Mitraclip θεραπεία για DMR σε ασθενείς υψηλού χειρουργικού κινδύνου. Αναγκαιότητα
και αποτελέσματα
Νινιός Βλάσης
Κλινική Άγιος Λουκάς
Θεσσαλονίκη
DISCLOSURES
• PROCTOR FOR MITRACLIP ABBOTT VASCULAR
ΑΝΕΠΑΡΚΕΙΑ ΜΙΤΡΟΕΙΔΟΥΣ
ΑΝΑΤΟΜΙΚΗ ΑΝΕΠΑΡΚΕΙΑ ΛΕΙΤΟΥΡΓΙΚΗ ΑΝΕΠΑΡΚΕΙΑ
87 Y. OLD MALE- RECENT PULMONARY OEDEMA
DISCHARGED AFTER 48 HOURS- 3 HOURS IN ITU- PROCEDURE DURATION 45 MINUTES
78 Y. OLD WITH COAD
DISCHARGED 24 HOURS LATER
OCCASIONALY YOU MAY NEED TO DO THIS….
Growing Body of Clinical Evidence
EVEREST II
RCT
ACCESS EU, REALISM,
EVEREST II HR cohort
Registries
Franzen, Schillinger, Sven, Treede, Auricchio,
Baldus, Van den Branden, Velasques
Large cohorts*
*large cohort is defined as >50 patients
Demonstrated overall concept, clinical
safety and effectiveness
Addressed specific
patient populations
COAPT and RESHAPE-HF
Randomized trials of MitraClip versus optimal medical
therapy
EVEREST II Randomized Controlled Trial Design
Patient Demographics
MitraClip Therapy (n=184)
Surgery (n=95) P-value
Age (mean) 67 years 66 years 0.32
Male 63% 66% 0.60
History of CHF 91% 78% 0.005
Degenerative MR Etiology 74% 73% 0.81
Functional MR Etiology 26% 27% 0.81
Mean Ejection Fraction 60% 61% 0.65
Previous Coronary Artery Bypass Grafting (CBAG)
21% 19% 0.54
NYHA Functional Class III/IV 51% 48% 0.61
Atrial Fibrillation 34% 39% 0.42
Surgery
N=95
279 Patients Randomized at
37 SitesSignificant MR (3+ or 4+)
Specific Anatomical Criteria
Echocardiography Core Lab
and Clinical Follow-upBaseline, 30 days, 6 months, 1 year,
18 months, and annually through 5 years
MitraClip Therapy
N=184R 2:1
Source: Feldman T, Foster E, Qureshi M, et al. The EVEREST II Randomized Controlled Trial: Three Year Outcomes Transcatheter Cardiovascular Therapeutics; October 22-26, 2012; Miami, FL.
Degenerative MR, Declined for Surgery
Reichenspurner, H. et al. Clinical Outcomes through 12 months in patients with Degenerative Mitral Regurgitation treated with the MitraClip device in the ACCESS-Europe Phase I trial. Eur J
Cardiothoracic Surgery. 2013: July 17
• ACCESS-EU DMR patients cohort: 117 elderly patients, 74% in NYHA class lll-lV
• Significant reduction in MR and clinical improvements reported at 12 months• Implant rate of 94.9%
• MitraClip therapy reduced symptoms and enhanced quality of life in patients deemed
inoperable or at high surgical risk
• Survival rate of 82.9% reported at 12 months
Mitral Regurgitation Grade Reduction
(N=71, matched)
P=0.0002
As assessed by sites
2+
3+
4+
0+
1+
2+
4+
3+
74.6% MR≤2+ at1 Year
Significant NYHA Functional Class Improvements
(N=78, matched)
p<0.0001
I
II
III
IV
I
II
III
80.8% NYHAClass I or IIat 1 Year
Outcomes of the Initial Experience
with Commercial Transcatheter Mitral
Valve Repair in the U.S.
A report from the STS/ACC TVT Registry
ACC 2015 LBCT
Paul Sorajja, MD, Saibal Kar, MD, Amanda Stebbins, Sreekanth
Vemulapalli, MD, D. Scott Lim, MD, Vinod Thourani, MD,
Michael Mack, MD, David R. Holmes, Jr., MD,
Wesley A. Pedersen, MD, and Gorav Ailawadi, MD
Outcomes of commercial experience unknown
TMVR with MitraClip in the U.S.
Over 100 sites activated
Surgical Risk and Cases564 patients at 61 hospitals
No.
Cases
Study Population564 Patients
• Median age (% men)…………………..…..
• NYHA III/IV……………………………….……….
• HF hospitalization prior yr…………….……....
• Atrial fibrillation………………………….……...
• Prior CVA………………………………….………
• Diabetes………………………………….……….
• Prior CABG……………………………….………
• Prior MI…………………………………………...
• Creatinine ≥2 g/dl……………………………….
• O2-dependency………………………….………
• Median STS-PROM MV repair..............…
• Median STS-PROM MV replacement.….
83 yrs (56%)
83.9%
51.8%
62.6%
8.7%
25.0%
32.4%
24.6%
16.7%
14.7%
7.9% (4.7, 12.2)
10.0% (6.3, 14.5)
Other Procedure Indications
•Frailty……………...........................................
•Hostile chest…………………….....................
•Porcelain aorta………………….……………..
•RV dysfunction with severe TR….…....……
•Immobility………………………………....……
•Severe liver disease (MELD >12)……..........
•IMA at high risk of injury…………………….
•Unusual extenuating circumstance…….…
57.2%
6.0%
3.4%
2.3%
1.2%
0.5%
1.4%
25.3%
Echocardiographic data
• LV ejection fraction..………..…..….
• MR severity grade 3 or 4……….….
• LV EDD………………………………..
• LV ESD………………………………..
• Degenerative MR…………...............
• Posterior prolapse.………………
• Posterior flail………………...……
• Functional MR………………............
• Mitral annular calcification…….….
• Leaflet calcification…….…………...
• Mitral gradient ≥5 mmHg…………...
• MVA <4 cm2…………………………..
• Severe TR…………………………….
56% (45, 63%)
94.0%
5.2 cm (4.6, 5.8 cm)
3.6 cm (3.0, 4.5 cm)
85.5%
28.9%
28.0%
14.4%
38.4%
17.2%
8.0%
19.7%
14.7%
Grade 4
Grade 3
Grade 2
Grade 1
Mitral Regurgitation
Change in Mitral RegurgitationClip implantation occurred in 94%
93% MR ≤2
63.7% MR≤1
p<0.001
Clinical Outcomes
• Procedure success….
• Complications............
• Length-of-stay............
• Home discharge.........
91.8%
7.8%
3 d (1,6 d)
81.9%
Adverse Events
• In-hospital mortality……………..…….
• 30-day mortality…………………………
• Cardiac surgery…….....………….…….
• Stroke……………………………..………
• Myocardial infarction……………...……
• Major bleeding………………….….……
• Cardiac perforation……………….……
• Device-related events……………..…...
• Single leaflet device attachment....
• Device embolization…………..……
• Other…………………………….….…
2.3%
5.8%
0.5%
1.8%
0%
3.9%
0.7%
2.7%
1.1%
0.4%
1.2%
• EDD
• Case vol. (per 2)
• A2-P2 clip site
Univariate Odds Ratios for MR grade ≤2
0 1 2 3
• Baseline MR
Clinical Variables and Residual
MR
p=0.01
p=0.03
p=0.01
p=0.03
Odds Ratios Less MRMore MR
Commercial TMVR with MitraClip
Data Summary
• Prohibitive risk population with 86% DMR
• Mortality: 2.3% in-hospital, 5.8% at 30-days
• 91.8% procedure success
• EDD, MR, volume, clip site related to success
• Procedure complications: 7.8%
• Device-related adverse events: 2.7%
U.S. vs. Other Registries
• STS/ACC TVT (US)...…….
• SENTINEL (EU)….………..
• ACCESS (EU)….……...….
• TRAMI (DE)………..………
• MitraSwiss (CH)................
• France (FR)……................
• GRASP (IT)……..….…….…
• Netherlands (NL)…………
• MARS (Asia)………………
93%
95%
91%
95%
85%
88%
100%
93%
94%
MR ≤2DMR
In-hospital
death
2.3%
2.9%
2.9%
4.0%
3.3%
4.2%
Age (yrs)
83
74
74
75
77
73
72
73
71
86%
28%
23%
29%
38%
23%
24%
18%
46%
• EVEREST I………………..
• EVEREST II RCT…...….…
• EVEREST II HRS……......
71
67
76
74%
77%
86%
0.9%
1.1%
2.6%
79%
51%
30%
Conclusions
1) In this first report of the U.S. commercial experience
with TMVR, procedure success, clinical outcomes,
and adverse events were favorable in comparison to
pre-approval studies and other national registries
2) These data demonstrate effectiveness and safety of
TMVR with MitraClip for the treatment of prohibitive
risk patients with symptomatic MR
ESC/EACTS 2012 Guidelines on the Management of Valvular Heart Disease
Source: http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/valvular-heart-disease.aspx
What should I expect from a Mitraclip in DMR?• MAYBE Not a perfect result…..
• SURGERY may be essential for a 30 year old with Barlow’s disease (a perfect surgical repair IS the treatment of choice but requires a dedicated surgeon, high level of expertise and proven results)
• A (MAYBE) less than perfect result may be acceptable for a High-surgical risk patient and Mitraclip can offer a lower risk intervention with similar mortality and less morbidity