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Current Status and Future Perspectives
Transcatheter Aortic Valve Implantation
Min – Suk Lee, RTAsan Medical Center, Seoul, Korea
History of Interventional Cardiology1953 Rubio-Alvarez Pulmonary wire valvuloplasty1966 Rashkind Atrial septostomy1966 Porstmann PDA closure1974 King/Mills ASD closure1975 Gianturco Coil occlusion of shunt1977 Grüntzig PTCA (coronary angioplasty)1979 Semb Pulmonary balloon valvuloplasty (newborns)1981 Singer Re-coarctation valvuloplasty1982 Kan Pulmonary balloon valvuloplasty1982 Gallagher His bundle ablation1983 Lababidi Aortic balloon valvuloplasty1984 Inoue Mitral balloon valvuloplasty1984 Fisher Ablation of WPW pathway1986 Puel Coronary stent implantation1987 Simpson Coronary atherectomy1990 Palacios Pericardial balloon fenestration1992 Bridges PFO closure1994 Sigwart Transluminal ablation of septal hypertrophy1996 Condado Brachytherapy against coronary restenosis1997 Oesterle PTMR (percutaneous tranmyocardial laser revascularization)1998 Waxman Transatrial pericardial access2000 Bonhoeffer Percutaneous pulmonary valve replacement2001 Sievert Obliteration of left atrial appendage in atrial fibrillation2002 Cribier Percutaneous aortic valve replacement2003 Feldman Percutaneous mitral valve repair
Today Topics are…
• General Aspectives of AS
• Case Presentations: AMC Experiences
• Clinical Outcomes
• Complications
• Evolving Indications and Future
Perspectives
Aortic Stenosis
• Etiology
- Congenital
• Bicuspid
- Acquired
• Degenerative- Calcium deposition
- AR : rare
- DM, hypercholesterolemia
- Smoking, HT, low HDL
• Rheumatic - Commissure fusion
- Cusp retraction & stiffening
- MV involvement
- AR : common
Natural History of AS
Circulation 1968;38[Suppl V]:61
40 50 7060 800
0
20
40
60
80
100
% S
urviva
l
Age (yr)
0 2 4 6
Average Survival (yr)
Heart Failure
Syncope
Angina
Latent Period
(increasing obstruction,
Myocardial overload)
Onset Severe Symptoms
Average Age
Death (male)
- Class I
• Symptomatic severe AS
• Severe AS undergoing CABG
• Severe AS undergoing surgery on the aorta or other valves
• Severe AS with LV systolic dysfunction (EF < 50%)
- Class IIa
• Moderate AS undergoing CABG or surgery on the aorta or other valves
Aortic Valve Replacement
2006 ACC/AHA guideline; 2008 Focused Update
Bonnow et al, JACC 48 (3) 2006
분류 Mitral AV TVMV+ AV
MV + TV MV+AV+TV
IE Failure Other total
건수 551 463 79 185 225 85 125 26 9 1748
% 31.5 26.5 4.5 10.6 12.9 4.9 7.2 1.5 0.5 100.0
사망건수 8 6 1 12 2 2 4 1 0 50
사망률 1.5 1.3 1.3 6.5 0.9 2.4 3.2 3.8 0.0 2.9
0
100
200
400
300
500
600
551
8
463
7
79
1185
12
225
42
85
2
125
4
1
26 9
0
건수 사망수
2007년국내판막질환수술진단분류
TAVI vs. AVR in EU Centers
2% 11% 25% 40% 51%45000
SAVR with
tissue valve
TAVI 40000
35000
30000
25000
20000
15000
10000
5000
02007 2008 2009 2010 2011
> 300 centers have active TAVI programs
± 85 centers have > 50 TAVI /yr implantation experience
Why TAVI ?
Inoperable and High Risk Group of Patients
With Symptomatic Severe Aortic Stenosis
Improves Survival,
Symptoms,
and Quality of life.
TAVI, Change of ConceptionLeading Theme !
1985
FIM, BAV
2002
FIM, THV Implantation
2007
CE mark commercialization
2011 Nov
Inoperable, FDA
2012 Oct
High risk, FDA
2012 Dec
KFDA
Explosive Growth Steps In TAVI
Current Active Devices
Edwards Sapien Balloon Expandable
Medtronic CoreValveSelf Expanding
Edwards Sapien Balloon Expandable
Basic Concept of the Procedure
TF
TA
Access Routes For TAVR
Femoral
- Edwards SAPIEN
- CoreValve
Trans-apical
- Edwards SAPIEN
Axillary
- CoreValveTrans-Aortic
- CoreValve
Case
Presentation
TAVI up to 2012
Transfemoral Approach
Brief History (82/F, 146cm, 65Kg)
Chief Complaints :Recurrent SyncopeDOE (NYHA III) Chest discomfort for 2 years
Medical Comorbidities :
HTN/ DM/ previous CABG/ COPD
Euroscore = 32%
Case Presentation
Severe Degenerative Aortic Stenosis
Aortic valve area: 0.8 cm2
Max gradient: 50 mmHg
Mean gradient: 35 mmHg
Vmax: 3.8 m/sec
Annulus: 20 mm
EF: 60%
TR Vmax: 2.1 mmHg
CT Measurement
Coronal view Sagittal view
= Parasternal long-axis view
Double oblique view
at annular level
19~21 mm
Ilio-femoral angiogram
8.5 mm
9.2 mm 10.3 mm
9.6 mm
9.2 mm
9.7 mm
Procedure
• Rt. femoral artery puncture with Proglide *3
with 7Fr sheath
• Lt. femoral vein puncture (6Fr) & pacing
wire into the RV & artery (6Fr) for pigtail
catheter
• Check the rapid pacing (200 bpm)
• Preparing Edward valve 23 mm
Aortogram
LAO 18 CAU 12
RCC
LCC
NCC
Three cusps in same plane
Femoral arterial sheath was changed with 18F one after sequential dilation using dilator
Crossing the Stenotic AV with Wire
Pre-dilatation Ballooningunder rapid pacing
23 mm balloon
Valve Preparing & Mounting
Introduction of the Flex catheter and Edward Valve
Valve Positioning & Deployment
Post procedure gradient = 8 mmHg
No leakage or perforation, Uneventful sheath removal
Before Sheath Removal Peripheral Angiogram
Volume Rendered Image
LM
RCA
4 D CT Image
4 D CT Image
Transapical Approach
Transapical TAVI
CoreValve Implantation
Medtronic CoreValveSelf Expanding
CoreValve Implantation
DOE Fc III-IV, Bicsupid AV, AVA=0.67, Mean PG=60
Vmax=5.0m/s, EuroSCORE=25%
CoreValve Implantation
CoreValve Implantation
Baseline, EF=28% 1 Hr After, EF=50%
CoreValve Implantation
Baseline, EF=28% 1 Hr After, EF=50%
Clinical
Outcomes
TAVI up to 2013
PARTNER trial
First Randomized Study
Extended 2 Yrs FU
PARTNER Manuscripts in NEJM(October, 2010 – May, 2012)
All Mortality at 1,2 Year: Inoperable
Numbers at Risk
TAVI 179 138 124 110 83
Standard Rx 179 121 85 62 42
Standard Rx
TAVI
All-
cause m
ort
alit
y (
%)
Months since Randomization
∆ at 1 yr = 20.0%
50.7%
30.7%
HR [95% CI] =
0.54 [0.38, 0.78]
P (log rank) < 0.0001
Leon et al, NEJM 2010; 363:1597-1607 Makkar et al, NEJM 2012; 366:1696-1704
∆ at 2 yr = 23.7%
HR [95% CI] =
0.56 [0.43, 0.73]
P (log rank) < 0.0001
68%
43.3%
Baseline
N=163
30 Day
N=143
6 Months
N=1001 Year
N=89
Mean
Gra
die
nt
(mm
Hg
)
50
40
30
20
60
70
10
0
Error bars = ± 1 Std Dev
Mean Gradients Over Time
P < 0.0001
33.0
39.5
44.4
43.2 9.69.59.3
44.6
Standard Rx
TAVI
2 Year
N=67
9.7
Paravalvular Regurgitation
Decrease in Amounts over time
None/Trace
Mild
Moderate
Severe
35%
52%
12%
1%
30 Day
40%
53%
7%
6 Month
45%
43%
10%
2%
1 Year 2 Years
77.7%17.9%
4.5%
0
0.1
0.2
0.3
0.4
0.5
0 6 12 18 24
TAVI
AVR
Months
348 298 260 147 67
351 252 236 139 65
Number at Risk
TAVR
AVR
26.8
24.2
HR [95% CI] =
0.93 [0.71, 1.22]
P (log rank) = 0.62
Non-inferiority P value
= 0.001
All Mortality at 1,2 Year: High Risk
33.9
35.0
HR [95% CI] =
0.90 [0.71, 1.15]
P (log rank) = 0.41
P value = 0.78
Smith et al, NEJM 2011; 364:2187-2198 Kodali et al, NEJM 2012; 366:1686-1695
Pressure Gradient Over Time
Numbers at Risk
TAVI 307 275 233 218 144
AVR 295 228 168 155 112
Gra
die
nt
(mm
Hg
)
Peak Gradient - TAVR
Mean Gradient - TAVR
Peak Gradient - AVR
Mean Gradient - AVR
Smith et al, NEJM 2011; 364:2187-2198 Kodali et al, NEJM 2012; 366:1686-1695
TAVI
TAVI
Baseline
N=76
30 Day
N=76
6 Months
N=251-2 Year
N=32
40
80
20
60
100
0
Subjective Symptom in TAVI: NYHA
I
II
III
II
III
IV
I
II
I
II
ESC/EACTS Guidelines - 2012
Class I:
• Heart Team required
• On-site cardiac surgery
• Inoperable Patients
Class IIa:
• High-risk operable as
an alternative to surgery;
determined by heart team
and case-based decisions
Current Status of TAVI in KoreaFeb 2010 to Dec 2012
Total
114
Edward
51
CoreValve
63
Current Status of TAVI in KoreaFeb 2010 to Dec 2012
Total
114
Edward
51
CoreValve
63
서울아산병원 56 30 26
연세대학병원 20 20
서울대학병원 18 1 17
서울삼성병원 9 9
강남성모병원 2 2
부천세종병원 9 9
Procedural Results
Total
(n=76)
Edward
(n=30)
CoreValve
(n=46)
Valve Size,mm
23 0
26 9 19
29 0 25
31 0 2
Transfemoral 69 (91%) 27 42
Surgical Closure 6 4 2
Percutaneous 63 23 40
Transapical 3 (4%) 3 0
Direct Aortic 3 (4%) 0 3
Subclavian 1 0 1
Total
(n=76)
Edward
(n=30)
CoreValve
(n=46)
Procedural Success 74 (97.4%) 29 (96.7%) -
Mortality 2 (2.6%) 1 (3.3%) 1 (2.2%)
Cardiovascular Death 2 (2.6%) 1 (3.3%) 1 (2.2%)
Major or Minor Stoke 1 (1.3%) 1 (1.3%) 0
Permanent Pacemaker 9 (11.9%) 0 9 (19.6%)
Vascular Complication 2 (2.6%) 0 0
Access site 1 1 (RF1) 0
Iliac Perforation 1 1 0
In-Hospital, 30 days
N=76
4529
Total Edwards CoreValve
Follow up
74No.
Readmission 2
1Mitral valve endocarditis
Heart failure exacerbation 1
Cardiovascular 1
Sepsis 1
Mortality 2 (4.4%)
0
0
0
1
0
0
Aspiration pneumonia 0 1
1
1
2 (2.7%)
3 (4.1%)
1
1
1
Median 1 yr (6 months to 1.3 yrs)
All Death at 1 year 3/46 (6.5%) 1/30 (3.3%)4/76 (5.3%)
Log Euroscore 22.8
Age, yrs 81.5
Female 52.0
NYHA 3 or 4
AVA, cm2 0.61
Mean gradient, mmHg 47.6
KOREAPooled Estimates (%)Endpoints
82.0
22.1
79.1
63.2
0.65
59.9
98.7
*VARC Meta-Analysis, (16 studies; 3,519 patients)
Comparison
J Am Coll Cardiol 2012;59:2297-306
J Am Coll Cardiol 2012;59:2297-306
Mortality
All at 30 days 7.8
CV at 30 days 5.6All at 1 year 22.1
CV at 1 year 14.4
KOREAPooled EstimatesEndpoints (%)
2.6
2.65.3
3.9
Stroke
Major at 30 days 3.2 1.3
Perm Pacemaker at 30 days
CoreValve 28.9 19.6
Vascular Cx at 30 days 18.8 2.6
Comparison
1. TAVI provides favorable short and longer term (1yr)
clinical outcomes.
2. TAVI showed definite objective and subjective
improvement and symptoms.
3. This results would be concordant in survival benefit as
accumulation of experiences.
4. We need a prospective cohort registry in Korea.
Lessons
from Korean Experiences
Procedural
Factors
TAVI 2012
Procedure-Related Complications
• Valve positioning events
• Peri-valvular aortic regurgitation
• Vascular complications
• Strokes
• Permanent pacemaker implantation
• Coronary obstruction
• VF or ischemia during rapid ventricular pacing
• Cardiac perforation (RV or LV)
Valve Positioning with Edward Valve
• Too high
- Embolization to aorta
- Potential risk of
coronary obstruction
• Too low
- Embolization to LV
cavity
Good Placement of Edward Valve
• To minimize device motion
- Stiffer LV wire, perpendicular to LV-
aorta axis
- Rapid ventricular pacing till complete
deployment of device ( 5 seconds)
- Device advancement (Sapien XT)
• Good positioning by operator
50 to 50
50 to 50% ratio for
proximal to distal
portion of device from
annulus to device
bottom is
recommended !
Good Positioning with Edward Valve
Deployment with a rule of 50 to 50Edward - NovaFlex
Perfect Position26mm Valve
50%
50%
Successful ResultEdward - NovaFlex
26mm Valve
50%
50%
But, this rule of 50 to 50% IS NOT
always right !
Edward Valve
50 to 50 DeplymentEdward NovaFlex
26mm Valve Perfect Position
50%
50%
50 to 50, Perfect PositionBut the device was migrated to LV.
Perfect Position
50%
50%
2 hours later
Why
Device migration into LV ?
1. Incomplete inflation ?
2. Inadequate positioning ?
50 to 50
Right
50 to 50
Wrong
Device Migration may happen in unusual AV morphology.
Very Severe Calcium50 to 50 may get the valve to dive into LV
50 to 50
Right
50 to 50
Wrong
70 to 30
Right
Annulus Level
Stent should be covered upto upper end of leaflet
In some heavily calcified AV, device should be positioned cranially to cover the calcified leaflets completely.
Less nervous in positioning than Edward valve
• Less hemodynamic
compromise, so no rush so in
device deployment
• Longer skirt
• Able to move the device during
deployment
• Deployable in beating heart
without rapid pacing
But…positioning is still important
• Too high
- Embolization to aorta
- Retrievable but, not easy
• Too low
- Higher chance of AV block
- Paravalvular leak
Positioning without PredilationCoreValve
29mm Valve Perfect Position
4-6 mm
Valve Visualization
• Implantable range is 8 mm• Optimal placement of the valve is between the 1st and 2nd
contact point being implanted within the aortic annulus
4-6 mm
29mm Valve
Successful Deployment without predilation, without rapid pacing
No more surgical opening of vascular access and use of percutaneous closure with 10 Fr ProStar or Multiple ProGlider
Vascular Complications
Not too much Concerns
Anymore !
System is Evolving...
18, 19F
(OD : 7.2-7.5 mm)
8.1+1.4
MLA, mm
Common iliac artery
10.3+2.42
Femoral artery 8.17+1.14
External iliac artery
8.73+1.60
10.6+3.1
9.21+1.4
Caucasian AMC data
22, 24F
(OD : 8.4-9.2 mm)
RF1,RF3
“18-19F is Safe”
Decrease Complications with Experiences and Device Developments
21 (100%)8 (88.9%)Procedural success
Mortality 0 0
Stroke 0 1 (4.8%)
Permanent pacemaker 0 0
Vascular complication
Access site 1 (11.1%) 0
Iliac artery perforation 1 (11.1%) 0
NovaFlex
N=21
RF I or III
N=9
Device embolization 2 (22.2%) 1 (4.8%)
Edwards Cases
AMC Edward Registry
Diffusion-Weighted MRI Study
80-year-old patient 4 hours after successful TAVI
Post-TAVI
Right MCA, Major Stroke
The risk of stroke after TAVI were in 1.5% to 6%.
Embolic Material
after TAVI
Embolic Material
Embolic Material
Paravalvular Regurgitation
Minimum
Diameter
Maximum
DiameterPerimeter
Area
Area-derived virtual Diameter√(4*Area/π)
Perimeter-derived virtual DiameterPerimeter/π
Ellipticity RatioMaximum Diameter/
Minimum Diameter
New CT Parameters
Circular Annulus is Very Small Proportion
3-D Image Is Very Helpful
paravalvular leak sites
paravalvular leak sites sealed
current gen tissue skirts
next gen “expandable” skirts
Endoluminal
Sciences
CoreValve Pacemaker Implantation
1. Avanzas P, et al; Rev Esp Cardiol. 2010;63:141-148
2. TAVI Facts, Figures and National Registries. EuroPCR 2010
New Pacemaker Implants
35.2%
26.9%23%
42.5%
26%
18.5%
31.3%
40.0%
0%
10%
20%
30%
40%
50%
60%
18 Fr S&E
N = 125
ANZ
N = 118 Spain1
N = 108
French2
N = 66
Belgian2
N = 119
German2
N = 588
UK2
N = 460
Italian2
N = 772
Perc
en
t o
f P
ati
en
ts (
%)
19%
Korea
N = 76
“Achilles’ Heel” of
CoreValve
CoreValveComplete AV Block
Complete AV block had developed
within 30 days after TAVI,“Delayed Injury” ?
Suggest !
Delayed Stretching Injury,
Ratio of Device and Annulus Size
Means,
Gradual Stretching Injury of Annulus and
Conduction System Over Time,
“Degree of Annulus Stretching”
May be Related with CAVB.
Delayed Occurring
Complete AV Block,
New
Technology
TAVI in 2013
Expanding the indication
Development of Devices
New TAVI Systems - Transfemoral
- Direct Flow
- Sadra
- AorTx
- HLT
- EndoTech
- ABPS PercValve
New TAVI Systems - Transapical
- Jena Valve
- Ventor (Embracer)
- Symetis
Lotus™ Valve
Design Goals
• Valve functions very early in deployment
• Allow for valve to be repositioned and redeployed at any time during procedure
• Fully recapturable at 100% deployment prior to release
• No balloon inflation or rapid pacing
• Valve expands radially as it shortens
• Central radiopaque positioning marker
• Adaptive Seal for conformity to annular anatomy to minimize paravalvular leakage
The Lotus Valve System is an investigational device, not available for sale.
Endoluminal
Sciences
Lotus™ Valve System
Preloaded Delivery System and Simple Handle Design
Unsheath, Lock
Release Unlock, Resheath
The Lotus Valve System is an investigational device, not available for sale.
SHEF
Cerebral Embolic Protection Devices
Deflectors and Filters
Embrella Claret
System is getting Thinner.
Bovine pericardiumStainl. steel frame23mm
Equine pericardiumStainl. steel frame 23mm
Cribier Edwards
2000
Treated bovine pericStainl. steel frame .23 and 26mm
Edwards Sapien
Treated bovine peric.Cobalt Chrom. FrameLower Crimp ProfileSurgical Leaflet Design23 and 26mm
Edwards Sapien XT
2012
18F, 19F24F 22F 22F, 24F
Edwards Valve is developing…
The eSheath expands from 16F to 18F which facilitates smooth delivery system passage, then returns to a reduced profile once the valve has passed through the sheath
Unexpanded Reduced ProfileExpanded
The New Edwards eSheath
CTA
3Mensio
Valves
Advanced Imaging Modalities
Junior Doctors
PhysiotherapistElderly Care
Physician
Intensive
Care Unit
Coronary
Care Team
Cath Lab
Team
Vascular
Surgeon
Anaesthetist
Cardiothoracic
Surgeon
CardiologistIntervention
Non-Invasive
The TEAM
Multidisciplinary TEAM Approach for Patient Selection and TAVI Managements
A unique collaborative experience !
For the TAVI,
