Total Occlusions PCI for Chronic Cardiovascular Research Foundation - - PDF document

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Total Occlusions PCI for Chronic Cardiovascular Research Foundation - - PDF document

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ANGIOPLASTY SUMMIT Total Occlusions PCI for Chronic Cardiovascular Research Foundation Chronic Total Occlusions 20- -40% 40% of patients with CAD of patients with CAD 20 Why should we open ? Why should we open ? ANGIOPLASTY SUMMIT

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SLIDE 1

PCI for Chronic Total Occlusions

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

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SLIDE 2

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Why should we open ? Why should we open ?

Chronic Total Occlusions

20 20-

  • 40%

40% of patients with CAD

  • f patients with CAD
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SLIDE 3

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Rationale for CTO Revascularization Rationale for CTO Revascularization

  • Relief of symtomatic ischemia and angina
  • Increase long-term survival
  • Improve left ventricular function
  • Reduced predisposition to arrhythmic events
  • Improved tolerance of contralateral

coronary occlusion

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SLIDE 4

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

12-Month Clinical Outcome of PCI in CTO TOAST-GISE

5 10 15 20 25

Success No success % Death & MI CABG angina 1.1 7.2 2.5 15.7 11.3 25 Olivari Z, et al. JACC 2003; 41:1672-1678

N=390, Success 73.3%

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SLIDE 5

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Long-term Survival

Success vs. Failure

Trial Number of Success Duration of Mortality(%) Patients(n) (n) follow-up(y) Success failure P Value British Columbia Cardiac Registry1 Suero et al.2 TOAST-GISE3 1458 1118(74.4%) 1 10.0 19.0 <0.001 2007 1491(76.7%) 10 26.6 35.0 0.001 369 286(77.5%) 6 1.1 3.6 0.13

1 Kandzari, et al. TCT 2003 2 Suero, et al. JACC 2001;38:409-414 3 Olivari Z, et al. JACC 2003; 41:1672-1678

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SLIDE 6

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Reopening of CTO

20 Years Experience

2 4 6 8 10 50 60 70 80 90 100

Years Percent surviving

CTO-Success CTO-Failure

P = 0.005

Suero, et al. JACC 2001;38:409-414

73.5% 65%

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SLIDE 7

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Van Belle E, et al. AJC 1997;80:1150-1154

Effect on LV function

*P < 0.05 LV EDVI PCWP Pre 6 Mo Post EF ESVI

89 46

49

19 82 35

57

14

PCI in CTO improves LV function (%)

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SLIDE 8

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Very dangerous
  • Low procedural success
  • High restenosis rate

Issues in CTO Intervention Issues in CTO Intervention

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SLIDE 9

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Very dangerous
  • Low procedural success
  • High restenosis rate

Issues in CTO Intervention Issues in CTO Intervention

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SLIDE 10

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Possibility of High Complication

  • Impairment of collateral flow
  • spasm, shearing off side-branches and collateral by dissection, distal embolization
  • Retrograde dissection with branch occlusion Perforation
  • intra-wall balloon expansion, side-branch dilatation, damage of neochannels connecting

vasa vasorum

  • Guidewire entrapment
  • Subacute vessel reocclusion
  • 8% of total occlusion within 24hr Vs. 1.8% of non total occluson
  • Extensive contrast use and fluoresence time
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SLIDE 11

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

In-Hospital Major Complication

Not dangerous !

CTO (n=2007) vs. Non-CTO (n=2007)

1 2 3 4 Non-CTO CTO

Death Q-MI Non-Q Urgent Urgent MACE MI CABG PCI Suero JA, et al. JACC 2001;38:409-414

%

All p=NS

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SLIDE 12

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Very dangerous
  • Low procedural success
  • High restenosis rate

Issues in CTO Intervention Issues in CTO Intervention

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SLIDE 13

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Reasons for PCI failure in CTO

  • Passage failure of guidewire
  • Long intimal dissection
  • Dye extravasation
  • Balloon did not cross or dilate
  • thrombus

63% 24% 11% 2% 1.2%

Kinoshita I, et al. JACC 1995;26:409-411

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SLIDE 14

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Predictors of Predictors of Procedural Success Procedural Success

  • Duration of occlusion
  • Length of occluded lesion
  • Presence of a non-tapered stump
  • Origin of a side branch at occlusion site
  • Vessel and lesion tortuosity and calcification
  • Absence of antegrade flow
  • Ostial occlusion
  • Bridging collateral
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SLIDE 15

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Olivari z, et al. JACC 2003;41:1672-1678

Variables Length ≥ 15 Vs. <8 mm Length not measurable Vs. <8 mm Moderate to severe calcification Duration ≥ 180 days Multivessel disease Stump morphology not discernable P value 0.028 0.019 0.023 0.013 0.009 0.048 Hazard Ratio 3.9 3.8 3.5 3.1 2.3 2.2 Multivariate analysis from TOAST-GISE

Predictors of Predictors of Procedural Success Procedural Success

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SLIDE 16

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Procedural Success Procedural Success

Favorable Unfavorable

Tapered stump Functional occlusion Pre or post occlusion Bridging collateral (-) Stump absent Total occlusion Side branch(+) Bridging collateral (+)

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SLIDE 17

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Better guiding support
  • Smart guidewire
  • New device
  • Technical advancement

How to improve procedural How to improve procedural success ? success ?

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SLIDE 18

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Hiroyuki tanaka, et al. ACC 2005

Improved Success Rate Improved Success Rate

We can improve ! We can improve !

64.6 67.9 81.0 87.7

50 60 70 80 90 100

1995-1996

  • 1998
  • 2001
  • 2004

No tapered tip Stepwise guidewire technique New guidewire: Conquest etc Double wire technique P<0.001 P=0.029 1039 lesions, 934 patients %

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SLIDE 19

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Better guiding support
  • Smart guidewire
  • New device
  • Technical advancement

How to improve procedural How to improve procedural success ? success ?

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SLIDE 20

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Guiding Catheter for RCA Guiding Catheter for RCA

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SLIDE 21

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Two Two Guiding Catheter for RCA Guiding Catheter for RCA

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SLIDE 22

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Guiding Catheter for LCA Guiding Catheter for LCA

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SLIDE 23

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Position of Support Catheter Position of Support Catheter

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SLIDE 24

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Better guiding support
  • Smart guidewire
  • New device
  • Technical advancement

How to improve procedural How to improve procedural success ? success ?

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SLIDE 25

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

New Technologies for CTO

  • Dedicated guidewires
  • Hydrophilic guidewire
  • Tapered-tip guidewire: Cross-IT, Conquest, Miracle
  • Guidewire manipulation by microchannel guidance
  • Re-entry technique
  • New devices
  • FrontRunnerTM Catheter
  • OCR SafeSteerTM System
  • Flow Cardia CrosserTM System
  • Biological approach
  • Prolonged urokinase/tPA infusion
  • Collagenase plaque digestion
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SLIDE 26

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Ability to Cross CTO

Lefevre et al, Am J Cardiol 2000;85:1144-7

1st GW success(%) Crossover(%) GW success after crossover(%) Total GW No. Procedure(min) Conventional (n=46) 35 59 37 1.7 ±0.6 84±33 Crosswire (n=42) 74 26 1.3±0.5 42±20 P 0.001 0.009 <0.001 <0.001 0.013

Hydrophilic Hydrophilic-

  • coated

coated Guidewire Guidewire

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SLIDE 27

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Ability to Cross CTO

Tapered Tapered guidewire guidewire

  • Technical success: 76%
  • Success rate in visible microchannel
  • incomplete micro-channel: 81%
  • micro-channels with distal filling: 100%

Buettner HJ, et al. JACC 2002;39:30A

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Miracle 12g
  • Conquest

to advance in the tight CTO with bending, to penetrate distal cap, to puncture from pseudo to true lumen. to puncture from pseudo to true lumen. is more controllable should be used to penetrate proximal cap,

  • nly when the appropriate direction can be seen
  • Conquest should not be used

to seek the true lumen or advance for long distance.

New CTO Wires for CTO Lesions

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SLIDE 29

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Special Device for CTO recanalization

  • Failed special device
  • Magum/Magnarail system
  • Kensey Catheter
  • ROTACS Low Speed Rotational Atherectomy

Catheter

  • Excimer Laser Wire
  • CTO device in current use
  • OCR SafeSteerTM System

(Optical Coherence Reflectometry)

  • FrontRunnerTM Catheter
  • Flow Cardia Crosser System
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SLIDE 30

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

OCR SafeSteer System OCR SafeSteer System

  • Forward looking

guidance system, using OCR to determine tissue types (plaque vs arterial wall).

  • Designed to

navigate through total occlusion.

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SLIDE 31

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

OCR SafeSteer System

OCR Waveform Displays OCR Waveform Displays

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

GREAT Registry

  • Device Success 63(54.3%)
  • Complication

MACE 8 (6.9%)

  • Non-Q MI 5 (5.2%)

Clinical perforation 3 (2.6%)

  • Device related 1 (0.9%)

116 Lesions 21 centers with CTO “failure to cross” median occlusion duration: 22montths Median lesion length: 25mm(>30mm long in 25%)

Baim DS et al. Am J Cardiol 2004;94:853-858

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SLIDE 33

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

FrontRunner Catheter

  • Blunt controlled passage through occlusion
  • Uses elastic properties of adventitia
  • vs. inelastic fibrocalcific plaque

Controlled Blunt Micro Controlled Blunt Micro-

  • Dissection

Dissection

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SLIDE 34

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

FrontRunner Catheter

  • Torqueable
  • Guide support
  • Directable/Steerable
  • Hydrophilic coating
  • Blunt tip to avoid

perforation

  • Avoids side

branches

Advantages Advantages

  • Difficult anatomy:

tortuosity, small vessel, heavy calcium

  • Expensive
  • 8 Fr guiding for

curved jaw

  • Failure Modes

Disadvantages

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SLIDE 35

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Clinical Outcomes of FrontRunner Catheter

  • N =909
  • Pre-approval phase: 119 (using the largest device),
  • Post-approval phase: 197 (using a smaller, more flexibe

catheter),

  • Current design: 593(using X-39 Frontrunner)
  • Lesion length: >30mm in 21%
  • Success rate
  • Pre-approval phase: 56%
  • Post-approval phase: 59%
  • Current design: 61%
  • Perforation: 0.9%

Yang YM, et al. Catheter Cardiovasc Interv 2004;63:462

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

FrontRunner Catheter

50 pts with 50 CTO, Refractory to guidewire Mean occlusion length 38.3 ± 22 mm

  • Overall Device Success

50 % (25)

  • Coronary perforation

17.3 % (9)

  • Adverse events @ 30 days

15.7 % (8) 7 non-Q wave MI, 1 sudden death

A Colombo et al, ACC 2004

Milan Experiences Milan Experiences

Relatively high risk of perforation !

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

The CrosserTM System

  • Generator

converts line power into high frequency current

  • Transducer

converts electric current into mechanical vibration

  • The Crosser catheter
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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

54 pts with 56 CTO, Refractory to guidewire Mean occlusion length 27 mm (8~46 mm)

  • Average time spent

2:43 min

  • MACE (2 NQMI)

3.6 % (2/56)

  • Clinical perforation 0 %
  • G. Sutsch et al, JIM 2004

Clinical Experiences Clinical Experiences

High frequency mechanical recanalization is a promising technology.

The CrosserTM System

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SLIDE 39

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Better guiding support
  • Smart guidewire
  • New device
  • Technical advancement

How to improve procedural How to improve procedural success ? success ?

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SLIDE 40

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Technical Advancement

Conventional Technique

  • Bilateral angiography
  • Over-the-wire catheter
  • Collateral angiography
  • Biplane angiographic equipment
  • Stepwise guidewire exchange
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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Technical Advancement

New Technique

  • Parallel wire technique
  • Side branch technique
  • Sub-intimal re-entry technique
  • IVUS-guided recanalization technique
  • Seesaw wiring technique
  • etc
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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

CONQUEST trial

  • Prospective Multicenter Registry in Japan
  • Method: stepwise guidewire change
  • First step: intermediate GW
  • Second step: Conquest GW sereies
  • Third step: additional Conquest GW, Seesaw wire

technique

  • T. Muramatsu, et al. TCT 2004

Stepwise guidewire change

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

CONQUEST trial

  • T. Muramatsu, et al. TCT 2004

110 patients, 116 CTO lesions

20 40 60 80 100 One step Two step Three step 1st wire 2nd wire 3rd wire

Success rate (%)

90.5%

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Side Branch Technique Side Branch Technique

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Parallel Wire Technique Parallel Wire Technique

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

IVUS Guided Technique IVUS Guided Technique

False lumen Guide wire True lumen

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SLIDE 47

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Stop When…

  • Creation of a large false lumen, especially if

adventitial staining is present

  • Shearing off collateral resulting in loss of

visualization of the distal flow

  • Excessive patient or operator fatigue
  • Excessive radiation exposure(e.g. 60 min of

fluroscopy time)

  • Excessive dye consumption

Second try at 6-8 weeks later

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SLIDE 48

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

PCI with DES for Chronic Total Occlusions PCI with DES for Chronic Total Occlusions

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

RESEARCH Registry

Serruys et al, JACC 2004;43:1594-8

6 6 Month Month Restenosis Restenosis Rate Rate

TOSCA (n=179)

(%)

STOP (n=48) GISSOC (n=56) SICCO (n=57) RESEARCH (n=33)

55% 42% 32% 32%

9%

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Asian Registry with Cypher

0.001 50 (42) 2 (3) 1 yr MACE, n(%) NS Death (%) NS 3 (3) MI (%) 0.001 44 (37) 2 (3) Re-PCI (%) 0.01 7 (6) CABG (%) 0.001 6 Reocclusion (%) 0.001 32 2 Restenosis (%) 0.001 1.36 ± 0.88 0.08 ± 0.10 Late loss (mm) P value BMS (n=120) SES (n=60)

Nakamura et al. AJC 2005;95:161-166

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Werner et al. JACC 2004;44:2301-6

German Study with Taxus

NS 12.8 CABG (%) <0.001 31.9 6.3 Re-PCI (%) NS 2.1 4.2 MI (%) NS 4.2 2.1 Death (%) <0.001 23 (47.9) 6 (12.5) 1 yr MACE, n(%) 0.003 23.4 2.1 Reocclusion (%) <0.001 51.1 8.3 Restenosis (%) <0.001 1.21 ± 0.70 0.19 ± 0.62 Late loss (mm) P value BMS (n=48) Taxus (n=48)

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

RECIPI study

Cypher vs. Taxus

Giuesppe Sangiorgi et al. ACC 2005

NS 1 (1.2) 3 (1.1) TVR

  • 85

142 Patients number NS 1(1.2) CABG NS 1 (0.7) Non-Q MI NS 1 (0.7) Death NS 1 (1.2) 5 (3.5) MACCE at 1 month, n(%) NS 1 (1.2) 1 (0.7) In hospital Re-PCI, n(%) NS 38 ± 25 41 ± 19 Stent length (mm) NS 1.4 ± 0.8 1.4 ± 0.7 Stent number p Taxus Cyper

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

179 patients, 185 CTO

BMS

75 patients (79 lesions)

February 2002-February 2003 March 2003-July 2004

DES

104 patients (106 lesions)

CTO in AMC

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

0.020 2.89 ± 0.60 2.69 ± 0.45 MLD 0.759 12.5 ± 16.1 13.5 ± 13.4 DS (%) P value BMS (N=79) DES (N=106) 0.066 2.82 ± 0.58 2.66 ± 0.45 Acute gain 0.070 3.29 ± 0.60 3.07 ± 0.49 Proximal RD Post-stenting, mm 0.003 25.8 ± 11.9 35.9 ± 19.5 Lesion length 0.052 3.11 ± 0.58 2.93 ± 0.50 Proximal RD Pre-stenting, mm

More Complex Lesion

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SLIDE 55

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

<0.000 40.29 ± 28.88 16.06 ± 23.66 Loss index P value BMS (N=54) DES (N=46) Follow-up Results 0.009 16 (29.6) 4 (8.7) Restenosis <0.000 1.13 ± 0.74 0.44 ± 0.64 Late loss, mm <0.000 34.7 ± 22.7 11.8 ± 19.3 DS, % <0.000 1.69 ± 0.88 2.37 ± 0.76 MLD, mm 0.053 3.12 ± 0.47 2.85 ± 0.57 Reference,mm

Restenosis Rate: 8.7%

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Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

Historical Comparison

Serruys et al, ACC 2004

6 6 Month Month Restenosis Restenosis Rate Rate

TOSCA (n=179)

(%)

STOP (n=48) GISSOC (n=56) SICCO (n=57) RESEARCH (n=33)

55% 42% 32% 32%

BMS Study SES Study

AMC (n=46)

9% 9%

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SLIDE 57

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

DES for CTO

  • DES implantation is much more effective in

reducing intimal growth and repeat intervention rate than BMS implantation for CTO lesions.

  • However, the technical difficulties in re-

crossing the occlusion keep the CTO lesion a challenging filed in interventional cardiology.

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SLIDE 58

Cardiovascular Research Foundation

ANGIOPLASTY SUMMIT

  • Very dangerous:

Not as expected

  • Low procedural success

Improved with new devices and techniques

  • High restenosis rate

No more in DES era

Issues in CTO Intervention Issues in CTO Intervention