Expert review of medical devices · 2025
A device profile of the SynCardia temporary total artificial heart as a bridge-to-transplantation in patients with biventricular failure.
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Rubin Gabrielle, Colón Modesto J, Mahar Jamal, Sunkara Anusha, Yenigalla Sowjanya, Arabía Francisco A
Аннотация
INTRODUCTION: The SynCardia Total Artificial Heart (TAH) offers a life-saving mechanical circulatory support (MCS) option for patients with end-stage biventricular (BiV) heart failure who are not candidates for traditional devices or are awaiting transplantation. The device and its prior success has opened doors to further research in newer devices and technologies to combat existing challenges with TAH.
AREAS COVERED: This review highlights the clinical utility, device profile and function, safety considerations, patient selection, and current challenges associated with the device. It summarizes key clinical studies, FDA approval history, technical specifications of the TAH, outcomes, complications, and logistical considerations. Literature was sourced through PubMed and clinical trial databases using terms such as 'SynCardia,' 'total artificial heart,' 'biventricular failure,' and 'bridge to transplant.'
EXPERT OPINION: TAH offers full heart replacement and is evolving toward becoming a long-term alternative to transplants. Challenges like power supply, long-term durability, and biocompatibility are being addressed through innovations such as fully implantable systems and hybrid biological-mechanical designs. Unlike transplantation, TAHs avoid immunosuppression and offer hope to patients who cannot wait for donor hearts.In the coming years, global development of advanced TAHs, coupled with better clinical acceptance could transform treatment of end-stage heart failure providing a more accessible, reliable, and life-sustaining solution.
AREAS COVERED: This review highlights the clinical utility, device profile and function, safety considerations, patient selection, and current challenges associated with the device. It summarizes key clinical studies, FDA approval history, technical specifications of the TAH, outcomes, complications, and logistical considerations. Literature was sourced through PubMed and clinical trial databases using terms such as 'SynCardia,' 'total artificial heart,' 'biventricular failure,' and 'bridge to transplant.'
EXPERT OPINION: TAH offers full heart replacement and is evolving toward becoming a long-term alternative to transplants. Challenges like power supply, long-term durability, and biocompatibility are being addressed through innovations such as fully implantable systems and hybrid biological-mechanical designs. Unlike transplantation, TAHs avoid immunosuppression and offer hope to patients who cannot wait for donor hearts.In the coming years, global development of advanced TAHs, coupled with better clinical acceptance could transform treatment of end-stage heart failure providing a more accessible, reliable, and life-sustaining solution.