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EURO CTO
CLUB
Madrid 2014
26 / 9/ 2014
Masahisa Yamane , MD, FACC
OLV Cardiovascular Center,
Aalst, Belgium
St Luke‘s International Hospital ,
Tokyo, Japan
SaitamaSekishinkai Hospital,
Saitama, Japan
Session 7 Registries
Purpose of Retrograde Summit
 Retrograde Summit was originally established to
investigate clinical results of percutaneous coronary
intervention to treat chronic total occlusions (CTO)
treated by retrograde approach.
 From year 2012, all procedure data for CTO
recanalization including attempted by antegrade
approach were acquired so as to deeply understand
clinical outcomes in real-world and investigate long-
term efficacy of successful CTO recanalization.
26 / 9/ 2014
Definitions of terms
• CTO
- TIMI flow grade 0 on coronary angiogram and occlusion
period with > 3 months or unknown
• Retrograde Approach
- Any CTO-PCI attempt, with wiring through collateral channels
• MACCE (Major Adverse Cardiac and Cerebrovascular Event)
- Death, Myocardial Infarction, Stroke, Emergent CABG and/or
TVR
• Procedure Success
- Recanalization of target lesion with restoration of TIMI flow
grade 3 and residual stenosis <50%
26 / 9/ 2014
Annual change of enrollment
1542
1472 1417
1553
1676
378
(24.5%)
423
(28.7%)
365
(25.8%)
490
(31.6%)
538
(32.1%)
0
400
800
1200
1600
2009 2010 2011 2012 2013
NumberofCTOprocedures
CTO-PCI Retrograde
WEB registry started from 2012
26 / 9/ 2014
57 Participant Hospitals (2013)
Saiseikai Yokohama-City Eastern Hospital
Sapporo Cardio Vascular Clinic
Sakurabashi Watanabe Hospital
Toyohashi Heart Center
Saitama Cardiovascular and Respiratory Center
Saitama Sekishinkai Hospital
Takase Clinic
The Cardiovascular Institute
Higashi Takarazuka Satoh Hospital
Sanda City Hospital
Edogawa Hospital
Nagoya Heart Center
Seirei Hamamatsu General Hospital
Hoshi General Hospital
Tokorozawa Heart Center
Saiseikai Fukuoka General Hospital
Hokkaido Social Insurance Hospital
Yotsuba Circulation Clinic
Shiga Medical Center for Adults
Nagoya Tokushukai Hospital
Rinku General Medical Center
Kusatsu Heart Center
Kakogawa East City Hospital
Fukaya Red Cross Hospital
Hokko Memorial Hospital
Showa University Hospital
Nagoya Daini Red Cross Hospital
Daini Okamoto General Hospital
Mie Heart Center
Kyoto Katsura Hospital
Kushiro City General Hospital
Showa General Hospital
Shinkoga Hospital
Kanagawa Cardiovascular and Respiratory Center
Tokeidai Memorial Hospital
Iwaki Kyouritsu Hospital
Hyogo Brain and Heart Center
Yokohama Sakae Kyosai Hospital
Hyogo Prefectural Amagasaki Hospital
Iwate Prefectural Central Hospital
Shuuwa General Hospital
Osaka Saiseikai Izuo Hospital
Itabashi Chuo Hospital
NTT East Sapporo Hospital
Todachuo General Hospital
Hamada Medical Center
Hokusetsu General Hospital
Tokuyama Chuo Hospital
Osaki Citizen Hospital
Tokushima Red Cross Hospital
Kobe Redcross Hospital
Yokohama Shintoshi Neurosurgical Hospital
Ohta General Hospital Ohta Nishinouchi Hospital
Toho University Omori Medical Center
Tsukuba Memorial Hospital
Mimihara General Hospital
Kansai Medical University Takii Hospital
In order of entry number
Jan 2012 – Dec 2013
The number of registry : 3294
Registered Hospital : 57
Case enrollment : 3,294 CTO-PCIs
Final subject for analysis:
3,229 CTO-PCIs
Total (n) 2012 (n) 2013 (n)
CTO-PCIs 3,229 1,553 1,676
- Antegrade alone 2,201 1,063 1,138
- Retrograde 1,028 490 538
65 cases were excluded due to
insufficient case card information
Registry Data 2012-2013
26 / 9/ 2014
Procedure flowchart
based on each procedure
CTO-PCI cases
Success
Antegrade Retrograde
Failure
Switched to
Retrograde
Antegrade
failure
Success Failure
Switched to
Antegrade
Retrograde
failure
Antegrade alone Retrograde
RetrogradeRetrograde RetrogradeAntegrade alone
26 / 9/ 2014
Patient characteristics (1)
2012 (1553) 2013 (1676) P
Age, yo 67.8±10.3 67.7±10.5 0.9133
Male 82.8% 84.1% 0.3262
Family history of CAD 17.0% 18.0% 0.5247
Previous MI 38.9% 40.8% 0.2831
Previous CABG 8.8% 8.5% 0.7667
Previous PCI 60.0% 61.7% 0.3235
# of diseased vessel
- 1-vessel
- 2-vessel
- 3-vessel
35.4%
38.2%
26.4%
41.1%
37.1%
21.8%
0.0009
Hypertension 80.1% 79.7% 0.7689
Diabetes 43.3% 45.6% 0.1839
Diabetes, type 1 6.5% 8.2% 0.0682
Hyperlipidemia 69.9% 70.9% 0.5131
26 / 9/ 2014
Patient characteristics (2)
2012 (1553) 2013 (1676) P
Smoker 47.8% 47.6% 0.9364
Unstable angina 8.6% 7.6% 0.3255
CCS classification
- 0
- I
- II
- III
- IV
30.7%
29.1%
31.0%
6.9%
2.3%
27.7%
30.6%
33.7%
5.6%
2.4%
0.1626
NYHA classification
- I
- II
- III
- IV
- Not applicable
30.5%
15.2%
4.1%
2.6%
47.6%
31.6%
15.7%
3.7%
2.6%
46.4%
0.9158
Pre creatinine >2.5mg/dl 7.5% 8.3% 0.3661
Hemodialysis 5.9% 7.3% 0.1071
LVEF <35% 10.0% 10.3% 0.7565
26 / 9/ 2014
Lesion characteristics (1)
2012 (1553) 2013 (1676) P
Re-attempt case 11.6% 9.0% 0.0155
Previous strategy in re-attempt case
- Antegrade
- Retrograde
- Both
- NA
79.7%
2.8%
11.3%
6.2%
64.2%
4.7%
20.9%
10.1%
0.0206
Previous failure reason
- Failure to cross CTO by GW
- Failure to cross collateral by GW
- Delivery failure of treatment device
- NA
79.1%
1.1%
4.5%
15.3%
80.4%
4.0%
6.0%
9.5%
0.1468
26 / 9/ 2014
Lesion characteristics (2)
2012 (1553) 2013 (1676) P
Target vessel
- RCA
- LAD
- LCx
- LMT
46.6%
31.8%
21.4%
0.3%
49.0%
29.9%
20.9%
0.2%
0.5070
Reference diameter <3.0mm 41.0% 38.8% 0.2262
Occlusion length >20mm 61.7% 55.8% 0.0017
Instent occlusion 14.7% 14.9% 0.9256
Occlusion period
- > 1 year
- 3m - 1 year
- Unknown
8.4%
9.0%
82.5%
9.3%
6.4%
84.2%
0.0188
Collateral filling grade
- CC 0
- CC 1
- CC 2
9.6%
57.7%
32.7%
7.1%
59.4%
33.4%
0.0774
26 / 9/ 2014
Lesion characteristics (3)
0%
20%
40%
Moderate Severe
Lesion calcification
0%
20%
40%
Moderate Severe
Proximal tortuosity
2012 2013
0%
20%
40%
Moderate Severe
Lesion bending
0%
20%
40%
60%
Blunt Funnel/Tapered None/NA
CTO stump
P<0.05
26 / 9/ 2014
J-CTO score
*Score was counted based on judgment more than
“moderate” grade for calcification and bending
2012
(1553)
2013
(1676)
P
Blunt tip/none or unclear tip 53.7% 52.3% 0.4235
Calcification* 33.7% 37.9% 0.0132
Bending* 8.5% 7.9% 0.5504
Occlusion length >20mm 61.7% 55.8% 0.0017
Re-try lesion 11.6% 9.0% 0.0155
Average JCTO-score 1.6±1.1 1.5±1.1 0.0610
0%
10%
20%
30%
40%
Easy (0) Intermediate (1) Difficult (2) Very difficult (>3)
Change of score distribution
2012
2013
P<0.05
Morino et al. JACC Interv 2011;4:231-211)
Procedure outcome
2012 (1553) 2013 (1676) P
Successful CTO crossing by GW 89.6% 89.6% 0.9925
Number of guidewire used for CTO
approach
3.1±2.2 3.2±2.3 0.1788
Stent deployment 93.5% 100.0% <0.0001
Number of stent 1.8±1.0 1.9±0.9 0.0033
Total stent length, mm 51.8±24.9 55.4±27.9 0.0008
Use of drug-eluting stent 98.0% 98.8% 0.0907
Procedure success 88.3% 88.4% 0.9437
Procedure time, min 142.7±83.4 153.2±88.0 0.0012
Contrast dose, ml 228.7±107.2 226.2±103.4 0.5187
Fluoroscopy time, min 64.2±42.4 70.6±47.8 0.0002
Air Kerma, mGy 4715.8±3760.8 4920.3±3879.7 0.2031
26 / 9/ 2014
MACCE
2012 (1553) 2013 (1676) P
MACCE 0.7% (11) 0.7% (11) NS
- Cardiac death 0.2% (3) 0.2% (3) NS
- Non cardiac death 0.1% (2) 0.2% (4) NS
- MI 0.3% (4) 0.1% (1) NS
- Stroke / non-bleeding 0.1% (2) 0.1% (1) NS
- Emergent CABG - 0.1% (2) NS
26 / 9/ 2014
Other procedural complications
2012 (1553) 2013 (1676) P
- Cardiac tamponade 0.5% (7) 0.1% (2) NS
- Heart failure - 0.1% (1) NS
- Transient Cerebral Ischemic Attack 0.1% (1) 0.1% (2) NS
- Stent thrombosis 0.1% (2) 0.2% (3) NS
- Thrombosis formation - 0.1% (1) NS
- Contrast induced nephropathy 0.1% (2) 0.1% (2) NS
- Radiation dermatitis - 0.1% (2) NS
- Access route complication 0.4% (6) 0.4% (7) NS
- Dissection caused by Guiding Catheter - 0.1% (2) NS
- Coronary perforation
due to guidewire
due to balloon
NA
0.8% (12)
0.3% (4)
0.1% (2)
0.4%(6)
2.7% (46)
0.9% (15)
0.1% (2)
1.7% (29)
<0.0001
- Guidewire fracture 0.1% (2) 0.1% (2) NS
26 / 9/ 2014
Including minor events
Retrograde approach relevant
complications
2012 (490) 2013 (538) P
Retrograde approach relevant 11.8% (58) 8.2% (44) NS
- Channel injury
 Additional treatment required
 Cardiac tamponade
11.0% (54)
4.1% (20)
0.4% (2)
8.0% (43)
3.0% (16)
0.2% (1)
NS
- Donor artery trouble 0.2% (1) - NS
- Other events 0.6% (3) 0.2% (1) NS
26 / 9/ 2014
J-CTO score and Success Rate
2012 vs. 2013
93.6%
89.4% 86.9% 84.4%
97.2%
91.3% 88.0%
74.9%
0%
20%
40%
60%
80%
100%
Easy (0) Intermediate (1) Difficult (2) Very difficult (>3)
2012 2013
P<0.05 NS NS P<0.05
26 / 9/ 2014
Procedure characteristics (1)
Antegrade alone
83%
12%
3% 2%
82%
15%
2% 1%
0%
20%
40%
60%
80%
100%
Single
wire
Parallel
wire
IVUS
guided re-
entry
STAR NA
2012 2013
Corsair use: 78.1%
22%
43%
27%
8%
28%
39%
25%
8%
0%
20%
40%
Easy (0) Intermediate
(1)
Difficult (2) Very Difficult
(>3)
2012 2013
Successful CTO crossing strategy J-CTO score for “single wire” technique
Total (2201) 2012 (1063) 2013 (1138) P
Procedure success 91.6% (2016) 90.8% (965) 92.4%(1051) 0.1835
P<0.05P< 0.05
0%
20%
40%
60%
80%
100%
Soft Intermediate Hard Very hard
Easy (0) Intermediate (1) Difficult (2) Very Difficult (>3)
P<0.0001
0%
20%
40%
60%
Soft (<1g) Intermediate
(1-3g)
Hard (3-9g) Very Hard
(>9g)
2012 2013
Guidewire for CTO crossing (1)
Antegrade alone
Guidewire by J-CTO scoreGuidewire by tip load
P< 0.05
Gaia 2 for 23→67%
Gaia 1 for 38→81%
Guidewire for CTO crossing (2)
Antegrade alone
XT
series,
31%
Con Pro,
10%
Gaia 1,
10%
Gaia 2,
6%
Wizard
3, 4%
ULTIM 3,
4%
SION,
4%
FFC, 4%
Other,
26%
2012
Total (2201) 2012 (1063) 2013 (1138) P
Guidewire cross 92.7% (2040) 91.8% (976) 93.5% (1064) 0.1300
XT series,
30%
Gaia 1,
23%
Gaia 2,
20%
Con Pro,
6%
Con Pro
12, 2%
Gaia 3,
2%
ULTIM3,
2%
SION, 2%
Other,
12%
2013
53.3%
44.6%
0%
20%
40%
60%
2012 2013
51.2%
40.8%
5.8%
2.1%
0%
20%
40%
60%
Immediately
after antegrade
failure
Start with
retrograde
approach
Start with
retrograde due
to previous
antegrade
failure
Start with
retrograde
again after
previous
retorgrade
failure
Primary retrograde approach
Background of retrograde approach Annual change from 2012 to 2013
P<0.05
Procedure characteristics (1)
Retrograde cases
Primary retrograde approach
has been decreasing
26 / 9/ 2014
Procedure characteristics (2)
Collateral approach
48%
19%
11%
10%
3%
11%
SION XT-R
SION blue Fielder FC
SUOH SION black
other
2012 61%18%
3%
3%
4%
4% 7%
60%
26%
7%
3%4%
Septal
Epicardial
AC
Ipsilateral
Bypass graft
68%
17%
7%
3%6%
2013
Total (1028) 2012 (490) 2013 (538) P
Guidewire cross 76.9% (791) 77.6% (380) 76.4%(411) 0.6600
2012 2013
P<0.001
Successful guidewire
Successful collateral route
P<0.05
P<0.05
26 / 9/ 2014
51%
35%
14%
1%
61%
26%
13%
1%
0%
20%
40%
60%
Reverse CART Retrogradewire
cross
Kissing wire
cross
CART
2012 2013
Sumitsuji et al. JACC Cardiovasc Interv 2011
Patterns of Success in Retrograde Approach
IVUS was used in 69.2%
of Reverse CART
Procedure characteristics (3)
CTO crossing
Total (1028) 2012 (490) 2013 (538) P
Guidewire cross 65.5% (673) 69.0% (338) 62.3%(335) 0.0033
26 / 9/ 2014
67.2%
24.1%
3.8%
4.9%
Couldn't cross collateral channel
Couldn't cross CTO by GW
Couldn't cross CTO by any catheter
Procedure discontinuation due to complication
Reason of retrograde procedure failure (370)
Retrograde Procedure Outcome (1)
Retrograde cases (1028)
Switched to antegrade approach ; 80.0% (296)
Total (1028) 2012 (490) 2013 (538) P
Procedure success 64.0% (658) 66.5% (326) 61.7%(332) 0.1078
26 / 9/ 2014
60.6%
30.3%
9.1%
0%
40%
80%
Single wire Parallel wire IVUS guided
re-entry
Successful CTO crossing strategy
by antegrade approach
Failure reason N=116
Couldn’t cross CTO by guidewire 84.5% (98)
Couldn’t cross CTO by any catheter 7.8% (9)
Procedure discontinuation due to
complication
5.2% (6)
NA 2.6% (3)
Retrograde Procedure Outcome (2)
In case switched to antegrade after retrograde (n=296)
Total 2012 2013 P
Antegrade procedure success
switched after retrograde failure
60.8%
(180/296)
64.8%
(81/125)
57.9%
(99/171)
0.2294
Overall procedure success in
retrograde cases
81.5%
(838/1028)
83.1%
(407/490)
80.1%
(431/538)
0.2236
26 / 9/ 2014
N =690
MACCE 120 (17.4%)
- Cardiac death 6 (0.9%)
- Non cardiac death 12 (1.7%)
- Stroke 8 (1.2%)
- CABG 6 (0.9%)
- TVR 53 (7.7%)
- TLR 35 (5.1%)
12M FU : MACCE
Follow up rate: 37.3% (690/1848)
26 / 9/ 2014
Follow up rate: 33.3% (616/1848)
197
180
138
29
11
5
22
13
3
5
6
2
1 1
1
1
1
0
50
100
150
200
CCS 0 CCS I CCS II CCS III CCS IV
Before PCI
CCS 0 CCS I CCS II CCS III CCS IV
12M FU : CCS classification
26 / 9/ 2014
EURO CTO
CLUB
Madrid 2014
26 / 9/ 2014
Year
No. of
CTO PCI
No. of
Retrograde
Retrograde
Failure
Change to
Antegrade
Antegrade
success
2009 1542
378
(24.5%)
112
(29.6%)
88
(78.6%)
52
(59.1%)
2010 1472
423
(28.7%)
119
(28.1%)
90
(75.6%)
57
(63.3%)
2011 1471
365
(25.8%)
102
(27.9%)
73
(72.6%)
43
(58.9%)
2012 1573
480
(30.5%)
165
(34.4%)
125
(75.8%)
83
(66.4%)
2013 1671
538
(32.1%)
206
(38.2%)
171
(83.0%)
99
(57.9%)
Limitations
 Selection of approach for CTO was physician- or hospital-
dependent
 Due to registry method, case report form was not always
completed and some cases were excluded from analysis
because of too much of missing data
 In the subanalysis using J-CTO score, our criteria for each
lesion difficulty were not always exact same as original
definition by J-CTO study
 For lower clinical follow-up rate, we are still under data
collecting from participant centers
26 / 9/ 2014
Summery in 2014
 In 2013, overall procedure success is 88.4%, which was
unchanged from 2012
 In antegrade approach alone, our data shows an excellent
procedure success rate (over 90%)
 In retrograde approach( the volume had decreased), there
are no significant difference with overall procedure
success
 Total MACCE rate was 0.7% in over 3200 cases
 12 month follow up MACCE rate was 17% among 690
follow-up, with TLR/TVR rate of 12.8%
 Change of registry system
26 / 9/ 2014
EURO CTO
CLUB
Madrid 2014
26 / 9/ 2014
32
CCT 2014 , 10-30 to 11-1, in Kobe, Japan
14:35 Yamane -  Update Japanese Multicenter Registry
14:35 Yamane -  Update Japanese Multicenter Registry
Difference of baseline & procedure characteristics
Retrograde cases
2012
(490)
2013
(538)
P
Male 84.7% 87.5% NS
Age 60.9% 62.7% NS
Previous MI 45.1% 42.0% NS
Previous CABG 14.6% 13.8% NS
Multi-vessel disease 64.1% 57.0% <0.05
Hypertension 79.8% 78.7% NS
DM 46.0% 46.5% NS
Hyperlipidemia 71.0% 75.6% NS
Smoking 52.6% 51.1% NS
Family history of CAD 16.2% 19.5% NS
Unstable angina 7.1% 5.4% NS
Previous PCI 65.8% 66.5% NS
Pre creatinine >2.5mg/dl 8.2% 5.7% NS
LVEF<35% 12.4% 11.0% NS
Target vessel - RCA
- LAD
- LCx
- LMT
61.4%
26.5%
11.4%
0.6%
63.9%
25.8%
9.7%
0.6%
NS
2012
(490)
2013
(538)
P
Lesion calcification 45.3% 49.3% NS
Prox. Tortuosity 13.6% 12.3% NS
Lesion bending 14.7% 13.1% NS
Blunt /no or unclear stump 69.4% 70.2% NS
Occlusion length >20mm 77.1% 72.2% NS
Ref. Diameter <3.0mm 27.7% 29.1% NS
Occlusion period - > 1year 60.3% 75.5% <0.05
ISR-CTO 9.6% 7.9% NS
Re-try case 22.3% 18.9% NS
Collateral channel(CC) grade
- CC 0
- CC 1
- CC 2
6.1%
56.3%
37.6%
2.7%
60.0%
37.3%
<0.05
Average J-CTO score 2.1±1.1 2.1±1.1 NS
Procedure time, min 201.4±90.9 225.7±88.5 <0.05
Contrast dose, ml 268.6±119.9 270.1±113.1 NS
Fluoroscopic time, min 94.2±46.7 108.0±49.7 <0.05
Air Karma , mGy 6132.5±4407.1 6639.3±4512.0 NS
26 / 9/ 2014
Difference of baseline & procedure characteristics
Antegrade alone cases
2012
(1063)
2013
(1138)
P
Male 81.9% 82.5% NS
Age 64.1% 63.4% NS
Previous MI 36.0% 40.2% <0.05
Previous CABG 6.1% 6.0% NS
Multi-vessel disease 64.8% 59.8% <0.05
Hypertension 80.2% 80.2% NS
DM 42.0% 45.2% NS
Hyperlipidemia 69.3% 68.7% NS
Smoking 45.6% 45.9% NS
Family history of CAD 17.4% 17.4% NS
Unstable angina 9.2% 8.6% NS
Previous PCI 57.3% 59.4% NS
Pre creatinine >2.5mg/dl 7.1% 9.6% <0.05
LVEF<35% 8.8% 10.0% NS
Target vessel - RCA
- LAD
- LCx
- LMT
39.7%
34.2%
26.0%
0.1%
42.0%
31.8%
26.2%
0.0%
NS
2012
(1063)
2013
(1138)
P
Lesion calcification 28.3% 32.4% <0.05
Prox. Tortuosity 8.2% 9.9% NS
Lesion bending 5.7% 5.5% NS
Blunt /no or unclear stump 46.5% 43.8% NS
Occlusion length >20mm 54.6% 48.2% <0.05
Ref. Diameter <3.0mm 47.1% 43.3% NS
Occlusion period - > 1year 39.7% 48.1% NS
ISR-CTO 17.1% 18.1% NS
Re-try case 6.6% 4.3% <0.05
CC grade from contralateral
- CC 0
- CC 1
- CC 2
11.6%
58.4%
29.9%
9.7%
59.7%
31.1%
NS
Average J-CTO score 1.3±0.9 1.2±1.0 NS
Procedure time, min 114.4±62.3 119.5±64.2 NS
Contrast dose, ml 209.4±94.7 205.4±91.5 NS
Fluoroscopic time, min 49.5±30.9 52.8±34.9 <0.05
Air Karma , mGy 3987.5±3144.74091.6±3225.1 NS
14:35 Yamane -  Update Japanese Multicenter Registry

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14:35 Yamane - Update Japanese Multicenter Registry

  • 1. EURO CTO CLUB Madrid 2014 26 / 9/ 2014 Masahisa Yamane , MD, FACC OLV Cardiovascular Center, Aalst, Belgium St Luke‘s International Hospital , Tokyo, Japan SaitamaSekishinkai Hospital, Saitama, Japan Session 7 Registries
  • 2. Purpose of Retrograde Summit  Retrograde Summit was originally established to investigate clinical results of percutaneous coronary intervention to treat chronic total occlusions (CTO) treated by retrograde approach.  From year 2012, all procedure data for CTO recanalization including attempted by antegrade approach were acquired so as to deeply understand clinical outcomes in real-world and investigate long- term efficacy of successful CTO recanalization. 26 / 9/ 2014
  • 3. Definitions of terms • CTO - TIMI flow grade 0 on coronary angiogram and occlusion period with > 3 months or unknown • Retrograde Approach - Any CTO-PCI attempt, with wiring through collateral channels • MACCE (Major Adverse Cardiac and Cerebrovascular Event) - Death, Myocardial Infarction, Stroke, Emergent CABG and/or TVR • Procedure Success - Recanalization of target lesion with restoration of TIMI flow grade 3 and residual stenosis <50% 26 / 9/ 2014
  • 4. Annual change of enrollment 1542 1472 1417 1553 1676 378 (24.5%) 423 (28.7%) 365 (25.8%) 490 (31.6%) 538 (32.1%) 0 400 800 1200 1600 2009 2010 2011 2012 2013 NumberofCTOprocedures CTO-PCI Retrograde WEB registry started from 2012 26 / 9/ 2014
  • 5. 57 Participant Hospitals (2013) Saiseikai Yokohama-City Eastern Hospital Sapporo Cardio Vascular Clinic Sakurabashi Watanabe Hospital Toyohashi Heart Center Saitama Cardiovascular and Respiratory Center Saitama Sekishinkai Hospital Takase Clinic The Cardiovascular Institute Higashi Takarazuka Satoh Hospital Sanda City Hospital Edogawa Hospital Nagoya Heart Center Seirei Hamamatsu General Hospital Hoshi General Hospital Tokorozawa Heart Center Saiseikai Fukuoka General Hospital Hokkaido Social Insurance Hospital Yotsuba Circulation Clinic Shiga Medical Center for Adults Nagoya Tokushukai Hospital Rinku General Medical Center Kusatsu Heart Center Kakogawa East City Hospital Fukaya Red Cross Hospital Hokko Memorial Hospital Showa University Hospital Nagoya Daini Red Cross Hospital Daini Okamoto General Hospital Mie Heart Center Kyoto Katsura Hospital Kushiro City General Hospital Showa General Hospital Shinkoga Hospital Kanagawa Cardiovascular and Respiratory Center Tokeidai Memorial Hospital Iwaki Kyouritsu Hospital Hyogo Brain and Heart Center Yokohama Sakae Kyosai Hospital Hyogo Prefectural Amagasaki Hospital Iwate Prefectural Central Hospital Shuuwa General Hospital Osaka Saiseikai Izuo Hospital Itabashi Chuo Hospital NTT East Sapporo Hospital Todachuo General Hospital Hamada Medical Center Hokusetsu General Hospital Tokuyama Chuo Hospital Osaki Citizen Hospital Tokushima Red Cross Hospital Kobe Redcross Hospital Yokohama Shintoshi Neurosurgical Hospital Ohta General Hospital Ohta Nishinouchi Hospital Toho University Omori Medical Center Tsukuba Memorial Hospital Mimihara General Hospital Kansai Medical University Takii Hospital In order of entry number Jan 2012 – Dec 2013 The number of registry : 3294 Registered Hospital : 57
  • 6. Case enrollment : 3,294 CTO-PCIs Final subject for analysis: 3,229 CTO-PCIs Total (n) 2012 (n) 2013 (n) CTO-PCIs 3,229 1,553 1,676 - Antegrade alone 2,201 1,063 1,138 - Retrograde 1,028 490 538 65 cases were excluded due to insufficient case card information Registry Data 2012-2013 26 / 9/ 2014
  • 7. Procedure flowchart based on each procedure CTO-PCI cases Success Antegrade Retrograde Failure Switched to Retrograde Antegrade failure Success Failure Switched to Antegrade Retrograde failure Antegrade alone Retrograde RetrogradeRetrograde RetrogradeAntegrade alone 26 / 9/ 2014
  • 8. Patient characteristics (1) 2012 (1553) 2013 (1676) P Age, yo 67.8±10.3 67.7±10.5 0.9133 Male 82.8% 84.1% 0.3262 Family history of CAD 17.0% 18.0% 0.5247 Previous MI 38.9% 40.8% 0.2831 Previous CABG 8.8% 8.5% 0.7667 Previous PCI 60.0% 61.7% 0.3235 # of diseased vessel - 1-vessel - 2-vessel - 3-vessel 35.4% 38.2% 26.4% 41.1% 37.1% 21.8% 0.0009 Hypertension 80.1% 79.7% 0.7689 Diabetes 43.3% 45.6% 0.1839 Diabetes, type 1 6.5% 8.2% 0.0682 Hyperlipidemia 69.9% 70.9% 0.5131 26 / 9/ 2014
  • 9. Patient characteristics (2) 2012 (1553) 2013 (1676) P Smoker 47.8% 47.6% 0.9364 Unstable angina 8.6% 7.6% 0.3255 CCS classification - 0 - I - II - III - IV 30.7% 29.1% 31.0% 6.9% 2.3% 27.7% 30.6% 33.7% 5.6% 2.4% 0.1626 NYHA classification - I - II - III - IV - Not applicable 30.5% 15.2% 4.1% 2.6% 47.6% 31.6% 15.7% 3.7% 2.6% 46.4% 0.9158 Pre creatinine >2.5mg/dl 7.5% 8.3% 0.3661 Hemodialysis 5.9% 7.3% 0.1071 LVEF <35% 10.0% 10.3% 0.7565 26 / 9/ 2014
  • 10. Lesion characteristics (1) 2012 (1553) 2013 (1676) P Re-attempt case 11.6% 9.0% 0.0155 Previous strategy in re-attempt case - Antegrade - Retrograde - Both - NA 79.7% 2.8% 11.3% 6.2% 64.2% 4.7% 20.9% 10.1% 0.0206 Previous failure reason - Failure to cross CTO by GW - Failure to cross collateral by GW - Delivery failure of treatment device - NA 79.1% 1.1% 4.5% 15.3% 80.4% 4.0% 6.0% 9.5% 0.1468 26 / 9/ 2014
  • 11. Lesion characteristics (2) 2012 (1553) 2013 (1676) P Target vessel - RCA - LAD - LCx - LMT 46.6% 31.8% 21.4% 0.3% 49.0% 29.9% 20.9% 0.2% 0.5070 Reference diameter <3.0mm 41.0% 38.8% 0.2262 Occlusion length >20mm 61.7% 55.8% 0.0017 Instent occlusion 14.7% 14.9% 0.9256 Occlusion period - > 1 year - 3m - 1 year - Unknown 8.4% 9.0% 82.5% 9.3% 6.4% 84.2% 0.0188 Collateral filling grade - CC 0 - CC 1 - CC 2 9.6% 57.7% 32.7% 7.1% 59.4% 33.4% 0.0774 26 / 9/ 2014
  • 12. Lesion characteristics (3) 0% 20% 40% Moderate Severe Lesion calcification 0% 20% 40% Moderate Severe Proximal tortuosity 2012 2013 0% 20% 40% Moderate Severe Lesion bending 0% 20% 40% 60% Blunt Funnel/Tapered None/NA CTO stump P<0.05 26 / 9/ 2014
  • 13. J-CTO score *Score was counted based on judgment more than “moderate” grade for calcification and bending 2012 (1553) 2013 (1676) P Blunt tip/none or unclear tip 53.7% 52.3% 0.4235 Calcification* 33.7% 37.9% 0.0132 Bending* 8.5% 7.9% 0.5504 Occlusion length >20mm 61.7% 55.8% 0.0017 Re-try lesion 11.6% 9.0% 0.0155 Average JCTO-score 1.6±1.1 1.5±1.1 0.0610 0% 10% 20% 30% 40% Easy (0) Intermediate (1) Difficult (2) Very difficult (>3) Change of score distribution 2012 2013 P<0.05 Morino et al. JACC Interv 2011;4:231-211)
  • 14. Procedure outcome 2012 (1553) 2013 (1676) P Successful CTO crossing by GW 89.6% 89.6% 0.9925 Number of guidewire used for CTO approach 3.1±2.2 3.2±2.3 0.1788 Stent deployment 93.5% 100.0% <0.0001 Number of stent 1.8±1.0 1.9±0.9 0.0033 Total stent length, mm 51.8±24.9 55.4±27.9 0.0008 Use of drug-eluting stent 98.0% 98.8% 0.0907 Procedure success 88.3% 88.4% 0.9437 Procedure time, min 142.7±83.4 153.2±88.0 0.0012 Contrast dose, ml 228.7±107.2 226.2±103.4 0.5187 Fluoroscopy time, min 64.2±42.4 70.6±47.8 0.0002 Air Kerma, mGy 4715.8±3760.8 4920.3±3879.7 0.2031 26 / 9/ 2014
  • 15. MACCE 2012 (1553) 2013 (1676) P MACCE 0.7% (11) 0.7% (11) NS - Cardiac death 0.2% (3) 0.2% (3) NS - Non cardiac death 0.1% (2) 0.2% (4) NS - MI 0.3% (4) 0.1% (1) NS - Stroke / non-bleeding 0.1% (2) 0.1% (1) NS - Emergent CABG - 0.1% (2) NS 26 / 9/ 2014
  • 16. Other procedural complications 2012 (1553) 2013 (1676) P - Cardiac tamponade 0.5% (7) 0.1% (2) NS - Heart failure - 0.1% (1) NS - Transient Cerebral Ischemic Attack 0.1% (1) 0.1% (2) NS - Stent thrombosis 0.1% (2) 0.2% (3) NS - Thrombosis formation - 0.1% (1) NS - Contrast induced nephropathy 0.1% (2) 0.1% (2) NS - Radiation dermatitis - 0.1% (2) NS - Access route complication 0.4% (6) 0.4% (7) NS - Dissection caused by Guiding Catheter - 0.1% (2) NS - Coronary perforation due to guidewire due to balloon NA 0.8% (12) 0.3% (4) 0.1% (2) 0.4%(6) 2.7% (46) 0.9% (15) 0.1% (2) 1.7% (29) <0.0001 - Guidewire fracture 0.1% (2) 0.1% (2) NS 26 / 9/ 2014
  • 17. Including minor events Retrograde approach relevant complications 2012 (490) 2013 (538) P Retrograde approach relevant 11.8% (58) 8.2% (44) NS - Channel injury  Additional treatment required  Cardiac tamponade 11.0% (54) 4.1% (20) 0.4% (2) 8.0% (43) 3.0% (16) 0.2% (1) NS - Donor artery trouble 0.2% (1) - NS - Other events 0.6% (3) 0.2% (1) NS 26 / 9/ 2014
  • 18. J-CTO score and Success Rate 2012 vs. 2013 93.6% 89.4% 86.9% 84.4% 97.2% 91.3% 88.0% 74.9% 0% 20% 40% 60% 80% 100% Easy (0) Intermediate (1) Difficult (2) Very difficult (>3) 2012 2013 P<0.05 NS NS P<0.05 26 / 9/ 2014
  • 19. Procedure characteristics (1) Antegrade alone 83% 12% 3% 2% 82% 15% 2% 1% 0% 20% 40% 60% 80% 100% Single wire Parallel wire IVUS guided re- entry STAR NA 2012 2013 Corsair use: 78.1% 22% 43% 27% 8% 28% 39% 25% 8% 0% 20% 40% Easy (0) Intermediate (1) Difficult (2) Very Difficult (>3) 2012 2013 Successful CTO crossing strategy J-CTO score for “single wire” technique Total (2201) 2012 (1063) 2013 (1138) P Procedure success 91.6% (2016) 90.8% (965) 92.4%(1051) 0.1835 P<0.05P< 0.05
  • 20. 0% 20% 40% 60% 80% 100% Soft Intermediate Hard Very hard Easy (0) Intermediate (1) Difficult (2) Very Difficult (>3) P<0.0001 0% 20% 40% 60% Soft (<1g) Intermediate (1-3g) Hard (3-9g) Very Hard (>9g) 2012 2013 Guidewire for CTO crossing (1) Antegrade alone Guidewire by J-CTO scoreGuidewire by tip load P< 0.05 Gaia 2 for 23→67% Gaia 1 for 38→81%
  • 21. Guidewire for CTO crossing (2) Antegrade alone XT series, 31% Con Pro, 10% Gaia 1, 10% Gaia 2, 6% Wizard 3, 4% ULTIM 3, 4% SION, 4% FFC, 4% Other, 26% 2012 Total (2201) 2012 (1063) 2013 (1138) P Guidewire cross 92.7% (2040) 91.8% (976) 93.5% (1064) 0.1300 XT series, 30% Gaia 1, 23% Gaia 2, 20% Con Pro, 6% Con Pro 12, 2% Gaia 3, 2% ULTIM3, 2% SION, 2% Other, 12% 2013
  • 22. 53.3% 44.6% 0% 20% 40% 60% 2012 2013 51.2% 40.8% 5.8% 2.1% 0% 20% 40% 60% Immediately after antegrade failure Start with retrograde approach Start with retrograde due to previous antegrade failure Start with retrograde again after previous retorgrade failure Primary retrograde approach Background of retrograde approach Annual change from 2012 to 2013 P<0.05 Procedure characteristics (1) Retrograde cases Primary retrograde approach has been decreasing 26 / 9/ 2014
  • 23. Procedure characteristics (2) Collateral approach 48% 19% 11% 10% 3% 11% SION XT-R SION blue Fielder FC SUOH SION black other 2012 61%18% 3% 3% 4% 4% 7% 60% 26% 7% 3%4% Septal Epicardial AC Ipsilateral Bypass graft 68% 17% 7% 3%6% 2013 Total (1028) 2012 (490) 2013 (538) P Guidewire cross 76.9% (791) 77.6% (380) 76.4%(411) 0.6600 2012 2013 P<0.001 Successful guidewire Successful collateral route P<0.05 P<0.05 26 / 9/ 2014
  • 24. 51% 35% 14% 1% 61% 26% 13% 1% 0% 20% 40% 60% Reverse CART Retrogradewire cross Kissing wire cross CART 2012 2013 Sumitsuji et al. JACC Cardiovasc Interv 2011 Patterns of Success in Retrograde Approach IVUS was used in 69.2% of Reverse CART Procedure characteristics (3) CTO crossing Total (1028) 2012 (490) 2013 (538) P Guidewire cross 65.5% (673) 69.0% (338) 62.3%(335) 0.0033 26 / 9/ 2014
  • 25. 67.2% 24.1% 3.8% 4.9% Couldn't cross collateral channel Couldn't cross CTO by GW Couldn't cross CTO by any catheter Procedure discontinuation due to complication Reason of retrograde procedure failure (370) Retrograde Procedure Outcome (1) Retrograde cases (1028) Switched to antegrade approach ; 80.0% (296) Total (1028) 2012 (490) 2013 (538) P Procedure success 64.0% (658) 66.5% (326) 61.7%(332) 0.1078 26 / 9/ 2014
  • 26. 60.6% 30.3% 9.1% 0% 40% 80% Single wire Parallel wire IVUS guided re-entry Successful CTO crossing strategy by antegrade approach Failure reason N=116 Couldn’t cross CTO by guidewire 84.5% (98) Couldn’t cross CTO by any catheter 7.8% (9) Procedure discontinuation due to complication 5.2% (6) NA 2.6% (3) Retrograde Procedure Outcome (2) In case switched to antegrade after retrograde (n=296) Total 2012 2013 P Antegrade procedure success switched after retrograde failure 60.8% (180/296) 64.8% (81/125) 57.9% (99/171) 0.2294 Overall procedure success in retrograde cases 81.5% (838/1028) 83.1% (407/490) 80.1% (431/538) 0.2236 26 / 9/ 2014
  • 27. N =690 MACCE 120 (17.4%) - Cardiac death 6 (0.9%) - Non cardiac death 12 (1.7%) - Stroke 8 (1.2%) - CABG 6 (0.9%) - TVR 53 (7.7%) - TLR 35 (5.1%) 12M FU : MACCE Follow up rate: 37.3% (690/1848) 26 / 9/ 2014
  • 28. Follow up rate: 33.3% (616/1848) 197 180 138 29 11 5 22 13 3 5 6 2 1 1 1 1 1 0 50 100 150 200 CCS 0 CCS I CCS II CCS III CCS IV Before PCI CCS 0 CCS I CCS II CCS III CCS IV 12M FU : CCS classification 26 / 9/ 2014
  • 29. EURO CTO CLUB Madrid 2014 26 / 9/ 2014 Year No. of CTO PCI No. of Retrograde Retrograde Failure Change to Antegrade Antegrade success 2009 1542 378 (24.5%) 112 (29.6%) 88 (78.6%) 52 (59.1%) 2010 1472 423 (28.7%) 119 (28.1%) 90 (75.6%) 57 (63.3%) 2011 1471 365 (25.8%) 102 (27.9%) 73 (72.6%) 43 (58.9%) 2012 1573 480 (30.5%) 165 (34.4%) 125 (75.8%) 83 (66.4%) 2013 1671 538 (32.1%) 206 (38.2%) 171 (83.0%) 99 (57.9%)
  • 30. Limitations  Selection of approach for CTO was physician- or hospital- dependent  Due to registry method, case report form was not always completed and some cases were excluded from analysis because of too much of missing data  In the subanalysis using J-CTO score, our criteria for each lesion difficulty were not always exact same as original definition by J-CTO study  For lower clinical follow-up rate, we are still under data collecting from participant centers 26 / 9/ 2014
  • 31. Summery in 2014  In 2013, overall procedure success is 88.4%, which was unchanged from 2012  In antegrade approach alone, our data shows an excellent procedure success rate (over 90%)  In retrograde approach( the volume had decreased), there are no significant difference with overall procedure success  Total MACCE rate was 0.7% in over 3200 cases  12 month follow up MACCE rate was 17% among 690 follow-up, with TLR/TVR rate of 12.8%  Change of registry system 26 / 9/ 2014
  • 32. EURO CTO CLUB Madrid 2014 26 / 9/ 2014 32 CCT 2014 , 10-30 to 11-1, in Kobe, Japan
  • 35. Difference of baseline & procedure characteristics Retrograde cases 2012 (490) 2013 (538) P Male 84.7% 87.5% NS Age 60.9% 62.7% NS Previous MI 45.1% 42.0% NS Previous CABG 14.6% 13.8% NS Multi-vessel disease 64.1% 57.0% <0.05 Hypertension 79.8% 78.7% NS DM 46.0% 46.5% NS Hyperlipidemia 71.0% 75.6% NS Smoking 52.6% 51.1% NS Family history of CAD 16.2% 19.5% NS Unstable angina 7.1% 5.4% NS Previous PCI 65.8% 66.5% NS Pre creatinine >2.5mg/dl 8.2% 5.7% NS LVEF<35% 12.4% 11.0% NS Target vessel - RCA - LAD - LCx - LMT 61.4% 26.5% 11.4% 0.6% 63.9% 25.8% 9.7% 0.6% NS 2012 (490) 2013 (538) P Lesion calcification 45.3% 49.3% NS Prox. Tortuosity 13.6% 12.3% NS Lesion bending 14.7% 13.1% NS Blunt /no or unclear stump 69.4% 70.2% NS Occlusion length >20mm 77.1% 72.2% NS Ref. Diameter <3.0mm 27.7% 29.1% NS Occlusion period - > 1year 60.3% 75.5% <0.05 ISR-CTO 9.6% 7.9% NS Re-try case 22.3% 18.9% NS Collateral channel(CC) grade - CC 0 - CC 1 - CC 2 6.1% 56.3% 37.6% 2.7% 60.0% 37.3% <0.05 Average J-CTO score 2.1±1.1 2.1±1.1 NS Procedure time, min 201.4±90.9 225.7±88.5 <0.05 Contrast dose, ml 268.6±119.9 270.1±113.1 NS Fluoroscopic time, min 94.2±46.7 108.0±49.7 <0.05 Air Karma , mGy 6132.5±4407.1 6639.3±4512.0 NS 26 / 9/ 2014
  • 36. Difference of baseline & procedure characteristics Antegrade alone cases 2012 (1063) 2013 (1138) P Male 81.9% 82.5% NS Age 64.1% 63.4% NS Previous MI 36.0% 40.2% <0.05 Previous CABG 6.1% 6.0% NS Multi-vessel disease 64.8% 59.8% <0.05 Hypertension 80.2% 80.2% NS DM 42.0% 45.2% NS Hyperlipidemia 69.3% 68.7% NS Smoking 45.6% 45.9% NS Family history of CAD 17.4% 17.4% NS Unstable angina 9.2% 8.6% NS Previous PCI 57.3% 59.4% NS Pre creatinine >2.5mg/dl 7.1% 9.6% <0.05 LVEF<35% 8.8% 10.0% NS Target vessel - RCA - LAD - LCx - LMT 39.7% 34.2% 26.0% 0.1% 42.0% 31.8% 26.2% 0.0% NS 2012 (1063) 2013 (1138) P Lesion calcification 28.3% 32.4% <0.05 Prox. Tortuosity 8.2% 9.9% NS Lesion bending 5.7% 5.5% NS Blunt /no or unclear stump 46.5% 43.8% NS Occlusion length >20mm 54.6% 48.2% <0.05 Ref. Diameter <3.0mm 47.1% 43.3% NS Occlusion period - > 1year 39.7% 48.1% NS ISR-CTO 17.1% 18.1% NS Re-try case 6.6% 4.3% <0.05 CC grade from contralateral - CC 0 - CC 1 - CC 2 11.6% 58.4% 29.9% 9.7% 59.7% 31.1% NS Average J-CTO score 1.3±0.9 1.2±1.0 NS Procedure time, min 114.4±62.3 119.5±64.2 NS Contrast dose, ml 209.4±94.7 205.4±91.5 NS Fluoroscopic time, min 49.5±30.9 52.8±34.9 <0.05 Air Karma , mGy 3987.5±3144.74091.6±3225.1 NS

Editor's Notes

  1. 黄色にハイライトされた施設が2012年には登録がなく、2013年から登録開始したところ。 但し、徳山中央(中山先生)、筑波記念(我妻先生)など2013年の4月からの異動によって施設として2つエントリがある。 この2施設は、2012年から登録があったので、2012VS2013では、新規参加施設には扱っていない。
  2. 解析対象外となった65例はすべて2013年のデータでございます。 患者背景や手技詳細の登録が不十分であったため、解析対象外と致しました。
  3. 【訂正】 AgeのP値 0.3262→0.9133 # of diseased vesselのP値 赤字
  4. 【訂正】 Re-attempt case 11.5%(2012)、9.1%(2013) 0.00227(P値) → 11.6%(2012)、9.0%(2013)、0.0155(P値) Previous strategy in re-attempt case P値 0.0257→0.0206 2013年 Antegrade 64.7%→64.2%、Retrograde 4.6%→4.7%、Both 20.7%→20.9%、NA 10.0%→10.1%、 Previous failure reason P値 0.1465→0.1468 Failure to cross CTO by GW 80.7%→80.4% NA 9.3%→9.5%
  5. 【訂正】 Lesion length →Occlusion length  52.4%→61.7%(2012)、47.4%→55.8%(2013) 0.0039→0.0017 (P値)   
  6. J-CTOスコアの当てはめは、正確には定義の部分が同一ではないため、 あくまでも「中等度」以上のもの(石灰化、病変部の屈曲)をスコア1に換算している。 【訂正】 Occlusion length P値 0.0074→0.0017 Retry lesion P値 0.0152→0.0155 JCTOスコアの参照文献追加
  7. Coronary perforationの発生頻度だけ有意に上がっている。 詳細にはGWによるもの、その他記載のないもの(NA)の発生が有意差あり。
  8. 【訂正】 リストの一段目の数値 2012(1553) 2013(1676) → 2012(490)、2013(580)
  9. Gaia1は1.7でIntermediate Gaia2は4.5でHardに分類している 各ワイヤーtip load別のJCTOスコア分布はこの2年で変わっていないので省略(グラフは2年間の合計で示している)
  10. 不成功理由やアンテスイッチ率に2012, 2013の違いは見られないので分けた記載は省略
  11. アンテスイッチ後の成功方法も毎回Single wireが60%前後で変化無し。 多少、Parallelが増えて(26.9%⇒33.0%)、IVUSガイドが減ったような(11.5%⇒7.2%)。 【訂正】Overall procedure success in retrograde case  P値 0.2230→0.2236
  12. Heart Failure が8例は(1.2%)報告されているが、定義上はMACCEではないので、スライドからは削除
  13. 【訂正】 Re-try case 2013 18.8%→18.9% Average J-CTO score 1.3±0.9(2012)、1.2±1.0(2013)→2.1±1.1(2012)、2.1±1.1(2013)
  14. JCTOスコアの平均はNSだが、Easyが19.4⇒24.9に、Intermediateが41.8⇒37.7に変わっている。Easyが増えたといえそう。 石灰化は増え、病変長は短くなった。リトライケースも減った。 腎機能の悪い患者は増えている。 【訂正】 Re-try case 2013 4.5%→4.3% MVDも減った。