Transcript Document

ClOsure devices iN TRansfemoral aOrtic
vaLve replacement:
The CONTROL multi-center study
Presenter: Israel Barbash, MD
Leviev Heart Center, Sheba Medical Center, Israel
IM Barbash, M Barbanti, J Webb, J Molina-Martin De Nicolas, Y Abramowitz,
A Latib, C Nguyen, F Deuschl, A Segev, K Sideris, M Santos, F Della Rosa,
C Tamburino, H Jilaihawi, T Miyazaki, D Himbert, N Schofer, V Guetta, S Bleiziffer,
D Tchetche, S Immè, RR Makkar, A Vahanian, H Treede, R Lange, A Colombo,
D Dvir
Potential conflicts of interest
Speaker's name: Israel Barbash
 I do not have any potential conflict of interest
Introduction
• The majority of TAVI procedures are currently
performed by percutaneous transfemoral
approach
• Arterial hemostasis is commonly achieved by
one of two vascular closure devices:
– Prostar XL
– Perclose ProGlide
Predictors of vascular complications
Patient-specific
Physician-specific
Device-specific
Gender
Anemia
Diabetes
Renal failure
Peripheral arterial
disease
 Arterial
calcification
 Sheath size
 Sheath-to-femoral
artery ratio (SFAR)
 Learning-curve
 Balloon crossover
technique
?





Objective
To compare the efficacy of a Prostar XL-based
vascular closure strategy versus a Perclose
ProGlide-based vascular closure strategy
CONTROL study sites
Proglide site
St. Paul’s Hospital,
Vancouver, Canada
Prostar site
Both devices
UHZ University Heart Center,
Hamburg, Germany
German Heart Center,
Munich, Germany
San Raffaele Scientific
Institute, Milan, Italy
Hôpital Bichat-Claude
Bernard, Paris, France
Clinique Pasteur,
Toulouse, France
Cedars-Sinai Medical
Center, Los Angeles, CA
Ferrarotto Hospital,
Catania, Italy
Sheba Medical Center,
Ramat Gan, Israel
5-8-4
Study population
Retrospective inclusion of percutaneous
transfemoral TAVI patients
(n=3,138)
Prostar XL-based strategy
(n=1,556)
ProGlide-based strategy
(n=1,582)
Propensity score matching variables:






Age
Gender
Renal failure
PVD
CAD
Arterial tortuosity
Prostar XL matched
patients
(n=635)
 Arterial Calcification
 Use of eSheath
 Sheath outer
diameter
 SFAR
ProGlide matched
patients
(n=635)
Baseline characteristics
(Matched cohort)
Prostar
(n=635)
ProGlide
(n=635)
P value
81.7±6.0
81.3±8.3
0.3
Females
50%
52%
0.34
STS score
8.3±6.2
8.4±5.9
0.78
Diabetes
29%
30%
0.62
CAD
48%
49%
0.65
Prior CABG
16%
16%
0.94
PVD
15%
15%
0.94
Renal failure
57%
57%
1.00
Age
Anatomy
Anatomic and sheath data
(Matched cohort)
Prostar
(n=635)
ProGlide
(n=635)
P value
Common femoral artery
minimal diameter (mm)
7.4±1.2
7.5±1.3
0.07
Calcification ≥ Moderate
35%
40%
0.11
Tortuosity ≥ Moderate
41%
39%
0.57
18.1±1.6
18.2±1.5
0.07
47%
46%
0.65
1.00±0.2
0.99±0.2
0.79
1.13±0.23
1.12±0.26
0.29
Sheath data
Sheath size (Fr)
Expandable sheath
SFAR
Non-expanded sheath
Expanded sheath
SFAR – Sheath-to-femoral artery ratio
Sheath type
Edwards
nonexpand
able
SoloPath
Cook
Check-flo
Performer
Direct
Flow
Other
Edwards
eSheath
Prostar group
Edwards SoloPath Direct
Flow
nonexpanda
ble
Cook
Check-flo
Performer
Other
Edwards
eSheath
ProGlide group
Trascatheter heart valve type
Direct
Flow
CoreValve
Other
SAPIEN
SAPIEN
XT
Prostar group
Direct
Flow
Other
CoreValve
SAPIEN
SAPIEN
XT
ProGlide group
SAPIEN
3
Procedural outcomes – VARC-2
35
30
25
Prostar
ProGlide
p <0.001
p=0.15
p=0.2
20
%
p <0.001
15
p=0.1
p<0.001
10
p <0.001
5
0
Any
Major
Minor
Vascular complications
Any
Life
Major
threatening
Bleeding
Minor
Femoral artery injuries and
interventions
14
p<0.001
Prostar
ProGlide
12
10
% 8
p=0.7
6
4
p<0.001
p=0.3
p=0.1
p=0.008
P=0.004
p=0.8
2
0
Rupture
Dissection
Stenosis
Injuries
Aneurysm Hematoma
Balloon
Stenting
angioplasty
Urgent
vascular
surgery
Interventions
Procedural outcomes – VARC-2
Prostar
n=635
ProGlide
n=635
P value
Myocardial infarction
1.3%
1.3%
1.0
Acute kidney injury ≥
Stage 2
6.6%
2.7%
<0.001
Any stroke
2.4%
2.1%
0.7
6 (3-9)
5 (1-9)
0.001
4.9%
5.8%
15.5%
3.5%
4.4%
15.2%
0.21
0.21
0.87
Outcome
Length of stay; Days
Median (IQR)
Mortality
In-hospital
30-day
1-year
Subgroup analysis for major vascular
complications
Subgroups
Major vascular
complications
Prostar
Proglide
Risk ratio (95% CI)
P value for
interaction
n (%)
Sheath data
Anatomy
Comorbidities
Overall
Gender
Female
Male
Diabetes mellitus
No
Yes
PVD
No
Yes
Chronic renal insufficiency
No
Yes
Arterial calcification ≥ Moderate
No
Yes
Arterial tortuosity ≥ Moderate
No
Yes
Common femoral artery MLD
≥ 7 mm
< 7 mm
eSheath
No
Yes
Sheath size
≤ 18 Fr
> 18 Fr
SFAR
≤ 1.05
> 1.05
48 (7.6)
11 (1.7)
4.64 (2.39-9.02)
19 (6.0)
29 (9.1)
9 (2.7)
2 (0.7)
2.30 (1.03-5.17)
15.00 (3.55-63.44)
36 (8.0)
12 (6.5)
11 (2.5)
0 (0.0)
3.41 (1.71-6.789)
N/A
13 (13.4)
35 (6.5)
2 (2.0)
9 (1.7)
4.08 (1.94-8.58)
7.43 (1.63-33.87)
24 (8.8)
24 (6.6)
4 (1.5)
7 (1.9)
31 (7.6)
17 (8.5)
6 (1.6)
5 (2.0)
5.13 (2.11-12.43)
4.05 (1.47-11.17)
24 (6.4)
24 (9.3)
7 (1.8)
4 (1.6)
3.69 (1.57-8.67)
6.26 (2.14-18.31)
2 (8.3)
46 (7.5)
0 (0.0)
11 (1.8)
4.34 (2.22-8.45)
N/A
26 (7.7)
22 (7.4)
6 (1.7)
5 (1.7)
4.72 (1.92-11.63)
4.54 (1.70-12.17)
44 (7.6)
4 (6.9)
9 (1.7)
2 (2.1)
4.86 (2.35-10.06)
3.48 (0.62-19.64)
31 (7.1)
17 (8.5)
6 (1.4)
5 (2.5)
5.53 (2.28-13.38)
3.57 (1.29-9.86)
0.026
0.995
0.487
0.401
6.48 (2.22-18.95)
3.60 (1.53-8.47)
0.791
0.451
0.998
0.955
0.727
0.524
0.1
40
1
Prostar better
ProGlide better
Summary and conclusions
• A ProGlide-based vascular closure strategy is
associated with:
– Lower rates of arterial rupture and hematomas
– Lower rates of major vascular complications,
bleeding and kidney injury
– Shorter hospital stay
• Lower adverse events with ProGlide were not
translated into mortality difference
Contributing sites and investigators
Center
Clinique Pasteur, Toulouse, France
Ferrarotto Hospital, University of
Catania, Catania, Italy
Cedars-Sinai Medical Center, Los
Angeles, California
St. Paul’s Hospital, Vancouver, British
Columbia, Canada
EMO-GVM Centro Cuore Columbus,
Milan, Italy
Bichat-Claude-Bernard Hospital, Paris,
France
University Heart Center, Hamburg,
Germany
Personnel
Javier Molina-Martin De Nicolas, Francesco Della
Rosa, Didier Tchetche
Marco Barbanti, Corrado Tamburino, Sebastiano
Immè
Yigal Abramowitz, Hasan Jilaihawi, Raj Makkar
Danny Dvir, Matheus Santos, John Webb
Azeem Latib, Tadashi Miyazaki, Antonio Colombo
Caroline Nguyen, Dominique Himbert, Alec
Vahanian
Florian Deuschl, Niklas Schofer, Hendrik Treede
Sheba Medical Center, Tel Hashomer,
Israel
Israel Barbash, Amit Segev, Victor Guetta, Paul
Fefer
German Heart Centre, Munich,
Germany
Kosta Sideris, Sabine Bleiziffer, Rüdiger Lange
Additional slides
Device specific “learning curve” effect
25
P=0.35
P=0.07
23.8
P=0.16
22.7
20
21
20.6
18.1
P=0.19
P=0.37
15
16.2
15
%
13
10
P=0.07
7.7
5
P=0.90
15.7
13
12.6
P=0.84
7.5
13.4
P<0.01
8
8
5
2.3
0
Any VC Major VC Minor VC
All
n=3,138
Any VC Major VC Minor VC
Prostar
First 20 procedures
Any VC Major VC Minor VC
Proglide
Others
Differences in design & use of the two
VCD
Prostar XL
• 2 sutures delivered
simultaneously
• Higher likelihood of two
suture failure
Perclose ProGlide
• Single suture delivered
• The 2nd suture is delivered
independently
• Possibility to add 3rd device
• Higher likelihood of single
suture failure
Limitations
• Retrospective analysis
• Unknown confounders
– Number of devices used
– Crossover rates
– Use of heparin, protamine, DAPT
– Use of the COBT
• No CT core-lab analysis