When the TAH patient has stabilized and no longer needs to be in the ICU, the patient is transferred to a step-down unit. Certain SynCardia TAH-t patients may be considered for transition to the Freedom® portable driver system (SynCardia Systems, Inc, Tucson, AZ), which was designed to allow TAH-t patients to be discharged home. It has approval from the FDA, Health Canada, and European Union. Weighing approximately 6 kg and packaged in a wearable backpack or bag, the Freedom® portable driver liberates the patient from being tethered to a larger pneumatic console (Figures 7 and 8). The Freedom® portable driver display shows beat rate, left ventricular fill volume, and cardiac output, but only the beat rate may be adjusted.108,109 Preliminary experiences have shown that it is possible to safely discharge a TAH-t patient home with a portable driver, allowing for improved quality of life and potential reduction in medical costs while awaiting heart transplantation.109–111
Despite advancements in the medical management of heart failure, the demand for heart transplantation continues to be a growing burden worldwide. The use of mechanical circulatory support has become more prevalent, and clinician familiarity with devices has become more significant. Several TAHs have been developed over the past 60 years, but currently the SynCardia TAH-t is the only 1 being used. The SynCardia TAH-t has shown that it can be an effective bridge to heart transplantation in patients with biventricular failure. With the Freedom® portable driver, certain TAH-t patients may even be discharged home to wait for a transplant offer as an outpatient. TAH technology will continue to evolve with hope that it may offer a more definitive treatment for patients with heart failure in the near future.
a Arabia F, Gregoric I, Kasirajan V, et al. Total Artificial Heart (TAH): Survival Outcomes, Risk Factors, Adverse Events in Intermacs. Abstract presented at: International Society for Heart and Lung Transplantation 36th Annual Meeting and Scientific Sessions; April 27–30, 2016; Washington, DC. Manuscript in preparation.
1. Mozaffarian D, Benjamin EJ, Go AS, et al; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133:e38–e360.
2. McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J. 1998;19(suppl P):P9–P16.
3. Heidenreich PA, Albert NM, Allen LA, et al; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6:606–619.
4. Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347:1397–1402.
5. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004;292:344–350.
6. Colvin-Adams M, Smith JM, Heubner BM, et al. OPTN/SRTR 2013 annual data report: heart. Am J Transplant. 2015;15(suppl 2):1–28.
7. Dandel M, Krabatsch T, Falk V. Left ventricular vs. biventricular mechanical support: Decision making and strategies for avoidance of right heart failure after left ventricular assist device implantation. Int J Cardiol. 2015;198:241–250.
8. Kormos RL, Teuteberg JJ, Pagani FD, et al; HeartMate II Clinical Investigators. 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.
9. Dang NC, Topkara VK, Mercando M, et al. Right heart failure after left ventricular assist device implantation in patients with chronic congestive heart failure. J Heart Lung Transplant. 2006;25:1–6.
10. Drakos SG, Janicki L, Horne BD, et al. Risk factors predictive of right ventricular failure after left ventricular assist device implantation. Am J Cardiol. 2010;105:1030–1035.
11. Lampert BC, Teuteberg JJ. Right ventricular failure after left ventricular assist devices. J Heart Lung Transplant. 2015;34:1123–1130.
12. Ochiai Y, McCarthy PM, Smedira NG, et al. Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients. Circulation. 2002;106:1198–1202.
13. Patel ND, Weiss ES, Schaffer J, et al. Right heart dysfunction after left ventricular assist device implantation: a comparison of the pulsatile HeartMate I and axial-flow HeartMate II devices. Ann Thorac Surg. 2008;86:832–840.
14. Atluri P, Goldstone AB, Fairman AS, et al. Predicting right ventricular failure in the modern, continuous flow left ventricular assist device era. Ann Thorac Surg. 2013;96:857–863.
15. Meineri M, Van Rensburg AE, Vegas A. Right ventricular failure after LVAD implantation: prevention and treatment. Best Pract Res Clin Anaesthesiol. 2012;26:217–229.
16. Matthews JC, Koelling TM, Pagani FD, Aaronson KD. The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates. J Am Coll Cardiol. 2008;51:2163–2172.
17. Fukamachi K, McCarthy PM, Smedira NG, Vargo RL, Starling RC, Young JB. Preoperative risk factors for right ventricular failure after implantable left ventricular assist device insertion. Ann Thorac Surg. 1999;68:2181–2184.
18. Santambrogio L, Bianchi T, Fuardo M, et al. Right ventricular failure after left ventricular assist device insertion: preoperative risk factors. Interact Cardiovasc Thorac Surg. 2006;5:379–382.
19. Morgan JA, John R, Lee BJ, Oz MC, Naka Y. Is severe right ventricular failure in left ventricular assist device recipients a risk factor for unsuccessful bridging to transplant and post-transplant mortality. Ann Thorac Surg. 2004;77:859–863.
20. Raina A, Seetha Rammohan HR, Gertz ZM, Rame JE, Woo YJ, Kirkpatrick JN. Postoperative right ventricular failure after left ventricular assist device placement is predicted by preoperative echocardiographic structural, hemodynamic, and functional parameters. J Card Fail. 2013;19:16–24.
21. Vivo RP, Cordero-Reyes AM, Qamar U, et al. Increased right-to-left ventricle diameter ratio is a strong predictor of right ventricular failure after left ventricular assist device. J Heart Lung Transplant. 2013;32:792–799.
22. Baumwol J, Macdonald PS, Keogh AM, et al. Right heart failure and ‘failure to thrive’ after left ventricular assist device: clinical predictors and outcomes. J Heart Lung Transplant. 2011;30:888–895.
23. Fitzpatrick JR 3rd, Frederick JR, Hsu VM, et al. Risk score derived from pre-operative data analysis predicts the need for biventricular mechanical circulatory support. J Heart Lung Transplant. 2008;27:1286–1292.
24. Fitzpatrick JR 3rd, Frederick JR, Hiesinger W, et al. Early planned institution of biventricular mechanical circulatory support results in improved outcomes compared with delayed conversion of a left ventricular assist device to a biventricular assist device. J Thorac Cardiovasc Surg. 2009;137:971–977.
25. Stevenson LW, Pagani FD, Young JB, et al. INTERMACS profiles of advanced heart failure: the current picture. J Heart Lung Transplant. 2009;28:535–541.
26. Kirklin JK, Naftel DC, Pagani FD, et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant. 2015;34:1495–1504.
27. Sale SM, Smedira NG. Total artificial heart. Best Pract Res Clin Anaesthesiol. 2012;26:147–165.
28. Gray NA Jr, Selzman CH. Current status of the total artificial heart. Am Heart J. 2006;152:4–10.
29. Arabia FA, Moriguchi JD. Machines versus medication for biventricular heart failure: focus on the total artificial heart. Future Cardiol. 2014;10:593–609.
30. Akutsu T, Kolff WJ. Permanent substitutes for valves and hearts. Trans Am Soc Artif Intern Organs. 1957;4:230.
31. Takatani S. In remembrance of Dr. Tetsuzo Akutsu: a man who started artificial heart research. J Artif Organs. 2008;11:1–3.
32. Debakey ME. The odyssey of the artificial heart. Artif Organs. 2000;24:405–411.
33. Cooley DA. Some thoughts about the historic events that led to the first clinical implantation of a total artificial heart. Tex Heart Inst J. 2013;40:117–119.
34. Cooley DA. Recollections of the early years of heart transplantation and the total artificial heart. Artif Organs. 2011;35:353–357.
35. Cooley DA. The total artificial heart. Nat Med. 2003;9:108–111.
36. Cooley DA, Akutsu T, Norman JC, Serrato MA, Frazier OH. Total artificial heart in two-staged cardiac transplantation. Cardiovasc Dis. 1981;8:305–319.
37. Kolff WJ. Early years of artificial organs at the Cleveland Clinic: Part II: open heart surgery and artificial hearts. ASAIO J. 1998;44:123–128.
38. DeVries WC, Anderson JL, Joyce LD, et al. Clinical use of the total artificial heart. N Engl J Med. 1984;310:273–278.
39. Mohacsi P, Leprince P. The CARMAT total artificial heart. Eur J Cardiothorac Surg. 2014;46:933–934.
40. Carpentier A, Latrémouille C, Cholley B, et al. First clinical use of a bioprosthetic total artificial heart: report of two cases. Lancet. 2015;386:1556–1563.
41. Slepian MJ, Smith RG, Copeland JG. Baughman KL, Baumgartner WA. The SynCardia CardioWest™ total artificial heart. In: Treatment of Advanced Heart Disease. 2006:New York, NY: Taylor and Francis Group; 473–490.
42. Copeland JG, Smith RG, Arabia FA, et al; CardioWest Total Artificial Heart Investigators. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med. 2004;351:859–867.
43. Gaitan BD, Thunberg CA, Stansbury LG, et al. Development, current status, and anesthetic management of the implanted artificial heart. J Cardiothorac Vasc Anesth. 2011;25:1179–1192.
44. Dowling RD, Gray LA Jr, Etoch SW, et al. The AbioCor implantable replacement heart. Ann Thorac Surg. 2003;75:S93–S99.
45. Copeland JG, Smith RG, Arabia FA, et al. Total artificial heart bridge to transplantation: a 9-year experience with 62 patients. J Heart Lung Transplant. 2004;23:823–831.
46. Dowling RD, Etoch SW, Stevens KA, Johnson AC, Gray LA Jr.. Current status of the AbioCor implantable replacement heart. Ann Thorac Surg. 2001;71:S147–S149.
47. Dowling RD, Gray LA Jr, Etoch SW, et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg. 2004;127:131–141.
48. Frazier OH, Dowling RD, Gray LA Jr, Shah NA, Pool T, Gregoric I. The total artificial heart: where we stand. Cardiology. 2004;101:117–121.
49. Arabia FA, Copeland JG, Pavie A, Smith RG. Implantation technique for the CardioWest total artificial heart. Ann Thorac Surg. 1999;68:698–704.
50. Mizuguchi KA, Padera RF Jr, Kowalczyk A, Doran MN, Couper GS, Fox AA. Transesophageal echocardiography imaging of the total artificial heart. Anesth Analg. 2013;117:780–784.
51. Sharma V, Wasowicz M, Brister S, Karski J, Meineri M. Postoperative transesophageal echocardiography diagnosis of inferior vena cava obstruction after mitral valve replacement. Anesth Analg. 2011;113:1343–1346.
52. Fine NM, Gopalan RS, Arabia FA, Kushwaha SS, Chandrasekaran K. Intraoperative transesophageal echocardiographic guidance of total artificial heart implantation. J Heart Lung Transplant. 2014;33:454–457.
53. Obeid AI, Carlson RJ. Evaluation of pulmonary vein stenosis by transesophageal echocardiography. J Am Soc Echocardiogr. 1995;8:888–896.
54. Copeland JG, Copeland H, Gustafson M, et al. Experience with more than 100 total artificial heart implants. J Thorac Cardiovasc Surg. 2012;143:727–734.
55. Kirsch ME, Nguyen A, Mastroianni C, et al. SynCardia temporary total artificial heart as bridge to transplantation: current results at La Pitié Hospital. Ann Thorac Surg. 2013;95:1640–1646.
56. Hermsen JL, Smith JW, Pal JD, et al. Late surgical bleeding following total artificial heart implantation. J Card Surg. 2015;30:771–774.
57. Christenson JT, Maurice J, Simonet F, Velebit V, Schmuziger M. Open chest and delayed sternal closure after cardiac surgery. Eur J Cardiothorac Surg. 1996;10:305–311.
58. Stulak JM, Romans T, Cowger J, et al. Delayed sternal closure does not increase late infection risk in patients undergoing left ventricular assist device implantation. J Heart Lung Transplant. 2012;31:1115–1119.
59. Spiliopoulos S, Autschbach R, Koerfer R, Tenderich G. Delayed sternal closure after total artificial heart implantation. J Thorac Cardiovasc Surg. 2015;150:417–418.
60. Zimmerman H, Coehlo-Anderson R, Slepian M, Smith RG, Sethi G, Copeland JG. Device malfunction of the CardioWest total artificial heart secondary to catheter entrapment of the tricuspid valve. ASAIO J. 2010;56:481–482.
61. El-Banayosy A, Arusoglu L, Morshuis M, et al. CardioWest total artificial heart: Bad Oeynhausen experience. Ann Thorac Surg. 2005;80:548–552.
62. Tayama E, Ueda T, Shojima T, et al. Arginine vasopressin is an ideal drug after cardiac surgery for the management of low systemic vascular resistant hypotension concomitant with pulmonary hypertension. Interact Cardiovasc Thorac Surg. 2007;6:715–719.
63. Currigan DA, Hughes RJ, Wright CE, Angus JA, Soeding PF. Vasoconstrictor responses to vasopressor agents in human pulmonary and radial arteries: an in vitro study. Anesthesiology. 2014;121:930–936.
64. Evora PR, Pearson PJ, Schaff HV. Arginine vasopressin induces endothelium-dependent vasodilatation of the pulmonary artery. V1-receptor-mediated production of nitric oxide. Chest. 1993;103:1241–1245.
65. Wallace AW, Tunin CM, Shoukas AA. Effects of vasopressin on pulmonary and systemic vascular mechanics. Am J Physiol. 1989;257:H1228–H1234.
66. Holmes CL, Landry DW, Granton JT. Science review: vasopressin and the cardiovascular system part 2—clinical physiology. Crit Care. 2004;8:15–23.
67. Hoeper MM, Granton J. Intensive care unit management of patients with severe pulmonary hypertension and right heart failure. Am J Respir Crit Care Med. 2011;184:1114–1124.
68. Kerbaul F, Rondelet B, Motte S, et al. Effects of norepinephrine and dobutamine on pressure load-induced right ventricular failure. Crit Care Med. 2004;32:1035–1040.
69. Price LC, Wort SJ, Finney SJ, Marino PS, Brett SJ. Pulmonary vascular and right ventricular dysfunction in adult critical care: current and emerging options for management: a systematic literature review. Crit Care. 2010;14:R169.
70. Kwak YL, Lee CS, Park YH, Hong YW. The effect of phenylephrine and norepinephrine in patients with chronic pulmonary hypertension*. Anaesthesia. 2002;57:9–14
71. Torregrossa G, Morshuis M, Varghese R, et al. Results with SynCardia total artificial heart beyond 1 year. ASAIO J. 2014;60:626–634.
72. Leprince P, Bonnet N, Rama A, et al. Bridge to transplantation with the Jarvik-7 (CardioWest) total artificial heart: a single-center 15-year experience. J Heart Lung Transplant. 2003;22:1296–1303.
73. Parker MS, Fahrner LJ, Deuell BP, et al. Total artificial heart implantation: clinical indications, expected postoperative imaging findings, and recognition of complications. AJR Am J Roentgenol. 2014;202:W191–W201.
74. Shoham AB, Patel B, Arabia FA, Murray MJ. Mechanical ventilation and the total artificial heart: optimal ventilator trigger to avoid post-operative autocycling—a case series and literature review. J Cardiothorac Surg. 2010;5:39.
75. Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R; CDC; Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care–associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep. 2004;53:1–36.
76. Chen HH, Burnett JC. Natriuretic peptides in the pathophysiology of congestive heart failure. Curr Cardiol Rep. 2000;2:198–205.
77. Cho Y, Somer BG, Amatya A. Natriuretic peptides and their therapeutic potential. Heart Dis. 1999;1:305–328.
78. de Lemos JA, McGuire DK, Drazner MH. B-type natriuretic peptide in cardiovascular disease. Lancet. 2003;362:316–322.
79. Egom EE, Feridooni T, Hotchkiss A, Kruzliak P, Pasumarthi KB. Mechanisms of renal hyporesponsiveness to BNP in heart failure. Can J Physiol Pharmacol. 2015;93:399–403.
80. Delgado R 3rd, Wadia Y, Kar B, et al. Role of B-type natriuretic peptide and effect of nesiritide after total cardiac replacement with the AbioCor total artificial heart. J Heart Lung Transplant. 2005;24:1166–1170.
81. Shah KB, Tang DG, Kasirajan V, Gunnerson KJ, Hess ML, Sica DA. Impact of low-dose B-type natriuretic peptide infusion on urine output after total artificial heart implantation. J Heart Lung Transplant. 2012;31:670–672.
82. Spiliopoulos S, Guersoy D, Koerfer R, Tenderich G. B-type natriuretic peptide therapy in total artificial heart implantation: renal effects with early initiation. J Heart Lung Transplant. 2014;33:662–663.
83. Starling RC, Moazami N, Silvestry SC, et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014;370:33–40.
84. Kirklin JK, Naftel DC, Kormos RL, et al. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2014;33:12–22
85. Uriel N, Han J, Morrison KA, et al. Device thrombosis in HeartMate II continuous-flow left ventricular assist devices: a multifactorial phenomenon. J Heart Lung Transplant. 2014;33:51–59.
86. Park SJ, Milano CA, Tatooles AJ, et al; HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5:241–248.
87. Stulak JM, Sharma S, Maltais S. Management of pump thrombosis in patients with left ventricular assist devices. Am J Cardiovasc Drugs. 2015;15:89–94.
88. Roussel JC, Sénage T, Baron O, et al. CardioWest (Jarvik) total artificial heart: a single-center experience with 42 patients. Ann Thorac Surg. 2009;87:124–129.
89. Harvey L, Holley C, Roy SS, et al. Stroke after left ventricular assist device implantation: outcomes in the continuous-flow era. Ann Thorac Surg. 2015;100:535–541.
90. Slaughter MS, Rogers JG, Milano CA, et al; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241–2251.
91. Starling RC, Naka Y, Boyle AJ, et al. Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2011;57:1890–1898.
92. Boyle AJ, Russell SD, Teuteberg JJ, et al. Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation. J Heart Lung Transplant. 2009;28:881–887.
93. Boyle AJ, Jorde UP, Sun B, et al; HeartMate II Clinical Investigators. Pre-operative risk factors of bleeding and stroke during left ventricular assist device support: an analysis of more than 900 HeartMate II outpatients. J Am Coll Cardiol. 2014;63:880–888.
94. Copeland J, Copeland H, Nolan P, Gustafson M, Slepian M, Smith R. Results with an anticoagulation protocol in 99 SynCardia total artificial heart recipients. ASAIO J. 2013;59:216–220.
95. Kirsch M, Mazzucotelli JP, Roussel JC, et al; Groupe de Réflexion sur l’Assistance Mécanique. Survival after biventricular mechanical circulatory support: does the type of device matter? J Heart Lung Transplant. 2012;31:501–508.
96. Ensor CR, Cahoon WD, Crouch MA, et al. Antithrombotic therapy for the CardioWest temporary total artificial heart. Tex Heart Inst J. 2010;37:149–158.
97. Szefner J. Control and treatment of hemostasis in cardiovascular surgery. The experience of La Pitié Hospital with patients on total artificial heart. Int J Artif Organs. 1995;18:633–648.
98. Warkentin TE, Greinacher A. Heparin-induced thrombocytopenia and cardiac surgery. Ann Thorac Surg. 2003;76:2121–2131.
99. Koster A, Huebler S, Potapov E, et al. Impact of heparin-induced thrombocytopenia on outcome in patients with ventricular assist device support: single-institution experience in 358 consecutive patients. Ann Thorac Surg. 2007;83:72–76.
100. Schenk S, El-Banayosy A, Prohaska W, et al. Heparin-induced thrombocytopenia in patients receiving mechanical circulatory support. J Thorac Cardiovasc Surg. 2006;131:1373–1381.e4.
101. Warkentin TE, Greinacher A, Koster A. Heparin-induced thrombocytopenia in patients with ventricular assist devices: are new prevention strategies required? Ann Thorac Surg. 2009;87:1633–1640.
102. Crouch MA, Kasirajan V, Cahoon W, Katlaps GJ, Gunnerson KJ. Successful use and dosing of bivalirudin after temporary total artificial heart implantation: a case series. Pharmacotherapy. 2008;28:1413–1420.
103. Samuels LE, Kohout J, Casanova-Ghosh E, et al. Argatroban as a primary or secondary postoperative anticoagulant in patients implanted with ventricular assist devices. Ann Thorac Surg. 2008;85:1651–1655.
104. Pappalardo F, Scandroglio AM, Potapov E, et al. Argatroban anticoagulation for heparin induced thrombocytopenia in patients with ventricular assist devices. Minerva Anestesiol. 2012;78:330–335.
105. Yasuda T, Shimokasa K, Funakubo A, Higami T, Kawamura T, Fukui Y. An investigation of blood flow behavior and hemolysis in artificial organs. ASAIO J. 2000;46:527–531.
106. Mankad AK, Tang DG, Clark WB, et al. Persistent anemia after implantation of the total artificial heart. J Card Fail. 2012;18:433–438.
107. Arabía FA, Copeland JG, Smith RG, et al. Infections with the CardioWest total artificial heart. ASAIO J. 1998;44:M336–M339.
108. Jaroszewski DE, Anderson EM, Pierce CN, Arabia FA. The SynCardia freedom driver: a portable driver for discharge home with the total artificial heart. J Heart Lung Transplant. 2011;30:844–845.
109. Friedline K, Hassinger P. Total artificial heart freedom driver in a patient with end-stage biventricular heart failure. AANA J. 2012;80:105–112.
110. Quader MA, Green AJ, Shah KB, Cooke R, Kasirajan V. Hospital readmissions after discharge to home with the Total Artificial Heart Freedom driver: readmission reasons, clinical outcomes, and health care costs. J Heart Lung Transplant. 2016;35:251–252.
111. Demondion P, Fournel L, Niculescu M, Pavie A, Leprince P. The challenge of home discharge with a total artificial heart: the La Pitie Salpetriere experience. Eur J Cardiothorac Surg. 2013;44:843–848.