Who will Benefit from Percutaneous Management of Mitral Regurgitation? An Imaging Guide to Management James D. Thomas, M.D., F.A.C.C. Department of Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Foundation Cleveland, Ohio, USA Conflicts: None MR2010:1
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Guangzhou Guangzhou Hong Kong MR2010:3
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Indications for MR Surgery Lessons from the Valve Guidelines Class 1 Severe MR with symptoms and EF > 30% Asymptomatic severe MR with 30%<EF<60% Class 2a Asymptomatic severe MR with normal LV and either new onset AF or PA pressure > 50 mmhg Asymptomatic severe MR with normal LV and likelihood of repair > 90% Severe MR must be assessed quantitatively ROA>0.4 cm 2, RF>50%, RV>60 ml Likelihood of repair Detailed anatomic assessment of valve MR2010:5
Proximal Convergence Method Underlying Principle Flow thru any isovelocity shell is equal to instantaneous orifice flow MR2010:6
Measurement of Mitral ROA Simplified PISA Formula LA 40 40 Assume LV-LA p is 100 mmhg Set aliasing velocity to 40 cm/sec Then ROA = r 2 /2 MV r = 8 mm LV ROA = 8 2 /2 = 32 mm 2 Pu et al., JASE 2001;14:180-5 MR2010:7
Simplified PISA Method 5 Easy Steps 1. Optimize view of proximal convergence zone from apex 2. Baseline shift to ~40 cm/sec 3. Zoom on valve 4. Measure first aliasing radius 5. ROA = r 2 /2 MR2010:8
Simplified PISA Method 5 Easy Steps 2. Baseline shift to ~40 cm/sec MR2010:9
Simplified PISA Method 5 Easy Steps 3. Zoom on valve MR2010:10
Simplified PISA Method 5 Easy Steps 4. Measure 1 st aliasing radius r = 9 mm 5. ROA = r 2 /2 = 9 2 /2 = 40 mm 2 MR2010:11
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Beware Late Systolic MR! 46 Year Old Woman Referred for Surgery Large jet and proximal convergence zone, but BRIEF Normal LV size, no PHTN MR2010:13
Mitral CW Doppler Can Show This Easily MV closure MR Significant MR only in latter half of systole MR2010:14
Morality (%) Isolated Mitral Valve Repair Extremely Safe in Suitable Candidates 2.5 2 1.5 1 0.5 STS benchmark CCF 0 2001 2002 2003 2004 2005 2006 2007 Year But some patients are too high risk for standard surgery MR2010:15
Percutaneous Mitral Valve Repair Edge to Edge Repair Double Mitral Orifice after Surgical Alfieri Stitch Echo short axis after Alfieri Animal Mitral Valve after Alfieri MR2010:16
Percutaneous Mitral Repair (PMR) Evalve Clip Catheter-based Delivery The Delivery System MR2010:17
MitraClip Technique Feldman et al. NEJM 2011; 364: 1395 MR2010:18
Anatomic Exclusions for Mitral Clipping Coaptation too short <2 mm Coaptation too deep >11 mm Flail gap too large 10 mm Flail too wide 15 mm MR2010:19
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Mitral Valve Prolapse/Flail 89 yo man with 4+ MR and CHF 1.0 cm PISA radius, ROA~0.5 cm 2 MR2010:21
Mitral Valve Prolapse/Flail 89 yo man with 4+ MR and CHF MR2010:22
Percutaneous Edge-to-edge Technique RAO Clip trying to grasp both leaflets simultaneously MR2010:23
Catheter Detached from Clip Post MR click MR2010:24
RAO Left Ventriculogram Baseline Post-device MR2010:25
Mitral Valve Prolapse/Flail 89 yo man with 4+ MR and CHF Follow-up, 1-2+ MR, no CHF MR2010:26
3D TEE is Critical to Guiding MV Clipping Guidance of trans-septal puncture MR2010:27
Clip Placement LA side LV side MR2010:28
After Two Clips Placed MR2010:29
N Engl J Med 2011;364:1395-406 MR2010:30
Percutaneous MV Repair Sustained MR Reduction FMR, n=34 DMR, n=20 00% 80% 18% 21% 100% 80% 20% 25% 60% 97% 82% 79% 60% 100% 80% 75% 40% 40% 20% 20% 0% Baseline 30 day 12 month Grade 1+/ 2+ Grade 3+/ 4+ 0% Baseline 30 day 12 month Grade 1+ = Mild MR Grade 2+ = Moderate MR Grade 3+ = Moderate - Severe MR Grade 4+ = Severe MR EVEREST II High Risk Registry Data Kar, S., EuroPCR 2009 Symposium Presentation 12 month Matched data MR2010:31
Freedom from Death 1.0 Percutaneous MV Repair Significant Mortality Benefit MitraClip Therapy vs. High Risk Control 0.8 HRR 76.4% 0.6 HRR Control 55.3% P=0.037 0.4 0.2 0.0 Impl 30d 6m 12m At Risk High Risk (n) 78 72 65 53 Control (n) 36 34 27 22 EVEREST II High Risk Registry Data Kar, S., EuroPCR 2009 Symposium Presentation MR2010:32
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Mitral Remodelling via Coronary Sinus MR2010:34
Mitral Remodelling via Coronary Sinus MR2010:35
Coronary Sinus Devices Carillon Monarc Viacor MR2010:36
Implantation of VIACOR Device Baseline Goldberg S, ACC Post Implant Combined data from AMADEUS (EU), PERSEUS (SA), VERITAS (AU) feasibility studies MR2010:37
CARILLON Device The AMADEUS Trial Prospective, single-arm, 6-month, multi-center trial Primary Endpoint Thirty day rate of Major Adverse Events Secondary Endpoints Long-term safety Hemodynamic and functional changes NYHA Class Exercise (6 minute walk test; Max Exercise Time QOL (KCCQ) MR Reduction Combined data from AMADEUS (EU), PERSEUS (SA), VERITAS (AU) feasibility studies Schofer et al, Circulation. 2009; 120:326-333 MR2010:38
ml cm ml cm MR Reduction 1.00 0.80 0.60 0.40 0.20 0.00 60 50 40 30 20 10 0 AMADEUS 0.71 Vena Contracta Regurgitant Volume P<0.001 N=30 N=28 N=24 35 N=30 0.56 0.53 23 N=28 P<0.001 24 N=23 1.00 0.80 0.60 0.40 0.20 0.00 60 50 40 30 20 10 0 P<0.01 P<0.05 TITAN (Interim) 0.61 0.48 N=34 N=34 Vena Contracta 35.9 27.1 N=34 N=34 Regurgitant Volume Baseline 1 month 6 months Schofer et al, Circulation. 2009 Jul 28;120(4):272-4. MR2010:39
Mitral Annulus-Coronary Sinus Relationship CS Often Far from the MA 7.84±2.75 mm 10.35±1.96mm Vertical distance between CS and MA at different sites. Choure et al. JACC 2006;48:1938-1945 Variable p<0.001 Shorter near to commisures MR2010:40
Coronary Sinus - Circumflex Relationship 80% LCX under CS 20% LCX Over CS MR2010:41
Many Wild Ideas Direct Annuloplasty: QuantumCore QuantumCore Catheter-based application of RF energy at subablative temperatures to the mitral annulus will heat and contract the collagen fibers, thereby reducing mitral annular circumference MR2010:42
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You get ALL the special bits. MR2010:44
Percutaneous MV Repair Current Approach Mitral clip Approved in Europe with over 6000 deployed Not approved in US with a few continued access pts» Currently on hold for 2 nd time (redesign) In high risk pts, good alternative to surgery» Confirm severity of MR and anatomic suitability Annuloplasty devices Carillon device approved in Europe, none in US Limited survival data, but MR reduced by ~50% with improved QOL Echo for severity and functional nature of MR CT to assess CS-MA distance and relation to LCx MR2010:45
Thanks, Steven! MR2010:46