Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report: Pre-implant characteristics and outcomes

Blume, Elizabeth D.; VanderPluym, Christina; Lorts, Angela; Baldwin, J. Timothy; Rossano, Joseph W.; Morales, David L.S.; Cantor, Ryan S.; Miller, Marissa A.; Louis, James D. St.; Koehl, Devin; Sutcliffe, D.; Eghtesady, Pirooz; Kirklin, James K.; Rosenthal, David N.; Investigators, Pedimacs

doi:10.1016/j.healun.2017.06.017

Cited by 124 publications

(116 citation statements)

References 4 publications

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“…Conversely, the use of adult continuous-flow VADs is becoming a common practice in the pediatric population (24). According to the most recent report from the PediMACS registry (Pediatric Interagency Registry for Mechanical Circulatory Support, a National Heart, Lung, and Blood Institute-sponsored North American database), more continuous-flow VADs are implanted than pulsatile VADs in the pediatric population (19). We felt, therefore, it would be prudent to test not only the standard pediatric pulsatile device (i.e., EXCOR) but also the commonly used continuous-flow device (i.e., HMII) in this study to serve as benchmark data for future pediatric device development.…”

Section: Discussionmentioning

confidence: 99%

“…This should help VAD developers to recognize the potential need for design iterations without delay. Given the fact that both pulsatile and continuous-flow devices are being used in the pediatric population (19), we opted to test two different types of devices that are widely used in the pediatric population, namely a pulsatile VAD (EXCOR, Berlin Heart, Inc.) and an axial continuous-flow VAD (HeartMate II, St. Jude Medical Inc.). These hemocompatibility results of the CentriMag blood pump have been used and referenced as a baseline control for many in vitro studies to benchmark and develop more hemocompatible new VADs (15)(16)(17)(18).…”

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confidence: 99%

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In Vitro Hemocompatibility Evaluation of Ventricular Assist Devices in Pediatric Flow Conditions: A Benchmark Study

Chan¹,

Diab

Moody³

et al. 2018

Artificial Organs

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Development of pediatric ventricular assist devices (VADs) has significantly lagged behind that of adult devices. This frustrating reality is reflected by the fact that the Berlin Heart EXCOR VAD is currently the only approved pediatric-specific device in the USA. An alternative option is an off-label use of adult continuous-flow VADs, such as HeartMate II (HMII), which inevitably causes patient-device size mismatch in small children. We sought to conduct in vitro hemocompatibility testing in a pediatric flow condition, with a specific aim to provide benchmark values for future pediatric device development. Given the aforementioned fact that both pulsatile and continuous-flow devices are being used in the pediatric population, we opted to test both types of devices in the present study. The EXCOR and HMII blood pumps were tested using bovine blood under constant hemodynamic conditions (flow rate, Q = 2.5 ± 0.25L/min; differential pressure across the pump, ΔP = 68 ± 5mm Hg). Hemolysis was measured by Harboe assay. There was a steady increase in plasma free hemoglobin during in vitro testing, with a statistically significant difference between 5 and 360 min for both EXCOR (P < 0.0001) and HMII (P < 0.001). However, the degree of an increase in plasma free hemoglobin was more significant with HMII (P < 0.001). Normalized index of hemolysis for EXCOR and HMII were 0.003 ± 0.0026g/100 L and 0.085 ± 0.0119g/100 L, respectively. There was also a steady increase in platelet activation detected by CAPP2A antibody using flow cytometry, with a statistically significant difference between 5 and 360 min for both devices (P < 0.05). The degree of an increase in platelet activation was similar between the two devices (P = 0.218). High molecular weight von Willebrand factor (HMW vWF) multimer degradation measured by immunoblotting was evident for both devices, however, it was more pronounced with the EXCOR. EXCOR blood samples from all three time points (120, 240, and 360 min) were significantly different from the baseline (5 min), whereas only 360 min samples had a significant difference from the baseline with the HMII. In conclusion, we have observed similarities and differences in hemocompatibility profiles between the EXCOR and HMII, both of which are commonly used in the pediatric population. We anticipate the benchmark values in the present study will facilitate future pediatric VAD development.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

In Vitro Hemocompatibility Evaluation of Ventricular Assist Devices in Pediatric Flow Conditions: A Benchmark Study

Chan¹,

Diab

Moody³

et al. 2018

Artificial Organs

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“…The risk‐benefit profile of pediatric VAD implantation varies with multiple factors including age, weight, cardiac diagnoses, and the degree of end‐organ dysfunction . Children with dilated cardiomyopathy (DCM) have superior survival to those with CHD and children >10 years have superior survival to infants <1 year . Risk stratification by weight is important in younger children.…”

Section: Patient Selection and Timingmentioning

confidence: 99%

“…Prior to VAD implantation 93% were receiving inotropic support and almost 50% of patients were intubated and on respiratory support. Significant renal dysfunction was documented in 6% of patients and significant liver dysfunction in 28% . Despite data supporting earlier VAD implantation, the primary reason for device implant was a decline in cardiac output with the majority of patients either in critical cardiogenic shock (INTERMACS level I) or with a progressive decline in cardiac output (INTERMACS level 2).…”

Section: Patient Selection and Timingmentioning

confidence: 99%

“…Over the last 5 years there has been an increased use of CF devices in the pediatric population due to the improved complication profile and the possibility of hospital discharge. Currently, approximately 60% of pediatric VAD implants are CF devices and the primary device of choice in most children >6 years of age or >25 kg. CF VADs have a 92% favorable survival outcome at 6 months and a superior survival outcome to pediatric patients on pulsatile devices .…”

Section: Evolution Of Cf Devices In Childrenmentioning

confidence: 99%

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Pediatric ventricular assist devices: Bridge to a new era of perioperative care

Navaratnam

Maeda

Hollander

2019

Pediatric Anesthesia

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Summary Pediatric ventricular assist devices (VADs) are evolving as a standard therapy for end stage heart failure in children. Major recent developments include the increased use of continuous flow (CF) devices in children and increased experience with congenital heart disease (CHD) and outpatient management. In the current and future era anesthesiologists will encounter more children presenting for VAD implantation, subsequent procedures and heart transplantation. Successful perioperative management requires an understanding of the interaction between the patient's physiology and the device and a framework to troubleshoot problems. This review focuses on CF devices, VAD support for CHD and perioperative management of pulsatile and CF devices in the pediatric population.

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Should Physicians Offer a Ventricular Assist Device to a Pediatric Oncology Patient With a Poor Prognosis?

Patel

Joong

Lelkes

et al. 2019

AMA Journal of Ethics

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Second annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) report: Pre-implant characteristics and outcomes

Cited by 124 publications

References 4 publications

In Vitro Hemocompatibility Evaluation of Ventricular Assist Devices in Pediatric Flow Conditions: A Benchmark Study

In Vitro Hemocompatibility Evaluation of Ventricular Assist Devices in Pediatric Flow Conditions: A Benchmark Study

Pediatric ventricular assist devices: Bridge to a new era of perioperative care

Should Physicians Offer a Ventricular Assist Device to a Pediatric Oncology Patient With a Poor Prognosis?

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