cardiology grand rounds · cardiology grand rounds title: chronic total occlusion interventions:...

C A R D I O L O G Y G R A N D R O U N D S Title: Chronic Total Occlusion Interventions: what is missing in 2016

Speaker(s): Emmanouil S. Brilakis, MD, PhDProfessor of Medicine University of Texas Southwestern Medical School

Date & Time: Monday, January 4, 2016, 7:00 – 8:00 AM

Location: ANW Education Building, Watson Room

OBJECTIVES At the completion of this activity, the participants should be able to:

1. Recognize the prevalence and clinical implications of coronary chronic total occlusion (CTO)s. 2. Examine the advantages and disadvantages of contemporary treatment options for coronary CTOs. 3. Determine the gaps of knowledge in the contemporary approach to coronary CTOs.

ACCREDITATION Physician: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians.

Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurse: This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.

DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) As of December 28, 2015, Dr. Brilakis discloses the following financial relationships: consulting/speaker honoraria from Abbott Vascular, Asahi, Boston Scientific, Elsevier, Somahlution, St Jude Medical, and Terumo; research support from InfraRedx and Boston Scientific; spouse is employee of Medtronic .

Planning Committee Dr. Michael Miedema, and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationships ‐ stockholder: Cardiomind, Interface Biologics, Aritech, DSI/Transoma, InstyMeds, Intervalve, Medtronic, Osprey Medical, Stout Medical, Tricardia LLC, CoAptus Inc, Augustine Biomedical; scientific advisory board: Abbott Laboratories, Boston Scientific, MEDRAD Inc, Thomas, McNerney & Partners, Cardiomind, Interface Biologics; options: BackBeat Medical, BioHeart, CHF Solutions; speakers bureau: Vital Images; consultant: Edwards LifeSciences.

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Allina Health - Learning & Development - 2925 Chicago Ave - MR 10701 - Minneapolis MN 55407

1

Emmanouil S. Brilakis, MD, PhDDirector, Cardiac Catheterization Laboratories

VA North Texas Healthcare System

Professor of Medicine

UT Southwestern Medical School

Emmanouil S. Brilakis, MD, PhDDirector, Cardiac Catheterization Laboratories

VA North Texas Healthcare System

Professor of Medicine

UT Southwestern Medical School

Minneapolis Heart InstituteCardiology Grand Rounds

January 4, 2016

CTO PCI in 2016: what is missing?

Consulting/speaker honoraria: Abbott Vascular, Asahi, Boston Scientific, Elsevier, Somahlution, Terumo, St Jude

Employment (spouse): Medtronic

Grants: InfraRedx, Boston Scientific

VA - I01-CX000787-01

VA CSP#571 – DIVA

ES Brilakis: Disclosures

2

I believe in the value of CTO PCI

Another disclosure…

Proximal RCA CTO – LAO viewCTO: occlusion in the coronary artery with TIMI 0 flow of ≥3 months duration

3

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: 2,193Unique patients: 1,699

No prior CABG; n=1,355CAD ; n=1,015

Prior CABG; n=344

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

PCIn=16150%

Medical Rxn=6119%

CABGn=9730%

PCIn=18260%

Medical Rxn=12140%

CABGn=20.6%

4

Goals of CTO PCI

Success + complications

Goals of CTO PCI

5

2000-2011

77% success3.0% MACE

Frequency of CTO complications65 studies - 18,061 Patients

Patel V et al – JACC Intv 2013

0.20.1 <0.01

2.5

3.1

0.2

2.9

0.3 0.30.6 0.4

3.8

<0.01

6

Patel V et al – JACC Intv 2013

Dissection Reentry

Antegrade

Retrograde

CTO crossing techniques

7

Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013

Antegrade crossing


Retrograde crossing

8


Antegrade dissection/re-entry

What is “hybrid”?

an offspring resulting from cross-breeding

Υβρίδιο

9

“the approach that focuses on opening the occluded vessel, using all feasible techniques

(antegrade, retrograde, true-to-true lumen crossing or re-entry) in the most safe, effective, and

efficient way”

“Hybrid” approach to CTO

Birth of the hybrid algorithmJan 2011 – Bellingham, WA

10

Hybrid CTO crossing algorithm

Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv 2012

RCA CTO

11

Proximal LAD

Retrograde failed

12

Proximal cap??

Lateral

13

AL 0.75

Confianza Pro 12

“scratch and go”

Aka

“move the cap”

14

Proximal dissection

1.5x8 mm anchor

Knuckle started

15

Distal RCA ISR

Wire is out!

16

CrossBoss Pilot 200

Some progress..

17

Getting closer..

Going the wrong way…

18

Gaia redirection

Gaia redirection

19

Threader

1st line

2nd line


Approach to “balloon uncrossable” CTO

“Balloon Uncrossable” CTO

• Inflate 1.20-1.5 mm balloon, Threader, Glider• Rupture balloon in vessel (grenadoplasty)

• Tornus, Corsair, Finecross• Wire “cutting”

• Guide catheter extensions• Anchor balloon strategies

• Laser• Rotational atherectomy

• Subintimal: external “crush” - retrograde

• Subintimal: distal anchor

combinations3rd line

4th line

20

Sticking UP

Sticking down

21

Swap

22

Confirm 1

Confirm 2

23

IVUS post crossing

Final

24

IVUS after stenting

1. Hybrid is key!2. Scratch and go for proximal cap

ambiguity3. CrossBoss knuckle for going

around old stent4. Gaia for redirection5. Threader to get through6. “Double blind stick and swap”

to re-enter

Conclusions

25

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;5:1273-9Michael, Karmpaliotis, Brilakis, Lombardi, Kandzari et al. Am J Cardiol 2013;112:488-492

CTO PCI: before hybrid

30%

N=1,363•Peacehealth Bellingham, WA •Piedmont Atlanta, GA •Dallas VAMC/UTSW

San Diego VAMC and University of California, CA

M. Patel

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. KandzariN. Lembo

Mid America Heart Institute, MO, J.A.

Grantham

Dallas VAMC and UTSW, TX,

E.S. Brilakis

Massachusetts General Hospital, MA,

F. JafferB. 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

Henry Ford, MI, K. Alaswad

Little Rock VAMC, B. Uretsky

Baylor Dallas, TX,J. ChoiHouston VAMC,

TX, A. Denktas

Denver VAMC, CO,

E. Armstrong

Columbia University, NY,

D. Karmpaliotis

Houston Methodist, TX,

A. Shah

Carolina East MC, NC D. Jessup

23 sites sponsors: DVARC and UTSWNational coordinator: BV RanganDatabase manager: A Karasakis

TulaneN Abi-Rafeh, O

Mogabgab

UPMCC. Toma

26

1/2012 to 3/2015

11 centers, 1,036 lesionsTechnical success: 91%Major complications: 1.7%

•Appleton Cardiology, WI•Columbia University, NY•Dallas VAMC/UTSW, TX•Massachusetts General Hospital, MA•Medical Center of the Rockies, CO•Peaceheath Bellingham, WA •Piedmont Heart Institute, GA•St Luke’s Mid America Heart Institute, MO•Torrance Medical Center, CA •VA Minneapolis, MN•VA San Diego and UCSD, CA

43

26

31

AntegradeAntegrade dissection/re-entryRetrograde

68

3644

0

20

40

60

80

100

Techniques Used

%

AntegradeAntegrade DRRetrograde

Successful technique


Christopoulos, Karmpaliotis, Alaswad, Yeh, Jaffer, Wyman, Lombardi, Menon, Grantham, Kandzari, Lembo, Moses, Kirtane, Parikh, Green, Finn, Garcia, Doing, Patel, Bahadorani, Tarar, Christakopoulos, Thompson,

Banerjee, Brilakis. Int J Cardiology 2015;198:222-228

87.2

93.7

78.1

90.0

70

80

90

100

2006-2011 2012-2013

%

No prior CABGPrior CABG

Pre Hybrid era

Michael, Karmpaliotis, Brilakis, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson, Banerjee, Lombardi, Kandzari.

Heart 2013;99:1515-8

∆=9.1%P<0.001

Christopoulos, Menon, Karmpaliotis, Alaswad, Lombardi, Grantham, Michael, Patel, Rangan, Kotsia, Lembo, Kandzari,

Lee, Kalynych, Carlson, Garcia, Banerjee, Thompson, Brilakis. Am J Cardiol 2014;113:1990-4

CTO PCI: success and prior CABG

N=1,3633 US sitesPrior CABG: 37%Complications: 1.5% vs. 2.1%Retrograde: 27.1% vs. 46.7%

∆=3.7%P=0.092

Hybrid era

N=6306 US sitesPrior CABG: 37%Complications: 2.5% vs. 0.8%Retrograde: 34% vs. 39%

27

∆=4.8%p=0.18

N=642In-stent restenosis=69 (10.7%), De novo lesions=5736 US centers

Major complications: ISR 2.9% vs. De novo 1.6%

Christopoulos, Karmpaliotis, Alaswad, Lombardi, Grantham, Rangan, Kotsia, Lembo, Kandzari, Lee, Kalynych, Carlson, Garcia, Banerjee, Thompson, Brilakis.

Catheter Cardiovasc Interv. 2014;84:646-51

In-stent restenosisPROspective Global REgiStry for the Study of CTO interventions

89.9

87.0

93.291.8

70

80

90

100

Technical success Procedural success

%ISR De novo

∆=3.3%p=0.31

Success and target vessel

Target vessel

RCA (61%)

LAD (21%)

LCX (18%)

75%

80%

85%

90%

95%

100%

RCA LAD LCX

Technical success

97%

87%

p=0.013

93%

N=6366 US centersRetrograde more frequently in RCA intervention:Initial strategy (26%), final successful strategy (33%)


Christopoulos, Karmpaliotis, Wyman, Alaswad, McCabe, Lombardi, Grantham, Marso, Kotsia, Rangan, Garcia, Lembo, Kandzari, Lee, Kalynych, Carlson, Thompson, Banerjee, Brilakis.

Can J Cardiol 2014;30:1588-94

28

Radial vs femoral access

N=6506 US centersTransradial (17%): mainly Appleton WITechnical success: 92.6% femoral vs. 93% radial, p=0.87


Alaswad, Menon, Christopoulos, Lombardi, Karmpaliotis, Grantham, Marso, Wyman, Pokala, Patel, Kotsia, Rangan, Lembo, Kandzari, Lee, Kalynych, Carlson, Garcia, Thompson, Banerjee, Brilakis. Cath Cardiovasc Intv 2015;85:1123-29

Patients, Procedures, and Patient Reported Health Status

A First Report from the OPEN CTO Trial Investigators

J. Aaron Grantham, MD, FACC

Saint Luke’s Mid America Heart Institute, Kansas City,MO USA

29

OPEN CTO Design

Design

• DESIGN: Prospective, non-randomized, single-arm, multi-center clinical evaluation of the Hybrid CTO-PCI

• 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

1000 consecutive patients enrolled between Feb 2014 and July 2015 at 12

clinical sites in the US

Comprehensive baseline clincal, angiographic, and HS assessment

Clinical follow-up at 1,6, 12 months

Success Failure

Angina

Complicated

Efficient

Dyspnea

Uncomplicated

inefficient

Baseline Patient and Lesion Characteristics

Patient Characteristic

Age (yrs) 65.4 ± 10.3

Male sex (%) 80.2%

BMI (Kg/m2 BSA) 30.8 ± 9.1

Heart Rate (bpm) 68.5 ± 12.8

Smoking (ever) 64.5%

Diabetes(%) 41.4%

Hypertension(%) 86.9%

Prior MI(%) 48.4%

Prior CABG(%) 36.9%

Prior PCI(%) 66.0%

Prior CHF(%) 22.6%

PAD(%) 17.4%

CKD>stage 1(%) 13.3%

EF (%) 51.1 ± 13.7

Angiographic Characteristic

CTO only (%) 86.2

Complete Revasc (%) 82.3

Target Vessel RCA (%) 60.5

LAD (%) 19.6

LCX (%) 13.3

Occlusion Length (mm) 29.9 ± 24.3

Length>20 mm (%) 54.8

Total lesion length (mm) 63.4 ± 28.6

JCTO score <3 (%) 81.2

JCTO score ≥3 (%) 19.7

30

OPEN CTO Results

119 ± 72 min

89%

265 ± 194 ml

2.5 ± 1.9 Gy

Complications

In Hospital Frequency

Death 0.9%

MI 2.4%

Emergent surgery 0.6%

Perforation 6.0%

Clinical perforation 4.9% (82%)

Bleeding Access 4.0%

Radiation injury 0.1%

30 Day Frequency

Death 1.3%

Rehospitalization 14.7%

Unplanned 12.1%

Revascularization 2.6%

Planned 2.6%

PCI 2.3%

CABG 0.3%

Skin change 3.1%

31

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

CTO PCI in NCDRProcedural success and MACE

594,510 procedures22,365 CTO PCI2009-2013

Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham.J Am Coll Cardiol Intv 2015;8:245–53

0.4

0.8

0.10.3

2.7

0.30.4

0.1 0.1

1.9

0

1

2

3

Death Urgent CABG Stroke Tamponade MI

%

CTO Non-CTO

p < 0.001

p < 0.001

MACE

p < 0.001

p < 0.001

P = 0.05


32

244.0

30.0

187.0

15.0

0

50

100

150

200

250

Contrast Fluoroscopy time

CTO Non-CTO

p < 0.001

p < 0.001

Procedural efficiency


Goals of CTO PCI

What is missing 1Consistently achieve good results

among various centers and operators

33

How to get there?

Motivation – the right people

Education

Standardization of techniques

New devices

Richard St. John. www.ted.com

8 secrets to success

34

The only way to do great work is to love what you do. If you haven’t found it yet, keep looking. Don’t

settle. As will all matters of the heart, you’ll know it when

you find it.Steve Jobs

1.

10,000 hour rule

2.

35

www.ctofundamentals.org

Studying2.

2.

36

Interventional Journals 2.

2.

37

Proctoring2.

Is Google Glass the answer to CTO proctoring shortage?

38

CTO basics

1.Approach: femoral – consider 45 cm sheath

2.Guide: 7 or 8 French – supportshort/shortened 90 cm

3.Virtually always: dual injections

4.Anticoagulation: heparin5.Monitor radiation: AK6.Ready to manage complications:

perforation - tamponade

2.

CTO cart

Short wires

Long wires

FinecrossCorsair

CoilsDelivery microcatheters

2.

39

Keep organized2.


Patient radiation dose

40


↓ fps – better X-rayRepositioning

Using radiation only when necessary

Shielding

Structural

CTO

Peripheral

Congenital

3.

41

1. By whom? Entire cath team

2. How long? 15-30 min

3. How?

Studying the CTO

1. Proximal cap ambiguity

2. Lesion length

3. Quality of distal vessel

4. Collaterals

3.

Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv 2012

Hybrid CTO algorithm4.

42

2004-2007The “early” years

2007-2010“Growth” years

2010- “Mature” years….

CTO PCI in Dallas VAMC5.

Michael, Karmpaliotis, Brilakis, Alomar, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson, Banerjee, Luna, Lombardi, Kandzari. Catheter Cardiovasc Interv 2015;85:393-9

CTO PCI: the learning curve

•Peacehealth Bellingham, WA •Piedmont Atlanta, GA •Dallas VAMC/UTSW

6.

43

only 8 operators performed 50 or more CTO PCI per year.


7.

44

8.

Patient testimonial after right coronary artery chronic total occlusion intervention

45

Can we simplify CTO PCI?

Morino, Y. et al. JACC Intv 2011;4:213-221

J-CTO Score

494 native CTO lesionsCrossing within 30 minutes

46

Progress CTO score

Christopoulos, Kandzari, Yeh, Jaffer, Karmpaliotis, Wyman,

Alaswad, Lombardi, Grantham, Moses, Christakopoulos, Tarar, Rangan, Lembo, Garcia, Cipher, Thompson, Banerjee, Brilakis.

JACC Intv 2015; in press

J-CTO score and CTO PCI approach

PROspective Global REgiStry for the Study of CTOinterventions

J-CTO score validation

Procedural time and J-CTO score

1/2012 to 7/20146 centers, n=650 lesions

Christopoulos, Wyman, Alaswad, Karmpaliotis, Lombardi, Grantham, Yeh, Jaffer, Cipher, Rangan, Christakopoulos, Kypreos, Lembo, Kandzari, Garcia, Thompson, Banerjee, Brilakis.

Circ Cardiovasc Interv. 2015;8:e002171

47

CTO technique: opinions differ!Especially about dissection/re-entry

Nagoya Heart Center

Asian-Pacific CTO Club Algorithm

48

The usual fate of new CTO devices…

The graveyard of CTO devices…

Safe Cross

49

101

Total Length 1900mm

SLIP-COAT® Coating Length 400mm

Coil Length 150mm 0.36mm (0.014inch) PTFE coat

Various models for different situations and/or lesions

Diameter ：0.26mm (0.010”) - 0.36mm (0.014”)Tip load ：1.7gfDiameter ：0.28mm (0.011”) - 0.36mm (0.014”)Tip load ：3.5gfDiameter ：0.30mm (0.012”) - 0.36mm (0.014”)Tip load ：4.5gf

ASAHI Gaia First

ASAHI Gaia Second

ASAHI Gaia Third

Successful DevicesGaia guidewires

50

LIMA

Gaia only wire to reach…

NOTPilot 200

CP 12Fielder XT

51

After multiple balloons

and Ostial-Flash

Contrast: 320 mLFluroscopy time: 73.2 minAK: 3.9 Gray

Ratchet Handle for FAST-Spin Technique

Atraumatic 1 mm Distal Tip

CrossBoss

Successful Devices

52

R

Wire escalation(n=123)

CrossBoss(n=123)

• Crossing time (1⁰ efficacy endpoint)

• MACE (1⁰ efficacy endpoint)

• Success• Total procedure time• Fluoroscopy time• AK radiation dose• Contrast volume• Equipment use

246 pts

Hospital DC

referred for antegrade CTO

PCI

12 sites: US, Canada, UKsponsors: Boston ScientificPI: ES Brilakis

Stingray® Coronary CTO Re-Entry SystemTarget and re-enter the true lumen from a subintimal position in

coronary arteries

180°opposed and offset exit

ports for selective guidewire re-entry

Self-orienting, flat balloon hugs the vessel, positioning one exit port toward the true lumen

Stingray Guidewire’s angled tip and distal probe are designed for facilitated re-entry into the true lumen

2 radiopaque marker bands

53

Prodigy catheter

CenterCross™ Self‐expanding anchor Coaxial alignment Central 3F lumenFDA Cleared – (Peripheral & Coronary)

MultiCross™ Self‐expanding anchor Coaxial alignment Three independent lumensFDA Cleared – (Peripheral & Coronary)

54

NovaCross microcatheter

• Guidewire positioning and support microcatheter for improving CTO crossability

• Outward curving of helical scaffold at distal end provides support and control of guidewire’s distal tip

• Extends distally up to 5cm to assist in inter-occlusion guidewire penetration

Goals of CTO PCI

What is missing 2

Useful new equipment to facilitate procedures and increase success

rates

55

Goals of CTO PCI

Why open a CTO?

Patient Physician

1.↓ angina1.↑ LV function2.↓consequences of

future ACS3.↓arrhythmias4.↓CABG5.↓nitrate use…

1. Help pts2. Improve PCI

skills3. ↑ PCI volume

56

Early Health Status Changes in CTO-PCI

0

10

20

30

40

50

60

70

80

90

100

SAQ AF SAQ PL SAQ QoL

Baseline

1 Month

Patient Reported Angina

Early Health Status Changes in CTO-PCI

0

1

2

3

4

5

6

7

RDS PHQ

Baseline

1 Month

Patient Reported Dyspnea and Depression

57

Success + complications

Success vs failure

EF/STEMI Stents

CTO meta-analyses

58

Odds Ratios of most commonly reported clinical outcomes based on subgroup.

Outcome StentsNon‐Stents

DESNon‐DES

CTO duration

≥ 3 months n/N (%)

CTO duration

≤ 3 months n/N (%)

Studies published before 2008

Studies published after 2008

All‐cause Mortality

0.44* 0.50* 0.51* 0.52* 0.47* 0.60* 0.50* 0.54*

MACE 0.45* 0.60* 0.38* 0.60* 0.57* 0.49* 0.60* 0.42*

MI 0.35* 0.95 0.39* 0.94 0.52 0.92 0.89 0.58*

CABG 0.15* 0.23* 0.12* 0.18* 0.16* 0.20* 0.22* 0.14*

25 studies25,486 pts

Christakopoulos G, Christopoulos G, Carlino M, Jeroudi O, Roesle M, Rangan BV, Abdullah S, Grodin J, Kumbhani D, Vo M, Luna M, Alaswad K, Karmpaliotis D, Rinfret S, Garcia S, Banerjee S, Brilakis ES. Am J Cardiol 2015

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

Impact of CTO on outcomes post STEMI

59

Complete vs. incomplete revascularization

Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. 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.

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.

60

Proc (Bayl Univ Med Cent) 2015;28(2):196–199

Made a difference for this one!

61

Interventional cardiologist

Fixed vs Growth mindset

Martinez-Rumayor et al. JACC Cardiovasc Interv

2012;5:e31-32

How CTO equipment can help in non-CTO

cases!

62

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=1,847Cost (Dollars)

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

63

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=1,847Cost (Dollars)

P<0.001

P<0.001P=0.58

$10,870

$7,436

$6,230

$3,060

$5,173

$5,730

Karmpaliotis D. CCI 2013

What has CTO PCI been proven to achieve in RCTs?

64

The impact of PCI for concurrent CTO on left ventricular function in STEMI patients

José PS Henriques, MDAcademic Medical Center of the University of Amsterdam,

Amsterdam, The Netherlands

A randomised multicenter trial

The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) trial

R.J. van der Schaaf, Co-PI

Explore Trial Design

Patients withSTEMI + CTO

LVEF and LVEDV MRI at 4 month

• DesignGlobal, multi-center, randomized, prospective two-arm trial with either PCI of the CTO or no CTO intervention after STEMI. Blinded evaluation of endpoints.

• Patients

Patients with STEMI treated with pPCI and with a non-infarct related CTO.

• Objective

CTO-PCI < 7d No CTO-PCI

1:1

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

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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) 0·597

Primary Endpoint #1 (LVEF @ 4m)

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) 0·703

Primary Endpoint #2 (LVEDV @ 4m)

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LVEF – Subgroup analyses

CTO-PCI treatment armCTO-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 (+2)

Multiple CTO arteries treated 6 (4%)

Technique CTO procedure Antegrade only 124 (84%)

Retrograde 23 (16%)

Crossboss/ Stingray 5 (3%)

PCI successful, self-reported 117 (80%)

PCI successful, corelab adjudicated 106 (72%)

Everolimus eluting stent 95 (90%)

Number of stents used (median, IQR) 2 (1-3)

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Goals of CTO PCI

What is missing 3Definitive proof of the benefits (or

lack thereoff) of CTO PCIi.e. RCT

DECISION-CTODrug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total

Occlusion

1,284 patients enrolled at 26 centers in Korea and 11 centers in Asia-pacific region

•Primary outcome: All cause death, MI, stroke, and any revascularization for 3 years after randomization

•Secondary Outcomes: • All Death (Cardiac death) at 3 & 5 years • Angina class; Quality of life at 3 & 5 years• MI, stroke, any revascularization, CTO-vessel

related revascularization, hospitalization due to ACS, LV function (at 3 years & 5 years)

PI: Seung-Jung Park, MD,PhD

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PI: Gerald Werner, MD

SuperiorityNon-inferiority

2011 PCI guidelines

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Han H et al. J Am Coll Cardiol 2015;65:2726–34

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Not all (patients with) CTOs are the same…

Improve symptoms Improve symptoms& reduce mortality

Single vessel CTO – Prior CABGCTO and Multivessel

disease

Why RCT for CTO PCI is needed

RCT

1. We now can do it

2. We need to know what CTO PCI can and cannot do

3. To improve CTO PCI

4. Payors will be asking for it

QualityQuantityof life

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1. CTOs are common2. CTO PCI can be achieved with

high success and low complication rates at experienced centers – what about the rest?

3. CTO revascularization can most likely provide significant clinical benefits – when are we going to prove it beyond any doubt?

Conclusions

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CTO PCI is a Journey

When you start on the way to Ithaca, wish that the way be long, full of adventure, full of knowledge…

Constantine P. Cavafy

cardiology grand rounds · cardiology grand rounds title: chronic total occlusion interventions:...

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