HeartMate 3 Fully Magnetically Levitated Left Ventricular Assist Device for the Treatment of Advanced Heart Failure -1 Year Results from the CE Mark Trial

Krabatsch, Thomas; Schmitto, Jan D.; Pya, Yuriy; Zimpfer, Daniel; Garbade, Jens; Rao, Vivek; Morshuis, Michiel; Marasco, Silvana; Beyersdorf, Friedhelm; Sood, Poornima; Damme, Laura; Netuka, Ivan

doi:10.1016/j.healun.2016.01.024

Cited by 47 publications

(73 citation statements)

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“…5,36,37 However, early experience with the third generation magnetically levitated left ventricular assist devices (LVAD) (HeartMate III) revealed very low (<1%) rates of hemolysis. 38,39 Similarly, the novel TORVAD toroidal-flow LVAD has shown negligible rates of hemolysis in preclinical testing. 40 A unique aspect of hemolysis in LVAD patients is its strong relationship with thrombotic complications.…”

Section: Hemolysis With Left Ventricular Assist Devicesmentioning

confidence: 99%

Cardiac prostheses‐related hemolytic anemia

Alkhouli

Farooq

et al. 2019

Clinical Cardiology

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Hemolysis is an unintended sequel of temporary or permanent intracardiac devices. However, limited data exist on the characteristics and treatment of hemolysis in patients with cardiac prostheses. This entity, albeit uncommon, often poses significant diagnostic and management challenges to the clinical cardiologist. In this article, we aim to provide a contemporary overview of the incidence, mechanisms, diagnosis, and management of cardiac prosthesis‐related hemolysis.

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Section: Hemolysis With Left Ventricular Assist Devicesmentioning

confidence: 99%

Cardiac prostheses‐related hemolytic anemia

Alkhouli

Farooq

et al. 2019

Clinical Cardiology

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“…LVADs increase perfusion, reduce pulmonary pressures, improve quality of life, and submaximal exercise capacity compared to pre LVAD condition (2)(3)(4)(5)(6). Significant improvements in NYHA functional class from NYHA class prior to LVAD implant of IIIb-IV to I-II after 1 year were reported (7,8). LVAD patients from our center perform cardiac rehabilitation to restore and improve aerobic work capacity, physical strength, and mobility after LVAD implantation (9).…”

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confidence: 94%

LVAD Pump Flow Does Not Adequately Increase With Exercise

Gross

Marko²,

Mikl³

et al. 2018

Artificial Organs

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Left ventricular assist devices (LVADs) restore cardiovascular circulatory demand at rest with a spontaneous increase in pump flow to exercise. The relevant contribution of cardiac output provided by the LVAD and ejected through the aortic valve for exercises of different intensities has been barely investigated in patients. The hypothesis of this study was that different responses in continuous recorded pump parameters occur for maximal and submaximal intensity exercises and that the pump flow change has an impact on the oxygen uptake at peak exercise (pVO ). Cardiac and pump parameters such as LVAD flow rate (Q ), heart rate (HR), and aortic valve (AV) opening were analyzed from continuously recorded LVAD data during physical exercises of maximal (bicycle ergometer test) and submaximal intensities (6-min walk test and regular trainings). During all exercise sessions, the LVAD speed was kept constant. Cardiac and pump parameter responses of 16 patients for maximal and submaximal intensity exercises were similar for Q : +0.89 ± 0.52 versus +0.59 ± 0.38 L/min (P = 0.07) and different for HR: +20.4 ± 15.4 versus +7.7 ± 5.8 bpm (P < 0.0001) and AV-opening with 71% versus 23% of patients (P < 0.0001). Multi-regression analysis with pVO (R = 0.77) showed relation to workload normalized by bodyweight (P = 0.0002), HR response (P = 0.001), AV-opening (P = 0.02), and age (P = 0.06) whereas the change in Q was irrelevant. Constant speed LVADs provide inadequate support for maximum intensity exercises. AV-opening and improvements in HR show an important role for higher exercise capacities and reflect exercise intensities. Changes in pump flow do not impact pVO and are independent of AV-opening and response in HR. An LVAD speed control may lead to adequate left ventricular support during strenuous physical activities.

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“…HeartMate 3 has an artificial pulse mode to not only create pulsatile flow but also enhance antithrombogenicity by washing the pump surfaces. 34 We believe that the addition of an impeller vibration can be included to further prevent pump thrombus especially when a pump can be removed from a patient. It is necessary to check the native heart function at a low flow rate during device weaning.…”

Section: Limitations and Future Workmentioning

confidence: 99%

Mechanical antithrombogenic properties by vibrational excitation of the impeller in a magnetically levitated centrifugal blood pump

Murashige

Hijikata

2019

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Mechanical circulatory support devices have been used clinically for patients with heart failure for over 10 years. However, thrombus formation inside blood pumps remains a risk to patient life, causing pump failure and contributing to neurological damage through embolization. In this article, we propose a method for preventing thrombus formation by applying vibrational excitation to the impeller. We evaluate the ability of this method to enhance the antithrombogenic properties of a magnetically levitated centrifugal blood pump and ensure that the impeller vibration does not cause undue hemolysis. First, 3 vibrational conditions were compared using an isolated pump without a mock circulation loop; the vibrational excitation frequencies and amplitudes for the impeller were set to (a) 0 Hz‐0 μm, (b) 70 Hz‐10 μm, and (c) 300 Hz‐2.5 μm. The motor torque was measured to detect thrombus formation and obtain blood coagulation time by calculating the derivative of the torque. Upon thrombus detection, the pump was stopped and thrombi size were evaluated. The results showed an increase in the blood coagulation time and a decrease in the rate of thrombus formation in pumps with the impeller vibration. Second, an in vitro hemolysis test was performed for each vibrational condition to determine the effect of impeller vibration on hemolysis. The results revealed that there was no significant difference in hemolysis levels between each condition. Finally, the selected vibration based on the above test results and the non‐vibration as control were compared to investigate antithrombogenic properties under the continuous flow condition. The blood coagulation time and thrombi size were investigated. As a result, vibrational excitation of the impeller at a frequency of 300 Hz and amplitude of 2.5 μm was found to significantly lengthen clotting time, decreasing the rate of pump thrombus compared to the non‐vibration condition. We indicate the potential of impeller vibration as a novel mechanical antithrombogenic mechanism for rotary blood pumps.

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HeartMate 3 Fully Magnetically Levitated Left Ventricular Assist Device for the Treatment of Advanced Heart Failure -1 Year Results from the CE Mark Trial

Cited by 47 publications

References 0 publications

Cardiac prostheses‐related hemolytic anemia

Cardiac prostheses‐related hemolytic anemia

LVAD Pump Flow Does Not Adequately Increase With Exercise

Mechanical antithrombogenic properties by vibrational excitation of the impeller in a magnetically levitated centrifugal blood pump

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