11:14 The Complex CTO Japanese Registry Masahisa Yamane (Tokyo - J) _____________________________________________ PARALLEL SESSION Cto & Chip Regitries & Trials Auditorium Zubin Mehta - Friday 11:00 - 12:00 Chairpersons: Paul Knaapen (Amsterdam - NL), Gennaro Sardella (Rome) Discussants: Björn Billmann (Wolfenbuettel - D), Laurent Drogul (Nice - F), Sergey Furkalo (Kiev - UA), Maciej Lesiak (Poznan - PL) ___________________________________________ 15th Experts Live CTO, EUROCTO Club meeting in partnership with the GISE CTO meeting. September 8th - 9th, 2023 Florence, Italy

1. The Complex CTO Japanese Registry
Date and Time of presentation: 08/09/2023 11:12 - 11:18
Masahisa Yamane MD, FACC
Saitama Sekishinkai Hospital

2. I have a financial interest/arrangement or affiliation with one or more organizations
that could be perceived as a real or apparent conflict of interest in the context of the
subject of this presentation.
Asahi Intecc Consultant
Nipro Honorarium

3. Purpose of the study
• In the most recent registry data (2020-2022) , CTO PCI with/
without low EF ( cutting point 30%) are compared
• Cohorts: Complete Data with LV low EF Group (≦30%
n=180), and without so low EF LVEF(>30% n=2708)
• Core lab adjudicated analysis was performed

4. Japanese CTO PCI Expert Registry (JCER)
◼ The Japanese Board of CTO Specialists(JBCS) was formulated in 2013
to accumulate reliable data to identify positive factors such as the
development of CTO-PCI techniques and to compare with other
databases of foreign countries.
◼ Japanese CTO PCI Expert Registry (JCER) started a database of CTO-
PCI performed by certified experts (≥50 cases, who have a certain
level of CTO-PCI expertise from JAN/2014
◼ Patients are enrolled by certified operators
◼ Procedure success is adjudicated by a Corelab

5. Japanese CTO Expert Registry Overview
• More than 300 cases of experience of CTO-PCI
• More than 50 cases of CTO-PCI per year
• Recommendation from two or more steering committee member
Pts. Enrollment
Participants as of JUN.2015
Criteria for Participants
Core lab.
Organization
Chairman
Jan.2014~
40 of Japanese Expert physicians
Adjudication of Indication and Procedure Success
Japanese Board of CTO interventional specialist
Etsuo Tsuchikane(initiated by Osamu Katoh and Kazuaki Mitsudo)

6. Registration Method
・Web based registration
・All cases registration
・Input articles
・Patient basic data
・CTO lesion data
・Procedure data
・Procedural and clinical result
・Follow up data(1M and Max 5years)
・Certificate of Consent
・Angiographic data

7. Baseline Patients Characteristics (2020-2022)
LVEF>30% n=2708 LVEF≦30% n=180 p.value
Age,yrs 68.6±10.9 68.2±10.8 0.593
Male 2363(87.3) 164(91.1) 0.161
BMI 24.9±4.0 23.2±4.1 <0.001
LVEF 54.5±10.7 24.7±4.6 <0.001
eGFR 63.2±18.3 n=2503 55.3±18 n=160 <0.001
Hypertension 2158(79.7) 128(71.1) 0.008
Dyslipidemia 2369(87.5) 155(86.1) 0.563
Diabetes 1233(45.5) 95(52.8) 0.064
Current smoking 453(16.7) 38(21.1) 0.151
OMI 1277(47.2) 122(67.8) <0.001
Prior CABG 194(7.2) 23(12.8) 0.012
Prior PCI 1858(68.6) 118(65.6) 0.408
EuroScore II 1.6±2.0 4.6±6.2 <0.001
Values are mean ± SD or ｎ(%)

8. Baseline Angiographic Characteristics
LVEF>30% n=2708 LVEF≦30% n=180 p.value
Target vessel
RCA 1330(49.1) 86（47.8） 0.794
LAD 889（32.8） 61（33.9）
LCX 479（17.7） 32（17.8）
LMT 9（0.3） 1（0.6）
Graft 1（0） 0（0）
Reattempt 395(14.6) 20(11.1) 0.227
ISR-CTO 468(17.3) 29(16.1) 0.760
J-CTO score 1.7±1.1 1.8±1.0 0.438
Distal run off ＜3.0mm 1906(70.4) 122(67.8) 0.450
CTO length≧20mm 1469(54.2) 105(58.3) 0.315
Side branch at proximal cap 1457(53.8) 93(51.7) 0.590
Collateral filling 0.603
Ipsilateral 273（10.1） 24（13.3）
Contralateral 1396（51.6） 88（48.9）
Both 946（34.9） 62（34.4）
None 15（0.6） 0（0）
Lack of Data 78(2.9) 6（3.3）
Lesion calcification 1378(50.9) 103(57.2) 0.106
Lesion calcification (Severe) 217(8.0) 16(8.9) 1.000
Proximal tortuosity(Severe) 103(3.8) 2(1.1) 0.063
Tortuosity of CTO lesion 572(21.1) 38(21.1) 1.000
Morphology of proximal cap 0.123
Blunt 351（13.0） 26（14.4）
Tapered／Tunnel 1878（69.4） 120（66.7）
No Stump 462（17.1） 30（16.7）
Lack of Data 17（0.6） 4（2.2）
Syntax Score 18.3 9.5 21.4 10.7 n=139 <0.001
Values are mean ± SD or ｎ(%)

9. Strategy Classification
Values are n ( % )
ITT actual strategy
additional
strategy
Class LVEF>30% n=
LVEF≦30%
n=
Antegrade
antegrade only (-) ① 1624(60.0) 98(54.4)
rescue bidirectional
(-) ② 284(10.5) 14(7.8)
antegrade ③ 109(4.0) 5(2.8)
Bidirectional
antegrade only (-) ④ 82(3.0) 6(3.3)
primary
bidirect-
ional
primary bidirectionalの
中での特殊例：
retroチャンネルのwire
通過が成功したがAnte
のみでcross
(-) ⑤ 55(2.0) 6(3.3)
⑤以外の意図的な全て
のretrograde access及
びその試み
(-) ⑥ 440(16.2) 46(25.6)
antegrade ⑦ 114(4.2) 5(2.8)

10. Procedural & Clinical Results
Values are mean ± SD or ｎ(%)
LVEF>30% n=2708 LVEF≦30% n=180 p.value
Procedure time (min) 157.2±98.3 163.2±103.7 0.402
Contrast volume (ml) 171.0±83 144.9±74.9 <0.001
GW success 2608(96.3) 175(97.2) 0.681
Technical success 2542(93.9) 174(96.7) 0.143
Reasons for technical failure
GW un-pass
Device un-pass
Poor dilatation /poor run off
Major side branch occlusion
Others
100(3.7)
11(1.4)
35(1.3)
20(0.7)
1(0)
5(2.8)
0(0)
1(0.6)
0(0)
0(0)
Procedural success 2528(93.4) 173(96.1) 0.161
Patient success 2496(92.2) 169(93.9) 0.559
In-hospital complication
Death 1(0) 1(0.6) <0.01
AMI 42(1.6) 0(0) 0.109
QMI 4(0.1) 0(0) 1.000
Acute stent thrombosis 2(0.1) 1(0.6) 0.176
Stroke 7(0.3) 2(1.1) 0.104
Emergent CABG 1(0) 0(0) 1.000
Emergent PCI 4(0.1) 1(0.6) 0.276
Coronary embolism 3(0.1) 0(0) 1.000
Complication of puncture site 29(1.1) 3(1.7) 0.448

11. Procedural & Clinical Results
LVEF>30% n=2708 LVEF≦30% n=180 p.value
IABP 7(0.3) 0(0) 1.000
Other Mechanical Circulatory Support 0(0) 0(0)
Need for additional Support
LVEF>30% n=2708 LVEF≦30% n=180 p.value
Coronary Perforation 93(3.4) 5(2.8)
0.899
Cardiac Tamponade 8(0.3) 0(0)
Other PCI Related Complications

12. One-month Outcomes
LVEF>30% n=2547/2708 LVEF≦30% n=164/180 p.value
Clinical Follow up rate 2549(94.1) 164(91.1)
Death 3(0.1) 1(0.6) 0.221
Non-fatal MI 2(0.1) 0(0) 1.000
Stent thrombosis 4(0.2) 0(0) 1.000
Revascularization 14(0.5) 1(0.6) 0.609
Cerebrovascular event 7(0.3) 2(1.2) 0.099
n(%)
LVEF>30% n=2547/2708 LVEF≦30% n=164/180 p.value
Radiation dermatitis 1(0.0) 0(0) 1.000
CIN 14(0.5) n=1536 6(3.7) n=111 <0.001
n(%)

13. • Mid 50s presented with SCD
• VT, VF DC, CPR
• Intubation and VA ECMO, E-Cath 2-V-D
• Recover well without neurological deficit
• Inferior wall ischemia
RCA long calcified CTO LVEF=20-25%

14. RCA CTO 50 s male c SCD

15. The Complex CTO Japanese Registry
• Given the nature of Registry recruitment in the COVID Era, groups consisted of the
modest lesion complexities ( 1.7±1.1 vs. 1.8±1.0 ), and limited indication of the
Impella device, limited number of CHIP equivalent cohort.
• In the Registry, EF >30% and EF ≦30% group did show similar high procedural success
rate with comparable low complication rates
• Major adverse Cardiovascular events ( Death, MI, Revas, and Stroke) did not differ
between the groups.
• EF in stable CAD patients did not seem to be a good indicator of high-risk patients
• One month follow-up revealed significantly higher incidence of CIN despite less
contrast consumption in the low EF group.