Intro & Latest Contemporary DES Data and Clinical Implications - PowerPoint PPT Presentation

Biotronik SCAI satellite session 7.05-7.20 pm Tuesday, May 21, 2019 Intro & Latest Contemporary DES Data and Clinical Implications Emmanouil S. Brilakis, MD, PhD Minneapolis Heart Institute

Disclosures • Consulting/speaker honoraria: Abbott Vascular, American Heart Association (associate editor Circulation), Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), CSI, Elsevier, GE Healthcare, InfraRedx, Medtronic • Research support: Regeneron, Siemens • Shareholder: MHI Ventures. • Board of Trustees: Society of Cardiovascular Angiography and Interventions

PCI complications: a classification CORONARY HEART OTHER 1. Vessel closes 1. MI 1. Access • Dissection 2. Arrhythmia - 2. Thromboembolic • Embolization arrest 3. Contrast • • Spasm 3. Tamponade Nephropathy • • Pseudolesion Allergies 4. Radiation 2. Vessel Leaks • Perforation 3. “Wrong place” • Equipment loss

Survey of 1,149 cardiologists on CTO PCI Patel S, Menon RV, Burke MN, Jaffer FA, Yeh RW, Vo M, Karmpaliotis D, Azzalini L, Carlino M, Mashayekhi K, Galassi A, Rinfret S, Ellis S, Patel M, Rangan BV, Karatasakis A, Danek BA, Karacsonyi J, Resendes E, Banerjee S, Brilakis ES. J Invasive Cardiol. 2018 Feb;30(2):43-50

Coronary perforation: Ellis classification severity Type 1 Crater extending outside lumen only Type 2 Pericardial or myocardial blush with < 1mm exit hole Type 3 Contrast jet through > 1mm exit hole Type 4 Perforation into anatomic cavity- Cavity Splitting Ellis et al. Circulation 1994;90:2725

Perforation definition Coronary vessel injury resulting in bleeding through the vessel wall CTO-ARC Proposed perforation classification Part 1 Part 2 Mechanism – location Severity 1. Large vessel 1. Ellis 1 2. Distal vessel 2. Ellis 2 3. Collateral septal 3. Ellis 3 4. Collateral epicardial Or Ellis 3 vs Ellis <3 ?

Types of coronary perforation mechanism Main Vessel Distal Wire Collateral Collateral perforation perforation perforation perforation - septal - epicardial CTO-ARC Proposed classification

Types of coronary perforation mechanism treatment Main Vessel perforation

LAD CTO

Predilation – balloon rupture next step? TIP 1 Balloon rupture TIP 2 can cause When a balloon ruptures do perforation an angiogram immediately!

} “Universal” Algorithm for Coronary Perforations } Type-specific Treatment

Stop bleeding TIP 3 The first step in any perforation is to inflate a balloon proximally to stop pericardial bleeding

Sealing a large vessel perforation TIP 4 Have a plan! Brilakis ES. Manual of coronary CTO interventions 2 nd edition. Elsevier 2017

Sealing a large vessel perforation Brilakis ES. Manual of coronary CTO interventions 2 nd edition. Elsevier 2017

Before: Graftmaster Rx • HDE - IRB approval needed • 2.8 - 4.0 mm stents: 6 French guide • 4.5 and 4.8 mm stents: 7 French guide Brilakis ES. Manual of coronary CTO interventions. Elsevier 2017

FDA Approved Covered Coronary Stents PK Papyrus 1 GRAFTMASTER 2 Single Stent Traditional Sandwich Stent Design Design 2 Polyurethane ePTFE Cover material 5F * 6F Guide catheter 15, 20, 26 16, 19, 26 Length Available sizes (mm) 2.5, 3.0, 3.5, 4.0, 2.8. 3.5, 4.0, Diameter 4.5, 5.0 4.5**, 4.8** 1. PK Papyrus (BIOTRONIK data on file); 2. Data obtained from GRAFTMASTER Coronary Stent Graft System Brochure 11/13/12; * Ø 2.5-4.0 mm; 6F compatible for 4.5-5.0 mm ** Diameters only 7F compatible GRAFTMASTER is a registered trademark of the Abbott Group of Companies. 17 23-MAY-19

Ping-pong

Unable to deliver 2.80x19 mm Graftmaster TIP 5 Delivery of covered stents can be very challenging

Now: PK Papyrus Jostent Graftmaster 3.0/16 PK Papyrus 3.0/15 Single stent design Double stent Sandwich design Crossing profile 1.63 23% [mm diameter] 1.25 reduction 20

PK Papyrus – An Ultrathin Strut Stent Platform BIOTRONIK’s BMS platform (CoCr) Based on BIOTRONIK PRO-Kinetic Energy bare metal stent platform Double helix stent design - for smooth outer contour, flexibility Longitudinal connectors - to resist longitudinal compression 21 23-MAY-19

PK Papyrus FDA Approved Sept 2018. FDA Press Release Here. A Covered Single Stent Design with an Electrospun Membrane. Ultrathin strut CoCr platform Fibers ~2 μ m Polyurethane fibers (2000x) Electrostatic forces spin polyurethane onto stent surface, creating an thin cover capable of sealing coronary perforations Polymer Fibers solution Cover Polyurethane fibers (50x) 22

PK Papyrus Maximum Stent Expansion Diameter and Size Range PK Papyrus – 17 sizes Stent Max Expansion mm 15 20 26 Diameter Diameter 2.5 N/A ø 2.5 - 3.0 mm 3.50 mm 3.0 3.5 4.0 ø 3.5 - 4.0 mm 4.65 mm 4.5 5.0 ø 4.5 - 5.0 mm 5.63 mm First FDA approved size 5F 6F ✓ First FDA approved 2.5 mm diameter 23

PK Papyrus Flexibility and Track Force More Similar to a Conventional Stent Track Force in coronary artery model 3 [N] Flexibility 1 53% Reduction in Maximum Track Force 2.5 2.0 PK Papyrus 53% reduction 58% lower 3.0/15 in maximum track 1.5 [N] force 1.0 JOSTENT GRAFTMASTER 0.5 3.0/16 0.0 0 20 40 60 80 100 120 0 50 100 150 200 Nmm² Distance [mm] Bending stiffness of crimped stent PRO-Kinetic Energy 3.0/20 PK Papyrus 3.0/20 Jostent Graftmaster 3.0/19 1. Compared to JOSTENT GRAFTMASTER 3.0/16, (BIOTRONIK data on file). 2. Compared to GRAFTMASTER 2.8/16, (BIOTRONIK data on file). 3. Source: BIOTRONIK data on file JOSTENT & GRAFTMASTER are registered trademarks of the Abbott Group of Companies. 24 23-MAY-19

Covered Stent Time to Deliver Limited Clinical Data Exists for Covered Coronary Stents Shorter time to deliver 3 Procedural outcomes from a single center, retrospective case study of 61 patients treated with covered coronary stents 3,4 Median time to deliver (p=0.001) n= 22 n= 39 Jostent PK Papyrus GRAFTMASTER Median stent length (mm) 16 20 1. Broad range of sizes available on the US market. 2. Compared to GRAFTMASTER with 15 sizes. 3. Hernândez-Enrìquez M, Outcomes after use of covered stents to treat coronary artery perforations. Comparison of old and new-generation covered stents. J Interv Cardiol. 2018; 1-7. 4. Population is representative of real world interventional practice and was not a randomized prospective clinical trial. JOSTENT & GRAFTMASTER are registered trademarks of the Abbott Group of Companies. 25 23-MAY-19

PK Papyrus Size Range Guiding catheter compatibility Ø (mm) Length (mm) 15 20 26 2.5 434887 434893 - 3.0 434888 434894 434899 3.5 434889 434895 434900 4.0 434890 434896 434901 4.5 434891 434897 434902 5.0 434892 434898 434903 5F 6F 26 23-MAY-19

PK Papyrus Compliance Chart Pressure Stent Diameter (mm) (ATM) 3.0 2.5 3.5 4.0 4.5 5.0 NP 7 4.01 4.55 4.93 NP 8 2.52 2.99 3.53 4.14 4.69 5.09 9 2.59 3.07 3.63 4.26 4.82 5.23 10 2.65 3.15 3.71 4.35 4.91 5.34 11 2.70 3.21 3.77 4.43 4.99 5.43 12 2.74 3.26 3.82 4.49 5.06 5.50 13 2.77 3.30 3.86 4.54 5.11 5.56 RBP 14 2.80 3.34 3.90 4.59 5.16 5.61 15 2.83 3.37 3.93 4.63 3.40 RBP 16 2.86 3.96 4.67 27 23-MAY-19

Covered stent through Guideliner TIP 6 Graftmaster stents can fit within an 8 Fr Guideliner

Perforation sealed

ACT=227 TIP 7 Perforation can be further complicated by thrombosis DON’T REVERSE HEPARIN UNTIL AFTER EQUIPMENT REMOVED FROM CORONARY ARTERY

Final result

TTE at the end TIP 8 Early balloon inflation can prevent tamponade

Covered Stents Are Available Through Unique Regulatory Pathway: FDA Humanitarian Use Device Program A. Humanitarian Use Device (HUD): A medical device intended to benefit patients in the ▪ treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals per year. 1 B. Humanitarian Device Exemption (HDE) Subject to certain use restrictions ▪ Exempt from the effectiveness requirements of • Sections 514 and 515 of the FD&C Act Institutional Review Board (IRB) oversight required • 1 Defined by 21 CFR 814.3(n) and updated by section 3052 of 21 st Century Cures Act ; https://www.fda.gov/downloads/Training/CDRHLearn/UCM519597.pdf 34 Section 520(m) of FD&C Act; https://www.fda.gov/downloads/Training/CDRHLearn/UCM519597.pdf HDE: Marketing application for an HUD; Exempt from effectiveness requirements of Sections 514 and 515 of FD&C Act

What is an Institutional Review Board (IRB)? Group formally designated to review and monitor research involving human subjects • Purpose is to assure that appropriate steps are taken to protect the rights and welfare of • humans participating as subjects in research IRBs use a group process to review research protocols and related materials • Note, use of PK Papyrus is not for research. It is a market-released product under an • HDE approval, but due to different effectiveness requirements, IRB oversight is required by FDA. FDA Guidance Document: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guida nceDocuments/ucm110203.pdf 35 23-May-19