1. Hsu, DT, Pearson, GD. Heart failure in children: part I: history, etiology, and pathophysiology. Circ Heart Fail 2009; 2: 63–70.
2. Rossano, JW, Dipchand, AI, Edwards, LB, et al. The Registry of the International Society for Heart and Lung Transplantation: Nineteenth Pediatric Heart Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant 2016; 35: 1185–1195.
3. Almond, CS, Thiagarajan, RR, Piercey, GE, et al. Waiting list mortality among children listed for heart transplantation in the United States. Circulation 2009; 119: 717–727.
4. Zafar, F, Castleberry, C, Khan, MS, et al. Pediatric heart transplant waiting list mortality in the era of ventricular assist devices. J Heart Lung Transplant 2015; 34: 82–88.
5. Section on Cardiology and Cardiac Surgery; Section on Orthopaedics. Off-label use of medical devices in children. Pediatrics 2017; 139: pii: e20163439.
6. Fraser, CD Jr, Jaquiss, RD, Rosenthal, DN, et al. Prospective trial of a pediatric ventricular assist device. N Engl J Med 2012; 367: 532–541.
7. Almond, CS, Morales, DL, Blackstone, EH, et al. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation 2013; 127: 1702–1711.
8. Blume, ED, Rosenthal, DN, Rossano, JW, et al. Outcomes of children implanted with ventricular assist devices in the United States: first analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (Pediatric Interagency Registry for Mechanical Circulatory Support). J Heart Lung Transplant 2016; 35: 578–584.
9. Sutcliffe, DL, Pruitt, E, Cantor, RS, et al. Post-transplant outcomes in pediatric ventricular assist device patients: A PediMACS-Pediatric Heart Transplant Study linkage analysis. J Heart Lung Transplant 2018; 37: 715–722.
10. Upperman, JS, Lacroix, J, Curley, MA, et al. Specific etiologies associated with multiple organ dysfunction syndrome in children: part 1. Pediatr Crit Care Med 2017; 18: S50–S57.
11. Jarral, OA, Saso, S, Harling, L, et al. Organ dysfunction in patients with left ventricular impairment: what is the effect of cardiopulmonary bypass? Heart Lung Circ 2014; 23: 852–862.
12. Sasse, M, Dziuba, F, Jack, T, et al. In-line filtration decreases systematic inflammatory response syndrome, renal and hematologic dysfunction in pediatric cardiac intensive care patients. Pediatr Cardiol 2015; 36: 1270–1278.
13. Apostolakis, E, Filos, KS, Koletsis, E, Dougenis, D. Lung dysfunction following cardiopulmonary bypass. J Card Surg 2010; 25: 47–55.
14. Dang, NC, Naka, Y. Perioperative pharmacotherapy in patients with left ventricular assist devices. Drugs Aging 2004; 21: 993–1012.
15. Ensor, CR, Paciullo, CA, Cahoon, WD Jr, Nolan, PE Jr. Pharmacotherapy for mechanical circulatory support: a comprehensive review. Ann Pharmacother 2011; 45: 60–77.
16. Fragasso, T, Ricci, Z, Grutter, G, et al. Incidence of healthcare-associated infections in a pediatric population with an extracorporeal ventricular assist device. Artif Organs 2011; 35: 1110–1114.
17. Cabrera, AG, Khan, MS, Morales, DL, et al. Infectious complications and outcomes in children supported with left ventricular assist devices. J Heart Lung Transplant 2013; 32: 518–524.
18. Monkowski, DH, Axelrod, P, Fekete, T, Hollander, T, Furukawa, S, Samuel, R. Infections associated with ventricular assist devices: epidemiology and effect on prognosis after transplantation. Transpl Infect Dis 2007; 9: 114–120.
19. Acharya, MN, Som, R, Tsui, S. What is the optimum antibiotic prophylaxis in patients undergoing implantation of a left ventricular assist device? Interact Cardiovasc Thorac Surg 2012; 14: 209–214.
20. Walker, PC, DePestel, DD, Miles, NA, Malani, PN. Surgical infection prophylaxis for left ventricular assist device implantation. J Card Surg 2011; 26: 440–443.
21. Kusne, S, Mooney, M, Danziger-Isakov, L, et al. An ISHLT consensus document for prevention and management strategies for mechanical circulation support infection. J Heart Lung Transplant 2017; 36: 1137–1153.
22. Massicotte, MP, Bauman, ME, Murray, J, Almond, CS. Antithrombotic therapy for ventricular assist devices in children: do we really know what to do? J Thromb Haemost 2015; 13 (Suppl 1): S343–S350.
23. Feldman, D, Pamboukian, SV, Teuteberg, JJ, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant 2013; 32: 157–187.
24. Baumann Kreuziger, LM. Management of anticoagulation and antiplatelet therapy in patients with left ventricular assist devices. J Thromb Thrombolysis 2015; 39: 337–344.
25. Steiner, ME, Bomgaars, LR, Massicotte, MP. Berlin Heart EXCOR Pediatric VAD IDE study investigators. Antithrombotic therapy in a prospective trial of a pediatric ventricular assist device. ASAIO J 2016; 62: 719–727.
26. Moffett, BS, Cabrera, AG, Teruya, J, Bomgaars, L. Anticoagulation therapy trends in children supported by ventricular assist devices: a multi-institutional study. ASAIO J 2014; 60: 211–215.
27. Adachi, I, Kostousov, V, Hensch, L, Chacon-Portillo, MA, Teruya, J. Management of hemostasis for pediatric patients on ventricular-assist devices. Semin Thromb Hemost 2018; 44: 30–37.
28. Rutledge, JM, Chakravarti, S, Massicotte, MP, Buchholz, H, Ross, DB, Joashi, U. Antithrombotic strategies in children receiving long-term Berlin Heart EXCOR ventricular assist device therapy. J Heart Lung Transplant 2013; 32: 569–573.
29. Monagle, P, Chan, AKC, Goldenberg, NA, et al. Antithrombotic therapy in neonates and children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141: e737S–e77801.
30. Stein, ML, Robbins, R, Sabati, AA, et al. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)-defined morbidity and mortality associated with pediatric ventricular assist device support at a single US center: the Stanford experience. Circ Heart Fail 2010; 3: 682–688.
31. Butler, AC, Tait, RC. Restarting anticoagulation in prosthetic heart valve patients after intracranial haemorrhage: a 2-year follow-up. Br J Haematol 1998; 103: 1064–1066.
32. Romualdi, E, Micieli, E, Ageno, W, Squizzato, A. Oral anticoagulant therapy in patients with mechanical heart valve and intracranial haemorrhage. A systematic review. Thromb Haemost 2009; 101: 290–297.
33. Kormos, RL, Teuteberg, JJ, Pagani, FD, et al. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes. J Thorac Cardiovasc Surg 2010; 139: 1316–1324.
34. Lampert, BC, Teuteberg, JJ. Right ventricular failure after left ventricular assist devices. J Heart Lung Transplant 2015; 34: 1123–1130.
35. Klodell, CT Jr, Morey, TE, Lobato, EB, et al. Effect of sildenafil on pulmonary artery pressure, systemic pressure, and nitric oxide utilization in patients with left ventricular assist devices. Ann Thorac Surg 2007; 83: 68–71; discussion 71.
36. Houston, BA, Kalathiya, RJ, Hsu, S, et al. Right ventricular afterload sensitivity dramatically increases after left ventricular assist device implantation: a multi-center hemodynamic analysis. J Heart Lung Transplant 2016; 35: 868–876.
37. Modica, M, Ferratini, M, Torri, A, et al. Quality of life and emotional distress early after left ventricular assist device implant: a mixed-method study. Artif Organs 2015; 39: 220–227.
38. Brouwers, C, Denollet, J, Caliskan, K, et al. Psychological distress in patients with a left ventricular assist device and their partners: an exploratory study. Eur J Cardiovasc Nurs 2015; 14: 53–62.
39. Wildschut, ED, Ahsman, MJ, Houmes, RJ, et al. Pharmacotherapy in neonatal and pediatric extracorporeal membrane oxygenation (ECMO). Curr Drug Metab 2012; 13: 767–777.
40. Wildschut, ED, van Saet, A, Pokorna, P, Ahsman, MJ, Van den Anker, JN, Tibboel, D. The impact of extracorporeal life support and hypothermia on drug disposition in critically ill infants and children. Pediatr Clin North Am 2012; 59: 1183–1204.
41. Harthan, AA, Buckley, KW, Heger, ML, Fortuna, RS, Mays, K. Medication adsorption in to contemporary extracorporeal membrane oxygenator circuits. J Pediatr Pharmacol Ther 2014; 19: 288–295.
42. Shekar, K, Roberts, JA, McDonald, CI, et al. Sequestration of drugs in the circuit may lead to therapeutic failure during extracorporeal membrane oxygenation. Crit Care 2012; 16: R194.
43. Watt, KM, Gonzalez, D, Benjamin, DK Jr, et al. Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation. Antimicrob Agents Chemother 2015; 59: 3935–3943.
44. Jennings, DL, Makowski, CT, Chambers, RM, Lanfear, DE. Dosing of vancomycin in patients with continuous-flow left ventricular assist devices: a clinical pharmacokinetic analysis. Int J Artif Organs 2014; 37: 270–274.
45. Shimamoto, Y, Fukuda, T, Tominari, S, et al. Decreased vancomycin clearance in patients with congestive heart failure. Eur J Clin Pharmacol 2013; 69: 449–457.
46. Heil, EL, Lowery, AV, Thom, KA, Nicolau, DP. Treatment of multidrug-resistant pseudomonas aeruginosa using extended-infusion antimicrobial regimens. Pharmacotherapy 2015; 35: 54–58.
48. Nicasio, AM, Ariano, RE, Zelenitsky, SA, et al. Population pharmacokinetics of high-dose, prolonged-infusion cefepime in adult critically ill patients with ventilator-associated pneumonia. Antimicrob Agents Chemother 2009; 53: 1476–1481.
49. Jennings, DL, Brewer, R, Williams, C. Impact of continuous flow left ventricular assist device on the pharmacodynamic response to warfarin early after implantation. Ann Pharmacother 2012; 46: 1266–1267.
50. Shekar, K, Roberts, JA, McDonald, CI, et al. Protein-bound drugs are prone to sequestration in the extracorporeal membrane oxygenation circuit: results from an ex vivo study. Crit Care 2015; 19: 164.
51. Preston, TJ, Hodge, AB, Riley, JB, Leib-Sargel, C, Nicol, KK. In vitro drug adsorption and plasma free hemoglobin levels associated with hollow fiber oxygenators in the extracorporeal life support (ECLS) circuit. J Extra Corpor Technol 2007; 39: 234–237.
52. Preston, TJ, Ratliff, TM, Gomez, D, et al. Modified surface coatings and their effect on drug adsorption within the extracorporeal life support circuit. J Extra Corpor Technol 2010; 42: 199–202.
56. Anderson, HL 3rd, Coran, AG, Drongowski, RA, Ha, HJ, Bartlett, RH. Extracellular fluid and total body water changes in neonates undergoing extracorporeal membrane oxygenation. J Pediatr Surg 1992; 27: 1003–1007; discussion 1007–1008.
57. Butler, J, Pathi, VL, Paton, RD, et al. Acute-phase responses to cardiopulmonary bypass in children weighing less than 10 kilograms. Ann Thorac Surg 1996; 62: 538–542.
58. Seghaye, MC, Grabitz, RG, Duchateau, J, et al. Inflammatory reaction and capillary leak syndrome related to cardiopulmonary bypass in neonates undergoing cardiac operations. J Thorac Cardiovasc Surg 1996; 112: 687–697.
59. Corry, DC, DeLucia, A 3rd, Zhu, H, et al. Time course of cytokine release and complement activation after implantation of the HeartMate left ventricular assist device. ASAIO J 1998; 44: M347–M351.
60. Petretta, M, Condorelli, GL, Spinelli, L, et al. Circulating levels of cytokines and their site of production in patients with mild to severe chronic heart failure. Am Heart J 2000; 140: E28.
61. Clark, AL, Loebe, M, Potapov, EV, et al. Ventricular assist device in severe heart failure: effects on cytokines, complement and body weight. Eur Heart J 2001; 22: 2275–2283.
62. Caruso, R, Verde, A, Campolo, J, et al. Severity of oxidative stress and inflammatory activation in end-stage heart failure patients are unaltered after 1 month of left ventricular mechanical assistance. Cytokine 2012; 59: 138–144.
63. Slaviero, KA, Clarke, SJ, Rivory, LP. Inflammatory response: an unrecognised source of variability in the pharmacokinetics and pharmacodynamics of cancer chemotherapy. Lancet Oncol 2003; 4: 224–232.
64. Reddy, RC, Goldstein, AH, Pacella, JJ, Cattivera, GR, Clark, RE, Magovern, GJ Sr. End organ function with prolonged nonpulsatile circulatory support. ASAIO J 1995; 41: M547–M551.
65. Russell, SD, Rogers, JG, Milano, CA, et al. Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device. Circulation 2009; 120: 2352–2357.
66. Demirozu, ZT, Etheridge, WB, Radovancevic, R, Frazier, OH. Results of HeartMate II left ventricular assist device implantation on renal function in patients requiring post-implant renal replacement therapy. J Heart Lung Transplant 2011; 30: 182–187.
67. Imamura, T, Kinugawa, K, Shiga, T, et al. Preoperative levels of bilirubin or creatinine adjusted by age can predict their reversibility after implantation of left ventricular assist device. Circ J 2013; 77: 96–104.
68. Imamura, T, Kinugawa, K, Shiga, T, et al. Novel risk scoring system with preoperative objective parameters gives a good prediction of 1-year mortality in patients with a left ventricular assist device. Circ J 2012; 76: 1895–1903.
69. Gonzalez, D, Melloni, C, Yogev, R, et al. Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther 2014; 96: 429–437.
70. Hornik, CP, Wu, H, Edginton, AN, Watt, K, Cohen-Wolkowiez, M, Gonzalez, D. Development of a pediatric physiologically-based pharmacokinetic model of clindamycin using opportunistic pharmacokinetic data. Clin Pharmacokinet 2017; 56: 1343–1353.