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Τρέχουσες Κατευθυντήριες Οδηγίες στη Διακαθετηριακή Εμφύτευση Αορτικής
Βαλβίδας: Χρειάζονται αναθεώρηση;
ΠΕΤΡΟΣ Σ. ΔΑΡΔΑΣ, MD, FESC
ΚΛΙΝΙΚΗ ΑΓΙΟΣ ΛΟΥΚΑΣ
7ο IICE, ΘΕΣΣΑΛΟΝΙΚΗ 2014
Aortic stenosis
Management challenges:
• The asymptomatic patient with severe AS
• Low-flow, low gradient severe AS
• Indications for TAVR
class I
Intervention for Severe AS
Indications for TAVR vs surgical AVR:
• Evaluation by a Heart Team
New 2014
Intervention for Severe AS
Indications for TAVR vs surgical AVR:
class I
class I
• Evaluation by a Heart Team
• Surgical AVR for patients at
low or intermediate risk
New 2014
Intervention for Severe AS
Indications for TAVR vs surgical AVR:
• Evaluation by a Heart Team
• Surgical AVR for patients at
low or intermediate risk
• TAVR for patients with
prohibitive surgical risk and
life expectancy >12 months
class I
class I
class INew 2014
Intervention for Severe AS
Indications for TAVR vs surgical AVR:
• Evaluation by a Heart Team
• Surgical AVR for patients at
low or intermediate risk
• TAVR for patients with
class I
class I
class I
class IIa
prohibitive surgical risk and
life expectancy >12 months
• TAVR alternative for patients
at high surgical risk
New 2014
Intervention for Severe AS
Indications for TAVR vs surgical AVR:
• Evaluation by a Heart Team
• Surgical AVR for patients at
low or intermediate risk
• TAVR for patients with
class I
class I
class I
?class
prohibitive surgical risk and
life expectancy >12 months
• TAVR alternative for patients
at MODERATE risk
New 2014
Aortic Stenosis
10%
10 %
25%
60%
Extreme Risk
High Risk
Intermed. Risk
Low Risk
TAVI orSAVR ?
universitätsklinikum giessen
Risk
“unethical”
KERCKHOFF HERZ- UND THORAXZENTRUM
Patients
5%
Outline
• Current status of TAVR
• Defining risk
• Current evidence for intermediate risk
patients
• Future trials
Outline
• Current status of TAVR
• Defining risk
• Current evidence for intermediate risk
patients
• Future trials
All causemortality 20%
10%
0
50%
40%
30%
0 6 12 18 24
TAVR
AVR
Months
24.2%
HR [95% CI] =0.93 [0.71, 1.22]
P (log rank) =
0.6226.8%
40%
20%
0%
100%
80%
60%
0 6 12 18 24
TAVR
Std Tx
30.7%
HR [95% CI] = 0.51 [0.38, 0.68]p (log rank) < 0.001
50.7%
Months
All Cause Mortality (%)
Standard Rx
TAVR
179
179
121
138
85
124
62
110
46
101
27
88
17
70
All Cause Mortality (ITT)Inoperable Cohort (3 years FU)
0%
40%
20%
60%
100%
0 6 12 18 24 30 36
50.8%
Months
Numbers at Risk
HR [95% CI] = 0.53 [0.41, 0.68]p (log rank) < 0.0001
25.0%
80.9%80%
68.0%26.8%
20.1%
30.7%
NNT = 5.0 pts
43.0%
NNT = 4.0 pts
54.1%
NNT = 3.7 pts
Standard Rx
TAVR
TAVR
AVR
348
351
298
252
261
236
239
223
222
202
187
174
149
142
No. at Risk
26.8%
24.3%
34.6%
33.7%
HR [95% CI] =
0.93 [0.74, 1.15]
p (log rank) = 0.483
44.8%
44.2%
TCT 2014 | September 13, 2014
Five-Year Outcomes of TranscatheterAortic Valve Replacement (TAVR) in
“Inoperable” Patients With SevereAortic Stenosis: The PARTNER Trial
Samir R. Kapadia, MDOn behalf of The PARTNER Trial Investigators
All-Cause Mortality (%)
93.6%
All-Cause Mortality (ITT)Crossover Patients Censored at Crossover
Standard Rx (n = 179)
TAVR (n = 179)
50.8%
30.7%
43.0%
68.0%
71.8%
87.5%
64.1%
53.9%
HR [95% CI] = 0.50 [0.39, 0.65]
80.9%
p (log rank) < 0.0001
Months
* In an age and gender matched US population without comorbidities,the mortality at 5 years is 40.5%.
Incidence (%)
Stroke (ITT)
Months
18.2%16.0%
Standard Rx
TAVR
Pivotal Trial Design
TCT 2014 4
TCT 2014 15
All-Cause Mortality or Major Stroke
* Calculated rate for 117 events in 179 patients (65.4%, lower confidence bound of
57.9% by Exact method) (Makkar RR, et al, New Engl J Med, 2012)
Pivotal Trial Design
20Adams NEJM 2014 March 29 (epub ahead of print) Increased Risk RCT
2-Year All-cause Mortality
P < 0.001 for non inferiority
P = 0.04 for superiority
22Adams NEJM 2014 March 29 (epub ahead of print) Increased Risk RCT
All Stroke
23Adams NEJM 2014 March 29 (epub ahead of print) Increased Risk RCT
25Adams NEJM 2014 March 29 (epub ahead of print) Increased Risk RCT
Subgroup Analysis for 1 Year Mortality
The Treatment Effect of
TAVR over SAVR was similar
in patients with STS < 7 and
STS > 7
Outline
• Current status of TAVR
• Defining risk
• Current evidence for intermediate risk
patients
• Future trials
Ospedale Ferrarotto
Università di Catania
The right indication
EACTS/ESC/EAPCI Position statement Eur Heart J 2008
Indication for TAVI is:
Symptomatic severe aortic stenosis and
HIGH-RISK (LES > 20%, STS > 10%) and/or
CONTRAINDICATION for surgical aortic valve replacement
KERCKHOFF HERZ- UND THORAXZENTRUMuniversitätsklinikum giessen
High Risk Intermed.
Risk
Low Risk
EURO > 20 <5
STS > 8 (10) < 4 (3)
What is Intermediate Risk?
?
Beohar, N., et al. Acquired Cardiovascular Disease, 2014.
Existing Risk Scores
Existing risk scores are
poor discriminators of 30
day and 1 yr TAVR
outcome
TAVR-specific risk models
are needed to optimize pt
selection
KERCKHOFF HERZ- UND THORAXZENTRUMuniversitätsklinikum giessen
Frailty
Porcelain aorta
Liver disease
Previous radiation
Hostile chest
Severe concomitant diseases
Not reflected in Scores:
New US Guidelines 2014
Ospedale Ferrarotto
Università di Catania
Coronary artery disease requiring revascularization
Frailty (Katz score + Ambulation Aid + Dementia)
Left ventricular dysfunction (EF <35% by TTE)
Neurological dysfunction (with functional impairment)
Pulmonary disease (GOLD stage II)
Peripheral vascular disease (including porcelain aorta)
Renal disease (KDOQI Stage 3, GFR < 60 mL/min)
Redo cardiac surgery
Pulmonary hypertension (> 60mmHg)
Diabetes
SURTAVI Model Co-Morbidities
Ospedale Ferrarotto
Università di Catania
How can we define the intermediate risk?
SURTAVI model Rationale
Outline
• Current status of TAVR
• Defining risk
• Current evidence for intermediate risk
patients
• Future trials
TAVR in Lower Surgical Risk Patients
Bern1 Munich2
Lower Risk(n=254)
Higher Risk(n=94)
Lower Risk(n=105)
Higher Risk(n=105)
STS (%)
Log EuroSCORE (%)
30 Day Mortality (%)
Total Vascular
Complications (%)
Stroke / TIA (%)
5.1± 1.4
22.1± 11.9
3.9
17.7
5.0
13.3± 7.1
35.1± 15.7
14.9
20.3
3.4
4.8± 2.6
17.8± 12.0
3.8
14.7
1
7.13± 5.4
25.44± 16.0
11.4
28.6
6.7
1Wenaweser,et al., Eur Heart J 2013; 34: 1894-905;2Lange, et al., J Am Coll Cardiol 2012; 59: 280-7
TAVR in Low/Moderate Risk Patients
2 EU centers have directly compared TAVR outcomes
of patients at lower- and higher-risk...
TAVR in Low/Moderate Risk PatientsThe Bern Experience
AUGUST 2007 - OCTOBER 2011 HEART TEAM DECISION
WENAWESER P ET AL. EUR HEART J. 2013
Piazza1 OBSERVANT2 Latib3
TAVI SAVR
p
TAVI SAVR
p
TAVI SAVR
p
STS
(%, mean)
Log EuroSCORE
(%, mean)
(n=255)
3-8
17.3
(n=255)
3-8
17.6
(n=133)
na
8.9
(n=133)
na
9.4
(n=111)
4.6
23.2
(n=111)
4.6
24.4
30 Day Mortality
(%)7.8 7.1 0.74 3.8 3.8 1.000 1.8 1.8 1.00
1Piazza, et al. , J Am Coll Cardiol Intv 2013; 6: 443-51;2D’Errigo,et al., Int J Cardiol 2013; 167: 1945-52;3Latib, et al., Am Heart J 2012; 164: 910-7
TAVR vs. Surgery in “Matched”
Moderate Risk Patients
3 EU studies have compared TAVR vs. Surgery using
propensity-matching in moderate risk patients...
Piazza, et al. , J Am Coll Cardiol Intv 2013; 6: 443-51
• TAVR and SAVR result in similar 30-day (7.8% vs. 7.1%, p=0.74) and 1-yearmortality(16.5% vs. 16.9%, p=0.64)
• Stratified analyses of 1-year all-cause mortality showed women to have agreater benefit from TAVR vs. SAVR compared to men (P interaction = 0.027).
BERMUDA - Clinical Outcomes
OBSERVANT registry propensity-matched analysis from more than 7600 patients
• In PARTNER A and the CoreValve High-Riskstudy, mean logistic EuroScores were 29 and 19, respectively. In OBSERVANT, the mean EuroScore was 9.8
0.00
0.40
Overall mortality (%)
0.30
0.20
0.10
0.00
Overall at risk analysis timemortality
Number
40 515
Mortalità502
180
549 535 525 519569 543 531 517
intervento = AVR intervento = TAVI
10
0
00
390
9270
12360
6
Monthsanalysis time
No. at risk:
650AVR SAVR 625TAVITAVI 625650
549569
535543
525531
519517
HR: 0.99, 95%CI 0.72-1.35; p=0.936
13.1%
20
13.3%
0
SAVR 625TAVI 625
360
495
492
intervento = TAVI25 552 525 intervento = AVR492
25 534
90 180
90
270
534
552502
180 270analysis time
360
515
525 509495
intervento = AVR
30intervento = TAVI
509 AVR
TAVI
1 year OBSERVANT - Marco Barbanti TCT, September 13 2014
Outline
• Current status of TAVR
• Defining risk
• Current evidence for intermediate risk
patients
• Future trials
TF TAVRSAPIEN XT
SurgicalAVR
Primary Endpoint: All-Cause Mortality +
Disabling Stroke at Two Years
(Non-inferiority)
TAVR:TA / TAo
SAPIEN XT
SurgicalAVR
VSVS
Operable(STS ≥4)
ASSESSMENT:
Transfemoral
Access
Transapical (TA) /
TransAortic (TAo)
1:1 Randomization
Transfemoral (TF)
1:1 Randomization
No
n = 2000Randomized
Patients
Yes
The PARTNER IIA TrialStudy Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT by Heart Valve Team
• 2011 patients enrolled
in 22 months!
• Mean STS ~6%
• ~75% TF access
76.2%
18.3%
5.5%
Transfemoral
Transapical
Transaortic
PARTNER IIA - Intermediate RiskVascular Access Sites
> 75% Patients with Trans-femoral Access
0
1
2
3
4
5
6
7
8
PARTNER IIA - Intermediate RiskMean STS Score by Site
Mean STS Score ~ 6
59 enrolling sites
TAVR in MODERATE Risk Patients
SURTAVI UPDATE…
STS risk score
1st 250 2nd 250
5.53±1.305.64±1.40
Up-date 5.08±1.38
Mean 5.42±1.38First patientenrolled withCIP version8
Patient number
8
Screened-Baseline characteristicsSTS risk score
102-Year All-cause Mortality: CoreValve US Pivotal Trial
ACC 2014
11
STS PROM estimateCoreValve US Pivotal Trial
As – Treated Population
STS PROM estimate
Mean estimate - %
< 4% - no. (%)
4 ~ 10% - no. (%)
> 10% - no. (%)
TAVR Group(N = 390)
7.3± 3.0
33 (8.5)
304 (77.9)
53 (13.6)
Surgical Group(N = 357)
7.5± 3.4
40 (11.2)
251 (70.3)
66 (18.5)
Adams DH et al. N Engl J Med 2014;370:1790-1798
12
STS PROM estimateCoreValve US Pivotal Trial
As – Treated Population
STS PROM estimate
Mean estimate - %
< 4% - no. (%)
4 ~ 10% - no. (%)
> 10% - no. (%)
TAVR Group(N = 390)
7.3± 3.0
33 (8.5)
304 (77.9)
53 (13.6)
Surgical Group(N = 357)
7.5± 3.4
40 (11.2)
251 (70.3)
66 (18.5)
Adams DH et al. N Engl J Med 2014;370:1790-1798
13
STS PROM estimateCoreValve US Pivotal Trial
As – Treated Population
STS PROM estimate
Mean estimate - %
< 4% - no. (%)
4 ~ 10% - no. (%)
> 10% - no. (%)
TAVR Group(N = 390)
7.3± 3.0
33 (8.5)
304 (77.9)
53 (13.6)
Surgical Group(N = 357)
7.5± 3.4
40 (11.2)
251 (70.3)
66 (18.5)
Adams DH et al. N Engl J Med 2014;370:1790-1798
14
STS PROM estimateCoreValve US Pivotal Trial
As – Treated Population
STS PROM estimate
Mean estimate - %
< 4% - no. (%)
4 ~ 10% - no. (%)
> 10% - no. (%)
TAVR Group(N = 390)
7.3± 3.0
33 (8.5)
304 (77.9)
53 (13.6)
Surgical Group(N = 357)
7.5± 3.4
40 (11.2)
251 (70.3)
66 (18.5)
Based on STS: > 80% of patients would be considered intermediate risk!Adams DH et al. N Engl J Med 2014;370:1790-1798
• Paravalvular leak
• Stroke
• Vascular complications
• Pacemaker implantation
• Coronary obstruction
TAVR in 2014
Future Directions
• Expanded Clinical Indications - Additional
indications for TAVR are being actively studied
(e.g. bioprosthetic valve failure and moderate risk
patients), and if valve durability can be assured, “less-
invasive” TAVR may offer new clinical treatment
possibilities, even beyond current surgical indications
(e.g. severe asymptomatic AS).
Treating bioprosthetic failure by transcatheter valve-in-
valve implantation has been shown to be feasible.
Current evidence is limited, therefore it cannot be considered
as a valid alternative to surgery except in inoperable or high-
risk patients as assessed by a ‘heartteam’.
A. Vahanian et al, Eur Heart J. 2012 Oct; 33(20):2569-619
ESC guidelines 2012
Valve in valve
Valve in valve
Components of an Ideal Valve•
•
•
•
•
•
•
•
•
Low profileExcellent hemodynamicsPredictable deploymentRetrievable/RepositionableMinimal paravalvular regurgitationMinimal interference with surrounding anatomyLow thrombotic riskDurableCost Effective
The SAPIEN 3 Valve is Designed to Minimize PVL
While Achieving an Ultra-low Delivery Profile
Outer skirt
• Polyethylene terephthalate (PET)
outer skirt designed to minimizeparavalvular leak
Ultra-low delivery profile
• 14F eSheath compatible1
• 18F Certitude sheath compatible2
1. 14FeSheath compatible for 23mmand 26mmSAPIEN3 valves. 16FeSheath compatible for 29mmSAPIEN3 valve. 2. 18FCertitude Sheath compatible for 23mmand 26 mmSAPIEN3valves. 21FCertitude Sheath compatible for 29mm SAPIEN3 valve.
10
• Full annulus range (18 – 29mm)
• True anatomical fit (TruFit™) forannular sealing
CoreValve Evolut R System
Fully Resheathable, Repositionable, Recapturable*
• Delivery system built on next
generation platform (InVia™)
• Includes InLine™ Introducer Sheathfor reduced delivery profile
* Until fully deployed
TAVR in 2014
Accomplishments
• Encouraging Valve Durability - Echocardiogrphy
results with follow-up for at least 5 years are without
evidence of structural valve deterioration and indicate
maintained excellent valve hemodynamics.
CONCLUSION
• three reasons for not extending TAVR beyond high surgical-risk patients are:
– the excellent outcomes with SAVR
– the high cost of TAVR
– the lack of durability data
• We [assume] these [TAVR] valves will last as long as biological surgical valves, but we have to act on evidence-based medicine
CURRENT PRACTICE
• Very old low-risk patients– TF approach – local anaesthesia
– Avoid discomfort of surgery and long term recovery
• Younger – low risk patients– Procedural safety
– Long term durability• In the event of accelerated valve failure, low risk patients would remain
good canditates for SAVR
• In the event of late valve deterioration, valve-in-valve TAVI could always be an option
Intervention for Severe AS
Indications for TAVR vs surgical AVR:
• Evaluation by a Heart Team
• Surgical AVR for patients at
low or intermediate risk
• TAVR for patients with
class I
class I
class I
?class
prohibitive surgical risk and
life expectancy >12 months
• TAVR alternative for patients
at MODERATE risk
New 2014
TAVR: A Medical Breakthrough
Finally, will we see in the future SAVR reserved to patients with
contra-indications to TAVR ?…
In the coming years, with continuous advances in technologies and
simplified techniques, TAVR should expand to a broad population
of lower risk AS patients