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Published on: May 11, 2018
First report of 90-day support of 2 calves with a continuous-flow total artificial heart
Jamshid H Karimov1, Nader Moazami2, Mariko Kobayashi1
1Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
Insights
The Cleveland Clinic continuous-flow total artificial heart (CFTAH) demonstrated reliable performance and biocompatibility in calves for up to 90 days without anticoagulation. This pulsatile pump shows promise for future human cardiac replacement therapy.
Area of Science:
- Biomedical Engineering
- Cardiovascular Surgery
- Medical Devices
Background:
- The Cleveland Clinic continuous-flow total artificial heart (CFTAH) is a novel, compact, valveless, pulsatile pump designed for self-regulated hemodynamic output.
- Existing cardiac replacement devices face challenges in long-term performance and biocompatibility.
Purpose of the Study:
- To evaluate the chronic in vivo pump performance, physiologic and hemodynamic parameters, and biocompatibility of the CFTAH.
- To assess the suitability of the CFTAH for potential human implantation.
Main Methods:
- Implantation of CFTAH pumps in 17 calves.
- Evaluation of hemodynamic parameters, pump performance, and device-related adverse events.
- Assessment of biocompatibility and thromboembolism at necropsy.
Main Results:
- CFTAH demonstrated good hemodynamic performance with stable parameters (e.g., pump flow 7.3 L/min, mean arterial pressure 103 mm Hg).
- The pump operated within design specifications without failure and showed no chronic hemolysis.
- Three animals survived 90 days post-implantation without anticoagulation, exhibiting good biocompatibility and no thromboembolism.
Conclusions:
- The CFTAH reliably self-regulates hemodynamic output and shows acceptable biocompatibility for up to 90 days in a chronic calf model.
- The device functions without anticoagulation, a significant advancement for potential clinical application.
- These findings support the transfer of CFTAH technology to human surgical practice for cardiac replacement therapy.
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. Hemodynamic parameters, 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, 16 ± 3 mm Hg; right atrial pressure, 17 ± 3 mm Hg; right atrial pressure-left atrial pressure difference, 1 ± 2 mm Hg; mean arterial pressure, 103 ± 7 mm Hg; arterial pulse pressure, 30 ± 11 mm Hg; and 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 animals with recent CFTAH implantation recovered well, with no postoperative anticoagulation, during planned in vivo durations of 30, 90, and 90 days (last 2 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 human surgical practice, thus filling the urgent need for cardiac replacement devices as destination therapy.
