Cardiologie Interventionnelle non Coronaire en Jean-Michel Juliard Hôpital Bichat, Paris
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1 Cardiologie Interventionnelle non Coronaire en 2010 Jean-Michel Juliard Hôpital Bichat, Paris
2 Cardiologie Interventionnelle non Coronaire en 2010 Rétrécissement aortique : valves aortiques par voie transfémorale et transapicale Insuffisance mitrale : réparations mitrales percutanées Foramen ovale perméable : fermeture? Auricule gauche : fermeture?
3 Native Valve Disease in Europe 34% 44%
4 Operative Mortality / Comorbidity Euro Heart Survey on Valvular Heart Disease Mortality EuroScore 16% of patients 32% of patients with severe VHD and NYHA class III-IV were not operated for cardiac and non-cardiac reasons
5 Aortic Stenosis R C A Edwards SAPIEN THVTM L M Medtronic CoreValveTM
6 The SOURCE Registry Thomas M et al. Circulation 2010;122:62-69
7 Baseline Demographics and Risk Factors Transfemoral 466 pts Transapical 594 pts p Age, mean (SD), y 81.7 (6.7) 80.7 (7.0) NS Female, n (%) 255 (55.2) 320 (56.0) NS Pulmonary disease, n (%) 117 (25.4) 169 (29.4) NS Renal dysfunction, n (%) 121 (26.3) 189 (32.9) Logistic EuroSCORE (SD) 25.7 (14.5) 29.1 (16.3) <0.001 Peripheral vascular disease, n (%) 50 (10.9) 158 (27.5) <0.001 Carotid artery stenosis >50%, n (%) 35 (7.6) 98 (17.1) <0.001 Incidence of CAD, n (%) 218 (47.4) 321 (56.0) Porcelain aorta, n (%) 21 (4.6) 66 (11.5) <0.001 Prior CABG, n (%) 81 (17.6) 154 (26.9) <0.001 Mitral valve disease, n (%) 74 (16.1) 188 (32.8) <0.001 Thomas M et al. Circulation 2010;122:62-69
8 Major Complications TF TA Total Death 29 (6.3) 59 (10.3) 88 (8.5) Stroke 11 (2.4) 16 (2.6) 27 (2.5) Renal failure requiring dialysis 6 (1.3) 41 (7.1) 47 (4.3) Permanent pacemaker 31 (6.7) 42 (7.3) 73 (7.0) Vascular complications 106 (22.9) 27 (4.7) 133 (12.8) Vascular access-related complications 91 (17.9) 15 (2.4) 106 (9.3) Aortic dissection 9 (1.9) 5 (0.7) 14 (1.3) Non-access-related complications 6 (1.1) 7 (1.2) 13 (1.2) Vascular access and nonaccess complications (%) Major 55/49 (10.6) 17/14 (2.4) 72/63 (7.0) Minor 51/48 (10.4) 10/10 (1.7) 61/58 (5.5) Thomas M et al. Circulation 2010;122:62-69
9
10 Death From Any Cause Leon MB et al New Engl J Med 2010;363:
11 SURTAVI Patient referred for severe aortic stenosis with indication for aortic valve replacement All-comers trial & Heart Team 1. Documentation of 3 scores (STS, EuroSCORE, Lee Score) 2. Clinical judgment based on State of the Art Moderate-High risk Surgical AVR registry Low risk Euroscore > 6% Randomize TAVI (transfemoral, subclavian, retroperitoneal, transapical) vs. SAVR TAVI registry Inoperable
12 Percutaneous Mitral Valve Repair Edge to edge Technique
13 ACC 2010
14 ACC 2010
15 ACC 2010
16 ACC 2010
17 ACC2010
18 PFO CLOSURE in 2010
19 Study Design Prospective, multi-center, randomized, open-label, two-arm superiority trial Study population: Patients 60 years old or younger with a cryptogenic stroke or TIA and a PFO documented by TEE Primary endpoint : 2-year incidence of stroke or TIA
20 Randomization 1 : 1 N = 909 N=447 N=462 STARFlex Closure (within 30 Days) 6 Months Aspirin and Clopidigrel followed by 18 Months Aspirin Best Medical Therapy 24 Months Aspirin Or Warfarin Or Combination Between June, 2003 and October 24, 2008, 909 patients were randomized at 87 sites in the United States and Canada.
21 Baseline Characteristics ITT STARFlex Medical P value N randomized Mean Age 46.3 (18-61) 45.7(18-61) Male 52.1% 51.5% White 89% 90% Index cryptogenic stroke 73% 71% Mod/substantial shunt* 58% (231/400) ASA > 10 mm* 38% (151/400) 51% (228/451) 35% (160/451) * modified ITT
22 2 Year Primary Endpoint ITT STARFlex n = 447 Composite 5.9% (n=25) Stroke 3.1% (n=12) TIA 3.3% (n=13) Medical n = % (n=30) 3.4% (n=13) 4.6% (n=17) Adjusted P value* *Adjusting performed using Cox Proportional Hazard Regression and adjusting for related patient characteristics including: age, atrial septal aneurysm, prior TIA/CVA, smoking, hypertension, hypercholesterolemia
23 Aspirin versus Warfarin Aspirin alone (n=243) Warfarin alone (n=139) P value Composite 6.7% (n=14) Stroke 3.9% (n=8) 8.1% (n=9) 2.7% (n=3) TIA 2.9% (n=6) 6.3% (n=7) 0.09
24
25 The Left Atrial Appendage: our Most Lethal Attachment! Johnson WD Eur J Cardiothorac Surg 2000;17:718-22
26 Magnitude of the Problem: AF and Stroke AF : Prevalence of 0.4% of general population (> 80 years: 10%) 2/3 of the AF population is considered at highrisk of stroke Anticoagulation (warfarin) therapy is proven effective but sometimes contraindicated and most often underutilized in clinical practice
27 Euro Heart Survey on Atrial Fibrillation Stroke Risk and Treatment
28 Results PLAATO device Stroke observed/expected (%) Death (%) Tamponade(%) Pericardial effusion(%) Plaato I 1 (n = 111) 2.2/ Plaato II 2 (n = 150) 1.8/ = Ostermayer. J Am Coll Cardiol 2005;46: = Y. Bayard, ESC Stockolm 2005
29 Holmes DR et al Lancet 2009;374:534-32
30 Results Efficacy Safety Stroke Mortality Primary endpoint: stroke, cardiovascular death and systemic embolism Holmes DR et al Lancet 2009;374:534-32
31 New Devices
32 Structural Interventional Cardiology Registries Randomized studies Team
33
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