Kỹ thuật kẹp van hai lá bằng clip

MitraClip: Introduction A/Prof (Adj) Yeo Khung Keong, MBBS, FAMS, FACC, FSCAI National Heart Centre Singapore Disclosures • Abbott Vascular: Speaker, Proctor (MitraClip) #1: Overview • 1st percutaneous MV repair technology for severe MR • Transvenous procedure • Clinical use since 2008 • >35,000 cases • Approved for use in USA, Europe, Australia/NZ, parts of Asia and Middle East MitraClip System MitraClip System Clip Delivery System Steerable Guide Handle Delivery Catheter Handle Gripper Stabilizer Steerable Guide, Steerable Sleeve, and Delivery Catheter Arm MitraClip Device (Clip) MitraClip Device (Clip) Gripper #2: Indications • USA: high surgical risk degenerative MR • Rest of world: high risk degenerative MR and symptomatic functional MR • FMR > DMR • Heart team assessment High Risk DMR Symptomatic severe FMR 10 #7: Procedure • Follow the steps • Do not move the device unless echo is showing the device • Key: Transseptal • Key: watch leaflet grasping • Key: verify MR severity • Key: Confirm final arm angle check 23 #8: Efficacy • EVEREST II: not as good as surgery for MR reduction • Efficacious for symptom relief • Real-world experience excellent • Steep learning curve 24 #9: Safety • • • • • • • 25 Generally very safe Bleeding Single leaflet attachment Leaflet damage Device issues/dislodgement Stroke ASD • Landmark RCT - Feasibility and Safety of percutaneous MVR • Surgery (Gold Standard) remains superior to MitraClip in MR reduction • MR reduction by MitraClip showed clinical benefits (QoL, NHYA, Hosp, Echo Volumes) 26 27 28 29 30 Extended use • • • • 31 Eccentric lesions High surgical risk Prior annuloplasty Tricuspid #10: Setting up a program • • • • • 32 Room set-up Training requirements Proctor: clinical specialist PATIENT SELECTION Sufficient volume to maintain skills Importance of the Learning Curve • The MitraClip learning curve is characterized by1: – Device time reduction: 180min to 55min – Acute procedural success* from 80% to 92% • Significant device time reduction is observed across the MitraClip centers of excellence Schillinger W et al Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients? European Journal of Heart Failure Advance Access October 24, 2013 Data sources: Apollo System; Case Observation Forms July 2013 This includes all submitted and reviewed procedures, including successful and unsuccessful procedures as 33 reported in Apollo #11: Cost • Device is approximately USD $25K • Programs need to find sustainable funding 34 #12: Registry • MitraClip in the Asia Pacific Registry (MARS) • Australia, Indonesia, Malaysia, China, Taiwan, Brunei, Hong Kong, Vietnam, Singapore 35 Open questions in Interventional Therapy for MR Degenerative Low Surgical Risk Matterhorn High Surgical Risk US Approval Functional ?? COAPT Mitra-France RESHAPE-HF EVOLVE-HF Mitra-CRT Courtesy Ted Feldman, MD 37 ... MitraClip System MitraClip System Clip Delivery System Steerable Guide Handle Delivery Catheter Handle Gripper Stabilizer Steerable Guide, Steerable Sleeve, and Delivery Catheter Arm MitraClip... Stabilizer Steerable Guide, Steerable Sleeve, and Delivery Catheter Arm MitraClip Device (Clip) MitraClip Device (Clip) Gripper #2: Indications • USA: high surgical risk degenerative MR • Rest of world:... Safety of percutaneous MVR • Surgery (Gold Standard) remains superior to MitraClip in MR reduction • MR reduction by MitraClip showed clinical benefits (QoL, NHYA, Hosp, Echo Volumes) 26 27 28 29