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The SynCardia freedom driver: A portable driver for discharge home with the total artificial heart
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COMMENT AND OPINION The SynCardia freedom driver: A portable driver for discharge home with the total artificial heart Dawn E. Jaroszewski, MD, MBA, Eric M. Anderson, BSE, Christopher N. Pierce, MS, CCP, and Francisco A. Arabia, MD, MBA Division of Cardiothoracic Surgery, Department of Surgery, Mayo Clinic Arizona, Phoenix, Arizona
In March 2010, the U.S. Food and Drug Administration approved the SynCardia Freedom Driver (SynCardia Systems Inc, Tucson, AZ) for an investigational device exemption study. We report the first use in our institution of the SynCardia temporary total artificial heart (TAH-t) Freedom Driver in a 41-year-old African American man (body surface area, 2.1 m2) 12 years after he underwent orthotopic heart transplant for anti-cardiolipin antibody-related thrombotic infarction. The patient presented with irreversible cardiogenic shock, and the TAH-t was implanted.1 Because of high antibody levels, he was hospitalized without a suitable donor for 83 weeks until he became the first patient in our institution to receive Freedom Driver implantation. Performance was good, including his ability to perform more than 7 minutes on the treadmill using a modified Bruce protocol. After a brief interruption due to software issues, he was discharged home on the portable driver. After 865 days on TAH-t support, the patient received a dual heart-kidney transplant and is home doing well. To date, 6 patients have been successfully transferred to the Freedom Driver at our institution while awaiting transplantation. The Freedom Driver is a 13-lb, piston-driven pneumatic compressor that delivers regulated pressures and vacuum (–10 mm Hg) to the TAH-t drivelines (Figure 1). The only clinically adjustable parameter is the beat rate, which is set to allow for partial filling of the ventricles and is calculated before the Freedom Driver is attached to the patient (125 ⫾ 15 beats/min). The TAH-t exhibits a Frank-Starling–like response to increase cardiac output for increased physical needs. Right and left ventricular filling and ejection (diastole and systole) are synchronized. Electric motors drive the piston and provide backup redundancy. Lithium batteries are charged in the driver when the patient plugs into normal power outlets or into a car auxiliary power plug, with a 3-hour battery life. All potential recipients with impending death in the absence of a suitable donor heart are candidates for TAH-t.2,3 TAH-t use has been limited by the large operating console
Figure 1 Photograph shows the Freedom Driver connected to the temporary total artificial heart (TAT-t; SynCardia Systems Inc, Tucson, AZ).
for the driver system that requires patients to remain hospitalized until transplantation. The Freedom Driver allows clinically stable patients to await a donor heart as an outpatient. United Network of Organ Sharing has designated these patients as IB status upon discharge from the hospital. Downlisting remains controversial due to the difference of potential survivability at home between the failure of a ventricular assist device vs the TAH-t, which would be uniformly fatal. Outcomes for TAH-t patients out of the hospital will give us a better idea of risks as an outpatient and ways to mitigate these risks while improving the patient’s quality of life and reducing the medical costs of hospitalization. Patient selection is critical, and the ability to deal with the complexities of the device is essential to preventing complications. The success of our first patient to be discharged home and then undergo transplantation is encouraging. Out-of-hospital management of the patient with a TAH-t appears feasible, and consideration for use of this device for longer-term applications may be held in the future.
Disclosure statement No funding was received for this manuscript by SynCardia Systems Inc, nor was SynCardia Systems Inc involved in the manuscript. Dr Arabia is a consultant for SynCardia Systems Inc. Dr Jaroszewski is the primary investigator for Mayo Clinic Arizona and the SynCardia Freedom Driver. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.
1053-2498/$ -see front matter © 2011 International Society for Heart and Lung Transplantation. All rights reserved. doi:10.1016/j.healun.2011.03.014
Comment and Opinion
References 1. Arabia FA, Copeland JG, Pavie A, Smith RG. Implantation technique for the CardioWest total artificial heart. Ann Thorac Surg 1999;68:698704. 2. El-Banayosy A, Arusoglu A, Morshuis M, et al. CardioWest total artificial heart: Bad Oeynhausen experience. Ann Thorac Surg 2005; 80:548-52. 3. Copeland JG, Smith RG, Arabia FA, et al. Cardiac Replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004;351:859-67.
A European first: Successful heart transplant in a human immunodeficiency virus–positive recipient Emanuele Durante-Mangoni, MD, PhD,a Ciro Maiello, MD,b and Costanza Sbreglia, MDc Units of a Internal Medicine and Transplants and bCardiac Surgery and Heart Transplants, 2nd University of Naples Medical School and Azienda Ospedaliera di Rilievo Nazionale, “V. Monaldi;” cDivision of Infectious and Immune Diseases, A.O. “D. Cotugno” Napoli, Italy
Advanced heart failure is increasingly recognized in individuals infected with human immunodeficiency virus (HIV) as anti-retroviral therapy (ART) continues to prolong their life.1 Since a favorable outcome was observed after kidney or liver transplant,2 selected HIV-infected patients fulfilling strict virologic and clinical criteria have recently undergone transplantation in the United States.3 In this report, we describe a heart transplant procedure in an HIVinfected patient performed in Europe. In January 2005, a 32 year-old-man was diagnosed with Centers for Disease Control and Prevention (CDC) A2/ World Health Organization (WHO) stage 1 HIV infection, with an HIV-RNA load of 6,900 IU/ml and CD4⫹ T lymphocytes at 480 cells/l. He was treated with zidovudine, lamivudine, and efavirenz. HIV-RNA cleared rapidly, with a durable restoration of his CD4⫹ cell count. At 2 years after starting ART, non-ischemic dilated cardiomyopathy developed, progressive worsening of cardiac structure and function occurred despite standard medical treatment and implantation of a biventricular defibrillator. He was referred to our hospital’s heart transplant service in June 2009 for further evaluation, which revealed severe, partly reversible pre-capillary pulmonary hypertension and a low cardiac index. A destination artificial heart was deemed unethical due to the patient’s young age and absence of significant pulmonary, renal, hepatic disorders, or overt neoplasia. The patient appeared to fulfill all existing requirements of the Italian National Transplant Center for wait listing of potential HIV-positive kidney and liver recipients. Indeed, his HIV-RNA had been undetectable throughout the previous 4 years, his CD4⫹ cell counts were within normal reference ranges, and he had never experienced any acquired immunodeficiency syndrome-defining illness or opportunistic infection. A decision was therefore made to proceed with heart transplantation. A standard immune suppressive protocol was begun after transplant, including anti-thymocyte globulin induction plus high-dose methylprednisolone, followed by oral cyclospor-
845 ine, everolimus, and prednisone. The previously effective ART was maintained without changes, despite interference between efavirenz and everolimus. Prophylaxis with cotrimoxazole was started. The patient’s early post-transplant course was uneventful, and he was discharged after 12 days. Increased doses of everolimus were needed for maintenance. No reactivation of cytomegalovirus or Epstein-Barr virus replication was detected. Serum levels of cholesterol and triglycerides were managed pharmacologically. At 4 months after the transplant, the patient experienced a grade 2R acute cellular rejection that was responsive to methylprednisolone pulse therapy. There were no infectious or neoplastic complications at 18 months. Our clinical experience seems to confirm that today, heart transplant may be contemplated among viable therapeutic options in carefully selected HIV-infected patients who show undetectable viral load, a CD4⫹ cell count within normal reference ranges, and no history of opportunistic infections.3
Disclosure statement This work was supported by the Azienda Ospedaliera di Rilievo Nazionale ‘V. Monaldi,’ Naples, Italy. None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose. The authors thank Maurizio Cotrufo, MD, Paolo A. Grossi, MD, and Alessandro Perrella, MD, PhD, for their support and valuable comments on the manuscript.
References 1. Barbaro G, Di Lorenzo G, Grisorio B, Barbarini G. Cardiac involvement in the acquired immunodeficiency syndrome: a multicenter clinical-pathological study. Gruppo Italiano per lo Studio Cardiologico dei pazienti affetti da AIDS Investigators. AIDS Res Hum Retroviruses 1998;14:1071-7. 2. Roland ME, Barin B, Carlson L, et al. HIV-infected liver and kidney transplant recipients: 1- and 3-year outcomes. Am J Transplant 2008; 8:355-65. 3. Uriel N, Jorde UP, Cotarlan V, et al. Heart transplantation in human immunodeficiency virus-positive patients. J Heart Lung Transplant 2009;28:667-9.
Clinical report of long-term support with dual Jarvik 2000 biventricular assist device Shunsuke Saito, MD, Taichi Sakaguchi, MD, and Yoshiki Sawa, MD Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
We report the successful implantation of dual Jarvik 2000 biventricular assist devices (BiVAD; Jarvik Heart Inc, New York, NY). A 27-year-old woman with arrhythmogenic right ventricular (RV) cardiomyopathy was referred to our hospital and approved for heart transplantation. Her body size was small (body surface area, 1.38 m2) due to cardiac cachexia. Her left ventricular (LV) ejection fraction
COMMENT AND OPINION The SynCardia freedom driver: A portable driver for discharge home with the total artificial heart Dawn E. Jaroszewski, MD, MBA, Eric M. Anderson, BSE, Christopher N. Pierce, MS, CCP, and Francisco A. Arabia, MD, MBA Division of Cardiothoracic Surgery, Department of Surgery, Mayo Clinic Arizona, Phoenix, Arizona
In March 2010, the U.S. Food and Drug Administration approved the SynCardia Freedom Driver (SynCardia Systems Inc, Tucson, AZ) for an investigational device exemption study. We report the first use in our institution of the SynCardia temporary total artificial heart (TAH-t) Freedom Driver in a 41-year-old African American man (body surface area, 2.1 m2) 12 years after he underwent orthotopic heart transplant for anti-cardiolipin antibody-related thrombotic infarction. The patient presented with irreversible cardiogenic shock, and the TAH-t was implanted.1 Because of high antibody levels, he was hospitalized without a suitable donor for 83 weeks until he became the first patient in our institution to receive Freedom Driver implantation. Performance was good, including his ability to perform more than 7 minutes on the treadmill using a modified Bruce protocol. After a brief interruption due to software issues, he was discharged home on the portable driver. After 865 days on TAH-t support, the patient received a dual heart-kidney transplant and is home doing well. To date, 6 patients have been successfully transferred to the Freedom Driver at our institution while awaiting transplantation. The Freedom Driver is a 13-lb, piston-driven pneumatic compressor that delivers regulated pressures and vacuum (–10 mm Hg) to the TAH-t drivelines (Figure 1). The only clinically adjustable parameter is the beat rate, which is set to allow for partial filling of the ventricles and is calculated before the Freedom Driver is attached to the patient (125 ⫾ 15 beats/min). The TAH-t exhibits a Frank-Starling–like response to increase cardiac output for increased physical needs. Right and left ventricular filling and ejection (diastole and systole) are synchronized. Electric motors drive the piston and provide backup redundancy. Lithium batteries are charged in the driver when the patient plugs into normal power outlets or into a car auxiliary power plug, with a 3-hour battery life. All potential recipients with impending death in the absence of a suitable donor heart are candidates for TAH-t.2,3 TAH-t use has been limited by the large operating console
Figure 1 Photograph shows the Freedom Driver connected to the temporary total artificial heart (TAT-t; SynCardia Systems Inc, Tucson, AZ).
for the driver system that requires patients to remain hospitalized until transplantation. The Freedom Driver allows clinically stable patients to await a donor heart as an outpatient. United Network of Organ Sharing has designated these patients as IB status upon discharge from the hospital. Downlisting remains controversial due to the difference of potential survivability at home between the failure of a ventricular assist device vs the TAH-t, which would be uniformly fatal. Outcomes for TAH-t patients out of the hospital will give us a better idea of risks as an outpatient and ways to mitigate these risks while improving the patient’s quality of life and reducing the medical costs of hospitalization. Patient selection is critical, and the ability to deal with the complexities of the device is essential to preventing complications. The success of our first patient to be discharged home and then undergo transplantation is encouraging. Out-of-hospital management of the patient with a TAH-t appears feasible, and consideration for use of this device for longer-term applications may be held in the future.
Disclosure statement No funding was received for this manuscript by SynCardia Systems Inc, nor was SynCardia Systems Inc involved in the manuscript. Dr Arabia is a consultant for SynCardia Systems Inc. Dr Jaroszewski is the primary investigator for Mayo Clinic Arizona and the SynCardia Freedom Driver. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.
1053-2498/$ -see front matter © 2011 International Society for Heart and Lung Transplantation. All rights reserved. doi:10.1016/j.healun.2011.03.014
Comment and Opinion
References 1. Arabia FA, Copeland JG, Pavie A, Smith RG. Implantation technique for the CardioWest total artificial heart. Ann Thorac Surg 1999;68:698704. 2. El-Banayosy A, Arusoglu A, Morshuis M, et al. CardioWest total artificial heart: Bad Oeynhausen experience. Ann Thorac Surg 2005; 80:548-52. 3. Copeland JG, Smith RG, Arabia FA, et al. Cardiac Replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004;351:859-67.
A European first: Successful heart transplant in a human immunodeficiency virus–positive recipient Emanuele Durante-Mangoni, MD, PhD,a Ciro Maiello, MD,b and Costanza Sbreglia, MDc Units of a Internal Medicine and Transplants and bCardiac Surgery and Heart Transplants, 2nd University of Naples Medical School and Azienda Ospedaliera di Rilievo Nazionale, “V. Monaldi;” cDivision of Infectious and Immune Diseases, A.O. “D. Cotugno” Napoli, Italy
Advanced heart failure is increasingly recognized in individuals infected with human immunodeficiency virus (HIV) as anti-retroviral therapy (ART) continues to prolong their life.1 Since a favorable outcome was observed after kidney or liver transplant,2 selected HIV-infected patients fulfilling strict virologic and clinical criteria have recently undergone transplantation in the United States.3 In this report, we describe a heart transplant procedure in an HIVinfected patient performed in Europe. In January 2005, a 32 year-old-man was diagnosed with Centers for Disease Control and Prevention (CDC) A2/ World Health Organization (WHO) stage 1 HIV infection, with an HIV-RNA load of 6,900 IU/ml and CD4⫹ T lymphocytes at 480 cells/l. He was treated with zidovudine, lamivudine, and efavirenz. HIV-RNA cleared rapidly, with a durable restoration of his CD4⫹ cell count. At 2 years after starting ART, non-ischemic dilated cardiomyopathy developed, progressive worsening of cardiac structure and function occurred despite standard medical treatment and implantation of a biventricular defibrillator. He was referred to our hospital’s heart transplant service in June 2009 for further evaluation, which revealed severe, partly reversible pre-capillary pulmonary hypertension and a low cardiac index. A destination artificial heart was deemed unethical due to the patient’s young age and absence of significant pulmonary, renal, hepatic disorders, or overt neoplasia. The patient appeared to fulfill all existing requirements of the Italian National Transplant Center for wait listing of potential HIV-positive kidney and liver recipients. Indeed, his HIV-RNA had been undetectable throughout the previous 4 years, his CD4⫹ cell counts were within normal reference ranges, and he had never experienced any acquired immunodeficiency syndrome-defining illness or opportunistic infection. A decision was therefore made to proceed with heart transplantation. A standard immune suppressive protocol was begun after transplant, including anti-thymocyte globulin induction plus high-dose methylprednisolone, followed by oral cyclospor-
845 ine, everolimus, and prednisone. The previously effective ART was maintained without changes, despite interference between efavirenz and everolimus. Prophylaxis with cotrimoxazole was started. The patient’s early post-transplant course was uneventful, and he was discharged after 12 days. Increased doses of everolimus were needed for maintenance. No reactivation of cytomegalovirus or Epstein-Barr virus replication was detected. Serum levels of cholesterol and triglycerides were managed pharmacologically. At 4 months after the transplant, the patient experienced a grade 2R acute cellular rejection that was responsive to methylprednisolone pulse therapy. There were no infectious or neoplastic complications at 18 months. Our clinical experience seems to confirm that today, heart transplant may be contemplated among viable therapeutic options in carefully selected HIV-infected patients who show undetectable viral load, a CD4⫹ cell count within normal reference ranges, and no history of opportunistic infections.3
Disclosure statement This work was supported by the Azienda Ospedaliera di Rilievo Nazionale ‘V. Monaldi,’ Naples, Italy. None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose. The authors thank Maurizio Cotrufo, MD, Paolo A. Grossi, MD, and Alessandro Perrella, MD, PhD, for their support and valuable comments on the manuscript.
References 1. Barbaro G, Di Lorenzo G, Grisorio B, Barbarini G. Cardiac involvement in the acquired immunodeficiency syndrome: a multicenter clinical-pathological study. Gruppo Italiano per lo Studio Cardiologico dei pazienti affetti da AIDS Investigators. AIDS Res Hum Retroviruses 1998;14:1071-7. 2. Roland ME, Barin B, Carlson L, et al. HIV-infected liver and kidney transplant recipients: 1- and 3-year outcomes. Am J Transplant 2008; 8:355-65. 3. Uriel N, Jorde UP, Cotarlan V, et al. Heart transplantation in human immunodeficiency virus-positive patients. J Heart Lung Transplant 2009;28:667-9.
Clinical report of long-term support with dual Jarvik 2000 biventricular assist device Shunsuke Saito, MD, Taichi Sakaguchi, MD, and Yoshiki Sawa, MD Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
We report the successful implantation of dual Jarvik 2000 biventricular assist devices (BiVAD; Jarvik Heart Inc, New York, NY). A 27-year-old woman with arrhythmogenic right ventricular (RV) cardiomyopathy was referred to our hospital and approved for heart transplantation. Her body size was small (body surface area, 1.38 m2) due to cardiac cachexia. Her left ventricular (LV) ejection fraction