Key result
Automated mitral chordal suturing shows no chord failures, reoperations, or deaths at 1 year.
Why the study?
A new automated ePTFE suture placement device and customized titanium fastener deployment device required clinical evaluation in open and less-invasive mitral valve repair.
Does a novel automated ePTFE suture placement and titanium fastener deployment device provide safe and durable mitral chordal implantation in patients undergoing mitral valve repair?
Observational (n=12)
Does a novel automated ePTFE suture placement and titanium fastener deployment device provide safe and durable mitral chordal implantation in patients undergoing mitral valve repair?
Initial evaluation of a novel automated suturing and fastener deployment device for mitral chordal implantation demonstrated safety and durability at 1 year with no chord failures or reoperations.
Should not yet change mitral valve repair practice; leaves open need for larger trials on durability.
PURPOSE: 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). DESCRIPTION: 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. EVALUATION: 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. CONCLUSIONS: The initial outcomes of new automated ePTFE suture placement and titanium fastener deployment devices encourage further clinical evaluations.
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Werner et al. (2023) conducted an observational in Mitral valve repair (n=12). Automated ePTFE suture placement and titanium fastener deployment devices was evaluated on Surgical outcomes, operative times, valve repair durability, adverse events, and mortality. A novel automated suturing technology for mitral chordal implantation in 12 patients resulted in no replacement chord failures, reoperations, or deaths at 1 year.
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