Emerging Mitral Technologies – Where Are We Now?

MICHAEL MACK, MD

BAYLOR SCOTT & WHITE HEALTH

DALLAS, TX

Conflict of Interest Disclosure Abbott Vascular- Co PI COAPT Trial

Medtronic- Executive Committee APOLLO Trial

Edwards Lifesciences- Co-PI PARTNER 3 Trial

SAVR & TAVR Volumes in US

48231 48355

46000

41490

16106

24908

37988

48434

0

10000

20000

30000

40000

50000

60000

2014 2015 2016 2017Est

AVR +/-CABG

TAVR

Source: STS and ACC database as of January 23, 2018

Transcatheter MV Repair: Device Landscape 2018

Coronary sinus annuloplasty • Cardiac Dimensions Carillon**

• Cerclage annuloplasty

Edge-to-edge • MitraClip***

• MitraFlex

Direct annuloplasty and basal ventriculoplasty

• Mitralign TAMR** • Valtech Cardioband**

• GDS Accucinch* • Millipede IRIS* • MVRx ARTO* • Mardil BACE* • Mitraspan*

• Valcare Amend* • Micardia enCor

• Cardiac Implants RDS • QuantumCor (RF)

MV replacement (cont) • MitralHeal

• HT Consultant Saturn • Lutter valve

• Transcatheter Technologies Tresillo • Venus • Verso

• Transmural Systems

Other approaches • NeoChord DS 1000** • Harpoon neochords*

• Babic chords* • Middle Peak Medical*

• St. Jude leaflet plication* • Cardiosolutions Mitra-Spacer*

• Valtech Vchordal • Mitralix

MV replacement • Edwards CardiAQ*

• Edwards Fortis* • Neovasc Tiara*

• Abbott Tendyne* • Medtronic Intrepid*

• HighLife* • MValve* • Caison*

• NCSI NaviGate • St. Jude

• Micro Interventional • Valtech CardioValve

• ValveXchange • MitrAssist

• Braile Quattuor • Cephea

• Direct Flow • Sinomed Accufit

Mitral

Regurgitation

Secondary Primary

Type IIIb Type II

Transcatheter Mitral Valve Therapy

PRIMARY MR

Repair ◦ MitraClip

◦ Pascal

◦ Neochord

◦ Harpoon

Adjunctive Annuloplasty

Replacement (TMVR)

SECONDARY MR

Repair ◦ MitraClip

◦ Pascal

Annuloplasty ◦ Direct

◦ Indirect

Replacement (TMVR)

Mitral

Regurgitation

Secondary Primary

Type IIIb Type II

MitraClip Approved in US for High Surgical Risk

Degenerative (Primary) MR Only

MitraClip Therapy - Global Adoption

Treating Centers 800

Patients (clinical & commercial) Over 50,000

Implant Rate 97%

Functional MR 64%

Degenerative MR 22%

Mixed 14%

MitraClip Patients TVT Registry

1159

2676

4305 4720

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

2014 2015 2016 2017

Source: STS/ACC TVT Registry Database as of January 23, 2018

6 Months

MitraClip In Hospital Mortality

2.50% 2.20%

2.30%

0.00%

0.50%

1.00%

1.50%

2.00%

2.50%

3.00%

3.50%

4.00%

4.50%

5.00%

2015 R4Q 2016 R4Q 2017 R4Q

Source: STS/ACC TVT Registry Outcomes Report as of Oct 17, 2017

Mitral Interventions Edwards PASCAL Repair System

PA S C

AL

ddles

pacer

lasps

fieri

FIM Ongoing

Mitral Interventions Edwards PASCAL Repair System

Mitral Interventions NEOCHORD

Leaflet Capture Verification

Monitor

Delivery Instrument

Suture Cartridge

Needle

• Transapical access • Off pump (beating

heart) • Echo guided • Free leaflet edge,

chordal implants • MV repair

Mitral Interventions NEOCHORD

CE Approved; U.S. Pivotal RCT Ongoing

Harpoon Artificial Cords

JACC Jan 2018

Mitral

Regurgitation

Secondary Primary

Type IIIb Type II

Mitral Interventions Annulus MV Repair Systems

• Direct Annuloplasty Mitralign Valtech Cardioband Valcare AMEND Cardiac Implants Millipede

• Indirect Annuloplasty Carillon (coronary

sinus approach) Mitral Cerclage MVRx

Cardioband

Millipede

#1 Placement

#2 Annular Attachment

#3 Annular Reduction

Complete Semi-rigid AV Valve Ring; Adjustable and Repositionable

Millipede

Surgical Human Implants – FIM Pending

1. Applicable to primary and secondary MR, regardless of anatomy or pathology

2. Ease of implantation (?)

3. Reliable elimination of MR

4. Greater durability ?

Transcatheter MV Replacement More than 30 in development!

Potential advantages (vs. repair)

New TMVR Systems First in Human Timelines

Early Feasibility Studies in US TMVR

CardiaQ

Currently in Trials in US

Caisson

Intrepid

Tendyne

Tendyne TMVR

A global registry of 30 patients with symptomatic severe MR; Tendyne TMVR with procedural and 30-day outcomes

Muller DWM et al. J Am Coll Cardiol 2016

JACC Jan 2018

Mitral Valve Disease Major Unanswered Questions Does MR need to be completely corrected?

Can primary MR be corrected sufficiently by a transcatheter approach?

Does correction of secondary MR improve survival or quality of life?

Which is preferable for secondary MR- repair or replacement?

New TMVR Systems

#8

Fusion Imaging

Transcatheter Valve Therapy TAVR Mitral Tricuspid

Summary None of This is Ever As Easy As It Looks!