TrattamentoTrans-catetere dell insufficienza mitralica Francesco Bedogni
Severe MR Leads to Increased Hospital Admissions and Lower Survival Rates Significantly higher hospital admissions experienced by patients with moderate to severe MR 1 Significantly lower survival rates experienced by patients with moderate to severe MR 2 HF Re-Hospitalizatio on Rate (# events / # patie ents) 20 18 16 14 12 10 8 6 4 2 0 79% Higher HF Readmission Rate 10.5 P= 0.021 18.8 No/Mild MR Moderate/Severe MR Through follow-up ~ 7 yrs (N=218 cases matched 1:1) In ptshospitalizedforhf ~ 74% hada moderate or severe MR 1 Markwick et al. Prognostic Implications of Moderate and Severe Mitral Regurgitation in Contemporary Clinical Care. TCT 2012 2 Trichon BH et al. Am J Card. 2003,91:538-43 Survival of Heart Failure Patients with MR by Degree of MR Adjusted for demographics and clinical variables at baseline Survival Probability 100% 80% 60% 40% 20% 0% No MR Mild MR (1+ or 2+) Mod/sev MR (3+ or 4+) 0 1 2 3 4 5 Years P= 0.0001 The riskofmortalityisproportionaltothe gradeof regurgitation
Survival Post-Surgery for Isolated FMR 77% at 1yr ~72% at 2yrs N = 482 Mean age = 65 yrs Prior MI = 100% Gillinov et al. J Thorac Cardiovasc Surg; 2001 Glower et al J Thoracic Cardiovasc Surg 2005
Edge-to-Edge MitraClip* Edwards Mobius Percutaneous MV Repair Device Landscape 2010-2015 2015 Coronary sinus annuloplasty Mitral valve replacement Cardiac Dimensions Carillon* Edwards Monarc* ViacorPTMA* Cerclageannuloplasty Indirect annuloplasty Ample PS3 St. Jude AAR Mycori-Coapsys Direct annuloplasty Mitralign* QuantumCor MiCardiaebCor Accucinch* ReCor(US)* Quantum Cor(RF) ValtechCardioband MicardiaenCor EndoValve CardiAQ Valtech Cardiovalve ValveXchange Tiara Chordalshortening and other Cardiosolutions Mitra-Spacer* NeoChord ValtechVChordal *in patients
MitraClipSystem
Growingadoption
Worldwide Experience Study Population N* EVEREST I (Feasibility) Feasibility patients 55 EVEREST II (Pivotal) Pre-randomized patients 60 EVEREST II (Pivotal) Non-randomized patients (High Risk Study) 78 EVEREST II (Pivotal) Randomized patients 279 (2:1 Clip to Surgery) 184 Clip 95 Surgery REALISM (Continued Access) Non-randomized patients 899 Compassionate/Emergency Use Non-randomized patients 66 ACCESS Europe Phase I Non-randomized patients 567 ACCESS Europe Phase II Non-randomized patients 286 Commercial Use Commercial patients 18,338 Total 20,533 +95 surgery *Data as of 02/28/2015. Source: Abbott Vascular
MitraClip Therapy Current Global Adoption Treating Centers Patients (clinical and commercial) Patients1 (commercial) Implant Rate1 Mixed 1. 2. 20,533 19,191 96% Functional MR Degenerative 483 MR2 65% 22% 13% First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients Etiology not inclusive of U.S. cases as of 04/14/2014
Expanding European Adoption 145 sites 20 countries United Kingdom Turkey Switzerland Sweden Spain Saudi Poland Arabia Austria Czech Republic Belgium Denmark Finland France Norway Netherlands Kuwait Italy Germany Israel Greece
Mitraclipimplantin Italy 291 GISE Dati Attività Lombardia Italia 74 620 126 122 126 291 419 122 68 102 161 204 2010 2011 2012 2013 2014
MR Etiology Degenerative MR Functional MR
Degenerative MR 85y MVP cordal roupture NYHA class III-IV BASAL 2 CLIP
Functional MR 82 y/o Ischemic CMP 25% EF ICD-CRT NYHA III-IV 3 hospitalisations in 2 months 1 year follow up: no more hospitalisations
Changing demographics
Mitraclip 2011-2013 347 pz Pazienti FMR DMR Totale 347 246 (70.8%) 101 (29.2%) <80 249 (71.7%) 208 (83.5%) 41(16.5 %) 80 98 (29.3%) 38 (38.7%) 60 (61.3%)
Evolving experience 75% considered high risk for MV surgery* * Log Euroscore >20 STSscore > 12 67% Functional MR Treating Centers: 476 Patients 1 : 19,191 Mixed 10% DMR 23% FMR 67%
What we have learned?
TRAMI Registry (Elderly) Acute Results
Mitral Regurgitation Grade * Maisano ACC 2012 N = 392 Matched Cases * As assessed by the sites Volker Rudolph EuroPCR 2012 N = 4,025 Matched Cases Percent Patients 100 80 60 40 20 0 80% MR 2+ at 6 Months p<0.0001 2+ 3+ 4+ Baseline 0 1+ 2+ 3+ 4+ 6 months 100% 80% 60% 40% 20% 0% 90% MR 2+ Post-Procedure 0+ 3+ 4+ Pre- Procedure 0+ 1+ 2+ 3+ 4+ Post- Procedure
Left Ventricular Volumes Left Ventricular End Diastolic Volume Mean = -17.9 ml 97.5% UCB = -13.5 ml p<0.0001 Left Ventricular End Systolic Volume Mean = -8.1 ml 97.5% UCB = -4.8 ml p<0.0001 Baseline 1 Year Baseline 1 Year Paired data (N=203) Paired data (N=202)
Anti Remodelling Effect of Various Therapies vs Placebo 2 % 10 20 Ace-i Beta blockers CRT Mitraclip * *vs baseline Courtesy of Michele Senni, Duino
Relation Between End Systolic Volume and Natural History Outcomes Migrino RO et al. Circulation. 1997;96:116-121 30 25 Mortality CHF Percent 20 15 10 5 0 <20 20-30 30-40 40-50 50-60 >60 End-Systolic Volume (ml/m 2 )
Functional improvement
Hospitalizations for Heart Failure 48% reduction p<0.0001 All treated
Che risultato possiamo accettare Per ottenere una adeguato successo clinico al follow-up?
Left Ventricular End Diastolic Volume Everest II High surgical risk cohort
Hospitalizations for CHF
Survival by MR Grade LIM DS et al JACC in Press
Mitraclip Long term efficacy Impact on long term mortaliy Timing of treatment
EVEREST II RCT 4-year Results Long term event free survival comparable to surgery *initial efficacy difference Source: Mauri et al JACC 2013
KM observed vs predicted survival following mitraclip therapy in FMR pts San Raffaele hospital FMR population Unpubblished data Courtesy of Francesco Maisano
J Am Coll Cardiol 2012;59:130 9
Survival Curves M.J Swans JACC Cardiovascular Intervention Vol 7 N.8 2014
Randomized trials vs OMT COAPT TRIAL RESHAPE-HF Trial Randomization 1:1 Device or Control Randomization 1:1 Device or Control DEVICE GROUP CONTROL GROUP DEVICE GROUP CONTROL GROUP MitraClip Device + Optimal Standard of Care Therapy (Device) Optimal Standard of Care Therapy (Control) MitraClip Device + Optimal Standard of Care Therapy (Device) Optimal Standard of Care Therapy (Control)
Mitraclip Long term efficacy Impact on long term mortaliy Timing of treatment
Vicious Circle Time is crucial
Robbins, Am J Cardiol 2003 Bursi, European J Heart failure 2010 Eisuke Amiya, Circ J 2006 Agricola, Eur J Heart Fail. 2009
MR:need for early diagnosis and referral
What we know from surgery Risk Factors with excess risk post-opop Symptoms LV EF LV ESD Pulm. HTN ERO LA enlargement BNP AFib.
Predictor of combined events post Mitraclip Eur J HeartFailure, Michael Neuss, 2013
Symptoms? (Franzen et al) End stage heart failure
Eur J HeartFailure, Michael Neuss, 2013
Natural history of MR
Trans-catheter Mitral Anuloplasty CARILLON CARDIOBAND
Trans-catheter Mitral Valve
CRT Mechanistic Outcomes Outcome Systolic BP (mm Hg) Inter-ventricular mechanical delay (ms) Ejection fraction (%) Left ventricular endsystolic volume (ml) Mitral regurgitation (% of LA Area) NT Pro-BNP [pg ml -1 ] Mean difference at 3 mo* at 18 mo* +5.8 +6.3 (P < 0.0001) (P < 0.0001) -21-21 (P < 0.0001) (P < 0.0001) +3.7 +6.9 (P < 0.0001) (P < 0.0001) -18.2-26.0 (P < 0.0001) (P < 0.0001) -5.1-4.2 (P < 0.0001) (P = 0.003) -225-1,122 (P = 0.36) (P = 0.0016) * Positive values indicate higher value with CRT compared to control 52