Emmanouil S. Brilakis, MD, PhD

Director, Cardiac Catheterization Laboratories

VA North Texas Healthcare System

Associate Professor of Medicine, UT Southwestern Medical School

35οΠανελλήνιο Καρδιολογικό Συνέδριο

Αθήνα, 24 Οκτωβρίου 2014

Coronary Chronic Total Occlusions:

state-of-the-art 2014

Consulting/speaker honoraria: St Jude

Medical, Terumo, Janssen, Sanofi,

Abbott Vascular, Somahlution,

Elsevier, Boston Scientific

Employment (spouse): Medtronic

Grants: NIH –1R01HL102442

VA - I01-CX000787-01

VA CSP#571 – DIVA

ES Brilakis: Disclosures

I believe in the

value of CTO PCI

Another disclosure…

1. Definition – prevalence

2. Indications

3. Technique

• Wire crossing strategies

• Balloon Crossing

• Stents

4. Complications

5. Economics

6. The Future

Outline

Proximal RCA CTO – LAO viewCTO: occlusion in the coronary artery with

TIMI 0 flow of ≥3 months duration

CTO prevalence: Canadian registry

0

2000

4000

6000

8000

10000

12000

14000

16000

CABG STEMI Coronary angio

CTO

No CTO

Fefer P et al. J Am Coll Cardiol. 2012;59(11):991-997

# of pts

54%10%

14.7%

18.4% among pts with CAD

Jeroudi O et al. CCI 2013

Prevalence of CTOs and choice of

revascularization in Dallas VAMC

Diagnostic caths 1/2011 to 12/2012: 2,193

Unique patients: 1,699

No prior CABG; n=1,355

CAD ; n=1,015Prior CABG; n=344

CTO, n=319, 31% CTO, n=305, 89%

PCI

n=161

50%

Medical Rx

n=61

19%

CABG

n=97

30%

PCI

n=182

60%

Medical Rx

n=121

40%

CABG

n=2

0.6%

1. Definition – prevalence

2. Indications

3. Technique

• Wire crossing strategies

• Balloon Crossing

• Stents

4. Complications

5. Economics

6. The Future

Outline

Patient testimonial after right coronary artery

chronic total occlusion intervention

Why open a CTO?

Patient Physician

1.↓ angina

2.↑ LV function

3.↓consequences of

future ACS

4.↓arrhythmias

5.↓CABG

6.↓nitrate use…

1. Help pts

2. Improve PCI

skills

3. ↑ PCI volume

Residual – recurrent angina

Joyal et al. AHJ 2010

From: Long-Term Follow-Up of Elective Chronic Total Coronary Occlusion Angioplasty: Analysis From the U.K.

Central Cardiac Audit Database

J Am Coll Cardiol. 2014;64(3):235-243. doi:10.1016/j.jacc.2014.04.040

Complete vs incomplete revascularization

Garcia, .., Brilakis. J Am Coll Cardiol. 2013;62:1421-1431

89,883 Patients

RR = 0.71 [0.65-0.77], p<0.001 .

12,259 out of 89,883

(13%) died during follow

up.

CR was associated with

reduced long-term

mortality relative to IR

(risk ratio (RR):0.71; 95%

[CI]:0.65-0.77, p<0.001

Mortality benefit in

patients treated with

CABG (RR 0.70; 95%

CI:0.61-0.80, p<0.001)

and PCI (RR 0.72, 95%

CI:0.64-0.81, p<0.001.

Mortality benefit did not

vary with definition of

CR.

Claessen, B. et al. J Am Coll Cardiol Intv 2009;2:1128-1134

Impact of CTO on outcomes post STEMI

Improvement in LV systolic wall

thickening

Kirschbaum SW AJC 2008;101:179

“Dysfunctional but viable

myocardium”

2011 PCI guidelines

5 of 18 categories: lower recommendation for CTO PCI

Patel MR et al. JACC 2012;59:857-881

Appropriateness Use Criteria for

Coronary Revascularization

59.0

1.6

96.0

0.8

0

20

40

60

80

100

Procedural Success MACE

%

CTO Non-CTO

p < 0.001

p < 0.001

Procedural success and MACE

Brilakis et al, JACC Cardiovasc Intv 2014 – in press

594,510 procedures

22,365 CTO PCI

3.2 3.5 3.8 4.2 4.8

55.557.1

59.2 59.861.9

1.9 1.6 1.7 1.4 1.3

0

10

20

30

40

50

60

70

2009 2010 2011 2012 2013

%

% of total PCI Procedural success MACE

Trends over time

Brilakis et al, JACC Cardiovasc Intv 2014 – in press

3. How?

CTOs

A B?

2004-2007 The “early” years

2007-2010 “Crazy years”

2010- Moving on….

CTO in Dallas VAMC

Hybrid CTO crossing algorithm

Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari,

Buller, De Martini, Lombardi, Thompson. JACC Intv 2012

Birth of the hybrid algorithmJan 2011 – Bellingham, WA

CTO basics

1.Approach: femoral – consider 45 cm

sheath

2.Guide: 7 or 8 French – support

short/shortened 90 cm

3.Virtually always: dual injections

4.Anticoagulation: heparin

5.Monitor radiation: AK

6.Ready to manage complications:

perforation - tamponade

The retrograde approach

67.5

24.8

7.6

Septal

Epicardial

SVG

Rathore, Circ Intv 2009

EpicardialSeptal

Tortuosity + ++ +++

Tamponade

risk

+ + +++

Wiring

difficulty

+ ++ +++

Able to

dilate

Yes Yes No

Bypass

graft

71

29

82

2

59

41

86

1.5

60

40

86

1.6

64

36

90

2.2

91

9

69

0

80

20

85

00

20

40

60

80

100

Antegrade Retrograde Overall Majorcomplications

%

2006

2007

2008

2009

2010

2011

Karmpaliotis, Michael, Brilakis, Lombardi, Kandzari et al. JACC Intv 2012;5:1273-9

Michael, Karmpaliotis, Brilakis, Lombardi, Kandzari et al. Am J Cardiol 2013;112:488-492

CTO PCI: success and complications

30%

N=1,363•Peacehealth Bellingham, WA

•Piedmont Atlanta, GA

•Dallas VAMC/UTSW

El Sabbagh,.., Brilakis. Int J Cardiol 2014;174:243-8

Retrograde CTO PCI: success and

complications meta-analysis

2006 – 4/2013

26 studies - 3,482 pts60

80

100

Overall successRetrograde success

83,3

74,5

%

0,7 0,7

1,4

6,9

2 2

5,4

0,5

0,0

1,0

2,0

3,0

4,0

5,0

6,0

7,0

8,0

%

Antegrade Dissection Re-Entry

Michael et al – Circulation Interventions 2012

BridgePoint Procedure

FAST CTOs: results

• Primary Effectiveness Endpoint

Technical Success 77%

• Primary Safety Endpoint

30-Day MACE 4.8%

• Secondary Endpoints

Mean Procedure Time 105 ± 54 min

Mean Fluoroscopy Time 44 ± 25 min

Whitlow et al. JACC Intv 2012

Bridgepoint system: mid-term outcomes

Mogabgab et al. JIC 2013

STAR technique: long-term outcomes

• Florence CTO PCI

registry

• 802 successful CTO

PCI between 2003-

2010

• 82% angiographic FU

• EES less reocclusion

than 1st generation

DES

• STAR: 57%

reocclusion rate

(16/28)

Valenti et al. JACC Intv 2013

How often is “hybrid” needed?

Michael,…,Brilakis Journal of Interventional Cardiology 2013

66/73 success rate (90.4%)

32 of 73 pts (44%) required 3.6±1.4 approach changesAntegrade wire: 50.0%; antegrade diss/re-entry: 24.2% retrograde: 25.8%

Torrance Medical

Center, CA

M.R. Wyman

PROspective Global REgiStry for the

Study of CTO interventions

Appleton

Cardiology, WI

K. Alaswad

Piedmont Heart

Institute, GA

D. Karmpaliotis

Mid America Heart

Institute, MO

J.A. Grantham

Dallas VAMC and

UTSW, TX

E. Brilakis

Massachusetts

General Hospital, MA

F. Jaffer, B. Yeh

Medical Center of

the Rockies, CO

A. Doing

Minneapolis VA

Medical Center, MN

S. Garcia

Banner Samaritan

Medical Center, AZ

A. Pershad Providence Health

Center, TX

C. Shoultz

PeaceHealth St.

Joseph Medical

Center, WA

W. Lombardi

1/2012 to 2/2014

n=632

Technical success: 92.4%

Major complications: 1.9%

•Appleton Cardiology, WI

•Dallas VAMC/UTSW, TX

•Peaceheath Bellingham, WA

•Piedmont Heart Institute, GA

•St Luke’s Mid America Heart

Institute, MO

•Torrance Medical Center, CA

Christopoulos, Karmpaliotis, Alaswad, Wyman, Lombardi, Grantham, Thompson, Brilakis et al

Journal of Invasive Cardiology 2014;26:427-432

65

3744

0

20

40

60

80

100

Techniques Used

%

Antegrade

Antegrade DR

Retrograde

Successful technique

PROspective Global REgiStry for the Study of CTO interventions

87.2

93.7

78.1

90.0

70

80

90

100

2006-2011 2012-2013

%

No prior CABG

Prior CABG

Pre “Hybrid” era

Michael, Karmpaliotis, Brilakis, Lombardi,

Kandzari et al. Heart 2013;99:1515-8

Δ=9.1%

P<0.001

Christopoulos, Menon, Karmpaliotis, Alaswad,

Lombardi, Grantham, Brilakis et al, AJC 2014;113-1990-4

CTO PCI: success and prior CABG

N=1,363

3 US sites

Prior CABG: 37%

Complications: 1.5% vs. 2.1%

Retrograde: 27.1% vs. 46.7%

Δ=3.7%

P=0.092

“Hybrid” era

N=630

6 US sites

Prior CABG: 37%

Complications: 2.5% vs. 0.8%

Retrograde: 34% vs. 39%

Δ=4.3%

p=0.31

N=521

In-stent restenosis=57 (10.9%), De novo lesions=464

5 US centers

Major complications: ISR 3.5% vs. De novo 2.2%

Christopoulos, Karmpaliotis, Alaswad, Lombardi, Grantham, Brilakis et al, CCI 2014;84:646-51

In-stent restenosis

PROspective Global REgiStry for the Study of CTO interventions

89.4

86.0

92.5

90.3

70

80

90

100

Technical success Procedural success

%

ISR De novo

Δ=3.1%

p=0.43

Martinez-Rumayor et

al. JACC Intv 2012

How CTO

equipment

can help in

non-CTO

cases!

1st vs 2nd generation DES

Lanka et al. Journal of Invasive Cardiology 2014; 26:304-10

Target Vessel Revascularization

Target Lesion Revascularization

1st vs 2nd generation DESMACE

Stent thrombosis

Lanka et al. Journal of Invasive Cardiology 2014; 26:304-10

1. Definition – prevalence

2. Indications

3. Technique

• Wire crossing strategies

• Balloon Crossing

• Stents

4. Complications

5. Economics

6. The Future

Outline

72. Succumb to fear and

insecurity or be afraid and go

ahead anyway!

Frequency of CTO complications

65 studies - 18,061 Patients

Patel V et al – JACC Intv 2013

Patel V et al – JACC Intv 2013

only 8 operators performed 50 or more

CTO PCI per year.

Brilakis et al, JACC Cardiovasc Intv 2014 – in press

IC-214402-AC AUG2014

Hybrid CTO Training & Education

>1000 physicians trained globally

Radiation Exposure

• Minimize fluoro

• 7.5 fps

• Fluoro-store

• Watch AKBrilakis ES. Manual of coronary CTO interventions. Elsevier 2013

0

0,2

0,4

0,6

0,8

1

1,2

1,4

1,6

Diagnostic PCI Overall

mre

m

Control

Bleeper Sv1.1

1.4

0.7

p<0.001 p<0.001p=0.323

36% relative

reduction in

overall

radiation!

1.0

1.4

0.9

Christopoulos et al. Late breaking clinical trial – SCAI 2014

Circ Cardiovasc Interv 2014; in press

1. Definition – prevalence

2. Indications

3. Technique

• Wire crossing strategies

• Balloon Crossing

• Stents

4. Complications

5. Economics

6. The Future

Outline

CTO Revascularization: Economic Outcomes

0

2.000

4.000

6.000

8.000

10.000

12.000

Total DirectCosts

ProceduralCosts

ContributionMargin

CTO, N=154

Non-CTO, N=1,847Co

st (

Do

llars

)

P<0.001

P<0.001P=0.58

$10,870

$7,436

$6,230

$3,060

$5,173

$5,730

~

Balloon angioplasty catheters

$600 vs $304

Guidewires

$715 vs $174

Stents

$3,590 vs $2,036

Karmpaliotis D.

CCI 2013

CTO Revascularization: Economic Outcomes

0

2.000

4.000

6.000

8.000

10.000

12.000

Total DirectCosts

ProceduralCosts

ContributionMargin

CTO, N=154

Non-CTO, N=1,847Co

st (

Do

llars

)

P<0.001

P<0.001P=0.58

$10,870

$7,436

$6,230

$3,060

$5,173

$5,730

Karmpaliotis D.

CCI 2013

1. Definition – prevalence

2. Indications

3. Technique

• Wire crossing strategies

• Balloon Crossing

• Stents

4. Complications

5. Economics

6. The Future

Outline

• Equipment

• Forward looking IVUS (?)

• Collagenase

• Trials-Registries

• DECISION CTO

• Euro CTO

• OPEN CTO

• Education - training

The future

1. CTOs are common

2. CTO revascularization can

provide significant clinical

benefits

3. CTO PCI can be achieved with

high success and low

complication rates and can be

cost-effective

Conclusions

www.ctofundamentals.org