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