Current Use of the EXCOR Pediatric Ventricular Assist Device

Bryant, Roosevelt; Steiner, Marie; Louis, James D. St.

doi:10.1007/s12265-010-9218-2

Cited by 10 publications

(4 citation statements)

References 24 publications

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“…During the 2124 days of circulatory support with Berlin Heart EXCORE system, there was no malfunction of the device. Compared to other series, 4,13 –17 our median support time of 151 days (range 4-488 days) for the 11 closed cases is probably the longest that have been reported for Berlin Heart EXCOR System.…”

Section: Commentmentioning

confidence: 54%

Safety of Long-Term Mechanical Support With Berlin Heart EXCOR in Pediatric Patients

Sandica

Knyphausen

Blanz

et al. 2012

World J Pediatr Congenit Heart Surg

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Background. The Berlin Heart EXCOR Pediatrics is utilized at our center as a bridge to transplantation or bridge to recovery. This retrospective study reviews our results regarding the safety of long-term support and outcome. Methods. Between January 2008 and December 2010, 12 patients (6 females and 6 males) underwent implantation of a ventricular assist device. The median weight was 14.2 kg (range 4.2-51.6 kg) and the median age was 4.12 years (range 0.25-11.83 years). All patients were on inotropes, five patients required mechanical ventilation and three patients experienced cardiopulmonary resuscitation. Results. Eight patients received a left ventricular assist device and four patients received a biventricular assist device. Of the 12 patients, 8 were bridge to heart transplantation, in 2 patients explantation was possible, and 1 patient died on support. The median support time for these 11 patients was 151 days (range 4-488 days), with 2124 days of cardiac support. One patient is on support. Survival rate was 91.6%. Seven patients had a blood pump change once. Four patients had local signs of infection. There was no mediastinitis and thromboembolism. One patient had intracerebral hemorrhage. There was no death after heart transplantation or after explantation of the device. Conclusions. The Berlin Heart EXCOR is effective in bridging children of almost all ages and sizes to cardiac transplantation or myocardial recovery. Our experience proved that long-term support is possible with a low rate of adverse events.

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Section: Commentmentioning

confidence: 54%

Safety of Long-Term Mechanical Support With Berlin Heart EXCOR in Pediatric Patients

Sandica

Knyphausen

Blanz

et al. 2012

World J Pediatr Congenit Heart Surg

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“…Continued refinement in techniques and expansion of the number of centers that offer this support is expected to occur. This expansion must be balanced against the recognized relationship between institutional commitment and volume, personnel expertise, and outcomes – …”

Section: Future Directionsmentioning

confidence: 99%

The Berlin Heart EXCOR Pediatric ventricular assist device: history, North American experience, and future directions

Fraser

Jaquiss

2013

Annals of the New York Academy of Sciences

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Options for long-term mechanical circulatory support to sustain pediatric heart failure patients requiring cardiac transplantation while they wait for donor hearts have been unsatisfactory. The conventional approach has been to use extracorporeal membrane oxygenation (ECMO), but its lack of feasibility for long-term use and the major complications associated with the technology have limited its use, especially in light of lengthy waiting lists for donor hearts. With the advent of the Berlin Heart EXCOR® Pediatric ventricular assist device (VAD), pediatric heart failure specialists have gained an important tool for helping this patient population survive until a donor heart can be identified. The EXCOR Pediatric VAD is designed to support pediatric patients of all age groups, from newborns to teenagers, and can be used successfully for many months. This paper describes the early experience with the EXCOR Pediatric VAD and the challenging journey undertaken to gain U.S. FDA approval, including successful completion of the first worldwide prospective clinical study of VADs in a pediatric population.

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“…4,5 In 2004, the pneumatic paracorporeal Berlin Heart EXCOR became the first ventricular assist device (VAD) that can be used for infants or neonates in the United States. 6,7 It is available in a variety of sizes suitable for children between 3 kg and adult-size. The extracorporeal blood pump and cannula restrict the movement of the patient and increase complications during the long term application.…”

Section: Introductionmentioning

confidence: 99%

Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model

Wei

et al. 2013

The Journal of Heart and Lung Transplantation

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BACKGROUND The infant Jarvik 2000 heart is a tiny hermetically-sealed intracorporeal axial-flow ventricular assist device (VAD) designed for circulatory support for neonates and infants. The anatomic fit, acute biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model. METHODS The infant Jarvik 2000 heart with two different blade profiles (low-flow blade design and high-flow blade design) was tested in 6 piglets (8.8±0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompability were studied for 6 hours. RESULTS All six pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics was stable throughout the 6 hours. The pump flow increased from 0.27 L/min to 0.95 L/min at increasing speeds from 18 krpm to 31 krpm for the low-flow blade design, while the pump flow increased from 0.54 L/min to 1.12 L/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. Under higher speeds, over 80% of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for both the blade designs. CONCLUSIONS The Infant Jarvik 2000 heart is anatomically and biologically compatible with an acute neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.

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Current Use of the EXCOR Pediatric Ventricular Assist Device

Cited by 10 publications

References 24 publications

Safety of Long-Term Mechanical Support With Berlin Heart EXCOR in Pediatric Patients

Safety of Long-Term Mechanical Support With Berlin Heart EXCOR in Pediatric Patients

The Berlin Heart EXCOR Pediatric ventricular assist device: history, North American experience, and future directions

Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model

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