Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children

Circulation

Volumn 127, Issue 16, 2013, Pages 1702-1711

  Almond, Christopher S ^a   Morales, David L ^b   Blackstone, Eugene H ^c   Turrentine, Mark W ^d   Imamura, Michiaki ^e   Massicotte, M Patricia ^f   Jordan, Lori C ^g   Devaney, Eric J ^h   Ravishankar, Chitra ⁱ   Kanter, Kirk R ^j   Holman, William ^k   Kroslowitz, Robert ^l   Tjossem, Christine ^l   Thuita, Lucy ^c   Cohen, Gordon A ^m   Buchholz, Holger ^f   St Louis, James D ⁿ   Nguyen, Khanh ^o   Niebler, Robert A ^p   Walters, Henry L ^q   Reemtsen, Brian ^r   Wearden, Peter D ^s   Reinhartz, Olaf ^t   Guleserian, Kristine J ^u   Mitchell, Max B ^v   Bleiweis, Mark S ^w   Canter, Charles E ^x   Humpl, Tilman ^y   more..

^a BOSTON CHILDREN S HOSPITAL   (United States)

^b CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d RILEY HOSPITAL FOR CHILDREN   (United States)

^e ARKANSAS CHILDREN S HOSPITAL   (United States)

^f STOLLERY CHILDREN S HOSPITAL   (Canada)

^g VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^h UNIVERSITY OF MICHIGAN   (United States)

ⁱ CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^j CHILDREN'S HEALTHCARE OF ATLANTA   (United States)

^k UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^l Berlin Heart Inc   (United States)

^m SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

ⁿ UNIVERSITY OF MINNESOTA   (United States)

^o Mount Sinai   (United States)

^p MEDICAL COLLEGE OF WISCONSIN   (United States)

^q CHILDREN'S HOSPITAL OF MICHIGAN   (United States)

^r MATTEL CHILDREN S HOSPITAL   (United States)

^s CHILDREN S HOSPITAL OF PITTSBURGH   (United States)

^t STANFORD UNIVERSITY   (United States)

^u CHILDREN S MEDICAL CENTER   (United States)

^v CHILDREN S HOSPITAL COLORADO   (United States)

^w UNIVERSITY OF FLORIDA   (United States)

^x ST LOUIS CHILDREN S HOSPITAL   (United States)

^y HOSPITAL FOR SICK CHILDREN   (Canada)

more..

Author keywords

cardiac surgical procedures; heart failure; heart assist devices; pediatrics; transplantation; waiting lists

Indexed keywords

BILIRUBIN;

ARTICLE; CHILD; COHORT ANALYSIS; FAMILY COUNSELING; FEMALE; HEART TRANSPLANTATION; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT SELECTION; PRESCHOOL CHILD; PRIORITY JOURNAL; PROSPECTIVE STUDY; RISK FACTOR; SCHOOL CHILD; SURVIVAL; VENTRICULAR ASSIST DEVICE;

BODY SIZE; CAUSE OF DEATH; CHILD; CHILD, PRESCHOOL; COMORBIDITY; COMPASSIONATE USE TRIALS; EQUIPMENT DESIGN; EXTRACORPOREAL MEMBRANE OXYGENATION; FEMALE; HEART DEFECTS, CONGENITAL; HEART DISEASES; HEART TRANSPLANTATION; HEART-ASSIST DEVICES; HEMORRHAGE; HUMANS; HYPERBILIRUBINEMIA; INFANT; KIDNEY DISEASES; LIVER DISEASES; MALE; MORTALITY; MULTIPLE ORGAN FAILURE; PROPORTIONAL HAZARDS MODELS; RISK; STROKE; SURVIVAL RATE; TREATMENT OUTCOME; WAITING LISTS;

EID: 84876584927     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.112.000685     Document Type: Article

References (42)

1. Mah D, Singh TP, Thiagarajan RR, Gauvreau K, Piercey GE, Blume ED, Fynn-Thompson F, Almond CS. Incidence and risk factors for mortality in infants awaiting heart transplantation in the USA. J Heart Lung Transplant. 2009;28:1292-1298.
2. HRSA. Organ procurement and transplant network data. http://optn.trans- plant.hrsa.gov. Accessed April 3, 2013.
3. Almond CS, Singh TP, Gauvreau K, Piercey GE, Fynn-Thompson F, Rycus PT, Bartlett RH, Thiagarajan RR. Extracorporeal membrane oxygenation for bridge to heart transplantation among children in the United States: analysis of data from the Organ Procurement and Transplant Network and Extracorporeal Life Support Organization Registry. Circulation. 2011;123:2975-2984.
4. Morales DL, Zafar F, Rossano JW, Salazar JD, Jefferies JL, Graves DE, Heinle JS, Fraser CD Jr. Use of ventricular assist devices in children across the United States: analysis of 7.5 million pediatric hospitalizations. Ann Thorac Surg. 2010;90:1313-1318.
5. Morales DL, Almond CS, Jaquiss RD, Rosenthal DN, Naftel DC, Massicotte MP, Humpl T, Turrentine MW, Tweddell JS, Cohen GA, Kroslowitz R, Devaney EJ, Canter CE, Fynn-Thompson F, Reinhartz O, Imamura M, Ghanayem NS, Buchholz H, Furness S, Mazor R, Gandhi SK, Fraser CD Jr. Bridging children of all sizes to cardiac transplantation: the initial multicenter North American experience with the Berlin Heart EXCOR ventricular assist device. J Heart Lung Transplant. 2011;30:1-8.
6. Fan Y, Weng YG, Huebler M, Cowger J, Morales D, Franz N, Xiao YB, Potapov E, Hetzer R. Predictors of in-hospital mortality in children after long-term ventricular assist device insertion. J Am Coll Cardiol. 2011;58:1183-1190.
7. Fraser CD Jr, Jaquiss RD, Rosenthal DN, Humpl T, Canter CE, Blackstone EH, Naftel DC, Ichord RN, Bomgaars L, Tweddell JS, Massicotte MP, Turrentine MW, Cohen GA, Devaney EJ, Pearce FB, Carberry KE, Kroslowitz R, Almond CS; Berlin Heart Study Investigators. Prospective trial of a pediatric ventricular assist device. N Engl J Med. 2012;367:532-541.
8. Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-fow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.
9. Schwartz GJ, Haycock GB, Edelmann CM Jr, Spitzer A. A simple estimate of glomerular fltration rate in children derived from body length and plasma creatinine. Pediatrics. 1976;58:259-263.
10. Andersen PK, Borgan O, Gill RD, Keiding N. Nonparametric estimation. In: Statistical Models Based on Couting Processes. New York, NY: Singer-Verlag; 1993:175-331.
11. Blackstone EH, Naftel DC, Turner ME. The decomposition of time-varying hazard into phases, each incorporating a separate stream of concomitant information. J Am Stat Assoc. 1986;81:615-624.
12. Altman DG, Andersen PK. Bootstrap investigation of the stability of a Cox regression model. Stat Med. 1989;8:771-783.
13. Breiman L. Bagging predictors. Machine Learning. 1996;24:123-140.
14. Sauerbrei W, Schumacher M. A bootstrap resampling procedure for model building: application to the Cox regression model. Stat Med. 1992;11:2093-2109.
15. Rubin DB. Multiple Imputation for Non-Response in Survey. New York: Wiley; 1987.
16. Robert C, Casella G. Monte Carlo Statistical Methods. New York: Springer; 2004.
17. Fan Y, Weng YG, Xiao YB, Huebler M, Franz N, Potapov E, Hetzer R. Outcomes of ventricular assist device support in young patients with small body surface area. Eur J Cardiothorac Surg. 2011;39:699-704.
18. Gandhi SK, Huddleston CB, Balzer DT, Epstein DJ, Boschert TA, Canter CE. Biventricular assist devices as a bridge to heart transplantation in small children. Circulation. 2008;118(suppl):S89-S93.
19. Imamura M, Dossey AM, Prodhan P, Schmitz M, Frazier E, Dyamenahalli U, Bhutta A, Morrow WR, Jaquiss RD. Bridge to cardiac transplant in children: Berlin Heart versus extracorporeal membrane oxygenation. Ann Thorac Surg. 2009;87:1894-1901.
20. Jeewa A, Manlhiot C, McCrindle BW, Van Arsdell G, Humpl T, Dipchand AI. Outcomes with ventricular assist device versus extracorporeal membrane oxygenation as a bridge to pediatric heart transplantation. Artif Organs. 2010;34:1087-1091.
21. Malaisrie SC, Pelletier MP, Yun JJ, Sharma K, Timek TA, Rosenthal DN, Wright GE, Robbins RC, Reitz BA. Pneumatic paracorporeal ventricular assist device in infants and children: initial Stanford experience. J Heart Lung Transplant. 2008;27:173-177.
22. Moreno GE, Charroqui A, Pilán ML, Magliola RH, Krynski MP, Althabe M, Landry LM, Sciuccati G, Villa A, Vogelfang H. Clinical experience with Berlin Heart EXCOR in pediatric patients in Argentina: 1373 days of cardiac support. Pediatr Cardiol. 2011;32:652-658.
23. Rockett SR, Bryant JC, Morrow WR, Frazier EA, Fiser WP, McKamie WA, Johnson CE, Chipman CW, Imamura M, Jaquiss RD. Preliminary single center North American experience with the Berlin Heart pediatric EXCOR device. ASAIO J. 2008;54:479-482.
24. Humpl T, Furness S, Gruenwald C, Hyslop C, Van Arsdell G. The Berlin Heart EXCOR Pediatrics: the SickKids Experience 2004-2008. Artif Organs. 2010;34:1082-1086.
25. Hetzer R, Potapov E V, Stiller B, Weng Y, Hübler M, Lemmer J, Alexi-Meskishvili V, Redlin M, Merkle F, Kaufmann F, Hennig E. Improvement in survival after mechanical circulatory support with pneumatic pulsatile ventricular assist devices in pediatric patients. Ann Thorac Surg. 2006;82:917-924.
26. Cleveland JC Jr, Naftel DC, Reece TB, Murray M, Antaki J, Pagani FD, Kirklin JK. Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database. J Heart Lung Transplant. 2011;30:862-869.
27. Holman WL, Pae WE, Teutenberg JJ, Acker MA, Naftel DC, Sun BC, Milano CA, Kirklin JK. INTERMACS: interval analysis of registry data. J Am Coll Surg. 2009;208:755-61; discussion 761.
28. Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte J V, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH; HeartMate II Clinical Investigators. Use of a continuous-fow device in patients awaiting heart transplantation. N Engl J Med. 2007;357:885-896.
29. Schmid C, Weyand M, Nabavi DG, Hammel D, Deng MC, Ringelstein EB, Scheld HH. Cerebral and systemic embolization during left ventricular support with the Novacor N100 device. Ann Thorac Surg. 1998;65:1703-1710.
30. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345:1435-1443.
31. Almond CS, Thiagarajan RR, Piercey GE, Gauvreau K, Blume ED, Bastardi HJ, Fynn-Thompson F, Singh TP. Waiting list mortality among children listed for heart transplantation in the United States. Circulation. 2009;119:717-727.
32. Morrow WR, Naftel D, Chinnock R, Canter C, Boucek M, Zales V, McGiffn DC, Kirklin JK. Outcome of listing for heart transplantation in infants younger than six months: predictors of death and interval to transplantation: the Pediatric Heart Transplantation Study Group. J Heart Lung Transplant. 1997;16:1255-1266.
33. Duncan BW, Hraska V, Jonas RA, Wessel DL, Del Nido PJ, Laussen PC, Mayer JE, Lapierre RA, Wilson JM. Mechanical circulatory support in children with cardiac disease. J Thorac Cardiovasc Surg. 1999;117:529-542.
34. Baldwin JT, Borovetz HS, Duncan BW, Gartner MJ, Jarvik RK, Weiss WJ, Hoke TR. The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program. Circulation. 2006;113:147-155.
35. Goldman AP, Cassidy J, de Leval M, Haynes S, Brown K, Whitmore P, Cohen G, Tsang V, Elliott M, Davison A, Hamilton L, Bolton D, Wray J, Hasan A, Radley-Smith R, Macrae D, Smith J. The waiting game: bridging to paediatric heart transplantation. Lancet. 2003;362:1967-1970.
36. Fang JC. Rise of the machines-left ventricular assist devices as permanent therapy for advanced heart failure. N Engl J Med. 2009;361:2282-2285.
37. Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. The Fourth INTERMACS Annual Report: 4, 000 implants and counting. J Heart Lung Transplant. 2012;31:117-126.
38. Baldwin JT, Borovetz HS, Duncan BW, Gartner MJ, Jarvik RK, Weiss WJ. The National Heart, Lung, and Blood Institute Pediatric Circulatory Support Program: a summary of the 5-year experience. Circulation. 2011;123:1233-1240.
39. Slaughter MS, Sobieski MA 2nd, Tamez D, Horrell T, Graham J, Pappas PS, Tatooles AJ, LaRose J. HeartWare miniature axial-fow ventricular assist device: design and initial feasibility test. Tex Heart Inst J. 2009;36:12-16.
40. Throckmorton AL, Chopski SG. Pediatric circulatory support: current strategies and future directions: biventricular and univentricular mechanical assistance. ASAIO J. 2008;54:491-497.
41. US Food and Drug Administration. Berlin Heart EXCOR pediatric ventricular assist device (VAD): H100004. http://www.Fda.Gov/medicalde-vices/ productsandmedicalprocedures/deviceapprovalsandclearances/recently- approveddevices/ucm302715. Accessed April 3, 2013.
42. Hsu DT, Pearson GD. Heart failure in children, part I: history, etiology, and pathophysiology. Circ Heart Fail. 2009;2:63-70.