Evaluation of a Novel Automated Suturing Technology for Mitral Chordal Implantation: 1-Year Results.

Abstract

A new automated expanded polytetrafluoroethylene (ePTFE) suture placement device and a new customized titanium fastener deployment device were clinically evaluated in open and less-invasive mitral valve repair (MVr). Twelve patients were monitored for 1 year after undergoing MVr using the study devices. The study end points included surgical outcomes, operative times, valve repair durability, adverse events, and mortality. Three patients received 1 ePTFE chord using the study technology, and 9 patients received 2 chords. Mitral regurgitation at 30 days was absent in 8 patients, trace in 2, and mild in 2. At the 1-year follow-up, mitral regurgitation was absent in 7 patients, trace in 2, mild in 2, and moderate in 1. There were no replacement chord failures, reoperations, or death. The initial outcomes of new automated ePTFE suture placement and titanium fastener deployment devices encourage further clinical evaluations.