Safety and Effectiveness Outcomes of a Novel Automated Titanium Suture Fastener Device Applied for Heart Valve Surgery in an Ovine Model.

ABSTRACT:

Objective

This study was designed to evaluate the operability, effectiveness, and safety of the automated titanium suture fastener in a preclinical ovine model in comparison with manual tying in a mitral valve annuloplasty ring implantation surgery.

Methods

Eighteen adult Small-tailed Han sheep were prepared for the surgery of mitral valve annuloplasty ring implantation through lateral thoracotomy under cardiopulmonary bypass (CBP). A total of 12 stitches were performed to secure an annuloplasty ring, with 6 stitches done with the automated fastener and the other 6 by manual tying. The knotting time for the automated fastener or manual tying was recorded, respectively. The firmness of knots, mitral valve integrity, biocompatibility, thrombosis, local reactions, and other asp

SUBMITTER: Li B 

PROVIDER: S-EPMC8874148 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature