Educational Objectives. Conflict of Interest Disclosure. TIMI Flow Classification TIMI= Thrombolysis in Myocardial Infarction TIMI 0 Flow

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1 Educational Objectives Percutaneous Coronary Interventions (PCI) in Chronic Total Occlusions (CTO s) The Last Frontier Ramon L. Lloret, MD, FACC, FSCAI At the end of this talk, attendees will: Understand the rationale for the treatment of Chronic Total Occlusions Understand the potential patient benefits of a successful CTO PCI Understand the current objections of performing CTO PCI and whether the clinical data and literature supports the objections Understand the criteria for appropriate patient selection for CTO PCI Be able to apply the concepts learned to case studies 2 Conflict of Interest Disclosure Consultant and Speaker Astra Zeneca Novartis Aralez Definition of a Chronic Total Occlusion A CTO is defined as: Occlusions in the coronary arteries with TIMI 0 flow Functional occlusions with TIMI 1 flow of at least three months duration Image courtesy of Dr.A Serra Stone et al. Percutaneous Recanalization of Chronically Occluded Arteries: A Consensus Document: Part 1. Circulation 2005;112: TIMI Flow Classification TIMI= Thrombolysis in Myocardial Infarction TIMI 0 Flow TIMI 1 Flow TIMI 2 Flow TIMI 3 Flow Chronic Total Occlusion (CTO) Morphology The Complexity of a CTO What s in the lumen? No Perfusion Penetration Without Perfusion Partial Perfusion Complete Perfusion The absence of any antegrade flow beyond a coronary occlusion. Faint antegradecoronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. Delayed or sluggish antegrade flow with complete filling in the distal territory. Normal flow which fills the distal coronary bed completely. Safi, et al. The Comparison of Intracoronary Versus Intravenous Eptifibatide Administration during Primary Percutaneous Coronary Intervention of Acute ST-Segment Elevation Myocardial Infarction. Life Sciences Journal, (4):

2 Histopathology of CTOs CTO ANTEGRADE LAD Thrombosis Thrombus Organization Tissue Aging Neovascularization Microchannels Fibrocalcification Calcified Areas Stone et al. Percutaneous Recanalization of Chronically Occluded Arteries: A Consensus Document: Part 1. Circulation 2005;112:

3 Benefits of CTO PCI Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias 14 Angina is one of the major symptoms and chief complaints of patients with a CTO CTO PCI was associated with a 55% reduction in residual or recurrent angina Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias Joyal et al., Effectiveness of recanalization of chronic total occlusions: A systematic review and meta-analysis, American Heart Journal, 2010: 160; 1: / Improved Exercise Tolerance 302 CTO PCI attempts 78% success 22% failed 70% follow up at 1 year A 5 point difference in AQL is considered clinically relevant. Successful CTO PCI procedures significantly improved AQL scores when compared to a failed attempt Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias Borgia F; et al. (1 Nov 2012). Improved cardiac survival, freedom from mace and angina-related quality of life after successful percutaneous recanalization of coronary artery chronic total occlusions. Int J Cardiol. 161:

4 Improved Survival / Mortality Successful CTO PCI demonstrated a 44% reduction in mortality over a failed attempt Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias Improved LV Function Improved LV Function In 39% of patients with LV dysfunction, significant myocardial recovery was observed at follow-up. (Werner, et al ) Recovery of LV function can be seen as late as two years post CTO recanalization. (Werner, et al ) Significant improvement in LV function post CTO PCI Chung, et al. Effect of Recanalization of Chronic Total Occlusions on Global and Regional Left Ventricular Function in Patients With or Without Previous Myocardial Infarction. Cath. CV Inter : Slide Adapted by Margolis 2010 Presentation. Werner, et al. Collateral and the recovery of left ventricular function after recanalization of a chronic total occlusion. Am Heart J Jan; 149(1): Werner, et al. Delayed Recovery of Left Ventricular Function After Recanalization of a Chronic Coronary Occlusion. Catheter Cardio Interv 2003; 60: Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias Improved Tolerance of a Future ACS Independent predictors of a fall in EF at follow up Age >60 CTO MVD without CTO 1.9( ) 3.5 ( ) 1.3 ( ) p=.03 p<.01 p=.64 The recanalized vessel may favorably impact mortality by providing a source of collateral flow during future ACS. Claessen, et al. Evaluation of the Effect of Concurrent Chronic Total Occlusion on Long-Term Mortality and Left Ventricular Function in Patients After Primary Percutaneous Coronary Intervention. JACC:Cardiovasc Int, 2009; 2(11):

5 Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias Reduce the Need for CABG CTO Recanalization was associated with a 78% reduction in the need for subsequent CABG Joyal et al., Effectiveness of recanalization of chronic total occlusions: A systematic review and meta-analysis, American Heart Journal, 2010: 160; 1: Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias Reduce Ischemic Burden MAHI evaluated 301 patients who underwent CTO PCI All patients had MPI (Myocardial Perfusion Imaging) before and after their procedure MPI is commonly referred to as Thallium study The investigators found that Baseline Ischemic Burden was a predictor of significant reduction in ischemic burden Mean ischemic burden at baseline = 13.1% Significant reduction is defined as >5% Reduce Ischemic Burden Baseline Ischemia Nominal / Minimal = <5% Mild = 5-9% Moderate = 10-16% Severe = >16% Cut Points >12.5% = significant reduction <=6.25% = significant increase Patients with 10-15% ischemia of the LV Mass will most likely see a 5% reduction in ischemia with successful CTO PCI Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias 30 5

6 Kaplan-Meier survival curves for freedom from first appropriate device therapy in CTO and non-cto populations. Reduce Arrhythmias CTO is an independent predictor for ventricular arrhythmias and has an adverse impact on long-term mortality Nombela-Franco L et al. Ventricular Arrhythmias Among Implantable Cardioverter-Defribrillator Recipients for Primary Prevention. Circ Arrhythm Electrophysiol 2012;5: Improved Exercise Tolerance Improve Survival Improved LV Function Improved Tolerance of a Future ACS Reduce the need for CABG Reduce Ischemic Burden Reduce Arrhythmias 32 The Naysayers There is no evidence for CTO-PCI in asymptomatic patients Collaterals in CTO Collaterals are usually not sufficient to substantially reduce ischemia in CTO Outside of ACS, PCI has never been shown to be life prolonging Vessel has been occluded a long time. The vessel has good collaterals Werner, et al. The functional reserve of collaterals supplying long-term chronic total coronary occlusions in patients without prior myocardial infarction. Euro. Heart J (2006)27: Patient Criteria for CTO-PCI Symptomatic Patients Angina refractory to Optimal Medical Therapy Poor Exercise Tolerance - Fatigue Ischemic Burden in the CTO Territory Viable Myocardium Conclusions There is evidence that recanalization of CTOs is beneficial to patients It is appropriate to continue to attempt recanalization of CTOs as long as it is done by knowledgeable and skilled operators, and patient selection is appropriate Asymptomatic Patients without documented ischemia and viable myocardium not on OMT will not benefit from CTO PCI Stone, et al. Percutaneous Recanalization of Chronically Occluded Coronary Arteries: A Consensus Document: Part II. Circulation. 2005; 112;

7 ANTEGRADE WITH AMBIGUOUS ORIGIN OF LAD 7

8 New Approach to Treat CTOs The Hybrid Strategy Retrograde Techniques Antegrade Dissection Re-Entry Antegrade Wiring FOUR ANGIOGRAPHIC CHARACTERISTICS DICTATE STRATEGY Proximal cap ambiguity Lesion length Quality of distal target Suitability of interventional collaterals HYBRID STRATEGY PRINCIPLES Consistent evaluation approach Emphasizes procedural safety, success, and efficiency Minimizes radiation and contrast Quick transition to alternate plans when failure mode occurs The Hybrid Algorithm Antegrade Wire Escalation YES Wire Escalation YES Antegrade FAIL NO Dissection Re- Entry FAIL Clear Proximal Cap Good Distal Target Length < 20mm YES Wire Escalation NO Retrograde FAIL NO Dissection Re- Entry (Reverse CART) FAIL Soft-tipped polymerjacketed Excellent Penetration Easier Perforation Excellent Steerability Poor Penetration Moderate stifftipped polymerjacketed Good Steerability Moderate Penetration Heavy tipped non-polymerjacketed Dissection Re-Entry (Reverse CART) Dissection Re-Entry Antegrade Dissection Re-Entry Coronary CTO Crossing and Re-entry System CTO crossing through the subintimal space, advancing across the occlusion, re-entering into the distal true lumen Cap-Fracturing Catheter Designed to quickly and safely deliver a guidewire via true lumen or subintimal pathways Re-Entry Balloon and Wire System Designed to accurately target and reenter the true lumen from a subintimal position 8

9 Dual injection Dual injection 1. Low magnification (10 inch) 2. Inject donor vessel first 3. Wait 1-2 sec before injecting CTO vessel 4. No panning 5. Cine until contrast clears Hybrid CTO crossing algorithm ANTEGRADE RCA Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv

10 Studying the CTO Strategic Plan 1. By whom? Entire cath team 2. How long? min 3. How? 1. Proximal cap ambiguity 2. Lesion length 3. Quality of distal vessel 4. Collaterals Brilakis ES. Manual of coronary CTO interventions. Elsevier Proximal cap 3. Distal vessel 1. Proximal vessel tortuosity - caliber 2. Ambiguous or clear? 1. Caliber and quality of distal vessel 3. Tapered or blunt? 4. Side branches? 5. Calcification 2. Bifurcation 3. Prior bypass graft insertion sites 10

11 4. Collaterals 1. Type (septal, bypass grafts, epicardial) 2. Size (Werner classification) 3. Tortuosity Conclusions 1.Dual injection critical for success of CTO PCI 2.Careful pre-procedure angiographic review 3.Focus on 4 elements 4. Dominance 5. Angle and location of entry ACCF/AHA/SCAI Guideline for PCI RETROGRADE LAD Levine et al J Am CollCardiol2011;58:e

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13 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% What is Really Happening? BARI Registry Substudy CTO Non-CTO PCI CABG Med Rx Current State of Care of Patients with CTO Revascularization is offered less often and with surgery Revascularization with PCI is variable Depends on operator experience and institutional treatment biases Revascularization with PCI dictated by angiogram not patient needs Christofferson et al. Am J Cardiol2005. Procedural Success vs. Complication Rate of CTO PCI James Sapontis (Co-PI) Angiographic core lab, Events adjudication, NCDR auditing Patel, V et al. Angiographic success an d Procedural Complications in patients undergoing prcutaneous Coronary CTO interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv Feb;6(2):

14 Interpretation of Angiography Four Characteristics Outlined by Treatment Algorithm Proximal Cap Location and Morphology Lesion Length CTO Lesion Target Coronary Vessel at the Distal Cap Proximal Cap Location and Morphology First Step of the Hybrid Algorithm Can we easily define the proximal cap or is it ambiguous? Ability to identify the proximal cap location unambiguously via angiography or intravascular ultrasound Ability to properly engage lesion Presence of side branches at the proximal cap Presence of bridging or other collaterals Size and Suitability of Collateral Circulation for Retrograde Technique Image courtesy Dr. Robert Feldman` <20 mm 20 mm Lesion Length Critical Measure = 20 mm in Length <20 mm success rates with antegrade wire escalation are high Substantially decreased success rates with standard antegrade wiring techniques Consider: Primary Dissection and Reentry Primary Retrograde Target Coronary Vessel at Distal Cap Assessing the Quality of the Distal Target Vessel for Re-Entry Size of the Lumen Presence of Side Branches or Bifurcations Presence or absence of disease at the re-entry zone Ability to adequately visualize this segment 82 Size and Suitability of Collateral Circulation for Retrograde Are there interventional collaterals present? CART and Reverse CART Controlled Antegrade and Retrograde subintimal Tracking Healthy or Repaired donor vessel CART Reverse CART Easily Accessed with Microcatheters Minimal Tortuosity Not the ONLY Source of Flow to the CTO segment Enter the CTO vessel well beyond the distal cap Connecting Proximal Distal Connecting Distal Proximal Utilized to connect the proximal true lumen to the distal true lumen via the subintimal space Utilized to connect the distal true lumen to the proximal true lumen via the subintimal space Septal Collaterals are the preferred Epicardial Collaterals carry a higher risk of perforation and associated tamponade Surmely, et al. New Concept for CTO Recanalization Using Controlled Antegrade and Retrograde Subintimal Tracking: The CART Technique. 2006: Vol 18(7): 83 14

15 Summary Starting a CTO PCI procedure with dual injection provides key information in determining how the operator will proceed with the case. By answering the questions in Step 2 of the algorithm (ambiguous proximal cap?, poor distal target?, presence of interventional collaterals?), the operator can determine the best lesion access technique, with which to begin the procedure. The key to successful utilization of the algorithm is to not get stuck in any section for a long period of time. This will cause you to reach your limits of radiation and contrast doses to your patient. The cadence of fluoro time and radiation dose should be evenly distributed at each stage of the procedure to avoid any one stage reaching critical dose levels. RETROGRADE RCA 15

16 Equipment and Procedural Differences Between CTO-PCI and PCI Functions in CTO-PCI Guide Wires Examples Microchannel probing and Crossing Wirewith a Taperedtip (.009), soft tip (1.2g or less) and has a polymer jacketed and is hydrophilic coated. Collateral Crossing for Retrograde Hydrophiliccoated, non tapered wirewith fine control (tip load < 3.4g) Compositecore wire with extra soft tip load of less than 0.9g Proximal or Distal Cap Penetration Tapered tip (.009) Non-polymerjacketed wire with hybrid coating and a 9.3g tip load. Knuckle Dissection Polymerjacketed, hydrophilic wires that easily knuckle Re-Entry Tapered tip (.009) Non-polymerjacketed wire with hybrid coating and a 9.3g tip load. 28 Angled tip wire that tapers from.014 to.007 to.003 distally. Non-tapered, full polymer jacketed wire with hydrophilic coating and a 4.1g tip load Externalization Wiresthat are > 300cm in length Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3): Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3):

17 Purpose Shaping Guide Wires for CTO PCI Wire shape to penetrate the occlusion cap or to find a microchannel. Shape Microcatheter Functions Facilitate wire exchanges Maintain position in the vessel during wire exchanges Improve wire torque response Provide backup support to the wire Provide dynamic wire tip loading Microcatheters Wire shape to reenter into the true lumen from the subintimal space. Microcatheters Multiple brands available OTW Balloon Asahi Intecc, Corsair Microcatheter Wire shape for controlled subintimal dissection. Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3): Image Source: Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3): Cap-Fracturing Catheter Multi-wire coiled shaft Tracks via FAST Spin Technique Highly torqueablecoiled-wire shaft FAST Spin reduces push required to cross CTO Ratchet Handle for FAST-Spin Technique Re-Entry Balloon and Wire System Goal: re-enter the true lumen from a subintimal position Compatibility: 6F Guide/0.014 Wire 2.9F shaft profile Atraumaticdistal tip advanced across a CTO ahead of the guide wire OTW guide wire compatible Atraumatic 1 mm Distal Tip Unique selforienting balloon has a flat shape for true lumen targeting 180 opposed and offset exit ports for selective guide wire re-entry Re-entry probe at Guide wire tip Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3): Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3): Tools for Complication Management Coils and Injectable Material Covered Stents Pericardiocentesis Equipment Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3): Sample CTO PCI Inventory Tool Quantity Large bore sheaths 6 8F and 6F Guide Catheters 5 of each configuration Multipleconfigurations required Each size and configuration should be stocked both with and without holes CoronaryGuide Wires 5 of each wire Multiple wires required Microcatheters 5 (OTW balloons); 2 (microcatheters) 6F and 8F Child cathetersfor mother-and-child guide catheter technique 4 of each SpecialtyWires 2 of each Multiplesizes required Specialty Microcatheters 5 Angulated AccessMicrocatheters 2 Snares 2 of eachsize Multiplesizes required SpecialtySystem for Controlled Dissection and Re-entry 5complete systems Coils and delivery system 2 ofeither of the following CoveredStents 1 Adapted from Alaswad, K. Toolbox and Inventory Requirements for Chronic Total Occlusion Percutaneous Coronary Intervention. Inter Card Clin, Vol. 1(3):