Novel Automated Suturing Technology For Minimally Invasive Mitral Chord Implantation: A Pre-clinical Evaluation Study
Paul Werner1, Thomas Poschner1, Christoph Gross1, Iuliana Coti1, Niv Ad2, Igor Gosev3, Hossein Amirjamshidi3, Alfred Kocher1, Guenther Laufer1, Jude Sauer3, Martin Andreas1.
1Medical University of Vienna, Vienna, Austria, 2Univesity of Maryland, Baltimore, MD, USA, 3Medical University of Rochester, Rochester, NY, USA.
BACKGROUND: While minimally invasive surgery for mitral valve repair can provide excellent results, outcomes are strongly related to centre volumes and expertise. A study of heart surgeons evaluating of a new automated ePTFE suturing technology for mitral chordal replacement using open and MICS simulators incorporating cadaver hearts is reported. METHODS: Practicing heart surgeons used the manually operated Mi-STITCH device for ePTFE mitral chord replacement suturing and the Mi-KNOT device for titanium fastener crimping and trimming suture through the left atria in 20 non-fixated human heart specimens. After training with bench-top plastic models, custom simulators were employed to represent open and minimally invasive mitral repair. The study was approved by the institutional ethical board (number 1229/2020). RESULTS: Forty-eight automated chordal replacements placing leaflet to papillary muscle ePTFE sutures secured with titanium fasteners were performed by 5 surgeons. (37.5% open model, 62.5% MICS). Mean duration of chordal replacement including knot fixation was 3.6±1.5 minutes (range: 55 sec to 7 min 60 sec). Good control of suture-delivery was reported in 95.8% (n=46) of leaflet sutures and 100% (n=48) of papillary sutures. No significant time differences between the open (mean 3.39±1.27 min) versus the minimally invasive model (3.67±1.63 min, p=0.44) were observed. CONCLUSIONS:The open and MICS automated mitral chordal ePTFE suturing simulated in this 5 surgeon study demonstrated practical handling and accurate placement of sutures in human heart specimens. The initial clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive minimally invasive mitral valve repair procedures.
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