The Hybrid Approach for CTO PCI

William L. Lombardi MD FACC FSCAIUniversity of Washington

Director Complex Coronary Artery Disease

Disclosure Statement of Financial InterestWithin 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 Company

Grant/ Research Support:

Consulting Fees/Honoraria: Boston Scientific, Abbot Vascular, Abiomed

Major Stock Shareholder/Equity Interest: Bridgepoint Medical Systems, Roxwood medical

Royalty Income:

Ownership/Founder:

Salary:

Intellectual Property Rights:

Other Financial Benefit: Spectranetics: spouse employee

Treatment According to

Appropriateness

CTO treatment in the ACUITY trial

• Interventional risk treatment paradox

• Untreated lesions

Values are n (%). *Presence of at least 1 segment in the nonrevascularized vessel described as small vessel/diffuse disease. rSS= residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score.

Baseline SYNTAX score 7.5 ± 5.6 9.3 ± 6.1 12.6 ± 6.9 21.7 ± 8.6 <.001

Residual SYNTAX score 0 1.5 ± 0.5 5.2 ± 1.6 15.8 ± 6.5 <.001

Delta† SYNTAX score 7.3 ± 5.4 7.5 ± 6.1 6.9 ± 6.3 5.7 ± 6.4 .15

Values are median (IQR), % (n/N), or mean ±SD (N). *Renal insufficiency is defined as a calculated creatinine clearance rate <60 ml/min determined by the Cockcroft-Gault equation. †Delta SYNTAX score

rSS >2–8 (n = 578)

rSS >8 (n = 501)

p Value

All Groups

rSS >0–2

(n = 523)

rSS >2–8

(n = 578)

rSS >8

(n = 501)p Value

All Groups

Severe calcification 0 (0%) 10 (1.7%) 59 (11.8%) <0.001

Chronic total occlusion 1 (0.2%) 58 (10.0%) 216 (43.1%) <0.001

Bifurcation/trifurcation 0 (0%) 179 (30.9%) 287 (57.3%) <0.001

Aorto-ostial lesion 1 (0.2%) 4 (0.7%) 14 (0.3%) <0.001

Lesion length >20 mm 3 (0.6%) 143 (24.7%) 351 (70.1%) <0.001

Small vessel/diffuse disease* 409 (78.2%) 303 (52.4%) 264 (52.7%) <0.001

Généreux et al J Am Coll Cardiol 2012;59:2165–74

De

ath

(%

)

0

5

10

Time in Days

0 30 60 90 120 150 180 210 240 270 300 330 360 390

1084 1047 1044 1038 756

523 494 490 488 355578 558 555 549 408

501 473 469 460 330

Number at Risk:

rSS = 0

1st rSS Tertile2nd rSS Tertile

3rd rSS Tertile

Log Rank P = 0.001

1.4%

2.8%

2.1%

4.8%

Residual Syntax Score = 01st rSS Tertile (>0-2)

2nd rSS Tertile (>2-8)

3rd rSS Tertile (>8)

Généreux et al. J Am Coll Cardiol.

2012 Jun 12;59(24):2165-74.

Meta-analysis of CR vs. IR

Garcia S et al. J Am Coll Cardiol

2013;62:1421–31

35 studies (only 1 RCT) of 89,883 pts. ICR more common after PCI than

CABG (56% vs. 25%; p<0.001). Mean FU 4.6 ±±±± 4 years.

CR:ICR - RR [95%CI] P value I2

Mortality, all studies 0.71 [0.65, 0.77] <0.001 71%

- PCI studies 0.72 [0.64, 0.81] <0.001 62%

- CABG studies 0.70 [0.61, 0.80] <0.001 80%

MI, all studies 0.78 [0.68, 0.90] 0.001 19%

- PCI studies 0.80 [0.71, 0.91] 0.001 0%

- CABG studies 0.69 [0.44, 1.10] 0.12 62%

Revasc, all studies 0.74 [0.65, 0.83] <0.001 65%

- PCI studies 0.72 [0.63, 0.81] <0.001 70%

- CABG studies 0.92 [0.67, 1.28] 0.64 22%

All-cause Mortality or Cardiovascular

Hospitalization:STITCH

CTO-PCI Indications Evidence for underutilization of PCI

• 14,439 patients underwent coronary angiography

• 2,630 CTOs (18.2%)

• Excluded prior CABG

– 54% had a CTO

• Excluded STEMI

– 10% had a CTO

• Attempt rate 10%

• Success rate 70%

• 87% reported >CCS class I angina.

Fefer et al J Am Coll Cardiol 2012;59:991–7

CTO-PCI Indications Current CTO prevalence and treatment

Fefer et al J Am Coll Cardiol 2012;59:991–7

CTO PCI attempt rate variability in Canada

Current CTO Treatment

Christofferson et al, AJC, 2005, 1088-91 and Grantham et JACC:CI, 2009

%

Canadian attempt rate 10%, success rate 70%

NCDR attempt rate 13.7%, success rate 72%

0

5

10

15

20

25

30

35

40

45

50

CTO NonCTO

PCI

CABG

Med Rx

Trial n % CTO

ARRIVE 1 2,586 1.8

ARRIVE 2 4,933 2.0

e-Cypher 14,316 2.9

Xience V 5054 2.6

CTO in Real World Trials are Lower

than Expected

Prognosis of successful CTO-PCI:

Angina free survivalLong-term survival free from Angina in success vs. failure

Joyal D, Afilalo J, Rinfret S. Am Heart J, 2010

Prognosis of successful CTO-PCI:

Angina free survival

Effect of Procedural Success

- 40 -20 0 20 40

SAQ Quality of Life

SAQ Physical Limitation

SAQ Angina Frequency

Symptomatic

SAQ Quality of Life

SAQ Physical Limitation

SAQ Angina Frequency

Asymptomatic

27.3 (16.5, 38.0)

15.9 (5.1, 26.7)

10.3 (-0.8, 21.3)

8.5 (-3.7, 20.7)

6.3 (-5.0, 17.6)

4.3 (-5.4, 13.9)

Grantham JA. et al, Circulation: QCOR; April, 2010.

125 pts completed the Seattle Angina Questionnaire (SAQ) before and one

month after PCI. 69 procedural success (55%), 56 failures (45%)

Prognosis of successful CTO-PCI:

SurvivalLong-term survival in success vs. failure

Joyal D, Afilalo J, Rinfret S. Am Heart J, 2010

Prognosis of successful CTO-PCI:Is there biological plausibility? Arrythmia

• 718 pts with AICD for primary prevention

• 162 pts with incomplete revascularization of major coronary artery

• 44% due to CTO 56% No CTO

• Appropriate ICD therapy (12% vs 7% 1 yr. 33% vs 15% at 3 yr)

• Mortality HR 5.6, 15% vs 4% (p<.01)

Nombila Circ Arrythmia and Electrophysiology, 2012

Prognosis of successful CTO-PCI:

Is there biological plausibility? Ischemic burden

% Ischemic Burden

0% 1- 5% 5-10% 11-20% >20%

Card

iac D

eath

Rate

7110 718 545 252

Hachamovitch et al Circulation. 2003; 107:2900-2907

1331

4.8%

6.7%

0.7%1.0%

2.9%

0%

2%

4%

6%

8%

10% Medical Rx

Prognosis of successful CTO-PCI:

Is there biological plausibility?

Ischemic burdenD

ea

th o

r M

I R

ate

(%

)

Shaw et al, Circulation 2008;117

p=0.063

p=0.023

p=0.002

>10%

(n=62)

5%-9.9%

(n=88)

1%-4.9%

(n=141)

0%

(n=23)

0.0%

15.6%

22.3%

39.3%

0%

10%

20%

30%

40%

Prognosis of successful CTO-PCI:

Is there biological plausibility? Double jeopardy STEMI

Independent predictors of a fall in EF at follow up

Age>60

CTO

MVD without CTO

1.9 (1.0-3.4) p=.03

1.3 (0.6-2.6) p=.64

3.5 (1.6-7.8) p<.01

Classen et al JACC:Cardiovasc Int, 2010

Prognosis of successful CTO-PCI: Conclusions

• Successful CTO-PCI is associated with symptom relief

and survival

• The preponderance of evidence in favor of CTO-PCI

in asymptomatic patients with ischemic burden >10%

for the benefit of survival

– Patients should understand that we do not know this

beyond a shadow of doubt through fully informed consent

in the office

– In 5-10 years we will have ISCHEMIA and DISCOVER CTO

trial results

What is limiting the adoption of CTO PCI

� Procedure Time

� Complexity of the Procedure

� Complexity of teaching procedure and inconsistency in

approaches

� Success Rates across wider array of operators

� Cost of the procedures

� Clinical justification

� What would you attempt if you knew you could not

fail

The Continuum of CTO PCI: Hybrid

Dissection

Reentry

Antegrade

Retrograde

Adoption of only 1 or 2 of these limbs will limit the patients

that can be treated on the basis of coronary anatomy

Hybrid CTO PCI

basic principles

� Procedural efficiency, contrast, radiation with greater priority

• Maintain safety, improve efficacy

� Always make progress…don’t let case stall

� Preplanned multistep procedural strategy

� Setup for seamless transition between antegrade wire escalation,

dissection reentry, and retrograde

� Quick transition to alternate plans when failure mode occurs

• Opportunity for contingency plan success

• Can return to more focused attempt to earlier strategies if needed

The “base of operations”

� Antegrade Goal

• Move gear safely and

quickly to distal cap to

focus on true lumen entry

or…

• Move gear beyond distal

cap to focus on reentry

� Retrograde Goal

• Move gear safely and

quickly to proximal cap for

true lumen entry or reverse

CART (dissection

connection)

Equipement� 4 Wire Platform

1. Fielder XT

� Antegrade microchannel/soft plaque

probing

� Knuckle wire technique

� Sion or Fielder FC

� Retrograde collateral wire

1. Pilot 200

� Lesion crossing

� Knuckle wire

� Facilitation of wiring in complex dissection and re-entry

2. Confienza Pro 12

� Lesion crossing

� Penetration of cap

� Externalization Wire R350 , Viperwire

� Antegrade Crossing and reentry

devices

• Crossboss

• Stingray balloon

• Stingray guidewire

� Microcatheters

• Corsair/Turpike

• Finecross/Micro 014

• Tornus/Turnpike gold

• Other equipment

• Guideliner/Guidezilla

• 18/30 Triple Loop Snare

Anatomy Dictates Strategy

�Anatomic Ambiguity

• Proximal cap

• Distal vessel poorly visualized or at a

bifurcation

�Occlusion Length greater or less than 20mm

�Collateral channel morphology

�Operator skillset

Wire Escalation

Fielder XT

Clear Path and Target

CONFIANZA PRO

12g

Unclear Path and Target,

+Tortuosity

PILOT 200

Antegrade

Dissection ReEntry

Dissection Method

CROSSBOSS

Reentry Method

STINGRAY

AN

TE

GR

AD

E

Retrograde

Dissection ReEntry

Dissection Method

KNUCKLE

WIRE

ReEntryMethod

REVERSE

CART

Wire Escalation

Fielder XT

Clear Path and Target

CONFIANZA PRO

12g

Unclear Path and Target,

+Tortuosity

PILOT 200

RE

TR

OG

RA

DE

Refractory

Guidewire Escalation: a simplified approach either

antegrade or retrograde

Confianza

Pro 12

Pilot 200

Fielder XT

noyes

Course of occluded

vessel known?

The Hybrid Algorithm for CTO PCI

provisional approaches

Dual Catheter Angiography

1. Clear proximal cap

2. Good Distal Target

3. Length < 20mm

Antegrade Retrograde

yes no

Wire

escalation

Dissection Reentry

(crossboss-stingray)

Wire

escalation

Dissection Reentry

(reverse CART)

yes yes nono

Dissection Reentry

(reverse CART)

Dissection Reentry

(crossboss-stingray))

fail

fail

fail

fail

J-CTO Score

Lesion Length >20 mm CA++

>45 bend

Blunt stump

Retry

• Developed from the J-CTO registry

• Derivation and Validation

• Predictor of wiring time < 30 minutes

• Procedural success

Morino et al. JACC CI 2011;4:213-21

CTO Angiographic Characteristics

Hybrid

Registry

(N=144 pts,

145 lesions)

J-CTO Registry

(N=498 pts,

528 lesions)

Royal

Brompton

Registry

(N=195 pts,

269 lesions)

p

Occlusion

Length

29.9 + 24.4 13.5 + 13.0 22 (IQR 15-32) *<0.001

Length > 20mm 59% 21% 63.1% *<0.001Ŧ0.44

Calcified 66% 58% 50.8% *0.036Ŧ 0.72

Tortuosity 30% 45% 22.1% * 0.002Ŧ0.06

Blunt Stump 61% 38% 47.2% *<0.001Ŧ 0.009

Prior Failure 15% 10% 37.9 *0.082Ŧ 0.10

Prior CABG 33% 10% 29.2% *<0.001Ŧ 0.60

*Hybrid Registry vs. J-CTO Registry, Ŧ Hybrid Registry vs Royal Brompton Registry

Morino et al. JACC CI 2011;4:213-21

Syrseloudis et al. Heart 2013; 10.1136/heartjnl-2012-303205

Retrograde Dissection/re-entry

� 64 year old previous CABG with LIMA-OMB, RIMA to

LAD and occluded SVG to RCA with inferior wall

ischemia and angina despite medical therapy

Retrograde dissection re-entry with

guideliner

Facilitated Antegrade dissection and re-entry

BridgePoint Medical

Wire Subintimal the new approach

Putting it all together

• Stick

• Knuckle

• Manage re-rentry zone

• Stick

• Swap

• stent

How to learn• www.ctofundamentals.org

• Get a proctor

• Manage expectations while developing skills sets

• Skillsets

• Retrograde collateral wiring

• If great collateral do it retrograde

• Antegrade Dissection/re-entry

• If no proximal cap ambiquity and good landing zone do re-

entry even if occlusion length less than 20mm

• Once you have skillsets then use hybrid to improve efficiency.

Conclusions

� Myocytes don’t know why they are ischemic

� Only the operator knows what the vessels look like

� Treat the patient and the physiology not the pictures

� There is no impossible case only those we need to get better to help

patients.

� www.ctofundamentals.org

� lombaw@uw.edu

How to learn• www.ctofundamentals.org

• Get a proctor

• Manage expectations while developing skills sets

• Skillsets

• Retrograde collateral wiring

• If great collateral do it retrograde

• Antegrade Dissection/re-entry

• If no proximal cap ambiquity and good landing zone do re-

entry even if occlusion length less than 20mm

• Once you have skillsets then use hybrid to improve efficiency.