| Objective:Mitral valve regurgitation is a common heart valve disease.The traditional standard treatment is surgery.Transcatheter mitral regurgitation treatment is currently the hottest and fastest growing direction of interventional cardiology in the world.At the same time,various technologies emerge in endlessly.The research purpose of this experiment is to evaluate the products of the Mitral Stitch mitral valve repair system through the application in healthy pigs,the artificial chordae repair of the mitral valve in the healthy pig heart and the "edge-to-edge" suture operation safety and effectiveness,provide necessary data and meaningful guidance for the clinic.Materials and Methods:Select 24 healthy domestic pigs,divided into group A and group B.Group A was implantation of artificial chordae,a total of 12 animals.After each animal’s thoracotomy was used to expose the heart,the artificial chordae were implanted into the anterior and posterior mitral leaflets of the heart with the assistance of ultrasound.The chordae is fixed on the apex of the heart.Each animal can get 2 specimens.The follow-up time was immediate(postoperative),30 days,and 180 days.In group B,“edge-to-edge”repair was performed,with 12 animals in total.After each animal’s chest was opened and the heart was exposed,artificial chordae were implanted in the anterior and posterior mitral leaflets of the heart with the aid of ultrasound,and then passed The locker drives the artificial tendons of the anterior and posterior lobes into titanium nails to lock and fix the mitral valve to form an "8" double-hole suture.Finally,the artificial tendons are fixed on the apex of the heart.Each animal can obtain 1 double-hole valve leaflet repair specimen.The follow-up time was immediate(postoperative),30 days,and 180 days.Observe the movement of the valve and the blood flow of the valve orifice under ultrasound at three time points,the fixation of the artificial gasket and the artificial chord after anatomy,the coverage of endothelial cells,and whether the major organs of the body are toxic and pathological Response,in order to evaluate the feasibility and safety of the mitral valve repair system under the two surgical methods.Result1 Intraoperative experimental resultsThe mitral valve repair operations of all animals were successfully completed.For animals undergoing artificial chordal repair,the sutures are successfully implanted in the predetermined position of the mitral valve leaflet and fixed on the apical wall to form an artificial chord;for animals with edge-to-edge sutures,after the suture is implanted and successfully implanted and fixed the titanium nail,and finally formed a double hole suture on the mitral valve.Animals underwent artificial tendon implantation.After the artificial tendon was implanted,the intraoperative ultrasound examination showed that there was no obvious mitral valve regurgitation and the artificial tendon morphology was normal.For the animals undergoing the “edge-to-edge” repair operation,the A flap and the P flap were successfully inserted into the gasket and sutures,and then titanium nails were implanted through the lock device to lock the sutures to complete the“edge-to-edge” operation."Fate" repair surgery operation.Intraoperative ultrasound examination showed that the mitral valve orifice had two blood streams,and there was no regurgitation.The mitral valve orifice formed a "figure eight" "double hole" structure.2 Follow-up experiment resultsAfter 30-day,60-day and 180-day follow-up,it can be concluded that after 180 days of implantation of the artificial chordae,the ultrasound results show that both artificial chordae are anchored to the valve leaflets and move normally with the movement of the valve leaflets.There is no obvious regurgitation of the mitral valve;after dissection,it is confirmed that the polyester gaskets are in the predetermined position of the valve leaflet,and the shape is good,and the polyester gasket has been completely covered by endothelial cells;after the animal internal organs are dissected,it is confirmed that there is no animal internal organs.Abnormal existence indicates that the implant is not sufficient to produce systemic toxicity in animals.After 30 days,60 days and 180 days of follow-up,the end-point results can be concluded that 180 days after the "edge-to-edge" repair is completed,the ultrasound results show that the mitral valve orifice has formed a figure of eight,and the valve has a "double hole" structure.There are two blood streams in the mouth,and there is no regurgitation of the mitral valve;the anatomy results confirmed that the anchoring parts of the gasket are all in the predetermined position of the valve leaflet,and the two sets of artificial chordae are locked and fixed together with the titanium nail.The chordae chordae and gasket pull the two leaflets together,and the valve mouth forms a "dual porosity" structure,completing the "edge-to-edge" repair,and 100%endothelial cells have crawled on the polyester gasket and the titanium nail;After dissecting the animal’s internal organs,it was confirmed that there was no abnormality in the animal’s internal organs,indicating that the implants were not enough to cause systemic toxicity to the animal.Conclusion1.The mitral valve repair system has simple operation steps and strong operability.The valve suturing device can easily clamp the valve leaflets,and the lock device can quickly lock the sutures.The operation success rate is 100%.2.During the operation,the positioning member shows good visibility under ultrasound,assists in positioning the position of the instrument in the animal body,and at the same time extends the outer diameter of the ejector rod in the axial direction,which can effectively drag the valve leaflet and reduce the valve leaflet.The clamping is particularly difficult;the surface of the probe assembly can accurately judge the effect of the valve leaflet clamping,and ensure that the valve leaflet puncture rate can reach 100%.3.The 30-day and 180-day follow-up showed that the valve function of all experimental animals maintained normal physiological state,no leaflets,no leg cords,regardless of the artificial leg cord implantation or the “edge-to-edge” repair surgery.Fracture,no gasket peeling and tearing phenomenon.The polyester gaskets and titanium nails implanted in the experimental animals have completed about 50%-70%of the endothelial cells crawling,and there is no attached thrombus on the surface of the gaskets and sutures.No stenosis or related serious complications occurred in the valves of all experimental animals,indicating that the product is safe.4.The 30-day follow-up and 180-day results showed that the artificial tendons implanted in all experimental animals were complete and clearly visible.The double hole suture has obvious double blood flow.At the same time,no significant mitral regurgitation occurred and no significant changes(compared with immediately after surgery),indicating that the product is effective. |
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