New Model for the Assessment of Transcatheter Aortic Valve Replacement Devices in Sheep

John P. Carney, Jill Schappa Faustich, Matthew T. Lahti, Paul E. Ashworth, Agustin P. Dalmasso, Yuriy Moklyak, Richard W. Bianco

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is an effective therapy in treating high-risk patients suffering from aortic stenosis. Animal models used to evaluate safety and efficacy of TAVR devices prior to clinical use lack a stenotic aortic annulus, a critical impediment to long-term TAVR device evaluation. We sought to create a reproducible model of aortic stenosis using a modified aortic annuloplasty (MAA) procedure in sheep, followed by deployment and long-term evaluation of TAVR devices using this model. Methods: Twelve sheep underwent the MAA procedure and were recovered. Transthoracic echocardiography (TTE) was used to monitor changes in the aortic annulus in the postoperative period. At 60 days post-MAA, Test group animals were anesthetized for TAVR insertion and Control animals underwent a necropsy. Test animals were recovered following TAVR insertion and observed for a postoperative period of 140 days. Results: Twelve sheep survived the annuloplasty procedure and the 60-day recovery period. Gross examination of seven Control group animals revealed the implanted annuloplasty ring segments formed hard protrusions into the aortic annulus. Five sheep in the Test group underwent successful deployment of Abbott’s experimental TAVR device without evidence of migration. Examination at 140 days post-TAVR insertion showed all devices tightly anchored within the modified aortic annulus. Conclusions: The MAA procedure creates stenotic segments in the aortic annulus with adequate rigidity for anchorage and long-term evaluation of TAVR devices. This represents the first model that successfully mimics human aortic stenosis and provides a clinically relevant TAVR deployment platform for long-term evaluation in sheep.

Original languageEnglish (US)
JournalJournal of Investigative Surgery
DOIs
StateAccepted/In press - 2020

Bibliographical note

Publisher Copyright:
© 2020 The Author(s). Published with license by Taylor & Francis Group, LLC.

Keywords

  • TAVI
  • TAVR
  • animal model
  • aortic stenosis
  • ovine model
  • sheep model

Fingerprint Dive into the research topics of 'New Model for the Assessment of Transcatheter Aortic Valve Replacement Devices in Sheep'. Together they form a unique fingerprint.

Cite this