OPENCTO Registry Update Dr James Sapontis Monash Heart

OPEN-CTO Registry Update Dr James Sapontis Monash. Heart Melbourne, Australia.

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship • • Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company • • None Boston Scientific, St Jude medical None None

2013 Projected 2012 2011 Increasing numbers of CTO-PCI 15 centers > 50 cases* 2, 375 CTOs* 33 centers > 50 cases* 5, 208 CTOs* 58 centers projected > 50 cases* *Industry estimate. Data on file as BSCI 62 centers 127 centers 9, 024 CTOs* 241 centers 2014 124 centers >50 cases

The Hybrid Approach PCI • • Systematic and easily teachable. Adoption of four strategies. Sequence based on probability of success. Rapid decision making and transition. Brilakis et al J Am Coll Cardiol Intv 2012; 5: 367– 79

The Hybrid Algorithm Four things determine how many and which option to begin with 1. Proximal Cap Anatomy • Defined or Ambiguous? 2. Target • Favorable for reentry? Direction 3. Collaterals • Useable or not? 4. Occlusion length • <20 mm or ≥ 20 mm? Crossing strategy

PI James Aaron Grantham. Co PIs James Sapontis, Bill Lombardi Manager Karen Nugent Statistician Kensey Gosch Core Lab Federico Gallegos Publications Spertus, Cohen, Marso, Yeh, Mc. Cabe, Grantham, Karmpaliotis

OPEN CTO Design • DESIGN: Prospective, nonrandomized, single-arm, multicenter clinical evaluation of the Hybrid CTO-PCI 1000 consecutive patients enrolled at 12 clinical sites in the US Comprehensive baseline clinical, angiographic, and HS assessment • OBJECTIVE: To evaluate the Success, safety, efficiency, appropriateness, health status outcomes, and costs of CTO-PCI • PRINCIPAL INVESTIGATOR • J. Aaron Grantham, MD, FACC Saint Luke’s Mid America Heart Institute, Kansas City, Mo. USA Clinical follow-up at 1, 6, 12 months Success Failure Angina Dyspnea Efficient Inefficient Complicated Uncomplicated

Peace. Health St. Joseph Med. Ctr. Bellingham, WA U. Washington Seattle, WA OPEN CTO Sites Saint Luke’s Hospital Mid America Heart Institute Kansas City, MO Alexian Brothers Medical Center Elk Grove Village, IL Peace. Health Sacred Heart Med. Ctr Springfield, OR York Hospital York, PA Torrance Medical Center Torrance, CA Banner Health System Phoenix and Mesa, AZ Columbia University Medical Center NY, NY Presbyterian Hospital/ Heart Group Albuquerque, NM Boone Hospital Center Columbia, MO

Strengths of OPEN CTO • Auditing through NCDR • • • Truly consecutive, funded, unselected, fully reported Angiographic core lab analysis • Unbiased QCA Centralized call center follow up (92% at 6 months) CEC adjudication Broad spectrum of operators using a single methodological approach Give detailed economic analysis.

Enrollment by Site

Baseline Patient Characteristics Patient Characteristic % Age (yrs) 65. 4 ± 10. 3 Male sex 80. 2 I 8. 3 BMI (Kg/m 2 BSA) 30. 8 ± 9. 1 II 40. 2 White Caucasian 90 III 43. 9 Smoking (ever) 64. 5 IV 7. 6 Diabetes 41. 4 Stable Angina 91. 8 Hypertension 86. 9 CCSC I 4. 2 Prior MI 48. 4 CCSC II 23. 4 Prior CABG 36. 9 CCSC III 56. 9 Prior PCI 66. 0 CCSC IV 15. 5 Prior CHF 22. 6 PAD 17. 4 CKD>stage 1 13. 3 EF (mean) 51. 1 ± 13. 7% NYHA Class Unstable Angina: TIMI Score (mean) 8. 1 2. 4 ± 0. 6 Seen By Cardiothoracic Surgery 10. 2 Suitable for Surgery 35. 6

Physician Assessment Risk Assessment based on Non. Invasive study 7. 50% Low 33. 90% 58. 60% Intermediate High

Appropriate Use Criteria Mapped • 719 Mapped vs 281 Unmapped 1% 24% Appropriate • 28. 1% Unmapped • No CCS • No Non-invasive testing May be Appropriate Rarely Appropriate 75% • Very few patients (68) had low risk non-invasive testing

Angiographic Characteristics Angiographic Characteristic % Angiographic Characteristic CTO only (%) 86. 2 Complete Revasc (%) 82. 3 Target Vessel RCA (%) 60. 5 Lesion type LAD (%) 19. 6 De novo LCX (%) 13. 3 Occlusion Length (mm) 29. 9 ± 24. 3 Length>20 mm (%) Total lesion length (mm) 54. 8 63. 4 ± 28. 6 JCTO score <3 (%) 81. 2 JCTO score ≥ 3 (%) 19. 7 Mean stent length In Stent Restenosis Prior Bypass to This Vessel % 75. 6 + 33. 33 90. 6 9. 4 30 Previously Attempted 22. 4 Investment Procedure 8. 8

Overall Results 89% 265 ± 194 ml 120 ± 72 min 2. 5 ± 1. 9 Gy

Procedural Time Breakdown Time between insertion of a device into catheter and crossing into true lumen Time between local and crossing into distal true lumen Time between local and insertion of a device into catheter

Hybrid Algorithm Adaptation

Hybrid Approach AWE 12% RDR 24% RDR 18% RWE 13% AWE 55% RWE 21% ADR 44% ADR 14% Success rate 58% Success rate 55%

Equipment Use General Equipment (% per 1000) Per case Sheaths 3± 1. 3 Guides 3. 2± 1. 0 Guidewires 9. 6± 6. 2 Balloons 4. 9± 3. 0 Corsair (83%) 1. 6± 0. 9 Fine Cross (10%) 1. 2± 0. 5 Peripheral Equipment Rota-blator (6%) 1. 8± 1. 7 burrs Guideliner (36%) 1. 2± 0. 5 Laser (14%) 1. 1± 0. 3 Covered stents (4%) 2. 3± 0. 9 Coils (0. 4%) 1. 5± 1

Health Status Changes

Health Status Changes A decrease in score represents improvement in symptoms

Safety In Hospital Frequency 30 Day Frequency 6 Month Death 0. 9%* Death 1. 3% Death MI 2. 4% Rehospitalization 14. 7% Rehospitalization Emergent surgery 0. 6% Unplanned Perforation 6. 0% Revascularization Clinical perforation 4. 9% (82%) Planned 2. 6% Bleeding Access 4. 0% PCI 2. 3% Radiation injury 0. 1% CABG 0. 3% Skin change 3. 1% *STS risk estimate for OPEN patients 1. 67% Frequency 2. 8% 32. 65% 12. 1% (82%) 2. 6% Skin change 3. 4% Not Adjudicated

Conclusions • OPEN has so far shown Hybrid CTO-PCI – high technical success – reasonable efficiency – significant health status improvement • HS improvement is maintained over 6 months • CTO-PCI risk may be higher than non-CTO-PCI • OPEN CTO will provide the most rigorous and reliable assessment of CTO-PCI practice and outcomes to date