Contemporary Treatment of Chronic Total Oclusions Valeri Gelev University Emergency Hospital

Contemporary Treatment of
Chronic Total Oclusions
Valeri Gelev
University Emergency Hospital
“N.I.Pirogov” Sofia
e-mail: [email protected]
Scope of the Problem
• CTO frequency 20 -30% of all coronary angiography.
• More than 50% are without previous MI
• Most of symptomatic and with preserved LV
function.
• Only 1/3 of these pts are revascularized.
SYNTAX Trial Design
62 EU Sites +
23 US Sites
Heart Team (surgeon & interventionalist)
Amenable for both
treatment options
Amenable for only one
treatment approach
Stratification:
LM and Diabetes
Randomized Arms
N=1800
CABG
n=897
Total Occlusion
26.2%
vs
Two Registry Arms
TAXUS*
n=903
CABG
n=1077
PCI
n=198
Total Occlusion
27.0%
Total Occlusion
59.3%
Total Occlusion
39.1%
*
TAXUS Express; Site-reported, patient-based
Patient Characteristics (I)
Total Occlusion Subset: CABG vs PCI
CABG TO
N=235
PCI TO
N=244
P value
64.3 ± 10.4
64.5 ± 10.3
0.82
85.5
79.1
0.07
28.2 ± 4.5
28.3 ± 4.7
0.91
Medically-treated Diabetes, %
26.4
31.6
0.21
Hypertension, %
76.5
76.5
0.99
Hyperlipidemia, %
78.2
83.3
0.16
Fasting Glucose 110 mg/dL, %
38.6
52.8
0.007
Triglycerides 150 mg/dL, %
44.4
38.7
0.22
Poor LVEF (<30%), %
3.0
2.5
0.73
Current smoker, %
20.5
18.0
0.49
Prior MI, %
45.5
34.9
0.02
Unstable angina, %
25.1
29.5
0.28
Additive euroSCORE, mean ± SD
3.6 ± 2.8
3.7 ± 2.7
0.73
Total Parsonnet score , mean ± SD
8.4 ± 6.9
8.7 ± 6.8
0.61
Age, mean ± SD (y)
Male, %
BMI, mean ± SD
Site-reported data
Clinical Indications
why open a chronically occluded coronary artery?
• Symptom control



Angina
CHF
Fatigue
• Improve LV function


Regional
Global
• Survival



Improved tolerance of AMI
Complete revascularization
Ischemic Risk
CTO Recanalization and Angina Control
Successful
PCI (n)
Follow-up
(months)
Asymptomatic
(%)
Olivari 2003
248
12
88.7
Berger 1996
139
6
87
Stewart 1993
45
12
68
Ivanhoe 1992
264
36
69
Ruocco 1992
160
24
69
Bell 1991
234
32
76
Series
Symptom Relief
FACTOR Trial
10
Angina Frequency
14
Physical Limitation
%
21
Quality of Life
-30 -20 -10
0
10 20 30
Effect of Procedural Success
Clinical Endpoints
SAQ Health Status at 1 Month
J. Aaron Grantham
Long Term Survival with CTO PCI
success vs. failure
N
Era
Mean
Follow-up
Survival %
Survival %
(years)
(CTO
Success)
(CTO Failure)
P Value
Suero
2007
1980-1999
Cumulative
10 yr
73.5
65.1
0.001
Hoye
874
1999-2002
4.47+/- 2.69
93.5
88.0
0.02
Aziz
199
2000-2004
Cumulative 2
year
98.0
94.2
0.045
Olivari
390
2003
1 Year
98.1
92.8
<0.005
Prasad
1,262
1979-2005
Cumulative
10 years
~78
~72
0.025*
De Labriolle
172
2003-2005
2 years
95.1
Valenti
486
2003-2006
Cumulative 4
year
91.6
87.4
0.025
*New YorkMilan CTO
registry
1362
2000-2007
3 years
96.4
91.3
0.012
*Dartmouth
487
1996-2008
Cumulative 7
years
87.0
74.0
0.09
94.7
0.30
↓ 44% Mortality
↓ 75% CABG
↓ 55 % Symptoms
13 CTO
Registries
# 7288
~ 6 years
D. Joyal et al. Am Heart J. 2010;160:179-87
SYNTAX Trial Design
62 EU Sites +
23 US Sites
Heart Team (surgeon & interventionalist)
Amenable for both
treatment options
Amenable for only one
treatment approach
Stratification:
LM and Diabetes
Randomized Arms
N=1800
CABG
n=897
Total Occlusion
26.2%
vs
Two Registry Arms
TAXUS*
n=903
CABG
n=1077
PCI
n=198
Total Occlusion
27.0%
Total Occlusion
59.3%
Total Occlusion
39.1%
*
TAXUS Express; Site-reported, patient-based
Total Occlusion Procedural characteristics
Per lesion analysis
CABG
n=266
12 were not treated with CABG
CABG
n=254
Not Bypassed
n=81
Bypassed
n=173
Reason not bypassed:
Not intended to treat (n=12)
Diseased (n=11)
Inadequate conduit (n=2)
Too small (n=19)
Unable to find (n=1)
Other (n=36)
Overall 68.1 % of TO
were successfully
bypassed
ITT, Per Lesion
Total Occlusion Procedural characteristics
Per lesion analysis
PCI
n=277
PCI
n=269
Attempted
to treat
n=250
Unsuccessful
n=117
8 were not treated with PCI
Not attempted
n=19
7%
Successful
n=133
Overall 49.4 % of TO
successfully treated
Per Lesion
Success rates
study
Puma et al review JACC 1995
no of CTOs % success
4664
65
397
81
Corco et al CCD 1998
56
79
Kähler et al CCI 2000
107
42
Serruys et al TOTAL EHJ 2000
303
50
Noguchi et al CCI 2000
226
59
LeFevre et al AJC 2000
88
53
Suero et al JACC 2001
2007
74
Saito et al CCI 2003
262
71
Hoye et al EHJ 2005
885
65
8995
68
Kinoshita et al JACC 1995
Overall
CONTEMPORARY CTO DEVELOPMENT
 Dual injection (recently widely adopted)
 Development of dedicated CTO wires
 Development of OTW balloons and microcatheters
 Development of CTO techniques
CTO GUIDE WIRE MILESTONES
1996
1995
Crosswire
Choice PT
1st Polymer
Covered GW
ASAHI
Miracle
1st Dedicated
CTO spring
coil GW
2008
GUIDANT
TERUMO
SCIMED
2010/11
1999
1st Nitinol
Hydrophilic
CTO Guide
Wire
2009
HT CROSS-IT XT
Tapered Tip Design
ASAHI
Confianza/Pro
Tappered
hydrophilic
wires
ASAHI
ASAHI
Fielder XT
Polymer
Covered
Tapered
Guide Wire
ABBOTT
PROGRESS
Polymer Sleeve
CTO GWi
incorporating
Penetration
Power
SION
Fielder XT-A/R
Tip
Double Coil GW
Development of CTO Techniques
Single wire
Parallel wire
IVUS guided
STAR
Retrograde
Antegrade SCTs
Dissection & Reentry
2008
2005
2004
2001
2000
Options for optimal antegrade strategies
 Anchoring technique in a side branch proximal to the occlusion
 Use of soft tapper tip polymeric/hydrophilic wire to start in combination with
a microcatheter (mosty Finecross antegradely; 1.6 Fr)
 Filder XT
 Whisper LS
 Pilot 50
 Escalation to stiff/stiffer spring coil wires with or without polymer/coatingsingle wire technique
 Parallel wire technique “step-up” wire approach
 Miracle/Miracle Ultimate
 Confianza / Confianza pro
 PROGRESS 140-200T
 Implementation of limited subintimal antegrade techniques
(dissection/reently)
 Mini STAR: stiff wire to cross the lesion followed by soft wires for re-enty
 LAST (limited antegrade subintimal tracking): stiff wire to cross the lesion
followed by soft wires for reentry
 Hydrodynamic recanalisation
 Use of dedicated devices (Bridge Point)
 Shift to the retrograde techniques
PARALLEL WIRE TECHNIQUE




Bilateral injection
Bi-radial access
GC: EBU 3.5 –JR4 6 Fr
Finecross MC/Fileder XT
67y♂, LAD CTO second attempt
Parallel wire technique
 Trapping technique for Finecross
MC exchange; 6Fr is enough
 Parallel wire - escalate to a
stiff/er wire usually tapper tip
wires
 Currently the “sequential stepup” stiff-er-st is not advocated
Confianza pro 12
Fielder XT
Wire cross in true lummen-Confirmation with contralateral injection
Final result after 2 XIENCE Prime DES
Trends in Antegrade Approach
Dissection / Reentry techniques
 STAR
 Hydrodynamic recanalisation
 Mini-STAR; stiff followed by soft wires
 LAST (Limited Antegrade Subintimal
tracking); soft (knuckle) followed by
stiff wires
73y♂, LCX CTO




Bilateral injection
Femoral-radial access
GC: EBU 4 –JR4 6 Fr
Finecross MC/Fielder XT
failed to puncture the
proximal cup
Stiff-st step up wire approach



From Fielder XT to
PROGRESS 200T
Proximal cup penetration
Finecross MC
advancement in the
occlusion body
Back to soft wires with of without Knuckle …….
Fielder XT CTO crossing with knuckle technique
Mini STAR technique
Final result after implantation of two XIENCE
Prime DES
Retrograde Techniques
CART / X-CART
Retrograde wire crossing
Marker/kissing wire
Concept of CART technique
1. Both wires in subintimal
space
2. Dilation by retrograde
balloon
3. Dilated subintimal space
4,5,6.
Then the antegrade wire is
easily directed into the dilated
subintimal space.
Concept of CART technique
-Controlled Antegrade and Retrograde subintimal Tracking
AW
RW
Concept of CART technique
-Controlled Antegrade and Retrograde subintimal Tracking
AW
RW
Concept of CART technique
-Controlled Antegrade and Retrograde subintimal Tracking
AW
RW
CART technique, Katoh 2005
Stent Reverse-CART technique
late 2006-2007
Stent Reverse-CART technique
late 2006-2007
Stent Reverse-CART technique
late 2006-2007
Adjunctive techniques
1. IVUS guidance (Japanese driven-not widely
adopted)
 Proximal/distal cup recognition
 Wire guidance in true lumen
 Antegrade/retrograde subintimal connection
2. Retrograde wire externalisation
 Dedicated wires
 Snare wires
3. Anchoring/Trapping techniques
 Retrograde wire (antegrade GC/donor GC)
 Antegrade wire (distal occluded vessel)
4. Septal overdilatation (2mm long balloons)
5. Knuckle wire technique
Retrograde wire externalisation
ECC CONSENSUS ON THE
RETROGRADE APPROACH
 The retrograde technique represents a breakthrough in CTO recanalisation with
success rates exceeding 90% in complex CTOs and it has comparable complication
rates with contemporary antegrade techniques.
 Current evidence suggests that they should be reserved for second attempts after
antegrade failure, or as strategies of choice in very complex CTOs where the
expected antegrade success rate is <50%.
 Recent trends in practice suggest implementation of the retrograde techniques
after short antegrade failures (aimed at reducing procedure duration, contrast
consumption and radiation exposure), but until more data become available this
approach should be reserved for very experienced operators.
 Retrograde techniques should be reserved for very experienced antegrade
operators (>300 CTOs and >50 per year). A minimum of 50 retrograde procedures
(25 as second operator and 25 as first under supervision) are required before a
cardiologist becomes an independent retrograde operator.
Sianos et al. EuroIntervention 2012
CTO-PCI Success Rate
in Toyohashi Heart Center
100
%
84,2
86,3
2004
2005
92,4
92,2
91,6
91,5
92,6
2006
2007
2008
2009
2010
79
80
71,3
74
73,5
2001
2002
64,9
60
40
20
0
1999
2000
2003
CTO PCI success in Europe (%)
06/07: all members - since 2008 Online Registry
100
90
80
70
60
50
40
30
20
10
0
75
77
80
82
86
2006 (3591) 2007 (3090) 2008 (1215) 2009 (1608) 2010 (1977)
*
Study
Year
n
Ivanhoe et al
Bell et al
Ruocco et al
Tan et al
Stewart et al
Kinoshita et al
Corcos et al
Noguchi et al
Kähler et al
Serruys et al
Lefevre et al
Suero et al
Olivari et al
Saito et al
Hoye et al
Drozd et al
Fang et al
Han et al
Han et al
Drozd et al
Arslan et al
Prasad et al
Valenti et al
De Labriolle et al
Meta-Analyses
Puma et al
Joyal et al
1992 480
317(66%)
1992 354
234(66%)
1992 271
160(59%)
1993 312
191(61%)
1993 100*
47(47%)
1995 397
352(89%)
1998 56*
44(79%)
2000 226
134(59%)
2000 107*
45(42%)
2000 303
152(50%)
2000
88
47(53%)
2001 2007
1403(70%)
2003 390*
286(73%)
2003 262
187(71%)
2005 885*
576(65%)
2005 460
299(65%)
2005 294
175(60%)
2005 1494* 1317(88%)
2006 1625* 1445(89%)
2006 459
293(64%)
2006 172
117(68%)
2007 1262
879(70%)
2008 527*
361(68%)
2008 172
127(74%)
1995 4664
2010 7288
Success (%) Study
2902(65%)
5058(69%)
Aziz et al
Soon et al
Safley et al
Mitsudo et al
Yi et al
Rathore et al
Garcia-Garcia et al
Rathore et al
Chen et al
Paizis et al
Ehara et al
Hsu et al
Grantham et al
Garibaldi et al
Matsukage et al
Werner et al
Morino et al
Yang et al
Li et al
Cho et al
Li et al
Kirschbaum et al
Tomasello et al
Liu et al
Year
n
2007
2007
2008
2008
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
2010
2010
2011
2011
2011
2011
572*
43*
2608
116*
1332
468
142
904*#
162*
106
110*
69*
125
121
141#
674
392*
419
74*
72
447
72
328*#
120 #
Success
(%)
400(70%)
24(56%)
1910(73%)
105(91%)
1202(90%)
390(83%)
89(63%)
791(88%)
138(85%)
82(77%)
93(84%)
62(90%)
69(55%)
78(64%)
124(88%)
405(60%)
354(90%)
292(70%)
57(77.0%)
55(76%)
382(86%)
43(60%)
283(86%)
97(81%)
Antegrade
Success
Rates
*Refers to the
number of CTO
lesions; # Small
percent of cases
with retrograde
approach is
included
Retrograde Approach; Success Rates
Author
RA Cases
RA Facilitated
Feasibility
Success Rate
Surmely et al (2006)
10
10
100% (10/10)
100% (10/10)
Surmely et al (2007)
21
19
90.5%(19/21)
78.9%(15/19)
Di Mario et al (2007)
17
13
76.5%(13/17)
100%(13/13)
Sheiban et al (2007)
18
16
88.9%(16/18)
75%(12/16)
Saito (2008)
45
37
82.2% (37/45)
83.8% (31/37)
Sianos et al (2008)
175
141
80.6% (141/175)
91.5% (129/141)
Rathore et al (2009)
157
115
73.2% (115/157)
89.5% (103/115)
28/31*
25
80.6% (25/31)
80% (20/25)
122
99
81.1% (99/122)
86.9% (86/99)
46/50*
31
62% (31/50)
100% (31/31)
Kimura et al (2009)
224
197
87.9% (197/224)
87.8% (173/197)
Morino et al (2010)
136
101
74.3% (101/136)
93.9% (95/101)
Rathore et al (2010)
31
31
n/a**
100%(31/31)
124
114
91.9%(114/124)
n/a
93
90
96.8%(90/93)##
98.9%(89/90)
Ge et al (2010)
42
34
80.9% (34/42)
94.1% (32/34)
Lee et al (2010)
24
18
75%(18/24)
94.4%(17/18)
Rinfret et al (2011) !#
42
36
36/42(85.7%)
97.2%(35/36)
1269
1037
1037/1269(81.7%)
91%(922/1013)
Chung et al (2009)
Thompson et al (2009)
Hsu et al (2009)
Tsuchikane et al (2010) #
OVERALL
* Lesions, ** Refers only to IVUS X-CART (non consecutive patients), # Refers only to patients
with X-CART technique, ## Refers to Corsair crossing, !# Bilateral access in 37(88%) of the cases
DES in CTO
Sianos et al, Eurontervention 2012
Relative paucity of data
There are no prospective randomized
trials, properly powered for hard clinical
endpoints (survival, MI), comparing
contemporary optimal medical therapy
with contemporary state of the art CTO
recanalisation
The EURO-CTO Trial
Evaluation of the Utilisation of Revascularisation vs Optimal medical therapy for CTOs
1200 patients
40 operators
>80% success rate
Started early 2012
2012 consensus document from
the EuroCTO club
Consensus on indication
Sianos et al. EuroIntervention 2012
“CTO recanalisation is indicated in
patients with symptoms and evidence
of ischemia. In patients with prior Qwave myocardial infarction viability
should be confirmed.”
CTO in 2012
Unfortunately contemporary CTO techniques still remain
in the hands of few experts……..The EuroCTO club
numbers around 40 members…..
Long term angiographic and clinical outcomes of
patients treated with contemporary CTO techniques are
largely unknown (paucity of data).
A good CTO operator is the one that he recognizes his
limits; safety above all.
Patients selection and training/education are of
paramount importance and are the key parameters that
will balance between what is feasible and what it make
sense to do…
Other Methods to Deal with CTOs…
Sobajima, M., T. Nozawa, et al. (2012).
"Repeated sauna therapy improves
myocardial perfusion in patients with
chronically occluded coronary arteryrelated ischemia."
Int J Cardiol.
BACKGROUND: Repeated low-temperature sauna (Waon) therapy relieves ischemic symptoms in
patients with peripheral arterial disease. We investigated whether Waon therapy could improve myocardial
perfusion in patients with ischemia related to chronic total occlusion (CTO) of coronary arteries.
METHODS: Twenty-four patients who had ischemia in the CTO-related area were examined. The severity
of ischemia was quantified by thallium-201 myocardial perfusion scintigraphy with adenosine. The Waon
group (n=16) was treated daily for three weeks with a 60 degrees C far infrared-ray dry sauna bath for
15min and then kept in a bed covered with blankets for 30min. The control group (n=8) underwent
myocardial perfusion scintigraphy twice with a three-week interval. RESULTS: In the control group, neither
summed stress score (SSS) nor summed difference score (SDS) of myocardial scintigraphy changed.
However, Waon therapy improved both SSS (16+/-7 to 9+/-6, p<0.01) and SDS (7+/-4 to 3+/-2, p<0.01),
and the improvement was greater in patients with higher SSS and SDS scores at the baseline. Waon
therapy extended treadmill exercise time (430+/-185 to 511+/-192s, p<0.01) and improved flow-mediated
dilation of the brachial artery (4.1+/-1.3 to 5.9+/-1.8%, p<0.05), but tended to decrease the number of
circulating CD34-positive bone marrow-derived cells. CONCLUSIONS: Waon therapy improves CTOrelated myocardial ischemia in association with improvement of vascular endothelial function. This therapy
could be a complementary and alternative tool in patients with severe coronary lesions not suitable for
coronary intervention.