Structural and Valvular interventions 2015-2016 A/Prof Michael Nguyen Fiona Stanley Hospital Australia Overview • • • • • Mitral valve interventions Aortic valve interventions Lef atrial appendage occlusion Heart Failure interventions Patent Foramen Ovale closure Mitral Valve Interventions How th e d evice works EVEREST A Freedom From Death, MV Surgery or Reoperation B Freedom From Death 1.0 1.0 L., 0.8 ,_ c: 0.8 ~ 0.6 i:::;:-::;- 0.6 ~ '- - ::; ~ ~ 0.4 0.4 0.2 0.2 evice (n = 178) rgery (n = 80) 0.0 0.0 12 24 Patients At Risk 48 - 36 RCT Device (n = 178) Months Device Group 178 Control Group 80 136 128 117 75 69 63 c · 60 RCT Surgery (n = 80) - 109 54 12 24 Patients At Risk 98 45 49 21 Freedom From MV Surgery or Reoperation 36 Months 48 - RCT D - RCT Su Device Group 178 165 158 143 133 Control Group 80 76 70 65 57 60 119 58 52 24 D Landmark Analysis of Freedom From MV Surgery or Reoperatton Beyond Months 1.0 0.8 :; I \: , 0.6 0.4 0.2 - 0.0 12 24 136 128 117 Control Group RCT Device (n = 178) - RCT Surgery (n 36 48 = 80) 178 80 75 Feldman, T et al J Am Coll Cardiol 2015; 66(25):2844-54 69 63 RCT Device (n = 136) - 24 Months Patients At Risk Device Group - RCT Surgery (n 36 = 75) 48 60 45 Months 109 54 98 117 109 98 49 63 54 49 21 A p=0.11 p=0.004 p=0.01 12 Months Years 100% 90% 80% 70% - # c: · :::; Q) ro V I c 60% 50% 40% 30% 20% 10% 0% Baseline B p=0.99 p=0.03 p=0.19 100% 90% 80% 70% - # c: · :: V I Q) c :; 60% 50% 40% 30% ro 20% 10% 0% Baseline 12 Months Years EVEREST II trial results Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv 2015;8:e001943 Table EVEREST II Trial: 5-Year Follow-Up Data Accordingto MR Etiology Degenerative MR MitraClip (n=130) Functional MR Surgery (n=62) MitraClip (n=48) Surgery (n=18) Freedom from mortality 89% [78%-95%] 86% [60%-96%] 60% [32%-79%] 55% [27%-76%] Freedom from MV surgery or reoperation 69% [55%-80%] 96% [62%-1 00%] 90% [43%-99%] 81 % [33%-96%] MR grade ~2+ 81% 100% 86% 86% NYHA class ~2 95% 97% 76% 100% lVEDV reduction, ml -31.7 -49.2 -23.8 -13.2 lVESV reduction, ml -5.6 -8.8 -4 -5.2 lVEDV indicates left ventricular end-diastolic volume; lVESV, left ventricular end-systolic volume; MR, mitral regurgitation; MV, mitral valve; and NYHA, New York Heart Association functional class Percutaneous Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv 2015;8:e001943 mitral annuloplasty devices The left atrial pressure monitoring system Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv 2015;8:e001943 The pulmonary artery pressure monitoring system Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv 2015;8:e001943 Left-to-right interatrial shunt devices Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv 2015;8:e001943 The parachute device Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv 2015;8:e001943 "" R P 2013 Parachute IV " C " • Pivotal randomised US trial • Approx 500 patients Therapy and the randomised to Medical Parachute v Medical alone • Primary for heart endpoint failure (event is death or rehospitalisation driven) Therapy "" R P 2013 Results " C• " Primary Endpoint: 90% (82/91) successfully implanted and free of patients were of device-related MACE - • (5) Unsuccessful implantations • {3} acute device removals due to positioning • (1) device removal due to suspected infection guide catheter perforation • (1) - (1) mitral apparatus damage leading to death - (2) heart failure - (1) peripheral embolization (left popliteal) hospitalization Stroke: 1% (1/91) - Non-device I non-procedure related "" R P 2013 NYHA Classification, n=86 ' C° r At Monti 100% 89 S, S, 89o/o C Pa tients Im'- Maintained Functi Maintained Functional Status • 80% 53°/o Improved 36% Maintained 60% 40% • Death • Transplant/VAD ••v 20% • 0% B 6M Ill r "" R P 2013 " C 300 LV Volume, n=74 - " 250 • Baseline •GM EDV (ml) All paired wlumescomparedto ESV (ml) baseline haw a p-vatueof< 0.001 PFO Occlusion RESPECT - Extend SignificantReduction 54% in Recurrent CryptogenicStroke Relative Risk Reduction in ITT Population 1.00 0.95 Event-free O Probability AMPLATZER™ PFOOccluder (N=499; # cryptogenic strokes= 10) • 0.90 Medical Management (N=481, # cryptogenic strokes= 19) • Device not in place HR: 0.460 Log-rank p-value: 0.042 0.85 499 (0%) MM 481 (0%) Time to Event(Years) # at Risk (KM Estimates) AMPLATZER 463 (1.2%) 394 (2.7%) 369 (1.5%) 307 (4.1%) 212 (2 5%) 168 (4 1%) 86 (2.5%) 71 (5.2%) 10 in Recurrent 70°/o Relative Risk Reduction CryptogenicStroke With Device In Place 1.00 0.95 D Event-free Probability (N=464 • 0.9 luder Implanted AMPLATZER™ PFO Occ okes = 7) #; cryptogenic str Not Implanted (N=516, i # cryptogen c stro kes= 22) HR: 0.302 Log-rank p-value: 0.004 0.85 -~-.-~ ,, ~ ~ ~ .-~~ ~ ~ # at Risk (KM Estimates) ~ ,. r I Time to Eve AMPLATZER 464 (0%) (0 9%) 445 357 (0 9%) nt (1.9%) 206 82 (1.9%) Not mplanted 516 (0%) 412 (3.0%) 319 (4 6%) (Ye(4 6%) 174 75 (5 7%) ars) 10 Greater Benefit 75% Relative Risk in Substantial Reduction in Shunt or ASA Subgroup Recurrent Cryptogenic Stroke in ITT Population 1.00 0.95 Event-free D Probability AMPLATZERTM PFO Occluder 4) (N=319, # cryptogenic strokes= • 0.90 Medical Management 13) (N=301, # cryptogenic strokes= HR: 0.245 Log-rank p-value: 0.007 # at Risk (KM Estimates) AMPLATZER 319 (0%) MM 301 (0%) 299 (0 6%) 243 (3.6%) 229 (1 0%) 186 (4 8%) Time to 134 (1 5%) 105 (4 8%) Event (Years) 52 (1 5%) (6.6%) 45 10 Conclusion • Structural Interventions are rapidly increasing as a fundamental treatment option for multiple areas of • cardiovascular disease We should embrace these technological advancements but should make sure that comprehensive research to assess safety and long-term effcacy of these procedures is undertaken • Dedicated training programs should be developed so that the best expertise can be achieved for our patients The Future is Exciting! ... 0.0 c (/) :.: cu :.: - r Q) s r r Watchman w > -~ - Q) :+:; , _, - 379 .I - , - 0 18 24 30 Time (Months) 36 42 48 54 60 No at Risk Watchman 463 404 38 38 373 360 35 34 330 294 202 244 233