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EURO CTO CLUB Madrid 2014
26 / 9/ 2014
Update Japanese Multicenter Registry: 14:35- 14:50
Based on WEB registry 2013
Masahisa Yamane , MD, FACCOLV Cardiovascular Center,
Aalst, BelgiumSt Luke‘s International Hospital ,
Tokyo, JapanSaitamaSekishinkai 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
2009 2010 2011 2012 20130
400
800
1200
1600 1542 1472 14171553
1676
378(24.5%)
423(28.7%) 365
(25.8%)
490(31.6%)
538( 32.1% )
CTO-PCI Retrograde
Num
ber o
f CTO
pro
cedu
res
WEB registry started from 2012 26 / 9/ 2014
57 Participant Hospitals (2013)Saiseikai Yokohama-City Eastern HospitalSapporo Cardio Vascular ClinicSakurabashi Watanabe HospitalToyohashi Heart CenterSaitama Cardiovascular and Respiratory CenterSaitama Sekishinkai HospitalTakase ClinicThe Cardiovascular InstituteHigashi Takarazuka Satoh Hospital Sanda City Hospital Edogawa Hospital Nagoya Heart Center Seirei Hamamatsu General HospitalHoshi General Hospital Tokorozawa Heart CenterSaiseikai Fukuoka General Hospital Hokkaido Social Insurance HospitalYotsuba Circulation ClinicShiga Medical Center for AdultsNagoya Tokushukai HospitalRinku General Medical Center Kusatsu Heart CenterKakogawa East City Hospital Fukaya Red Cross Hospital Hokko Memorial Hospital Showa University HospitalNagoya Daini Red Cross HospitalDaini Okamoto General HospitalMie Heart Center
Kyoto Katsura HospitalKushiro City General HospitalShowa General HospitalShinkoga Hospital Kanagawa Cardiovascular and Respiratory CenterTokeidai Memorial HospitalIwaki Kyouritsu HospitalHyogo Brain and Heart CenterYokohama Sakae Kyosai HospitalHyogo Prefectural Amagasaki HospitalIwate Prefectural Central HospitalShuuwa General HospitalOsaka Saiseikai Izuo HospitalItabashi Chuo HospitalNTT East Sapporo HospitalTodachuo General HospitalHamada Medical CenterHokusetsu General HospitalTokuyama Chuo HospitalOsaki Citizen HospitalTokushima Red Cross HospitalKobe Redcross HospitalYokohama Shintoshi Neurosurgical HospitalOhta General Hospital Ohta Nishinouchi Hospital
Toho University Omori Medical CenterTsukuba Memorial HospitalMimihara General HospitalKansai 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) PRe-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% 0.2262Occlusion length >20mm 61.7% 55.8% 0.0017Instent 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)
Moderate Severe0%
20%
40% Lesion calcification
Moderate Severe0%
20%
40% Proximal tortuosity
2012 2013
Moderate Severe0%
20%
40% Lesion bending
Blunt Funnel/Tapered
None/NA-20%
0%
20%
40%
60% 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
Easy (0) Intermediate (1) Difficult (2) Very difficult (>3)
0%
10%
20%
30%
40% Change of score distribution20122013P<0.05
Morino et al. JACC Interv 2011;4:231-211)
Procedure outcome2012 (1553) 2013 (1676) P
Successful CTO crossing by GW 89.6% 89.6% 0.9925Number of guidewire used for CTO approach 3.1±2.2 3.2±2.3 0.1788
Stent deployment 93.5% 100.0% <0.0001Number of stent 1.8±1.0 1.9±0.9 0.0033Total stent length, mm 51.8±24.9 55.4±27.9 0.0008Use of drug-eluting stent 98.0% 98.8% 0.0907Procedure success 88.3% 88.4% 0.9437Procedure time, min 142.7±83.4 153.2±88.0 0.0012Contrast dose, ml 228.7±107.2 226.2±103.4 0.5187Fluoroscopy time, min 64.2±42.4 70.6±47.8 0.0002Air 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 complications2012 (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 Rate2012 vs. 2013
Easy (0) Intermediate (1) Difficult (2) Very difficult (>3)
0%
20%
40%
60%
80%
100% 93.6%89.4% 86.9% 84.4%
97.2%91.3% 88.0%
74.9%
2012 2013
P<0.05 NS NS P<0.05
26 / 9/ 2014
Procedure characteristics (1)Antegrade alone
Single wire
Parallel wire
IVUS guided
re-entry
STAR NA0%
20%
40%
60%
80%
100%83%
12%3% 2%
82%
15%
2% 1%
2012 2013
Corsair use: 78.1%
Easy (0) Intermediate (1)
Difficult (2) Very Difficult (>3)
0%
20%
40%
22%
43%
27%
8%
28%
39%
25%
8%
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
Soft Intermediate Hard Very hard0%
20%
40%
60%
80%
100%
Easy (0) Intermediate (1) Difficult (2) Very Difficult (>3)
P<0.0001
Soft (<1g) Intermediate (1-3g)
Hard (3-9g) Very Hard (>9g)
0%
20%
40%
60%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 se-
ries; 31%
Con Pro; 10%
Gaia 1; 10%Gaia 2; 6%
Wizard 3; 4%
UL-TIM 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 se-
ries; 30%
Gaia 1; 23%Gaia 2; 20%
Con Pro; 6%
Con Pro 12; 2%
Gaia 3; 2%
UL-TIM3;
2%SION;
2%
Other; 12%
2013
2012 20130%
20%
40%
60% 53.3%
44.6%
0%
20%
40%
60%51.2%
40.8%
5.8%2.1%
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-RSION blue Fielder FCSUOH SION blackother
2012 61%
18%
3%
3%4
%
4%
7%
60%26%
7%3% 4%
SeptalEpicardialACIpsilateralBypass 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 2013P<0.001
Successful guidewire
Successful collateral route
P<0.05
P<0.05
26 / 9/ 2014
Reverse CART Retrogradewire cross
Kissing wire cross
CART0%
20%
40%
60%51%
35%
14%
1%
61%
26%
13%
1%
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 channelCouldn't cross CTO by GWCouldn't cross CTO by any catheterProcedure 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
Single wire Parallel wire IVUS guided re-entry
0%
40%
80%60.6%
30.3%
9.1%
Successful CTO crossing strategy by antegrade approach
Failure reason N=116Couldn’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 : MACCEFollow up rate: 37.3% (690/1848)
26 / 9/ 2014
Follow up rate: 33.3% (616/1848)
CCS 0 CCS I CCS II CCS III CCS IV0
50
100
150
200
197180
138
2911
522
13
3
1 1
1
5
6
2
1
1
CCS 0 CCS I CCS II CCS III CCS IV
Before PCI
12M FU : CCS classification
26 / 9/ 2014
EURO CTO CLUB Madrid 2014
26 / 9/ 2014
Current limitations of ante grade approach and retrograde approaches
Year No. ofCTO PCI
No. ofRetrograde
RetrogradeFailure
Change toAntegrade
Antegradesuccess
2009 1542 378(24.5%)
112(29.6%)
88 (78.6%)
52 (59.1%)
2010 1472423
(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/ 201432
CCT 2014 , 10-30 to 11-1, in Kobe, Japan
Difference of baseline & procedure characteristicsRetrograde cases
2012 (490)
2013 (538) P
Male 84.7% 87.5% NSAge 60.9% 62.7% NSPrevious MI 45.1% 42.0% NSPrevious CABG 14.6% 13.8% NSMulti-vessel disease 64.1% 57.0% <0.05Hypertension 79.8% 78.7% NSDM 46.0% 46.5% NSHyperlipidemia 71.0% 75.6% NSSmoking 52.6% 51.1% NSFamily history of CAD 16.2% 19.5% NSUnstable angina 7.1% 5.4% NSPrevious PCI 65.8% 66.5% NSPre creatinine >2.5mg/dl 8.2% 5.7% NSLVEF<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% NSProx. Tortuosity 13.6% 12.3% NSLesion bending 14.7% 13.1% NSBlunt /no or unclear stump 69.4% 70.2% NSOcclusion length >20mm 77.1% 72.2% NSRef. Diameter <3.0mm 27.7% 29.1% NSOcclusion period - > 1year 60.3% 75.5% <0.05ISR-CTO 9.6% 7.9% NSRe-try case 22.3% 18.9% NSCollateral 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 <0.05Contrast dose, ml 268.6±119.9 270.1±113.1 NSFluoroscopic time, min 94.2±46.7 108.0±49.7 <0.05Air Karma , mGy 6132.5±4407.1 6639.3±4512.0 NS
26 / 9/ 2014
Difference of baseline & procedure characteristicsAntegrade alone cases
2012 (1063)
2013 (1138) P
Male 81.9% 82.5% NSAge 64.1% 63.4% NSPrevious MI 36.0% 40.2% <0.05 Previous CABG 6.1% 6.0% NSMulti-vessel disease 64.8% 59.8% <0.05 Hypertension 80.2% 80.2% NSDM 42.0% 45.2% NSHyperlipidemia 69.3% 68.7% NSSmoking 45.6% 45.9% NSFamily history of CAD 17.4% 17.4% NSUnstable angina 9.2% 8.6% NSPrevious PCI 57.3% 59.4% NSPre 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% NSLesion bending 5.7% 5.5% NSBlunt /no or unclear stump 46.5% 43.8% NSOcclusion length >20mm 54.6% 48.2% <0.05 Ref. Diameter <3.0mm 47.1% 43.3% NSOcclusion period - > 1year 39.7% 48.1% NSISR-CTO 17.1% 18.1% NSRe-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 NSContrast dose, ml 209.4±94.7 205.4±91.5 NSFluoroscopic time, min 49.5±30.9 52.8±34.9 <0.05Air Karma , mGy 3987.5±3144.7 4091.6±3225.1 NS
Recommended