Treating Functional MR ? Lyon Cardiothoracic and Vascular Surgery - - PowerPoint PPT Presentation

Cardiothoracic and Vascular Surgery Department Hôpital Louis Pradel LYON - France

Lyon

Treating Functional MR ?

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Declaration of Interest

Research grant : Abbott, Neochord Consulting : Delacroix-Chevalier, Edwards, Landanger, Medtronic, Novartis, SJM, Servier

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Secondary / Functional Treatment Recommendations ........a percutaneous edge-to-edge procedure may be considered.....

MR with poor LV : Which treatment ?

Annuloplastie-N=126 Ttt Med-N=293

Wu, Bolling et al JACC 2005

Propensity score analysis (EF < 30%) 4,8 %

MR with poor LV : Acute mortality is low

Magne et al. Cardiology 2009;112:244

Recurrent MR ≥ grade 2 after Downsized Annuloplasty

Dion et al, Eur J Cardiothorac Surg. 2005 May;27(5):847-53

0% 10% 20% 30% 40% 50% 60% 1 2 3 4 5 6 100 87 82 60 40 27 11 Patie nts at ris k

Ye ar s since surge ry All-caus e de ath

LVEDD >65 LVEDD 65 P

• va

lue 0.002 HR 3.4 a nd 95% CI 1.5-7.4 71 ± 8.5% 49 ± 11% 93 ± 3.0% 80 ± 5.2%

2004

Freedom from recurrence of MR≥3+ in dilated Cardiomyopathy. De Bonis M. et al. Circulation 2005

• Circulation. 2007;115:782-791

• Circulation. 2007;115:782-791

MR was a PL angle 45 degrees (sensitivity 100%, specificity 97%

• Duration of CHF
• LVEDD > 65 mm
• LVESD > 51 mm
• Coaptation Distance > 10mm
• Posterior Leaflet-annular plane angle > 45°
• Distal ant Leaflet-annular plane angle > 25°
• End Syst interpapillary muscle distance > 20mm
• Systolic sphericity index > 0,7
• Symetric < Asymetric

REPAIR or REPLACEMENT

Results At 1 2 m

• n

t h s, t h e m e a n L VE SVI a m

• n

g su r v i v i n g p a t i e n t s w a s 54 . 6± 2 5. m l p e r sq u a r e m e t e r

• f

b

• d

y

• su

r f a c e a r e a i n t h e r e p a i r g r

• u

p a n d 60 . 7 ± 3 1 . 5 m l p e r sq u a r e m e t e r i n t h e r e p l a c e m e n t g r

• u

p ( m e a n c h a n g e f r

• m

b a se l i n e , ฀6. 6 a n d ฀6. 8 m l p e r sq u a r e m e t e r , r e sp e c t i v e l y ) . T h e r a t e

• f

d e a t h w a s 1 4 . 3 % i n t h e r e p a i r g r

• u

p a n d 1 7 . 6% i n t h e r e p l a c e m e n t g r

• u

p ( h a z a r d r a t i

• w i

t h r e p a i r , . 7 9 ; 9 5% c

• n

f i d e n c e i n t e r v a l , . 4 2 t

• 1

. 4 7 ; P = . 4 5 b y t h e l

• g
• r

a n k t e st ) . T h e r e w a s no significant between-group difference in LVESVI a f t e r a d j u st m e n t f

• r

d e a t h ( z sc

• r

e , 1 . 3 3 ; P = . 1 8 ) . T h e r a t e

• f

m

• d

e r a t e

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se v e r e r e c u r r e n c e

• f

mitral regurgitation at 12 months was higher in the repair group t h a n i n t h e r e p l a c e m e n t g r

• u

p (32.6% vs. 2.3%, P<0.001). T h e r e w e r e no significant between-group differences in the rate of a composite of major adverse c a r d i a c

• r

c e r e b r

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a sc u l a r events, i n functional status, o r i n quality of life a t 1 2 m

• n

t h s.

Ac k e r , N E n g l J M e d . 2 1 4 J a n 2 ; 3 7 ( 1 ) : 2 3

• 3

2 .

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37 Centres 307 patients

614 Patients

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Mitra.fr (304 pts @ 37 centers) COAPT (610 pts @ 89 centers)

NYHA II, III, or ambulatory IV II, III, or ambulatory IV Other Inclusion Hospit for HF during 12m Hospit for HF during 12m

• r BNP > 300 or NT proBNP>1500

Control arm GDMT + CRT GDMT + CRT FMR Grade EROA>20mm2 or R.vol 30ml 3+ or EROA>30mm2 or R.vol>45ml EF 15 to 40% 20 to 50% EDD

• < 70 mm

Primary End point Death + Hospitalization for HF at 12 m All Hospitalization for HF at 24 m GDMT at baseline and FU “real-world” practice GDMT at baseline few changes during FU

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Mitra-fr (304 pts @ 37 centers) COAPT (610 pts @ 89 centers) Technical Implantation success 96% 98% EROA (mean ± SD) 31 ± 10 mm2 41 ± 15 mm2 LVEDV (mean ± SD) 135 ± 35 mL/m2 101 ± 34 mL/m2 GDMT at baseline and FU variable adjustment in each group per “real-world” practice GDMT at baseline few major changes during FU Different Primary Endpoints 54,6% /51.3% p=NS at 12m 151 of 283 / 92 of 160 at 24m p<0.001 Mortality at 1y

≈ 23% p=NS

28% versus 22% p < 0.001 MR ≥ 2+ at BL  12m  24m 8%  17%  ? 7.4%  5.3%  0.9%

Safety/ Periprocedural Complications

Conversion to surgery within 1 year: 3.4% 30 day mortality: 2.3% Conversion to surgery within 1 year: 3.9% 30 day mortality: 3.3% Every peri-procedural complication : 14.6%

Everest II N=279 MITRA-FR N=304 Coapt N = 610

Access Europ N=567

Sentinel Pilot N=628

TRAMI N=740

Secondary MR 27% 100% 100 % 77% 72% 71% Mean Age 67y 70y 72y 74y 74y 76y Mean EF 60 % 33 % 31 % NA 43% NA Procedural success 77% 94% 96% 91% 95% 97% 30 days Mortality 1% 2.3 % 3.4% NA 4.5% 1 year Follow-up 73% > 99% > 95% NA NA NA 1y NYHA I/II 98% 72% 71% 74% 63% 1y MR Grade III/IV 18% 17 % 5 % 21.1% NA NA 1 y Mortality 6.1 % 24.3 % 22% - 28% 17.3% 15.3% 20.3% 1 y Hospit for HF NA 48.7 % NA NA 34%

21 N = 89 (P<0.001)

MR grade evolution (paired data)

100% 75% 50% 25% 0% Baseline Discharge 12months

MR Severity (Core Lab)

MR grade ≤1+ 2+ 3+ 4+ Ptrend ≤2+ P-value Baseline MitraClip (n=302)

• 49.0%

51.0%

• GDMT (n=311)
• 55.3%

44.7%

• 30 days

MitraClip (n=273) 72.9% 19.8% 5.9% 1.5% <0.001 92.7% <0.001 GDMT (n=257) 8.2% 26.1% 37.4% 28.4% 34.2% 6 months MitraClip (n=240) 66.7% 27.1% 4.6% 1.7% <0.001 93.8% <0.001 GDMT (n=218) 9.2% 28.9% 42.2% 19.7% 38.1% 12 months MitraClip (n=210) 69.1% 25.7% 4.3% 1.0% <0.001 94.8% <0.001 GDMT (n=175) 11.4% 35.4% 34.3% 18.9% 46.9% 24 months MitraClip (n=114) 77.2% 21.9% 0% 0.9% <0.001 99.1% <0.001 GDMT (n=76) 15.8% 27.6% 40.8% 15.8% 43.4% 3+-4+ 6.3% 5.3% 0.9% 7.4%

• Cumul. Inc. of Cardiac Death
• Cumul. Inc. of MR ≥ 3

2016

Two studies, two very different results

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What about Mitra.fr at 2 Years ?

Secondary MR

Conclusion  treating secondary MR

Correct LV MR++

GDMT