Key result
Implantation of a left atrial pressure sensor showed minimal-to-moderate tissue overgrowth and no active thrombogenesis across 7 patients and 63 animals over 22 to 1,686 days.
Why the study?
Is the permanent implantation of a left atrial pressure sensor safe in terms of thrombosis and tissue overgrowth in humans and animal models?
Observational (n=70)
Is the permanent implantation of a left atrial pressure sensor safe in terms of thrombosis and tissue overgrowth in humans and animal models?
The implantable left atrial pressure sensor demonstrates favorable long-term safety and structural integrity, with animal models closely approximating human pathology.
Supports sensor biocompatibility in limited data; leaves open larger prospective trials before clinical adoption.
A left atrial pressure (LAP) monitoring system was developed for guiding the management of patients with heart failure. The LAP sensor is implanted into the left atrium via transseptal catheterization and affixed to the interatrial septum by nitinol anchors. The long-term safety of permanent implantation of the LAP sensor in patients was evaluated based on the comparative pathology in animals. Tissue specimens of the LAP sensor from 7 patients, 49 canines, and 14 ovine were examined for thrombosis and tissue overgrowth. Implant duration ranged from 22 to 1,686 days. Gross examination showed minimal-to-moderate tissue overgrowth with no evidence of migration, erosion, or perforation. There was no excessive host-to-device reaction or active thrombogenesis in any of the subjects that followed the antithrombotic therapy protocol. Micro-computed tomography scanning confirmed the structural integrity of the device. Low vacuum scanning electron microscopy and histology showed neoendocardial tissue overgrowth with no inflammation or fibrin. The pathology of both animal models was found to closely approximate the pathology in humans and favorably supports the long-term safety of the device.
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Trainor et al. (2013) conducted an observational in Heart failure (n=70). Implantable left atrial pressure (LAP) sensor was evaluated on Thrombosis and tissue overgrowth. Implantation of a left atrial pressure sensor showed minimal-to-moderate tissue overgrowth and no active thrombogenesis across 7 patients and 63 animals over 22 to 1,686 days.
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