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. 2021 Oct 1;67(10):1100-1108.
doi: 10.1097/MAT.0000000000001485.

First Clinical Experience With the Pressure Sensor-Based Autoregulation of Blood Flow in an Artificial Heart

Ivan Netuka  1 , Yuriy Pya  2 , Bastien Poitier  3 , Peter Ivak  1 , Miroslav Konarik  1 , Jean-Christophe Perlès  4 , Zuzana Blažejová  1 , Hynek Riha  1 , Makhabbat Bekbossynova  1 , Assel Medressova  1 , Fabien Bousquet  4 , Christian Latrémouille  3 , Piet Jansen  4
Affiliations

First Clinical Experience With the Pressure Sensor-Based Autoregulation of Blood Flow in an Artificial Heart

Ivan Netuka et al. ASAIO J. .

Abstract

The CARMAT-Total Artificial Heart (C-TAH) is designed to provide heart replacement therapy for patients with end-stage biventricular failure. This report details the reliability and efficacy of the autoregulation device control mechanism (auto-mode), designed to mimic normal physiologic responses to changing patient needs. Hemodynamic data from a continuous cohort of 10 patients implanted with the device, recorded over 1,842 support days in auto-mode, were analyzed with respect to daily changing physiologic needs. The C-TAH uses embedded pressure sensors to regulate the pump output. Right and left ventricular outputs are automatically balanced. The operator sets target values and the inbuilt algorithm adjusts the stroke volume and beat rate, and hence cardiac output, automatically. Auto-mode is set perioperatively after initial postcardiopulmonary bypass hemodynamic stabilization. All patients showed a range of average inflow pressures of between 5 and 20 mm Hg during their daily activities, resulting in cardiac output responses of between 4.3 and 7.3 L/min. Operator adjustments were cumulatively only required on 20 occasions. This report demonstrates that the C-TAH auto-mode effectively produces appropriate physiologic responses reflective of changing patients' daily needs and represents one of the unique characteristics of this device in providing almost physiologic heart replacement therapy.

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Conflict of interest statement

Disclosure: Dr. Netuka reports grants, personal fees, and nonfinancial support from Carmat SA, during the conduct of the study; grants, personal fees and nonfinancial support from Carmat SA, grants, personal fees and nonfinancial support from Abbott Int., nonfinancial support and other from LeviticusCardio Ltd., personal fees and nonfinancial support from Evaheart Inc., outside the submitted work. Dr. Poitier reports personal fees from Carmat, during the conduct of the study; personal fees from Carmat, outside the submitted work. Dr. Ivak reports personal fees and nonfinancial support from CARMAT, during the conduct of the study; grants, personal fees and nonfinancial support from Abbott, grants from Ministry of Health of Czech Republic, outside the submitted work. Dr. Konarik reports personal fees and nonfinancial support from CARMAT during the conduct of the study; grants and nonfinancial support from Abbott, grants from Ministry of Health of Czech Republic outside the submitted work. Perlès and Bousquet report being employed by Carmat SA, during the conduct of the study. Dr. Riha reports grants from Carmat SAS, during the conduct of the study; personal fees from Abbott, outside the submitted work. Dr. Latrémouille reports to be a Carmat consultant during the conduct of the study. Dr. Jansen reports being employed by Carmat SA, during the conduct of the study. The other authors have no conflicts of interest to report.

Figures

Figure 1.
Figure 1.
The CARMAT-TAH. LV, left ventricle; RV, right ventricle; TAH, total artificial heart.
Figure 2.
Figure 2.
Real-time ventricular pressure curves with a RVIP set at 0 mm Hg. RVIP, right ventricular inflow pressure; TAH, total artificial heart.
Figure 3.
Figure 3.
Flowchart describing the autoregulation mechanism of the CARMAT-TAH. TAH, total artificial heart.
Figure 4.
Figure 4.
Responsiveness of the C-TAH when switched from manual to auto-mode with a targeted right ventricular inflow pressure of 0 mm Hg is demonstrated. Cardiac output in the first day, in the first week, and in the first month after the switch into auto-mode is shown for one patient in the three figures at the bottom. C-TAH, CARMAT-Total Artificial Heart; LV, left ventricle; RV, right ventricle.
Figure 5.
Figure 5.
Pump output variation in response to inflow pressures is accomplished by beat rate changes while stroke volume (50–60 cc) is maximized. The C-TAH data of the device of the 10 patients when set at the default auto-mode setting were accumulated. C-TAH, CARMAT-Total Artificial Heart; LV, left ventricle; RV, right ventricle.
Figure 6.
Figure 6.
The left and right ventricular cardiac output variations in response to inflow pressures, at three RVIP settings, in a representative patient. A lower set RVIP resulted in a higher cardiac output, at the same averaged inflow pressure. C-TAH, CARMAT-Total Artificial Heart; LV, left ventricle; RV, right ventricle; RVIP, right ventricular inflow pressure.
Figure 7.
Figure 7.
Daily average cardiac output and inflow pressure in autoregulation without setting changes, measured over 1 year of support. C-TAH, CARMAT-Total Artificial Heart.
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