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Novel Chordal Repair-leaflet Tip To Mitral Annulus-concept, Validation And Transcatheter System
Valavanur Subramanian1, Nirav C. Patel, M.D
1, Piotr Suwalski, MD PhD
2.
1Creative Heart Valve Solutions LLC, New York, NY, USA,
2Central Clinical Hoispital, Warsaw, Poland.
BACKGROUND: Trans- catheter intra- ventricular chordal repair of mitral valve prolapse has procedural challenges of echo visualization of the papillary muscle and the exact site of implantation in the Left ventricular myocardium with many trabeculae. Increased chordal stress, chordal entanglement
with frequent post procedural chordal loosening and rupture are some of the device performance and chordal implantation unresolved issues, emphasizing the need for an alterative site for chordal implantation. A sub-annular/ sub-leaflet chordal implantation from the tip of the leaflet (coursing underneath the leaflet) to the (MA) Mitral Annulus (LTMA) is a novel concept which can avoid many of the pitfalls of the trans -ventricular chordal repair.
METHODS: Validation of the concept was performed in in 2 bench ex vivo pulsatile left heart porcine mitral valve ruptured chordae model with endoscopic visualization, color flow echocardiogram and mitral flow hemodynamics followed by 3 open surgical P2 prolapse patients with pressurized saline infusion tests and finally 1 MICS surgical patient with 2 ruptured P2 chordae with serial echo follow up (post procedure, 2- and 18-months).
RESULTS: In all 3 validation testing phases mitral regurgitation (MR) was eliminated from the base line of severe MR as evidenced by no reversal of flow into left atrium with endoscopic view, echocardiographic color flow and mitral flow hemodynamics and during pressurized saline test . In the single patient with serial echo follow up the reduction in MR was maintained. Leaflet coaptation was enhanced in all three test periods. Based on these results development of a trans catheter prototype chordal repair system is in progress and a short video will be shown.
CONCLUSIONS:: Sub-annular/leaflet chordal implantation from the tip of the leaflet to the MA(LTMA) is feasible with positive result. Advantages of this procedure are -MA is stronger & easily identifiable on echo and can overcome visualization, chordal entanglement, and implant location issues. This method can treat both posterior and anterior mitral prolapse with insertion of multiple chords. Simplified workflow may increase the procedural adoptability. Annular SLD reduction with a single platform and future bailout intervention by other devices is possible
Legends: TS-Trans septal, ML-Mitral annular Lock, TLMA-Tip of the leaflet to Mitral Annular Chord,LI-Leaflet Implant, VC- Venticular C hords
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