Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Ann Thorac Surg. 2024 Feb;117(2):474-478. doi: 10.1016/j.athoracsur.2023.10.014. Epub 2023 Oct 27.
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.
新型自动化膨体聚四氟乙烯(ePTFE)缝线安置装置和新型定制钛紧固件部署装置在开放式和微创二尖瓣修复(MVr)中进行了临床评估。
12 名患者在使用研究装置进行 MVr 后随访 1 年。研究终点包括手术结果、手术时间、瓣膜修复耐久性、不良事件和死亡率。
3 名患者使用研究技术接受了 1 根 ePTFE 缝线,9 名患者接受了 2 根缝线。30 天时,8 名患者无二尖瓣反流,2 名患者微量反流,2 名患者轻度反流。在 1 年随访时,7 名患者无二尖瓣反流,2 名患者微量反流,2 名患者轻度反流,1 名患者中度反流。没有缝线断裂、再次手术或死亡的情况。
新型自动化 ePTFE 缝线安置和钛紧固件部署装置的初步结果令人鼓舞,值得进一步临床评估。