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Proximal Ambiguity, Impenetrable Cap:
Multi-Center US Experience
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
EUROCTO 2018
Toulouse, France, September 14-15, 2018
Disclosures
• As a faculty member for this program,
I disclose the following relationships
with industry:
• Speakers Bureau for Abbott Vascular,
MDT vascular and Boston Scientific
Proximal Cap 1
CASE 1
Proximal Cap 2
The Scratch ‘n Go
PROspective Global REgiStry for the Study
of CTO interventions
www.progresscto.org
Balloon uncrossable lesions
2012-2016
11 centers, 755 lesions
Balloon uncrossable: 9%
90.5% 88.9%
1.6%
98.3% 96.6%
2.2%
Technical success Procedural success MACE
Balloon uncrossable lesions Balloon crossable lesions
Δ=7.8%
p<0.001
Δ=0.6%
p=0.751
Δ=7.7%
p=0.004
23%
5%
18%
15
11
16
8 4
Grenadoplasty Guide anchoring techniques
Laser Guide catheter extensions
Tornus Rotational atherectomy
Other Threader
Techniques used to treat balloon
uncrossable lesions
Karacsonyi J, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Bahadorani J, Doing A, Ali ZA,
Karatasakis A, Danek BA, Rangan BV, Alame AJ, Banerjee S, Brilakis ES.
Catheter Cardiovasc Interv. 2017;90:12-20
Balloon uncrossable CTO lesions: CTO lesions that could not be crossed
with balloon after true lumen guidewire crossing.
Prevalence of uncrossable lesions: 6-9%.1,2
Balloon undilatable CTO lesions: CTO lesions that could not be expanded
despite multiple 1:1 sized balloon at maximum inflation pressure up to 20
atm after true lumen guidewire crossing.
Prevalence of undilatable lesions: unknown.
Goal: to evaluate the prevalence and treatment outcomes of balloon
undilatable CTOs
Background
Karacsonyi et al. Catheter Cardiovasc Interv. 2017;90(1):12-20.
Patel et al. J Invasive Cardiol. 2015;27(2):78-84.
Design
• DESIGN: Sub-study of a prospective, observational, non-randomized,
multi-center: the PROGRESS-CTO (Prospective Global Registry for the
Study of Chronic Total Occlusion Intervention, NCT02061436)
• OBJECTIVE: To evaluate the prevalence, clinical and procedural
outcomes of PCIs for balloon undilatable CTOs in a contemporary
multicenter US registry between 2015 and 2017 in 425 CTO PCI of 415
patients
• Fields for data collection on undilatable lesions were added lately to
the PRGORESS-CTO Registry
12%
88%
Balloon undilatable lesions (n=52)
Balloon dilatable lesions (n=373)
Prevalence of balloon undilatable lesions
Clinical characteristics
Undilatable CTOs
n = 52
Dilatable CTOs
n = 373
P Value
Age (years) a 67.1±9.7 64.3±10.2 0.056
Male gender, n (%) 39 (75) 302 (85) 0.074
BMI (kg/m2) a 31.7±5.7 30.3±5.7 0.114
Smoking (current), n (%) 13 (27) 82 (24) 0.641
Diabetes, n (%) 34 (67) 146 (41) <0.001
Dyslipidemia, n (%) 51 (100) 33 (95) 0.110
Prior MI, n (%) 29 (59) 182 (52) 0.336
Prior heart failure, n (%) 22 (44) 98 (28) 0.027
Prior PCI, n (%) 35 (70) 221 (63) 0.336
Prior CABG, n (%) 23 (45) 125 (35) 0.175
Baseline creatinine (mg/dL) b 1 (1, 1) 1 (1, 1) 0.634
Left ventricular EF (%) a 45.2±13.4 50.3±13.3 0.015
a Mean ± standard deviation, b Median (interquartile range)
Undilatable CTOs
n = 52
Dilatable CTOs
n = 373
P Value
CTO length (mm) b 40 (20, 50) 30 (15, 40) 0.016
Proximal cap ambiguity, n (%) 107 (35) 0.632 0.632
Moderate/severe calcification, n (%) 41 (87) 169 (54) <0.001
Moderate/severe tortuosity, n (%) 25 (53) 125 (40) 0.089
In-stent restenosis, n (%) 12 (25) 59 (19) 0.324
J-CTO score a 3.2±1.1 2.5±1.3 <0.001
PROGRESS-CTO score a 1.6±1.1 1.4±1.1 0.287
PROGRESS-CTO Complications score a 3.9±1.7 3.1±2.0 0.005
Angiographic Characteristics
a Mean ± standard deviation, b Median (interquartile range)
92.1 88.2
7.7
98.4 95.8
1.7
0.0
20.0
40.0
60.0
80.0
100.0
Technical success (%) Procedural success (%) In-hospital MACE (%)
Undilatable CTOs Dilatable CTOs
Procedural outcomes
p = 0.008
p = 0.042p = 0.024
3.9
0.0 0.0
1.9 1.9
5.8
11.5
0.8
0.2 0.3 0.2 0.0 0.3
1.9
0.0
2.0
4.0
6.0
8.0
10.0
12.0
Death (%) Acute MI (%) Stroke (%) Re-PCI (%) Re-CABG (%) Pericardial
tamponade (%)
Perforation (%)
Undilatable CTOs Dilatable CTOs
In-hospital major complications
p = 0.120
p = 1.000 p = 1.000
p = 0.235
p = 0.008
p = 0.003
p = 0.007
Procedural characteristics
Undilatable CTOs
n = 52
Dilatable CTOs
n = 363
P
Value
Procedure time (min) a 195 (115, 262) 141 (97, 205) 0.007
Contrast volume (mL) a 284 (185, 315) 262 (200, 350) 0.642
Fluoroscopy time (min) a 67 (40, 104) 49 (30, 76) 0.007
Patient AK dose (Gray) a 3 (2, 4) 3 (2, 4) 0.083
a Median (interquartile range)
0.9 mm laser
0.9 mm - peripheral
Energy: 30-80 mJ/mm2
frequency 25 – 80
No need to change wire!
Even if laser does not cross
lesion is modified
saline
50% contrast
100% contrast
Caveat: need to change guidewire – may lose position…
Rotablator
Subintimal techniques
Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
Balloon undilatable lesions:
• Are common (12% in our study)
• Often require use of aggressive vessel preparation
techniques
• Are associated with lower technical and procedural
success and higher in-hospital MACE (due to higher
risk for perforation and tamponade)
• Novel techniques (lithoplasty, very high pressure
balloon) can be useful in facilitating dilation in such
resistant lesions
Conclusions
1. No long-term follow
2. No core laboratory assessment of study angiograms or
clinical event adjudication
3. Procedures were performed at dedicated, high volume
CTO centers by experienced operators limiting
extrapolation to lower volume centers
Limitations
DO NOT TRY ANYTHING OF WHAT
WILL BE PRESENTED
UNTIL AFTER
YOU HAVE CONFIRMED THAT
YOUR WIRE IS INTO THE DISTAL
TRUE LUMEN USING TWO
ORTHOGONAL PROJECTIONS!
DOING OTHERWISE MAY RESULT
IN SEVERE INJURY OR DEATH…
DISCLAIMER
RM
• 63 yo male with:
 HTN
 HLD
• Developed CCS III angina over 4 months
• Underwent a nuclear stress test (SPECT)
demonstrating mod-severe inferior
ischemia (LVEF 62%)
• Referred for coronary angiography @ OSH
which demonstrated the following:
Diagnostic
Diagnostic
Diagnostic
INTERVENTION
11/20/2017
Intervention
Pilot 200
Intervention
Unable to
advance wire
without
pushing out
hardware, so
anchor
balloon
(Emerge 2.0 x
12 mm) used
Intervention
Sion used to
wire epicardial
collateral
Intervention
Reverse CART
Snaring of Retrograde Wire
Intervention
Switched out
for a RG3
wire which
was
externalized
Multiple NC
balloons
used
proximally
but with non-
dilatable area
Switch Antegrade Wire
RG3
Switched
out Rota
Floppy
Rotablation with 1.5 Burr
Intervention
Still unable to dilate lesion
with NC balloons to high atms
Rotablation with 2.0 Burr
Followed by NC Quantum Apex
3.0 x 15 inflated to 30 atms
1st line
2nd line
• Inflate 1.20-1.5 mm balloon, Threader, Glider
• Rupture balloon in vessel (grenadoplasty)
• Microcatheter, Carlino
• Wire “cutting”, Wire puncture
• Guide catheter extensions
• Anchor balloon strategies
• Laser
• Rotational atherectomy
• Subintimal: external “crush” - retrograde
• Subintimal: distal anchor
combinations
3rd line
4th line
Brilakis ES. Manual of coronary CTO interventions, 2nd edition. Elsevier 2017
Approach to “balloon uncrossable” CTO
Cath Lab TTE
Thank You
Thank You

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Proximal ambiguity, impenetrable cap

  • 1. Proximal Ambiguity, Impenetrable Cap: Multi-Center US Experience 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 EUROCTO 2018 Toulouse, France, September 14-15, 2018
  • 2. Disclosures • As a faculty member for this program, I disclose the following relationships with industry: • Speakers Bureau for Abbott Vascular, MDT vascular and Boston Scientific
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  • 24. PROspective Global REgiStry for the Study of CTO interventions www.progresscto.org Balloon uncrossable lesions 2012-2016 11 centers, 755 lesions Balloon uncrossable: 9% 90.5% 88.9% 1.6% 98.3% 96.6% 2.2% Technical success Procedural success MACE Balloon uncrossable lesions Balloon crossable lesions Δ=7.8% p<0.001 Δ=0.6% p=0.751 Δ=7.7% p=0.004 23% 5% 18% 15 11 16 8 4 Grenadoplasty Guide anchoring techniques Laser Guide catheter extensions Tornus Rotational atherectomy Other Threader Techniques used to treat balloon uncrossable lesions Karacsonyi J, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Bahadorani J, Doing A, Ali ZA, Karatasakis A, Danek BA, Rangan BV, Alame AJ, Banerjee S, Brilakis ES. Catheter Cardiovasc Interv. 2017;90:12-20
  • 25. Balloon uncrossable CTO lesions: CTO lesions that could not be crossed with balloon after true lumen guidewire crossing. Prevalence of uncrossable lesions: 6-9%.1,2 Balloon undilatable CTO lesions: CTO lesions that could not be expanded despite multiple 1:1 sized balloon at maximum inflation pressure up to 20 atm after true lumen guidewire crossing. Prevalence of undilatable lesions: unknown. Goal: to evaluate the prevalence and treatment outcomes of balloon undilatable CTOs Background Karacsonyi et al. Catheter Cardiovasc Interv. 2017;90(1):12-20. Patel et al. J Invasive Cardiol. 2015;27(2):78-84.
  • 26. Design • DESIGN: Sub-study of a prospective, observational, non-randomized, multi-center: the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention, NCT02061436) • OBJECTIVE: To evaluate the prevalence, clinical and procedural outcomes of PCIs for balloon undilatable CTOs in a contemporary multicenter US registry between 2015 and 2017 in 425 CTO PCI of 415 patients • Fields for data collection on undilatable lesions were added lately to the PRGORESS-CTO Registry
  • 27. 12% 88% Balloon undilatable lesions (n=52) Balloon dilatable lesions (n=373) Prevalence of balloon undilatable lesions
  • 28. Clinical characteristics Undilatable CTOs n = 52 Dilatable CTOs n = 373 P Value Age (years) a 67.1±9.7 64.3±10.2 0.056 Male gender, n (%) 39 (75) 302 (85) 0.074 BMI (kg/m2) a 31.7±5.7 30.3±5.7 0.114 Smoking (current), n (%) 13 (27) 82 (24) 0.641 Diabetes, n (%) 34 (67) 146 (41) <0.001 Dyslipidemia, n (%) 51 (100) 33 (95) 0.110 Prior MI, n (%) 29 (59) 182 (52) 0.336 Prior heart failure, n (%) 22 (44) 98 (28) 0.027 Prior PCI, n (%) 35 (70) 221 (63) 0.336 Prior CABG, n (%) 23 (45) 125 (35) 0.175 Baseline creatinine (mg/dL) b 1 (1, 1) 1 (1, 1) 0.634 Left ventricular EF (%) a 45.2±13.4 50.3±13.3 0.015 a Mean ± standard deviation, b Median (interquartile range)
  • 29. Undilatable CTOs n = 52 Dilatable CTOs n = 373 P Value CTO length (mm) b 40 (20, 50) 30 (15, 40) 0.016 Proximal cap ambiguity, n (%) 107 (35) 0.632 0.632 Moderate/severe calcification, n (%) 41 (87) 169 (54) <0.001 Moderate/severe tortuosity, n (%) 25 (53) 125 (40) 0.089 In-stent restenosis, n (%) 12 (25) 59 (19) 0.324 J-CTO score a 3.2±1.1 2.5±1.3 <0.001 PROGRESS-CTO score a 1.6±1.1 1.4±1.1 0.287 PROGRESS-CTO Complications score a 3.9±1.7 3.1±2.0 0.005 Angiographic Characteristics a Mean ± standard deviation, b Median (interquartile range)
  • 30. 92.1 88.2 7.7 98.4 95.8 1.7 0.0 20.0 40.0 60.0 80.0 100.0 Technical success (%) Procedural success (%) In-hospital MACE (%) Undilatable CTOs Dilatable CTOs Procedural outcomes p = 0.008 p = 0.042p = 0.024
  • 31. 3.9 0.0 0.0 1.9 1.9 5.8 11.5 0.8 0.2 0.3 0.2 0.0 0.3 1.9 0.0 2.0 4.0 6.0 8.0 10.0 12.0 Death (%) Acute MI (%) Stroke (%) Re-PCI (%) Re-CABG (%) Pericardial tamponade (%) Perforation (%) Undilatable CTOs Dilatable CTOs In-hospital major complications p = 0.120 p = 1.000 p = 1.000 p = 0.235 p = 0.008 p = 0.003 p = 0.007
  • 32. Procedural characteristics Undilatable CTOs n = 52 Dilatable CTOs n = 363 P Value Procedure time (min) a 195 (115, 262) 141 (97, 205) 0.007 Contrast volume (mL) a 284 (185, 315) 262 (200, 350) 0.642 Fluoroscopy time (min) a 67 (40, 104) 49 (30, 76) 0.007 Patient AK dose (Gray) a 3 (2, 4) 3 (2, 4) 0.083 a Median (interquartile range)
  • 33. 0.9 mm laser 0.9 mm - peripheral Energy: 30-80 mJ/mm2 frequency 25 – 80 No need to change wire! Even if laser does not cross lesion is modified
  • 35. Caveat: need to change guidewire – may lose position… Rotablator
  • 36. Subintimal techniques Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
  • 37. Balloon undilatable lesions: • Are common (12% in our study) • Often require use of aggressive vessel preparation techniques • Are associated with lower technical and procedural success and higher in-hospital MACE (due to higher risk for perforation and tamponade) • Novel techniques (lithoplasty, very high pressure balloon) can be useful in facilitating dilation in such resistant lesions Conclusions
  • 38. 1. No long-term follow 2. No core laboratory assessment of study angiograms or clinical event adjudication 3. Procedures were performed at dedicated, high volume CTO centers by experienced operators limiting extrapolation to lower volume centers Limitations
  • 39. DO NOT TRY ANYTHING OF WHAT WILL BE PRESENTED UNTIL AFTER YOU HAVE CONFIRMED THAT YOUR WIRE IS INTO THE DISTAL TRUE LUMEN USING TWO ORTHOGONAL PROJECTIONS! DOING OTHERWISE MAY RESULT IN SEVERE INJURY OR DEATH… DISCLAIMER
  • 40. RM • 63 yo male with:  HTN  HLD • Developed CCS III angina over 4 months • Underwent a nuclear stress test (SPECT) demonstrating mod-severe inferior ischemia (LVEF 62%) • Referred for coronary angiography @ OSH which demonstrated the following:
  • 46. Intervention Unable to advance wire without pushing out hardware, so anchor balloon (Emerge 2.0 x 12 mm) used
  • 47. Intervention Sion used to wire epicardial collateral
  • 51. Intervention Switched out for a RG3 wire which was externalized Multiple NC balloons used proximally but with non- dilatable area
  • 54. Intervention Still unable to dilate lesion with NC balloons to high atms
  • 55. Rotablation with 2.0 Burr Followed by NC Quantum Apex 3.0 x 15 inflated to 30 atms
  • 56. 1st line 2nd line • Inflate 1.20-1.5 mm balloon, Threader, Glider • Rupture balloon in vessel (grenadoplasty) • Microcatheter, Carlino • Wire “cutting”, Wire puncture • Guide catheter extensions • Anchor balloon strategies • Laser • Rotational atherectomy • Subintimal: external “crush” - retrograde • Subintimal: distal anchor combinations 3rd line 4th line Brilakis ES. Manual of coronary CTO interventions, 2nd edition. Elsevier 2017 Approach to “balloon uncrossable” CTO