Initial experience with the AbioCor implantable replacement heart system (original) (raw)
Related papers
The AbioCor implantable replacement heart
Annals of Thoracic Surgery, 2003
The AbioCor implantable replacement heart http://ats.ctsnetjournals.org/cgi/content/full/75/6\_suppl/S93 located on the World Wide Web at:
1623: Common Hurdles in the Postoperative Management of a Patient with a Total Artificial Heart
Critical Care Medicine, 2016
Learning Objectives: Cardiac replacement with a total artificial heart (TAH) is increasingly being used for patients with biventricular failure. We describe the use of a TAH in a patient with severe biventricular failure from Loeffler endocarditis and highlight these patients’ perioperative management. Methods: A previously healthy 20-year old male with acute-onset, severe biventricular failure attributable to hypereosinophilic syndrome and Loeffler’s endocarditis was considered ineligible for isolated heart transplant due to severe pHTN. Notable echocardiography findings included left apical and ventricular thrombi. His condition worsened rapidly despite aggressive medical management, and due to the aggressive nature of his disease, a SynCardia TAH was placed. He made a largely uneventful recovery and was ambulating by post-implantation day 6. Oliguria was combated with supplementation of brain natriuretic peptide (BNP), and pulmonary pressures monitored by CardioMEMS. Results: Loe...
Temporary and permanent left ventricular bypass: Laboratory and clinical observations
World Journal of Surgery, 1985
Temporary circulatory support with a pneumatic, axisymmetric, paracorporeal ventricular assist device (VAD) has been undertaken in 22 postcardiotomy patients. During VAD function, 9 patients demonstrated hemodynamic improvement (group I), and eventually, 8 of these stabilized sufficiently to permit device removal. Three remain alive and well up to 5 years postoperatively. The clinical course of 13 others (group II) was complicated by severe postoperative bleeding and abnormalities in renal function, leading to lack of hemodynamic improvement and death. In group I, the duration of cardiopulmonary bypass (CPB) ranged from 4.3 to 9.0 hr (mean 6.0 hr), and in group II, from 3.7 to 10.0 hr (mean 5.9 hr). The duration of VAD function was 125 hr (mean) in group I, and 25 hr (mean) in group II. Major hematologic abnormalities (secondary to prolonged CPB) included thrombocytopenia, abnormal platelet function studies, severe hypofibrinogenemia, and low levels of fibrinogen/fibrin degradation products. Efforts to develop a permanent, electrically powered ventricular assist system (VAS) for patients with irreversible cardiomyopathy and end-stage coronary artery disease are also progressing. In a recent series of animal experiments, 2 components of the VAS, an electromechanical energy converter and pusher-plate blood pump (stroke volume 85 ml) were evaluated (9 calves, 30–149 days). The bloodcontacting surfaces of the device consisted of textured fibrils to attract a fibrin coagulum. Conversion of this layer to a collagenous membrane was achieved by preliminary seeding of the pump with cultured, bovine fetal fibroblasts (5 calves). These were compared with 4 non-cell-seeded devices (controls), and functioned for longer periods without thromboembolic complications. Une assistance circulatoire temporaire a été mise en place chez 22 malades après chirurgie cardiaque en utilisant une pompe d'assistance ventriculaire paracorporelle pneumatique. Pendant le fonctionnement de cette assistance ventriculaire, 9 malades ont eu une amélioration hémodynamique (groupe I) dont 8 ont eu une stabilisation hémodynamique suffisante pour permettre d'arrêter l'assistance; 3 ont survécu et vont bien plus de 5 ans après l'intervention. L'évolution clinique de 13 autres malades (groupe II) a été compliquée par des hémorragies postopératoires abondantes, et des altérations de la fonction rénale entrainant une détérioration de l'hémodynamique et le décès. Pour les malades du groupe I, la durée de circulation extra-corporelle (en heure) allait de 4.3 à 9.0 (moyenne 6) et pour les malades du groupe II, de 3.7 à 10.0 (moyenne 5.9). La durée de l'assistance ventriculaire a été de 125 heures en moyenne pour le groupe I et de 25 heures en moyenne pour le groupe II. Les complications hématologiques (les plus graves dûes à une circulation extra-corporelle prolongée) furent des thrombocytopénies, des fonctions plaquettaires anormales, une diminution marquée du taux de fibrinogène et des produits de dégradation du fibrinogène. Des efforts pour développer un système d'assistance ventriculaire permanente, à energie électrique, pour les malades ayant des cardiomyopathies irreversibles et des coronaropathies au stade terminal, ont été tentés. Dans une série récente d'expérimentation animale, deux composantes de l'assistance ventriculaire: convertisseur d'energie electromécanique et pompe pulsée (de volume d'éjection 85 ml/s) ont été étudiées chez 9 veaux (30 à 149 jours). Les éléments en contact avec le sang de la pompe d'assistance furent recouverts d'un textile fibrillaire pour faciliter un dépôt de fibrine et la transformation de cette paroi en une membrane collagène fut réalisée par mise en culture sur la paroi de fibroblastes foetaux d'origine bovine (5 veaux). Ces pompes qui ont été comparées avec 4 pompes sans mise en place de culture cellulaire sur la paroi (à type de témoin) ont fonctionné pendant des durées plus importantes sans complication thrombo-embolique. El soporte circulatorio temporal ha sido emprendido en 22 pacientes post-cardiotomía mediante un sistema de asistencia mecánica ventricular (AMV) paracorpórea de tipo neumático interpuesto entre el apex del ventrículo izquierdo y la aorta. Durante la AMV, 9 pacientes demostraron mejoría hemodinámica (grupo I) y eventualmente 8 de estos lograron suficiente estabilidad para permitir la remoción del sistema. Tres continuaron vivos y en buenas condiciones hasta 5 años después de la operación. La evaluación clínica de los otros 13 (grupo II) resultó complicada por hemorragia postoperatoria severa y alteraciones en la función renal, lo cual, al impedir mejoría hemodinámica, resultó en defunción. En el grupo I la duración de la perfusión cardiopulmonar extracorpórea osciló entre 4.3 y 9.0 (promedio 6.0) horas, y en el grupo II entre 3.7 y 10.0 (promedio 5.9) horas. La duración de la AMV fué de 125 horas (promedio) en el grupo I, y de 25 horas (promedio) en el grupo II. Las alteraciones hematológicas mayores (secundarias a perfusión cardiopulmonar prolongada) incluyeron trombocitopenia, función plaquetaria anormal, hipofibrinogenia severa y bajos niveles de productos de degradación de fibrinógeno/fibrina. Los esfuerzos para desarrollar sistemas de asistencia ventricular (SAV) accionados eléctricamente para uso en pacientes con cardiomiopatía irreversible y con enfermedad coronaria terminal también están progresando. En una reciente serie de experimentos en animales, dos componentes de los SAV, un convertidor electromecánico de energía y una bomba de pistón de disco (volumen de eyección de 85 ml) fueron evaluados (9 terneros, 30–149 días). Las superficies de contacto sanguíneo del sistema son de fibrilla tejida para atraer un coágulo de fibrina. La conversión de esta capa a una membrana colagenosa fué lograda mediante la siembra preliminar de la bomba con fibroblastos bovinos fetales cultivados (5 terneros). Estos fueron comparados con 4 sistemas no sembrados con células (controles) y se encontró que funcionaron por períodos más prolongados y libres de complicaciones tromboembólicas.
A bioprosthetic total artificial heart for end-stage heart failure: Results from a pilot study
The Journal of Heart and Lung Transplantation, 2017
BACKGROUND: The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. METHODS: Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. RESULTS: Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. CONCLUSIONS: Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study.
A bioprosthetic Total Artificial Heart for end-stage heart failure: results from the pilot study
The Journal of Heart and Lung Transplantation
BACKGROUND: The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. METHODS: Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. RESULTS: Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. CONCLUSIONS: Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study.
European Journal of Cardio-Thoracic Surgery, 1997
Objecti6e: To evaluate retrospectively the effect of 'high-dose' aprotinin on blood losses, donor blood requirements and morbid events on patients undergoing ascending aorta and/or aortic arch procedures with the employ of deep hypothermic circulatory arrest (HCA). Methods: During the period 1987-1994, 39 patients underwent a thoracic aorta procedure with the employ of circulatory arrest; of these 18 (46.2%) were operated on during the period 1990-1994 and were given aprotinin intraoperatively following the 'high-dose' protocol (group I), while 21 (53.8%) who underwent surgery during the years 1987-1989, did not receive intraoperative aprotinin and served as historical controls (group II). Twenty-seven (69.2%) patients were male, 18 (46.2%) were operated on on an emergency basis, 15 (38.5%) were acute type A dissections, and two (5.1%) were redo-operations. Circulatory arrest times were not significantly different between the two groups (40 9 4 (S.E.) group I vs. 43 9 4 min group II, P =0.62) likewise cardiopulmonary bypass (CPB) times (181 9 9 vs. 201 9 20 mm, P= 0.74) and the amount of heparin administered (32 0569 1435 vs. 31 69191935 IU, P= 0.56). Results: Postoperative blood loss was comparable between the two groups (1213 9243 (median 850) group I vs. 1528 9 377 (median 880) ml group II, P= 0.87), as well as the number of units of donor blood transfused (9.4 93.0 (median 6) vs. 9.9 9 3.6, (median 5) P= 0.87), and revisions for bleeding (2/18, 11.1% vs. 3/21, 14.3%, P=0.77). In-hospital mortality rate was not statistically different (5/18, 27.7% group I vs. 6/21, 28.6% group II, P = 0.92). There were no significant differences between the two groups in myocardial infarction (2/18, 11.1% vs. 0/21, 0%, P =0.21), and postoperative renal failure rates (3/18, 16.7% vs. 2/21, 9.5%, P= 0.65). On the other hand, there was a trend towards an increased incidence of permanent neurological deficit (5/18, 27.7% group I vs. 1/21, 4.8% group II, P= 0.07) and towards a more complicated postoperative course (perioperative renal failure and/or myocardial infarction and/or neurological deficit either transient or permanent) (8/18, 44.4% group I vs. 4/21, 19% group II, P= 0.09) in group I patients. Forward stepwise logistic regression analysis, performed on the whole group of patients, identified chronic obstructive pulmonary disease (P = 0.010, Odds ratio (OR)=5.7), aprotinin use (P =0.017, OR=5.1), and the number of units of blood collected intraoperatively by the cellsaver (P=0.045, OR =1.3/unit) as independent predictors of complicated postoperative course in the whole group of patients. CPB time (P= 0.040, OR =1.032/min), circulatory arrest time (P = 0.053, OR=1.22/min), and overall donor blood units transfused (P=0.067, OR =1.37/unit) emerged as independent risk factors for in-hospital mortality at multivariate analysis. Conclusions: Even when appropriate amounts of heparin are administered, 'high-dose' aprotinin probably is not an effective blood-sparing drug in deep HCA. Aprotinin should be employed cautiously in this clinical setting because of its possible correlation with an increased rate of postoperative morbid events.
Pharmacotherapy, 2008
The temporary total artificial heart (TAH-t) has emerged as an effective bridge to transplantation for individuals with biventricular failure. Implantation of a TAH-t creates a hypercoagulable state requiring a multidrug approach that includes low-dose unfractionated heparin (UFH) in order to minimize thromboembolism. A concern with UFH is the development of heparindependent antibodies, which develop in up to 50% of patients receiving the drug as part of cardiopulmonary bypass. If UFH therapy continues postoperatively, the risk of heparin-induced thrombocytopenia approaches 3%. Small investigations have demonstrated that bivalirudin, given as a bolus of 0.75-1 mg/kg followed by an infusion at 1.75-2.5 mg/kg/hour, is an effective alternative to UFH for therapeutic anticoagulation during coronary artery bypass surgery, valve replacement, or both. We describe a series of five adults (age range 24-58 yrs) who received bivalirudin as an alternative to low-dose UFH after TAH-t implantation. None of the patients had documented heparin-induced thrombocytopenia. Treatment was started at the discretion of the treating physician, and adjustments were based principally on the results of thromboelastography. Additional general monitoring included activated partial thromboplastin time, prothrombin time, international normalized ratio, fibrinogen, D-dimer, platelet count, hemoglobin, hematocrit, and platelet aggregation studies. Bivalirudin therapy was continued until successful warfarin implementation. All five patients received bivalirudin in addition to standard antithrombotic therapy. Bivalirudin treatment started at a dosage of 0.005 or 0.01 mg/kg/hour with titration to maintain normocoagulability, which occurred (without concomitant warfarin therapy) within the dosage range of 0.01-0.02 mg/kg/hour. Duration of TAH-t implantation was a mean of 38.8 days (range 25-60 days), and bivalirudin was continued for a mean of 15.2 days (range 7-24 days). No major hemorrhagic events occurred during treatment, and all patients successfully transitioned to warfarin therapy. Low-dose bivalirudin, as an alternative to UFH, maintained normocoagulability after TAH-t implantation. Further investigation is warranted to define the role and dosing of bivalirudin in this situation.
European Journal of Cardio-Thoracic Surgery, 1997
As the number of potential heart donors remains constant and the number of potential recipients continuous to increase, the need for circulatory devices to bridge patients becomes more important. The CardioWest total artificial heart (TAH) is a pneumatic, implantable system that totally replaces the failing ventricles. It has been utilized worldwide as a bridge to heart transplantation in 79 patients. There were 73 males and six females who received the TAH. Currently three patients remain on the device waiting for transplantation.