메뉴 건너뛰기




Volumn 162, Issue 3, 2011, Pages

Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: Study design and rationale

(16)  Almond, Christopher S a   Buchholz, Holger b   Massicotte, Patricia b   Ichord, Rebecca c   Rosenthal, David N d   Uzark, Karen e   Jaquiss, Robert D B f   Kroslowitz, Robert g   Kepler, Mary Beth g   Lobbestael, Aaron g   Bellinger, David a   Blume, Elizabeth D a   Fraser, Charles D h   Bartlett, Robert H i   Thiagarajan, Ravi a   Jenkins, Kathy a  


Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; BODY SURFACE; CHILD; CLINICAL ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED STUDY; CONVALESCENCE; DEVICE SAFETY; DISEASE SEVERITY; EXTRACORPOREAL OXYGENATION; HEART ASSIST DEVICE; HEART FAILURE; HEART TRANSPLANTATION; HUMAN; INFANT; MULTICENTER STUDY; POPULATION; PRESCHOOL CHILD; PRIORITY JOURNAL; PROSPECTIVE STUDY; SCHOOL CHILD; STUDY DESIGN; SURVIVAL;

EID: 80052283184     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2011.05.026     Document Type: Article
Times cited : (100)

References (64)
  • 2
    • 0036260228 scopus 로고    scopus 로고
    • Mechanical circulatory support for infants and children with cardiac disease
    • DOI 10.1016/S0003-4975(01)03027-2, PII S0003497501030272
    • B.W. Duncan Mechanical circulatory support for infants and children with cardiac disease Ann Thorac Surg 73 2002 1670 1677 (Pubitemid 34596631)
    • (2002) Annals of Thoracic Surgery , vol.73 , Issue.5 , pp. 1670-1677
    • Duncan, B.W.1
  • 6
    • 0036386090 scopus 로고    scopus 로고
    • Use of extracorporeal membrane oxygenation in pediatric thoracic organ transplantation
    • P.M. Kirshbom, N.D. Bridges, and R.J. Myung Use of extracorporeal membrane oxygenation in pediatric thoracic organ transplantation J Thorac Cardiovasc Surg 123 2002 130 136
    • (2002) J Thorac Cardiovasc Surg , vol.123 , pp. 130-136
    • Kirshbom, P.M.1    Bridges, N.D.2    Myung, R.J.3
  • 8
    • 33644854087 scopus 로고    scopus 로고
    • The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program
    • DOI 10.1161/CIRCULATIONAHA.105.571422, PII 0000301720060103000023
    • J.T. Baldwin, H.S. Borovetz, and B.W. Duncan The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program Circulation 113 2006 147 155 (Pubitemid 43958501)
    • (2006) Circulation , vol.113 , Issue.1 , pp. 147-155
    • Baldwin, J.T.1    Borovetz, H.S.2    Duncan, B.W.3    Gartner, M.J.4    Jarvik, R.K.5    Weiss, W.J.6    Hoke, T.R.7
  • 9
    • 61549112147 scopus 로고    scopus 로고
    • Waiting list mortality among children listed for heart transplantation in the United States
    • C.S. Almond, R.R. Thiagarajan, and G.E. Piercey Waiting list mortality among children listed for heart transplantation in the United States Circulation 119 2009 717 727
    • (2009) Circulation , vol.119 , pp. 717-727
    • Almond, C.S.1    Thiagarajan, R.R.2    Piercey, G.E.3
  • 11
    • 12844258855 scopus 로고    scopus 로고
    • Extracorporeal life support registry report 2004
    • DOI 10.1097/01.MAT.0000151922.67540.E9
    • S.A. Conrad, P.T. Rycus, and H. Dalton Extracorporeal life support registry report 2004 ASAIO J 51 2005 4 10 (Pubitemid 40165243)
    • (2005) ASAIO Journal , vol.51 , Issue.1 , pp. 4-10
    • Conrad, S.A.1    Rycus, P.T.2    Dalton, H.3
  • 12
    • 35148884316 scopus 로고    scopus 로고
    • Extracorporeal membrane oxygenation to aid cardiopulmonary resuscitation in infants and children
    • DOI 10.1161/CIRCULATIONAHA.106.680678
    • R.R. Thiagarajan, P.C. Laussen, and P.T. Rycus Extracorporeal membrane oxygenation to aid cardiopulmonary resuscitation in infants and children Circulation 116 2007 1693 1700 (Pubitemid 47537843)
    • (2007) Circulation , vol.116 , Issue.15 , pp. 1693-1700
    • Thiagarajan, R.R.1    Laussen, P.C.2    Rycus, P.T.3    Bartlett, R.H.4    Bratton, S.L.5
  • 14
    • 1842340919 scopus 로고
    • Extracorporeal membrane oxygenation support as a bridge to pediatric heart transplantation
    • P.J. del Nido, J.M. Armitage, and F.J. Fricker Extracorporeal membrane oxygenation support as a bridge to pediatric heart transplantation Circulation 90 5 Pt 2 1994 II66 II69
    • (1994) Circulation , vol.90 , Issue.5 PART. 2
    • Del Nido, P.J.1    Armitage, J.M.2    Fricker, F.J.3
  • 15
    • 33744987129 scopus 로고    scopus 로고
    • Outcomes of children bridged to heart transplantation with ventricular assist devices: A multi-institutional study
    • DOI 10.1161/CIRCULATIONAHA.105.577601, PII 0000301720060516000011
    • E.D. Blume, D.C. Naftel, and H.J. Bastardi Outcomes of children bridged to heart transplantation with ventricular assist devices: a multi-institutional study Circulation 113 2006 2313 2319 (Pubitemid 43947977)
    • (2006) Circulation , vol.113 , Issue.19 , pp. 2313-2319
    • Blume, E.D.1    Naftel, D.C.2    Bastardi, H.J.3    Duncan, B.W.4    Kirklin, J.K.5    Webber, S.A.6
  • 16
  • 17
    • 80052303965 scopus 로고    scopus 로고
    • Debakey VAD Child Left Ventricular Assist System-H030003
    • Rockville, MD; February, Last Accessed November 030011, 032010
    • Debakey VAD Child Left Ventricular Assist System-H030003 US Food and Drug Administration DoHaHS 2004 Rockville, MD; February, Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num= H030003 Last Accessed November 030011, 032010
    • (2004) US Food and Drug Administration DoHaHS
  • 18
    • 33645898319 scopus 로고    scopus 로고
    • Preliminary experience with the MicroMed DeBakey pediatric ventricular assist device
    • C.D. Fraser Jr., K.E. Carberry, and W.R. Owens Preliminary experience with the MicroMed DeBakey pediatric ventricular assist device Semin Thorac Cardiovasc Surg 2006 109 114
    • (2006) Semin Thorac Cardiovasc Surg , pp. 109-114
    • Fraser, Jr.C.D.1    Carberry, K.E.2    Owens, W.R.3
  • 22
    • 33747360390 scopus 로고    scopus 로고
    • Improvement in survival after mechanical circulatory support with pneumatic pulsatile ventricular assist devices in pediatric patients
    • (discussion 924-915)
    • R. Hetzer, E.V. Potapov, and B. Stiller Improvement in survival after mechanical circulatory support with pneumatic pulsatile ventricular assist devices in pediatric patients Ann Thor Surg 82 2006 917 924 (discussion 924-915)
    • (2006) Ann Thor Surg , vol.82 , pp. 917-924
    • Hetzer, R.1    Potapov, E.V.2    Stiller, B.3
  • 23
    • 79953054347 scopus 로고    scopus 로고
    • Outcomes of ventricular assist device support in young patients with small body surface area
    • Y. Fan, Y.G. Weng, and Y.B. Xiao Outcomes of ventricular assist device support in young patients with small body surface area Eur J Cardiothorac Surg 2010
    • (2010) Eur J Cardiothorac Surg
    • Fan, Y.1    Weng, Y.G.2    Xiao, Y.B.3
  • 27
    • 26444568706 scopus 로고    scopus 로고
    • Pediatric circulatory support: An FDA perspective
    • DOI 10.1097/01.mat.0000181508.26853.dc
    • J.E. Rinaldi, E.A. Chen, and M.R. Berman Pediatric circulatory support: an FDA perspective ASAIO J 51 2005 533 535 (Pubitemid 41434237)
    • (2005) ASAIO Journal , vol.51 , Issue.5 , pp. 533-535
    • Rinaldi, J.E.1    Chen, E.A.2    Berman, M.R.3
  • 28
    • 62449247036 scopus 로고    scopus 로고
    • Pediatric circulatory support contractors' meeting: Report of the Clinical Trials Working Group
    • S. Webber Pediatric circulatory support contractors' meeting: report of the Clinical Trials Working Group ASAIO J 55 2009 10 12
    • (2009) ASAIO J , vol.55 , pp. 10-12
    • Webber, S.1
  • 30
    • 84872659734 scopus 로고    scopus 로고
    • Last Accessed November 29, 2010
    • Extracorporeal Life Support Organization. Available at: http://www.elso.med.umich.edu. Last Accessed November 29, 2010.
    • Extracorporeal Life Support Organization
  • 33
    • 84855686964 scopus 로고    scopus 로고
    • Central venous catheter sampling of low molecular heparin levels: An approach to increasing result reliability
    • M.E. Bauman, and M. Belletrutti Central venous catheter sampling of low molecular heparin levels: an approach to increasing result reliability Pediatric Critical Care Medicine 2011 Feb 10
    • (2011) Pediatric Critical Care Medicine
    • Bauman, M.E.1    Belletrutti, M.2
  • 34
    • 0031672239 scopus 로고    scopus 로고
    • Central venous catheter related thrombosis in children: Analysis of the Canadian registry of venous thromboembolic complications
    • M.P. Massicotte, D. Dix, and P. Monagle Central venous catheter related thrombosis in children: analysis of the Canadian Registry of Venous Thromboembolic Complications J Pediatr 133 1998 770 776 (Pubitemid 28563947)
    • (1998) Journal of Pediatrics , vol.133 , Issue.6 , pp. 770-776
    • Massicotte, M.P.1    Dix, D.2    Monagle, P.3    Adams, M.4    Andrew, M.5
  • 35
    • 45949090606 scopus 로고    scopus 로고
    • Antithrombotic therapy in neonates and children: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition)
    • DOI 10.1378/chest.08-0762
    • P. Monagle, E. Chalmers, and A. Chan Antithrombotic therapy in neonates and children: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition) Chest 133 6 SUPPL. 2008 887S 968S (Pubitemid 351892979)
    • (2008) Chest , vol.133 , Issue.SUPPL. 6
    • Monagle, P.1    Chalmers, E.2    Chan, A.3    DeVeber, G.4    Kirkham, F.5    Massicotte, P.6    Michelson, A.D.7
  • 36
    • 26444458805 scopus 로고    scopus 로고
    • US Food And Drug Administration Dohahs Last accessed November 29, 2010
    • US Food and Drug Administration DoHaHS Guidance for industry and FDA staff: pre-market assessment of pediatric medical devices Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm089740.htm#3a Last accessed November 29, 2010
    • Guidance for Industry and FDA Staff: Pre-market Assessment of Pediatric Medical Devices
  • 38
    • 36549004633 scopus 로고    scopus 로고
    • Reference values for kaolin-activated thromboelastography in healthy children
    • DOI 10.1213/01.ane.0000287645.26763.be, PII 0000053920071200000019
    • K.L. Chan, R.G. Summerhayes, and V. Ignjatovic Reference values for kaolin-activated thromboelastography in healthy children Anesth Analg 105 2007 1610 1613 table of contents (Pubitemid 350190554)
    • (2007) Anesthesia and Analgesia , vol.105 , Issue.6 , pp. 1610-1613
    • Chan, K.-L.1    Summerhayes, R.G.2    Ignjatovic, V.3    Horton, S.B.4    Monagle, P.T.5
  • 39
    • 17144365499 scopus 로고    scopus 로고
    • Thrombelastography/thromboelastometry
    • DOI 10.1111/j.1365-2257.2005.00681.x
    • R.J. Luddington Thrombelastography/thromboelastometry Clin Lab Haematol 27 2005 81 90 (Pubitemid 40515992)
    • (2005) Clinical and Laboratory Haematology , vol.27 , Issue.2 , pp. 81-90
    • Luddington, R.J.1
  • 40
    • 80052296330 scopus 로고    scopus 로고
    • Haemoscope pre-market notification: Thromboelastograph, hemostatic analyzer and platelet mapping assay
    • US Food And Drug Administration Cfdarh Last accessed June 1, 2011
    • US Food and Drug Administration CfDaRH Haemoscope pre-market notification: thromboelastograph, hemostatic analyzer and platelet mapping assay Services UDoHaH 2004 Vol. Available at: http://www.accessdata.fda.gov/cdrh- docs/pdf4/K041502.pdf Last accessed June 1, 2011
    • (2004) Services UDoHaH
  • 42
    • 0036090620 scopus 로고    scopus 로고
    • Modified National Institutes of Health Stroke Scale for use in stroke clinical trials: Prospective reliability and validity
    • DOI 10.1161/01.STR.0000015625.87603.A7
    • B.C. Meyer, T.M. Hemmen, and C.M. Jackson Modified National Institutes of Health Stroke Scale for use in stroke clinical trials: prospective reliability and validity Stroke 33 2002 1261 1266 (Pubitemid 34517045)
    • (2002) Stroke , vol.33 , Issue.5 , pp. 1261-1266
    • Meyer, B.C.1    Hemmen, T.M.2    Jackson, C.M.3    Lyden, P.D.4
  • 43
    • 29144512277 scopus 로고    scopus 로고
    • Critical appraisal and review of the rankin scale and its derivatives
    • DOI 10.1159/000089536
    • P.W. New, and R. Buchbinder Critical appraisal and review of the Rankin scale and its derivatives Neuroepidemiology 26 2006 4 15 (Pubitemid 41797932)
    • (2006) Neuroepidemiology , vol.26 , Issue.1 , pp. 4-15
    • New, P.W.1    Buchbinder, R.2
  • 44
    • 70450195021 scopus 로고
    • Functional evaluation: The Barthel index
    • F.I. Mahoney, and D.W. Barthel Functional evaluation: the Barthel index Md State Med J 14 1965 61 65
    • (1965) Md State Med J , vol.14 , pp. 61-65
    • Mahoney, F.I.1    Barthel, D.W.2
  • 45
    • 0034084410 scopus 로고    scopus 로고
    • Neurologic outcome in survivors of childhood arterial ischemic stroke and sinovenous thrombosis
    • G.A. deVeber, D. MacGregor, and R. Curtis Neurologic outcome in survivors of childhood arterial ischemic stroke and sinovenous thrombosis J Child Neurol 15 2000 316 324 (Pubitemid 30341363)
    • (2000) Journal of Child Neurology , vol.15 , Issue.5 , pp. 316-324
    • DeVeber, G.A.1    MacGregor, D.2    Curtis, R.3    Mayank, S.4
  • 46
    • 33744790326 scopus 로고    scopus 로고
    • A validation study of the paediatric stroke outcome measure.
    • (Abstract #P331)
    • L. Kitchen, S. Friefeld, and P. anderson A validation study of the paediatric stroke outcome measure. Stroke 34 2003 316 (Abstract #P331)
    • (2003) Stroke , vol.34 , pp. 316
    • Kitchen, L.1    Friefeld, S.2    Anderson, P.3
  • 47
    • 0035735643 scopus 로고    scopus 로고
    • Concurrent validity of the functional independence measure for children (WeeFIM™) and the pediatric evaluation of disabilities inventory in children with developmental disabilities and acquired brain injuries
    • J. Ziviani, K.J. Ottenbacher, and K. Shephard Concurrent validity of the Functional Independence Measure for Children (WeeFIM) and the Pediatric Evaluation of Disabilities Inventory in children with developmental disabilities and acquired brain injuries Phys Occup Ther Pediatr 21 2001 91 101 (Pubitemid 34461313)
    • (2001) Physical and Occupational Therapy in Pediatrics , vol.21 , Issue.2-3 , pp. 91-101
    • Ziviani, J.1    Ottenbacher, K.J.2    Shephard, K.3    Foreman, S.4    Astbury, W.5    Ireland, P.6
  • 48
    • 77749243156 scopus 로고    scopus 로고
    • Design of the silent cerebral infarct transfusion (SIT) trial
    • Casella JF, King AA, Barton B, et al. Design of the silent cerebral infarct transfusion (SIT) trial. Pediatr Hematol Oncol.27(2):69-89.
    • Pediatr Hematol Oncol , vol.27 , Issue.2 , pp. 69-89
    • Casella, J.F.1    King, A.A.2    Barton, B.3
  • 49
    • 44449137650 scopus 로고    scopus 로고
    • Quality of life in children with heart disease as perceived by children and parents
    • K. Uzark, K. Jones, and J. Slusher Quality of life in children with heart disease as perceived by children and parents Pediatrics 121 2008 e1060 e1067
    • (2008) Pediatrics , vol.121
    • Uzark, K.1    Jones, K.2    Slusher, J.3
  • 50
    • 0036549713 scopus 로고    scopus 로고
    • The PedsQL™ 4.0 Generic Core Scales: Sensitivity, Responsiveness, and Impact on Clinical Decision-Making
    • DOI 10.1023/A:1014836921812
    • J.W. Varni, M. Seid, and T.S. Knight The PedsQL 4.0 generic core scales: sensitivity, responsiveness, and impact on clinical decision-making J Behav Med 25 2002 175 193 (Pubitemid 37490058)
    • (2002) Journal of Behavioral Medicine , vol.25 , Issue.2 , pp. 175-193
    • Varni, J.W.1    Seid, M.2    Knight, T.S.3    Uzark, K.4    Szer, I.S.5
  • 52
    • 0037167691 scopus 로고    scopus 로고
    • Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: Analysis of 245 patients
    • Y. Ochiai, P.M. McCarthy, and N.G. Smedira Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients Circulation 106 12 SUPPL. 1 2002 I198 I202
    • (2002) Circulation , vol.106 , Issue.12 SUPPL. 1
    • Ochiai, Y.1    McCarthy, P.M.2    Smedira, N.G.3
  • 53
    • 80052277090 scopus 로고    scopus 로고
    • Last accessed November 29, 2010
    • Thoratec instructions for use Available at: http://www.thoratec.com/ medical-professionals/resource-library/ifus-manuals/thoratec-pvad.aspx Last accessed November 29, 2010
    • Thoratec Instructions for Use
  • 54
    • 10244234105 scopus 로고    scopus 로고
    • Prediction of right ventricular dysfunction after left ventricular assist device implantation
    • S. Nakatani, J.D. Thomas, and R.M. Savage Prediction of right ventricular dysfunction after left ventricular assist device implantation Circulation 94 9 SUPPL. 1996 II216 II221
    • (1996) Circulation , vol.94 , Issue.9 SUPPL.
    • Nakatani, S.1    Thomas, J.D.2    Savage, R.M.3
  • 55
    • 24644481862 scopus 로고    scopus 로고
    • Long-term results in patients with idiopathic dilated cardiomyopathy after weaning from left ventricular assist devices
    • abstract
    • M. Dandel, Y. Weng, and H. Siniawski Long-term results in patients with idiopathic dilated cardiomyopathy after weaning from left ventricular assist devices Circulation 112 9 SUPPL. 2005 I37 I45 abstract
    • (2005) Circulation , vol.112 , Issue.9 SUPPL.
    • Dandel, M.1    Weng, Y.2    Siniawski, H.3
  • 56
    • 27944505504 scopus 로고    scopus 로고
    • Prediction of cardiac function after weaning from ventricular assist devices
    • DOI 10.1016/j.jtcvs.2005.08.020, PII S0022522305013863
    • H. Liang, H. Lin, and Y. Weng Prediction of cardiac function after weaning from ventricular assist devices J Thorac Cardiovasc Surg 130 2005 1555 1560 (Pubitemid 41676918)
    • (2005) Journal of Thoracic and Cardiovascular Surgery , vol.130 , Issue.6 , pp. 1555-1560
    • Liang, H.1    Lin, H.2    Weng, Y.3    Dandel, M.4    Hetzer, R.5
  • 61
    • 80052287026 scopus 로고    scopus 로고
    • US Food And Drug Administration (Ventricular Assist Devices): January 20, 2006. Rockville, MD, January 20, 2006
    • US Food and Drug Administration FDA workshop on regulatory process for pediatric mechanical circulatory support devices (VADs) (Ventricular Assist Devices): January 20, 2006. Rockville, MD, January 20, 2006: Available at: www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm114615
    • FDA Workshop on Regulatory Process for Pediatric Mechanical Circulatory Support Devices (VADs)
  • 62
    • 85108550579 scopus 로고    scopus 로고
    • US Food And Drug Administration Last accessed November 29, 2010
    • US Food and Drug Administration The Pediatric Device Consortia Grants Program. Silver Spring, MD Available at: www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseasesConditions/ PediatricDeviceConsortiaGrantsProgram Last accessed November 29, 2010
    • The Pediatric Device Consortia Grants Program. Silver Spring, MD


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.