current limitations of transcatheter aortic valve implantation

Transcription

CURRENT LIMITATIONS OF
TRANSCATHETER AORTIC VALVE
IMPLANTATION
Amit Segev, MD, FESC, FACC
Interventional Cardiology Unit
Chaim Sheba Medical Center
Sheba Medical Center
Tel Hashomer
The Leviev Heart Center
CURRENT LIMITATIONS OF
TRANSCATHETER AORTIC VALVE
IMPLANTATION?
Amit Segev, MD, FESC, FACC
Interventional Cardiology Unit
Chaim Sheba Medical Center
Tel Hashomer
Disclosures
• Proctor (TAVI) – Edwards, Medtronic
• Global advisory board – Medtronic
• Speaker – Boston Scientific, Medtronic,
Edwards
Tel Hashomer
Outline
• Complications after TAVI / SAVR
– Stroke
– Vascular complications and bleeding
– Para-valvular leak
– High degree AV block  perm. pacemaker
• Significance of PVL after TAVI
• Valve durability
• Non “classical” AS indications
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Stroke in PARTNER -1y
Smith CR et al NEJM 2011
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Stroke at 2y – PARTNER
Kodali SK et al. NEJM 2013
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Vascular Complications
PARTNER – Cohort A
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This can be expected with TF TAVI
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Increased rate of stroke and
vascular complications in
PARTNER
22-24F Sheaths
No retroflex delivery system
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CoreValve US Pivotal: Study Disposition
18F delivery system
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2-Year All-cause Mortality
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CoreValve US Pivotal: All Stroke
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CoreValve US Pivotal: Major Stroke
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CoreValve US Pivotal: All-Cause Mortality or Major Stroke
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Subgroup Analysis for 1 Year Mortality
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Subgroup Analysis for 1 Year Mortality
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FRANCE 2 Registry
NEJM 2012
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Prevalence & significance of
para-valvular leak
Sining JM et al. JACC 2012
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Percent of Evaluable Echocardiograms
Paravalvular Leak
PARTNER Cohort B – 5y
N=
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Mortality by Paravalvular Leak
All-Cause Mortality
Cardiovascular Mortality
None-Mild (n = 142)
None-Mild (n = 142)
Moderate-Severe (n = 23)
Moderate-Severe (n = 23)
78.3%
74.6%
69.2%
51.3%
p (log rank) = 0.510
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p (log rank) = 0.043
PVL in US Pivotal – Extreme Risk
TCTTel
2014
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PVL in US Pivotal Randomized Patients
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23
PVL and All-Cause Mortality – US Pivotal
TCTTel
2014
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24
Significant PVL after TAVI
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Post-dilation
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High degree AV block requiring
permanent pacemaker
• PARTNER (Sapien) – 2y
– TAVI – 7.2%
– SAVR – 6.4%
• France Registry
– Sapien XT – 11.5%
– CoreValve – 24.2%
• CoreValve US Pivotal randomized trial – 1y
– TAVI – 22.3%
– SAVR – 11.3%
• Evolute R – 11.7%
• Sapien3 – 10.1%
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Impact of PPM on prognosis
Buellesfeld L, JACC 2012
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TAVI Valve Durability
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Valve durability (PARTNER)
Mean Gradient & Valve Area
EOA
Mean Gradient
Valve Area (cm²)
Mean Gradient (mmHg)
Error bars = ± 1 Std Dev
N=
159
86
70
44
31
15
163
91
71
46
31
15
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US Pivotal - Echo Findings
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Non-AS Indications
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Bicuspid Aortic Valve Stenosis
Not suitable for TAVI?
• Oval-shaped annulus? Annulus size over-estimated?
• Asymmetric calcifications
• Diseased and enlarged ascending aorta
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• 11 patients with Edwards-sapien valve
• 2 deaths
• 1 late conversion to sAVR
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Sapien
(n = 51)
CoreValve
(n = 91)
P value
Transcatheter
Valve Mean size,
mm
26.4
28.5
0.0001 <
CT-based Valve
Sizing
78.8%
56.0%
0.01
Femoral Access
64.7%
86.8%
0.003
Valve Malposition
4.0%
7.8%
0.5
Valve
Embolization
4.0%
1.1%
0.29
Tamponade
0
5.7%
0.16
Conversion to
SAVR
3.9%
1.1%
0.29
Fluoroscopy time,
min
14
20
0.004
Mortality: 30d 4.9%, 6M 9.3%, 1y 15.9%.
No difference according to valve type
Borderline predictors of worse 1y survival
CoreValve (OR 0.45; 95% CI 0.16-0.99; P = 0.05)
valve embolization (OR 5.70; 95% CI 0.99-32.72; P = 0.052
Mylotte D et al. ACC 2014
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Patho-Anatomical issues of
AS vs. AR
• Thickening and calcification AS >> AR
• Annular size AS < AR
• Aortic root dilation AS << AR
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Pure Aortic Regurgitation – Case
•
•
•
•
63y old male
s/p CABG
s/p repair of type A aortic dissection
Intractable heart failure
– Severe AR, LVEF 30%
– Aortic annulus 27 mm
• EUROSCORE – 49.9%!!
• Trans-axillary CoreValve 29
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Evaluation of aortic arch by CTA & angio
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Severe AR – After CoreValve
Implantation
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Alive @ 3y
NYHA FC I
Mild-mod AR
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TAVI for Pure Native AR
World Wide Registry
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Results - VARC Outcomes
TAVI for Pure Native Valve AR
• 30-day mortality
• Total – 4 (9.3%)
• Cardiovascular – 1 (2.3%)
• 30-day stroke
• Major – 2 (4.7%)
• Minor - 0
• 1-year mortality
• Total - 6/28 (21.4%)
• Cardiovascular - 3/28 (10.7%)
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30d NYHA FC
NYHA Functional Class
100%
Number of Patients
90%
80%
Deaths
70%
Class 4
60%
Class 3
50%
Class 2
40%
Class 1
30%
20%
10%
0%
0
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30 day
Valve-in-Valve Global Registry
JAMA 2014
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Outcome according to mechanism of
valve failure
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Dvir D et al. JAMA 2014
Outcome according to surgical valve size
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Outcome in Sapien vs. Corevalve use
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Severe AS & AR (Mitroflow 23)
LVEDP = Ao diastloic pressure
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Post VIV CoreValve 23mm
AI Index >25
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TAVI in failed mitral & tricuspid
bioprostheses
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All-Cause Mortality at 30 Days
Edwards SAPIEN Valves (As Treated Patients)
PARTNER I and II Trials
Overall and TF Patients
175
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344
240
SAPIEN
271
282
SXT
583
491
1072
SAPIEN 3
947
All Strokes at 30 Days
Edwards SAPIEN Valves
PARTNER I and II Trials
Neurologist evaluations (pre- and post)
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30-Day Outcomes – Evolute R
Event, % *
KM Rate (%)
All-cause mortality
0.0
All stroke
0.0
Moderate or severe PVL
3.4
Permanent pacemaker implantation
11.7
* Percentages obtained from Kaplan Meier estimates
Source: Meredith IT, et al. Early Results from the CoreValve Evolut R CE Study [2101-295]. Presented at the
Annual Meeting of the American College of Cardiology. March 14, 2015.
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Conclusions
• TAVI is a well-established procedure
currently evaluated for intermediate risk
patients.
–
–
–
–
Low stroke rate
PVL is still the main obstacle for the procedure
PPM – similar to surgery
Durability – optimism….
• S3 & EvoluteR – excellent initial results
• TAVI can be safely and efficaciously
expanded to “non-classical” AS patients
– VIV
– Need more data in bicupid valves and pure AR
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Thank-you
Tel Hashomer

current limitations of transcatheter aortic valve implantation

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