Management in Wire refractory cases Hybrid CTO PCI

Management in Wire refractory cases Hybrid CTO PCI Craig A. Thompson, M. D. , MMSc. Director, Invasive Cardiology and Vascular Medicine Yale University School of Medicine/Yale New Haven Hospital Consultant (Hon) Heart Hospital, London and London Chest Hospital

Craig A. Thompson, MD Consulting: Abbott Vascular Terumo Cardiovascular Systems Group Stocks, Stock Options, other ownership interest: Bridge. Point

The Goal of Hybrid CTO PCI • Harmonization of antegrade and retrograde wiring and reentry methods • Standardization of initial and provisional approaches to CTO PCI • Opportunity to try multiple higher Retrograde success strategies earlier in the procedure – Conditional probability • Prioritization of efficiency when equipoise exists with effectiveness and safety – Increase CTO PCI uptake – Reduce radiation and contrast exposure – Improve cath lab workflow Dissection Reentry Antegrade

The “Base of Operations” the model for effectiveness and efficiency • Antegrade Goal – Move gear safely and quickly to distal cap to focus on true lumen entry or… – Move gear beyond distal cap to focus on reentry • Retrograde Goal – Move gear safely and quickly to proximal cap for true lumen entry or reverse CART (dissection connection) • Mobile, not fixed, base – Move up and down vessel as circumstances dictate

Patient Selection Anatomy Dictates Strategy The Four Questions 1. Is the Proximal cap clear by angio +/IVUS or ambiguous? 2. Lesion length < or > 20 mm 3. Quality of the distal target 4. Suitability of “interventional” collaterals

The Hybrid Algorithm for CTO PCI initial approaches Dual Catheter Angiography yes 1. Clear proximal cap 2. Good Distal Target no Antegrade yes Wire escalation Retrograde no 3. Length < 20 mm Dissection Reentry (crossboss-stingray) yes Wire escalation no Dissection Reentry (reverse CART)

The Hybrid Algorithm for CTO PCI provisional approaches Dual Catheter Angiography yes 1. Clear proximal cap 2. Good Distal Target no Antegrade yes fail Wire escalation Retrograde no 3. Length < 20 mm Dissection Reentry (crossboss-stingray) fail Dissection Reentry (reverse CART) no yes Wire escalation fail Dissection Reentry (reverse CART) fail Dissection Reentry (crossboss-stingray)

Wire escalation antegrade or retrograde

Dissection Reentry Techniques CTO Lumen Distal cap Random STAR reentry CTO LAST redirection CTO Lumen Distal cap Controlled, Precise Distal cap Lumen Bridgepoint reentry CTO Distal cap Reverse CART Lumen

Managing the Subintimal Space to Facilitate CTO PCI Knuckle wire Cross. Boss

Knuckle wire technique

The Cross. Boss™ CTO Catheter • • • Cross. Boss is designed to quickly and safely deliver a guidewire via true lumen or subintimal pathways Multi-wire coiled shaft Tracks via FAST Spin Technique – Highly torqueable coiled-wire shaft – FAST Spin reduces push required to cross CTO • • Atraumatic distal tip advanced across a CTO ahead of the guidewire OTW 0. 014” guidewire compatible

The Stingray™ CTO Re-Entry System • • Stingray System (catheter and guidewire) is designed to accurately target and re-enter the true lumen from a subintimal position Unique self-orienting balloon has a flat shape for true lumen targeting 180° opposed and offset exit ports for selective guidewire re-entry Re-entry probe at Stingray Guidewire tip

Stingray Reentry Precise reentry and control of outflow vessels Meaningful outflow vessels True Lumen Control

Retrograde Dissection Re-entry Concept of Reverse CART Technique

The 4 Fates of Retrograde and Antegrade Wires - XCART False True

Retrograde Dissection Re-entry Concept of Reverse CART Technique Antegrade wire Retrograde wire

Retrograde Dissection Re-entry Concept of Reverse CART Technique

Retrograde Dissection Re-entry Concept of Reverse CART Technique

Retrograde Dissection Re-entry Concept of Reverse CART Technique

Retrograde Dissection Re-entry Concept of Reverse CART Technique

Reverse CART Precise reentry and control of outflow vessels Meaningful outflow vessels True Lumen Control

Mechanism for Stingray Reentry and Reverse CART are similar Precise reentry and control of outflow vessels Meaningful outflow vessels True Lumen Control

Conclusions • Antegrade wire escalation, antegrade dissection reentry, and retrograde wire escalation and dissection reentry techniques are complimentary and necessary for full spectrum CTO PCI • Hybrid strategy optimizes opportunity for success by conditionally exploring sequential options – Ease of education – Potentially improve adoption of CTO PCI • Hybrid strategy can potentially shorten procedure times, reduce radiation exposure with quality and safety equal or superior to conventional approaches