Progress on the Design and Development of the Continuous‐Flow Total Artificial Heart

Kobayashi, Mariko; Horvath, David J.; Mielke, Nicole; Shiose, Akira; Kuban, Barry D.; Goodin, Mark; Fukamachi, Kiyotaka; Golding, Leonard A.R.

doi:10.1111/j.1525-1594.2012.01489.x

Cited by 42 publications

(29 citation statements)

References 18 publications

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“…To create balance between the left and right flow of a continuous-flow pump, there is a method of making a shunt and changing the diameter of the outflow. The CFTAH [14] and the BiVACOR [15] are defined by passively changing the pressure H-Q characteristic using a pressure gradient of LAP and RAP. fCFTAH is incapable of changing the passive H-Q characteristic because two pumps of fCFTAH are independent.…”

Section: Discussionmentioning

confidence: 99%

Hemodynamics of a functional centrifugal-flow total artificial heart with functional atrial contraction in goats

et al. 2015

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Implantation of a total artificial heart (TAH) is one of the therapeutic options for the treatment of patients with end-stage biventricular heart failure. There is no report on the hemodynamics of the functional centrifugal-flow TAH with functional atrial contraction (fCFTAH). We evaluated the effects of pulsatile flow by atrial contraction in acute animal models. The goats received fCFTAH that we created from two centrifugal-flow ventricular assist devices. Some hemodynamic parameters maintained acceptable levels: heart rate 115.5 ± 26.3 bpm, aortic pressure 83.5 ± 10.1 mmHg, left atrial pressure 18.0 ± 5.9 mmHg, pulmonary pressure 28.5 ± 9.7 mmHg, right atrial pressure 13.6 ± 5.2 mmHg, pump flow 4.0 ± 1.1 L/min (left) 3.9 ± 1.1 L/min (right), and cardiac index 2.13 ± 0.14 L/min/m(2). fCFTAH with atrial contraction was able to maintain the TAH circulation by forming a pulsatile flow in acute animal experiments. Taking the left and right flow rate balance using the low internal pressure loss of the VAD pumps may be easier than by other pumps having considerable internal pressure loss. We showed that the remnant atrial contraction effected the flow rate change of the centrifugal pump, and the atrial contraction waves reflected the heart rate. These results indicate that remnant atria had the possibility to preserve autonomic function in fCFTAH. We may control fCFTAH by reflecting the autonomic function, which is estimated with the flow rate change of the centrifugal pump.

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Section: Discussionmentioning

confidence: 99%

Hemodynamics of a functional centrifugal-flow total artificial heart with functional atrial contraction in goats

et al. 2015

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“…The nominal external dimensions of the latest CFTAH design used in these studies are 98.4 mm (length), 62 mm (diameter), 160 cc (volume displacement), and 486 g (device weight with cable and connector off the scale) (Figure 1). Descriptions of the CFTAH’s parameters and design features have previously been detailed (10). …”

Section: Methodsmentioning

confidence: 99%

“…This device uses a single, centrally located, rotating assembly that has impellers for both left and right centrifugal pumps (9,10). The position of the centrally located rotating assembly is primarily determined by the differential force between the right and left pump filling pressures acting on this part.…”

Section: Introductionmentioning

confidence: 99%

First report of 90-day support of 2 calves with a continuous-flow total artificial heart

Karimov

Moazami

Kobayashi

et al. 2015

The Journal of Thoracic and Cardiovascular Surgery

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Objective The Cleveland Clinic continuous-flow total artificial heart (CFTAH) is a compact, single-piece, valveless, pulsatile pump providing self-regulated hemodynamic output to left/right circulation. We evaluated chronic in vivo pump performance, physiologic and hemodynamic parameters, and biocompatibility of the CFTAH in a well-established calf model. Methods CFTAH pumps have been implanted in 17 calves total. Hemodynamics, pump performance, and device-related adverse events were evaluated during studies and at necropsy. Results In vivo experiments demonstrated good hemodynamic performance (pump flow, 7.3 ± 0.7 L/min; left atrial pressure [LAP], 16 ± 3 mm Hg; right atrial pressure [RAP], 17 ± 3 mm Hg; RAP-LAP difference, 1 ± 2 mm Hg; mean arterial pressure, 103 ± 7 mm Hg; arterial pulse pressure, 30 ± 11 mm Hg; pulmonary arterial pressure, 34 ± 5 mm Hg). The CFTAH has operated within design specifications and never failed. With ever-improving pump design, the implants have shown no chronic hemolysis. Three recent animals with the CFTAH recovered well, with no postoperative anticoagulation, during planned in vivo durations of 30, 90, and 90 days (last two were intended to be 90-day studies). All these longest-surviving cases showed good biocompatibility, with no thromboembolism in organs. Conclusions The current CFTAH has demonstrated reliable self-regulation of hemodynamic output and acceptable biocompatibility without anticoagulation throughout 90 days of chronic implantation in calves. Meeting these milestones is in accord with our strategy to achieve transfer of this unique technology to surgical practice, thus filling the urgent need for cardiac replacement devices as destination therapy.

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“…2 The device's characteristics and functionality under a range of hemodynamic conditions have previously been reported. 3 The nominal external dimensions of the CFTAH taken as a reference for this study are 103.7 mm (length), 62 mm (diameter), 170 cc (volume displacement), and 486 g (device weight with cable and connector off the scale).…”

Section: Methodsmentioning

confidence: 99%

“…As a part of the development program for the Cleveland Clinic continuous-flow total artificial heart (CFTAH), 2,3 we evaluated the fit of the device within the thoracic cavity of five patients. The aim was to determine the smallest body size that can accommodate the current CFTAH design.…”

Section: Introductionmentioning

confidence: 99%

Human Fitting Studies of Cleveland Clinic Continuous-Flow Total Artificial Heart

et al. 2015

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Implantation of mechanical circulatory support devices is challenging, especially in patients with a small chest cavity. We evaluated how well the Cleveland Clinic continuous-flow total artificial heart (CFTAH) fit the anatomy of patients about to receive a heart transplant. A mock pump model of the CFTAH was rapid-prototyped using biocompatible materials. The model was brought to the operative table, and the direction, length, and angulation of the inflow/outflow ports and outflow conduits were evaluated after the recipient's ventricles had been resected. Thoracic cavity measurements were based on preoperative computed tomographic data. The CFTAH fit well in all five patients (height, 170 ± 9 cm; weight, 75 ± 24 kg). Body surface area was 1.9 ± 0.3 m2 (range, 1.6-2.1 m2). The required inflow and outflow port orientation of both the left and right housings appeared consistent with the current version of the CFTAH implanted in calves. The left outflow conduit remained straight, but the right outflow direction necessitated a 73 ± 22 degree angulation to prevent potential kinking when crossing over the connected left outflow. These data support the fact that our design achieves the proper anatomical relationship of the CFTAH to a patient's native vessels.

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Progress on the Design and Development of the Continuous‐Flow Total Artificial Heart

Cited by 42 publications

References 18 publications

Hemodynamics of a functional centrifugal-flow total artificial heart with functional atrial contraction in goats

Hemodynamics of a functional centrifugal-flow total artificial heart with functional atrial contraction in goats

First report of 90-day support of 2 calves with a continuous-flow total artificial heart

Human Fitting Studies of Cleveland Clinic Continuous-Flow Total Artificial Heart

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