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Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Angelo Ramondo, MD; Anna Sonia Petronio, MD; Federica Ettori, MD; Gennaro Santoro, MD; Silvio Klugmann,

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Presentation on theme: "Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Angelo Ramondo, MD; Anna Sonia Petronio, MD; Federica Ettori, MD; Gennaro Santoro, MD; Silvio Klugmann,"— Presentation transcript:

1 Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Angelo Ramondo, MD; Anna Sonia Petronio, MD; Federica Ettori, MD; Gennaro Santoro, MD; Silvio Klugmann, MD; Francesco Bedogni, MD; Francesco Maisano, MD; Antonio Marzocchi, MD; Arnaldo Poli, MD; David Antoniucci, MD; Massimo Napodano, MD; Marco De Carlo, MD, PhD; Claudia Fiorina, MD; Gian Paolo Ussia, MD Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis Circulation. 2011;123:299-308.

2 Ospedale Ferrarotto Università di Catania  Transcatheter aortic valve implantation (TAVI) has emerged as a promising alternative to conventional aortic valve replacement for patients with severe aortic stenosis who are otherwise left untreated due to the perceived high risk of operative mortality  There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after TAVI with the self-expanding CoreValve Revalving prosthesis Background

3 Ospedale Ferrarotto Università di Catania CoreValve Revalving ® System CoreValve Revalving® System (CRS) SELF-EXPANDABLE FRAME ML  Diamond cell configuration  Laser cut nitinol  Three levels of radial force  Radiopaque TOP: primarily orients the system to blood flow and optimizes anchoring MIDDLE: designed to avoid coronaries (convexo-concave with sinus avoids need for rotational positioning) and contains the 3 valve leaflets for supra-annular function BOTTOM: compresses the native valve in native annulus for secure anchoring and minimized para- valvular leak

4 Ospedale Ferrarotto Università di Catania 22mm 20-23mm annulus Native Ascending aorta ≤ 40mm 24mm 24-27mm annulus Native Ascending aorta ≤ 45mm Two CoreValve sizes fit 90% of patients CoreValve Revalving ® System

5 Ospedale Ferrarotto Università di Catania Italian CoreValve Registry Since June 2007 a web-based registry was started 14 participating sites First patient June 2007 Catania, University Pisa, University Brescia, H. Civile Padova, University Milano, S.Ambrogio Milano, Niguarda Firenze, Careggi Milano, S.Raffaele Bologna, University Roma, S. Camillo Legnano Firenze, Careggi Bari, University Mirano

6 Ospedale Ferrarotto Università di Catania Overall population (n = 663) Pts who died (n = 114) Pts who Survived (n = 549) p value Age, years±SD 81.0±7.380.9±6.681.3±5.7 0.54 Female gender, n (%) 371 (56.0)59 (51.8)312 (56.8)0.32 Logistic EuroSCORE, %±SD 23.0±13.724.9±15.122.6±13.4 0.13 Diabetes mellitus, n (%) 175 (26.4)42 (36.8)133 (24.2)0.005* Coronary artery disease, n (%) 320 (48.3)60 (52.6)260 (47.4)0.31 Prior acute pulmonary edema, n (%) 213 (32.1)53 (46.5)160 (29.1)< 0.001* Prior balloon valvuloplasty, n (%) 113 (17.0)22 (19.3)91 (16.6)0.48 Prior myocardial infarction, n (%) 143 (21.6)28 (24.6)115 (20.9)0.39 Prior stroke, n (%) 48 (7.2)9 (7.9)39 (7.1)0.77 Prior bypass graft surgery, n (%) 104 (15.7)14 (12.3)90 (16.4)0.27 Prior PCI, n (%) 189 (28.5)38 (33.3)151 (27.5)0.21 Peripheral vascular disease, n (%) 127 (19.2)28 (24.6)99 (18.0)0.11 COPD, n (%) 141 (21.3)28 (24.6)113 (20.6)0.35 Cirrhosis Child class A or B, n (%) 13 (2.0)3 (2.6)10 (1.8)0.48 Renal insufficiency, n (%) 154 (23.2)40 (35.1)114 (20.8)0.001* Atrial fibrillation, n (%) 109 (16.4)21 (18.4)88 (16.0)0.53 Prior pacemaker, n (%) 42 (6.3)5 (4.4)37 (6.7)0.35 Porcelain aorta, n (%) 72 (10.9)16 (14.0)56 (10.2)0.23 NYHA class III and IV, n (%) 434 (71.5)95 (83.3)379 (69.0)0.002* Italian CoreValve Registry Baseline Characteristics 663 pts

7 Ospedale Ferrarotto Università di Catania Overall population (n = 663) Pts who died (n = 114) Pts who Survived (n = 549) p value Left ventricular ejection fraction, %±SD 52.1±25.548.9±13.552.8±27.4 0.14 Left ventricular ejection fraction < 40%, n (%) 135 (20.4)28 (24.6)107 (19.5)0.22 sPAP > 60 mmHg, n (%) 76 (11.5)22 (19.3)54 (9.8)0.004* Peak pressure gradient, mmHg±SD 83.7±25.179.0±25.684.7±24.9 0.03* Mean pressure gradient, mmHg±SD 51.8±17.048.2±17.652.6±16.8 0.02* Annulus diameter, mm±SD 22.2±2.222.6±2.222.1±2.1 0.03* Mitral regurgitation 3+ or 4+, n (%) 42 (6.3)15 (13.2)27 (4.9)0.001* Aortic regurgitation 3+ or 4+, n (%) 35 (5.3)8 (7.0)27 (4.9)0.36 Italian CoreValve Registry Baseline echo paramethers 663 pts

8 Ospedale Ferrarotto Università di Catania Overall population (n = 663) Pts who died (n = 114) Pts who Survived (n = 549) p value Procedure time, minutes±SD 79.1±33.678.4±35.979.2±33.10.83 Approach0.73 Trans-femoral, n (%) 599 (90.3) 102 (89.5) 497 (90.5) Trans-subclavian, n (%) 64 (9.7) 12 (10.5) 52 (9.5) Anesthesia0.02* General, n (%) 183 (27.6) 42 (36.8) 141 (25.7) Local, n (%) 480 (72.4) 72 (63.2) 408 (74.3) Arterial hemostasis 0.35 Percutaneous, n (%) 566 (85.4) 94 (82.5) 472 (86.0) Surgical, n (%) 97 (14.6) 20 (17.5) 77 (14.0) Post-dilatation, n (%) 68 (10.2) 18 (15.8) 50 (9.1) 0.03* Procedural success, n (%) 650 (98.0) --- Italian CoreValve Registry Procedural Variables 663 pts

9 Ospedale Ferrarotto Università di Catania Overall population (n = 663) Pts who died (n = 114) Pts who Survived (n = 549) p value Death, n (%) 6 (0.9) --- Myocardial infarction, n (%) 0 (0) 1.00 Stroke, n (%) 8 (1.2) 4 (3.5) 4 (0.7) 0.03* Post-procedural paravalvular leak ≥2+ 139 (21.0) 33 (28.9) 106 (19.3) 0.11 Valve embolization, n (%) 4 (0.6) 1 (0.9) 3 (0.5) 0.53 Valve-in-valve implantation, n (%) 24 (3.6) 3 (2.6) 21 (3.8) 0.78 Conversion to open heart surgery, n (%) 5 (0.8) 4 (3.5) 1 (0.2) 0.004* Major access site complications, n (%) 13 (2.0) 3 (2.6) 10 (1.8) 0.48 Life-threatening arrhytmias, n (%) 13 (2.0) 6 (5.3) 7 (1.3) 0.01* Cardiac tamponade, n (%) 8 (1.2) 4 (3.5) 4 (0.7) 0.03* Need for permanent pacemaker †, n (%) 110 (16.6) 17 (14.9) 93 (16.9) 0.60 Italian CoreValve Registry Procedural Outcomes 663 pts † Implanted within 14 days from the procedure

10 Ospedale Ferrarotto Università di Catania MACCE16.6% Death15.0% Myocardial infarction 1.2% Stroke2.5% CHF requiring hospitalization 8.2% Major bleeding 3.2% Pacemaker implantation 19.1% Prosthesis dysfunction 0.2% Endpoint Cumulative incidence Italian CoreValve Registry One-year clinical results

11 Ospedale Ferrarotto Università di Catania Overall mortalityHazard ratio95% LCL95% UCLp value Intraprocedural stroke15.763.2775.900.001 Pre-procedural mitral regurgitation 3+ or 4+4.621.6612.870.003 Systolic pulmonary artery pressure > 60 mmHg3.211.198.710.02 Prior acute pulmonary edema2.751.325.720.007 Diabetes mellitus2.451.195.070.02 Early mortalityOdds ratio95% LCL95% UCLp value Conversion to open heart surgery38.682.86522.590.006 Cardiac tamponade10.971.5975.610.02 Major access site complications8.471.6742.820.01 Left ventricular ejection fraction < 40%3.511.627.620.002 Prior balloon aortic valvuloplasty2.871.246.650.01 Diabetes mellitus2.661.265.650.01 Late mortalityHazard ratio95% LCL95% UCLp value Prior stroke5.4681.4720.390.01 Post-procedural paravalvular leak ≥2+3.7851.579.100.003 Prior acute pulmonary edema2.6961.096.680.03 Chronic kidney disease2.5321.016.350.048 Italian CoreValve Registry Multivariate analysis

12 Ospedale Ferrarotto Università di Catania Early mortality Late mortality Cumulative mortality Italian CoreValve Registry Distribution of mortality over time

13 Ospedale Ferrarotto Università di Catania Same or better worse Italian CoreValve Registry NYHA Class

14 Ospedale Ferrarotto Università di Catania N=661 Same or better worse Italian CoreValve Registry Aortic Regurgitation

15 Ospedale Ferrarotto Università di Catania N=661 Same or better worse Italian CoreValve Registry Paraprosthetic Leak

16 Ospedale Ferrarotto Università di Catania 25 20 15 10 5 0 060120180240300360 Death (%) Time (days) 15% N=663 pts 30 Italian CoreValve Registry 1-year Overall Mortality

17 Ospedale Ferrarotto Università di Catania N=663 pts 25 20 15 10 5 0 060120180240300360 Death (%) Time (days) 30 25 20 15 10 5 0 05 15202530 Death (%) Time (days) 30 5.4% Early Events (0-30 days) Late Events (30-365 days) 9.7% Italian CoreValve Registry 1-year Overall Mortality Subdivided Into Early And Late Events

18 Ospedale Ferrarotto Università di Catania 25 20 15 10 5 0 060120180240300360 Death, MI or stroke (%) Time (days) 16.6% N=663 pts 30 Italian CoreValve Registry 1-year Overall Incidence of Death, MI or Stroke

19 Ospedale Ferrarotto Università di Catania N=663 pts 25 20 15 10 5 0 060120180240300360 Time (days) 30 25 20 15 10 5 0 05 15202530 Death, MI or stroke (%) Time (days) 30 6.4% Early Events (0-30 days) Late Events (30-365 days) 10.3% Death, MI or stroke (%) Italian CoreValve Registry 1-year Overall Incidence of Death, MI or Stroke Subdivided Into Early And Late Events

20 Ospedale Ferrarotto Università di Catania  This large multicenter experience demonstrates that TAVI with the CRS is associated with early and sustained clinical and hemodynamic benefits in patients with severe AS at high risk for surgery-related mortality.  Thirty-day mortality is acceptably low when compared to the anticipated risk calculated by means of the EuroSCORE and is strongly associated with the occurrence of procedural complications.  Late mortality continues to occur after 30 days from TAVI up to 1 year, primarily as the effect of postprocedural moderate to severe paravalvular aortic regurgitation and nonvalve related comorbidities such as cerebrovascular disease, chronic kidney disease, and heart failure. Conclusions

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