system chief of cardiovascular president, … bleeding both received mv repair, no mr at d/c...

William A. Gray MD

System Chief of Cardiovascular

Services, Main Line Health

President, Lankenau Heart Institute

Wynnewood, Pennsylvania

USA

Main Line Health Lankenau Heart Institute

Mitral Valve Disease Today…

Nkomo VT et al. Lancet. 2006; 368:1005-1011

AHA Heart Disease and Stroke Statistics – 2017 Update, Circulation 2017

Mitral regurgitation is the most common type of heart valve insufficiency in the US

Prevalence increases with increasing age, from 0.5% for 18-44 yr old rising to 9.3% for ≥75 yo


Mitral Valve Repair Today…

Feldman et al, JACC 2015;66:2844-54.

5-year Results of EVEREST II Primary MR

Survival

>50,000

Procedures

worldwide

The only FDA approved TMVr device

High surgical risk patients Primary MR

Evanston Hospital Sorajja et al, JACC 2016;67:1129-40


STS/ACC TVT Registry Outcomes

564 patients treated Nov 2013-Aug 2014 Primary MR 90.8%

Evanston Hospital Sorajja et al, JACC 2017;70:2315-27


STS/ACC TVT Registry Outcomes

2,952 patients treated Nov 2013-Sep 2015 Primary MR 85.9%

Presented at TCT

10-31-17

Evanston Hospital

Functional MR, unmet need with unmet evidence base…

Enrollment complete

Stone, TCT 2017

Evanston Hospital

Evanston Hospital Stone, TCT 2017

Evanston Hospital

Many New Technologies

Evanston Hospital Worthley et al, TCT 2017

New TMVs devices today…

ARTO-MVRx System


Characteristic All Patients (N=45)

Device Technical Success (MVARC)*% 100

Compression of LCX or other coronary

artery n (%) 0(0)

New Onset Atrial Fibrillation, n (%) 0 (0)

ARTO procedure time (mins) 88.0 ± 28.7

Fluoro Time (mins) 43.5 ± 16.2

Total Contrast Vol (ml) 96.0 ± 82.0

Days in Hospital (median)

(IQR)

2.0

(1-5)

Device Technical success defined as: At exit from cath lab, alive, with: 1) Successful access, delivery and retrieval of the

device delivery system, and 2)Deployment and correct positioning (including repositioning/recapture if needed) of the

single intended device, and 3)No need for additional unplanned or emergency surgery or re-intervention related to the

device or access procedure

Procedural Outcomes (Phase I/II)

Effective MR Reduction at 30 days (Phase I/II)

30 day Safety Outcomes (Phase I/II)


MR Grade Reduction Maintained to 3 years

(Phase I)


Reduced Heart Failure Hospitalization (Phase I)

The post ARTO number includes a hospitalization for a patient who died but was not hospitalized

P=0.01


NYHA Class Reduction

Maintained to 3 years (Phase I)

*

Evanston Hospital Gammie et al, TCT 2017


HARPOON System

Harpoon: Technology

21-gauge needle with pre-wound

ePTFE suture in preformed knot

configuration

Hemostatic introducer to

reduce blood loss

Delivered to the valve via a low profile

3mm delivery system

Double helix anchor with ePTFE

suture as the only implant

Harpoon Procedure

Real-Time Titration of ePTFE

Cordal Length

Early Feasibility Study

First 13 Patients

Feb 2015 – Feb 2016

-Safe

-Effective MR Reduction

Circulation. 2016;134:189–197

Technical success rate:

95 % (41/43)

Two intraoperative conversions to conventional surgery

-Patient #14 poor imaging, insufficient MR reduction

-Patient #23 poor imaging prolonged proc, access

site bleeding

Both received MV repair, No MR at D/C

Procedural success at 30 days:

93% (40/43)

One repaired valve MSSA infective endocarditis POD #27

Preop elevated WBC, dental disease unrecognized: successful MVR

Results

Excludes 3 conversions to conventional surgery

100% 100%

87.5%

12.5%

100%

0%

20%

40%

60%

80%

100%

Baseline(43)

Procedure(41)

Discharge(38)

30-Day(40)

Mass General Core Lab Adjudicated

Harpoon Patients MR Grades

Severe

Moderate

Mild or Less

Results: MR Grades

P2

Pr

e

Post

5 mm

Harpoon Annuloplasty Effect

Evanston Hospital Praz et al, Lancet 2017;390:773-80


Edwards PASCAL TMVr System

23 patients treated with

compassionate use

Spacer delivered via TS approach

Evanston Hospital Praz et al, Lancet 2017;390:773-80

Edwards PASCAL TMVr System


Evanston Hospital

Ongoing Clinical Trials today…

Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Multicenter, multi-national, prospective, single arm, early feasibility

60 patients, 20 sites

3 (+) to 4 (+) MR (FMR or DMR)

NYHA II or greater

Candidate for surgery but surgery considered not the best option

Evanston Hospital

Ongoing Clinical Trials today…

Cardioband The Carrillon Trial (FDA IDE)

400 patients, 50 sites US, Canada, EU, Australia

EF <50%

At least 2+ MR and EORA ≥0.2 cm2

NYHA II, III or IV

2:1 Device vs GDMT

Blinded sham-controlled

400 patients

Ischemic or non-ischemic CMP

2:1 Device vs GDMT

Evanston Hospital

Combo therapy today…

+ =

“Tool Box” Concept

Evanston Hospital

CardiaQ Tendyne Tiara Twelve

SAPIEN 3 MAC-ViR-ViV

SAPIEN XT MAC-ViR-ViV

TMVR Early Feasibility Study Trials today…

Caison

Evanston Hospital

Evanston Hospital

TMVR EFS Trials today…

Tendyne Feasibility Trial

30 high risk surgical patients

Muller et al, J Am Coll Cardiol Dec 2016;S0735-1097(16)37122-4.

Evanston Hospital

Tendyne 30-Day Outcomes

Device Success at 30 Days

Success 80% (60/75)

Failure* 20% (15/75)

Mortality 6.7% (5/75)

Implant not Successful 4.0% (3/75)

LVOT Obstruction 1.3% (1/75)

Valve did not seat properly 1.3% (1/75)

Patient became hemodynamically unstable,

procedure not completed, unplanned circulatory support

1.3% (1/75)

Re-intervention 2.6% (2/75)

Reposition Device- resolve PVL 1.3% (1/75)

Bleeding with re-operation 1.3% (1/75)

Device-related performance or Adverse Events* 5.3% (6/75)

Mitral valve gradient > 6 mmHg 5.3% (4/75)

Paravalvular Leak 1.3% (1/75)

Device Malpositioning 1.3% (1/75)

Device Thrombosis 1.3% (1/75) Muller, London Valves 2017

Kaplan-Meier survival curve (n=30)

•

1.0

0.8

0.6

0.4

0.2

0.0 0 100 200 300

Days

All-cause mortality

0.83


Tendyne TMVR: 1yr outcomes

Outcome N=30

Death (all cause) 5 (16.7%)

Cardiac 4 (13.3%)

Non-cardiac 1 (3.3%)

CVA/TIA 0 (0%)

Re-hospitalisation

Heart failure 3 (10.0%)

MV surgery 0 (0%)

Valve performance (n=28)

Malposition/PVL/hemolysis 1 (3.6%)

Leaflet thrombosis 1 (3.6%)

•

MR severity 1 year post-TMVR Paired data

N: 19 19 19

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Baseline 1mth 12mths

Grade 4

Grade 3

Grade 2

Grade 1

Grade 0

89.5

10.5

94.7

5.3

94.7

5.3

LVEF post-TMVR Paired analysis

p=NS

N: 18 18 18

0

5

10

15

20

25

30

35

40

45

50

Baseline 1mth 12mths

46.7

38.4 42.0

p<0.01 vs baseline p=NS

LVEF (%)


Functional capacity post-TMVR (n=30)

>1 class improvement in 60%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Baseline 1month 12months

NYHA Class

Class 4

Class 3

Class 2

Class 146.7

53.3 55.0

40.0

5.0 7.1

25.0

50.0

17.9

N: 30 28 20

Quality of Life: KCCQ

•

0

20

40

60

80

100

120

baseline 30 day 12 months

KC

CQ

KCCQ in subjects with complete data at three timepoints (n=22)

* *

p<0.001 p<0.001

* vs baseline

Evanston Hospital

Intrepid Pilot study

Sorajja, TCT 2017

Evanston Hospital

APOLLO Pivotal Trial

650 patients, 60 sites

2 cohorts:

1 randomized to surgery to demonstrate non-inferiority

1 single arm for high surgical patients

Press release 10-23-17

Evanston Hospital

Conclusions

Large number of patients need MV intervention

The era of TMVr and TMVR has begun

The is an explosion of new devices and clinical trials

TMVR is developing at a lower pace than TAVR

With aging population, more patients will need MV intervention

Outcomes of TMVr & TMVR will be superior than surgical outcomes

Most MV patients will be treated with transcatheter therapies

Most procedures will be performed with a transseptal approach

Today…

Tomorrow…

Evanston Hospital

Tissue engineered THV’s ?

Bioabsorbable valve stent frames ?

The day after tomorrow…

system chief of cardiovascular president, … bleeding both received mv repair, no mr at d/c...

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