“The present and the future of TMVR” - EuroValve...

“The present and the future of TMVR”

Why to refer now to TMVR Therapy?

Fausto Castriota MD, FESC

Chairman Cardiovascular Units

GVM Care and Research – (Italy)

Global MitraClip Experience

1. Includes clinical and commercial procedures as of 30/11/2016. Source: Data on file at Abbott Vascular

OVER 40,000 PATIENTS TREATED

GLOBALLY1

Treating Centers 777

Patients (clinical and

commercial)Over 40,000

Implant Rate1 97%

Functional MR2 64%

Degenerative MR2,3

22%

Mixed 14%

1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients2. OUS Commercial Experience3. Etiology not inclusive of U.S. cases as of 14/04/2014Data As of November 30, 2016. Source: Data on file at Abbott Vascular

MitraClip Therapy Current Global Adoption

Background EVEREST II RCT

1Feldman et al. NEJM 2011;364:1395-406

PML04247 Rev. A

EVEREST - Endovascular Valve Edge-to-Edge REpair STudy

The EVEREST II RCT was a prospective, multi-center trial designed to compare the safety and effectiveness of the MitraClip System with mitral valve surgery in the treatment of patients

with significant (≥3+) mitral regurgitation

Feldman T, ACC 2014 Washington

Long- Term MitraClip Device SafetyLong-Term MitraClip Device Safety

EVEREST II RCT

Through 1 Year # (%) of patients

1 Year to 5 Years # (%) of patients

Single Leaflet Device Attachment (SLDA)

10 (6.3%) 0 (0.0%)

MV stenosis 1 (0.6%) 0 (0.0%)

Device Embolization 0 (0.0%) 0 (0.0%)

Based on N=158 who were implanted with 1 or 2 MitraClip devices

PML04247 Rev. A

Feldman T, ACC 2014 Washington

Mitral Regurgitation Grade Everest II RCT all treated patients 258

Stable improvement NYHA Funtional ClassEverest II RCT all treated patients 258

5-Years FU mortality in EVEREST II

9Feldman T, ACC 2014 Washington

EU Registries in the Real Word

Access EUN = 487

Grasp-ITN = 304

SentinelN = 552

Quality of Life Score (MLHFQ) and6-minute Walk Distance

27/01/2017 Direzione o Dipartimento

18

Investigational Device only in the U.S. Not available for sale in the U.S.ACCESS EU – ESC 2012

Quality of Life Score (MLHFQ) and 6-Minute Walk Distance

41.6

28.1

0

15

30

45

60

Mean Q

oL

Sco

re (

MLH

FQ

)

Baseline 1 Year

N = 264 Matched Cases

Mean improvement -13.5 points95% CI: (-16.0, -11.0)

p<0.0001

MLHFQ

275334

0

100

200

300

400

Mean M

ete

rs W

alk

ed

Baseline 1 Year

p<0.0001

N = 216 Matched Cases

Mean improvement 59.5 meters95% CI: (44.5, 74.6)

6MWT

Whitlow, ACC 2012

Hospitalization

1. Nkomo et al. Burden of valvular heart diseases: a population-based study. Lancet 2006 Sep 16;368(9540):1005-11.

Moderate or severe MR is estimated to be present in 1.7% of the adult population The prevalence rises strikingly with advancing age (> 9% for ≥ 75-year-old subjects, p<.0001) 1

Prevalence of Mitral Regurgitation

% on total population ≥ 75-year-old subjects

Italian Population ≥ 75-year-old

Trend of Aging Population

Source: Italian National Institute for Statistical Studies (ISTAT). 2014

Prognostic implications of Mitral Regurgitation

1919

JACC: CARDIOVASCULAR INTERVENTIONS. VOL. 7, NO. 8, 2 0 1 4

21

2014

22

American Heart Journal, Nov 2015. 170 (5) p.1050-1059

2015

23

The American Journal of Cardiology , Accepted on October 2015

2016

Predictors of Poor Prognostic Implication

Piotr Ponikowski, MD, PhD, FESCMedical University, Centre for Heart Disease Clinical Military Hospita HFA Athens 2014

WHEN refer to TMVR: Timing is crucial

The importance of a timely intervention at an early stage

Why to refer now to TMVR Therapy?

Conclusion

Thank Youfor yourattention