PCI for Chronic Total Occlusions
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- Amos Morris
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1 PCI for Chronic Total Occlusions
2 Chronic Total Occlusions 20-40% of patients with CAD Why should we open?
3 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
4 12-Month Clinical Outcome of PCI in CTO TOAST-GISE % 25 N=390, Success 73.3% Success No success Death & MI CABG angina Olivari Z, et al. JACC 2003; 41:
5 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 Registry 1 Suero et al (74.4%) < (76.7%) TOAST-GISE (77.5%) Kandzari, et al. TCT Suero, et al. JACC 2001;38: Olivari Z, et al. JACC 2003; 41:
6 Reopening of CTO 20 Years Experience P = Percent surviving CTO-Success CTO-Failure 73.5% 65% Years Suero, et al. JACC 2001;38:
7 Effect on LV function PCI in CTO improves LV function (%) Pre 6 Mo Post *P < LV EDVI ESVI EF PCWP Van Belle E, et al. AJC 1997;80:
8 Issues in CTO Intervention Very dangerous Low procedural success High restenosis rate
9 Issues in CTO Intervention Very dangerous Low procedural success High restenosis rate
10 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
11 In-Hospital Major Complication Not dangerous! % 4 CTO (n=2007) vs. Non-CTO (n=2007) 3 2 Non-CTO CTO All p=ns 1 0 Death Q-MI Non-Q Urgent Urgent MACE MI CABG PCI Suero JA, et al. JACC 2001;38:
12 Issues in CTO Intervention Very dangerous Low procedural success High restenosis rate
13 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:
14 Predictors of 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
15 Variables Predictors of Procedural Success Multivariate analysis from TOAST-GISE Hazard Ratio P value Length 15 Vs. <8 mm Length not measurable Vs. <8 mm Moderate to severe calcification Duration 180 days Multivessel disease Stump morphology not discernable Olivari z, et al. JACC 2003;41:
16 Procedural Success Favorable Unfavorable Tapered stump Stump absent Functional occlusion Total occlusion Pre or post occlusion Side branch(+) Bridging collateral (-) Bridging collateral (+)
17 How to improve procedural success? Better guiding support Smart guidewire New device Technical advancement
18 100 % Improved Success Rate We can improve! 1039 lesions, 934 patients P= P< Double wire technique Stepwise guidewire technique New guidewire: Conquest etc No tapered tip Hiroyuki tanaka, et al. ACC 2005
19 How to improve procedural success? Better guiding support Smart guidewire New device Technical advancement
20 Guiding Catheter for RCA
21 Two Guiding Catheter for RCA
22 Guiding Catheter for LCA
23 Position of Support Catheter
24 How to improve procedural success? Better guiding support Smart guidewire New device Technical advancement
25 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 - FrontRunner TM Catheter - OCR SafeSteer TM System - Flow Cardia Crosser TM System Biological approach - Prolonged urokinase/tpa infusion - Collagenase plaque digestion
26 Ability to Cross CTO Hydrophilic-coated coated Guidewire Conventional (n=46) Crosswire (n=42) P 1 st GW success(%) Crossover(%) GW success after crossover(%) Total GW No. Procedure(min) ±0.6 84± ±0.5 42± <0.001 < Lefevre et al, Am J Cardiol 2000;85:1144-7
27 Ability to Cross CTO Tapered 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
28 New CTO Wires for CTO Lesions Miracle 12g is more controllable to penetrate proximal cap, to advance in the tight CTO with bending, to puncture from pseudo to true lumen. Conquest should be used only when the appropriate direction can be seen to penetrate distal cap, to puncture from pseudo to true lumen. Conquest should not be used to seek the true lumen or advance for long distance.
29 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 SafeSteer TM System (Optical Coherence Reflectometry) - FrontRunner TM Catheter - Flow Cardia Crosser System
30 OCR SafeSteer System Forward looking guidance system, using OCR to determine tissue types (plaque vs arterial wall). Designed to navigate through total occlusion.
31 OCR SafeSteer System OCR Waveform Displays
32 GREAT Registry 116 Lesions 21 centers with CTO failure to cross median occlusion duration: 22montths Median lesion length: 25mm(>30mm long in 25%) 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%) Baim DS et al. Am J Cardiol 2004;94:
33 FrontRunner Catheter Controlled Blunt Micro-Dissection Blunt controlled passage through occlusion Uses elastic properties of adventitia vs. inelastic fibrocalcific plaque
34 FrontRunner Catheter Advantages Torqueable Guide support Directable/Steerable Hydrophilic coating Blunt tip to avoid perforation Avoids side branches Disadvantages Difficult anatomy: tortuosity, small vessel, heavy calcium Expensive 8 Fr guiding for curved jaw Failure Modes
35 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
36 FrontRunner Catheter Milan Experiences 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 30 days 15.7 % (8) 7 non-q wave MI, 1 sudden death Relatively high risk of perforation! A Colombo et al, ACC 2004
37 The Crosser TM System Generator converts line power into high frequency current Transducer converts electric current into mechanical vibration The Crosser catheter
38 The Crosser TM System Clinical Experiences 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 % High frequency mechanical recanalization is a promising technology. G. Sutsch et al, JIM 2004
39 How to improve procedural success? Better guiding support Smart guidewire New device Technical advancement
40 Technical Advancement Conventional Technique Bilateral angiography Over-the-wire catheter Collateral angiography Biplane angiographic equipment Stepwise guidewire exchange
41 Technical Advancement New Technique Parallel wire technique Side branch technique Sub-intimal re-entry technique IVUS-guided recanalization technique Seesaw wiring technique etc
42 CONQUEST trial Stepwise guidewire change 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
43 Success rate (%) CONQUEST trial 110 patients, 116 CTO lesions 1st wire 2nd wire 3rd wire 90.5% One step Two step Three step T. Muramatsu, et al. TCT 2004
44 Side Branch Technique
45 Parallel Wire Technique
46 IVUS Guided Technique False lumen Guide wire True lumen
47 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
48 PCI with DES for Chronic Total Occlusions
49 RESEARCH Registry 6 Month Restenosis Rate (%) 55% 42% 32% 32% 9% TOSCA (n=179) STOP (n=48) GISSOC (n=56) SICCO (n=57) RESEARCH (n=33) Serruys et al, JACC 2004;43:1594-8
50 Asian Registry with Cypher Late loss (mm) Restenosis (%) Reocclusion (%) SES (n=60) 0.08 ± BMS (n=120) 1.36 ± P value yr MACE, n(%) Death (%) MI (%) Re-PCI (%) CABG (%) 2 (3) (3) 0 50 (42) NS 3 (3) NS 44 (37) (6) 0.01 Nakamura et al. AJC 2005;95:
51 German Study with Taxus Taxus (n=48) BMS (n=48) P value Late loss (mm) 0.19 ± ± 0.70 <0.001 Restenosis (%) <0.001 Reocclusion (%) yr MACE, n(%) 6 (12.5) 23 (47.9) <0.001 Death (%) NS MI (%) NS Re-PCI (%) <0.001 CABG (%) NS Werner et al. JACC 2004;44:2301-6
52 RECIPI study Cypher vs. Taxus Patients number Stent number Stent length (mm) In hospital Re-PCI, n(%) MACCE at 1 month, n(%) Death Non-Q MI TVR CABG Cyper Taxus p ± ± 0.8 NS 41 ± ± 25 NS 1 (0.7) 1 (1.2) NS 5 (3.5) 1 (1.2) NS 1 (0.7) 0 NS 1 (0.7) 0 NS 3 (1.1) 1 (1.2) NS 0 1(1.2) NS Giuesppe Sangiorgi et al. ACC 2005
53 CTO in AMC 179 patients, 185 CTO March 2003-July 2004 February 2002-February 2003 DES 104 patients (106 lesions) BMS 75 patients (79 lesions)
54 More Complex Lesion Pre-stenting, mm Proximal RD Lesion length Post-stenting, mm Proximal RD MLD DS (%) Acute gain DES (N=106) 2.93 ± ± ± ± ± ± 0.45 BMS (N=79) 3.11 ± ± ± ± ± ± 0.58 P value
55 Restenosis Rate: 8.7% Follow-up Results DES BMS P value (N=46) (N=54) Reference,mm 2.85 ± ± MLD, mm 2.37 ± ± 0.88 <0.000 DS, % 11.8 ± ± 22.7 <0.000 Late loss, mm 0.44 ± ± 0.74 <0.000 Loss index ± ± <0.000 Restenosis 4 (8.7) 16 (29.6) 0.009
56 Historical Comparison 6 Month Restenosis Rate (%) 55% BMS Study SES Study 42% 32% 32% 9% 9% TOSCA (n=179) STOP (n=48) GISSOC (n=56) SICCO (n=57) RESEARCH (n=33) AMC (n=46) Serruys et al, ACC 2004
57 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 recrossing the occlusion keep the CTO lesion a challenging filed in interventional cardiology.
58 Issues in CTO Intervention Very dangerous: Not as expected Low procedural success Improved with new devices and techniques High restenosis rate No more in DES era
PCI for Chronic Total Occlusions
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