Case and Techniques Reviews: PCI for

Chronic Total Occlusions-Why and How

Dimitri Karmpaliotis, MD,PhD FACC
Associate Professor of Medicine
Columbia University Medical Center
Director of CTO, Complex and High Risk Angioplasty
NYPH/Columbia

Email: dk2787@columbia.edu

CRF Fellows Course

Orlando, Fl, April 12-15, 2019

 Disclosures

• As a faculty member for this program,

I disclose the following relationships
with industry:

• Honoraria from Abbott Vascular,

Abiomed and Boston Scientific
 594,510 procedures
22,365

3.8

96.2
572,145

CTO Non-CTO

234 of 1,387 sites (17%) never performed CTO PCI

Operators % CTO PCI IQR: 0.3% to 4.9%
Brilakis et al, JACC Cardiovasc Intv 2014 – in press
 only 8 operators performed 50 or more
CTO PCI per year.

Brilakis et al, JACC Cardiovasc Intv 2014

 Who Is Performing my CTO PCI?
ACC/NCDR Database: 45,826 CTO Patients

25 22.3 All Comparisons

significant
17.6
20
89% of CTO PCI
Attempt Rate (%)

15 11.7
10 is done by Low
5

0
Volume
Low Volume Operators!!!
Intermediate
Volume
High Volume

<150/yr 150-299/yr >300/yr

N=4112 N=344 N=188

Grantham et al, I2 Summit 2007

 PROspective Global
REgiStry for the Study of
CTO interventions
NCT02061436
 PROspective Global REgiStry for the
Study of CTO interventions
PeaceHealth St. Appleton Minneapolis VA
Joseph Medical Cardiology, WI Medical Center, MN Massachusetts
Center, WA K. Alaswad S. Garcia General Hospital, MA
W. Lombardi F. Jaffer
B. Yeh

Medical Center of Columbia University,

Torrance Medical
the Rockies, CO NY
Center, CA
A. Doing D. Karmpaliotis
M.R. Wyman Mid America Heart
J. Moses
Institute, MO
J.A. Grantham

San Diego VAMC and

University of California, CA
M. Patel Piedmont Heart
VANTHCS, TX Institute, GA
E. Brilakis D. Kandzari
Banner Samaritan N. Lembo
Medical Center, AZ Houston
A. Pershad Providence Health Methodist, TX
Center, TX A. Shah
14 sites C. Shoultz

sponsors: DVARC and UTSW

National coordinator: B. Rangan
Database manager: G. Christopoulos
Hybrid Strategy Treatment Algorithm

Brilakis et al.
 CTO PCI: the learning curve

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

Michael, Karmpaliotis, Brilakis, Alomar, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson,
Banerjee, Luna, Lombardi, Kandzari. Catheter Cardiovasc Interv 2015;85:393-9
 PROspective Global REgiStry for the Study of CTO interventions

•Appleton Cardiology, WI 1/2012 to 2/2014

•Dallas VAMC/UTSW, TX n=632
•Peaceheath Bellingham, WA Technical success: 92.4%
•Piedmont Heart Institute, GA Major complications: 1.9%
•St Luke’s Mid America Heart
Institute, MO
•Torrance Medical Center, CA
Successful technique
100 Antegrade
Antegrade DR
80
65 Retrograde
60
%

44
37
40

20

0
Techniques Used
Christopoulos, Karmpaliotis, Alaswad, Wyman, Lombardi, Grantham, Thompson, Brilakis et al
Journal of Invasive Cardiology 2014;26:427-432
 CTO PCI: success and prior CABG

Pre “Hybrid” era “Hybrid” era

No prior CABG
Δ=9.1%
P<0.001 Prior CABG
100
Δ=3.7%
93.7 P=0.092

90 87.2 90.0
%

80 78.1

70
2006-2011 2012-2013
N=1,363 N=630
3 US sites 6 US sites
Prior CABG: 37% Prior CABG: 37%
Complications: 1.5% vs. 2.1% Complications: 2.5% vs. 0.8%
Retrograde: 27.1% vs. 46.7% Retrograde: 34% vs. 39%
Michael, Karmpaliotis, Brilakis, Lombardi, Christopoulos, Menon, Karmpaliotis, Alaswad, Lombardi,
Kandzari et al. Heart 2013;99:1515-8 Grantham, Brilakis et al. AJC 2014;113-1990-4
 Effect of Prior CABG
100%
Pre Hybrid era Hybrid era
Δ=9.1% Δ=4.6%
90% p<0.001 p=0.001 No prior
CABG
87.2% 86.5% Prior CABG
80% 81.9%
78.1%

70%
2006-2011 2012-2017
1,363 lesions; 3 US sites 2967 lesions; 20 international sites
Prior CABG: 37% Prior CABG: 32%
Complications: 1.5% vs. 2.1% Complications: 2.9% vs. 3.5%
Retrograde: 27.1% vs. 46.7% Retrograde: 31% vs. 54%
Michael, Karmpaliotis, Brilakis, Abdullah, Kirkland, Mishoe,
Lembo, Kalynych, Carlson, Banerjee, Lombardi, Kandzari. Current available data in PROGRESS-CTO Registry
Heart 2013;99:1515-8 02/05/2018
 PROGRESS CTO
complications score
11 centers, 1,569 lesions

In-hospital MACE 2.8%

MACE = MI, stroke, urgent re-PCI or CABG,

tamponade requiring pericardiocentesis, death

Danek, Karatasakis, Karmpaliotis, Alaswad, Yeh, Jaffer, Patel, Mahmud, Lombardi,

Wyman, Grantham, Doing, Kandzari, Lembo, Garcia, Toma, Moses, Kirtane, Parikh,
Ali, Karacsonyi, Rangan, Thompson, Banerjee, Brilakis. JAHA 2016 Oct 11;5(10).
 Retrograde vs. antegrade-only: outcomes

2012-2015
11 centers, 1,301 lesions Δ= 8.9% Δ=11.4%
Retrograde
Retrograde utilization: 41% p<0.001 p<0.001
Antegrade-only
100 93.7 93.3
84.8 81.9
Success rate (%)

50

0
Technical Success Procedural Success

Karmpaliotis D, Karatasakis A, Alaswad K, Jaffer FA, Yeh RW, Wyman RM, Lombardi W, Grantham JA, Kandzari DE, Lembo NJ, Doing A, Patel M, Bahadorani
J, Moses JW, Kirtane AJ, Parikh M, Ali Z, Kalra S, Nguyen-Trong PJ, Danek BA, Karacsonyi J, Rangan BV, Roesle M, Thompson CA, Banerjee S, Brilakis ES.
Circ Cardiovasc Interv 2016 Jun;9(6)
Retrograde CTO PCI May Present Unique
Risks in MVD Patients

Karmpaliotis et al. Circ Intv 2016.

 Intravascular imaging
2012-2015
7 centers, 619 lesions
Intravascular imaging: 38%

Proximal cap
ambiguity
9%
26% To guide wiring
19%
To guide
8% reverse-CART
Stent
38% optimization
Stent sizing

Karacsonyi J, Alaswad K, Jaffer FA, Yeh RW, Patel MP, Bahadorani JN, Karatasakis A, Danek BA, Doing AH, Grantham JA, Karmpaliotis D, Moses JW, Kirtane AJ, Parikh M, Ali
Z, Lombardi WL, Kandzari DE, Lembo NJ, Garcia S, Wyman RM, Alame AJ, Nguyen-Trong PJ, Resendes E, Kalsaria P, Rangan BV, Ungi I, Thompson CA, Banerjee S, Brilakis ES.
J Am Heart Assoc. 2016 Aug 20;5(8)
 Radial vs femoral access

650 lesions; 6 US centers

Transradial (17%): mainly Appleton WI
Technical 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
 CTO IVUS Study
In-hospital Findings
 Tracking Pattern Percentages

Guidewire Tracking Pattern Compared with Angiography Defined Successful

Approach and Difficulty Grades
(A) Guidewire tracking pattern and successful approach by angiography. (B) Guidewire
tracking pattern and difficulty grades.
 Clinical outcomes – In hospital

Intraplaque Tracking Subintimal Tracking

p Value
(n = 105) (n = 114)

Composite cardiovascular endpoint* 2 (1.9%) 9 (7.9%) 0.04

All-cause death 0 0 —
SCAI PMI 2 (1.9%) 8 (7.0%) 0.10
Universal definition PMI 3 (2.9%) 10 (8.8%) 0.06

Target lesion revascularization 0 1 (0.9%) 1.00

Secondary cardiovascular endpoint† 22 (21.0%) 64 (56.1%) <0.01

Any dye staining/extravasation 4 (3.8%) 16 (14.0%) 0.01

Clinically significant perforation‡ 1 (1.0%) 7 (6.1%) 0.07

Collateral injury 1 (1.0%) 0 0.48
Wire perforation 0 3 (2.6%) 0.25
Balloon/stent related 0 4 (3.5%) 0.12
Tamponade 1 (1.0%) 2 (1.8%) 1.00
Stent thrombosis 0 0 —

In-hospital CABG 0 0 —

Stroke 1 (1.0%) 0 0.48

Acute renal failure 1 (1.0%) 1 (0.9%) 1.00

CTO IVUS 1 Year results
Landkmark Analysis
 Quality of life at 1 year
No difference between groups
Overall large improvement
Conclusions from the IVUS studies

• In adjusted analyses, subintimal

tracking was not associated with TVF at
1-year, despite numerically higher
upfront rates of MI and TLR.
• Subintimal tracking was a marker of
higher patient and anatomic CTO
complexity with greater use of the
retrograde approach
CoPIs James Sapontis, Bill Lombardi
Manager Karen Nugent
Statistician Kensey Gosch
Core Lab Federico Gallagos
Publications Spertus, Cohen, Marso, Yeh,
McCabe, Grantham, Karmpaliotis
 OPEN CTO Design
1000 consecutive patients enrolled between
Design Feb 2014 and July 2015 at 12 clinical sites in
the US
• DESIGN: Prospective, non-
randomized, single-arm, multi-center
clinical evaluation of the Hybrid
Comprehensive baseline clincal, angiographic,
CTO-PCI and HS assessment

• OBJECTIVE: To evaluate the

Success, safety, efficiency, Clinical follow-up at
appropriateness, health status 1,6, 12 months
outcomes, and costs of CTO-PCI

• PRINCIPAL INVESTIGATOR
• J. Aaron Grantham, MD, FACC
Saint Luke’s Mid America Heart Success Failure
Institute, Kansas City, Mo. USA
Angina Dyspnea

Efficient inefficient

Complicated Uncomplicated
 OPEN CTO Sites
PeaceHealth
St. Joseph Med. Ctr. Alexian Brothers Medical
Saint Luke’s Hospital Center
Bellingham, WA
Mid America Heart Elk Grove Village, IL
U. Washington Institute
Seattle, WA Kansas City, MO
Columbia
University
Medical Center
NY, NY
PeaceHealth
Sacred Heart York
Med. Ctr Hospital
Springfield, OR York, PA

Torrance Medical
Center
Torrance, CA

Banner Health System Boone Hospital

Phoenix and Mesa, AZ Center
Presbyterian Hospital/ Heart Columbia, MO
Group Albuquerque, NM
 Strengths of OPEN CTO

• Auditing through NCDR

• Angiographic core lab analysis
• Centralized call center follow up (92%)
• CEC adjudication
• Broad spectrum of operators using a
single methodological approach
 Baseline Patient and Lesion
Characteristics
Patient Characteristic Angiographic Characteristic
Age (yrs) 65.4 ± 10.3 CTO only (%) 86.2
Male sex (%) 80.2% Complete Revasc (%) 82.3
BMI (Kg/m2 BSA) 30.8 ± 9.1 Target Vessel RCA (%) 60.5
Heart Rate (bpm) 68.5 ± 12.8 LAD (%) 19.6
Smoking (ever) 64.5% LCX (%) 13.3
Diabetes(%) 41.4% Occlusion Length (mm) 29.9 ± 24.3
Hypertension(%) 86.9% Length>20 mm (%) 54.8
Prior MI(%) 48.4% Total lesion length (mm) 63.4 ± 28.6
Prior CABG(%) 36.9% JCTO score <3 (%) 81.2
Prior PCI(%) 66.0% JCTO score ≥3 (%) 19.7
Prior CHF(%) 22.6%
PAD(%) 17.4%
CKD>stage 1(%) 13.3%
EF (%) 51.1 ± 13.7
Indications and Appropriateness

Primary Indication Appropriateness

Symptom relief

Ischemia
Unmappable
Reduction
Staged Appropriate
procedure 81%
Low EF May be
74% Appropriate
ACS Rarely
Appropriate
Other
 OPEN CTO Results

89%

265 ± 194 ml
119 ± 72 min

2.5 ± 1.9 Gy
Early Health Status Changes in CTO-PCI

Patient Reported Angina

100
90
80
70
60
50 Baseline
40 1 Month
30
20
10
0
SAQ AF SAQ PL SAQ QoL
 Complications

In Hospital Frequency 30 Day Frequency

Death 0.9% Death 1.3%
MI 2.4% Rehospitalization 14.7%
Emergent surgery 0.6% Unplanned 12.1%
Perforation 6.0% Revascularization 2.6%
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%
 Health Status in Refractory Angina Cohort
of OPEN CTO
148 patients with RA, 132 with baseline and 1 yr HS, 108 successes and 24 failures
RA=SAQ AF<100 despite 3 AA Rx therapy

Hirai, Grantham et al, Accepted Circ: Intv

 Health Status Improved Across the
Spectrum of EF with Successful CTO
PCI

These data suggest robust health status improvements can be expected,

regardless of LVEF, after successful CTO PCI.
 Summary:
Rationales for CTO Recanalization
• Relief of angina/ischemia (typically
exertional symptoms)
• Improvement of ventricular
function
• Reduced incidence of late CABG
• Possible Improvement in event-
free survival
4 options to crossing CTOs

Antegrade
Wire Escalation
(AWE)

Antegrade Retrograde
Dissection Dissection
Re-entry Re-entry
(ADR) (RDR)

Retrograde
Wire Escalation
(RWE)
Degree of disease
in the distal
“landing zone”
 Base of Operation

- Term describing the

location in the vessel at
which the operator is
trying to employ
techniques to cross the
CTO or utilize re-entry
strategies to enter the
true lumen
 Vessel Architecture

- Term used in reference to

the location of a guidewire
in an effort to distinguish
its binary location of either
outside of the vessel (i.e.
in the pericardial space)
or anywhere within the
three layers of the target
vessel
 Knuckle Wire

- Creating a blunt
dissection tool by forward
advancing a polymer-
jacketed guidewire
(Fielder XT or Pilot 200)
until it prolapses on itself
to form a tight loop which
can be advanced past the
occlusion in the
suboptimal space
 Basic Principles

• Know the wires you are using VERY WELL

• Limit the number of wires you are using
• Use wires with vastly different properties
• When we mean change, we mean CHANGE!
• If one wire/strategy is not working, then SWITCH
• Once a Specialty wire has achieved its mission,
CHANGE to a safer wire
 Wires
• Fielder XT
• Fielder FC/Pilot 50
• Confienza Pro 12
• Pilot 200
• Sion
• Gaia
• Hornet (14) Sentai Family
• Fighter Sentai Family
• Samurai RC Sentai Family
• Sion Black
• Suoh 3
 Corsair

①0.86mm (2.6Fr) ②0.82mm (2.5Fr) ③0.86mm (2.6Fr)

Marker coil

Polyurethane resin + Tungsten powder

Tungsten braiding

Available in 135 mm (antegrade) and 150mm

(retrograde) lengths.
 Components

Unique dual-layer, bidirectional coil over braid provides the

ultimate combination of flexibility with torque response

Turnpike
Turnpike Spiral
Turnpike Gold

Polymer outer layer Braid PTFE liner for

Dual-layer, bidirectional coil
for smooth outer for longitudinal excellent
for kink-resistance with torque
surface strength guidewire movement

Turnpike LP
Integrated Tip solves the Durability Pro

Competitive microcatheter tips:

prone to fatigue, kinking, and
fractures

MAMBA tip designed to avoid Corsair tip failures

Coil Supported Not Coil Supported MAMBA’s Integrated Tip
• Coil ends less than 1mm
MAMBA from tip
• Torque transmission all
Corsair the way to tip helps
deliverability

Boston Scientific Confidential – For Internal Use Only. Do Not Copy, Display or Distribute Externally. IC-538201-AA 2018MAR
Antegrade Wire Escalation
Case
AWE with Pilot 200 (Sub-Intimal)

TurnPike® 135 cm
AWE with Gaia 2
Sub intimal tract
Re orient wire in true distal lumen
After PCI-RCA and post dilation
2nd CTO of 3RD and 4TH RPL
AWE with initial Pilot 200 and Gaia 2 (Success)
Final Result
Antegrade Dissection Re-Entry (ADR)
 Antegrade Dissection Re-Entry

• Subintimal wire position is obtained

• Space is made in subintimal space (SIS) by gentle ballooning
• Re-entry catheter is advanced into (SIS) proximal to desired re-
entry point along supportive wire (Miracle Bros 12)
• Re-entry into true lumen achieved using stiff re-entry wire via
catheter is conduit
Skills/Skillsets
Case
Kissing balloon
inflation
Case
Hybrid Strategy Treatment Algorithm: Final Thoughts

Brilakis et al.
 Hybrid Strategy Treatment Algorithm: Final Thoughts

• Always use a systematic approach

• Try the simplest/safer approach first
• Be flexible and change approach once things don’t work out as per the initial
plan
• Select patients wisely (risk/benefit ratio)
• It is beyond doubt that there has been underreporting of complications in CTO
PCI (Findings from OPEN CTO Registry)
• Shift focus from high acute success rates to safety and durability of the
procedure
• There is accumulating evidence to suggest that the use of the sub-intimal
stenting is safe, and provides durable results, but more studies are clearly
needed
• Intravascular imaging is imperative in CTO PCI as in all CHIP cases
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Thank You