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Roosevelt Bryant, Farhan Zafar, Chesney Castleberry, John L Jefferies, Angela Lorts, Clifford Chin, David L S Morales
The Berlin Heart EXCOR pediatric ventricular assist device is approved by the FDA for bridge to cardiac transplantation (BTT) in children. As the clinical outcomes of the EXCOR continue to be evaluated in the U.S., data on post transplant survival are needed. The UNOS database was used to identify patients < 18 years old undergoing orthotopic heart transplantation (OHT) from 6/2004 to 6/2014. Patients undergoing BTT with the EXCOR were identified. A matched cohort of (358) patients undergoing OHT without pre-transplant mechanical circulatory support (no-MCS) was also identified as controls...
September 20, 2016: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
James H Hertzog, Thomas E Pearson, Marc A Priest, Ellen Spurrier, Ryan R Davies
Ventricular assist devices (VADs) for the mechanical support of cardiac failure are being used more frequently in children of increasingly younger age. These children have significant and multiple medical comorbidities, and their length of hospital stay has been increasing. As this population of hospitalized VAD-supported children increases, so does the possibility of their need for interfacility transport for specialized diagnostic or therapeutic procedures. Reports on such transports are limited to 3 children who underwent scheduled elective transfers...
September 2016: Air Medical Journal
Nathan Gossai, Nicholas M Brown, Rebecca Ameduri, Nicole D Zantek, James St Louis, Marie E Steiner
BACKGROUND: The balance of hemostasis and anticoagulation is a concern for patients dependent upon ventricular assist devices (VADs). Bleeding is a common complication with both short- and long-term use of these devices. A better understanding of the risk factors and etiologies of bleeding associated with these devices is needed and could improve the overall results. We sought to determine the relationship of mechanical circulatory assist device use with acquired von Willebrand disease (avWD) in children...
September 2016: World Journal for Pediatric & Congenital Heart Surgery
Marie E Steiner, Lisa R Bomgaars, M Patricia Massicotte
Efficacious ventricular assist device (VAD) support in pediatric patients depends on successful antithrombotic management. The experience with antithrombotic management for the EXCOR® Pediatric VAD Investigational Device Exemption (IDE) study is described. All 68 children in North America enrolled in the IDE study May 9, 2007 to December 10, 2010 are included. The Edmonton Anticoagulation and Platelet Inhibition Protocol was provided for management guidance. Monitoring parameters, drug dosing, targeted serious adverse events and pump changes were reviewed...
August 22, 2016: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
Arianna Di Molfetta, Sergio Filippelli, Gianfranco Ferrari, Aurelio Secinaro, Krystzof Zielinski, Antonio Amodeo
A 2-year-old child was implanted with an Berlin Heart EXCOR Ventricular Assist Device (Berlin Heart, Berlin, Germany) as a bridge to heart transplantation for idiopathic dilated cardiomyopathy. At postoperative day 296, a significant reduction of membrane movement was observed. The device was explanted and tested on a hydronumerical circulation simulator. Findings suggested that the integrity of the multilayered membrane had been compromised. This was confirmed by a computed tomography scan of the device. The computed tomography evidenced a detachment of the 3-layered membrane, with a thinner, convex layer on the side of the air chamber and an opposite convexity of the remaining membranes...
August 2016: Annals of Thoracic Surgery
George J Arnaoutakis, David Blitzer, Stephanie Fuller, Aaron W Eckhauser, Lisa M Montenegro, Joseph W Rossano, J William Gaynor
BACKGROUND: Circulatory failure necessitating cardiac transplantation will ultimately develop in many patients with functional single-ventricle physiology. Interest in the use of mechanical circulatory support (MCS) in this population is growing. METHODS: This was a retrospective case series of patients with functional single-ventricle physiology who underwent MCS with a ventricular assist device or a total artificial heart as a bridge to cardiac transplantation between January 2006 and December 2014...
July 14, 2016: Annals of Thoracic Surgery
Iago Sousa Casasnovas, Pablo Díez Villanueva, Felipe Díez Del Hoyo, Manuel Ruiz Fernández, Ángel González Pinto, Francisco Fernández-Avilés
No abstract text is available yet for this article.
May 2016: Revista Española de Cardiología
Zumrut Tuba Demirozu, Deniz Suha Kucukaksu
Long-term mechanical circulatory support is a life-saving technology while briding to heart transplantation. It increases the quality of life and preserves end-organ function for patients with advanced heart failure. The number of patients with advanced heart failure scheduled for heart transplantation before comorbidities escalate is on the rise. However, the device function is complicated by the bleeding-thrombosis and infection paradigm, hence the interest in understanding device thrombosis and infection...
October 27, 2015: Journal of Tehran Heart Center
Norihide Fukushima
By renewal of Japanese Organ Transplantation Act on 17th July in 2010, organs can be donated after brain death with consent from their family, if he or she did not deny organ donation and brain dead organ donation increased from 10 to 50 cases in a year. Despite of an increase of heart transplantation (HTx), a waiting period for HTx has become longer because more candidates for HTx have been registered to Japan Organ Transplant Network. By renewal of the act, organ donation from brain dead children can be performed since then and pediatric left ventricular assist device, EXCOR was finally accepted to use in August 1st, 2015...
January 2016: Kyobu Geka. the Japanese Journal of Thoracic Surgery
Roland Hetzer, Friedrich Kaufmann, Eva Maria Delmo Walter
This paper reviews the development and establishment of the Berlin Heart EXCOR® (BHE®) as a paediatric mechanical circulatory support and reports our entire experience with regard to indications, timing of implantation and explantation and outcome. The Berlin group reported the first successful paediatric bridge to transplantation using a pulsatile pneumatic paracorporeal biventricular assist device, the BHE®, in 1990 in an 8-year-old boy with end-stage heart failure and coarctation of the aorta. This experience prompted them to develop miniaturized pump systems for children through the company Berlin Heart Mediproduct GmbH...
August 2016: European Journal of Cardio-thoracic Surgery
Jennifer Conway, Christina VanderPluym, Aamir Jeewa, Selvi Sinnadurai, Amanda Schubert, Angela Lorts
The last five yr have been monumental for the pediatric heart failure community. In the US, the most notable has been the FDA approval of the first pediatric specific device (Berlin Heart EXCOR(®) ; Berlin Heart, Inc., Berlin, Germany). Subsequently, the field of heart failure has gained a great deal of knowledge regarding the nuances of MCS in children. Despite FDA approval in the US, the Berlin EXCOR(®) is only currently indicated for in-hospital use. Due to the limitations with discharge and the positive in- hospital experiences with the Berlin EXCOR(®) , there has been an increased interest in the implantation of adult durable devices into children...
March 2016: Pediatric Transplantation
Iki Adachi, Sarah Burki, Farhan Zafar, David Luis Simon Morales
The domain of pediatric ventricular assist device (VAD) has recently gained considerable attention. Despite the fact that, historically, the practice of pediatric mechanical circulatory support (MCS) has lagged behind that of adult patients, this gap between the two groups is narrowing. Currently, the Berlin EXCOR VAD is the only pediatric-specific durable VAD approved by the U.S Food and Drug Administration (FDA). The prospective Berlin Heart trial demonstrated a successful outcome, either bridge to transplantation (BTT), or in rare instances, bridge to recovery, in approximately 90% of children...
December 2015: Journal of Thoracic Disease
William Y Shi, Silvana F Marasco, Pankaj Saxena, Yves d'Udekem, Matthew S Yong, Sergei Mitnovetski, Christian P Brizard, David C McGiffin, Robert G Weintraub, Igor E Konstantinov
BACKGROUND: We evaluated our experience with ventricular assist device (VAD) implantation in children and young adults. METHODS: A total of 64 patients underwent VAD implantation in two centres. The mean age was 15 ± 7.2 years. Thirty-five (55%) patients were under 18 years of age. Devices implanted included the Thoratec Paracorporeal in 30 (47%) patients, Berlin Heart EXCOR in 11 (17%) and VentrAssist in 14 (22%). The diagnosis was cardiomyopathy in 53, congenital heart disease in 11, and graft failure in four patients...
November 27, 2015: ANZ Journal of Surgery
Kalervo Werkkala, Janne J Jokinen, Leena Soininen, Göran Dellgren, Stefan Hallhagen, Fredrik Sundberg, Jonas Andersson, Lars I Dahms, Nadine Jurrmann, Simon Ersel
The durability of CBAS Heparin Surface on EXCOR pumps retrieved after clinical use for varying periods of time was studied by analyzing samples for surface heparin density and bioactivity. The mean time of clinical use of the investigated 14 EXCOR pumps was 178 days (range, 15-461 days). Mean heparin density was 3.1 ± 0.6 μg/cm² (range, 2.2-4.8 μg/cm²), and the measured mean heparin bioactivity was 14 ± 5 ρmol/cm² (range: 7-27 ρmol/cm²). There was no detectable degradation or loss of function of CBAS Heparin Surface over time...
March 2016: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
James K Kirklin
PURPOSE OF REVIEW: Mechanical circulatory support (MCS) has rapidly evolved toward continuous flow technology in adults. In the pediatric population, the Berlin EXCOR, a paracorporeal pulsatile pump, is the only MCS device specifically approved for pediatric use. The current era of pediatric MCS includes an increasing application of adult continuous flow pumps to pediatric patients. RECENT FINDINGS: The Berlin EXCOR pulsatile pump has been studied in over 200 patients...
October 2015: Current Opinion in Pediatrics
Robert A Niebler, Tejas K Shah, Michael E Mitchell, Ronald K Woods, Steven D Zangwill, James S Tweddell, Stuart Berger, Nancy S Ghanayem
Our objective is to describe the use of a ventricular assist device (VAD) in single-ventricle patients with circulatory failure following superior cavopulmonary anastomosis (SCPA). We performed a retrospective chart review of all single-ventricle patients supported with a VAD following SCPA. Implantation techniques, physiologic parameters while supported, medical and surgical interventions postimplant, and outcomes were reviewed. Four patients were supported with an EXCOR Pediatric (Berlin Heart Inc., The Woodlands, TX, USA) following SCPA for a median duration of 10...
February 2016: Artificial Organs
Yasuhiro Fujii, Giuseppe Ferro, Hiroshi Kagawa, Luca Centola, Liqun Zhu, William T Ferrier, Linda Talken, R Kirk Riemer, Katsuhide Maeda, Teimour Nasirov, Bill Hodges, Saleh Amirriazi, Eric Lee, Donald Sheff, Judith May, Robert May, Olaf Reinhartz
Durable mechanical support in situations of physiologic single ventricle has been met with little success so far, particularly in small children. We created an animal model to investigate whether pulsatile or continuous flow would be superior. Three 1 month old sheep (10-16 kg) were instrumented. Via sternotomy and with cardiopulmonary bypass, a large ventricular septal defect and atrial septal defect were created. The left ventricle was cannulated using a Berlin Heart inflow cannula. This was connected sequentially to a continuous flow device (Thoratec HeartMate X, Pleasanton, CA) and to a pulsatile device (Berlin Heart Excor, The Woodlands, TX)...
July 2015: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
Farhan Zafar, John L Jefferies, Christine J Tjossem, Roosevelt Bryant, Robert D B Jaquiss, Peter D Wearden, David N Rosenthal, Antonio G Cabrera, Joseph W Rossano, Tilman Humpl, David L S Morales
BACKGROUND: Biventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival...
April 2015: Annals of Thoracic Surgery
Jonathan W Byrnes, Adnan T Bhutta, Mallikarjuna Rao Rettiganti, Alberto Gomez, Xiomara Garcia, Umesh Dyamenahalli, Charles Johnson, Robert D B Jaquiss, Michiaki Imamura, Parthak Prodhan
BACKGROUND: Hyperfibrinogenemia, which can create a procoagulant milieu, is frequently observed in patients supported with the Berlin EXCOR (Berlin Heart GmbH, Berlin, Germany) ventricular assist device (VAD). We began initiating corticosteroids in patients with systemic inflammatory response syndrome (SIRS) episodes to mitigate hyperfibrinogenemia. We set forth to describe the impact of corticosteroids on the hyperfibrinogenemic state in our institutional experience. METHODS: Retrospective data was collected on 44 consecutive patients implanted with the Berlin EXCOR VAD from April 15, 2005 through May 6, 2013...
April 2015: Annals of Thoracic Surgery
David M Hoganson, Umar S Boston, Avihu Z Gazit, Charles E Canter, Pirooz Eghtesady
In patients with failed Fontan circulation, end-stage heart failure can develop or Fontan physiology failure requiring transplantation. Experience with ventricular assist device support for these patients as a bridge to heart transplantation has been limited and often not resulted in successful hospital discharge. We report the successful use of the Berlin Heart EXCOR (Berlin Heart, The Woodlands, TX) ventricular assist device in bridging a child with Fontan circulation and systolic dysfunction to heart transplantation and discharge home...
February 2015: Annals of Thoracic Surgery
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