Etsuo Tsuchikane, MD, PhD

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1 Etsuo Tsuchikane, MD, PhD Toyohashi Heart Center, Japan

2 Disclosure Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organizations listed below. Physician Name Etsuo Tsuchikane, MD, PhD Company/Relationship Boston Scientific, Japan Consultant Asahi Intecc, Japan Consultant NIPRO, Japan Consultant

3 CCT History CCT was started in early 1990, as Osaka intervention meeting Osaka Intervention Meeting Naka-Nihon Live Demonstrations CCIC 2001-present CCT (Complex Cardiovascular Therapeutics) Naka-Nihon Nihon CCIC Complex Cardiovascular Therapeutics

4 6,000 5,000 Industrial Professional Co-medical Medical Industrial Professional, Others 1,758 4,000 Co-medical 1,063 3,000 2,000 Medical 2,451 1,

5 International Participants Comparison between 2014, 2015 and 2015 Asia America Europe Middle East Oceania Total 1, Total Total 922 Best ever attendance from overseas

6 CCT History CCT was started in early 1990, as Osaka intervention meeting Osaka Intervention Meeting Naka-Nihon Live Demonstrations CCIC 2001-present CCT (Complex Cardiovascular Therapeutics) Naka--Nihon Naka 1992 CCIC Complex Cardiovascular Therapeutics

7 Japanese CTOCTO-PCI Registry Currently, Retrograde Summit General Registry and Japanese CTO PCI Expert Registry are being conducted in Japan.

8 Registry Overview Retrograde Summit General Registry Registry Pts. Enrollment Participants As of Jun Criteria for Participants Core lab Jan Jan Dec of 40 of Japanese Centers Japanese CTO PCI Expert Registry Jan of Japanese Expert physicians Centers approved by More than 300 cases of experience of CTORetrograde Summit PCI Cases treated by Expert are More than 50 cases of CTO-PCI per year excluded Recommendation from two or more steering committee member None Adjudication of Indication and Procedure Success Organization Retrograde Summit Japanese Board of CTO interventional specialist Chairman Habara (initiated by Tsuchikane) Tsuchikane (initiated by Katoh, late Mitsudo)

9 Etsuo Tsuchikane, MD, PhD on behalf of Japanese Board of CTO Interventional Specialist

10 Japanese CTO PCI Expert Registry The Japanese Board of CTO Interventional Specialists was established in 2013 to accumulate quantitative data to identify issues such as stagnation in the development of CTO-PCI techniques. Starting from 2014, Japanese CTO PCI Expert Registry began establishing a database of CTO-PCI performed by certified expert physicians who have a certain level of CTO-PCI skills. Patients are enrolled by certified expert operators. Procedure success is adjudicated by an independent Corelab.

11 The database for Retrograde Summit general registry has already been modified to collect same dataset as Japanese CTO PCI Expert Registry. The outcome from both Retrograde Summit General Registry and Japanese CTO PCI Expert Registry will be compared and reported in the near future.

12 Officially it started from January 2014, will end in December All clinical data including patient background data and details of the procedures are input via an electronic capture system. Pre-procedural CAG and CTA (optional), and procedural angiograms and IVUS images are sent as DICOM data to an independent core laboratory. Annual clinical follow-up data are collected for 5 years (only in domestic pts).

13 Number of Enrollment t t Number of Expert

14

15 The enrolled CTO-PCI procedure; n=4205 procedures the number of target CTO lesion in each procedure 1 lesion n=4148, 2 lesions n=57 CTO-PCI outside Japan n=1359 CTO-PCI in Japan n= CTO lesions in one procedure: n=30 N= 2816 Inadequate anatomical indication n=62 sub-total lesion: n=104, non-cto lesion: n=1, unanalyzable n=4 N=2645 Inappropriate data of pt. /lesion background: n=49 N=2596

16 The procedure was defined here as bidirectional approach (BA) where an attempt was made to cross the collateral channel for retrograde revascularization techniques. Cases were divided into 3 groups based on ITT principle; primary antegrade approach (PAA), primary BA (PBA), and rescue BA (RBA). PAA included rescue BA and re-switched antegrade approach. No antegrade dissection and reentry device was used.

17 Overall N=2596 Age BMI LVEF egfr Male gender, % Hypertension, % Dyslipidemia, % Diabetes, % Current smoking, % OMI, % Prior CABG, % Prior PCI, % Reattempt, % Syntax score J-CTO score Target vessel, % LAD LCX LMT RCA 66.9± ± ± ± ± ±1.1 PAA N= % 66.8± ± ± ± ± ±1.1 PBA N= % 66.9± ± ± ± ± ± PAA vs. PBA P-value

18 In-stent occlusion, % Distal run off (<3.0mm), % CTO length ( 20mm), % Side branch at proximal cap, % Collateral filling, % Contralateral Ipsilateral Both None Lesion calcification, % Proximal tortuosity, % Tortuosity of CTO lesion, % Morphology of proximal cap, % Blunt No stump Tapered/tunnel Overall N= PAA N= PBA N= PAA vs. PBA P-value

19 GW success, % Technical success, % Procedural success, % Procedure time Contrast volume In hospital death, % MI, % Acute stent thrombosis, % Stroke, % Emergent CABG, % Emergent PCI Coronary embolism, % Coronary perforation (tamponade), % Complications of puncture site, % CIN, % Overall N= ± ± PAA PBA PAA vs. PBA N=1872 N=724 P-value ± ± ± ±

20 (74.3%) Antegrade Alone N=1390 Antegrade approach N=1872 (25.7%) Rescue Bidirectional N=482

21 Age BMI LVEF egfr Male gender, % Hypertension, % Dyslipidemia, % Diabetes, % Current smoking, % OMI, % Prior CABG, % Prior PCI, % Syntax score J-CTO score Target vessel, % LAD LCX LMT RCA Antegrade alone N= ± ± ± ± ± ±1.1 RBA N= ± ± ± ± ± ± Ant vs. RBA P-value

22 Reattempt, % In-stent occlusion, % Distal run off (<3.0mm), % CTO length ( 20mm), % Side branch at proximal cap, % Collateral filling, % Contralateral Ipsilateral Both None Lesion calcification, % Proximal tortuosity, % Tortuosity of CTO lesion, % Morphology of proximal cap, % Blunt No stump Tapered/tunnel Antegrade alone N= RBA N= Ant vs. RBA P-value

23 (74.3%) Antegrade approach N=1872 Rescue Bidirectional N=482 Antegrade Alone N=1390 Success N=1327 Failure N=63 (25.7%) Rescue Bidirectional alone N=400 Re-switched to antegrade N= % Failure N=70 Success N=330 Success N= % Failure N=36

24 Frequency % 100 Success Parallel wire PAA IVUS guide Parallel wire IVUS guide Antegrade after PBA failure

25 Primary bidirectional approach N=724 (84.0%) (16.0%) Bidirectional alone N=608 Failure N=69 Success N=539 Switched to antegrade N= % Success N= % (93/116) Failure N=23

26 Frequency % 100 Success Parallel wire PAA IVUS guide Parallel wire IVUS guide Antegrade after PBA failure

27 Age BMI LVEF egfr Male gender, % Hypertension, % Dyslipidemia, % Diabetes, % Current smoking, % OMI, % Prior CABG, % Prior PCI, % Syntax score J-CTO score Target vessel, % LAD LCX LMT RCA RBA N= ± ± ± ± ± ±1.1 PBA N= ± ± ± ± ± ± RBA vs. PBA P-value

28 Reattempt, % In-stent occlusion, % Distal run off (<3.0mm), % CTO length ( 20mm), % Side branch at proximal cap, % Lesion calcification, % Proximal tortuosity, % Tortuosity of CTO lesion, % Morphology of proximal cap, % Blunt No stump Tapered/tunnel Collateral used, % Sepal Epicardial Arterial Graft RBA N= PBA N= RBA vs. PBA P-value

29 Failed collateral crossing, % GW success, % Technical success, % Procedural success, % Procedure time Contrast volume In hospital death, % MI, % Acute stent thrombosis, % Stroke, % Emergent CABG, % Emergent PCI Coronary embolism, % Coronary perforation (tamponade), % Complications of puncture site, % CIN, % RBA N= ± ± PBA N= ± ± RBA vs. PBA P-value

30 PBA Univariate analysis OR Prior CABG 1.87 Dyslipidemia Side branch at proximal cap Tortuosity of CTO Severe lesion calcification CI P-value multivariate analysis OR Severe lesion calcification Tortuosity of CTO Side branch at proximal cap Dyslipidemia CI p-value

31 RBA Univariate analysis OR Sex BMI Diabetes egfr< In-stent occlusion Lesion>20mm Tortuosity of CTO Severe lesion calcification multivariate analysis OR Severe lesion calcification Sex BMI CI P-value < CI p-value

32 Japanese experts frequently chose the bidirectional approach as the primary strategy (27.9%), especially for more complex CTO lesions, with a technical success rate of about 90%. For intermediate CTO lesions (J-CTO score < 2), experts mainly performed the antegrade approach alone, with a very high success rate (more than 95%). However, for RBA, the success rate decreased to less than 80%. The experts frequently used the parallel wiring and IVUSguided penetration in antegrade approach, with high technical success (75.0% 88.9%). Severe lesion calcification was a strong predictor of failure.

33 CTO-PCI performed by highly experienced experts achieved a high technical success rate and a low rate of major complications.

34 Development of CTO-PCI procedure Miracle Conquest Fielder XT Corsair BridgePoint SION Fielder XTR wire, device GAIA imaging modality MDCT IVUS guidance Parallel wiring wiring technique 1995 Bidirectional approach Euro CTO Club CTO Fundamentals Hybrid approach 2015

35 Beijing Seoul Nagoya Shanghai Guangzhou Taipei Singapore Brisbane Sydney Auckland Wellington

36 Kick-off Beijing March 19th, 2015

37 Objective To promote CTO-PCI based on the well developed technology (devices, techniques) for more than 20 years in Asian-Pacific region. To educate the next generation of Asian-Pacific CTO operators for the patients living in this region.

38 Directors Ji Yan Chen Lei Ge Scott Harding Paul Hsien-Li Kao Seung-Whan Lee Soo Teik Lim Sidney Tsz Ho Lo Jie Qian Etsuo Tsuchikane Eugene B. Wu Guangdong General Hospital Zhongshan Hospital Fudan University Wellington Hospital National Taiwan University Hospital Asan Medical Center National Heart Centre Singapore Liverpool Hospital Fu Wai Hospital Toyohashi Heart Center Prince of Wales Hospital China China New Zealand Taiwan Korea Singapore Australia China Japan Hong Kong

39 Qian Lee Tsuchikane Ge Chen Kao Wu Lim Lo Harding

40 Supervisors Jumbo Ge Yang-Soo Jang Osamu Katoh Tian Hai Koh Sum Kin Leung Jim Stewart Yeujin Yang Chiung-Jen Wu Zhongshan Hospital Fudan University Severance Hospital, Yonsei University Hospital National Heart Centre Singapore Keen Heart Medical Practice Auckland City Hospital Beijing Fuwai Hospital Kaohsiung Chang Gung Memorial Hospital China Korea Japan Singapore HongKong New Zealand China Taiwan

41 What s AP CTO Club role and activity in AP region? 1. Development of AP CTO-PCI Algorithm

42 Careful analysis of angiogram / MSCT Proximal cap ambiguity In-stent restenosis Yes No Yes No Poor quality distal vessel or bifurcation at distal cap Consider use of CrossBoss as primary crossing strategy for straight ISO IVUS guided entry Yes Interventional collaterals present Yes No No Antegrade wire based approach Retrograde approach If suitable re-entry zone Dissection Reentry (Stingray) IVUS guided wiring Primary use of KWT and/or dissection re-entry Parallel wiring Ambiguous course in CTO Tortuous CTO segment Heavy calcification Rescue use of KWT and/or dissection re-entry Length >20 mm Previous failed attempt Consider stopping if >3 hours, 3.7 x egfr ml contrast, Air Kerma > 5 Gy unless procedure well advanced

43 What s AP CTO Club activities Umbrella covering CTO workshops and major meetings in AP region Jun CTO Club in Nagoya Aug Guangzhou CTO Workshop in China Sep CTO Interventions Live course in Singapore Oct CTOCC in Shanghai 2015 Oct CCT in Kobe Nov ANZCCT in Brisbane Jan. 8-9 TTT in Taipei 2016 Jan Asia PCR in Singapore Mar CIT in Beijing Apr. 26 CTO Live@TCT AP in Seoul Jun ANZCTO Club in Perth Jun CTO Club in Nagoya Aug Guangzhou CTO Workshop in China Sep CTO Interventions Live course in Singapore Oct CCT in Kobe Jan. 7-8 TTT in Taipei 2017

44 What s AP CTO Club activities Umbrella covering CTO workshops and major meetings in AP region Jun CTO Club in Nagoya Aug Guangzhou CTO Workshop in China Sep CTO Interventions Live course in Singapore Oct CTOCC in Shanghai 2015 Oct CCT in Kobe Nov ANZCCT in Brisbane Jan. 8-9 TTT in Taipei 2016 Jan Asia PCR in Singapore Mar CIT in Beijing Apr. 26 CTO Live@TCT AP in Seoul Jun ANZCTO Club in Perth Jun CTO Club in Nagoya Aug Guangzhou CTO Workshop in China Sep CTO Interventions Live course in Singapore Oct CCT in Kobe Jan. 7-8 TTT in Taipei 2017

45 What s AP CTO Club role and activity in AP region? 1. Development of AP CTO-PCI Algorithm 2. Web Site Open

46 What s AP CTO Club role and activity in AP region? 1. Development of AP CTO-PCI Algorithm 2. Web Site Open 3. APCTO Registry by course directors from 2016 by using same database as Japanese Expert Registry 4. Educational Training Program Workshop with live cases for young physician s CTO training w/wo proctorship

47 What s AP CTO Club activities Umbrella covering CTO workshops and major meetings in AP region Jun CTO Club in Nagoya Aug Guangzhou CTO Workshop in China Sep CTO Interventions Live course in Singapore Oct CTOCC in Shanghai Oct CCT in Kobe Nov ANZCCT in Brisbane Jan. 8-9 TTT in Taipei Jan Asia PCR in Singapore Mar CIT in Beijing Apr. 26 CTO Live@TCT AP in Seoul Jun ANZCTO Club in Perth Jun CTO Club in Nagoya Aug Guangzhou CTO Workshop in China Sep CTO Interventions Live course in Singapore Oct CCT in Kobe Jan. 7-8 TTT in Taipei Feb The 1st APCTO Club Proctorship Live in HKCTO Live Dr. Eugene B Wu

48 What s AP CTO Club role and activity in AP region? 1. Development of AP CTO-PCI Algorithm 2. Web Site Open 3. APCTO Registry from course directors from 2016 by using same database as Japanese Expert Registry 4. Educational Training Program Workshop in each regional meeting for young physician s CTO training w/wo proctorship

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