Paris, August 28 th Gian Paolo Ussia on behalf of the CoreValve Italian Registry Investigators
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1 Paris, August 28 th 2011 Is TAVI the definitive treatment in high risk patients? Impact Of Coronary Artery Disease In Elderly Patients Undergoing TAVI: Insight The Italian CoreValve Registry Gian Paolo Ussia on behalf of the CoreValve Italian Registry Investigators Cardiovascular Department and Division of Cardiology Ferrarotto Hospital - University of Catania Catania, Italy
2 Disclosure Proctor physician for CoreValve Medtronic
3 Background Coronary artery disease in patients with degenerative aortic stenosis is a common condition The presence of CAD increases procedural risk with conventional aortic valve replacement When both conditions are present, a strategy of CABG and AVR in the same session is the current standard of care Impact of ischemic heart disease on outcomes of TAVI has not been well delineated yet
4 171 patients Coexisting coronary artery disease negatively impacts procedural outcomes and long-term survival in patients undergoing TAVI 136 patients Presence of CAD or nonrevascularized myocardium was not associated with an increased risk of adverse events
5 First patient June 2007 Methods The Italian CoreValve Registry Since June 2007 a web-based registry was started 14 participating sites Catania, University Pisa, University Brescia, H. Civile Padova, University Milano, S.Ambrogio 663 patients treated with TAVI 359 patients with CAD 54.5% Milano, Niguarda Firenze, Careggi Milano, S.Raffaele Bologna, University Roma, S. Camillo Legnano Firenze, Careggi Bari, University Mirano
6 Methods Endpoints & Definitions Prior Myocardial Infarction Prior PCI Angiographic finding of coronary stenosis >70% Prior CABG One of these Coronary Artery Disease
7 Results Baseline Clinical Characteristics I Overall population (n = 659) CAD group (n = 356) nocad group (n = 303) p value Age, years±sd 81.2± ± ± Female gender, n (%) 368 (55.8) 159 (44.3) 209 (68.9) <0.001* Diabetes mellitus, n (%) 173 (26.2) 106 (29.5) 67 (22.1) 0.026* Hypertension, n (%) 494 (74.9) 270 (75.2) 224 (73.9) Prior acute pulmonary edema, n (%) 212 (32.2) 120 (33.4) 92 (30.4) Prior balloon valvuloplasty, n (%) 112 (16.9) 62 (17.3) 50 (16.5) Prior stroke, n (%) 48 (7.3) 28 (7.8) 20 (6.6) Peripheral vascular disease, n (%) 126 (19.1) 96 (26.7) 30 (9.9) <0.001* COPD, n (%) 139 (21.1) 72 (20.0) 67 (22.1) Cirrhosis Child class A or B, n (%) 13 (1.9) 5 (1.4) 8 (2.6) Prior neoplasia, n (%) 86 (13.0) 52 (14.5) 34 (11.2) 0.198
8 Results Baseline Clinical Characteristics II Overall population (n = 659) CAD group (n = 356) nocad group (n = 303) p value Renal insufficiency, n (%) 154 (23.3) 102 (28.4) 42 (13.9) 0.001* Atrial fibrillation, n (%) 108 (16.4) 41 (11.4) 67 (22.1) 0.001* Prior pacemaker, n (%) 42 (6.4) 22 (6.1) 20 (6.6) Porcelain aorta, n (%) 72 (10.9) 51 (14.2) 21 (6.9) 0.002* Unstable Angina, n (%) 31 (4.7) 24 (6.7) 7 (2.3) 0.001* Prior CABG, n (%) 104 (15.8) 104 (28.9) - - Prior PCI, n (%) 188 (28.5) 188 (52.4) - - Prior MI, n (%) 143 (21.7) 143 (39.8) - - NYHA class III and IV, n (%) 471 (71.5) 246 (68.5) 225 (74.2) CCS class 2, 3 and (15.5) 73 (20.3) 29 (9.6) <0.001* Logistic Euroscore, %±SD 23.1± ± ±12.1 <0.001*
9 Results Baseline Echo characteristics Overall population CAD group nocad group p value (n = 659) (n = 356) (n = 303) Left ventricular ejection fraction, %±SD 51.2± ± ±12.9 <0.001* Peak pressure gradient, mmhg±sd 83.4± ± ±25.0 <0.001* Mean pressure gradient, mmhg±sd 52.1± ± ± * Mitral regurgitation 3+ or 4+, n (%) 41 (6.2) 23 (6.4) 18 (5.9) 0.783
10 Results Procedural variables Overall population CAD group nocad group p value (n = 659) (n = 356) (n = 303) Procedure time, minutes±sd 79.1± ± ± Approach 0.013* Trans-femoral, n (%) 595 (90.3) 312 (86.9) 283 (93.4) Trans-subclavian, n (%) 64 (9.7) 44 (13.1) 20 (6.6) Anesthesia Local, n (%) 476 (72.2) 248 (69.9) 228 (75.2) General, n (%) 183 (27.8) 108 (30.1) 75 (24.8) Device 0.001* CRS 26-mm 403 (61.1) 188 (52.4) 215 (70.9) CRS 29-mm 256 (38.9) 155 (47.6) 101 (33.3)
11 Results Procedural Outcomes Overall population (n = 659) CAD group (n = 356) nocad group (n = 303) p value Procedural success, n (%) 648 (98.3) 351 (97.8) 297 (98.0) Valve-in-Valve, n (%) 24 (3.6) 14 (3.9) 10 (3.3) Post dilatation, n (%) 67 (10.2) 41 (11.4) 26 (8.6) Death, n (%) 6 (0.9) 3 (0.8) 3 (0.9) Myocardial infarction, n (%) 0 (0) 0 (0) 0 (0.0) Stroke, n (%) 8 (1.2) 3 (0.8) 5 (1.6) Conversion to open heart surgery, n (%) 5 (0.8) 3 (0.8) 2 (0.7) MACCE, n (%) 14 (2.1) 6 (1.7) 8 (2.6) Major access site complications, n (%) 13 (1.9) 6 (1.7) 7 (2.3) Cardiac tamponade, n (%) 8 (1.2) 5 (1.4) 3 (0.9) 0.454
12 Survival, probability (%) Results 1-year survival % 84.0% nocad group CAD group N=659 pts Adjusted HR 1.01 (95% CI 0.55 to 1.88) Log Rank: p= Days (time)
13 Freedom from MI, probability (%) Results 1-year freedom from spontaneous MI % 98.0% nocad group CAD group N=659 pts 0.2 Log Rank: p= Days (time)
14 Freedom from MACCE, probability (%) Results 1-year freedom from MACCE % % nocad group CAD group N=659 pts Adjusted HR 0.84 (95% CI 0.46 to 1.53) Log Rank: p= Days (time)
15 Results Subgroups Analysis 1 year MACCE 1 year All-cause death HR 95% LCL 95% UCL P value P interaction HR 95% LCL 95% UCL P value P interaction Angina Angina Age> Age LV-EF> LV-EF Diabetes mellitus Diabetes mellitus Logistic EuroSCORE> Logistic EuroSCORE
16 Results Type of revascularization pre TAVI 100% 80% N=275 pts* 83% 60% 40% 51% 49% 41% 33% 26% 20% 0% 5% 0% 1-vessel 2-vessels 3-vessels 12% Complete revascularization Incomplete revascularization No-revascularization *patents with significant coronary stenosis (not protected by bypass grafting), found at the time of the angiographic screening for TAVI
17 Survival, probability (%) Results Type of revascularization - Mortality % % Complete revascularization Incomplete revascularization No revascularization 81.9% 0.2 N=275 pts 0.0 Log Rank: p= Days (time)
18 Freedom from MACCE, probability (%) Results Type of revascularization - MACCE % % Complete revascularization Incomplete revascularization No revascularization 79.0% 0.2 N=275 pts 0.0 Log Rank: p= Days (time)
19 86 yo Angina CCs3/Pulmonary Edema Aortic Stenosis LM, LAD, Cx disease BAV PCI LM & LAD Study Limitations
20 PCI LAD Endeavor 2.5/18, 2.5/18, 2.75/241 LM Endeavor 3.5/9 NYHA 2 Successful TAVI with CRS 26 1 month later 3 years follow up NYHA class 2
21 Study Limitations Potential differences in TAVI experience among the participating centers Short Follow-up (The presence and extent of CAD is likely to impact long-term survival in patients treated with TAVI, but the length of follow-up reported in this analysis was not adequate to demonstrate this difference) The lack of specific tools such as fractional flow reserve, intravascular ultrasound, quantitative coronary analysis to assess significance of coronary stenosis
22 Conclusions The association of aortic stenosis and CAD is frequent Acute and mid-term outcomes of patients who underwent TAVI with CRS device were not affected by the presence of concomitant CAD In a TAVI setting for elderly, complete revascularization might not be always necessary Heart Team involvement is mandatory in the decision making
23 Conclusions Heart Team Mission Indications for PCI? Timing of PCI? PCI with or without Balloon Valvuloplasty? Complete or incomplete revascularization? Which stent? Reconsider SAVR + CABG? Optimal Medical Therapy?
24 Thank you on behalf of the CoreValve Italian Registry investigators
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