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