1. S.G. Worthley, MB, BS, PhD., S. Redwood, MD, PhD.,
MAVERIC: 6-Month Outcomes of Transcatheter MV Repair in Patients With Severe Secondary Mitral Regurgitation
S.G. Worthley, MB, BS, PhD., S. Redwood, MD, PhD.,
D. Hildick-Smith, MD., T. Rafter, MB, BBS., F. Demarco, MD., M. Horrigan, MB., V. Paul, MB., A. Erglis, MD, PhD.

2. Potential conflicts of interest
Speaker's name: Stephen Worthley
I have no potential conflict of interest to report
X I have the following potential conflict(s) of interest to report:
Type of affiliation / financial interest:
Receipt of honoraria or consultation fees
Medtronic and Abbott

3. Functional Mitral Regurgitation: The Clinical Problem
The global annual incidence of FMR is estimated to be >2,500,000
Left untreated, the 3 year survival rate for those with mod/severe MR is ~ 55%

4. The ARTO™ System Transcatheter Annular Reduction Therapy (TART)
Ample Medical, Inc.
9/12/2018
The ARTO™ System Transcatheter Annular Reduction Therapy (TART)
Septal Device
Immediate and Direct A-P Diameter Shortening to Treat FMR
No compression of LCX or other coronary artery
Venous Based Delivery Under Fluoroscopic Imaging
Acutely Reversible or Removable
12 Fr Delivery System
No residual ASD, no trauma to native MV leaflets or chords
Ample room for future septal access
Procedure generally takes <90 mins
Bridge
Reduces FMR by pulling the lateral wall to the septum; short T- bar anchor in the GCV with a ligature/bridge to a septal anchor;
docking magnets allow safe delivery of device with no possibility of perforation; 47 clinical cases, no instances of LCX compression
GCV Device
Confidential

5. MAVERIC STUDY DESIGN
Multi-Centre, Single Arm 45 Patient Safety and Efficacy Study
30 day, 6 month, 1, 2 and 3 year clinic/echo visit follow-up
Primary Outcome Measures:
Safety: Major Adverse Events at 30 days
Efficacy: Mitral Regurgitation Grade at 30 days
Secondary Outcome Measures
NYHA Class
HF Hospitalization
Device success measures
Major Inclusion Criteria:
MR Grade > 2+
NYHA Class II-IV
Optimized medical therapy
Major Exclusion Criteria:
Significant structural abnormality of the mitral valve
Known need for any cardiac surgery
Life expectancy <1 year
Echo Core Lab: CERC
Study Mgmt: CERC
All Events CEC Adjudicated

6. Safety at 6 months Safety Composite Endpoint at 6 months* Death
CEC Adjudicated Event
30 days
N=45
N(%)
6 months
N=42
Safety Composite Endpoint at 6 months*
2(4.4)
7(16.0)
Death
3(7.2)
Cardiovasc
Non-cardiovasc
Stroke
1(2.3)
Myocardial Infarction
Mitral Operation/Intervention
Cardiac Tamponade
1(2.2)
Renal Failure
3(6.9)
You will see that there are 9 events in total but only 7 show in the primary. 2 patients had more than 1 of the composite events (both had both renal failure +death) and for the primary only one event counts.
3 deaths between 30d and 6 mos: all cardiovascular – none related to device or procedure. 2 in patients with prior history of renal insufficiency and 1 in patient with mitochondrial myopathy – autopsy ischemic heart disease.
1 stroke at day 69 in pt diagnosed 23 days post-procedure with recurrent lymphoma
1 mitral reoperation due to a migration of the T-bar into the left atrium. Believe procedure related – wire handling may have created a very small slit – very early in device experience. Upon operation surgeons found no evidence of erosion and no evidence of a hole.
*Death, Stroke, MI, cardiac tamponade, device related cardiac surgery, renal failure

7. MR Grade Reduction at 6 months
18.4
39.5
29.0
13.2
Paired Data N=38
P<0.0001 1
36.8 8 e g a t 6 n e c
31.6 r e P 4 2
TART = Transcatheter Annular Reduction Therapy
50% of patients 0-1 MR at 30 days, 57.9% at 60 days
68.4% in Grade 3+/4+ at baseline, 13.2% at 6 mo FU
38 paired patients: start at patients not eligible ( MR <2+) = pts died before 6 months = pt had echo outside hospital and could not be retrieved. Pt finally came back this week but data not analyzed yet.
31.6
Pre-procedure
6 Months
0-Trace 1+ 2+ 3+ 4+

8. NYHA Class Improvement at 6 months
29.3
63.4
7.3
17.1
61.0
22.0 2 4 6 8 1 P e r c n t a g
Pre 6M
Paired data N=41
P<0.0001 I II
III IV
TART = Transcatheter Annular Reduction Therapy
45 patients. 3 deaths = patient did not have a clinic visit at 6 months = 41

9. MAVERIC: Reduced Volumes and Indices at 6 months
Paired data

10. MAVERIC CONCLUSIONS
MR Grade, AP Diameter, NYHA Class and RVols after the ARTO procedure were all significantly reduced at 6 months and improvements evident and maintained from 30 day outcomes
The primary safety composite endpoint was low at 16%, as was mortality (7.2%) with no deaths attributed to the device or procedure
Importantly, the rate of hospitalization for heart failure and heart failure or death were both low at 9.3% and 16.2% respectively
This study demonstrates the 6 month efficacy and safety of the ARTO System for the treatment of FMR