Acute Clinical Adverse Outcomes Associated With the Cor-Knot.

BACKGROUND

Although an integral component of cardiac valve operations, manual knot tying has been linked with increased operative times and greater costs. The introduction of the Cor-Knot device (LSI Solutions) has eliminated hand-tied knots through an automatic titanium fastener system. However, adverse outcomes related to this device remain unknown. We thus used a nationally representative cohort to characterize adverse events of the Cor-Knot.

METHODS

All adverse events for the Cor-Knot from 2015-2023 were tabulated from the Manufacturer and User Facility Device Experience database. Reports were screened to assess incident type and complication. Device and patient complications were categorized and reported as proportions to further ascertain factors contributing to the development of adverse incidents.

RESULTS

Of an estimated 74 adverse events, the number of reported occurrences increased over the study period from 1 in 2015 to 13 in 2023. The greatest proportion of adverse events involved the Cor-Knot Mini (41.9%) or the Cor-Knot (37.4%), with malfunction representing the most frequent device incident (63.5%). Problems related to device usage (22.8%) or misfire (22.8%) constituted the most frequent complications after Cor-Knot usage. The most frequent complications included valve insufficiency (10.8%), presence of a foreign body (8.1%), or hemorrhage (2.7%).

CONCLUSIONS

Of all reported adverse events, malfunction was most likely to occur due to misfire or device usage issues. Patient complications comprised valve insufficiency, foreign body presence, or hemorrhage. As adoption and utilization of the Cor-Knot increases, future work is necessary to ensure adequate device training and minimize the incidence of adverse events.