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Comparative pathology of an implantable left atrial pressure sensor. | LitMetric

AI Article Synopsis

  • A new left atrial pressure (LAP) monitoring system was created to help manage heart failure, using a sensor implanted in the heart.
  • The long-term safety of this device was assessed by examining tissue samples from both animals (like dogs and sheep) and seven patients, focusing on issues like thrombosis and tissue overgrowth.
  • Results indicated minimal tissue overgrowth with no serious complications, confirming that the device remains structurally sound and safe for long-term use in humans.

Article Abstract

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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Source
http://dx.doi.org/10.1097/MAT.0b013e31829bdffdDOI Listing

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