Pediatric Circulatory Support: Current Strategies and Future Directions. Biventricular and Univentricular Mechanical Assistance

Throckmorton, Amy L.; Chopski, Steven G.

doi:10.1097/mat.0b013e318188bde3

Cited by 40 publications

(78 citation statements)

References 59 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…3,[33][34][35][36][37] This fundamental change in US clinical practice represents a major milestone for the field of pediatric heart failure therapy. With a growing number of novel miniaturized pediatric VADs now on the horizon, [38][39][40] FDA approval of the EXCOR marks the beginning of a new era in pediatric mechanical circulatory support.…”

Section: Downloaded Frommentioning

confidence: 99%

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

et al. 2013

View full text Add to dashboard Cite

Background— Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and to identify risk factors for mortality to facilitate patient selection. Methods and Results— This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device at 47 centers from May 2007 through December 2010. Multiphase nonproportional hazards modeling was used to identify risk factors for early (<2 months) and late mortality. Of 204 children supported with the EXCOR, the median duration of support was 40 days (range, 1–435 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device support, and elevated bilirubin as risk factors for early mortality and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death. Conclusions— Use of the Berlin Heart EXCOR has risen dramatically over the past decade. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.

show abstract

Section: Downloaded Frommentioning

confidence: 99%

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

et al. 2013

View full text Add to dashboard Cite

show abstract

“…9 The scalar stress levels within the blood pump were also well below the design criterion of 425 Pa for the development of axial flow assist devices. 27 The linear and increasing trend of the pfHb concentration during the hemolysis experiments met expectations. 3 The design objective for the maximum N.I.H level for an adult left ventricular assist device (LVAD) during a 1-month support duration is 0.01 g/ 100 L. 16 The axial flow pump prototype in this study demonstrated an average N.I.H of 0.0097 g/100 L for all experiments and a maximum N.I.H level of 0.0107 g/100 L. A direct comparison of this design objective to our results for the repeated 6-hr study is not encouraging.…”

Section: Discussionmentioning

confidence: 64%

“…Clinicians have theorized that a mechanical pump specifically designed to augment pressure from the great veins through the lungs would ameliorate the poor physiology of the failing univentricular circulation. 27 Current mechanical blood pumps were designed and developed for adult patients with congestive heart failure and to support the systemic circulation, not the unique anatomic physiology of the cavopulmonary connection. These devices produce pressures far exceeding the desired range to be used for cavopulmonary support.…”

Section: Discussionmentioning

confidence: 99%

“…Without surgical intervention, this combination of cardiac anomalies is fatal within the first 2 weeks of life. 11,27 For these patients, the current treatment paradigm consists of three staged, open heart surgeries, which culminate in the Fontan physiology, as originally described in 1971 for patients with tricuspid atresia. 7,8 The Fontan procedure has remained the prominent means of surgical palliation for these patients with modifications and staging evolving over the past three decades.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, a rising interest in the implementation of mechanical circulatory assistance in the cavopulmonary connection has emerged for the growing population of ailing Fontan patients. 27 As a new therapeutic alternative for patients with a failing Fontan physiology, we are developing a collapsible, percutaneously-inserted, magnetically levitated axial flow blood pump to support the cavopulmonary circulation. 9 This pump is intended to serve as a bridge-to-transplant, bridge-to-hemodynamic stability, or bridge-to-surgical reconstruction.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Numerical, Hydraulic, and Hemolytic Evaluation of an Intravascular Axial Flow Blood Pump to Mechanically Support Fontan Patients

et al. 2010

Self Cite

View full text Add to dashboard Cite

Currently available mechanical circulatory support systems are limited for adolescent and adult patients with a Fontan physiology. To address this growing need, we are developing a collapsible, percutaneously-inserted, axial flow blood pump to support the cavopulmonary circulation in Fontan patients. During the first phase of development, the design and experimental evaluation of an axial flow blood pump was performed. We completed numerical modeling of the pump using computational fluid dynamics analysis, hydraulic testing of a plastic pump prototype, and blood bag experiments (n=7) to measure the levels of hemolysis produced by the pump. Statistical analyses using regression were performed. The prototype with a 4-bladed impeller generated a pressure rise of 2-30 mmHg with a flow rate of 0.5-4 L/min for 3000-6000 RPM. A comparison of the experimental performance data to the numerical predictions demonstrated an excellent agreement with a maximum deviation being less than 6%. A linear increase in the plasma-free hemoglobin (pfHb) levels during the 6-h experiments was found, as desired. The maximum pfHb level was measured to be 21 mg/dL, and the average normalized index of hemolysis was determined to be 0.0097 g/100 L for all experiments. The hydraulic performance of the prototype and level of hemolysis are indicative of significant progress in the design of this blood pump. These results support the continued development of this intravascular pump as a bridge-to-transplant, bridge-to-recovery, bridge-to-hemodynamic stability, or bridge-to-surgical reconstruction for Fontan patients.

show abstract

Pediatric Mechanical Circulatory Support

Duncan¹

2012

Pediatric Cardiac Surgery

View full text Add to dashboard Cite

Pediatric Circulatory Support: Current Strategies and Future Directions. Biventricular and Univentricular Mechanical Assistance

Cited by 40 publications

References 59 publications

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

Numerical, Hydraulic, and Hemolytic Evaluation of an Intravascular Axial Flow Blood Pump to Mechanically Support Fontan Patients

Pediatric Mechanical Circulatory Support

Contact Info

Product

Resources

About