“the present and the future of tmvr” - eurovalve...
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“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