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Evaluation of a Virtual Implant Technique to Optimise Implantation of a Bioprosthetic Total Artificial Heart
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The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017
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Evaluation of a Virtual Implant Technique to Optimise Implantation of a Bioprosthetic Total Artificial Heart C. Latrémouille ,1 J.C. Roussel,2 M. Kindo,3 P. Leprince,4 D. Duveau,5 B. Tchakgarian,6 J.C. Perlès,6 P. Jansen,6 A. Carpentier.1 1Cardiovascular Surgery, Hôpital Européen Georges Pompidou, APHP, Université Paris Descartes-Sorbonne Paris Cité, Paris, France; 2Cardiovascular Surgery, Hôpital Guillaume et René Laënnec, Université de Nantes, Saint-Herblain, France; 3Cardiovascular Surgery, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France; 4Cardiovascular Surgery, Groupe Hospitalier Pitié-Salpétrière, APHP, Université Pierre et Marie Curie, Paris, France; 5Cardiovascular Surgery, Faculté de Médecine, Université de Nantes, Nantes, France; 6Carmat SA, VélizyVillacoublay, France.
Performance of a Novel Shuttling Total Artificial Heart on a on a Mock Circulatory Loop R. Wampler ,1 J. Glynn,2 S. Withers,2 B. Hull,2 M. Slaughter,3 A. Starr,1 H.K. Song.1 1Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR; 2Oregon Heart, Inc, Portland, OR; 3Cardiothoracic Surgery, University of Louisville, Louisville, KY.
Purpose: A bioprosthetic total artificial heart (TAH) designed as a singleunit device with the size and shape of the natural heart is intended for biventricular replacement therapy in patients with end-stage heart failure. A 3-dimensional virtual implantation tool has been developed to assist clinicians in assessing anatomical compatibility of eligible patients. The study objective was to evaluate the critical thoracic dimensions employed and to compare the pre-operative anatomical assessment with post-operative positioning of the TAH. Methods: Internal thoracic dimensions, from standard chest CT scans, were quantified, followed by a 3-D rendering of the chest cavity. A 3D-model of the TAH was then placed on the atrioventricular plane and the anatomical compatibility assessed by cardio-thoracic surgeons. The actual anatomical fit was determined, during clinical implantation, and at 1 month post implantation, allowing a comparison to be made between the virtual modelling and the actual anatomical fit. Results: Five male patients (age 58-76 years) were implanted with the TAH. Anatomical compatibility was based on internal sagittal distance (154179mm), the absence of thoracic cage intersection and pulmonary artery length (5cm to bifurcation). The device fit was confirmed peri-operatively, in all patients, at primary chest closure, and confirmation of no device inflow/ outflow obstruction. One-month post-operative scans demonstrated sustained positioning with a slight posterior reorientation (15°) in the atrioventricular plane. Conclusion: Virtual implantation of this TAH with 3D rendering of routine thoracic CT scans provides a simple, accurate and useful tool to assess preimplant anatomic compatibility. The virtual implantation tool will continue to be further evaluated to assist clinicians with patient eligibility during ongoing clinical studies.
Purpose: Widespread use of heart transplantation is limited by scarcity of donor organs. Total artificial heart (TAH) development has been pursued to address this shortage, especially to treat patients who are poor candidates for left ventricular assist device support, such as those with biventricular failure or complex congenital heart disease. Methods: We have developed a novel TAH that utilizes a continuously spinning rotor that shuttles between two positions to provide alternating blood flow to the systemic and pulmonary circulations without artificial valves (https://www.youtube.com/watch?v= 15XkJ60Fz0c). Flow rates and pressures generated by the TAH are controlled by adjusting rotor speed, cycle frequency, and the proportion of each cycle spent pumping to either circulation. To validate the design, a TAH prototype was placed in a mock circulatory loop that simulates preload, afterload, and capacitance in normal and pathophysiologic conditions. Results: Under normal conditions, TAH output was maintained at 7.5 L/ min, with instantaneous flows reaching 15 L/min at a systemic blood pressure of 120/80 and 65 bpm. Pulmonary artery, right atrial, and left atrial pressures also were maintained in the normal range (Figure 1). At a MAP of 100 mmHg, a maximum TAH output of 10 L/min of flow was achieved. To simulate implant into a patient with chronic congestive heart failure (CHF), the pulmonary vascular resistance of the mock loop was increased to 5 Woods units. By increasing pump speed to the pulmonary circulation, cardiac output could be maintained at 7.5 L/min with similar systemic blood pressures as pulmonary artery pressure increased to 50/35. Power consumption of the TAH was approximately 10 W. Conclusion: In vitro testing of a novel, shuttling TAH demonstrated maintenance of normal hemodynamics with pulsatile flow. Cardiac output was maintained across a range of pathophysiologic conditions including chronic CHF. These experiments serve as a proof-of-concept for the design, which has proceeded to in vivo testing.
The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017
1( 23)
1( 24)
Evaluation of a Virtual Implant Technique to Optimise Implantation of a Bioprosthetic Total Artificial Heart C. Latrémouille ,1 J.C. Roussel,2 M. Kindo,3 P. Leprince,4 D. Duveau,5 B. Tchakgarian,6 J.C. Perlès,6 P. Jansen,6 A. Carpentier.1 1Cardiovascular Surgery, Hôpital Européen Georges Pompidou, APHP, Université Paris Descartes-Sorbonne Paris Cité, Paris, France; 2Cardiovascular Surgery, Hôpital Guillaume et René Laënnec, Université de Nantes, Saint-Herblain, France; 3Cardiovascular Surgery, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France; 4Cardiovascular Surgery, Groupe Hospitalier Pitié-Salpétrière, APHP, Université Pierre et Marie Curie, Paris, France; 5Cardiovascular Surgery, Faculté de Médecine, Université de Nantes, Nantes, France; 6Carmat SA, VélizyVillacoublay, France.
Performance of a Novel Shuttling Total Artificial Heart on a on a Mock Circulatory Loop R. Wampler ,1 J. Glynn,2 S. Withers,2 B. Hull,2 M. Slaughter,3 A. Starr,1 H.K. Song.1 1Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR; 2Oregon Heart, Inc, Portland, OR; 3Cardiothoracic Surgery, University of Louisville, Louisville, KY.
Purpose: A bioprosthetic total artificial heart (TAH) designed as a singleunit device with the size and shape of the natural heart is intended for biventricular replacement therapy in patients with end-stage heart failure. A 3-dimensional virtual implantation tool has been developed to assist clinicians in assessing anatomical compatibility of eligible patients. The study objective was to evaluate the critical thoracic dimensions employed and to compare the pre-operative anatomical assessment with post-operative positioning of the TAH. Methods: Internal thoracic dimensions, from standard chest CT scans, were quantified, followed by a 3-D rendering of the chest cavity. A 3D-model of the TAH was then placed on the atrioventricular plane and the anatomical compatibility assessed by cardio-thoracic surgeons. The actual anatomical fit was determined, during clinical implantation, and at 1 month post implantation, allowing a comparison to be made between the virtual modelling and the actual anatomical fit. Results: Five male patients (age 58-76 years) were implanted with the TAH. Anatomical compatibility was based on internal sagittal distance (154179mm), the absence of thoracic cage intersection and pulmonary artery length (5cm to bifurcation). The device fit was confirmed peri-operatively, in all patients, at primary chest closure, and confirmation of no device inflow/ outflow obstruction. One-month post-operative scans demonstrated sustained positioning with a slight posterior reorientation (15°) in the atrioventricular plane. Conclusion: Virtual implantation of this TAH with 3D rendering of routine thoracic CT scans provides a simple, accurate and useful tool to assess preimplant anatomic compatibility. The virtual implantation tool will continue to be further evaluated to assist clinicians with patient eligibility during ongoing clinical studies.
Purpose: Widespread use of heart transplantation is limited by scarcity of donor organs. Total artificial heart (TAH) development has been pursued to address this shortage, especially to treat patients who are poor candidates for left ventricular assist device support, such as those with biventricular failure or complex congenital heart disease. Methods: We have developed a novel TAH that utilizes a continuously spinning rotor that shuttles between two positions to provide alternating blood flow to the systemic and pulmonary circulations without artificial valves (https://www.youtube.com/watch?v= 15XkJ60Fz0c). Flow rates and pressures generated by the TAH are controlled by adjusting rotor speed, cycle frequency, and the proportion of each cycle spent pumping to either circulation. To validate the design, a TAH prototype was placed in a mock circulatory loop that simulates preload, afterload, and capacitance in normal and pathophysiologic conditions. Results: Under normal conditions, TAH output was maintained at 7.5 L/ min, with instantaneous flows reaching 15 L/min at a systemic blood pressure of 120/80 and 65 bpm. Pulmonary artery, right atrial, and left atrial pressures also were maintained in the normal range (Figure 1). At a MAP of 100 mmHg, a maximum TAH output of 10 L/min of flow was achieved. To simulate implant into a patient with chronic congestive heart failure (CHF), the pulmonary vascular resistance of the mock loop was increased to 5 Woods units. By increasing pump speed to the pulmonary circulation, cardiac output could be maintained at 7.5 L/min with similar systemic blood pressures as pulmonary artery pressure increased to 50/35. Power consumption of the TAH was approximately 10 W. Conclusion: In vitro testing of a novel, shuttling TAH demonstrated maintenance of normal hemodynamics with pulsatile flow. Cardiac output was maintained across a range of pathophysiologic conditions including chronic CHF. These experiments serve as a proof-of-concept for the design, which has proceeded to in vivo testing.