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Coronary Chronic Total Occlusions CTOâ&#x20AC;&#x2122;s: Latest Devices, Techniques and Outcomes

Samin K Sharma, MD, FACC, FSCAI Zena and Michael A Weiner Professor Director Clinical & Interventional Cardiology President Mount Sinai Heart Network Mount Sinai Hospital, NY, USA Speaker Bureau: Abbott, Medicines Co, DSI, BSC, Abiomed

Chronic Total Occlusion (CTO) From Randomized Trials to Daily Practice 1. CTO is present in 20-22% of cath cases but PCI is attempted only in 5-13% of these cases 2. From BARI trial (1994) to SYNTAX trial (2007) , the single most common reason for a patient to be referred to surgery and not randomized was a CTO with low success rate of recanalization 3. Even in the recent era of increasing success rate of CTO recanalization, the PCI success rate for CTO lesions attempted in the SYNTAX trial was only 53%

Long-Term Outcome of Percutaneous Coronary Intervention for Chronic Total Occlusions: Multicenter Registry 100

Success Rate (%)

Overall success rate 68% 80

40 1998 # of cases 76 Success rate (%) 72.4

1999

2000

2001

2002

2003

2004

2005

2006

2007

120 68.3

102 67.6

185 51.4

223 56.5

214 65.9

231 76.2

319 74.9

249 77.1

72 70.8

Annual Success Rates of CTO PCI in the Multinational CTO Registry Mehran et al. J Am Coll Cardiol Inv 2011;4:952

Current Perspective on Coronary CTO The Canadian Multicenter CTO Registry Patients with chronic total occlusion (CTO) N = 1697 (18.4% of CAD pts on cath) PCI N = 515 30% Attempted CTO PCI N = 162 10% Successful CTO PCI N = 123 7%

Medical therapy N = 747 44%

Management of CTO Registry Patients

CABG N = 435 26%

CTO bypassed N = 388 23%

Fefer et al, J Am Coll Cardiol 2012;59:991

Current Perspective on Coronary CTO The Canadian Multicenter CTO Registry

Management of CTO Registry Patients by Treating Center Fefer et al, J Am Coll Cardiol 2012;59:991

Live Case #11: NC, 66 yrs old F Presentation: New exertional Class II angina with + stress MPI for moderate inferior and moderate anterior ischemia Past History:

Hypertension, Hyperlipidemia, Smoking, Asthma, + F/H Pt had new onset angina & +stress MPI for multiple ischemia

Medications:

ASA, Atorvastatin, Clopidogrel, Bronchodilators

Cath/PCI on 4/30/10: 3V CAD & LVEF 60%. Syntax score 29.5 Left dominance, LM: Mild diffuse disease LAD: 80% proximal, Calcified CTO mid LAD with distal vessel incompletely visualized by RCA and retrograde collaterals, 80-90% D1 bifurcation with mid LAD lesion LCx: large and non-obstructive except 90% LPDA RCA: 80% prox lesion, small size S/p PCI of LPDA using Xience V DES (3/28mm) Plan Today:

PCI of LAD CTO

5/18/2010

Live Case #11: NC, 66 yrs old F Presentation: New exertional Class II angina with + stress MPI for moderate inferior and moderate anterior ischemia Past History:

Hypertension, Hyperlipidemia, Smoking, Asthma, + F/H Pt had new onset angina & +stress MPI for multiple ischemia

Medications:

ASA, Atorvastatin, Clopidogrel, Bronchodilators

Failed CTO of LAD; No complications This was the only unsuccessful LCx: large and non-obstructive except 90% LPDA Complex case of our first year (12) livecase series RCA: 80% prox lesion, small size

S/p PCI of LPDA using Xience V DES (3/28mm) Plan Today:

PCI of LAD CTO

7/13/2010

Chronic Total Occlusion (CTO) Adverse Factors for PCI 1. Lower success rates: disappointment 2. Longer cases: disrupts the schedule 3. More radiation exposure: dermatitis 4. More resource utilization: without â&#x2021;&#x2018; reimbursement 5. Minimal incidence but potentially catastrophic complications: thrombus, dissection, perforation, cardiac tamponade, collaterals shut off, side-branch occlusion, Contrast Induced AKI, MI, uCABG

TOAST-GISE Study 376pts (390 0cclusions) 29 Centers Technical success Procedural success Death Q-wave MI Non-Q-wave MI Urgent CABG Urgent repeat PCI Cerebrovascular accident Vessel perforation Acute kidney injury (AKI, CIN) In-hospital MACE

301 (77.2%) 286 (73.3%) 1 (0.26%) 1 (0.26%) 16 (4.3%) 2 (0.53%) 2 (0.53%) 0 8 (2.11%) 11 (2.92%) 19 (5.1%) Olivari Z et al, J Am Coll Cardiol 2003;41:1672

In-Hospital Outcomes and Complications Post PCI According to Procedural Success sCTO (n = 582)

uCTO (n = 254)

p Value

Arterial complications

6 (1.0)

2 (0.8)

0.680

Coronary dissection

12 (2.1)

33 (12.9)

<0.0001

Side-branch occlusion

6 (1.0)

1 (0.4)

0.172

No/slow flow

2 (0.3)

3 (1.2)

0.183

Coronary Perforation

2 (0.3)

15 (5.9)

<0.0001

Tamponade

0 (0.0)

1 (0.4)

0.303

MACE

12 (2.1)

8 (3.1)

0.393

Death

0 (0.0)

1 (0.4)

0.303

Q-wave MI

7 (1.2)

4 (1.6)

0.861

Reintervention PCI

2 (0.3)

0 (0,0)

0.765

CVA

2 (0.3)

1 (0.4)

0.303

Emergency CABG

1 (0.2)

2 (0.8)

0.576

Complications

In-hospital adverse events

Jones et al., JACC Cardio Interv 2012;5:380

Chronic Total Occlusion (CTO) Why Bother to do PCI? Presence of CTO in CAD Imparts Adverse Prognosis Because successful CTO recanalization may result in

Angina/Ischemia relief Freedom from subsequent CABG Improved LV function Improvement in event-free survival

Chronic Total Occlusion (CTO)

Presence of CTO in CAD Imparts Adverse Prognosis

Impact of Completeness of PCI Revascularization on LongTerm Outcomes in the Stent Era HRs for Mortality for Various Subgroups of Incomplete Revascularization in BMS Era N

Unadjusted HR Compared with CR [95%CI]

Adjusted HR Compared with CR [95%CI]

Complete Revascularization

6817

1.00

1 IR vessel with no CTO

8518

1.20 [1.04-1.38]

1.00 [0.87-1.15]

≥ 2 IR vessel with no CTO

2057

1.88 [1.57-2.27]

1.25 [1.03-1.50]

1 IR vessel CTO

3232

1.81 [1.53-2.13]

1.35 [1.14-1.59]

≥ 2 IR vessels at least 1 CTO

1321

2.77 [2.29-3.35]

1.36 [1.12-1.66]

Hannah, Holmes, King, Sharma et al. Circulation 2006;113:2406

Incomplete Revascularization in the Era of DES: NY State Database Report • 11,294 stented pts with MVD; 88% had DES • Oct 2003-Dec 2004, F/U through Dec 2005

Hannan, Sharma et al. JACC Intv 2009;2:17

Incomplete Revascularization in the Era of DES: NY State Database Report

Conclusion: Pts with â&#x2030;Ľ2 IR vessels with a CTO, have the worst long-term prognosis (death/MI) and greater need for CABG Hannan, Sharma et al. JACC Intv 2009;2:17

Effect of a Concurrent CTO on Long-Term Mortality and LVEF in Pts After Primary PCI in AMI 3277 STEMI pts 1997-05: SVD 65%, MVD 22%, MVD + CTO 13%

Landmark Survival Analysis

Endpoint: Survival at 5 yrs, LVEF at 12 mo (median F/U 3.1 yrs) Claessen et al. JACC Intv 2009;2:1128.

Chronic Total Occlusion (CTO) Because successful CTO recanalization may result in

Angina/Ischemia relief Freedom from subsequent CABG Improved LV function Improvement in event-free survival

Chronic Total Occlusion (CTO) Because successful CTO recanalization may result in

Angina/Ischemia relief Freedom from subsequent CABG Improved LV function Improvement in event-free survival

Chronic Total Occlusion (CTO) CTO Recanalization and Angina Relief Series Name/Year

Successful PCI (N)

FU (months)

Asymptomatic (%)

Olivari, 2003

248

Berger, 1996

139

Ivanhoe, 1992

264

Ruocco, 1992

160

Bell, 1992

234

>1000

>24 mo

>80%

TOTAL

TOAST-GISE Study 1 Year Clinical Status of Complication Free Patients CTO Success (n = 248)

CTO Failure (n = 60)

No angina

220 (88.7%)

45 (75.0%)

0.008

ETT performed

210 (84.7%)

42 (70.0%)

0.010

Maximal ETT

155 (62.5%)

20 (33.3%)

<0.0001

Negative ETT

181 (73.0%)

28 (46.7%)

0.0001

P Value

Olivari Z et al, J Am Coll Cardiol 2003;41:1672

Chronic Total Occlusion (CTO) Because successful CTO recanalization may result in

Angina/Ischemia relief

Freedom from subsequent CABG Improved LV function Improvement in event-free survival

Chronic Total Occlusion (CTO) Successful CTO Recanalization Reduces Long-Term Incidence of CABG 100

Successful Failure

7 0

Finci 1990

Warren 1990

36 13 Ivanhoe 1992

Bell 1992

TOAST-GISE Study 12-Month Clinical Outcome CTO Success (n = 286)

CTO Failure (n = 83)

n (%)

p Value

All deaths

3 (1.05)

3 (3.61)

0.130

Cardiac death

1 (0.35)

3 (3.61)

0.037

Nonfatal MI

2 (0.70)

3 (3.61)

0.077

CABG

7 (2.45)

13 (15.7)

PCI, TLR

27 (9.44)

7 (8.43)

0.834

Any TLR

33 (11.5)

19 (22.9)

0.012

Any PCI

38 (13.3)

9 (10.8)

0.584

Any MACE

35 (12.2)

21 (25.3)

0.005

<0.0001

Olivari Z et al, J Am Coll Cardiol 2003;41:1672

Chronic Total Occlusion (CTO) Because successful CTO recanalization may result in

Angina/Ischemia relief Freedom from subsequent CABG

Improved LV function Improvement in event-free survival

Evaluation of LV Function 3-Yrs after Percutaneous Recanalization of CTO Changes in LV Volume Indexes and EF between Baseline and 3-Yr FU Measured Using Magnetic Resonance Imaging (N=21)

86 35

Mean ejection fraction was unchanged, but end-systolic and end-diastolic volume indexes decreased significantly. (Normal values for ejection fraction and end-systolic and end-diastolic volumes are 63 ± 4%; 162 ± 28 ml, and 60 ±

Kirschbaum S et al, Am J Cardiol 2008;101:179

MRI Predicts LV EF and Wall Motion Improvement with CTO Revascularization (N=21) Segmental wall thickening (%)

90 80 70

SWT at Baseline (n=21) SWT 5 mths post Stent Implantation SWT 3 yrs post stent Implantataion

P<0.001 P<0.05

60 50

P=ns P=ns P<0.05

P<0.05

P<0.001

P<0.05

P=ns

30 20

P<0.05 P=ns

P=ns

0 -10 -20

<25%

25-75%

>75%

Remote

Transmural extent of infarction Kirschbaum et al, Am J Cardiol 2008;101:179

Chronic Total Occlusion (CTO) Because successful CTO recanalization may result in

Angina/Ischemia relief Freedom from subsequent CABG Improved LV function

Improvement in event-free survival

TOAST-GISE Study 12-Month Clinical Outcome CTO Success (n = 286)

CTO Failure (n = 83)

n (%)

p Value

All deaths

3 (1.05)

3 (3.61)

0.130

Cardiac death

1 (0.35)

3 (3.61)

0.037

Nonfatal MI

2 (0.70)

3 (3.61)

0.077

CABG

7 (2.45)

13 (15.7)

PCI, TLR

27 (9.44)

7 (8.43)

0.834

Any TLR

33 (11.5)

19 (22.9)

0.012

Any PCI

38 (13.3)

9 (10.8)

0.584

Any MACE

35 (12.2)

21 (25.3)

0.005

<0.0001

Olivari Z et al, J Am Coll Cardiol 2003;41:1672

Clinical Impact of PCI in Totally Occluded LAD 1341 Consecutive Pts (1362 CTOs): Jan 2000-May 2007 Primary Endpoint: 3 yr mortality LAD CTO

Non-LAD CTO

Conclusion: Patency of the LAD appears to be more important than patency of the LCX or RCA Gordino et al. JACC 2009;53:A79

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

100

OR: 1.70, 0.40 - 7.32

Warren et al., 1990

2.6

N/A

Ivanhoe et al., 1992

317

163

OR: 0.21, 0.05 - 0.83

Angioi et al., 1995

3.6

108

OR: 0.37, 0.10 - 1.40

Noguchi et al., 2000

4.3

134

OR: 0.28, 0.11 – 0.72

Suero et al., 2001

1,491

514

OR: 0.67, 0.54 – 0.83

Olivari et al., 2003

289

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

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

5,056

2,236

OR: 0.56, 0.43 – 0.72

Joyal et al., 2010

Moses et al., JACC Cardio Interv 2012;5:389

Successful Recanalization of CTO Associated with Improved Long-Term Survival

Jones et al., JACC Cardio Interv 2012;5:380

Successful Recanalization of CTO Associated with Improved Long-Term Survival

Jones et al., JACC Cardio Interv 2012;5:380.

Successful Recanalization of CTO is Associated with Lower TVR at Long-Term F/U

Jones et al., JACC Cardio Interv 2012;5:380

Long-Term Outcome of CTO PCI Independent Predictors of Mortality, MI and CABG up to 5 year F/U HR

95% CI

p Value

CKD

2.72

1.37-5.39

<0.01

Diabetes mellitus

2.02

1.25-3.26

<0.01

Age (per-yr increment)

1.09

1.06-1.11

<0.01

Procedural success of CTO

0.63

0.40-1.00

0.05

2.50

1.08-5.75

0.03

CTO located in LAD

1.88

1.16-3.06

0.01

Hypercholesterolemia

0.56

0.35-0.91

0.02

Procedural Success of CTO

0.21

0.13-0.36

<0.01

Independent predictors of mortality

Independent predictors of MI CKD

Independent predictors of CABG

Mehran et al. J Am Coll Cardiol Inv 2011;4:952

Chronic Total Occlusion (CTO) PRISON II Trial: DES vs. BMS for CTO – 3 Year Outcome BMS (n = 100) DES (n =100)

P <0.001

P = 0.002

P = 0.002 34

ST 2% 5%

TLR

TVR

MACE Rahel B. et al, Am Heart J 2009;157:149

Propensity Score-Matched Event Rates by Stent Type for CTO PCI: 30-Month Follow up DES (n=8,218) BMS (n=2,043) 25 20

p = 0.014 20.8

19.3 20.5

15.9 p = 0.512

p = 0.744

5.7 6.3

5 0

p = 0.721

Death

4.0

Revascularization

4.9

Bleeding

Patel et al., J Am Coll Cardio Intv 2012;5:1054

Chronic Total Occlusion (CTO) Antegrade CTO Wiring Technique Controlled Drilling Penetration Technique Sliding Technique

Treating CCTO Lesions with ASAHIAbbott Vascular Guide Wires Tapered Tip

Straight Tip

ASAHI MIRACLEBROS™ 4.5

ASAHI MIRACLEBROS™ 6

ASAHI MIRACLEBROS™ 12

ASAHI CONFIANZA™ 9

Increasing Support

ASAHI MIRACLEBROS™ 3

ASAHI CONFIANZA PRO™ 9

ASAHI CONFIANZA PRO™ 12

Stiff Guide Wires for CSL/CTO

Tip Stiffness Stiffest Stiffer Stiff CROSS-IT CROSS-IT MiracleBro MiracleB CROSS-IT Confianza MiraclebB CROSS-IT 100 200 3 4.5 300 9 400 9-12

Chronic Total Occlusion (CTO) HI-TORQUE PROGRESS Guidewires (40-200T)

Variation in tip diameter & stiffness

Step up approach to penetrate lesions

Uncoated, exposed tip coils

Tactile feedback, minimize perforation

Tapered hydrophilic polymer

Core-to-tip transitionless core

Lesion crossing and distal access

Torque and control

Lubricious proximal coating

Device compatibility

Advanced Techniques for Chronic Total Occlusion Japanese Specialized Technique

• • • • •

Anchor balloon technique Mother-Child catheter technique Parallel wire IVUS guidance Retrograde approach

‘Mother and Child Guide Catheters’

Parallel Wire Technique

IVUS-Guided CTO Crossing

Advanced Techniques for Chronic Total Occlusion Japanese Specialized Technique

• • • • •

Anchor balloon technique Mother-Child catheter technique Parallel wire IVUS guidance Retrograde approach

Retrograde Wire Technique of CTO Recanalization

Retrograde Techniques for CTO Recanalization • Typically reserved for LAD or RCA CTOs via septal collaterals; avoid using epicardial collaterals • Four techniques: – Direct retrograde crossing – Kissing wire – Controlled Antegrade and Retrograde Subintimal Tracking (CART); balloon dilatation or knuckle wire – Reverse CART, LaST

Retrograde Wire Technique for Chronic Total Occlusion Recanalization Four Patterns of Success in Retrograde CTO Recanalization

Sumitsuji et al. J Am Coll Cardiol Intv 2011;4:941.

Concept of CART Technique Controlled Antegrade and Retrograde Subintimal Tracking

Surmely JF, J Invasive Cardiol. 2006;18:334

Knuckle Wire Technique/Reverse CART Technique

Knuckle Wire Technique (A) A knuckle is created on the retrograde wire with support from the Corsair catheter. (B) Illustration of the technique. Note the position of the wire within the subintimal/subadventitial space, which is expended by the knuckle

Reverse Cart Technique (A) A balloon is inflated on the antegrade wire with the subintimal/subadventitial space. A retrograde wire, supported by the Corsair catheter, is aimed at the space created. (B) Illustration of the technique.

Joyal et al., JACC Intv 2012;5:1.

Retrograde Wire Technique for CTO Recanalization

When to do Retrograde technique? - Minimum 200 CTO cases via antegrade technique - Dedicated setup, equipments and ability to handle complications - Usually after failed antegrade (once or twice) approach - Ostial stump occlusion (RCA, LAD, LCx)

Retrograde Wire Technique of CTO Recanalization

New Devices for Chronic Total Occlusion CTO Devices â&#x20AC;&#x201C; FDA Approved PRIMA (Laser) Wire

CTO Devices FDA approved FAST-CTOs Study

BridgePoint

CrossBoss & Stingray

Devices

Frontrunner (Mechanical) Catheter Safe Cross (RF) Guidewire Crosser (Vibration) Catheter

FAST-CTOs Trial: Use of Novel Crossing and ReEntry System in Coronary CTOs

Crossing Catheter: CrossBoss

Re-Entry Balloon Catheter and Guidewire: Stingray

Whitlow et al. J Am Coll Cardiol Intv 2012;5:293.

Support Catheters

Finecross 1.5mm OTW Balloon Quick cross Minicross Corsair

Chronic Total Occlusion (CTO) Corsair Micro-Catheter For crossing & dilating small vessels: SHINKA Shaft

8 thin wires wound with 2 larger ones = pushability, trackability

New Devices for Chronic Total Occlusion Novel Approach to CTO Under Investigation • Therapeutic Ultrasound Sonicross System Ultrasound wire

Thrombolytic therapy

Collagenase infusion

• Lumen Re-entry Pioneer catheter • Penetration device Tornus, Corsair • Vibrational/Acoustic Devices OmniWave, Resolution

• Magnetic navigation Cronus wire

CTO PCI: Technical Considerations • Planned procedure – not >1-2 in a day - Careful assessment of symptoms, and target site viability + ischemia based on the appropriateness criteria • Proper views - Must visualize stump, collaterals and distal parent vessel beyond the CTO segment (consider contra-lateral injection) • Strong guiding catheter support - 6-8 Fr, trans-femoral preferred - Long sheaths, short guides for retrograde • Bilateral angiography from the outset in essentially ALL cases • Time limit of radiation exposure and contrast volume • Initial floppy wire passage for distal or angulated CTOs • Increasing stiffness of the wires- Wire escalation • Support/transit catheters or small OTW balloon

ACCF/SCAI/STS/AATS/AHA/ASNC 2012

Appropriateness Criteria for Coronary Revascularization Chronic Total Occlusions: Indications for PCI Appropriateness Score (1-9)

INDICATION

CCS Angina Class Asymptomatic

I or II

III or IV

• Chronic total occlusion of 1 major epicardial coronary artery, without other stenoses • Low-risk findings on noninvasive testing • Receiving no or minimal anti-ischemic medical therapy

• Chronic total occlusion of 1 major epicardial coronary artery, without other stenoses • Low-risk findings on noninvasive testing • Receiving a course of maximal anti-ischemic medical therapy

• Chronic total occlusion of 1 major epicardial coronary artery, without other stenoses • Intermediate-risk findings on noninvasive testing • Receiving no or minimal anti-ischemic medical therapy

• Chronic total occlusion of 1 major epicardial coronary artery, without other stenoses • Intermediate-risk criteria on noninvasive testing • Receiving a course of maximal anti-ischemic medical therapy

• Chronic total occlusion of 1 major epicardial coronary artery, without other stenoses • High-risk findings on noninvasive testing • Receiving no or minimal anti-ischemic medical therapy

• Chronic total occlusion of 1 major epicardial coronary artery, without other stenoses • High-risk criteria on noninvasive testing • Receiving a course of maximal anti-ischemic medical therapy

Patel et al. JACC 2012;53:530-553

CTO PCI: Technical Considerations • Planned procedure – not >1-2 in a day - Careful assessment of symptoms, and target site viability + ischemia based on the appropriateness criteria • Proper views - Must visualize stump, collaterals and distal parent vessel beyond the CTO segment (consider contra-lateral injection) • Strong guiding catheter support - 6-8 Fr, trans-femoral preferred - Long sheaths, short guides for retrograde • Bilateral angiography from the outset in essentially ALL cases • Time limit of radiation exposure and contrast volume • Initial floppy wire passage for distal or angulated CTOs • Increasing stiffness of the wires • Support/transit catheters or small OTW balloon

Fundamental Wire Technique and Current Strategy for Chronic Total Occlusion PCI Procedural Steps of Current CTO-PCI

CTO - PCI

Cotralateral Dual Injection

Antegrade approach x2 Retrograde approach (ostial) IVUS guide re-entry Success

Failure

Single Wire Technique Parallel Wire Technique Retrograde Wire Cross Kissing Wire Cross CART Reverse CART

Procedural Success of CTO PCI at MSH Mount Sinai Experience

100

Asahi wires

Retrograde technique

Planned 2nd (18%) or 3rd (8%) attempt

397

806

665

2003-2005

2006-2008

2009-10

EXPERT CTO US Trial Completed: MSH leader 782

2011-12

Algorithm for Crossing CTOs

Brilakis et al., J Am Coll Cardiol Intv 2012;5:367.

CCC Live Cases and ACC Collaboration

16TH AUNNUAL LIVE SYMPOSIUM June 12-15,2013