Download A portable driver for discharge home with the total

http://www.jhltonline.org
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
This posting is valid until Sept. 19, 2011
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
This posting is valid until Sept. 19, 2011
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