C A R D I O L O G Y G R A N D R O U N D S

Title:

Transcatheter Mitral Valve Replacement

Speaker: Wesley R. Pedersen, MD, FACC, FSCAI, FAHA Medical Director of Valve & Structural Heart Disease Program Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: Monday, January 18, 2016 Time: 7:00 – 8:00 AM

Location: ANW Education Building, Watson Room OBJECTIVES At the completion of this activity, the participants should be able to:

1. What are the current indications for TMVR 2. What are the options for TMVR 3. How does mid-term outcomes for Mitraclip hold up to surgery: 5 year FU EVEREST 2 Trial

Physician: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians. Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse: This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education. DISCLOSURE STATEMENTS Speaker Dr. Pedersen has declared that he does not have any conflicts of interest to disclose. Planning Committee Dr. Michael Miedema, Dr. Scott Sharkey and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationship - consultant: Boston Scientific.

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Transcatheter Mitral Valve Therapies

What are the

alternatives?

Normal Mitral Valve Anatomy

Degenerative (Primary) MRMitral Valve Prolapse

Problem results from leaflet/submitral apparatus

Normal Mitral Valve

Functional Mitral Regurgitation

Functional (Secondary) MR

Problem results from Left Ventricular Dysfunctiona) Global: cardiomyopathyb) Regional: ischemic (CAD)

Ischemic Functional Mitral Regurgitation

Mitral Valve Repair vs. Replacement

Early experience with TMVR

• Focus for transcatheter therapies in valvular heart diseases shifted from AS to MR

• TAVR is well established therapy in non-surgical and extreme risk with FDA approval (intermediate risk undergoing evaluation)

• TMVR in early investigation

• Limitations have been related to complexity of mitral valve anatomy and pathology

• Initial patients have end stage disease/multiple comorbidities

TMVR●The past year TMVR has begin in earnest

●MV disease ~3 times as prevalent as AV disease

●EuroHeart Survey

○16% of severe/functional MR undergo surgery

○53% of degenerative MR undergo surgery

●Current numbers are driven by perceived risk/benefit rations

TMVR technically hindered by…

• Saddle shaped annulus

• Subvalvular apparatus

• Possibility of mitral valve prosthesis interacting with LVOT

• Larger sizes of mitral valves

• Limited modes of delivery

• Thus far, access predominantly transapical and some transvenous

• Multiple mechanisms for development of MR

Valve-in-Valve for Failed Mitral Valve Prosthesis

• Initial successes in transcatheter replacement for failed surgical bioprosthesis and rings

• Initial successes using BE Sapien and Sapien XT

• Consistent successes with transapical delivery

• Recently, transvenous, transeptal approach gaining some favor (wire: femoral vein LV apex)

CEMark now obtained for valve-in-valve.

Mitral Valve in Valve

Pre

Post

Valve in MAC

EVEREST Trial

REALISM Trial

COAPT Trial

FDA Approval for limited use 2014

Mitral Valve Regurgitation – Percutaneous Valve Repair

Mitra Clip

Expanding Indications

1. Non-central MR jets (A1-P1 or A3-P3)

2. Calcification in grasping area

3. Status post mitral valve repair

4. 3 clips (providing MVA>2 cm2)

5. No leaflet coaptation interface

6. LVEF < 20%

Current Treatment Groups

● FDA Approval

○Degenerative MV disease patients who are at prohibitive risk for mitral valve surgery

● Investigational

○COAPT – randomized CHF study (MitraClip vs. Medical rx)

■Functional MR patients with LV systolic dysfunction and prohibitive risk for MV surgery

Transcatheter Direct Annuloplasty

Compliments of Valtech

F Maisano, M Taramasso EuroIntervent September Supplement 2015

Cardioband

Design Considerations

D Mylotte N Piazza EuroIntervent September Supplement 2015.

LVOT Obstruction.. Potential Problem

Others: valve dislodgement

Key points Why almost now for TMVI ? (1 to 2 years ago unclear)

● Progress is palpable :

○Recent industry investment

○Early chronic implant data mostly encouraging

○Our implant experience at Abbott Northwestern

○FDA focus and regulatory : is it more favorable

CDRC acknowledged TAVR approval was five years behind Europe/CE mark. ? How far behind with the transcatheter mitral valve.

. Several feasibility/single arm CE Mark trials

MDMA conference, May 2015

Big Time funding from major industry ●Transcatheter Mitral Valve funding 2015

○> 2 Billion dollars

○2 to 4 million cases

● Includes both repair and replacement

CardiAQFortis

Twelve

CardioBandCardioValve

MValve

MitraclipTendyneCephea

• Complete elimination of MR

• Preservation of the subvalvular apparatus

• Minimize risk of LVOT obstruction

• Minimize risk of paravalvular leak post implant

• Minimize closing stress for leaflet durability

• Address wide range of patient sizes / prevent dislodgement

• Prevention of valve thrombosis

• Ease of delivery / eventual TF approach

• One valve should not fit all? Anatomic and functional differences in MR lesions

Design Goals for TMVR

TMVR in Mitral Regurgitation for Either Degenerative or Functional MR

A)CardiAQValve(Edwards)

B) TendyneValve(AbbottVascular)

C)Tiara Valve(Neovasc)

D) Fortis Valve(Edwards)

E)Twelve(Medtronic)

●Focus on implanted Valve technologies

Technology and Data Review

Valve Owner Access Etiology Enrollment Active

Fortis Edwards TA mixed N=13 ? soon

CardiAQ Edwards TA/TF mixed N=8 soon

Tiara Neovasc TA mixed N=4 Yes

Tendyne Abbott TA mixed N=12 Yes

Twelve Medtronic TA mixed N=4 Yes

Edwards – Fortis ●Atrial flange

○Adapts to geometry

• Paddles (2) Leaflet capture

• Anchoring

• Self-expanding nitinol frame

• Bovine pericardial leaflets

• 32 Fr Guide • 3 sizes

Fortis - Procedural and 30 day outcomes

N = 13

Procedural success 10 (76.9)

Conversion to open heart surgery 2 (15.4)

In hospital mortality 4 (30.8)

30 day results

Mortality 5 (38.5)

Probable prosthesis thrombosis 1 ( ? 3 )

Major bleeding 2 (15.4)

Echo at discharge N=9

LVEF (%) 31 ± 12

Mitral regurgitation

None/trace 8

Mild 1

oseph Rodes Cabau, MD; EuroPCR2015

values are expressed as N (%) or mean ± SD

Fortis ( cont.)

oseph Rodes Cabau, MD; EuroPCR2015

Edwards – CardiAQ

●Symmetric

○No rotation required

• Ventricular anchors Leaflet capture

• Atrial anchors Axial stability

• Self-expanding nitinol frame

• 1 size• Annullar skirt for

sealing

• Supra annular valve leaflets

• Tapered outflow to limit LVOT obstruction

• MORE THAN ONE DELIVERY SYSTEM

TS – Transseptal approach

TA – Transapical approach

• ANCHORING MECHANISM :

The frame features 2 sets of opposing anchors for valve

securing

• OTHER:

- Valves are in a Supra-annular position and tapered outflow to minimize the risk of LVOT obstruction

- Intra-annular skirt to minimize PVL’s

- Self expanding nitinol frame

- 32 Fr Guide

- Bovine pericardial

The CardiAQ-Edwards Transcatheter Mitral Valve

●Designed to minimize paravalvular leak

The CardiAQ-Mitral Valve: Intra-annular Sealing Skirt

CardiaAQ - Procedural Outcomes

● Eight (8) compassionate use patients

● Five (5) European centres

● Two procedural complications – deaths

○Malpositioning due to MAC

○Complications with mechanical AO valve

● Two US sites identified for feasibility phase

○University of Pennsylvania

○Cedars-Sinai

Lars Sondergard, MD; EuroPCR 2015

Neovasc – Tiara ●Atrial skirt

○Anatomically shaped

• Leaflet anchors Sealing

• Self-expanding nitinol frame

• Bovine pericardial leaflets

• 42 Fr Guide

Tiara - Procedural Outcomes ● Four (4) patients for severe MR

(8 total patients)

● All at St. Paul Hospital, Vancouver, Canada

●No procedural complications

●MR grade reduced to none:3pts and trivial:1pt

● Two deaths out 69 and 157 days post op

○Functioning prosthesis confirmed at day 60 and day 150 respectively

Cheung A, Webb J et al: JACC 2014; 64(17): 1814-1819

Abbott Vascular – Tendyne●Patient specific fit

○20 valve configurations• Saddle shaped

• 2 self expanding outer and inner nitinol frame• Inner frame

remains symetric and holds leaflets

• Outer frame conforms to patient anatomy

• Fully Retrievable/ Repositionable

• Porcine pericardial leaflets

• Apical teathering chord Secure valve fixation ? LV remodeling

Tendyne - Procedural Outcomes

●Twelve (12) patients for severe MR

●One of 1 valves was successfully retrieved

●Abbott Northwest Hosp (7 Pts.)

●No deaths

●9/10 : 0 PVL leak 1/10 : mild PVL

TENDYNE Case PresentationTENDYNE Case Presentation

Wes Pedersen MD

Director of Transcatheter Valve Intervention

PI Tendyne Feasibility Trial at MHIF/ANW

Minneapolis Heart Institute at Abbott Northwestern Hospital

Wes Pedersen MD

Director of Transcatheter Valve Intervention

PI Tendyne Feasibility Trial at MHIF/ANW

Minneapolis Heart Institute at Abbott Northwestern Hospital

April 8, 2015

First Transcatheter MVR in U.S.

First Transcatheter MVR in U.S.

…eh another day at the shop

YESSSSS!

OH YEAH!

Tendyne Deployment

TEE IMAGING

3D TEE Left Atrial View

3D TEE Left Atrial View

APICAL PAD

Tendyne Feasability Trial

●Methods:

○Criteria:

■Nonsurgical candidate

■3-4+ MR

■NYHA Class III-IV

■LVEF > 30%

■Severe TR or Severe RV dysfunction

■Prior valve prosthesis

Patient Gender 20 male; 1 female

Age (years) 77.1 (range 55-91 years old)

Valve pathology 18 secondary, 1 primary, 1 mixed

LVEF (%) 43.2 ± 12.4%

STS Score 10.0 ± 13.4%

Outcomes:

Success 19/20 (90%)

Unsuccessful deployment 2/21 (10%)

1. LVOT obstruction2. Inadequate angle of

delivery

No deaths or emergent surgery

PRBC Transfusions 14.3%

Strokes None

Perivalve Leaks None

Results

Conclusion: This feasibility trial demonstrates that the Tendyne TMVT can successfully treat severe, high risk MR in patients without significant complications

Fasten your seat belts, we will be landing!!!