Harvard Medical “Soon, I Will Remodel Your Valve” Evolving Interventional Therapies for Treatment of Mitral Regurgitation Duane Pinto, MD MPH Beth Israel Deaconess Medical Center Ha
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“Soon, I Will Remodel Your Valve”
Evolving Interventional Therapies for
Treatment of Mitral Regurgitation
Duane Pinto, MD MPH
Beth Israel Deaconess Medical Center
Harvard Medical School
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nonischemic
MR Etiology
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Edge to Edge (Evalve)
Evalve clip repair in
porcine heart (6 mos post repair) Circulation 2003;108(Supp IV):493
Circulation 2002;106:e173
Human S/P surgical Alfieri
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The MitraClip System
Gripper
Arm
MitraClip Device (Clip)
Clip Delivery System
MitraClip System
Delivery Catheter Handle
Stabilizer
Steerable Guide Handle
Steerable Guide, Steerable Sleeve, and Delivery Catheter
MitraClip Device (Clip)
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MitraClip Features
• Venous puncture
• Standard Percutaneous Left Atrial Access
• Versatile Positioning Capabilities
o Adaptability to varying patient anatomy
• Precise MitraClip Placement Control
o Re-positioning capability
• Allows multiple tissue releases and grasps
• Allows optimal MR reduction
• Provides option to not deploy Clip
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P2 P3
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*Data as of 2/28/2014 Source: Abbott Vascular
Study Population N*
EVEREST II (Pivotal) Non-randomized patients
(High Risk Study)
Compassionate/Emergency Use Non-randomized patients 66
+95 surgery
Worldwide Experience
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Commercial MitraClip Implant
1 First-time procedures only Includes commercial patients, ACCESS I and ACCESS II patients
2 Successful implants only
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Long-Term Durability of Clinical Success
EVEREST II RCT Clinical Success Groups
Outcome MitraClip (N=97) Surgery (N=64) Freedom From Death at 5 Years 87% 90% Freedom From MV Surgery (or Re-operation) at 5 Years 94% 95%
MR ≤ 2+ at 5 Years 86% 97%
MR ≤ 1+ at 5 Years 47% 92% NYHA Class III/IV (%) Baseline 5 Years 47% 6% 40% 3% Mean Change in LVEDV From Baseline to 5 Years -27 ml -45 ml Mean Change in Diastolic SLAD From Baseline to 5 Years 0.0 cm -0.4 cm
5-Year Outcomes in Patients Who Were Alive and Free From
MR 3+/4+ and MV Surgery (or Re-Operation) at 1 Year
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nonischemic
MR Etiology
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430 patients enrolled at up to 75 US sites
Randomize 1:1
Clinical and TTE follow-up:
Baseline, Treatment, 1-week (phone), 1, 6, 12,
18, 24, 36, 48, 60 months
Control group
Standard of care
N=215
Symptomatic heart failure subjects who are treated per standard of care
Determined by the site’s local heart team as not appropriate for mitral valve surgery
Specific valve anatomic criteria
MitraClip
N=215
Significant FMR (≥3+ by core lab)
Trial design
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COAPT
High Surgical
Risk
MitraClip COAPT
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• Guided Delivery Systems
• QuantumCor, Cordis DPA
• MiCardia, Mitral Solutions
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…cinch the valve
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Coronary Sinus Approach
CARILLON
– Reduces annulus by traction
– Varying degrees of tension to system
– Effect on FMR can be assessed during implantation
– Implant can be recaptured if placement is not as
desired (e.g LCX compression)
Proximal
anchor
Distal anchor
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Mitralign Direct Annuloplasty System
Before and after implant: Atrial view
• Direct reduction of the annular SL dimension based
on posterior leaflet surgical plication
• Small (1 cm, 20%) plication of the posterior annulus reduces ischemic MR, with durable surgical results
Tibayan et al Ciculation 2003;108:II-128-133
Aybek et al JTCS 2006; Nagy et al Scand Cardio J 2000
Trang 17• In DMR, there is something physically wrong with the valve apparatus
• With the exception of MitraClip, percutaneous repair technologies apply less to DMR
• Also the use of MitraClip in DMR, may limit future
ability to place a percutaneous replacement valve,
complicating the choice of therapy
• Therefore, percutaneous replacement may become a viable option earlier in DMR patients
Percutaneous Mitral Valve Replacement: Role in DMR and FMR may be different
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(all but one are pre-clinical)
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CardiaQ
• NiTi, self-expanding
• Trileaflet, symmetric
• 2 sets of 12 anchors
• Transcatheter venous, transseptal
• Percutaneous FIM Gen1 in 2012 (1 patient)
• Percutaneous FIM Gen2 planned for 2013
• The only percutaneous replacement technology to
perform a human case
Status of Emerging Replacement Systems
Trang 20Successful First-in-Human procedure in June 2012
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Trang 22•FIM target late ‘13 or early ‘14
Status of Emerging Replacement Systems
Trang 23• FIM not yet planned
Status of Emerging Replacement Systems
Trang 24•FIM planned for late ‘13
Status of Emerging Replacement Systems
Trang 25• FIM not yet planned
Status of Emerging Replacement Systems
Trang 26Many others in development
Trang 27• Mitral replacement poses a much greater technical
challenge when compared to TAVR
• We look forward to future developments