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

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

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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:

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SLIDE 1

Intro & Latest Contemporary DES Data and Clinical Implications

Emmanouil S. Brilakis, MD, PhD Minneapolis Heart Institute

Biotronik SCAI satellite session Tuesday, May 21, 2019

7.05-7.20 pm

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SLIDE 2

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

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SLIDE 3

CORONARY

  • 1. Vessel closes
  • Dissection
  • Embolization
  • Spasm
  • Pseudolesion
  • 2. Vessel Leaks
  • Perforation
  • 3. “Wrong place”
  • Equipment loss

PCI complications: a classification

HEART

  • 1. MI
  • 2. Arrhythmia -

arrest

  • 3. Tamponade

OTHER

  • 1. Access
  • 2. Thromboembolic
  • 3. Contrast
  • Nephropathy
  • Allergies
  • 4. Radiation
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SLIDE 4

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

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SLIDE 5
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SLIDE 6

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

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SLIDE 7

Perforation definition

Coronary vessel injury resulting in bleeding through the vessel wall

Part 1 Mechanism – location

  • 1. Large vessel
  • 2. Distal vessel
  • 3. Collateral septal
  • 4. Collateral

epicardial Part 2 Severity

  • 1. Ellis 1
  • 2. Ellis 2
  • 3. Ellis 3

Or Ellis 3 vs Ellis <3 ?

CTO-ARC Proposed perforation classification

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SLIDE 8

Types of coronary perforation

Main Vessel perforation Distal Wire perforation Collateral perforation

  • epicardial

Collateral perforation - septal

CTO-ARC Proposed classification

mechanism

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SLIDE 9

Types of coronary perforation

Main Vessel perforation mechanism treatment

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SLIDE 10

LAD CTO

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SLIDE 11

Predilation – balloon rupture next step?

TIP 1 Balloon rupture can cause perforation TIP 2 When a balloon ruptures do an angiogram immediately!

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SLIDE 12

“Universal” Algorithm for Coronary Perforations Type-specific Treatment

} }

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SLIDE 13

Stop bleeding

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

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SLIDE 14

Brilakis ES. Manual of coronary CTO interventions 2nd edition. Elsevier 2017

Sealing a large vessel perforation

TIP 4 Have a plan!

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SLIDE 15

Brilakis ES. Manual of coronary CTO interventions 2nd edition. Elsevier 2017

Sealing a large vessel perforation

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SLIDE 16

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

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SLIDE 17
  • 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.

FDA Approved Covered Coronary Stents

23-MAY-19 17

Single Stent Design Traditional Sandwich Stent Design2 Cover material

Polyurethane ePTFE

Guide catheter

5F* 6F

Available sizes (mm) Length

15, 20, 26 16, 19, 26

Diameter

2.5, 3.0, 3.5, 4.0, 4.5, 5.0 2.8. 3.5, 4.0, 4.5**, 4.8**

PK Papyrus1 GRAFTMASTER2

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SLIDE 18

Ping-pong

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SLIDE 19

Unable to deliver 2.80x19 mm Graftmaster

TIP 5 Delivery of covered stents can be very challenging

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SLIDE 20

1.63 1.25

Crossing profile

[mm diameter]

Jostent Graftmaster 3.0/16 Double stent Sandwich design PK Papyrus 3.0/15 Single stent design

20

23% reduction

Now: PK Papyrus

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SLIDE 21

BIOTRONIK’s BMS platform (CoCr)

PK Papyrus – An Ultrathin Strut Stent Platform

Based on BIOTRONIK PRO-Kinetic Energy bare metal stent platform

23-MAY-19 21

Double helix stent design - for smooth

  • uter contour, flexibility

Longitudinal connectors - to resist longitudinal compression

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SLIDE 22

PK Papyrus FDA Approved Sept 2018. FDA Press Release Here. A Covered Single Stent Design with an Electrospun Membrane.

Polyurethane fibers (50x) Polyurethane fibers (2000x)

Electrostatic forces spin polyurethane onto stent surface, creating an thin cover capable of sealing coronary perforations

Polymer solution Fibers Cover

Fibers ~2μm Ultrathin strut CoCr platform

22

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SLIDE 23

PK Papyrus Maximum Stent Expansion Diameter and Size Range

23

Stent Diameter Max Expansion Diameter ø 2.5 - 3.0 mm 3.50 mm ø 3.5 - 4.0 mm 4.65 mm ø 4.5 - 5.0 mm 5.63 mm

6F 5F First FDA approved size

mm 15 20 26 2.5 N/A 3.0 3.5 4.0 4.5 5.0

PK Papyrus – 17 sizes ✓ First FDA approved 2.5 mm diameter

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SLIDE 24

20 40 60 80 100 120

Nmm²

PK Papyrus Flexibility and Track Force

More Similar to a Conventional Stent

Flexibility1 PK Papyrus 3.0/15 JOSTENT GRAFTMASTER 3.0/16 58% lower 53% Reduction in Maximum Track Force

Bending stiffness of crimped stent [N]

24 23-MAY-19

Track Force in coronary artery model3 [N]

  • 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.

PK Papyrus 3.0/20 Jostent Graftmaster 3.0/19 PRO-Kinetic Energy 3.0/20

0.0 0.5 1.0 1.5 2.0 2.5 50 100 150 200 Distance [mm] 53% reduction in maximum track force

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SLIDE 25

Limited Clinical Data Exists for Covered Coronary Stents

Covered Stent Time to Deliver

Shorter time to deliver3

23-MAY-19 25

Procedural outcomes from a single center, retrospective case study of 61 patients treated with covered coronary stents3,4

n= 22 n= 39

Median time to deliver (p=0.001) Jostent GRAFTMASTER PK Papyrus 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.

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SLIDE 26

Guiding catheter compatibility

PK Papyrus Size Range

23-MAY-19 26

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

6F 5F

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SLIDE 27

PK Papyrus Compliance Chart

23-MAY-19 27

Pressure (ATM) Stent Diameter (mm)

2.5 3.0 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 RBP 16 2.86 3.40 3.96 4.67

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SLIDE 28

Covered stent through Guideliner

TIP 6 Graftmaster stents can fit within an 8 Fr Guideliner

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SLIDE 29

Perforation sealed

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SLIDE 30

ACT=227

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

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SLIDE 31

Final result

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SLIDE 32

TTE at the end

TIP 8 Early balloon inflation can prevent tamponade

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SLIDE 33
  • 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

Covered Stents Are Available Through Unique Regulatory Pathway: FDA Humanitarian Use Device Program

1 Defined by 21 CFR 814.3(n) and updated by section 3052 of 21st Century Cures Act ; https://www.fda.gov/downloads/Training/CDRHLearn/UCM519597.pdf

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

34

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SLIDE 34
  • 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

What is an Institutional Review Board (IRB)?

23-May-19

35

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SLIDE 35

Example of IRB Approval Process

23-May-19

36

IRB Package

  • Hospital compiles information

the hospital needs to complete IRB submission

  • E.g.: FDA approval
  • rder, etc
  • Hospital determines whether

local or central IRB is appropriate for PK Papyrus Clinical Sales Rep IRB Chair or Coordinator Physician Principal Investigator Administrator/ Cath Lab Manager

IRB Committee IRB Approval Letter IRB Submission IRB Committee

  • Administrative body established to

protect the rights and welfare of human research subjects recruited to participate in research activities

Research Coordinator

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SLIDE 36
  • The patient must be at risk of serious harm or death
  • Additional reporting to the IRB is required
  • e.g.: in such emergency, within 5 days after use of the device, provide written notification to

chairman of IRB (ie. identification of patient involved, date device was used, reason for use) FDA has made a determination of safety and probable benefit for use of the HUD only within its approved indication. Use outside labeled indication without proper notification/documentation will put the IRB approval at risk.

  • If a physician wants to use a HUD outside its approved indication(s), FDA recommends
  • btain informed consent from the patient and ensure that reasonable patient protection

measures are followed, such as devising schedules to monitor the patient

  • submit a follow-up report on the patient’s condition to the HDE holder and first check with

the IRB before such use to review any institutional policy

After IRB approves use of the HUD at the facility, Emergency Use of HUD is Allowed Under Certain Circumstances

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SLIDE 37

Courtesy of Dr. R. Thieme, Jewish Hospital, Berlin, Germany; 2014; Case taken from the PK Papyrus Post Market Survey: Case 005.

Case Report – Coronary Type III Perforation in Mid LAD

23-MAY-19 38

Baseline: 75% ostial and 85% mid LAD stenosis Type 3 perforation in stent

  • verlap zone

PK Papyrus implantation Final result with TIMI 3 flow

Patient history

75% ostial and 85% mid to distal LAD stenosis.

Stent implantation

Second Biomatrix NeoFlex created an ~5 mm long perforation in stent overlap area.

Treatment

  • Balloon inflation (2x60 sec.).
  • Protamine injection.
  • Emergency pericardiocentesis.
  • PK Papyrus passage of
  • stial stenosis and proximal

stent without complication.

  • Delivery behavior similar

to a normal coronary stent.

Final result

Patient discharged without further complications 7 days post procedure.

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SLIDE 38

Types of coronary perforation

Distal Wire perforation mechanism treatment

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SLIDE 39

Brilakis ES. Manual of coronary CTO interventions 2nd edition. Elsevier 2017

Distal vessel perforation

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SLIDE 40

Brilakis ES. Manual of coronary CTO interventions 2nd edition. Elsevier 2017

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SLIDE 41

Coils Axium – ev3 Azur – Terumo Finecross 1.8 Fr Progreat 2.8 Fr

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SLIDE 42

A C B D

Lesson Fat floats!

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SLIDE 43

Coil vs. fat embolization

Fat Coil

Visibility + Controlled delivery + Catheter needed for delivery Any microcatheter Larger microcatheter* Availability Universal Often limited Cost High

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SLIDE 44

Brilakis ES. Manual of coronary CTO interventions 2nd edition. Elsevier 2017

Covered stent for distal vessel perforation

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SLIDE 45

Attempted to wire perforated branch with Fielder FC wire

  • ver a Transit

microcatheter with intent to perform fat- embolism “Block and deliver”

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SLIDE 46

2.8x19 mm Graftmaster covered stent delivered next to balloon through a single 8 Fr guide catheter

“Block and deliver”

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SLIDE 47
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SLIDE 48

Types of coronary perforation

Collateral perforation - septal mechanism treatment

Nothing

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SLIDE 49

Types of coronary perforation

mechanism treatment Collateral perforation

  • epicardial
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SLIDE 50

Conclusion – Coronary perforation

  • 1. Prompt recognition
  • Frequent tests
  • Look at your pressure + ECG
  • 2. Know what can happen and what you can

do about it

  • Keep up to date
  • 3. Papyrus stent major advancement in

perforation management

  • 4. Remain calm – communicate with team