.004). Median hospital length of stay increased (37 d [interquartile range, 12-64 d] in era 1 vs 69 d [interquartile range, 35-130] in era 3; p < 0.001) and median adjusted hospital charges increased ($630,630 [interquartile range, $227,052-$853,318] in era 1 vs $1,577,983 [interquartile range, $874,463-$2,280,435] in era 3; p < 0.001). Factors associated with increased mortality include age less than 1 year (odds ratio, 2.04; 95% CI, 1.01-3.83), acute renal failure (odds ratio, 2.1; 95% CI, 1.26-3.65), cerebrovascular disease (odds ratio, 2.1; 95% CI, 1.25-3.62), and extracorporeal membrane oxygenation (odds ratio, 3.16; 95% CI, 1.79-5.60). Ventricular assist device placement in era 3 (odds ratio, 0.3; 95% CI, 0.15-0.57) and a diagnosis of cardiomyopathy (odds ratio, 0.5; 95% CI, 0.32-0.84), were associated with decreased mortality. Large-volume centers had lower mortality (odds ratio, 0.55; 95% CI, 0.34-0.88), lower use of extracorporeal membrane oxygenation, and higher charges. The use of ventricular assist devices and survival after ventricular assist device placement in pediatric patients have increased over time, with a concomitant increase in resource utilization. Age under 1 year, certain noncardiac morbidities, and the use of extracorporeal membrane oxygenation are associated with worse outcomes. Lower mortality was seen at larger volume ventricular assist device centers.

Modified TandemHeart Ventricular Assist Device for Infant and Pediatric Circulatory Support

The development of pediatric ventricular assist device (VAD) circuits with lower flow ranges for infants and small children is ongoing. We present our results with modifying a readily available adult VAD to support the pediatric population. The TandemHeart VAD (CardiacAssist, Pittsburgh, PA) circuit was modified to include a variable restrictive recirculation shunt to permit lower flow ranges in small pediatric patients. Initial benchtop flow rates and pressures were studied. Hemolysis trials were performed using whole bovine blood to compare plasma-free hemoglobin levels between modified and unmodified VAD circuits. The modified VAD was surgically implanted in 7 piglets (6 to 14 kg) and which supported them for 4 hours. Levels of hemolysis did not increase and full hemodynamic support was achieved. The modified TandemHeart VAD with a recirculation shunt was subsequently implanted in 2 pediatric patients who were bridged to transplant successfully. Because of its simplicity, availability, low prime volume, greater patient flow range, and lower cost, the modified TandemHeart VAD with a recirculation shunt should be considered as an alternative to extracorporeal membrane oxygenation and other pulsatile VADs in children.