Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Angelo Ramondo, MD; Anna Sonia Petronio, MD;...

Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Corrado Tamburino, MD, PhD; Davide Capodanno, MD;

Angelo Ramondo, MD; Anna Sonia Petronio, MD; Federica Angelo Ramondo, MD; Anna Sonia Petronio, MD; Federica

Ettori, MD; Gennaro Santoro, MD; Silvio Klugmann, MD; Ettori, MD; Gennaro Santoro, MD; Silvio Klugmann, MD;

Francesco Bedogni, MD; Francesco Maisano, MD; Antonio Francesco Bedogni, MD; Francesco Maisano, MD; Antonio

Marzocchi, MD; Arnaldo Poli, MD; David Antoniucci, MD; Marzocchi, MD; Arnaldo Poli, MD; David Antoniucci, MD;

Massimo Napodano, MD; Marco De Carlo, MD, PhD;Massimo Napodano, MD; Marco De Carlo, MD, PhD;

Claudia Fiorina, MD; Gian Paolo Ussia, MDClaudia Fiorina, MD; Gian Paolo Ussia, MD

Incidence and Predictors of Early and Late Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Implantation in 663 Patients With Severe

Aortic StenosisAortic Stenosis

Circulation. 2011;123:299-308.Circulation. 2011;123:299-308.

Ospedale Ferrarotto

Università di Catania

Transcatheter aortic valve implantation (TAVI) has Transcatheter aortic valve implantation (TAVI) has

emerged as a promising alternative to conventional emerged as a promising alternative to conventional

aortic valve replacement for patients with severe aortic aortic valve replacement for patients with severe aortic

stenosis who are otherwise left untreated due to the stenosis who are otherwise left untreated due to the

perceived high risk of operative mortalityperceived high risk of operative mortality

There is a lack of information on the incidence and There is a lack of information on the incidence and

predictors of early mortality at 30 days and late predictors of early mortality at 30 days and late

mortality between 30 days and 1 year after TAVI with mortality between 30 days and 1 year after TAVI with

the self-expanding CoreValve Revalving prosthesisthe self-expanding CoreValve Revalving prosthesis

BackgroundBackground

Ospedale Ferrarotto


CoreValve RevalvingCoreValve Revalving®® System SystemCoreValve 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

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22mm

20-23mm

annulus

Native

Ascending

aorta

≤ 40mm

24mm

24-27mm

annulus

Native

Ascending

aorta

≤ 45mm

Two CoreValve sizes fit Two CoreValve sizes fit 90% of patients90% of patients

CoreValve RevalvingCoreValve Revalving®® System System

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ItalianItalian CoreValve CoreValve RegistryRegistry

•Since June 2007 a web-based registry was started

•14 participating sites

First patientFirst patientJune 2007June 2007

Catania, UniversityCatania, University

Pisa, UniversityPisa, University

Brescia, H. CivileBrescia, H. Civile

Padova, UniversityPadova, University

Milano, S.AmbrogioMilano, S.Ambrogio

Milano, NiguardaMilano, Niguarda

Firenze, CareggiFirenze, Careggi

Milano, S.RaffaeleMilano, S.Raffaele

Bologna, UniversityBologna, University

Roma, S. CamilloRoma, S. Camillo

LegnanoLegnano

Firenze, CareggiFirenze, Careggi

Bari, UniversityBari, University

MiranoMirano

Ospedale Ferrarotto


Overall populationOverall population

(n = 663)(n = 663)

Pts who diedPts who died

(n = 114)(n = 114)

Pts who SurvivedPts who Survived

(n = 549)(n = 549)

p valuep value

Age, years±SD 81.0±7.3 80.9±6.6 81.3±5.7 0.54

Female gender, n (%) 371 (56.0) 59 (51.8) 312 (56.8) 0.32

Logistic EuroSCORE, %±SD 23.0±13.7 24.9±15.1 22.6±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*

ItalianItalian CoreValveCoreValve RegistryRegistryBaseline Characteristics 663 ptsBaseline Characteristics 663 pts

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(n = 663)(n = 663)


(n = 114)(n = 114)


(n = 549)(n = 549)

p valuep value

Left ventricular ejection fraction, %±SD 52.1±25.5 48.9±13.5 52.8±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±25.1 79.0±25.6 84.7±24.9 0.03*

Mean pressure gradient, mmHg±SD 51.8±17.0 48.2±17.6 52.6±16.8 0.02*

Annulus diameter, mm±SD 22.2±2.2 22.6±2.2 22.1±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

ItalianItalian CoreValveCoreValve RegistryRegistryBaseline echo paramethers 663 ptsBaseline echo paramethers 663 pts

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(n = 663)(n = 663)


(n = 114)(n = 114)


(n = 549)(n = 549)

p valuep value

Procedure time, minutes±SDProcedure time, minutes±SD 79.1±33.679.1±33.6 78.4±35.978.4±35.9 79.2±33.179.2±33.1 0.830.83

ApproachApproach 0.730.73

Trans-femoral, n (%)Trans-femoral, n (%) 599 (90.3)599 (90.3) 102 (89.5)102 (89.5) 497 (90.5)497 (90.5)

Trans-subclavian, n (%)Trans-subclavian, n (%) 64 (9.7)64 (9.7) 12 (10.5)12 (10.5) 52 (9.5)52 (9.5)

AnesthesiaAnesthesia 0.02*0.02*

General, n (%)General, n (%) 183 (27.6)183 (27.6) 42 (36.8)42 (36.8) 141 (25.7)141 (25.7)

Local, n (%)Local, n (%) 480 (72.4)480 (72.4) 72 (63.2)72 (63.2) 408 (74.3)408 (74.3)

Arterial hemostasisArterial hemostasis 0.350.35

Percutaneous, n (%)Percutaneous, n (%) 566 (85.4)566 (85.4) 94 (82.5)94 (82.5) 472 (86.0)472 (86.0)

Surgical, n (%)Surgical, n (%) 97 (14.6)97 (14.6) 20 (17.5)20 (17.5) 77 (14.0)77 (14.0)

Post-dilatation, n (%)Post-dilatation, n (%) 68 (10.2)68 (10.2) 18 (15.8)18 (15.8) 50 (9.1)50 (9.1) 0.03*0.03*

Procedural success, n (%)Procedural success, n (%) 650 (98.0)650 (98.0) -- -- --

ItalianItalian CoreValveCoreValve RegistryRegistryProcedural Variables 663 ptsProcedural Variables 663 pts

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(n = 663)(n = 663)


(n = 114)(n = 114)


(n = 549)(n = 549)

p valuep value

Death, n (%)Death, n (%) 6 (0.9)6 (0.9) -- -- --

Myocardial infarction, n (%)Myocardial infarction, n (%) 0 (0)0 (0) 0 (0)0 (0) 0 (0)0 (0) 1.001.00

Stroke, n (%)Stroke, n (%) 8 (1.2)8 (1.2) 4 (3.5)4 (3.5) 4 (0.7)4 (0.7) 0.03*0.03*

Post-procedural paravalvular leak ≥2+Post-procedural paravalvular leak ≥2+ 139 (21.0)139 (21.0) 33 (28.9)33 (28.9) 106 (19.3)106 (19.3) 0.110.11

Valve embolization, n (%)Valve embolization, n (%) 4 (0.6)4 (0.6) 1 (0.9)1 (0.9) 3 (0.5)3 (0.5) 0.530.53

Valve-in-valve implantation, n (%)Valve-in-valve implantation, n (%) 24 (3.6)24 (3.6) 3 (2.6)3 (2.6) 21 (3.8)21 (3.8) 0.780.78

Conversion to open heart surgery, n (%)Conversion to open heart surgery, n (%) 5 (0.8)5 (0.8) 4 (3.5)4 (3.5) 1 (0.2)1 (0.2) 0.004*0.004*

Major access site complications, n (%)Major access site complications, n (%) 13 (2.0)13 (2.0) 3 (2.6)3 (2.6) 10 (1.8)10 (1.8) 0.480.48

Life-threatening arrhytmias, n (%)Life-threatening arrhytmias, n (%) 13 (2.0)13 (2.0) 6 (5.3)6 (5.3) 7 (1.3)7 (1.3) 0.01*0.01*

Cardiac tamponade, n (%)Cardiac tamponade, n (%) 8 (1.2)8 (1.2) 4 (3.5)4 (3.5) 4 (0.7)4 (0.7) 0.03*0.03*

Need for permanent pacemaker †, n (%)Need for permanent pacemaker †, n (%) 110 (16.6)110 (16.6) 17 (14.9)17 (14.9) 93 (16.9)93 (16.9) 0.600.60

ItalianItalian CoreValveCoreValve RegistryRegistryProcedural Outcomes 663 ptsProcedural Outcomes 663 pts

† Implanted within 14 days from the procedure

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MACCEMACCE 16.6%16.6%

DeathDeath 15.0%15.0%

Myocardial infarctionMyocardial infarction 1.2%1.2%

StrokeStroke 2.5%2.5%

CHF requiring hospitalization CHF requiring hospitalization 8.2%8.2%

Major bleedingMajor bleeding 3.2%3.2%

Pacemaker implantationPacemaker implantation 19.1%19.1%

Prosthesis dysfunction Prosthesis dysfunction 0.2%0.2%

EndpointEndpoint Cumulative incidence Cumulative incidence

ItalianItalian CoreValveCoreValve RegistryRegistryOne-year clinical resultsOne-year clinical results

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Overall mortality Hazard ratio 95% LCL 95% UCL p value

Intraprocedural stroke 15.76 3.27 75.90 0.001

Pre-procedural mitral regurgitation 3+ or 4+ 4.62 1.66 12.87 0.003

Systolic pulmonary artery pressure > 60 mmHg 3.21 1.19 8.71 0.02

Prior acute pulmonary edema 2.75 1.32 5.72 0.007

Diabetes mellitus 2.45 1.19 5.07 0.02

Early mortality Odds ratio 95% LCL 95% UCL p value

Conversion to open heart surgery 38.68 2.86 522.59 0.006

Cardiac tamponade 10.97 1.59 75.61 0.02

Major access site complications 8.47 1.67 42.82 0.01

Left ventricular ejection fraction < 40% 3.51 1.62 7.62 0.002

Prior balloon aortic valvuloplasty 2.87 1.24 6.65 0.01

Diabetes mellitus 2.66 1.26 5.65 0.01

Late mortality Hazard ratio 95% LCL 95% UCL p value

Prior stroke 5.468 1.47 20.39 0.01

Post-procedural paravalvular leak ≥2+ 3.785 1.57 9.10 0.003

Prior acute pulmonary edema 2.696 1.09 6.68 0.03

Chronic kidney disease 2.532 1.01 6.35 0.048

ItalianItalian CoreValveCoreValve RegistryRegistryMultivariate analysisMultivariate analysis

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Early mortality

Late mortality

Cumulative mortality

ItalianItalian CoreValveCoreValve RegistryRegistryDistribution of mortality over timeDistribution of mortality over time

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Same or betterSame or better

worseworse

ItalianItalian CoreValveCoreValve RegistryRegistryNYHA ClassNYHA Class

Ospedale Ferrarotto


N=661


worseworse

ItalianItalian CoreValveCoreValve RegistryRegistryAortic RegurgitationAortic Regurgitation

Ospedale Ferrarotto


N=661


worseworse

ItalianItalian CoreValveCoreValve RegistryRegistryParaprosthetic LeakParaprosthetic Leak

Ospedale Ferrarotto


25

20

15

10

5

0

0 60 120 180 240 300 360

Dea

th (

%)

Time (days)

15%

N=663 ptsN=663 pts30

ItalianItalian CoreValveCoreValve RegistryRegistry1-year Overall Mortality1-year Overall Mortality

Ospedale Ferrarotto


N=663 ptsN=663 pts

25

20

15

10

5

0

0 60 120 180 240 300 360D

eath

(%

)

Time (days)

30

25

20

15

10

5

0

0 5 10 15 20 25 30

Dea

th (

%)

Time (days)

30

5.4%

Early Events (0-30 days)Early Events (0-30 days) Late Events (30-365 days)Late Events (30-365 days)

9.7%

ItalianItalian CoreValveCoreValve RegistryRegistry1-year Overall Mortality Subdivided Into Early 1-year Overall Mortality Subdivided Into Early

And Late EventsAnd Late Events

Ospedale Ferrarotto


25

20

15

10

5

0

0 60 120 180 240 300 360

Dea

th,

MI

or

stro

ke (

%)

Time (days)

16.6%

N=663 ptsN=663 pts30

ItalianItalian CoreValveCoreValve RegistryRegistry1-year Overall Incidence of Death, MI or Stroke1-year Overall Incidence of Death, MI or Stroke

Ospedale Ferrarotto


N=663 ptsN=663 pts

25

20

15

10

5

0

0 60 120 180 240 300 360

Time (days)

30

25

20

15

10

5

0

0 5 10 15 20 25 30

Dea

th,

MI

or

stro

ke (

%)

Time (days)

30

6.4%

Early Events (0-30 days)Early Events (0-30 days) Late Events (30-365 days)Late Events (30-365 days)

10.3%

Dea

th,

MI

or

stro

ke (

%)

ItalianItalian CoreValveCoreValve RegistryRegistry1-year Overall Incidence of Death, MI or Stroke 1-year Overall Incidence of Death, MI or Stroke

Subdivided Into Early And Late EventsSubdivided Into Early And Late Events

Ospedale Ferrarotto


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.

ConclusionsConclusions

Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Angelo Ramondo, MD; Anna Sonia Petronio, MD;...

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