1. Complex Coronary Cases
Supported by:
Abbott Vascular Inc
Boston Scientific Corp
Terumo Vascular Corp
Vascular Solutions Inc
Cardiovascular Science Inc
St Judes medical
Abiomed Inc
Trireme Medical
Roxwood Medical

2. Disclosures
Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, ABIOMED, CSI, Trireme Medical Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company

3. May 17th 2016 Case #83: CH, 36 yrs M Presentation:
Patient with NIDDM presented with new onset CCS Class III angina. A stress MPI revealed moderate anterior, septal, apical and inferior ischemia with TID. Cardiac cath on April 14th 2016 revealed 3 V CAD; 100% mid RCA, 95% prox LAD, 80% OM2 and 90% LCx-LPL with LVEF 50% and Syntax score of 26. Heart team discussion took place and PCI was decided in view of pt’s young age. Pt underwent successful PCI of LAD and LCx branches using Xience Alpine DES x3.
Prior History:
Hypertension, Hyperlipidemia, NIDDM, SAQ score-67
Medications: All once daily dosage except Ticagrelor
ASA 81mg, Ticagrelor 90mg, Metoprolol XL 50mg, ISMN 60mg, Glipizide 10mg, Rosuvastatin 10mg 3

4. Case# 83: cont… Cardiac Cath 4/14/2016: Right Dominance
SYNTAX Score was: 26
Cardiac Cath 4/14/2016: Right Dominance
III V CAD with LVEF 52%
LM: no obstruction
LAD: 95% prox LAD and 50% D2 lesion
LCx: 80% OM2 and 90% LPL1 lesions
RCA: 100% distal RCA, fills antegrade and retrograde
Hospital course: Pt underwent DES of pLAD (Xience Alpine 3/18mm), OM2 (Xience Alpine 2.5/15mm) and LPL1 (Xience Alpine 2.75/38mm)
with excellent results. Pt was discharged home & has Class II angina
Plan Today:
Planned for staged PCI of CTO RCA via antegrade approach using CenterCross device or via retrograde septal collaterals 4

5. CenterCross– Anchoring and Centering Catheter
Guidewire
Microcatheter
Inner Shaft
Scaffold
Outer Sheat
Resheathable NiTi Scafffold
Amplified Support
Co-Axial 3F Central Lumen
Indpt GW & Microcatheter
Coronary & Peripheral
True Lumen Crossing
Technical Aspects
Up to 4+ mm vessels
OTW guidewire lumen
3F microcatheter compatible
Finecross Corsair, Micro 014
7Fr guide compatible
130 cm working length
Roxwood Medical

6. Roxwood CenterCross Catheter Device

7. Roxwood Medical – Micro 014
2.5F body, 1.6F tip
155 cm, 0.14” GW compatible
FDA Cleared
Extended 155 cm shaft with Ultra low-profile
Variable-pitch stainless steel braid for ultimate push and trackability
State-of-the –art Serene™ hydrophilic coating

8. Hornet™ Guide Wire (BSc Inc.)
Closest Comparators:
Hornet: GAIA 1st
Hornet 10: Confianza Pro, Confianza Pro 12
Hornet 14 : Confianza Pro 12
Key Features
Tapered tip: lowest tip profile on market (.008”)
Hornet 14: highest tip load on market
Hornet 10 & 14: highest penetration force on market
Hydrophilic coating
Radiopaque (3.5 cm)
Coil Length(15cm) / Hydrophilic Coating
0.008 inch
Hydrophilic Coating
Stainless Steel Core
0.014 inch
PTFE Coating
Name
Coil
Diameter
(inch)
Tip Diameter
Total
Length (cm)
Coil Length
(cm)
Radiop-aque
Tip Load (gf)
Penetration Force
(gf/mm2)
Core Material
Tip
Shape
Coating
Hornet
0.014
0.008
190
300 15
3.5 1 31
Stainless Steel
Straight
Hydrophilic
Hornet 10 10
308
Hornet 14 14
432

9. Appropriateness Criteria for Coronary Revascularization

10. Issues Involving The Case
Update in predictors of CTO recanalization
Update in prognosis after CTO recanalization

11. Issues Involving The Case
Update in predictors of CTO recanalization
Update in prognosis after CTO recanalization

12. Chronic Total Occlusion Lesion Characteristics in CTO Wire Success
Favorable
Age of occlusion <3months
Short occlusion
Long, straight proximal segment
Residual stump, taper
Distal vessel visible via collaterals
Unfavorable
Proximal tortuosity, calcification
Flush occlusion, side branch
Bridging collaterals
Lesion angulation, calcification
Old, long in-stent stenosis

13. Difficulty Score for CTO Lesions (J-CTO Score):
5 Selected Independent Prediction Identified by the Forward/Backward Procedure of Lesion Crossing in 30-min
Variables
Odds Ratio
(95% CI)
Beta Coefficient
Point
Previously failed lesion
0.93 ( )
0.93 1
Blunt stump type
0.32 ( )
1.14
Bending >45
0.34 ( )
1.09
Calcification
0.26 ( )
1.36
Occlusion length ≥20 mm
0.19 ( )
1.65
Morino et al., J Am Coll Cardiol Intv 2011;4:213

14. The J-CTO Score Sheet
Morino et al., J Am Coll Cardiol Intv 2011;4:213

15. J-CTO Score
Morino et al., J Am Coll Cardiol Intv 2011;4:213

16. Angiographic Score Predicting CTO PCI Success
Independent Predictive Variables Scored According to OR OR
Score
Severe calcified lesion
2.72 +2
Previous CABG
2.49
+1.5
Lesion length ≥ 20 mm
2.04
Previous MI
1.60 +1
Blunt stump
1.39
Non-LAD CTO location
1.56
Alessandrino et al., J Am Coll Cardiol Intv 2015;8:1540

18. 10-Year Experience with PCI of CTO (2005-2014)
(n=1,019 pts) (n=1,073 CTO attempts)
Number of CTO procedures
Complexity of CTO lesions assessed by J-CTO Score
Technical success rate
Galassi et al., J Am Coll Cardiol Intv 2016;9:911

19. Independent Predictors of Technical Failure by Multivariate Analysis
Galassi et al., J Am Coll Cardiol Intv 2016;9:911

20. Predictive Model for Technical Failure
Galassi et al., J Am Coll Cardiol Intv 2016;9:911

21. Receiver-Operating Characteristic Curves and Relationship Between Procedure Categories and Technical Success
Derivation Set
Validation Set
Galassi et al., J Am Coll Cardiol Intv 2016;9:911

24. CTO PCI Success Rate (61.3% success)
Hospital Success Rate
Operator Success Rate
Hannan, Sharma et al., Circ Cardiovasc Intv May 9, 2016 Epub

25. Significant Risk Factors for CTO PCI Success:
Hierarchical Multivariable Logistic Regression Model
Hannan, Sharma et al., Circ Cardiovasc Intv May 9, 2016 Epub

27. Potential Value of MSCT
in CTO Treatment
Identify entry location near side-branch
Identify stump morphology
Assess occlusion length
Quantify degree and location of calcifications
Define vessel angulation, tortuosity and intervening side-branches
Identify optimal views

28. Value of MSCT Road-mapping for CTOs Visualization Challenge
Typical CTO
Visualization Challenge
Added CTO Road-map
Data from MSCT

30. Results: Clinical and Angiographic Data
LV vol and EF assessed by cine CMR at baseline and 3 mos after CTO recanalization
MPR before and after revascularization in CTO and remote coronary artery territories
Bucciarelli-Ducci et al., J Am Coll Cardiol Img 2016;9:547

32. The Hybrid Strategy for CTOs Four Angiographic Characteristics
Establishes a consistent framework that can be used to evaluate patients considered for CTO PCI
Emphasizes procedural success and efficiency, using the least amount of radiation, contrast, and equipment
Quick transition to alternate plans when failure mode occurs; Always make progress – don’t let case stall
Four Angiographic Characteristics
Dictate Strategy:
Is the proximal cap clear by angio +/- IVUS or ambiguous?
Lesion length < or > 20mm
Quality of distal target
Suitability of “interventional” collaterals

33. The Hybrid Algorithm

34. Patient Flow Chart
Wilson et al., Heart 2016, May 10, 2016 Epub

35. Patient Flow Chart
Wilson et al., Heart 2016, May 10, 2016 Epub

36. Multivariate Analysis (OR for Technical Success)
Wilson et al., Heart 2016, May 10, 2016 Epub

37. Complication Rates of 30 Days According to
Final Strategy
Wilson et al., Heart 2016, May 10, 2016 Epub

38. Issues Involving The Case
Update in predictors of CTO recanalization
Update in prognosis after CTO recanalization

39. Effect of Successful vs
Effect of Successful vs. Failed CTO PCI in All-Cause Mortality During Long-Term Follow-up
Author, Year
Yr Follow-up
PCI Success (n)
PCI Failure (n)
OR/HR, 95% CI
Finci, et al., 1990 2
100
OR: 1.70,
Warren et al., 1990
2.6 26 18
N/A
Ivanhoe et al., 1992 4
317
163
OR: 0.21,
Angioi et al., 1995
3.6 93
108
OR: 0.37,
Noguchi et al., 2000
4.3
134 92
OR: 0.28, 0.11 – 0.72
Suero et al., 2001 10
1,491
514
OR: 0.67, 0.54 – 0.83
Olivari et al., 2003 1
289 87
OR: 0.19, 0.03 – 1.14
Hoye et al., 2005
4.5
567
304
OR: 0.52, 0.32 – 0.84
Drozd et al., 2006
2.5
298
161
OR: 0.74, 0.23 – 2.37
Aziz, et al.,2007
1.7
377
166
OR: 0.31, 0.13 – 0.76
Prasad et al., 2007
914
348
OR: 0.82, 0.62 – 1.08
Valenti et al., 2008
344
142
OR: 038, 0.19 – 0.77
de Labriolle et al., 2008
127 45
OR: 1.25, 0.25 – 6.27
Mehran et al., 2011
2.9
1,226
565
HR: 0.63, 0.40 – 1.0
Jones et al., 2012
3.8
582
254
HR: 0.28, 0.15 – 0.52
Joyal et al., 2010
5,056
2,236
OR: 0.56, 0.43 – 0.72
Moses et al., JACC Cardio Interv 2012;5:389 39

40. Outcomes for Complete, Partial and Failed CTO Revascularization
KM Curves Showing Mortality with CTO Procedure Success
CTO Procedures
Cumulative Percentage
Failed revascularization
Partial revascularization
Complete revascularization
Follow-Up Time (Years)
George et al., J Am Coll Cardiol 2014;64:235

41. (4.6yrs)

42. Study Flow Chart Lee et al., J Am Coll Cardiol 2016 Article in Press
CTO Registry (March 2003 – May 2014)
1287 patients with 1346 lesions
In-stent restenosis
86 patients
Vein graft
2 patients
Primary failure
173 patients
Primary success
1026 patients
Successful reattempt
14 patients
Failed reattempt
7 patients
No reattempt
162 patients
Bare-metal stent
26 patients
Final failure
169 patients
Final success with DES implantation
1004 patients with 1021 CTO lesions (85.6%)
Lee et al., J Am Coll Cardiol 2016 Article in Press

43. Patient Clinical Characteristics According to the Procedural Success or Failure
Lee et al., J Am Coll Cardiol 2016 Article in Press

44. Angiographic and Procedural Characteristics According to the Procedural Success or Failure
Lee et al., J Am Coll Cardiol 2016 Article in Press

45. Distribution of Study Patients According to Canadian Cardiovascular Society Functional Class
Lee et al., J Am Coll Cardiol 2016 Article in Press

46. Kaplan-Meier Curves for Clinical Endpoints
Death
Death or Q-wave MI
TVR
CABG
Lee et al., J Am Coll Cardiol 2016 Article in Press

47. Crude and Adjusted HR of Clinical Outcomes in Patients with Successful and Failed PCI of a CTO
Successful CTO PCI (n=1004)
Failed CTO PCI (n=169) %
All-cause MI TVR CABG Stroke Death,
mortality MI or TVR
p=<0.001
p=<0.001
p=<0.001
p=0.83
p=0.49
p=0.16
Lee et al., J Am Coll Cardiol 2016 Article in Press

49. Correlates of 2.5-Year Mortality for Patients with CTO PCIs
Using Cox Proportional Hazard Model with Stepwise Selection
Hannan, Sharma et al., Circ Cardiovasc Intv May 9, 2016 Epub

50. The Evaluating Xience and Left Ventricular Function in PCI on Occlusions After STEMI (EXPLORE) Trial
The Impact of PCI for Concurrent CTO on Left Ventricular Function in STEMI Patients

51. EXPLORE Trial: Background
CTO in non-IRA in 10% of STEMI patients
Excess mortality in MVD patients mainly driven by presence of CTO
Reduced LV function in MVD patients mainly driven by presence of CTO
Van der Schaaf et al., Heart 2006;92:1760
Claessen et al., J Am Coll Cardiol Intv 2009;2:1128

52. Patients with STEMI + CTO LVEF and LVEDV MRI at 4 month
EXPLORE Trial Design
Patients
Patients with STEMI treated with pPCI and
with a non-infarct related CTO.
Patients with STEMI + CTO
Design
Global, multi-center, randomized, prospective
two-arm trial with either PCI of the CTO or no
CTO intervention after STEMI.
Blinded evaluation of endpoints.
1:1
CTO-PCI < 7d
N=136
No CTO-PCI
N=144
Objective
To determine whether PCI of the CTO
within 7 days after STEMI results in a
higher LVEF and a lower LVEDV
assessed by MRI at 4 months
LVEF and LVEDV MRI at 4 month
Henriques, TCT 2015

53. EXPLORE Trial: CTO-PCI Treatment Arm
CTO-PCI (n=147)
Number of days from primary PCI to CTO PCI (mean, SD) 5
(+2)
Number of days from randomization to CTO PCI (mean, SD) 2
Multiple CTO arteries treated 6
(4%)
Technique CTO procedure Antegrade only
124
(84%)
Retrograde 23
(16%)
Crossboss/ Stingray
(3%)
PCI successful, self-reported
117
(80%)
PCI successful, corelab adjudicated
106
(72%)
Everolimus eluting stent 95
(90%)
Number of stents used (median, IQR)
(1-3)
Henriques, TCT 2015

54. EXPLORE Trial: Primary Endpoint #1
(LVEF at 4months)
CTO-PCI (n=136)
LVEF (%)
No CTO-PCI (n=144)
p=0.60
CTO-PCI (n=136)
No CTO-PCI (n=144)
Difference (95%CI) p
LVEF (%)
44∙1
(12∙2)
44∙8
(11∙9)
-0∙8
(-3∙6 to 2∙1)
0∙60
Henriques, TCT 2015

55. EXPLORE Trial: Primary Endpoint #2
(LVEDV at 4months)
CTO-PCI (n=136)
LVEDV (%)
No CTO-PCI (n=144)
p=0.70
CTO-PCI (n=136)
No CTO-PCI (n=144)
Difference (95%CI) p
LVEDV (mL)
215∙6
(62∙5)
212∙8
(60∙3)
2∙8
(-11.6 to 17.2)
0.70
Henriques, TCT 2015

56. Indications of CTO Revascularization
According to Symptoms, Ischemia and Viability

57. Take Home Message: Predictors of CTO recanalization and Prognosis after CTO recanalization
Traditional J-CTO factors of CTO recanalization still continue to be predictive of success or failure of CTO. CMR and MSCT can help in success and identify CTO pts who can/will benefit from revascularization. CTO lesion success continues to correlate with operator’s volume
Contrary to earlier report, a recent long-term study did not show benefit of successful CTO recanalization in improving long-term survival while reducing the need for TVR and CABG. Also a small CTO trial did not show benefit of CTO on LV functional parameters.

58. Question # 1
Following statement is false for the predictors of successful quick CTO recanalization based on J-CTO score:
Previously failed PCI
Tapered stump type
C. Bend >45
D. Calcification
E. Occlusion length >20mm

59. Question # 2
Recent report from Korea reported following favorable outcomes of successful CTO recanalization at 4.6 years except;
Lower longterm mortality
Lower CABG rates
Lower TLR rates
No difference in MI
No difference in MI and death

60. Question # 3
Hybrid algorithm for CTO recanalization includes the following except:
A. Proximal cap type
B. Status of distal target vessel
C. Status of interventional collaterals
D. Lesion calcification
E. Major side branch at distal cap

61. Question # 1 The correct answer is B
Following statement is false for the predictors of successful quick CTO recanalization based on J-CTO score:
Previously failed PCI
Tapered stump type
C. Bend >45
D. Calcification
E. Occlusion length >20mm
The correct answer is B

62. Question # 2 The correct answer is A
Recent report from Korea reported following favorable outcomes of successful CTO recanalization at 4.6 years except;
Lower longterm mortality
Lower CABG rates
Lower TLR rates
No difference in MI
No difference in MI and death
The correct answer is A

63. Question # 3 The correct answer is D
Hybrid algorithm for CTO recanalization includes the following except:
A. Proximal cap type
B. Status of distal target vessel
C. Status of interventional collaterals
D. Lesion calcification
E. Major side branch at distal cap
The correct answer is D