SHA24/033002

ESC in Saudi Arabia Valve Disease: TAVI & MitraClip: European Perspective

Abbott MitraClip

Medtronic CoreValve

Edwards Sapien XT

Carlo Di Mario, FRCP; Rodrigo Estevez, MD; Tom Snow, MRCP; Michael Chan, MD; Eduardo Alegria, MD; Richard Trimlett, FRCS; Ulrich Rosendhal, MD; Andrea Koelliker, FRCA; Alison Duncan, MRCP; John Pepper, FRCS; Simon Davies, FRCP; Neil Moat FRCS Royal Brompton Hospital & Imperial College, London, UK

Alan Cribier, Rouen, France

ESC Andreas Gruentzig Lecture 2010 •Cardiogenic shock , surgery denied

16th of April 2002

Transcatheter Valve Treatment

The concept of stented valve End of the 80’s

•A. Cribier

« The most stupid idea I have ever heard »

Respect the anatomical structures: Coronary arteries, septum and mitral valve

Mitral Valve

Pre – TAVI MSCT Scans 1.

2.

3.

Calcium scan (prospectively gated) Retrospectively gated scan through the heart Whole body CT arteriogram from base of skull to femoral arteries

Total contrast volume: 165ml No β-blocker

TAVI: Ideal Implantation Angle

LAO 15 Caudal 10

TAVI: Annular measurements

TAVI: Perimeter

Coronary ostia distance

Ascending aorta

TAVI – Access Routes Right and Left Ilio-femoral arteries

Solid line sensitivity; broken line specificity.

Sheath-to-Femoral Artery Ratio (SFAR)

Conclusion: VARC major vascular Cx increases mortality and predicted

by SFAR, femoral calcification, center experience

Recommendation: non-calcified vessel: 6.5 mm for 18 Fr sheath calcified vessel: 7.2 mm for 18 Fr sheath JACC Cardiovasc Interv 2011

Entry Routes Edwards

CoreValve

Balloon expandable

Self expandable

23, 26 and 29 mm

23, 26, 29 and 31 mm

SUB-CLAVIAN

FEMORAL

TRANS-APICAL

DIRECT AORTIC

FEMORAL

18-19 Fr

24 Fr

18 Fr

TAVI – Access Routes Left subclavian artery

Direct Aortic Access

CoreValve European Registry R anterior minithoractomy N = 49 (52.5%)

Upper ministernotomy N = 44 (47.5%)

From Moat et al, submitted

Patient Evaluation and Procedural Planning Pre-operative CT mandatory • Determine aortic access site is ≥6 cm from the basal plane of the annulus • Select access site to achieve a delivery trajectory that optimizes coaxial alignment with native aortic valve • Identify appropriate thoracic access location • Assess absence of calcification at aortic access site • Identify critical vessels (e.g. right internal thoracic artery, patent RIMA graft) in delivery trajectory

THV Delivery under RVP Edwards Balloon Expandable

2

3

Inflation

Deflation

Pacing

Pacing

ON

OFF

1

4

Severe AR

AR 2+

Inoperable PARTNER Cohort Primary Endpoint: All-Cause Mortality Standard Rx

All-cause mortality (%)

TAVI

∆ at 1 yr = 20.0% NNT = 5.0 pts

HR [95% CI] = 0.54 [0.38, 0.78] P (log rank) < 0.0001 50.7%

30.7%

Months

Leon et al, NEJM 2010; 363:1597-1607 Numbers at Risk TAVI Standard Rx

179 179

138 121

122 83

67 41

26 12

The PARTNER Trial N Engl J Med 2011;364:2187-98

2 years- PARTNER P1B All Stroke (ITT) Standard Rx

Incidence (%)

TAVR

HR [95% CI] = 2.79 [1.25, 6.22] p (log rank) = 0.009

∆ at 1 yr = 5.7%

∆ at 2 yr = 8.3% 13.8%

11.2%

5.5% 5.5% Months Numbers at Risk TAVR 179 Standard Rx 179

Raj Makkar, TCT 2011

128 118

116 84

105 62

79 42

Paravalvular Regurgitation: TAVI •No changes over time

•30 Day

•6 Month

•1 Year

•None/Trace

•Moderate

•Mild

•Severe

The PARTNER Trial

Paravalvular Leaks > Mild Significantly Associated with Late Mortality P < .001

P < .001

30 Days

6 Months

2 Years

Patients, %

P < .001

None

Trace

Mild

Moderate

Severe

Pilot Sentinel Registry TCVT Executive Committee Carlo Di Mario, UK (Chairman), EAPCI Neil Moat, UK, ESC WG of Cardiovascular Surgery Bernhard Iung, France, ESC WG on Valve Disease Gerhard Schuler, Germany, EAPCI Pepe Zamorano, Spain, EAE Ottavio Alfieri, Italy, EACTS Olaf Franzen, Denmark, EAPCI Susanna Price, UK, ESC WG Acute Cardiac Care Luigi Tavazzi, ESC, Oversight Committee Aldo Maggioni, EHH, Statistical Analysis

Transcatheter Valve Pilot Sentinel Registry TAVI: Type and Size of Valve Implanted

4,571 Pts from 10 Countries Enrolled 2011-12 Valve Type

1943 (42.6%)

2604 (57.4%)

Small (23 E/26 C)

40.8%

44.2%

Medium (26 E/ 29 C)

53.1%

48.7%

Large (29 E/ 31 C)

6.1%

7.1%

TCVT Pilot Registry July 10, 2012

Transcatheter Valve Pilot Sentinel Registry

TAVI 4571 Pts: Patient Distribution

CENTRES

BE

CZ

FR

DE

IL

IT

PL

SP

CH

GB

2

9

33

2

2

13

11

26

12

25

141

2279

12

4

254

157

689

129

886

3.1

49.9

0.3

0.1

5.5

3.4

15.1

2.8

19.4

PATIENTS 20 %

0.4

ď&#x192;źConsecutive enrolment in participating centres for the entire 2011 (national registries) or between EC approval and June 2012 (web-based entries) ď&#x192;źMonitoring program of registries of participating countries (adjudicated results) or via queries generated at the Heart House

Transcatheter Valve Pilot Sentinel Registry TAVI 4571 Pts: Sex, Age and Body Mass Index Age

70

Mean 81.4 (SD 7,14) y/o

%

60

Gender

M 50.1

49.9

50 40

total

30

male

F 20

female

10

BMI 26.6 (SD 4.9)

0 <70 y

71-80

81-90 TCVT Pilot Registry July 10, 2012

>90

TAVI: Patient Characteristics (I) by Age Variable (# observations)

Total, n (%) 4571

<80, n (%) 1721 (37.5)

>80, n (%) 2850 (62.4)

P value

2291(50.1)/2280(49.9)

(58.6)/(41.4)

(45.0)/(55.0)

< 0.01

Diabetes mellitus (4547 pts)

1259 (27.7)

618 (36.1)

641 (22.6)

< 0.01

Hypertension (3664 pts)

2709 (73.9)

956 (73.3)

1753 (74.3)

0.52

Current Smoking (4357 pts)

185 (4.2)

122 (7.4)

63 (2.3)

< 0.01

Atrial fibrillation (2773 pts)

557 (20.1)

177 (19.7)

380 (20.3)

0.65

COPD (3844 pts)

981 (25.5)

438 (31.5)

543 (22.1)

< 0.01

Dialysis (3821 Pts)

265 (6.9)

142 (10.2)

123 (5.1)

< 0.01

Previous stroke (4282 pts)

206 (12.1)

218 (12.7)

333 (11.7)

0.32

Previous MI (4549 pts)

769 (16.9)

348 (20.3)

421 (14.8)

< 0.01

Prev cardiac surgery (4505 pts)

824 (18.0)

469 (27.8)

355 (12.6)

< 0.01

Previous PCI (2289 pts)

463 (20.2)

227 (22.1)

236 (18.7)

0.04

Male/Female (4571 pts)

TAVI: Patient Characteristics (II) by Age Variable (# observations)

Total, n (%) 4571

<80, n (%) 1721 (37.5)

>80, n (%) 2850 (62.4)

P value

Previous PM (3676 pts)

430 (11.7)

114 (8.7)

316 (13.3)

< 0.01

Extracard arteriopathy (2707pts)

671 (24.8)

238 (27.1)

433 (23.7)

<0.05

Porcelain Aorta (465 pts)

104 (22.4)

58 (28.4)

46 (17.6)

< 0.01

Chest deformity (409 pts)

12 (2.9)

8 (4.6)

4 (1.7)

0.08

Previous AVR (2141 pts)

74 (3.4)

40 (4.1)

34 (2.9)

0.05

40 (5.7) 191 (27.2) 470 (67.0)

28 (9.5) 74 (25.2) 192 (65.3)

12 (2.9) 117 (28.7) 278 (68.3)

< 0.01

Significant CAD (3343 pts)

669 (20.0)

289 (21.5)

380 (19.0)

0.07

Significant LM (3343 pts)

215 (6.7)

92 (7.01)

123 (6.5)

0.54

20.2 (13.3)

17.4 (13.2)

22.0 (13.1)

<0.01

LVEF (701 pts)

<30% 30-50% >50%

Logistic Euroscore (4394 pts)

Transcatheter Valve Pilot Sentinel Registry TAVI Logistic EuroSCORE by Country

: insufficient country sample

Speaker

TCVT Pilot Registry July 10, 2012

Transcatheter Valve Pilot Sentinel Registry TAVI: Access Site

%

Access Site

Femoral

Apical

Other

3390 (74.2%)

749 (16.4%)

432 (9.4%)

TCVT Pilot Registry July 10, 2012

Patient and Procedural Characteristics by Access Site Transfemoral 3390 (74.2%)

Transapical 749(16.4%)

Other 432(9.4%)

P value

(46.5)/(53.5)

(62.4)/(37.5)

(57.4)/(42.6)

< 0.01

Diabetes mellitus

905 (26.8)

221 (29.9)

133 (30.9)

0.07

COPD

719 (25.3)

131 (22.3)

131 (31.7)

< 0.01

Dialysis

176 (6.1)

45 (7.5)

44 (12.6)

< 0.01

Previous MI

519 (15.4)

164 (22.1)

86 (19.9)

< 0.01

Previous cardiac surgery

543 (16.2)

220 (30.2)

61 (14.2)

< 0.01

Previous PCI

331 (19.0)

90 (24.5)

42 (23.3)

0.03

Previous PM

342 (12.3)

53 (9.0)

35 (11.1)

0.07

58 (1.7)

9 (1.2)

7 (1.6)

0.21

30 (5.0) 165 (27.1) 408 (67.9)

3 (5.6) 16 (29.6) 35 (64.8)

7 (15.2) 12 (26.1) 27 (58.7)

0.07

477 (18.8)

116 (23.3)

76 (24.8)

< 0.01

19.6±12.9

22.2±14.2

21.6±13.9

< 0.01

Male/Female

Previous AVR (valve-in-valve) LVEF

<30% 30-50% >50% Significant CAD (>= 1 vessel) Logistic Euroscore

Transcatheter Valve Pilot Sentinel Registry TAVI: Transfemoral Access by Country

Speaker

: insufficient country sample

Transcatheter Valve Pilot Sentinel Registry TAVI: Local Anaesthesia for Femoral Approach

Speaker

: insufficient country sample

Transcatheter Valve Pilot Sentinel Registry TAVI: Successful Deployment

VALVE SUCCESSFULLY DEPLOYED: 96.5% Access

AGE

%

<= 80 y/o

96.5

> 80 y/o

96.5

%

p= 0.96

Transfemoral

96.8

Transapical

95.1

Valve

%

Other

97

Corevalve

96.4

Sapien-XT

96.8

p= 0.08

TCVT Pilot Registry July 10, 2012

p= 0.55

TCVT Registry In-Hospital Complications

by Access Site Death (Total 7.4%)

5.9

12.8

9.7

<0.01

Stroke (Total 1.8%)

1.9

1.6

1.4

0.68

MI (Total 0.9%)

0.7 4.5

1.9 10.7

0.09

PM implantation

0.9 15.5

<0.01

Haemodialysis

1.2

2.4

3.6

<0.01

Transfusion(s)

20.8 9

22.9 6.5

<0.01

New onset AF

15 5.1

Hosp. stay >10 days

22

43.8

39.5

<0.01

<0.01

TCVT Pilot Registry TAVI In-Hospital Complications

by Valve Type

Death (Total 7.4%)

6.7

7.9

0.15

Surgical conversion

5.5

3.3

<0.01

Second valve implanted

1.4 2.1 6

<0.01

PM implantation

3.7 1.1 23.4

AR grade 2

9.9

6.1

<0.01

2.3

0.6

<0.01

Haemodialysis/filtration

AR grade 3

Speaker

<0.01 <0.01

Transcatheter Valve Pilot Sentinel Registry Predictors of TAVI In-Hospital Mortality at Multivariate Analysis VARIABLE

ODDS-RATIO

95% CI

P-VALUE

Age (8 years interval)

1.18

1.01 – 1.37

0.0414

Euroscore (>Q3 vs <=Q1)

1.74

1.24 – 2.46

0.0002

Pre MR (Grade ≥2 vs no/grade1)

1.45

1.08 – 1.93

0.0099

Valve successfully deployed (No vs Yes)

7.30

5.04 – 10.57

< 0.0001

TCVT Pilot Registry July 10, 2012

HIGHLIGHT SESSION

German Aortic Valve Registry Y R Patients GA (GARY) Inclusion from 01/01/2011 to 31/12/2011 53 cardiac surgery units

69 cardiology units

13.860 patients

6.523 surgical AVR

3.462 surgical

2.694 transvascular

1.181 transapical

without CABG

AVR with CABG

TAVI

TAVI

6.523

3.462

2.694

1.181 C. Hamm | DE | 2166

Higher Risk for TAVI Patients

HIGHLIGHT SESSION

Patients referred for TAVI were - older (85% vs. 38% >75 yrs) - more female gender (55% vs. 33%) and had higher rates - of heart failure (86% vs. 65%) - LVEF <30% (8% vs. 4%) - atrial fibrillation (29% vs. 15%) - pulmonary hypertension (31% vs. 11%) - COPD (20% vs. 11%) - IDDM (15% vs. 9%) than surgical AVR patients C. Hamm | DE | 2166

Y G AR

HIGHLIGHT HIGHLIGHT SESSION SESSION

Results – Outcome

Outcome Data

9,0% 8,0%

n=6517

n=3458

n=2689

n=1177

Mortality (in-hospital) 7,7%

7,0% 6,0% 5,0%

5,1%

4,0%

4,5%

Y GAR

3,0% 2,0%

2,1%

1,0% 0,0%

Results – Outcome

4,0%

without CABG

with CABG

Surgical AVR

transvascular

transapical TAVI

Cerebrovascular Events n=6517

n=3458

3,5%

3,6%

n=2689

n=1177

3,7%

3,5%

3,0% 2,5% 2,0%

2,2%

1,5% 1,0% 0,5% 0,0%

without CABG

with CABG

Surgical AVR

transvascular

transapical TAVI

C. Hamm | DE | 2166

HIGHLIGHT SESSION

HIGHLIGHT SESSION

HIGHLIGHT SESSION

HIGHLIGHT SESSION

HIGHLIGHT SESSION

Two very different entities â&#x20AC;Ś..

Etiology of MR

Degenerative MR

Functional MR

P2 Prolapse

Central MR

Mitral Valve Repair Alfieri Stitch Edge-to-Edge Technique POSTERIOR P2

ANTERIOR A2

MitraClip® Device Key Technology Design Features

 Repositionable and removable  Independent leaflet capture Arm on ventricular side; Gripper on atrial side

 Polyester cover designed to promote tissue healing  Dimensions replicate surgical E2E coaptation area Two clip option to increase coaptation area  MRI safe to 3 Tesla

Description of MitraClip System Clip delivery handle Steerable sleeve

Guide Stabilizer

TransSeptal Puncture Technique  TOE-guided “two-dimensional” puncture – Through “Posterior - Mid” aspect of fossa  Guide tip positioned near line of coaptation (LOC) – More posterior than expected – Through “Superior” portion of fossa  Guide further away from plane of MV: “working space” above valve in LA  Use TOE! – Observe tenting in the bi-caval view AND – Observe “tenting” in SAX view at base (A-P) AND – In “4-Chamber” view (Height/Working Space)

Guide crossing Guide Marker

Guide across Guide

Amplatz

On fluoro, advance steerable sleeve to tip of guide

Advance Steerable sleeve

Guide

Continue to Advance CDS Bullet nose Bullet nose

Sleeve Markers

Turn M knob, torque guide posterior

Loosen Fastener

Long Axis (“LVOT”) For A-P Adjustments (loosen fastener on stabilizer)

Torque guide

Loosen Fastener

(Inter)Commissural-2 chamber

For Angle adjustments

Medial-Lateral

Clip M

L M L Knob

(Inter)Commissural-2 Chamber

For

Medial-Lateral Adjustments

M

Clip L

Move Entire System M L

Align clip to MR origin (2 Chamber)

Clip

Origin medial to clip

Clip moved medial

3D assessment for perpendicularity perpendicular alignment of the Clip Arms to Line of Coaptation

Central alignment

Torque

Clockwise torque rotates the clip clockwise

Translate several times Translate to remove stored torque

Advance clip below valve leaflets

Grippers

May need to check TGSAX again

Importance of Leaflet Insertion Slowly pull back the Delivery Handle to capture the Leaflets

Leaflet

Arm

Note height of prolapse

Leaflet resting on arm

Healing Over Implanted Clip

Organized fibrous endocardial growth over polyester Clip covering (562 d Clip explant, 10 X)

EVEREST II

 Multicenter randomised trial (2:1)  MitraClip (n=184) vs MV surgery (n=95)  Primary efficacy EP: death, MV surgery and MR >2+ at 12 month  Primary safety EP: MACE at 30d (death, myocardial, infarction, reoperation for failed mitral valve surgery, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, mechanical ventilation for more than 48 hours, gastrointestinal complication requiring surgery, newonset permanent atrial fibrillation, septicemia, and transfusion of 2 units or more of blood)  Stringent echo criteria Feldman T, N Engl J Med 2011; 2011;364:1395

Freedom Surgery or Reoperation

Feldman ACC 2011

ď&#x192;&#x2DC; 50 HF patients

MR reduction

NYHA class

Franzen O, Eur J Heart Fail 2011;13:569

   

51 pts Functional MR>2 Highly symptomatic in spite of CRT 2 periprocedural deaths

Auricchio A, JACC 2011;58:2183

NYHA class improvement

MR improvement

Auricchio A, JACC 2011;58:2183

Improving in LV remodelling and LVEF

Auricchio A, JACC 2011;58:2183

ACCESS Europe Registry

HIGHLIGHT SESSION

A Post Market Study of the MitraClip-System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at 1 Year, n=567 pts. (99,6% success rate)

W. Schillinger | DE | 5317

HIGHLIGHT SESSION

Echocardiographic and Clinical Outcome Mitral Regurgitation Grade*

NYHA Functional Class p<0.0001

100

I II

I

Percent Patients

80 72% NYHA Class I or II at 1 Year

60 II

40

III

20 0

III IV

IV

Baseline

1 Year

N = 343 Matched Cases

W. Schillinger | DE | 5317

Kaplan-Meier Freedom from Death

HIGHLIGHT SESSION

EuroScore <20 (n=314) Total pts.

EuroScore >20 (n=253)

W. Schillinger | DE | 5317

HIGHLIGHT SESSION

Management of Valvular Heart Disease (2012) TAVI is indicated for patients with severe symptomatic AS who are not suitable for AVR as assessed by a “heart team” and who are likely to gain improvement in their quality of life and have life expectancy of more than 1 year

B

TAVI should be considered in high risk patients with severe symptomatic aortic stenosis who may still be suitable for surgery but in whom TAVI is favoured by a “heart team” based on the individual risk profile and anatomic suitability

IIa

B

MitraClip may be considered in eligible pts with symptomatic severe primary MR are judged inoperable or at high surgical risk and have a life expectancy greater than 1 year

IIb

C

MitraClip may be considered in eligible pts with symptomatic severe secondary MR despite OMT including CRT

IIb

C