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“Soon, I Will Remodel Your Valve”
Evolving Interventional Therapies for
Treatment of Mitral Regurgitation

Duane Pinto, MD MPH
Beth Israel Deaconess Medical Center
Harvard Medical School

Harvard
Medical
School


MR Etiology

Normal

Degenerative MR
—Prolapse

Degenerative MR
—Flail

Functional MR
Ischemic vs.
nonischemic

Harvard
Medical
School

Edge to Edge (Evalve)
Human
S/P surgical Alfieri
Circulation. 2002;106:e173

Evalve clip repair in
porcine heart
(6 mos post repair)
Circulation 2003;108(Supp IV):493

Harvard
Medical
School


The MitraClip System
Clip Delivery System

MitraClip Device (Clip)

MitraClip System
Arm

Steerable
Guide Handle

Delivery
Catheter
Handle

Gripper

Steerable Guide, Steerable
Sleeve, and Delivery Catheter

Stabilizer

MitraClip Device
(Clip)

Harvard
Medical
School


MitraClip Features
• Venous puncture
• Standard Percutaneous Left Atrial Access
• Versatile Positioning Capabilities
o Adaptability to varying patient anatomy
• Precise MitraClip Placement Control
o Re-positioning capability
• Allows multiple tissue releases and grasps
• Allows optimal MR reduction
• Provides option to not deploy Clip

Harvard
Medical
School

Echo Related Valve Anatomy
Use of common
anatomically
based
vocabulary
reinforces clear
communication

MEDIAL
0

60

POSTERIOR

FOSSA

P3
30

A3

0

AO

P2
A2

A1 P1

30
0

ANTERIOR

LAA

LATERAL


Worldwide Experience
Study

Population

N*

EVEREST I (Feasibility)

Feasibility patients

55

EVEREST II (Pivotal)

Pre-randomized patients

60

EVEREST II (Pivotal)

Non-randomized patients
(High Risk Study)

78

EVEREST II (Pivotal)

Randomized patients
(2:1 Clip to Surgery)

REALISM (Continued Access)

Non-randomized patients

899

Compassionate/Emergency Use

Non-randomized patients

66

ACCESS Europe Phase I

Non-randomized patients

567

ACCESS Europe Phase II

Non-randomized patients

286

Commercial Use

Commercial patients

Total

*Data as of 2/28/2014. Source: Abbott Vascular

279
184 Clip
95 Surgery

10,754
12,949
+95 surgery

Harvard
Medical
School


Commercial MitraClip Implant

Experience
–
–
–
–
–

Treating Centers: 305
Patients1:
11,607
Implant Rate1:
96%
Acute MR reduction1,2: 99%
Etiology
• Functional MR
• Degenerative MR
• Mixed

Etiology

67%
21%
12%

1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients
2. Successful implants only.

Data as of 2/28/2014. Source: Abbott Vascular.

Harvard

Medical
School


Long-Term Durability of Clinical Success
5-Year Outcomes in Patients Who Were Alive and Free From
MR 3+/4+ and MV Surgery (or Re-Operation) at 1 Year

EVEREST II RCT
Clinical Success Groups
MitraClip
(N=97)

Surgery
(N=64)

Freedom From Death at 5 Years

87%

90%

Freedom From MV Surgery (or Re-operation) at 5 Years

94%

95%

MR ≤ 2+ at 5 Years

86%

97%

MR ≤ 1+ at 5 Years

47%

92%

47%  6%

40%  3%

Mean Change in LVEDV From Baseline to 5 Years

-27 ml

-45 ml

Mean Change in Diastolic SLAD From Baseline to 5 Years

0.0 cm

-0.4 cm

Outcome

NYHA Class III/IV (%) Baseline  5 Years

Harvard
Medical
School


MR Etiology

Normal

Degenerative MR
—Prolapse

Degenerative MR
—Flail

Functional MR
Ischemic vs.
nonischemic

Harvard
Medical
School


Trial design

430 patients enrolled at up to 75 US sites
Significant FMR (≥3+ by core lab)
Symptomatic heart failure subjects who are treated per standard of care
Determined by the site’s local heart team as not appropriate for mitral valve surgery

Specific valve anatomic criteria

Randomize 1:1
MitraClip
N=215

Control group

Standard of care
N=215

Clinical and TTE follow-up:
Baseline, Treatment, 1-week (phone), 1, 6, 12,
18, 24, 36, 48, 60 months
Harvard
Medical
School


Patient Selection:
Bottom Line
Degenerative

Functional

Low Surgical
Risk

Surgical Mitral
Valve Repair

COAPT

High Surgical
Risk

MitraClip

COAPT

Harvard
Medical
School


Edge-to-edge (2)
• eValve
• Edwards Mobius
Coronary sinus annuloplasty (3)
• Edwards Monarc
• Cardiac Dimensions Carillon
• Viacor PTMA
Indirect annuloplasty (3)
• Ample PS3
• Myocor i-Coapsys
• St. Jude AAR
Direct annuloplasty (5)
• Mitralign
• Guided Delivery Systems
• QuantumCor, Cordis DPA

• MiCardia, Mitral Solutions

Device Landscape:
Percutaneous MV Repair

Harvard
Medical
School


The Coronary Sinus Approach
to Mitral Regurgitation

A

L
P

…cinch the valve

Harvard
Medical
School


Coronary Sinus Approach
CARILLON

–
–

–
–

Reduces annulus by traction
Varying degrees of tension to system
Effect on FMR can be assessed during implantation
Implant can be recaptured if placement is not as
desired (e.g. LCX compression)
Distal
anchor
Proximal
anchor

Harvard
Medical
School


Mitralign Direct
Annuloplasty System
Before and after
implant: Atrial view

• Direct reduction of the annular SL dimension based
on posterior leaflet surgical plication
• Small (1 cm, 20%) plication of the posterior annulus
reduces ischemic MR, with durable surgical results
Tibayan et al. Ciculation. 2003;108:II-128-133
Aybek et al. JTCS. 2006; Nagy et al. Scand Cardio J. 2000

Harvard
Medical
School


Percutaneous Mitral Valve Replacement:
Role in DMR and FMR may be different
• In DMR, there is something physically wrong with the
valve apparatus
• With the exception of MitraClip, percutaneous repair
technologies apply less to DMR

• Also the use of MitraClip in DMR, may limit future
ability to place a percutaneous replacement valve,
complicating the choice of therapy
• Therefore, percutaneous replacement may become a
viable option earlier in DMR patients


Status of Emerging
Replacement Systems
(all but one are pre-clinical)


Status of Emerging Replacement Systems
CardiaQ
• NiTi, self-expanding
• Trileaflet, symmetric
• 2 sets of 12 anchors
• Transcatheter venous, transseptal

• Percutaneous FIM Gen1 in 2012 (1 patient)

• Percutaneous FIM Gen2 planned for 2013
• The only percutaneous replacement technology to
perform a human case


Successful First-in-Human procedure in June 2012


CardiaQ - Acute In Vivo Results


Status of Emerging Replacement Systems
Neovasc
•NiTi, self-expanding
•Trileaflet, D-shaped
•3 ventricular tabs
•Transapical access
•150d animals completed
•FIM target late ‘13 or early ‘14


Status of Emerging Replacement Systems
Medtronic
• NiTi, self-expanding
• Trileaflet, D-shaped
• 3 ventricular arms
• Transatrial access
• Acute animals

• FIM not yet planned


Status of Emerging Replacement Systems
Tendyne
•NiTi, self-expanding
•Neochords with apical tethering
•Transapical
•30d animals completed
•FIM planned for late ‘13


Status of Emerging Replacement Systems
Valtech
• NiTi, self-expanding
• Trileaflet
• Transapical with hope for transfemoral
• 30d animals completed
• FIM not yet planned