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

Treating Functional MR ? Lyon Cardiothoracic and Vascular Surgery Department Hôpital Louis Pradel LYON - France

Declaration of Interest Research grant : Abbott, Neochord Consulting : Delacroix-Chevalier, Edwards, Landanger, Medtronic, Novartis, SJM, Servier 2

Treatment Secondary / Functional Recommendations ........a percutaneous edge-to-edge procedure may be considered..... 3

MR with poor LV : Which treatment ? 4,8 % Propensity score analysis (EF < 30%) Annuloplastie-N=126 Ttt Med-N=293 Wu, Bolling et al JACC 2005

MR with poor LV : Acute mortality is low

Recurrent MR ≥ grade 2 after Downsized Annuloplasty Magne et al. Cardiology 2009;112:244

e de All-caus ath 60% P -va lue 0.002 49 ± 11% HR 3.4 a nd 95% CI 1.5-7.4 50% LVEDD >65 40% 71 ± 8.5% 30% 80 ± 5.2% 20% LVEDD 65 93 ± 3.0% 10% 0% 0 1 2 3 4 5 6 since surge Ye ar s ry at ris Patie nts k 100 87 82 60 40 27 11 Dion et al, Eur J Cardiothorac Surg. 2005 May;27(5):847-53

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%

REPAIR or REPLACEMENT - 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

Results At 1 2 m o n t h s, t h e m e a n L VE SVI a m o 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. 0 m l p e r sq u a r e m e t e r o f b o 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 o 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 o u p ( m e a n c h a n g e f r o 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 o 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 o 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 o u p ( h a z a r d r a t i o w i t h r e p a i r , 0 . 7 9 ; 9 5% c o n f i d e n c e i n t e r v a l , 0 . 4 2 t o 1 . 4 7 ; P = 0 . 4 5 b y t h e l o 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 o r d e a t h ( z sc o r e , 1 . 3 3 ; P = 0 . 1 8 ) . T h e r a t e o f m o d e r a t e o r se v e r e r e c u r r e n c e o f mitral regurgitation at 12 months was higher in the repair group t (32.6% vs. 2.3%, P<0.001) . no h a n i n t h e r e p l a c e m e n t g r o u p T h e r e w e r e significant between-group differences in the rate of a composite of major adverse c a r d i a c o r c e r e b r o v a sc u l a r events, i n functional status, o r i n quality of life a t 1 2 m o n t h s. Ac k e r , N E n g l J M e d . 2 0 1 4 J a n 2 ; 3 7 0 ( 1 ) : 2 3 - 3 2 .

614 Patients 37 Centres 307 patients 16

Mitra.fr (304 pts @ 37 centers) COAPT (610 pts @ 89 centers) NYHA II, III, or ambulatory IV II, III, or ambulatory IV Hospit for HF during 12m Other Inclusion Hospit for HF during 12m or 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 17

Mitra-fr (304 pts @ 37 centers) COAPT (610 pts @ 89 centers) Technical Implantation success 96% 98% 31 ± 10 mm 2 41 ± 15 mm 2 EROA (mean ± SD) 135 ± 35 mL/m 2 101 ± 34 mL/m 2 LVEDV (mean ± SD) variable adjustment in each group GDMT at baseline GDMT at baseline and FU per “real - world” practice 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 ≈ 23% p=NS Mortality at 1y 28% versus 22% p < 0.001 MR ≥ 2+ at BL  12m  24m 8%  17%  ? 7.4%  5.3%  0.9% 18

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

Everest II MITRA-FR Coapt Access Europ Sentinel TRAMI N=567 N=740 N=279 N=304 N = 610 Pilot N=628 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%

MR grade evolution ( paired data) Baseline Discharge 12months 100% 75% 50% 25% 0% N = 89 (P<0.001) 21

MR Severity (Core Lab) ≤1+ ≤2+ MR grade 2+ 3+ 4+ P trend P-value Baseline 3+-4+ MitraClip (n=302) - - 49.0% 51.0% - - - GDMT (n=311) - - 55.3% 44.7% - 30 days 7.4% MitraClip (n=273) 72.9% 19.8% 5.9% 1.5% 92.7% <0.001 <0.001 GDMT (n=257) 8.2% 26.1% 37.4% 28.4% 34.2% 6 months 6.3% MitraClip (n=240) 66.7% 27.1% 4.6% 1.7% 93.8% <0.001 <0.001 GDMT (n=218) 9.2% 28.9% 42.2% 19.7% 38.1% 12 months 5.3% MitraClip (n=210) 69.1% 25.7% 4.3% 1.0% 94.8% <0.001 <0.001 GDMT (n=175) 11.4% 35.4% 34.3% 18.9% 46.9% 24 months 0.9% MitraClip (n=114) 77.2% 21.9% 0% 0.9% 99.1% <0.001 <0.001 GDMT (n=76) 15.8% 27.6% 40.8% 15.8% 43.4%

2016 Cumul. Inc. of Cardiac Death Cumul . Inc. of MR ≥ 3

Two studies, two very different results

What about Mitra.fr at 2 Years ? 25

Secondary MR

Conclusion  treating secondary MR Correct LV GDMT MR++